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Biopharma Consulting

News and Publications

Publications & Presentations

1.

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

2.

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

3.

Overcoming challenges in technology transfer for cell therapies - 2015 PDA Annual Meeting, 3/26-3/18, Las Vegas, NV

News

1.

6-24-2020 - Linda Barnes and Ali Siahpush Join ImmuID's Executive Board to help America get Back to Work.

2.

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

3.

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

4.

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

5.

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

Guidance Documents

Cell And Gene Therapy

1.

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

2.

Proposed approach to regulation of cellular and tissue based products

3.

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

4.

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

5.

Guidance for Human Somatic Cell Therapy and Gene Therapy

6.

Application of current statutory authorities to human somatic cell therapy products

7.

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

BioSimilars

1.

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

2.

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

Recombinant Proteins & Biologics

1.

Content and Format of IND for Drugs and Well Characterized Biologics

2.

IND application

3.

ICH Q5D - Guideline for Derivation and Characterization of Cell Substrates

4.

ICH Q8- Guidance for Industry on Pharmaceutical Development

5.

ICH Q9- Guidance for Industry Quality Risk Management

6.

ICH Q10- Guidance for Industry Pharmaceutical Quality System

7.

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

8.

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

General Documents

1.

Process Validation General Principles and Practices - Life Cycle Approach to Validation

2.

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

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