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.
New horizons opened by personalized (or precision) medicine are also opportunities for combination products, explains Bill Zeruld, a senior Business Development–Digital Strategy executive with Otsuka America Pharmaceuticals, Inc., and a member of the program committee for DIA’s Combination Products Conference. “It’s an exciting time for industry because you start to now have the power of the traditional medicines and traditional medical devices enhanced with the power of digital technology and the underlying data that supports those technologies,” he explains.
As the Director of CDER's Office of Generic Drugs' Clinical Safety Surveillance Staff, Dr. Howard Chazin leads a multidisciplinary team of pharmacists, medical officers and data analysts to identify and assess emerging complex safety issues related to generic drugs. “Generic drugs provide considerable cost savings. They also enhance the availability of quality medications to the American public,” he explains. “The American public should have confidence in generic drugs.”
Kathleen Maxian, founder of the Ovarian Cancer Project, attended the DIA 2018 Global Annual Meeting as a Patient Scholar where she shared the mission, the vision, and other insights into the work of the Ovarian Cancer Project with Senior Managing Editor and Associate Director for DIA Publications Dr. Ranjini Prithviraj. Watch the video of this podcast interview.
Dr. José Vega is Vice President, Global Clinical Safety and Pharmacovigilance and Chief Safety Officer at Merck Research Laboratories. He also serves as Executive Sponsor of the TransCelerate Pharmacovigilance initiatives and as Merck's representative on the Clinical Trials Transformation Initiative Steering Committee. At the DIA 2018 Global Annual Meeting, Dr. Vega chaired the session Novel Approaches to Pharmacovigilance Collaboration and was interviewed after this session by Global Forum Editor Dr. Alberto Grignolo. Watch the video of this podcast interview.
“The relationship between an endpoint and an outcome is similar in many ways to the relationship between data and evidence,” explains Michael Lees, Head of Value, Evidence and Portfolio for Europe and Canada at Takeda Pharmaceutical Company Limited, and a program committee member for DIA’s Advancing the Science of Study Endpoints conference. “You can take a similar approach if you’re a clinical or regulatory expert: The transformation of the endpoint that’s measured in a clinical study into something that has meaning when you’re making a decision.”
At the DIA 2018 Global Annual Meeting, Dr. Nancy Bradish Myers, President and Founder of Catalyst Healthcare Consulting, Inc., chaired the panel discussion Analyzing Innovation's Progress in the Gottlieb Era, which brought together thought leaders from FDA, industry, and the venture capital world to discuss FDA’s modernization plan and its impact on development of innovative treatments. Dr. Myers was thereafter interviewed by DIA Global Chief Executive Barbara Lopez Kunz to discuss the key takeaways of the session. Watch the video of this podcast interview.