Dr. Howard J. Fingert: DOMAIN EXPERTISE   MEETS AI FLUENCY

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Dr. Fingert is a distinguished physician-executive, board-certified in internal medicine, hematology, and oncology, and certified by the Harvard/Emeritus program in AI applications to healthcare and clinical drug development.  His career spans more than three decades at the forefront of biopharmaceutical and digital innovation, building on broad and deep understanding of oncology, patient care, and regulatory sciences.  He has been repeatedly awarded by senior managers for commercial results and for training Teams in accelerated drug development and regulatory science, leading complex therapies from early-stage discovery through sustained commercialization. His results-oriented work reflects a commitment to productivity, operational excellence, quality by design.

Throughout his career, Dr. Fingert has demonstrated an exceptional ability to bridge clinical insight, patient-centered value, and strategic execution. His leadership has influenced multi-regional clinical programs spanning Phases 1 through 4, contributing to the expanded development of blockbuster therapies across both solid tumors and hematologic malignancies. His experience extends across organizations of all sizes—from nimble biotech startups to global pharmaceutical leaders—giving him a uniquely comprehensive perspective on the challenges and opportunities within modern drug development.

Most recently, Dr. Fingert served as Vice President of Medical Oncology at ONO Pharmaceuticals, where he led major R&D initiatives and played a pivotal role in advancing diverse products, including immuno-oncology/PDL1 combinations, cell therapies, small molecules. He succeeded to accelerate enrollment and decision-making for Phases 1-3  trials, advancing ONO’s global presence in oncology innovation. In this role, he oversaw large-scale, multi-regional operations while fostering a culture rooted in collaboration, scientific integrity, patient-centered outcomes, and clinical safety risk management.

Prior to ONO, Dr. Fingert held senior leadership roles at Serono, Rhone Poulenc, Pfizer, and Takeda Pharmaceuticals, where he pioneered new approaches to accelerate clinical development and regulatory strategy, including successful FDA Advisory Committee endorsements and FDA approvals of blockbuster products for Oncology, GI, Neurology, Infertility indications.  At Pfizer, he became the first Head of Oncology Clinical Safety Risk Management, training and guiding Business Development and diverse internal functions in oncology-specific regulatory submissions, clinical safety analytics, and risk mitigation in context of oncology patient care – results measured by accelerated FDA approvals, favorable product labels, worldwide adoption, and blockbuster commercialization.  He introduced digital innovations to train coworkers and vendors about oncology-specific data management, leading Pfizer managers to designate him as a Subject Matter Expert in areas of safety data coding, management, analytics.  Coupled with his leadership of new protocol and statistical designs, reducing burdens and costs by 90%, his contributions were recognized by the prestigious Pfizer President’s Award for R&D Excellence—an honor awarded to only one individual among thousands of employees.

During his tenure at Takeda, Dr. Fingert led global clinical programs and introduced new strategies for internal and external innovation. He was instrumental in launching strategic partnerships with academic institutions, government agencies, and industry stakeholders, including participation in initiatives such as the Biden Cancer Moonshot intiative. His leadership extended to portfolio governance & safety committees, and evidence-based decision-making across internal and partnered oncology portfolios bringing novel therapies to become worldwide standard care by caregivers, clinical practice guidelines, and payers.

Dr. Fingert’s expertise is further distinguished by his deep engagement with regulatory bodies and professional organizations. Notably, he was selected by FDA to serve a 4-year appointment as Representative to the FDA Oncology Drugs Advisory Committee (ODAC), as well as on the National Cancer Institute’s Clinical Trials and Translational Research Advisory Committee, and on the multi-national ICH Expert Working Group that updated the global Guidance for Clinical Protocols (ICH-E8).  Most recently, Dr. Fingert was US President appointee to the National Cancer Advisory Board (NCAB). In these roles, he has contributed to shape national policy, advancing clinical trial designs, integrating real-world data into regulatory decision-making.  These efforts continue to provide insights about FDA Advisory Board working practices, emerging standards for clinical data management, and related Industry cost- and data-sharing opportunities for collaboration with NCI, VA, other non-profit organizations.   Moreover, these latter roles continue to provide extensive networking with KOLs and Regulators, supporting foresight about dynamic updates to biopharma clinical and regulatory working practices, and opportunities from current and emerging Drug Development Tools, including regulated biomarkers, devices, FDA-qualified AI application. 

In addition to his corporate leadership, Dr. Fingert is an accomplished academic and educator. He has held faculty roles at Harvard Medical School and served as a guest lecturer at Suffolk Law School and MIT, where he has taught on topics including cancer pharmacology, regulatory science, clinical development strategy. His decade of volunteer service to the Pharmaceutical Education and Research Institute reflects his dedication to mentoring the next generation of clinical researchers and industry leaders.

A prolific contributor to scientific literature, Dr. Fingert has authored more than 40 publications, chapters in major Oncology textbooks, and he holds a patent in oligonucleotide therapeutics. His research spans cancer biology, clinical pharmacology, and innovative trial methodologies, underscoring his commitment to advancing both scientific knowledge and practical application. His work continues to influence how oncology therapies are developed, evaluated, and delivered worldwide.

Beyond his professional achievements, Dr. Fingert maintains a strong commitment to community engagement. He contributes his efforts to nonprofit organizations, patient advocates, advisory boards, and public-private partnerships aimed at improving healthcare access and innovation. His global experience—including extensive work in Japan, Europe, and Asia—has further strengthened his ability to navigate diverse regulatory environments and cultural contexts in advancing medical progress.

Dr. Fingert’s leadership philosophy is grounded in Quality of Thought and responsible decision-making. He is widely regarded as a collaborative and forward-thinking executive who can see ‘around corners’ to bring clarity to complex challenges and guide teams to achieve meaningful, measurable impact, both clinical and commercial. His growing focus on artificial intelligence and data science reflects his vision for the future of oncology—one where technology and human insight converge to deliver better outcomes for patients worldwide.

Today, as Principal Consultant of his own advisory practice, Dr. Fingert continues to guide small and large biopharma companies, investors, and emerging innovators. His work centers on accelerating clinical development, optimizing regulatory pathways, and integrating responsible AI into drug development processes. He remains driven by a desire to create lasting value and to accelerate the paths to cure cancer—both for sustained commercial success of organizations he serves, and for the patients whose lives depend on commercial access to important therapies.

Character: Dr. Fingert demonstrates integrity and humility in every aspect of his career, consistently prioritizing patient outcomes above all else. He is known for his thoughtful and measured approach, ensuring that decisions are both ethical and impactful. His commitment to service, mentorship, and collaboration reflects a deeply rooted sense of purpose and responsibility.

Knowledge: With over 30 years of experience, Dr. Fingert possesses an unparalleled depth of expertise in oncology, regulatory science, and clinical development. His contributions to advisory boards, regulatory committees, and scientific literature highlight his role as a trusted authority in the field. He continuously evolves his knowledge base, embracing and training others about emerging technologies such as responsible AI to stay at the forefront of innovation.

Strategic: Dr. Fingert excels at navigating complex, multi-stakeholder environments and translating vision into actionable strategy. He has successfully led global programs, high-value partnerships, and regulatory initiatives that drive both clinical and commercial success. His ability to align scientific rigor with business objectives makes him a highly effective and forward-thinking leader.

Communication: A skilled communicator, Dr. Fingert conveys complex scientific and regulatory concepts with clarity and precision. He has extensive experience engaging with diverse audiences, from executive leadership and regulatory agencies to academic and public forums. His ability to educate, influence, and inspire has been a cornerstone of his leadership impact.

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