Discover how the microbiome influences the consumer products industry and the critical role it plays. Learn about the tools used at Procter & Gamble to measure and understand microbiome interactions, leading to the development of better and safer consumer goods. This presentation will provide valuable insights into the interplay between our products and microbial communities.

Speaker: 
Dr. Jay Tiesman
R&D Senior Director Research Fellow, Procter & Gamble

Dr. Jay Tiesman is an R&D Senior Director Research Fellow in the Global BioScience Division of The Procter & Gamble Company in Cincinnati, Ohio, USA. He is the Genomics and Multi-Omics Group Leader and, since joining P&G in 1993, has been actively involved in developing genomics and metagenomics capabilities within the Company. He has been particularly interested in the use of these platforms to gain insight into epithelial cell biology. Before joining P&G, he completed postdoctoral training in the laboratory of Dr. Charlie Hart at ZymoGenetics, Inc. in Seattle, Washington. At ZymoGenetics, he pursued research in the field of growth factor signal transduction associated with wound healing and tissue remodeling. He obtained his Ph.D. in Pathology from the University of Nebraska Medical Center in Omaha, Nebraska. In Omaha, he worked in the Laboratory of Dr. Angie Rizzino at the Eppley Cancer Institute, delineating the roles and impact of growth factors on embryonic development. Before joining Dr. Rizzino, he obtained a Bachelor’s degree in Philosophy and Biology at Creighton University in Omaha.

Dr. Tiesman is an acknowledged expert in genomics and microbiome experimental design and has published over 55 articles and book chapters, two of which have earned “Publication of the Year” honors and one of which has earned recognition from the Faculty of 1000. He also speaks extensively at international meetings on the topic of transcriptomics experimental design and is listed on 150 presentations. He collaborates broadly with scientists in academia and the biotechnology industry and has been a member of many academic/governmental/industrial organizations and scientific advisory boards. He serves on the NIST International Microbiome and Multiomics Standards Alliance (IMMSA), the Kisaco Skin Microbiome Advisory Board, and the Microbiology Society Microbiome Safety Working Team. He most recently served as an adjunct professor at The Hong Kong Polytechnic University and currently sits on the Board of Directors of Ischemia Care Diagnostics, LLC and Production Services Unlimited, Inc.

Growing regulatory and consumer calls for sustainable cosmetics have led consumer product companies to develop programs addressing this specifically. This presentation will delve into Unilever’s approach, representing a world-leading model at the cutting edge of industry efforts.

Speaker:

Stefani Millie Grant
Associate Director, External Affairs & Sustainability, Unilever

Stefani Millie Grant is Associate Director, External Affairs & Sustainability for Unilever. In her role, she works with brands; procurement; suppliers; and farmers to implement and deliver Unilever’s sustainable and regenerative sourcing goals in the U.S. and Canada. Ms. Grant also works with elected officials and NGO’s on Unilever’s sustainability efforts, including packaging and climate issues. 

Ms. Grant currently serves on the Board of Directors for the Circular Action Alliance (CAA), the first U.S. producer responsibility organization for packaging. She also served two terms (2016-2020) as Chair of Field to Market: The Alliance for Sustainable Agriculture and Co-Chair of the Midwest Row Crop Collaborative from 2020-2022.

An Iowa native, Ms. Grant holds a Master of Business Administration degree from the University of Iowa and a Bachelor of Arts degree in Accounting and Public Administration from Buena Vista University. 

The potential impact of UV filters on coral reefs has been widely debated sparking significant concern among scientists, policymakers, and the cosmetics industry. In this session, Dr. Raimondo will discuss the latest research around this area and the challenges associated with the development of standardized coral toxicity tests. Attendees will gain insights into the challenges and opportunities in developing these standards, the role of regulatory bodies, and the collaboration required between industry and scientific communities to protect fragile marine ecosystems.

Speaker:

Dr. Sandy Raimondo
Senior Research Ecologist, U.S. Environmental Protection Agency (USEPA)

Sandy Raimondo is a Senior Research Ecologist with the United States Environmental Protection Agency’s Office of Research and Development Gulf Ecosystem Measurement and Modeling Division. Dr. Raimondo’s research focuses on statistical and ecological modeling aimed at reducing uncertainty in ecological risk assessments with a focus on endangered species, maximizing limited data, interspecies extrapolation, and lab-to-field translation. Her research develops methodologies to improve hazard assessments of aquatic systems, including impacts of pesticides, industrial chemicals, and pharmaceutical and personal care products on species ranging from coral to fish. She was the EPA lead on developing the scope of the National Academy of Sciences recent report on the Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and is currently a co-lead of EPA’s research program investigating the impacts of UV-filters on coral. 

Discover the remarkable resilience of our skin’s microbiota in maintaining skin health and protecting against pathogens. This talk will explore how the skin’s microbial community rebounds from daily environmental stressors, ensuring a stable and balanced relationship with the immune system. Learn how these insights can inform better personal care practices and product formulations.

Speaker: 

Dr. Greg Hillebrand
Associate Professor of Pharmaceutical and Cosmetic Sciences, University of Cincinnati

Dr. Hillebrand is currently an Associate Professor of Cosmetic Science at the James L. Winkle College of Pharmacy at the University of Cincinnati. Prior to academics, he was principal research at Procter & Gamble (26 years) and then Amway (10 years) with a focus on new beauty care technology. Greg received his BS from Michigan State University, his PhD from Baylor College of Medicine, and Post-Doctoral training at the University of Illinois. He is a past president and emeritus member of the SCC and a current member of the PCPC INC.

This presentation will explore the rising consumer demand for microbiome-friendly skincare products and the challenges surrounding unregulated claims. It will provide an overview of available testing methods, comparing in vivo and in vitro studies, and discuss whether preservatives compromise microbiome safety.

Speaker: 

Dr. Sabrina Behnke
Associate Business Director, Tri-K Industries

Dr. Sabrina Behnke holds a BSc in Water Sciences from the University of Duisburg-Essen in Germany and a PhD in Microbiology from Montana State University. During her graduate studies, she investigated microbial biofilms in water distribution systems at the Center for Biofilm Engineering in Bozeman, MT, where she collaborated with multinational consumer goods companies. Dr. Behnke then joined Reckitt Benckiser as an R&D microbiologist, supporting EPA claim substation for disinfectant household products. Additionally, she held roles in Personal Care Formulation Innovation and Technology Scouting. In 2018, she switched from the manufacturers to the supplier’s side of the industry as a Global Product Manager for Symrise where she managed a portfolio of Multifunctionals and Preservatives. Today, Dr. Behnke is an Associate Business Director for biopolymers and preservatives with TRI-K Industries.

She was the chair of the PCPC Microbiology Committee from 2021 to 2023 and is currently co-chair of the Microbiome Task Force within the Microbiology Committee. 

Speaker:

Nisha Sipes
Assistant Center Director, Research Translations and Programs/Regulatory Support, US EPA

Dr. Nisha S. Sipes currently serves as an Assistant Center Director within the Center for Computational Toxicology and Exposure (CCTE) in the U.S. EPA’s Office of Research and Development, and is the Product Owner of the CompTox Chemicals Dashboard where she facilitates the translation of CCTE’s research for decision contexts and provides scientific and technical expertise to internal and outside stakeholders. Dr. Sipes has 15 years of diverse work experience in computational toxicology approaches utilizing in vitro high-throughput and new approach methods (NAMs) to estimate in vivo likelihood of chemical-biological interaction. 

Nisha received her BS in Mechanical Engineering, MS in Biomedical Engineering, and PhD in Cell and Cancer Biology from the University of Cincinnati, Ohio. Previous work experiences include high-throughput data analysis, occupational exposure research, medical device and drug design in government, academia, and industry. Dr. Sipes has been involved in several leadership and advisory positions in programs such as the Society of Toxicology, ToxForum, Tox21, and the international intergovernmental collaboration Accelerating the Pace of Chemical Risk Assessment (APCRA).   

This presentation will explore the journey of UV filters traveling from beach to ocean and their potential risks to marine ecosystems. An expert in this field, Dr. Mitchelmore will present the latest research of UV filter monitoring study conducted at a busy beach in Fort Lauderdale, Florida. Her results highlight the influences of where and when samples were taken and the implications for environmental safety assessment.

Speaker: 
Dr. Carys Mitchelmore
Professor and Interim Director, University of Maryland Centre for Environmental Science (UMCES)

Dr. Carys L. Mitchelmore is a Professor and Interim Director at the University of Maryland Center for Environmental Science, Chesapeake Biological Laboratory in Solomons, Maryland. Her research is directed towards the detection of chemical contaminants in various environmental matrices and understanding their fate, toxicity, and implications to organism and ecosystem health for application to risk assessment, regulation, and management activities to provide solutions to environmental problems

Dr. Mitchelmore is heavily invested in integrating scientific research for the management and regulatory communities serving on numerous International and National science advisory groups and as an environmental toxicologist including five National Academies of Science, Engineering, and Medicine committees, including the 2022 “Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health”.

Speaker: 

Steven Schnittger, SME
Independent Consultant

Steve Schnittger retired from the Estée Lauder Companies after 38 years of service. During his tenure at Estee Lauder, he worked closely with the formulation and safety team to ensure preservative efficacy and safety for all product types.

Steve was also responsible for the EL’s Global Fermentation Department which had been tasked with delivering new “active” ingredients using state of the art fermentation technology to continue to feed Estée Lauder’s Innovation Pipeline. Over these past twenty years, the fermentation team developed over 50 new breakthrough technologies which has led the Estée Lauder Companies to be recognized as the leader in fermentation technology within the Personal Care Industry.

Externally, Steve represented the U.S. Cosmetic Industry in ISO – International Standards Organization, European Cosmetic Trade Organization, ICCR – International Cooperation on Cosmetic Regulation and PCPC – The US Cosmetic industry Trade Organization.

Steve has a degree in Microbiology from Tulsa University in Oklahoma and has over 20 patents in the area of fermentation and preservation. He is recognized as an expert in the area of preservation, microbiology and fermentation and is asked frequently to give lectures in each of these areas.

Join us for an insightful presentation by Dr. Huang on cosmetic product quality and consumer safety. Learn about the development of the FDA’s Bacteriological Analytical Manual (BAM) Chapter 23 for microbiological analyses of cosmetics. We’ll also explore new testing approaches to differentiate between beneficial microorganisms and contaminants, ensuring safe and effective cosmetic products.

Speaker:

Dr. Jo Mei-Chiung Huang
Microbiologist, Office of Cosmetics & Colors, FDA

Jo Huang received her Ph.D. in microbiology from the University of California, Davis. She worked on postdoctoral research on expressing human lysozyme genes in transgenic animals. Her industry experiences include contract laboratory services and personal care products.

Dr. Huang joined FDA as a microbiologist in the Office of Regulatory Affairs in 2003. She was certified to perform pulse field gel electrophoresis (PFGE) of Salmonella, Listeria, and E. coli. She participated in domestic and foreign firm inspections. Dr. Huang transferred to the Office of Cosmetics and Colors in 2011. She serves as a senior reviewer of microbiological safety of cosmetic products and ingredients. She is also involved in developing regulations and policies for new cosmetic categories. Dr. Huang has orchestrated changes in Bacteriological Analytical Manual (BAM), Chapter 23 for microbiological analyses of cosmetic products in recent years.

Driven by industry to find alternative solutions to animal testing, next generation risk assessment (NGRA) has been a focus point for several decades. While the focus of NGRA has largely been about the human safety of cosmetics, many of the same approaches are available for next generation ecological risk assessment. In this presentation, Dr. DeLeo will present an overview of a recent publication exploring whether the science is suitably mature to enable next generation risk assessment (NGRA) of chemicals.

Speaker:

Dr. Paul DeLeo
Senior Director, Chemical Management, American Chemistry Council (ACC)

Dr. Paul C. DeLeo serves as a Senior Director for Chemical Management at the American Chemistry Council. Over the past 25 years, his career has focused on applied research and advocacy related to the human and environmental safety of food ingredients, pesticides, drugs, cosmetics, and cleaning products. During that time, he has worked at the Office of Food Additive Safety, U.S. Food and Drug Administration (1999–2007), the American Cleaning Institute (2007–2017) and as a consultant to chemical manufacturers and users regarding the safety of their ingredients and products (2017–2021). He shares his professional passion for consumer, occupational and general population exposure to chemicals in commerce as an active member of the American Industrial Hygiene Association, the International Society for Exposure Science, the Society for Environmental Toxicology and Chemistry, and the Society of Toxicology, and has published dozens of articles in those topic areas in the peer-reviewed scientific literature. Dr. DeLeo obtained a PhD from Cornell University and a master’s degree in environmental engineering from Rensselaer Polytechnic Institute. 

Non-animal testing methods in the form of New Approach Methodologies (NAMs) have evolved over the years and we can now assess the safety of chemical ingredients. This speeds up the process and reduces unnecessary experimental testing. In this presentation, Dr. Ott will provide an overview of the challenges and opportunities presented by the need to develop (NAMs) and Next Generation Risk Assessment (NGRA) frameworks to demonstrate the environmental safety of cosmetic ingredients.

Speaker: 
Dr. Amelie Ott
Director, Environmental Sciences, International Collaboration on Cosmetics Safety (ICCS)

 Dr. Amelie Ott is an experienced scientist and manager, leading global multi-stakeholder projects to improve the environmental safety of chemicals.

She is currently the Director, Environmental Sciences at the International Collaboration on Cosmetics Safety (ICCS) where she is tasked with overseeing the strategic development and tactical management of their environmental science program. ICCS is a global not-for-profit organization to advance the adoption of animal-free science for human and environmental safety assessment of cosmetics, through science, education & training, and regulatory engagement.  Before this role, she worked at the European personal care trade association, Cosmetics Europe as an Environmental Sciences Manager and as a scientist at Newcastle University, co-leading the validation and standardization of a new biodegradation method. She also worked as a parliamentary researcher for the UK Parliament and as a scientific secretary consultant for the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC). She is still a visiting researcher at Newcastle University, representing the UK in an OECD Expert Group. She holds a Ph.D. in environmental engineering on emerging contaminants from Newcastle University, UK.

This presentation aims to explore the potential of non-growth approaches for evaluating microbial bioburden by considering them as particles, rather than relying on proliferation or metabolic indicators for detection. The presentation will share insights gained from comparing traditional approaches with cytometric approaches in simple systems and discuss the opportunities and challenges that lie ahead.

Speaker:

Dr. Terry Amoroso
Corporate QA Technical Director of Industrial Microbiology, Procter & Gamble

Terry L. Amoroso is a Technical Director in the Industrial Microbiology Group for P&G Corporate Quality Assurance. In his 20+ years at P&G, Terry has held a variety of positions in the R&D and Corporate Microbiology organizations, including roles as Microbiology Lab Manager and as Microbiology Section Head for Beauty & Grooming, Fabric & Home Care, and Compliance, accountable for ensuring microbial integrity and compliance for product initiatives. Prior to joining P&G, he held a Group Leader role at Pfizer, focused on high-throughput screening of antimicrobial actives. In his current role as Technical Director in Industrial Microbiology, his focus areas include ultra-rapid/real-time microbiological detection methods, microbial risk assessment, clean design, and external engagement. Terry is active in the Personal Care Products Council (PCPC) and has served as the Chair of the PCPC Microbiology subcommittee and serves as an expert on the US TAG for ISO/TC217 Cosmetics for WG1 – Microbiological Standards. 

Speaker:

Nicholas Georges
Senior Vice President, Scientific & International Affairs, Household & Commercial Products Association

Nicholas Georges is the Senior Vice President, Scientific & International Affairs of the Household & Commercial Products Association (HCPA). Georges leads HCPA’s activity on aerosol products and industrial & automotive products, as well as multiple scientific and regulatory areas both domestically and internationally such as air quality. Georges has a monthly column in Spray Technology & Marketing and often contributes to other publications such as World Aerosols and Aerosol Europe. 

Before joining HCPA, Georges was the Director of Regulatory Affairs at PLZ Aeroscience and the Technical Director at Nyco Products Company. Georges has a B.S. in Chemistry from the University of Illinois Urbana-Champaign. 

Microbiologists play a pivotal role in bringing innovative and safe products to market. PCPC is committed to nurturing talent and paying it forward to support the future of our industry. Join us as we celebrate the 2024 recipient of this distinguished award.

Speaker:

Joyce Lam
Senior Manager, Science Programs, Personal Care Products Council

Microbiology program wrap and final reflections. 

Speaker:

Dennis Neeson
Sr. Quality & Technical Manager, Colgate-Palmolive

One of the biggest issues facing the research community is how research data information is misunderstood or misused which can spread disinformation. Often the issue might be due to poor communication and how the information was relayed and presented. In this session, Dr. Chan will provide an effective communication toolbox that scientists can use to help tackle issues and avoid misusing their research.

Speaker: 

Dr. Aegean Chan
Dermatologist and Dermatopathologist, California Dermatology Group (CDG)

Aegean H. Chan, MD, FAAD is a double board-certified dermatologist and dermatopathologist. She is the medical director of California Dermatology Group, in Santa Barbara, CA. She is also an adjunct professor in the Department of Dermatology at the Keck School of Medicine of the University of Southern California. Her area of clinical expertise is in complex medical dermatology, skin cancer, acne, and cutaneous infectious diseases. She has published numerous articles in peer-reviewed medical journals on the science of the skin barrier, electron microscopy, and congenital skin diseases. Her most recent work on regressed melanoma is included in the fourth edition of the World Health Organization Classification of Skin Tumors.

Dr. Chan is an advocate of evidence-based skincare. She uses her social media platform to debunk pervasive skincare myths and misinformation and provide relevant, useful skin education to a wide audience. Her expert opinion has been featured in a variety of publications, including the New York Times, Huffington Post, and Allure. She is on Instagram and TikTok @draegeanchan.

Dr. Katz, who oversees the cosmetics program at the FDA, will deliver a keynote address on the FDA’s work toward implementing the requirements of the Modernization of Cosmetics Regulation Act (MoCRA). Dr. Katz will provide timely information on the priorities and enforcement activities for cosmetics.

Keynote Speaker: 

Dr. Linda M. Katz
Director, Office of Cosmetics and Colors, U.S. Food and Drug Administration (FDA)

Dr. Linda M. Katz is the Director of the Office of Cosmetics and Colors (OCAC) and serves as the Senior Advisor, Cosmetics, to the Office of the Chief Scientist.  Dr. Katz joined FDA in 1989 in the Center for Drug Evaluation and Research (CDER) first as a primary medical officer and later as Team Leader and Acting Director of the Pilot Drug Evaluation Staff, which reviewed anti-rheumatic drugs, anesthetic agents, and drugs of abuse.  Other positions in CDER included Deputy Director of the Division of Dermatologic and Dental Drug Products, and Deputy Director of the Division of Over-the-Counter Drug Products. In 2002, Dr. Katz joined the Center for Food Safety and Applied Nutrition (CFSAN), as the Director of OCAC and served over 10 years as the Acting Chief Medical Officer. Dr. Katz is responsible for establishing the strategic plans for OCAC and directing regulatory and research activities, and for liaising with industry, nongovernmental organizations, consumers, stakeholder groups, and national and international regulators on policy and research related issues.  She is recognized nationally and internationally for cosmetic initiatives involving harmonization, safety, and legislative activities. Dr. Katz received her MD from the University of Connecticut School of Medicine, her MPH in Epidemiology from the University of Michigan School of Public Health, and her BA in Biology from the University of Pennsylvania. She did her residency in Internal Medicine and fellowship in Rheumatology at the George Washington Medical Center.  Dr. Katz is an elected Fellow in the American College of Physicians and a Fellow in the American College of Rheumatology.  In addition, Dr. Katz has taught at Walter Reed Army Medical Center and the Uniformed Services University of the Health Sciences and has numerous publications in the scientific and medical literature.   

Learn first-hand from CDR Thompson on strategies for a successful FDA inspection, and key elements for an inspection readiness plan.

Speaker:

CDR Chad N. Thompson
Director, Investigations Branch, Office of Pharmaceutical Quality, Division 1, FDA

CDR Thompson is a Director of the Investigations Branch in the Office of Pharmaceutical Quality Operations, Division I, within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). He is responsible for pharmaceutical quality inspections and investigations, working in conjunction with the FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine. He has over 15 years of inspectional experience with the FDA. Prior to working for the FDA, he was a Senior Research Scientist for a contract research organization conducting small-molecule drug discovery. CDR Chad Thompson has a Masters in Chemistry from the University of Albany and a Bachelor’s in Chemistry from Gardner-Webb University. He currently resides in Albany, NY with his wife, Heather, and their four children. 

As the lines between cosmetics and drugs continue to blur, managing facilities that produce both types of products presents unique regulatory, operational, and quality control challenges. An expert panel of industry leaders to discuss practical strategies for managing these dual facilities offering insights into overcoming common obstacles and optimizing operations for efficiency and safety. Attendees will walk away with a deeper understanding of how to balance the operational demands of producing both product types while ensuring full compliance with all applicable regulations.

Roundtable with Industry Quality Experts: 

Don Ye

Vice President of Global Corporate and R&D Quality, The Estée Lauder Companies Inc.

Don has worked the past 20 years for The Estée Lauder Companies Inc. (ELC). His tenure at Estee Lauder started in Canada leading the Quality organization supporting the manufacturing, distribution, and R&D (Toronto/Markham, Canada). In 2014, Don started to hold roles leading global Estee Lauder programs such as Validation and Data Integrity. For the past 3 years, he has been leading the Global Corporate Quality team (and holding interim position as NA Quality lead and Global Supplier Quality lead).

Don is an experienced Quality Assurance and R&D professional with a demonstrated history of working in the cosmetics industry. Strong professional skilled in Manufacturing, Management, Consumer Products, Government Relations, and Continuous Improvement. He hails from the wonderful country to the north, Canada where he attended the University of Toronto where he earned degrees in Bachelor and Master in Science. Prior to working for ELC, Don’s career path has led him through both Food and Cosmetic industries spending time with George Weston Group, Loblaw Corp, Unilever and privately owned cosmetic contract manufacturing.

Liam Jablesnik

Vice President, Quality & Regulatory, Mana Products

Steve Riedell

Director, Corporate Quality Assurance, Procter & Gamble

Steve Riedell is with The Procter & Gamble Company and is currently the Corporate Quality Assurance Director for the Americas Auditing organization. In his 32 years with P&G Steve has experience in R&D and manufacturing quality assurance positions focused primarily on drug, cosmetic, and food products. He has extensive experience with quality management systems, auditing, validation, and operations. Steve received his B.S. in Chemical Engineering from Iowa State University.

Cathleen Owen

Director of Pharmaceutical and Personal Care Services, Q Laboratories

Cathleen Owen is the Director of Pharmaceutical and Personal Care Services for Q Laboratories located in Cincinnati, Ohio. Cathleen has extensive experience in the pharmaceutical, cosmetic and beauty care industries having spent time at Merck, Elizabeth Arden, Barr Laboratories, and KDC (Tri Tech Labs, Inc.) where she served as Sr. Director of Quality and Regulatory Affairs. In her current role at Q Laboratories, Cathleen works with cGMP-focused clients providing technical support for areas including laboratory testing, validation studies, stability studies, water system qualifications, and regulatory compliance. She holds a B.S. in Chemistry from North Carolina State University and is currently Chair of the Quality Assurance Committee for the Personal Care Products Council (PCPC).

As Director of The Center for Research on Ingredient Safety at Michigan State University (CRIS), Dr. Norbert Kaminski leverages the expertise of established investigators to tackle the tough questions about ingredient safety in our everyday products, including cosmetics. At CRIS, expert knowledge is employed to research, fact-check, and demystify the science. Dr. Kaminski will be sharing an insightful presentation on the current concerns and debates surrounding chemical safety and public perception featuring case studies on titanium dioxide and BPA.

Speaker:

Dr. Norbert Kaminski
Director, Center for Research on Ingredient Safety, Michigan State University

Dr. Norbert Kaminski is a professor in the Department of Pharmacology and Toxicology and is the director for the Center for Research on Ingredient Safety and director of the Institute for Integrative Toxicology, at Michigan State University. Dr. Kaminski is also the Food and Consumer Product Ingredient Safety Endowed Chair. He holds joint appointments in the College of Human Medicine and Veterinary Medicine. He has served on various scientific advisory panels for National Academy of Science and the US Environmental Protection Agency and has served as the member of the NIEHS National Advisory Environmental Health Sciences Council. Dr. Kaminski served as the President for the Society of Toxicology from 2014-2015. His research is in the areas of immunotoxicology and immunopharmacology. Dr. Kaminski received the Merit Award from the Society of Toxicology (2020) and the George Scott Award from the Toxicology Forum (2017).

Recent research has provided valuable insights on the exposure levels to fragrance ingredients in consumer products, revealing that these exposures are extremely low and generally well within safety margins. This session will explore the findings of these studies, offering a comprehensive understanding of what they mean for product safety, consumer perceptions, and regulatory compliance.

Speaker:

Anne Marie Api
President, Research Institute of Fragrance Materials (RIFM)

Dr. Anne Marie Api was elected to serve as President of The Research Institute for Fragrance Materials, Inc. (RIFM) by the RIFM Board of Directors, a role she took on beginning in April 2023. Previously, Dr. Api served as Vice President of RIFM, a position she has held since 2006. RIFM is an independent international scientific organization that tests and evaluates the safety of fragrance materials. The Institute represents more than seventy member companies worldwide. Dr. Api combines an advanced knowledge of fragrance ingredient safety, senior leadership experience, an excellent work ethic, and exceptional communication skills to establish a quality record of managing fragrance ingredient safety at RIFM. In addition, she is committed to investigating new scientific methodologies to keep RIFM at the cutting edge of advancements in toxicology. She is also committed to educating and inspiring others on current and future goals. Dr. Api holds a Bachelor of Science degree in biochemistry from Manhattan College and a Master of Science degree in toxicology from St. John’s University. In addition, Dr. Api earned a Doctor of Philosophy from Aston University in Birmingham, England. In 2020, she became a Fellow of the Academy of Toxicological Sciences (ATS). Dr. Api has authored over 100 scientific publications and is a member of numerous scientific organizations. Dr. Api received the 2018 Toxicology Forum Philippe Shubik Distinguished Scientist Award. The Philippe Shubik Award honors an individual in the field of toxicology who has led a long and productive career in toxicology and who has made significant and noteworthy contributions to the field of toxicology, including all aspects of traditional and regulatory toxicology along with consistent contributions to the field through the support and mentoring of other toxicologists. In addition, she was the Women in Flavor & Fragrance Commerce Woman of the Year in 2006. 

Transitioning to the new requirements under MoCRA presents challenges throughout an organization. In this presentation, Ms. Schneider will address how to prepare and implement strategies to manage change successfully.

Speaker:

Melissa Schneider
Associate Director of Regulatory Compliance, Compliance Insights

Melissa Schneider, CQA, is currently the Associate Director of Regulatory Compliance for Compliance Insight, Inc. In this role, she is responsible for providing a wide range of regulatory and quality assurance services to assist clients in achieving regulatory compliance. These services range from establishment registrations and compliance audits to recall support and FDA inspection response and remediation support. Ms. Schneider has over thirty years of experience in FDA-regulated industries, including cosmetics, dietary supplements, pharmaceuticals, medical devices, and biotechnology. The majority of her experience has dealt with ensuring companies implement and improve their quality systems from their new product development through commercialization. Ms. Schneider has been a member of the American Society of Quality and the American Society for Cell and Gene Therapy and has been a Certified Quality Auditor since 2019. 

Speaker:

Lauren Brown
Associate Director, Supervising Scientist, ToxsStrategies

Lauren Brown is a US board certified toxicologist who has provided risk assessment related consulting services for a variety of clients including government, NGOs and industry for more than a decade. Currently, she serves as a Supervising Scientist and Associate Practice Director for ToxStrategies, a multidisciplinary scientific consulting firm. In this role, most of her day to day revolves around conducting safety and risk assessments for a variety of ingredients used in consumer products including cosmetics, OTCs and food. She has experience collating diverse evidence streams to develop weight of the evidence conclusions as it pertains to ingredient safety. Ms. Brown is also an active member of PCPC’s safety and regulatory toxicology committee and serves in various capacity for several professional organizations including as President of the SOT’s Sustainable Chemicals through Toxicology Specialty Section.

Hear from Alonza Cruse, FDA’s Director of Pharmaceutical Quality Operation who will present the latest investigative activities facing the pharmaceutical industry and the emerging Agency priorities for the coming year.

Invited Speaker:

Alonza Cruse
Director, Office of Pharmaceutical Quality Operations, U.S. Food and Drug Administration (FDA)

Alonza Cruse is Director, Office of Pharmaceutical Quality Operations (OPQO) within the FDA Office of Regulatory Affairs (ORA). His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA’s Center for Drug Evaluation & Research (CDER) and Center for Veterinary Medicine (CVM).

From 2013 – 2015 Mr. Cruse served as the Director (Acting) of the Office of Medical Products & Tobacco Operations (OMPTO) within ORA, overseeing activities such as Generic Drug User Fee Amendments (GDUFA) implementation, pharmacy compounding, and the development of a New Inspection Protocols Program (NIPP). From 2000 – 2015, Mr. Cruse was the Director, FDA’s Los Angeles District Office, where his responsibilities included providing executive leadership to implementing, managing and evaluating FDA’s regulatory operations. Mr. Cruse first joined ORA in 1983 as a microbiologist. He received his Bachelor of Science degree in Medical Technology from York College (City University of New York).

Join us as Ms. Katz addresses why quality agreements with your contract manufacturers, packagers, laboratories, and component suppliers are critical tools to ensure the delivery of safe, quality products to the consumer and the overall success of your business.

Speaker:

Paula R. Katz
Of Counsel, Covington & Burling LLP

Paula Katz advises clients on pharmaceutical compliance and enforcement. She joined the firm after serving as Director of Guidance and Policy for the Office of Manufacturing Quality in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). While at the FDA, Paula focused on current good manufacturing practice (CGMP) enforcement and drug quality policy issues. She advised CDER and FDA leadership regarding manufacturing supply chain controls, contract manufacturing, data and application integrity, administrative law and procedure, and regulatory policy development and enforcement strategy.

As an effort to be more sustainable, the use of post-consumer resin (PCR) in cosmetic packaging has emerged as a key strategy to reduce environmental impact. This presentation explores the opportunities and challenges of incorporating PCR in cosmetic packaging while ensuring safety, regulatory compliance, and maintaining brand aesthetics. Attendees will learn of the latest innovations in PCR technology, strategies for sourcing high-quality recycled materials, and the testing protocols necessary to ensure that packaging made from PCR meets stringent safety standards.

Speaker:

Dr. Ramez Labib
Principal Toxicologist, Venebio Consulting

Ramez is an experienced leader, manager, scientist, and teacher. He has more than 20 years in toxicology, working most of those years for Avon and Johnson and Johnson leading teams dedicated to regulatory compliance, risk assessment, and product safety in the consumer industry sector. He has recently joined Venebio Consulting to lead the toxicology program and support all aspects of safety projects for the consumer business. He has a proven track record in building and managing successful toxicology programs, delivering scientific expertise, and providing strategic leadership. Ramez is also proud to pass on his knowledge to others as an adjunct professor at Rutgers University for 20 years. Ramez obtained his PhD (Biomedical Sciences in Pharmacology and Toxicology in 2002) at the University of Medicine and Dentistry of New Jersey and an MBA at the New Jersey Institute of Technology in 2012. In 2009, he became a Diplomat of the American Board of Toxicology (re-certified in 2024) and in 2014 was recognized as European Registered Toxicologist. He is a full member of the Society of Toxicology, the Society of Environmental Toxicology and Chemistry and the Mid-Atlantic Chapter of the Society of Toxicology. 

The Over-the-Counter (OTC) Monograph reform represents a significant shift in how nonprescription drugs are regulated, with profound implications for product development, compliance, and market entry. This session offers an in-depth exploration of the ongoing activities related to the OTC Monograph system, providing critical insights into the latest regulatory updates, industry responses, and future expectations.

Join us to stay ahead of the curve on OTC Monograph activities and learn how to adapt your strategies to the changing regulatory environment.

Speaker:

Dr. Theresa Michele
Director of the Office of Nonprescription Drugs (ONPD) in the Office of New Drugs, Center of Drug Evaluation and Research (CDER),
U.S. Food and Drug Administration (FDA)

Dr. Theresa Michele is currently the Director of the Office of Nonprescription Drugs (ONPD) in the Office of New Drugs, Center of Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). Prior to joining the FDA in the Division of Pulmonary and Allergy Drug Products, she spent 10 years in the industry, with clinical research experience across a variety of therapeutic areas in both commercial and development-stage companies. She is board-certified in internal medicine, pulmonary medicine, and critical care medicine, completing her training at Johns Hopkins University, where she currently serves on the faculty.

Join us for a lively panel discussion that will wrap up the day with practical real-life regulatory adventures.

Speakers:

Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, U.S. Food and Drug Administration (FDA)

Paula Katz, Of Counsel, Covington & Burling

Melissa Schneider, Associate Director of Regulatory Compliance, Compliance Insights

Chad Thompson, Director, Investigations Branch, Office of Pharmaceutical Quality, Division 1, FDA

Alexandra Kowcz, Chief Scientist, Executive Vice President, Personal Care Products Council

The advancement of AI will revolutionize the toxicology field and safety testing by enhancing the speed, accuracy, and scope of risk assessments. AI can identify patterns and correlations in large and complex datasets that might be missed by human analysts, leading to more precise predictions of chemical toxicity, human exposure risks, and environmental impacts. Join us for an in-depth discussion on what’s in store for the industry using AI and how it will impact and accelerate the development of safer products.

Speaker:

Thomas Hartung
Director of the Johns Hopkins Center for Alternatives to Animal Testing

Thomas Hartung is the director of the Johns Hopkins Center for Alternatives to Animal Testing, which was founded in 1981 as part of the Johns Hopkins University Bloomberg School of Public Health, with a European branch (CAAT-Europe) located at the University of Konstanz, Germany. 

Hartung steers the revolution in toxicology to move away from 50+ year-old animal tests to organoid cultures and the use of artificial intelligence.