Project Safety

Zbigniew Christopher Kosman, D.V.M., M.S., RAC

***** ******* ***** *****

Apt.26

San Diego, CA 92126

tel.: (C) 858-***-****

e-mail: *****************@*****.***

SUMARY

• Extensive industry knowledge of the drug discovery and development process (small and large molecule).

• Education: DVM and MS in toxicology.

• Regulatory Affairs Certificate (RAC).

• Training: cardiology, safety pharmacology, pathology and laboratory animal medicine.

• Comprehensive understanding and hands-on experience in conducting different study types in all laboratory animal species, including toxicity and safety pharmacology studies.

• Certification in regulatory pharmacology. Knowledge of recent ICH, FDA, EMEA, Japanese and other Health Authorities guides and recommendations.

• Formal training and experience in laboratory animal medicine, laboratory animal physiology, pathology and histopathology.

• Knowledge of USDA regulations and NIH guide.

• Hands on expertise in the development and/or validation of in vitro and in vivo models including: hypertension, oncology, inflammation, arthritis, pain, addiction, anxiety, diabetes and sepsis.

• Strong interpersonal and managerial skills with extensive background in training staff, writing SOPs and in communication of results to project teams, senior management, business partners, investors, sponsors and regulatory agencies.

• Experienced Project Toxicologist and Exploratory Toxicology Scientist:

1. Established and implemented the preclinical development plans needed to satisfy internal and regulatory requirements on a project basis.

2. Developed the exploratory toxicology/safety pharmacology programs (MRL San Diego, Encysive).

3. Provided early drug safety data and its interpretation to Project Team Managers.

4. Evaluated published/unpublished data and provided risk evaluation on new ingredients for regulatory submissions and clinical trials in humans.

5. Evaluated, selected and overnighted of contract research organizations (CROs) and ensuring compliance with good laboratory practice (GLP) and international committee of harmonization (ICH) guidelines.

6. Communicated with the team leaders and members on a regular basis and promptly notified functional head and team leaders of issues.

• Experienced Study Director:

1. Established optimal toxicological testing requirements, provided the study protocols, provided data interpretation and created the research reports in compliance with GLP regulations.

2. Experienced Study Monitor:

3. Served as key contact for outsourced studies and assured that studies are executed according to protocol, SOP and contract. Negotiated timing, cost and quality of outsourced studies

4. Reviewed and approved the interpretation, analysis, documentation and reporting of results of toxicology, safety pharmacology and pathology studies to assure accurate safety assessments of drugs and devices.

5. Reviewed and approved summaries of safety evaluations prepared for internal research release documents, regulatory agencies and clinical investigator brochures.

6. Provided scheduling and technical input for the project functional development plans.

PROFESSIONAL EXPRIENCE:

Safety Pharmacology Consulting, LLC 2008-2011

Consultant – toxicology, safety pharmacology and regulatory affairs

Ricerca Biosciences Inc. 2007- 2008

Study Director.

Encysive Pharmaceuticals Inc, a Pfizer company. 2004- 2006

Principal Scientist III, Pre-clinical Drug Development.

Perry Scientific Inc. 2003-2004

Study Director.

Merck 1999–2003

Principal Scientist II, Investigative Drug Safety.

AstraZeneca, Wilmington, DE 1998 –1999

Principal Scientist I, Investigative Safety Pharmacology.

EDUCATION

DVM, School of Veterinary Medicine, Warsaw, Poland

MS, Pharmacology/Toxicology, Thomas Jefferson University, Philadelphia.

Certification, Regulatory Pharmacology, UCSD, San Diego.

Postdoctoral training, Temple University, Philadelphia,

ADDENDUM

RELEVANT CONTINUING EDUCATION:

Scientific Courses:

Laboratory Animal Medicine, Seminars, University of Pennsylvania, PA, USA

In- vivo pharmacology, SmithKline.

Cardiovascular and Respiratory Safety Pharmacology, Society of Safety Pharmacology (certification).

Training and certification, Regulatory Pharmacology, UCSD, San Diego, CA USA (certification).

Management Courses:

Core Leadership.

Building and Leading Effective Teams

Guaranteeing the success of New Employees

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