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Liberty Science Centers Inaugural Genius of New Jersey to Honor Innovators Who Make the State a World Leader in Cutting-Edge Applied Science – Yahoo…

November 26th, 2019 9:46 am

JERSEY CITY, N.J.--(BUSINESS WIRE)--

Ceremony to host Bonnie Bassler, molecular biologist and microbe fighter; Robert J. Hariri, stem cell and human longevity expert; and David Rosenberg, world leader in urban vertical farming

Plus a special honoree from California whom LSC is feting because hes a tech badass: AI giant Sebastian Thrun, the godfather of the self-driving car

New Jersey is home to some of the worlds most accomplished innovators in applied science. Three of them who are pioneering research and solutions in antibacterial therapies, genetics, human life extension, and food production are being honored by Liberty Science Center at its inaugural The Genius of NJ celebration on Monday, December 2.

The celebration starts at 5:30 pm with cocktails and unique technology demonstrations: a full-body 3D scanner from Lenscloud that can scan a person in half a second with 120 cameras and create a realistic 3D avatar; bomb-disposing robots and an autonomous fighting robot from Picatinny Arsenal; and Flyer, a personal aerial vehicle from Kitty Hawk, headquartered in Mountain View, CA.

The New Jersey honorees are Bonnie Bassler, Chair of Molecular Biology at Princeton University, who is developing novel antimicrobial therapies to render pathogenic bacteria harmless; Dr. Robert J. Hariri, Chairman, Founder & CEO of Celularity, Inc. who is pioneering the use of stem cells to cure disease and slow aging; and David Rosenberg, CEO and Co-Founder of AeroFarms, the worlds leader in mass-scale vertical indoor farming.

Our inaugural Genius of NJ Award Winners represent the best this state and the world have to offer in harnessing science for the betterment of humanity, said Liberty Science Center President and CEO Paul Hoffman. Each is using his or her exceptional intellect and creative abilities to disrupt and innovate both in their respective fields and in their commitment to making the world healthier and safer.

Bonnie Bassler is the Squibb Professor of Molecular Biology and Chair of the Department of Molecular Biology at Princeton University, as well as a Howard Hughes Medical Institute Investigator. Professor Bassler deciphered the chemical language bacteria cells use to communicate by studying a harmless marine bacterium called Vibrio fischeri, known to bioluminesce, or make light, like fireflies do. She is a winner of the MacArthur Genius Grant and is now developing therapies that disrupt communication among harmful bacteria and strengthen communication among helpful bacteria. At a time when an increasing number of bacteria are resistant to traditional kinds of antibiotics, Dr. Bassler offers a promising new approach to antimicrobial therapy.

The Chairman, Founder and CEO of Celularity, Inc., in Warren, NJ, and Co-Founder and Vice Chairman of Human Longevity, Inc., Dr. Robert Hariri is the quintessential renaissance man. Hes a neurosurgeon, a medical researcher, and a serial entrepreneur in two technology sectors: aerospace and biomedicine. Dr. Hariri has advised the Vatican on genetics, and in 2018, Pope Francis bestowed on him the Pontifical Key Award for Innovation. Dr. Hariris path to discovering that the placenta, a temporary organ discarded after birth, was a potent source of stem cells began in the 80s when he viewed a first trimester ultrasound of his oldest daughter and wondered why the placenta was so large. Today Dr. Hariri is working to use placental stem cells to cure disease, slow aging, and augment healthy human lifespan.

Prominent entrepreneur David Rosenberg, CEO and Co-Founder of AeroFarms, set out to reinvent one of the most basic aspects of food production, farming. AeroFarms has grown 800 species of plants indoors and can grow them 365 days a year without sun or soil, achieving yields 130 times greater than conventional farming. His system uses 95 percent less water than field farming and no pesticides, herbicides, or fungicides. Rosenbergs adoption of cutting-edge technology has been a cornerstone of AeroFarms, which set up its first indoor vertical farms in abandoned warehouses in Newark. He employs plant biologists, microbiologists, geneticists, systems engineers, and data scientists. AeroFarms innovations in indoor vertical farming have improved not just plant yields but also taste, texture, nutritional density, and shelf life.

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Additionally, LSC will honor non-New Jersian Sebastian Thrun, CEO of Kitty Hawk, a company spun off from a Google moonshot effort to free the world from traffic. Kitty Hawk is developing all-electric, vertical take-off flying machines for everyday use. Known as the godfather of self-driving cars, as a Stanford professor in 2005, Thrun led a team that won the $2-million Defense Department Grand Challenge to build an autonomous vehicle which drove itself unassisted on a 132-mile course across the Mojave Desert. His winning entry, Stanley, is now on display at the Smithsonian in Washington, DC. While at Stanford, in 2011 he and colleague Peter Norvig offered their Introduction to Artificial Intelligence course online to anyone, for free. Over 160,000 students in more than 190 countries enrolled! The MOOC (which stands for Massive Open Online Course) was born, and Thrun founded the online education company Udacity, with the goal of democratizing education. Thrun relinquished his tenured Stanford professorship to join Google and founded the companys semi-secret R&D division called Google X (now called simply X) to develop breakthrough technologies, such as self-driving cars, that make the world a radically better place.

Ticket prices for The Genius of NJ start at $750 per guest with options for table sponsorship from $12,500 to $50,000. For more details, please visit The Genius of NJ online. All proceeds from this event will support LSCs mission to inspire the next generation of scientists and engineers.

About Liberty Science Center

Liberty Science Center (LSC.org) is a 300,000-square-foot nonprofit learning center located in Liberty State Park on the Jersey City bank of the Hudson near the Statue of Liberty. Dedicated to inspiring the next generation of scientists and engineers and bringing the power, promise, and pure fun of science and technology to learners of all ages, Liberty Science Center houses the largest planetarium in the Western Hemisphere, 12 museum exhibition halls, a live animal collection with 110 species, giant aquariums, a 3D theater, live simulcast surgeries, a tornado-force wind simulator, K-12 classrooms and labs, and teacher-development programs. More than 250,000 students visit the Science Center each year, and tens of thousands more participate in the Centers off-site and online programs. Welcoming more than 750,000 visitors annually, LSC is the largest interactive science center in the NYC-NJ metropolitan area.

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Partnership aims to accelerate cell and gene therapy – Harvard Gazette

November 26th, 2019 9:44 am

MIT Provost Martin A. Schmidt said sharing the risk among several institutions will not only make possible work that would be difficult for a single institution to tackle, it will also encourage collaboration that accelerates the process of moving discoveries from lab to patient.

MIT researchers are developing innovative approaches to cell and gene therapy, designing new concepts for such biopharmaceutical medicines as well as new processes to manufacture these products and qualify them for clinical use, Schmidt said. A shared facility to de-risk this innovation, including production, will facilitate even stronger collaborations among local universities, hospitals, and companies and ultimately, such a facility can help speed impact and access for patients. MIT appreciates Harvards lead in convening exploration of this opportunity for the Commonwealth.

Richard McCullough, Harvards vice provost for research and professor of materials science and engineering, who also helped lead the project, said although the centers activity will revolve around science and manufacturing, its true focus will be on patients.

The centers overarching goal will be improving patient care, McCullough said. This would occur both by speeding access to the essential, modified cells that patients in clinical trials await, and by fostering discoveries through collaborations within the centers innovation space. The aim is that discoveries result in whole new treatments or improved application of existing treatments to provide relief to a wider universe of patients.

Organized as a private nonprofit, the center will be supported by more than $50 million pledged by its partners. It will be staffed by a team of at least 40, experienced in the latest cell-manufacturing techniques and trained in the use of the latest equipment. Among its goals is disseminating badly needed skills into the Boston life-sciences workforce.

We have to be sure that we are constantly feeding the industry with talented people who know the right things, so personally, I am very excited about education programs, Ligner said. Initiatives like [this center] are essential to advancing the industry because they help organizations build on one anothers advances. For example, the full potential of cell and gene therapies will only be realized if we collaborate to address challenges, such as manufacturing, improving access, accelerating innovation, tackling cost issues, and then sharing our learnings.

The new center emerged from conversations with state officials, including Gov. Charlie Baker and Attorney General Maura Healey, and industry sector leaders about ways to bolster Massachusetts preeminence in life science research and medical innovation. Those conversations sparked a two-year consultation process at the invitation of Garber and Harvard Corporation Senior Fellow Bill Lee, that was coordinated with state officials and included representatives from industry, academia, venture capital, area hospitals, and government.

Cell and gene therapies have the potential to revolutionize the global health system. Recently, in Sweden, the first patient received cell therapy outside of a clinical trial. Its the start of an incredible time in the industry and in human health.

Emmanuel Ligner, president and chief executive of GE Healthcare Life Sciences

Called the Massachusetts Life Sciences Strategies Group, members reached out to regional experts beginning in 2017to discover what fields they considered most important and how best to support them. Cell and gene therapy rose to the top because of the considerable excitement generated by activity already going on, its potential to help patients, and its high potential for future growth and innovation. Also important were the opportunities to spread the high cost of these technologies across multiple institutions and, while so doing, capture the collaborative power of housing each player in the development chain within a single facility.

The centers board of directors will be comprised of Harvard, MIT, and industry partners Fujifilm, Alexandria Real Estate Equities, and GE Healthcare Life Sciences. Other members will include Harvard-affiliated teaching hospitals Massachusetts General Hospital, Brigham and Womens Hospital, Beth Israel Deaconess Medical Center, Boston Childrens Hospital, and the Dana-Farber Cancer Institute; as well as the Commonwealth of Massachusetts and life-sciences company MilliporeSigma.

When you look at the constellation of players coming together, you really have the best universities and the best teaching hospitals and the best corporate players all supporting it, McGuire said, which I think is a great opportunity.

The facility intends to provide researchers and emerging companies outside the consortium with access to excess material, though organizers said they expect it to be in high demand by center partners.

The centers boost to the areas cell and gene therapy endeavors comes early enough that it should help maintain leadership over places like California and China, which have made clear their interest in life-science research, McGuire said.

I think getting this early mover advantage is going to be huge [in] developing the technology and the know-how and, ultimately, the intellectual property around it, McGuire said.

For Sharpe, the ultimate payoff will come from using cancer immunotherapys checkpoint blockade and other cell and gene therapies to save and improve lives.

We are seeing long-term benefits in some patients whove received checkpoint blockade, Sharpe said. There are patients who are more than a decade out and are melanoma-free. I think that it really has transformed patient care, quality of life, and longevity. So Im optimistic that the more we learn, the more were going to be able to do to help patients.

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Encouraging early results from first human CRISPR gene therapy trials – New Atlas

November 26th, 2019 9:44 am

Promising preliminary data from one of the first human trials testing the safety and efficacy of a CRISPR gene therapy has just been revealed. Although it is too early to evaluate long-term effects, the initial reports are impressively successful for two patients with severe genetic blood diseases.

Until February of this year, when pharmaceutical companies CRISPR Therapeutics and Vertex began a large global trial into a treatment called CTX001, no human outside of China had been officially treated with a CRISPR-based gene editing therapy.

CTX001 was developed to treat two types of inherited blood disease, beta-thalassemia and sickle cell disease. Both conditions are caused by a mutation in a single gene and the treatment involves engineering a patient's stem cells with a single genetic change designed to raise levels of fetal hemoglobin in red blood cells.

The newly announced data from the first two patients treated with CTX001 is nothing short of extraordinary. The first patient was treated with the CRISPR therapy at the beginning of 2019 for transfusion-dependent beta-thalassemia. The patients illness was so severe they required around 16 blood transfusions every year. Nine months after the single CTX001 treatment the patient was completely independent of the need for blood transfusions and their total hemoglobin levels were near normal.

The second patient, treated for sickle cell disease, demonstrated similar remarkable responses to the one-off gene therapy treatment. Four months after the CTX001 infusion the patients total hemoglobin levels had returned to normal and many of the disease symptoms had disappeared.

We are very encouraged by these preliminary data, the first such data to be reported for patients with beta thalassemia and sickle cell disease treated with our CRISPR/Cas9 edited autologous hematopoietic stem cell candidate, CTX001, says Samarth Kulkarni, CEO of CRISPR Therapeutics. These data support our belief in the potential of our therapies to have meaningful benefit for patients following a one-time intervention.

Both patients did suffer from a small number of serious adverse events following the CTX001 treatment, however, the researchers conducting the trial are confident none of these side effects were related to the gene therapy. Instead, these side effects seem primarily related to a pre-CTX001 treatment involving the elimination of pre-existing mutated bone marrow cells to enable the healthy CRISPR-edited cells to reproduce.

It is certainly very early days for the research, and a number of patients are yet to be enrolled and treated in this current trial. Both the beta-thalassemia and sickle cell disease trials plan to enroll up to 45 patients, with a two-year follow-up planned to evaluate safety and efficacy. The Phase 1/2 open-label trials precede larger Phase 3 trials required for ultimate market approval, so these new therapies are still at least a decade away from clinical implementation.

Still, these initial results are as positive as one could hope for at this stage, establishing CRISPR gene editing as having exciting curative potential in human subjects. Whether the treatment holds for extended periods of time, and demonstrates longer safety profiles is yet to be determined. But, these early results are leaving researchers cautiously optimistic.

The data we announced today are remarkable and demonstrate that CTX001 has the potential to be a curative CRISPR/Cas9-based gene-editing therapy for people with sickle cell disease and beta thalassemia, says CEO of Vertex, Jeffrey Leiden. While the data are exciting, we are still in the early phase of this clinical program.

Source: CRISPR Therapeutics

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Gene therapy pioneer: Field is behind, and delivery tech is ’embarrassing’ – STAT

November 26th, 2019 9:44 am

CAMBRIDGE, Mass. Gene therapy pioneer Dr. James Wilson is disappointed by the progress in his field and expects current therapies and technologies to be soon surpassed by new approaches.

In five years, when we look back on the way were executing on gene therapy now, were going to realize that things are going to be very different, Wilson said at the STAT Summit on Thursday. The way in which were going to treat Duchenne muscular dystrophy, potentially cure it, is not the way in which its being evaluated in the clinic now.

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STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis.Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

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Takeda sees cell, gene therapy in its future. Is it too late? – BioPharma Dive

November 26th, 2019 9:44 am

Thanks to a $62 billion acquisition of Shire, Takeda is one of the world's largest developers of rare disease drugs.

Despite that, the 238-year-old Japanese pharmaceutical company lacks any mid- or late-stage cell or gene therapies, two technologies that figure to play a large role in how many rare cancers and inherited diseases will eventually be treated.

It's a mismatch Takedais putting substantial effort into addressing. Last week, executives made cell and gene therapy a notable focus of the company's first R&D day since closing its Shire deal.

"We have a world-class gene therapy platform," Dan Curran, head of Takeda's rare disease therapeutic area unit, told investors and Wall Street analysts gathered in New York city.

"We intend to build on that over the next five years. Because as we look to lead in the second half of [next]decade, we believe patients will demand and we can deliver transformative and curative therapies to patients globally."

But right now that's just an ambition. While Takedahas begun to explore how it can improve on current gene therapies, its candidates are early stage and lag their would-be competitors.

"Our heme A program we're behind. Our heme B program we're behind," admitted Curran in an interview. "But we're behind the first generation and when has there only been one generation of anything?"

Takeda's hemophilia A program is currently in Phase 1, with the hemophilia B candidate about to join it in human testing well back from leaders BioMarin Pharmaceutical, Spark Therapeutics and SangamoTherapeutics in hemophilia A and UniQure in hemophilia B.

Curran laid out three priorities for Takeda'spush: exploring whether gene therapy, typically pitched as a one-time treatment, can be re-dosed; lowering the doses currently used for first-generation therapies; and developing alternative gene delivery vehicles than the adeno-associatedand lentiviralvectors that are predominant today.

"We need to figure out how to re-dose AAVvectors if we want to provide functional cures for patients for the rest of their lives."

How long a gene therapy's benefit lasts is a critical question. In theory, it could last decades or potentially for life, depending on the treatment's target.

But clinical evidence presented to date suggests that benefit for some therapies could wane over time. BioMarin, for example, presented data this year that it argued is proof its gene therapy could raise Factor VIII expression levels in patients with hemophilia A above the threshold for mild disease for at least eight years a long time, to be sure, but not life-long.

Still, it's an unusual objective. Much of gene therapy's promise lies in the potential for it to be given just once and still deliver lasting benefits. And the therapies that have reached market most notably Spark Therapeutics' Luxturna, Novartis' Zolgensma and Bluebird bio's Zynteglo are among the most expensive drugs to ever reach market. Were a gene therapy to be re-dosed, the current value proposition those drugmakers describe would need to be re-evaluated.

Curran recognizes that bringing down costs substantially will be essential to any attempt to advance a multi-use gene therapy. But Takeda might have an advantage. In buying Shire, the pharma inherited a viral vector manufacturing plant, originally built by Baxalta, that Curran calls the company's "best kept secret."

"It's an enormous competitive advantage," he said, adding that Takeda believes it's among the industry's top three facilities by production capacity. "Roche trying to acquire Spark, Novartis and AveXis a significant component of value of those transactions was that these companies had actually invested in manufacturing capabilities."

Curran emphasized that Takeda's ambitions in gene therapy will require it to partner with academic leaders in the field, a playbook that it's followed over the past three years as it's worked to expand into cell therapy.

"In the cell space, there's more innovation you can bring up into proof of principle milestones in academia," said Andy Plump,Takeda'shead of R&D, in an interview.

"An academic can manipulate a cell, but it's very hard in an academic setting to optimize a small molecule," he added. "This is a space where Novartis, and now we, have been quite successful in creating those relationships."

Takeda has put partnerships in place with Japan's Center for iPS Cell Research and Application, GammaDelta, Noile-Immune Biotech, Memorial Sloan Kettering Cancer Center and, just this month, The University of Texas MD Anderson Cancer Center.

That last collaboration gives Takeda access to a chimeric antigen receptor-directed natural killer, or NK, cell therapy.The drugmaker believes NK cells could offer advantages over the T cells modified to create the currently available cell therapies Kymriah and Yescarta.

Most notably, MD Anderson's approach uses NK cells isolated from umbilical cord blood, rather than extracting T cells from each individual patient a time-consuming and expensive process that has complicated the market launch of Kymriah and Yescarta. Cord blood-derived NK cells are designed to be allogeneic, or administered "off the shelf."

Additionally, CAR NK cells haven't been associated (yet) with cytokine release syndrome or neurotoxicity, two significant side effects often associated with CAR-T cell therapies. That could help Takeda position its cell therapies as an outpatient option.

"Even if we were a company that entered a little bit later into the immuno-oncology space, we've very much tried to turn this into an advantage," said Chris Arendt, head of Takeda's oncology drug discovery unit, at the company's event.

"We believe we have a chance to establish a leadership position rather than jumping on the bandwagon and being a follower."

While Takeda's choice to pursue NK cell therapy stands out, its choice of target does not. TAK-007, a drug candidate from MD Anderson that is now Takeda's lead cell therapy program, is aimed at a cell surface protein called CD19 that's found in leukemias and lymphomas.

Both Yescarta and Kymriah target CD19, and a recent count by the Cancer Research Institute tracked 181 cell therapy projects aimed at the antigen.

Takeda is planning to advance TAK-007 into pivotal studies in two types of lymphoma and chronic lymphocytic leukemia by 2021, with a potential filing for approval in 2023.

By then, Kymriah and Yescarta will have been on the market for six years and current bottlenecks in cell therapy treatment could be solved, helping both Takeda's potential entry as well as the host of competitors it will likely face.

Next year will be a test of how productive Takeda'scell therapy unit can be. In addition to TAK-007, the pharmaexpects to have four other CAR-T and gamma delta cell therapies in the clinic, two of which will target solid tumors.

Cell and gene therapy are part of what Takeda calls its "second wave" of R&D projects, a group of early-stage drugs and programs that it sees as progressing to regulatory stages by 2025 or later.

In the nearer term, the drugmakeris advancing a "first wave" of clinical candidates that it told investors will deliver 14 new molecular entities by 2024. Five of those will come in rare disease, with the others spread across oncology, neuroscience, gastro-enterology and vaccines.

"We think the cascade of news coming forward on these programs will transform how people view Takeda," Curran said.

More importantly to the investors gathered in New York, Takeda expects these experimental drugs will eventually earn $10 billion in peak annual sales, which would represent a sizable addition to a business that generated $30 billion in sales last year.

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Breakthrough Gene Therapy Clinical Trial is the World’s First That Aims to Reverse 20 Years of Aging in Humans – PRNewswire

November 26th, 2019 9:44 am

MANHATTAN, Kan., Nov. 21, 2019 /PRNewswire/ -- Libella Gene Therapeutics, LLC("Libella") announces an institutional review board (IRB)-approved pay-to-play clinical trial in Colombia (South America) using gene therapy that aims to treat and ultimately cure aging. This could lead to Libella offering the world's only treatment to cure and reverse aging by 20 years.

Under Libella's pay-to-play model, trial participants will be enrolled in their country of origin after paying$1 million. Participants will travel to Colombia to sign their informed consent and to receive the Libella gene therapy under a strictly controlled hospital environment.

Traditionally, aging has been viewed as a natural process. This view has shifted, and now scientists believe that aging should be seen as a disease. The research in this field has led to the belief that the kingpin of aging in humans is the shortening of our telomeres.

Telomeres are the body's biological clock. Every time a cell divides, telomeres shorten, and our cells become less efficient at dividing again. This is why we age. A significant number of scientific peer-reviewed studies have confirmed this. Some of these studies have shown actual age reversal in every way imaginable simply by lengthening telomeres.

Bill Andrews, Ph.D., Libella's Chief Scientific Officer, has developed a gene therapy that aims to lengthen telomeres. Dr. Andrew's gene therapy delivery system has been demonstrated as safe with minimal adverse reactions in about 200 clinical trials. Dr. Andrews led the research at Geron Corporation over 20 years ago that initially discovered human telomerase and was part of the team that led the initial experiments related to telomerase induction and cancer.

Telomerase gene therapy in mice delays aging and increases longevity. Libella's clinical trial involves a new gene-therapy using a proprietary AAV Reverse (hTERT) Transcriptase enzyme and aims to lengthen telomeres. Libella believes that lengthening telomeres is the key to treating and possibly curing aging.

Libella's clinical trial has been posted at the United States National Library of Medicine (NLM)'s clinicaltrials.gov database. Libella is the world's first and only gene therapy company with a clinical trial posted at clinicaltrials.gov that aims to reverse the condition of aging.

On why they decided to conduct its project outside the United States, Libella's President, Dr. Jeff Mathis, said, "Traditional clinical trials in the U.S. can take years and millions, or even billions,of dollars. The research and techniques that have been proven to work are ready now. We believe we have the scientist, the technology, the physicians, and the lab partners that are necessary to get this trial done faster and at a lower cost in Colombia."

Media Contact:Osvaldo R. Martinez-ClarkPhone: +1 (786) 471-7814Email: ozclark@libellagt.com

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william-bill-andrews-ph-d.jpg William (Bill) Andrews, Ph.D. Dr. Bill Andrews is a scientist who has spent his entire life trying to defeat the processes that cause us to age. He has been featured in Popular Science, The Today Show, and numerous documentaries on the topic of life extension including The Immortalists documentary.

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Dr. Bill Andrews speech at RAADfest 2018 (Sept 21, San Diego, CA)

bioaccess: Libella's CRO partner in Colombia.

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The Point, Nov. 25, 2019: Gene Therapy Work Gets $6 Million Home In Alachua – WUFT

November 26th, 2019 9:44 am

Subscribe to The Point, arriving in your inbox Mondaythrough Friday at 8 a.m.

When its not working and we keep getting the same outcomes, something will change and it will be an urgent matter. The Alachua County School Board is starting to put together bold plans for closing the achievement gap between the districts black and white students. (WUFT News)

Global company Thermo Fisher Scientific has concluded its $6 million expansion at Progress Park in Alachua. One of its vice presidents celebrated that progress Friday, saying, Ive been in this industry for over 20 years in gene therapy, and over the last three years, its completely transformed. (WUFT News)

Marketplace visited Gainesville to see a University of Florida professors efforts to improve the flavor of tomatoes.

State Sen. Keith Perry is taking an interest in the problem of police arresting people with epilepsy during their seizures. (WTSP)

The first two Democrats vying to replace state Rep. Clovis Watson, who is term-limited from running again next November, have filed paperwork during the past month or so. Watson now intends to unseat Alachua County Sheriff Sadie Darnell. (WUFT News, News Service of Florida)

UFs fall semester is wrapping up in the next few weeks, but as it does so, theres a racial and political mess simmering that on Friday afternoon prompted a campuswide email from a vice president. (The Alligator)

One of Micanopys longtime religious leaders is stepping down after 37 years. Les Singletons final service as vicar took place yesterday at Church of the Mediator. (WCJB)

Three years ago, it seemed Amtrak was on a path to returning to serving parts of north Florida. The process of getting passenger trains going again between Pensacola and Jacksonville has moved extremely slowly. (WUFT News, Pensacola News Journal)

A slice of old Florida has been preserved at the Orange Lake Overlook at a cost of $1.3 million. Another piece of local Florida natural history was celebrated this weekend at Little Orange Creek. (Ocala Star-Banner, WUFT News)

Correction from Fridays edition, which had the incorrect title of Ibram X. Kendis latest book. It is called How to Be an Antiracist.

Theres no denying the importance of a good education.

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WFSU put together a helpful guide on how state Supreme Court justices come to hold that position. Its particularly timely with the governor set to make two more selections.

USA Today tracked a man who in the 1990s was to face trial on rape charges in Vermont but who has been living in Florida without consequence for more than two decades.

CBS spotlights the role Florida played in the 2016 election hacking by Russian operatives, including what happened within Annette Taddeos failed run for the U.S. House.

Not everyone is on board with recreational marijuana in Florida, and that group now has a political action committee. (BayNews9)

Being a prisoner (of high water) in Key Largo is not that bad, but it is reality, a resident there tells the New York Times. Its report on King Tide flooding is worth your time.

Whats west of Key West? The Dry Tortugas, and they have a fascinating 500-year history. (Florida Memory Blog)

Heres a helpful guide on some of the states worst invasive plant species. (Florida Today)

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IVERIC bio Appoints Guangping Gao, PhD, Internationally Recognized Gene Therapy Pioneer as Chief Strategist, Gene Therapy – Business Wire

November 26th, 2019 9:44 am

NEW YORK--(BUSINESS WIRE)--IVERIC bio, Inc. (NASDAQ: ISEE) announced today the appointment of Guangping Gao, PhD, as Chief Strategist, Gene Therapy. Dr. Gao brings over 30 years of scientific research experience in gene-based treatments. As one of the worlds leading gene therapy experts, Dr. Gaos highly distinguished career includes major contributions to the development of adeno-associated virus (AAV) gene delivery technology. Dr. Gao is the current President of the American Society of Gene and Cell Therapy (ASGCT). In his advisory role, Dr. Gao will help shape IVERIC bios gene therapy strategy going forward.

On behalf of the Board of Directors and management team at IVERIC bio, we are extremely excited to welcome Dr. Gao to IVERIC bio, stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. Our goal at IVERIC bio is to become a leading retina company with a diversified portfolio addressing significant unmet medical needs in large market age-related retinal indications and inherited retinal diseases by utilizing both therapeutics and gene therapies. Dr. Gaos extensive background in gene therapy will be instrumental in shaping the direction of our gene therapy portfolio. It is a true privilege to work with him closely and benefit from his extensive expertise during these exciting times at our company.

I am delighted to have the opportunity to be a part of the IVERIC bio team, stated Dr. Gao. I am impressed with the progress that IVERIC bio had made with their diverse pipeline of novel gene therapy solutions to treat orphan inherited retinal diseases (IRDs). I look forward to working closely with the team to help build and maximize the potential of the Companys gene therapy programs.

Dr. Gao is a world-renowned scientist and researcher who is a pioneer in AAV gene delivery technology, stated Kourous A. Rezaei, MD, Chief Medical Officer of IVERIC bio. We believe that the combination of Dr. Gaos expertise in gene therapy and our knowledge and experience in drug development for retinal diseases will help set the stage for the proficient execution of our gene therapy strategy, advancing it to the next stage of evolution. We will also continue to move forward our Zimura, complement C5 inhibitor, programs as expeditiously as possible.

About Guangping Gao, PhD

Dr. Gao is the Co-Director, Li Weibo Institute for Rare Diseases Research, Director, Horae Gene Therapy Center and Viral Vector Core, Professor of Microbiology and Physiological Systems and Penelope Booth Rockwell Professor in Biomedical Research, at the University of Massachusetts Medical School; an elected fellow of both the US National Academy of Inventors (NAI) and the American Academy of Microbiology; and the current President of the American Society of Gene and Cell Therapy.

Dr. Gao is an internationally recognized gene therapy researcher who has played a key role in the discovery and characterization of a new family of adeno-associated virus (AAV) serotypes, which was instrumental in reviving the gene therapy field, providing technology to enable potential treatments for many currently untreatable human diseases. For nearly 30 years of his scientific research career, Dr. Gao has primarily focused on molecular genetics and viral vector gene therapy for rare genetic diseases, with research encompassing disease gene cloning, causative mutation identification, pathomechanism investigation, animal modeling, novel viral vector discovery and engineering for in vivo gene delivery, vector biology, preclinical and clinical gene therapy product development, and viral vector manufacturing for preclinical and clinical gene therapy applications, as well as development of technology platforms for novel approaches for human gene therapy.

Dr. Gao has published 267 research papers, 6 book chapters, and 5 edited books and serves as Editor of Human Gene Therapy, Senior Editor of the Gene and Cell Therapy book series, Associate Editor of Signal Transduction and Targeted Therapy, and on the editorial boards of several other gene therapy and virology journals. Dr. Gao holds 135 patents with 239 additional patent applications pending. Dr. Gaos inventions have been licensed to and are currently in development by over ten pharmaceutical companies. Recently, Dr. Gao was ranked as #4 on Nature Biotechnologys list of the Worlds Top 20 Translational Researchers for 2017.

About IVERIC bio

IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. Vision is Our Mission. For more information on the Company please visit http://www.ivericbio.com.

IVERIC bio Forward-looking Statements

Any statements in this press release about the Companys future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about the Companys strategy, future operations and future expectations and plans and prospects for the Company, and any other statements containing the words anticipate, believe, estimate, expect, intend, goal, may, might, plan, predict, project, target, potential, will, would, could, should, continue, and similar expressions. In this press release, the Companys forward looking statements include statements about the implementation of its strategic plan to seek to address significant unmet medical needs in large market age-related retinal indications and inherited retinal diseases by utilizing both therapeutics and gene therapies, the timing, progress and results of clinical trials and other research and development activities, including manufacturing activities, the potential utility of its product candidates and the potential for its business development strategy. Such forward-looking statements involve substantial risks and uncertainties that could cause the Companys development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the initiation and the conduct and design of research programs and clinical trials, establishment of manufacturing capabilities, availability of data from these programs, reliance on university collaborators and other third parties, expectations for regulatory matters, need for additional financing and negotiation and consummation of business development transactions and other factors discussed in the Risk Factors section contained in the quarterly and annual reports that the Company files with the Securities and Exchange Commission. Any forward-looking statements represent the Companys views only as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change. While the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law.

ISEE-G

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For Hemophilia A, BioMarin Seeks Approval of Its Gene Therapy in Europe – Hemophilia News Today

November 26th, 2019 9:44 am

BioMarin Pharmaceuticals is seeking marketing approval in Europe for its investigational gene therapy, valoctocogene roxaparvovec, for the treatment of adults with severe hemophilia A.

The company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for the experimental gene therapy, formerly known as BMN 270. Administered as a single infusion, the therapy uses adeno-associated virus (AAV) vectors to deliver a functional copy of clotting factor VIII, the protein that is missing in people with hemophilia A.

An ongoing Phase 3 trial, GENEr8-1 (NCT03370913), is investigating the treatments safety and efficacy, and is still recruiting adult patients. Go here for more information on trials locations and here for eligibility criteria.

The EMA had previously given valoctocogene roxaparvovec the designation of priority medicines, or PRIME, in 2017. Now, the potential therapy has been granted accelerated assessment, which may potentially shorten its MAA review process from 210 to 150 days.

Accelerated assessment is given by the EMAs Committee for Medicinal Products for Human Use and Committee for Advanced Therapies to innovative medications that are of major interest to public health. This endorsement is meant to speed up the review process of eligible medications, but does not impact the committees decision to recommend their approval.

BioMarins MAA submission was based on updated three-year data from a Phase 1/2 study (NCT02576795)and on an interim analysis of the ongoing Phase 3 GENEr8-1 trial (NCT03370913), which is still recruiting an anticipated 130 patients from 73 sites around the world to test the dose of 6e13 vg/kg (vector genomes per kilogram). Another Phase 3 trial, the GENEr8-2 (NCT03392974) study, is also ongoing and testing a lower dose (4e13 vg/kg).

Three-year data from the Phase 1/2 trial showed that a single administration of valoctocogene roxaparvovec at the higher dose markedly reduced bleeding episodes and the need for factor VIII infusions in a small group of adults with severe hemophilia A. Specifically, there was a 96% reduction in both the mean ABR (annualized bleed rate) and the mean factor VIII usage over the three years.

The levels of clotting factor VIII remained stable over the course of three years following treatment.

Valoctocogene roxaparvovec was generally well-tolerated by patients. None of the participants developed inhibitors to factor VIII, and none withdrew from the study due to adverse events.

We are grateful to the study participants, who have made this progress possible in the span of approximately four years since the first participant was enrolled in the clinical program, Hank Fuchs, MD, president of BioMarins global research and development, said in a press release.

We are very pleased with the level of engagement we have had with global health authorities, as it aligns with our belief that gene therapy represents the next wave of innovation and potentially could be a meaningful advancement for treating people with severe hemophilia A, Fuchs said.

Valoctocogene roxaparvovec will be the first gene therapy for hemophilia whose MAA will be reviewed by health authorities for potential approval in the E.U. BioMarin is expecting the EMA to start reviewing its application in January 2020 and said it will provide an update at that time.

In the meantime, the company is planning to submit a biologics license application for valoctocogene roxaparvovec to the U.S. Food and Drug Administration (FDA) by the end of the year. The investigational treatment has been given a breakthrough therapy designation by the FDA, as well asorphan drug status from both the FDA and EMA.

Joana is currently completing her PhD in Biomedicine and Clinical Research at Universidade de Lisboa. She also holds a BSc in Biology and an MSc in Evolutionary and Developmental Biology from Universidade de Lisboa. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells cells that make up the lining of blood vessels found in the umbilical cord of newborns.

Total Posts: 121

Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Tcnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.

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The hemophilia gene therapy race faces a critical year in 2020 – BioPharma Dive

November 26th, 2019 9:44 am

The gene therapy field made significant strides this year, and 2020 looks set to bring further advances, particularly as a three-way race to develop a hemophilia A gene therapy progresses.

BioMarin Pharmaceutical, Spark Therapeutics and Sangamo Therapeutics are all developing gene therapies for hemophilia A, the inherited disorder characterized by frequent bleeding episodes due to the lack of an essential blood-clotting protein.

While drug candidates from all three biotechs are currently in clinical testing, each is in a distinctly different spot as the companies head into 2020. Here's an overview of how the hemophilia gene therapy space is shaping up and what to watch for over the next 12 months.

BioMarin is well-positioned to be first to market with a gene therapy known as valrox, short for valoctocogene roxaparvovec.

The San Rafael, California-based biotech reported interim Phase 3 results from 16 patients in May, and stated it would file for accelerated approval with the Food and Drug Administration by year end. Since then, BioMarin executives have reiterated that regulatory timeline.

Yet even as BioMarin nears an FDA submission, clinical questions still surround valrox.

Interim Phase 3 data fell short of an earlier trial, leading company executives to blame a difference in timing of steroid use. In the prior study, steroids were typically given to study participants three weeks after infusion, while the Phase 3 trial prescribed steroid treatment after 10 weeks.

And three-year follow-up data from that Phase 1/2 trial showed patient levels of the Factor VIII clotting protein declined over time, raising questions on the product's long-term durability.

That sets up 2020 as the potential year for valrox's approval and launch, which could make it the third or fourth gene therapy for an inherited disease to reach market.

If that occurs, BioMarin will face an important decision on setting valrox's price.Unlike Novartis' Zolgensma, a gene therapy for spinal muscular atrophy that launched this year with a $2.1 million price, hemophilia patients have a range of existing treatments that are used to manage and control their disease.

Particularly if the therapy's price falls in the seven figures, payers could very well push back and negotiate. Concepts such as installment payment plans or outcome-based arrangements have floated as options around by gene therapy companies but remain incremental changes to a system still geared toward chronic therapy.

BioMarin also plans to present four-year follow-up data from the Phase 1/2 study in mid-2020 and Phase 3 data on reducing annual bleed rates in the fourth quarter of 2020 or first quarter of 2021.

At least publicly, Spark has gone quiet on how it's hemophilia candidate is progressing. The Philadelphia-based biotech stopped providing updates on its clinical testing since announcing a deal in February to be acquired by Roche. But that $4.8 billion acquisition has been held up for months by the Federal Trade Commission.

A portion of that scrutiny is presumably over Roche acquiring a gene therapy candidate while also marketing Hemlibra, a prophylaxis factor treatment first approved in 2017. Hemlibra has quickly become a key drug for the Swiss pharma, recording $930 million in sales through the first nine months of 2019.

As FTC mulls the deal, Spark has pushed off sharing interim updates on its gene therapy SPK-8001. While company slides presented at the beginning of 2019 showed plans for a midyear update, that never materialized.

"The guidance we provided about a hemophilia A update in mid-2019 was made prior to the announcement of the pending Roche acquisition," a Roche spokesperson wrote to BioPharma Dive in July. "We have no further comment at this time while we focus on completing the transaction."

In the months since, the biotech has stayed quiet. The latest clinical update is more than a year old, with a data cut-off of Nov. 2, 2018 for its Phase 1/2 trial. Those results included 12 patients, with seven tested at the high dose.

While most patients stopped suffering from bleeds and needing infusions, one patient treated with SPK-8001 was hospitalized and needed adrenocortical steroids. Spark stated it planned to include prophylactic steroids going forward in testing.

Spark has started a run-in study for the Phase 3 program, the company disclosed in its first quarter financial filing. While the company has not clarified where that program now stands, a federal database of clinical trials shows the lead-in study actively recruiting for 55 patients with a completion date of July 2020.

Sangamo has been the wild card in the race with impressive, albeit early, efficacy and safety data.

Early results from a Phase 1/2 trial turned heads in April by showing a small handful of patients treated with SB-525 had normal Factor VIII activity levels six weeks after treatment. And a further update in July backed that result up, showing more patients sustaining normal levels of the essential blood-clotting protein, so far at least.

Pfizer will take over late-stage testing of SB-525 through a 2017 licensing deal with Sangamo. CEO Albert Bourla said it has completed transferring the manufacturing process and enrolled the first patient in October for a six-month lead-in trial for the Phase 3 program.

Phase 3 dosing is expected to begin in the first half of 2020, Bourla said on Pfizer's third quarter earnings call.

For its part, Sangamo will also present updated data from its Phase 1/2 trial on Dec. 7 at the American Society of Hematology's annual meeting in Orlando, Florida.

The hemophilia gene therapy race is poised to evolve in 2020. BioMarin could submit valrox for potential approval, while industry leaders in Roche and Pfizer will both be working to advance Spark's and Sangamo's products, respectively.

And while BioMarin has a sizable lead, the biotech will still need to capitalize on its pole position to gain FDA approval and establish the market.

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Fujifilm to invest $120M in gene therapy, build center in Texas – BioPharma Dive

November 26th, 2019 9:44 am

Dive Brief:

Fujifilm is looking to take advantage of the gene therapy market which, for CDMOs, is expected to reach $1.7 billion by 2025, according to Fujifilm Diosynth Biotechnologies' market research.

"We are very much aware of the incredible growth in such an important therapeutic space," Martin Meeson, president and chief operating officer of FDB U.S., said in a Nov. 14 statement. "We know that we need to invest now, in technology, assets and people in order to achieve a market leadership position."

The new Gene Therapy Innovation Center on the existing FDB campus in Texas will be about 60,000 square feet and operational starting in fall 2021. FDB expects the center to triple its gene therapy development capabilities and add about 100 jobs.

Meanwhile, the first stage of the expansion for the existing manufacturing facility should be complete by the spring of 2021, Fujifilm said.

The Japan-based company's fresh investments in gene therapy come amid a wave of expansions, mergers and partnerships in the growing field.

This month, Swiss manufacturer Lonza announced a new partnership with cold chain specialist Cryoport as part of its goal to provide a seamless "vein-to-vein" network in cell and gene therapy. Lonza also opened a 300,000-square-foot plant last year in Texas dedicated to manufacturing the therapies.

Catalent earlier this year bought Paragon Bioservices for $1.2 billion to strengthen its position as a CDMO of gene therapies. And Thermo Fisher acquired viral vector manufacturer Brammer Bio for $1.7 billion.

Fujifilm forecasts sales of 100 billion yen for its CDMO business in the fiscal year ending March 2022.

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Scientists target gene therapy to ‘switch off’ heart attack-causing genes – Verdict

November 26th, 2019 9:44 am

The future treatment of heart attacks could see doctors deploying gene therapy treatments that deactivate key genes, thanks to research underway at the University of Sheffield.

Researchers at the university, which has been awarded 800,000 from the British Heart Foundation to conduct the project, are working on developing a drug to deactivate the gene that is key to the development of cardiovascular disease (CVD).

We will be identifying a drug to target a gene which contributes to the build-up of fatty material in the arteries, explained Professor Paul Evans, from the University of Sheffields Department of Infection, Immunity and Cardiovascular Disease (IICD), who is leading the project.

Switching this gene off will make the arteries in the heart less leaky, preventing cholesterol from building up and causing blockages which present as heart attacks and stroke.

Atherosclerosis, where theres a build-up of fatty substances in the blood vessels, is an underlying cause of life-threatening conditions such as heart attacks and strokes, added Professor Jeremy Pearson, associate medical director at the British Heart Foundation.

We know that variations in our genes play a part in the development of atherosclerosis, so if these genes can be switched off, many lives could be saved from heart and circulatory diseases.

Gene therapy is an emerging field within medicine that is often characterised as one of the most high-potential areas for future healthcare.

The first gene therapy drug to enter the market only gained approval in 2017, making it a very young field, and one where there is still considerable potential for development.

Treating heart attacks and other CVDs with gene therapy remains a very novel concept, requiring considerable cross-disciplinary skills to explore.

As a result, Evans team is collaborating with IICD and gene specialists in the Department of Neuroscience, as well as colleagues at other institutions, both nationally and internationally.

We are partnering with many organisations known for their research excellence, including scientists at the Georgia Institute of Technology in the USA who will contribute their expertise and technology to process and develop the resulting gene therapy, said Evans.

Read more: A groundbreaking gene therapy is offering hope for a haemophilia cure

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CODA Biotherapeutics Deepens Gene Therapy Expertise with Industry Veteran, Annahita Keravala, Ph.D., and Key Promotions – P&T Community

November 26th, 2019 9:44 am

SOUTH SAN FRANCISCO, Calif., Nov. 21, 2019 /PRNewswire/ --CODA Biotherapeutics, Inc., a preclinical-stage biopharmaceutical company developing a chemogenetic gene therapy platform to treat neurological diseases, today announced the appointment of Annahita Keravala, Ph.D., as Senior Vice President, Gene Therapy. In this role, Annahita will lead the gene therapy aspects of CODA's chemogenetic platform. The company also announced the promotions of Orion Keifer, M.D., Ph.D., to Vice President, Discovery and Translational Research, and Steve Dodson, Ph.D., to Vice President, Pharmacology and Early Development, respectively.

Michael Narachi, President and Chief Executive Officer, said, "We are excited to have Annahita, Orion, and Steve in these vital roles as we advance our lead candidates toward the clinic, as well as build our pipeline based on CODA's chemogenetic gene therapy platform. Their combined gene therapy, neuroscience and small molecule expertise, and experience in early stage research and development, will prove invaluable. With this leadership team, we will fulfill our mission of discovering and developing transformative therapies for patients with intractable neurological diseases for whom limited or no treatment options exist."

Annahita brings more than two decades of experience in gene therapy using viral and non-viral vectors. In particular, she has extensive expertise in discovering novel vector technologies and gene therapy drug development for ophthalmic, systemic and inflammatory diseases. Annahita joins CODA from Rocket Pharmaceuticals, where she was Associate Vice President, AAV Platform. At Rocket, she provided strategic, scientific and operational leadership, oversaw all aspects of discovery research, preclinical and assay development, and provided technical insight to the Chemistry, Manufacturing and Controls (CMC) team. This culminated in a successful Investigational New Drug (IND) application filing.

"I am thrilled to be joining CODA at such an exciting time in the Company's development and growth. What attracted me was the opportunity to partner with Mike, Orion, Steve and our talented team to help bring cutting-edge therapeutic options to patients living with some of the most challenging and debilitating neurological conditions and disorders like chronic neuropathic pain and focal epilepsy for which there remains great unmet medical need," said Dr. Keravala.

Prior to her tenure at Rocket Pharma, Annahita held several positions of increasing responsibility at Adverum Biotechnologies (formerly Avalanche Biotechnologies). As Director of Adverum's Novel Vector Technology group, she designed the overall research strategy, led her team to discover and optimize next-generation adeno-associated virus (AAV) vectors, and oversaw process development and preclinical testing to support the company's pipeline. Earlier, Annahita was a Research Scientist at Stanford University School of Medicine. An author of multiple patents, she is also widely published in prestigious scientific journals. Annahita earned a Ph.D. in molecular genetics and biochemistry from the University of Pittsburgh, a M.Sc. in life sciences and biotechnology from the University of Bombay, Bombay, India, and a B.Sc., with Honors in life sciences and biochemistry from St. Xavier's College, Bombay, India. She completed a post-doctoral fellowship in the Department of Genetics at Stanford University School of Medicine.

CODA's Vice President, Discovery and Translational Research, Orion Keifer, M.D., Ph.D., is a neuroscientist with neurosurgical training and hands-on expertise in small and large animal models, focused small molecule, and cell and gene therapies for neurological diseases. Before joining CODA, he worked as consultant translational scientist and surgeon for Above and Beyond focusing on precision medicines for neurodegenerative disorders. Orion earned an M.D. and a Ph.D. in neuroscience from Emory University, and a M.S. in brain and cognitive neurosciences and B.S. degrees in biomedical engineering, applied psychology and applied biology with Highest Honors from Georgia Tech. He completed his post-doctoral training in the Department of Neurosurgery at Emory University.

Steve Dodson, Ph.D., is CODA's Vice President, Pharmacology and Early Development.Prior to joining CODA, Steve served as Senior Director, Drug Discovery and Development at Second Genome, Inc. Previously he held positions of increasing responsibility at NeuroTherapeutics Pharma, Inc., and Renovis, Inc., where his work focused on the discovery and development of small molecule therapeutics to treat pain, central nervous system disorders and inflammation. Steve received his Ph.D. in biological sciences from Stanford University and a B.S. in genetics from University of California, Berkeley.

About CODA BiotherapeuticsCODA Biotherapeutics, Inc., is a preclinical-stage biopharmaceutical company developing an innovative gene therapy platform to treat neurological disorders and diseases. The company is creating the ability to control neurons with its revolutionary chemogenetics-based technology. CODA is located in South San Francisco, CA. For more information, please visit http://www.codabiotherapeutics.com.

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Why we need root and branch fertility law reform – BioNews

November 26th, 2019 9:42 am

25 November 2019

We are currently experiencing powerful digital, artificial intelligence, genomic science, epigenetics and human reproductive revolutions. These will increasingly blur the lines between the physical, digital and biological spheres.

However, as these technological advances create immense responsibilities, new national and international laws, policies and safeguards will become increasingly necessary.

As more people embrace the transformational impact of these technological revolutions and calculate the economic benefits, I predict that we will see new trends resulting in fewer natural conceptions, more genetically planned parenthood and increased demand for fertility treatment. This is good news for the fertility sector.

DNA (genetic) sequencingnow costs a few hundred pounds per genome, making its integration into the mainstream possible. Interpretation costs are additional, but seem likely to fall. It makes increasing economic sense to invest in genomic sequencing and possible remedies at the outset of fertility patient treatment.

Whole genome sequencing can currently help identify upwards of 40006000 diseases and this number is likely to grow. It is far cheaper than the cost of treating a sick child or adult and lost productivity in the workplace. It is likely to decrease the costs of institutionalised care and result in healthier people living better quality lives. This in turn is likely to increase GDP and lead to greater innovation and development of society as a whole.

Genome editing technologies are becoming more accurate, affordable and accessible to researchers, and could in future help switch genes on and off, target and study DNA sequences.

As genomic science and medicine becomes part of mainstream healthcare provision, I predict we will see a shift in perception towards genetically-planned parenthood to have a healthy child. This technology will help alleviate a biological lottery at birth, avoid condemning children and adults to preventable disease, pain and suffering and has the potential to improve opportunities in life. It could also help address fundamental societal issues of declining fertility levels, later-life conceptions and ageing populations.

At ground level, I expect to see changes to delivery of fertility treatment and patient care. The typical fertility patient treatment model is likely to evolve, incorporating three additional genomic steps at the outset: genomic sequencing, genetic counselling and genetic medicine (including genetic screening and genome editing).

Genomic technology, therefore, has great potential in preventing serious and deadly hereditary diseases and over time we will inevitably see greater pressure to push the boundaries of human genetic enhancements.

In the UK, the implantation of a genetically-altered embryo into a woman is currently prohibited under the Human Fertilisation and Embryology Act 1990, (as amended), excepting under certain conditions to prevent the transmission of serious mitochondrialdisease.

Taking account of these rapidly evolving sectors will require centralised state law and integrated policies. We would benefit from a dedicated Ministry for Fertility and Genomics, with a Minister providing a unified voice, agenda and future direction for the fertility sector as a whole. This would help develop a robust genomic and fertility policy and political strategy encompassing pre-conception through to birth and future genetic legacy.

Added to this, we should ensure the integration of specialist legal services to help protect fertility patients (and future born children) undertaking complex treatment and provide a truly multi-disciplinary medico-legal process.

We will also need informed and effective oversight of genomic science and medicine to protect standards and prevent abuse of this technology. Close oversight, accountability and transparency will be required, and regulation must strike a careful balance between respect for the individual and the interests of the state.

Law and policymakers must adopt caution in deploying these powerful technologies, and it will be important to see how countries across the globe meet the challenge. It will be vital to seek international consensus and build new international legal infrastructures to mitigate the risks and prevent rampant genomic and fertility tourism.

It will require engagement and commitment to help law and policymakers build effective legal and regulatory frameworks that will safely and successfully harness the enormous transformational power of genomic science and medicine in the fertility sector over the next 1020 years and beyond.

Success is there for the taking, but the stakes are very high and we overlook root and branch law and policy reform at our peril.

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Ancestry Websites Great for Finding Relatives and Suspects – Governing

November 26th, 2019 9:42 am

(TNS) Orlando police Det. Michael Fields was sure he had the break he needed right in front of him to close in on a serial rapist: a list of people whose DNA partially matched the man he hunted.

Then the list disappeared.

After a year of criticism from privacy advocates and genealogy experts, the owner of a popular DNA-sharing website had decided law enforcement had no right to consumer data unless those consumers agreed.

"It was devastating to know that there's information out there," Fields said. "It wasn't fair."

So he persuaded a judge to grant him access to the entire database, the genetic records of more than 1 million people who never agreed to police search. It was the first court order in the nation for a blanket consumer DNA search, kept secret from those whose genetic code was involuntarily canvassed.

Genealogical databases are a potential gold mine for police detectives trying to solve difficult cases.

But law enforcement has plunged into this new world with little to no rules or oversight, intense secrecy and by forming unusual alliances with private companies that collect the DNA, often from people interested not in helping close cold cases but learning their ethnic origins and ancestry.

A Times investigation found:

There is no uniform approach for when detectives turn to genealogical databases to solve cases. In some departments, they are to be used only as a last resort. Others are putting them at the center of their investigative process. Some, like Orlando, have no policies at all.When DNA services were used, law enforcement generally declined to provide details to the public, including which companies detectives got the match from. The secrecy made it difficult to understand the extent to which privacy was invaded, how many people came under investigation, and what false leads were generated.California prosecutors collaborated with a Texas genealogy company at the outset of what became a $2-million campaign to spotlight the heinous crimes they can solve with consumer DNA. Their goal is to encourage more people to make their DNA available to police matching.There are growing concerns that the race to use genealogical databases will have serious consequences, from its inherent erosion of privacy to the implications of broadened police power.

There are growing concerns that the race to use genealogical databases will have serious consequences, from its inherent erosion of privacy to the implications of broadened police power.

In California, an innocent twin was thrown in jail. In Georgia, a mother was deceived into incriminating her son. In Texas, police met search guidelines by classifying a case as sexual assault but after an arrest only filed charges of burglary. And in the county that started the DNA race with the arrest of the Golden State killer suspect, prosecutors have persuaded a judge to treat unsuspecting genetic contributors as "confidential informants" and seal searches so consumers are not scared away from adding their own DNA to the forensic stockpile.

After L.A. County prosecutors filed two counts of murder against a man linked to a pair of decades-old cold cases byconnecting the suspect through a genealogy match, Dist. Atty. Jackie Lacey refused to provide details of the genetic work including the commercial genealogy service used. Similar genealogy searches remain sealed elsewhere in California, Texas and Florida.

"They're afraid that if the public finds out what we're doing, we won't be allowed to do it anymore. So the solution is, 'Don't tell the public,'" said Erin Murphy, a former defense attorney who teaches law at New York University and has become an outspoken critic of what she says is open season on consumer DNA.

DNA for decades has been law enforcement's slam dunk, an invaluable tool to identify human remains and put killers and rapists at the scene of the crime. But until a year ago, searches for unknown suspects were limited to the partial "junk DNA" of felons and criminal suspects held in government-supervised databases.

That changed dramatically in April 2018 when a team of investigators in Sacramento County announced they had matched 38-year-old crime-scene DNA with the killer's relatives on a public genealogy site. The arrest of former police officer Joseph James DeAngelo, now charged with 13 murders and awaiting trial, unleashed a wave of consumer DNA hunts across the United States.

The Times found consumer DNA used to declare closure of 66 cases. They involved 14 suspected serial killers and rapists and unsolved crimes going back to 1967, but also the remains of a miscarriage pulled from a sewer and the hunt for a man sneaking into bedrooms. Forensic labs claim to have closed more than a dozen other cases.

"It is probably one of the greatest revolutions, at least I would say, in my lifetime as a prosecutor," said Sacramento County Dist. Atty. Ann Marie Schubert. "But it is a difficult, evolving topic because there are privacy interests at stake and in an area that's unregulated."

Government DNA databases for a decade have allowed crude familial searching that can identify a suspect's parent, child or sibling. But the full chromosomal information held by private services can identify those who share 1% of DNA and are five or more generations removed. Merging that with other consumer data, researchers then can identify relatives two and three generations removed.

Those consumer databases contain genetic code of some 26 million Americans, and so many of European descent that scientists say in a few years they'll be able to identify every Anglo-Saxon American through family DNA.

"There are a whole bunch of stressed-out white guys right now," Schubert quipped.

But critics say police searches invade the privacy of those who submitted their DNA strictly out of curiosity about their ancestry, and their relatives who didn't even consent to that.

Suspects in the Golden State Killer case and most of those that followed were pinpointed by identifying DNA relatives on GEDMatch, a no-frills DNA registry popular with genealogists and adoptees seeking their birth parents. At least twice, GEDMatch allowed police access in cases that ultimately did not meet its policies, and at least once police conducted their hunt without permission using a fake account.

The nation's two largest genealogy services, Ancestry and 23andMe, say they do not grant law enforcement access to their consumer data. But a third, smaller company, FamilyTreeDNA, openly permits law enforcement use except for those customers who specifically opt out.

Few safeguards protect the genetic profiles of millions of consumers on genealogy sites.

Familial DNA searches of the past, done on those within the FBI's national criminal database, were restricted, and California's Department of Justice required case-by-case oversight by an independent committee. The private lab in Virginia handling the bulk of public gene-matching cases argues consumers don't require the same level of protection because they voluntarily mailed in their DNA.

What oversight exists is inconsistent. A U.S. Justice Department policy that went into effect this month limits consumer DNA searches to violent crimes and strictly as a tool of last resort.

Prosecutors in a handful of California counties, including Los Angeles, Sacramento, Orange and Ventura, this spring created their own more lenient rules. Sacramento and Ventura permit consumer searches before all other leads have been exhausted, and in the case of Ventura County, the crime involved does not have to be violent.

Sacramento prosecutor Schubert said the rules guard against uses that might backfire and restrict DNA searches even further.

"I don't want some cop out there doing genealogy on a car [burglar]," Schubert said. "We're identifying people through other people. ... I recognize there are privacy rights."

But most police agencies are like Orlando, which has no DNA policy. Det. Fields said he was guided by "common sense" in the two cases he has searched consumer DNA the July hunt for a serial rapist, and a 2018 arrest of a man for the unsolved murder of a college co-ed.

Fields had spent half a dozen years looking for leads in the 2001 murder of Christine Franke. A Virginia based forensics service, Parabon Nanolabs, used DNA found on Franke's body to predict the race and facial characteristics of her killer. But Fields could get no further until the day Sacramento announced its arrest of the suspect in the Golden State Killer case.

Parabon called Fields offering to replicate the methods to look for Franke's killer.

"I said, absolutely," the detective recalled. "Parabon turned that case around overnight and came up with two family matches, actually three, immediately."

What Parabon provided were GEDMatch accounts of two second and third cousins of the suspected killer the same information any other user of the DNA registry would see. The results show the number of genome locations that match, with each match called a centimorgan. A mother and son would share about 3,400 centimorgans; a suspect's second cousin once removed might have 123 in common.

Field's team then used traditional genealogy to trace those relatives back to a common ancestor from the 1890s. They then built out a huge family tree of every descendant of that ancestor, and started going down the branches.

But eight branches had no DNA, so investigators asked 15 people to provide it. Fields declined to say how these people were convinced. The defense lawyer for the man Fields subsequently arrested said it was by lying.

"They went to Georgia, said there was an African American female murdered who was more than likely related to them," said Orlando lawyer Jerry Girley. Relatives were told that by providing their DNA, Girley said, "their loved one could rest in peace."

Instead, Orlando police days later arrested the son of one of the elderly women tested.

"She is devastated," Girley said.

"Give them an inch, and they'll take it to Mars," he said. "I tell people, 'Don't put your DNA in the system.' (Police) see it as a side door around the 4th Amendment."

The suspect in that case, Benjamin Lee Holmes, has pleaded not guilty. He is jailed awaiting trial, which is set for next year.

Researchers at Baylor College of Medicine found more than 90% of those polled online favored police access to consumer DNA when it comes to murder cases.

"None of us want violent criminals roaming the street," said medical ethicist Amy McGuire, one of the Baylor researchers and also an advisor to FamilyTreeDNA.

But the Baylor study found public support for DNA searching dropped to 34% when the crimes were not violent and police wanted the names of account holders.

GEDMatch at first allowed law enforcement searches only for violent crimes. But GEDMatch permitted gene matching for a teen who broke into a Utah church, assaulting a woman in the process. And it helped police in Texas hunt for a man creeping into women's bedrooms.

The bedroom intruder had slipped into 14 apartments, stealing nothing but sometimes touching a sleeping woman while masturbating. College Station police hired Parabon Nanolabs in Virginia, which used DNA from one break-in to identify a cousin on GEDMatch.

The arrested man is charged with second-degree burglary, a crime that does not meet GEDMatch's restricted use policy. But Parabon's chief genealogist, CeCe Moore, said the case was presented to the company as a sexual assault.

"We wanted to catch him before it escalated," said College Station Officer Tristan Lopez. Like most law enforcement departments, the police agency would not provide details of that DNA hunt.

Moore said Parabon has opened about 300 DNA searches and that the lab has solved almost 100 cases though arrests have not yet been made in several dozen of those cases.

In reaction to growing privacy concerns, GEDMatch in May closed its database to law enforcement unless users specifically agreed to opt in.

By then Fields had moved on to a second case an unsolved rape and had already seen early results on GEDMatch identifying relatives of the suspected rapist. Rather than lose that list with the policy change, he secured a warrant to the entire database. The search remained a secret for four months, until Fields revealed it at a law enforcement conference, encouraging other agencies to conduct DNA matching.

The warrant does not completely undermine efforts to ensure privacy, said GEDMatch co-founder Curtis Rogers.

"The protection offered by having a court review is better than no protection at all," he said.

Critics did not agree, and said the repeated policy breaches and global search warrant show how easily privacy falls away.

"There's always a danger that things will be used beyond their initial targets, beyond their initial purpose," said Vera Eidelman, a DNA expert for the American Civil Liberties Union. She pointed to the way DNA searches at first limited to convicted felons now span the mothers, brothers, uncles, grandparents and cousins twice removed of people who simply want to know if they are German or a Viking.

FamilyTreeDNA lab manager Connie Bormans bristles at any use of the word 'searching.' Police see no more than any other user just the account name and contact information a user provides unless they get a warrant. She has turned away law enforcement efforts that don't meet the company's permitted-use rules.

Bormans said she can't envision a scenario where the familial search would backfire. "It is only a tool," Bormans said. "There is no way that they will get a profile and arrest someone solely on the profile."

But in California early this year, police investigating the 1995 rape of a 9-year-old schoolgirl in Lake Forest and a 1998 rape of a jogger in the same town used FamilyTreeDNA to identify not one, but two suspects. They were identical twins, sharing the same DNA. Both brothers were jailed until undisclosed additional evidence led to freedom for one and rape charges against the other. The Orange County district attorney's office and Sheriff's Department did not respond to requests for additional information about the basis for the arrests. The district attorney subsequently adopted a DNA searching policy that precludes arrests based on family matching alone.

Legal scholars said it is only a matter of time before courts weigh in on the privacy of DNA.

Only one of the 66 DNA-derived cases identified by The Times has gone to trial a Washington man convicted of killing a Canadian couple in the 1980s and the defense lawyer there agreed not to challenge the GEDMatch work that led police to her client.

In 27 other cases, the accused perpetrators either were already dead, confessed or pleaded guilty. Prosecutors in Virginia and California have asked judges to treat the DNA as a "genetic informant."

Schubert's office is blocking disclosure of the DNA trail that led to the arrest of two accused serial rapists from the 1980s and 1990s. Her attorneys told one judge that secrecy must extend beyond the names of relatives whose DNA was examined to the names of the companies providing that information keeping it secret even from defense lawyers.

Schubert's staff successfully argued such disclosure might "result in a backlash against that site resultingin a tightening of restrictions on the site or use of the site."

They added: "If individuals in society stop wanting to enter DNA in consumer genealogical databases for fear their privacy is not being protected, then law enforcement loses a powerful technique to solve crime."

Concern about losing access to the DNA brought two California prosecutors to Texas.

Public records show Schubert and Orange County assistant prosecutor Jennifer Contini met on a Sunday in June with Bennett Greenspan, the CEO of FamilyTreeDNA. They sought his help in expanding the DNA available to police, including a campaign to convince consumers to share their genetic data.

"We both really feel that we ought to start an 'I'm in campaign'" Schubert wrote to Greenspan the next day. "Jennifer and I thought perhaps something like 'I'm in for Freedom and Safety' ... or 'I'm in for Safety and Freedom' might be an idea for a tag line."

The FamilyTreeDNA executive offered the help of his public relations company to arm Schubert with "compelling content."

"We need to provoke the question in a way that we will be able to provide the reasonable answer," Greenspan wrote.

Less than a month later, the Institute for DNA Justice was born.

The nonprofit has announced a $2-million campaign. Registration papers identify Schubert as its CEO and Ventura County Dist. Atty. Greg Totten as chief financial officer. There is no direct link to FamilyTreeDNA, but inquiries by The Times to the law firm handling the papers were forwarded to FamilyTreeDNA's media relations firm. A spokeswoman for the media firm said its work for FamilyTreeDNA and the nonprofit are separate, though performed by the same people.

The Orlando cop who bypassed GEDMatch's privacy policy is nonplussed by the concerns over privacy and public buy-in.

"It's Big Brother, but Big Brother's been here for decades," Fields said. "Everyone's trying to focus in on this because it's DNA, but it's no different than anything else that we do in our everyday lives. Police with a piece of paper and the judge can override almost anything."

2019 the Los Angeles Times.Distributed byTribune Content Agency, LLC.

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Ventolin is used for – Ventolin gsk recall – What are the drugs called that are used to dilate the walls of the bronchi and treat asthma – Laughlin…

November 26th, 2019 9:42 am

November 19, 2019 Cover

Pam Tillis keeps busy touring, making appearances and forever moving forward to her next musical project. Just last week she was a presenter for the Country Music Association awards with Women of Country Music as the theme.Country music is lucky to have her in their genre. But it wouldnt have mattered what Tillis chose to record and perform, she has one of those rare voices that lends itself to anything she wants to sing. She can easily move from classic country, to pop, to a bluesy torch singer wherever her heart, her soul and the lyrics lead.

Its rare when the puzzle pieces just seem to fit the first time a person opens the jigsaw box, but when Norm Stulz had the ability to make people laugh as early as the second grade in Detroit, there was no denying opening the comedy box was his lifes calling.Just a few years later in the seventh grade, he met the girl of his dreams and to this day, he and his wife Sharon, continue to build on a life together as two crazy kids in love. Laughter has been the glue for the relationship and the career path that has sustained Stulz for nearly 40 years.

Hosting a holiday dinner for your family is an undertaking in itself, but resorts are tasked with preparing the perfect menu for thousands of guests at multiple restaurants.Which items do guests want on the menu? How much food to order? When to start cooking? How many guests to prepare for? These are all questions the food and beverage departments must consider when planning for a holiday.

This time of year box stores are filled to the brim with every electronic device and latest phone known to man, but are there people on your list who already have all that stuff? Everyone has that one relative who is a challenge when comes to finding the perfect gift. Unique people require unique items and thinking outside the traditional box store offerings. Maybe that difficult-to-buy-for person is yourself because you never know what might strike your fancy.

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Startup ‘gamifies’ gut health with diet app aimed at long-term change – NutraIngredients.com

November 26th, 2019 9:41 am

Personalised nutrition startup Atlas Biomed claims to be the only company in the world offering both DNA and microbiome testing kits for a holistic picture of health and now it is launching a phone app allowing people to discover what foods will best improve their gut health with the simple snap of the camera.

Sergey Musienko, bioinformatician andfounder of the UK-based firm launched in 2014, says the app differs from all other diet apps on the market as it will allow customers to genuinely learn how to modulate their microbiomes through their diet choices by teaching them about diet variety and fibre intake.

He tells NutraIngredients: Itallows the customer to take a photo of their meal and the special algorithm allows us to identify the specific ingredients in the meal and based on their latest microbiome test results the app provides a scoring system for each ingredient, showing how beneficial they are to the users microbiome composition.

The whole idea behind this is to help people gamify the process and better understand what ingredients can be harmful or beneficial to their gut bacteria.

The entrepreneur points out that research has shown that the majority of the population in Europe and the US are not eating enough fibre - a nutrient essential for a healthy microbial diversity.

He points out that therecommended daily intake is 30 grams but according to the Scientific Advisory Committee on Nutrition, UK adults are only eating around 18 grams per day.

He says people should ideally be eating at least 30 different sources of fibre each week in order to keep their microbial diversity up and the app helps people achieve this.

Believe me, its harder than you would imagine to reach this number. I think when I first checked I was getting maybe 20 on a good week.

There are a lot of apps out there that help people track their calories or their macros but this is the first to concentrate of fibre as well as some vitamins, polyphenols and sugar which also have an impact on microbiome composition.

This will help people to discover the best fibre sources for them and it will help people to diversify their diets. We really want to help people to live healthy lives for longer and as soon as you have a basic understanding its quite easy to stay on track its like learning to ride a bike!

Musienko graduated from the Moscow Institute of Physics and Technology before going on to join theSilicon Valley think tank, at Singularity UniversityCaliforniain 2011,where they train entrepreneurial minds on how to apply technology into projects that can improve the lives of people around the world.

There I had a chance to meet lots of visionaries and entrepreneurs around health technology."Musienko explains, "I spoke to lots of researchers and shared ideas with them and discussed whats the future of preventative medicine. Thats when I had the idea which would lay the foundation for Atlas Biomed taking a personalised proactive approach to health care by predicting conditions and doing everything we can to prevent them.

Back then, in 2011, companies were offering affordable genomics tests but these tests were in their really early days and there was a lot of criticism that they couldnt tell you in a precise way whats likely to happen to the persons health. Of course with all these common but complex issues, like chrones disease, diabetes, obesity, lifestyle has a huge impact as well as genes.

I realised if we want to personalise healthcare or nutrition in an accurate manner it has to be a combination of different factors and thats how we came up with the concept of multiple tests a saliva test for genes and a stool sample test for the microbiome which covers changes in diet and lifestyle.

The company launched its DNA and microbiome tests commercially in Europe in 2017 and since then it has quickly expanded with sales in 17 countries across Europe as well as Canada with hopes to establish itself in the US soon.

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Chip Warren: One day of giving thanks isn’t enough, but it’s good start – Sand Mountain Reporter

November 26th, 2019 9:41 am

Is it just me, or have you noticed how we seem to go straight from Halloween to Christmas, almost bypassing Thanksgiving altogether? That is unfortunate because not only is Thanksgiving an important American holiday that reflects our heritage, but individuals, families and churches need one day set aside for the purpose of giving thanks to the Lord and acknowledging that all that we have is from Him.

Is the giving of thanks only on this one day enough? Certainly it is not, but it is a good place to start.

There are numerous benefits to the giving of thanks. Please allow me to mention only a few.

First, the giving of thanks to the Lord is preventative medicine for developing a critical spirit. One with a critical spirit is constantly criticizing others. He tends to see what others are doing wrong and not right, and is constantly finding fault. A person with a critical spirit can always do anything and everything better than the one he is criticizing.

Instead of finding faults in others, why not begin to thank God for them and pray for them. It is difficult to criticize someone you are thanking God for, whether it be government officials, church leaders and even family and friends.

Those that were closest to the late Billy Graham said they never heard him speak a critical word about anyone. Does that mean that Dr. Graham never observed something in others that could not be criticized? I suspect that a man who lived so long and traveled so extensively encountered those he could have criticized, but he chose to keep those observations to himself.

Another benefit of giving thanks is that of learning to be content with what we have. By the time you read this, the collection week for Operation Christmas Child will have just concluded. This ministry of Samaritans Purse collects literally millions of shoeboxes filled with small toys, school supplies, hygiene items, etc. The reports indicate that the kids who receive them are absolutely overwhelmed with joy, appreciation and thanksgiving.

Now, imagine how the average American child would react if one of these shoe boxes was all he or she received for Christmas. I suspect most would complain and be very ungrateful. And why is this? Perhaps one reason is that so many kids have been spoiled and been trained to expect lavish gifts at Christmas time. Many of them have not been raised to be thankful and thus content.

There are many reasons the Greatest Generation is considered to be such. One of those is that they were grateful for what they had. That generation, who is slowly ebbing away, lived through the Great Depression when millions were out of work, and poverty was the norm of the day from rural areas to metropolitan cities. They learned to be grateful just to have something to eat and a roof over their heads.

That generation also survived WWII. Those stateside had to deal with rationing of almost everything. And of course those called into service had to cope with the horrible conditions that go with war. Those who survived were grateful just to be alive. That generation knew how to get by on what they had and were thankful for what they had.

We all could learn a lesson from that generation about being thankful instead of complaining. Instead of complaining about not having a bigger and more up to date house, we should be thankful that we have a house period. We should appreciate the fact that we have a roof over our head, not to mention indoor plumbing and electricity. Instead of complaining that we dont have a newer and nicer car, we should give thanks for the car that we do have, and that it is paid for.

Career missionaries to foreign nations and those who have done short term mission work can testify that some of the happiest people in the world are those who have very little in the way of material possessions. I suspect they have learned the secret of contentment and to give thanks in all things.

Parents, are you teaching your children to be thankful? It starts with the small things like saying thank you, or even writing a thank you note for a gift or some act of kindness shown by another. Does your family take time to say a prayer of thanks to the Lord when you sit down to a meal, whether at home or in a restaurant?

Is one day of giving thanks a year enough? Of course not, but it is a good place to start.

For we have brought nothing into the world, so we cannot take anything out of it either. If we have food and covering, with these we shall be content. I Timothy 6:7-8.

Chip Warren is the past president of the Albertville Ministerial Fellowship.

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A Tucson business is helping women find the perfect lipstick … by matching their nipple color – Arizona Daily Star

November 26th, 2019 9:41 am

Renae Moomjian pretty much gets the same reaction from everyone she tells about her new business, NipLips.

In fact, it's the same reaction she had when her teenage daughter Helena Moomjian first told her about the concept.

"I was driving my daughter home from school, and she was reading something called 'Uncle John's Bathroom Reader'" Moomjian recalls. (Uncle John's Bathroom Reader, by the way, is a trivia book). "And it was very quiet, and then all of a sudden, she said, 'Hey, Mom. Did you know your perfect lipstick color is your nipple color?'"

To which Moomjian responded. "WHAT?"

Renae Moomjian, left, and her daughter Helena started NipLips.

Intrigued, Moomjian went home and tested the theory with the lipsticks in her makeup drawer. None of them matched.

"So I was like, 'Let's take pictures and go to Walgreens' ... so we are walking around Walgreens, looking at our phones secretly and putting lipstick in our cart," Moomjian says. "It was about $110 worth of lipstick, and we went home and found our perfect match and one shade darker. And we both loved it."

Neither would have normally selected those colors.

"And I said to Helena, 'Maybe there's something to this,'" Moomjian says. That was in May 2018.

When the internet went crazy

The beauty trend seems to have taken off in spring 2017 when a segment on the talk show "The Doctors" made the connection between a person's nipple color and her ideal nude lipstick. The internet went crazy, and beauty magazines including Marie Claireand Refinery 29tried it out, with mixed results. Some people loved the lipstick shade they picked and others, not so much.

Margarita Potts GoDiva, a hair and makeup artist of more than 20 years and owner of I Do Hair and Makeup Artistry, says that the idea of using your body as a reference has been around for way longer.

"The rule of thumb has always been, nature knows best," says Potts GoDiva, who does celebrity, print, film and TV makeup. The inner cheek and upper lip are go-tos for her when color matching.

"For us in the TV world, you know if you're going with the inner cheek or upper lip or body, it's going to be a good match on camera," she says. "It makes people look fresher, youthful and more alive."

Matching to your nipple color is the same premise.

"Beauty trends come and go, but you can always come back to yourself," Potts GoDiva says, adding that it's also case-by-case. Getting too matchy-matchy can actually wash you out or make you look flat, she says. Plus, sometimes you just want to wear a bright, bold color.

There's an app for that

A few months after Moomjian and her daughter did their own experimenting, Moomjian asked 20 friends to give it a try. She wanted to know if matching your lipstick color to your nipple was actually a thing. She says 80 percent of her friends loved their exact match and all of them liked one shade darker.

The mother-daughter duo launched NipLips at the beginning of 2019to help women find a nude lipstick that flatters their skin tone.

Right now, NipLips has eight colors with Tucson-inspired names, such as Prickly Pear, Purple Agave or Burnt Adobe. Using the NipLips app, you can scan a close-up of your nipple to get matched to the closest color for you.

"Nothing is ever saved on your phone or uploaded to us," Moomjian says. "I was very clear that there could never be any invasion of someone's privacy. The only thing we save is the color."

Moomjian also owns a medical device consulting business, which is why after she and Helena took their Walgreens field trip, sneakily checking their phone photos as they shopped, she knew tech could make the process easier. Hence the color-matching app.

Eventually, NipLips hopes to customize colors specifically from your scan, but they'refundraisingfor that right now.

Ada Trinh, a makeup artist in Los Angeles, is a brand ambassador for NipLips and loves the product. As someone who has seen plenty of beauty trends come and go, Trinh says the tech part of NipLips sets it apart.

"You're not just talking about it," says Trinh, a celebrity, film, TV and print makeup artist. "They have an app that can actually show people that this is how it works."

Keeping it au naturel

Moomjian has also made a point to make NipLips a clean beauty business because that's the way she lives her life.

"Because I bring new medical technologies to the market, I deal with very sick people ..." she says. "I feel like preventative medicine is the best medicine so I live clean and I eat clean."

Moomjian says clean beauty means no synthetic or toxic ingredients. The NipLips website clarifies that products have "no parabens, phthalates, DEHP, SLS, petrolatum, talc, synthetic fragrances or colorants or silicons." So even if you're not keen to match your nipple color or use the app, the lipstick is worth checking out, at $22.50 each.

"I've used it on a couple of clients," Trinh says. "On set, I couldn't do the nipple scan ... but I could tell them about the concept ... and use the product on them without the scan."

Trinh says she has also used it on set to go from a day look to a night look just by adding another layer.

"A lot of the colors are really poppy, but the app gives you choices if you don't want to be as poppy, you can use one that's more natural," she says. "The pigment is great and buildable, or you can use it almost as a nice tint that doesn't go on too harsh."

The cosmetics are made locally, by the same lab that makes Sia Botanics, using some naturally-sourced Sonoran Desert ingredients such as prickly pear seed and jojoba oil. The next, soon-to-be-released NipLips collection a glosswill take its inspiration from the ocean. The one after that, the rainforest. The goal is to package all of it sustainably.

NipLips helps women find the right lipstick shade by matching it to their nipple color.

As the business grows, Moomjian wants to eventually support nonprofits that work in women's health issues, specifically heart disease and breast and ovarian cancers all diseases that have impacted her family. In the meantime, Moomjian says they will gift lipstick to any woman with breast cancer or a mastectomy.

Potts GoDiva adds that if you're checking your nipple color, it's also a great time to do a self breast exam.

"That, to me, is a great reason for this," she says.

A mother-daughter business

Before launching NipLips, Moomjian says she mostly wore bright reds and pinks. Helena, a student at University High School, mostly wore dramatic makeup for theater productions.

"I'm not a big makeup person," Helena, 16, says. "But putting the right lipstick on is a boost of self confidence."

The whole experience has been a ride, she adds.

"When I was younger and imagined my life in the future, I never ever would have imagined such a wild thing," Helena says with a laugh.

Although school keeps Helena busy, Moomjian says working together on the business has been one of the sweetest parts.

"We do a lot together," she says. "And to see her excitement and input along the way has been really fun, and for us to work together like this has been very special."

Try it out

Besides shopping online, you can try NipLips at upcoming markets including the Made in Tucson Market on Sunday, Dec. 1 and Cultivate on Saturday, Dec. 7. A privacy booth will allow you to use the app to find your best shade. You can also buy the lipsticks and try samples of the NipLips Desert Botanical matte collection at English Salon Spa, 27 N. Scott Ave., downtown.

"For Helena and me, it's about looking within to define your beauty and who you are and speaking from that place," Moomjian says.

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Remodeled Winn-Dixie opens in Zephyrhills, and other Pasco business news – Tampa Bay Times

November 26th, 2019 9:41 am

Briefs

WINN-DIXIE REOPENS: Winn-Dixie reopened its remodeled store at 36348 State Road 54 in Zephyrhills on Nov. 3. The store includes an updated farm-fresh produce department, improved deli with expanded grab-and-go meals and wing bar, upgraded meat case and floral department, and a new Dollar Shop section.

LOCAL ECONOMIC DEVELOPMENT PRESIDENT NAMED TO INTERNATIONAL COUNCIL: The Board of Directors of the International Economic Development Council has elected Bill Cronin, president and CEO of the Pasco Economic Development Council, to serve on its board of directors. The nomination took place during the International EDCs 2019 conference in Indianapolis Oct. 13-16. Cronins term begins Jan. 1.

BABY ITEMS DRIVE: Butash and Donovan Law is hosting a Baby Stuff Drive through the end of November at its office at 23554 State Road 54, Lutz. The drive is to benefit GuidingStar of Tampa, a womens healthcare practice offering medical and educational services, as well as ongoing support for women. Items needed include: gently used or new baby clothing for boys and girls, sizes newborn to 4T; newborn diapers; baby wipes, baby shampoo, baby soap and other toiletries; gently used maternity clothes; and small- and medium-sized stuffed animals. For information, call (813) 341-2232.

GRAND RE-OPENING OF HOSPITAL WOUND CARE CENTER: Regional Medical Center Bayonet Point held a grand re-opening of its Wound Care and Hyperbaric Medicine Center on Nov. 13. The center underwent a $500,000 renovation that took six months and included renovations of everything from podiatry chairs to updating all the furniture. Hyperbaric chambers were added, and the wound care center has been expanded to two suites, totaling 3,865 square feet.

HOSPITAL NAMES NEW CHIEF MEDICAL OFFICER: Medical Center of Trinity has appointed William Bill Killinger, MD, as its new chief medical officer. Dr. Killinger is a third-generation Florida physician. He was trained in cardiothoracic surgery, and was in private practice for 27 years in Raleigh, N.C. He is completing work on his healthcare executive masters degree with Brandeis University.

NEW DQ GRILL & CHILL OPENS: American Dairy Queen Corporation announced its new DQ Grill and Chill restaurant has opened in Hudson, at 14671 State Road 52. The restaurant is owned by Carlos and Pam Saenz. The Saenzes have been owners of a DQ Grill and Chill since 2016, with their first location in Land O Lakes. Carlos served five years in the U.S. Air Force, and still serves as a Reservist. Pam is also an elementary school teacher.

ALARM COMPANY MOVES TO PASCO: AFA Protective Systems recently relocated to a 5,800-square-foot facility in the West Pasco Industrial Park off State Road 54 in Odessa. The company designs, installs and monitors fire, safety and security systems.

CARES NAMES NEW DIRECTOR: Community Aging and Retirement Services (CARES) has named Melissa Kehler its new director of community engagement. Kehler has more than 20 years experience in nonprofit leadership roles, most recently serving as executive director of Chinsegut Hill Retreat and Museum in Hernando County.

HEALTH SEMINAR: AdventHealth will host a seminar, Treating Pain without Pills, from noon to 1 p.m. Dec. 3 at AdventHealth Zephyrhills, 7050 Gall Blvd. The speaker is Kamal Patel, MD, a fellowship-trained pain specialist who is double-board certified in preventative and occupational medicine. Reservations are required. RSVP to 877-534-3108.

HOLIDAY PARADE: The Greater Pasco Chamber of Commerce will host its 43rd-annual Holiday Parade on Dec. 14. The deadline for sponsorships and to enter a company float is Dec. 3. For details, contact the Chamber at (727) 842-7651.

Trinity Positive Business Network: 8:30 a.m. Mondays at Oasis Coffee Spot, 9213 Little Road, New Port Richey. Call Kelly Steen at (813) 388-8726.

Womens Connection of New Port Richey: 11:30 a.m. the second Monday of each month (September through May) at Spartan Manor, 6121 Massachusetts Ave., New Port Richey. Cost is $15 and includes lunch and a speaker. To RSVP, call Linda at (727) 856-4042 or Betty, (727) 807-6760.

BNI Overachievers Chapter: 7 to 9 a.m. Wednesdays at Myrtle Lake Baptist Church, 2017 Reigler Road, Land O Lakes. Call (813) 317-5556 or visit facebook.com/bnioverachievers.

BNI Outlook to Success: 7:30 a.m. Tuesdays at Verizon Event Center, 8718 Trouble Creek Road, New Port Richey. Cost is $10 and includes breakfast. Call (727) 815-7744.

Suncoast Women in Networking: 11:30 a.m. to 1 p.m. the third Tuesday of each month at Beef O Bradys, 5546 Main St., New Port Richey. Suncoast WIN is a group of professional businesswomen. Membership is $10 per year. Call Linda McFarland at (727) 863-6151.

Rotary Club of Lutz: 11:45 a.m. to 1 p.m. Tuesdays at Heritage Harbor Golf and Country Club, 19502 Heritage Harbor Parkway, Lutz. Cost is $12, includes lunch and speaker. Call (813) 857-7089 or visit lutzrotary.org.

West Pasco Business Association: Monday Lunch Chapter, noon to 1 p.m. Mondays, Johnny Bruscos, 10730 State Road 54, Trinity. Tuesday Breakfast Chapter, 8:30 to 9:30 p.m. at Hampton Inn, 1780 State Road 54, Odessa. Tuesday After Hours Chapter, 5:30 to 6:30 p.m. Tuesdays, FlameStone Grill Trinity, 10900 State Road 54, Trinity. Thursday Lunch Chapter, noon to 1 p.m. Thursdays, Giovannis Fresh Italian Kitchen, 37611 U.S. 19, Palm Harbor. Friday Breakfast Chapter, 8:30 to 9:30 a.m. Fridays at the Oasis Coffee Spot, 9213 Little Road, New Port Richey. The group is made up of professionals who promote each others businesses. Each chapter is seat-specific. Contact Maria Johnson, maria@wpba.biz or (727) 934-0940. Visit wpba.biz.

Coffee First: 8 to 9 a.m. the fourth Tuesday of the month at First National Bank of Pasco, 23613 State Road 54, Lutz. The event is hosted by the Central Pasco Chamber of Commerce in partnership with First National Bank of Pasco. Free and open to the public. (813) 607-2555.

East Pasco Networking Group: 7:30 p.m. the second and fourth Tuesdays of the month at IHOP, 13100 U.S. 301, Dade City. Annual dues are $25. Nils Lenz, (813) 782-9491.

Trinity Business Association: 6 to 7:30 p.m. the first and third Tuesdays of each month at Fox Hollow Country Club, 10050 Robert Trent Jones Parkway. Networking begins at 5:30 p.m., meeting starts at 6 p.m. Guests welcome. Cost is $12. Call Ginny Pierce at (727) 433-4073.

BNI Platinum: 7:15 a.m. Wednesdays at Heritage Harbor Golf & Country Club, 19502 Heritage Harbor Parkway, Lutz. Call Bob Nixon at (813) 263-5632.

Pasco Business Connections: 7:30 a.m. Wednesdays at the Broken Yolk, 3350 Grand Blvd., Holiday. Email noworries@tampabay.rr.com.

Wednesday Morning Networking Group: 7:30 a.m. the first Wednesday of each month at Hungry Harrys Family Bar-B-Que, 3116 Land O Lakes Blvd. A short networking presentation will be followed by a chance for all attendees to do a 30-second commercial. Cost is $7 in advance for members, $10 for guests, and includes breakfast. Call the Central Pasco Chamber of Commerce at (813) 909-2722.

Keep It Local-Trinity Chapter: 8 a.m. Wednesdays at Havana Dreamers Cafe, 3104 Town Ave., Trinity. (813) 405-7815.

Pasco Aging Network: 8 to 10 a.m. the second Wednesday of each month. Location changes each month. For information or to RSVP, visit pascoagingnetwork.org. PAN is a coalition of agencies and private providers of elder services in Pasco.

Keep It Local-Wesley Chapel Chapter: 8:30 a.m. Wednesdays at Lexington Oaks Golf & Country Club, 26133 Lexington Oaks Blvd., Wesley Chapel. (813) 405-7815.

Keep It Local-Christian Womens Network Chapter: 9:30 a.m. Wednesdays at the Direction Connection, 2632 U.S. 19, Holiday. (813) 405-7815.

Free Networking International: 11:30 a.m. to 1 p.m. Wednesdays at Cantina Laredo, 2000 Piazza Ave., Building 4, Suite 170, Wesley Chapel (at the Shops at Wiregrass). Attendees pay for their own lunch. Call Martine Duncan at (813) 929-6816.

Keep It Local-New Port Richey Chapter: 11:30 a.m. Wednesdays at the Direction Connection, 2632 U.S. 19, Holiday. (813) 405-7815.

Keep It Local-Odessa/Trinity Chapter: 11:30 a.m. Wednesdays at Seven Springs Golf & Country Club, 3535 Trophy Blvd., Trinity. (813) 405-7815.

BNI Eagles: 7:15 a.m. Thursdays at Spartan Manor, 6121 Massachusetts Ave., New Port Richey. Cost is $10 and includes breakfast. Call Clay Henderson at (727) 534-5191.

BNI Referral Connection: 7:15 to 9 a.m. Thursdays at Vallartas Mexican Restaurant, 22948 State Road 54, Lutz. Call Rob Hamilton at (813) 431-5887.

Christian Business Connections of Central Pasco: 7:45 to 9:15 a.m. Thursdays at Quail Hollow Golf Club, 6225 Old Pasco Road, Wesley Chapel. Cost of $9 per meeting, includes breakfast and beverages. Annual membership dues are $100. Call Rene Van Hout at (813) 300-7511.

Trinity/West Pasco Chapter of NPI: 7:45 a.m. Thursdays at The Grand Plaza Caf, 4040 Little Road, New Port Richey. Call Rob Marlowe at (727) 847-2424.

Networking For Your Success: 8 a.m. Thursdays at Lexington Oaks Country Club, 2615 Lexington Oaks Blvd., Wesley Chapel. Cost is $5 and includes a continental breakfast. Annual membership is $79. Call Matt at (813) 782-1777.

Women-n-Charge: 11:30 a.m. on the first Friday of each month, Plantation Palms Golf Club, 23253 Plantation Palms Blvd., Land O Lakes. The cost is $15 for members and $18 for guests who RSVP by Monday prior to the meeting. Tuesday and after, the cost is $20 for members and $23 for guests. To RSVP, visit women-n-charge.com/meetings/. For information, call Judy at (813) 600-9848.

Women of Wesley Chapel (WOW): 7:30 to 9 a.m. first Friday of each month, Beach House Assisted Living and Memory Care at Wiregrass Ranch, 30070 State Road 56, Wesley Chapel. WOW is the North Tampa Bay Chamber of Commerces women only networking group. The cost is $5, includes breakfast and networking. To RSVP, call (813) 994-8534 or email office@northtampabaychamber.com.

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Remodeled Winn-Dixie opens in Zephyrhills, and other Pasco business news - Tampa Bay Times

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