About Us

Andreas is an accomplished global leader with over 30 years of broad commercial and development experience in Biotech, Pharmaceuticals and Medical Devices. With a background in pharmacy and a PhD in toxicology, he started his professional career in the Regulatory Affairs department of Bayer Healthcare in Germany. After moving to the U.S., he worked in a number of different functions (Regulatory Affairs, Project Management, Lifecycle Management, Portfolio Management and Marketing) with increasing responsibility, particularly focusing on Biotech and rare diseases. In his last role as Vice President Global Strategic Marketing, he was responsible for the Bayer's second largest brand at the time, a recombinant FVIII product with >€1 billion annual revenue. 

After 17 years at Bayer, he further broadened his scope into Medical Devices as Vice President International Marketing at KCI Inc., a global wound-healing company. 

In 2014, he started his own consulting business and established ProDeMaCon based on the experience from his diverse experience in multiple international roles. Over the last 10 years, he has worked with several clients of different sizes (from Top 3 Pharma to small start-ups) from around the world.

David has 40 years of experience in progressive leadership roles in R&D, manufacturing, quality, marketing, sales, customer service and strategic sourcing functions including 20 years with GIBCO, which specializes in providing research reagents and critical raw materials to the pharmaceutical and biotechnology industry, and then 10 years at Amgen as Head of Global Strategic Sourcing, Direct Materials. Responsibilities included partnering with all stakeholders to assure effective supplier selection, management and qualification for critical raw materials supply for Amgen’s global product development and manufacturing operations.

Over the past 6 years, David has been working with a variety of Cell Therapy-based start-up organizations including Celgene, Juno, bluebirdbio, Atara Bio, Allogene, Autolus, and TCR2 Therapeutics to develop and execute strategies to ensure effective material and supplier sourcing, onboarding, and qualification and has successfully supported development and regulatory filing preparation for pivotal trials and commercial Biological License Applications.

David has a BS in Biotechnology from SUNY and an MBA from Canisius College.

Drew is a biochemist and immunologist with 37 years of experience in the biopharmaceutical industry, including 10 years at Bayer Healthcare and 12 years at Amgen Inc. During his career, he has been engaged in the development of innovative medicines for cancer, hemophilia, anemia, osteoporosis, and rheumatoid arthritis. Drew is a proven scientific and business leader with expertise in biochemistry, immunology, cell biology, and pharmacokinetics.  He has extensive experience in the development and licensure of biopharmaceuticals,  and he is a recognized expert in analytical method development,  method qualification/validation, biochemical, biophysical, and biological characterization of biopharmaceutical products, and protein formulation. In addition, he has broad experience with global regulatory filings at all stages of the product lifecycle (INDs, INDAs, etc.), including successful Marketing Applications for 10 biopharmaceutical products (including two biosimilars) and lifecycle management amendments/variations for 6 additional products, including Kogenate (rec. factor VIII), Enbrel, Aranesp, Epogen, Neupogen/Neulasta, Prolia/Xgeva, and two first-in-class cancer medicines. 

Drew has also served as an industry expert for regulatory documents (FDA and EMA), including guidances on monoclonal antibody production and quality control, analytical method development and validation, the application of Quality by Design to biotechnology product development, product specifications, product comparability, and biosimilarity.

Drew was educated at Haverford College (B.S., Chemistry) and Duke University (Ph.D., Biochemistry).  

Among others, ProDeMaCon LLC has special knowledge in: 

• Rare diseases
• Cell Therapy
• Gene Therapy
• Hemophilia and blood coagulation
• Blood and Plasma-Derived Products
• Hematology
• Oncology
• Diabetes & glucose monitoring
• Medical Devices & Combination Products
• Wound healing
• Inflammatory diseases

ProDeMaCon LLC has extensive expertise in:

• Product Launches & Go-to-Market Strategy
• Lifecycle Management
• Project Management
• Raw Material & Supplier management for Cell&Gene, Biotech 
• Business Development
• Pricing & Market Access
• Regulatory Affairs
• Preclinical & Clinical Development
• Biotech CMC
• Emerging Markets
• European Markets

Examples of current and previous client projects can be provided upon request.