Synthetic Drug Product Development Expert - Marketing and IP Management

Technical Consultant #1941


Expertise

  • More than 30 years leadership in the pharmaceutical and chemical industry.
  • New compounds and discoveries in chemical processes.
  • Expertise in the chemistry of vitamin D and analogs, anti-infectives (macrolides, quinolones, HIV protease inhibitors), taxanes, peptidomimetics, and other anticancer drugs, steroids, prostaglandins and cannabinoids.

Experience

Undisclosed University, Chicago, IL, 2008 - Present

  • Research Assistant Professor in the Department of Chemistry.
  • Working with graduate students in the laboratory to develop new chemical technology.

Undisclosed Company, 2003 - Present

Vice President, Research and Development, 2003 - 2006

Chief Scientific Officer, 2006 - Present

  • Provide company support in developing creative approaches to solving the customer's synthetic challenges and scale-up problems using a scientific understanding of mechanisms and manufacturing processes; responsibilities include, but are not limited to, literature searching, designing experiments, providing scientific leadership to process development chemists, writing patent applications and scientific publications, attending and making presentations at scientific conferences.
  • Market development responsibilities: Reviewing proposals and making presentations to customers.

Natural Pharmaceuticals, Inc., Beverly, MA, 2001 - 2003

  • Senior Research Advisor, process chemistry and intellectual property.
  • Establishing the patent portfolio and conducting research on the chemical processes for NPI (New Product Introduction), especially semisynthetic paclitaxel.

Protarga, Inc., King of Prussia, PA, 1999 - 2001

Vice President Chemistry, Manufacturing and Process Research

  • Finding and qualifying drug substance and drug product manufacturers. Placing orders, overseeing the QA (Quality Assurance) audits.
  • Creating and directing the manufacturing budgets and schedules.
  • Supervising the preparation of documentation for regulatory filings.
  • Recruiting, hiring and managing the synthetic and analytical chemists for process research, analytical methods development, technology transfer and vendor audit functions.
  • Member of senior management team.

CP Consulting, Inc., Zion, IL, Consultant, 1995 - 1999

  • Technical consultant to the chemical sciences division of G.D. Searle and other pharmaceutical companies.
  • Regularly participated in technical meetings and trade shows.
  • Consulted on chemical, business and marketing issues.
  • Helped design several laboratories, including a state-of-the-art cGMP final product isolation laboratory that also accommodates hazardous materials and is used for the manufacturing of a highly potent commercial drug.

Abbott Laboratories, North Chicago, IL, 1989 - 1995

Department Manager Process Research - Chemical and Agricultural Products Division

  • Created the Process Chemistry Research Department in the chemical products division, reporting to Vice President of chemical research and development and manufacturing.
  • Recruited and hired a superior professional staff that won nearly all the divisional scientific awards each year. Built the department to 50 chemists and engineers.
  • Provided scientific leadership and mentoring, encouraged the writing of publications and patents.
  • Responsible for synthesizing all clinical bulk drugs for new pharmaceutical candidates from medicinal discovery, developing efficient cost-effective processes, validating the new processes and moving them to large manufacturing scale when clinically viable.
  • Supervised the writing of research reports, batch records and FDA CMC documentation, working closely with analytical and formulations groups.
  • Negotiated budgets and schedules with top research and development management, assigned process groups, coordinated analytical support for the pilot plant time and consultants, developed raw material sources, technology transfer and vendor supply strategies.
  • Worked closely with the "Customer Teams" to assure their satisfaction. Met or exceeded incentive goals.
  • Annual budgets as high as $20 million.
  • Served on committees to design several laboratory buildings: Scale-up laboratories and R9, a $40 million state-of-the-art GMP (Good Manufacture Practice) pilot plant.
  • Part of the divisional incentive bonus plan; received incentive stock options.

Department Manager, Process Research, Pharmaceutical Products Division, 1983 - 1989

  • Established and built the first process chemistry department in Abbott's Pharmaceutical Division.
  • Recruited and hired the professional staff of 15 chemists.
  • Designed and equipped two laboratory modules and a kilo scale laboratory.
  • Provided medicinal chemists with larger supplies of key intermediates, high-pressures hydrogenations and practical scale-up chemistry.
  • Hands-on laboratory work included a new synthesis of a cardiovascular drug and pioneering new chemistry that produced leads for the anti-infective discovery and anti-viral discovery projects. Several patents resulted.

Honors & Publications

Credentials

  • Focused studies in Synthetic Organic Chemistry
  • Analytical Chemistry Minor

Academic and Professional Affiliations

  • Chairman of the Organizing Committee for the 20th IUPAC Symposium on the Chemistry of Natural Products.
  • Elected Chairman of the Gordon Research Conference on Organic Reactions and Processes.
  • Former Associate Editor of Organic Process Research and Development; an American Chemical Society scholarly publication; currently a member of the Editorial Board.
  • Member of the American Chemical Society, Organic, Medicinal and Physical Sections; Chicago and Milwaukee Local Sections.

Publications and Patents

  • More than twenty-five scientific publications in peer-reviewed journals.
  • Two technical book chapters and several published marketing interviews.
  • Eleven invited presentations at major scientific conferences; fifteen invited presentations at Universities and Institutes.
  • Enthusiastic Lecturer, delivering numerous scientific and business development presentations, chairing sessions and organizing conferences worldwide.
  • Ten issued U.S. patents; several other patents pending, some with foreign issue.

Education

  • Ph.D. Organic Chemistry, Purdue University, West Lafayette, IN.
  • B.S. Chemistry University of Wisconsin-Milwaukee, Milwaukee, WI
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