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 Expert  722186

Expert in Pharmaceutical Manufacturing


Available for your Consulting and Expert Witness Needs

California (CA)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
Expert career as a senior executive in the pharmaceutical manufacturing industry spans over 25 years and includes experience and understanding of every facet of the manufacturing process, in addition to strong skills in technical, operational and managerial leadership within multi-functional disciplines. These include R&D, quality, logistics, new business development and advertising, marketing and sales. He is also experienced in facility expansion and renovation. Additionally, Expert is experienced in contract manufacturing, contract proposal development and writing, service marketing and pricing.
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pharmaceutical manufacturing

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pharmaceutical drug

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pharmaceutical industry

He has been intimately involved in product design and product improvement. He has helped redesign a complicated plastic syringe at a cost of less than 10 cents per syringe for Monsanto, and his contribution was key to the redesign of a series of freeze-dried syringes and ready-to-use syringes for DuoJect Medical Systems (a Canadian firm). Monsanto will be selling 60,000,000 syringes annually and Duoject will be selling tens of millions of syringes annually. Expert also designed a very difficult injectable in CZ Resin from the West Company, which has characteristics of glass, but does not break and circumvents lyophilization for certain products.
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medical device product improvement

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pharmaceutical design

Expert started very early in his career and still maintains a high degree of competence in R&D regarding dosage form development, drug formulation, drug processing and technical transfer. He is primary inventor and co-inventor on several patent submissions. He directed the development of two syringe patents accompanied by continuations in part with the U.S. Patent Office. He developed a ready-to-use process formulation which was previously freeze-dried only. This reduced the costs of manufacturing by fifty percent. He has developed and co-developed many drug formulations, and also developed efficiency in drug processing of each.
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drug development

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drug formulation

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drug processing

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pharmaceutical product formulation

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dosage form

Regarding excipient, generic drugs and generic drug manufacturing, Expert shows advanced knowledge in active ingredient sourcing, drug development and integrated automation to increase output and minimize cost. This also includes investigational drugs. He has extensive sources for pharmaceutical grade raw materials worldwide. He has been instrumental in the development and/or process optimization of over 50 drugs, including Amphotericin B, Taxol (Paclitaxel), Cisplatin (Platinol), Toradol (Ketorolac), Stadol (Butorphanol) and Methotrexate.
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generic drug manufacturing

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investigational drug

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cisplatin

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ketorolac

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taxol

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excipient

During the past 25 years, Expert has been an important member of all internal and external GMP audit teams which surveyed each department causing changes in practical and implementation of new procedures. He has direct experience working with FDA auditors resulting in positive outcomes.
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Good Manufacturing Practice

Expert has applied his knowledge regarding marketing and advertising at every company he has worked for during the past 25 years. His marketing and advertising experience includes market planning, industry journals, industry presentations, booth display design, video, DVD, brochures and direct mail. He has extensive experience with trade shows, such as PDA, ISPE, Biopharm, Interphex, and others. He designed booths for all shows and participated in manning the booths. Journal advertising coupled with actual client visits proved to be very successful, increasing revenue from $2 million to $16 million in three years. Over his entire career, Expert has helped to generate over $50 million in sales.
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advertising

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direct mail

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trade show

Expert's experience as VP of Operations and VP of New Business Development within the pharmaceutical manufacturing industry is enhanced by his Executive Master's degree in Business Management. He has written business plans, operation plans, five-year strategic plans and marketing plans. He has been directly responsible for new business development and is skilled in contract proposal development. Expert's expertise in these areas has resulted in lower costs, higher quality, greater efficiency and increased revenue and gross profit.
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business operations

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business development

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strategic planning

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business management

Expert's education from his Executive Master's degree program in Business Administration coupled with years of experience in competitive analysis and competitive intelligence has enabled him to ascertain the market, products, growth, etc., gaining each employer an excellent competitive advantage in the pharmaceutical manufacturing industry. Recently, this has been done for LifeCore Biomedical and NeoRx.
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competitive analysis

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competitive intelligence

He has hands-on experience working with and for contract manufacturing firms. He understands the players, competence advantages of most players, and has developed a SWOT (Strengths Weaknesses Opportunities Threats) analysis for each. This knowledge provides a significant competitive advantage in the pharmaceutical manufacturing marketplace. Expert acquired his expertise with Ben Venue, the largest contract manufacturing company, where he underwent a structured departmental rotation for a minimum of two years in each department, providing training for a strong foundation in senior management.
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contract manufacturing

He is highly experienced in quality, quality-by-design and defect detection. With historical data, along with changes to the process, allow him to monitor each new batch for potential problems. He has purchased automated inspection devices to increase quality and decrease defects. The equipment includes freeze dryers, washers, tunnels, filling machines, cappers, automated cleaning equipment and many machines to support packaging. The results of his focus on quality have been to increase production, reduce costs and increase gross profit.
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defect

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total quality management

Expert has been called one of the leaders in the industry in marketing. He is experienced in market assessment, development, forecasting, positioning, trends, research and communications and has successfully set up strong marketing functions with each employer he has worked for. The results of his strong marketing talents and initiatives have generated more than $50 million in sales.
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market assessment

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market development

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market forecasting

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market positioning

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market potential

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market trend

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marketing communications

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market research

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new product market survey

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strategic market planning

Expert is experienced in proposal writing and RFPs (request for proposals) from the National Cancer Institute, culminating in the award of contracts in excess of $10 million.
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proposal writing


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Los Angeles, California;  San Diego, California;  Long Beach, California;  Santa Ana, California;  Anaheim, California;  Riverside, California;  Glendale, California;  Huntington Beach, California;  San Bernardino, California;  and Chula Vista, California.

Often requested
with this expert:

Pharmaceutical Product Development and Good Manufacturing...
Pharmaceutical Technology, Manufacturing, Quality Systems...
Pharmaceutical Manufacturing, Research and Development,...
Pharmaceutical Operations Management

Education:
Year   Degree   Subject   Institution   Honors
1985   Executive M.B.A.     Baldwin Wallace University   Graduated top in class with 4.0 GPA
1968   B.S.   Pharmacy   Butler University College of Pharmacy   Cum Laude

Work History:
Years   Employer   Title   Responsibilities

1990 to

 

(Undisclosed Consulting Company)

 

President

 

Expert is involved in all phases of the parenteral pharmaceutical manufacturing business, including direct management of operations, new business development, research and development. He is also responsible for plant expansions and $80 million in sales.

1997 to 2000

 

Taylor Pharmaceuticals, a Division of Akorn, Inc.

 

Vice President of Operations

 

He was responsible for plant operations in Decatur, Illinois, and Somerset, New Jersey, with special emphasis on automation, enhancement of gross profit and generating sales growth through contract manufacturing and internally-developed injectable products. Expert also had divisional responsibility for approximately 350 employees.

1993 to 1997

 

Survival Technology, Inc.

 

Corporate Senior Vice President, Plant General Manager

 

He was responsible for total plant operations with special emphasis on cost reduction, continuous improvement, project management, research and development, and new business development.

1991 to 1993

 

Duoject Medical Systems, Inc.

 

Executive Vice President of New Business Development

 

He directed new business development, marketing and technical affairs for this R&D firm specializing in syringe delivery technology.

1988 to 1991

 

Pharmacia Adria-SP, Inc.

 

Director of Operations, Marketing and New Business Development

 

Expert was responsible for plant operations, contract manufacturing sales and marketing of the firm's unique injectable capabilities, especially lyophilization services.

1987 to 1988

 

Summa Manufacturing Corporation

 

Executive VP of Operations, Marketing and New Business Development

 

At Summa, Expert directed all aspects of process development, formulation, production, packaging and engineering. He was also responsible for all marketing functions, soliciting of contract development/manufacturing and sourcing of key active raw materials.

1982 to 1987

 

Ben Venue Laboratories, Inc.

 

Director of Marketing

 

He managed contract manufacturing business development. He instituted marketing, advertising and public relations programs. He planned and implemented a highly successful niche branded generic strategic business unit. He was responsible for contract pricing and supply agreement execution for current and future business.


Career Accomplishments:
Associations/Societies

Expert is a member of the Parenteral Drug Association and the International Society for Pharmaceutical Engineers.

Licenses/Certifications

He is a registered pharmacist in Indiana, Ohio and Oklahoma.

Professional Appointments

Expert was appointed to the National Cancer Institute's ad hoc technical RFP review group for the analysis of chemicals and pharmaceutical formulations for anti-AIDS agents. He was appointed Commissioned Officer, First Lieutenant, in the United States Public Health Service.

Awards/Recognition

He is listed in Who's Who Worldwide and also the International Who's Who.


Publications:
Publications and Patents Summary

Expert holds two process patents and authored an article published in Pharmaceutical Manufacturing International (1993) entitled "A universal system for parenteral drug delivery."

Selected Publications and Publishers  
 - Pharmaceutical Manufacturing International  

Government Experience:
Agency   Role  
United States Public Health Service   Appointed Commissioned Officer, First Lieutenant  

Consulting Services:
Selected Consulting Examples:
  • Expert recently helped a client evaluate their plant for construction and led the development of pricing models.
  • He led the creation of sterile liquid and lyophilized products for a client resulting in facility capability and cost efficiency.
  • He has experience conducting plant inspections and helping to purchase equipment and people for his clients.
  • Expert evaluated and developed a product questionnaire for several clients as a primer for cost quotations.
  • He has developed the necessary procedures for the handling of a dangerous drug and its associated cleaning procedure.
Recent Client Requests:
  • FDA expert for consultation to provide pre approval and post approval support to ensure approval of a NADA with a minimum of time spent in the review cycle of T-Pro.
  • Medical telemetry expert for consulting on MBAN and other Medical telemetry, RTLS.
  • Expert in Robotics for Pharmaceutical manufacturing.
  • Pharmaceutical manufacturing business development expert for consulting on CMO.
  • Pharmaceutical manufacturing expert for consulting on software development.
  • Pharmaceutical manufacturing expert for consulting on controlled release oral solid dosage form manufacture, testing and packaging.
  • Expert in GMP certification for consulting on the manufacturing of small scale ca. 2-5 kg of product.
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:
Expert Witness Experience Summary:
Expert has experience acting as an expert witness for several clients.
Recent Litigation Client Requests:
  • Contract manufacturing expert witness pharmaceuticals for consulting on Trial on pharmaceutical contract manufacturing.
  • Expert pharmaceutical manufacturing for consulting on Product liability litigation involving.
  • Expert in pharmaceutical manufacturing.
  • Expert in deviations in manufacturing pharmacutical resulting in alleged contamination.
  • Expert in drug manufacturing safety for consulting on drug manufacturing safety.
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
1990 to 2001   Paris, France   Expert designed, reviewed and purchased GMP freeze-dryers and loading systems from Serial with a cost of $1.5 million each.
1993 to 2001   Florence, Italy   He designed, reviewed and purchased of multiple filling lines from Comos, between $500,000 - $1 million per line.
1985 to 2001   Munich, Germany   He designed, reviewed and purchased inspection and washing equipment for Seidenader.
1988 to 2001   Japan   He conducted a GMP inspection of Daikyo Seiko Ltd., for GMP inspection of rubber and plastic facilities. Expert was the first individual to market a product in C-Z Resin for import into the U.S.
1990 to 1996   England and Montreal   He promoted the Duoject Syringe System which culminated into a 15-year licensing agreement with Zeneca for their leading anethestic.

Market Research:
He also has experience helping clients speed their products to market. He recently helped a client market a product that no one else would take. The anti-cancer product was approved in four months.

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

He was a speaker for the Parenteral Drug Association. The name of his presentation was "What it takes to be a world-class contract manufacturer."

Supplier and Vendor Location and Selection

Expert has extensive vendor experience locating packaging equipment, research and development equipment, freeze dryers, and many other products ranging from filling machines to straight line tunnels.


 

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