Advanced Therapy Medicinal Products (ATMPs) have emerged as a novel class of biological products offering huge potential for the treatment of cancer and rare diseases where limited or no alternative treatment options exist. ATMPs have already demonstrated outstanding results in treatment in patients with B-cell acute lymphoblastic leukaemia (ALL), melanoma and rare inherited disorders such as treatment of children with spinal muscular atrophy and patients with vision loss due to inherited retinal dystrophy. ATMPs provide life-changing benefits to patients and their families.

These innovative products are based on somatic cells, tissue-engineered products, gene therapies, and a combination of a medical device that embedded a cell or tissue components.

ATMPs is a fast-growing area of novel and complex products still at its early stage of development. Despite the unique possibilities that these products illustrate, there are some key challenges associated with the development of these innovative and promising therapies, including regulatory, scientific, manufacturing and commercialization ones.

On 25th Sep 2020 notable experts from PharmaLex Group will discuss the most current challenges and future perspectives of ATMPs. The workshop, which is organized by PharmaLex and Biotech Atelier will include topics on: non-clinical and CMC challenges with real-life case studies, marketability of ATMPs, industry perspectives, and market access and reimbursement challenges.

Agenda

All times are in Eastern European Summer Time (EEST) / UTC +3

11:00
 – 11:20

Opening

Eva Maydell

11:20
 – 11:30

Introduction

Miglena Manova

11:30
 – 12:00

EU ATMP development landscape and outlook

Violeta Georgieva

11:30
 – 12:30

ATMP update and Regulatory Strategy

Zaklina Buljovcic

12:30
 – 12:45

Q&A session

12:45
 – 13:15

Break

13:15
 – 13:45

Nonclinical Challenges and Cases with ATMPs

13:45
 – 14:15

CMC Challenges and case studies with ATMPs

14:15
 – 14:30

Q&A session

14:15
 – 14:45

Break

14:45
 – 15:15

The ATMP post approval path - patient and market access

Annabelle Forsmark

15:15
 – 15:45

Riding the clinical trial rollercoaster - a patient’s perspective

Jonathan Clark

15:45
 – 16:15

Q&A session

Speakers

United Kingdom

Adeyemi Afuwape

Associate Director, Regulatory Affairs CMC
PharmaLex UK

The Netherlands

Jonathan Clark

Independent advisor on strategy and innovation
Founder at Jonathan Clark & Partners B.V.

Bulgaria / Belgium

Violeta Georgieva

Manager Legal Affairs
EuropaBio – the European Association for Bioindustries

United Kingdom

Zeb Younes

Director, Regulatory Affairs
PharmaLex UK

Special Guest

Organizers
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