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Prevent issues through lifetime of medical care – Lima Ohio

August 3rd, 2017 10:43 am

Primary care is where preventative medicine takes place. It is the job of your primary care provider or family doctor to help you prevent illness or disease from occurring. Your health and well-being is our No. 1 priority. Our goal is to protect you from disease, promote and maintain your good health and prevent disability or even death. Preventative medicine involves many things from the simple to the complex and from the young to the elderly.

As a primary care provider, it is my responsibility to manage my patients chronic medical conditions and provide information and education on how to prevent chronic illness. This is accomplished through resources and one-on-one teaching about healthy lifestyle choices and preventative screenings.

Starting with the very young, well-child examinations are vital to ensure the child is growing and developing as a normal child should. As a primary care provider, I measure developmental milestones with each year of age. These exams occur from the time the child is born until the adolescent becomes an adult at 18 years of age. Vision and hearing screening as well as immunizations are an important part of preventing disease and keeping children well. Dental screenings are essential to prevent cavities and other more serious mouth issues. Parents are educated on the proper nutrition, activities and healthy habits that will help children learn and grow. This is where prevention starts! Teaching children good healthy habits now prevents them from becoming obese, having type 2 diabetes, joint problems, cavities and many other ailments. Mental health screenings are also performed as children grow and become more like adults during their middle and high school years.

Young adults are the next area of focus for preventative medicine. Similar to children, hearing and vision screenings are performed and good dental health habits are encouraged by keeping regular checkups. Immunizations continue with young adults to include HPV, meningitis, TDAP and annual flu vaccines. Sexually transmitted disease screenings and PAP smears begin with young adults. Educating young adults on alcohol, tobacco and drugs continues. Many aspects of safety to prevent accident or injury are discussed as well. All of the education provided to children continues into adulthood, with emphasis on issues like diet, exercise and avoiding risky behaviors.

Middle age is another very important era where preventative medicine continues to build. In addition to the preventative topics already shared, patients now become more regularly engaged with regard to routine check-ups to monitor weight, blood pressure and blood work to screen for high cholesterol or even thyroid issues. Mammograms to screen for breast cancer, PSA levels/prostate exams to screen for prostate cancer, PAP smear exams for cervical cancer screening and annual immunizations are done. Chest X-rays and low dose CT scans of the lungs are completed for smokers and smoking cessation options are discussed and encouraged. Screening for alcohol abuse is involved as well.

As we continue to age and approach our senior years of life, preventative medicine remains crucial. Pneumonia and shingles vaccine are very important in this age group as these immunizations can help prevent these infections from occurring or reduces the severity if they do occur. In addition, DEXA scans to monitor bone density looking for osteoporosis begin. This is the top of the pyramid, so to speak, as all of the other things we taught the little ones in the very beginning of life are the base.

Preventative medicine expands throughout the lifespan from infancy to the elderly. There are many areas of prevention that I have not covered in this short article, so it is vital to have an appointment scheduled with your primary care provider or family physician. Your health truly is your wealth. Making routine visits with your primary care provider when you are healthy could prevent you from a long-term chronic illness in the future.

Dr. Lorina Zenz is a certified nurse practitioner with Lima Memorial Internal Medicine & Family Healthcare.

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Pharma and proactive, preventative healthcare: how to use the pharmacy channel – pharmaphorum

August 3rd, 2017 10:43 am

Across Europe, a shift towards greater prevention, earlier diagnosis and treatment is needed in order to contain the growing cost of healthcare.

But how can healthcare systems make this transition and how do pharmaceutical companies play a role in this, while also growing their market?

A forthcoming webinar hosted by pharmaphorum with sponsor PHOENIX group looks at how harnessing the data and expertise of pharmacies, and via greater engagement with patients, consumers and shoppers can meet this emerging need.

Key topics include:

Why watch the webinar?

The expert panel will provide practical advice and real-life examples of how pharmaceutical companies can work with pharmacies to grow their market and better serve patient needs.

Thelive webinar will take place on Wednesday 6 September at 14.00 GMT/15.00 CET/09.00 EST. To register, please click here or on the button above/below.

Participants

John Munson, Head of Global Accounts, MylanJohn Munson is the Head of Global Accounts at Mylan, responsible for the account management of global customers and key European accounts. John joined Mylan in the UK in 2007 as Sales & Marketing Director and moved into the Country Manager role for the UK & IRE before taking up his current position. John has a 20 year history in pharmaceuticals with roles at Astra, Ivax and Ranbaxy and during his time at Mylan he has also held the position of Area Director for Northern and Western Europe. John studied Business, Finance and Marketing in Bournemouth and later gained an MBA from the same college. He is also a Member of the Chartered Institute of Marketing.

Nemanja Jankovic, Head of Commercial Partnerships Europe, PHOENIX groupNemanja Jankovic heads the Commercial Partnerships at PHOENIX group and is responsible for strategic cooperation with the pharmaceutical industry on a European level. After working in the pharmaceutical industry for many years, the experienced market expert joined PHOENIX group four years ago.

Nina Felton, Head of Business Intelligence, PHOENIX groupNina has extensive experience in the healthcare industry,having worked for companies such as Pfizer and Wyeth in marketing and sales roles, which involved the launching of new products. She also worked for over 12 years with IMS Health in their management consulting division. Nina started her career as a biochemist and has gained experience as the Managing Director of a primary market research company, in medical communications and is a qualified psychotherapist and executive coach. She joined the PHOENIX group two years ago and is responsible for developing their new initiatives in Business Intelligence, working across Europe.

Andrew McConaghie,Managing Editor, pharmaphorum (moderator)Andrew is pharmaphorums managing editor, feature media. He writes on a range of topics covering pharmaceutical and biotech R&D, marketing and market access, and issues affecting patients and global healthcare systems, especially the UKs NHS.

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CHI St. Luke’s heading to Valley Ranch in far northeast Houston area – Chron.com

August 3rd, 2017 10:43 am

By Nancy Sarnoff, Houston Chronicle

A rendering of Vivacity at Valley Ranch.

A rendering of Vivacity at Valley Ranch.

A site plan of Valley Ranch.

A site plan of Valley Ranch.

At more than 1.5 million square feet, the retail portion of this development is bigger than the Woodlands Mall and is considered 2016's biggest retail project in the Houston area.

At more than 1.5 million square feet, the retail portion of this development is bigger than the Woodlands Mall and is considered 2016's biggest

An outdoor ampitheater with seating for approximately 10,000 people is in the conceptual phase.

An outdoor ampitheater with seating for approximately 10,000 people is in the conceptual phase.

The entertainment district will also include a splash pad and Cinemark movie theater.

The entertainment district will also include a splash pad and Cinemark movie theater.

Plans for the development's medical district include an acute care hospital and 500,000 square feet in medical office buildings.

Plans for the development's medical district include an acute care hospital and 500,000 square feet in medical office buildings.

The commerce district will include a full-service hotel, conference center and Class-A office space, set to attract a large corporate relocation.

The commerce district will include a full-service hotel, conference center and Class-A office space, set to attract a large corporate relocation.

Academy Sports + Outdoors will be the first business to open at Valley Ranch, with a soft opening on Sept. 23 and a grand opening on Sept. 30, 2016.

Academy Sports + Outdoors will be the first business to open at Valley Ranch, with a soft opening on Sept. 23 and a grand opening on Sept. 30, 2016.

Other businesses moving into the center include Hobby Lobby, Sam's Club, a Kroger Marketplace, an array of fast food restaurants and more.

Other businesses moving into the center include Hobby Lobby, Sam's Club, a Kroger Marketplace, an array of fast food restaurants and more.

The northwest corner of the property will include 500 garden-style, multi-family units.

The northwest corner of the property will include 500 garden-style, multi-family units.

New Caney ISD's Texan Drive football stadium, opened in 2014, is near the town center.

New Caney ISD's Texan Drive football stadium, opened in 2014, is near the town center.

Five home builders have joined Valley Ranch, and developer The Signorelli Co. expects the community to sell out in two to three years.

Five home builders have joined Valley Ranch, and developer The Signorelli Co. expects the community to sell out in two to three years.

The developer boosted the 1,400-acre development's non-residential percentage to 50 percent after realizing the area's demand for entertainment, healthcare and business options.

The developer boosted the 1,400-acre development's non-residential percentage to 50 percent after realizing the area's demand for entertainment, healthcare and business options.

Residents in East Montgomery County fought to change the liquor laws back in 2006, which helped set the stage for new developments.

Residents in East Montgomery County fought to change the liquor laws back in 2006, which helped set the stage for new developments.

CHI St. Luke's heading to Valley Ranch in far northeast Houston area

A local developer has inked a deal with CHI St. Luke's Health to be part of a new medical district proposed in the far northeast corner of the Houston area.

The Signorelli Co. said the "partnership" with the hospital group is a first critical piece in creating a complex that addresses the next generation of health care. Plans for what the hospital would build were not released.

The medical district will comprise 186 acres in Valley Ranch, a 1,400-acre planned community in the New Caney areaat the intersection of Grand Parkway and U.S. 69.

RELATED:Once rural area north of town attracts development

The Woodlands-based developer has branded the project "Vivacity." Its master plan calls for more than 2.5 million square feet of health, wellness and life science facilities along with hospitality, retail and other services.

"Vivacity is focused on becoming the destination where emerging preventative wellness and Personalized Medicine will be brought to the individual in a unique, patient-friendly environment," Signorelli's Tom Wittenberg said in an announcement.

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10 Things You Never Knew About Chakras By Patricia Mercier – FemaleFirst.co.uk

August 3rd, 2017 10:43 am

3 August 2017

Chakras are amazing! If you havent heard about them before here are the top ten things you need to know.

The Little Book of Chakras

Chakras have been known about in India since ancient times possibly for 5,000 years.

Chakras are our vital link to the energy that keeps us alive. In yoga terms this is called Prana.

Like electricity, chakra pranic energy cannot be seen or touched, but lack of it results in increasing levels of physical illness, whilst balanced chakra energies bring vitality, mental strength, management of anger, inner sight, tranquillity and compassion to name just a few qualities.

Looking after our chakras and auric field is preventative medicine, an energy medicine that keeps us well. Imagine these energies playing together in a dance of nourishing rainbow coloured light bringing this essential energy into your body and returning any unwanted or disharmonious thoughts, feelings and energies into the earth.

Chakras do this for us all the time we dont even have to think about it, but if we do it improves our conscious connection to our body, mind and what some call spirit.

Yogic teaching tells us that there are seven major chakras and around twenty-one minor ones.

Focussing upon each of our seven major chakras in turn (from Base to Crown) means that their delicate coloured light frequencies can be fine tuned and balanced, leading to optimum health and wellbeing.

There are many ways to re-balance our chakras, including Yoga asanas, correct breathing, aromatherapy oils, crystals, herbs, mindfulness meditation and other stress reduction techniques.

Our chakras respond to colour, in our environment, in meditational visualization and even in the colours of the clothes we choose to wear.

When our chakras are functioning well, we become like a rainbow of energy to those gifted people who can see auras. Actually, we know our own chakras very well after all they are with us all the time!

Discover all you need to know in Patricia Merciers latest book, The Little Book of Chakras, just published by Gaia/Octopus, brings chakra teachings to life with easy explanations of chakras and prana and how they can be balanced with simple relaxation techniques, colour, essential oils, yoga and meditation. She is also the author of the best-selling The Chakra Bible, The Complete Chakra Workshop, other books on Chakras, New Awareness, Maya Cosmovision, as well as being a trained yoga teacher and holistic healer/practitioner.

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Crosstalk: It’s time to stop the nonsense – Dalles Chronicle

August 3rd, 2017 10:43 am

Before I dissect the Democrats Better Deal for America, which is just repackaging of the same tired socialistic schemes that have always failed and will always fail, I want to address the dysfunction of Republicans in Congress.

It appears our squishy GOP leaders cant find their way out of a sock. What is wrong with you people? Voters gave you the House, the Senate and the White House in November so why are you not getting anything done?

We expected you all to get to work reversing the destructive health care policies, and others, enacted by the Obama Administration. Instead, you wring your hands and offer a Skinny Obamacare Repeal that does nothing. Are you kidding me right now?

The horrible and largely unvetted health care plan approved by Democrats only hours after it was unveiled in 2010 is on life support and you promised to pull the plug.

I suggest Republicans in the Senate review the U.S. Constitution to refresh themselves on its guiding principles. That will probably be much less exciting than planning your next campaign but then, you probably are going to get kicked to the curb if you dont get your act together. Do what you say and say what you mean.

Republicans, you must grow a spine and stand against the craziness being perpetrated by Democrats, who should be ashamed of their infantile behavior. Their obstruction is unprecedented, borders on madness and threatens to unravel the underpinnings of our government.

As just one example, President Obama had 206 of his nominees for judicial and administration positions confirmed by the Senate in the first six months of his administration. Trump has only managed to get 55 nominees throughDemocratic roadblocks, even when the individuals are non-controversial.

Gridlock does not benefit the 323 million Americans that Congress is supposed to represent. Enough of this nonsense.

The Democrats and the left-media are defining the narrative and you, the GOP leaders, are allowing that to happen by not uniting and getting out a clear message about the need for change.

This is the defining battle of our times for the heart and soul of our culture and the Democrats Better Deal clearly outlines how high the stakes are.

As usual, liberals offer three empty slogans: Better jobs, better wages and a better future. Although the rhetoric sounds great, you cannot achieve any of those goals when you are over-regulating businesses and spending more money than the government takes in.

Our national debt is perilously high and our industries are being choked by red tape that is driving them out of the country or out of business.

Nancy Pelosi, the princess of the Democratic Party, gushes about the Better Deal creating 10 million more American jobs in the next five years.

Of course, the way to pay for this is to impose even tougher standards and more regulations on evil corporations, you know, the ones actually creating the jobs.

Democrats seem oblivious to the fact that eight years of excessive regulations was the primary reason for the slowest period of economic growth in our nations history.

There is nothing in the Better Deal about letting the free market create the competition needed to lower prescription drug costs or reverse any of the other failed policies that Americans have rejected at the ballot box.

Every proposal that Democrats have made is the antithesis of what our founders intended for America: Less government, more freedom and more individual rights and responsibilities.

Republicans, the people have nowhere to go to get order restored if you continue to be cowards.

Do something about this mess, and do it now. More than two million soldiers, sailors, airmen and Marines have died to defend our way of life. You owe it to them to do your part in your time.

If the GOP cant get it together, and if Democrats refuse to see that the people dont want their regressive proposals, then there is no hope to stop Americas slide into mediocrity, or worse.

Unless the people finally realize that only term limits will truly drain the swamp of corrupt politicians.

RaeLynn Ricarte

When RaeLynn suggest the Democrat's Better Deal as a crosstalk topic I hadn't heard much about it.

Presented early this week, the Better Deal has three components: raising wages, lowering costs, and giving workers "the tools to succeed."

A quick look below the rhetoric, and there is very little better, and nothing new, in this deal: A major infrastructure overhaul, but with few details as to what that means or how it will be funded; an increase in the minimum wage; and lowering costs (the party promises to "lower the crippling cost of prescription drugs and the cost of a college or technical education that leads to a good job.")

It also says it "will fight for families struggling with high monthly bills like childcare, credit card fees, and cable bills."

In Oregon we have just raised the minimum wage, and for years now the Oregon Health Plan has promised to lower the cost of health care and prescription drugs: The theory was that having more people covered would lower the overall cost of care, preventative medicine being cheaper than emergency care.

Instead, a great deal of money was spent with little or no return and the state is seeking to increase taxes and fees to replace the federal seed money to keep a flawed system afloat.

I'll speak more to this, but since RaeLynn said she was going to start off railing at the Republicans I have to take a moment to speak in their support:

I am pleased to report that, according to New York Times White House correspondent Mark Lander in an interview on National Public Radio's Fresh Air, both the House and Senate have passed legislation meant to tie the hands of President Trump regarding Russian sanctions.

Once reconciled, the bill will go to the president for his signature. Lander noted the president will have little choice but to sign it... although as we have learned you never really know what Trump will do.

In the same interview, Lander reported that suggestions Trump will fire Attorney General Jeff Sessions have also hit opposition from the Republican-controlled House and Senate, whose leadership has threatened to block even a temporary interim replacement.

While I personally think Sessions has his legal head buried in the sand of the mid-1980s with his drug war and three strikes mentality, I find it encouraging that the Republican Party is opposing Trump on these issues.

Where was I? Oh yeah, the economy. The idea of closing the skill's gap in America sounds fine and Democratic, but as Pedro Nicolaci da Costa writes in an opinion piece for the Business Insider, Heidi Shierholz, former chief economist at the Labor Department, has a great saying when it comes to an alleged 'skills gap' in the job market: 'If you hear an employer complain they cant find skilled workers, always ask, at what wage?'

Research shows that if such a gap really existed, wages would be rising more quickly because of a shortage of available workers, and companies would not be shy about investing in training themselves, Costa said.

American companies are rushing to outsource a host of jobs from creative work to product descriptions to English-speaking countries in Africa and elsewhere, where individuals contract to work from home via the internet at fantastically low wages.

I understand you can have an app built for $50, which calculates out to something like 10 cents an hour, according to a friend who does that sort of thing.

Thousands of long-haul semi-truck drivers are looking forward to being replaced by robotic convoys. College graduates struggle to find living-wage employment, skilled though they may be.

We don't need a New Deal re-named to be a Better Deal, with all the economic shadow puppets and hype thrown out by both Republicans and Democrats. We need real solutions focused on real needs and threats to our economy.

We don't have a skill gap, we have a wage and wealth gap, an environmental crisis and we are rapidly approaching a time when the words refugee and immigrant will be used not for those fleeing war or economic collapse abroad but for Americans fleeing economic collapse within America itself.

Mark Gibson

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Opinion: Human genome editingwe should all have a say – Phys.Org

August 2nd, 2017 11:53 am

Mitalipov's team is not the first to genetically modify human embryos. This was first accomplished in 2015 by a group of Chinese scientists led by Junjiu Huang. Mitalipov's team, however, may be the first to demonstrate basic safety and efficacy using the CRISPR technique.

This has serious implications for the ethics debate on human germline modification which involves inserting, deleting or replacing the DNA of human sperm, eggs or embryos to change the genes of future children.

Ethically controversial

Those who support human embryo research will argue that Mitalipov's research to alter human embryos is ethically acceptable because the embryos were not allowed to develop beyond 14 days (the widely accepted international limit on human embryo research) and because the modified embryos were not used to initiate a pregnancy. They will also point to the future potential benefit of correcting defective genes that cause inherited disease.

This research is ethically controversial, however, because it is a clear step on the path to making heritable modifications - genetic changes that can be passed down through subsequent generations.

Beyond safety and efficacy

Internationally, UNESCO has called for a ban on human germline gene editing. And the "Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine" the Oviedo Convention specifies that "an intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants."

In a move away from the positions taken by UNESCO and included in the Oviedo Convention, in 2015 the 12-person Organizing Committee of the first International Summit on Human Gene Editing (of which I was a member) issued a statement endorsing basic and preclinical gene editing research involving human embryos.

The statement further stipulated, however, that: "It would be irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application."

Mitalipov's research aims to address the first condition about safety and efficacy. But what of the second condition which effectively recognizes that the human genome belongs to all of us and that it is not for scientists or other elites to decree what should or should not happen to it?

Modification endorsed

Since the 2015 statement was issued, many individuals and groups have tried to set aside the recommendation calling for a broad societal consensus.

For example, in February 2017, the U.S. National Academy of Sciences and National Academy of Medicine published a report endorsing germline modification. It states unequivocally that "clinical trials using heritable germline genome editing should be permitted" provided the research is only for compelling reasons and under strict oversight limiting uses of the technology to specified criteria.

Seeds of change in Canada

In Canada, it is illegal to modify human germ cells. Altering "the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants" is among the activities prohibited in the 2004 Assisted Human Reproduction Act.

Worried that "Canadian researchers may fall behind on the international scene" and that "restrictive research policies may lead to medical tourism," the Canadian Institutes for Health Research (with input from the Canadian Stem Cell Network) has begun to plant the seeds of change.

In its Human Germline Gene Editing report, CIHR hints at the benefits of changing the legislation. It also suggests professional self-regulation and research funding guidelines could replace the current federal statutory prohibition.

Future of the species

With the recent announcement of Mitalipov's technological advances and increasing suggestions from researchers that heritable modifications to human embryos be permitted, it is essential that citizens be given opportunities to think through the ethical issues and to work towards broad societal consensus.

We are talking about nothing less than the future of the human species. No decisions about the modification of the germline should be made without broad societal consultation.

Nothing about us without us!

Explore further: Genome editing in human cells

This article was originally published on The Conversation. Read the original article.

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Patents in Brazil – Lexology (registration)

August 2nd, 2017 11:53 am

What are the criteria for patentability in your jurisdiction?

A creation must first be considered an invention or utility model. There is no statutory definition of invention, although the Brazilian Patent Statute does provide a list of what is not an invention. A utility model, on the other hand, is defined as an object of practical use or a part thereof.

To be patentable, an invention must meet the requirements of novelty, inventiveness and industrial applicability. Utility models share the same requirements of novelty and industrial applicability, but the level of inventiveness required for utility models is lower than that required for inventions.

What are the limits on patentability?

The Patent Statute stipulates that the following are not considered to be inventions or utility models and are therefore unpatentable:

To what extent can inventions covering software be patented?

Only the softwareper se that is, the source code is excluded from patentability. Any technical result obtained from a given software can be patented (eg, a method carried out by software instructions and systems or devices affected by software instructions). The Brazilian Patent and Trademark Office (BPTO) Examination Guidelines state:

An industrial creation process or product associated with the process implemented by a computer program, which solves a problem found in the technique not solely concerning the way in which this computer program is written, can be considered an invention.

To what extent can inventions covering business methods be patented?

Business methodsper seare not patentable. However, the simple fact that a method has a commercial nature does not necessarily render it ineligible for patent protection. The claimed matter must be analysed as a whole, particularly if it solves a technical problem. For example, a method for authenticating a user for a financial transaction and a method for increasing the security of bank accounts both constitute patentable subject matter.

To what extent can inventions relating to stem cells be patented?

Stem cells are not eligible for patent protection a claim directed to a stem cell in its preamble will be rejected. Natural living beings (eg, animals), in whole or in part (eg, cells), are excluded from patentability even if they are in modified or recombinant form. Therefore, cells derived from animals are not considered to be inventions in Brazil.

However, compositions containing stem cells, the processes of obtaining stem cells and applications (ie, uses) thereof may be patentable if they do not imply or include a therapeutic or surgical method.

Are there restrictions on any other kinds of invention?

Yes, the Patent Statue sets out additional limitations on patentable subject matter. The following are not patentable:

Grace period

Does your jurisdiction have a grace period? If so, how does it work?

Yes. Any disclosure of the invention or the utility model made within one year before filing the application in Brazil or the priority date claimed will not be considered as a prior art reference, provided that such disclosure is made by:

Oppositions

What types of patent opposition procedure are available in your jurisdiction?

Pre-grant and post-grant oppositions are available. Pre-grant oppositions essentially entail submitting observations up to the end of the patent application examination period. It is not a formal opposition procedure, inasmuch as the applicant is not obliged to submit a response. The BPTO examiner will take into account any submitted observations during the substantive examination phase. Post-grant oppositions, on the other hand, must be formally commenced by a party with a legitimate interest within six months from grant. The patentee will be notified to respond within 60 days, after which a first opinion from the BPTO concerning the nullity request will be issued. Both parties will then have 60 days to submit their final considerations.

Apart from oppositions, are there any other ways to challenge a patent outside the courts?

Yes. If a patent application is rejected after substantive examination and the applicant decides to appeal, it is possible for a third party to submit counterarguments to the appeal within 60 days of its publication.

How can patent office decisions be appealed in your jurisdiction?

Before the BPTO or the courts.

Timescale and costs

How long should an applicant expect to wait before being granted a patent and what level of cost should it budget for?

The average backlog at the BPTO is around 11 years. This timeframe may increase, depending on the technical nature of the application (eg, backlogs for telecoms and pharmaceutical applications can extend up to 15 years). In view of this, applicants should consider using some of the fast-track options available. Costs will depend on the complexity of each matter, but applicants should budget $10,000 on average.

Enforcement through the courts

Strategy

What are the most effective ways for a patent owner to enforce its rights in your jurisdiction?

Filing an infringement suit before a state trial court is the best way to enforce patent rights in Brazil. The patent owner can request the court to grant preliminary injunctive relief against the infringer. In practice, the legal standards for obtaining injunctions are relatively low when compared to other jurisdictions, since there is no need to give notice to the defendant or to post a bond or give security, and typically there are no discussions regarding the balance of hardships or public interest. This makes Brazil an attractive jurisdiction for patent owners seeking to enforce their rights.

What scope is there for forum selection?

As a general rule, the plaintiff must file the suit before the state trial court of the venue where the infringer is headquartered. Nevertheless, patent infringement suits in which damages are claimed alongside restraining orders may be filed wherever the infringement is taking place or even where the plaintiff resides.

Pre-trial

What are the stages in the litigation process leading up to a full trial?

First, there is a mandatory conciliation hearing as an attempt at alternative dispute resolution, unless both parties indicate that they have no interest in doing so. Thereafter, if no agreement is reached, the parties are entitled to file briefs with their arguments and to present documents in support of their case. At this stage, it is common to file technical and legal opinions prepared by renowned scholars or experts in their respective fields. Next, the judge decides on the controversies that need to be resolved and an unbiased court-appointed expert prepares a technical report regarding the case. Courts typically rely on the technical report prepared by the court-appointed expert. After this, the parties can file briefs in response to the technical report prepared by the court-appointed expert and can present final arguments. Finally, the judge in charge of the case issues a decision on the merits (bench trial).

How easy is it for defendants to delay proceedings and how can plaintiffs prevent them from doing so?

Most of the delay depends on the judges schedule and willingness to rule on the case. Another factor is the time that it takes the court-appointed expert to deliver the technical report. Defendants often try to delay the proceedings by filing pointless motions, unnecessary questions for the courts expert or unnecessary interlocutory appeals. However, the new Federal Rules of Civil Procedure (adopted in 2015) provide parties fewer appeal opportunities, which makes delaying attempts less effective. Also, it is now harder to delay the proceedings because such attempts may be punished by a court-issued fine. Nevertheless, if the plaintiff can obtain preliminary injunctive relief, the defendant will have no interest in delaying the procedure.

How might a party challenge the validity of a patent through the courts in anticipation of a potential suit for infringement being issued against it?

Brazil has a bifurcated system (similar to the German and Japanese systems) whereby invalidity suits must be filed in separate court proceedings before federal district courts (while infringement actions are filed before state trial courts).

At trial

What level of expertise can a patent owner expect from the courts?

Most patent-related cases are filed before the courts sitting in Rio de Janeiro, Sao Paulo and Brasilia. Except for certain judges in these jurisdictions, most Brazilian courts have no expertise in patent law.

Are cases decided by one judge, a panel of judges or a jury?

Cases are decided by a single judge at the first-instance trial level and by a panel of appellate court judges at the appellate level. Juries do not decide IP-related disputes in Brazil.

If jury trials do exist, what is the process for deciding whether a case should be put to a jury?

Not applicable.

What role can and do expert witnesses play in proceedings?

Expert witnesses play a key role in convincing the judge to grant or reject a request for preliminary injunctive relief. Moreover, they work with the unbiased court-appointed expert during the expert examination, addressing questions to him or her and delivering opinions on his or her technical report.

Does your jurisdiction apply a doctrine of equivalents and, if so, how?

Yes, the Patent Statute provides for patent infringement on an equivalence of means basis. However, it does not set out the criteria for applying the doctrine of equivalents and there is no binding precedent establishing a test or standard for applying the doctrine.

Is it possible to obtain preliminary injunctions? If so, under what circumstances?

Yes. The legal requirements for obtaining injunctions arefumus boni juris(ie, there is a likelihood of the complaint being decided in favour of the plaintiff) andpericuluminmora(ie, immediate measures are needed to cease the infringement and thus prevent the plaintiff from bearing further damages).

How are issues around infringement and validity treated in your jurisdiction?

Infringement suits must be brought before state courts, while invalidity suits must be brought before federal courts against both the patent owner and the Brazilian Patent and Trademark Office.

Will courts consider decisions in cases involving similar issues from other jurisdictions?

Attorneys typically quote foreign precedents in support of their arguments, particularly when there is no Brazilian precedent or rule dealing with the issue. However, judges rarely cite foreign cases or rely on them to ground their own decisions.

Damages and remedies

Can the successful party obtain costs from the losing party?

The prevailing party may recover a small part of the attorneys fees, in addition to court costs and the fees charged by the court-appointed expert.

What are the typical remedies granted to a successful plaintiff?

A permanent injunction preventing the defendant from using the claimed technology and damages.

How are damages awards calculated? Are punitive damages available?

Damages are calculated based on:

The basis chosen for damages calculation depends on what works best for the plaintiff. There are no statutory punitive damages and such requests are usually rejected pursuant to case law.

How common is it for courts to grant permanent injunctions to successful plaintiffs and under what circumstances will they do this?

Courts often grant permanent injunctions whenever the final ruling favours the rights holder.

Timescale and costs

How long does it take to obtain a decision at first instance and is it possible to expedite this process?

Most courts take approximately three years to issue a first-instance decision on the merits. The timescale depends on the judges schedule and willingness to rule on the case, as well as on how long the court-appointed expert takes to prepare and present his or her technical report.

How much should a litigant plan to pay to take a case through to a first-instance decision?

Costs vary significantly according to the case, but a litigant should expect to spend at least $200,000 from the beginning of the case until a first-instance decision on the merits, including legal fees, court costs and fees charged by the court-appointed expert.

Appeal

Under what circumstances will the losing party in a first-instance case be granted the right to appeal? How long does an appeal typically take?

The defeated party is always entitled to appeal the decision. A ruling by the court of appeals usually takes up to three years.

Options away from court

Are there other dispute resolution options open to parties that believe their patents to be infringed outside the courts?

Alternative dispute resolution methods are available, but they are not relevant to most patent infringement cases.

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Plan to plug 250million NHS funding gap in Coventry, Nuneaton and Warwickshire gathers pace – Coventry Telegraph

August 2nd, 2017 11:52 am

Plans to change healthcare across Coventry, Nuneaton, Bedworth and Warwickshire and save around 250million are forging ahead with an action plan for maternity services expected in the autumn.

The Coventry and Warwickshire Sustainability and Transformation Plan (STP) has now been renamed the Better Health, Better Care, Better Value programme.

According to a report to the Warwickshire Health and Wellbeing Board, progress is underway on the plan and, under the transformation work stream updates, it states that an action plan is set to be agreed for maternity and paediatrics by October.

A Maternity System Transformation Group has been set up to look at implementing better births, improving maternal safety and wellbeing, reviewing and implementing the West Midlands Neonatal Review and implementing the saving lives care bundle.

The first draft of the STP, which must bridge a 250 million funding gap across Coventry and Warwickshire, was released in December and included proposals for stroke care across the region.

It was criticised for being vague and not giving details on how savings will be made.

The initial plans confirmed a review of the sustainability of under-pressure emergency care at George Eliot Hospital and UHCW, while also highlighting the potential need for capital to right size the A&E department in Coventry due to GEH and UHCW collaboration activity.

The latest report also outlines progress on what has been described as urgent and emergency care.

In the report it says that work is underway to assess progress of the national A&E plan and that an assessment of current capacity issues has taken place.

A patient mapping exercise is now being undertaken to identify patient flows to emergency and urgent care centres, the report adds.

Under the cancer section, the latest report says that a pilot project is underway in opthalmology to reduce patient follow-ups appointments in Coventry and Warwickshire North.

It also includes a section on the Health and Wellbeing Campus plan for the George Eliot Hospital, which could see education and housing brought on to the sprawling 34 acre site.

The Warwickshire Health and Wellbeing Board is made up of key stakeholders from across the county, and they specifically asked to be kept up-to-date on the progress of the STP.

After the initial STP was released in December, STP chief Prof Andy Hardy insisted no decision had been made over the future of A&E and maternity services at George Eliot as part of the process.

The 62-page initial STP report was slammed as opaque, incomprehensible and secretive at the time and one of the bosses at the head of the plan, Andrea Green, admitted it needed to be made easier to understand.

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20th World Congress on Biotechnology and Biotech Industries Meet – Technology Networks

August 2nd, 2017 11:52 am

20th World Congress on Biotechnology and Biotech Industries Meet during March 05-07, 2018 at London, UK with a theme Future prospects for Biotechnology and Economic Growth. Conference Series LLC through its Open Access Initiative is committed to make genuine and reliable contributions to the scientific community.

Scope and Importance

Biotech Congress 2018 Conference aims to bring together the Professors, Researchers, scientists, business giants, and technocrats to provide an international forum for the dissemination of original research results, new ideas and practical development and discover advances in the field of biotechnology, management and education in relation to biotechnology as well as a breadth of other topics. The applications of biotechnology include therapeutics, diagnostics, genetically modified crops for agriculture, processed food, bioremediation, waste treatment, and energy production. Biotech Congress 2018 is an excellent opportunity for the delegates from Universities and Institutes to interact with the world class Scientists.

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Bolder BioTechnology Announces Initiation of Phase 1 Clinical Trial of BBT-015 for Treating Neutropenia and Acute … – PR Newswire (press release)

August 2nd, 2017 11:52 am

Joe Cox, Ph.D., Bolder BioTechnology's President said: "Initiation of this clinical trial represents a major milestone for Bolder BioTechnology and the culmination of many years of effort by our dedicated and talented employees."

"BBT-015 is a novel G-CSF analog that exhibits a longer duration of action and greater potency than other G-CSF products. In preclinical studies, BBT-015 stimulated larger and longer-lasting increases in neutrophils, and faster neutrophil recovery in chemotherapy-treated, neutropenic animals compared to other G-CSF products.BBT-015 also significantly increased survival and accelerated recovery of neutrophils, platelets, and red blood cells in animals exposed to lethal doses of radiation, even when administered 24 hours following radiation exposure."

"BBT-015's increased potency and longer duration of action may stimulate faster neutrophil recovery in cancer patients and / or allow the drug to be administered less frequently and at lower doses than competing G-CSF products, with associated cost savings for patients."

"G-CSF products are some of the best selling biopharmaceuticals in the world, with annual worldwide sales exceeding $6 billion, primarily from the treatment of neutropenia in cancer patients."

About BBT-015BBT-015 is a long-acting G-CSF analog produced using site-specific PEGylation technology.G-CSF is a human protein that stimulates production of neutrophils, a type of white blood cell that is important for fighting infections.G-CSF has a short half-life in humans and typically is administered to patients by daily injection.BBT-015 has been selectively modified with the polymer polyethylene glycol at a unique site in the protein, which allows the protein to last longer in patients, reducing the need for frequent administration and increasing the protein's ability to stimulate long-lasting production of neutrophils.

About Chemotherapy-Related NeutropeniaNeutropenia (severely reduced numbers of neutrophils) is a common side effect of chemotherapy treatment in cancer patients.Neutropenia increases the patient's risk of developing serious bacterial infection and requiring expensive hospitalization.G-CSF products are commonly administered to cancer patients following chemotherapy to accelerate neutrophil recovery and decrease the length of time that patients are neutropenic.

About Acute Radiation SyndromeAcute Radiation Syndrome, often referred to as radiation sickness, is a collection of illnesses that occurs following exposure to high doses of ionizing radiation within a short period of time, such as might occur following an accident at a nuclear power plant or detonation of a nuclear weapon.Bone marrow, which is responsible for producing new blood cells, is one of the most radiation-sensitive tissues, and subjects acutely exposed to high doses of radiation typically develop bone marrow aplasia and severe neutropenia and thrombocytopenia (low numbers of platelets) within a few weeks of exposure, Many subjects die from infections due to a lack of neutrophils, or from uncontrolled bleeding due to a lack of platelets.

About Bolder BioTechnologyBolder BioTechnology, Inc. is a private company that uses advanced protein engineering technologies to create proprietary human protein pharmaceuticals with enhanced therapeutic properties for the treatment of hematopoietic and endocrine disorders, cancer and infectious diseases. For additional information about Bolder BioTechnology, Inc., please visit our web site at http://www.bolderbio.com.

Government SupportPreclinical research reported in this press release was supported by The National Cancer Institute and The National Institute of Allergy and Infectious Diseases of the National Institutes of Health under awards R43CA078094, R44CA078094, R43AI084288, R44AI084288, andU01AI107340. The content of this press release is solely the responsibility of Bolder BioTechnology and does not necessarily represent the views of the National Institutes of Health.

Forward Looking StatementsStatements contained herein that are not historical facts are forward-looking statements that are subject to a variety of risks and uncertainties.There are a number of important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by the Company.These factors include, but are not limited to: (1) the Company's ability to successfully complete product research and development, including pre-clinical and clinical studies, and commercialization; (2) the Company's ability to obtain required government approvals; (3) the Company's ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (4) the Company's ability to develop and commercialize its products before its competitors.

View original content:http://www.prnewswire.com/news-releases/bolder-biotechnology-announces-initiation-of-phase-1-clinical-trial-of-bbt-015-for-treating-neutropenia-and-acute-radiation-syndrome-300498287.html

SOURCE Bolder BioTechnology, Inc.

http://www.bolderbio.com

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Why Investors remained buoyant on: Puma Biotechnology, Inc. (PBYI), Digital Realty Trust, Inc. (DLR) – StockNewsJournal

August 2nd, 2017 11:52 am

Puma Biotechnology, Inc. (NASDAQ:PBYI)market capitalization at present is $3.29B at the rate of $89.95 a share. The firms price-to-sales ratio was noted 0.00 in contrast with an overall industry average of 100.62. Most of the active traders and investors are keen to find ways to compare the value of stocks. The price-to-sales ratio offers a simple approach in this case. They just need to take the companys market capitalization and divide it by the companys total sales over the past 12 months. The lesser the ratio, the more attractive the investment. During the key period of last 5 years, Puma Biotechnology, Inc. (NASDAQ:PBYI) earnings per share growth remained at -44.40%.

How Company Returns Shareholders Value?

Dividends is a reward scheme, that a company presents to its shareholders. There can be various forms of dividends, such as cash payment, stocks or any other form. This payment is usually a part of the profit of the company. A companys dividend is mostly determined by its board of directors and it requires the shareholders approval.Puma Biotechnology, Inc. (NASDAQ:PBYI)for the trailing twelve months paying dividend with the payout ratio of 0.00% to its shareholders. Currently it is offering a dividend yield of 0.00% and a 5 year dividend growth rate of 0.00%. Over the last year Companys shares have been trading in the range of $28.35 and $98.85. However yesterday the stock remained in between $83.13 and $93.95. The stock is above its 52-week low with 217.28% and is in the wake of its 52-week high with -9.00%.

Performance & Technicalities

In the latest week Puma Biotechnology, Inc. (NASDAQ:PBYI) stock volatility was recorded 6.05% which for the previous full month was noted 4.93%. Meanwhile the stock weekly performance was subdued at -5.66%, which was upheld for the month at 2.92%. Likewise, the upbeat performance for the last quarter was 130.64% and for the full year it was 83.42%. Moreover the Companys Year To Date performance was 193.00%. Now a days one of the fundamental indicator used in the technical analysis is called Stochastic %D, Stochastic indicator was created by George Lane. The stochastic is a momentum indicator comparing the closing price of a security to the range of its prices over a fix period of time. The gauge is based on the assumption that if price surges, the closing price tends towards the values that belong to the upper part of the area of price movements in the preceding period. On the other hand if price drops, the contrary is right. For Puma Biotechnology, Inc. (NASDAQ:PBYI), Stochastic %D value stayed at 72.69% for the last 9 days. Considering more the value stands at 79.05% and 79.07% for 14 and 20 days, in that order.

Digital Realty Trust, Inc. (NYSE:DLR)closed at $117.59 a share in the latest session and the stock value rose almost 19.67% since the beginning of this year. The company has managed to keep price to sales ratio of 8.23 against an industry average of 10.53. The price to sales ratio is the ratio of the market value of equity to the sales. This ratio is internally not steady, since the market value of equity is divided by the total revenues of the firm. Its revenue stood at 15.10% a year on average in the period of last five years. Firms net income measured an average growth rate of 10.80%. Following last close companys stock, is 2.09% above their SMA 50 and -3.24% below the 52-week high. A simple moving average (SMA) is an mathematical moving average calculated by adding the closing price of the security for a number of time periods and then dividing this total by the number of time periods. Its most recent closing price has a distance of 4.77% from SMA20 and is 11.48% above than SMA200.

In-Depth Technical Study

Investors generally keep an extensive variety of technical indicators at their disposal for completing technical stock analysis. The average true range is a moving average, generally 14 days, of the true ranges.

The average true range (ATR) was fashioned to allow traders to more precisely evaluate the daily volatility of an asset by using straightforward calculations. However the indicator does not specify the price direction, rather it is used first and foremost to measure volatility caused by gaps and limit up or down moves. The ATR is fairly simple to calculate and only needs historical price data.

ATR is counted for different periods, like 9-day, 14-day, 20-day, 50-day and 100-day. At the moment, the 14-day ATR for Digital Realty Trust, Inc. (NYSE:DLR) is noted at 2.01.

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Dr Pushpa Mitra Bhargava, pioneer in biotechnology, passes away at 89 – Times of India

August 2nd, 2017 11:52 am

HYDERABAD: Dr P M Bhargava, eminent scientist and founder-director of the city-based Centre for Cellular and Molecular Biology (CCMB), died here on Tuesday after a brief illness. He was 89 and is survived by two children.

Pushpa Mittra Bhargava was born on February 22, 1928. He was a pioneer in the field of biotechnology in India and among the first persons to use the term "genetic engineering". Bhargava was instrumental in the formation of the Department of Biotechnology in the '70s. He was also chairman of Medically Aware and Responsible Citizens of Hyderabad, Sambhavna Trust, Bhopal, and Basic Research, Education and Development Society (BREAD), New Delhi. He served as vice-chairman of the National Knowledge Commission between 2005 and 2007.

Bhargava received over 100 national and international honours and awards. He was awarded the Padma Bhushan in 1986 but returned it in 2015 citing "matters of principle". He was honoured with the Legion d'honneur in 1998. He is popularly known as the architect of modern biology in India.

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NJSBA magazine explores biotechnology and genetics – Yahoo News

August 2nd, 2017 11:52 am

The August issue of the New Jersey State Bar Association's bi-monthly magazine, New Jersey Lawyer, focuses on the evolving topic of biotechnology, genetics and the law.

"Although a very specialized area, biotechnology law crosses many legal disciplines, including litigation, licensing, intellectual property, patents, agriculture, business, venture capitalism, antitrust, biosecurity and bioethics," said Angela Foster and David Opderbeck, who served as special editors for the issue.

"The use of biotechnology has raised a number of legal, ethical and social issues, including who owns genetically modified organisms (GMOs), whether genetically modified foods are safe to eat, and who controls a person's genetic information. This issue explores contemporary biotechnology issues impacting the legal community."

A dozen articles explore the topic in the award-winning magazine, beginning with a look at whether organs-on-chips are patentable in an article by Douglas Bucklin. Richard Catalina Jr.'s article on the Biologics Price Competition and Innovation Act follows.

Nancy Del Pizzo's article looks at the open source model in biotechnology, while Foster explores the truth and fiction behind genetically modified food. Jonathan Lourie reviews strategic licenses and collaborations.

Reproduction is the topic of two articles, one analyzing assisted reproductive technology, written by Alan Milstein, and one penned by Kimberly Mutcherson on regulating the right to procreate.

Opderbeck's contribution focuses on synthetic biology and biosecurity, while Anjana Patel and Patricia Wagner discuss biotech mergers, acquisitions and antitrust issues and Marina Sigareva and Ryan O'Donnell look at global strategies for protecting biotech inventions.

The edition closes with articles on the Patent Trial and Appeal Board's influence on the biotech and pharma industries, written by Nichole Valeyko and Maegan Fuller, and the privacy implications for biotechnology by Wagner.

The October edition of New Jersey Lawyer will explore pro bono issues.

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High school student gets an early start in stem cell research at USC – USC News

August 2nd, 2017 11:51 am

Even though Richard Lopez is still in high school, he can already tell you a thing or two about the ureteric bud, the metanephric mesenchyme and the developing kidney.

More impressively, he was familiar with these terms before starting his summer internship in the lab of Andy McMahon, kidney researcher and director of the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research at USC.

I knew I was going to come here, Lopez said. So from December on, I was just reading papers that were written by Dr. McMahons lab. And so I read about the development of the kidney, kidney organoids, experimental methods like in situ hybridization, immunohistochemistry, all that stuff. Im really glad I did all of that because now that Im here, I understand whats going on.

Lopez undertook this intense preparation as part of the Science Research Program at his Connecticut boarding school, Choate Rosemary Hall. In addition to familiarizing him with the McMahon labs research, the program provided experience with useful molecular biology techniques, ranging from gel electrophoresis to polymerase chain reaction.

Lopez didnt start his high school career at Choate. Growing up in Lennox near the Los Angeles International Airport, he attended local public schools until his sophomore year in high school. At that point, his exceptional scores on the California Standardized Test attracted the attention of the Young Eisner Scholar program, which empowers underserved students to fulfill their potential.

As an Eisner Scholar, he earned both admission and a full scholarship to attend Choate. But the decision to leave home wasnt easy.

I was terrified at first, leaving everything behind, he said. I talked to my mom about it, and at first she was hesitant because I was born and raised here, and Im the only child. But then she realized that this is an amazing opportunity, and I cant let it go by.

Lopez recalls that Choate was initially in a huge culture shock from the occasional Maserati to the international student body to the exceptional academic opportunities such as the Science Research Program that brought him to USC.

In the McMahon lab, Lopez has learned about the molecular signals that drive the branching development of the kidney, and he has practiced a wide range of lab techniques.

Im really excited about science because I know its potential.

Richard Lopez

Im really excited and passionate about science because I know its potential, he said. If you pair that with math, you have no boundaries. If you look at the lab where Im working right now creating kidney organoids, learning about kidney development, these kinds of things can solve really burdensome illnesses that are fatal to some people, like end-stage renal disease and polycystic kidney disease.

To get to the lab every day, Lopez bike commutes a total of 32 miles from his home in Lennox to USCs Health Sciences Campus. Hes run the Los Angeles Marathon once and the San Francisco Marathon twice. In November, hes planning to travel to Florida to celebrate his 18th birthday with his first Ironman Triathlon a 2.4-mile swim, 112-mile bike ride and 26.2-mile run.

Hes participating in these events not only for fun and fitness, but also as a way to give back. Hes currently raising sponsorship money for the Partnership Scholars Program, which provides underserved junior high and high school students with educational and cultural experiences, ranging from theatergoing to restaurant outings to college tours. His goal is to raise $54,000 to fund three new scholars.

I was very lucky, he said. So I want to raise money for the scholarships that have helped me out along the way.

More stories about: Research, Stem Cells

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ViaCyte Announces First Patients Implanted with PEC-Direct Islet Cell Replacement Therapy in International Clinical … – Markets Insider

August 2nd, 2017 11:51 am

SAN DIEGO, Aug. 1, 2017 /PRNewswire/ -- ViaCyte, Inc., a privately-held, leading regenerative medicine company, announced today that the first patients have been implanted with the PEC-Direct product candidate, a novel islet cell replacement therapy in development as a functional cure for patients with type 1 diabetes who are at high risk for acute life-threatening complications. The first implant procedures of the clinical trial took place at the University of Alberta Hospital in Edmonton, Alberta, and the UC San Diego School of Medicine's Altman Clinical Trials Research Institute. The goal of the open-label clinical trial is to evaluate the PEC-Direct product candidate for safety and definitive evidence of efficacy. In the coming months, the company expects to expand the trial to additional centers including the University of Minnesota and other sites in the US and Canada.

The first cohort of type 1 diabetes patients is receiving multiple small-format cell-filled devices called sentinels in order to evaluate safety and implant viability. These sentinel units will be removed at specific time points and examined histologically to provide early insight into the progression of engraftment and maturation into pancreatic islet cells including insulin-producing beta cells. A second cohort of up to 40 patients is expected to begin enrolling later this year to evaluate both safety and efficacy. The primary efficacy measurement in the trial will be the clinically relevant production of insulin, as measured by the insulin biomarker C-peptide, in a patient population that has little to no ability to produce endogenous insulin at the time of enrollment. Other important endpoints will be evaluated including injectable insulin usage and the incidence of hypoglycemic events. ViaCyte's goal is to demonstrate early evidence of efficacy in the first half of 2018 and definitive efficacy 6 to 12 months later.

"Islet transplants have been used to successfully treat patients with unstable, high-risk type 1 diabetes, but the procedure has limitations, including a very limited supply of donor organs and challenges in obtaining reliable and consistent islet preparations," said trial investigator James Shapiro, MD, PhD, FRCSC, Director of the Clinical Islet Transplant Program, University of Alberta. "An effective stem cell-derived islet replacement therapy would solve these issues and has the potential to help a greater number of people."

"Patients with high-risk type 1 diabetes complications, such as hypoglycemia unawareness, are at constant risk of life-threatening low blood glucose," said Jeremy Pettus, MD, investigator in the clinical trial and Assistant Professor of Medicine at UC San Diego. "The PEC-Direct islet cell replacement therapy is designed to help patients with the most urgent medical need."

The PEC-Direct product candidate is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or severe hypoglycemic episodes. It is estimated that about 140,000 people in Canada and the US have such high-risk type 1 diabetes. In addition to providing an unlimited supply of cells for implantation, the PEC-Direct approach has other potential advantages relative to cadaver islet transplants such as delivering a more consistent product preparation under quality-controlled cGMP conditions, and a more straightforward and safe mode of delivery.

The clinical trial is being supported in part by JDRF, the leading global organization funding type 1 diabetes research. "JDRF remains dedicated to accelerating the delivery of beta cell replacement therapies to the T1D community, and we commend ViaCyte in its announcement of the first patients to be implanted with the PEC-Direct islet cell replacement therapy," said Derek Rapp, JDRF President and Chief Executive Officer. "JDRF is excited to support this clinical development given its potential to help those people with type 1 diabetes that need it the most those at high risk of life-threatening acute complications. JDRF and ViaCyte share a continuing commitment to realizing the potential of beta cell replacement strategies to deliver insulin independence without immune suppression for people living with type 1 diabetes, and ultimately, at JDRF we hope this will move us forward in fulfilling our vision of a world without type 1 diabetes."

"There are limited treatment options for patients with high-risk type 1 diabetes to manage life-threatening hypoglycemic episodes," said Paul Laikind, PhD, President and Chief Executive Officer of ViaCyte. "We believe that the PEC-Direct product candidate has the potential to transform the lives of these patients and we are excited to move closer to that goal with the initiation of clinical evaluation announced today. This also represents a step towards a broader application of the technology. We remain fully committed to developing a functional cure for all patients with insulin-requiring diabetes. To that end, we are hard at work on next-generation approaches as well, and expect the work with PEC-Direct to further advance our knowledge and drive progress."

In addition to JDRF, the California Institute for Regenerative Medicine (CIRM)'s Alpha Clinic, the Sanford Stem Cell Clinical Center, the JDRF Canadian Clinical Trials Network (CCTN), the Stem Cell Network, and Alberta Innovates Health Solutions (AIHS) are all providing support for the trial.

About the PEC-Direct Product Candidate The PEC-Direct product candidate delivers stem cell-derived pancreatic progenitor cells, called PEC-01 cells, in a device designed to allow direct vascularization of the cells in the device. After implantation, these cells are expected to become mature human islet tissue including well-regulated beta cells producing insulin on demand. The direct vascularization of the implanted cells is expected to allow for robust and consistent engraftment but will necessitate the use of maintenance immune suppression therapy.

About ViaCyte ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte's product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in a durable and retrievable cell delivery device. Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels. ViaCyte has two products in clinical development. The PEC-Direct product candidate delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin. ViaCyte is headquartered in San Diego, California. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit http://www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

View original content with multimedia:http://www.prnewswire.com/news-releases/viacyte-announces-first-patients-implanted-with-pec-direct-islet-cell-replacement-therapy-in-international-clinical-trial-300497290.html

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Diabetes Impact Is Rising Fastest Among Millennials | Fortune.com – Fortune

August 2nd, 2017 11:51 am

An estimated 30.3 million Americans have diabetes. The emotional and physical toil for those suffering from the disease is large, as are the associated medical bills: In 2012, the cost for caring for Americans with diabetes was $245 billion.

A new report from Blue Cross Blue Shield ranks the disease behind only mood disorders and hypertension as having the largest negative impact on commercially insured Americans health.

It also found that diabetes impact, which measures prevalence and severity of the condition as well as the risk of premature death, is growing at the fastest clip for millennials, defined as those between 18 to 34 years of age.

The worrying trend coincides with rising rates of obesity among the demographic. Nearly 90% of people diagnosed with diabetes are overweight or obese. Between 2001 and 2015, teenage rates of obesity rose over 30%, according to the CDC.

"Despite the impact of diabetes' continued growth across America, the good news is that this epidemic is preventable, Dr. Trent Haywood, senior vice president and chief medical officer for Blue Cross Blue Shield, said in a statement.

Type 2 diabetes was once thought to be largely irreversible, but today many doctors believe it can be managedin some cases, reversedthrough lifestyle changes and moderate weight loss. By losing as little as 5% of their body weight, participants in several studies were able to transition off medication to manage the condition.

A number of startups have launched to help people manage and/or reverse their diabetes by changing their diet and exercise routines. Virta Health, Glooko, and Omada Health have all raised venture capital to build technology platforms to this effect.

For millennials, a demographic endlessly lauded and derided for being the first generation to grow up with Internet, this could be encouraging news. Whereas many of their need to be taught to interact with a diabetes management app, theyre digital natives.

It remains to be seen, of course, whether a technology-based approach is enough to curb the tide. But as diabetes management goes digital, familiarity with a smartphone doesn't hurt.

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Weight Gain Between Babies Linked to Diabetes – WebMD

August 2nd, 2017 11:51 am

By Mary Elizabeth Dallas

HealthDay Reporter

TUESDAY, Aug. 1, 2017 (HealthDay News) -- Women who gain weight after having a baby may be more likely to develop diabetes during their next pregnancy, a new study suggests.

Women's weight before conception and how much they gain during pregnancy are known risk factors for gestational diabetes, the study authors explained. Gestational diabetes is a form of high blood sugar diagnosed during pregnancy. It can cause complications for both mother and baby.

Led by Linn Sorbye of the University of Bergen in Norway, researchers investigated the diabetes risk among women who had been pregnant once or twice before.

The study involved about 24,200 women who gave birth between 2006 and 2014. The researchers considered the women's previous history of gestational diabetes and body mass index (BMI) when they got pregnant again. BMI is an estimate of body fat based on weight and height. A BMI of 30 is considered obese.

About 36 percent of the women gained more than 1 BMI unit of weight between the start of their first pregnancy and their second, the study found. These women were more likely than women whose weight was stable to develop diabetes during a second pregnancy.

Women who gained twice as much weight had double the risk for gestational diabetes. And the risk rose fivefold for women who had the greatest weight gain, the researchers found.

These risks were most striking among women whose weights were normal before their first pregnancy. The study showed, however, that overweight women who lost weight after delivery reduced their risk of diabetes during another pregnancy.

The study was published Aug. 1 in the journal PLOS Medicine.

WebMD News from HealthDay

SOURCE: PLOS, news release, Aug. 1, 2017.

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WNY’s Great Kids: Wheatfield Boy Goes to Washington to Fight for Diabetes Research – WGRZ-TV

August 2nd, 2017 11:51 am

WNY's Great Kids: Wheatfield Boy Part of JDRF Childrens' Congress

Melissa Holmes, WGRZ 8:56 AM. EDT August 02, 2017

Mason Gfroerer, 11 of Wheatfield, doesn't let type 1 diabetes slow him down. His push for research and funding has earned him a spot as one of "WNY's Great Kids."

WHEATFIELD, NY- 11-year-old Mason Gfroerer's life revolves around soccer. The St. Christopher student plays in Northtown's travel league and is always out in his backyard practicing.

"I've been playing for 2 years now. I really enjoy it," said Mason.

But often he has to give himself a timeout in order to check his blood sugar, because Mason has type-1 diabetes.

"Sometimes I'll feel shaky, I get sweaty, my eye vision is a little blurry," said Mason. "I have to sit out until my blood sugar comes back up and then I can play again."

He was first diagnosed when he was 8-years-old, after his parents took him to the doctor for frequent and sudden urination. It turned out to be a diagnosis that affected the whole family. From the changing of his glucose monitor and insulin pump, to the constant worry and uncertainty.

"Every day is difficult," said Lauren Gfroerer, Mason's mother. "When his blood sugar is low, I give him what he needs. But sometimes I give him too much. And then his blood sugar is high, and he doesn't feel good either."

But this disease has given Mason a purpose - to be a voice for other kids just like him. He was recently selected from 1500 applicants to be part of theJDRFChildren's Congress. Only 10 children from New York State were selected.

Last week, Mason went to Washington, DC, and met with Sen. Chuck Schumer and Rep. Tom Reed and our other elected officials to help secure continued funding for important type 1 diabetes research.

"I was nervous because I didn't want to mess up and I want funding to keep going," said Mason.

His mother couldn't be more proud.

"What he does with diabetes, his strength, what he has to endure. He perseveres. He doesn't let it hold him back," she said.

Mason imagines a day when there's better treatment or even a cure, so diabetes won't keep him on the soccer sidelines.

"Someday I won't have to live with type-1 diabetes anymore," he said.

If you know of a boy or girl or group of kids who should be featured on Daybreak's "WNY's Great Kids," call 716-849-2216 or email melissa.holmes@wgrz.com .

2017 WGRZ-TV

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WNY's Great Kids: Wheatfield Boy Goes to Washington to Fight for Diabetes Research - WGRZ-TV

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American Diabetes Association and Oakmont present Diabetes 101 – Santa Clarita Valley Signal

August 2nd, 2017 11:51 am

American Diabetes Association and Oakmont present Diabetes 101

By Signal Staff

Last update:5 hours ago

Diabetes strikes nearly 30 million Americans. Thats 1 in 10 SCV residents.

To help us learn more about diabetes and adopting healthy habits, the American Diabetes Association presents an informative diabetes discussion about the importance of knowing the risk and available Type 2 diabetes prevention programs.

It will be held on Tuesday, August 1 from 4-5:30 p.m. at Oakmont of Santa Clarita, 28650 Newhall Ranch Road, Santa Clarita.

The Association will provide free health screenings, cooking demonstrations, exercise demonstrations, diabetes workshops, giveaways, and more.

The discussion will be given by the Prevent T2 program, a 12-month lifestyle change program for helping people with the little things that reduce the risk of developing Type 2 diabetes.

To attend, RSVP by July 28, 2017. You can register at Oakmont of Santa Clarita; 661-295-2025. The event is free.

For more information, contact the American Diabetes Association at 1.800.DIABETES or 323.966.2890, or visit http://www.diabetes.org.

Diabetes strikes nearly 30 million Americans. Thats 1 in 10 SCV residents.

To help us learn more about diabetes and adopting healthy habits, the American Diabetes Association presents an informative diabetes discussion about the importance of knowing the risk and available Type 2 diabetes prevention programs.

It will be held on Tuesday, August 1 from 4-5:30 p.m. at Oakmont of Santa Clarita, 28650 Newhall Ranch Road, Santa Clarita.

The Association will provide free health screenings, cooking demonstrations, exercise demonstrations, diabetes workshops, giveaways, and more.

The discussion will be given by the Prevent T2 program, a 12-month lifestyle change program for helping people with the little things that reduce the risk of developing Type 2 diabetes.

To attend, RSVP by July 28, 2017. You can register at Oakmont of Santa Clarita; 661-295-2025. The event is free.

For more information, contact the American Diabetes Association at 1.800.DIABETES or 323.966.2890, or visit http://www.diabetes.org.

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American Diabetes Association and Oakmont present Diabetes 101 - Santa Clarita Valley Signal

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Could a little alcohol lower your diabetes risk? – CBS News

August 2nd, 2017 11:51 am

That glass of wine or pint of beer you enjoy with dinner every night might come with an added benefit -- a lower risk of type 2 diabetes, a new Danish study contends.

The researchers found that men who had 14 drinks each week and women who had nine drinks a week appeared to have the lowest risk of type 2 diabetes, compared to nondrinkers or people who drank more heavily, said senior researcher Janne Tolstrup.

People received the most benefit if they spread those drinks out during the week, rather than downing them all in one or two binges, Tolstrup added.

"Drinking pattern seemed to play a role for the risk of diabetes," Tolstrup said. "Drinking frequency was important, as those who were drinking three to four times per week had lower risk as compared to those drinking only once per week -- regardless of the total weekly amount."

The potential protective effect of alcohol also appeared to be limited to wine and beer, Tolstrup said. Hard liquor provided no benefit to men, and could actually increase a woman's risk of diabetes, the findings showed.

"There seemed to be little beneficial effects from spirits," Tolstrup said.

She's a professor of epidemiology with the University of Southern Denmark's National Institute of Public Health in Copenhagen.

But at least one diabetes expert suggested that if you're thinking of drinking just to prevent type 2 diabetes, you might want to put the corkscrew down.

"I wouldn't recommend increasing alcohol consumption on the basis of this study," said Dr. Adrian Vella, an endocrinologist and internist with the Mayo Clinic in Rochester, Minn.

Also, the study only found an association between alcohol consumption and diabetes risk, not a cause-and-effect connection.

The new research included data from the Danish Health Examination Survey. The survey of more than 70,000 people was done in 2007-2008. The participants provided details of their alcohol consumption, lifestyle and overall health. These people were followed through 2012, with an average follow-up of about five years.

The study revealed that men who had 14 drinks per week had a 43 percent lower risk of type 2 diabetes compared to non-drinkers, and women who had nine drinks per week had a 58 percent lower risk compared to non-drinkers.

The risk of type 2 diabetes was lower when people spread their drinking over three or four days a week, rather than drinking once per week. The researchers found a 27 percent lower risk in men and a 32 percent lower risk in women who drank on about half the days of a typical week.

Wine appeared to provide the most protective benefit, as men and women who drank seven or more glasses per week had up to a 30 percent lower risk of type 2 diabetes compared with those having less than one glass per week.

Women didn't benefit at all from drinking beer, but men who drank one to six beers a week had a 21 percent lower risk of diabetes, the investigators found.

Hard liquor provided no benefit to men. Women who had seven or more shots per week had an 83 percent increased risk of diabetes, the study reports.

Researchers can't say why alcohol might protect against diabetes, since this was an observational study rather than an experiment or clinical trial, Tolstrup said.

"Alcohol has been suggested to increase insulin sensitivity and lower fasting insulin resistance, which might play an important role in the progression of diabetes," Tolstrup said.

"But again, due to limited knowledge about mechanisms between alcohol and [blood sugar] control, the mechanism explaining our results is not clear," she added.

Mayo Clinic's Vella pointed out that studies that depend on people's self-reported food and alcohol consumption can be flawed, since participants may have a hard time remembering what they ate and drank in the past.

It's also tough to accurately capture through a questionnaire other things that might lower type 2 diabetes risk, such as daily exercise and a family history of diabetes.

In addition, it's not likely that a lot of people would develop type 2 diabetes during the relatively short follow-up time of five years used in this study, according to Vella.

The new study was published July 27 in the journalDiabetologia.

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Could a little alcohol lower your diabetes risk? - CBS News

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