PLENARY KEYNOTE SESSIONS

MONDAY, AUGUST 11, 2025 | 8:00-9:35 AM

8:00 am Organizer’s Welcome Remarks
Nikki Cerniuk, Conference Producer, Cambridge Healthtech Institute

8:05 Plenary Keynote Introduction (Sponsorship Opportunity Available)

8:15 Off-the-Shelf Allogeneic CAR T Therapy in the Treatment of Severe Autoimmune Diseases
Biao Zheng, PhD, CEO, BRL Medicine
Current treatments for severe autoimmune diseases have considerable toxicity and are not effective in all patients. Conceptually, a deep depletion of B cells and plasmacytes could trigger an immune reset in autoimmune diseases. Autologous patient-derived CD19-targeted CAR T therapies have been explored in several autoimmune diseases and reported promising efficacy in recent studies. In this study, a healthy donor-derived, multiplex genome-edited allogeneic CD19-targeted CAR T product was developed for severe refractory autoimmune diseases. Here we report efficacy and safety profiles of BRL-303 after treating patients with systemic lupus erythematosus, systemic sclerosis, and immune-mediated narcotizing myopathy.

Dr. Biao Zheng graduated with a medical degree from Zhejiang University School of Medicine. He received his PhD in Immunology from King’s College, University of London. Dr. Zheng served at the faculty of University of Maryland School of Medicine and Duke University Medical Center. He was a tenured professor in the Department of Pathology and Immunology, Baylor College of Medicine. Dr. Zheng worked for GlaxoSmithKline R&D Center as the head of Immunological Discovery Sciences. He was a global vice president of the Immunology Therapeutic Area, Janssen Pharmaceuticals, and Johnson & Johnson Innovation Center, Asia Pacific, responsible for the innovative immunological drug pipeline in the region. Dr. Zheng is now the Chief Executive Officer at BRL Medicine.

Dr. Zheng is an experienced physician scientist, drug hunter, and professor with a demonstrated history working both in academia and pharmaceutical industry. He has more than thirty years of experience in biomedical research and drug discovery. He has published extensively in world top journals including Cell, Nature, and Science. His major areas of research and development include autoimmune diseases, immuno-oncology, and novel vaccine development.

9:00 PANEL DISCUSSION: Advancing Immunotherapy: Strategies for Preventing Attrition
Moderator: Rakesh Dixit, PhD, DABT, President & Founder, Bionavigen Oncology, LLC and Regio Biosciences

• Navigating regulatory pathways
• Addressing toxicity during discovery
• Securing funding and optimizing budgets
• Improving translation from preclinical models

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.

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.

Karen Chagin, MD, Senior Vice President, Early Stage Development, Adaptimmune

Karen joined Adaptimmune in September 2023 as the Senior Vice President of Early Stage Development and is responsible for overseeing the early stage pipeline activities from pre-IND and IND activities through Phase 1 clinical trials.

Prior to Adaptimmune, Karen served as Chief Medical Officer at Tmunity. She led and was accountable for the development strategy, planning, and execution of Tmunity’s CAR T cell therapies in multiple solid tumor indications. Subsequently, she became the Head of Kite Philadelphia following Kite’s acquisition of Tmunity. From 2015 to 2019, Karen served as Adaptimmune’s Vice President of Clinical Development and was the clinical lead for the afami-cel and lete-cel programs. Prior to joining Adaptimmune in 2015, she served as a Scientific Director in Oncology Early Development at Janssen leading development activities for Phase 1 assets.

Karen began her career in the pharmaceutical industry in 2009 at GSK and served as a Safety Development leader before transitioning to clinical development. As a Medical Director for Promacta®/Revolade®, she was responsible for the development and execution of multiple Phase 2 and 3 clinical trials. In her roles in safety and clinical development, Karen led and contributed to the registration of several products and indications globally.

Dr. Chagin holds a BA from the University of Pennsylvania and an MD from Temple University School of Medicine. She performed her residency at Children’s Memorial Hospital in Chicago and her fellowship in pediatric hematology and oncology at The Children’s Hospital of Philadelphia.

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.

WEDNESDAY, AUGUST 13, 2025 | 3:45-4:30 PM

3:45 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