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  4.  » Road to IND: Accelerating Viral-Vector Based Gene Therapies to Patients

Road to IND: Accelerating Viral-Vector Based Gene Therapies to Patients

Date: April 24, 2024
Program Duration: 9:00 am – 1:30 pm

Location: JLABS @ SSF, 329 Oyster Point Blvd 3rd Floor, South San Francisco, CA 94080

Viral vector-based gene therapies continue to advance at breakneck speed. The last year alone saw the approval of the first ever CRISPR technology (sickle cell disease) as well as approvals for Duchenne Muscular Dystrophy and Hemophilia A. Hundreds of cell and gene therapy clinical trials are underway ensuring a rich pipeline for years to come.

With the landscape of gene therapy rapidly evolving, it is undeniably met with challenges. The availability of treatments relies on the ongoing development of enabling technologies and processes that enhance capabilities, address larger patient populations, improve safety profiles, and reduce manufacturing costs. Gene therapy programs often operate on expedited timelines. Success in this dynamic field hinges on proactive and strategic approaches throughout the development and manufacturing processes. Key to this are early planning and adherence to good manufacturing practice (GMP) standards, coupled with the timely sourcing of high-quality materials and standardizing on platform equipment. Additionally, innovators looking to treat new diseases know that being first to clinic studies is critical, so they will look for ways to accelerate the production of material for first-in-human trials.

This half-day program featuring key opinion leaders aims to explore significant innovation and improvements in starting materials, including engineered plasmids and clonally-selected production cell lines. We will discuss platform strategies to enable a rapid and templated approach to first-in-human clinical studies, while also streamlining the path for late-stage clinical trials and commercial release in compliance with regulatory agencies. Additionally, experts will discuss funding, strategic benefits of partnering and outsourcing with a CDMO and other advanced topics, including the use of AI in creating improved AAV gene delivery vehicles.

Key learning objectives:

  • Discuss the challenges and opportunities that lie ahead in the rapidly growing area of gene therapy
  • Understand the critical pathways throughout the development and manufacturing process
  • Explore innovative approaches to unlock full potential for patients
  • Assess the venture capital landscape to develop and execute a fundraising action plan

Space is limited, register today to secure your spot!

Who Should Attend: C-Suite, R&D, Formulation Scientists, Product Development and CMC personnel, Consultants from biotech industry

AGENDA

TIME

SESSION TITLE

SPEAKERS

10:00 am – 10:20 am

Registration and Networking Breakfast

10:20 am – 10:30 am

Welcome Note

Chris Haskell
Site Head

Ronak Savla
Director, Strategic Ventures
Catalent

10:30 am – 11:15 am

The Promise and Challenge of Vectored Therapies: A CDMO Perspective

George Buchman, Ph.D.
Research Fellow, CGT
Catalent

11:15 am – 12:00 pm

Integrated Viral Vector Platform for Speed to Clinic: A perspective of Off-the-shelf plasmids and clonal cell-line

Bhargavi Kondragunta, Ph.D.
Director,
Internal Research &
Product Development, CGT
Catalent

12:05 pm – 12:50 pm

Panel discussion on Fundraising, Partnership Strategies, and Outsourcing

Jayson Punwani
Managing Director
Abingworth

Jonathan Norris
Managing Director
HSBC Innovation

Evan Caplan
Principal
OrbiMed Advisors

Moderated by Ronak Savla

1:00 pm – 1:30 pm
Networking Lunch & Meet the Experts