27 - 28 October, 2020
| Online Event - GMT
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
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
Geoff Fatzinger PhD
Managing Director CCPS UK, Global VP QA/RA and Strategic ServicesCaligor 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
Raj Nijjar
Clinical Lead Cancer Pharmacist & Specialised Cancer Commissioning PharmacistBarts Health NHS Trust & NHS England - London Region
2:30 pm - 3:00 pm
Coffee Break
3:00 pm - 3:40 pm
Making It Real: Patient Engagement in Early Access
Jodi Wolff -
Head of Patient Advocacy US,
Santhera
Holly Lumgair - Patient Advocacy, Clinigen Group
Bettina Ryll - Founder, Melanoma Patient Network Europe
· 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
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
4:20 pm - 5:05 pm
Panel Discussion: Is there one standard for Covid and one for other therapeutic areas?
Alison Bateman-House -
Co-Chair,
NYU Working Group on Compassionate Use and Preapproval Access (CUPA)
Pat Furlong - Founding President & CEO, Parent Project Muscular Dystrophy (PPMD) and CUPA Member
Kenneth Moch - President & CEO, Cognition Therapeutics and CUPA Member
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?
Alison Bateman-House
Co-ChairNYU Working Group on Compassionate Use and Preapproval Access (CUPA)
Pat Furlong
Founding President & CEOParent Project Muscular Dystrophy (PPMD) and CUPA Member
