Expert Details

Expert in Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery

Expert ID: 729835 New Jersey, USA

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Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems – Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation Research Leadership Team – Four successfully launched peptide/protein products as formulation expert –Technical Team Leader responsible for all technical aspects of a successfully launched product–Extensive international experience-technical liaison with FDA/ EMEA - Lead several external peptide drug delivery collaborations - Evaluated new licensing opportunities as formulation research representative- Implemented successful outsourcing strategy for clinical supplies and formulation research - Managed groups/section from 10 – 45 employees – Over fifteen years experience in-formulation development at all levels – drug discovery support through product launch – key CMC leader for approved antiviral compound – Global Formulation leader for 3 other approved biotech products – specialization in peptide drug delivery and solubilization – lead package research group for qualification of pharmaceutical injectable packaging including extractable and IV infusion compatibility studies – Key leader in international harmonization of formulation development – responsible for GLP and GMP manufacturing facilities for clinical batches utilizing automated equipment, lyophilization and isolation technology for processing of potent compounds - Lead technology transfer effort for sterile products from Nutley to other Roche sites – Personal research in sustained release subcutaneous injection formulations particularly PLGA microspheres and lecithin organogels (patented) -Experience with FDA and EMEA for product approval (CMC package) and Pre-Approval Inspections


Array

Consulted investment firm on the status and potential use of polymers as primary packaging material for prefilled syringes. Related experience in this area, provided expert guidance and regulatory status and current trends including information on vendors.Consulted journal publishing company on ways to communicate technical issues effectively to medical doctors, Business Plan for Web-Based Pharmaceutical KPO Elements of Target Product Profiles in Pharma Development Manufacturing process for sterile pharmaceuticals.

Extensive experience in formulation development, clinical manufacturing and drug delivery systems. Sterile Product Subject Matter Expert and Former Head, Sterile Product Formulation Development and Technology Transfer at Roche, Nutley. Peptide/Protein formulation expert. Leadership role in development of 9 marketed products and Sterile Product Head of Sterile Clinical Manufacturing with 7 successful Pre-Approval Inspections Substantial GMP, FDA R&D and manufacturing experience. Advise pharma, legal and investment firms. Technical Team Leader for several projects over 3 year period.

AREAS OF EXPERTISE

• Formulation Development
• Technology Transfer
• Drug Development
• Excipient/Package Selection
• Sterile Products
• Injection Devices
• Drug Delivery
• Solubilization
• Aseptic Processing
• Critical 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

KEY INDUSTRY ACHIEVEMENTS:
Leadership role in development of 9 marketed products and Sterile Product Subject Matter Expert for Sterile products at Roche Nutley. Global Peptide Delivery Champion. Head of Sterile Clinical Manufacturing with 7 successful Pre-Approval Inspections. Very High success rate for providing clinical batches on time. Extensive FDA interactions and FDA trainer for Biopharmaceutical Formulation and Stability. Leader in international harmonization and Chair International Formulation technology Working Group for Sterile Products. Successful CMC leader.

Expert may consult nationally and internationally, and is also local to the following cities: New York, New York - Yonkers, New York - Newark, New Jersey - Jersey City, New Jersey - Paterson, New Jersey - Elizabeth, New Jersey - Bridgeport, Connecticut - New Haven, Connecticut - Stamford, Connecticut - Philadelphia, Pennsylvania

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Education

Year Degree Subject Institution
Year: 1989 Degree: PhD Subject: Pharmaceutical Sciences Institution: Saint John's University
Year: 1985 Degree: Masters Subject: Pharmaceutical Sciences Institution: Saint John's University
Year: 1980 Degree: BS Subject: Pharmacy Institution: Long Island University

Work History

Years Employer Title Department Responsibilities
Years: 2011 to Present Employer: Undisclosed Title: Pharmaceutical Consultant and Principal Department: Responsibilities: Provide technical guidance and report writing to manufacturers, investment firms and legal firms in all aspects of drug product development.
Key Pharma Projects
• CMC Consultant/Writer – Synchrogenix Inc. (2018)
• Primary Packaging for Proteins (2017)
• Microneedles for delivery of peptides/proteins (2017)
• Excipients for sterile dosage forms – lyophilized powders (2016)
• Biopharma Contract Manufacturing Research (2014)
• Therapeutic Area Pipeline Review (2014)
• Webcast Presentation - Drug Delivery Systems for Proteins and Peptides (2014)
• Peptide Excipients and Packaging (2014)
• Technical Writing (QBD) Criticality Analysis – Large and Small Molecules (2012 -2013)
• Professional Blogging – The Female Patient/Quadrant Communications (2012 – 2013)
• Selection of CMOs (2012)
• Manufacturing Processes for Sterile Products (2012)
• Primary Packaging for Sterile Pharmaceuticals (2012)
• Injection Delivery Devices (2012)
• Business Plan - Web-Based KPO (2011)
• Selecting Target Product Profiles (2011)

Key Patent Litigation Projects
• Patent Consultation: Peptide Hormone Injection Formulation (2018-2019)
- Opening Report
- Reply Report
- Deposition
• Patent Consultation: Prostaglandin Vasodilator Injection Formulation (2019)
- Opening Report
- Reply Report
• Patent Consultation: Osmotic Delivery Technology
- Expert Declaration
• Patent Consultation: mAb Injection Formulation (2017)
• Patent Consultation: Hypoglycemic Agent Injection Formulation (2017)
• Patent Litigation: GLP 1 Analog formulation (2017)
• Deposition: Patent Litigation for Intramuscular Injection Formulation (2016)
• Patent Consultation: Formulation for Diagnostic Product (2016)
• Patent Consultation – Patent Litigation for Diagnostic Product
• Rebuttal Expert Declaration of Expert, Ph.D., Patent for Intravenous Diagnostic Product. (2016)
• Patent Consultation - Sustained Release Hormone Formulation (2016)
• Patent Consultation: Antimicrobial Effectiveness of Injectable Antiarrhythmic Formulations (2016)
• Patent Consultation Hypocalcemic Agent Formulation and Packaging (2015)
• Inter Partes Review: Exendin Analogs and Formulation pH (2015)
• Deposition Patent Litigation: - Fast Disintegrating Tablet Formulations (2015)
• Patent Consultation: Fast Disintegrating Tablet Formulations (2015)
• Testimony at Markman Hearing – Excipients for Peptide Formulations (2015)
• Patent Consultation: Retinoid Formulations in Soft Gelatin Capsules (2014)
• Patent Consultation: Intravenous Antihypertensive Injectable Buffers and Packaging (2014)
• Deposition: Antibiotic Formulation and Packaging (2013)
• Patent Consultation – Antibiotic Formulation and Packaging (2013)
Years: 1989 to 2011 Employer: Hoffmann-La Roche Inc. Title: Director, Sterile Product Formulation Department: Formulation Research Responsibilities: -Sterile formulation development for Nutley Site
-GLP and GMP supplies for sterile product clinical programs
-GLP and GMP qualified sterile manufacturing facility
-Peptide drug delivery systems
-siRNA formulation research
-evaluation of outside drug delivery technologies, CROs and CMOs
-member of Global Formulation Research Management Team
-Directed 15 scientist group and groups as large as 45 scientists
-International harmonization and outsourcing efforts

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 and directed the Preformulation Group.

Research Leader – Formulation and Toxicology Supply (1994)
Research Investigator – Formulation Development (1992-1993)
Associate Research Investigator – Formulation (1989-1992)

Years: 1987 to 1989 Employer: SCHERING-PLOUGH INC. Title: Senior Scientist Department: Responsibilities: 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.
Years: 1981 to 1985 Employer: HOFFMANN - LA ROCHE INC. Title: Associate Scientist - Parenteral Formulation Department: Responsibilities: 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.

International Experience

Years Country / Region Summary
Years: 2000 to 2003 Country / Region: London, England Summary: Intermiitent - regulatory subnissions - EU product approval.
Years: 2000 to 2010 Country / Region: Basel Switzerland Summary: Intermittent - formulation research - global harmonization.

Career Accomplishments

Associations / Societies
American Association of Pharmaceutical Scientists
American Pharmacy Association
Parenteral Drug Association
Licenses / Certifications
Registered Pharmacist- New York State
Professional Appointments
Invited Lecturer TIDES Conference,” Peptide Formulation Development”;

FDA Trainer “Formulation and Stability Evaluation of Therapeutic Proteins;

Invited Lecturer, American Association of Pharmaceutical Scientists Eastern Regional Meeting, “Technology Transfer for Sterile Dosage Forms;"

Adjunct Assistant Professor in Pharmaceutical Sciences, Long Island University;

Elected Chair, Basic Pharmaceutical Sciences, Academy of Research and Science
American Pharmaceutical Association;

Basic Pharmaceutical Sciences Representative, Education Standing Committee
American Pharmaceutical Association.
Awards / Recognition
H.B. Smith Award (highest standing in all subjects) – LIU;
B.S. Alstodt Award (highest standing in Pharmacotherapeutics – LIU;
B.P. Tuthill Award (highest standing in Pharmacy Practice) – LIU;
Elected Officer Rho Chi Society -LIU.
Publications and Patents Summary
19 publications, 1 patent.

Additional Experience

Expert Witness Experience
EXPERT REPORTS:
• Reply Report Peptide Hormone Injection Formulation (2019)
• Opening Expert Report for Peptide Hormone Injection Formulation (2018)
• Reply Report for Prostaglandin Vasodilator Injection Formulation (2019)
• Opening Expert Report for Prostaglandin Vasodilator Injection Formulation (2018)
• Expert Declaration for Osmotic Delivery Technology (2018)
• Supplementary Expert Report of Expert, Ph.D. Regarding Infringement of Patent for Sustained Release Hormone Intramuscular Formulation (2016)
• Expert Report of Expert, Ph.D. Regarding Infringement of Patent for Sustained Release Hormone Intramuscular Formulation (2016)
• Expert Declaration U.S. Patent for Antimicrobial Effectiveness of Injectable Formulation (2016)
• Inter Partes Review - U.S. Patent for Antimicrobial Effectiveness of Injectable Formulation Declaration of Expert, Ph.D. (2015)
• Reply Expert Report Of Expert, Ph.D. Hypocalcemic Agent Formulation and Packaging (2015)
• Rebuttal Expert Report of Expert, Ph.D. Hypocalcemic Agent Formulation and Packaging (2015)
• Inter Partes Review of U.S. Patent- Declaration of Expert, Ph.D. Hypocalcemic Agent Formulation and Packaging (2015)
• Responsive Expert Report of Expert, Ph.D. Regarding Non-infringement Of Fast Dissolving Table Formulation (2015)
• Inter Partes Review of Lipopeptide Antibiotic Formulation ( 2015)
• Inter Partes Review - Declaration of Expert, Ph.D. Lipopeptide Antibiotic Formulation (June, 2015)
• Opening Expert Report of Expert, Ph.D. Regarding Infringement Injectable Peptide Formulation (June, 2015)
• Review of Indications for CNS Drug (June, 2015)
• Expert Declaration - Claim Construction for Injectable Peptide Formulation (2014)
• Consultant for Plaintiffs’ Responses To Defendants’ Preliminary Invalidity Contentions - Oral Retinoid Soft Gelatin Capsule Formulation (2014)
• Declaration of Expert on Obviousness– Injectable Peptide Formulation (2014)
• Opposition Expert Report – Injectable Antibiotic Formulation 2014)
• Expert Report Regarding Infringement – Injectable Formulation (2013)
• Declaration on Infringement – Oral Retinoid Soft Gelatin Capsule Formulation (2013)
• Declaration for Claim Construction – Antibiotic formulation and packaging (2013)
• Criticality Analysis Consultant, Johnson And Johnson, Inc., Raritan, NJ - Led international project teams in the criticality analyses of late development and marketed products. Wrote and issued 3 major criticality analyses for small molecule and biotechnology products. (2012 -2013)
Training / Seminars
-FDA Trainer “Formulation and Stability Evaluation of Therapeutic Proteins
-Invited Lecturer, American Association of Pharmaceutical Scientists Eastern Regional Meeting, “Technology Transfer for Sterile Dosage Forms”
-Invited Lecturer TIDES Conference,” Peptide Formulation Development”
-Various internal management and organizational training sessions
Vendor Selection
Responsible for identifying and establishing business relationships with outsourcing partners for sterile formulation development and clinical supply
- Successfully outsourced clinical batches to maintain development timelines during peak activity periods
- Successfully outsourced preformulation work to gain increased knowledge of phyisco-chemical properties of Phase 00 compounds
-Outsourced equipment qualification and validation studies in order to shorten stat up time for sterile facility
Marketing Experience
The Pharmaceutical industry has been trending towards outsourcing basic development functions and large Pharma in particular has attempted to improve the quality for their research portfolios by developing compounds identified by smaller startups – he has considerable experience in both areas - he led the formulation effort for development of antiviral peptide in collaboration with a small startup company The effort led to an approved product (FUZEON) .In addition to directing internal formulation development research he has extensive experience in evaluation outside collaborations with drug delivery technology companies and working with companies found to be promising – as such he was the Peptide Delivery Champion at Roche – he has effectively used outsourcing to meet project needs during peaks in formulation support demand and played an active role in identifying and qualifying appropriate vendors – he has done extensive international work as a part of international project teams and worked with FDA and EMEA.
Other Relevant Experience
Project Planning;
GMP Knowledge;
Drug Development Process.


PHARMA REPORTS:
• Lyophilization – Development Through Tech Transfer, Workshop Leader (20176)
• Review of Indications for CNS Drug (2015)
• Biopharma Contract Manufacturing Report (2014)
• Webcast Presentation - Drug Delivery Systems for Proteins and Peptides (2014)
• Therapeutic Area Pipeline Review (2014)
• Criticality Analysis (QBD) for Small Molecule (2013)
• Criticality Analysis (QBD) for Large Molecule (2013)
• Criticality Analysis (QBD) for Small Molecule (2012)
• Business Plan - Web-Based KPO (2011)

Fields of Expertise

ampule, antitumor drug, antiviral agent, bio-clean room equipment, biodegradable system, clean room contamination assessment, clean room contamination detection, clean room fluid filtration, clean room operations, clean room technology, controlled-release drug delivery technology, cytotoxic drug, drug development, drug dosage form development, drug implant, drug release polymer, drug-delivery microsphere, excipient, hypodermic needle, hypodermic syringe, in vivo biodegradable polymer, infusion pump, infusional chemotherapy, injectable drug, injectable pharmaceutical product, intramuscular infusion, intravenous administration set design, intravenous drug delivery, intravenous infusion equipment, medical infusion, medical injection process, microsphere coating process, parenteral container manufacturing, parenteral container processing, parenteral drug delivery, parenteral product manufacturing, parenteral product packaging, parenteral product processing, pharmaceutical product development, pharmaceutical solution, polymer drug-delivery microsphere, polymer microsphere, product delivery process, protein drug, protein drug delivery, sterile product aseptic manufacture, subcutaneous infusion, aseptic packaging process, auto-injector, biodegradable plastic, drug delivery, excipient compatibility, polymer drug conjugate, intravaginal administration, intranasal administration, inhalation administration, nanobiotechnology, drug targeting, nano drug delivery, active pharmaceutical ingredient, cleanroom compressed gas handling, bulk drug, oral protein, electrotransport drug delivery, antisense drug, polymer powder, agglomeration, ophthalmic pharmaceutical product, inhaler, softgel capsule, lipid prodrug, drug degradation, medical perfusion, delivery system, central venous catheter, clean-in-place technology, macromolecule, skin permeability coefficient, ocular irritation, transdermal patch, transdermal, polymer drug-delivery method, cream, colloid technology, parenteral nutrition, intravenous nutrition, pharmaceutics, polymer science, eye drop solution, parenteral product, aseptic pharmaceutical process validation, skin absorption, biofiltration, sealing, pharmacy science, polymer toxicology, prolonged-action drug, controlled-release drug delivery, particle, pharmaceutical drug, polypeptide, transdermal drug delivery, nasal drug delivery, microsphere, magnetic microsphere, implantable drug infusion pump, drug therapy, dosage form, colloid, colloid and interface chemistry, clean room

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