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 Administration (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.”
Because they require no R&D investment, biosimilars – nearly identical copies of a biologic therapy that can be marketed when the original’s patent expires – can make these therapies available at reduced costs. This makes biosimilars very attractive to financially overburdened health care systems (and to patients). Dr. Cecil Nick has worked for more three decades in global clinical development and regulatory affairs, and will chair DIA’s Biosimilars 2017 Conference. “I think this is going to be the most exciting biosimilars event ever,” he explains in this Global Forum conference preview. “It’s not just a question of tracking through issues that the audience has heard many, many times before, but really delving into the really critical issues that are evolving as biosimilars are developing, as we’re gaining more experience, and as the regulations are evolving.”
In 2002, the FDA established the Office of Combination Products (OCP) to help manage complicated jurisdictional issues in the regulatory review and approval of drug delivery devices and diagnostics growing in both number and complexity. “I can only imagine what the possibilities will be with respect to the use of things like artificial intelligence and smart devices as they pertain to the delivery of medical products going forward. I feel it’s going to go far beyond where we could have ever foreseen,” suggests Kim Quaintance-Lunn, Vice President and Head of US Regulatory Policy for Bayer, and a member of the program committee for DIA's Combination Products 2017 Conference, in this Global Forum podcast. “The challenge that comes with that is, of course, from a regulatory perspective, how do you regulate that? How do you get in front of an area that moves so quickly as to be hard to even predict?”