ARM in the News

Cell Therapy Manufacturing – Opportunities and Challenges
March 20, 2018 - (The Cell Culture Dish) - In this podcast and accompanying we interviewed Dr. Robert Preti about the past, present and future of global cell therapy manufacturing. 

Europe’s Pharma Companies Join with Non-Profit Group in Push to Measure Outcomes of Medical Treatments
March 19, 2018 - (Science Business) - An alliance with outcomes measurement body ICHOM intends to accelerate the push towards value-based care. The aim is to square the circle between the budget squeeze facing healthcare systems and paying for medical innovation coming through the pipeline.

The 21st Century Cures Act: FDA Implementation One Year Later
March 2, 2018 - (P&T Journal) - Michael Werner, Co-Founder and Senior Policy Counsel for the Alliance for Regenerative Medicine (ARM), says the FDA “has moved very, very quickly to implement statutory language from the Cures bill.”

RMAT vs. Breakthrough vs. Fast Track: Companies Seek Clarity on FDA Draft Guidance
February 19, 2018 - (RAPS) - Industry groups BIO, the Alliance for Regenerative Medicine and the International Society for Cellular Therapy (ISCT), as well as biopharma companies Gilead and Biocom, are seeking clarity from the US Food and Drug Administration (FDA) on guidance related to its relatively new Regenerative Medicine Advanced Therapy (RMAT) designation, according to comments submitted last week.

What Gilead Taught Pharma About Pricing a Cure
February 12, 2018 - (BioPharma Dive) - Debate over about 'how to price a cure' entered the pharma industry lexicon when Gilead Sciences Inc. priced its highly effective hepatitis C drug Sovaldi (sofosbuvir) at $84,000 per treatment course.

Cryoport Supporting TiGenix Sepsis Clinical Trial
February 5, 2018 - (Outsourcing Pharma) - The number of new clinical trials in the regenerative market space continues to grow, says Cryport, which will provide global logistics support for TiGenix’s upcoming Phase Ib/IIa study.

ARM Hails the Breakthrough Year for Cell and Gene Therapies
January 22, 2018 - (BioWorld) - The superlatives were flowing for the continuing progress of the regenerative medicine sector at the Alliance for Regenerative Medicine's (ARM) state of the industry briefing on cell and gene therapies presented at the recent Biotech Showcase 2018 conference. Speaking to a packed audience of pharma and biotech company delegates as well as industry analysts and media, Robert Preti, chairman of ARM and president and CEO of Hitachi Chemical Advanced Therapeutics Solutions, proclaimed that 2017 represented a truly breakthrough year for the sector in his opening remarks of the event.

Clashes Over the Future of Gene Therapy at the U.S.'s Biggest Biotech Meeting
January 12, 2018 - (WIRED) - For one dizzying, schmooze and booze-filled week every January, thousands of tech execs, VCs, and investment bankers grind their way through a four-day slog of panel sessions, poster presentations, networking meetings, and cocktail-drenched after-hours parties in their industry’s premier orgiastic dealmaking event.

Recap of the 2018 Alliance for Regenerative Medicine Cell and Gene Therapy State of the Industry
January 9, 2018 - (CIRM) - What happened in the Cell and Gene Therapy sector in 2017, and what should we be looking out for in 2018? Over 500 executives, investors, scientists and patient advocates gathered together yesterday to find out at the Alliance for Regenerative Medicine (ARM) State of the Industry Briefing in San Francisco, California.

Spark Divides Opinion with $850,000 Gene Therapy
January 4, 2018 - (PharmaPhorum) - The Alliance for Regenerative Medicine there are more than 70 regenerative medicine and advanced therapy products in late-stage development and hundreds more further down the pipeline.  It says there is a pressing need to find ways to ensure these products will reach patients while ensuring industry gets a return on its investment  in R&D.

In Vivo's Top 10 For 2017
January 3, 2018 - (In Vivo) - Our 10 most-read thought leadership pieces of last year. Not surprisingly, our looks at pricing, reimbursement and patient access scored well. Readers also responded to our deep dives into technology innovation and our conversations with industry leaders.

Growth Medium 
December 15, 2017 - (BioCentury) - FDA’s regenerative medicines framework could level the global regulatory playing field for products like cell and gene therapies. It describes approaches to implementing expedited development and review pathways that make them comparable, and in some ways more attractive than those available in Japan and Europe.

FDA's New Framework For Streamlining RMAT Reg Requirements Offers Clarity, But Some Questions Remain
December 5, 2017 - (Inside Health Policy) - One of FDA's newest regenerative medicine advanced therapies (RMAT) draft guidances provides the regenerative medicine industry with much-needed regulatory clarity and consistency, according to the head of lobby group Alliance for Regenerative Medicine (ARM), but some questions remain. The group's head said it will be interesting to see how FDA steps up enforcement in the space and predicts manufacturing and standardization questions will pop up.

RARECast: What the FDA's New Framework Means for Regenerative Therapies
November 29, 2017 - (RARECast) - We spoke to Michael Werner, Executive Director of the Alliance for Regenerative Medicine, about the framework, whether it provides the clarity industry sought, and what it will mean for patients hoping to see safe and effective regenerative therapies reach them as quickly as possible.

FDA to Speed up Gene Therapy and Regenerative Medicine Approvals
November 20, 2017 - (BioNews) - The US Food and Drug Administration (FDA) has announced a fast-track review process for gene therapies and other regenerative medicine treatments.

‘No Longer the Stuff of Science Fiction’ – US FDA Publishes Regenerative Med Policies
November 17, 2017 - (BioPharma Reporter) - The US FDA has published a series of guidelines to spur development of regenerative medicines while ensuing safety and efficacy of such products.

F.D.A. Speeds Review of Gene Therapies, Vowing to Target Rogue Clinics
November 16, 2017 - (New York Times) - The Food and Drug Administration on Thursday issued new guidelines to speed the introduction of treatments involving human cells and tissues, including gene therapy. But the agency also said it would crack down on rogue clinics offering dangerous or unproven versions of those treatments.

FDA Works to Get Regenerative Medicines to Patients Faster
November 16, 2017 - (Bloomberg BNA) - Michael Werner, co-founder and senior policy adviser for the Alliance for Regenerative Medicine, called the framework a significantly positive development for patients and their families. “Therapeutic developers now have further clarity on the regulatory process requirements to meet the FDA’s high product approval standards,” Werner told Bloomberg Law in a Nov. 16 email. “The ongoing implementation of the RMAT designation also is a boon to regenerative medicine and advanced therapy manufacturers.”

US Health Agency to Crack Down on Risky Stem Cell Offerings
November 16, 2017 - (Associated Press) - U.S. health authorities announced plans Thursday to crack down on doctors pushing stem cell procedures that pose the gravest risks to patients amid an effort to police a burgeoning medical field that previously has received little oversight.

Out of the Darkness: New Gene Therapies for Eye Diseases
October 24, 2017 - (PharmaPhorum) - US FDA expert committee’s ‘yes’ could pave the way for a new generation of gene therapies for rare inherited eye disorders. Richard Staines speaks to a patient who says her life has been transformed by Spark Therapeutics’ treatment Luxturna, which could carry a price tag of $1 million, if approved.

'Luxturna' Recommendation Good for all AAV Based Gene Therapies, Says Advocacy Group
October 18, 2017 - (BioPharma Reporter) - The US approval recommendation for Spark Therapeutics’ blindness gene therapy voretigene neparvovec is also an endorsement of AAV delivery technologies according to the Alliance for Regenerative Medicine.

Call for Overhaul of EU Rules on GMO Clinical Trial
October 11, 2017 - (Chemistry World) - Rules designed around genetically modified plants crops are holding back new cell and gene-based medicines.

GMO Regulations a ‘Significant Burden’ on Gene Therapy Clinical Trials
October 11, 2017 - (Outsourcing Pharma) - Gene therapy developers should start planning earlier, as EU GMO regulations are delaying clinical trial start-up across the bloc, according to a new expert position paper. 

Children with Sanfilippo Type A Given Gene Therapy Showing Signs of Stabilization
October 9, 2017 - (Rare Disease Report) - At the Alliance for Regenerative Medicine’s Cell & Gene Meeting on the Mesa held in La Jolla, CA, Abeona Therapeutics, Inc. provided an update on its gene therapy trial for patients with Sanfilippo syndrome Type A (MPS IIIA).

Meeting on the Mesa - Conference Update
October 6, 2017 - (Life Science Capital) - We are attending the 2017 Cell & Gene Meeting on the Mesa conference from October 4 th to 6 th. As part of our coverage, we attended multiple oral discussions on October 4 th and 5 th and our notes are below. 

Gene Therapies Save Lives, But How to Pay for Them?
October 5, 2017 - (San Diego Union Tribune) - Stem cell and gene therapies for cancer and other diseases used to be considered exotic. But stunning successes are fast moving them into the medical mainstream.

Interview: Annie Hubert – Senior Director, EU Section and Public Policy, Alliance for Regenerative Medicine (ARM)
October 2, 2017 - (Pharma Board Room) - Annie Hubert, Senior Director, EU Section & Public Policy for the Alliance for Regenerative Medicine (ARM) describes some of the issues that companies in the advanced therapies field are facing in terms of market access and stakeholder education in Europe, as well as some of the key breakthroughs that European companies have made in this dynamic sector.

Gene Therapy Trials Held Back by Fragmented EU Rules
September 27, 2017 - (Pharma Phorum) - Biotech and pharma organisations are calling for EU countries to harmonise regulations, or otherwise face falling behind in cutting-edge gene and cell therapy trials.

Even at $500K, Gene Therapy Could Be a Bargain for Some Diseases
September 21, 2017 - (MIT Technology Review) - A one-time gene therapy that costs half a million dollars sounds crazy until you add up what it costs to treat some diseases over a lifetime.

Why the FDA May Need to Rethink Its Approach to Gene and Cell Therapy
September 21, 2017 - (The Bio Report Podcast) - Regenerative medicine is rapidly moving from the lab to the clinic, but as life-saving therapies advance to the marketplace, there are questions about whether the U.S. Food and Drug Administration needs to modernize its regulatory approach to gene and cell therapies. We spoke to Michael Werner, executive director of the Alliance for Regenerative Medicine, about the state of the industry, the regulatory environment today, and whether it will ultimately be payers who are more demanding of data to convince them of the worth of a therapy.

List of Top 50 Stem Cell Influencers on Twitter to Follow
September 19, 2017 - (The Niche - Paul Knoepfler) - I picked this list of 50 below based simply on my impressions of their influence or because they do interesting tweets and/or have a fresh perspective on things, not strictly based on metrics.

New Gene-Therapy Treatments Will Carry Whopping Price Tags
September 11, 2017 - (The New York Times) - With gene therapy, scientists seek to treat or prevent disease by modifying cellular DNA. Many such treatments are in the wings: There are 34 in the final stages of testing necessary for F.D.A. approval, and another 470 in initial clinical trials, according to the Alliance for Regenerative Medicine, an advocacy group.

Preparing for Market: Reimbursement Strategies for Cell and Gene Therapies
September 8, 2017 - (RAPS) - In this interview with Regulatory Focus, Ted Slocomb and Michael Werner, two leaders from the Alliance for Regenerative Medicine (ARM), provide insight into future challenges and opportunities for ensuring market access and value-based reimbursement for gene and cell therapies.

Interview: Janet Lynch Lambert – CEO, Alliance for Regenerative Medicine, USA
August 31, 2017 - (Pharma Board Room) - Janet Lynch Lambert, CEO of the Alliance for Regenerative Medicine, discusses the association's aims and membership, the importance of creating a supportive reimbursement environment for regenerative medicine, and the huge and expanding need for education in this critical area. 

Crackdown On Bad Regenerative Medicine Could Benefit Gene Therapy
August 28, 2017 - (The Pink Sheet) - US FDA is vowing a crackdown on "unscrupulous actors" in the regenerative medicine industry as part of a policy that could also benefit honest manufacturers.

F.D.A. Cracks Down on ‘Unscrupulous’ Stem Cell Clinics
August 28, 2017 - (The New York Times) - The Food and Drug Administration announced a crackdown on dangerous stem cell clinics on Monday, while at the same time pledging to ease the path to approval for companies and doctors with legitimate treatments in the growing field.

Gottlieb: Gene Therapies Eligible For Cures-Created Designation, FDA Stepping Up Enforcement
August 28, 2017 - (Inside Health Policy) - FDA Commissioner Scott Gottlieb said Monday that certain gene therapy products will be eligible for a 21st Century Cures-created expedited pathway for regenerative medicine products. 

U.S. Scientists Fix Disease Genes in Human Embryos for 1st Time
August 2, 2017 - (USA Today) - “There are still a lot of safety issues, a lot of legal and ethical issues,” even in medical uses, said Michael Werner, executive director of the Alliance for Regenerative Medicine in Washington, D.C.  The group promotes the use of gene therapy to treat diseases, but has drawn a line at treating embryos. "You are talking about permanently changing the genome of a person without their consent,” Werner said. “That’s an ethical question even if the technical challenges and safety get worked out.”

Scientists Correct Genetic Flaw in Human Embryos
August 2, 2017 - (Axios) - Another ethical question is the idea of "changing progeny," and the implications of that for society, Michael Werner, executive director at the Alliance for Regenerative Medicine, told Axios. 

First U.S. Team to Gene-Edit Human Embryos Revealed
July 27, 2017 - (The Scientist) - “It’s noteworthy that … they’ve been able to make some of these claims,” offers Michael Werner, executive director of the Alliance for Regenerative Medicine in Washington, D.C., who argued in a 2015 Nature commentary that ethical and safety issues should put germline editing research off limits. “It’s still a little premature to say that we’ve resolved all these safety issues now.”

New Payment And Financing Models For Curative Regenerative Medicines (subscriber access) (non-subscriber access here)
July 24, 2017 - (In Vivo) - Cell and gene therapies that have the potential to cure require new approaches to value assessment, payment and financing. In the second of a series, the Alliance for Regenerative Medicine identifies potential payment models, highlights key stakeholder concerns and identifies the barriers that must be overcome to enable their uptake across the health care system.

Innovation Initiative to Modernize the FDA
July 17, 2017 - (Center Watch Weekly) - The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the gene and cellular therapies and broader regenerative medicine sector, commended the FDA’s new initiative.

FDA Votes Yes on CAR T-Cell Therapy
July 13, 2017 - (The Scientist) - “We couldn’t be more pleased and encouraged to see CAR-T products and other cell-based immuno-therapies moving ahead in the appropriately rigorous regulatory review process,” says Lyndsey Scull, communications director for the Alliance for Regenerative Medicine, an advocacy group, in a statement sent to The Scientist.

CAR-T on the Road to Market – if FDA Follows ODAC Advice
July 12, 2017 - (BioWorld) - Ushering in what could be a new era of treatment for hard-to-fight cancers, members of the FDA's Oncologic Drugs Advisory Committee (ODAC) voted unanimously Wednesday in support of Novartis AG's CTL-019 (tisagenlecleucel), the first bespoke chimeric antigen receptor T-cell (CAR T) immunotherapy to be considered by the panel.

FDA To Unveil Regenerative Medicine Regulatory Framework In September
July 7, 2017 - (Inside Health Policy) - In September FDA will unveil a comprehensive framework detailing how the agency plans to regulate and oversee regenerative medicine though a series of guidance documents aimed at streamlining agency policies to help manufacturers demonstrate safety and effectiveness, Commissioner Scott Gottlieb announced Friday (July 7). 

The Hill - Lobbying World
June 27, 2017 - (The Hill) - The Alliance for Regenerative Medicine is bringing on Janet Lynch Lambert to serve as the industry group’s first chief executive officer. Prior to that, she held senior roles at the National Institutes of Health. Lambert has also served as a lobbyist for Life Technologies and Invitrogen, two biotechnology companies, and led the Washington-based business development effort for General Electric’s Corporate Research and Development Center.

Politico Influence: June 23, 2017
June 23, 2017 - (Politico) - The Alliance for Regenerative Medicine has tapped Janet Lambert as its first chief executive. She previously worked at the National Institutes of Health running outreach for NIH Director Francis Collins and as the acting head of engagement for the “All of Us” research project.

Banks Targets Embryonic Stem Cell Research Funding
June 21, 2017 - (Indiana Journal Gazette) - Rep. Jim Banks, R-3rd, introduced legislation Thursday that would prevent the use of federal funds for stem cell research involving human embryos.

GE Healthcare Adds to Its Cell Therapy Portfolio by Acquiring Asymptote
April 11, 2017 - (Genetic Engineering and Biotechnology News) - GE Healthcare reasons that demand for manufacturing and clinical delivery will increase as the cell therapy market grows and develops. The company cited statistics from the Alliance for Regenerative Medicine showing 804 clinical trials underway by the end of last year for cell therapies, as well as gene-modified cell therapies, gene therapies, and tissue-engineering therapies.

As Cell Therapy Matures, It Will Likely Alter What It Means to Get a Cancer Diagnosis
April 10, 2017 - (GE - The Pulse) - The race to deliver the world’s first-ever approved autologous cancer cellular therapy is quickly approaching its first major milestone. 

PIC/S Raises Concerns About EC Plan for Advanced Therapy GMP
March 20, 2017 - (In-Pharma Technologist) - Separate GMP rules for advanced therapies would put patients at risk according to the PIC/S, which has called on the European Commission to rethink the idea.

Biotech Engages Patients Earlier Than Ever
March 13, 2017 - (Genetic Engineering and Biotechnology News) - Biopharma companies are working with patient advocacy foundations sooner—and closer—than ever before. As a result, companies are gaining insights very early in the therapeutic development stage that can streamline and speed scientific advances and regulatory approval.

Regenerative Medicine Has a Bright Future
February 10, 2017 - (Healthline) - The Army is already using regenerative medicine to help wounded soldiers while Duke University is researching it to help repair spinal cord injuries.

Lee Buckler: Will 2017 Be the Year of Cell Therapies?
January 20, 2017 - (Huffington Post) - While 2016 may not go down as a lot of people’s favorite year, one development most people will agree to put a positive checkmark beside is the near-unanimous passing of the 21st Century Cures Act in the United States.

Under 21st Century Cures Legislation, Stem Cell Advocates Expect Regulatory Shortcuts
December 12, 2016 - (Science) - Because it backs away from the idea of conditional approval, the Cures language has the support of some groups who saw REGROW as too radical/aggressive, including the Alliance for Regenerative Medicine—a high-profile industry opponent of the older bill. 

After Criticism from Scientists, Congress Eases its Pursuit of Faster Stem Cell Therapies
November 30, 2016 - (STAT) - Tapping the brakes on an effort to speed new stem cell treatments to patients by relaxing regulations, Congress this week is considering a modified proposal that is attracting cautious support from the research community.

Chat with Michael Werner of ARM on Cures Act Regenerative Medicine Provisions
November 29, 2016 - (Paul Knoepfler - The Niche) - One of the hottest topics in the world of stem cells this year has been the REGROW ACT and at a larger level the movement for changes in FDA oversight of investigational regenerative medicine therapies (see my past posts on it here), so the related provisions in the 21st Century Cures Act are stirring much discussion today.

Funding Surges in Canada as Trump Win Throws U.S. Stem Cell Research in Doubt
November 29, 2016 - (The Globe and Mail) - Michael Werner, who heads the Washington-based Alliance for Regenerative Medicine, an advocacy group that supports stem cell research, said that, for the moment, “people are taking a wait-and-see approach” in the absence of any indication of where Mr. Trump’s opinions may lie. “Is this the kind of issue that [Republicans] will want to work on right out of the gate? It’s hard to know,” he said.

Lawmakers Close to Finishing New Cures Package
November 21, 2016 - (Politico) - “There might be an opportunity to support regenerative medicine and do it in a way that doesn’t weaken FDA’s regulatory authority or lower any of FDA’s safety or effectiveness standards,” Michael Werner, executive director of the Alliance for Regenerative Medicine, told us. ARM had opposed REGROW.

Curative Regenerative Medicines: Preparing Health Care Systems For The Coming Wave (for subscribers - here for non-subscribers)
November 15, 2016 - (IN VIVO) - We may be at the dawn of a new era of curative regenerative therapies, but their inherent nature may create barriers to adoption. The Alliance for Regenerative Medicine frames the opportunities and challenges for the industry, arguing that policy makers must begin to understand the ways that these therapies represent value for money.

Accelerating Cell and Gene Therapy is Not Just About the Science, It’s the Ecosystem
November 11, 2016 - (GE Healthcare - The Pulse) - Much of the discussion at the Alliance for Regenerative Medicines’ Advanced Therapies Investor Day 2016 in London last week was about the science and technology of the medicine and manufacturing of cell and gene therapies. It’s not too much to say that we know it can be delivered, we know it needs to scale, and it’s just a matter of time before these therapies are regularly curing patients’ cancer and other devastating diseases.

OPINION: What Scientists Should Focus On — and Fear — Under Trump
November 11, 2016 - (Nature) - Nine experts reflect on where researchers should direct their efforts during the next US administration.

Alliance for Regenerative Medicine Conference, October 2016: White Paper
October 14, 2016 - (Datamonitor Healthcare) - Datamonitor Healthcare attended the 6th annual meeting / partnering forum of the Alliance for Regenrative Medicine (ARM), held between 5-6 October 2016. Over the course of the two days, several important issues affecting the cell and gene therapy field were discussed during the panels at the conference. This paper presents some of the key highlights from various panel discussions on cell-based immuno-oncology, gene editing, pricing and reimbursement, financing and commercialization. 

Commercial Considerations for Cell and Gene Therapies: Viewpoints from the 2016 ARM Meeting
October 2016 - (IN VIVO) - The Alliance for Regenerative Medicine held its annual Cell & Gene Meeting on the Mesa in La Jolla, CA, in early October. Over the course of the three-day partnering meeting and scientific symposium, several important issues affecting the cell and gene therapy industries were discussed, including commercial considerations.

Biotech Companies Adjust to Risks, Challenges
October 7, 2016 - (San Diego Union Tribune) - Companies in the evolving field of cell and gene therapies are encountering these surprises as their projects run into the complicated and messy facts of human biology. And they’re busy figuring out how to deal with them in order to deliver these promising new therapies to patients. Scores of these companies told their stories this week at the Cell and Gene Therapy Meeting on the Mesa in La Jolla.

Organovo to Make Liver Tissue for Transplant; Meeting on the Mesa Begins
October 5, 2016 - (San Diego Union Tribune) - The Cell and Gene Meeting on the Mesa, formerly called the Stem Cell Meeting on the Mesa, is set to run from Wednesday through Friday. It attracts scientists and business leaders from the United States and internationally to San Diego’s biotech-rich environment on the Torrey Pines Mesa.

Advocacy Group Criticises EC's Plan for Stand-Alone Cell & Gene Therapy GMP Doc
September 30, 2016 - (BioPharma Reporter) - European stand-alone guidelines for the manufacture of Advanced Therapy Medicine Product (ATMP) could lead to disparities in GMP standards, says the Alliance for Regenerative Medicine.

Industry Seeks More Clarity on Proposed Federal Stem Cell Research Rules
September 12, 2016 - (California Stem Cell Report) - The nation's leading industry group for regenerative medicine today called for a clearer federal pathway to help bring stem cell products to the marketplace. The Alliance for Regenerative Medicine (ARM), which has 240 business, academic and patient advocacy members, testified today at a Food and Drug Administration hearing into proposals for more regulation of the stem cell industry. Randy Mills, president of the California stem cell agency, is scheduled to speak later today.

VIDEO: Stem Cell Treatment Promised by Clinics, But Has It Been Proven?
August 29, 2016 - (The Wall Street Journal) - Nearly 600 clinics in the U.S. are touting stem-cell therapies to combat everything from “aging” to autism and Alzheimer’s disease. While stem-cell research is booming, mainstream scientists say it will be years before such therapies are proven safe and effective. WSJ's Melinda Beck explains on Lunch Break with Tanya Rivero along with Alliance for Regenerative Medicine's Michael Werner.

New Stem Cell Legislation 'Fails to Address Safety and Efficacy Concerns' (subscriber access only)
August 19, 2016 - (The Pharma Letter) - Proposed new legislation which aims to promote faster patient access to effective new cellular therapies fails to adequately address safety and efficacy concerns, according to the International Society for Cellular Therapy (ISCT).

Just What the Doctor Ordered: GE Acquires Biosafe to Advance Cell Therapy
August 16, 2016 - (GE Reports) - Cell therapy is the next great frontier in medicine. The treatment, which removes and, in some cases, genetically modifies cells and then places them into a patient, holds amazing potential to fight many diseases and disorders ranging from cancer to complications from diabetes, as well as rare ailments like amyotrophic lateral sclerosis.

Trump vs Clinton: Worlds Apart on Science
July 26, 2016 - (Nature) - Presidential candidates begin to make clear their stark differences on climate change, energy production and stem-cell research.

Stanford Team Creates Bone, Heart Muscle from Embryonic Stem Cells
July 14, 2016 - (San Jose Mercury News) - Some day -- when your heart needs healing, your bones need bonding or your skin needs stitching -- clusters of new cells now growing in a Stanford University lab could offer a fix.

A Dish Called Hope
July 9, 2016 (The Economist) - The flourishing, unregulated industry in expensive, experimental treatments. 

Unregulated Stem-Cell Clinics Are Proliferating Across the United States
June 30, 2016 - (Washington Post) - For years, American "stem-cell tourists" have flocked to unregulated clinics in Mexico, the Caribbean and China in search of everything from heart treatments to facelifts. But now, these kinds of clinics are popping up across the United States.

A Nasty Political Fight Is Brewing On Stem Cells — Again
June 24, 2016 - (BuzzFeed News) - A Senate bill letting stem cell therapies skip over the most rigorous step of the FDA approval process is drawing fire from scientists worried about patient safety.

Big Money Stem-Cell Therapy Push Raises Concerns (subscriber access only)
April 29, 2016 - (Politico Pro) - A bill that would make it easier to bring stem-cell treatments to market is getting a major push from a GOP senator in a tough reelection fight, a deep-pocketed GOP donor and a centrist Washington think tank - and it's raising alarm among federal regulators and some medical research experts who say the measure could put patients at harm.

Alliance for Regenerative Medicine Opposes REGROW Act, Danger to Patients Cited
April 10, 2016 - (Paul Knoepfler - The Niche) - The biggest debate today in the stem cell world is over how much regulation is needed for new, investigational stem cell therapies that are not as yet approved. Sometimes it feels very lonely being out there publicly advocating for appropriately thorough regulation of stem cell therapies and at times I get a lot of heat for that, especially from stem cell clinics. For instance, I am publicly opposed to the REGROW Act, a piece of legislation that would dangerously weaken oversight of experimental stem cell therapies. 

UK Government Agency Approves Editing Genes in Human Embryos
February 1, 2016 - (STAT) - A team of scientists in London on Monday received the first government approval in the world to edit the genomes of human embryos for research purposes, opening a new front in genetics research.

Baldwin Bill Mandates FDA Facilitate Regenerative Medicine Best Practices 
January 27, 2016 - (Inside HealthPolicy) - Sen. Tammy Baldwin (D-WI) introduced legislation that directs FDA to facilitate the establishment of a public-private Standards Coordinating Body on Regenerative Medicine, and to participate in developing standards and guidance on how standards could be used in the agency's review of regenerative medicine products.

Senate Bill Seeks to Create Standards Body for Regenerative Medicine
January 15, 2016 - (RAPS) - Sen. Tammy Baldwin (D-WI) introduced a bill on Tuesday to promote the development of regulatory science and standards for regenerative medicine and advanced therapies.

U.S. Senator Tammy Baldwin Introduces Bill to Support Regenerative Medicine
January 14, 2016 - (Senator Tammy Baldwin) - U.S. Senator Tammy Baldwin has introduced legislation that would direct the U.S. Food and Drug Administration (FDA) to facilitate the establishment of a public-private Standards Coordinating Body (SCB) in Regenerative Medicine. The Advancing Standards in Regenerative Medicine Act also directs FDA to participate in developing such standards and to issue guidance on how these standards could be used in FDA review of regenerative medicine products.

Year in Review: CRISPR Blossoms
December 16, 2015 - (The Scientist) - As researchers work to improve the precision gene-editing technology, the community discusses the best way to use it.

Advanced Therapies: No Longer Just Hype?
November 18, 2015 - (BiotechandMoney) - I was fortunate enough to be invited to attend the Alliance for Regenerative Medicine’s EU Advanced Therapies Investor Day, and spoke to several of the CEO’s to get the skinny.

Cell Therapy Developers Debate Challenges As Big Pharma Drags Its Feet
November 12, 2015 - (Scrip Intelligence) - Companies developing 'advanced' treatments such as cell therapies face many of the same challenges in getting their innovative products to market, yet the attitudes of management towards the various hurdles differs quite significantly, Scrip found at Alliance for Regenerative Medicine's third annual 'European Advanced Therapies Investor Day' on Nov. 12.

Report from the Alliance for Regenerative Medicine (ARM) Investor Day in London: As Cell and Gene Therapies Turn in Positive Clinical Data, Attention Turns to Delivery to Patients
November 12, 2015 - (EBE) - As one pioneering company after another took the stage to report progress at the Alliance for Regenerative Medicine (ARM) Investor Day in London on 12th November realisation dawned: cell, gene and tissue therapies, are poised to deliver long-promised clinical benefits.

Japan Seeks Leadership Role in Stem Cell Medicine
October 7, 2015 - (San Diego Union Tribune) - In the second half of the 20th century, Japan emerged as a world leader in automobiles and consumer electronics. In the first half of this century, the country plans to do the same with stem cells and regenerative medicine.

Stem Cell Clinical Trials Are Multiplying
October 3, 2015 - (San Diego Union Tribune) - It’s been a long wait for patients hoping for stem cell science to be turned into new treatments. After years of frustration at the incremental progress, stem cell therapies at last are streaming into clinical trials - in San Diego, nationwide and across the world.

Researchers Apply For Permission To Alter DNA Of Human Embryos
September 18, 2015 - (The Huffington Post) - The first British researchers have applied for permission to alter the DNA of human embryos to better understand the reason women have miscarriages, amid a broader debate over whether the testing is appropriate.

British Scientists Seek to Edit the Genes of Embryos; Bioethicists Warn of Potential Dangers
September 18, 2015 - (The Washington Post) - Earlier this year, Chinese scientists caused an international furor when they reported that they had taken 86 human embryos and attempted to modify the gene that causes β-thalassaemia, a blood disorder that is potentially fatal.

Emerging Biopharma Field Draws Investors
September 18, 2015 - (The Boston Globe) - More than 525 clinical trials are underway worldwide to test new ways of growing human tissue, implanting cells, and modifying genes to treat patients with a range of diseases, drawing nearly $5 billion in financial backing in the second quarter, according to new data.

UK Scientists Seek Permission to Genetically Modify Human Embryos
September 17, 2015 - (The Guardian) - Scientists in Britain have applied for permission to genetically modify human embryos as part of a research project into the earliest stages of human development.

GM Embryos: Time for Ethics Debate, Say Scientists
September 1, 2015 - (The Guardian) - Leading UK research funders are calling for an urgent national debate on the ethics of genetically modifying human embryos and other tissues to prevent serious diseases.

The Age of the Red Pen
August 22, 2015 - (The Economist) - In the summer of 2005 Karen Aiach and her husband received heartbreaking news about their four-month-old daughter, Ornella: she had a rare disorder known as Sanfilippo syndrome. 

PDUFA VI: FDA Hears Stakeholder Comments in First Public Meeting
July 15, 2015 - (RAPS) - The US Food and Drug Administration (FDA) today heard from various groups representing patients, healthcare professionals and the regulated industry for their input on the iteration of the Prescription Drug User Fee Act (PDUFA).

CRISPR: Science Can't Solve It
June 23, 2015 - (Nature) - This year, several leading researchers have sounded warnings about the risks of using the CRISPR gene-editing technique to modify human and other species' genomes in ways that could have “unpredictable effects on future generations” and “profound implications for our relationship to nature.” 

Should Human Germline Gene Editing Even Be Considered for Future Use?
May 12, 2015 - (Genetic Literacy Project) - Rumors about human germline editing experiments prompted scientists to gather in January in Napa, Calif. Discussions there led two groups to publish recommendations. One group, reporting March 26 in Nature, called for scientists to “agree not to modify the DNA of human reproductive cells,” including the nonviable zygotes used in the Chinese study. 

Mixed Reactions to Work on Human Embryos
May 9, 2015 - (Digital Journal) - News that researchers have undertaken human genome editing using embryos has sparked mixed reactions among the world's scientific community.

CRISPR/Cas Faces the Bioethics Spotlight
May 2015 - (
BioTechniques) - The speed and efficiency of the CRISPR/Cas system is creating not only experimental opportunities but also ethical challenges. Jeffrey Perkel looks at how researchers are approaching this powerful genome editing technology.

Chinese Scientists Edit Genomes of Human Embryos
April 25, 2015 – (The Star) – When scientists describe a research paper as “landmark,” they usually mean it as an unreserved compliment. But in the case of a Chinese-led study published this week, the term is being applied with a hefty dose of trepidation.

Ethics of Embryo Editing Paper Divides Scientists
April 24, 2015 – (Nature) – In the wake of the first ever report that scientists have edited the genomes of human embryos, experts cannot agree on whether the work was ethical. They also disagree over how close the methods are to being an option for treating disease.

Human Embryo 'Editing' Experimental 1st Ignites Ethical Furor
April 23, 2015 – (Reuters) - Biologists in China reported carrying out the first experiment to alter the DNA of human embryos, igniting an outcry from scientists who warn against altering the human genome in a way that could last for generations.

Human Embryo Editing Is Incredibly Risky, Experts Say
April 23, 2015 – (Live Science) – With the news that Chinese scientists have attempted to modify the genes of human embryos, many scientists have called for a halt to such technology, saying the techniques are too risky to use in human embryos.

Researchers Edit Early Embryos
April 23, 2015 – (The Scientist) – Just more than a month after MIT Technology Review reported on the imminent publication of a paper in which researchers describe editing human embryos using the CRISPR/Cas9 system, investigators from Sun Yat-sen University in Guangzhou, China, report their  work editing human tripronuclear zygotes—nonviable early embryos that had one egg nucleus and two sperm nuclei—in an April 18 Protein & Cell article.

Scientists Edit a Human Embryo’s Genes for First Time Ever, but Here’s Why Two Major Scientific Journals Reportedly Refused to Publish the Study
April 23, 2015 – (The Blaze) – Some scientists recently called for their colleagues to agree not to modify the genes of human embryos, citing the ethical debate and the potentially negative impact it could have on other research.

Scientists Genetically Modify Human Embryos for the First Time: Controversial Technique Could Lead to Designer Babies
April 23, 2015 – (Daily Mail) – Chinese scientists have admitted to changing the genes of human embryos for the first time.The announcement confirms rumors that some researchers have been conducting ethically questionable genetic experiments.

Scientists Urge Moratorium After Chinese ‘Edit’ Human Embryos
April 23, 2015 – (AFP) – Global scientists on Thursday renewed calls to halt controversial research to genetically edit human embryos after a Chinese team published details of a stunted but breakthrough attempt in this new frontier in science.

Chinese Scientists Genetically Modify Human Embryos
April 22, 2015 – (Nature) – In a world first, Chinese scientists have reported editing the genomes of human embryos. The results are published1 in the online journal Protein & Cell and confirm widespread rumours that such experiments had been conducted—rumours that sparked a high-profile debate last month about the ethical implications of such work.

For The First Time, Researchers Edit The Genes Of Human Embryos
April 22, 2015 – (Popular Science) – Rumors have been buzzing for months that a team of Chinese researchers was intending to edit the genes of a human embryo. According to a study published this week in Protein & Cell, the rumors are true.

Scientists Create First Genetically Modified Human Embryo
April 22, 2015 – (Engadget) – For the first time in history, a team of researchers have successfully edited the genes of a human embryo.

Regenerative Medicine Finally Feels the Love
April 9, 2015 - (InVivo) - Investment in regenerative medicine – cell therapies, gene therapies, tissue engineering, and other advanced therapies – is booming. That was one of the key takeaways from the Alliance for Regenerative Medicine’s third annual Regen Med Investor Day, held in New York in late March.

Have Scientists Genetically Modified Human Embryos So Changes Are INHERITED?
April 8, 2015 - (Daily Mail) - Human embryos have been genetically modified so that any changes made will be carried on into future generations for the first time, according to scientists. Researchers around the world are bracing themselves for the results of a study by scientists in China that has introduced DNA changes to reproductive cells.

Germline Editing: Time for Discussion 
April 7, 2015 – (Nature Medicine) – On March 5, the MIT Technology Review published an article, “Engineering the Perfect Baby,” in which unnamed sources asserted that scientists in China had used clustered regularly interspersed short palindromic repeat (CRISPR)-Cas9 technology to genetically alter an early stage in vitro–fertilized human embryo, and that their results might soon be published.

Editing the Germline – a Time for Reason, Not Emotion
March 31, 2015 – (University of Oxford) – There are rumours in the scientific community that the first studies involving the genetic modification of a human embryo are about to be published.

Human Embryo Modifications Must Be Halted, Scientists Urge
March 26, 2015 - (CBC) - The emerging ability to modify human embryos in a way that gets passed on to future generations has raised alarm bells for scientists who've called for a moratorium.

Caution Voiced on Gene-Edited Babies
March 25, 2015 – (INYT) – A group of senior American scientists and ethics experts is calling for debate on the gene-engineering of humans, warning that technology able to change the DNA of future generations is now “imminent.”

'Ban DNA Editing Of Sperm And Eggs'
March 23, 2015 – (Forbes) – Designer babies are on their way, said experts in genetic engineering as they called for a global ban on the practice. “It is thought that studies involving the use of genome-editing tools to modify the DNA of human embryos will be published shortly,” said the authors of a paper in Nature.

Ban Urged on Gene Editing Tools that can Create Superior Human Beings
March 22, 2015 – (China Topix) – Fears the extraordinary advances in genome editing might resurrect the immoral idea of creating a new "Master Race" has prompted prominent scientists to call for a worldwide ban on a new gene editing technique that might make this nightmare scenario possible.

Should There Be a Halt on Germline Editing?
March 22, 2015 - (Digital Journal) - Gene-editing technologies must not be used to edit human eggs, sperm, or embryos, and if such work has taken place, then it should stop immediately. This is the call made by Edward Lanphier, chairman of the Alliance for Regenerative Medicine in Washington, DC.

Scientists Urge Temporary Moratorium on Genome Edits
March 21, 2015 - (National Monitor) - A group of American scientists and scientific ethics experts has published a list of recommendations and called for debate on gene-engineering in humans. The researchers warn that the technology to alter human beings for generations to come is now “imminent”.

How ARM's Edward Lanphier Is Fighting for Cell Therapy Cures that Save Patients and Portfolios 
March 19, 2015 - (Life Sciences Report) - Stem cell, gene therapy and genetically modified cell therapy companies have begun to attract serious capital from investors who understand biotechnology and have the wherewithal to move products into the clinic and into the market.

Scientists Seek Ban on Method of Editing the Human Genome
March 19, 2015 - (New York Times) - A group of leading biologists on Thursday called for a worldwide moratorium on use of a new genome-editing technique that would alter human DNA in a way that can be inherited.

Ethics of Embryo Editing Divides Scientists
March 18, 2015 - (Nature) - Research that uses powerful gene-editing techniques on human embryos needs to be restricted, scientists agree — but they are split over why.

Is 'Editing’ Human Embryos Ethical?
March 18, 2015 – (The Hindu) – In a strongly worded comment published last week in Nature, a group of scientists has raised ethical and safety concerns over genetically editing human embryos.

Stop Editing Human Embryos for Now, Say Geneticists
March 16, 2015 - (Popular Science) - It’s no secret that scientists can now edit genes. Resolving disease-causing mutations could help cure some of the world’s most deadly diseases, such as HIV/AIDS and hemophilia. 

Designer Babies and Genetically Edited Humans are Coming Far Sooner Than We Think
March 14, 2015 - (Business Insider Australia) - The ability to edit human genes and, consequently, actually engineer a human being from birth, is something science is far closer to achieving than many may think.

GMO Humans? Scientists Warn of Risks
March 14, 2015 – (Sputnik News) – A group of biotechnology experts have written an open letter to the journal Nature, which it published on March 12, that they have "grave concerns regarding the ethical and safety implications" of soon-to-be published research involving the use of genome-editing tools to modify the DNA of human embryos. 

Scientists Want Experiments of DNA Editing in Human Embryos to Stop
March 14, 2015 – (TechieNews) – Scientists call for halt on experiments involving modification of DNA in human eggs, sperms or embryos after rumours surfaced that scientists have managed to do so in America. Five prominent researchers have asked biologists to halt such experiments due to fears about safety and eugenics.

Alarm Over Genetic Editing of Human Embryos That Opens Door to Designer Babies and Superhumans 
March 13, 2015 – (International Business Times) – Amidst rumours that precise gene-editing techniques have been used to create designer human embryos, researchers have called for a moratorium on the use of the technology.

Sangamo CEO Wants Moratorium on Germline Gene Editing
March 13, 2015 - (BioCentury) - A commentary published in the journal Nature by Edward Lanphier and colleagues calls for a moratorium on studies that use genome-editing technology to modify the DNA of human germ cells and embryos to allow for stakeholders to discuss ethical issues of such research.

Call for Germline Editing Moratorium
March 13, 2015 - (The Scientist) - Gene-editing technologies should not be used to edit human eggs, sperm, or embryos, Edward Lanphier, chairman of the Alliance for Regenerative Medicine in Washington, DC, and four other researchers argued in a Nature commentary published this week (March 12). 

Don’t Edit the Human Germ Line
March 12, 2015 - (Nature) - It is thought that studies involving the use of genome-editing tools to modify the DNA of human embryos will be published shortly. There are grave concerns regarding the ethical and safety implications of this research. 

Don’t Edit Embryos, Researchers Warn
March 12, 2015 – (Science Magazine) - Scientists should refrain from studies that alter the genome of human embryos, sperm, or egg cells, researchers warn in a commentary published today in Nature.

Industry Body Calls for Gene-Editing Moratorium
March 12, 2015 - (MIT Technology Review) - Officials of a biotechnology industry group have called for a voluntary moratorium on using new DNA-editing techniques to change the genetic characteristics of human embryos in laboratory research.

Scientists Call for Halt on Experiments Changing DNA of Human Embryos
March 12, 2015 – (Reuters) – With rumors that scientists are about to announce they have modified the genes of human eggs, sperm, or embryos, five prominent researchers on Thursday called on biologists to halt such experiments due to fears about safety and eugenics.

Scientists Call For Moratorium On Human Genetic Experiments
March 12, 2015 - (Buzzfeed) - Citing safety fears for babies, genetics researchers on Thursday called for a halt to experiments that would alter the DNA of human sperm, eggs, and embryos.

Scientists Sound Alarm over DNA Editing of Human Embryos
March 12, 2015 - (Nature) - Amid rumours that precision gene-editing techniques have been used to modify the DNA of human embryos, researchers have called for a moratorium on the use of the technology in reproductive cells.

Momentum Building for Regenerative Medicine and Gene Therapy
January 20, 2015 – (BioWorld) – The Washington-based Alliance for Regenerative Medicine (ARM) presented its state-of-the-industry briefing at the Biotech Showcase meeting last week, which re-affirmed the regenerative medicine and advanced therapies industry is extremely vibrant.

Regenerative Medicine: A Growing Global Industry, ARM Reports
January 13, 2015 – (BioWorld) – Last year at this time the regenerative medicine and advanced therapies industry had begun its coming-out party riding a wave of promising clinical data readouts that ignited strong investor interest and catalyzed involvement and interest from big pharma companies.

ARM State of the Industry Briefing Gives Clear Evidence That Regen Med/Advanced Therapies Are the Next Big Thing in Biotech
January 12, 2015 – (partnering360) – Biotech Showcase 2015 kicked off today with the Alliance for Regenerative Medicine’s (ARM) Regenerative Medicine and Advanced Therapies State of the Industry Briefing.

Where Do Cures Reside? Morrie Ruffin and Michael Werner of the Alliance for Regenerative Medicine Think the Answer Is in Regenerative Medicine
January 8, 2015 - (The Life Sciences Report) - On Dec. 22, the stem cell and regenerative medicine space saw a very significant development. The U.S. Food and Drug Administration (FDA) published a new draft guidance paper on what constitutes minimal manipulation of human tissues and cells. Although this document is not binding, it does tell us what the agency is thinking. In effect, tissues and cells that have been processed in some way will be treated as drugs, and will come under the regulatory umbrella of the FDA. What does this mean for the industry?

Moving from Chronic Therapies to Cures
January 7, 2015 - (The Bio Report) - The rapidly growing area of regenerative medicine is promising to replace chronic therapies with cures. As the biotechnology industry gathers in San Francisco for a big week of meetings, the Alliance for Regenerative Medicine is readying to deliver its annual State of the Industry Briefing. 

Cell Therapy 2015: With Maturity Comes Promise
December 23, 2014 – (Life Sciences Report) – Cell therapies have been gaining momentum in the life sciences for more than half a century. The first cell therapies, bone marrow transplants, were performed in the 1960s, and since then the idea of using healthy cells to replace or regenerate diseased cells has expanded into a number of indications, from cancer to cardiac disease to cosmetic therapy.

Cell and Gene Therapy Readouts in 2015
November/December 2014 - (MedNous) - Scientists expect to have readouts next year from cell and gene therapy trials that could show that regenerative medicine is finally gaining traction.Scientists expect to have readouts next year from cell and gene therapy trials that could show that regenerative medicine is finally gaining traction.

This was one of the points to emerge from a meeting of regenerative medicine developers and financial industry representatives in London on 13 November. Organised by the Alliance for Regenerative Medicine, the meeting heard about late-stage development programmes at companies with prospective products in the ophthalmic, inflammatory and cardiovascular disease areas.

Stem Cell Treatments Face Reimbursement Challenges: Panel
October 9, 2014 - (BioWorld) - Subscription needed; Click link above for more information

NIH Plans To Restrict Scope Of Recombinant DNA Advisory Committee
May 30, 2014 - (InsideHealthPolicy) - Subscription needed; Click link above for more information

Gene Therapy is Back on the Radar After First Product Approval
May 28, 2014 - (BioWorld) - "The concept is compellingly attractive: replace a faulty, disease-promulgating gene with a normal one and, voila, a cure should be initiated. This has been the hope for gene therapies for many years. Unfortunately, everything has not gone according to plan, and the technology fell out of favor until comparatively recently. Confidence is now returning and expectations are once again high that the gene therapy field can finally make good on its promise to transform 21st century medicine." Subscription needed; Click link above for more information

Senators Support Regenerative Medicine Promotion Act of 2014
April 28, 2014 - (MarketWatch) - "Last month, the regenerative medicine industry received important support that could facilitate a road map to accelerate the discovery of new therapies for some of the world's most hard-to-treat and cost-intensive diseases and conditions. Senators Mark Kirk (R-IL) and Barbara Boxer (D-CA) introduced the Regenerative Medicine Promotion Act of 2014 in the U.S. Senate seeking to establish a national strategy to support regenerative medicines and a Regenerative Medicine Coordinating Council."

Regenerative Medicine Deal-making Warms Up But Still Faces Hurdles
March 28, 2014 - (The Pink Sheet) - "The regenerative medicine space may never be as hot as it once was, but big pharma is keeping a close eye on the space as it waits for the science to mature. The industry is starting to put some money toward cell therapy companies."

Biotechnology Companies Hunting for the Keys to Immortality
 March 27, 2014 - (FT Wealth) - "Daniel Defoe’s assertion that death and taxes are life’s two certainties may soon need revision. Regenerative medicines – therapies that replace or regenerate damaged cells, tissue and organs – that were once the domain of science fiction and alchemy are moving into the mainstream..."

Podcast: Regenerative Medicine Gets Ready for Prime Time
January 16, 2014 - (Burill Report) - "Regenerative medicine companies raised more than $1.3 billion dollars during 2013 and an expanding range of products continues to advance in the clinic. We spoke to Geoff MacKay, chairman of the Alliance for Regenerative Medicine, about the state of the industry, the growing success of the sector, and how investors and Big Pharma have changed their view of these technologies."

Regenerative Medicine's Future Looking Bright
January 14, 2014 - (UT San Diego) - "Regenerative medicine became a true business sector of biotech in 2013, executives and analysts said Monday, and continued progress is likely this year. With 40 products on the market, and more in clinical trials, pharmaceutical companies have warmed up to companies working on cell therapies, panelists said at the Biotech Showcase in San Francisco."

Regenerative Medicine on the Move and the Best is Yet to Come
January 14, 2014 - (BioWorld) - Subscription needed; Click link above for more information

State of the Industry Briefing Shows a Field Coming of Age, Ready to Start Benefiting Patients
January 13, 2014 - (CIRM Blog) - "It’s an auspicious start to the week when you begin your day at a conference and one of the first lines you hear from the podium is: “This industry is ready for prime time.” In this case, the words were spoken by Geoff MacKay chair of the Alliance for Regenerative Medicine (ARM) at the group’s fourth annual State of the Industry briefing at the BioTech Showcase which runs parallel with the massive JP Morgan life sciences meeting that comes to San Francisco every January."

Bipartisan Group of Senators Seek GAO Report on Federal Agencies' Regenerative Medicine Policies
November 13, 2013 - (Inside Health Policy) - Subscription needed; Click link above for more information

Start Reimbursement Planning Now for Regenerative Medicine
November 4, 2013 - (BioWorld) - Subscription needed; Click link above for more information

Investor Interest Strong for Stem Cell Companies
October 16, 2013 - (UT San Diego) - "Good stem cell companies will get the funding they need to bring their products to market, financial and medical executives said at this year’s Stem Cell Meeting on the Mesa. Biotech companies continue to attract investor interest, speakers said at the meeting this week in La Jolla, pointing to a stream of biotech initial public offerings as well as purchases of biotechs by large pharmaceutical companies."

Companies Focus on Hard Science, Long-term Pay-off at Stem Cell Meeting
October 16, 2013 - (Scrip Intelligence) - Subscription needed; Click link above for more information

Researchers Present Advanced Drug Discovery Technology at the “Stem Cell Meeting on the Mesa”
October 15, 2013 - (Sanford-Burnham Beaker) - "On October 14-16, 2013, two Sanford-Burnham researchers participated in the world-renowned “Stem Cell Meeting on the Mesa” held each year in La Jolla, Calif. The two scientists are presenting Sanford-Burnham’s unique capability of combining induced pluripotent stem cells (iPSCs) with ultra-high-throughput screening capabilities at the Institute’s Conrad Prebys Center for Chemical Genomics to discover molecules that effect cell differentiation and function."

CIRM Grantees Discuss Heart Failure Research at Stem Cell Meeting on the Mesa
October 15, 2013 - (CIRM Blog) - "Several of CIRM's grantees are located down on the Mesa that's the namesake of the Stem Cell Meeting on the Mesa (in La Jolla, near San Diego). Among those is Sanford-Burnham Medical Research Institute, which has several scientists talking about their CIRM-funded work as part of the meeting. Sanford-Burnham wrote in their blog about a presentation by Mark Mercola, who is working on finding therapies for heart disease."

Meeting Tackles Stem Cell Field’s Business Challenges
October 12, 2013 - (UT San Diego) - "Stem cell science is at last moving into clinical trials. But delivering its results to patients will require huge investments by drug and biotech companies, and health insurers must decide how to reimburse for such therapy. Just how that’s going to happen is part of the Stem Cell Meeting on the Mesa, which begins Monday and ends Wednesday. The annual conference, which began as a scientific symposium, has extended into business matters as research gets closer to patient treatments."

Investors: Take Note of the Opportunity of the Stem Cell Meeting on the Mesa Conference
October 8, 2013 - ( - "Regenerative Medicine is no longer a term that the investment community is unaware of.  The industry has gained substantial traction and exposure, reaching its tipping point with numerous products in late stage clinical development utilizing stem cells, whether allogeneic or autologous, to treat diseases and conditions at the cellular or molecular level.  What investors may not be aware of is the robust number of applications for regenerative medicines that are no longer philosophic in nature."

FDA Seeks Input on Cellular, Regenerative Drug Standards
July 29, 2013 - (Washington Drug Letter) - Subscription needed; Click link above for more information

Regenerative Medicine Holds Considerable Promise
July 20, 2013 - (Honolulu Star-Advertiser) - "Regenerative medicine is a rapidly emerging field that aims to replace or regenerate cells, tissues or organs to restore normal function. Some strategies involve cell therapy and gene therapy that foster the body's ability to regrow damaged or aged tissues. Another approach involves tissue engineering to create new organs. This column recently covered the development of a 3-D printer designed for that purpose.Subscription needed for full article; Click above for preview and more information.

Stem Cell Meeting on the Mesa Approaches
July 16, 2013 - (UT San Diego) - "The 2013 Stem Cell Meeting on the Mesa, San Diego's biggest meeting of stem cell science and business, takes place Oct. 14-16 in La Jolla. This symposium has grown over the years from a strictly scientific event to a major nexus of biotech science and business in regenerative medicine. It's sponsored by the Alliance for Regenerative Medicine, the California Institute for Regenerative Medicine and the Sanford Consortium for Regenerative Medicine."

Position Yourself for Big Returns in the Stem Cell Space: Jason Kolbert
May 10, 2013 - (The Life Sciences Report) - "Stem cell companies have languished long enough in micro-cap territory. The industry is now approaching highly visible phase 2 and phase 3 catalysts that will produce results never before seen in medicine. Managing Director and Senior Biotechnology Analyst Jason Kolbert of the Maxim Group has staked out a select group of nascent cell therapy companies positioned to reap huge gains for investors willing to diversify. In this interview with The Life Sciences Report, Kolbert reflects on the regenerative medicine space following the recent RegenMed Investor Day conference, and makes an enthusiastic case for his very best ideas."

What Will It Take for Stem Cell Companies to Close the Valuation Gap?: ARM's Chairman Geoff MacKay
April 16, 2013 - (The Life Sciences Report) - "Naysayers may harp on the low market valuations of stem cell companies, but Geoff MacKay has an insider's perspective. The Alliance for Regenerative Medicine chairman and Organogenesis Inc. president and CEO asserts that though the regenerative medicine and cell technology industry is still largely in phase 1/2, phase 3 and commercial success are imminent. In this interview with The Life Sciences Report, MacKay explains the promise of cell therapies for both patient health and investors' portfolios."

The Stem Cell Revolution Can Jump-Start Your Portfolio: Jason Kolbert
March 14, 2013 - (The Life Sciences Report) - "No single solution will emerge from the growing realm of stem cell technology and regenerative medicine. Instead, multiple innovations will succeed in a field that promises to forever change the practice of medicine—innovations generated by the recognition that living cells are capable of performing a platform of functions that present-day drugs simply cannot. In this Life Sciences Report interview, Jason Kolbert, senior vice president and biotechnology analyst with Maxim Group, provides a detailed analysis of the industry and names companies that investors should be aware of now, while valuations are remarkably low."

Small Companies Are Hubs of Future Profit in Regenerative Medicine: Gil Van Bokkelen
February 28, 2013 - (Streetwise Reports) - "Gil Van Bokkelen has been in the stem cell industry for more than a decade. In recent years, the co-founder, chairman and chief executive officer of Athersys Inc. has stepped into regenerative medicine’s forefront, acting as a spokesman for the industry as well as demonstrating his love of science and passionately advocating for patients. In this interview with The Life Sciences Report, Van Bokkelen explores the past, present and future of the cell therapy and regenerative medicine industry, and outlines the investment possibilities in small companies on the sector's cutting edge."

Preventative Therapy
February 13, 2013 - (Nature) - "Stem-cell trials must be made easier, so that treatments can be based on real data. Last November, a Nevada court convicted two men of fraud for selling ineffective stem-cell treatments to people chronically ill with, among other disorders, multiple sclerosis or cerebral palsy."

Stem Cells in Texas: Cowboy Culture
February 13, 2013 - (Nature) - "By offering unproven therapies, a Texas biotechnology firm has sparked a bitter debate about how stem cells should be regulated. Ann McFarlane is losing faith. In the first half of 2012, the Houston resident received four infusions of adult stem cells grown from her own fat. McFarlane has multiple sclerosis (MS), and had heard that others with the inflammatory disease had experienced improvements in mobility and balance after treatment. The infusions — which have cost her about US$32,000 so far — didn't help, but she knew that there were no guarantees."

Regenerative Medicine May Be at its Inflection Point
January 15, 2013 - (EBD Group's PartneringNews) - "Regenerative medicine may be at the long-desired inflection point, with companies bringing products to market or in late stage trials, according to Regenerative Medicine panelists speaking at Biotech Showcase™ 2013. Industry revenues have grown from USD 460 million in 2010 to an estimated USD 900 million in 2012, according to the Alliance for Regenerative Medicine (ARM). By the end of 2011, more than 500,000 patients had been treated. “There is much more than proof of concept,” observed Geoff MacKay, incoming chairman of ARM, and president and CEO at Organogenesis, Inc."

Regenerative Medicine: Has It Reached a Tipping Point?
January 9, 2013 - (BioWorld Insight)

Industry Leaders Predict a Great Year for Regenerative Medicine
January 8, 2013 - (CIRM Blog) - "The Alliance for Regenerative Medicine (ARM) held its third annual “State of the Industry” briefing this morning at the Biotech Showcase that occurs every January in San Francisco. These events bring together the leadership of companies seeking to develop new therapies with the investors needed to fund their work and can be tense affairs. The two groups often don’t see eye-to-eye on predicting the future of the field."

Regenerating Excitement
January 7, 2013 - (Burrill Report Podcast) - "The field of regenerative medicine is here today with a growing list of products already on the market treating patients. As the Alliance for Regenerative Medicine readies to offer its annual State of the Industry Briefing in San Francisco January 8, the organization’s new chairman Geoff MacKay spoke to us. Mackay, who is also president and CEO of Organogenesis, discussed developments in the field, the challenges the industry faces, and why 2013 could be a big year for clinical developments in regenerative medicine."

Biotechnology Company Proves Resiliency is a Required Ingredient
November 27, 2012 - (UT San Diego) - "In 2004, several leading dentists approached Organogenesis about applying its bio-wound-healing technology to making a product for oral soft issue regeneration. Eight years and many millions of dollars later, the company received approval from the Food and Drug Administration for Gintuit, which helps to generate new gum tissue without resorting to painful palatal graft surgery."

For Cutting-Edge Stem Cell Work, California Billions Still Unmatched
November 26, 2012 - (Start-Up)

Showtime for Stem Cells at San Diego Biotechs
November 14, 2012 – (UT San Diego) – “About a dozen San Diego-based companies, such as ViaCyte, Histogen and Medistem, are working on treatments with various kinds of stem cells, the “ancestral” cells that give rise to the various cells in the body. Some are using cells derived from human embryos, still a controversial practice to many. But most others are using cells derived from nonembryonic sources, such as skin and umbilical cord blood.”

How 5 Companies Strive for Cures
November 3, 2012 – (UT San Diego) – “The 35 companies and researchers who spoke at last week's stem cell conference in La Jolla faced a big challenge. They were given just 15 minutes each to pique the interest of potential investors and corporate partners. To get that brief time in the spotlight at the Stem Cell Meeting on the Mesa, they came from across the country; indeed, two came from Europe.”

San Diego Life Sciences Roundup
November 2, 2012 – (Xconomy) – “Dean Tozer, a corporate development executive with Shire Regenerative Medicine, joined Life Technologies CEO Greg Lucier and other industry executives during the Seventh Annual Stem Cell Meeting on the Mesa to talk about the clinical outlook for regenerative medicine. Tozer said Big Pharma business executives are getting involved in talks with prospective biotech partners much sooner to determine whether prospective business deals are really worth it. Shire is basing most of its new regenerative medicine business in San Diego.”

In San Diego Talk, Venter Says Biofuels ‘Dead’ Without Carbon Policy
November 2, 2012 – (Xconomy) – “Blunt to the bone, human genome pioneer J. Craig Venter flatly declared in San Diego this week that algae-based biofuels “are just dead” unless the federal government sets an effective carbon policy.”

The Zombies of Cancer Research (Scientific Symposium Only)
October 31, 2012 – (Sanford-Burnham Beaker Blog) – “Robert Wechsler-Reya, Ph.D., director of Sanford-Burnham’s Tumor Development Program, once said, “Current cancer therapies are like trying to kill a zombie by kicking it in the shins.”

Grants first, 'obliterating' VC second the best early funding route for 'under-loved' stem cell therapies?
October 31, 2012 - (Scrip Intelligence)

Stem Cell Meeting Draws Interest From Far and Wide
October 31, 2012 – (UT San Diego) - La Jolla’s annual meeting about stem cells was once about stem cell science in San Diego, largely presented and attended by stem cell scientists in San Diego. But the Stem Cell Meeting on the Mesa has grown to take on a national or even international flavor. Along with the growing emphasis on commercializing regenerative medicine research, companies in the field are hunting for corporate partners. And to reach the right people, they’re willing to travel far.

Venter: Biofuels Dead Without U.S. Aid
October 31, 2012 – (UT San Diego) – “Venter’s strongly worded statement came Tuesday night at the annual Stem Cell Meeting on the Mesa, after he was asked when synthetic biology might have a meaningful impact on the country’s energy production.”

Meeting on the Mesa: reimbursement prospects should drive cell therapy development
October 30, 2012 - (Scrip Intelligence)

ViaCyte CEO Says $10M Grant Will Move Stem Cell Therapy to Trial
October 30, 2012 – (Xconomy) – “A $10.1 million grant the California Institute for Regenerative Medicine (CIRM) awarded to ViaCyte last week will be used to move the San Diego diabetes company’s stem cell and cell encapsulation technologies into human clinical trials, according to ViaCyte CEO Paul Laikind. CIRM administers $3 billion in funding for stem cell science that California voters approved in 2004 with the passage of Proposition 71.”

Stem Cell Therapies a Big Risk for Biotechs
October 29, 2012 – (UT San Diego) – “Companies that want to make big money developing therapies with stem cells and regenerative medicine must take big risks.Health care executives involved in commercializing these technologies made that point Monday morning at the annual Stem Cell Meeting on the Mesa. But with the science increasingly looking solid, it's time for companies to do their part to bring new treatments to patients, they said in a panel discussion.”

Shire Hunts More Deals Amid Reawakening Interest in Stem Cell R&D
October 29, 2012 – (Xconomy) – “As the Stem Cell Meeting on the Mesa convenes its second annual investor and partnering forum in San Diego this morning, Dean Tozer says the last 18 to 24 months have seen a rejuvenation of interest in the commercial prospects for biomedical products arising from stem cell research and development.”

Next Week’s Stem Cell Meeting Focuses on Business
October 25, 2012 – (North County Times) – “Small biotech and big drug companies dominate the agenda at next week's Stem Cell Meeting on the Mesa. Two days of the three-day conference, Monday and Tuesday, will tackle the business of commercializing stem cells -- of embryonic and non-embryonic origin -- into treatments that can help patients.”