Expert Details

Expert in Manufacturing technologies for Pharmaceuticals, Biologicals, Biotech and Vaccines

Expert ID: 733859 Arizona, USA

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Expert is an independent consultant to bio-pharmaceutical, medical device and vaccine manufacturers, associated equipment suppliers and investors, with over 40 years experience in aseptic process technology, new product and business development, marketing strategy and regulatory compliance for manufacturing of pharmaceuticals and biologicals across the globe. He previously served in several management roles as Sr. V.P. Marketing, Training, Technical Director and Global Scientific Affairs for Pall Life Sciences (1978-2015) and as 3-term Chairman of the Bio-Process Systems Alliance (BPSA, 2007-2015), a 50+ corporate member trade association of biotech drug manufacturing equipment suppliers and users. While at BPSA, he spearheaded industry best practices for bio-manufacturing technologies and in 2012 was honored as Thought Leader of the Decade by BioProcess International Magazine for his contributions to the biotech industry. He has co-authored several industry technical guides and standards on sterilizing filtration, aseptic processing and bio-manufacturing from PDA, ISPE, ASTM, ISO and USP. He holds an M.Sc. in Microbiology from the University of Toronto (Canada).


Education

Year Degree Subject Institution
Year: 1980 Degree: M.Sc. Subject: Microbiology Institution: University of Toronto

Work History

Years Employer Title Department Responsibilities
Years: 2015 to 2017 Employer: Self Employed Title: Consultant Department: Responsibilities: - Provide technical, regulatory, validation, training and marketing guidance to pharmaceutical, medical, vaccine and
biotech drug manufacturers, analytical and process equipment suppliers, investment and law firms.
- Pharmaceutical and Life Sciences Consultant to PMMI, The Association of Packaging and Processing Technologies
- Expert contributor to United States Pharmacopoeia and ASTM Int’l Pharmaceutical Standards Committees
Years: 1978 to 2015 Employer: PALL CORPORATION Title: Sr VP Global Scientific Affairs, Marketing Department: BioPharma/Life Sciences Responsibilities: * Senior Vice President, Global Scientific Affairs – Biopharmaceuticals, Pall Life Sciences Group (8/05 – 07/15)
* Senior Vice President, Global Technical Director – Biopharmaceuticals (8/00 – 8/05)
- Strategic marketing for $1B division supplying pharmaceutical and biotech drug manufacturing technologies.
- Corporate spokesperson to biopharma customers, regulators, industry groups, media and financial analysts.
- Coordinated technical communications programs with >120 conference presentations and >25 publications per year.
- Dean of global technology learning – corporate, customer and regulatory agency training programs.
- Developed and mentored global $6M/yr laboratory/consulting services program for customers and internal R&D/QC
- Extensive experience troubleshooting process and regulatory challenges

Career Accomplishments

Associations / Societies
Parenteral Drug Association, Distinguished Service Award Winner, Chair 1999 Annual Meeting, Co-other of multiple Technical Report guides on Aseptic Processing, Sterile Filtration of Liquids and Gases, Virus Removal, Mycoplasma Removal
Bio-Process System Alliance, Trade Association Chairman - 3 terms, Chair of Technical Communications Committee - Co-authored multiple best practice guides on Single-use Manufacturing of biologicals
Professional Appointments
United States Pharmacopoiea - Expert Committee Member - Plastics used in Pharmaceutical Manufacturing - Co-author of USP Standard on safety evaluation of plastics for drug/vaccine process equipment
Awards / Recognition
BioProcess International Magazine - Thought Leader of the Decade
Publications and Patents Summary
2 issued patents on filter devices used in in vitro diagnostics and purification
Over 100 published papers on aseptic processing, filtration, single-use equipment
Details available upon request.

Additional Experience

Expert Witness Experience
One Patent Infringement/Invalidation case (settled after my deposition).
Marketing Experience
30 yrs in Product Management, Technical Communications, Global Market Strategy, Regulatory Liaison for Pall Corp - In vitro diagnostic and biopharma/vaccine filters and fluid handling equipment
Contributed to sales revenue growth from $15 million to ~$1 billion p.a.

Language Skills

Language Proficiency
English Native Speaker, Extensive Public Speaking and Writing

Fields of Expertise

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