Pharma & Biotech

Pricing and Market Access of ATMPs

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

LEARNING OBJECTIVES

Discuss strategies for ATMP pricing and innovative value-based contracting (risk sharing)

Explore the opportunities of real-world evidence for ATMP value demonstration

Consider payer uncertainties and strategize how to address these barriers to access

Gain insight into full-spectrum value evidence generation through the timely integration of market access strategy with clinical development and regulatory affairs

Discover the crucial role of patient engagement throughout the ATMP lifecycle

Analyse current ATMP successes and failures and create learnings for the next 3-5 years

KEY TOPICS

An Introduction to Advanced Therapy Medicinal Products (ATMPs)

Learning from cell and gene therapy market access successes and failures

Addressing payer uncertainties with early approvals and fewer clinical data

TRAINER

Dr. Simon Day

Clinical Trials Consulting & Training,

Simon has spent 30 years working in clinical trials, mostly in the pharmaceutical industry but also including five years at the UK and European regulatory agencies. He now works as a statistical and regulatory consultant to pharmaceutical and biotechnology companies around the world. He specialises in training and consulting on drug development programmes, scientific advice/end of Phase II meetings and preparations for oral explanations and advisory committees. He is particularly well known for his work in the area of developing treatments for rare diseases. Simon has served on a variety of data monitoring committees both for industry-sponsored and government-sponsored trials. He is chairman of the External Advisory Panel for the Department of Statistics at Oxford University and an Associate on the faculty at Johns Hopkins University in Baltimore. He formerly served as vice-Chairman of the West London Research Ethics Committee. He has given numerous lectures and courses on statistics and clinical trials all around the world, including courses at the FDA on the development and regulatory assessment of orphan drugs.

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