Kristen Hege, MD

Celgene/UCSF

At-Large Director Candidate

Biography

Dr. Hege joined Celgene in September 2010 as the San Francisco Site Head and Vice President, Translational Development, Hematology & Oncology and was promoted to Corporate Vice President, Translational Development in December 2015. She has oversight of the translational development operations group and global phase I cancer clinical trials programs focused on immunotherapy, biologics, next generation kinase inhibitors, IMiDs, and epigenetic therapies.  She participates in extensive Business Development diligence activities and management of Celgene research alliances with companies focused on immune-oncology.  Prior to joining Celgene, Dr. Hege worked in a consulting capacity as Acting Chief Medical Officer for several West Coast biotechnology startups including Aragon, Theraclone, Cellerant and the Cancer Vaccine Company, focused on small molecule, antibody and cell-based therapies for cancer and infectious diseases.  In addition, Dr. Hege spent 14 years at Cell Genesys, ultimately as Vice President, Clinical Research and Development and a member of the executive team.  At Cell Genesys she was responsible for early and late-stage clinical development, clinical operations, biometrics and drug safety.  Programs focused on cancer immune and gene therapies, including engineered “CAR” T cells, cancer vaccines, and oncolytic viruses.

In addition to her biotechnology industry roles, Dr. Hege holds an active faculty appointment at the University of California, San Francisco (UCSF) where she is a Clinical Professor of Medicine, Division of Hematology/Oncology.  She served as attending physician on the inpatient leukemia/bone marrow transplant service for 12 years and continues to see outpatients with benign and malignant hematologic disorders weekly. 

Dr. Hege is Board certified in Hematology and Medical Oncology. She received her MD from UCSF, Internal Medicine training at the Harvard-affiliated Brigham & Women’s Hospital, and Hematology & Oncology fellowship training at UCSF.  Academic honors include graduation from Dartmouth College summa cum laude and election to the Phi Beta Kappa and Alpha Omega Alpha Academic and Medical Honor Societies.  She is an active member of the American Society of Hematology, American Society of Clinical Oncology, American Association of Cancer Research and Society for the Immunotherapy of Cancer. She is an Associate Editor of the Journal of Immunotherapy of Cancer, a member of the PhRMA Translational Development Advisory Committee, California Life Sciences Association Board of Directors, Arcus Bio Board of Directors (Observer), Parker Institute of Cancer Immunotherapy Strategic Advisory Group, Immune Design Clinical Advisory Board and immediate Past Chairperson of the Executive Leadership Committee for the Leukemia and Lymphoma Society San Francisco Light the Night event. Dr. Hege was recently recognized by Fierce Biotech as one of the top 12 women in Biopharma in 2015.

SITC Election Platform Statement

What are the two or three critical issues facing cancer immunotherapy?

Key issues facing the field of cancer immunotherapy include: 1) intelligent and strategic development of the most relevant combination immunotherapy approaches to expand on the promise of T cell checkpoint inhibitors as a new cornerstone therapy in the treatment of cancer, 2) expansion of the success of engineered T cells from blood-based cancers to the more common and difficult to target solid tumors, 3) and establishment of novel regulatory paradigms and commercial infrastructure to successfully manufacture and deliver autologous, genetically modified T cell therapies to patients with cancer on a multi-national scale.

Optimal combinatorial immunotherapy approaches will be needed to activate a tumor-specific immune response, while reversing tolerance mechanisms, and manipulating the tumor microenvironment to favor immune-mediated tumor cell kill.  Finding strategies to facilitate, efficiently test and prioritize novel combinations in pre-clinical and early clinical trials will be critical to the ongoing success of this field. Interactions within and between academia, industry, and regulatory authorities to facilitate and unburden such approaches will be key.  A final critical issue is the development of patient enrichment strategies and companion diagnostics to better focus cancer immunotherapies on those subjects most likely to benefit while better understanding the mediators of resistance in those patients who do not respond. 

Engineered T cell therapies have shown great promise in B cell malignancies and early data suggest that T cells targeting plasma cell malignancies may also be relevant.  These early successes will drive the development of entirely new regulatory, commercial and reimbursement paths for patient-derived, autologous cell therapies.  Optimizing and standardizing manufacturing and distribution channels to deliver such therapies to patients in a cost-effective manner will be a key challenge for the field.  Extending these early successes to solid tumors will pose additional challenges related to target specificity, tumor heterogeneity, effective T cell trafficking and strategies to address the immune-inhibitory microenvironment of solid tumors.

SITC is in a key position to educate, guide and facilitate cross-functional approaches to these many opportunities for the explosive growth of this field.

How do you feel the Society for Immunotherapy of Cancer would benefit from your involvement as an At-Large Director on the Board?

I have had the good fortune of maintaining, from its inception, a professional career that bridges academic medical practice and industry-based cancer immunotherapy development.  This provides me with a historic and somewhat unique perspective on the opportunities and challenges faced by this field.  As an early witness to the dramatic leukemia regressions induced by infusion of donor lymphocytes after hematopoietic stem cell transplant, I never doubted the potential power of immunotherapy to eradicate cancer.  Caring for patients with severe chronic graft-vs-host disease, on the other hand, has provided me with the appropriate respect for the risk associated with uncontrolled immune activation.  In my early days in the biotechnology industry, I focused on the development of first generation CART cells.  While ultimate clinical success required additional technical breakthroughs, it has been a great pleasure to witness and participate in the resurrection of this field. The breakthroughs made by iterative science and the renewed investment by industry now has to potential to turn this boutique product into a commercial reality. 

Having lived through the early days of repeated immunotherapy failures, including the failure of the phase III GVAX prostate cancer vaccine program at Cell Genesys, I believe that I have a relevant measure of humility when it comes to both the successes and challenges this field will continue to face moving forward. I will endeavor to bring this perspective of longstanding passion balanced by realistic pragmatism to my role on the SITC board.

I hope and expect that my personal experience with both the successes and failures in this field as well as the scientific, clinical, regulatory and commercial hurdles associated with development of truly novel cancer immunotherapies will help me to guide this Society in its future endeavors.