Consultancy specializing in science-based regulatory strategies and development services to facilitate translation of biomedical research, emerging technologies and product development. Product classes include vaccines, cellular [including stem cells] and gene therapies, animal-based and plant-based bio-therapeutics, biotechnology-derived and tissue engineered products as well as novel small molecule chemical entities. Specific areas of focus include due diligence assessments of preclinical data and preclinical development strategies to support First in Human studies.

Established the Regulatory Affairs Department, which included regulatory affairs and clinical data management data programming functions and assisted in identifying and developing new pre-clinical opportunities.Served as company spokesperson with the FDA and foreign agencies in all aspects of the regulatory process.Provided regulatory oversight for the pilot manufacturing facility start-up and commissioning, validation, and expansion initiatives.Additional responsibilities included management of an Integrated Compliance Program, a unit formed in 1998, comprised of Quality Assurance (QA), Environmental Health & Safety (EH&S) function and the cross-functional Quality Systems Team (QST.)Provided oversight for development of the HGS EH&S Master Health and Safety Plan which was designed to enhance the management of corporate compliance activities.

Responsible for inter-center and international policy guidance for the preclinical development and safety assessment of biological products. Spokesperson for CBER at local, and national and international meetings related to pharm/tox aspects of biologic product review. From 1990-1997 served as FDA safety topic lead for the International Conference on Harmonization of Technical requirements for Pharmaceuticals (ICH) initiative and as rapporteur for the ICH S6 guidance on preclinical safety evaluation of biotechnology-derived pharmaceuticals. Appointed to Senior Biomedical Research Service (SBRS).Monitored quality and consistency of CBER review activities and provided oversight for CBER technical committees created to support review activities. Ensured the accuracy of review and tracking of application data collected and reported by CBER. Chaired and Clinical Hold and Refuse to File Oversight Committees and served as Product Jurisdiction Liaison and center Ombudsman for resolution of review activity disputes unresolved at the division or office level between individuals or entities inside and outside of CBER. Additional responsibilities included supervising the regulatory information management system (RIMS) staff and the project manager of electronic submissions.Served as a member of the Intercenter Prescription Drug User Fee Application (PDUFA) Reauthorization Team. In 1997 chaired the FDA Science Symposium. Served as CBER representative to the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and chaired the Immunotoxicity Working Group."

Served as ex officio center representative to the National Center for Toxicological Research Scientific Advisory Board.(1993-1997) Assisted in planning and developing policy and programs that set standards for traditional biologicals and biotechnology products. Served as a member on the Review Management Coordinating Committee. Chaired working group to develop guidance for comparability programs for biological products (April 1996 Guidance Document onComparability), Chaired the Clinical Hold and Refuse to File Oversight Committees.

Developed pharmacology/toxicology policy and implemented guiding principles for CBER product application review and surveillance. Ensured interdivisional and interoffice consistency regarding design and analysis of pre-clinical studies. Co-chaired the Intercenter Committee on the Use of Transgenic Animals to Produce Therapeutics for Human Use. From 1993-1996, served as CBER representative to the FDA Regulatory Scientist Peer Review Committee and the FDA Chemical Selection Working Group.

Managed OBRR interface with intramural and extramural pharmacology/toxicology programs and issues. Provided leadership in addressing pharmacology/toxicology issues to the five research division staffs of OBR as well as other offices within CBER. Served as toxicology reviewer on hundreds of INDs and six product license application (PLA) committees. FDA representative to Office Technology Assessment Report on Identifying and Controlling Immunotoxic Substances and member of the Naval Research Advisory Committee Panel on Delivery of Artificial Blood to the Military.

Principal study director for pharmaceutical products derived from biotechnology. Planned, executed, and carried out the program for the safety evaluation of biotechnology-derived products in cooperation with appropriate scientific specialists at the various Hazleton laboratories worldwide. Served as the primary contact for developing pre-clinical development testing strategies including protocol design, standards of technical performance, methods for data interpretation, and recommendations for future directions of the corporation. Managed costs for assigned studies.Also served as the primary contact for inquiries related to immunotoxicology for Hazleton Corporation worldwide. Authored more that 100 confidential study reports.

As principal investigator for all genetic toxicology studies, directed programs to evaluate chemicals, particulate, drugs, and biologics in a series of assays designed to determine potential, mutagenic or carcinogenic risks. Managed all costs and revenues for the laboratories under supervision. Interfaced with the FDA, EPA an other regulatory agencies to assist clients in meeting regulatory requirements. Chaired, Hazleton R&D committee.