EBE Plots Path from “Flawed Underfunded Biotech System”

April 27, 2017

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, Barbara 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 or DIA Venture Summit in the US.

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RCT & RWE: Evolution, Revolution or Integration?

April 21, 2017

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!

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New MD and IVD Regulations: Implications of Implementation

April 12, 2017

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.

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DIA EMEA: Research in Europe “Disconnected from Business”

April 12, 2017

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 or DIA Venture Summit in the US.

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Blockchain, AI and Other Radical Drivers of Biopharmaceutical Innovation

April 6, 2017

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!

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FDA Overviews New EU-US MRA on GMP

April 6, 2017

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. 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

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

April 6, 2017

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.

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DIA Forum Acts on Statistical Impact of 21st Century Cures

March 28, 2017

The 21st Century Cures Act provides significant funding for scientific and medical research to promote innovation that speeds development of treatments for cancer and similar devastating diseases. Many such innovations, like using real-world evidence and patient-centered drug development, themselves require innovation in how data is collected and analyzed as scientific and regulatory evidence. In this exclusive podcast, Deputy Director for the Duke Margolis Center for Health Policy Dr. Gregory Daniel shares his expert perspective on the role that statisticians will play in advancing these initiatives. A Senior Advisor to the Reagan-Udall Foundation for the FDA, Dr. Daniel will also be a featured speaker at DIA’s Annual Statistics Forum. “What FDA really needs is to engage with statisticians within FDA but also outside of FDA, to better understand these statistical techniques, establish best practices for them, and how to ensure that their results are valid and reliable,” he explains. Register to attend DIA’s Annual Statistics Forum!

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Q12 Aims to Align CMC with Accelerated Development & Approval

March 28, 2017

Dr. Moheb M. Nasr, who serves as Vice President, CMC Regulatory Strategy for GlaxoSmithKline, is a member and rapporteur of the Expert Working Group for the ICH Q12 Guideline, Technical and Regulatory Considerations for the Pharmaceutical Product Lifecycle. “We realized that the ICH 8 through ICH 11 Guidelines were mostly on the development stage of the life cycle, and there is a gap that needs to address the commercial phase of the life cycle,” he explains in this exclusive Global Forum podcast. “Hence, there was an agreement to develop an ICH Q12 to address this gap and in particular to develop a roadmap to facilitate the management, from the technical, commercial, and regulatory perspectives, of the life cycle.” Dr. Nasr also serves on the program committee for DIA’s 2017 CMC Workshop, where he will co-chair the session that further explains the Benefits and Challenges of ICH Q12 Life Cycle Management. Register to attend the DIA 2017 CMC Workshop!

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EuroMeeting Preview: Real-World Data + AI = Clinical Evidence?

March 1, 2017

Using social media and artificial intelligence (AI) in health care product development presents opportunities and challenges to regulatory systems and professionals in the EU. “The use of artificial intelligence, in terms of deep learning tools but also automation and things like that, is an area in the making, and there are a number of companies which are involved in these kind of tools and trying to adapt them to use in the pharmaceutical and clinical environment,” explains Dr. Joseph Scheeren, Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer Consumer Care, Switzerland. “We will see a high flight of these tools in order to help us to further generate real-world evidence for the use of medical evidence questions.” In this exclusive podcast, Dr. Scheeren further explores this topic and previews the Major European Regulatory Science Challenges DIAmond session which he will co-chair at the DIA EuroMeeting 2017 in Glasgow, Scotland. Register for our DIA EuroMeeting 2017 today!

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