Mark Backer

Mark Backer Email and Phone Number

General Manager at Alava Biopharm Partners @ Stanford University School of Medicine
Mark Backer's Location
San Mateo, California, United States, United States
Mark Backer's Contact Details

Mark Backer personal email

n/a
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 www.alavabp.com!Core 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

Mark Backer's Current Company Details
Stanford University School of Medicine

Stanford University School Of Medicine

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General Manager at Alava Biopharm Partners
Mark Backer Work Experience Details
  • Alava Biopharm Partners
    General Manager
    Alava Biopharm Partners 2013 - Present
    The team at Alava Biopharm Partners LLC provides consulting and contracting services for product developers and investors. In 2014, Alava expanded from its initial focus on CMC activities, adding Regulatory Affairs and Nonclinical Development consulting. Please check our website and team members at www.alavabp.com!
  • Stanford University School Of Medicine
    Industry Advisor To Spark Program
    Stanford University School Of Medicine 2010 - Present
    Palo Alto, Ca, Us
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  • Jennerex Biotherapeutics
    Sr. Vp, Technical Operations
    Jennerex Biotherapeutics 2010 - 2012
    Responsible for CMC activities including Technical Development, Manufacturing and Quality functions.
  • Vaxart, Inc.
    Ceo
    Vaxart, Inc. 2006 - 2009
    Developing oral vaccine products based on a nonreplicating vector and novel adjuvant. Raised Series A financing. Formerly known as West Coast Biologicals.
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  • Molecular Medicine Bioservices
    Chairman
    Molecular Medicine Bioservices Sep 2001 - May 2007
    Us
    Founding Chairman, 2001-04. Board member through May, 2007. Company was purchased by Sigma (SAFC Pharma). The company provides contract manufacturing and filling services for viral-based vectors and vaccines.
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  • Pdl Biopharma
    Vice President, Technical Development
    Pdl Biopharma 2001 - 2005
    Us
    Developed a portfolio of antibodies for cancer and autoimmune diseases. Led over 100 staff including process, analytical and formulation development teams, and engineering/production support group.
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  • Aviron (Now Medimmune Vaccines)
    Sr. Director, Process Development
    Aviron (Now Medimmune Vaccines) 1997 - 2001
    Gaithersburg, Maryland, Us
    Led process/formulation development and commercial production support teams through filing of FluMist BLA, development of refrigerator-stable FluMist format currently on market, and clinical manufacturing through Phase II.
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  • Coulter Pharmaceutical
    Director, Development
    Coulter Pharmaceutical 1995 - 1997
    Directed outsourced development and production activities, including overseas antibody manufacture at 10kL scale. Acquired by Corixa and then GSK.
  • Systemix, Inc.
    Director, Product Development
    Systemix, Inc. 1991 - 1995
    Pioneering stem cell technology for hematologic cancers and gene therapy; developed ex vivo culture approach for human stem cells. Acquired by Novartis.
  • Idec Pharmaceuticals
    Director, Manufacturing
    Idec Pharmaceuticals 1989 - 1991
    Early stage development and manufacturing of Rituxan, prior to the company's relocation to La Jolla.
  • Eli Lilly
    Senior Biochemical Engineer
    Eli Lilly 1985 - 1989
    Indianapolis, Indiana, Us
    Initiated the company's cell culture development efforts, with operations at 1300-L scale.
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  • Genentech, Inc.
    Production Manager
    Genentech, Inc. 1978 - 1980
    Seventh employee of Genentech. Worked as RA on cloning of insulin and growth hormone, set up pilot plant, and produced the world's first recombinant products at 600-L scale.

Mark Backer Skills

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

Mark Backer Education Details

  • University Of Washington
    University Of Washington
    Chemical Engineering
  • Stanford University
    Stanford University
    Chemistry

Frequently Asked Questions about Mark Backer

What company does Mark Backer work for?

Mark Backer works for Stanford University School Of Medicine

What is Mark Backer's role at the current company?

Mark Backer's current role is General Manager at Alava Biopharm Partners.

What is Mark Backer's email address?

Mark Backer's email address is ba****@****ing.com

What schools did Mark Backer attend?

Mark Backer attended University Of Washington, Stanford University.

What skills is Mark Backer known for?

Mark Backer has skills like Biotechnology, Technology Transfer, Vaccines, Biopharmaceuticals, Cell Culture, Gmp, Manufacturing, Antibodies, Formulation, Purification, Strategy, Life Sciences.

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