In the spirit of “radical collaboration”, the Journal of Business and Intellectual Property Law (JBIPL), has chosen to focus its spring symposium on Regenerative Healthcare and the Law. The Wake Forest Institute of Regenerative Medicine (WFIRM) is home to the largest regenerative medicine facility in the world, making Winston-Salem the perfect place for us to identify and discuss three subtopics through interactive panels that will focus on: (1) the FDA’s Role in Regenerative Healthcare; (2) Bioethics and the Law in Regenerative Healthcare; and (3) Going to Market and the Future of Business in Regenerative Medicine. The symposium will encompass frank and insightful discussions on each subtopic while emphasizing the role and prevalence of regenerative healthcare at large; a topic that needs to be further researched, scrutinized and debated amongst students and professors alike.
Session 1 Info: The FDA’s Role in Regenerative Healthcare:
One of the FDA’s many responsibilities when protecting our public health is to ensure the safety, efficacy, and security of the markets various biological products and medical devises. (FDA Website). In this session we will explore the role that today’s FDA plays in regenerative healthcare through the lens of those who are implementing tech-based economic development, implementing the regulatory oversight, and advising companies on how to best comply in this constantly evolving field. We will also discuss the impacts of a potential shrinking regulatory landscape as the Supreme Court considers the scope of agency deference under the Chevron doctrine.
Speakers:
Mr. Steven R. Bauer, PhD: Mr. Bauer is the Chief Regulatory Science Affairs Program Officer at WFIRM. Before joining WFIRM, Dr. Bauer was Chief of the Cellular and Tissue Therapies Branch (CTTB) in the Division of Cellular and Gene Therapies, in the Office of Tissues and Advanced Therapies (OTAT) at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA). Dr. Bauer has three decades of experience in regulatory science research, regulatory oversight, and policy development for regenerative medicine product development. Dr. Bauer was a member of FDA’s Senior Biomedical Research and Biomedical Product Assessment Service (SBRBPAS). As the Chief of CTTB, Dr. Bauer supervised CBER scientific staff engaged in review of cell- and gene-based biological therapies, policy development in emerging areas of cellular therapies, and research relevant to their use in clinical trials. Dr. Bauer has extensive regulatory experience with review of hundreds of regulatory submissions from all phases of product development from IND to BLAs including many novel cell, gene and tissue engineering applications. Dr. Bauer also headed FDA’s multipotent stromal cell (MSC) research consortium that published over twenty papers illustrating challenges and improvement strategies for characterization of complex MSC-based cellular and tissue engineering products. Dr. Bauer received his Ph.D. in Biochemistry from the University of Maryland in 1986. From 1986 through 1991, Dr. Bauer was a scientific member of the Basel Institute for Immunology in Basel, Switzerland. His research interests include development of strategies to improve characterization of stem-cell based therapies and to enhance our understanding of how manufacturing of regenerative medicine products influences the biological properties of these complex and heterogenous products.
Dr. John Hardin, PhD: John Hardin is the Executive Director for the North Carolina Board of Science, Technology & Innovation, which is staffed by Office of Science, Technology & Innovation in the North Carolina Department of Commerce. Hardin’s duties include developing and justifying legislation related to defining statewide research capacity and structure; implementing science, technology and innovation-related economic development policy and resource allocations; research, analysis, and review of substantive policy issues and proposals; preparing public policy and budget analyses; preparing and presenting high-level state policy briefings, assessments, and reports to policy makers and external constituencies; conducting strategic planning and making recommendations for technology-based economic development; directing and overseeing strategic initiatives with impact at the state level; and overseeing the administration of grant programs to support technology commercialization by North Carolina small businesses.
Professor Sidney Shapiro: Professor Shapiro is the Frank U. Fletcher Chair in Administrative Law and a Professor of Law at Wake Forest. Mr. Shaprio is one of the country's leading experts in administrative procedure and regulatory policy. He has written ten books, contributed chapters to seven additional books, authored or co-authored over fifty-five articles, and is currently working on a book on administrative expertise. Mr. Shapiro has been a consultant to government agencies and has testified before Congress on regulatory subjects. He is the Vice-President of the Center for Progressive Reform, a nonprofit research and educational organization of university-affiliated academics. Before coming to Wake Forest, Mr. Shaprio taught at the University of Kansas where he was a distinguished professor. Prior to teaching, Mr. Shaprio was a trial attorney with the Federal Trade Commission and Deputy Legal Counsel of the Secretary's Review Panel at the U.S. Department of Health, Education, and Welfare.
Ben Martie, Partner at Morningstar Law Group: Ben Martie is a seasoned life sciences attorney and industry expert with unique insight and a deep understanding of the needs of pharmaceutical, biotechnology, medical device, and other life sciences companies. Ben also provides counsel to life sciences companies on a variety of laws and regulations administered and enforced by federal authorities, such as FDA, FTC, OIG, CMS, and DOJ, as well as state authorities, such as attorneys general, boards of pharmacy, departments of health, and others. Ben assists companies with development and administration of effective compliance programs, particularly with regard to applicable laws, regulations, agency guidance, and industry codes and standards, e.g., PhRMA Code, AdvaMed Code.
Prior to joining the firm, Ben spent more than a decade as in-house counsel with both privately-held and publicly-traded pharmaceutical and life sciences companies in the Triangle. Most recently, Ben served as the General Counsel and Chief Compliance Officer for RedHill Biopharma, a commercial-stage pharmaceutical company.
Professor Ana Iltis, PhD: Ana S. Iltis, PhD is Director of the Center for Bioethics, Health and Society and Professor of Philosophy at Wake Forest University. She holds a PhD in Philosophy from Rice University. Prior to joining Wake Forest University, she was Associate Professor of Health Care Ethics and PhD Program Director in the Center for Health Care Ethics at Saint Louis University and held an appointment in the Department of Medicine at Washington University in St. Louis where she taught research ethics. She has published widely in bioethics, serves on several National Institutes of Health data safety monitoring boards and holds a wide range of editorial positions, including: Co-Editor of the Annals of Bioethics book series (Routledge), Senior Associate Editor of The Journal of Medicine and Philosophy (Oxford University Press), and Co-Editor of Narrative Inquiry in Bioethics (Johns Hopkins University Press).
Session 2 Info: Bioethics and the Law in Regenerative Healthcare:
“Regenerative medicine has the potential to treat genetic disorders and replace damaged or missing tissue.” However, as the technology advances and delivers greater patient benefits, it also raises new ethical and legal risks. Session 2 will focus on the ethical and legal implications of regenerative medicine. Panelists will give an overview on emerging ethical and legal issues in this field both in the United States and around the world. Discussion will additionally focus on the unproven stem cell industry, and the ethical and legal issues around transplantation.
Speakers:
Nancy King: Nancy M.P King, JD is an Emeritus Professor of Social Sciences and Health Policy at Wake Forest University School of Medicine. Her scholarship addresses a range of bioethics issues, including: informed consent, benefit, and uncertainty in health care and research; the development and use of novel experimental biotechnologies; international and cross-cultural questions in human subjects research; and equity and justice in health care and research. Professor King will discuss current research of xenotransplantation and will highlight three aspects of regenerative medicine: (1) the relationship between surgery and research; (2) the transplantation industry and how candidates are chosen; (3) the difference between regulating ordinary drugs and biologics.
Zubin Master: Dr. Zubin Master is currently an Associate Professor within the Department of Social Science and Health Policy at Wake Forest University School of Medicine and will be affiliated with WFIRM. He recently joined the Wake Forest community from his previous position at Mayo Clinic’s Biomedical Ethics Research Program. Dr. Master’s research interests broadly cover ethical and policy issues related to stem cells and regenerative medicine, genetics, research ethics, and the responsible conduct of research. Dr. Zubin will focus on regulation of biologics and the regulatory tension at state and federal levels, specifically with the unproven stem cell industry.
Christine Coughlin: Christine Coughlin, JD is a Professor of Law at Wake Forest University School of Law. She is a core member in the Wake Forest University Center for Bioethics, Health & Society. Her publications include “Research on Emerging Biotechnologies” in the Oxford Handbook of Research Ethics, and “Regenerative Medicine and the Right to Try.” Professor Coughlin will discuss emerging ethical and legal issues in regenerative medicine that consistently arise, and will present a global perspective by presenting on how regulation around the world will affect the United States.
Joe Singleton: Joe Singleton, JD is a Fellow at Wake Forest University School of Law. Guiding the discussion as a moderator, Mr. Singleton will bridge the gap between other speakers and incorporate his own expertise into the discussion.
Session 3 Info (Bringing Regenerative Medicine Technologies to Market):
Session 3 will focus on the legal and business implications of bringing regenerative medicine technologies to market. The discussion will lead by providing a brief overview of panels 1 and 2 to describe the process of bringing these technologies to market. It will follow by discussing the regulatory considerations for start-up companies. Included in this discussion will be intellectual property rights of start-ups, funding considerations, and legal hurdles that such technologies face. Panelists will engage in discussions on the business strategies and market feasibility of certain products. Additionally, this session will emphasize the importance of strategic partnerships which many companies need to better market and compete in the industry.
Speakers:
Dr. Ronald K. Hann, Jr.: Dr. Hann is the Director for Technology Integration at the Wake Forest Institute for Regenerative Medicine (WFIRM), Wake Forest University Medical School in Winston-Salem, NC. Dr. Hann supports development and growth across a myriad of activities including the RegenMed Development Organization (ReMDO), the Innovation Quarter, staff professional development, and international and government business development. Dr. Hann holds an extensive background in various scientific fields. Dr. Hann will provide audience members with at-market perspectives, engaging with start-ups and various businesses which aspire to bring regenerative medicine technologies to patients.
Dr. Amol Joshi: Dr. Joshi is the Bern Beatty Fellow and an Associate Professor of Strategic Management at the Wake Forest University (WFU) School of Business. Dr. Joshi has an extensive background in innovation management, especially in advising start-up companies. As the dynamic and expanding market grows for regenerative medicine technologies, more of the skills Dr. Joshi possesses are needed. Dr. Joshi will provide session 3 with a comprehensive, strategic analysis of the regenerative medicine market. Audience members will have the opportunity to interact with the extensive experience Dr. Joshi has to offer. Guiding the discussion as a moderator, Dr. Joshi will bridge the gap between other speakers and incorporate his own expertise into the discussion.
Dr. Eva Mueller: Dr. Eva Mueller is a Biomaterial scientist and chemical engineer passionate in translating emerging 3D bioprinting technologies in healthcare. Dr. Mueller has technical expertise in biomaterials, polymer chemistry, drug delivery, tissue engineering, 3D (bio)printing, cell biology and regenerative medicine. Dr. Mueller’s expertise will provide a unique perspective on how a regenerative medicine company operates in the market. Her perspective will bring audience members practical insight into how start-ups engaging in the market bring products to patients and the challenges that are included in this process.
Julie M. Watson: Julie M. Watson is chief intellectual property officer and legal counsel for the Wake Forest Institute for Regenerative Medicine, as well as special counsel at Marshall Gerstein & Borun, a Chicago-based intellectual property law firm, where she concentrates her practice on counseling related to intellectual property transactions, with a particular emphasis in technology startups and university technology transfer. Ms. Watson provides session 3 with expertise bringing strategic solutions to complex intellectual property transactions. Ms. Watson brings to the discussion deep knowledge of university licensing and tech transfer, and will provide this perspective to the panel. Audience members can gain an understanding of Ms. Watson’s experience, as her role is essential to the viability of university-sponsored research which is a key component of bringing regenerative medicine technologies to market.
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