Expert Details

Manufacturing Technologies for Pharmaceuticals, Biologicals, Biotech and Vaccines

ID: 733859 Arizona, USA

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 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).

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Education

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

Work History

Years	Employer	Title	Department
Years: 2015 to Present	Employer: Undisclosed	Title: Consultant	Department: Sole Proprietorship
Responsibilities: - Provide technical, regulatory, validation, training, and marketing guidance to pharmaceutical, medical, vaccine, and biotech drug manufacturers, analytical and process equipment suppliers, - Provide market information to investment firms. - Expert in patent disputes.
Years	Employer	Title	Department
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 (2005-2015) * Senior Vice President, Global Technical Director – Biopharmaceuticals (2000-2005) * Senior Vice President, Marketing (1988-2000) * R&D Manager Biotech (1982-1988) - 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 developing filtration and bioprocess technologies, troubleshooting process and regulatory challenges

Career Accomplishments

Associations / Societies
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

Professional Appointments
United States Pharmacopoiea - Expert Committee Member

Awards / Recognition
BioProcess International Magazine - Thought Leader of the Decade - Biomanufacturing (also finalist in both Upstream and Downstream Processing categories). Parenteral Drug Association, Distinguished Service Award Winner

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 Co-authored multiple best practice guides on Single-use Manufacturing of biologicals Co-author of USP Standard on safety evaluation of plastics for drug/vaccine process 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 - 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

Fields of Expertise

biopharmaceutical, injectable pharmaceutical product