Steritech Solutions LLC, Middletown, NJ

 

Pharmaceutical Consultant and Principal April 2011 –

Extensive experience in formulation development, clinical manufacturing and drug delivery systems. Sterile Product Subject Matter Expert and Former Head, Sterile Product Formulation Development at Roche, Nutley. Peptide/Protein formulation expert. Substantial GMP, FDA R&D and manufacturing experience. CMC Technical Leader. Advise pharma, legal and investment firms. Consultant in thirteen litigation cases and Expert Witness. Consultant/Writer for Criticality Analyses of development and marketed drug product.

 

• Formulation Development • Technology Transfer• Drug Development • Excipient/Package Selection • Sterile Products

• Injection Devices• Drug Delivery• Solubilization • Aseptic Processing  • Criticality Analysis • Sustained Release Parenteral • Common Technical Document • Clinical Manufacturing • ICH Q 8, 9 and 10 • Development Pharmaceutics • Patent Infringement/Validity • Excipients • Claim Construction • IND/NDA • Inter Partes Patent Review• Expert Reports • Testimony in Patent Litigation

Consultation to legal firms in patent litigation for formulation development (injectable, and oral), primary packaging, preformulation and analytics. Expertise provided in ten cases. Twenty-two Expert Declarations/Reports issued, Deposed four times. Expert Witness at one trial and one Markman Hearing.

 

Hoffmann - La Roche Inc., Nutley, NJ

 

Research Director, Global Head Sterile Product Formulation (2009-2011)

Led sterile formulations group (15 scientists and technicians), including GLP and GMP manufacturing and peptide delivery efforts. Evaluated drug delivery systems and devices for investigational and marketed products. Managed international technology transfer, harmonization processes and clinical manufacturing outsourcing for sterile clinical products.

 

Research Director – Sterile Product Formulation & Clinical Mfg. (2000-2009)

Led sterile formulations and package research group, including GLP and GMP manufacturing. Evaluated drug delivery systems and devices for investigational and marketed products. Managed international technology transfer, harmonization processes and clinical manufacturing outsourcing for sterile clinical products.

 

Director - Clinical Manufacturing (1995-2000)

Led clinical manufacturing and packaging group for all Roche US clinical supplies, sterile and oral dosage forms. Evaluated drug delivery systems and devices for investigational and marketed products. Founded and led Drug Discovery Support Group. Served as CMC Leader for 3 development programs. Responsible for departmental compliance.

 

Research Leader – Formulation and Toxicology Supply (1994)

Led aerosol, liquid and semisolid dosage form development Directed the manufacture of all clinical trial materials and drug delivery research. Led preformulation group.
 

Research Investigator – Formulation Development (1992-1993)

Directed development of all injectable products. Supervised clinical trial materials production.  Implemented CGMP's and coordinated SOP generation for the clinical materials department in Nutley. Managed the aerosol, liquid and semisolid dosage form development groups and drug delivery coordination effort. Led preformulation group

 

Associate Research Investigator – Formulation (1989-1992)

Directed a formulation research and development group that developed injectable dosage forms, oral dosage forms and drug delivery systems.

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Schering-Plough Inc. Kenilworth, NJ
 

Senior Scientist – Animal Health Formulation (1987-1989)
Developed animal health dosage forms and manufactured of clinical supplies.  Successfully developed poorly soluble drug in high concentration injectable dosage form. Additional experience was acquired with liquid/semi-solid manufacturing equipment from bench scale through production.

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Scientist – Animal Health Formulation (1985-1987)  

Developed animal health dosage forms and manufactured clinical supplies. Projects included sustained release injectable formulations and a semi-solid otic product.  Successfully developed semi-solid product from inception through NADA submission and approval. 

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Hoffmann - La Roche Inc., Nutley, NJ

 

Associate Scientist – Parenteral Formulation (1981 -1985)

Developed injectable dosage forms. Successfully reformulated major product in LVP dosage form.  Additional experience was gained in oral dosage form development.  Successfully reformulated major product to improve oral bioavailability.  Special projects included SEG capsule formulation and solubilization of oil soluble vitamins.

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American Cyanamid Co., Pearl River, New York

 

Clinical Materials Pharmacist 1980-1981

Supervised Clinical Trial Materials Production.  Implemented CGMP's and Coordinated SOP generation for the Clinical Materials Department.

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