Advisors

Michael R. Kurman, MD

Clinical development

Michael R. Kurman, MD is a consultant to the pharmaceutical and biotechnology industries who has spent 40 years in the oncology drug development field. He is a board-certified medical oncologist who was a community-based physician in New Jersey where he participated as an investigator in oncology clinical trials sponsored by the National Cancer Institute. During his career in the pharmaceutical industry, he has held positions of progressive responsibility at Janssen Pharmaceutica as Director of Oncology, at Cyotgen Corporation as Senior Director of Research and at U.S. Bioscience as Vice-President for Research. Dr. Kurman also served as Vice-President for Clinical and Scientific Operations for Quintiles’ Oncology Therapeutics Division. Dr. Kurman received his bachelor’s degree summa cum laude in biology from Syracuse University and his M.D. degree from Cornell University Medical College. He received his training in internal medicine at the State University of New York – Upstate Medical Center, and his oncology training at Mt. Sinai Medical Center in New York.

Dr. Kurman has served on the scientific advisory boards and boards of directors of several companies. He is also a member of the Syracuse University Arts and Sciences Dean’s Advisory Board, is a past President of the Upper Saddle River Board of Health and is a member of several professional societies.

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Eyal S. Ron, PhD.

Drug Dev

Dr. Eyal S. Ron creates tremendous value for life-sciences enterprises (pharmaceutical, biotechnology and device companies) by effective mentoring while accelerating the timeline toward the value inflection point. Dr. Ron provides entrepreneurial out-of-the-box thought-process and deep science-based expertise to enhance the enterprise overall value and its product candidates without building costly infrastructure.

Dr. Ron has over 30 years of experience in the development of drugs, biomaterials, devices and drug delivery systems. He has a record of accomplishments for combining science with innovative business strategies, having developed and implemented the scientific, regulatory and clinical strategy for several companies. He has in-depth understanding of total development process including project management, Manufacturing scale-up, clinical trials, regulatory, formulations, drug delivery systems, QC & QA.

Dr. Ron is the author of over 100 papers, book chapters and abstracts. He is also the inventor of over 50 patents principally in the area of drug formulations, drug delivery, tissue engineering, devices and biomaterials. Dr. Ron is a regular invited lecturer in the area of innovative approaches to create trusted partnership with service providers.

Dr. Ron facilitated the formation of over 12 Biotech companies and under his leadership over ten products were brought to market.

Dr. Eyal S. Ron creates tremendous value for life-sciences enterprises (pharmaceutical, biotechnology and device companies) by effective mentoring while accelerating the timeline toward the value inflection point. Dr. Ron provides entrepreneurial out-of-the-box thought-process and deep science-based expertise to enhance the enterprise overall value and its product candidates without building costly infrastructure.

Dr. Ron has over 30 years of experience in the development of drugs, biomaterials, devices and drug delivery systems. He has a record of accomplishments for combining science with innovative business strategies, having developed and implemented the scientific, regulatory and clinical strategy for several companies. He has in-depth understanding of total development process including project management, Manufacturing scale-up, clinical trials, regulatory, formulations, drug delivery systems, QC & QA.

Dr. Ron is the author of over 100 papers, book chapters and abstracts. He is also the inventor of over 50 patents principally in the area of drug formulations, drug delivery, tissue engineering, devices and biomaterials. Dr. Ron is a regular invited lecturer in the area of innovative approaches to create trusted partnership with service providers.

Dr. Ron facilitated the formation of over 12 Biotech companies and under his leadership over ten products were brought to market.

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Gary T. Elliott, PhD.

CMC and Drug Dev.

Dr. Elliott possesses over 30 years experience in the biotechnology and pharmaceutical industry provide an experienced perspective in preclinical/manufacturing-analytical/pharmaceutical/safety/quality and clinical drug development strategic areas.  With a formal didactic, fellowship and employment background in pharmacy, clinical pharmacology, pharmaceutical sciences, medicinal chemistry, clinical research, and quality compliance, the consultant has guided overall drug development strategies for numerous pharmaceutical and biotech companies. 

Dr Elliott has had extensive interaction over the years with US, Canadian and European drug and biologics regulatory authorities, considerable experience authoring and supervising compilation of many regulatory filings (e.g. INDs, NDAs, annual reports, end of Phase 2, Phase 3 and NDA CMC, toxicology and clinical technical documents) and experience organizing participating and leading associated face to face and telephonic meetings with regulatory authorities.  Consequently this consultant has developed comprehensive insight and appreciation of what are “development phase appropriate” levels of cGMP and cGLP compliance. 

In various senior management positions held in the past including: VP Product Development, Ribi ImmunoChem; Sr, Dir. Product Development, Corixa Corp; VP Product Development, Salmedix Inc.; Executive VP Product Development, Aires Pharmaceuticals; and VP Technical Operations and Quality, Adventrx Pharmaceuticals, Dr. Elliott has built out and supervised a variety of disciplines including in-vitro biology, pharmacology, toxicology, pharmaceutics/formulation, medicinal and analytical chemistry, API and drug product process manufacturing development, cGMP manufacturing, Quality Assurance, CMC and Safety Regulatory Affairs and clinical development (infectious disease, oncology and cardiovascular areas).  Overall pre-clinical and clinical drug development plan design, budgeting, execution and Gantt based project management are activities the consultant routinely provides to his clients.

The consultant also provides critical review of in-licensing opportunities and competitive assessment of external drug candidates, allowing identification across clinical, CMC, Quality and preclinical areas of the strengths and weaknesses of such technologies using a GAP analysis approach and has extensive experience with due diligence and in-licensing negotiations of drug candidates from China, and Korea.  

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Nancy J. Harper, PhD.

Formulation

Accomplished pharmaceutical product development scientist with emphasis on development of parenteral, oral liquid and DPI inhalation products. Unique talent for merging scientific rigor, regulatory expertise, and pragmatism into drug product development while ensuring that customer needs are met. Expert in commercial drug product design and development (formulation and manufacturing process), application of Quality by Design (QbD) concepts, CMC regulatory strategy/authorship, technical risk assessment and problem solving. Key contributor as formulator or pharmaceutical expert to the development and successful commercialization of 10 new drug products. Experience with NCE’s (human and veterinary), product enhancements, and generic products for developed and emerging markets.

Expertise includes:

  • Formulation design and development
  • Process development and scale-up
  • CMC regulatory strategy
  • CMC submission component authorship
  • Technical risk assessment and problem-solving
  • Technical due diligence for business development
  • Data analysis and interpretation
  • Life cycle management

Accomplished pharmaceutical product development scientist with emphasis on development of parenteral, oral liquid and DPI inhalation products. Unique talent for merging scientific rigor, regulatory expertise, and pragmatism into drug product development while ensuring that customer needs are met. Expert in commercial drug product design and development (formulation and manufacturing process), application of Quality by Design (QbD) concepts, CMC regulatory strategy/authorship, technical risk assessment and problem solving. Key contributor as formulator or pharmaceutical expert to the development and successful commercialization of 10 new drug products. Experience with NCE’s (human and veterinary), product enhancements, and generic products for developed and emerging markets.

Expertise includes:

  • Formulation design and development
  • Process development and scale-up
  • CMC regulatory strategy
  • CMC submission component authorship
  • Technical risk assessment and problem-solving
  • Technical due diligence for business development
  • Data analysis and interpretation
  • Life cycle management
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David Brewster, PhD.

Toxicology

DWB Tox Consult ,LLC:  Global Regulatory Toxicology and Drug Development

Dr. Brewster is a Board-certified toxicologist with 30 years of research experience in toxicology and nearly 25 years experience in the pharmaceutical industry. He has extensive experience in the development of new molecular entities, medical devices, reformulations of marketed products and global product registration and support.  Most recently as Global Head of Preclinical Drug Safety Evaluation at Vertex pharmaceuticals he was responsible for oversight of the toxicology, pathology, safety pharmacology, toxicology operations, and investigative toxicology departments.  He has authored or co-authored ~50 IND’s and 10 NDAs/BLAs. During his long career, Dr. Brewster continued to build the presence and recognition of the organizations he represented to academia, US trade organizations, and professional drug development organizations and is an active member of various Scientific and Pharma trade organizations. His interests not only include drug development and working collaboratively with the FDA but also seeking alternatives to classical toxicology testing, evaluating the application of stem cell technologies and investigating the use of non-invasive biosensors and whole-body imaging in safety assessment.  Since leaving the corporate sector and now as an independent consultant providing advice for Global preclinical regulatory strategies and oversight of early and late stage drug development projects, his passion is working with small companies to bring promising new therapies into the clinic in order to assess patient outcome.

DWBToxConsult,LLC:  Global Regulatory Toxicology and Drug Development

Dr. Brewster is a Board-certified toxicologist with >30 years of research experience in toxicology and nearly 25 years’ experience in the pharmaceutical industry. He has extensive experience in the development of new molecular entities, medical devices, reformulations of marketed products and global product registration and support.  Most recently as Global Head of Preclinical Drug Safety Evaluation at Vertex pharmaceuticals he was responsible for oversight of the toxicology, pathology, safety pharmacology, toxicology operations, and investigative toxicology departments.  He has authored or co-authored ~50 IND’s and 10 NDAs/BLAs. During his long career, Dr. Brewster continued to build the presence and recognition of the organizations he represented to academia, US trade organizations, and professional drug development organizations and is an active member of various Scientific and Pharma trade organizations. His interests not only include drug development and working collaboratively with the FDA but also seeking alternatives to classical toxicology testing, evaluating the application of stem cell technologies and investigating the use of non-invasive biosensors and whole-body imaging in safety assessment.  Since leaving the corporate sector and now as an independent consultant providing advice for Global preclinical regulatory strategies and oversight of early and late stage drug development projects, his passion is working with small companies to bring promising new therapies into the clinic in order to assess patient outcome.

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