Expert in Drug Delivery, Drug Development, Business Development, IP Strategy, Medical Nanotechnology,
Expert ID: 723808 North Carolina, USA
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.
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.
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.
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.
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.
|Year: 1987||Degree: MBA||Subject: Management of Technology||Institution: MIT|
|Year: 1976||Degree: PhD||Subject: Biology||Institution: Syracuse University|
|Year: 1968||Degree: BS||Subject: Biology, Chemistry||Institution: University of Pittsburgh|
|Years: 2006 to 2007||Employer: Liquidia Technologies||Title: Leader, Biotechnology and Pharmaceuticals||Department:|
Responsibilities:Part-time position: Strategy, planning and execution of therapeutic product sector for a nanotechnology manufacturing platform
|Years: 2005 to 2006||Employer: Wake Forest University||Title: Executive VP||Department: Health Sciences|
Responsibilities:Directed development of a research park.
|Years: 1992 to 2005||Employer: Nobex Corporation||Title: CEO, President and Director||Department:|
Responsibilities:General management, capital raising, product development, business development, intellectual property. Company sold in 2006 to Biocon
|Years: 1994 to 1998||Employer: Larex International||Title: CEO, President and Director||Department:|
Responsibilities:General management, capital raising, manufacturing, product development, business development, intellectual property. Company sold in 2006 to Lonza
|Years: 1993 to 1994||Employer: Medical Innovation Partners||Title: Principal||Department:|
Responsibilities:Entrepreneur-in-Residence. reviewed business plans, performed due diligence, business development. Left to join MIP-funded Larex.
|Years: 1987 to 1992||Employer: Nobex Pharmaceutical||Title: VP Business Development||Department:|
Responsibilities: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
|Years: 1979 to 1987||Employer: Boston University||Title: Assistant Professor||Department: Biology|
Responsibilities:NIH supported research and teaching in neurobiology and Director of Graduate Studies.
|Years: 1968 to 1972||Employer: US Navy||Title: Lieutenant||Department: Special Warfare Group|
Responsibilities:Line Officer serving in SE Asia and Japan
|Years: 1988 to 1991||Agency: NIH||Role: Principle Investigator||Description: Led mulit-year, several million dollar contract for receptor binding screening of bioactive molecules for the National Institute of Mental Health|
|Years||Country / Region||Summary|
|Years: 2004 to 2005||Country / Region: Malaysia and Singapore||Summary: 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.
|Years: 2003 to 2005||Country / Region: India||Summary: 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.
|Years: 2000 to 2005||Country / Region: Taiwan||Summary: As CEO of a biotechnology company, he made 8 trips to Taipei to raise equity investments (closed on >$10 million) and to establish alliances with Taiwan based biotechnology and pharmaceutical companies. He maintains a network of contacts in Taiwan.|
|Years: 1988 to 2005||Country / Region: Japan||Summary: While in the US Navy, he lived in Japan for 7 months. As VP for Business Development for a biotechnology company, he was responsible for Japan, traveling to Japan an average of 2 times per year for 6 years to close service contracts and form strategic alliances with Japanese pharmaceutical companies.|
|Years: 1988 to 2005||Country / Region: Europe||Summary: As VP for business development for one firm and CEO for two others, he travelled at least 3 times per year over 7 years to various EU countries, primarily UK, France, Germany, Sweden, and Switzerland. Several strategic alliances for drug product development in the pharmaceutical industry were established and run for multiple years. In addition, he raised equity investment ($>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.
|Associations / Societies|
|He is a member of the Licensing Executives Society, The Association for Corporate Growth, Controlled Release Society, and the Society for Neuroscience|
|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 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.|
|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.|
|Managed staff who did so.|
|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.|
|Other Relevant Experience|
|Inventor (34 US patents issued and pending); Director on several early stage company boards; scientific writer|
Fields of Expertise
business development, pharmaceutical product development, research and development management, controlled-release drug delivery, drug delivery, oral drug delivery, polymer drug-delivery method, protein drug delivery, protein drug, innovation, intellectual property, intellectual property, technology management, nanotechnology, nano drug delivery, life science research, nanobiotechnology, strategic alliance, brain tumor, active pharmaceutical ingredient, small business, entrepreneurship, business operations, pharmaceutical technology, SBIR grant writing, business management, drug release polymer, business incubator, ideation, drug formulation, prodrug, proposal writing, controlled-release oral drug delivery, licensable technology, polymer drug-delivery microsphere, parenteral drug delivery, patent cost reduction, drug development, biomedical product development, pharmaceutical industry, technology innovation, technology transfer, drug dosage form development, technology licensing, licensing, new product development management, pharmaceutical drug, investigational drug, drug screening, dosage form