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

Technical Consultant #1760

Accomplished engineer/scientist with over 35 years’ experience in the design and development of drug products, pharmaceutical manufacturing processes and medical devices. Successful track record of progressing products from lab bench to commercialization.

.Technical Competencies

Drug product development and characterization, Process development and scale up, Project management, Identifying and managing vendors, CROs, CMOs, Tech transfer & trouble-shooting, Authoring CMC regulatory submissions, Development of micro- and nano-particle drug delivery products, Lyophilization/drying, Polymer technology, Emulsions/suspensions technology, GMPs, and Intellectual property assessment.

Independent Cosnultant, 2015 - Present

Consulting firm providing scientific and technical consultation to biopharmaceutical industry.
Principal and Owner
Recent client services include:
Performed CMC assessment on two pre-Phase III controlled release particulate products for VC.
Provided technical support to law firm for patent defense case against generic product entry.
Drafted Formulation Development Report and supporting reports for NDA submission of microencapsulation product for small start-up.
Provided process development guidance on several chemotherapeutic nanoparticle products for startups.
Served as VP of Technical Operations for nanoparticle start-up.
Preformed 3rd party technology assessment, assisted with formulation development, identified vendors and CMOs for veterinary sol-gel medical device.
Provided CMC assessment and identified CMOs for nasal drug delivery product for start-up.
Assisted in troubleshooting and provided formulation guidance on microencapsulation products for several large and small pharma companies.

Tarveda Therapeutics, Watertown, MA, 2013- 2015

A private biopharmaceutical company focused on the development of platinum-based drugs and nanoparticle delivery systems for oncology treatment.

Scientific Fellow II

Lead company efforts in the process development and manufacture of platinum-based drugs and targeting nanoparticles. Manage suppliers and CMOs for production of clinical materials.
Developed pilot scale capability for producing drug-loaded polymer and liposome nanoparticles.
Guided process development and clinical manufacture of company’s first product, BTP-114, a cisplatin pro-drug.

Cerulean Pharma, Inc., Cambridge, MA, 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

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.

Academic and Professional Affiliations

Publications and Patents