Home : Leadership : Leo Pavliv

Leo Pavliv, R.Ph., M.B.A., R.A.C.

PROFESSIONAL EXPERIENCE/ACCOMPLISHMENTS:

Principal
PharmDev Consulting
Cary, North Carolina

Assisting client companies in all aspects of drug and device development. Developing strategies and then integrating pharmaceutical development, regulatory affairs, non-clinical and clinical development to target efficient product development. Responsibilities include overseeing various product development activities including, API selection and manufacture, preformulation, formulation development, clinical supply manufacture and testing, scale-up, validation, packaging, labeling, distribution, blinding of clinical materials, regulatory meetings and document preparation, audits, and due diligence activities. Design programs to most efficiently meet client objectives from proof of concept through marketing approval and distribution.

Vice President Operations
Cumberland Pharmaceuticals Inc.
Nashville, Tennessee

Responsible for all aspects of drug development including, regulatory affairs, pharmaceutical development, quality assurance, clinical affairs, and manufacturing of clinical and commercial products. Oversee drug development candidates through all phases of development, including oversight of multiple contractors. Select new development candidates to commercialize. Particpate in varied business development activities.

Vice-President Pharmaceutical Development
Cato Research Ltd.
Durham, North Carolina

Responsible for directing the pharmaceutical development activities for numerous products. Areas of planning and oversight include preformulation, formulation, manufacture, scale-up, validation, packaging, labeling, distribution, and blinding of clinical materials. Products include recombinant and natural proteins, peptides, DNA, small molecules, oligonucleotides, and devices in parenteral, oral, and topical dosage forms. Additional areas include the preparation of numerous CMC-related regulatory submissions including INDs, NDAs, BLAs, and 505b2s, planning and attendance at a variety of FDA meetings, and the conduct of GMP and GLP audits. Also, oversees the complete development programs of various products.

Senior Development Pharmacist
Manager, Clinical Supplies
Agouron Pharmaceuticals, Inc.
La Jolla, California

Responsible for numerous, diverse pharmaceutical development projects including the dosage form development of parenteral, oral, and topical products. Novel projects included liposomes, colloidal dispersions, lyophilized products, sustained‑release tablets and capsules, floating tablets, and soft gelatin capsules. Additional responsibilities included manufacturing, packaging, labeling, and distribution of clinical supplies, including extensive international pivotal trials. Evaluated, selected, and managed contract manufacturers and packagers. Managed a staff of three professionals. Chaired the Manufacturing Facilities Task Force. Served as liaison for assigned projects at various companies and institutions. Served as a representative of the Specification Committee. Prepared pharmaceutical development sections of regulatory documents (INDs, amendments, and annual reports). Supervised a contract research organization and acted as liaison with clinical sites on assigned project prior to formation of the clinical group.

Section Leader, Pharmaceutical Development
ProCyte Corporation
Kirkland, Washington

Responsible for the product development activities of ProCyte�s therapeutic peptides. Dosage form development of topical products including; creams, ointments, gels, and sprays; parenteral products including intravenous, intradermal, and subcutaneous injections, oral and rectal solutions, and oral enteric coated beads. Six formulations tested in human or veterinary clinical trials. Designed, equipped, and managed a clinical manufacturing facility. Evaluated, selected, and managed contract manufacturers. Prepared product development sections of regulatory documents. Wrote and implemented Standard Operating Procedures; over 30 SOPs were written and implemented to bring the newly constructed clinical manufacturing facility into GMP compliance. Chaired or member of numerous compliance related committees, including the Dosage Form Specification, the GMP, the Raw Material, the SOP, and the Protocol Committees.

Development Pharmacist
National Patent Development Company ‑ Interferon Sciences and NPDC‑AS101 Divisions
New Brunswick, New Jersey

Developed parenteral and topical dosage forms with an emphasis on natural and recombinant proteins. One product brought to market. Managed contract manufacturers. Served as technical contact between NPDC‑AS101 and marketing partner. Wrote and implemented Standard Operating Procedures. Initiated and administered stability program.

Assistant Scientist
Parke‑Davis, Division of Warner Lambert
Morris Plains, New Jersey

Developed liquid and semisolid dosage forms. Projects included the following: creams, ointments, ophthalmics, suppositories, oral solutions, and emulsions.