Clinical research and regulatory science professionals in Europe are currently dealing with implementing the Medical Device and In Vitro Diagnostic Regulations, the new clinical trial data transparency framework, big data, and framing how new artificial intelligence and other new tools can improve drug development. “We are very conservative as an industry, and obviously there’s always concerns about things like data protection, data integrity, and whatever we do with artificial intelligence has got to be within the bounds of data protection and data integrity guidelines,” explains Karen Roy, Senior Vice President, Client Solutions, for Phlexglobal, a provider of electronic Trial Master Files (TMFs). Ms. Roy co-chairs the DIA TMF Reference Model, an industry-driven initiative to standardize the content, naming and structure of Trial Master Files, and also serves on the program committee for DIA’s first Clinical and Regulatory Operational Excellence Forum in Europe.
In May 2017, the China Food and Drug Administration (CFDA) issued four new draft policies, the latest in a series of regulatory reforms which began in 2015 to accelerate the review and approval, and improve the quality, of new drugs and medical devices, for public comment. In June 2017, ICH and the CFDA jointly announced that CFDA had joined ICH as a Member. “CFDA is continuing to enhance the regulatory standards and regulatory system to promote innovation to improve the drug R&D ecosystem and, ultimately, to improve the access of medicines to patients,” explains pharmaceutical industry veteran Dr. Ling Su, Director and Professor at the Institute of Drug Regulatory Science at Shenyang Pharmaceutical University, and a Venture Partner at Lilly Asia Ventures, in this Global Forum podcast. “The CFDA has clearly indicated that, by joining ICH, the CFDA will comply with the rules and principles of ICH. This new development aligns very well with CFDA’s intention to become more aligned with international standards.”
The new data transparency framework, the Medical Device and In Vitro Diagnostic Regulations, the impact of Brexit – what else is new for clinical research in Europe? As Senior Vice President, Drug Development Services, CNS, for ICON plc in Frankfurt (Germany), Dr. Peter Schueler can share extensive knowledge on this topic; he serves on the program committee and will be a featured speaker for DIA’s first Clinical and Regulatory Operational Excellence Forum in Europe, September 2017. “The whole meeting will be based very much on dialogue between regulatory and operational people. We plan to have two people holding the opening lecture, one from the operational field and one from the regulatory field, to bridge between ‘What do regulators expect?’ and ‘What can operational people deliver?,’” Dr. Schueler explains in this Global Forum podcast. “The tension between these diverse expectations among these two groups should be sorted to a certain extent in the dialogue during the session, finding out where common ground is and where both parties can actually contribute to provide best quality data about medicines that address unmet medical needs.”
Growing globalization of supply chains, patient recruitment and clinical trials has made cooperation among the world’s regulatory agencies more important than ever. In this exclusive Global Forum podcast, Dr. Sandra Kweder, Deputy Director in the FDA Office of International Programs’ Europe Office, and FDA’s Liaison to the European Medicines Agency, discusses regulatory collaboration in the modern health care product ecosystem. “My role specifically is to bring our two agencies together. That’s my job,” she explains. “My job operates at many levels. One is to provide someone onsite at EMA to help EMA understand FDA. We do the same things but our systems could not be more different. At the same time, my job is to observe EMA and try to translate EMA back to my FDA colleagues. Simply because we have arisen from different roots, we often approach the same thing from different angles.” Dr. Kweder will be featured speaker in several DIA 2017 Global Annual Meeting sessions.
What IS real-world evidence? Who owns it, and how do we define, collect, analyze and use it? DIA EuroMeeting 2017 explored these questions in the DIAmond session Major Regulatory Challenges Enabling Decision Making for Early Patient Access: Regulatory Tools and Sources of Real-World Evidence. “After the initial assessment of a medicine, medicines are being used by health care providers and patients across the globe to treat illnesses. And we don’t seem to have a good way of collecting the data from that actual use in those settings to help us learn and refine our knowledge about the safety and effectiveness of medicine,” explains Session Chair Dr. Sandra Kweder, Deputy Director in the FDA Office of International Programs’ Europe Office, and Liaison to the European Medicines Agency, in this exclusive Global Forum podcast. “The concept of real-world evidence seeks to bridge those two spheres of inquiry.” Dr. Kweder will be featured speaker in several DIA 2017 Global Annual Meeting sessions.
Developing therapies to meet the needs of children has always featured unique challenges, including and especially clinical trials. But due, at least in part, to the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) in the US and the Paediatric Regulation in the EU, much progress has been made. Recap this progress at the DIAmond session Progress in Pediatric Therapeutics, chaired by Dr. Ronald Portman, Executive Director, Pediatric Therapeutic Area for Novartis Pharmaceuticals Corporation, at our DIA 2017 Global Annual Meeting. “As a parent, you want a drug that is being given to your child to have been fully evaluated in the pediatric population – but your initial feeling is, evaluated in somebody else’s child, not mine,” Dr. Portman explains in this exclusive Global Forum podcast. “We as a society have a lot of work to do in educating parents that doing drug development through research is actually very beneficial to their child, and not only their child but children in the future. ” Register for our DIA 2017 Global Annual Meeting in Chicago!
Health economics plays a crucial role in informing healthcare resource allocation decisions for the reimbursed markets, explains Madhur Garg, Director, Real World Evidence and Market Access, Sciformix Corporation. Health technology assessment (HTA) is often applied to assess the affordability and value of new healthcare technologies like drugs, medical devices, diagnostics, etc. QALY is often employed in the HTA process to quantify and compare health benefits of various treatment options. QALY is a measure of quality and quantity of an individual’s health state and is commonly used in health economics and outcomes research (HEOR). This podcast is part of DIA's White Paper library: Download and listen to this podcast.
Dr. Christine Colvis, Director of Drug Development Partnership Programs for the National Center for Advancing Translational Sciences (NCATS) at the US National Institutes of Health, leads the Center’s Discovering New Therapeutic Uses for Existing Molecules program, and will share her expertise at the DIAmond session Drug Repurposing: Where Will It Take Us? at our DIA 2017 Global Annual Meeting. “The academic community has really, really embraced this. As you can imagine, having the opportunity to potentially in your own lifetime (especially for preclinical researchers) have your research have an impact on health is almost a dream come true,” Dr. Colvis explains in this exclusive Global Forum podcast. “Most academic researchers are not simply going through an academic exercise; they really do want to have an impact on health and disease, and we’ve had such positive responses.” Register for our DIA 2017 Global Annual Meeting in Chicago!
Who determines what constitutes a representative, appropriately diverse population for a clinical trial – and how? In this exclusive Global Forum podcast, Dr. Sam Oh, Director of Epidemiology, Asthma Collaboratory at the University of California San Francisco School of Medicine, previews the DIAmond session Does Diversity Matter in Clinical Trials? which he will help lead at our DIA 2017 Global Annual Meeting. “From 1993 to 2013, we found that less than five percent of NIH-funded studies of respiratory diseases included populations of non-European descent,” he explains. “If only two percent of cancer clinical trials and less than five percent of pulmonary studies have studied enough minorities to provide useful information, we’re missing half of the scientific pie; from an economic and fairness perspective, a growing proportion of Americans are not fully benefitting from the medical and scientific discoveries that they are funding through their tax dollars.” Register to attend our DIA 2017 Global Annual Meeting in Chicago or our Clinical & Regulatory Operational Excellence Forum in Europe.
The European Regulatory Town Hall Meeting convened against a compelling backdrop – including the official adoption of new medical device and in vitro diagnostic device regulations in Europe, Brexit, and uncertainty surrounding the future and future location of the European Medicines Agency – at our DIA EuroMeeting 2017. In this exclusive Global Forum podcast, Dr. Thomas Senderovitz, Director General of the Danish Medicines Agency and one of our European Regulatory Town Hall panelists, discusses the importance of multi-stakeholder collaboration in drug development and regulation, and introduces the new China-Denmark Food & Drug Regulatory Cooperation Centre. “It’s the largest operation of its kind that the Chinese FDA has ever signed, and we’re the first country in the world to go into this type of collaboration,” he explains. “Within this framework, we’re going to exchange best practices, telephone conferences, seminars, and staff exchanges for shorter or longer durations of time in areas such as licensing, inspection, medical devices, procedures, guidelines, etc.” To learn more, attend sessions in the Regulatory Track at our DIA 2017 Global Annual Meeting.