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 Expert  729835

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


Available for your Consulting and Expert Witness Needs

New Jersey (NJ)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

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
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ampule

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antitumor drug

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antiviral agent

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bio-clean room equipment

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biodegradable system

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clean room contamination assessment

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clean room contamination detection

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clean room fluid filtration

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clean room operations

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clean room technology

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controlled-release drug delivery technology

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cytotoxic drug

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drug development

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drug dosage form development

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drug implant

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drug release polymer

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drug-delivery microsphere

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excipient

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hypodermic needle

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hypodermic syringe

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in vivo biodegradable polymer

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infusion pump

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infusional chemotherapy

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injectable drug

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injectable pharmaceutical product

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intramuscular infusion

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intravenous administration set design

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intravenous drug delivery

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intravenous infusion equipment

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medical infusion

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medical injection process

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microsphere coating process

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parenteral container manufacturing

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parenteral container processing

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parenteral drug delivery

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parenteral product manufacturing

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parenteral product packaging

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parenteral product processing

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pharmaceutical product development

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pharmaceutical solution

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polymer drug-delivery microsphere

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polymer microsphere

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product delivery process

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protein drug

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protein drug delivery

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sterile product aseptic manufacture

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subcutaneous infusion

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aseptic packaging process

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auto-injector

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biodegradable plastic

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drug delivery


Show Secondary and Basic Areas of Expertise
Localities:
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;  and Philadelphia, Pennsylvania.

Education:
Year   Degree   Subject   Institution   Honors
1989   PhD   Pharmaceutical Sciences   Saint John's University   Summa Cum Laude
1985   Masters   Pharmaceutical Sciences   Saint John's University   Summa Cum Laude
1980   BS   Pharmacy   Long Island University   Magna Cum Laude

Work History:
Years   Employer   Department   Title   Responsibilities

1989 to 2011

 

Hoffmann-La Roche Inc.

 

Formulation Research

 

Director, Sterile Product Formulation

 

-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


Career Accomplishments:
Associations/Societies

AAPS; Controlled Releas Society

Licenses/Certifications

Registered Pharmacist

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:
Publications and Patents Summary

19 publications, 1 patent.

Selected Publications and Publishers  
 - Pharmaceutical Research  
 - Peptide Science  

Consulting Services:
Selected Consulting Examples:
  • 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
Recent Client Requests:
  • Expert for consulting on Sterility.
  • Expert for consulting on Evaluation of contract medical device manufacturer.
  • Expert for consulting on Pharmaceutical for Food Product.
  • Expert for consulting on Transdermal patch development for Cannabinoids.
  • Hair related topicals.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • Clean room testing expert for consulting on contamination issue.
  • Home infusion therapy expert for consulting on hOME INFUSION.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

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

Market Research:
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.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
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

Supplier and Vendor Location and 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

Other Skills and Services

Project Planning; GMP Knowledge; Drug Development Process.


 

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