IPQ’s Publicly Available Pandemic-Related Coverage

Recent Technology and Partnership Advances Made Possible Precision and Speed of Vaccine Response to Pandemic, NIAID’s Graham Stresses at CASSS WCBP Conference

The precision and speed of COVID-19 vaccine development was made possible by recent R&D advancements and a strengthened network of public-private partnerships, NIH National Institute for Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VCR) Deputy Director Barney Graham affirmed in his keynote presentation at the opening session of the CASSS Well-Characterized Biotechnology Products (WCBP) conference in late January.

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CBER Director Marks Traverses the Complex COVID-19 Vaccine/Therapy Regulatory Landscape at FDLI’s Annual Conference

Last week, IPQ released a story on the difficult terrain that regulators have to navigate with industry to reach the goal of getting effective vaccines and therapies for COVID-19 available as efficiently as possible. The story includes the valuable and timely insights on these issues provided at the October FDLI annual conference by FDA Center for Biologics Director Peter Marks.

As was the case with our November 2018 and April/May 2020 Monthly Updates, IPQ has decided to make this story publicly available so that its valuable content can be as helpful as possible in meeting the pandemic challenges.

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● Biogen and Baxter among Pharma Companies Investing More in Disaster Preparation
● FDA Rises to the Emergency Response Challenge
● Natural, Societal, and Political Drivers Are Putting Supply Chains at Risk
● Expert Panel Discusses Impact of Hurricane Maria

Click the download button for the full November 2018 special report on the increasing industry and regulator engagement with preparing for and managing emergencies like the current pandemic, which also addresses the climatic, epidemiological, demographic, economic, and political megatrends driving them.

COVID-19 Vaccine Urgency Throws Spotlight on Next-Generation
Sequencing for Virus Control

● Sanofi Pasteur and Ghent University Experience with NGS
● A Decade of Regulator/Industry Collaboration on NGS
● Stakeholder Engagement Begins on ICH Q5A Revision
● Effort to Reduce Animal Testing for Vaccines Includes Global Health Fund Support for NGS

NIIMBL Progress Includes Partnership with Biophorum on Buffer
Mixing and Global Health Fund with Gates Foundation

Click the download button for the full April/May 2020 issue on the collaborative efforts now going on globally to advance the use of in vitro testing in assessing and controlling adventitious viruses for vaccines and biotherapeutics – and to unleash the potential of next-generation sequencing (NGS) in particular. Included is a review of the contributions being made to solving some of the pressing biomanufacturing challenges by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), and the NIIMBL/Gates Foundation collaboration, the Global Health Fund.

Keeping the global communication channels open is not an easy task in the face of the obstacles the pandemic is putting in the way, but a critical one in facilitating the collaboration needed to address it, and IPQ is doing all it can to help. Subscription fees are an important component of the resources we need to support us in this mission, and we invite companies and organizations to join us “Inside the Global Regulatory Dialogue.” Just contact Jonathan Trethowan (Jonathan@IPQ.org) who will inform you about our reduced fees for new subscribers that will make it easy for you to get to know the work we do and the contribution we make. And our special thanks to the IPQ supporters who have been making it possible for us to do this kind of resource-intensive journalism.