Saudi Arabia has the largest population and economy in the Gulf region, and the Saudi Food & Drug Administration (SFDA) has correspondingly grown into one of the region’s leading regulatory agencies. “The existence of a well-defined and strong pharmaceutical industry is important for promoting and sustaining research and development efforts and initiatives in the economy, as well as making available quality medicines to all at affordable prices,” says Dr. Sami Al-Sager, SFDA Executive Director for Cosmetic Products Safety, and Acting Vice President for Drug Affairs. SFDA is among the 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,” Dr. Al-Sager explains in this Global Forum podcast. “We are looking forward to know the key challenges facing the industry in terms of all transactions with the SFDA, whether it’s drug approval or the pharmacovigilance system or clearance in importing their products. We are interested to know their challenges and to figure out our weaknesses to improve our services to them.”
Information is king – but to be most useful, information must be accurately and fairly communicated. “Medical information is not just about the information that we provide, but it’s about the whole relational aspect of talking to a physician or a patient who may have a question about a product or the diseases that they treat,” 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). “When you’re able to tailor the information to what the customer actually wants, you are then providing communication that is of value and is particularly relevant.”
“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 and Director of the Tufts Center. But what does the Center’s recent 2017 eClinical Landscape Study reveal? “Now we’re looking at time periods that are substantially longer than they were even ten years ago. That was a big surprise for us,” Dr. Getz explains. “What it really shows is the challenge that rising complexity in all of its various forms – scientific complexity, operating complexity, technology complexity – what all these complexity domains are doing in terms of challenging performance, speed, efficiency, and quality.” Learn more at DIA’s Regulatory Submissions, Information & Document Management Forum.
In the European Union (as elsewhere), drugs are approved for market only after closely controlled clinical trials. Approved drugs are, however, used by a larger patient population, or for a longer period of time, and side effects sometimes arise. Managing these effects to ensure patient safety is the domain of a European Qualified Person for Pharmacovigilance (QPPV) such as Vicki Edwards, QPPV and Vice President, Pharmacovigilance Excellence, for AbbVie, Inc. (UK). Vicki 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. “There is concern in the industry that divergence of regulation, and therefore duplication of effort, will result from the MHRA moving out of Europe,” she explains. Don't miss 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?”
Oligonucleotides, short nucleic acid polymers used for research and genetic testing, have emerged as a critical element challenging scientists, clinicians and regulators working in personalized medicine. “Instead of targeting proteins like small molecules typically do, with oligonucleotides you're typically targeting nucleic acid, the DNA inside the cell, the genes in the nucleus, or the mRNA in the cytoplasm. So it greatly expands the capabilities of a drug to alter the biology of a cell,” explains Dr. Arthur Krieg, President and CEO of Checkmate Pharmaceuticals, an oligonucleotide expert and inventor on 48 US-issued patents. Dr. Krieg also serves on the program committee developing DIA’s Oligonucleotide-Based Therapeutics Conference. “It's a challenge for regulators as it's a challenge for scientists working in the field, too, to keep pace with all of this. That's one of the areas where the DIA/FDA Oligonucleotide meeting is so important,” he explains in this Global Forum podcast.