Loading…
Type: 14: DIAmond clear filter
Monday, June 16
 

11:00am EDT

#114: Leveraging Global Identification of Medicinal Products Standards to Strengthen the Drug Supply Chain and Improve Lives
Monday June 16, 2025 11:00am - 12:00pm EDT
146BC
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


Speakers
avatar for Janis Bernat

Janis Bernat

Director, Scientific and Regulatory Affairs, IFPMA, Switzerland
Janis leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team... Read More →
avatar for Isabel Chicharo

Isabel Chicharo

Head of Regulatory Data Management, European Medicines Agency, Netherlands
I am responsible for Regulatory Master Data Management Services, currently on Substances, Products, Organisations and Referential data (also known as SPOR). I also coordinate the implementation of ISO IDMP in EU. I over 20 years of data management experience in the field of Medicines... Read More →
avatar for Peter Hjelmstrom

Peter Hjelmstrom

Director/CEO, Uppsala Monitoring Centre, Sweden
Peter Hjelmström is the Director/CEO of Uppsala Monitoring Centre (UMC) and he has overall responsibility for the operations of the centre. Peter is physician and scientist, with MD and PhD degrees from Karolinska Institutet, and he did his postdoctoral fellowship at Yale University... Read More →
avatar for Joseph Kannarkat

Joseph Kannarkat

Physician, Johns Hopkins University School of Medicine, United States
Joseph is a physician with a deep interest in drug regulatory policy and has previously published articles in venues like The New England Journal of Medicine, The Journal of the American Medical Association, and The Brookings Institution. His research interests include studying the... Read More →
avatar for Raphael Sanches Pereira

Raphael Sanches Pereira

General Manager of the Office for Medicines, ANVISA, Brazil
General Manager of the Office of Medicines, responsible for evaluations off small molecules registrations and post-approval changes requests. Previously manager of Office for Quality Evaluation for Registration of Small Molecules and Manager of Office for Quality Evaluation of Small... Read More →
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   14: DIAmond, Forum
 
Tuesday, June 17
 

8:30am EDT

#211: Redesigning Research and Development with Women in Mind: Turning Ambition to Impact
Tuesday June 17, 2025 8:30am - 9:30am EDT
146BC
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-561-L04-P; CME 1.00; RN 1.00

Discover how to redesign R&D policies with women in mind. Join experts to explore why women’s inclusion in clinical trials matters, what changes are needed, and how stakeholders can drive impact. Together, let's shape a more inclusive future for research.

Learning Objectives

Recognize the historical underrepresentation of women in clinical trials, its healthcare impact, and the role of initiatives in addressing gender disparities; Identify key policy changes and strategies for including gender considerations into clinical trial design; Describe ways to develop actionable approaches to foster cross-sector collaboration among industry, regulatory bodies, government, and research institutions to advance gender diversity in clinical research.

Chair

Anna Bode, PhD

Speaker

Panelist
Jessica Federer, MPH

Panelist
Nicole Richie, PhD

Panelist
Martin Hodosi, MSc

Panelist
Melissa H. Laitner, PhD, MPH

Panelist
Neosho Ponder, PhD


Speakers
avatar for Anna Bode

Anna Bode

Principal, Kearney, Germany
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 →
avatar for Martin Hodosi

Martin Hodosi

Partner, Healthcare and Life Sciences Practices, Kearney, United Kingdom
More than a decade of experience in Strategy Consulting across sectors, with 8+ years across value chains in Pharmaceuticals, MedTech and Life Sciences. Focused on helping biopharma Research & Development (R&D) leaders bring superior treatments to patients more quickly by transforming... Read More →
avatar for Melissa Laitner

Melissa Laitner

Director, Strategic Initiatives, National Academy of Medicine, United States
Melissa Laitner is Director of Strategic Initiatives and Special Assistant to the President at the National Academy of Medicine, where she leads initiatives addressing critical domestic and global health policy challenges and directs cross-cutting projects on biomedical innovation... Read More →
avatar for Neosho Ponder

Neosho Ponder

National A.N.G.E.L. Lead, Tigerlily Foundation, United States
Dr. Neosho C. Ponder is an accomplished educator, passionate advocate, and impactful speaker originally from Kansas City, Missouri. As the Marketing and Communications Officer at the National Council of the Churches of Christ in the USA (NCC), she brings her extensive background in... Read More →
avatar for Nicole Richie

Nicole Richie

Vice President & Global Head Health Equity & Population Science, Genentech, United States
Dr. Nicole Richie, Ph.D. is the Vice President and Global Head of Health Impact & Population Science at Genentech, Roche responsible for leading the product development vision and developing strategies to broaden scientifically driven representation of understudied populations in... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  14: DIAmond, Session
  • Level Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Diversity Equity and Inclusion (DEI)
  • Tags Session
 
Wednesday, June 18
 

8:30am EDT

#312: Rare but Real: Navigating Rare Disease Product Development and Market Access Challenges
Wednesday June 18, 2025 8:30am - 9:30am EDT
146BC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-619-L04-P; CME 1.00; RN 1.00

Experts representing industry, non-profit, research, regulatory, and payor perspectives will explore key hurdles and solutions to rare disease treatment development, from recruitment and diagnosis to late-stage development and access after accelerated approval.

Learning Objectives

Identify hurdles and solutions to clinical trial recruitment, including early diagnosis and newborn screening; Identify approaches to patient stratification, disease understanding, and novel biomarkers, while de-risking late-stage development in competitive and high-failure landscapes; Examine challenges of market access and pricing after accelerated approval, and gain insights into addressing payer-specific concerns to ensure equitable access.

Chair

James Valentine, JD, MHS

Speaker

Panelist
Philip (P.J.) Brooks, PhD

Panelist
Anish Bhatnagar, MD

Panelist
Kim Quaintance-Lunn

Panelist
Matthew Klein, MD, MS

Panelist
Annie Kennedy

Panelist
Kerry Jo Lee, MD


Speakers
AB

Anish Bhatnagar

Chief Executive Officer, Soleno Therapeutics Inc, United States
Dr. Bhatnagar, CEO of Soleno since its inception in 2017, brings over 20 years of medical expertise to the biopharmaceutical and medical device industries. His extensive background encompasses the development of biologics, drugs, drug-device combinations, and diagnostic/therapeutic... Read More →
avatar for Philip (P.J.) Brooks

Philip (P.J.) Brooks

Deputy Director, Division of Rare Diseases Research Innovation, National Center for Advancing Translational Sciences (NCATS), NIH, United States
Philip J. (P.J.) Brooks is the deputy director of NCATS’ Division of Rare Diseases Research Innovation. Brooks represents NCATS in the NIH-wide Gene Therapy Working Group, the Regenerative Medicine Innovation Project and the International Rare Diseases Research Consortium (IRDiRC... Read More →
avatar for Annie Kennedy

Annie Kennedy

Chief of Policy, Advocacy, and Patient Engagement, EveryLife Foundation for Rare Diseases, United States
Annie has served within the community for nearly three decades through her roles with Parent Project Muscular Dystrophy (PPMD) and the Muscular Dystrophy Association (MDA). In that time she helped lead legislative efforts around passage and implementation of the MD-CARE Act (2001... Read More →
MK

Matthew Klein

CEO, PTC Theraputics, United States
Dr. Matthew Klein is CEO or PTC Therapeutics, a global biopharmaceutical company that discovers, develops and commercializes innovative therapies for rare disorders. Dr. Klein completed his undergraduate degree at the University of Pennsylvania graduating summa cum laude and Phi Beta... Read More →
avatar for Kerry Jo Lee

Kerry Jo Lee

Assoc. Dir. for Rare Diseases; Program Manager, Accelerating Rare Disease Cures, FDA, United States
Dr. Kerry Jo Lee is a pediatric gastroenterologist/hepatologist and the Associate Director for Rare Diseases in the Office of New Drugs (OND), CDER. In this role she leads CDER’s Rare Diseases Team and the Accelerating Rare disease Cures (ARC) Program. Dr. Lee joined the FDA in... Read More →
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Vice President, Head of Regulatory Science and Execution, Alexion, United States
Kim Quaintance-Lunn is Vice President, Head of Regulatory Science & Execution, for Alexion Pharmaceuticals; Strategic Advisor to the DIA Board of Directors; and Director at Large and Treasurer for the FDA Alumni Association. At Alexion, Kim is responsible for leading and implementing... 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 8:30am - 9:30am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  14: DIAmond, Session
 
  • Filter By Date
    Jun 9 - 19, 2025
    June 2025
    SunMonTueWedThuFriSat
    1234567
    891011121314
    15161718192021
    22232425262728
    2930 
  • Filter By Venue
    Washington, D.C., USA
    All
    143ABC
    144ABC
    145AB
    146ABC
    146BC
    147AB
    150AB
    151A
    151B
    152AB
    201
    202A
    204ABC
    206
    207A
    207B
    209ABC
    Ballroom
    Ballroom Foyer 3rd Floor
    EH
    Exhibit Hall / Zone A
    Exhibit Hall / Zone B
    Exhibit Hall / Zone C
    Exhibit Hall Lunch
    Innovation Theater 1
    Innovation Theater 2
    Innovation Theater 3
    L Street Bridge
    Nationals Park
    Planet Word
    Room 145-147 Lobby
    Salon B
    Salon C
    TBD
    Virtual
    West Salon
  • Filter By Type
    00: Plenary
    All
    Forum
    01: ClinSafety-PV
    All
    Forum
    Session
    02: ClinTrials-Ops
    All
    Forum
    Session
    Tutorial
    Workshop
    03: Data-Tech
    All
    Forum
    Session
    Tutorial
    Workshop
    04: MedAffairs-SciComm
    All
    Forum
    Session
    05: Patient-Impact-Product-Dev
    All
    Forum
    Session
    06: PersonalizedMed-ComboProd-Diagnostics
    All
    Forum
    Session
    Tutorial
    07: ProjectManagement-StrategicPlanning
    All
    Forum
    Session
    Tutorial
    Workshop
    08: RD-Quality-Compliance
    All
    Forum
    Session
    Tutorial
    09: Regulatory
    All
    Forum
    Session
    Tutorial
    Workshop
    10: RegCMC-Product Quality
    All
    Forum
    Session
    Tutorial
    Workshop
    11: Statistics-Data Science
    All
    Forum
    Session
    Tutorial
    12: ProfDevelopment
    All
    Forum
    Session
    Tutorial
    Workshop
    13: Spotlight
    All
    Forum
    Session
    14: DIAmond
    All
    Forum
    Session
    15: Content-Hubs
    All
    Workshop
    16: Community-Rounds
    All
    Session
    Workshop
    17: Posters
    All
    Session
    18: InnovationTheaters
    All
    Session
    19: Networking Opportunities
    All
    Session
    Social Event
    20: Short-Courses
    All
    Tutorial
  • 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
  • Timezone
Need help? View Support Guides
Event questions? Contact Event Planner
Powered by Sched Event Planning App
©2025 Sched • About • Privacy • Terms
Share Modal

Share this link via

Or copy link

Filter sessions
Apply filters to sessions.
Monday, June 9
Tuesday, June 10
Wednesday, June 11
Thursday, June 12
Sunday, June 15
Monday, June 16
Tuesday, June 17
Wednesday, June 18
Thursday, June 19
143ABC
144ABC
145AB
146ABC
146BC
147AB
150AB
151A
151B
152AB
201
202A
204ABC
206
207A
207B
209ABC
Ballroom
Ballroom Foyer 3rd Floor
EH
Exhibit Hall / Zone A
Exhibit Hall / Zone B
Exhibit Hall / Zone C
Exhibit Hall Lunch
Innovation Theater 1
Innovation Theater 2
Innovation Theater 3
L Street Bridge
Nationals Park
Planet Word
Room 145-147 Lobby
Salon B
Salon C
TBD
Virtual
West Salon
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 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