Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Blacher, Russ, BS
Business Name Biopharmaceutical Development Consulting
Business Address P.O. Box 20215
Castro Valley, CA 94546
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  • Independent Review of Program Data
    • Identification of a Suitable Development Molecule
    • Fill in Development Gaps and Plan Forward
  •     Selection and Management of Peptide or Protein R&D Drug Manufacturing
    •        Research or Clinical Drug Substance (API)
    •        Formulated Clinical Drug Product
      •        Synthetic and Biosynthetic Methods (Bacterial, Insect cell, Mammalian cell expression) 
  •     Compound Specific Analytical Methods Development (Stability or Function Indicating)
    •        Expertise in All Current State-of-the-Art Analytical Peptide & Protein Methods:
      •        HPLC, PAGE, Western Blot, IEF, Peptide Mapping, Mass Spectrometry, LC-MS, CE 
  •     Pre-Formulation, Clinical Formulation and Sustained Release Development
  •     Design & Development of Research Reagents and Multifunctional Antibodies
    •     Compound Detection or Quantitation (Western Blot or ELISA) or Activity Neutralization 
  •     Development of Clinical Assays for Detection of Drug in Animal/Human Serum
    •      ELISA or LC-MS Methods
  •     Tech Transfer of Methods to GMP Contract Laboratories
  •      Guidance on Setting Appropriate Specifications for Drug Substance and Drug Product 
  •     Design and Implementation of ICH Stability Studies for Drug Substance (API) and Drug Product 
  •     Establish Drug Development Reports and History 
  •     Write and Review CMC Section for Regulatory Filings
    •      Participate in Meetings with FDA to Discuss or Defend CMC Topics
    •      Annual CMC Updates of Open INDs 
  •     Support Business Development Activities
    •      In-Licensing: Program and Data Review
    •      Out-Licensing: Preparation of Due Diligence Documentation of Product Development Activities

Russ Blacher has more than 25 years of experience in the pharmaceutical and biotechnology industry with a proven track record of transforming novel academic research discoveries into viable drug candidates leading to clinical trials in the U.S., Canada and Europe and five currently marketed biological pharmaceuticals.  Mr. Blacher most recently served as Senior Director, Biopharmaceutical Development at MDS Pharma Services and has held R & D positions with large pharmaceutical, start-up and established biotechnology companies including Hoffmann-La Roche, Chiron, Abgenix, Acologix and others.  He is current in Good Manufacturing Practices (cGMP) and has published more than 50 peer reviewed scientific papers, book chapters and patents.

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