Dr. Luca Pani, a current Member of the European Medicine Agency’s Committee for Human Medicine Products and Scientific Advice Working Party, served as Director General of the Italian Medicines Agency from 2011 to 2016. Dr. Pani has published the eBook Sustainable Innovation: Medicines and the Challenges for the Future of Our National Health System and delivered a presentation titled Health System Financing and Reimbursement of Innovation: Is Parallel Micro-Innovation Overburdening the Health Care System? at DIA’s first BioVenture Day in Europe. “What is the good of a drug that is absolutely life-saving but cannot be sustained? Zero!” he suggests in this exclusive DIA Global Forum podcast. Dr. Pani will Co-Chair our 30th Anniversary EuroMeeting 2018 in Basel, Switzerland; learn more about these topics at our Value & Regulatory Strategy Workshop in Europe.
The Bill and Melinda Gates Foundation estimates that neglected tropical diseases affect one billion people worldwide, and that these diseases have the greatest impact on the most vulnerable patient communities. At our DIA EuroMeeting 2017, Dr. Murray Lumpkin, Deputy Director, Integrated Development; and Lead for Global Regulatory Systems Initiatives at the Gates Foundation, chaired the session titled Vaccine Pandemic Preparedness: New Approaches, and joins this exclusive Global Forum podcast to discuss regulatory and caregiver responses to pandemics, and a new collaboration between The Coalition for Epidemic Preparedness Innovations and the World Health Organization. “Uncertainty as to what the pandemic will be adds a real complication and a real challenge as you look to putting together systems in place to meet the outbreak. Likewise, you don’t know where the outbreak is going to be,” he explains. “This uncertainty as to where the outbreak is going to occur and what the outbreak is going to be caused by really puts a level of challenge forward.” To learn more about these topics, plan to attend Designing & Implementing a Robust Pharmacovigilance System for Vaccines or Update from CBER: Advancing the Development of Complex Biologic Products at our DIA 2017 Global Annual Meeting.
How and where do venture capital organizations fit into the scientific research community and biotechnology business community in Europe? A Partner in the investment firm Life Science Partners, Dr. Joep Muijrers participated in the panel discussion on Innovative Funding Models which focused on innovative cures at DIA’s first BioVenture Day, presented March 2017 in Glasgow. “You reach a certain critical mass but you need more cash to take that over the hill to become a clinical company with a couple of products in clinical development – there’s a huge gap there. And it’s not only for private companies, it is also the case for earlier stage public companies in Europe,” Dr. Muijrers explains in this exclusive Global Forum podcast. “I would be a strong advocate of additional funding being made available – for example, by the European Union – to bridge that gap, which is very apparent.” Learn more about these topics at our Value & Regulatory Strategy Workshop in Europe.
The International Association of Mutual Benefit Societies (AIM) is the international umbrella organization of non-profit healthcare payers, health mutuals and health insurance funds, and defends access to health care for all through solidarity-based and non-profit healthcare coverage. AIM Executive Director Menno Aarnout was one of the panelists featured at DIA’s first BioVenture Day and in this exclusive Global Forum podcast discusses the ongoing evolution of biotechnology – as science, and as business – in Europe. “Payers have become more and more interested in the development process. They see expensive drugs coming their way, they see aging societies, they see reducing funds and increasing overall health care costs, and they feel the need to be more involved in that development process,” he explains. “There is discussion about what is our role in the development process: How can we understand that better and how can we create, for ourselves and for industry, more predictability, more certainty, about what’s going on?” Learn more about these topics at our Value & Regulatory Strategy Workshop in Europe.
Dr. Barbara Freischem serves as Executive Director of the European Biopharmaceutical Enterprises (EBE). EBE was founded in 2000 as the voice of biopharma and emerging science in Europe, within the European Federation of Pharmaceutical Industries and Associations (EFPIA). During DIA’s first DIA BioVenture Day, Dr. Freischem delivered a presentation titled Europe’s Flawed and Underfunded Biotech System, which she explores in this exclusive Global Forum podcast. “Europe’s issue is its translation capability of basic science into commercial research,” she explains. “In Europe, there is fantastic funding available for research, but when we try to translate the outcome of that research into successful businesses, we seem to fail.” Learn more about these topics at our Value & Regulatory Strategy Workshop in Europe.
For decades, the randomized controlled trial (RCT) has been “the gold standard” of clinical research, but its role in clinical evidence generation is now being revisited in a broader context. In this exclusive Global Forum podcast, Dr. Nancy Dreyer (Global Chief of Scientific Affairs and Senior Vice President and Head of the Center for Advanced Evidence Generation at Quintiles-IMS) explores this new context and previews the DIAmond session The Evolution of Evidence Generation: Real-World Evidence and the Next Generation of Decision Making, that she will help lead at our DIA 2017 Global Annual Meeting. “The message is growing: The opportunities for using supplementary tools in addition to RCTs will promote access to better medicines more quickly,” explains Dr. Dreyer. “Real-world evidence reflects the kind of patients and the kind of health care practitioners that patients see every day.” Register to attend our DIA 2017 Global Annual Meeting!
As Director of Devices for the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK, John Wilkinson helped to strategize and develop the medical devices and combination products sessions delivered at our DIA EuroMeeting 2017. As the European Parliament approved the new MDR (medical device regulation) and IVDR (in vitro diagnostics regulation) on 5 April 2017, these sessions were of particular importance. “We have seen the final text and we should see that translated into formal legislation at the end of May or early June. Although there are transition periods for the medical device regulation of three years, and for the IVD regulation it’s five years, some of the provisions start coming into force pretty much immediately – particularly in the market surveillance area,” Mr. Wilkinson explains in this Global Forum podcast. “Products are just getting so much more sophisticated, complex and invasive. So, therefore, the risk profile of products that are out there is increasing, and that demands a higher level of scrutiny.” To learn more, attend our DIA Workshop on Benefit-Risk Strategy, or our 11th Annual Forum for Qualified Persons in Pharmacovigilance, in Europe.
In this Global Forum podcast, Dr. Holger G. Adelmann, Senior Vice President/Managing Director for DIA EMEA (Europe, Middle East & Africa), explains the background and vision for DIA BioVenture Day, a new platform connecting stakeholders key to the success of bioventures and investigating if the current bioventure paradigm delivers equitable return for patients, investors, and health care systems, in Europe. “Several IPOs are currently happening in the US, and we have only a handful of mature biotechs in Europe,” Dr. Adelmann explains. “Why is that so? What prevents more biotechs from maturing and doing their final IPO in Europe?” Learn more about these topics at our Value & Regulatory Strategy Workshop in Europe.
As Head of Clinical Innovation, Global Product Development, at Pfizer, Craig Lipset works with artificial intelligence, advanced analytics, and other radical technologies that will improve tomorrow’s biopharmaceutical development process today. From this perspective, he is exceptionally qualified to chair the Radical Technologies: Changing the Future of Biopharmaceuticals DIAmond Session at DIA’s 2017 Global Annual Meeting this June. “Once upon a time, it was almost considered absurd that a large pharmaceutical company would give up their data farms and allow clinical trial data to exist in cloud-based systems outside of their physical control,” Craig suggests. “When we think about technologies in our studies, I’m excited at how that feels more and more like co-developing – as we engage patients earlier and earlier in the process of thinking about the tools that are most meaningful to them.” Register to attend DIA’s 2017 Global Annual Meeting!
In February 2017, regulatory authorities in the European Union and the United States signed a mutual recognition agreement (MRA) on good manufacturing practice inspections to maximize inspection capacity, reduce duplication, and encourage greater international harmonization. Ms. Dara Corrigan, Associate Commissioner for Global Regulatory Policy in the FDA Office of Global Regulatory Operations and Policy, is responsible for the FDA’s Mutual Reliance Initiative with the EU. “Industry can expect that duplicative inspections will decrease significantly in the EU and in the US, and that those inspection resources will be deployed in areas of higher risk outside of the US and EU,” she explains. “For the industry, that is a benefit. For our consumers and patients in the EU and the US, it is a huge benefit.” Have additional questions? Join us at the CMC Workshop for a Regulators Update, or during the EMA/FDA Question Time session at our DIA 2017 Global Annual Meeting!