Drs. David Parkinson (ESSA Pharmaceuticals) and Gary Kelloff (US National Cancer Institute), Global Forum Translational Medicine content stream editors, explore the world’s first genetically-engineered immune therapy, CRISPR technology, the American Association for Cancer Research Project GENIE, and the potential personalization of “you on a chip.”
Global Forum Translational Medicine content stream editors Dr. Gary Kelloff (US National Cancer Institute) and Dr. David Parkinson (ESSA Pharmaceuticals) discuss the newly-formed US FDA Oncology Center of Excellence, novel data sharing initiatives in oncology, circulating tumor DNA, and their current and anticipated impacts.
Dr. Dorothee Grimald, Director of Global Regulatory Policy for MSD International in Singapore, and Chair for Accelerating Access to Innovative Products: Improving Responses to Pandemic Diseases, discusses ways to expedite patient access to combative therapies.
Saudi Arabia has the largest population and economy in the Gulf region; the Saudi Food & Drug Authority (SFDA) has correspondingly grown into one of the region’s leading regulatory agencies. The SFDA is one of many regional regulatory agencies participating in DIA EMEA's Middle East Regulatory Conference 2017 in Kuwait City. “It’s very important for us as a regulatory authority,” explains Dr. Sami Al-Sager, SFDA Executive Director for Cosmetic Products Safety, and Acting Vice President for Drug Affairs, in this Global Forum podcast.
Information is king – but to be most useful, information must be accurately and fairly communicated, explains DIA EMEA’s 11th Annual Medical Information and Communications Conference Co-Chair Dr. Lillian Auberson (Medical Information Lead for Europe at Hoffmann-La Roche, Switzerland) in this Global Forum podcast. “It’s really about thoroughly understanding exactly why we’re being asked a question,” concurs Co-Chair Janet Davies (Director, Medical Information, EMEA, Gilead Sciences Europe, UK).
“We generally view the introduction of new technology solutions, particularly very expensive ones, as those that would contribute to a level of efficiency and speed,” suggests Dr. Ken Getz, Research Associate Professor at the Tufts Center for the Study of Drug Development. But, what does the Center’s recent 2017 eClinical Landscape Study reveal? Listen to find out, and learn more about technology's growing and often surprising impact at DIA’s Regulatory Submissions, Information & Document Management Forum.
Vicki Edwards, QPPV and Vice President, Pharmacovigilance Excellence, for AbbVie, Inc. (UK), has served on the program committee for every DIA EMEA Annual Forum for QPPVs in Europe, and in this Global Forum podcast discusses the impact of Brexit and relocation of the EMA on pharmacovigilance in the EU. To learn more, attend DIA EMEA's Brexit Summit: Ensuring Continuity for Patients and Business.
Many of the US FDA’s drug initiatives over the past decades have been led by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER). In 2000, she introduced the concept of risk management to drug safety. Since 2002, she has led the Pharmaceutical Quality for the 21st Century Initiative, FDA's successful effort to modernize drug manufacturing and its regulation; more recently, Dr. Woodcock launched the "Safety First" and "Safe Use" initiatives designed to improve drug safety management inside and outside FDA. Dr. Woodcock shares her thoughts on real-world evidence, randomized clinical trials, the relationship between the two, and patient-focused drug development, in this Global Forum podcast, as well as drug pricing: "How do we get the cost of drug development to be more reasonable, so that society can afford these interventions when they come out?”
Conducting clinical trials in the EU will drastically change when the new Clinical Trial Regulation comes into force in 2019. In this Global Forum podcast, Conference Chair Nick Sykes (Senior Director, Worldwide Safety & Regulatory, Pfizer UK) and Dr. Elke Stahl, Co-Chair of the Clinical Trial Facilitation Group and preclinical assessor for the Clinical Trial Unit at BfArM, discuss the impact of this Regulation and DIA EMEA’s December 2017 Clinical Trial Regulation Conference. “It’s a big step forward because the new upcoming regulation will have, I call it always ‘the matter of one’,” explains Dr. Stahl. “We only have one set of documents, one communication route, and therefore you have one contact as a sponsor.”
Does a drug’s price reflect what the drug costs, what the drug is worth, some combination of the two, or something completely different? “The work that’s being done in the space of drug pricing, particularly some of the value-based pricing, indication-specific pricing, some of the novel ideas that are now being considered, are really important steps forward,” suggests Dr. Sean Tunis, Founder and Chief Executive Officer of the Center for Medical Technology Policy, former Chief Medical Officer at the US Centers for Medicare and Medicaid Services, and DIA Global Forum Value & Access Content Editor. “To what degree is that value-based price in any way supposed to be close to or related to what is an economically-viable price from a drug developer perspective, or from an industry perspective? There’s a big gap between, ‘What’s the value-based price’ and what the healthcare system ought to actually pay for something.”