FasterCures: Clinical Trials Recruitment and Retention

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I never wanted Zach Hall’s job. Now it appears he doesn’t want it anymore either. The former President of the California Institute for Regenerative Medicine (CIRM) resigned earlier this week citing ill health and frustration.

By most accounts Hall did an admirable job under difficult circumstances. Some folks complained that he could have handled some issues – and people – more deftly. But the record shows that the CIRM came a long way over the course of Hall’s tenure, and he deserves credit for that.

From its inception, the CIRM faced enormous obstacles trying to implement a complex and costly program with numerous stakeholders and a relentless opposition. It had to balance the interests of patient advocates, universities, industry, anti-technology groups, anti-abortion groups and others from all sides of the ideological spectrum. Adding to the challenge, the CIRM was forced to do its work under the glare of state government officials, the media, and others.

Many of these challenges, of course, came with the territory. Proposition 71 authorized the expenditure of billions of state dollars over many years and embryonic stem cell research is hotly opposed by a vocal and aggressive minority of Americans.

In addition, as a quasi-public agency responsible for administering and dispensing billions of dollars in state funds, the CIRM had to go through the complex process of developing procedures for: identifying funding priorities; grant application and approval mechanisms; conflict of interest and intellectual property rules; and other matters. CIRM leaders, including Hall, believed that the circumstances necessitated that these procedures be worked out in a thoughtful way that allowed public input.

The biggest obstacle to progress was a relentless opposition. Despite being handily defeated at the ballot box, critics of stem cell research were determined to stop or slow the California program. Using often frivolous lawsuits and other techniques, critics did their best to make Hall – and everyone else interested in advancing this promising field – miserable.

That won’t change with Hall’s departure. Opponents have shown themselves to be tenacious and will no doubt continue their fight against the CIRM, its grantees, and stem cell research generally.

And that’s the more important issue. For many reasons, the scrutiny and media coverage around Proposition 71, CIRM, and stem cell research has too often focused on personalities. But which celebrities support stem cell research, the personal traits of the individuals who advocated for Proposition 71, and now the discussion about the circumstances surrounding Zach Hall’s departure are all beside the point.

Patients and their families who suffer from diabetes, Parkinson’s Disease, heart disease, spinal cord injury and other afflictions need help. And the demographic trends in our nation tell us that these problems will only worsen in the years ahead.

Our nation’s top scientists have been saying for years that stem cell research holds enormous potential to lead to cures and treatments for a vast array of diseases. It also will no doubt be an extraordinarily useful technology platform to understand basic cell biology and for life science companies to perform drug discovery and testing. Dr. Harold Varmus, the former Director of the National Institutes of Health has said the human embryonic stem cell could “revolutionize” the practice of medicine.

And life sciences – whether in academia or the private sector – will continue to bring us remarkable discoveries as well as being an economic growth engine that leads to investment and high paying jobs.

These larger forces will push Proposition 71 as implemented by the CIRM to success. Right now, we don’t know what that success will look like or how many years it will take. But we know we still have more to do to achieve our goals.

Rather than focusing on individuals, we should be discussing how we can advance this research – by changing relevant government policy, supporting researchers, and aiding entrepreneurs.

So we should thank Dr. Hall for his service and wish him well. Then we should get on with the priorities surrounding advancing stem cell research. The challenge for the CIRM Board is to find someone with the vision to guide the organization and program in its next phase. The challenge for all of us is to stay focused on patients and their families and on promoting the science that will one day help them.

About Michael Werner

Michael J. Werner, Esq. is President of The Werner Group (, a Washington DC-based firm that provides legislative, regulatory, and bioethics consulting services for life sciences companies, health care providers, health plans, investors, and broad-based coalitions. Michael has over 20 years of health care law, policy development and legislative/regulatory advocacy experience in Washington and is a leader in the biotechnology industry.

Prior to founding The Werner Group, Michael was Chief of Policy for the Biotechnology Industry Organization (BIO), representing over 1000 biotechnology companies in the US and other countries. In that role, he was responsible for virtually all major issues affecting biotech companies including: drug evaluation and review by FDA; CMS policies and reimbursement, Medicare, intellectual property, stem cell research and other sensitive bioethics issues.

Michael is also a founding member of the Board of Directors of the Coalition for the Advancement of Medical Research (CAMR), an organization of almost 100 nationally-recognized patient organizations, universities, scientific societies, foundations, and individuals that advocates for the advancement of breakthrough research and technologies in stem cell research and related fields.

Before coming to BIO, he spent six years as Counsel for Legislation and Policy for the American College of Physicians where he performed legal analysis, and congressional and regulatory advocacy on such issues as Medicare reform; liability reform; integration and delivery system re-structuring; quality improvement; and end of life care. He is currently a member of the Ethics Committee of the Biomedical Engineering Society.

Michael was senior health care advisor to US Senate Majority Leader George Mitchell, a congressional investigator for the US Senate Special Committee on Aging, and senior advisor to Maryland Governor William Donald Schaefer.

Michael is a heavily sought-after speaker for meetings and conferences, and the author of over 30 published articles. His most recent article “Managing Conflicts of Interest: A Survival Guide for Biotechs” appears in the February issue of Nature Biotechnology. He is a frequent media commentator and has appeared in The Wall Street Journal, The Washington Post, BIOWorld, Congressional Quarterly, and The Baltimore Sun, as well as on many TV and radio news programs.

Michael is a graduate of The University of Michigan and George Washington University Law School. He is married with two daughters. In addition to his family and his business, Michael’s passion is University of Michigan football.

This week's events

7th Annual Somatic Cell Therapy Symposium

Dates: September 26, 2007 - March 28, 2007

Presented by International Society for Cellular Therapy
Venue: Hyatt Regency Bethesda Hotel

36th Annual Meeting ISEH Society for Hematology & Stem Cells

Dates: September 28, 2007 - September 30, 2007

Presented by the International Society for Experimental Hematology
Venue: Congress Center Hamburg


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