FiercePharma reported (link to the news below) that FDA veteran Janet Woodcock will take over as commissioner at least temporarily. President Biden tapped Dr. Woodcock as interim FDA commissioner.
There is some speculation that Dr. Woodcock could become the next commissioner – and this makes me feel more bullish on the pace of innovation of biotech because her reputation is such that she is very pro-innovation – based on her achievements so far:
ONCOLOGY REVIEW BECAME EXTREMELY EFFICIENT AND FAST UNDER HER LEADERSHIP AS HEAD OF CDER (CENTER OF DRUG EVALUATION AND RESEARCH)
She was critical to the current efficient review process in oncology. Oncology is one of the fastest path to approval right now. There are factors that are more specific to oncology, such as very hard endpoint that is not subject to interpretation (like survival), but there has been a lot of regulatory innovation as well specifically for oncology, including
Real-Time Oncology Review (RTOR): FDA allows submission of data before completion of BLA filings for drugs that address very high unmet need in oncology.
Faster review timeline: during covid19, oncology was pretty the only therapeutic area that saw approvals that came earlier than PDUFA date (legally mandated date by which FDA is required to deliver its decision).
SHE IS ALSO INDUSTRY-FRIENDLY IN TERMS OF PROVIDING THE RIGHT FEEDBACK
As a hedge fund analyst, I met many management teams and in many closed door meetings, management teams have always been highly laudatory of Dr. Woodcock. FDA can be seen as blackbox and has been blackbox, but many management teams saw Dr. Woodcock to be very refreshing – she has reputation of being clear and responsive so that companies have clear guideline to get the drug across the finish line and this can help patients’ lives. It is generally known that she gives clarity and responsiveness to industry because she is passionate about helping patients.
This is very different from what I heard about opioid / pain management segment of the FDA – management teams say the communication is poor and there are a lot of surprises in that division – this further delays the pace of innovation.
As a biotech investor, I am very excited about potential acceleration of innovation on the regulatory side because even if there is advance in science, pharmaceutical industry is heavily dependent on regulators at the FDA to bring those innovation to the market. I hope Dr. Woodcock would be a commission so that she can bring her passion for rapid pace of innovation across the entire organization with her strong leadership!
What do you think about potential appointment of Dr. Woodcock?
