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.

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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. 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

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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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Cures Within Reach at DIA 2017: Good Therapies at Reasonable Cost

February 27, 2017

Drug repurposing and reformulation leverage already expended costs for compounds that failed to reach the market for one disorder, to develop reformulated or repurposed drugs for a different condition in less time and with less cost. How will repurposing disrupt the current market? Where are the stress points in delivering repurposed products to patients? A special DIAmond panel discussion titled Drug Repurposing: Where Will It Take Us?, chaired by President and Chief Scientific Officer of Cures Within Reach Dr. Bruce Bloom, will explore this topic at our DIA 2017 Global Annual Meeting. “If you can repurpose a generic drug for some unmet medical need and you’re charging the same price for that drug as any other generic in use, you’re liable to be creating a good therapy at a very reasonable cost,” Dr. Bloom explains in this exclusive podcast. “If you’re able to do that, the net health care cost benefit is almost always significantly positive.” Register for our DIA 2017 Global Annual Meeting today!

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EuroMeeting Co-Chair Envisions “Continuous Loop” from Bench to Bedside and Back

February 13, 2017

Dr. Susan Forda serves as Vice President of International Regulatory Affairs for Eli Lilly & Company Limited in the UK. She also contributes her expertise to various committees for the European Federation of Pharmaceutical Industries and Associations (EFPIA) and will serve as Co-Chair for DIA’s EuroMeeting 2017. In this interview with DIA Global Forum Editor Dr. Alberto Grignolo, Dr. Forda explains her perspective on health care and regulatory challenges facing Europe and on the EuroMeeting theme, From Bench to Bedside and Back. “This theme is really important at this juncture because we know that patients are increasingly taking an active role in their health care, and this connectivity is enabled by rapid improvements in technology – for instance, through the immediate availability of credible information in the palm of our hands,” she suggests. “The patient can provide access to knowledge that no one else does.” To learn more, register for our DIA EuroMeeting 2017 in Glasgow!

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BfArM President: Real-World Data & Randomized Trials “Compatible, Complementary Tools”

February 10, 2017

Early access, real-world evidence and data generation, and Brexit are just a few of the high-level challenges facing European health care and regulatory systems. DIA’s EuroMeeting 2017 will discuss ways to approach these challenges in forums such as Major European Regulatory Science Challenges, which will be co-chaired by Dr. Karl Broich, President, Federal Institute for Drugs and Medical Devices in Germany (BfArM). “You will learn about early access to innovative products, that we have all our regulatory tools available. However, you will see as well that we have to improve our methodology and find ways into real-world evidence in addition to our usual randomized, controlled trials,” explains Dr. Broich. “They will complement each other in future clinical development plans, particularly if we are discussing early access for patients.” To learn more, register for our DIA EuroMeeting 2017 in Glasgow!

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