My Biography

I have a B.S. in Biology and a B.A. in Chemistry both from the University of California - Irvine.  I have a Ph.D. in Chemistry from the University of Oregon.  I will not mention the micro-gravity toilets or the nasal delivery of insulin on which I worked before moving to Genentech, Inc. in 1991.

I have worked in the pharmaceutical industry for 30 years. My experience is broad and deep in pharmaceutical development and wide in a range of drug delivery technologies.  My knowledge in pharmaceutical development spans:

   basic formulation development

      designing stability studies and evaluating results

      knowledge of mechanisms of degradation

      surfactant analysis and stability

   lyophilization cycle development

   freeze/thaw stability

      drug substance

      analytical reference standards for bioassays

      purification unit operation pools used for batch testing at a later time

   face-to-face discussions with FDA CMC reviewers and panels/workshops at WCBP

   development and evaluation of pre-filled syringes (including silicone free)

   pH and excipient concentration changes after UFDF

   buffer and pH analysis

   troubleshooting and resolution of operational deviations

      occurance of particulates in DP

       foreign material introduction in DS and DP

      hold step discrepencies

       temperature excursions during storage and shipping of DS and DP

I was the director of Pharmaceutical R&D at Genentech for ~5 years during which I was responsible for: protein pharmaceutical development, process engineering, drug delivery and small molecule formulation development.  Although I loved being director, I eventually decided to step down and return to the science of proteins and formulation development.  In my post-directorship position, I solved instability issues in the frozen state of large scale (and sometimes small scale) both at -20C and even -70C, started a molecular dynamics program to study protein motions in silico to predict chemical stability and viscosity at high protein concentrations, wrote several computer programs which predict the pH shift and changes in excipient concentrations after UFDF and created buffer recipes taking into account ionic strength non-ideality.  In addition, I led a company-wide evaluation of technologies to deliver proteins/drugs to the vitreous humor of the eye, and was the divisional (analytical, purification, cell culture, pharmaceutical) point person for evaluating new drug entities and technologies offered by other outside entities.  Other than all that, I don't know very much.

Lastly, and for full disclosure, my services do not include review of SOPs or manufacturing tickets with the exception of reviewing calculations, suitability of equipment and methods that are used therein.  I am also quite candid and speak up when I believe I have something of value to contribute.  My opinions, based on science and my experience, have at times been “unwelcomed” when they are in conflict with the organization's view seeking my advice.  However, I can take that challenge and push so the best decision will be made to the benefit of the company.

I am more than happy to answer any questions about my experience and background and whether I can help solve any problem a biotech company might run into. 

Aloha,  tom