PLENARY KEYNOTE SESSIONS

MONDAY, AUGUST 11, 2025 | 8:30-10:05 AM

8:30 am Organizer’s Welcome Remarks
Nikki Cerniuk, Conference Producer, Cambridge Healthtech Institute

8:35 Plenary Keynote Introduction
Jennifer Wu, PhD, Mary and Patrick Scanlan Professor, Urology and Immunology, Northwestern University

8:45 Bispecific Immune Cell Engagers: Efficacy Opportunities and Safety Challenges
Rakesh Dixit, PhD, DABT, CEO & President, Bionavigen Oncology, LLC and CSO, TMAB Therapeutics, Regio Biosciences
Bispecific immune cell engagers are engineered antibodies that connect immune effector cells (like T or NK cells) to tumor-associated antigens (TAAs), enabling rapid cytotoxicity without MHC processing. They can address checkpoint inhibitor resistance and moderate antigen expression while offering engineering flexibility. Challenges include cytokine release syndrome, neurotoxicity, off-tumor toxicity, T cell exhaustion, and immunogenicity, requiring strategies to balance safety and efficacy through engineering and clinical methods.

Rakesh Dixit is an accomplished executive, inventor, and scientist with over 35 years of success with top biotechnology and pharmaceutical companies, including Merck, Johnson & Johnson, and Medimmune - AstraZeneca. Currently, he is President and CSO of Regio Biosciences and Bionavigen, LLC. He is a Board Member of Regio Biosciences and a key member of multiple scientific advisory boards. Rakesh is also a chief adviser and consultant for more than 20 companies worldwide. His biopharmaceutical peers selected Rakesh as one of the 100 Most Inspiring People in the Pharmaceutical Industry by PharmaVOICE in 2015. Rakesh received the Most Prestigious Award of Long-Standing Contribution to ADCs by World ADC (Hanson-Wade), 2020. From 2006 to 2019, Rakesh was a Global Vice President of the Biologics R&D at Medimmune - AstraZeneca. Rakesh has unique expertise in developing biologics (e.g., monoclonal antibodies, bispecific biologics, antibody-drug conjugates, fusion proteins, peptides, gene and cell therapies, etc.) and small-molecule biopharmaceuticals. His areas of expertise include discovery, early and late preclinical development, safety assessment, DMPK, and translational sciences. Dr. Dixit conducted extensive graduate and post-graduate training in Pharmacology/Toxicology–Biochemistry with both Indian and USA institutions (e.g., Case Western Reserve University, Medical College of Ohio, University of Nebraska) and is a Diplomate and Board Certified in Toxicology from the American Board of Toxicology, Inc. since 1992.

9:30 PANEL DISCUSSION: Advancing Immunotherapy: Strategies for Preventing Attrition
Moderator: Jennifer Wu, PhD, Mary and Patrick Scanlan Professor, Urology and Immunology, Northwestern University

• Securing funding and optimizing budgets
• Addressing toxicity during discovery & improving translation from pre-clinical models
• Navigating regulatory pathways

Dr. Wu’s research focuses on understanding how cancer cells disable the immune system with the ultimate goal of developing effective immunotherapy of cancer. Her work was the first to show that tumors shed NKG2D ligand sMIC to perturb the maintenance of tumor-killing NK cells and to facilitate tumor metastasis. Her research team has developed the novel multi-modal sMIC-targeting antibody that demonstrated remarkable efficacy in reducing tumor burden and eliminating metastasis as a single agent. The antibody will be entering clinical testing in Summer 2025. Dr. Wu’s group has been focused on understanding the impact of this pathway on NK cell, CD8 T cell, and macrophages in tumor microenvironment.

Panelists:

Carter Caldwell, MBA, Co-Investment Program Director, University of Pennsylvania

Carter leads Penn Medicine's investments in the cell therapy, gene therapy, mRNA, lipid nanoparticle, and connected health sectors. Utilizing multiple decades of experience as both an entrepreneur and an investor, he sources investment opportunities, manages relationships with co-investors, completes due diligence, and supports the governance of the funded companies. He was previously a Managing Director with Cross Atlantic Capital Partners, a venture capital firm with 4 funds and over $500 million under management. Carter holds an MBA from Columbia University and a BA in Philosophy, Politics and Economics from the University of Pennsylvania.

Margery Ma, PhD, Principal Consultant, NonClinical Regulatory Affairs, Eliquent Life Sciences

Dr. Ma is trained in cellular immunology, with over 20 years of combined experience in pharmaceutical R&D and regulatory affairs within consulting firms. Her extensive background provides her with deep technical expertise and strategic insight, enabling her to guide drug development from preclinical stages to the clinic. She specializes in offering nonclinical regulatory support for a wide range of drug products and has successfully led interactions with health authorities. Dr. Ma is dedicated to helping clients navigate complex challenges and achieve meaningful advancements in public health.

David Sommerhalder, MD, Clinical Investigator, Oncology, NEXT Oncology

My name is David Sommerhalder and I am the director of clinical research for NEXT Oncology San Antonio. Most of my time is spent being a clinical investigator on Phase 1 oncology studies for solid tumors. I have been fortunate to be a principal investigator on over 50 trials and a sub-investigator on over 200 trials. I entered Phase 1 research with the goal of bringing new treatments to cancer patients quickly, and while doing this I have been inspired by patients' willingness to participate to help others as well as their families’ support. I completed my residency and fellowship training at LSU Shreveport. I was born and raised in Texas. I have three wild children, including two-year-old identical twins.

Sri Sriadibhatla, PhD, Director, Healthcare Investment Group, Ben Franklin Technology Partners

WEDNESDAY, AUGUST 13, 2025 | 3:15-4:00 PM

3:15 pm PANEL DISCUSSION: Accelerating IO through Target Discovery
Moderator: Tatiana Novobrantseva, PhD, CSO, NextPoint Therapeutics

• Driving target identification and validation
• Synergistic strategies: promising target combinations for solid tumors
• Balancing efficacy and toxicity in IO

Tatiana Novobrantseva is the Chief Scientific Officer at NextPoint Therapeutics. Most recently she served as the CSO of Immuno-oncology at Moderna. In the prior role, she co-founded Verseau Therapeutics and served as CSO, guiding programs from target identification to an advanced novel therapeutics pipeline, staying as an advisor to the company. Tatiana is currently serving on several Scientific Advisory Boards. Tatiana also consulted on drug development programs for various companies throughout the years. At Jounce, she directed programs on immune system reactivation against cancer. Tatiana held roles at Alnylam and Biogen, uncovering the critical role of B cells in fibrosis, advancing siRNA delivery, and leading a dendritic cell cancer vaccine initiative.

She earned her PhD in B cell immunology from the University of Cologne in Germany in the Laboratory of Klaus Rajewsky. She holds a Diploma in Engineering in Physics and a Master’s degree in Molecular Biology from the Moscow Institute of Physics and Technology.

Panelists:
Vitalay Fomin, PhD, Co-Founder, Numenos AI

Shameer Khader, PhD, Executive Director, Global Head of Data Science, Data Engineering and Computational Biology, Sanofi

Dr. Shameer Khader is a senior director of advanced analytics, data science, and bioinformatics at AstraZeneca, a global, science-led biopharmaceuticals company. At AstraZeneca, he leads a global team of data scientists, biomedical scientists, statisticians, and software engineers. He oversees a portfolio of projects in oncology and biopharma to accelerate drug discovery and development using biomedical and clinical big data using machine intelligence approaches. He has published more than 120+ peer-reviewed research papers, patents, and conference publications in pharma informatics, healthcare data science, bioinformatics, drug discovery, and precision medicine. Various national and international media, business, biotechnology, and scientific publishers have featured his work. His work was featured in media outlets including Forbes, Fast Company, Bloomberg News, Times of India, The Indian Express, HealthIT Analytics, ScienceDaily, The Sun, MedScape, Medical Express, MedPage Today, The Economic Times, Cardiology Today, NewsWise, BioPortfolio, Science Xpress, Business Standard, eCancer News, PhysOrg, UroToday, etc. His work was also featured in worldwide publications and includes blogs by MedGadget, UNESCO, International Society for Computational Biology, American Chemical Society, American Heart Association, and the NEJM Journal Watch.

Kristen Meerbrey, PhD, Director of Target Discovery, Therapeutic Innovation Center, Baylor College of Medicine

Dr. Meerbrey is Co-Director of the Therapeutic Innovation Center (THINC) at Baylor College of Medicine. At THINC, she leads a team of cell, molecular and computational biologists focused on discovering and validating novel targets in oncology and immuno-oncology, with a focus on emerging areas of RNA biology. Dr. Meerbrey trained in genetics and technology development in the laboratory of Dr. Thomas Westbrook where she developed new tools for genetic perturbation (ex. the pINDUCER toolkit) that are now used in over 3,000 laboratories across the globe. Leveraging these tools, Dr. Meerbrey discovered new genetic causes of familial cancer predispositions and identified vulnerabilities in poor prognosis cancers like triple negative breast cancer. After graduate school, Dr. Meerbrey extended her training in target identification and drug discovery, with a focus on RNA splicing. At THINC, Dr. Meerbrey builds collaborative therapeutic programs emanating from BCM’s $640M research portfolio, focusing on diseases (especially cancer) where RNA dysregulation is a major culprit. Her work has led directly to new therapeutic initiatives both in collaboration with pharma partners and in the form of new biotech start-ups. Dr. Meerbrey actively seeks to bridge new innovations in RNA biology with private sector partners for the benefit of cancer patients.