Medical Device, Medical Drug Delivery Design and Development for the Biotechnology and Pharmaceutical Industries

Technical Consultant #1760


Expertise

  • Ph.D. Chemical Engineer with extensive experience and demonstrated success in the design and development of devices, drug delivery systems and manufacturing processes for the biotechnology, medical device and pharmaceutical industries.

Technical Competencies

  • Process science/engineering, material science, solid state characterization, polymers, membrane separations, surface and interfacial science, emulsions/suspensions, drying, particle technology, in vivo PK testing, design of experiments (DOE), technical writing, project management, regulatory submissions, and patent consultation.

Experience

Undisclosed Company, 2008 - Present

  • A private biopharmaceutical company focused on the development of novel, nanotechnology-based therapeutics in the areas of oncology, cardiovascular, autoimmune and inflammatory diseases.

Principal Fellow

  • Lead company efforts in the development of process platforms for making drug-loaded nanoparticles, provide technical guidance on formulation development and mentor junior level scientists.

Accomplishments

  • Developed semi-continuous process for making nanoparticles.
  • Designed proprietary nanoparticle generator.
  • Led CMC development team for company's first nanoparticle product.

Alermes, Inc, Cambridge, MA, 1991 - 2008

  • Positions filled: Research Fellow (Associate Director), Sr. Staff Scientist, Sr. Engineer
  • A biotech company focused on developing and manufacturing controlled drug delivery products, including controlled release microsphere products made with biodegradable polymers.
  • Responsible for directing technical project teams and maintaining client relationships in the development of microsphere products and processes.
  • Identified advantageous areas of research and new technologies.
  • Company expert on microsphere technology.

Accomplishments

  • Technical/Scientific Leader for the development of two commercial microsphere products including Risperdal Consta%uFFFF, $1 billion controlled release antipsychotic.
  • Developed two proprietary microsphere process platforms.
  • Guided batch size scale-up efforts from gms to 10's of kgs.
  • Developed novel and proprietary microencapsulation method using non-toxic solvents.
  • Developed proprietary extraction procedure to reduce residual solvents in product.
  • Developed 4-week line extension formulation of current 2-week Risperdal Consta%uFFFF.
  • Authored pharmaceutical development sections of NDA.
  • Led efforts to improve scientific understanding of microsphere drug delivery technology by exploring alternate characterization techniques, developing original performance tests and soliciting external collaborations.
  • Led teams to investigate causes and identify corrective measures for a number of technical issues including: injectability failures, poor powder flow ability, variable drug release behavior, and poor product stability.
  • Developed numerous other controlled release formulations including a contraceptive, hormone for cancer therapy, and an HIV vaccine. Processes were scaled-up from laboratory to clinical trial scale for clinical evaluation.
  • Consulted as Technical Expert for company patent defense and opposition cases.
  • Compiled over 20 patents.

DuPont Company, Extracorporeal Therapy Group, Wilmington, DE, 1981 - 1990

  • As Product Engineering Supervisor and Senior Biomedical Engineer of an internal DuPont business venture focused on the development of extracorporeal blood treatment systems.
  • Managed engineer and 2 technicians. Coordinated internal research and external contract projects for instrument design, consumable manufacture, and sterilization.

Accomplishments

  • Developed therapeutic plasmapheresis system. Developed novel technique to improve plasma separation.
  • Guided $2 million program to design and construct prototype disposables and instrument.
  • Designed and developed immunosorbent columns for therapeutic depletion of specific blood pathogens.
  • Identified critical need and supplier of automatic regeneration instrument resulting in joint development agreement and acceleration of program by 2 years.
  • Developed product specification for second generation instrument answering customer demands of increased utility and less manpower and launching a $1.2 million instrument development program.
  • Developed and designed second generation column reducing critical raw material component by 40% and cutting unit costs by 70%.

Johnson & Johnson Co, King of Prussia, PA and New Brunswick, NJ, 1978 - 1981

  • J&J subsidiaries focused on developing, manufacturing and marketing cardiovascular surgical products.

Senior Research Scientist

  • Managed device development laboratory including supervision of three technicians.
  • Developed product specifications and manufacturing processes.
  • Conducted in-house laboratory and external animal product tests.
  • Participated in the design and development of innovative membrane oxygenator. Novel to the design was the use of secondary flows to improve gas transfer rates.
  • Assisted in the design and development of ancillary cardiovascular products: venous reservoir, arterial blood filter, cardiotomy reservoir, and tubing sets.

Honors & Publications

Academic and Professional Affiliations

  • American Association of Pharmaceutical Scientists
  • Controlled Release Society

Publications and Patents

  • Author and Co-Author, journal, posters, and abstracts.
  • Over 25 patents.

Education

  • Ph.D. Chemical Engineering, Northwestern University, Evanston, IL
  • M.S. Biomedical Engineering, Northwestern University, Evanston, IL
  • B.S. Mechanical Engineering, University of Notre Dame, Notre Dame, IN
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