Live Chat Software
05 - 07 November, 2019 | Hilton London Olympia , London, United Kingdom

Conference Day One

9:00 am - 9:15 am Chairperson's Opening Remarks

Anne Cropp Pharm.D., Chief Scientific Officer at Early Access Care LLC

Anne Cropp Pharm.D.

Chief Scientific Officer
Early Access Care LLC

9:15 am - 9:50 am Starting Off on the Right Foot: Setting Your Objectives with Cross-Functional Collaboration

  • Identify the key functions and stakeholders that should be present during the initial preparation of an EMAP
  • Drive results by establishing the principle objectives of the programme and who takes ownership
  • Analyse how cross-functional collaboration facilitates the smooth running of your EMAP, with examples from Zogenix’s current compassionate use programme for their investigational therapy ZX008, for the orphan disease Dravet Syndrome 
Arun Mistry, Vice President Clinical Development & Medical Affairs Europe at Zogenix

Arun Mistry

Vice President Clinical Development & Medical Affairs Europe
Zogenix

  • Explore how you can tackle the regulatory and logistical grey areas that exist across the European Market Place, with regards to Early Access Programmes
  • Understand the importance of a local point of contact or legal representative in your targeted market
  • Define how labelling requirements can differ when supplying drugs for a clinical trial and for an Early Access Programme and the challenges associated with importation
  • Ensure you retain oversight of an outsourced programme by defining an effective logistics strategy for your vendor
Elie Dechesne, Associate Director, R&D Logistics at Bristol-Myers Squibb

Elie Dechesne

Associate Director, R&D Logistics
Bristol-Myers Squibb

Sylwia Stachura, Clinical Protocol Manager at Bristol-Myers Squibb

Sylwia Stachura

Clinical Protocol Manager
Bristol-Myers Squibb

Ana-Zeralda Canals Hamann, Preclinical and Supply Chain Manager at Laboratoris Sanifit

Ana-Zeralda Canals Hamann

Preclinical and Supply Chain Manager
Laboratoris Sanifit

10:35 am - 11:20 am Networking Break

11:20 am - 11:55 am Early Patient Access Strategy: Successful Execution of a Named Patient Program

  • Understand the necessity of viewing an Early Patient Access (EPA) Programme as part of a continuum of product development and why early access considerations should be embedded within standard procedures
  • Ensure the success of your EPA Programme by gaining insight into the development of Bristol-Myers Squibb’s clear set of Guiding Priniples around early access
  • Highlight the importance of creating a detailed EPA Programme plan for each asset, with defined ‘trigger points’ and clear ownership and governance – assuring a successful initiation and execution of a Named Patient Programme
Sylwia Stachura, Clinical Protocol Manager at Bristol-Myers Squibb

Sylwia Stachura

Clinical Protocol Manager
Bristol-Myers Squibb

11:55 am - 12:25 pm Strategic Programme Considerations for Open Label Extension versus Early Access Programmes

  • Selecting the right path: Optimise your key Product Development Team discussions by comparing and contrasting the objectives and design of Open Label Extensions versus Early Access Programmes
  • Analyse the opportunities for data collection and consider the risks and impact of scope creep
  • Deep-dive into the fiscal realities of Open Label Extensions versus Early Access Programmes and how this should influence your strategic decision making
Alita Hassan, Executive Director at Early Access Care LLC

Alita Hassan

Executive Director
Early Access Care LLC

12:25 pm - 12:55 pm Operationalizing RWD within Expanded Access

  • How to optimally benefit from tracking a patients journey
  • Historic perspective of the utility of RWD within EA (viewpoints from regulators, viewpoints from industry, payors) 
  • How we operationalize, legal, data management, dedicated team
Dennis Akkaya, Corporate Development at myTomorrows

Dennis Akkaya

Corporate Development
myTomorrows

12:30 pm - 1:30 pm Networking Lunch

2:30 pm - 3:05 pm Incorporating Your Early Access Plan as Part of Your Early Clinical Trial (1 or 2A) or a Substitute in a Regional Market Without Infrastructure

  • Understand the critical success factors that ensure alignment between Early Access Programmes and Clinical Trials
  • Analyse the implications of a lack of infrastructure in regional markets has on Early Access Programmes and how you can leverage existing capabilities to bridge the gap
  • Explore lessons learned from previous case-studies and gain insight into best practice 
Tom Watson, Executive Vice President, Early Access Programs at Bionical Emas

Tom Watson

Executive Vice President, Early Access Programs
Bionical Emas

3:05 pm - 3:50 pm Fire-Side Q&A: Post-Trial Programmes– Bridging the Gap Between Clinical Trials and Commercialisation

  • Define the guiding principles that you should use to effectively manage your Early Access Programmes by comparing and contrasting methodologies from Janssen and Novartis
  • Analyse the challenges that are associated with post-trial programmes and understand how you can adopt effective policies and procedures to overcome these operationally
  • Developing a global framework and post trial responsibility – ensuring continued access – close access between end of trial and commercialization 
Gregory Tuyteleers, Global Operations Lead - Managed Access at Janssen

Gregory Tuyteleers

Global Operations Lead - Managed Access
Janssen

Ramona Reichenbach, Global Medical Governance Lead – Managed Access Programs (MAPs) at Novartis

Ramona Reichenbach

Global Medical Governance Lead – Managed Access Programs (MAPs)
Novartis

3:50 pm - 4:20 pm Networking Break

4:20 pm - 4:55 pm Meeting Unmet Patient Needs and Showing it Through Data

  • Discuss the internal communication issues that arise when conducting an Early Access Programme and the need to differentiate from a clinical trial, in the context of rare and orphan disease
  • Explore both the internal and external challenges and opportunities associated with the capture of real world data, and how it can be achieved in clinical practice
  • Examine how this secondary purpose of early access programmes can be utilised to guide benefit risk management, life cycle planning and hypothesis testing while still adhering to the basic premise of meeting an unmet medical need
Peter Rutherford, Global Medical Lead Orphan Unit at Vifor Pharma

Peter Rutherford

Global Medical Lead Orphan Unit
Vifor Pharma

  1. Managing Varying Stakeholder Perspectives and Effective Communication - Peter Rutherford,  Global Medical Lead Orphan Unit, Vifor Pharma
  2. Vendor Validation and Qualification: Managing an Outsourced EMAP
  3. Building an Effective and Collaborative Relationship with your Stakeholders
  4. Understanding the quirks of Pediatric Early Access Programmes - Alison Batement-House, Co-Chair, NYU Working Group on Compassionate Use and Preapproval Access (CUPA)
Peter Rutherford, Global Medical Lead Orphan Unit at Vifor Pharma

Peter Rutherford

Global Medical Lead Orphan Unit
Vifor Pharma

Alison Bateman-House, Co-Chair at NYU Working Group on Compassionate Use and Preapproval Access (CUPA)

Alison Bateman-House

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

5:30 pm - 5:40 pm Chairperson's Closing Address

Anne Cropp Pharm.D., Chief Scientific Officer at Early Access Care LLC

Anne Cropp Pharm.D.

Chief Scientific Officer
Early Access Care LLC