ORC Expert Advisory Services ORC International

  home    |    find an expert    |    request an expert    |    join our network    |    about us     expert login  
Expert Consulting and Expert Witness Services
  
  search tips 
Share this page:  Send to LinkedIn Send to Facebook Tweet This Email Print

 Expert  731583

Expert in Pharmaceutical Development


Available for your Consulting and Expert Witness Needs

Florida (FL)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

Expert has over 28 years experience as a pharmaceutical executive managing various aspects of drug product development, including outsourced pharmaceutical manufacturing and broad aspects of the CDMO industry. Previously, Expert was the President of Pharmaceutical Development Services and the Chief Scientific Officer for one of the largest global contract development and manufacturing organizations (CDMO) in the industry. Expert was also the past Divisional Vice President of Global Pharmaceutical & Analytical Sciences at Abbott, the Chief Scientist and SVP of R&D at Ventaira, Senior Director at Pfizer, Pharmacia, Searle, and Associate Director, Section Manager and Senior Principal Scientist at Boehringer Ingelheim.

He has managed drug product development programs through preformulation, solid form identification and characterization, formulation, process development, GMP clinical trial supply manufacture, scale up, technology transfer, product validation, analytical method development and validation, lot release testing, stability testing, specifications development, IND, NDA and BLA CMC sections of regulatory submissions, device development, drug - device combination products, and package development. Expert has extensive experience with both small molecule and large molecule (biologic) drugs, and has considerable experience with solid oral dosage forms (tablets, capsules, softgels, lipids in hard gelatin capsules, powder in bottle), parenteral dosage forms (lyophilized vials, sterile liquid in vials, prefilled syringes, pens and auto-injectors, micro-needle injectors, needle free injectors), inhalation dosage forms (metered dose inhalers, dry powder inhalers, aqueous based systems), topical dosage forms (gels, creams, ointments), nasal spray dosage forms, and ophthalmic dosage forms. Expert has directed development of NCEs, NBEs and life cycle management programs. He has contributed to the commercialization of over 30 pharmaceutical products, and several hundred compounds evaluated in clinical and pre-clinical testing. Some notable drug products that Expert has contributed to include: Humira®, Humira® Pen, Humira® Pre-filled Syringe Japan, TriCor® No Food Effect tablet, Kaletra® tablet, Trilipix® capsule, Norvir®/Aluvia® tablet, Zemplar® tablet, Uloric® Tablet, Simcor® tablet, Celebrex® capsules, Bextra® tablets, Deramaxx® tablet, Dynastat lyophilized vial, Inspra tablet, Somavert®, Zyvox®, Xalatan®/ Xalcom®, Atrovent® HFA inhaler, Combivent® HFA inhaler, Berotec HFA® inhaler, Berodual® HFA inhaler, and Spiriva® Handihaler. He has experience with device development and drug-device combination products. Expert is adept at developing dosage form strategies suitable for the physical chemical properties of the drug, developing appropriate CMC regulatory strategies and in managing pharmaceutical development operations to deliver drug product technology on-time and on budget. Expert has managed product development organizations with over 600 scientists. His teams have been equally proficient in developing drug product technology inhouse or through utilization of contract development and manufacturing service organizations. At Patheon, Expert turned around a contract development business to demonstrate over 9% YOY top line growth and over 20% improvement in EBITDA YOY. His PDS organization supported between 300-400 active dosage form development programs for approximately 300 clients. Expert has expertise in conducting due diligence investigations of drug development programs, drug delivery companies & technologies and CDMO drug product development companies. He has successfully managed integrations post acquisitions.

 • 

aerosol technology

 • 

Chemistry, Manufacturing and Controls

 • 

development management

 • 

drug delivery

 • 

drug development

 • 

drug dosage form development

 • 

drug formulation

 • 

drug product approval

 • 

drug stability

 • 

due diligence

 • 

inhalation administration

 • 

inhaler

 • 

new drug application

 • 

oral drug delivery

 • 

outsourcing

 • 

parenteral drug delivery

 • 

pharmaceutical industry

 • 

pharmaceutical life cycle management

 • 

pharmaceutical manufacturing

 • 

pharmaceutical product development

 • 

pharmaceutical product formulation

 • 

pharmaceutical research and development

 • 

pharmaceutical technology

 • 

solid pharmaceutical product

 • 

tablet

 • 

contract manufacturing

 • 

pharmaceutical manufacturer

 • 

pharmaceutical science


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Jacksonville, Florida;  Gainesville, Florida;  Deltona, Florida;  and Daytona Beach, Florida.

Education:
Year   Degree   Subject   Institution  
1985   PhD   Pharmaceutics (Pharmacy)   University of Wisconsin- Madison  
1983   MS   Pharmaceutics (Pharmacy)   University of Wisconsin- Madison  
1980   BS   Pharmacy   University of Wisconsin- Madison  

Work History:
Years   Employer   Department   Title   Responsibilities

2012 to

 

(Undisclosed)

 


 

President

 

Expert provides consulting services to the life sciences industry in pharmaceutical product development, pharmaceutical manufacturing, formulation science, drug delivery, outsourcing strategy and execution, managing pharmaceutical development organizations, due diligence for merger and acquisitions, drug delivery technologies, and management of contract development and manufacturing businesses.

2010 to 2012

 

Patheon

 

Pharmaceutical Development Services

 

President and Chief Scientific Officer

 

P&L responsibility for Pharmaceutical Development Services business, a $140MM business that provided pharmaceutical product development services to large, mid-size, small and virtual companies. Managed 9 development sites in North america and Europe with focus on solid oral dosage forms and sterile product development. Services included formulation and process development, analytical development, lot release and stability testing, CTM manufacture and consulting srevices for small molecules and biologic drugs

2004 to 2010

 

Abbott

 

R&D (Global Pharmaceutical & Analytical Sciences)

 

Divisional Vice President

 

Responsibility for development of pharmaceutical products in support of R&D pipeline and life cycle management products. Managed organization on 4 development sites (Chicago, Worcestor, MA, Ludwigshafen Germany and Singapore) with focus on solid oral dosage forms and sterile product development. Conducted preformulation, solid state selection, formulation and process development, device development, analytical method development and validation, lot release and stability testing, CTM manufacture, preparation of CMC sections of INDs, BLAs and NDAs for small molecules and biologics.

2003 to 2004

 

Ventaira

 

R&D

 

Chief Scientist and SVP

 

Managed R&D organization responsible for Mystic inhalation device develoment, formulation and analytical development, and engineering to incorporate drugs into the device for inhouse and client programs

1995 to 2003

 

Pfizer, Pharmacia, GD Searle

 

R&D (Global Pharmaceutical Sciences)

 

Sr. Director

 

Managed organization(s) in product development of oral solid, parenteral and topical products in support of R&D and Life Cycle Management programs for small molecules and biologics. Responsible from preclinical through phase I,II and III clinical and technology transfer to commercial manufacturing for preformulation, formulation, process development, analytical development, release and stability testing, CTM Manufacturing and CMC regulatory packages

1985 to 1995

 

Boehringer Ingelheim

 

R&D (Pharmaceutics)

 

Associate Director

 

Manager and Formulation leader for inhalation product development. Team Member R&D Head for Global Alternative Propellant Project team and Team Member R&D Head for Global Dry Powder Inhaler Project team.


Career Accomplishments:
Associations/Societies

University of Wisconsin School of Pharmacy Board of Visitors (3 terms; 2006 – present) National Institute for Pharmaceutical Technology & Education (NIPTE) Scientific & Education Advisory Council (2006-2007 & 2012-2013) Pharmacia Preclinical Development Patent Award (2002) United States Pharmacopeia (USP) Panel on Aerosols (1992 - 1996) North Eastern Regional Pharmaceutics Association (NERPA) Planning Committee (1986-1989) American Association of Pharmaceutical Scientists (AAPS) Parenteral Drug Association (PDA) Controlled Release Society (CRS) American Chemical Society (ACS) Eino Nelson Conference Planning Committee Respiratory Drug Delivery IV Planning Committee Association of Analytical Communities (AOAC) International Special Symposium Planning Committee (1994) for “Recent Advances on the Analysis of Pharmaceutical Inhalation Products for Process Control and Quality Assessment" United States Pharmacopeial Fellow (1983-1985) Sigma XI Rho Chi

Awards/Recognition

Citation Award - University of Wisconsin-Madison School of Pharmacy (2013)


Publications:
Publications and Patents Summary

Expert 19 publications, 70 invited presentations at symposia and conferences and presented papers, and 18 patents and patent applications

Selected Publications and Publishers  
 - Tablets & Capsules  
 - Innovations in Pharmaceutical technology  
 - chapter in Encyclopedia of Pharmaceutical Technology, Swarbrick & Boylan, eds., Marcel Dekker  
 - Pharmacopeial Forum  
 - Pharmaceutical Research  

Government Experience:
Years   Agency   Role   Description
1992 to 1996   US Pharmacopeia   Panel on Aerosols   Panel member to review and upgrade pharmacopeial standards for aerosol testing
1994 to 1994   FDA   Lecturer   Provided lecture to FDA staff on "MDI Redevelopment With Alternative Propellants", on behalf of IPAC
2009 to 2009   FDA   Coordinator   Provided lectures and hands on tours for FDA staff in formulation development labs at Abbott

Consulting Services:
Selected Consulting Examples:
  • Two month assignment to review and provide expert assessment of drug delivery technologies across broad drug delivery space
  • One year assignment to aid development of a business plan for a commercial manufacturing organization interested in expanding into pharmaceutical development services market
  • Ongoing assignment to guide an emerging pharma company develop strategy for dosage form development, select outsourcing providers, manage providers and provide clinical trial supplies for clinical studies and CMC section of IND
  • Engagement to provide due diligence support for a potential drug delivery technology acquisition
  • Provide perspectives across CDMO space for venture capital firms following pharmaceutical outsorcing trends and consolidations
Recent Client Requests:
  • Expert for consulting on Require ophthalmic formulation expertise
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:
  • Expert for consulting on breach of contract case.
  • Expert for consulting on breach of contract case
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
1988 to 1995   Europe (Germany, France, UK, Switzerland)   Provide leadership and management to Boehringer Ingelheim global alternative propellant amd dry powder inhaler project teams. Manged vendors in Germany, UK, Switzerland.
2004 to 2010   Germany   Managed Pharmaceutical and Analytical Sciences organization in drug product development in Ludwigshafen Germany for Abbott
2008 to 2010   Singaopre   Conceived and operationalized a lab in Singapore for analytical development and formulation development for Abbott
2010 to 2012   Canada   Managed 3 Pharmaceutical Development sites in Toronto, Whitby and Burlington, Canada for Patheon
2010 to 2012   Europe (UK, France and Italy)   Managed 4 sites in the UK (Milton Park and Swindon), France (Bourgoin) and Italy (ferentino) in drug product development services

Market Research:
Expert across entire spectrum of CDMO space, including industry trends, market growth, business strategies, key players, CDMO segmentation and consolidation, business plan development, cost drivers, technologies

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

Accomplished speaker in pharmaceutical development sciences, dosage form development, formulation strategies and outsourcing

Supplier and Vendor Location and Selection

Actively consult in CDMO space, identifying vendors and executing outsourced pharmaceutical development and manufacturing

Other Skills and Services

Experience and expertise in managing due diligence, acquisitions, and organizational integrations


 

Need the right expert?  We can help!

home       find an expert       request an expert       join our network       about us

Intota is now ORC Expert Advisory Services

FOLLOW ORC ON