Biopharma Consulting

A Roadmap for efficient transition from Development to Commercial-2016 BPI West Conference, Oakland, CA

Improving the success of your academia to industry transfers for autologous cell therapies - 2015 IBC Conference on Cell and Gene Therapy - Alexandria, VA 9/29-10/2

Overcoming challenges in technology transfer of cell therapies - 2015 PDA Annual Meeting, 3/16-3/18, Las Vegas, NV

4-11-2020 - How to Open Our Country Rapidly and Safely

9-20-2019 - Pharmefex and Beck Life Sciences announce creation of strategic collaboration

7-11-2018 - Pharmefex and Jeff Yuen and Associates announce creation of partnership

2-1-2018 - Pharmefex and CDDG announce creation of partnership

10-5-2015 - Bio-process Online article and interview with Dr. Siahpush on Cell Therapy Tech Transfer

A-VAX Application of Quality By Design to Vaccines - 2012

Proposed approach to regulation of cellular and tissue based products

Points to consider in collection, processing and testing of ex-vivo-activated mononuclear leukocytes

Guidance for Industry- Minimally manipulated unrelated allogeneic placental umbilical cord blood for hematopoetic reconstitution

Guidance for Human Somatic Cell Therapy and Gene Therapy

Application of current statutory authorities to human somatic cell therapy products

Guidance for Industry - Potency tests for Cellular and Gene Therapy Products

Guidance for Industry - Demonstrating Biosimilarity to a Reference Protein Product -2012-02

Guidance for Industry - Scientific Considerations in Demonstrating Biosimilarity to a Reference Product - 2012-02

Content and Format of IND for Drugs and Well Characterized Biologics

IND application

ICH Q5D- Guideline for Derivation & Chracterization of cell substrates

ICH Q8- Guidance for Industry on Pharmaceutical Development

ICH Q9- Guidance for Industry Quality Risk Management

ICH Q10- Guidance for Industry Pharmaceutical Quality System

Points to consider in the chracterization of cell lines used to produce biologicals

A-Mab - A Case Study in Risk Based Approach to Bio-process Development

Guidance for Industry - Contract Manufacturing Arrangements for Drugs: Quality Agreements