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Analytical Procedures & Methods Validation Europe

PC15019

This Compendium consists of materials submitted by the speakers that complement their presentations. We understand what an important resource this material is and we have made a concerted effort to secure biographical sketches, outlines and related materials.

Additionally, you will find included, helpful information on solution providers, publications and associations, including links their websites.

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Presentations

OPENING ADDRESS Paving the Path for Expanded Access to Investigational Drugs —
Update on Legislation and Public Policy Impacting Patients and Programs

Diane Edquist Dorman
Former Vice President, Public Policy
NORD

PATIENT ADVOCACY PANEL Patient Perspective on Compassionate Use and Early Access to Life-Transforming Treatment

Moderator:

Wayne Pines
President, Regulatory Services and Healthcare
APCO Worldwide

Panelists:

Steven Walker, M.S., P.G.
Co-Founder
Abigail Alliance for Better Access to Developmental Drugs

Richard Plotkin
Vice Chairman/Co-Founder
Max Cure Foundation, Inc.

Ernest Voyard
Senior Director, Regulatory Affairs
The Leukemia & Lymphoma Society

OHCA/FDA ADDRESS New Models for Simplified and Accelerated Access to Investigational Medicine

Richard Klein
Patient Liaison Program Director,
Office of Health and Constituent Affairs
FDA

Industry and Physician Collaboration Models for Advancing Access to Lifesaving Therapies

Jess Rabourn, CFA
Chief Executive Officer, Ax-S Pharma;
Managing Director, ALS Emergency Treatment Fund

EXTENDED SESSIONStrategies for Ethical, Compliant and Successful Managed Access Programs

I.Operational Policies, Processes and Procedures

II.Site Success Strategies

III.Real-World Data Collection and Preparing for the Regulatory Approval Process

Jose Ricardo Perez, M.D.
Senior Medical Director
Novartis Oncology

Jodie Gillon
Head, External Interface Office
AstraZeneca

U.S. CONSIDERATIONS

BIO ADDRESS Policy, Science and Compassion — Company Commitment, Challenges and Considerations for Access to Unapproved Product

Kay Holcombe
Senior Vice President, Science Policy
Biotechnology Industry Organization

Strategies for Forecasting and Establishing Supply

Todd Hatajik
Supply Chain Lead
Pfizer Inc

ROUNDTABLE DISCUSSION Navigate the Pricing, Payment and Reimbursement Policy for Expanded Access Programs

Jess Rabourn, CFA
Chief Executive Officer, Ax-S Pharma;
Managing Director, ALS Emergency Treatment Fund

Social Media — Leveraging the New Channel for Advocacy, Access and Awareness

Richard Plotkin
Vice Chairman/Co-Founder
Max Cure Foundation, Inc.

GLOBAL CONSIDERATIONS

EXTENDED SESSION Effective Global Access Programs within an International Regulatory Landscape

I. Deep-Dive into Country-Specific Regulations

II. Planning — Protocol Development and Novel Strategies

III. Implementation — Study Start-Up

IV. Program Maintenance

V. Close Out of Global EAP

Stephen Billinson
Senior Global Trial Manager
Janssen R&D

Speaker Bios

Stephen Billinson
Senior Global Trial Manager
Janssen R&D

Diane Edquist Dorman
Former Vice President, Public Policy
NORD

Jodie Gillon
Head, External Interface Office
AstraZeneca

Karen Grosser
Vice President, Development,
Infectious Disease and Vaccine Therapeutic Area
Janssen Pharmaceutical Companies of Johnson & Johnson

Todd Hatajik
Supply Chain Lead
Pfizer Inc

Kay Holcombe
Senior Vice President, Science Policy
Biotechnology Industry Organization

Richard Klein
Patient Liaison Program Director,
Office of Health and Constituent Affairs
FDA

Paul Nitschmann
Head, Regulatory Affairs Pharmaceuticals
Alcon

Jose Ricardo Perez, M.D.
Senior Medical Director
Novartis Oncology

Wayne Pines
President, Regulatory Services and Healthcare
APCO Worldwide

Richard Plotkin
Vice Chairman/Co-Founder
Max Cure Foundation, Inc.

Jess Rabourn, CFA
Chief Executive Officer, Ax-S Pharma;
Managing Director, ALS Emergency Treatment Fund

Ramana Sonty, M.B.B.S, Ph.D.
Pre-Approval Access Project Leader, Global Medical Organization
Janssen Research & Development,
LLC Pharmaceutical Companies of Johnson & Johnson

C. Amelia Sumandea, Ph.D.
Global Expanded Access Consultant, Global Medical Strategy and Operations, Medicines Development Unit
Eli Lilly and Company

Cherry T. Thomas, M.D.
Group Director, U.S. Medical, Immuno-Oncology
Bristol-Myers Squibb

Ernest Voyard
Senior Director, Regulatory Affairs
The Leukemia & Lymphoma Society

Steven Walker, M.S., P.G.
Co-Founder
Abigail Alliance for Better Access to Developmental Drugs

  Agenda
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