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Pharmaceutical Scientist, Pharmacology, Toxicology, Immunology, GLP Compliance Expert Consultant Resume

Resume of IHR, Ph.D. Consultant
Principal Industries Served:
  • Pharmaceutical
  • Pharmacology
  • Toxicology
  • Immunology
  • GLP Compliance

Education:

This expert has a Ph.D. from WPI / UMASS Medical School (joint program).

This associate has a B.A. in Psychology from Salem State College.


Expertise and Services:

Pharmaceutical Scientist, Pharmacology, Toxicology, Immunology, GLP Compliance Expert Consultant Resume

This associate is an expert in pharmaceutical science, with more than 20 years of advanced training in toxicology, human physiology, immunology, and GLP compliance applied to drug development.

This consultant offers a proven track record of advancing small molecule therapeutics from discovery through NDA submission in multiple therapeutic areas. This consultant has had key responsibilities for long-term and short-term planning of projects requiring interaction with regulatory, commercial, clinical and CMC units. This expert has recruited and supervised preclinical development personnel, worked closely with medical science liaisons to identify thought leaders, review grant proposals and provide training, and budgeted and managed internal and external resources to develop new drugs for development in a highly regulated environment.

This expert identified and in-licensed drug candidates in the therapeutic areas of respiratory, CNS and women's health. This expert is a focused, congenial and effective collaborator within multi-disciplinary teams that successfully led to 6 marketed prescription drugs. This expert is the CEO and co-founder of a drug development organization funded by private and venture capital to develop an in-incensed synthetic estrogen for topical use and has been a consultant to start-up biotechnology companies.


Professional Experience:

Consultant, Kevin Kennedy Associates Inc.

Providing expertise in pharmaceutical science, pharmacology, toxicology, human physiology, immunology, GLP compliance, and related expertise to a wide variety of clients.

 

Founder, CEO and President, Biomedical firm

Adapted and streamlined strategies to ensure effective achievement of scientific and business objectives. Evaluated and negotiated an exclusive license for a novel topical estrogen. Raised private equity investment. Increased company valuation by carefully managing limited capital to accomplish key preclinical development objectives. Recruited key personnel. Cultivated relationships with thought leaders in women’s health.

 

Adjunct Assistant Professor, Massachusetts College of Pharmacy, Worcester, MA

Delivered lectures and developed course content to Doctor of Pharmacy student in Human Physiology and Immunology.

 

Visiting Assistant Professor of Biology, Worcester Polytechnic Institute, Worcester, MA

Implemented curriculum development and lecture content in Toxicology, Endocrinology, Immunology and Physiology. Served on two Master’s Thesis committees and two Doctoral Dissertation committees.

 

Adjunct Assistant Professor, Quinsigamond Community College, Worcester, MA

Developed lecture and course content in General Biology, Anatomy and Physiology, Nutrition, and Cellular and Molecular Biology.

 

Director of Pharmacology and Discovery Research, Sepracor Inc., Marlborough, MA

Key responsibility for the preclinical pharmacology content of Arformoterol NDA (Brovana®) for the treatment of COPD. Drafted the pharmacology section for an IND for a triple reuptake inhibitor for the treatment of depression. Supported marketing efforts for Lunesta and Xopenex®. Directed multi-disciplinary team responsible for the evaluation of in-licensing candidates for improvement of sleep architecture, COPD, asthma and depression.

 

Associate Director of Pharmacology and Discovery Research, Sepracor Inc., Marlborough, MA

Directed in vivo and in vitro pharmacology of discovery compounds for the treatment of pain (allodynia), respiratory ailments, and CNS disorders. Served as Lead Pharmacologist of the Scientific Research Committee for Xopenex® and Lunesta®. Monitored internal and CRO-outsourced preclinical studies. Authored preclinical pharmacology content for two NDAs (Xopenex UDV®, Xopenex MDI®, two Investigator Brochures and other regulatory documents. Active participant on scientific, business development, commercial and publication teams. Provided educational support, scientific guidance and grant review expertise to the Medical Science Liaison Division.

 

Senior Pharmacologist, Sepracor Inc., Marlborough, MA

Designed, implemented, tracked, summarized and coordinated the preclinical development of small molecule therapeutics in respiratory and urogenital pharmacology. Established an extensive network with opinion leaders in asthma, incontinence, inflammation, pain and CNS disorders as adjunct support for the Medial Science Liaison Division. Direct responsibility for the preclinical content of End-of-Phase II regulatory submissions.

 

Clinical Data Manager, Parexel International, Waltham, MA

Responsible for data review, data validation specification, quality control of deliverables, CRF development, query generation, resolution and integration for Phase IIb and Phase III clinical trials addressing cardiac safety of Carvedilol®

 

Research Assistant, Veterans Administration Hospital, Memphis, TN

Assisted in the development and implementation of experimental protocols in a diabetes research laboratory.

Additional Experience:

Senior Toxicologist, Dana-Farber Cancer Institute, Boston, MA

Developed protocols and SOPs to test the efficacy and safety pharmacology of novel adriamycin analogues.


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