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Revolutionizing Wellness: Legal Frameworks and Implications Surrounding Regenerative Healthcare

Journal of Business and Intellectual Property Law 2024 Spring Symposium

Published onMar 06, 2024
Revolutionizing Wellness: Legal Frameworks and Implications Surrounding Regenerative Healthcare
  • Date: Friday, April 5th, 2024

  • Location: Wake Forest Biotech Place: 575 Patterson Ave, Winston-Salem, NC 27101

  • Registration Link: To Register for this event, please click the following LINK

  • Schedule: Below is the full breakdown of the 2024 symposium schedule.

    The schedule can also be accessed by clicking the following PDF.

  • Parking: Lot P2 will be available to all guests on April 5th. It sits uphill, behind the atrium, with access to the second floor of the Atrium at Wake Biotech Place. P2's gate arm will be down. Guests just need to buzz security at the gate arm and tell them that they are here for the WFU Symposium. No names are necessary, they will be aware of the group. There will also be volunteers out front who will help guide you into the building.

Please reach out to our symposium editors with any questions: 


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. 


Keynote Speaker:

Dr. Anthony Atala, M.D: 

Dr. Atala is the Chair and Institute Director at Wake Forest’s institute for Regenerative Medicine. Dr. Atala is a practicing surgeon and a researcher in the area of regenerative medicine. Fifteen applications of technologies developed in his laboratory have been used clinically. He is editor of 25 books and three journals. Dr. Atala has published over 600 journal articles, and has received over 250 national and international patents. Dr. Atala was elected to the Institute of Medicine of the National Academies of Sciences, to the National Academy of Inventors as a Charter Fellow, and to the American Institute for Medical and Biological Engineering. Dr. Atala is a recipient of the US Congress funded Christopher Columbus Foundation Award, bestowed on a living American who is currently working on a discovery that will significantly affect society; the World Technology Award in Health and Medicine, for achieving significant and lasting progress; the Edison Science/Medical Award for innovation, the R&D Innovator of the Year Award, and the Smithsonian Ingenuity Award for Bioprinting Tissue and Organs. Dr. Atala’s work was listed twice as Time Magazine’s Top 10 medical breakthroughs of the year, and once as one of 5 discoveries that will change the future of organ transplants. He was named by Scientific American as one of the world’s most influential people in biotechnology, by U.S. News & World Report as one of 14 Pioneers of Medical Progress in the 21st Century, by Life Sciences Intellectual Property Review as one of the top key influencers in the life sciences intellectual property arena, and by Nature Biotechnology as one of the top 10 translational researchers in the world.  

Dr. 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:


Professor Nancy King: Nancy M. P. King, JD, is Emeritus Professor of Social Sciences and Health Policy at Wake Forest University School of Medicine. She has also been affiliated with the Wake Forest Institute for Regenerative Medicine and the Wake Forest University Center for Bioethics, Health, and Society and Bioethics Graduate Program. 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. She has published over 100 scholarly articles and book chapters, and is co-editor of The Social Medicine Reader (3rd ed., Duke University Press, 2019), Beyond Regulations: Ethics in Human Subjects Research (UNC Press 1999), and Bioethics, Public Moral Argument, and Social Responsibility (Routledge 2012). Her most recent book is Bioethics Reenvisioned: A Path Toward Health Justice, coauthored with Larry R. Churchill and Gail E. Henderson (UNC Press 2022). Professor King has taught a variety of courses in bioethics, medical humanities, and research ethics to medical students and faculty and to graduate students in bioethics and the health sciences, and has taught bioethics in national and international settings. She is a fellow of the Hastings Center and a member of the AAHRPP Board of Directors, and has served on hospital ethics committees, IRBs, DSMBs, the NIH Recombinant DNA Advisory Committee, and the DHHS Secretary’s Advisory Committee for Human Research Protections. 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; and (3) the difference between regulating ordinary drugs and biologics.

Dr. Zubin Master, PhD: 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 Wake Forest Institute of Regenerative Medicine. He recently joined the Wake Forest community from his previous position at Mayo Clinic’s Biomedical Ethics Research Program. Previously, Dr. Master held appointments at Albany Medical College, and worked in public service as a Senior Policy Advisor for Health Canada. He is currently a non-resident scholar of the Baker Institute for Public Policy at Rice University and has held multiple adjunct/visiting professor appointments. Dr. Master is currently a member of the International Society for Stem Cell Research’s Public Policy Committee and the Education Committee, and was one of the society’s first Goldstein Science Policy Fellows. He is Associate Editor for the journal Accountability in Research which publishes research on research integrity and has been an invited reviewer for Societal and Ethical Issues in Research special emphasis panel which reviews bioethics grants for the NIH. 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. Master will focus on regulation of biologics and the regulatory tension at state and federal levels, specifically with the unproven stem cell industry.

Professor Christine Coughlin: Christine Coughlin, JD is a Professor of Law at Wake Forest University School of Law. She is a multiple-award winning teacher, recognized for both her teaching and scholarship. She is the recipient of the 2017 Mary S. Lawrence Award from the Legal Writing Institute, the Wake Forest University Teaching and Learning Center's Teaching Innovation Award, the Joseph Branch Award for Excellence in Teaching and a multi-year recipient of the Graham Award for Excellence in Teaching Legal Research and Writing. Professor Coughlin also has appointments in the Wake Forest University Graduate School of Arts and Sciences, and the Wake Forest School of Medicine's Translational Science Institute. She is a core faculty member in the Wake Forest University Center for Bioethics, Health & Society. She is a member of the American Law Institute. Professor Coughlin will discuss emerging ethical and legal issues in regenerative medicine that consistently arise, and will provide 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. Joe Singleton, JD is a Health Law and Policy Fellow at Wake Forest University School of Law. He also works as a Research Assistant for the American Law Institute, with Professor Mark Hall, JD. 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):


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. 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.

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.

Carrie DiMarzio: Carrie DiMarzio is the Chief Executive Officer for BMI OrganBank. BMI OrganBank provides for preservation and transportation of organs. BMI OrganBank provides patients and doctors with feasibility of organ transplant surgeries. As part of the business model, BMI OrganBank’s preservation technology allows for transportation of organs in order to give doctors essential time to schedule and analyze surgeries. Audience members will have the opportunity to learn about the importance of organ preservation and the potential life-saving benefits. Additionally, Carrie DiMarzio will provide insight into a demanding market with over 90 thousand patients waitlisted for kidney transplants.


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