SITC Immuno-Oncology Drug Development Summit

This program is supported, in part, by grants from these sponsors (as of July 1, 2024):

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Keynote

Monday, Sept. 30 from 8:05–8:55 a.m.

Dr. Ignacio MeleroWe are thrilled to announce that Ignacio Melero, MD, PhD from the Clinica Universidad de Navarra Medical School and Cima will be presenting his keynote on Cancer Immunotherapy: Tomorrow's Treatment Combinations Today. Dr. Melero is the Co-Director of the Department of Immunology and Immunotherapy and the Principal Investigator of the Combined Translational Immunotherapy Strategies Research Group.

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 

Program Schedule

Day One: Primer on Drug Development

Day One: Primer on Drug Development
Time

Sessions

8–8:05 a.m.

Opening Remarks
Jon Wigginton, MD – Bright Peak Therapeutics 

Keynote Address
8:05–8:55 a.m.
Moderator: Jon Wigginton, MD – Bright Peak Therapeutics

8:05–8:45 a.m. Cancer Immunotherapy: Tomorrow's Treatment Combinations Today
Ignacio Melero, MD, PhD – Clinica Universidad de Navarra Medical School and Cima
8:45–8:55 a.m. Question and Answer

Session I: Preclinical Models
8:55–10:55 a.m.
Moderator: Pedro Romero, MD – Novigenix

8:55–9:25 a.m.

Overview of Mouse Models for Drug Development
Nikhil Joshi, PhD – Yale School of Medicine

9:25–9:55 a.m.

State-of-the-Art Multicellular Models
Russell Jenkins, MD, PhD – Massachusetts General Hospital

9:55–10:25 a.m.

Toxicology Models
Lois Lehman-McKeeman, PhD – BMS

10:25–10:55 a.m.

FDA Requirements for Preclinical Models
Tiffany Ricks, PhD – FDA

Break
10:55–11:10 a.m.

Session II: IO Clinical Protocol Development
11:10 a.m.–12:40 p.m.
Moderator: Jon Wigginton, MD – Bright Peak Therapeutics

11:10–11:40 a.m.

Early-stage IO Drug Development
Jon Wigginton, MD – Bright Peak Therapeutics

11:40 a.m.–12:10 p.m.

Lessons Learned in Development of CD-3-based Bispecifics
Stan Frankel, MD – Precision BioSciences

12:10–12:40 p.m.

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

Lunch
12:40–1:40 p.m.

Session III: Clinical Trial Design and Terminology, Endpoints, Etc.
1:40–3:20 p.m.
Moderator: Amy McKee, MD – Parexel

1:40–2 p.m.

Dose Finding
Dinesh de Alwis, PhD – Generate Biomedicines

2–2:20 p.m.

Evolving Approach to Endpoints in CAR T Studies
Lynn Navale, MS – Allogene

2:20–2:40 p.m.

Title TBA
Amy McKee, MD – Parexel

2:40–3:15 p.m.

Panel Discussion
Dinesh de Alwis, PhD – Generate Biomedicine
Lynn Navale, MS – Allogene
Amy McKee, MD – Parexel

Break
3:15–3:30 p.m.

Session IV: FDA Initiatives
3:30–5 p.m.
Moderator: Amy McKee, MD – Parexel

3:30–3:55 p.m.

Project Optimus
Nicole Gormley, MD – FDA

3:55–4:20 p.m.

Accelerated Approval
Nicole Verdun, MD – FDA

4:20–4:45 p.m. FrontRunner
4:45–5:15 p.m.

Panel Discussion
Nicole Gormley, MD – FDA
Nicole Verdun, MD – FDA

Networking/Topical Event
5:15–6:45 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
Luisa Salter-Cid, PhD – Flagship Pioneering

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

8:05–8:35 a.m.

Fireside Chat
Priti Hegde, PhD – Kite Pharma
Jedd D. Wolchok, MD, PhD – Weill Cornell Medicine

Session V: Investor Perspectives
8:35–9:35 a.m.
Moderator: Luisa Salter-Cid, PhD – Flagship Pioneering

8:35–9 a.m.

Investor Perspective
Jakob Dupont, MD – Safinnova Investments

9–9:35 a.m.

Panel Discussion
Christiana Bardon, MD, MBA – MPM BioImpact 
Jason Ruth, PhD – MRL Ventures 
Daina Graybosch, PhD – Leerink
Jakob Dupont, MD – Safinnova Investments
Asish Xavier, PhD, MBA – Venture Investments

Break
9:35–9:55 a.m.

Session VI: Chimeric Antigen Receptors
9:55–11:35 a.m.
Moderator: Pedro Romero, MD – Novigenix

9:55–10:20 a.m.

Where We've Been and Where We're Going
Marcela Maus, MD, PhD – Massachusetts General Hospital

10:20–10:45 a.m.

In Vivo Methods of Delivery
Chris Ramsborg – Flagship Pioneering

10:45–11:10 a.m.

Acute and Long-Term Safety
Denis Migliorini, MD – University of Geneva, Switzerland

11:10–11:35 a.m.

Panel Discussion
Marcela Maus, MD, PhD – Massachusetts General Hospital
Chris Ramsborg – Flagship Pioneering
Denis Migliorini, MD – University of Geneva, Switzerland

Lunch
11:35–12:35 p.m.

Session VII: Artificial Intelligence
12:35–2:15 p.m.
Moderator: Alexandra Synder, MD – Generate Biomedicines

12:35–1:05 p.m.

Target Discovery
Philip Tagari (CSO) – insitro

1:05–1:25 p.m.

Creating Drugs (Large Molecules)
Heather Van Epps, PhD – Generate Biomedicines

1:25–1:45 p.m.

Creating Drugs (Small Molecules)

1:45–2:15 p.m.

Clinical Trial Execution

Break
2:15–2:30 p.m.

Session VIII: Immune Cell Engagers
2:30–4:40 p.m.
Moderator: Pedro Romero, MD – Novigenix

2:30–2:55 p.m.

T cell Engagers in Solid Tumors
Lawrence Fong, MD – UCSF

2:55–3:20 p.m.

Next-Gen Mechanisms of T cell Engagers
Danielle Townsley, MD, MSc – Amgen

3:20–3:45 p.m. T cell Engagers for Liquid Tumors
3:45–4:10 p.m.

Panel Discussion
Moderator: Jessica Kirshner, PhD – Regeneron
Lawrence Fong, MD – UCSF
Danielle Townsley, MD, MSc – Amgen

4:10–4:20 p.m.

Closing Remarks

Target Audience

Investors and physicians and scientists in academia, industry (including emerging biotech companies), 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

Upon completion of the program, participants will be able to:

  1. Describe key informational resources and implement best practices regarding the development of immuno-oncology therapeutics beginning with selection of mouse models, multicellular models, organoids and toxicology approaches
  2. Foster relationships between regulatory agencies, industry members, and academic investigators to develop effective strategies for the development of immuno-oncology therapeutics through discussion of case studies, lessons learned and looking ahead across mechanisms (including deeper dives into immune cell engagers, cell therapies and AI for IO drug development)
  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 (including trial designs, dose-finding, and endpoints) 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. (Please note, this is an in person only event) 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.