In 2018, the US FDA approved a record high number–59–of new, novel drugs. “We are at a point now where there is so much innovation in this space and the regulatory aspects are catching up, so we now have three approved gene therapy products in the US and over seven to eight hundred INDs for cell and gene therapy filed with FDA,” explains Dr. Adora Ndu, Executive Director of Global Regulatory Policy, Research & Engagement, BioMarin Pharmaceutical, and Regulatory Science Co-Editor for DIA Global Forum. “With each interaction with each product that’s filed and with each product that’s approved, the regulatory experience is broadened.”
“Genetics is about everybody, and this information is really fundamental to you and your health,” explains Dr. Emily Drabant Conley, Vice President of Business Development for 23andMe, the first company to receive US regulatory approval for their over the counter genetic ancestry and health tests. “If individuals are empowered with information about their genetic predisposition, it puts them in a position to take action.”
“One of the best questions we can ask is, why?” explains Deborah Collyar, Founder and President of Patient Advocates in Research. “People in industry are beginning to realize that we have reached a tipping point,” suggests Dr. Lode Dewulf, Chief Patient Officer at Servier Group. “The risk of not engaging patients has for the first time become bigger than the risk of engaging patients.” Deborah and Lode serve as Patient Engagement Editors for DIA's Global Forum.
Niklas Hedberg, Chief Pharmacist for the Dental and Pharmaceuticals Benefits Agency in Sweden, chairs the executive board for the European Network for Health Technology Assessment known as EUnetHTA. “We typically see that there are a lot of comparative questions that are not or even cannot be answered by traditional randomized control trials,” he explains. “Anything that is outside the typical randomized controlled trial scope is probably going to be of increasing importance for the relative effectiveness and relative cost evaluation.” Mr. Hedberg hosted the EUnetHTA Town Hall at DIA Europe 2019.
With more than 30 leading multinational pharmaceutical companies choosing Singapore as their base for operations in this region, this island nation has emerged as one of the most advanced biomedical R&D hubs in Asia. “The Singapore government understands the importance for Singapore, as a small country, to follow international standards,” explains Jin Shun, Head of Regulatory Affairs, Asia-Pacific, Middle East and Africa, for Sandoz, a Unit of Novartis. “HSA (the Health Sciences Authority) joined ICH in November 2017, and announced the implementation of eCTD at the end of last year.” Mr. Shun serves on the program committee for the DIA-CoRE Singapore Annual Meeting 2019.
Barbara Nardi, Associate Director of Medical Communications, PPD (Brazil), and Emanuela Lopes Fernandes Saraiva, Customer Service & Medical Information Manager in Pharmacovigilance, Libbs Farmaceutica (Brazil), discuss topics from DIA’s first Latin America Medical Information and Communication Workshop. “The biggest challenge we have is capturing the patient voice and promoting the patient-centric future at the core of the business model,” suggests Emanuela.
Dr. Esa Heinonen is Director, Assessment of Medicinal Products, for the Finnish Medicines Agency, and Co-Chair of the EU Innovation Network, established in 2016 “to facilitate the development of innovative medicines by addressing gaps in early regulatory support to innovation.” Dr. Heinonen discusses How Can the EU Regulatory Network Support Innovation?, the title of the session that he will chair at DIA Europe 2019.
Global Forum Translational Science Co-Editors Dr. David Parkinson (President, CEO, and Director, ESSA Pharmaceuticals) and Dr. Gary Kelloff (Advisor to Associate Director, Cancer Imaging Program, US National Cancer Institute) describe revolutionary advances in the science of genetics and other fields in the global march toward delivering true personalized/precision medicine in the fight against cancer.
“The digitalization of the world will radically change the medical industry, the healthcare industry, and particularly the pharmaceutical space,” explains Dr. Tamas Suto, Head of Medical Excellence for Sanofi. “But communication is all about creating effective partnership, and the leadership aspect of communication cannot be substituted with robots.” Dr. Suto will chair the session Improving Pharmaceutical Communication & Exchange - Focusing on the Trends in the Medical Function at DIA Europe 2019.
Improving regulatory review of drugs and devices (R2D2) and protecting citizens from unsafe drugs (Bill C-17) are two critical components of the current pharmaceutical landscape in Canada and our 2018 DIA Canadian Annual Meeting, explain Melissa Hunt, Director of the Bureau of Metabolism, Oncology & Reproductive Sciences within the Therapeutic Products Directorate of Health Canada; and Loretta Del Bosco, Director of Regulatory Affairs Quality Assurance Operations, AbbVie Corporation, Canada.