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| Name and Educational Degree: |
| Wojcinski, Zbigniew, BS, DVM |
BSc (Zoology): University of Toronto (1976) DVM: Ontario Veterinary College, University of Guelph (1982) DVSc (Pathology): Ontario Veterinary College, University of Guelph (1986) |
Drug Development Preclinical Services, LLC
4782 Northgate Drive
Ann Arbor, MI 48103
United States |
| Telephone: |
(734)660-4564 |
| Mobile Number: |
(734)660-4564 |
| Email Address: |
zwwojcinski@ddpsllc.com |
| Web Site URL: |
http://www.ddpsllc.com |
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| Nonclinical drug discovery/development including toxicology (specializing in dermatotoxicology), toxicologic pathology; nonclinical safety assessment; regulatory toxicology including preparation of the nonclinical sections of INDs/NDAs/IMPDs/MAAs/JNDAs/505(b)(2)s; gap analysis; study monitoring; preparation of out-licensing packages; and due diligences. |
Zbigniew W. Wojcinski, DVM, DVSc, DACVP, DABT is principal and co-founder of DDPS, LLC. Dr. Wojcinski is a board-certified veterinary pathologist and toxicologist with over 25 years experience in the pharmaceutical industry, having worked at Parke-Davis, Pfizer, and Fulcrum Pharma Developments, Inc. He has worked with small molecules, biologics, dermatologics, and medical devices. Dr. Wojcinski has extensive experience as Study/Review Pathologist for toxicity studies, including 5 carcinogenicity studies. Throughout his career, he has managed successful cross-functional drug development teams in CNS, Metabolic Diseases, and Dermatology therapeutic areas. Dr. Wojcinski has also been directly involved in the preparation of pre-IND documents, Nonclinical Safety Assessments for IND/IMPD/NDA/MAA, Investigator’s Brochures and labeling (USPI, SmPC) negotiations in CNS and/or Dermatology therapeutic areas. He has had numerous interactions with regulatory agencies in the US, Europe, Canada and Australia for compounds at various stages of development. Most notably, Dr. Wojcinski was the toxicology representative throughout the entire development of the CNS drug, Lyrica®, which is now marketed worldwide. While at Fulcrum, Dr. Wojcinski successfully completed 3 pre-IND documents, 4 INDs, modules 2.4 and 2.6 of an eNDA, an NDA, provided consultation on a JNDA, and worked on 2 IND-enabling projects. He also provided pathology consultation and histopathology peer review on several projects. CV available upon request. For additional information please visit our website at: www.ddpsllc.com
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