Advanced Therapies Clinical Development

 

Advanced Therapies - Clinical, Wednesday 29 April 2020

last published: 17/Jan/20 21:45

 

Advanced Therapies - Clinical, Thursday 30 April 2020

Emil Kakkis
08:30

Keynote Address: The future of rare diseases: developing and accessing the next generation of therapies

Mark Rothera
08:55

Sponsored Keynote Address: Gene therapy: the future is now

10:30

10:30 SPEED NETWORKING FOLLOWED BY MORNING NETWORKING BREAK

Translation and Regulatory

Gavin Corcoran
Advanced Therapies - Clinical
11:30

Translating gene therapies from academia to industry - The need to create a common standard for development, vernacular and data quality to ensure faster regulatory approvals

Sara Nochur
Advanced Therapies - Clinical
11:50

Regulatory considerations in getting the first RNAi therapy approved - case study of ONPATTRO

Advanced Therapies - Clinical
12:10

Making use of accelerated programs and design flexibility to expedite cell and gene therapies through the clinic

Speaker to be announced.
Advanced Therapies - Clinical
12:30

GOLD SPONSOR SESSION

If you are interested in sponsoring this session, contact André Singer now at +1 646 619 1797 or andre.singer@terrapinn.com
Jan Nielsen
14:20

ROUNDTABLE 10: Patient and provider experiences - A tailored tech + talent approach to enhance the journey

Rachel Sher
14:20

ROUNDTABLE 11: Orphan Drug Act-assessing the impact since 1983 and looking forward

Alexander Natz
14:20

ROUNDTABLE 12: Real World Evidence – examining recent cases of real world evidence for approvals and reimbursement in Europe

Sara Nochur
14:20

ROUNDTABLE 16: Diversity & inclusion - The importance of D&I in a global company - exploring its impact on employee morale, engagement and retention of workforce, and also the need for D&I in clinical

Jennifer Helfer
14:20

ROUNDTABLE 17: Internal Patient Perspective – blocking and tackling actionable implementation of patient voice throughout company functions

Debbie Drell
14:20

ROUNDTABLE 18: Splinter Groups - How to advance your organization, unify communities and focus on your mission while navigating challenges with personalities, emotions and leadership differences among

Scott Schliebner
14:20

ROUNDTABLE 1: Reducing study burden – approaches for assessing and reducing the burden of clinical trial participation for patients

14:20

ROUNDTABLE 23: Gene therapy education – best practices for educate patient populations on the science and implications of gene therapy

Chelsea Catsburg
14:20

ROUNDTABLE 2: Synthetic control arms - using RWE to streamline the regulatory process

Scott Gray
14:20

ROUNDTABLE 3: The patient journey - improving clinical trial performance and delivering better study outcomes through a personalized approach to the patient experience

Anne Cropp
14:20

ROUNDTABLE 4: Early Access – effective measures for successful EAPs

Meagan Spychala
14:20

ROUNDTABLE 5: Patient-Focused Drug Development – how to get started

Amanda Finlayson
14:20

ROUNDTABLE 6: Balancing the Patient Experience & ROI – understanding when to incorporate patient accommodations into study programs and balancing short and long term financial goals

Michelle Berg
14:20

ROUNDTABLE 7: Gene therapy CMC – early pDNA considerations for late stage success

David Lapidus
14:20

ROUNDTABLE 8: Forecasting & epidemiology - rare-disease epidemiology methods and resources to support commercial forecasts

Becky Thompson
14:20

ROUNDTABLE 9: Access Programs - discussion on the value of rare and orphan access programs, next generation registries and post marketing surveillance for products

ROUNDTABLE SESSIONS (1-hour roundtable sessions split between 2 rounds of 30min) – Sign up for two roundtables by registration

3:20 END OF ROUNDTABLES

Trial Design

Olivier Danos
Advanced Therapies - Clinical
15:25

Examining challenges in gene therapy clinical development and the future of the field for rare diseases

Wilson Bryan
Advanced Therapies - Clinical
15:45

FDA update: real world evidence in place of control arm studies for advanced therapies clinical trial designs

Advanced Therapies - Clinical
16:05

Title to be announced

Speaker to be announced.
Advanced Therapies - Clinical
16:25

Session will be hosted by Catalent Pharma Solutions

More information will be available soon.
16:45

4:45 AFTERNOON NETWORKING BREAK

Nick Page
17:25

Keynote Address: KYMRIAH case study: what it takes to bring an organization from clinical to commercial scale for vector manufacture

18:05

END OF CONFERENCE DAY 1 FOLLOWED BY NETWORKING DRINKS RECEPTION

last published: 17/Jan/20 21:45