#SITCQuestfor100

SITC Biotech Strategic Meeting at the New York Stock Exchange (NYSE)

SITC hosted the 3^rd Annual Biotech Strategic Meeting at the New York Stock Exchange (NYSE) on Friday, June 27, welcoming a sold-out audience of nearly 100 biotech leaders, investors and drug development professionals. This exclusive event convened experts and innovators to discuss the future of T-cell engagers, China’s influence on IO clinical research and strategic pathways for IO biotech companies to create value in today’s market. The evening before the main program, SITC partnered with ZS Associates to host The Last Mile of Developing Next Wave IO, which featured a panel discussion and networking mixer. The conversation focused on the path to launching an IO biotech and the final stages of bringing next-generation therapies to market.

Biotech Regulatory Roundtable

The SITC Biotech Regulatory Roundtable, held on Wednesday, Nov. 5, in National Harbor, MD, convened leading experts along with key stakeholders from industry and biotech to discuss pressing regulatory topics in immuno-oncology drug development.

Panels focused on FDA guidance initiatives, parent-child INDs, regulatory flexibility, and CMC optimization. An additional panel explored orphan and rare disease designations and regulatory pathways for rare disease drug development. The agenda closed with a panel on innovations in digital health, covering digital pathology, biomarkers and AI automation.

Designed for biotech innovators and IO stakeholders, this sold out preconference event offered a unique opportunity to engage directly with former FDA representatives.

Biotech Virtual Programs

As part of the Biotech Initiative, the Talent Development pillar held two webinars in March. Both webinars featured three expert panelists who shared their career journeys and engaged in a robust Q&A session with the attendees.

Biotech Education Excellence Virtual Interviews: From Conception to Launch to Funding: The Business of IO Biotech

The SITC Biotech Committee launched an inaugural series of three interviews that offered the community valuable insights into the business of biotech: academic tech transfer, early-stage IO biotech launches and investor decisioning. Led by co-chairs, Praveen Bommareddy, MS, PhD and Johanna Grossman, PhD, the series featured engaging discussions with experts in the field.

Episode 1: Spinning Technology from Academia to Biotech

The first interview explores the transition of academically developed IO technologies and intellectual property into a biotech company. Dr. Bommareddy (Replimune) led the conversation with Samir N. Khleif, MD (Georgetown University Medical Center) and Bruce Levine, PhD (University of Pennsylvania). Topics Include:

• Knowing when your dataset is ready to share
• Differences between sponsor-initiated trials and investigator-initiated trials
• Strategies for connecting with investors

Episode 2: Founding a Biotech

SITC hosted an engaging conversation with biotech entrepreneurs Robert Coffin, PhD (Replimune), and Rachel Humphrey, MD (Normunity, Inc.), moderated by Dr. Bommareddy. They shared first-hand lessons from founding and growing biotech companies, from early IP filings to building teams, navigating funding, and staying true to their scientific vision.

• How to define a vision and recruit the right people to bring it to life
• Building a strong IP and business strategy from day one
• Tips for fundraising in the current biotech landscape
• Balancing courage, humility, and adaptability as a founder

Episode 3: Early Investors

Johanna Grossman, PhD (New York Stock Exchange) interviewed Nandita Shangari, PhD (RA Capital) and Artavazd (Artie) Arumov, PhD (Qiming Venture Partners USA). They discussed how top investors discover, evaluate, and support early-stage cancer immunotherapy startups, with insights into funding strategies, company building, and navigating today’s market environment.

• Investor Evaluation Frameworks
• Sourcing Opportunities
• Investor Role Post-Investment
• Market & Funding Climate
• Advice for Founders

Whether for aspiring biotech entrepreneurs or established professionals seeking to sharpen their leadership insight, these interviews offered actionable advice from those with deep, firsthand experience. The full program is now available to stream on demand.

The Next Wave of Immuno-oncology: A Roadmap from the Society for Immunotherapy of Cancer (SITC)

The rapid clinical and scientific progress of immuno-oncology since the approval of the first immune checkpoint inhibitors has permanently transformed the landscape of patient care. Recognizing both the milestones achieved and the challenges that lie ahead, the Society convened a diverse group of leaders from academia, the pharmaceutical and biotechnology industries, patient advocacy and the regulatory community. Together, these experts developed a forward-looking roadmap to guide the next wave of novel immunotherapies for cancer patients.

Within this JITC special series, contributors highlight the current state of the field, articulate the most pressing scientific and regulatory challenges, and identify the most promising opportunities for high clinical impact across cancer immunotherapy. The Next Wave of Immuno-Oncology: A Roadmap from the Society for Immunotherapy of Cancer (SITC) is positioned to serve as a leading resource for charting the path from discovery to patient care.

Published manuscripts: