insitro, a machine learning-powered drug discovery and development company, today announced the appointment of S. Michael Rothenberg, M.D., Ph.D., as chief medical officer. In this new role, which begins in February, Dr. Rothenberg will lead all aspects of clinical development, including strategy on clinical trial design; oversee medical affairs, pharmacovigilance and regulatory affairs; and drive translational biology.

Dr. Rothenberg, an oncologist, joins insitro from Pfizer, where, as vice president of early oncology development and clinical research, he led a portfolio of early-phase oncology trials from first-in-human through proof-of-concept stages. He brings two decades of clinical care and drug development experience spanning target identification through approval. He has worked across multiple therapeutic modalities, including small molecules, antibodies, antibody drug conjugates, bispecific engagers, and novel protein-engineered therapeutics, making significant contributions to many first- and best-in-class medicines.

“We are incredibly excited to welcome Dr. Mike Rothenberg to our leadership team,” said Daphne Koller, Ph.D., CEO and founder of insitro. “Mike has an incredible track record of innovation in clinical trial design, developing and implementing data-driven strategies that have significantly accelerated the journey of bringing medicines to patients. He brings a deep understanding of genetics and multimodal data, and has used them to inform the design of biomarkers and improve clinical development. He will be a critical leader in achieving our mission of bringing better drugs faster to patients who can benefit most.”

At Pfizer, Dr. Rothenberg oversaw Pfizer’s oncology and hematology early clinical development portfolio, advancing more than 20 first-in-patient clinical trials, including supervising elranatamab (Elrexfio™, a CD3-targeting bispecific antibody) through the first-in-human trial to human proof-of-concept.

“Having had the privilege of closely partnering with Mike at Pfizer to collaboratively transform the early oncology pipeline and clinical trials, I know first-hand his ability to drive innovation in clinical trial designs and accelerate development timelines," said Dr. Sandeep Menon, chief development officer at Alnylam (formerly chief scientific officer, AI digital, and SVP, head of early clinical development and bioMedicine AI, at Pfizer). "Mike's strong scientific acumen and expertise in designing and executing efficient trials will be invaluable in advancing the development of impactful medicines as chief medical officer at insitro."

Prior to Pfizer, Dr. Rothenberg was vice president of research and development at Loxo Oncology, where he led early clinical development for novel, targeted anticancer therapies, including the approved RET inhibitor RETEVMO® (selpercatinib) from seamless clinical trial design and protocol authoring through trial oversight and New Drug Application. He previously served as a medical oncologist and researcher focused on targeted therapeutics at Massachusetts General Hospital.

“insitro is combining human clinical and genetic data, disease-relevant cellular models, and ML analysis to bear directly on serious diseases,” said Dr. Rothenberg. “I look forward to helping the insitro team bring novel, first-in-class medicines for unmet medical needs rapidly to patients.”

About insitro

insitro is a drug discovery and development company using machine learning (ML) and data at scale to decode biology for transformative medicines. At the core of insitro’s approach is the convergence of in-house generated multi-modal cellular data and high-content phenotypic human cohort data. These data are used to develop ML models that expand insitro’s data tensor via imputation, uncover underlying biologic state, and elucidate high-impact genetic modulators of disease. These powerful models rely on extensive biological and computational infrastructure and allow insitro to advance novel targets and patient biomarkers, design therapeutics, and inform clinical strategy. insitro is advancing a wholly owned and partnered pipeline of insights and therapeutics in neuroscience, oncology, and metabolism. Since launching in 2018, insitro has raised over $700 million from top tech, biotech, and crossover investors, and from collaborations with pharmaceutical partners. For more information on insitro, please visit www.insitro.com.

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