SITC Immuno-oncology Drug Development Summit

Program Overview

The SITC Immuno-oncology Drug Development Summit will educate the IO community on the regulatory paths for the next wave of IO therapeutics, including:

  • Cellular therapies (CAR T, TCR T, gamma delta T cells, other immune cells)
  • CD3 TCE and bi-specifics
  • mRNA vaccine and other vaccines
  • Oncolytic virus
  • Next generation ICI (TIGIT, LAG3, bi-specifics, small molecule)
  • Innovative cytokines

Program Schedule

Day One: Primer on Drug Development

Day One: Primer on Drug Development
Time

Sessions

8–8:05 a.m.

 Opening Remarks

Keynote Address
8:05–9:05 a.m.
8:05–8:55 a.m. Keynote Address
8:55–9:05 a.m. Question and Answer

Session I: Preclinical Models
9:10–11:10 a.m.
9:05–9:35 a.m.

Overview of Mouse Models for Drug Development
Nikhil Joshi, PhD – Yale School of Medicine
9:35–10:05 a.m.

State-of-the-Art Multicellular Models
Russell Jenkins, MD, PhD – Massachusetts General Hospital
10:05–10:35 a.m.

Toxicology Model
10:35–11:05 a.m.

FDA Requirements for Preclinical Models

Break
11:05–11:20 a.m.

Session II: IO Clinical Protocol Development
11:20 a.m.–12:35 p.m.
11:20–11:45 a.m.

Early-stage IO Drug Development
Jon Wigginton, MD – Bright Peak Therapeutics
11:45 a.m.–12:10 p.m.

Lessons Learned in Development of CD-3-based Bispecifics
12:10–12:35 p.m.

Late-stage IO Drug Development (Cell Therapy)
Kristen Hege, MD – UCSF

Lunch
12:35–1:35 p.m.

Session III: Clinical Trial Design and Terminology, Endpoints, Etc.
1:35–3:15 p.m.
1:35–2 p.m.

Dose Finding
Dinesh de Alwis, PhD – Generate Biomedicines
2–2:25 p.m.

Evolving Approach to Endpoints in CAR T Studie
2:25–2:50 p.m.

Title TBA
Amy McKee, MD – Parexcel
2:50–3:15 p.m.

Panel Discussion
Dinesh de Alwis, PhD – Generate Biomedicines
Amy McKee, MD – Parexcel

Break
3:15–3:30 p.m.

Session IV: FDA Initiatives
3:30–5 p.m.
3:30–3:55 p.m.

Project Optimus
3:55–4:20 p.m.

Accelerated Approval
4:20–4:45 p.m. FrontRunner
4:45–5 p.m.

Panel Discussion

Networking/Topical Event
5–6:30 p.m.

Day Two: Strategies & Hot Topics in Drug Development

Day Two: Strategies and Hot Topics in Drug Development

8–8:05 a.m.

 Opening Remarks

Fireside Chat - The Future of IO
8:05–8:45 a.m.
Moderator: Alexandra Snyder, MD – Generate Biomedicines
8:05–8:45 a.m.

Fireside Chat

Session V: Investor Perspectives
8:45–9:35 a.m.
8:45–9:10 a.m.

Investor Perspective
9:10–9:35 a.m.

Panel Discussion
Jason Ruth, PhD – MRL Ventures 

Break
9:35–9:55 a.m.

Session VI: Chimeric Antigen Receptors
9:55–11:35 a.m.
9:55–10:20 a.m.

Where We've Been and Where We're Going
10:20–10:45 a.m.

In Vivo Methods of Delivery
10:45–11:10 a.m.

Acute and Long-Term Safety
11:10–11:35 a.m.

Panel Discussion

Lunch
11:35–12:35 p.m.

Session VII: Artificial Intelligence
12:35–2:15 p.m.
12:35–1 p.m.

Target Discovery
1–1:25 p.m.

Creating Drugs (Large Molecules)
Heather Van Epps, PhD – Generate Biomedicines
1:25–1:50 p.m.

Creating Drugs (Small Molecules)
1:50–2:15 p.m.

Clinical Trial Execution

Break
2:15–2:30 p.m.

Session VIII: Immune Cell Engagers
2:30–4:40 p.m.
2:30–2:55 p.m.

T cell Engagers in Solid Tumors
2:55–3:20 p.m.

Next-Gen Mechanisms of T cell Engagers
3:20–3:45 p.m. T cell Engagers for Liquid Tumors
3:45–4:10 p.m.

Panel Discussion
Moderator: Jessica Kirschner, PhD – Regeneron
4:10–4:20 p.m.

Closing Remarks

Organizers

Amy McKee, MD

Amy McKee, MD
Parexel

Pedro Romero, MD

Pedro J. Romero, MD
Novigenix

Luisa Salter-Cid, MD

Luisa Salter-Cid, PhD
Flagship Pioneering

Alexandra Snyder, MD

Alexandra Snyder, MD
Generate Biomedicines

Dr. Jon Wigginton_Bright Peak.png

Jon M. Wigginton, MD
Bright Peak Therapeutics 

Target Audience

Physicians and scientists in academia, industry (including emerging biotech companies), investors and regulatory agencies who have an interest in the strategic, preclinical, clinical and regulatory aspects of efficient IO drug development. This program will also support those who are beginning careers in IO drug development.

Learning Objectives

  1. Describe key informational resources and implement best practices regarding the development of immuno-oncology therapeutics
  2. Develop relationships between regulatory agencies, industry members, and academic investigators to develop effective strategies for the development of immuno-oncology therapeutics
  3. Integrate scientific and regulatory objectives to develop preclinical and clinical strategies that drive efficient development of immuno-oncology therapeutics
  4. Design effective clinical trials specific to immuno-oncology therapeutics that reflect regulatory expectations and requirements

Registration & Housing Information

See you at the Revere Hotel Boston Common

Located in historic downtown, immersed in the city's cultural energy, Revere Hotel Boston Common is an urban refuge that blends authentic local character with its own original swagger. Book your room today >

Register Today for the SITC Immuno-oncology Drug Development Summit

This program will be a key forum for continuing exploration and discussion of best practices for modern IO drug development. Register today >

SITC Member Pricing

SITC Member Pricing
Immuno-oncology Drug Development Summit

Early Reg. Rates
Closes Aug. 31 at 11:59 pm PST.

 Regular Rates
Begins Sept. 1 at 12:00 am PST. Closes Sept. 26 at 11:59pm PST.
 Onsite Rates
Begins Sept. 27 at 12:00 am PST. Closes at Oct. 1 at 11:59pm PST.
Regular $650 $780 $830
Industry $1,365 $1,525 $1,575
Small Biotech (50 or less company employees) $865 $1,025 $1,075
Student $80 $100 $150
Low to lower-middle income economies (LMIE) $0 $0 $0

SITC Non-member Pricing

SITC Non-member Pricing
Immuno-oncology Drug Development Summit

Early Reg. Rates
Closes Aug. 31 at 11:59 pm PST.

 Regular Rates
Begins Sept. 1 at 12:00 am PST. Closes Sept. 26 at 11:59pm PST.
 Onsite Rates
Begins Sept. 27 at 12:00 am PST. Closes at Oct. 1 at 11:59pm PST.
Regular  $735 $890 $940
Industry $1,500 $1,660 $1,710
Small Biotech (50 or less company employees) $1,030 $1,190 $1,240
Student $300 $360 $410
Low to lower-middle income economies (LMIE) $25 $25 $25

Cancellation & Refund Policy

The cancellation deadline is October 8, 2024. Refund requests should be submitted in writing to the SITC office at events@sitcancer.org by October 8, 2024. A $25 processing fee will be charged for all paid registrations. All refunds will be processed within two weeks of receipt. No refunds will be granted if cancellation is received after the deadline.

Covid-19 Measures

At SITC programs, our goal is to have a safe and meaningful in-person experience. SITC will refer to the CDC COVID-19 Community Levels to guide health precautions for in-person meetings. In addition, SITC strongly recommends that in-person meeting attendees take the following precautions:

  • Stay up to date with COVID-19 vaccinations
  • Take a rapid COVID test prior to attending a meeting and do not attend in person if you test positive
  • Do not attend the meeting if you have symptoms that could be consistent with a “cold” or any other respiratory infection and leave the meeting if you develop such symptoms
  • Wear a mask in crowded indoor settings
  • Follow all health and safety protocols as required by SITC and local and state health departments.
  • Review current CDC and applicable local guidance for protecting yourself from COVID-19

Attendees will have access to the meeting content online if they are unable to attend in person due to illness or a positive COVID test. For hybrid programs, attendees can change from in-person to online-only registration by contacting events@sitcancer.org.