DIA: Driving Insights to Action

EBE Plots Path from “Flawed Underfunded Biotech System”

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.

RCT & RWE: Evolution, Revolution or Integration?

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!

New MD and IVD Regulations: Implications of Implementation

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.

DIA EMEA: Research in Europe “Disconnected from Business”

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.

Blockchain, AI and Other Radical Drivers of Biopharmaceutical Innovation

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!

FDA Overviews New EU-US MRA on GMP

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! 

Networking 101: Extrovert or Introvert? In Person or Online?

The global nature of the modern marketplace makes networking, in person and online, more important to business growth than ever. “Regardless of whether you’re an extrovert or an introvert, you can always improve your networking skills, and your networking skills should bring you greater success whether within your company or outside of your company,” explains Bob Muzerall, Vice President for Sales and Sales Training at AMPLEXOR Life Sciences. Bob will help to lead the Networking Within Your Company workshop at our DIA 2017 Global Annual Meeting. To learn more about the benefits of networking, visit the DIA Career Center.