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.
Howard Chazin serves as Director of Clinical Safety Surveillance Staff in the Office of Generic Drugs for the FDA Center for Drug Evaluation and Research. At the DIA 2018 Global Annual Meeting, Dr. Chazin chaired the session titled Generic Drug Products: Comparison of Safety Profile With Branded Cousin. He was interviewed after this session by Mr. Thomas Bols, Senior Vice President & Managing Director for DIA Europe, Middle East, and Africa. Watch the video of this podcast interview.
Recent efforts to bring about agreement on the meaning of “unmet medical need” include a series of Unmet Medical Need sessions at the DIA 2018 Global Annual Meeting. This podcast, recorded after one such session, features DIA Senior Scientist Inka Heikkinen with two experts in this field: Dr. Kenneth Kaitin, Professor and Director of the Tufts Center for the Study of Drug Development at Tufts University School of Medicine; and Dr. Luca Pani, former Director General of the Italian Medicines Agency and current Executive Director for Global Medical Innovation at NeuroCog Trials, and Professor of Clinical Psychiatry at the University of Miami. Watch the video of this podcast interview.
Dr. Gregory Daniel, Deputy Director and Clinical Professor in the Duke-Robert J. Margolis Center for Health Policy, served as panelist in the DIA 2018 Global Annual Meeting session about real world evidence titled Triple-A RWE: Adequate Data, Appropriate Study Designs, and Actionable Evidence. He was interviewed after this session by Mr. Thomas Bols, Senior Vice President & Managing Director for DIA Europe, Middle East, and Africa. Watch the video of this podcast interview.