Anne Marie Api, Ph.D. W: +1-201-689-8089 ext. 103 C: +1-914-433-1205 Summary of Experience Research Institute for Fragrance Materials Inc. (RIFM) 1984-present Woodcliff Lake, New Jersey USA Vice President, Human Health Sciences 2006-present RIFM, the most comprehensive source worldwide for toxicology data, literature and information on the evaluation of fragrance materials is the international scientific authority for the safe use of fragrance materials. Combining an advanced knowledge of fragrance ingredient safety, senior leadership experience, an excellent work ethic and exceptional communication skills, I have established a quality record of managing fragrance ingredient safety at RIFM. I am committed to investigating new scientific methodologies to keep RIFM at the cutting edge of advancements in toxicology. I am also committed to education and inspiring others on current and future goals. Responsible for the human health scientific program. Continue to maintain and oversee implementation of the RIFM Safety Assessment program with respect to all human health endpoints as well as computational toxicology. Investigate and initiate new research and testing projects, including those that would involve development of new testing methodologies. I continue to promote and initiate new research projects that evaluate and improve test methodologies and assessment procedures to address the emerging safety challenges. Initiated and oversee the publication of the RIFM safety assessments on the Food and Chemical Toxicology Fragrance Material Safety Assessment Center (http://fragrancematerialsafetyresource.elsevier.com). This is a partnership between RIFM and Elsevier for an open access resource center. Initiated and continue to update an aggregate exposure model for providing a realistic exposure assessment to fragrance ingredients. I coordinate the implementation of this project with an industry core team Creme Global (www.cremeglobal.com), a well- established partner to industry in modeling exposure for cosmetics and foods, and their methodology is accepted by regulators. Prior to the evolution to the safety assessment process was initiated in 2012, I directed the RIFM group summary and fragrance material review program and oversight of completion of safety assessments [for publication and submissions to regulatory groups]. Plan and maintain an annual human health research and test program budget of $7 million. Direct interaction with the RIFM Expert Panel, an international panel of experts. Act as RIFM liaison to the Panel. Responsible for development of agendas, minutes, invited guests, management of all data for review and ensuring research program is presented and thoroughly reviewed by the Expert Panel. Supervise a total of six full-time employees and three toxicologists who work off-site. Anne Marie Api, Ph.D. September 2015 Manage RIFM representation to the fragrance industry scientific committees; providing safety evaluation data. Act as liaison for RIFM human health and safety program with external expert committees. Scientific Director 1999-2005 Key job responsibilities and accomplishments were: Responsible for the scientific program, which includes conduct of human health and environmental toxicity studies. Completed 5-year strategic plan. Direct the RIFM group summary and fragrance material review program. Plan and maintain an annual research and test program budget of $1.4 million. Direct interaction with the RIFM Expert Panel. Developed procedures and implement the flavor/fragrance ingredient data sheets (MSDS) program. Supervise a team of eight full-time employees, five toxicologists who work off-site and four part-time employees. Developed procedures and implement the flavor/fragrance ingredient data sheets (MSDS) program. Manage the extensive database for RIFM and the Flavor and Extract Manufacturers’ Association (FEMA). Developed procedures for database; implement maintenance and ensure integration of new references. Supervise computer consultant. Manager, Human Health & Safety 1996 - 1999 Key job responsibilities and accomplishments were: Managed the human health and safety program. Plan and maintain an annual research and test program budget. Directed the continued update and improvements of the database, which was made available to Members. Transferred the database to a personal computer-based database software system; helped develop a more user-friendly system. Supervised four full time employees and up to four part-time employees and two professionals who work off-site. From January to June, 1998, managed the RIFM office in the absence of a RIFM President. Completed a doctoral degree, while working. Toxicologist 1987 – 1996 Key job responsibilities and accomplishments were: Coordinated and managed human health and safety studies of fragrance ingredients. Interact with experts to achieve the functional excellence of the test program. Organized data entry and maintenance of the database Developed, refined and implemented the document retrieval system. Planned the annual testing budget. Supervised two full time employees and up to four part-time employees and two professionals who work off-site. Scientific Assistant 1984 - 1987 Key job responsibilities and accomplishments were: 2 Anne Marie Api, Ph.D. September 2015 Outsource studies with CRO’s and managed interactions. Active role in developing the newly formed RIFM database. Developed guidelines for data entry. Lever Research Inc., Safety Assurance Section 1980-1984 Edgewater, New Jersey, USA Senior Research Biologist 1982-1984 Key job responsibilities and accomplishments were: Supervised animal sensitization and rabbit eye tests. Supervise activities of technician and graduate. Prepared perfume safety clearance reports and developed labels for Industrial Products. Metabolism work in rats. Used radiolabeled material to determine excretion pattern. Responsible for initial screening and dissemination of toxicology work requisitions. Created and established, an on-line system for storage and retrieval of all requisitions and formulations received. Prepare and issue Standard Operating Procedures in accordance with GLP regulations. Research Biologist 1980-1982 Key job responsibilities and accomplishments were: Assisted in planning and monitoring human sensitization studies. Prepared Material Safety Data Sheets for raw materials as well as finished products. Responsible for creating new MSDS forms. Devised and implemented retrieval system for raw material data files. Performed clinical hematology tests in subacute studies. Assisted computer programmers in adopting software package to interface with hematology instrument. Certified prosector for necropsy procedure. 3 Anne Marie Api, Ph.D. September 2015 Education Ph.D., Aston University, Birmingham England, 1996. Graduate degrees were achieved while maintaining a full-time position. M.S. Toxicology, St. John's University, Jamaica, New York, USA 1983. Graduate degrees were achieved while maintaining a full-time position. B.S. Biochemistry, cum laude, Manhattan College, Riverdale, New York, USA, 1980. Professional organizations American Academy of Dermatology American Chemical Society, American Contact Dermatitis Society, American Management Association American Society for Photobiology, Dermal Clinical Evaluation Society (Board of Director 1991-1997), European Society Contact Dermatitis Society of Investigative Dermatology Society of Toxicology Dermal Toxicology Specialty Section Secretary/Treasurer 2006-2008 Society of Toxicology Mid-Atlantic Chapter, Women in Flavor & Fragrance Commerce Board of Director (1997-2015; Treasurer 2008- present) University Appointments Adjunct Assistant Professor, University of Medicine and Dentistry of New Jersey, School of Health Related Professions, Departments of Clinical Laboratory Sciences, Newark, NJ (2004- 2008). Peer Review Panels 1. Dr. Api has served on the independent scientific peer review panel organized by the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) to review the validation status of several recent modifications to the Murine Local Lymph Node Assay (LLNA), March 4-7, 2008. Continuing Education Courses 1. American Management Association seminar on October 19-21, 1998 - Managing Technical Professionals (Meeting 02285-119); 1.8 CEUs awarded 4 Anne Marie Api, Ph.D. September 2015 2. American Management Association seminar on June 18, 1999 - Handling People With Diplomacy and Tact (Meeting KBT9039); 0.6 CEUs awarded 3. American Management Association On-Site Seminar, May 7-8, 2003 - Effective Presentation Skills for Technical Professionals, 1.2 CEUs awarded 4. American Management Association Seminar, December 16-17, 2004 – Confronting the Tough Stuff: Turning Managerial Challenges into Positive Results, 1.2 CEUs awarded 5. American Management Association Seminar, July 11-13, 2005 – Fundamentals of Finance and Accounting for Nonfinancial Managers, 1.8 CEUs awarded 6. American Management Association Seminar, March 19-21, 2007 – The Essentials of Budgeting: From Creation through Application, 1.8 CEUs awarded 7. American Society Contact Dermatitis, July 2001 - 6th Contact Dermatitis State-of-the-Art Conference, 0.9 CEUs awarded. 8. American Society Contact Dermatitis, July, 2003 - 7th Contact Dermatitis State-of-the-Art Conference, 0.9