Expert in Manufacturing technologies for Pharmaceuticals, Biologicals, Biotech and Vaccines
Expert ID: 733859 Arizona, USA
|Year: 1980||Degree: M.Sc.||Subject: Microbiology||Institution: University of Toronto|
|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
|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
|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.
|Expert Witness Experience|
|One Patent Infringement/Invalidation case (settled after my deposition).|
|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.
|English||Native Speaker, Extensive Public Speaking and Writing|