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.
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.