Dr. Shafer-Weaver, a dedicated scientific and immuno-oncology leader, has committed her career to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Kimberly’s experience includes 20 years in basic, translational and clinical research focused on immune responses to cancer with a special emphasis on mechanism of action and novel therapeutics aimed at overcoming immunological tolerance to cancer. She currently is the Scientific Director, GU Portfolio at Merck & Co., Inc, Global Oncology Medical Affairs.
Kimberly has been the recipient of numerous awards, given several invited presentations, and is an author of peer-reviewed journal articles. She is an active leader in the Society of Immunotherapy for Cancer (SITC) since 2001 including: Chair, Communications Committee; Chair, Membership Committee; Faculty, Women Immuno-Oncology Leadership Network, JITC Editorial Board, Regulatory Committee, Chair, Early Career Scientists Committee; Trustee Committee; Forward Fund committee; and the Council for Immunotherapy Education & Outreach. Kimberly is SITC Champion, has served on several SITC Leadership Meetings and is a Checkpoint Groupie. As Membership Chair, Kimberly oversaw a key initiative that expanded SITC membership to Nurses and Pharmacists.
Kimberly also serves on several editorial boards and scientific committees of other National and International societies. She holds a PhD in Immunology from The George Washington University and performed her dissertation research at the National Cancer Institute within the Cancer Inflammation Program focusing on elucidating mechanisms of T cell tolerance in cancer. Kimberly also received her MBA, with specialization in Healthcare, from The George Washington University. While at NCI, she also worked in the Laboratory of Cell-Mediated Immunity where she helped develop and CLIA certify immunoassays to support cancer immunotherapy trials.
After completing her PhD, Kimberly joined Intrexon as the Clinical Immunology Manager and served as a subject matter expert for the cancer immunotherapy clinical trials and translational research studies. Kimberly returned to NIH as a Staff Scientist in the Laboratory of Immunology, NIAID, NIH focusing on novel therapeutics that induce immune tolerance in autoimmune diseases and as the Program Director for Immunology, Oncology, and Metabolic Disease at Health Analytics as a SME for oncology and autoimmune HEOR research. Prior to joining Merck, she was at AstraZeneca as the Associate Director, Immuno-Oncology Scientific Training for Global and US Medical Affairs. At AstraZeneca, she strategically aligned and collaborated with stakeholders, external experts and organizations to drive and execute immuno-oncology cross-functional initiatives and scientific training to ensure oncology acumen. Kimberly joined Merck in October 2018 as a Field Medical Alignment Director for GU within U.S. Oncology Medical Affairs. In this position, she is was a core member of the U.S. Oncology Field Leadership Team and was accountable for the design and execution of scientific and medical plans across the matrix organization.
SITC Election Platform Statement
What are the two or three critical issues facing the field of cancer immunotherapy?
Discrepancy between immune and clinical responses – combination therapies. In the past decade, major advancements and regulatory approvals in cancer immunotherapy have occurred. While many patients are benefiting from immuno-oncology (IO) therapies including durable responses, only a percentage of patients (20-30%) treated are responding to IO leaving a major question unanswered – how does the field move the needle and increase the response rate to IO in more patients? Authorities in IO had predicted the movement from IO monotherapy to combination therapies with IO as a back bone to enhance efficacy. Over 2,500 clinical trials evaluating immunotherapy are currently registered world-wide to help elucidate this question and determine rational combination therapies, appropriate sequencing, potential new safety signals and the warranted duration of IO therapy. This underscores the need to better understand appropriate clinical trial design, clinical trial endpoints and the molecular and cellular events leading to tumor rejection or resistance to IO in patients. Such information should provide a better understanding of tumor classification for treatment and prediction of response, appropriate treatment regimes, and treatment scheduling/dosage thus enhancing patient outcomes to IO therapies (mono- or combination therapies). Insight gained from cancer modeling and Big Data analytics (real-world data) can be utilized to help drive more strategic/informed decisions and identify new potential drug candidates/combinations, predictive biomarkers/new tests (e.g. liquid biopsies, imaging) that facilitate patient-treatment matching, clinical trial design and patient selection. And, perhaps, help overcome the limitation of data obtained from murine cancer models or facilitate scientific laboratory studies based from clinical studies and patient outcomes. Combining insight from human cancer modeling, real world evidence and clinical trials should drive improved patient care and the development and approval of effective, safe, and reimbursed IO therapies for patients with cancer. SITC’s continued resolve towards combining basic tumor immunology research, biomarker validation and clinical trial evidence to drive better patient outcomes is essential to overcoming these hurdles.
Immunotherapy in practice – The FDA approval of numerous immunotherapies for cancer, including checkpoint inhibitors and CAR T-cells and combination regimes, provides cancer patients access to immunotherapy beyond clinical trials. New clinical trials and approvals are occurring at an accelerated pace and with the success of immuno-oncology (IO) in later-stage cancer, IO is now moving into earlier stages of the disease. The plethora of potential new options for cancer treatment is a double-edged sword for clinicians and patients as the quick-pace and changes presents challenges to successfully integrating IO into current models of cancer care and application in real-world practice. Additionally, there is limited accessibility to many appropriate cancer patients. Significant hurdles to greater application of IO include, but are not limited to, a greater understanding of the differences between immunotherapies and current standards of care combined with demonstrating a clear therapeutic benefit and better evidence of patient-treatment matching. In particular, education on the identification, differential diagnosis, and management of immune-mediated adverse events (imAEs) is needed for both physicians and patients. Most imAE are low grade in severity and are manageable, but if not properly managed, symptoms can worsen to the point of irreversibility and treatment discontinuation. As IO therapies become options in earlier stage of the disease, education for potential new treaters less versed with delivering IO therapies is warranted. For decades, the main focus of IO has been on efficacy and ensuring survival and quality of life for patients. Now, as the number of cancer survivors in the world significantly increase, a new focus needs to be on understanding the health and outcomes of cancer survivors as a result of IO treatments.
Insights into the use of immunotherapy for different minority groups and real-world evidence are warranted as well, along with a fuller understanding of biomarkers for efficacy and safety, selecting appropriate patients, and better treatments and management with IO therapies. Clearly, clinical trials need to increase the diversity of patients enrolled and insure that the most affect populations are represented. Enhanced research into validating targeted managements for irAEs beyond global immunosuppression with steroids. Additionally, the cost of immunotherapy and reimbursement can also pose a significant challenge to its use in practice. SITC is poised to be a critical organization to drive appropriate immune-therapy education and practice guidance to these key stakeholders. The society has already demonstrated leadership to this end through its ACIs, Cancer Connect initiatives and Virtual Trainings. Expansion or additions to the SITC programs, either independently or through collaborations, will be essential for greater application of immunotherapy, especially in the community setting.
Ensuring the right patients get the right treatment and the right time. There is evidence that the benefits of immunotherapy can be increased in certain populations of cancer patients. Some patients may respond to monotherapies whereas others my need combination therapies. Combining immunotherapies with conventional therapies (e.g. chemotherapies, radiation, surgery), targeted therapies, small molecule inhibitors or other immunotherapies is thought to broaden the group of responders thus improving response rate and duration of response, limit toxicity profiles, and overcome resistance to single-agent therapy. Combination therapies should help to overcome “cold tumors” that have no immune response to stimulate, the immunosuppressive tumor microenvironment, or patients that relapse after immunotherapy (~30% relapse rate in immunotherapy treated patients). The field is already seeing promise in applying the appropriate combination of immuno-modulatory therapeutics - a more personalized medicine approach. However, there are large hurdles to running combination trials including developing appropriate preclinical models and determining appropriate dose levels, administration frequencies, durations of treatment, and sequence of administration. Additional challenges occur within earlier stage disease and the use of IO in the adjuvant or neo-adjuvant setting. Changes in the healthcare landscape, access to certain drugs, regulations, policies and funding, are also major hurdles to driving novel combination therapies research, clinical trials, and approval. This includes regulations at the preclinical level, such as pharmacologic and toxicology studies to estimate a safe dose for first-in-human trials through the clinical trial and post-marketing period. SITC is uniquely positioned to bring the right stakeholders from different sectors together (government, industry, regulatory, advocacy) to drive knowledge transfer and collaborations. SITC can serve as the central organization to use collective knowledge in a manner that will move the field forward.
What is your vision for SITC?
My vision is for SITC to continue to strengthen and increase its reputation and membership in the scientific community as the world’s premiere organization dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. That SITC is recognized as the leading resource to drive immunotherapy from bench to bedside, set standards for the field and is the “go to” authority to inform/influence translation of science and research, influence regulation and shape policy for immunotherapy world-wide. By innovating beyond the annual scientific meeting, several SITC-lead initiatives can help: 1) SITC’s continued resolve for educational and outreach, such as the certification/accreditation programs, timely virtual knowledge transfers and consensus statements. Formalize SITC as the premier organization for the certification of healthcare professionals and researchers in immunotherapy for cancer through the development of programs aimed at community practices, ER and pharmacy groups, oncology nurses, specialty clinicians, multidisciplinary teams and patients and patient advocacy groups; 2) continued and expanded strategic partnerships with other organizations, to serve as the key partner or authority on tumor immunotherapy. Shaping the definition of what is new/important to the field; and 3) ensuring that SITC has a seat at the table to shape guidelines, the regulatory landscape and payor reimbursement decisions. In short – my vision is for SITC to be the leading authority and to truly make the word “cure” a reality for cancer patients.