2024 Science Symposium & Expo – Agenda

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Conference

2024 Science Symposium & Expo – Agenda

The Ritz-Carlton Pentagon City

Agenda

October 8, 2024

8:45 - 9:35 AM

The Microbiome and Consumer Products: Tools, Measures, and Insights

Microbiology

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.

Dr. Jay TiesmanR&D Senior Director Research FellowProcter & Gamble
10:10 - 11:00 AM

Balancing Act: The Skin Microbiome's Temporal Stability and Resilience to Soaps, Cleansers, and Cosmetics

Microbiology

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.

Dr. Greg HillebrandAssociate Professor of Pharmaceutical and Cosmetic SciencesUniversity of Cincinnati
11:00 - 11:50 AM

Navigating the Microbiome World - Wild West of Claims and Methods?

Microbiology

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.

Dr. Sabrina BehnkeAssociate Business DirectorTri-K Industries
1:15 - 2:05 PM

Microbiological Methods: Do We Validate or Do We Verify

Microbiology
Steven Schnittger, SMEIndependent Consultant
2:05 - 2:55 PM

Evolution of Microbiological Testing for Cosmetics in FDA

Microbiology

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.

Dr. Jo Mei-Chiung HuangMicrobiologistOffice of Cosmetics & Colors, FDA
3:25 - 4:15 PM

Ultra-Rapid Non-Growth Methods: Shift, Approach, Learnings, Opportunities

Microbiology

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.

Dr. Terry AmorosoCorporate QA Technical Director of Industrial MicrobiologyProcter & Gamble
4:15 - 4:30 PM

Early Career Microbiology Award

Microbiology

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.

Joyce LamSr Manager, Science Programs
4:30 - 4:45 PM

Final Address

Microbiology

Microbiology program wrap and final reflections.

Dennis NeesonSr. Quality ManagerColgate-Palmolive

October 8, 2024

8:45 - 9:35 AM

Unilever Sustainability Roadmap

Environmental Science

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.

Stefani Millie GrantAssociate Director, External Affairs & SustainabilityUnilever
10:10 - 11:00 AM

Untangling Coral Sensitivity to UV Filters and Moving Towards Standardized Methods for Ecological Risk Assessment

Environmental Science

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.

Dr. Sandy RaimondoSenior Research EcologistU.S. Environmental Protection Agency (USEPA)
11:00 - 11:50 AM

US EPA's Comptox Chemicals Dashboard: Exporing the Chemical Data Landscape

Environmental Science


In the research and science community, the EPA’s CompTox Dashboard (formerly Chemistry Dashboard) can be powerful tool to help with the environmental risk assestment. Join us in this session as Dr. Sipes will provide a detail overview of this suite of tools that contains chemistry, toxicity and exposure information for over one million chemicals, with over 300 chemical lists based on structure or category to help decision-makers and scientists quickly and efficiently evaluate thousands of chemicals.

Nisha SipesAssistant Center DirectorResearch Translations and Programs/Regulatory Support, US EPA
1:15 - 2:05 PM

How Time and Place Define the Concentration of UV Filters off a Florida Beach

Environmental Science

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.

 

Dr. Carys MitchelmoreProfessor and Interim DirectorUniversity of Maryland Centre for Environmental Science (UMCES)
2:05 - 2:55 PM

Can Next Generation Ecological Risk Assessment Decisions be Made Today? A Case Study of Regulatory Risk Assessment in the United States

Environmental Science

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.

Dr. Paul DeLeoSenior Director, Chemical ManagementAmerican Chemistry Council (ACC)
3:25 - 4:15 PM

Environmental Animal-Free Safety Assessments: A Global View on Challenges & Opportunities

Environmental Science

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.

Dr. Amelie OttDirector, Environmental SciencesInternational Collaboration on Cosmetics Safety (ICCS)
4:15 - 4:55 PM

The Future of Compliance with VOC Regulations

Environmental Science

For more than 35 years, the California Air Resources Board (CARB) has led the way in regulating consumer products in the U.S. Personal care and cosmetic companies have invested a significant amount of time and resources into developing compliant products that meet CARB’s volatile organic compound (VOC) regulations. This presentation will explore the future of VOC regulations, discuss photochemical reactivity, and explain how companies can ensure they are formulating compliant products, including aerosols.

Nicholas GeorgesSenior Vice President, Scientific & International AffairsHousehold & Commercial Products Association
4:55 - 5:35 PM

Translating Science into a Story: Tools to Optimize Science Communication

Environmental Science

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.

Dr. Aegean ChanDermatologist and DermatopathologistCalifornia Dermatology Group (CDG)

October 9, 2024

8:35 - 9:20 AM

MoCRA Implementation Activities and Agency Priorities

Safety, Quality

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.

Dr. Linda M. KatzDirector, Office of Cosmetics and ColorsU.S. Food and Drug Administration (FDA)
9:20 - 10:00 AM

FDA Inspection Readiness

Safety, Quality

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

CDR Chad N. ThompsonDirector, Investigations BranchOffice of Pharmaceutical Quality, Division 1, FDA
10:30 - 11:15 AM

From Titanium Dioxide to BPA: Have We Entered an Era of Chemophobia

Safety

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.

Dr. Norbert KaminskiDirector, Center for Research on Ingredient SafetyMichigan State University
11:15 AM - 12:00 PM

Detailed Aggregate Exposure Analysis Shows that Exposure to Fragrance Ingredients in Consumer Products Is Extremely Low

Safety

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.

Dr. Anne Marie ApiPresidentResearch Institute of Fragrance Materials (RIFM)
1:30 - 2:15 PM

Building your Evidence Base: Approaches and Tools for Identification, Selection, Evaluation, and Assembly of Existing Data for Ingredient Safety

Safety

In an era where consumer trust and regulatory scrutiny are paramount, robust ingredient safety substantiation is more critical than ever. This session will explore the best evidence-based approaches to ensure the safety of ingredients used in cosmetics, personal care products, and other consumer goods.

This presentation is essential for product development, regulatory affairs, and safety evaluation professionals, offering a roadmap to building consumer confidence through rigorous and reliable safety substantiation.

Lauren BrownAssociate Director, Supervising ScientistToxsStrategies
2:15 - 3:00 PM

Use of Post Consumer Resin (PCR) in Cosmetic Packaging: Balancing Safety and Sustainability

Safety

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.

Dr. Ramez LabibPrincipal ToxicologistVenebio Consulting
3:20 - 4:00 PM

OTC Monograph Activities

Safety

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.

Dr. Theresa MicheleDirector of the Office of Nonprescription Drugs (ONPD) in the Office of New DrugsCenter of Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)
4:00 - 4:40 PM

How AI will Transform Toxicology: Focus on Cosmetic Safety Assessment

Safety

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.

Thomas HartungDirector of the Johns Hopkins Center for Alternatives to Animal Testing

October 9, 2024

8:35 - 9:20 AM

MoCRA Implementation Activities and Agency Priorities

Safety, Quality

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.

Dr. Linda M. KatzDirector, Office of Cosmetics and ColorsU.S. Food and Drug Administration (FDA)
9:20 - 10:00 AM

FDA Inspection Readiness

Safety, Quality

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

CDR Chad N. ThompsonDirector, Investigations BranchOffice of Pharmaceutical Quality, Division 1, FDA
10:30 - 11:15 AM

Cosmetic vs. Drug: How to Manage Dual Facilities

Quality

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.

Don YeVice President of Global Corporate and R&D QualityThe Estée Lauder Companies Inc.
Liam JablesnikVice President, Quality & RegulatoryMana Products
Steve RiedellDirector, Corporate Quality AssuranceProcter & Gamble
Cathleen OwenDirector of Pharmaceutical and Personal Care ServicesQ Laboratories
11:15 AM - 12:00 PM

Change Management

Quality

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.

Melissa SchneiderAssociate Director of Regulatory ComplianceCompliance Insights
1:30 - 2:15 PM

FDA Update

Quality

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.

Alonza CruseDirector, Office of Pharmaceutical Quality OperationsU.S. Food and Drug Administration (FDA)
2:15 - 3:00 PM

Quality Agreements

Quality

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.

Paula R. KatzOf CounselCovington & Burling LLP
3:20 - 4:00 PM

Case Study and Panel Discussion: Featuring Regulatory Adventure Stories - Myths or Facts

Quality

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

Alexandra KowczChief Scientist & Executive Vice President, SciencePCPC
CDR Chad N. ThompsonDirector, Investigations BranchOffice of Pharmaceutical Quality, Division 1, FDA
Melissa SchneiderAssociate Director of Regulatory ComplianceCompliance Insights
Alonza CruseDirector, Office of Pharmaceutical Quality OperationsU.S. Food and Drug Administration (FDA)
Paula R. KatzOf CounselCovington & Burling LLP