Toxicologist: Pharmaceutical, Nutraceutical and Consumer Healthcare Products

Expertise

• Focused toxicity investigations in the consumer health, nutrition pharmaceutical and product safety industries.
• Drug and food ingredient preclinical development, (all phases) and healthcare products (OTC and personal care products).
• Product safety and product regulatory consultant frequently interacting with FDA, EPA, international regulatory agencies, U.S. and foreign pharmaceutical and chemical companies.
• Risk assessments and management of preclinical development and regulatory programs for pharmaceutical, nutraceutical, consumer healthcare, and chemical products.
• Food ingredient toxicology studies.

Experience

Undisclosed Company, President, 2008 - Present

• Independent toxicologist servicing clients; preclinical development, product safety, and regulatory, toxicological assessments of pharmaceutical, food ingredient, nutraceutical, and consumer healthcare products.

Firmenich, Princeton, NJ, Vice President, 2009 - 2010

• Headed the Product Safety and Regulatory Affairs Department (PSRA) of North America.
• Overall responsibility for all NA safety and regulatory affairs issues relative to flavor and fragrance chemicals.
• Managed a team of 24 regulatory scientific staff and their functions, and annual budget of approx. $8 million.
• Successfully led PSRA efforts to obtain core listings for 2 new NA customers.
• Filed and received approval for 6 chemical PMNs with EPA.
• Filed and received approval for 2 GRAS submissions with FEMA.
• Revised and signed approximately 25 confidentiality agreements with customers that improved transfer of information between companies.
• Managed and reviewed approximately 90 safety and toxicology studies for EPA and FEMA submissions and, or internal safety database. All were acceptable to external regulatory agencies.
• Led the PSRA SAP conversion team.
• Successfully converted old system into SAP, and aligned with the business divisions with no regulatory disruptions.
• Successfully led the integration of 700 newly acquired flavor chemicals into internal regulatory safety database that enabled the business to sell these products.
• Successfully led the kosher and halal certification teams for flavor ingredients that allowed their sale as kosher and halal products.
• Served as company lead with external research and development partner to develop 2 new flavor ingredients for future sale those were approved by FEMA.
• Served as PSRA representative to 7 FEMA, FMA and/or RIFM scientific committees.
• Revised 22 department SOPs that improved quality and efficiency of work functions.
• Regularly met with 6 NA flavor and fragrance customers to enhance and/or improve regulatory relationships.

Johnson and Johnson, Pharmaceutical Research and Development, Raritan, NJ, 1978 - 1988 (and 1991 - 2007)

Senior Director, Preclinical Development Team Leader

• Provided leadership within Global Preclinical Development (GPCD) for all aspects of the nonclinical development plan, and its implementation, for assigned drugs.
• Served as the single point of accountability within GPCD to the Compound Development Team (CDT) and as the interface between the CDT and GPCD functional and senior management. Managed GPCD nonclinical project deliverables to the CDT in conjunction with GPCD functional and senior management.
• Projects included Concerta®, Topamax®, Ultram®, Ultracet®, Pancrease® and Senicapoc®.
• Served on due diligence teams for 2 License and Acquisition (L&A) drug candidates.

Senior Director

• Head of Preclinical Development in specialty pharmaceuticals division for McNeil Consumer, (Johnson & Johnson, Washington, PA).

Director, Preclinical Development, Department of Drug Development and Safety

• Created and led the Preclinical Development Department. Held overall responsibility for the nonclinical development programs for all Rx and OTC drugs, as well as personal care products, in McNeil's portfolio. Generated toxicology and risk assessments for L&A prescription drugs, OTC switch candidates, OTC product specification deviations, dietary supplements, food ingredients and shampoos, as well as for materials to be incorporated into these products.
• Managed approximately 75 preclinical drug safety and efficacy studies conducted at contract laboratories.
• Prescription drugs: Concerta®, Senicapoc®, Ketoprofen®, Benzydamine®, Ditropan®. OTC drugs - Tylenol®, Motrin®, Imodium®, and Nizoral. Nutraceuticals: Lactaid®, Benecol® and Policosanol.
• Served on 12 due diligence teams for U.S. and European L&A drug candidates.
• Established all department SOP's.
• Managed 3 scientific staff and department budget of approximately $3 million per year.
• Generated pharmaceutical and toxicology sections of 3 IND, 1 NDA, and 2 Monograph submissions.
• Established relationships and had frequent interactions with FDA, toxicology consultants, and contract laboratories.
• Served on J &J Corporate Toxicology Committees, and CHPA TIO2 Task Force.

Principal Toxicologist, Medical Affairs Department, Personal Products Worldwide

• Head of the Preclinical Development Group for J&J Consumer Franchise Worldwide, Skillman, NJ.
• Managed generation of risk assessments and toxicology and safety studies on materials relative to their safety for use in external sanitary protection, incontinence, tampon, diaper, condom, and wound care products in the U.S. and, or international markets. Materials included adhesives, chemicals, colorants, fabrics, fibers, films, fragrances, papers and pulps.

Senior Toxicologist, Product Safety and Regulatory Affairs Department, J&J/McNeil Specialty Products

• Initiated, monitored and, or evaluated multiple acute, subchronic, reproductive and chronic toxicology studies, as well as immunotoxicology, carcinogenicity and pharmacokinetic studies, conducted at European and U.S. contract laboratories on Splenda® (Sucralose).

Study Director, J&J/McNeil Pharmaceutical

• Department of Drug Safety Evaluation.

Temple University School of Pharmacy, Philadelphia, PA, 1988 - 1991

• Teaching Assistant and Doctoral Student, Pharmacology Department.

Honors & Publications

Credentials

• Board Certified Toxicologist
• Patent Law, Healthcare Compliance, Manager and Law, Inquisitive Leader
• Global Cultural Training, Transformational Leadership, Diversity Training, GAP
• Dissertation Research - Developmental Toxicology: The Developmental Toxicity in Mice of 13-Cis-Retinoic Acid Administered Alone or in Combination with Phenobarbital.

Academic and Professional Affiliations

• American Board of Toxicology, Diplomat
• Society of Toxicology
• American College of Toxicology
• Society of Toxicology, Mid-Atlantic Chapter
• Greater Philadelphia Senior Executives Group
• Regulatory Affairs Professionals Society
• Pennsylvania BIO

Awards

• Standards of Leadership Awards, Johnson & Johnson
• Achievement Awards, Johnson & Johnson
• Upjohn Pharmacy Research Award for Excellence in Research
• Rho Chi Pharmacy Honor Society
• Phi Sigma Biological Honor Society

Publications

• Numerous national and international presentations, posters, and publications.

Education

• Ph.D. Pharmaceutical Sciences, Temple University, Philadelphia, PA
• M.S. Biology, Villanova University, Villanova, PA
• B.S. Biology, The Pennsylvania State University, University Park, PA