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Day 2

5th Expanded Access Programmes World Congress 2023 Americas

Strategies and Considerations in Launching an Expanded Access Programmes
Revere Hotel Boston Common, Boston, MA, USA

Day 2 - Friday 17th November 2023

Eugean Jiwanmall, Sr Research Analyst, Med. Policy & Tech Evaluation, Independence Blue Cross

ACCESS & COMMERCIALIZATION

  • Deep-dive into the reality of healthcare access around the world
  • Streamlining the process and navigating early access regulations globally
  • What does the future of health access look like? The interconnected ecosystem where all healthcarestakeholders work together

Panelists:
Jennifer E. Miller, PhD, Associate Professor, Yale School of Medicine
Monica L Weldon, President/CEO/Founde, SYNGAP1 Foundation

  • Ideal Accelerated Pathway
  • Problems of Excluding Some Disease
  • Brainstorming: Removing the Barriers
  • What’s the Long Game?: Rethinking the Regulatory Rules

Monica L Weldon, President/CEO/Founde, SYNGAP1 Foundation

  • Building access specific competencies in emerging Market Medical Affairs
  • Pivotal role of Early Access Programs

Siddharth Jain, Medical Director –LSDs & HAE, Global Medical Affairs, Takeda

  • Companies should anticipate the need for EA and should have a written policy
  • The policy should be available to the person entitled to expanded access
  • Companies must be accountable to the patients sending expanded access requests
  • Sharing of data analysis is crucial for improvement

Donna Cowan, Associate Director, EAP & Registry, Stealth Biotherapeutics*

  • The importance of patient advocacy in providing much-needed information on EAP’s available for patients
  • Collaborating with one another to enable a much richer understanding of patient needs
  • Patient groups’ importance in working with health authorities to advance policies that accelerate patientaccess to investigational medicine
  • Creating a state of the art payer engagement strategies to address challenges in pricing and reimbursement

Moderator:

Panelist:
Misty Gravelin, Project Lead, Expanded Access Support Unit, University of Michigan
Alan J. Balch, Chief Executive Officer, Patient Advocate Foundation
Eugean Jiwanmall, Sr Research Analyst, Med. Policy & Tech Evaluation, Independence Blue Cross

MULTI-STAKEHOLDER APPROACH & COLLABORATION

  • Challenges & Opportunities of a company-wide roll-out of Early Access Programme
    Strategies & consideration for a successful implementation
    Established responsibilities from everyone involved to ensure smooth delivery to patients in need
  • The importance of patient advocacy in providing much-needed information on EAP’s available for patients
  • Collaborating with one another to enable a much richer understanding of patient needs
  • Patient groups’ importance in working with health authorities to advance policies that accelerate patient access to investigational medicines
  • Creating a state of the art payer engagement strategies to address challenges in pricing and reimbursement

Eugean Jiwanmall, Sr Research Analyst, Med. Policy & Tech Evaluation, Independence Blue Cross

  • Interaction between pharmaceutical companies and healthcare providers could foster the development of new medicines which will ultimately benefit patients.
  • Would this enhance technological innovation, fosters knowledge creation, aids disease control, and reducespolypharmacy issues?
  • Guidelines to help professionals navigate the opposing explanations of interactions with pharmaceutical companies
  • The importance of patient advocacy in providing a much-needed information on EAP’s available for patients
  • Collaborating with one another to enable a much richer understanding of patient needs
  • Patient groups importance in working with health authorities to advance policies that accelerates patientaccess to investigational medicines
  • Creating a state-of the art payer engagement strategies to address challenges in pricing and reimbursement

END OF CONFERENCE

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