Nigel Hughes is the Scientific Director of Real World Evidence at Janssen Clinical Innovation. He collaborates with the EFPIA Digital Strategic Governing Group, and he is also co-lead of Big Data for Better Outcome’s €30 million flagship consortium, the European Health Data & Evidence Network, or EHDEN. Janssen and Nigel have long been at the forefront of developing the needed tools and infrastructure to harness health data, both through their involvement with previous IMI projects such as EMIF and EHR4CR, as well as supporting open source data sharing platforms such as OMOP and OHDSI.

Nigel brings his decades of experience in nursing and directing NGOs in AIDS and Hepatitis C to IMI's EHDEN. His unique perspective on the need for global collaboration to address societal challenges like Alzheimer's disease is well-reasoned and refreshing in today's fractured and divisive political climate.

Nigel Hughes is the Scientific Director of Real World Evidence at Janssen Clinical Innovation. He collaborates with the EFPIA Digital Strategic Governing Group, and he is also co-lead of Big Data for Better Outcome’s €30 million flagship consortium, the European Health Data & Evidence Network, or EHDEN. Janssen and Nigel have long been at the forefront of developing the needed tools and infrastructure to harness health data, both through their involvement with previous IMI projects such as EMIF and EHR4CR, as well as supporting open source data sharing platforms such as OMOP and OHDSI. Nigel brings his decades of experience in nursing and directing NGOs in AIDS and Hepatitis C to IMI's EHDEN. His unique perspective on the need for global collaboration to address societal challenges like Alzheimer's disease is well-reasoned and refreshing in today's fractured and divisive political climate.

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess, Managing Director of Vital Tran…

Vital Health Podcast

Nigel Hughes is the Scientific Director of Real W…

Nigel Hughes, on a quest to find big data's garden of EHDEN.

John LaMattina was President of Pfizer Global Research and Development and ran an international team of over 13,000 scientists and professionals. He has authored several books, including the highly acclaimed Pharma and Profits – Balancing Innovation, Medicine, and Drug Prices. He is also a senior partner at PureTech Health and a contributor to Forbes.

Last year, when John was a guest on the Vital Health Podcast, the potential impacts of the Inflation Reduction Act (IRA) were still theoretical. But one year on, the Centers for Medicare and Medicaid Services (CMS) released their prices for drug negotiations, and the impacts of the IRA have now become real. John discusses how the IRA will impact the development of critically needed new therapies and provides his insights into the Biden Administration’s recent threats to use march-in rights to confiscate intellectual property as a way to control the price of drugs. 

John LaMattina was President of Pfizer Global Research and Development and ran an international team of over 13,000 scientists and professionals. He has authored several books, including the highly acclaimed Pharma and Profits – Balancing Innovation, Medicine, and Drug Prices. He is also a senior partner at PureTech Health and a contributor to Forbes.
Last year, when John was a guest on the Vital Health Podcast, the potential impacts of the Inflation Reduction Act (IRA) were still theoretical. But one year on, the Centers for Medicare and Medicaid Services (CMS) released their prices for drug negotiations, and the impacts of the IRA have now become real. John discusses how the IRA will impact the development of critically needed new therapies and provides his insights into the Biden Administration’s recent threats to use march-in rights to confiscate intellectual property as a way to control the price of drugs.

John LaMattina – Drug Price Controls and IP Attacks Get Real

This podcast features Kate Hudson, the Associate Vice President and Counsel for Policy at the Association of American Universities, and Joseph P. Allen, the Executive Director of the Bayh-Dole Coalition. They discuss the unintended consequences that the Biden Administration’s Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights in the Bayh-Dole Act is having on small companies and VCs inside and outside of the biopharmaceutical sector. 

As well, they detail how well-funded advocacy groups had promoted the use of march-in rights as an effective tool for price controls, and were mistaken in this belief. Kate and Joe also describe a new strategy being pressure tested in DC, promoting the expansion of the application of march-in rights to IP created by the private sector.

This podcast features Kate Hudson, the Associate Vice President and Counsel for Policy at the Association of American Universities, and Joseph P. Allen, the Executive Director of the Bayh-Dole Coalition. They discuss the unintended consequences that the Biden Administration’s Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights in the Bayh-Dole Act is having on small companies and VCs inside and outside of the biopharmaceutical sector.    As well, they detail how well-funded advocacy groups had promoted the use of march-in rights as an effective tool for price controls, and were mistaken in this belief. Kate and Joe also describe a new strategy being pressure tested in DC, promoting the expansion of the application of march-in rights to IP created by the private sector.

Kate Hudson & Joseph P. Allen – The Fact Free Attacks on IP

On December 8, 2023, The Biden Administration under the National Institute of Standards and Technology (“NIST”) released a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights in the Bayh-Dole Act. VT’s Grumpy Old Men are back to discuss what this means to R&D.

Vital Transformation released our report, March-in rights under the Bayh-Dole Act & NIH contributions to pharmaceutical patents one week before the Biden Administration released its guidance. We found that of the 363 novel therapies we’ve investigated over the last ten years, only 5 had mechanism of action and composition of matter patents where all had government interest statements. 

On December 8, 2023, The Biden Administration under the National Institute of Standards and Technology (“NIST”) released a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights in the Bayh-Dole Act. VT’s Grumpy Old Men are back to discuss what this means to R&amp;D.
Vital Transformation released our report, <a href="https://vitaltransformation.com/2023/11/march-in-rights-under-the-bayh-dole-act-nih-contributions-to-pharmaceutical-patents/">March-in rights under the Bayh-Dole Act &amp; NIH contributions to pharmaceutical patents</a> one week before the Biden Administration released its guidance. We found that of the 363 novel therapies we’ve investigated over the last ten years, only 5 had mechanism of action and composition of matter patents where all had government interest statements.

Nigel Hughes, on a quest to find big data's garden of EHDEN.

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