Webinar Day Two

12:25 pm - 12:30 pm Chairperson's Opening Address

12:30 pm - 1:10 pm Connecting Pharma with the Pharmacist: Roche’s Platform for Integration and Information

Dr. Philipp Schlatter - Community of Practice Leader, Post Trial Access & Drug Supply, Roche


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Dr. Philipp Schlatter

Community of Practice Leader, Post Trial Access & Drug Supply
Roche

1:10 pm - 1:50 pm Mapping Regulatory Differences Between Europe and the US for Pre-Approval Access

Geoff Fatzinger PhD - Managing Director CCPS UK, Global VP QA/RA and Strategic Services, Caligor Coghlan Pharma Services
  • Early Access to Medicines Programs (EAMs) in Europe provide pre-launch, pre- Market Authorisation, ULM, pre-commercialisation, and NPP access to drugs and treatments for patients with life-threatening conditions and no approved treatment options
  • EAM programs are country-specific, are based on what you can negotiate, should not be cookie cutter, and are able to provide valuable information and in some cases limited financial returns
  • Increasingly, EAMs provide opportunities for early stakeholder engagement, RWE, Clinical adoption support and in some cases could foster swift patient access to breakthrough medical products
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Geoff Fatzinger PhD

Managing Director CCPS UK, Global VP QA/RA and Strategic Services
Caligor Coghlan Pharma Services

1:50 pm - 2:30 pm Joint Presentation: Building a Proactive Development Strategy to Avoid Reactive Decisions Across Your Route to Market

Raj Nijjar - Clinical Lead Cancer Pharmacist & Specialised Cancer Commissioning Pharmacist, Barts Health NHS Trust & NHS England - London Region
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Raj Nijjar

Clinical Lead Cancer Pharmacist & Specialised Cancer Commissioning Pharmacist
Barts Health NHS Trust & NHS England - London Region

2:30 pm - 3:00 pm Coffee Break


·        Discuss structures, motivations and best practices for patient engagement, introducing a three-way perspective across oncology and rare disease

·        Examine experience to date at MPNE within oncology, directions for the future, possible framework for action

·        Engage with a examples of patient engagement & communication in a rare disease US Expanded Access Program

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Jodi Wolff

Head of Patient Advocacy US
Santhera

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Holly Lumgair

Patient Advocacy
Clinigen Group

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Bettina Ryll

Founder
Melanoma Patient Network Europe

3:40 pm - 4:20 pm Moving from Talk to Action – Collaborating to Drive Access To Medicines Forward

Paul Aliu - Head Global Governance Office, Chief Medical Office, Novartis
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Paul Aliu

Head Global Governance Office, Chief Medical Office
Novartis

A discussion from multiple stakeholder perspectives on what’s currently happening in various therapeutic areas with all the attention current being focused on COVID-19. Focus topics will include the conduct of trials, investment into new research, patient engagement and regulatory pathways.

The central question to be asked will be: How do we justify what we are doing under – and with - Covid in comparison to what we are doing for other diseases?

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Alison Bateman-House

Co-Chair
NYU Working Group on Compassionate Use and Preapproval Access (CUPA)

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Pat Furlong

Founding President & CEO
Parent Project Muscular Dystrophy (PPMD) and CUPA Member

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Kenneth Moch

President & CEO
Cognition Therapeutics and CUPA Member

5:05 pm - 5:15 pm Chairperson's Closing Address