X. SHERWIN YAN, MD, PhD, DABT, ERT

Randolph, NJ *7869

973-***-****

ac8k45@r.postjobfree.com

SUMMARY

US Board certified toxicologist (DABT), EU certified safety assessor, with over 20 years of extensive experience in Global regulatory compliance, product safety regulation, toxicological risk assessment, clinical trials in biopharmaceutical, OTC, medical device, and consumer products industries. A physician with 4 years of medical practice and clinical research experience in China.

QUALIFICATION

Regulatory Affairs

Extensive working knowledge of EPA TSCA regulation, PMN, SNAP, and SNUN process

Detailed understanding of practical regulatory requirements of chemical registration (REACH) and product information dossier to support product commercialization

Capability to engage with global regulatory agencies, develop regulatory strategies to support product development

Successful experience and knowledge of the regulatory requirement and process of OTC medical devices [510(k) / PMA, EU Medical Device Technical File], nonclinical and clinical program regulatory filing for oral pharmaceutical, and OTCs (IND/NDAs)

FDA’s adverse event report requirements for medical devices, OTC and cosmetic products

Strategic guideline for claims support, artwork and labeling review, and regulatory toxicology issues such as global product labeling issues and new regulatory restrictions on ingredients

Toxicology & Product Safety

Development and implementation of strategy for assessing the safety of new ingredients for OTCs, medical devices, oral pharmaceuticals, and consumer products

Toxicological risk assessment of ingredients to determine Margin of Safety (MOS) per Weight of Evidence (WoE) approach by reviewing safety information from literature search, read across from analogues, (Q)SAR predictions (e.g., OECD tool box, DEREK, ToxTree and TOPKAT), in vitro, in vivo and clinical studies

Design, execution, and reporting of in vitro toxicity, biocompatibility, and pre-clinical studies in conformance with GLP, ISO, OECD and ICH guidelines

Expertise in product safety substantiation and compliance to domestic and global regulations

Preparation of product safety dossier, pre-clinical and medical part of safety reports (e.g. PSR, PSURs, Clinical Study Report, Annual Product Review Report, safety due diligence reports)

Clinical Trial

Substantial experience in designing, conducting and interpreting clinical studies (Safety & Efficacy) in Pharmacology, Toxicology, Dermatology, and Otolaryngology in compliance with ISO and ICH guidelines

Successful applications in IND and related clinical trial authorization applications with regulatory authorities

Hands-on experience and in-depth understanding of clinical trials for PKPD, Biomarker, Dermotoxicity, Phototoxicity, Photoallergy, and Safety-In-Use evaluations

Good Clinical Practice (GCP) and IRB Ethical review

Proficiency in clinical protocol development, biochemical and instrumental evaluation methodologies

Data analysis, publication, and filing for legal claim substantiation and warning label support

Team Leadership and Supervisory Skills

Over 15+ years’ experience in leading product safety, regulatory affairs, and clinical teams

Managing experience on world-wide program to ensure compliance with global regulatory requirements

Confidence and capability to represent on multi-disciplinary project teams, providing scientific advice and contributing to strategic discussions

Representing in trade associations and scientific committees

Demonstrated leadership and influence skills to work effectively in a collaborative environment

Providing training to toxicologists and regulatory affair staff

PROFESSIONAL EXPERIENCE

Honeywell International Inc.

Director of Product Stewardship & Toxicology (Sep. 2017 – Present)

Lead the Performance Materials and Technology (PMT) Product Stewardship team in the US, providing expert guidance and leadership to the Product Stewardship and Toxicology function. Direct cross-functional teams in support of EPA PMNs, SNAPs, SNURs. Chair the OEL/PAC and Risk Assessment Committee, offering strategic and technical guidance to business leaders and technology developers regarding all aspects of regulatory compliance, toxicology and risk assessment.

The Yankee Candle Company (Acquired by Newell Brands Inc.)

Global Head, Product Safety and Regulatory Compliance (Mar. 2015 – Sep.2017)

A member of the Senior Leadership team. Overall responsibility included development and implementation of global policies and procedures governing all aspects of ingredient/product safety, regulatory strategy and compliance for North America, APAC, and EMEA. Close collaboration with Legal, Brands, Marketing, Operation, Manufacturing, and Corporate Communications as well as outside vendors. Led a team of toxicologists and regulatory affair professionals that developed and maintained a world-class regulatory compliance program, ensuring all Company policies and processes related to health, safety packaging and labeling in compliance with local, state, federal and foreign regulations.

Lorillard Tobacco Company, Inc., Greensboro, NC (Lorillard acquired by Reynolds American, Inc. in 2015)

Principal, Scientific Affairs & Product Stewardship 2014 – 2015

Vice Chair of Lorillard Product Stewardship Committee leading project teams developing new and improved product from a scientific and product stewardship perspective. Developed and established the process and procedure in human health risk assessment model of chemicals in regular and electronic cigarettes. Served as Scientific Affairs subject matter expert in regulatory toxicology and clinical trials. Monitored multiple phases of clinical trials (PKPD, Biomarkers) according to SOPs, ICH- GCP and local regulations. Supervised activities in developing written scientific publications and positions, safety evaluation and risk assessments, product safety dossier, regulatory submissions to support product stewardship and enable the sale of exciting and new products in a complex and dynamic regulatory environment. Represented Scientific Affairs on various task forces within the company, represented the company in industry. Maintained and advanced awareness in key areas of the science in order to anticipate, identify, and investigate developments with potential to impact the company’s business.

Colgate-Palmolive Company, Global Technology Center, Piscataway, NJ

Associate Director, Global Product Safety 2010 – 2013

Chair of the across-functional Global Safety Working Group responsible for developing strategy and managing the world-wide program to ensure compliance with global regulatory requirements. Led the Global Product Safety team to develop and implement strategy in safety assessments for ingredients, formulas and packaging to support the safety of Colgate oral and personal care products for regulatory agency approval. Formulated successful solutions for domestic and international regulatory toxicology issues. Active interactions with Product Development, Legal, Consumer Affairs, Corporate Communication to ensure solid supports in regulatory toxicology compliance. Represented the Company on trade associations and scientific committees, e.g., the Safety and Regulatory Toxicology Committee (SRTC) and CIR Scientific Support Committee (CIR SSC) of the Personal Care Products Council (PCPC), the PCPC China Task Force, Colipa Expert Ingredient Defense Committees, and EU Commission Cosmetic Regulation Annex I Committee.

The Estee Lauder Companies Inc., Melville, NY

Director of Safety & Toxicology, Global Regulatory Affairs 2008 – 2009

Served as a technical expert to provide regulatory and toxicology support to ELC global operations. Responsible for global raw material safety, product safety dossier, regulatory assurance, and cosmetovigilance program. Successful in time review of more than 3,000 raw materials from safety, toxicology, and regulatory compliance perspectives for ELC global products. Tactical advice in formula technology and toxicology provided to ELC staff, raw material vendors, and subcontractors to enhance the efficiency in product development. Close interaction with Product Development, Legal, and other ELC departments in the US and around the world on product safety and stewardship.

Playtex Products, Inc. (acquired by Energizer Holdings), Allendale, NJ

Sr. Manager, Product Safety and Biomedical Evaluations 2005 – 2008

Manager, Product Safety and Regulatory Affairs 2001 – 2004

Led a team of the Regulatory/Biomedical Affairs, Clinical and Product Safety, and Microbiology professionals responsible for the regulatory compliance and safety of raw materials and finished products, labeling claim substantiation, product registration, and review of consumer issues related to Playtex Feminine Care, Infant Care, and Personal Care products. Directed the long-term mission of the group in evaluating raw materials, microbiological testing, and the clinical trials on the finished products (medical devices, OTCs, toys, and skin care products) as well as the review of consumer events related to products. Five successful applications of FDA pre-market notification 510(k) supported with comprehensive biocompatibility studies. Established safety and regulatory requirements and internal processes with SOPs for all Playtex products in compliance with Medical Device, OTC drug, and cosmetic regulations. Provided regulatory toxicology support for Australia, China, EU and other international markets. Short period of employment with Limited Brands, Inc. (2003-2005) with similar managerial responsibilities in product safety and product stewardship due to unstable business situation.

EDUCATION

PhD, Toxicology, Rutgers University/UMDNJ

Doctoral dissertation: Biomarker identification and exposure assessment of environmentally toxic substances in a population of pregnant women and newborns.

MS, Pharmaceutical Science /Toxicology, St. John's University, NY

Master thesis: In vitro neurotoxicity of methyl mercury: Effects on astroglial cytoskeleton.

BS/MD, Medicine (8 years), Shanghai Medical University, P.R. China.

Medical practice and clinical research

CERTIFICATES

Diplomat of the American Board of Toxicology (DABT). 2006, 2011, 2016

UK and EUTOX Registered Toxicologist. Since 2015.

Fellow Royal Society of Biology. Since 2015.

CONTINUING EDUCATION

Society of Toxicology

Extrapolation in the Airways: Strategies to Incorporate In Vivo and In Vitro Data to Better Protect Human Health

Protecting Human Health: Use of Toxicological and Epidemiological Data in Determining Safe Levels for Human Exposure

Evaluating Toxicity of Engineered Nanomaterials: Issues with Conventional Toxicology Approaches

New Technologies and Approaches in Genetic Toxicology and Their Expanding Role in General Toxicology and Safety Assessment

Current approaches in mixture risk assessment

International Harmonization of Technical Requirements for Conducting Non-clinical Safety Studies of Human Pharmaceuticals: Guidelines, Case Studies, and Challenges

Developmental Toxicology Studies: Design, Interpretation and Risk Assessment

Fundamentals of Nanotechnology: Chemistry, Exposure, Health/Environmental Assessments and Societal Impacts

Skin Sensitization and Allergic Contact Dermatitis

The Safety Assessment of Proteins: Applications to Agricultural Biotechnology

Toxicology Excellence for Risk Assessment (TERA)

Dose response and risk Assessment

Drug Information Association, Inc.

Regulatory Affairs Part I: The Investigational New Drug (IND) Phase

Regulatory Affairs Part II: The New Drug Application (NDA) Phase

OECD Computational Toxicology Toolbox – QSAR Application

Systems Toxicology: Multiscale Modeling of Environmental Impacts on Bionetworks.

European Union SCCP/Vrije Universiteit Brussel

Safety Assessment of Cosmetics in the EU.

The Center for Professional Advancement

Skin Product Development – Formulation, Safety, and Efficacy Evaluation

Analytical Methods Validation for FDA Compliance

· Current Good Manufacturing Practice for Pharmaceutical Quality Control Personnel Validation and Certification of the Pharmaceutical Quality Control Laboratory

Skin Imaging Instrumentation and Methods

Medical Algorithm for Wound Healing: A Pathway of Wound Management

ASSOCIATIONS

ASHRAE SSPC 34 Toxicology Committee

ECETOC

Society of Toxicology (SOT)

American Association of Chinese in Toxicology SOT

oPresident-Elect, 2017 - 2018

oPresident, 2018 - 2019

oImmediate Past President, 2019 - 2020

SOT Risk Assessment Specialty Section

Drug Information Association (DIA)

Royal Society of Biology

Consumer Specialty Products Association Air Care and Scientific Affairs Committees

Cooperation Centre for Scientific Research Relative to Tobacco

PCPC Safety and Regulatory Compliance Committee

PCPC International RA Committee China Task Force

Former CIR Science and Support Committee

Former Cosmetic Europe Ingredient Defense Committee

APPENDIX

Publications and Presentations

D'Ruiz, C.D., O'Connell, G., Graff, D.W., Yan, X.S., 2017. Measurement of cardiovascular and pulmonary function endpoints and other physiological effects following partial or complete substitution of cigarettes with electronic cigarettes in adult smokers, Regulatory Toxicology and Pharmacology 05.002.

X. Yan, C. D’Ruiz, 2015. Effects of using electronic cigarettes on nicotine delivery and cardiovascular function in comparison with regular cigarettes. Regulatory Toxicology and Pharmacology, 71: 24-34.

C. D’Ruiz, D.W. Graff and X. Yan, 2015. Nicotine delivery, tolerability and reduction of smoking urge in smokers following short-term use of one brand of electronic cigarettes. BMC Public Health, 15:991.

X. Yan, C. D’Ruiz, 2014. Effects of Using Electronic Cigarettes on Nicotine Delivery and Cardiovascular Function in Comparison with Regular Cigarettes. . Submitted to Society of Toxicology, Society for Research on Nicotine and Tobacco for annual presentation and publication.

C. D’Ruiz, X. Yan, 2014. Characterization of Nicotine Exposure and Urge-to-Smoke Following a Single Controlled Administration and Short-Term Ad Lib Use of Electronic Cigarettes and Conventional Cigarettes in Adult Smokers. Submitted to Society of Toxicology, Society for Research on Nicotine and Tobacco for annual presentation and publication.

X. Yan, 2014. Speech and Panel at the IIVS Workshop: Assessment of In Vitro COPD Models for Tobacco Regulatory Science. Bethesda, MD.

Y. Jiang, X. Yan, 2014. Safety Assessment of Oral Care Ingredients and Products. Chapter in Book “Safety Evaluation Guideline for Oral Care and Cleaning Products”, issued by China Oral Products Industrial Association.

X. Yan. 2012. Speech at the International Association Meetings (Oral and Personal Care) organized by ABIHPEC, ANVISA, and ITEHPEC: Harmonization of Techniques for Safety Evaluation of Cosmetics and Their Ingredients. Brasilia, Brazil.

X. Yan. 2011. Cosmetic Safety Reviews: Industry Perspective. Speech at the Annual Technical Seminar, Chinese American Cosmetic Professional Association, Society of Cosmetic Chemist.

D. Barr, C. Ananth, X. Yan, S. Lashley, J. Smulian, T. Ledoux, P. Hore, M. Robson. 2010. Pesticide Concentrations in Maternal and Umbilical Cord Serum and their Relation to Birth Outcomes in a Population of Pregnant Women and Newborns in New Jersey. Science of the Total Environment (STOTEN), 408 (4):790–795.

X. Yan, S. Lashley, J. Smulian, C. Ananth, D. Barr, T. Ledoux, P. Hore, M.G. Robson. 2009. Pesticide Concentrations in Matrices Collected in the Perinatal Period in a Population of Pregnant Women and Newborns in New Jersey. Human and Ecological Risk Assessment, 15 (5): 948-967.

X. Yan, A. Calafat, S. Lashley, J. Smulian, C. Ananth, D. Barr, M. Silva, T. Ledoux, P. Hore and M.G. Robson. 2009. Phthalates Biomarker Identification and Exposure Estimates in a Population of Pregnant Women. Human and Ecological Risk Assessment, 15(3): 565-578.

X. Yan, M. G. Robson, J. C. Smulian, C. V. Ananth, and S. Lashley. 2008. Biomarker Identification and Exposure Estimate for Phthalates in a Pregnant Population. 47th SOT Annual Poster presentation.

X. Yan, G. Riccardi, M. Meola, A. Tashjian, J. SaNogueira, T. Schultz. 2008. A Tear-free, SPF 50 Sunscreen Product. Cutaneous and Ocular Toxicology. 27: 231-239.

X. Yan, C. Piterski, S. Nitka. 2007. Evaluation of the Hen's Egg Test-Chorioallantonic Membrane (CAM) Method in Prediction of the Eye Irritation Potential Formulated Personal Wash Products. Cutaneous and Ocular Toxicology. 26 http://www.informaworld.com/smpp/title~content=t713597280~db=all~tab=issueslist~branches=26(1), 25 – 36.

G. Solodkin, U. Chaudhari, K. Subramanyan, A.W. Johnson, X. Yan, A. Gottlieb. 2006. Benefits of Mild Cleansing: Synthetic Surfactant-Based (Syndet) Bars for Patients with Atopic Dermatitis. Cutis 77 (5), 317-24.

X. Yan, C. Piterski and S. Nitka. Evaluating the Precision, Sensitivity and Correlation of the Hen’s Egg Test-Chorioallantonic Membrane Method (HET-CAM) for the Assessment of Eye Irritation Potential of Formulated Personal Rinse-off Products. The Toxicological Sciences / Toxicologist. 90:1, 327, 2006.

E.A. Choudhury, X. Yan, S. Nitka, S. Arshad,. Evaluation of Chemical Interactions and Dose-response Relationship in Eye Makeup. The Toxicological Sciences / Toxicologist. 90:1, 480, 2006.

X. Yan, E. Choudhury. Determination of the Dose-Response Relationship for Surfactants Using the BCOP. Toxicological Sciences. 84:1, 2005.

X. Yan, E. Choudhury, J. Szweda, J. Harbell. 2005. Benefits of Using Bovine Corneal Opacity and Permeability Assay for the Formula Development and Safety Assessment of Surfactant-based Bath Products. 44th SOT Annual Poster Presentation.

M. Ovadia, D. H. Zavitz, X. Yan, K. B. Pajonas, M, Moskowitz, D. Frenkel. 1997. The Equivalent Circuit of Pacing in the Limit as Surface Area goes to Zero: A Complex Impedance Plane Analysis. The Journal of the American College of Cardiology. 29:2, 512A.

X. Yan, L. D. Trombetta. 1996. In Vitro Neurotoxicity of Methyl Mercury: Effects on Astroglial Cytoskeleton. St. John’s University and MASOT Poster presentation.

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