Industry Experience BioPharmaceutical
Writes for Pink Sheet
Latest From Cole Werble
The Evolving Door? What Having A ‘Big Data’ Commissioner Might Mean For US FDA
Robert Califf’s nomination to return as FDA commissioner will raise protests about a ‘revolving door’ pathway between industry and agency. But, in this case, it may be more apt to talk about how Califf’s time outside FDA led to evolving views on the role of big data in drug regulation.
AAV Vector Consortia Address Quality Assays, Endpoints
Two outside groups aim to help CBER on gene therapy questions from ‘N of one’ to markers for hemophilia.
Patent Thickets And Legislative Logjams
US Senate hearing on pharmaceutical competition brought renewed interest to idea of pruning so-called ‘patent thickets.’ But the choking growth of legislative proposals may itself by hampering progress on Capitol Hill.
Biden Administration Will Back New Health Research Contracting Agency
Upcoming budget proposal likely to include a proposal for funding of a DARPA-like contracting entity. Any focus on innovations and breakthroughs is likely welcome news for industry – though perhaps not the message that government is taking on work that drug companies can’t or won’t do.
COVID Vaccine ‘Miracle’ May Set Unrealistic Expectations For US Supply Chains
The story of the US coronavirus vaccine production ramp-up is putting the drug industry in an extraordinarily favorable public relations position. One downside, however, may be complicating the industry’s message about the limits of ‘Buy American’ efforts on pharmaceutical supply chains overall.
COVID Therapeutics Progress (Or Lack Thereof) May Be Political Vulnerability For US FDA
COVID treatments have not advanced as rapidly or as publicly as vaccines. That may trigger some issues for the US FDA as Congress digs into the next phase of the COVID response – and starts to assess agency performance and leadership after the crisis.