On March 29, 2017, British Prime Minister Theresa May triggered Article 50 of the Treaty of Lisbon, providing formal notice to the European Union of the UK's intention to leave the EU. In this exclusive Global Forum podcast, Dr. Virginia Acha, Executive Director for Research, Medical and Innovation, for the Association of the British Pharmaceutical Industry, discusses the opportunities and challenges as well as the public health, operational and other aspects of what is now known as “Brexit.” “This is going to be a game in two halves. The next two years is about understanding the withdrawal agreement, how we intend to leave the European Union, and then, specifically following from that, an idea of what our new relationship will be,” she explains. “Where does the UK fit within the wider scheme of things? Up until now, the definition of the UK has been its contribution as part of the European Union – a much bigger market, a much bigger patient population, a much bigger research region. Now, as it sets out on its own, it’s incumbent on the UK to set out its stall of what it wants to be as a life sciences country in the world.” Learn more about Brexit and other global regulatory challenges through the Regulatory Track at our DIA 2017 Global Annual Meeting.
At DIA’s first BioVenture Day in Europe, Dr. Wija Oortwijn, a founding Member of the International Society for Health Technology Assessments and Sector Leader for Health and Partner of Ecorys, delivered the presentation Links Between Pharmaceutical R&D Models and Access to Affordable Medicines, which highlighted a year-long study on access to affordable medicines conducted on behalf of the European Parliament Committee on Environment, Public Health and Food Safety. “We concluded that a health care system can only be truly effective if full information on the effectiveness and cost-effectiveness of each medicine is available,” explains Dr. Oortwijn in this exclusive Global Forum podcast. “Processes to optimize available budgets to pay for innovative but also effective new medicines need to be in place, and health technology assessment should be enabled to collect information that is valuable for all stakeholders – including the public.” Learn more about these topics at our Value & Regulatory Strategy Workshop in Europe.
Founder of the Melanoma Patient Network Europe (MPNE), Dr. Bettina Ryll contributed the patient perspective to the session Immuno-Oncology: Therapeutic Breakthrough Area or Nightmare for Health Care Funding at DIA’s first BioVenture Day in Europe. In this exclusive Global Forum podcast, Dr. Ryll shares the challenges to patient-centric drug development and patient access to those drugs in Europe. “Melanoma as a disease has completely changed. We’ve moved from one with no hope, a disease full of despair where patients had a median survival of six to nine months after being diagnosed, to one where all of a sudden we have survivors and we’re discussing the possibility of a cure!” she explains. “This is how we as the MPNE got interested in the process of innovation: How do we get to these new therapies? Now, in the next step, how do we actually make them accessible for our patients? Because a drug that is just sitting on a shelf that we cannot access is as good as non-existent for patients.” Learn more by attending Challenges and Issues in Early-Phase Oncology Trials, Evolution of Novel Registration Endpoints as Diseases Become Chronic and other sessions at our DIA 2017 Global Annual Meeting.
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.