Updated: Jul 8
The 16th New York Health Forum, titled “Regulatory Strategy for Therapeutic Products," will provide a setting for stimulation and informative discussions about regulatory pathways, landscapes, status, and opportunities for both pharmaceuticals and medical devices. Approximately 100 biopharma and medtech representatives and healthcare professionals will come together to connect, learn, and share.
To view the recording, visit https://www.nyhealthforum.net/16th-forum
PANEL DISCUSSION SUMMARY
Regulatory strategies are crucial in clinical development of therapeutic products, from pharmaceuticals to medical equipment. FDA approval pathways as well as assessing the applicability of unique programs could be key items for companies' success. Preparation for relevant regulatory documentation and deciding which pathway to undergo are critical elements of regulatory strategy development and companies must have comprehensive knowledge of the regulatory requirements.
Entering the US market – drugs and devices
The greatest regulatory challenges that medical device and pharmaceutical companies face when entering the US market is that they do not have sufficient knowledge of the FDA requirements or the regulatory landscape in the US. Companies should be prepared for the regulatory work at the beginning of their development, which is earlier than most companies anticipate.
Orphan drug development under FDA regulation
The FDA has a division to streamline orphan drug projects, called the Office of Orphan Products Development. Companies can utilize the resources provided by the FDA. The FDA issues clear guidance on Orphan Drug Designation (ODD) applications and developing rare disease drugs, and it offers meetings for companies to receive feedback on their products.
FDA policies during COVID-19
The FDA created an Emergency Use Authorization (EUA) system to streamline the approval process for COVID-19-related products.
During the pandemic, the major changes with the FDA were a quick transition to electronic submissions/communications and FDA’s remote facility inspections and audits. The FDA turned to more interactive evaluations and requested documents that they would have requested if they were on site.
Supply chain for therapeutic products in the US
The COVID-19 pandemic revealed many shortcomings in the US supply chain of therapeutic products. It was revealed that just-in-time (JIT) inventory practices do not work in a pandemic. The key to preparing for another situation like this is having a resilient and robust supply chain, building redundancies.
Global manufacturers must ensure redundancies in their supply chain and pay close attention to other regulatory authorities. Also, they should learn how to effectively utilize the remote audit system to get the most value out of it.
Ji Soo Yoon, JD (Moderator | Legal Counsel and Director, W Medical Strategy Group)
Ji Soo Yoon is the Director of Project Management and Legal Counsel at W Medical Strategy Group (WMSG) and the Legal Counsel at Enzychem Lifesciences. He is also the Director of Project Management at WR Regulatory Services, a joint venture established by two healthcare consultancies, WMSG and Reguliance. He has been working on IP portfolio management, licensing due diligence, exit strategy development, and various legal issues for bio/medical companies. He previously worked at KOTRA BioMedical Team to promote the Korean pharmaceutical industry and medical device industry to the global market while supporting two major projects. He currently serves as the FDA compliance and legal advisor at Korea University Medical Center and Gachon Gil Medical Center in Korea. He received his J.D. degree from Boston College Law School. He has a Bachelor’s degree with a major in Economics and Political Science with a minor in Chinese from the University of Rochester.
Bruce Thompson, MBA (Pharmacuetical Expert | Managing Partner, WR Regulatory Services)
Bruce Thompson is the Co-founder and the Managing Partner of WR Regulatory Services. He has over 25 years of experience in pharmaceutical regulatory affairs and project management. An independent consultant since 2002, he founded Reguliance LLC which specializes in providing regulatory support and project management to small- and medium-size drug and biotech firms. Prior to becoming a consultant, he was the Managing Director of Chiesi Pharmaceuticals where he directed US regulatory and R&D activities and played a key role in product and business development. Before joining Chiesi Pharmaceuticals, he was the Director of Regulatory Affairs for Armstrong Pharmaceuticals focusing on respiratory product development. In this capacity, he designed and managed the first successful pharmacodynamic bioequivalence study leading to approval of generic albuterol inhalation aerosol. He has a Bachelor of Science degree with a major in Biochemistry University of Guelph in Ontario, Canada, and earned his MBA from Clarkson University in Potsdam, New York.
Mark Paxton, JD, MS (Pharmaceutical Expert | FDA Sponsor's Representative, US Army Medical R&D Command)
Mark Paxton is the FDA Sponsor's Representative at the US Army Medical Research and Development Command. He was the first CEO of RX-360 until December 2017. Prior to joining RX-360, he served as a Regulatory Counsel in the FDA CDER Office of Compliance where he was responsible for assisting in the development of supply chain security policies, both domestically and internationally. He also served as the Associate Vice-President at International Regulatory Affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA). In that capacity, he established a number of ongoing dialogs and work programs with drug regulatory authorities throughout, Japan, China, East Asia, India, Europe, and Latin America. He is a regulatory attorney by education, experience, and training; prior to joining PhRMA, he was in private practice in Lexington, Kentucky where he focused his practice on food and drug law. He received his B.S. and M.S. degrees in Economics from the University of Kentucky, and his J.D. from the University of Dayton School of Law.
Rob Packard (Medical Device Expert | Founder and President, Medical Device Academy)
Rob Packard is the Founder and President of Medical Device Academy. He has 20 years of experience in the medical device industry and 10 years of experience in biotech manufacturing validation and scale-up. He was the Director of Quality and Regulatory Affairs at four different medical device start-ups, and he was President/CEO of a laparoscopic imaging company he co-founded in 2004. His quality management system expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. He has a Bachelor's degree with a major in chemical engineering from the University of Connecticut.
New York Health Forum was founded to strengthen healthcare partnerships and knowledge sharing around the world, supporting innovation and collaboration in global medicine and life sciences. Following the motto scientia potentia est (“knowledge is power”), the NYHF brings together knowledge from industry experts, academia, medical and research facilities, service providers, financial investors, as well as policymakers to further the scope of healthcare. Expert knowledge has fueled the unparalleled development of the health industry, and has empowered the growth of one of the most rapidly changing fields of the 21st century.
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