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Wednesday, June 18
 

8:30am EDT

#302: From Bedside to Bench to Bedside: How Adverse Events Converge Clinical Research and Clinical Care
Wednesday June 18, 2025 8:30am - 9:30am EDT
202A
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


Speakers
avatar for Jeremy Jokinen

Jeremy Jokinen

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States
Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring... Read More →
avatar for Narayan Nair

Narayan Nair

Associate Director Regulatory Affairs, Office of Biostatistics and Pharmacovigil, FDA, United States
Narayan Nair, M.D. is the Director of the Division of Pharmacovigilance in the Center for Biologic Evaluation and Research at the FDA. He oversees the Division that performs pharmacovigilance activities for vaccines and other biologic products regulated by FDA. Dr. Nair is a Board-Certified... Read More →
avatar for Rebecca Noss

Rebecca Noss

President, Global Pharmacovigilance Consultant, Noss Research Consulting, United States
Global Pharmacovigilance ‘PV’ Consultant with twenty-eight years of solid clinical research experience and post-marketing in pharmaceuticals. Excellence in providing safety strategy to product development teams, ensuring timely and high-quality execution of safety documents such... Read More →
avatar for Allison Cuff Shimooka

Allison Cuff Shimooka

Chief Operating Officer, TransCelerate Biopharma Inc, United States
Allison is Chief Operating Officer of TransCelerate BioPharma Inc. In this role, Allison is responsible for shaping and delivering on TransCelerate’s strategic vision: to advance collaboration in driving efficient, effective and high-quality delivery of new medicines through the... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

10:30am EDT

#328: Artificial Intelligence in the Medicines Lifecycle: Delivering Globally for Public and Animal Health
Wednesday June 18, 2025 10:30am - 11:30am EDT
146BC
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


Speakers
avatar for Timothe Menard

Timothe Menard

Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics), F. Hoffmann-La Roche Ltd, Switzerland
Started in drug safety at Merck KGaA, joined Roche as a GCP/PV auditor. Transitioned to analytics; now heads Quality Excellence Digital. Focuses on digital & analytics for core quality deliverables. Co-founded the Inter coMPany quALity Analytics consortium to drive data/quality policy... Read More →
avatar for Luis Pinheiro

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands
Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce, Real World Evidence Workstream, in the European Medicines Agency, where he designs and conducts real-world data studies and works on digital methods development. He also coordinates... Read More →
avatar for Tala Fakhouri

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States
Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session

10:30am EDT

#329: Leader Effectiveness: Inclusive Leadership Practices to Improve Employee Engagement and Performance
Wednesday June 18, 2025 10:30am - 11:30am EDT
206
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


Speakers
avatar for Tamei Elliott

Tamei Elliott

Director, Global Scientific Content, DIA, United States
Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant... Read More →
avatar for Ruby Ford

Ruby Ford

Research Analyst, Tufts School of Medicine, United States
Madison Ford is a Research Analyst at the Center where she conducts grant-funded research including survey and database design, quantitative and qualitative data analysis, and literature reviews. In 2021, Madison received her BS in Public Health from The University of Alabama. She... Read More →
avatar for Jennifer Kim

Jennifer Kim

Research Associate Professor, Tufts Center for the Study of Drug Development, United States
I'm a Research Associate Professor and Organizational Psychologist at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on health and work equity, examining strategies and interventions that can positively impact individual... Read More →
avatar for Elizabeth Rosenkrands-Lange

Elizabeth Rosenkrands-Lange

Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, Part of Merck KGaA, Darmstadt, Germany, United States
Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session

1:45pm EDT

#347: EMA Town Hall
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
146BC
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


Speakers
avatar for Ralf Herold

Ralf Herold

Head of Regulatory Science and Academia Workstream, European Medicines Agency, Netherlands
Ralf Herold MD PhD is the head of EMA’s Regulatory Science and Academia Workstream, part of the Regulatory Science & Innovation Taskforce, coordinating research and engagement with researchers and developers from the academic sector and not-for-profit organisations. Previously... Read More →
avatar for Anabela Marcal

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →
avatar for Luis Pinheiro

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands
Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce, Real World Evidence Workstream, in the European Medicines Agency, where he designs and conducts real-world data studies and works on digital methods development. He also coordinates... Read More →
avatar for Corinne de Vries

Corinne de Vries

Head of Translational Sciences Office, European Medicines Agency, Netherlands
Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

1:45pm EDT

#351: Transforming Industry through Mentorship
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
206
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


Speakers
avatar for Tywnia Brewton

Tywnia Brewton

Executive Director, Human Resources, Astellas , United States
Tywnia Brewton is a seasoned Human Resource Executive who established herself as an employee Advocate... Proactive Problem Solver... Leader... Effective Negotiator... Consummate HR Partner. Tywnia specializes in improving individual and organization performance. She has over 25 years... Read More →
avatar for Meghann Hartnett

Meghann Hartnett

Associate Director, Global Products, DIA, United States
Meghann Hartnett is the Associate Director of Global Products at DIA, where she manages a diverse portfolio of both dues-based and non-dues products, including DIA’s Membership and Communities. With over seven years at DIA, she has led the development and implementation of innovative... Read More →
avatar for Carol Morales

Carol Morales

Lead, Quality Management and Capabilities, Astellas, United States
Carol Morales is a Quality Management and Capabilities professional at Astellas, leading the QA Astellas Professional Development Program, which includes the Chicago State University Pharm D Rotation and Mentor Intensive Program. With extensive experience in business development... Read More →
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC, United States
With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →
avatar for Sarah Tremethick

Sarah Tremethick

Global Consortia Program Lead and Global Member Network Executive Sponsor, Roche Products Limited, United Kingdom
A catalyzer for change who connects like-minded people across the biopharmaceutical community to solve common challenges. A Roche leader responsible for mobilizing a diverse team of innovators from across the organization, passionate about solving problems and disrupting our industry... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Forum

4:00pm EDT

#359: Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now?
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
209ABC
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


Speakers
LB

Leo Barella

Chief Technology Officer, Takeda, United States
avatar for Jessica Federer

Jessica Federer

Board Member, Angelini Ventures, United States
Ms.Federer is an independent board member for public and private companies, and is a globally recognized leader in digital transformation and health technologies. Previously, she was the Chief Digital Officer for one of the world’s largest life sciences companies, leading the enterprise-wide... Read More →
DR

Diogo Rao

Chief Information Officer, Eli Lilly, United States
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Forum

4:00pm EDT

#365: International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
150AB
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


Speakers
avatar for Ginny Beakes-Read

Ginny Beakes-Read

Head, Global Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States
Ms. Beakes-Read is VP, Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the policy group, which works to shape the regulatory environment to support innovative drug development and patient access to new therapies. Before that, Ginny was at Amgen leading the... Read More →
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →
avatar for Ralf Herold

Ralf Herold

Head of Regulatory Science and Academia Workstream, European Medicines Agency, Netherlands
Ralf Herold MD PhD is the head of EMA’s Regulatory Science and Academia Workstream, part of the Regulatory Science & Innovation Taskforce, coordinating research and engagement with researchers and developers from the academic sector and not-for-profit organisations. Previously... Read More →
avatar for Louis Stancato

Louis Stancato

VP Enabling Technologies, Indiana Biosciences Research Institute, United States
Dr. Stancato is a cancer biologist at the Indiana Biosciences Research Institute, pursuing his passion to bring life-saving therapies to children with cancer. Upon his retirement from Eli Lilly and Company, Dr. Stancato had 26 years of comprehensive drug discovery experience, and... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

4:00pm EDT

#366: FDA Rare Disease Town Hall
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
146BC
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


Speakers
TB

Teresa Buracchio

Director, Office of Neuroscience, OND, CDER, FDA, United States
Teresa Buracchio, MD, is Director of the Office of Neuroscience in the Center for Drug Evaluation and Research, Food and Drug Administration (FDA). She oversees the review of new drug programs for neurologic and psychiatric diseases. Dr. Buracchio joined FDA in 2013. Dr. Buracchio... Read More →
NN

Nikolay Nikolov

Director, Office of Immunology and Inflammation, OND, CDER, FDA, United States
Dr. Nikolay P. Nikolov is a board-certified Internist and Rheumatologist and is currently the Director of the Office of Immunology and Inflammation, CDER. During rheumatology fellowship at NIAMS, NIH, he studied cellular and molecular mechanisms of autoimmunity. Then, at the Sjögren's... Read More →
avatar for James Valentine

James Valentine

Director, Hyman, Phelps & McNamara, PC, United States
James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   02: ClinTrials-Ops, Forum

4:00pm EDT

#367: Beyond Weight Loss: Pioneering the Future of Obesity Drug Development
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
147AB
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


Speakers
avatar for Brad Jordan

Brad Jordan

Associate Vice President, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Brad Jordan is the Associate Vice President of Regulatory Policy and Strategy at Eli Lilly, where he is responsible for the regulatory policy strategy for Lilly’s cardiometabolic and immunology therapeutic areas.
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States
Dr. Jingyu (Julia) Luan is an Executive Regulatory Science Director in AstraZeneca, overseeing the global regulatory strategy and supporting the research, development and commercialization of CVRM products. She is a core member of CVRM Regulatory Leadership Team. Prior to AZ, she... Read More →
avatar for Joseph Nadglowski

Joseph Nadglowski

President/Chief Executive Officer, Obesity Action Coalition, United States
Joe Nadglowski is President & CEO of the Obesity Action Coalition (OAC) – a nonprofit organization formed in 2005 dedicated to elevating and empowering individuals affected by obesity through education, advocacy and support. A frequent speaker and author, Mr. Nadglowski is especially... Read More →
JS

John Sharretts

Director at Division of Diabetes, Lipid Disorders, and Obesity, FDA, United States
avatar for Maria Vassileva

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States
Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   02: ClinTrials-Ops, Forum

4:00pm EDT

#371: Business Agility: Recognizing Global Business Environment and Appropriate Strategies Adaptations
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
206
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


Speakers
avatar for Rosalyn Bailey

Rosalyn Bailey

Executive Director NA & LATAM Head – Global Regulatory Affairs Solultions, Syneos Health, United States
Rosalyn Bailey, MS, is an experienced Regulatory Affairs leader with over 20 years in the drug development industry. As Executive Director of Global Regulatory Affairs Solutions at Syneos Health, she oversees regulatory teams across the Americas, guiding products through the regulatory... Read More →
avatar for Lawrence Fine

Lawrence Fine

Business Consultant, Lawrence Fine, LLC, United States
Extensive experience working with companies of various sizes, including Fortune 500 companies. Deep expertise in Technology, Healthcare, Hospitality and Biotechnology industries across different functions including but not limited to marketing, information technology, and personnel... Read More →
avatar for Tetyana Fine

Tetyana Fine

Director, Global Regulatory Affairs, Astrazeneca, United States
Fifteen (15) years of diverse biotechnology and pharmaceutical industry experience, including leadership, regulatory strategy development and execution, chemistry manufacturing and controls (CMC), and program and project management. Effectively direct multinational, cross-functional... Read More →
avatar for Darshini Trivedi

Darshini Trivedi

Global Regulatory Affairs and Product Strategy, Amgen, Inc, United States
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session
 
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  • 00: Plenary
  • 01: ClinSafety-PV
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  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 19: Networking Opportunities
  • 20: Short-Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Keyword
  • Advanced Analytics
  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming