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Good Data? $100. Good Product Development? $100. Good Commercialization Strategy? Priceless.

♫ Sunday, August 14th, 2011

I'm not going to fool anyone into believing I'm a therapeutic product development expert but that's not going to stop me from making a few humble observations in light of the Dendreon "fiasco" of last week which I have no doubt will one day be considered an unfortunate pothole on their road to eventual success.

(though perhaps not before certain current management finds themselves polishing their CVs or retiring to spend their time alternating between their yachts and the courtroom defending their questionable stock trading antics)

I received the following message this morning by email. I don't include it here to promote or endorse or even comment on NWBT, DCVax, Linda Powers, or Toucan Capital in any way -- or in a way that is blind to all the things right or wrong about any of them -- but simply to illustrate the 3 points I want to make below the email.
NWBT HIGHLIGHTS COST EFFECTIVENESS OF DCVAX® IN VIEW OF RECENT IMMUNOTHERAPY PRICING CONCERNS

Northwest Biotherapeutics' (OTC.BB: NWBO)... DCVax® immune therapies for a broad range of cancers (including prostate, brain, ovarian and others) hold the promise, based on available data to date, of being cost effective and priced below other immune therapies while still providing substantial profit margins for the Company and longer survival for patients.

The investor concerns in the news relate to the pricing and reimbursement of Provenge for late stage, metastatic prostate cancer. Provenge is priced at $93,000 for one month of treatment and was approved by the FDA based upon having added 4.5 months of patient survival (to reach overall survival of 25.9 months).

NWBT’s DCVax® will be priced in the range of $37,000 per year for up to 3 years of treatments. In NWBT’s Phase I/II multi-center clinical trial in late stage, metastatic prostate cancer, DCVax® added 18 months of patient survival (to reach overall survival of 38.7 months). DCVax® has previously been cleared by the FDA for a 612-patient, randomized, controlled Phase III trial, although the trial has not yet begun. As is typical before a Phase III trial, the manufacturing processes and product costs have already been determined.
...
...

The key to the substantial pricing advantage of DCVax® is NWBT’s proprietary batch manufacturing process together with its cryopreservation technology for frozen storage of the finished vaccine. NWBT has spent a decade developing and improving its manufacturing and cryopreservation processes. The manufacturing of personalized, living cell products is expensive. But the frozen storage of living cells is quite low-cost – once the specialized freezing technology is worked out for a particular type of cells (the culture conditions, rate of freezing, density of cells and many other factors).

NWBT’s manufacturing methods produce – in a single manufacturing run – a large batch of personalized DCVax® product for 3 years of treatments are much less costly than separate manufacturing runs for each treatment. The technology for freezing the master immune cells (dendritic cells) which comprise DCVax® enables these
cells to remain frozen for years and, when needed, to be thawed and “come back to life” with full potency.

This approach makes DCVax® an "off the shelf” product [for that patient] for several years of treatments after just one manufacturing run. In contrast, Dendreon must do a separate manufacturing run for each one month of treatments. In addition, Dendreon's Provenge product is fresh and not cryopreserved, which limits its shelf life to at most a few weeks.

Another important factor in the cost effectiveness of DCVax® is its simplicity and ease of administration. DCVax® is delivered as a small intra-dermal injection under the skin, similar to a flu shot. As such, it can be administered in any physician’s office or clinic. There is no lengthy intravenous infusion, with the attendant patient discomfort, cost and need for a specialty infusion center. In contrast, Dendreon’s Provenge is delivered by intravenous infusion.

The cost effectiveness of NWBT’s DCVax® is enhanced by the fact that DCVax® is targeting a portion of the prostate cancer market that is 4 times the size of the market segment that Dendreon’s Provenge is currently targeting....

Now this is NWBT clearly blowing their horn - nothing wrong with that - in an attempt to woo back frightened investors. I'm agnostic as to whether any of it is true but it does serve to draw out several points of distinction between what some companies might do to optimize their products for commercial success versus what others might do in an overriding belief that clinical benefit is the only precursor to the happiness of investors, the physician community, patients, and partners.
What I say below is not a commentary, in criticism or praise, on any particular company including NWBT or Dendreon. Many others - Luke Timmerman among the best of them - have provided outstanding and in-depth analysis of the Dendreon story along the way.
I'm only interested in what we as an industry might learn from recent experiences or trends and to perhaps facilitate a useful discussion based on 3 simple observations from someone who has swum in this cell therapy pond for now just over a decade:
1. There is a tendency among some to believe that what we are making (cell-based therapies) are so revolutionary and compelling that the products should almost sell themselves - to investors, partners, regulators, insurers, physicians, and patients.
Of course we know it's not true but sometime we act like it is.
Appligraf and Dermagraft didn't sell themselves to physicians even after regulatory approval. Neither is Provenge apparently-- though they did a good job of selling it to very vocal patient groups. Organogenesis and Advanced Biohealing had to work very long and hard to get profitable reimbursement and market penetration. Dendreon will too.
Investing early in understanding potential clinical adoption hurdles, reimbursement issues, and how the product is and will be perceived not by its champions but by its critics and most importantly, the average agnostic practitioner, is not easy to do because it means spending precious resources long before there is a product to sell but it may mean the difference between a product which eventually sells and one which doesn't.
2. There is a tendency to de-emphasize what I call the "ancillary sciences" around a product -- like lowering the cost of goods, optimizing fresh or frozen storage, cell delivery (e.g., injection/application science) mechanisms, in vivo cell tracking, onsite clinical handling, etc.
Product development science is a science. The science that turns good data into something commercially viable. Not everyone is good at it and certainly this is where a lot of companies fail. PD is not the 'second cousin' in the room of esteemed basic and clinical science.
Take these examples when considering the cellular immunotherapy sector:
Several prominent immunotherapy investigators I have spoken with strongly believe cell-based immunotherapies will require long-term administration to be meaningfully effective -- certainly longer than 3 doses in 3 months. Did Dendreon lock into their clinical protocol too early?
Other immunotherapy companies - like Opexa Therapeutics for instance - create multiple doses for a patient from a single patient collection thus saving considerable expense and creating a better patient experience. Did Dendreon lock into their manufacturing protocol too early?
Other companies are investing heavily in finding ways to extend viable shelf-life of their fresh products or to create cryopreserved versions of their product to optimize its commercial viability.
Imagine a Dendreon that only had to build one manufacturing facility (with a backup CMO) to serve the US market rather than 3 facilities. With a cryopreserved version of the product or a version that had longer than its current limited shelf-life (~72 hours I believe?) that might have been possible.
At every point in clinical development there must be concurrent R&D towards the product's:
  1. science (e.g., MOA, characterization, etc),
  2. clinical effect, and
  3. how to optimize its commercial viability - a big part of which is what we think of as 'product development'.
This is the 3-legged footstool of a commercialization strategy geared for success (credit to Bob Preti of Progenitor Cell Therapy for this analogy).
But 'product development' is also not always about the product strictly speaking and even an expansive definition of product development is only part of a good commercialization strategy.
There is significant component of it that is about studying ways to lower the cost of goods, improving manufacturability and scalability, how hard/easy it is to handle, the patient treatment experience, the physician experience, how it impacts patient's QOL (quality of life), not just what side effects it generates but what side effects it prevents (resulting from other treatments or no treatment) and the cost-savings that generates, etc.
Other cell therapy companies have been more proactive in terms of engaging not only KOLs but average practitioners in a meaningful way that might impact their product and clinical design as well as reimbursement and clinical delivery issues.
3. There is an understandable, largely VC-driven, desire to race forward to the next trial phase when a phase-repeat to optimize or better understand different aspects of the product might be the better way to go.

What's worse? Facing the prospect of not being able to get funding or a partner on the terms one wants for a 2nd phase II or burning through a bunch more money in phase III in an attempt to bring a product to market that isn't market ready? I understand its a tough choice -I'm not saying it's an easy one - but one is certainly more strategic and, as pharma says, is certainly a "de-risking" pathway.
Consider the ratio of products we've seen thus far in the cell therapy industry's short life-span that have been raced to phase III or (worse yet) market only to seriously stumble if not fail when they get there. I can think of 8-10 off the top of my head and there are less than 20 cell or tissue based therapies on the market in US/EU that have received any kind of formal regulatory approval.
Some would argue that this is a prime example of why spinning companies out of academia too early is not beneficial because companies want to minimize exploratory science and lock into a "product" too early. I would argue that this may be true if the problem is understanding the product characterization or mechanism of action but not if your problem is related to how best to develop/optimize the product for commercial viability. Few academics are geared to think this way.
Summary
I certainly don't believe Dendreon failed to identify or consider each and every one of the things they might have done better along the way. I'm sure they did and sure they made calculated judgement-calls about how to approach each one.
Since I'm not a shareholder I don't have to worry myself about being critical of their decisions but rather simply to do what I can to ensure that we as an industry do our best to learn from what - with the benefit of retrospect - may be apparent they did right and wrong.
What are your thoughts? To what extent are the problems that Dendreon has experienced along the way with PROVENGE a predicable result of it being a first-generation product or the result of insufficient focus on critical investigation into the less sexy "ancillary sciences" of product and commercial optimization?
(comment below and/or in the LinkedIn Cell Therapy Industry Group)



http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
Read More...

♫ Posted in Regenerative Medicine | | Comments Off»

Good Data? $100. Good Product Development? $100. Good Commercialization Strategy? Priceless.

♫ Sunday, August 14th, 2011

I'm not going to fool anyone into believing I'm a therapeutic product development expert but that's not going to stop me from making a few humble observations in light of the Dendreon "fiasco" of last week which I have no doubt will one day be considered an unfortunate pothole on their road to eventual success.

(though perhaps not before certain current management finds themselves polishing their CVs or retiring to spend their time alternating between their yachts and the courtroom defending their questionable stock trading antics)

I received the following message this morning by email. I don't include it here to promote or endorse or even comment on NWBT, DCVax, Linda Powers, or Toucan Capital in any way -- or in a way that is blind to all the things right or wrong about any of them -- but simply to illustrate the 3 points I want to make below the email.
NWBT HIGHLIGHTS COST EFFECTIVENESS OF DCVAX® IN VIEW OF RECENT IMMUNOTHERAPY PRICING CONCERNS

Northwest Biotherapeutics' (OTC.BB: NWBO)... DCVax® immune therapies for a broad range of cancers (including prostate, brain, ovarian and others) hold the promise, based on available data to date, of being cost effective and priced below other immune therapies while still providing substantial profit margins for the Company and longer survival for patients.

The investor concerns in the news relate to the pricing and reimbursement of Provenge for late stage, metastatic prostate cancer. Provenge is priced at $93,000 for one month of treatment and was approved by the FDA based upon having added 4.5 months of patient survival (to reach overall survival of 25.9 months).

NWBT’s DCVax® will be priced in the range of $37,000 per year for up to 3 years of treatments. In NWBT’s Phase I/II multi-center clinical trial in late stage, metastatic prostate cancer, DCVax® added 18 months of patient survival (to reach overall survival of 38.7 months). DCVax® has previously been cleared by the FDA for a 612-patient, randomized, controlled Phase III trial, although the trial has not yet begun. As is typical before a Phase III trial, the manufacturing processes and product costs have already been determined.
...
...

The key to the substantial pricing advantage of DCVax® is NWBT’s proprietary batch manufacturing process together with its cryopreservation technology for frozen storage of the finished vaccine. NWBT has spent a decade developing and improving its manufacturing and cryopreservation processes. The manufacturing of personalized, living cell products is expensive. But the frozen storage of living cells is quite low-cost – once the specialized freezing technology is worked out for a particular type of cells (the culture conditions, rate of freezing, density of cells and many other factors).

NWBT’s manufacturing methods produce – in a single manufacturing run – a large batch of personalized DCVax® product for 3 years of treatments are much less costly than separate manufacturing runs for each treatment. The technology for freezing the master immune cells (dendritic cells) which comprise DCVax® enables these
cells to remain frozen for years and, when needed, to be thawed and “come back to life” with full potency.

This approach makes DCVax® an "off the shelf” product [for that patient] for several years of treatments after just one manufacturing run. In contrast, Dendreon must do a separate manufacturing run for each one month of treatments. In addition, Dendreon's Provenge product is fresh and not cryopreserved, which limits its shelf life to at most a few weeks.

Another important factor in the cost effectiveness of DCVax® is its simplicity and ease of administration. DCVax® is delivered as a small intra-dermal injection under the skin, similar to a flu shot. As such, it can be administered in any physician’s office or clinic. There is no lengthy intravenous infusion, with the attendant patient discomfort, cost and need for a specialty infusion center. In contrast, Dendreon’s Provenge is delivered by intravenous infusion.

The cost effectiveness of NWBT’s DCVax® is enhanced by the fact that DCVax® is targeting a portion of the prostate cancer market that is 4 times the size of the market segment that Dendreon’s Provenge is currently targeting....

Now this is NWBT clearly blowing their horn - nothing wrong with that - in an attempt to woo back frightened investors. I'm agnostic as to whether any of it is true but it does serve to draw out several points of distinction between what some companies might do to optimize their products for commercial success versus what others might do in an overriding belief that clinical benefit is the only precursor to the happiness of investors, the physician community, patients, and partners.
What I say below is not a commentary, in criticism or praise, on any particular company including NWBT or Dendreon. Many others - Luke Timmerman among the best of them - have provided outstanding and in-depth analysis of the Dendreon story along the way.
I'm only interested in what we as an industry might learn from recent experiences or trends and to perhaps facilitate a useful discussion based on 3 simple observations from someone who has swum in this cell therapy pond for now just over a decade:
1. There is a tendency among some to believe that what we are making (cell-based therapies) are so revolutionary and compelling that the products should almost sell themselves - to investors, partners, regulators, insurers, physicians, and patients.
Of course we know it's not true but sometime we act like it is.
Appligraf and Dermagraft didn't sell themselves to physicians even after regulatory approval. Neither is Provenge apparently-- though they did a good job of selling it to very vocal patient groups. Organogenesis and Advanced Biohealing had to work very long and hard to get profitable reimbursement and market penetration. Dendreon will too.
Investing early in understanding potential clinical adoption hurdles, reimbursement issues, and how the product is and will be perceived not by its champions but by its critics and most importantly, the average agnostic practitioner, is not easy to do because it means spending precious resources long before there is a product to sell but it may mean the difference between a product which eventually sells and one which doesn't.
2. There is a tendency to de-emphasize what I call the "ancillary sciences" around a product -- like lowering the cost of goods, optimizing fresh or frozen storage, cell delivery (e.g., injection/application science) mechanisms, in vivo cell tracking, onsite clinical handling, etc.
Product development science is a science. The science that turns good data into something commercially viable. Not everyone is good at it and certainly this is where a lot of companies fail. PD is not the 'second cousin' in the room of esteemed basic and clinical science.
Take these examples when considering the cellular immunotherapy sector:
Several prominent immunotherapy investigators I have spoken with strongly believe cell-based immunotherapies will require long-term administration to be meaningfully effective -- certainly longer than 3 doses in 3 months. Did Dendreon lock into their clinical protocol too early?
Other immunotherapy companies - like Opexa Therapeutics for instance - create multiple doses for a patient from a single patient collection thus saving considerable expense and creating a better patient experience. Did Dendreon lock into their manufacturing protocol too early?
Other companies are investing heavily in finding ways to extend viable shelf-life of their fresh products or to create cryopreserved versions of their product to optimize its commercial viability.
Imagine a Dendreon that only had to build one manufacturing facility (with a backup CMO) to serve the US market rather than 3 facilities. With a cryopreserved version of the product or a version that had longer than its current limited shelf-life (~72 hours I believe?) that might have been possible.
At every point in clinical development there must be concurrent R&D towards the product's:
  1. science (e.g., MOA, characterization, etc),
  2. clinical effect, and
  3. how to optimize its commercial viability - a big part of which is what we think of as 'product development'.
This is the 3-legged footstool of a commercialization strategy geared for success (credit to Bob Preti of Progenitor Cell Therapy for this analogy).
But 'product development' is also not always about the product strictly speaking and even an expansive definition of product development is only part of a good commercialization strategy.
There is significant component of it that is about studying ways to lower the cost of goods, improving manufacturability and scalability, how hard/easy it is to handle, the patient treatment experience, the physician experience, how it impacts patient's QOL (quality of life), not just what side effects it generates but what side effects it prevents (resulting from other treatments or no treatment) and the cost-savings that generates, etc.
Other cell therapy companies have been more proactive in terms of engaging not only KOLs but average practitioners in a meaningful way that might impact their product and clinical design as well as reimbursement and clinical delivery issues.
3. There is an understandable, largely VC-driven, desire to race forward to the next trial phase when a phase-repeat to optimize or better understand different aspects of the product might be the better way to go.

What's worse? Facing the prospect of not being able to get funding or a partner on the terms one wants for a 2nd phase II or burning through a bunch more money in phase III in an attempt to bring a product to market that isn't market ready? I understand its a tough choice -I'm not saying it's an easy one - but one is certainly more strategic and, as pharma says, is certainly a "de-risking" pathway.
Consider the ratio of products we've seen thus far in the cell therapy industry's short life-span that have been raced to phase III or (worse yet) market only to seriously stumble if not fail when they get there. I can think of 8-10 off the top of my head and there are less than 20 cell or tissue based therapies on the market in US/EU that have received any kind of formal regulatory approval.
Some would argue that this is a prime example of why spinning companies out of academia too early is not beneficial because companies want to minimize exploratory science and lock into a "product" too early. I would argue that this may be true if the problem is understanding the product characterization or mechanism of action but not if your problem is related to how best to develop/optimize the product for commercial viability. Few academics are geared to think this way.
Summary
I certainly don't believe Dendreon failed to identify or consider each and every one of the things they might have done better along the way. I'm sure they did and sure they made calculated judgement-calls about how to approach each one.
Since I'm not a shareholder I don't have to worry myself about being critical of their decisions but rather simply to do what I can to ensure that we as an industry do our best to learn from what - with the benefit of retrospect - may be apparent they did right and wrong.
What are your thoughts? To what extent are the problems that Dendreon has experienced along the way with PROVENGE a predicable result of it being a first-generation product or the result of insufficient focus on critical investigation into the less sexy "ancillary sciences" of product and commercial optimization?
(comment below and/or in the LinkedIn Cell Therapy Industry Group)



http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
Read More...

♫ Posted in Regenerative Medicine | | Comments Off»

Clinical trial costs

♫ Sunday, July 31st, 2011
Based on a survey* of 21 drug makers, 12 biotechs, nine device makers and 23 contract research organizations, PharmaLot has recently published the following metrics for current clinical trial costs (see full article here)
Average per-patient trial costs across all therapeutic areas:
Phase I: $21,883
Phase II: $36,070
Phase IIIa: $47,523
Phase IIIb: $47,095
Phase IV: $17,042
Average cost per patient for a cardiovascular trial:
Phase II: $33,700
Phase IIIa: $21,750
Phase IIIb: $6,830
In oncology, the average per patient trial cost:
Phase II: $73,303
Phase IIIa: $57,207
Phase IIIb: $65,900
For central nervous system disorders:
Phase II: $28,197
Phase IIIa: $33,768
Phase IIIb: $41,824
For diabetes:
Phase II: $ 8,854
Phase IIIa: $12,667
Phase IIIb: $10,700
Anyone have any thoughts or data as to how this compares to cell therapy trials?
--Lee
*survey conducted by Cutting Edge Information.
http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
Read More...

♫ Posted in Regenerative Medicine | | Comments Off»

Clinical trial costs

♫ Sunday, July 31st, 2011
Based on a survey* of 21 drug makers, 12 biotechs, nine device makers and 23 contract research organizations, PharmaLot has recently published the following metrics for current clinical trial costs (see full article here)
Average per-patient trial costs across all therapeutic areas:
Phase I: $21,883
Phase II: $36,070
Phase IIIa: $47,523
Phase IIIb: $47,095
Phase IV: $17,042
Average cost per patient for a cardiovascular trial:
Phase II: $33,700
Phase IIIa: $21,750
Phase IIIb: $6,830
In oncology, the average per patient trial cost:
Phase II: $73,303
Phase IIIa: $57,207
Phase IIIb: $65,900
For central nervous system disorders:
Phase II: $28,197
Phase IIIa: $33,768
Phase IIIb: $41,824
For diabetes:
Phase II: $ 8,854
Phase IIIa: $12,667
Phase IIIb: $10,700
Anyone have any thoughts or data as to how this compares to cell therapy trials?
--Lee
*survey conducted by Cutting Edge Information.
http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
Read More...

♫ Posted in Regenerative Medicine | | Comments Off»

Cell Therapy’s Got Talent Technology Showcase – A Call for Cell Therapy Manufacturing Technology Presentations

♫ Sunday, July 10th, 2011


in collaboration with:

In an effort to showcase the latest technologies driving the production of cell therapies, the Cell Therapy Group and Informa Life Sciences are proud to announce the introduction of the "Technology Showcase" session and award to be held in conjunction with Informa's Cell Therapy Manufacturing conference to be held 30 November to 1 December 2011 in Brussels Belgium.

Having held the same conference last year in London, Informa is committed to building on the success of last year's event by continuing to create a meaningful European forum for the issues related to the clinical and particularly commercial-scale production of cell-based therapies.

The Technology Showcase session, taking place on the main agenda, will feature 6 x 10 minute presentations from innovative companies developing cutting-edge technologies in the field of cell therapy manufacturing, and is particularly relevant to SME and academic groups with limited marketing resources.

All presentations will be reviewed by the Scientific Advisory Board with the winner announced at the end of the session. Exposure on BioProcess International's website is also included.

Technologies we'd like to promote include:

  • Manufacturing systems including bioreactor technologies
  • Cell harvest/collection technologies
  • Cell storage/logistics technologies
  • Clinical cell delivery and/or other point-of-care technologies
  • Automation technologies
  • Cell separation system
  • Cell process devices
  • Innovative reagents, scaffolds, matrices, and other “ancillary” tools
  • Technologies to close currently open systems
  • Suspension-based production systems
  • Disposable technologies

How to apply:

To apply to present companies must submit an abstract (<300 words) to daniel.barry@informa.com and lbuckler@celltherapygroup.com outlining the product or service to be presented and why it is a critical technology related to cell therapy manufacturing.

The deadline for applications is SEPTEMBER 15 2011 - Priority given to early submissions

    The cost of taking part in the Technology Showcase is £2,700 which includes the following benefits:

    • 1 x 2-day conference pass (normal price £1,599)
    • 10-minute podium presentation within main conference room
    • 1 poster display in the Exhibition Hall
    • Marketing - company logo displayed on website and event guide
    • Exposure in BPI Magazine

    Terms and conditions:

    To be eligible the product or service to be presented must be:

    • On the market for no less than 2 years or expected to be on the market no later than Q4 2012
    • Appropriate for, applicable to, and compliant with clinical-grade manufacturing requirements (technologies only available for research use will not be considered)

    Plus...

    • The company must have no more than 15 employees
    • The company has been running for no more than 5 years, and
    • The company generates annual revenue of no more than $5m

    For further information please contact: daniel.barry@informa.com or lbuckler@celltherapygroup.com

    http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
    Read More...

    ♫ Posted in Regenerative Medicine | | Comments Off»

    Cell Therapy’s Got Talent Technology Showcase – A Call for Cell Therapy Manufacturing Technology Presentations

    ♫ Sunday, July 10th, 2011


    in collaboration with:

    In an effort to showcase the latest technologies driving the production of cell therapies, the Cell Therapy Group and Informa Life Sciences are proud to announce the introduction of the "Technology Showcase" session and award to be held in conjunction with Informa's Cell Therapy Manufacturing conference to be held 30 November to 1 December 2011 in Brussels Belgium.

    Having held the same conference last year in London, Informa is committed to building on the success of last year's event by continuing to create a meaningful European forum for the issues related to the clinical and particularly commercial-scale production of cell-based therapies.

    The Technology Showcase session, taking place on the main agenda, will feature 6 x 10 minute presentations from innovative companies developing cutting-edge technologies in the field of cell therapy manufacturing, and is particularly relevant to SME and academic groups with limited marketing resources.

    All presentations will be reviewed by the Scientific Advisory Board with the winner announced at the end of the session. Exposure on BioProcess International's website is also included.

    Technologies we'd like to promote include:

    • Manufacturing systems including bioreactor technologies
    • Cell harvest/collection technologies
    • Cell storage/logistics technologies
    • Clinical cell delivery and/or other point-of-care technologies
    • Automation technologies
    • Cell separation system
    • Cell process devices
    • Innovative reagents, scaffolds, matrices, and other “ancillary” tools
    • Technologies to close currently open systems
    • Suspension-based production systems
    • Disposable technologies

    How to apply:

    To apply to present companies must submit an abstract (<300 words) to daniel.barry@informa.com and lbuckler@celltherapygroup.com outlining the product or service to be presented and why it is a critical technology related to cell therapy manufacturing.

    The deadline for applications is SEPTEMBER 15 2011 - Priority given to early submissions

      The cost of taking part in the Technology Showcase is £2,700 which includes the following benefits:

      • 1 x 2-day conference pass (normal price £1,599)
      • 10-minute podium presentation within main conference room
      • 1 poster display in the Exhibition Hall
      • Marketing - company logo displayed on website and event guide
      • Exposure in BPI Magazine

      Terms and conditions:

      To be eligible the product or service to be presented must be:

      • On the market for no less than 2 years or expected to be on the market no later than Q4 2012
      • Appropriate for, applicable to, and compliant with clinical-grade manufacturing requirements (technologies only available for research use will not be considered)

      Plus...

      • The company must have no more than 15 employees
      • The company has been running for no more than 5 years, and
      • The company generates annual revenue of no more than $5m

      For further information please contact: daniel.barry@informa.com or lbuckler@celltherapygroup.com

      http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
      Read More...

      ♫ Posted in Regenerative Medicine | | Comments Off»

      In vivo cell trafficking just took a leap forward

      ♫ Sunday, July 3rd, 2011


      Today Celsense, Inc. and the University of Pittsburgh Cancer Center announced that the FDA has authorized the use of the Cell Sense imaging reagent for use in a phase I clinical trial of a dendritic cell caccine to treat colorectal cancer patients.

      This is the first FDA authorization of the use of Cell Sense in patients. Cell Sense is a novel perfluorocarbon tracer agent used to safely and efficiently label cells ex vivo without the use of transfection agents. Labeled cells are then transplanted into the patient enabling researchers and clinicians to non-invasively track the administration and migration of therapeutic cells using MRI. Applications include tracking cells in immunotherapy or regenerative medicine as well as the diagnosis of inflammatory sites by tracking selected populations of immune cells.

      Cell Sense has been studied extensively in preclinical testing with many different human cell types including human cells in animals. For instance, in 2009 a paper was published in Informa's Cytotherapy, in which Celsense’s novel perfluorocarbon tracer agent (product “Cell Sense”) was used to label human DCs ex vivo for the purpose of tracking the cells in vivo post-transplant by 19F MRI. The paper provided an assessment of the technology and demonstrated that human DCs were effectively labeled without significant impact on cell viability, phenotype or function. Furthermore, the labeled dendritic cells were clearly detected in vivo by 19F MRI in a model system, with the labeled cells being shown to migrate selectively towards draining lymph node regions within 18 hours after transplant.

      Many investigators looking at various ways to label cells to enable in vivo imaging have expressed concern that the FDA would delay the regulatory progress of their therapeutic candidates if an imaging modality was introduced.

      This concern is based on numerous reports of MRI contrast reagents, such as the commonly investigated USPIO (ultrasmall superparamagnet iron oxide), deleteriously affecting the cells (see recent paper in Cell Transplantation).

      "We believe that the authorization of this IND will alleviate such concerns and lower the barriers for adoption. The agency’s tangible support for bringing new technologies to bear in the translation of cell-based therapeutics is very encouraging,” s Charlie O'Hanlon, President and CEO of Celsense.

      While there have been approved uses of imaging reagents (e.g., Feridex, etc) with cell therapies in other countries (e.g. Isreal), I believe this may be the first FDA-sanctioned use of a particle-based imaging label with a cell-based therapy. Other approaches to cellular imaging include nuclear imaging reagents and genetically modifying cells with reporter genes such as those provided by CellSight Technologies.

      Imaging labels are capable of providing investigators with data demonstrating where the cells go, at what volumes, and for how long they stay at the target location.

      The industry has been keen to see these kinds of technologies clinically employed but different cell-based labels have created their own technical, clinical, and/or regulatory hurdles. I'm hopeful that Celsense and others like them are now ushering us into a new era where we will eventually be able to use various technologies to monitor and collect valuable data concerning cells after they have been administered as a therapy to a patients.

      Additional resources on the topic of imaging for cell therapies:

      CIRM recently hosted a webinar - "CIRM/RMC Webinar: Imaging Technology for Cellular Therapies. One of the speakers, Dr. Shahriar Yaghoubi from CellSight Technologies, provides an overview of cell therapy imaging with emphasis on PET. Click hear for the archived playback.

      A very interesting article posted today on Harvard's StemBook website. "In-vivo Stem Cell Imaging - Regulatory Challenges and Advances". Nice overview intel from J. Bulte and a snapshot into E. Wirth's (of Geron) perspective re: stem cell imaging.

      A new book from CRC Press edited by Dara Kraitchman and Joe Wu will be out soon. It gathers together different methods for comparison. The issue will remain the sensitivity of the methods to track few cells. "Stem Cell Labeling for Delivery and Tracking Using Non-Invasive Imaging".

      MRI contrast agents can change stem cell proliferation

      There s also a very informative discussion thread on the topic in the Cell Therapy Industry group on LinkedIn.

      http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
      Read More...

      ♫ Posted in Regenerative Medicine | | Comments Off»

      In vivo cell trafficking just took a leap forward

      ♫ Sunday, July 3rd, 2011


      Today Celsense, Inc. and the University of Pittsburgh Cancer Center announced that the FDA has authorized the use of the Cell Sense imaging reagent for use in a phase I clinical trial of a dendritic cell caccine to treat colorectal cancer patients.

      This is the first FDA authorization of the use of Cell Sense in patients. Cell Sense is a novel perfluorocarbon tracer agent used to safely and efficiently label cells ex vivo without the use of transfection agents. Labeled cells are then transplanted into the patient enabling researchers and clinicians to non-invasively track the administration and migration of therapeutic cells using MRI. Applications include tracking cells in immunotherapy or regenerative medicine as well as the diagnosis of inflammatory sites by tracking selected populations of immune cells.

      Cell Sense has been studied extensively in preclinical testing with many different human cell types including human cells in animals. For instance, in 2009 a paper was published in Informa's Cytotherapy, in which Celsense’s novel perfluorocarbon tracer agent (product “Cell Sense”) was used to label human DCs ex vivo for the purpose of tracking the cells in vivo post-transplant by 19F MRI. The paper provided an assessment of the technology and demonstrated that human DCs were effectively labeled without significant impact on cell viability, phenotype or function. Furthermore, the labeled dendritic cells were clearly detected in vivo by 19F MRI in a model system, with the labeled cells being shown to migrate selectively towards draining lymph node regions within 18 hours after transplant.

      Many investigators looking at various ways to label cells to enable in vivo imaging have expressed concern that the FDA would delay the regulatory progress of their therapeutic candidates if an imaging modality was introduced.

      This concern is based on numerous reports of MRI contrast reagents, such as the commonly investigated USPIO (ultrasmall superparamagnet iron oxide), deleteriously affecting the cells (see recent paper in Cell Transplantation).

      "We believe that the authorization of this IND will alleviate such concerns and lower the barriers for adoption. The agency’s tangible support for bringing new technologies to bear in the translation of cell-based therapeutics is very encouraging,” s Charlie O'Hanlon, President and CEO of Celsense.

      While there have been approved uses of imaging reagents (e.g., Feridex, etc) with cell therapies in other countries (e.g. Isreal), I believe this may be the first FDA-sanctioned use of a particle-based imaging label with a cell-based therapy. Other approaches to cellular imaging include nuclear imaging reagents and genetically modifying cells with reporter genes such as those provided by CellSight Technologies.

      Imaging labels are capable of providing investigators with data demonstrating where the cells go, at what volumes, and for how long they stay at the target location.

      The industry has been keen to see these kinds of technologies clinically employed but different cell-based labels have created their own technical, clinical, and/or regulatory hurdles. I'm hopeful that Celsense and others like them are now ushering us into a new era where we will eventually be able to use various technologies to monitor and collect valuable data concerning cells after they have been administered as a therapy to a patients.

      Additional resources on the topic of imaging for cell therapies:

      CIRM recently hosted a webinar - "CIRM/RMC Webinar: Imaging Technology for Cellular Therapies. One of the speakers, Dr. Shahriar Yaghoubi from CellSight Technologies, provides an overview of cell therapy imaging with emphasis on PET. Click hear for the archived playback.

      A very interesting article posted today on Harvard's StemBook website. "In-vivo Stem Cell Imaging - Regulatory Challenges and Advances". Nice overview intel from J. Bulte and a snapshot into E. Wirth's (of Geron) perspective re: stem cell imaging.

      A new book from CRC Press edited by Dara Kraitchman and Joe Wu will be out soon. It gathers together different methods for comparison. The issue will remain the sensitivity of the methods to track few cells. "Stem Cell Labeling for Delivery and Tracking Using Non-Invasive Imaging".

      MRI contrast agents can change stem cell proliferation

      There s also a very informative discussion thread on the topic in the Cell Therapy Industry group on LinkedIn.

      http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
      Read More...

      ♫ Posted in Regenerative Medicine | | Comments Off»

      Cell Therapies: Commercializing a New Class of Biopharmaceuticals

      ♫ Monday, February 14th, 2011


      Over the past six months I have been honored and pleased to have seen and been part of an increasing focus and attention being paid to the unique manufacturing and bioproduction issues related to cell therapy.


      Certainly it is the Cell Therapy Group's view, that this is both timely and much-needed as more cell therapies reach later-stage. Issues related to larger scale production and lowering the costs associated with it will be critical to successful commercialization of these products. It is encouraging to see both content-providers and and companies involved in potentially bringing solutions to these issues now bringing their focused energies to this sector.

      This focus has come from a number of different sources including conferences focused solely on the topic, companies engaging stakeholders in identifying potential bottlenecks they might be positioned to solve, more conference sessions dedicated to these issues, and now a commitment by one of the leading publications in bioprocessing to engage both the cell therapy industry and the traditional bioprocessing community in stepping up the level of two-way education, dialog, and problem-solving that will be critical to commercializing these products.

      In March/April 2011, watch for a special issue of BioProcess International entitled "Cell Therapies: Commercializing a New Class of Biopharmaceuticals".

      BioProcess International is a publishing leader of cutting edge technologies, improved processes and breakthrough sciences. With this cell therapy focused issue, in partnership with ISCT and others, BPI is launching what we hope will be a regular supplement and increased focus on the unique bioproduction issues related to cell-based therapies.

      BioProcess International aims to accomplish three main objectives with this supplement:
      • Educate the bioprocess and cell therapy market (suppliers and end-users) on the similarities and differences between the two processes;
      • Educate and encourage the investor community to keep increasing their interest and investment;
      • Expedite the commercialization process.

      Distribution will include:

      • BPI's 30,010 qualified readers;
      • Delegates attending ISCT's 2011 Annual Meeting (included in all delegate bags)
      • Delegates attending ESACT 2011 (Chair drop at the Cell Therapy Plenary Session)
      • INTERPHEX 2011 Cell Therapy Roundtable (VIP Invitations, 200 attendees, produced by BPI)
      • BIO 2011 International Convention (BioProcess Theatre - Cell Therapy track)

      If you are interested in advertising, click here for more info.

      While the content for this issue is now being finalized, it you are interested in contributing something to BPI, we are looking for more cell therapy related content. As the cell therapy representative on BPI's advisory board I would be happy to champion it through submission.

      Cheers.

      --Lee

      http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
      Read More...

      ♫ Posted in Regenerative Medicine | | Comments Off»

      The LinkedIn Cell Therapy Industry Group – 1,000 members strong

      ♫ Monday, February 14th, 2011

      As some of you may know, much of my recent social media energy has been spent on LinkedIn rather than blogging. This was not a conscious decision but I will admit to finding the immediacy and interconnectivity of the LinkedIn/Twitter combo to be more seductive of my limited time than the more laborious and seemingly more unidirectional facets of blogging. I'm still working on a return to more diligent and regular blogging - we'll see how that goes.

      In any event, today's blog entry is ironically about the very thing which has replaced my blogging in many ways for the interim: the LinkedIn Cell Therapy Industry Group which I founded in July 2008 (about the same time as I launched this blog).
      Primarily due to the outstanding participation of great members, the group has turned out to be what I had hoped would be and I believe has become a fairly valuable resource for those in or interested in the cell therapy industry.
      The group grew exponentially throughout 2010 and we are proud today to announce our 1,000th member. Without his knowledge, Luc Gervais today became the 1,000th member of the LinkedIn Cell Therapy Industry Group.
      Luc Gervais lists himself on LinkedIn as a "Technologist Entrepreneur" but is also a Researcher at IBM Research, Zurich Research Laboratory in addition to being a researcher at the University Hospital Basel.
      He was recently involved in the development of IBM's novel, microfluidic "lab on a chip" technology that uses capillary action to create a potential one-step diagnostic tool, and which could ultimately test for a wide range of diseases and viruses. The chip requires only a small drop of blood, which it draws through tiny channels within the device. The blood reacts with different disease markers to provide accurate diagnoses in about 15 minutes.
      Luc represents what I believe is one of the most exciting signs of development in and maturation of the cell therapy industry. Luc's career has included being a Game Developer at Unlikely Games, a Computational Chemistry Developer at Boehringer Ingelheim Pharmaceuticals, and a Quality Assurance Specialist at Steltor. On LinkedIn, he lists "regenerative medicine" as one of his interests.
      People with the kind of experience Luc possesses are bringing a world of scientific, technical, and commercial expertise to regenerative medicine and cell therapy from outside the sector. This promises to revolutionize the way we think about, develop, and apply our technologies.
      Luc and others like him who are exploding into the regenerative medicine and cell therapy field bring with them the potential for interdisciplinary exploration, the opportunity to draw from lessons already learned in other sectors, and the chance to view our field not just in terms of the incredible potential for new therapeutics which cell therapy represents but how that fits into the broader world in which cell therapy is growing up. A world that includes phenomenal advancements in personalized medicine, diagnostics, theranostics, biomarkers, bioinformatics, the ability to access and interpret personal genomics data, etc.
      I have yet to speak to Luc (this was all posted from publicly available information) but I'm hoping to bring you an interview of him shortly not because being the 1,000th member of the LinkedIn Cell Therapy Industry Group is deserving of any particular attention (and certainly will not rank in his list of accomplishments I'm sure) but because I'm curious about what Luc represents.
      Stay tuned....
      --Lee
      http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
      Read More...

      ♫ Posted in Regenerative Medicine | | Comments Off»

      Cell Therapies: Commercializing a New Class of Biopharmaceuticals

      ♫ Monday, February 7th, 2011


      Over the past six months I have been honored and pleased to have seen and been part of an increasing focus and attention being paid to the unique manufacturing and bioproduction issues related to cell therapy.


      Certainly it is the Cell Therapy Group's view, that this is both timely and much-needed as more cell therapies reach later-stage. Issues related to larger scale production and lowering the costs associated with it will be critical to successful commercialization of these products. It is encouraging to see both content-providers and and companies involved in potentially bringing solutions to these issues now bringing their focused energies to this sector.

      This focus has come from a number of different sources including conferences focused solely on the topic, companies engaging stakeholders in identifying potential bottlenecks they might be positioned to solve, more conference sessions dedicated to these issues, and now a commitment by one of the leading publications in bioprocessing to engage both the cell therapy industry and the traditional bioprocessing community in stepping up the level of two-way education, dialog, and problem-solving that will be critical to commercializing these products.

      In March/April 2011, watch for a special issue of BioProcess International entitled "Cell Therapies: Commercializing a New Class of Biopharmaceuticals".

      BioProcess International is a publishing leader of cutting edge technologies, improved processes and breakthrough sciences. With this cell therapy focused issue, in partnership with ISCT and others, BPI is launching what we hope will be a regular supplement and increased focus on the unique bioproduction issues related to cell-based therapies.

      BioProcess International aims to accomplish three main objectives with this supplement:
      • Educate the bioprocess and cell therapy market (suppliers and end-users) on the similarities and differences between the two processes;
      • Educate and encourage the investor community to keep increasing their interest and investment;
      • Expedite the commercialization process.

      Distribution will include:

      • BPI's 30,010 qualified readers;
      • Delegates attending ISCT's 2011 Annual Meeting (included in all delegate bags)
      • Delegates attending ESACT 2011 (Chair drop at the Cell Therapy Plenary Session)
      • INTERPHEX 2011 Cell Therapy Roundtable (VIP Invitations, 200 attendees, produced by BPI)
      • BIO 2011 International Convention (BioProcess Theatre - Cell Therapy track)

      If you are interested in advertising, click here for more info.

      While the content for this issue is now being finalized, it you are interested in contributing something to BPI, we are looking for more cell therapy related content. As the cell therapy representative on BPI's advisory board I would be happy to champion it through submission.

      Cheers.

      --Lee

      http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
      Read More...

      ♫ Posted in Regenerative Medicine | | Comments Off»

      The LinkedIn Cell Therapy Industry Group – 1,000 members strong

      ♫ Tuesday, January 18th, 2011

      As some of you may know, much of my recent social media energy has been spent on LinkedIn rather than blogging. This was not a conscious decision but I will admit to finding the immediacy and interconnectivity of the LinkedIn/Twitter combo to be more seductive of my limited time than the more laborious and seemingly more unidirectional facets of blogging. I'm still working on a return to more diligent and regular blogging - we'll see how that goes.

      In any event, today's blog entry is ironically about the very thing which has replaced my blogging in many ways for the interim: the LinkedIn Cell Therapy Industry Group which I founded in July 2008 (about the same time as I launched this blog).
      Primarily due to the outstanding participation of great members, the group has turned out to be what I had hoped would be and I believe has become a fairly valuable resource for those in or interested in the cell therapy industry.
      The group grew exponentially throughout 2010 and we are proud today to announce our 1,000th member. Without his knowledge, Luc Gervais today became the 1,000th member of the LinkedIn Cell Therapy Industry Group.
      Luc Gervais lists himself on LinkedIn as a "Technologist Entrepreneur" but is also a Researcher at IBM Research, Zurich Research Laboratory in addition to being a researcher at the University Hospital Basel.
      He was recently involved in the development of IBM's novel, microfluidic "lab on a chip" technology that uses capillary action to create a potential one-step diagnostic tool, and which could ultimately test for a wide range of diseases and viruses. The chip requires only a small drop of blood, which it draws through tiny channels within the device. The blood reacts with different disease markers to provide accurate diagnoses in about 15 minutes.
      Luc represents what I believe is one of the most exciting signs of development in and maturation of the cell therapy industry. Luc's career has included being a Game Developer at Unlikely Games, a Computational Chemistry Developer at Boehringer Ingelheim Pharmaceuticals, and a Quality Assurance Specialist at Steltor. On LinkedIn, he lists "regenerative medicine" as one of his interests.
      People with the kind of experience Luc possesses are bringing a world of scientific, technical, and commercial expertise to regenerative medicine and cell therapy from outside the sector. This promises to revolutionize the way we think about, develop, and apply our technologies.
      Luc and others like him who are exploding into the regenerative medicine and cell therapy field bring with them the potential for interdisciplinary exploration, the opportunity to draw from lessons already learned in other sectors, and the chance to view our field not just in terms of the incredible potential for new therapeutics which cell therapy represents but how that fits into the broader world in which cell therapy is growing up. A world that includes phenomenal advancements in personalized medicine, diagnostics, theranostics, biomarkers, bioinformatics, the ability to access and interpret personal genomics data, etc.
      I have yet to speak to Luc (this was all posted from publicly available information) but I'm hoping to bring you an interview of him shortly not because being the 1,000th member of the LinkedIn Cell Therapy Industry Group is deserving of any particular attention (and certainly will not rank in his list of accomplishments I'm sure) but because I'm curious about what Luc represents.
      Stay tuned....
      --Lee
      http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
      Read More...

      ♫ Posted in Regenerative Medicine | | Comments Off»

      Careers in cell therapy & regenerative medicine

      ♫ Monday, October 11th, 2010


      As you will see just below, this post falls under the category of a thinly veiled and somewhat shameless plug which I hope you'll tolerate if I'm transparent about it upfront and I add what may be a little useful commentary along the way.

      I won't have to convince "regular" readers of this "irregular" blog that regenerative medicine is one of the fastest growing life science sectors.

      Given the pace of the industry's growth, the amount of public money being "invested" in the sector, and the general enthusiasm that the science generates, it is no surprise that is increasingly an area of interest for those seeking a new career path.

      One commonly held misconception is that career opportunities in the sector are limited largely to those in early-stage research.

      While it is true that the industry is still in the nascent stages of commercial development compared to other more mature segments in the broader biopharmaceutical industry, careers in regenerative medicine span the full research and commercial spectrum from pre-clinical to clinical research in both academic and corporate settings, manufacturing, regulatory, quality, operations, logistics, finance, business development, marketing, sales, communications, and executive management.

      As has been discussed here in the past, most analysts agree that in 2008 the industry passed the $1 billion mark in annual revenue generated from sale of approved therapeutic products falling under the regenerative medicine category (see here for more in-depth analysis).

      Furthermore, most large multinational life science companies are now investing heavily into the sector on the promise that it will revolutionize healthcare in the coming decades.

      I believe the 2008 decision by Pfizer to create a substantial new Regenerative Medicine division will be seen as a seminal turning point in corporate perspectives on the industry. Since that point most life sciences have begun investing in regenerative medicine strategies and the trend has even leaked outside of life science to companies such as Google Ventures which has informally identified regenerative medicine as one of their primary areas of interest when looking at companies in which to invest.

      Most major universities have now created both academic and research programs dedicated to the emerging field of regenerative medicine such that there is a new class of graduates now emerging in both scientific and commercial disciplines with regenerative medicine as a primary focus.

      However, one of the difficulties with finding a career in regenerative medicine is that it is comprised of what has heretofore been fairly discrete disciplines of stem cell biology, pharmaceutical sciences, biotechnology, tissue engineering, stem cell transplantation, device technologies, cell therapies, etc.

      Furthermore, most recruiters and online job sites have very little experience or focus on the industry making recruiting difficult for positions in regenerative medicine companies or departments. The task is further complicated by the fact that the candidate pool is small and diversely spread over a multitude of disciplines, centers, and a multitude of small companies.

      Finally there are only now emerging industry publications, organizations, online communities, and websites that truly represent the broad spectrum of regenerative medicine and that can be used as central resources for recruiting.

      All this is why my partners and I saw the need for an online recruiting tool that really focused on regenerative medicine in a way that would support the industry's maturation. What we wanted to bring was a very simple solution that would create as much value as possible for those looking to recruit the right talent into their regenerative medicine efforts. This was the genesis behind RegenerativeMedicineJobs.com.

      (here comes the shameless part....)

      About RMJ

      At RegenerativeMedicineJobs.com, we believe the growth trajectory of this industry requires a specialized, online recruiting system – one that is more than just a website for posting jobs but also plugged into the large and diverse network of associations, publications, and social media that serves this industry.

      RegenerativeMedicineJobs.com is a specialized online job board focused on recruiting for positions in the rapidly growing field of regenerative medicine. The site is simple to use and focused in scope. But this is more than just another website.

      RMJ has developed a sophisticated system designed to leverage our extensive network in RM to ensure every post gets maximum attention and attracts the best candidates.

      Traffic is pulled to the site and job postings are pushed to a targeted audience by focused social media and marketing campaigns. This is the latest way to recruit for any position in a regenerative medicine department, division, or company. This is regenerative medicine recruiting with a focus.

      RegenerativeMedicineJobs.com (RMJ) is a collaboration between CTG Consulting, Co. and Pencilneck Software, Co. The personnel behind this collaboration created Cell Therapy News, Cell Therapy Blog, the LinkedIn Cell Therapy Industry Group, and have produced over a dozen organizational or event-based websites in the cell therapy, stem cell, and regenerative medicine space.

      The site has been designed to be simple and intuitive with only one goal in mind: to be the best online tool for recruiting personnel into positions in the regenerative medicine industry.

      We don't offer resume posting, career advice, assistance building your CV, hand holding, shoulders to cry on, or job postings outside of regenmed. We believe in the value of specialization.

      The site is a listing of regenerative medicine jobs (period). All types of jobs for all types of organizations but only regenmed job (period).

      We have only one rule: the jobs posted must be for a position within the regenerative medicine space. We define regenerative medicine as anything involving cell therapy, stem cells as therapies or tools for discovery or toxicity testing, or non-cell based programs/products (e.g., small molecules, biologics, devices, etc) used to replace or regenerate cells, tissues, or organs to restore, repair, or establish normal function.

      The site has a topical niche with no regional focus or bias. This is meant to be a global tool equally useful for a company or university in Poland, Taiwan, Brazil, the United States, etc.

      The site is also meant to be useful for recruiting any positions scientific or commercial, business or technical, executive or laborer.

      *

      We hope you find it useful.

      We hope it contributes to the industry's growth and maturation.

      We hope you will provide us feedback on what we're doing well and what we can do better.



      http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
      Read More...

      ♫ Posted in Regenerative Medicine | | Comments Off»

      Careers in cell therapy & regenerative medicine

      ♫ Monday, October 11th, 2010


      As you will see just below, this post falls under the category of a thinly veiled and somewhat shameless plug which I hope you'll tolerate if I'm transparent about it upfront and I add what may be a little useful commentary along the way.

      I won't have to convince "regular" readers of this "irregular" blog that regenerative medicine is one of the fastest growing life science sectors.

      Given the pace of the industry's growth, the amount of public money being "invested" in the sector, and the general enthusiasm that the science generates, it is no surprise that is increasingly an area of interest for those seeking a new career path.

      One commonly held misconception is that career opportunities in the sector are limited largely to those in early-stage research.

      While it is true that the industry is still in the nascent stages of commercial development compared to other more mature segments in the broader biopharmaceutical industry, careers in regenerative medicine span the full research and commercial spectrum from pre-clinical to clinical research in both academic and corporate settings, manufacturing, regulatory, quality, operations, logistics, finance, business development, marketing, sales, communications, and executive management.

      As has been discussed here in the past, most analysts agree that in 2008 the industry passed the $1 billion mark in annual revenue generated from sale of approved therapeutic products falling under the regenerative medicine category (see here for more in-depth analysis).

      Furthermore, most large multinational life science companies are now investing heavily into the sector on the promise that it will revolutionize healthcare in the coming decades.

      I believe the 2008 decision by Pfizer to create a substantial new Regenerative Medicine division will be seen as a seminal turning point in corporate perspectives on the industry. Since that point most life sciences have begun investing in regenerative medicine strategies and the trend has even leaked outside of life science to companies such as Google Ventures which has informally identified regenerative medicine as one of their primary areas of interest when looking at companies in which to invest.

      Most major universities have now created both academic and research programs dedicated to the emerging field of regenerative medicine such that there is a new class of graduates now emerging in both scientific and commercial disciplines with regenerative medicine as a primary focus.

      However, one of the difficulties with finding a career in regenerative medicine is that it is comprised of what has heretofore been fairly discrete disciplines of stem cell biology, pharmaceutical sciences, biotechnology, tissue engineering, stem cell transplantation, device technologies, cell therapies, etc.

      Furthermore, most recruiters and online job sites have very little experience or focus on the industry making recruiting difficult for positions in regenerative medicine companies or departments. The task is further complicated by the fact that the candidate pool is small and diversely spread over a multitude of disciplines, centers, and a multitude of small companies.

      Finally there are only now emerging industry publications, organizations, online communities, and websites that truly represent the broad spectrum of regenerative medicine and that can be used as central resources for recruiting.

      All this is why my partners and I saw the need for an online recruiting tool that really focused on regenerative medicine in a way that would support the industry's maturation. What we wanted to bring was a very simple solution that would create as much value as possible for those looking to recruit the right talent into their regenerative medicine efforts. This was the genesis behind RegenerativeMedicineJobs.com.

      (here comes the shameless part....)

      About RMJ

      At RegenerativeMedicineJobs.com, we believe the growth trajectory of this industry requires a specialized, online recruiting system – one that is more than just a website for posting jobs but also plugged into the large and diverse network of associations, publications, and social media that serves this industry.

      RegenerativeMedicineJobs.com is a specialized online job board focused on recruiting for positions in the rapidly growing field of regenerative medicine. The site is simple to use and focused in scope. But this is more than just another website.

      RMJ has developed a sophisticated system designed to leverage our extensive network in RM to ensure every post gets maximum attention and attracts the best candidates.

      Traffic is pulled to the site and job postings are pushed to a targeted audience by focused social media and marketing campaigns. This is the latest way to recruit for any position in a regenerative medicine department, division, or company. This is regenerative medicine recruiting with a focus.

      RegenerativeMedicineJobs.com (RMJ) is a collaboration between CTG Consulting, Co. and Pencilneck Software, Co. The personnel behind this collaboration created Cell Therapy News, Cell Therapy Blog, the LinkedIn Cell Therapy Industry Group, and have produced over a dozen organizational or event-based websites in the cell therapy, stem cell, and regenerative medicine space.

      The site has been designed to be simple and intuitive with only one goal in mind: to be the best online tool for recruiting personnel into positions in the regenerative medicine industry.

      We don't offer resume posting, career advice, assistance building your CV, hand holding, shoulders to cry on, or job postings outside of regenmed. We believe in the value of specialization.

      The site is a listing of regenerative medicine jobs (period). All types of jobs for all types of organizations but only regenmed job (period).

      We have only one rule: the jobs posted must be for a position within the regenerative medicine space. We define regenerative medicine as anything involving cell therapy, stem cells as therapies or tools for discovery or toxicity testing, or non-cell based programs/products (e.g., small molecules, biologics, devices, etc) used to replace or regenerate cells, tissues, or organs to restore, repair, or establish normal function.

      The site has a topical niche with no regional focus or bias. This is meant to be a global tool equally useful for a company or university in Poland, Taiwan, Brazil, the United States, etc.

      The site is also meant to be useful for recruiting any positions scientific or commercial, business or technical, executive or laborer.

      *

      We hope you find it useful.

      We hope it contributes to the industry's growth and maturation.

      We hope you will provide us feedback on what we're doing well and what we can do better.



      http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
      Read More...

      ♫ Posted in Regenerative Medicine | | Comments Off»

      FDA files injunction again Regenerative Sciences citing Regenexx violates regulations

      ♫ Thursday, August 12th, 2010
      For those of you who follow this blog, you'll imagine my surprise to wake up the morning to the following announcement from the FDA:
      _____________________________________________________________
      FDA NEWS RELEASE
      For Immediate Release: August 6, 2010
      Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
      Consumer Inquiries: 888-INFO-FDA
      FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product
      Violations of current good manufacturing practice and labeling requirements cited
      The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP) that cause its cultured cell product to be adulterated. The product is also misbranded due to the lack of adequate directions for use and the failure to bear the “Rx only” symbol.
      The company’s cultured cell product is derived from a patient’s bone marrow or fluid surrounding the patient’s joints (synovial fluid). The cells are grown, processed, and mixed with drug products outside the body before being injected back into the patient.
      Regenerative Sciences’ cultured cell product is not approved by the FDA, and no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication.
      “FDA recognizes the importance of the development of novel and promising new therapies,” said Karen Midthun, M.D., acting director of FDA’s Center for Biologics Evaluation and Research. “However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public’s health at risk.”
      The complaint for the injunction was filed Aug. 6, 2010, by the Justice Department on behalf of the FDA in the U.S. District Court for the District of Columbia, against Regenerative Sciences and three of its employees, Christopher J. Centeno, M.D., John R. Schultz, M.D., and Michelle R. Cheever. The injunction would permanently prevent the company and cited individuals from adulterating and misbranding the cultured cell product while the product, or one or more of its components, is held for sale after shipment in interstate commerce.
      Regenerative Sciences has agreed to cease production of the cultured cell product while the case is pending.
      The FDA warned Regenerative Sciences about its cGMP violations as recently as June 2010. The company failed to make sufficient corrections, and the conduct of the individuals cited in the complaint demonstrates refusal to comply with the law.
      http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
      Read More...

      ♫ Posted in Regenerative Medicine | | Comments Off»

      FDA files injunction again Regenerative Sciences citing Regenexx violates regulations

      ♫ Thursday, August 12th, 2010
      For those of you who follow this blog, you'll imagine my surprise to wake up the morning to the following announcement from the FDA:
      _____________________________________________________________
      FDA NEWS RELEASE
      For Immediate Release: August 6, 2010
      Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
      Consumer Inquiries: 888-INFO-FDA
      FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product
      Violations of current good manufacturing practice and labeling requirements cited
      The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP) that cause its cultured cell product to be adulterated. The product is also misbranded due to the lack of adequate directions for use and the failure to bear the “Rx only” symbol.
      The company’s cultured cell product is derived from a patient’s bone marrow or fluid surrounding the patient’s joints (synovial fluid). The cells are grown, processed, and mixed with drug products outside the body before being injected back into the patient.
      Regenerative Sciences’ cultured cell product is not approved by the FDA, and no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication.
      “FDA recognizes the importance of the development of novel and promising new therapies,” said Karen Midthun, M.D., acting director of FDA’s Center for Biologics Evaluation and Research. “However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public’s health at risk.”
      The complaint for the injunction was filed Aug. 6, 2010, by the Justice Department on behalf of the FDA in the U.S. District Court for the District of Columbia, against Regenerative Sciences and three of its employees, Christopher J. Centeno, M.D., John R. Schultz, M.D., and Michelle R. Cheever. The injunction would permanently prevent the company and cited individuals from adulterating and misbranding the cultured cell product while the product, or one or more of its components, is held for sale after shipment in interstate commerce.
      Regenerative Sciences has agreed to cease production of the cultured cell product while the case is pending.
      The FDA warned Regenerative Sciences about its cGMP violations as recently as June 2010. The company failed to make sufficient corrections, and the conduct of the individuals cited in the complaint demonstrates refusal to comply with the law.
      http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
      Read More...

      ♫ Posted in Regenerative Medicine | | Comments Off»

      Using Stem Cells Scientists Grow a Rat Lung, Humans are Next

      ♫ Tuesday, June 29th, 2010

      Scientists grow a rat lung in the laboratory

      By LAURAN NEERGAARD (AP) – 4 days ago

      WASHINGTON — It's an early step toward one day building new lungs: Yale University researchers took apart and regrew a rat's lung, and then transplanted it and watched it breathe.

      The lung stayed in place only for an hour or two, as the scientists measured it exchanging oxygen and carbon dioxide much like a regular lung — but also spotted some problems that will take more research to fix.

      Still, the work is a step in the science fiction-sounding hunt for ways to regenerate damaged lungs — although lead researcher Dr. Laura Niklason cautions that it may be 20 or 25 years before a build-a-new-organ approach is ready for people.

      The work was reported online Thursday in the journal Science.

      Nearly 400,000 people die of lung diseases each year in the U.S. alone, according to the American Lung Association, and lung transplants are far too rare to offer much help.

      But how to replicate these spongy organs? Niklason's team stripped an adult rat's lung down to its basic structural support system — its scaffolding — to see if it's possible to rebuild rather than starting completely from scratch.

      First, they essentially washed away the different kinds of cells lining that lung. It gradually faded from a healthy red to a white structure of mostly collagen and other connective tissue that maintained the shape and stretchiness of the original lung, even the tubes where airways would be.

      This scaffolding is like a universal donor that shouldn't pose rejection problems, said Niklason: "Your collagen and my collagen are identical."

      The researchers put the lung scaffolding into a bioreactor, an incubator-style container designed to mimic the environment in which fetal lungs develop, with fluid pumping through them.

      Then they injected a mixture of different lung cells taken from a newborn rat. In the bioreactor, those cells somehow migrated to the right spots and grew air sacs, airways and blood vessels.

      In short-term implants in four different rats, engineered lungs replaced one of the animals' native lungs and proved 95 percent as efficient at exchanging oxygen and carbon dioxide, Niklason said.

      However, among the problems she spotted were small clots that formed inside the engineered lung, a sign that the new cells hadn't grown a thick enough cover in some places.

      The biggest challenge: For this approach ever to work without a person's body rejecting the new tissue, scientists would need to use a recipient's own cells, Niklason explained. But there isn't a way yet to cull the kind of personalized stem cells that would be needed, meaning stem cell research must improve first, she said.

      This overall approach also worked in a 2008 University of Minnesota experiment that grew a beating rat heart, and Minnesota researcher Dr. Doris Taylor welcomed the Yale lung work.

      Separately in Science, a Harvard University team coated a flexible chip with layers of living lung cells, creating a laboratory tool that mimics some of the action of a breathing human lung. The goal: To replace some of the animal studies needed to test how lungs react to environmental toxins or inhaled drugs.

      Online: http://www.sciencemag.org

      Read More...

      ♫ Posted in Genetic medicine, Molecular Genetics, Regenerative Medicine, Veterinary Medicine | | Comments Off»

      Stem Cell Therapy: Age of Human Cell Engineering is Born

      ♫ Friday, June 25th, 2010

      (06-18) 13:42 PDT SAN FRANCISCO -- Dr. Shinya Yamanaka, a stem cell researcher at UCSF's Gladstone Institutes who discovered a technique for transforming adult skin cells into "pluripotent" stem cells without resorting to human embryos, has won Japan's $550,000 Kyoto Prize, an international award that honors scientific, cultural and spiritual contributions to human knowledge.

      His discovery resulted in a class of much-sought stem cells that scientists can induce to become virtually any other type of functioning human cell that one day might be used to treat varied diseases or injuries.

      During their research, Yamanaka and his colleagues altered the genetics of adult skin cells by inserting four specific viral genes that produce proteins known as transcription factors into the cells. Those proteins in turn yielded other genes that reprogrammed the skin cells so they acquired all the characteristics that made them what are now known as induced pluripotent cells.

      Before his discovery, those pluripotent human stem cells could only be harvested from human embryos, a source posing such powerful ethical issues that former President George W. Bush banned virtually all embryonic stem cell research eight years ago. The ban remained in force until President Obama reversed it last year.

      Yamanaka, 47, who is attending the annual meeting of the International Society of Stem Cell Research in San Francisco this week, was not told of his award until just before midnight Pacific time on Thursday.

      The Kyoto Prize is awarded annually by Japan's Inamori Foundation for major discoveries in many fields of advanced technology, and four other Bay Area scientists have won it in recent years.

      They are Leonard Herzenberg, a Stanford geneticist and immunologist who developed a revolutionary cell-sorting machine now crucial to advanced biomedical research; Alan Kay, a Silicon Valley pioneer at Hewlett-Packard who led advanced computing technology for 40 years; Donald E. Knuth, a Stanford information technology expert and specialist in computer programming, language analysis and computerized printing and Richard Karp, a UC Berkeley computer scientist and pioneer in computational biology.

      In addition to heading his laboratory at the Gladstone Institute for Cardiovascular Research on the Mission Bay campus of UCSF, Yamanaka is also a professor at Kyoto University, where he began his efforts seeking a way of transforming adult cells.

      Besides resolving ethical issues by his achievement, Yamanaka's success also means that the pluripotent stem cells needed to treat a patient's disease can be obtained from the ordinary skin cells of a patient's own body - thus making stem cell therapy possible without the hazards involved in immunologic rejection of cells from other people.

      Robert Lanza, chief scientific officer of Advanced Cell Technology and an adjunct professor at Wake Forest University's stem cell research center, said recently that Yamanaka's work "is likely to be the most important stem cell breakthrough of all time."

      "The ability to generate an unlimited supply of patient-specific stem cells will revolutionize the future of medicine," Lanza said.

      Read more: http://www.sfgate.com

      Read More...

      ♫ Posted in Biotechnology, Genetic Engineering, Genetic medicine, Genetics, Molecular Genetics, Regenerative Medicine | | Comments Off»

      The changing face of PR and why it matters to regenmed

      ♫ Saturday, June 12th, 2010

      This may seem a little off-topic for those who don't know me but for those of you who do, you'll know this is a little mix of many of my primary loves - cell therapy/regenerative medicine, communications/public relations, social media, and all things internet/technology.

      This is a reprint (with permission) of an article I was invited to write for the 2009 World Stem Cell Report.

      ______________________________________________________________________

      If you’re breathing, you’re in PR [1]
      Some Do’s and Don’ts and 2.0s for orgs/co’s in cell therapy & ReGEN

      You may be one of them. The scientist who can’t get the job or promotion you want. The company not securing customers fast enough. The investigator not finding collaborators. The company not finding quality employees. The company failing to secure much needed investment. The big company not effectively penetrating new, niche markets like cell therapy-regenerative medicine. The executive or investigator not getting the speaking invites to create the buzz needed to help move things forward.

      Whatever the challenge, consider a healthy dose of marcom. [2]

      Ok, I’m biased and it certainly isn’t a single panacea for all these problems, but seriously. A good profile (personal or corporate) – built from a solid reputation and strong relationship network – can help address almost any challenge you or your company is facing.

      INTRODUCTION

      I know. You don’t believe me. Humor me and answer this one question. If you could double the number of people that know about your company or technology, the number of people that learn, hear, or read something about your research, product or service in the average 30–day period, and/or the number of people that interact with one of your employees or colleagues every week, would that – on the whole – likely help or hinder you in addressing at least some of the primary challenges you are currently facing?

      See where I’m going with this? Even if your challenges are deeply scientific or technical, is it possible to imagine that if only you knew the right person …?

      Your existence depends on human interaction. Your success depends on how well you interact and the impressions you make. The impressions are not solely or even primarily driven by the brilliance of your technology or the compelling weight of your data. This is likely more true than you may think. For those of you who have read Malcolm Gladwell’s book, Blink, you will appreciate just how much people’s perceptions are influenced not by logic, data, or comprehensive consideration but by the judgments of the subconscious in a matter of seconds.

      The PR (public relations) I discuss in the following pages is not spin and it’s not advertising. It’s about establishing and maintaining relationships that result in profile among your various kinds of constituents be they your collaborators, peers, investors, employers, employees, customers, or potential strategic partners.

      Successful people and companies use effective PR to create relationships, turn them into interactive networks, and then leverage them to help solve the challenges they face.

      This has always been true. What are so radically changing today are the tools which people and companies can now employ to conduct effective PR, create relationships, and build networks all at a fraction of the cost, with greater returns, and performed by individuals or small companies not previously capable of affecting global impact. These tools are, of course, online.

      A successful strategy for PR is now increasingly determined by how well online tools are employed to engage in conversation, create relationships, and build profile.

      As it turns out, there are, in my opinion, too few people in this industry who, as yet, understand the power of PR and fewer still who understand the potential of web2.0 to change their fate.

      What I will share with you in the next couple pages is:

      1. why if you’re breathing, you’re in PR - if you can’t avoid it (and I don’t recommend you try), you should learn to embrace it;

      2. the cost of dodging the embrace; and

      3. how you can embrace it.

      POINT #1: YOU’RE IN PR. REALLY.

      There are a zillion reasons why you underestimate the importance of PR in your career or to your company. There are a zillion other reasons why you think online social media is irrelevant to what you do. Let’s look at five.

      1. My company is a research-based, early-stage company conserving burn-rate, with few employees, and nothing to sell. Ergo we don’t have a need for PR stuff like marketing, communications, or profile building.

      There is nothing new but certainly nothing outdated in the adage: Everyone is selling something.

      Don’t pretend you have no one to impress, you have nothing to sell, or that content is the only thing that impresses in the science business. If you thing you have nothing to market, you just haven’t figured out what it is yet.

      Are you looking to recruit quality people? Do you anticipate needing to find and impress new investors sometime this year or next? Would you be interested in engaging in discussions from parties potentially interested in licensing or acquiring some of your IP? Are you looking to impress potential academic or corporate collaborators? Do or will you need to recruit patients for a clinical trial? Do you need to start educating doctors about the potential of your therapeutic or engage them in giving advice about your trial or product? Would you benefit from increased government funding for cell therapy and regenerative medicine? Do you believe there are policy changes that could be made that would benefit this industry?

      A better profile and a wider network of contacts can’t help but help you address these needs. If you have anyone to impress (and everyone does), then you need to be talking with them. Will a bigger and better profile hurt your efforts to find good employees, seduce investors, recruit patients, identify collaborators, secure partners, etc? It’s hard to imagine how.

      At the very minimum, as a member of the life sciences industry you have an obligation to get out of your lab and communicate to the world around you about the science you are so passionate about. As President Obama encouraged in his address to the April 27, 2009 National Academy of Sciences [3], we all have a duty to do a better job of engaging the people around us in a discussion about the importance of science and the science we’re doing.

      2. My company is a big, public, multi-national company with departments that handle marketing, communications, PR, and advertising. Ergo I don’t need to pay attention to these things because they do that.

      Firstly, unless you have tenure, chances are between now and retirement you may want/need/be recruited for another job. A strong, personal “brand” (profile) is certainly a huge asset in terms of ensuring you are successful in finding that job and negotiating the right remuneration.

      Secondly, if you are ever let out of the lab/office or given internet access, you have the capacity to (and likely already) influence your company’s profile and brand. You are either complementing or distracting from your company’s primary messages and brand.

      Thirdly, if you care about your company’s success, don’t assume your company’s department or external marcom firm is doing what needs to be done. Investor relations, marketing and communications firms or departments may be good at investor relations, marketing, and communications but that doesn’t necessarily mean they are good at the kind of profile building that is going to attract and support meaningful business development opportunities or potential investigators, customers, licensees, collaborators, employees, or clinical trial patients.

      Finally, too many big companies haven’t yet figured out how or how to successfully use Social Media. If you’re using Social Media (e.g., Facebook, Twitter, FriendFeed, Digg, etc), you might be able to play a leadership role in being the face of your company on these platforms – just don’t do it without permission!

      3. My company is a science-based company with a technical sale to scientists who are not receptive to glitzy marketing, advertising, PR, and-the-like. Ergo there is little ROI on spending money on these kinds of things. We don’t “do” marketing.

      You may be in a company that believes putting out press releases is an unnecessary distraction from the business of science; or the company that believes that communications is something done only big companies, public companies, stock hustlers, or companies with something to sell.

      Wrong. First you’re working on the assumption that all marketing looks like a drug ad.

      Second your target audience is human. Humans are susceptible to having their perceptions influenced via all the usual means. Even if you don’t want to look at it so crassly, you would have to agree they are susceptible to forming more positive impressions of your company or product if information about it is available, packaged nicely, and easily accessible. You would also have to agree that any impression or sale is easier to make when there is a personal relationship/contact.

      Your network is one of your most valuable assets to you and to your company. Building a global network and industry profile is marketing under what ever name you want to call it.

      4. All this web 2.0 and social media stuff is for tech geeks and kids. They are not my target market and don’t have a critical mass of the kinds of people I need to building profile among.

      Let’s assume for a moment, this is true. If you’re looking to be an attractive employer to potential, young employees you may want to reconsider.

      Secondly, young people grow up and become industry leaders and executives. Is it too early to start shaping their perceptions?

      Thirdly, there is the occasional executive that is actually occasionally influenced by input from their younger employees. I know – it’s crazy!

      Furthermore, it’s not true. For example, I have a very high percentage of c-level executives on my LinkedIn Cell Therapy Industry Group, Jim Till who proved the existence of the stem cell in his ground-breaking nature paper in 1963, is an active poster on Twitter, and the average age of social media users is much older than you believe - check your data.

      5. Twitter-schmitter. Today’s social media sites are tomorrow’s relics. They’re all hype when they launch and then they fall out of favor and are no longer useful. I’m a serious business professional with no time or need for these gimmicks that have no real business applications or executives like me on them.

      If you think LinkedIn, Twitter, or Facebook (my three favorite and most used social media sites) are not going to be around and successful for long enough to have a real impact on your business, you’re definitely one to bet against the odds.

      If you think serious business is not being done and useful business connections being made on these sites (see the last paragraph in the point above), you’re dead wrong. I’ve found customers, employees, and collaborators for my customers using social media in addition to getting them speaking engagements and highlighted in publications.

      The point? Everyone has some kind of PR (marketing, communications, profile building, networking, advertising, community participation, publishing, speaking, etc) to do. Your potential audience, network, and impact are all much bigger than likely believe to be true.

      My guess? You have more than likely significantly underestimated the value of engaging in PR. And, you have likely significantly overestimated the time and financial cost of engaging in PR.

      That brings me to Point #2.

      POINT #2: THERE IS A REAL COST TO YOU AND YOUR COMPANY IN PRETENDING YOU DON’T DO OR NEED TO DO PR.

      All I should really have to do here is refer you back to point #1. The benefits of engaging in PR are the costs for not. Nevertheless, I will briefly expound.

      Your next job, employee, collaboration, investor, customer, patient, etc will be influenced by the profile of you and/or your company. While your CV – comprised of its peer-reviewed publications, presentations, and collegial references – is still an important driver in people’s perceptions in our industry what often makes someone or some company stand out among the others (perhaps even imperceptibly) is the overall profile one has created. One’s profile is increasingly judged online.

      That brings me to revise Point #2 to the following:

      There is a real cost to you and your company in pretending you can/should ignore the PR power of web2.0’s social media.

      I’m going to steal now from my October 2008 blog posting on the subject. [4]

      Only a few minutes ago (relatively speaking in the passage of time) most companies didn't think they needed to have a website or a domain name strategy. This seems as foolish now as ignoring social medial will seem in a few minutes from now.

      In 1995 - a mere 14 years ago - I was a young associate in a downtown law firm making a pitch to a skeptical management committee at a weekend retreat that the firm needed a website and an email "system". It was not an easy sell. They "knew" lawyers would never send their own emails and certainly not use it to communicate with clients. Similarly they were convinced a website would likely not bring in any new clients and existing clients would not likely find a website useful.

      How quickly they were proven wrong.

      We are at a similar technological threshold. Most companies are ignoring the importance of "social media" to their corporate strategy. Most consider using social media an unnecessary "luxury" in exactly the same way websites, domain names, and email were considered by people in their positions only a few years ago. They do not understand how social media is already changing the way they do business, the importance of staking position/profile early, nor the pain they will feel in the very near future for having failed to be proactive in building and leveraging online communities.

      This is very understandable. In times of fiscal constraint one tends to focus on that which hurt you yesterday or causes you the most pain today. Nonetheless, the companies that will succeed tomorrow are looking at tomorrow now and preparing for it. Tomorrow's mainstream business activities involve social media as much as today's involves website and email.

      For those thinking that this will be true only for businesses that deal direct with the retail consumer, they’re dead wrong. If you have a constituency that you need to keep informed about and actively engaged in your company, then this applies to you. Whether its business (B2B) customers, investors, media, patients, recruits, employees, or collaborators, they are online and engaging in social media. If you're not there, they're listening to and engaging with someone else.

      LinkedIn now has 42 million members with 1,945,047 members who identify themselves in biotech, pharma, or healthcare. Some 300,000+ of them are in biotechnology. There are 293 biotechnology groups in LinkedIn and 375 biotechnology groups on Facebook. The LinkedIn cell therapy industry group has 400+ members engaging in active discussions and exchanges of information in the public forum and using the platform to make and strengthen connections offline.

      Bottom line? There are so many different kinds of social media out there that can be used to reach so many different kinds of audiences at a fraction of the cost of traditional media that it's just good business to figure out how to use it to your advantage. In fact, you may be feeling the pain of ignoring it already and just don't know it...

      Which brings me to point #3.

      POINT #3: WEB 2.0 HAS PUT THE ABILITY TO DO EFFECTIVE, LOW-COST PR IN YOUR HANDS. THERE ARE NO MORE GATEKEEPERS.

      The internet has blown the sense of community up and redefined it. Gone are the days when it was feared the web would destroy “community”. Instead web 2.0 is all about creating more and larger communities than we ever thought possible eliminating all kinds of barriers and cutting across all kinds of definitions.

      It used to be (before web 2.0) that corporate profile, marketing, communications, PR, advertising was all quite carefully controlled by managing the one-way push of information to the open receptacles we called “readers” or “audience”. If you wanted a global profile, you needed a global PR firm.

      Just like the internet has taken the magic out of the business of travel agents, web 2.0 has forever changed the grip that marketing, communications and PR firms had on the business of managing global corporate profiles. Similarly, a global profile is no longer only the purview of companies sufficiently large to retain the services of such firms or have big, internal PR departments.

      Just as the information on how to build long-range missiles is no longer the exclusive domain of rocket scientists, with the empowering tools of web 2.0, successful marcom can now be effectively done by subject-matter experts who are not big-budget marcom professionals.

      It’s why newspaper are dying and bloggers are thriving. It’s why small companies are building niche profiles that beat out their Fortune 500 competitors. It’s why startups can have a global profile in weeks on next-to-no budget.

      All of that is a rather lengthy introduction to primary point of this article:

      In this new world of interconnectedness and easy-to-access information, it is easier than ever for everyone and anyone to influence the profile of a company and what it is offering to the world. That’s the good news. The bad news is that you are expected to. All of which leads to one not-so-original observation of the impact of web 2.0 on companies.

      If you’re breathing with an internet connection, you can and should have significant and immediate impact on the awareness and perceptions of your company among people around the globe.

      If you’re not creating global awareness and positive perceptions, it may be assumed you’re terminally short of breath.

      Like it or not. You can’t help it and you certainly can’t avoid it. And the people forming these perceptions are not just the potential customers of companies with something to sell – they’re current or potential investors, partners, collaborators, patients, purchasers, journalists, regulators, policy-makers, employees, employers, etc.

      LIGHTS, CAMERA, ACTION

      So what can you do to begin leveraging the power of the PR tools at your fingertips and turn a bungalow profile into a chateau; a respectable list of contacts into a vibrant, enviable network of relationships?

      10 Ways to a Better Profile for RegenMed and Cell Therapy Organizations

      I’ll start with some rules that apply regardless of the PR platform you’re employing (e.g., traditional ones like conference presentations or journal publications or web2.0 ones like blogging or social networking).

      1. You need to have a communications strategy and then mandate and empower your people to communicate your message/story to your audiences.

      This doesn’t have to be complicated. It’s about defining your primary/secondary audiences, messages, keywords, and tactics to accomplish your primary/secondary goals.

      2. Talk about what you’ve done not about what you’re going to do.

      It is very rare that news about what you are going to do is really newsworthy. Don’t be tempted to put out a press release that’s not news just because you haven’t put one out in awhile. For example, a press release that your executive is going to speak at a conference is not news unless they are presenting new data or they are the keynote at the biggest conference of the year. That doesn’t mean you can’t post it on your website or let your network know in other ways but the press release should be used judiciously.

      3. Make sure you tell the market story not just the science story. Similarly, be clear about what problem your technology solves not just how brilliant it is.

      4. Be upfront about the limitations of your product/service. Don’t try to pretend you have the perfect product/service. Don’t try to be everything to everyone – defining who you are (your company and its product/service profile) is just as much what about what it is than what it is not.

      5. Avoid the temptation to promise when you will do something by (e.g., begin or end your trial, submit your IND, launch your product, etc) unless it’s the subject of a contractual obligation. There are too many unknowns that may prevent you from meeting the expectation you created. The ensuing disappointment will hurt your profile and perceptions of your company and its product/service and management.

      6. Don’t over communicate your regulatory interactions with the FDA – this is one area where the less said is often better.

      7. Wait on that hiring announcements just a little while. It’s critically damaging to put out a press release that now has a very, long online life outside of your control announcing the hire of a key executive only to have him/her not last beyond the first few weeks.

      8. Understand that communications, marketing and profile building are very different from advertising. Act accordingly.

      9. Value the untapped potential of your existing customers and prospects to spread your gospel.

      One of the real discoveries from social media is the alarming willingness of people to zealously proselytize on behalf of companies and products win which they believe. Find ways to actively engage them in doing so. [5]

      10. Engage online.

      The 8-step Plan to Enhance your Online Profile and Network

      1. SEO.

      If you’ve decided your profile matters, then your online profile really matters. The fastest way to an impressive online profile is Search Engine Optimization. There are a lot of tricks up the SEO tricksters sleeve and I’m not about to give them all away but suffice it to say that SEO is a multi-pronged attack and there are many arrows in the quiver each with a different use to the same end: higher rankings on the major search engines = increased traffic to the website = greater profile = whatever your end goal is (sales, investors, collaborations, changing the world, etc).

      2. Listen & Monitor.

      Whether you employ Google Alerts, Twitter search tools, or simple subscriptions to topical news services or blogs, there is a lot of content and discussions being added to the internet every day. You will likely be amazed how much (or how shockingly little) your company and product/service is being discussed and who is behind the discussions. Listening to and reading what’s going on the internet will get you intel about your competitors, new ideas for potential products or studies, new leads for potential collaborators or customers, etc.

      3. Follow/Subscribe.

      Find your favorite content providers, writers, resources, publications, etc and follow or subscribe to the content their pushing out and discussions they are leading.

      4. Join

      There’s no harm in joining. People join for all different reasons. There’s no problem in being an observer. In fact it’s likely best you just observe for a while after you join to assess the flavor of the group and discussion so when you do participate you don’t offend.

      5. Participate

      Once you’re comfortable, start to participate. Engage in discussion, exchange information, and above all make sure you are providing value to the other participants not just talking about yourself. This will be punished.

      6. Connect (yourself and others)

      There’s a reason why these are called online networks or communities. Use them to connect with people not just for the sake of building a bigger ‘friends’ list but because you have something in common and want to begin building a relationship.

      7. Create

      Be original. Create something of value you can share. That might just be facilitating a channel in which 3rd party information is exchanged. It might be you writing original content. It might be facilitating introductions.

      8. Enjoy and don’t offend.

      Most importantly find the online networks that you enjoy, that give something of value to you, then contribute value in return and ensure you don’t offend the rules. Nothing slaps harder than an online, viral slap from a community you’ve offended online. [6]

      CONCLUSION

      Don’t pretend you have no one to impress. Everyone needs to engage in PR.

      Even in the business of science, man cannot live on data alone. You need more than just solid content to affect the kind of impressions that will be critical to your success. Don’t let your data or career speak for itself – it can’t talk.

      Web 2.0 has made it exponentially easier – if not expected - to engage in PR and profile building.

      What’s missing from this article is the web 2.0 tools I’d recommend you use to put the 8-step plan in place. For that, watch here for further blog postings on the subject. See what I did there?

      [1] In this article, I use “PR” not to mean “public relations” as you may have come to understand it used but rather simply to mean any kind of relating to the public via marketing, communications, writing, profile building, networking, advertising, community participation, publishing, speaking, proselytizing, lobbying, etc. It’s a not-so-dirty little secret that we all do it in one form or another or several all at once.

      [2] Marketing & communications

      [3] See http://www.youtube.com/watch?v=k5-MgZD5IMc at around the 30 minute mark.

      [4] Oh, I haven’t mentioned my blog? It’s at http://www.celltherapyblog.com/. Of course if you are a subscriber, this will be a refresher. For those who haven’t read this on my blog, you would have benefited from reading these same thoughts back in October 2008 if you had been a blog subscriber, or if you followed me on Twitter (I’m @celltherapy) or if you were connected with me on LinkedIn (http://www.linkedin.com/in/celltherapy). I’m just saying…

      [5] One the flip side these same people will use these same tools to punish companies mercilessly for offending them or the rules of social media.

      [6] Just ask Johnson & Johnson about the power of mommy bloggers. Look it up.



      http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
      Read More...

      ♫ Posted in Regenerative Medicine | | Comments Off»

      The changing face of PR and why it matters to regenmed

      ♫ Saturday, June 12th, 2010

      This may seem a little off-topic for those who don't know me but for those of you who do, you'll know this is a little mix of many of my primary loves - cell therapy/regenerative medicine, communications/public relations, social media, and all things internet/technology.

      This is a reprint (with permission) of an article I was invited to write for the 2009 World Stem Cell Report.

      ______________________________________________________________________

      If you’re breathing, you’re in PR [1]
      Some Do’s and Don’ts and 2.0s for orgs/co’s in cell therapy & ReGEN

      You may be one of them. The scientist who can’t get the job or promotion you want. The company not securing customers fast enough. The investigator not finding collaborators. The company not finding quality employees. The company failing to secure much needed investment. The big company not effectively penetrating new, niche markets like cell therapy-regenerative medicine. The executive or investigator not getting the speaking invites to create the buzz needed to help move things forward.

      Whatever the challenge, consider a healthy dose of marcom. [2]

      Ok, I’m biased and it certainly isn’t a single panacea for all these problems, but seriously. A good profile (personal or corporate) – built from a solid reputation and strong relationship network – can help address almost any challenge you or your company is facing.

      INTRODUCTION

      I know. You don’t believe me. Humor me and answer this one question. If you could double the number of people that know about your company or technology, the number of people that learn, hear, or read something about your research, product or service in the average 30–day period, and/or the number of people that interact with one of your employees or colleagues every week, would that – on the whole – likely help or hinder you in addressing at least some of the primary challenges you are currently facing?

      See where I’m going with this? Even if your challenges are deeply scientific or technical, is it possible to imagine that if only you knew the right person …?

      Your existence depends on human interaction. Your success depends on how well you interact and the impressions you make. The impressions are not solely or even primarily driven by the brilliance of your technology or the compelling weight of your data. This is likely more true than you may think. For those of you who have read Malcolm Gladwell’s book, Blink, you will appreciate just how much people’s perceptions are influenced not by logic, data, or comprehensive consideration but by the judgments of the subconscious in a matter of seconds.

      The PR (public relations) I discuss in the following pages is not spin and it’s not advertising. It’s about establishing and maintaining relationships that result in profile among your various kinds of constituents be they your collaborators, peers, investors, employers, employees, customers, or potential strategic partners.

      Successful people and companies use effective PR to create relationships, turn them into interactive networks, and then leverage them to help solve the challenges they face.

      This has always been true. What are so radically changing today are the tools which people and companies can now employ to conduct effective PR, create relationships, and build networks all at a fraction of the cost, with greater returns, and performed by individuals or small companies not previously capable of affecting global impact. These tools are, of course, online.

      A successful strategy for PR is now increasingly determined by how well online tools are employed to engage in conversation, create relationships, and build profile.

      As it turns out, there are, in my opinion, too few people in this industry who, as yet, understand the power of PR and fewer still who understand the potential of web2.0 to change their fate.

      What I will share with you in the next couple pages is:

      1. why if you’re breathing, you’re in PR - if you can’t avoid it (and I don’t recommend you try), you should learn to embrace it;

      2. the cost of dodging the embrace; and

      3. how you can embrace it.

      POINT #1: YOU’RE IN PR. REALLY.

      There are a zillion reasons why you underestimate the importance of PR in your career or to your company. There are a zillion other reasons why you think online social media is irrelevant to what you do. Let’s look at five.

      1. My company is a research-based, early-stage company conserving burn-rate, with few employees, and nothing to sell. Ergo we don’t have a need for PR stuff like marketing, communications, or profile building.

      There is nothing new but certainly nothing outdated in the adage: Everyone is selling something.

      Don’t pretend you have no one to impress, you have nothing to sell, or that content is the only thing that impresses in the science business. If you thing you have nothing to market, you just haven’t figured out what it is yet.

      Are you looking to recruit quality people? Do you anticipate needing to find and impress new investors sometime this year or next? Would you be interested in engaging in discussions from parties potentially interested in licensing or acquiring some of your IP? Are you looking to impress potential academic or corporate collaborators? Do or will you need to recruit patients for a clinical trial? Do you need to start educating doctors about the potential of your therapeutic or engage them in giving advice about your trial or product? Would you benefit from increased government funding for cell therapy and regenerative medicine? Do you believe there are policy changes that could be made that would benefit this industry?

      A better profile and a wider network of contacts can’t help but help you address these needs. If you have anyone to impress (and everyone does), then you need to be talking with them. Will a bigger and better profile hurt your efforts to find good employees, seduce investors, recruit patients, identify collaborators, secure partners, etc? It’s hard to imagine how.

      At the very minimum, as a member of the life sciences industry you have an obligation to get out of your lab and communicate to the world around you about the science you are so passionate about. As President Obama encouraged in his address to the April 27, 2009 National Academy of Sciences [3], we all have a duty to do a better job of engaging the people around us in a discussion about the importance of science and the science we’re doing.

      2. My company is a big, public, multi-national company with departments that handle marketing, communications, PR, and advertising. Ergo I don’t need to pay attention to these things because they do that.

      Firstly, unless you have tenure, chances are between now and retirement you may want/need/be recruited for another job. A strong, personal “brand” (profile) is certainly a huge asset in terms of ensuring you are successful in finding that job and negotiating the right remuneration.

      Secondly, if you are ever let out of the lab/office or given internet access, you have the capacity to (and likely already) influence your company’s profile and brand. You are either complementing or distracting from your company’s primary messages and brand.

      Thirdly, if you care about your company’s success, don’t assume your company’s department or external marcom firm is doing what needs to be done. Investor relations, marketing and communications firms or departments may be good at investor relations, marketing, and communications but that doesn’t necessarily mean they are good at the kind of profile building that is going to attract and support meaningful business development opportunities or potential investigators, customers, licensees, collaborators, employees, or clinical trial patients.

      Finally, too many big companies haven’t yet figured out how or how to successfully use Social Media. If you’re using Social Media (e.g., Facebook, Twitter, FriendFeed, Digg, etc), you might be able to play a leadership role in being the face of your company on these platforms – just don’t do it without permission!

      3. My company is a science-based company with a technical sale to scientists who are not receptive to glitzy marketing, advertising, PR, and-the-like. Ergo there is little ROI on spending money on these kinds of things. We don’t “do” marketing.

      You may be in a company that believes putting out press releases is an unnecessary distraction from the business of science; or the company that believes that communications is something done only big companies, public companies, stock hustlers, or companies with something to sell.

      Wrong. First you’re working on the assumption that all marketing looks like a drug ad.

      Second your target audience is human. Humans are susceptible to having their perceptions influenced via all the usual means. Even if you don’t want to look at it so crassly, you would have to agree they are susceptible to forming more positive impressions of your company or product if information about it is available, packaged nicely, and easily accessible. You would also have to agree that any impression or sale is easier to make when there is a personal relationship/contact.

      Your network is one of your most valuable assets to you and to your company. Building a global network and industry profile is marketing under what ever name you want to call it.

      4. All this web 2.0 and social media stuff is for tech geeks and kids. They are not my target market and don’t have a critical mass of the kinds of people I need to building profile among.

      Let’s assume for a moment, this is true. If you’re looking to be an attractive employer to potential, young employees you may want to reconsider.

      Secondly, young people grow up and become industry leaders and executives. Is it too early to start shaping their perceptions?

      Thirdly, there is the occasional executive that is actually occasionally influenced by input from their younger employees. I know – it’s crazy!

      Furthermore, it’s not true. For example, I have a very high percentage of c-level executives on my LinkedIn Cell Therapy Industry Group, Jim Till who proved the existence of the stem cell in his ground-breaking nature paper in 1963, is an active poster on Twitter, and the average age of social media users is much older than you believe - check your data.

      5. Twitter-schmitter. Today’s social media sites are tomorrow’s relics. They’re all hype when they launch and then they fall out of favor and are no longer useful. I’m a serious business professional with no time or need for these gimmicks that have no real business applications or executives like me on them.

      If you think LinkedIn, Twitter, or Facebook (my three favorite and most used social media sites) are not going to be around and successful for long enough to have a real impact on your business, you’re definitely one to bet against the odds.

      If you think serious business is not being done and useful business connections being made on these sites (see the last paragraph in the point above), you’re dead wrong. I’ve found customers, employees, and collaborators for my customers using social media in addition to getting them speaking engagements and highlighted in publications.

      The point? Everyone has some kind of PR (marketing, communications, profile building, networking, advertising, community participation, publishing, speaking, etc) to do. Your potential audience, network, and impact are all much bigger than likely believe to be true.

      My guess? You have more than likely significantly underestimated the value of engaging in PR. And, you have likely significantly overestimated the time and financial cost of engaging in PR.

      That brings me to Point #2.

      POINT #2: THERE IS A REAL COST TO YOU AND YOUR COMPANY IN PRETENDING YOU DON’T DO OR NEED TO DO PR.

      All I should really have to do here is refer you back to point #1. The benefits of engaging in PR are the costs for not. Nevertheless, I will briefly expound.

      Your next job, employee, collaboration, investor, customer, patient, etc will be influenced by the profile of you and/or your company. While your CV – comprised of its peer-reviewed publications, presentations, and collegial references – is still an important driver in people’s perceptions in our industry what often makes someone or some company stand out among the others (perhaps even imperceptibly) is the overall profile one has created. One’s profile is increasingly judged online.

      That brings me to revise Point #2 to the following:

      There is a real cost to you and your company in pretending you can/should ignore the PR power of web2.0’s social media.

      I’m going to steal now from my October 2008 blog posting on the subject. [4]

      Only a few minutes ago (relatively speaking in the passage of time) most companies didn't think they needed to have a website or a domain name strategy. This seems as foolish now as ignoring social medial will seem in a few minutes from now.

      In 1995 - a mere 14 years ago - I was a young associate in a downtown law firm making a pitch to a skeptical management committee at a weekend retreat that the firm needed a website and an email "system". It was not an easy sell. They "knew" lawyers would never send their own emails and certainly not use it to communicate with clients. Similarly they were convinced a website would likely not bring in any new clients and existing clients would not likely find a website useful.

      How quickly they were proven wrong.

      We are at a similar technological threshold. Most companies are ignoring the importance of "social media" to their corporate strategy. Most consider using social media an unnecessary "luxury" in exactly the same way websites, domain names, and email were considered by people in their positions only a few years ago. They do not understand how social media is already changing the way they do business, the importance of staking position/profile early, nor the pain they will feel in the very near future for having failed to be proactive in building and leveraging online communities.

      This is very understandable. In times of fiscal constraint one tends to focus on that which hurt you yesterday or causes you the most pain today. Nonetheless, the companies that will succeed tomorrow are looking at tomorrow now and preparing for it. Tomorrow's mainstream business activities involve social media as much as today's involves website and email.

      For those thinking that this will be true only for businesses that deal direct with the retail consumer, they’re dead wrong. If you have a constituency that you need to keep informed about and actively engaged in your company, then this applies to you. Whether its business (B2B) customers, investors, media, patients, recruits, employees, or collaborators, they are online and engaging in social media. If you're not there, they're listening to and engaging with someone else.

      LinkedIn now has 42 million members with 1,945,047 members who identify themselves in biotech, pharma, or healthcare. Some 300,000+ of them are in biotechnology. There are 293 biotechnology groups in LinkedIn and 375 biotechnology groups on Facebook. The LinkedIn cell therapy industry group has 400+ members engaging in active discussions and exchanges of information in the public forum and using the platform to make and strengthen connections offline.

      Bottom line? There are so many different kinds of social media out there that can be used to reach so many different kinds of audiences at a fraction of the cost of traditional media that it's just good business to figure out how to use it to your advantage. In fact, you may be feeling the pain of ignoring it already and just don't know it...

      Which brings me to point #3.

      POINT #3: WEB 2.0 HAS PUT THE ABILITY TO DO EFFECTIVE, LOW-COST PR IN YOUR HANDS. THERE ARE NO MORE GATEKEEPERS.

      The internet has blown the sense of community up and redefined it. Gone are the days when it was feared the web would destroy “community”. Instead web 2.0 is all about creating more and larger communities than we ever thought possible eliminating all kinds of barriers and cutting across all kinds of definitions.

      It used to be (before web 2.0) that corporate profile, marketing, communications, PR, advertising was all quite carefully controlled by managing the one-way push of information to the open receptacles we called “readers” or “audience”. If you wanted a global profile, you needed a global PR firm.

      Just like the internet has taken the magic out of the business of travel agents, web 2.0 has forever changed the grip that marketing, communications and PR firms had on the business of managing global corporate profiles. Similarly, a global profile is no longer only the purview of companies sufficiently large to retain the services of such firms or have big, internal PR departments.

      Just as the information on how to build long-range missiles is no longer the exclusive domain of rocket scientists, with the empowering tools of web 2.0, successful marcom can now be effectively done by subject-matter experts who are not big-budget marcom professionals.

      It’s why newspaper are dying and bloggers are thriving. It’s why small companies are building niche profiles that beat out their Fortune 500 competitors. It’s why startups can have a global profile in weeks on next-to-no budget.

      All of that is a rather lengthy introduction to primary point of this article:

      In this new world of interconnectedness and easy-to-access information, it is easier than ever for everyone and anyone to influence the profile of a company and what it is offering to the world. That’s the good news. The bad news is that you are expected to. All of which leads to one not-so-original observation of the impact of web 2.0 on companies.

      If you’re breathing with an internet connection, you can and should have significant and immediate impact on the awareness and perceptions of your company among people around the globe.

      If you’re not creating global awareness and positive perceptions, it may be assumed you’re terminally short of breath.

      Like it or not. You can’t help it and you certainly can’t avoid it. And the people forming these perceptions are not just the potential customers of companies with something to sell – they’re current or potential investors, partners, collaborators, patients, purchasers, journalists, regulators, policy-makers, employees, employers, etc.

      LIGHTS, CAMERA, ACTION

      So what can you do to begin leveraging the power of the PR tools at your fingertips and turn a bungalow profile into a chateau; a respectable list of contacts into a vibrant, enviable network of relationships?

      10 Ways to a Better Profile for RegenMed and Cell Therapy Organizations

      I’ll start with some rules that apply regardless of the PR platform you’re employing (e.g., traditional ones like conference presentations or journal publications or web2.0 ones like blogging or social networking).

      1. You need to have a communications strategy and then mandate and empower your people to communicate your message/story to your audiences.

      This doesn’t have to be complicated. It’s about defining your primary/secondary audiences, messages, keywords, and tactics to accomplish your primary/secondary goals.

      2. Talk about what you’ve done not about what you’re going to do.

      It is very rare that news about what you are going to do is really newsworthy. Don’t be tempted to put out a press release that’s not news just because you haven’t put one out in awhile. For example, a press release that your executive is going to speak at a conference is not news unless they are presenting new data or they are the keynote at the biggest conference of the year. That doesn’t mean you can’t post it on your website or let your network know in other ways but the press release should be used judiciously.

      3. Make sure you tell the market story not just the science story. Similarly, be clear about what problem your technology solves not just how brilliant it is.

      4. Be upfront about the limitations of your product/service. Don’t try to pretend you have the perfect product/service. Don’t try to be everything to everyone – defining who you are (your company and its product/service profile) is just as much what about what it is than what it is not.

      5. Avoid the temptation to promise when you will do something by (e.g., begin or end your trial, submit your IND, launch your product, etc) unless it’s the subject of a contractual obligation. There are too many unknowns that may prevent you from meeting the expectation you created. The ensuing disappointment will hurt your profile and perceptions of your company and its product/service and management.

      6. Don’t over communicate your regulatory interactions with the FDA – this is one area where the less said is often better.

      7. Wait on that hiring announcements just a little while. It’s critically damaging to put out a press release that now has a very, long online life outside of your control announcing the hire of a key executive only to have him/her not last beyond the first few weeks.

      8. Understand that communications, marketing and profile building are very different from advertising. Act accordingly.

      9. Value the untapped potential of your existing customers and prospects to spread your gospel.

      One of the real discoveries from social media is the alarming willingness of people to zealously proselytize on behalf of companies and products win which they believe. Find ways to actively engage them in doing so. [5]

      10. Engage online.

      The 8-step Plan to Enhance your Online Profile and Network

      1. SEO.

      If you’ve decided your profile matters, then your online profile really matters. The fastest way to an impressive online profile is Search Engine Optimization. There are a lot of tricks up the SEO tricksters sleeve and I’m not about to give them all away but suffice it to say that SEO is a multi-pronged attack and there are many arrows in the quiver each with a different use to the same end: higher rankings on the major search engines = increased traffic to the website = greater profile = whatever your end goal is (sales, investors, collaborations, changing the world, etc).

      2. Listen & Monitor.

      Whether you employ Google Alerts, Twitter search tools, or simple subscriptions to topical news services or blogs, there is a lot of content and discussions being added to the internet every day. You will likely be amazed how much (or how shockingly little) your company and product/service is being discussed and who is behind the discussions. Listening to and reading what’s going on the internet will get you intel about your competitors, new ideas for potential products or studies, new leads for potential collaborators or customers, etc.

      3. Follow/Subscribe.

      Find your favorite content providers, writers, resources, publications, etc and follow or subscribe to the content their pushing out and discussions they are leading.

      4. Join

      There’s no harm in joining. People join for all different reasons. There’s no problem in being an observer. In fact it’s likely best you just observe for a while after you join to assess the flavor of the group and discussion so when you do participate you don’t offend.

      5. Participate

      Once you’re comfortable, start to participate. Engage in discussion, exchange information, and above all make sure you are providing value to the other participants not just talking about yourself. This will be punished.

      6. Connect (yourself and others)

      There’s a reason why these are called online networks or communities. Use them to connect with people not just for the sake of building a bigger ‘friends’ list but because you have something in common and want to begin building a relationship.

      7. Create

      Be original. Create something of value you can share. That might just be facilitating a channel in which 3rd party information is exchanged. It might be you writing original content. It might be facilitating introductions.

      8. Enjoy and don’t offend.

      Most importantly find the online networks that you enjoy, that give something of value to you, then contribute value in return and ensure you don’t offend the rules. Nothing slaps harder than an online, viral slap from a community you’ve offended online. [6]

      CONCLUSION

      Don’t pretend you have no one to impress. Everyone needs to engage in PR.

      Even in the business of science, man cannot live on data alone. You need more than just solid content to affect the kind of impressions that will be critical to your success. Don’t let your data or career speak for itself – it can’t talk.

      Web 2.0 has made it exponentially easier – if not expected - to engage in PR and profile building.

      What’s missing from this article is the web 2.0 tools I’d recommend you use to put the 8-step plan in place. For that, watch here for further blog postings on the subject. See what I did there?

      [1] In this article, I use “PR” not to mean “public relations” as you may have come to understand it used but rather simply to mean any kind of relating to the public via marketing, communications, writing, profile building, networking, advertising, community participation, publishing, speaking, proselytizing, lobbying, etc. It’s a not-so-dirty little secret that we all do it in one form or another or several all at once.

      [2] Marketing & communications

      [3] See http://www.youtube.com/watch?v=k5-MgZD5IMc at around the 30 minute mark.

      [4] Oh, I haven’t mentioned my blog? It’s at http://www.celltherapyblog.com/. Of course if you are a subscriber, this will be a refresher. For those who haven’t read this on my blog, you would have benefited from reading these same thoughts back in October 2008 if you had been a blog subscriber, or if you followed me on Twitter (I’m @celltherapy) or if you were connected with me on LinkedIn (http://www.linkedin.com/in/celltherapy). I’m just saying…

      [5] One the flip side these same people will use these same tools to punish companies mercilessly for offending them or the rules of social media.

      [6] Just ask Johnson & Johnson about the power of mommy bloggers. Look it up.



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