DIA 2025 Global Annual Meeting

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-510-L04-P; CME 1.00; RN 1.00

This session will explore perspectives on the future vision for pharmacovigilance. Examining how advances in technology and science can be leveraged to protect patient safety and will discuss what progress is being made against these ambitions.

Learning Objectives

Evaluate developments in technology being implemented by regulators to advance safety and surveillance of medicinal products; Discuss the importance of pharmacogenomics for introducing better risk mitigation strategies; Assess opportunities for better ways of working across different stakeholders in pharmacovigilance.

Chair

Sarah Vaughan

Speaker

Panelist
Monica Munoz, PharmD, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-519-L04-P; CME 1.00; RN 1.00

This session will explore the critical role of Identification of Medicinal Products (IDMP) standards in addressing global healthcare challenges, such as pharmacovigilance, drug shortages, and medicinal product traceability.

Learning Objectives

Discuss how IDMP standards address drug shortages by enhancing supply chain transparency and traceability; Identify the challenges and opportunities in implementing IDMP globally, focusing on the need for regulatory collaboration and interoperability; Explain the significance of global identifiers, such as PhPID, in ensuring consistent product identification across regions.

Chair

Janis Bernat, MSc

Speaker

Introduction of Regulatory Levers to Address the Problem: Global Implementation of Identification of Medicinal Products Standards
Ron Fitzmartin, PhD, MBA

Panelist
Vada Perkins, DrSc, MSc

EMA Perspective
Isabel Chicharo, MPharm

ANVISA Perspective
Raphael Sanches Pereira, SR

HealthCare Professional Perspective on the Issue and Examples
Joseph Kannarkat, MD

Panelist
Peter Hjelmstrom, MD, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-529-L04-P; CME 1.00; RN 1.00

The forum will explore key legislative proposals affecting FDA regulation of drugs and devices, while FDA and industry prepare to negotiate the next round of user fees and performance goals.

Learning Objectives

Describe key legislative initiatives that could alter FDA's regulation of drugs and medical devices; Discuss the interplay between current FDA legislative proposals and the upcoming FDA user fee negotiations and legislation; Recognize the impact of legislative proposals on FDA and regulated industries.

Chair

Jeffrey K. Francer, JD, MPA

Speaker

Panelist
Andrea Stern Ferris, MBA

Panelist
Barrett Tenbarge

Panelist
Elizabeth Jungman, JD, MPH

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-530-L04-P; CME 1.00; RN 1.00

In this session, leaders from Health Canada will provide an update on regulatory priorities for Canada. The audience will be invited to submit questions of general interest.

Learning Objectives

Describe Health Canada’s regulatory initiatives and strategic priorities; Identify opportunities for engagement with the Canadian regulator.

Chair

Alysha Croker, PhD

Speaker

Panelist
Kelly Robinson, MSc

Panelist
Sophie Sommerer

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-523-L04-P; CME 1.00; RN 1.00

The ICH improved global drug development, but rising country-specific regulations increase complexity and costs for multinational submissions. This session explores key harmonization challenges, regulatory trends, and strategies to navigate diverse requirements for successful drug approvals. Effective communication between sponsors and regulatory agencies is critical for the successful development and approval of new medicines. This forum will explore the similarities and differences in how major global regulators—such as the U.S. Food and Drug Administration (FDA), China’s National Medical Products Administration (NMPA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and the European Medicines Agency (EMA)—engage with sponsors throughout the drug development lifecycle. We will delve into the formal channels and informal practices each regulatory body uses to guide sponsors, address compliance issues, and expedite approvals. Key similarities, such as scientific advice meetings, regulatory guidance documents, and the use of conditional approval pathways, will be examined. At the same time, critical differences, including cultural approaches to engagement, the role of pre-submission meetings, and divergent regulatory timelines, will be highlighted. Through a comparative lens, this forum will also address how recent trends, such as digital transformation, the COVID-19 pandemic, and emerging policies on patient-centric drug development are shaping interactions with regulators worldwide. The session will provide attendees with practical insights into navigating global regulatory landscapes, fostering better communication with agencies, and optimizing regulatory strategies for successful drug approvals across diverse markets.

Learning Objectives

Identify the similarities and differences in how major global regulators (FDA, NMPA, PMDA, EMA) engage with sponsors throughout the drug development lifecycle; Analyze key similarities, such as scientific advice meetings, regulatory guidance documents, and the use of conditional approval pathways among different regulatory agencies; Recognize ways to gain practical insights into navigating global landscape.

Chair

Steve Sibley, MS

Speaker

EMA Perspective
Anabela Marcal, PharmD

Perspective on Best Practices for Navigating Divergent Regulatory Feedback - My Perspectives from Previous Experience at FDA
Namandjé Bumpus, PhD

Best Practices for Navigating Divergent Regulatory Feedback
Natalie Tolli, MS, RPh

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-532-L04-P; CME 1.00; RN 1.00

This session will provide the transformative potential of Gen AI like ChatGPT. The session will explore the art of prompt engineering and the potential of LLM-based QnA system and will equip the attendees with the practical skills to harness the power of Gen AI.

Learning Objectives

Recognize Gen AI’s potential to enhance productivity; Discuss how to master prompt engineering techniques (zero-shot learning, few-shot learning, and chain of thought); Identify how to frame questions, analyze responses, and extract actionable insights more effectively.

Chair

Kevin Lee, MS

Speaker

Twenty Percent More Productivity with ChatGPT? Discover how Prompt Engineering is a Game Changer for Professional Development
Kevin Lee, MS

Harnessing Generative AI for Scientific Intelligence and Information Extraction
Ankush Chandna, MSc

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-25-545-L04-P; CME 1.00; RN 1.00

Explore the transformative potential of generative AI (genAI) in Regulatory Affairs. This session will share insights and experiences from industry, focusing on education, culture change, and impactful use cases.

Learning Objectives

Recognize the value and potential of generative Artificial Intelligence (genAI) in Regulatory Affairs (RA); Outline how use cases are selected and implemented by Industry in their RA departments; Identify examples of application of genAI in RA; Discuss how to adapt and practice genAI within your own RA organization.

Chair

Paul Bolot, PharmD, MSc

Speaker

Introduction to genAI
Ben Moscovitch, MA, MBA

J&J Experience
Joseph Markmann, PhD, MBA

BMS Experience
Sandra Krogulski, MA

Novartis Experience
David Yao, PharmD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-547-L04-P; CME 1.00; RN 1.00

Explore WHO-led initiatives and global collaborations driving regulatory harmonization and innovation to ensure equitable access to medical products. This session highlights strategic efforts to address shared challenges and advance global health.

Learning Objectives

Discuss the progress and challenges in achieving regulatory convergence and harmonization; Recognize the role of regulatory reliance and collaboration in facilitating access to medical products; Discuss international partner’s perspective on navigating regulatory landscapes to enhance global health equity.

Chair

Hiiti Sillo, MSc, RPh

Speaker

CIP Network and its role in Advancing Global and Regional Regulatory Harmonization, Collaboration, and Work-Sharing
Jude Nwokike, MPH, MSc, RPh, RAC

Regulatory Harmonization: Advancing Global Health through Collaboration
Marion Laumonier, MSc

Shaping Global Health Research and Development through WHO Resources and Coordinated Scientific Advice
Mercedes Perez Gonzalez, MSc

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-549-L04-P; CME 1.00; RN 1.00

This session will include techniques for having robust documentation to deliver clear, confident messages and strategies which improve individual and team performance, confidence and compliance using insights backed by data and real-world examples.

Learning Objectives

Discuss the Impact of Language and how the choice of words and tone can influence performance, collaboration and compliance in the workplace; Recognize practical techniques and strategies for communicating with confidence in various professional scenarios; Describe ways to enhance performance through effective communication.

Chair

Tony Johnson, MS

Speaker

Panelist
Ana Sharma, MPH

Panelist
Anne Marie Inglis, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-557-L04-P; CME 1.00; RN 1.00

This session will focus on the attractiveness of developing and obtaining marketing approval of pharmaceutical products in Japan from regulatory and industry perspectives, aiming to get rid of old-fashioned ideas and views about Japan.

Learning Objectives

Discuss outdated misconceptions and “urban legends” about Japan when considering Research and Development (R&D) on new medicines in Japan; Examine the attractiveness of performing R&D in Japan, both from regulatory and industrial perspectives: attractive market, flexibility/predictability, designation for each product characters; Analyze the Roles and Prospects of the PMDA’s Overseas Offices.

Chair

Daisuke Koga, MSc, RPh

Speaker

Panelist
Eri Sekine

Panelist
Sarah Rhee

Panelist
Shinichi Noda, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-574-L04-P; CME 1.00; RN 1.00

In this forum, leaders from ANVISA will provide an update on regulatory priorities for Brazil, and inform about local trends, regulatory convergence, and collaboration initiatives. The discussion will also invite questions of general interest from the audience.

Learning Objectives

Describe ANVISA’s regulatory initiatives and strategic priorities; Discuss regulatory convergence of Brazilian regulations for medicines and medical devices to international guidelines and standards; Identify trends and opportunities for engagement with the Brazilian regulator

Chair

Bianca Zimon, LLM

Speaker

Panelist
Daniel Pereira

Panelist
Marcelo Moreira, MS

Panelist
Dandara Braga Santana, MHS

Component Type: Workshop
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-25-577-L04-P; CME 1.00; RN 1.00

Turnover in the clinical research industry hovers at 27%. Given the high stress, high turnover nature of the industry, the need for stress reduction tools is critical. In this session you will learn techniques to implement for yourself and teams.

Learning Objectives

Identify a simple way to immediately reduce stress in less than 2 minutes; Practice a technique to increase energy, clarity and decision making; Complete a guided non-sleep deep rest practice to calm, soothe and restore.

Chair

Leanne Woehlke, MA

Speaker

Pause, Breathe, Connect
Jess Thompson, MBA, MS, PMP

The Effects of Mindful Breathing on Stress and Well-Being
Eddie Stern

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-579-L04-P; CME 1.00; RN 1.00

This session will review the 2024 revision of the Declaration of Helsinki, one of the foundational codes of clinical research ethics, and the rationale and practical implications of the changes made in the current version.

Learning Objectives

Discuss the history of the Declaration of Helsinki and its relevance and importance for the healthcare industry; Recognize the changes made in the 2024 version and how they will impact the conduct of biopharma clinical trials; Discuss multi-stakeholder efforts that are working towards operationalizing ethical principles in the DOH and where more collaboration and alignment is needed.

Chair

Melissa Heidelberg, MS

Speaker

Speaker
Karla Childers, MS

Speaker
Ann Meeker-O'Connell, MS

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-581-L04-P; CME 1.00; RN 1.00

Tufts CSDD and DIA collaborated on a research study with a working group of 16 biopharmaceutical companies and CROs examining the current use of artificial intelligence (AI) and machine learning (ML) to support clinical research.

Learning Objectives

Describe the level of adoption of artificial intelligence (AI) and machine learning (ML) across biopharmaceutical companies and contract research organizations and the top activities where AI/ML is being implemented and utilized; Discuss the impact of AI/ ML on time savings, investment, and deployment of organizational resources.

Chair

Mary Jo Lamberti, PhD, MA

Speaker

Panelist
Mukul Virmani, Esq, MS

Use Case Examples within Clinical Development
Emily Carter, MBA

Organizational Use Case
Luciana Petcu, MS

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-588-L04-P; CME 1.00; RN 1.00

Representatives from pediatric cluster health authorities will describe the common deficiencies they see in global pediatric development programs and describe best practices and what to expect for those companies that seek a common commentary.

Learning Objectives

Describe common deficiencies in global pediatric development plans; Explain the process for obtaining a common commentary; Recognize topics that are discussed at monthly pediatric cluster calls.

Chair

Melodi J McNeil, MS, RPh

Speaker

PMDA Perspective
Junko Sato, PhD

EMA Perspective
Corinne de Vries, PhD, MA, MSc

Panelist
Franca Ligas

FDA Perspective
Dionna J. Green, MD

Australia Perspective
Robyn Langham, MD, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-589-L04-P; CME 1.00; RN 1.00

In this forum, speakers from the National Medical Products Administration (NMPA) , academia and industry will present the progress in drug regulation, review China's biopharma innovation in the past decade, and discuss accelerating innovative drug approvals in China. Attendees will have an opportunity to discuss the issues related to drug development with NMPA officials, clinical researcher and industry executive.

Learning Objectives

Describe the latest information on the National Medical Products Administration’s activities in drug regulation; Describe the trend in biopharma innovation in the past decade; Discuss the strategies for accelerating innovative drug development and approval in China.

Chair

Ling Su, PhD

Speaker

Brief Introduction from the NMPA
Feng Zhu

The Progress of China's Drug Review and Approval Reform
Jianwu Zhang, PhD

Accelerating the Development and Approval of Innovative Drugs in China: Industry's Perspective
Wei Zhang

The Past Decade of China's Biopharma Innovation
Xiaoyuan Chen, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-592-L04-P; CME 1.00; RN 1.00

This session outlines an approach to developing technical experts into global leaders by breaking the "expert trap" and aligning talent development with organizational growth strategy.

Learning Objectives

Identify strategies for breaking the "expert trap" and enhancing career growth for technical talent; Recognize how to align talent development with organizational growth through strategic initiatives; Identify methods to cultivate a diverse leadership pipeline in life sciences.

Chair

Amber Meriwether, JD, MA

Speaker

Industry Perspective
Elizabeth Iorns, PhD

Industry Perspective
Michael Torok, PhD

Industry Perspective
Cecilia Zvosec

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-597-L04-P; CME 1.00; RN 1.00

The ability to find, access, understand, and apply healthcare-related information (health literacy) plays a large role in global health outcomes. This session reviews health literacy and strategies to increase health literacy in a digital age.

Learning Objectives

Discuss the basics of health literacy and how they relate to health outcomes; Explain ways to apply new strategies for communicating healthcare information to a broad audience with a range of health literacy levels; Utilize digital tools to achieve strategic goals around healthcare information dissemination.

Chair

Chantelle Rein-Smith, PhD

Speaker

Panelist
Anna Osinski

Panelist
James Lindsay Cobbs

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-607-L04-P; CME 1.00; RN 1.00

Regulatory decisions are often a widely discussed topic, but have you considered how a breadth of experience in the career journeys of regulators positively influences decision making within regulatory bodies? Join us to hear from our panel about the impact of their varied career paths in the critical work that they do. This is your opportunity to hear directly from regulators from the UK, Canada & Brazil about what they do, how they got there and what they have experienced and learnt along the way!

Learning Objectives

Recognize how breadth of experience within regulators supports medicines development for patients and society; Identify how skills developed in one sector (e.g., industry, academia, healthcare) can contribute to the skills needed in another (e.g., regulators).

Chair

Paula Walker, MA

Speaker

Panelist
Sophie Sommerer

Panelist
Marcelo Moreira, MS

ANVISA Career Pathway: Impact to Medicines Development
Bianca Zimon, LLM

MHRA Career Pathway: Impact to Medicines Development
Mandy Kaur Budwal-Jagait, MSc

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-608-L04-P; CME 1.00; RN 1.00

This session will present two contrasting approaches to workforce development which address the challenges in attracting and retaining the ideal talent. First, what can pharma learn from other industries who have developed a remote, agile and on-demand talent base responsive to changing needs. Second a case study in meeting the challenge of extraordinary growth in product pipeline and expansion by implementing an integrated, multi-faceted, workforce development ecosystem in collaboration with academic institutions and other manufacturing companies that also builds and sustains the local economy.

Learning Objectives

Discuss how to maximize agility and attract the best talent to get the critical work of drug development and manufacturing done; Identify novel approaches to developing and retaining a skilled workforce capable of meeting the needs of a highly regulated industry; Recognize how the organization can achieve unprecedented agility by embracing the Future of Work tools and methodologies.

Chair

Denyse Baker, RAC

Speaker

Far Beyond Remote Work: NASA, The Ford Motor Company, and The New World of Work - Opportunities for Pharma
Sheila Mahoney Jewels, MBA

Transforming Talent: Leveraging Partnerships for Biopharma Success
Dedric Day

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-610-L04-P; CME 1.00; RN 1.00

This session explores adverse event collection, processing, and actioning fundamentals as critical for integrating patient safety within teams, organizations, and the broader clinical research and patient care ecosystems.

Learning Objectives

Discuss improvements within the drug safety landscape to adverse event reporting, processing, decision-making, and communication; Appraise stakeholder roles in protecting patients and promoting public health; Discuss opportunities for adverse event stakeholders to collaborate across the health care continuum (clinical development, safety, advocacy).

Chair

Allison Cuff Shimooka, MBA

Speaker

Panelist
Rebecca Noss, MS

Panelist
Narayan Nair, MD

Panelist
Jeremy Jokinen, PhD, MS

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-634-L04-P; CME 1.00; RN 1.00

Aftificial Intelligence (AI) is being adopted across the medicine lifecycle to increase insights into data and improve efficiency of processes, for the benefit of public and animal health. This session will address key elements to enable the safe and responsible use of AI.

Learning Objectives

Identify AI opportunities across the medicine lifecycle; Examine the legal ecosystem of AI across jurisdictions and identify opportunities for convergence; Discuss how regulators worldwide are developing guidance to support AI innovation in the medicine lifecycle; State other strategic AI initiatives, including approaches to leveraging AI with healthcare data.

Chair

Luis Pinheiro, PharmD, MSc

Speaker

Panelist
Timothe Menard, PharmD, MSc

Panelist
Tala Fakhouri, PhD, MPH

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-635-L04-P; CME 1.00; RN 1.00

This interactive workshop designed by a behavioral scientist from Tufts CSDD will provide an experiential learning experience covering levers that can enhance leadership effectiveness using an inclusive leader framework.

Learning Objectives

Identify specific inclusive leadership behaviors that can enhance individual and team-level outcomes; List the challenges and barriers associated with inclusive leadership practices; Discuss evidence-based ways to practice inclusive leadership that resonate with all employees.

Chair

Jennifer Kim, PhD

Speaker

Challenges of Leading Inclusively in Cross-Functional, Mixed Teams
Tamei Elliott, MS

Inclusive Leadership Strategies to Effectively Manage Teams
Ruby Madison Ford, MPH

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-647-L04-P; CME 1.00; RN 1.00

In this session, leaders from the EMA will provide an update on regulatory priorities. The audience will be invited to submit questions of general interest.

Learning Objectives

Describe EMAs regulatory initiatives and strategic priorities; Identify opportunities for engagement with the regulators.

Chair

Ralf Herold, DrMed, MD

Speaker

Panelist
Anabela Marcal, PharmD

Panelist
Corinne de Vries, PhD, MA, MSc

Panelist
Luis Pinheiro, PharmD, MSc

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-651-L04-P; CME 1.00; RN 1.00

This panel discussion will offer valuable insights and practical strategies for organizations looking to implement or refine mentorship programs that drive professional development, organizational cohesion, and a culture of continuous learning.

Learning Objectives

Discuss how mentorship fosters meaningful connections and knowledge sharing, impacting engagement, retention, and growth; Identify clear roles and responsibilities to ensure program success; Recognize mentorship’s role in collaboration and career development; Discuss ways to inspire organizations to adopt mentorship and individuals to seek or become mentors.

Chair

Carol Morales

Speaker

Insights as a Mentorship Program Organizer
Meghann Hartnett

Panelist
Tywnia Brewton

The Executive Mentor Perspective
Leslie Sam

The Mentee Perspective
Sarah Tremethick

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-655-L04-P; CME 1.00; RN 1.00

We’ve all heard the hype around emerging technologies and what it means for our industry, but when it comes down to adding value on the ground today, what advancements are actually making a difference in drug discovery, development, and distribution?

Learning Objectives

Describe and explain the advancements in data analytics and emerging technologies that are adding value to biopharma companies today.

Chair

Jessica Federer, MPH

Speaker

Panelist
Leo Barella

Panelist
Diogo Rao

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-661-L04-P; CME 1.00; RN 1.00

Regulators will showcase how working together to advance regulatory science is key for new approaches. Participants will discuss how to efficiently translate drug development tools into practice, how industry and not-for-profits can drive innovation.

Learning Objectives

List the usefulness of engaging in advancing regulatory science tools and subsequent translation into research practice, product development and evaluation; Discuss global regulatory convergence and activities towards new regulatory science approaches to enable new products.

Chair

Ralf Herold, DrMed, MD

Speaker

How Industry Is Shaping Public-private Partnerships To Facilitate New Development Pathways For Products
Ginny Beakes-Read, BSN, JD

The ITCC-P4 Consortium: A Pediatric Oncology Case Study In Innovative Multistakeholder Collaboration To Address R&D Challenges
Louis Stancato, PhD

Accelerating Translation of Regulatory Science Research – EFPIA’s perspective
Solange Corriol-Rohou, DrMed, MD, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-662-L04-P; CME 1.00; RN 1.00

This annual town hall provides a forum for senior FDA officials to reflect on key trends and discuss opportunities in rare disease drug development and review. Officials answer moderated and audience burning questions facing the work that they do.

Learning Objectives

Describe new FDA programs and initiatives intended to help facilitate development of drugs for rare diseases; Evaluate opportunities for sponsors and patient stakeholders to engage with regulators; Identify current trends in challenges and opportunities facing orphan drug development.

Chair

James Valentine, JD, MHS

Speaker

Perspectives on Rare Immunology & Inflammation Product Development
Nikolay Nikolov, MD

Perspectives on Rare Neuroscience Product Development
Teresa Buracchio, MD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-663-L04-P; CME 1.00; RN 1.00

This forum on obesity drug development helps the audience understand the present landscape, participate in discussions on the prevention and treatment of comorbidities, and assess various strategies in enhancing clinical trial efficiency.

Learning Objectives

Discuss the present landscape, opportunities, and challenges of obesity drug development; Identify the prevention and treatment of comorbidities associated with obesity; Assess various considerations and strategies in enhancing the efficiency of obesity drug development.

Chair

Jingyu (Julia) Luan, PhD

Speaker

Panelist
Joseph Nadglowski, JR

Panelist
Maria Vassileva, PhD

Panelist
John Sharretts

Panelist
Brad Jordan, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-667-L04-P; CME 1.00; RN 1.00

The session aims to enhance the participant's ability to recognize the global business environment, focusing on critical factors influencing business strategy. We will illustrate adopting business and regulatory strategies to evolving landscapes.

Learning Objectives

Identify key factors and trends influencing the biotechnology and pharmaceutical industries; Evaluate the impact of these trends on business and regulatory strategies; Propose strategic adaptations to address evolving industry and regulatory challenges.

Chair

Lawrence Fine, PhD, MBA

Speaker

Beyond Borders: Impact of Economic Shifts on Regulatory Strategies in Obesity Care
Tetyana Fine, MS

Global Strategy Considerations for Biosimilar Approvals
Rosalyn Janine Bailey, MPharm, MS

Artificial Intelligence in Drug Development
Darshini Trivedi, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-672-L04-P; CME 1.00; RN 1.00

In this interactive forum experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas as well as on how both Agencies collaborate in addressing current regulatory, scientific, and communication challenges.

Learning Objectives

Identify an overall understanding of the regulatory and scientific collaboration between EMA and FDA; Describe experience and explore specific areas of collaboration between the two Agencies; Examine how EMA and FDA are addressing regulatory and scientific challenges in new areas.

Chair

Anabela Marcal, PharmD

Speaker

Advanved Manufacturing
Evdokia Korakianiti, PhD, MSc

Artificial Intelligence
Luis Pinheiro, PharmD, MSc

Advanced Manufacturing
Manuel Osorio, PhD

GCP
Kassa Ayalew, MD, MPH

GCP
Peter Twomey, MA, MPharm

Artificial Intelligence
Tala Fakhouri, PhD, MPH

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-674-L04-P; CME 1.00; RN 1.00

This session empowers pharmaceutical scientists and researchers with essential business skills, strategies for commercialization, and solutions for industry challenges, enabling a successful transition from lab innovation to entrepreneurial leadership.

Learning Objectives

Identify essential business and entrepreneurial skills to navigate the transition; Discuss the intersection of scientific innovation and business strategy, helping professionals identify and develop viable commercial opportunities from their research; Recognize the unique challenges in the pharmaceutical industry, from regulatory complexities to funding obstacles, and provide strategies for overcoming them.

Chair

Angela Men, MD, PhD

Speaker

Panelist
Bei Ma

Panelist
Matthew Chervenak

Panelist
Shou-Bai Chao

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-25-675-L04-P; CME 1.50; RN 1.50

The FDA Town Hall is the forum to hear from FDA leadership about Center priorities. The audience will be invited to submit questions of general interest.

Learning Objectives

Discuss FDA Center priorities.

Chair

Amy Bertha

Speaker

Panelist
Tala Fakhouri, PhD, MPH

Panelist
Hussein Ezzeldin, PhD

Panelist
Gabriel Innes, DVM, PhD

Panelist
Marie C. Bradley, PhD, MPH, MPharm