Regulating biosimilars; stem cell therapies and 3-D printing; increasing FDA oversight overseas
Hot topics facing drug development and access—evolving regulatory guidelines for novel therapies, a shifting pharmaceutical research and development (R&D) landscape, and U.S. regulatory challenges at home and overseas—will be discussed by global innovators at the
DIA 2014 50th Annual Meeting
, to be held at the San Diego Convention Center from June 15 to 19.
“Today’s thought leaders dedicated to accelerating health care delivery will have a unique opportunity to address these urgent issues with the brightest minds in medicine and regulation,” said Barbara Lopez Kunz, DIA’s global chief executive.
Research resulting in the first stem cells that are pluripotent—meaning they have the potential to transform into almost any cell in the body—will be the backdrop for an examination of trends in regulation at the “Pioneering Regenerative Medicine: Trends in Regulations for New Therapy” session on June 16 at 8:30 a.m. Led by Shinji Miyake, professor of clinical research at Keio University School of Medicine in Japan, the discussion will review updated guidance to bring regenerative medicine to patients who need healthy tissue or organs.
The science of human stem cell research spans many regulatory jurisdictions of the Food and Drug Administration (FDA) and poses unique challenges for companies seeking to develop products safely. The forum on “FDA Regulation of Therapeutic Products Derived From Human Stem Cells: Successfully Navigating the Regulatory Hurdles,” to be held June 16 at 11 a.m., will feature leaders in research discussing the regulatory framework to govern stem cell products and how to improve interactions with FDA to bring the therapeutics to market.
Regulatory guidelines do not yet exist for 3-D printing, despite breakthroughs in producing new tissue and bones in this science-fiction-like arena. Steven Pollack, director of the FDA’s Office of Science and Engineering Laboratories, will discuss the hurdles in approving 3-D printing products at the “Health Care’s Revolutionary Printing Press? 3-D Printing – Blue Sky and Regulatory Path
” session, to be held June 17 at 10:30 a.m.
Domestic and international regulators are pushing for increased regulatory guidance of biosimilars, but the debate continues on how to tackle this emerging market of therapeutic products. On June 19 at 10:45 a.m., leaders in biosimilar innovation will provide a comparative analysis of the current global discussion about regulatory guidance at the “Trends in Biosimilars Regulation Within Developed and Emerging Markets” session, facilitated by Andrew Robertson, director of global regulatory policy at Merck & Co., Inc.
The industry is evolving from one dominated by large pharmaceutical companies and markets to an industry focused on smaller specialty companies and targeted medicines. Parts one and two of “The Changing Landscape for Bioinnovation: The Emergence of Small Pharma, Strategic Alliances, and Precision Medicine” will discuss navigating the new environment and the potential impact on R&D. The first session will be held June 17 at 8 a.m., and the second will follow at 10:30 a.m.
Christopher Hickey, director of the FDA’s office in China, will discuss efforts to increase the number of inspectors in China in a rapidly expanding global drug market during the “Challenges and Opportunities Facing FDA’s International Posts” session, to be held June 18 at 1:30 p.m. Topics will include increasing FDA’s regulatory staff in 11 locations worldwide, implementing quality manufacturing systems, dealing with inconsistencies in regulatory oversight among nations and obtaining visa approvals.
Contact: Tiffany Cohen
DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org
ABOUT DIA’s 2014 50th ANNUAL MEETING:
Celebrate the Past – Invent the Future is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines involved in the discovery, development and life cycle management of medical products. The meeting aims to foster innovation that will lead to the development of safe and effective medical products and therapies for patients. For more information, visit www.diahome.org/dia2014