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 Expert  723808

Expert in Drug Delivery, Drug Development, Business Development, IP Strategy, Medical Nanotechnology,


Available for your Consulting and Expert Witness Needs

North Carolina (NC)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

As a business development exectuive and as CEO of several life sciences companies, he has had the opportunity to be closely involved and lead the identification, negotiation and closing of a number of licensing and R&D agreements with pharmaceutical, biotechnology, and government entities. In aggregate over his 20 years in life science businesses, he has closed on more than $500 million in R&D funding and licensing fees. Throrough knowledge of intellectual property adds an important dimension to constructing effective deals.
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business development

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pharmaceutical product development

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research and development management

He has been closely involved in controlled and sustained release technology in several instances, having developed and out-licensed two products that reached the market (Gliadel for brain tumors) and Skedaddle (topical repellant) and two others (antibiotic and an analgesic) that were out-licensed.
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controlled-release drug delivery

Throught his business career, drug delivery has been a constant focus of expertise and experience. Having managed the development of several medical and consumer products based on drug delivery technology, he has accumulated extensive experience with in-house proprietary technology as well as broad knowledge of competitive approaches. His exposure has included polymer, lipid, and carbohydrate matrices, medicinal chemistry (PEGylation, amphiphillic polymers), crystallization, nasal and lung devices, and most recently, nanotechnology.
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drug delivery method

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oral drug delivery

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polymer drug-delivery method

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protein drug delivery

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protein drug

Innovation has been at the heart of this expert's career, from his academic research period and throughout his business career. Passion for the interface between science and making products that can be commercialized has been a key motivator for his long interest in early-stage company innovation and product development. The process of innovation is of crucial importance to the efficient conversion of science into useful technology and must be tightly coupled to understanding of and proper utilization of intellectual property protection.
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innovation

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intellectual property

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intellectual property

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technology management

The emergence of nano-scale technology for developing new solutions to deliver bioactive compounds into the body and then to selected tissues (and away from tissues) is redrawing the drug delivery and drug formulation sectors. The structural instability, high cost of goods, and side effect potential of modern drug classes (e.g., polyamino acids, nucleic acids) require new, engineered approaches to deliver bioactive substances to targets. He has been closely involved in this field, both developing specific nanotechnology and cultivating expertise in the competitive arena.
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nanotechnology

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nano drug delivery

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life science research


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Raleigh, North Carolina;  Greensboro, North Carolina;  Durham, North Carolina;  Winston Salem, North Carolina;  Fayetteville, North Carolina;  Cary, North Carolina;  High Point, North Carolina;  Greenville, North Carolina;  Concord, North Carolina;  and Lynchburg, Virginia.

Education:
Year   Degree   Subject   Institution  
1987   MBA   Management of Technology   MIT  
1976   PhD   Biology   Syracuse University  
1968   BS   Biology, Chemistry   University of Pittsburgh  

Work History:
Years   Employer   Department   Title   Responsibilities

2006 to 2007

 

Liquidia Technologies

 


 

Leader, Biotechnology and Pharmaceuticals

 

Part-time position: Strategy, planning and execution of therapeutic product sector for a nanotechnology manufacturing platform

2005 to 2006

 

Wake Forest University

 

Health Sciences

 

Executive VP

 

Directed development of a research park.

1992 to 2005

 

Nobex Corporation

 


 

CEO, President and Director

 

General management, capital raising, product development, business development, intellectual property. Company sold in 2006 to Biocon

1994 to 1998

 

Larex International

 


 

CEO, President and Director

 

General management, capital raising, manufacturing, product development, business development, intellectual property. Company sold in 2006 to Lonza

1993 to 1994

 

Medical Innovation Partners

 


 

Principal

 

Entrepreneur-in-Residence. reviewed business plans, performed due diligence, business development. Left to join MIP-funded Larex.

1987 to 1992

 

Nobex Pharmaceutical

 


 

VP Business Development

 

Member of Management Committee, P&L responsibility for two divisions, NovaScreen (pharmacology services) and drug delivery, business development in Japan and EU. Company sold to Scios (division of J&J) in 1992

1979 to 1987

 

Boston University

 

Biology

 

Assistant Professor

 

NIH supported research and teaching in neurobiology and Director of Graduate Studies.

1968 to 1972

 

US Navy

 

Special Warfare Group

 

Lieutenant

 

Line Officer serving in SE Asia and Japan


Career Accomplishments:
Associations/Societies

He is a member of the Licensing Executives Society, The Association for Corporate Growth, Controlled Release Society, and the Society for Neuroscience

Professional Appointments

He is Chairman of the Board for one early stage company and is a Director of 2 other entrepreneurial companies in the life sciences

Awards/Recognition

He has several medals from his period in the US Navy


Publications:
Publications and Patents Summary

He has 34 issued and pending patents in the US (>350 related patents issued or filed in foreign countries). He has 28 peer-reviewed papers (1976 - 2002) and is co-author on a book on Global Patent Strategy to be published in 2007.

Selected Publications and Publishers  
 - Licensing Executives Society  
 - Burger's Medicinal Chemistry and Drug Discovery  

Government Experience:
Years   Agency   Role   Description
1988 to 1991   NIH   Principle Investigator   Led mulit-year, several million dollar contract for receptor binding screening of bioactive molecules for the National Institute of Mental Health

Consulting Services:
Selected Consulting Examples:
  • He has participated in several half-day consulting sessions on topics in drug delivery strategy and tactics, engaged by companies directly or through consulting firms who engaged me as a participant in a multi-consultant session.
  • He performed several on-site consulting engagements over a 6 month period in 1987 with Boston companies entering life-sciences markets and seeking expert advice on biotechnology product pre-clinical development and on adapting a chemistry manufacturing software program for protein manufacturing.
Recent Client Requests:
  • Oral dosage form expert for consulting on formulation development.
  • Expert in drug delivery system for consulting on SBIR grant.
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:
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
2004 to 2005   Malaysia and Singapore   He made four trips of 2-3 days each to explore potential new business opportunities for the company he was CEO of and as a member of a scientific advisory board for another, Malaysia-based company. For the latter company, we successfully established a start-up company in Malaysia, operated by local staff, and continue to develop product opportunities. He maintains a network of contacts in Kuala Lumpur.
2003 to 2005   India   During a three year period, he made 6 trips to Bangalore, India to establish and operate a strategic alliance with India's largest biotechnology company. Three product licensing agreements and related equity investments were completed. Also toured and held discussions with several Bangalore area companies specializing in preclinical and clinical studies as well as product manufacturers.
2000 to 2005   Taiwan   As CEO of a biotechnology company, he made 8 trips to Taipei to raise equity investments (closed on >$10 million) and to establish alliances with Taiwan based biotechnology and pharmaceutical companies. He maintains a network of contacts in Taiwan.
1988 to 2005   Japan   While in the US Navy, he lived in Japan for 7 months. As VP for Business Development for a biotechnology company, he was responsible for Japan, traveling to Japan an average of 2 times per year for 6 years to close service contracts and form strategic alliances with Japanese pharmaceutical companies.
1988 to 2005   Europe   As VP for business development for one firm and CEO for two others, he travelled at least 3 times per year over 7 years to various EU countries, primarily UK, France, Germany, Sweden, and Switzerland. Several strategic alliances for drug product development in the pharmaceutical industry were established and run for multiple years. In addition, he raised equity investment ($>5 million) from EU venture capital groups and attended several biotechnology conferences to present his companies. He has traveled to Israel twice to work with Israeli university researchers for whom his companies sponsored product development research. He maintains a large network of contacts across the EU in pharmaceutical and biotechnology.

Language Skills:
Foreign Language   Description
English   Native language

Market Research:
Extensive marketing of pharmacology services to pharmaceutical companies. Marketing (business development) of technology of biotechnology companies to pharmaceutical companies. Key executive in bringing 4 therapeutic products into human clinical studies; to date, one has reached market. Key executive in developing consumer dermal product that reach market.

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 has led many scientific seminars in neurobiology and pharmacology during his professorship period. He has served on several invited panels on intellectual property at national conferences. He has been invited to speak in seminars and on panels on the topic of entrepreneurialism in life sciences.

Supplier and Vendor Location and Selection

Managed staff who did so.

Other Skills and Services

Inventor (34 US patents issued and pending); Director on several early stage company boards; scientific writer


 

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