My industry-focused career began at Genentech; here is some of the work I did there.
- Developed a novel transient expression system that shortened the production time of recombinant proteins from three months to one week.
- Led group efforts to produce over 20 recombinant proteins and redesigned the prototype expression vector that led to up to 1,000-fold increased yield of recombinant protein.
- Developed a novel, patented scheme for the production of insulin variants that have formed the basis of all insulin gene therapy.
- Played a key role in the development of the following therapeutics: Kogenate, Activase, Herceptin, Xolair, and Raptiva.
My work in Regulatory CMC began at Genentech and continues to this day. I have more than 25 years of experience in the pharmaceutical industry. My expertise lies in developing, manufacturing, and delivering therapeutic modalities to market. I have a strong history of leading initiatives that lower costs and increase profits for targeted biologics, including ATMP products such as gene therapies (viral and non-viral) and cell therapies (autologous and allogenic), including iPSC-derived therapies. I have a proven track record of identifying innovative solutions to regulatory issues and collaborating with the FDA and EMA. I have played a significant role in the development of five FDA/EMA-approved drugs.
My work in cell and gene therapy has focused on manufacturing (CMC) and regulatory aspects, particularly for gene therapies delivered via vectors such as adeno-associated virus (AAV).
In this context, my responsibilities include keeping up with the constantly evolving guidelines from the FDA, MHRA, and EMA programs aimed at expediting the approval of cell and gene therapies with a focus on viral vector safety as required by CBER.
As a result of staying current with these guidelines, my AAV gene therapy projects have ranged from advising early-stage companies seeking to streamline AAV production for orphan drug therapies to late-stage companies advancing to approval.
And I learned the hard way that it’s important to conduct due diligence when looking for a CDMO to manufacture the AAV: what is their expertise and track record? Do you have access to all the raw data?