Mark Backer

About Mark Backer

Experienced, versatile executive with deep expertise and a record of success in developing biological products from applied research through licensure (7 approved products over 25+ years). Currently managing Alava Biopharm Partners, a consulting firm providing CMC, Regulatory and Nonclinical Development consulting for biologicals and small molecules. Check our website at technical experience in cell culture and fermentation, process development, scaleup and tech transfer, management of outsourced development and manufacturing.Business experience as a CEO, board member and advisor to biotech firms and investors.Industry advisor to Stanford Medical School SPARK programProducts:• 13 years vaccine development and manufacturing experience • Antibodies and recombinant proteins • Cell and gene therapies

Experience

1. Advisor to Stanford High Impact Technology (Hit) Fund

   Stanford Office Of Technology Licensing Otl

   Apr 2025 — Present

Education

• University of Washington

  Ph.D, Chemical Engineering

  1980 — 1985

• Stanford University

  B.S., Chemistry

  1974 — 1978

Skills

• U.s. Food and Drug Administration (Fda)
• Manufacturing
• Assay Development
• Drug Discovery
• Due Diligence
• Tecombinant Dna Technology
• Regulatory Affairs
• Purification
• Cell Culture
• Gene Therapy
• Formulation
• Technology Transfer
• Gmp
• Business Planning
• Life Sciences
• Venture Financing
• Biotechnology
• Stem Cells
• Pharmaceutical Industry
• Fda
• Outsourcing Management
• Drug Development
• Biopharmaceuticals
• Antibodies
• Vaccines
• Strategy
• Quality Management
• Cell Therapy
• Analytical Methods Development
• Pharmaceutical Process Development
• Cmc