Dr. George Pierce PhD

Dr. George Pierce has over 40 years of experience related to the production, recovery, purification and stabilization of proteins in translational applied microbiology and biotechnology, with particular emphasis on development, process research and scale-up, of regulated products (pharmaceutical and food-grade).  

During the past five years his focus has been in two main areas: The development of practical enzyme-based catalyst platforms for food grade applications, and pure enzyme formulations for pharmaceutical applications.  This work has resulted in 8 issued US Patents and over a dozen applications in process.  He is the Director of the Fermentation Scale-up and Process Research Center at Georgia State University.

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Education
Rensselaer Polytechnic Institute, Troy, NY. Post-Doctoral Fellow, 1976-1977 Microbiology
Rensselaer Polytechnic Institute, Troy, NY. Ph.D. 1976 Microbiology
Rensselaer Polytechnic Institute, Troy, NY.  B.S. 1969 Biology

Dr. Pierce has held many elected offices, positions and honors in the field of applied and environmental microbiology:

  • 2007-2013    Member Department of Biology Executive Committee
  • 2007-2009 and 2012-2014. Member, College of Arts and Sciences Executive Committee
  • 2002-2007  Chairman, Homeland Security Committee, Georgia State University
  • 2003-2006   Chairman, University Oversight Committee on Laboratory Safety, Compliance, and Training
  • 2000-present   Professor, Department of Biology Georgia State University
  • 2000-present   Graduate Director; Applied & Environmental Microbiology
  • 1990-2000   Manager Technology Development and Engineering, American Cyanamid /Cytec
  • 1988-1990   Director of Research & Development, Celgene Corp
  • Charles Porter Award from the Society for Industrial Microbiology for contributions to the Society and to industrial microbiology (1995)
  • Co-Chairman 1995 Annual Meeting, Society for Industrial Microbiology
  • Editor-in-Chief, Journal of Industrial Microbiology (1985-1993)
  • Chairman, EPA Sub-Committee on Pollution Prevention (1992)
  • U.S. National Delegate, International Union of Microbiological Societies (1985 – 1998)
  • Member U.S. Dept. of Commerce Committee on Biotechnology (1991 – 2000)
  • Director, Society for Industrial Microbiology (1982 – 1985)
  • Reviewer for Applied and Microbial Biotechnology (2001 –2004)

     

Dr. Pierce has an in-depth knowledge of metabolism and extensive experience in the optimization of industrial fermentations. While working for a chemical manufacturing company Dr. Pierce developed a biological process to degrade pollutants in wastewater.  This process led to the isolation of the R. Rhodochrous 96253, and the realization of its catalytic potential.

Elizabeth Fuller JD

Elizabeth Fuller, JD is a senior biotech/pharma executive and attorney with significant private and public sector experience in advising CEOs, investors, and boards of directors on key issues related to intellectual property, global strategic development and pharmaceutical regulation (biologic and small molecule) and pharmaceutical distribution. Fuller has particular experience in the development and authorization of biosimilars, orphan medicinal products and vaccines and data and marketing exclusivity in Europe and the US. Finally, she has worked on complex international technology licensing and development agreements in the pharmaceutical sector. Fuller has extensive experience working successfully with the EMA and the FDA.

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Fuller has been an attorney licensed in the State of NY since 1985. Her first legal work at Proskauer Rose and Morgan Lewis & Bockius was in corporate law. Fuller began to work in pharmaceutical development when she moved to Switzerland in 1994.

Fuller’s experience is international. A dual (Swiss/US) national, Fuller lived in Europe for 20 years. While in Geneva, she worked for 9 years as GC of Triskel Integrated Services, SA, a boutique biotech consultancy, and at WHO, both for the Global Programme on Vaccination and the Polio Eradication Initiative (where she was responsible for all legal work in the development of an inactivated polio vaccine based on the Sabin strain) for a total of 6 years. Fuller was an Equity Partner in Life Sciences at Bird & Bird in Lyon and in London. She returned to a US in late 2014 to manage and wind up several family businesses and estates after the death of family members. Having completed that work, Fuller is eager to return to Switzerland or the EU and to work in international life sciences. Due to her Swiss passport, Fuller has the right to live and work in all EU countries.

Fuller’s background includes compliance and regulatory affairs, IP licensing, contract negotiation, mergers and acquisitions, divestitures, drug registration and distribution. She has significant experience in ensuring that development plans for biologics are genuinely global, thereby saving clients from expensive duplication of effort and wasted patent life. Fuller has significant experience in biosimilars, medical devices, orphan medicinal products and vaccines.

Fuller can advise clients on all legal aspects of international pharmaceutical and biotech development including:

  • Contract negotiations and lobbying
  • Strategic planning for commercial development
  • Compliance and regulatory affairs in the US and Europe
  • Drug development and registration
  • Pharmaceutical pricing and reimbursement in various countries in Europe.
  • Use of data, market, paediatric and orphan exclusivity to increase value of IP in licensing and also to lengthen the life cycle of pharmaceuticals
  • Investor and board relations
  • Mergers, acquisitions, and divestiture

 

From September of 2017 through January 2019, Fuller worked exclusively for CEPI, negotiating and finalizing vaccine development agreements with industry for vaccines against diseases with epidemic or pandemic potential, specifically Lassa, MERS and Nipah. These agreements with companies included significant IP provisions, which were complicated due to prior US government research grant requirements under which these companies operated. Fuller also negotiated and closed vaccine platform development agreements with universities to ensure rapid development and deployment in the event of outbreaks. This was all done in accordance with the requirements of CEPI’s donors, including governments and large foundations.

Since April of 2019, Fuller has been GC of a startup biotech in the US.