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OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015) BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Satish Gopal eRA COMMONS USER NAME (credential, e.g., agency login): satish_gopal POSITION TITLE: Cancer Program Director, UNC Project-Malawi EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) DEGREE Completion Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) University of North Carolina, Chapel Hill NC BA 05/1997 Biology/music University of North Carolina, Chapel Hill NC MPH 05/2000 Public health Duke University, Durham NC MD 05/2001 Medicine University of Michigan, Ann Arbor MI Residency 06/2005 Medicine/pediatrics University of North Carolina, Chapel Hill NC Fellowship 06/2011 Infectious diseases University of North Carolina, Chapel Hill NC Fellowship 06/2012 Medical oncology MM/YYYY A. Personal Statement I am a medical oncologist and infectious diseases physician. I have lived in Malawi with my family since 2012, where I am the only medical oncologist in a country of ~18 million people. I am an AIDS Malignancy Consortium investigator, a Cancer Working Group member for the Centers for AIDS Research Network of Integrated Clinical Systems network (CNICS), and a Cancer Working Group member for the International Epidemiologic Databases to Evaluate AIDS (IeDEA) network, an NIH-funded consortium of HIV cohorts worldwide. I am an Honorary Senior Lecturer at the University of Malawi College of Medicine. I am PI for a large multicenter HIV-associated lymphoma cohort study in CNICS, and PI for the Kamuzu Central Hospital Lymphoma Study, one of the first large clinical cohorts of lymphoproliferative disorders in sub-Saharan Africa. I am PI for the NIH U54 Malawi Cancer Consortium, a broad national effort focused on developing capacity for HIV-associated cancer research, and conducting high-impact research for Kaposi sarcoma and lymphoma in Malawi. I am PI for a new NCI P20 planning grant to establish a Regional Center of Research Excellence for non-communicable diseases in Malawi. I am also PI for an NCI supplement award to help establish Malawi as a site for a planned Burkitt Lymphoma Trial Network. I am uniquely qualified to lead the work outlined in this proposal focused on infectious complications of cancer treatment in Malawi, where HIV prevalence among cancer patients is high. Additionally, I have close collaborative relationships with all co-investigators and the demonstrated ability to lead multidisciplinary clinical research teams spanning the United States and Malawi. 1. Gopal S, Wood WA, Lee SJ, Shea TC, Naresh KN, Kazembe PN, Casper C, Hesseling PB, Mitsuyasu RT. Meeting the challenge of hematologic malignancies in sub-Saharan Africa. Blood 2012;119:5078-87. PMC4507039. 2. Gopal S, Achenbach CJ, Yanik EL, Dittmer DP, Eron JJ, Engels EA. Moving forward in HIV-associated cancer. J Clin Oncol 2014;32:876-80. PMC3948093. 3. Gopal S, Fedoriw Y, Montgomery ND, Kampani C, Krysiak R, Sanders MK, Dittmer DP, Liomba NG. Multicentric Castleman Disease in Malawi. Lancet 2014;384:1158. PMC4470481. 4. Gopal S. Moonshot to Malawi. N Engl J Med 2016;374:1604-5. PMC4871710. 5. Chinula L, Moses A, Gopal S. HIV-associated malignancies in sub-Saharan Africa: progress, challenges, and opportunities. Curr Opin HIV AIDS 2017;12:89-95. PMC5241291. B. Positions and Honors 1 Positions and Employment 2005-2007 Hospitalist Clinician-Educator, Department of Internal Medicine, Norwalk Hospital, Norwalk, Connecticut 2007-2009 Pediatric AIDS Corps Physician, Baylor International Pediatric AIDS Initiative, Moshi, Tanzania 2009-2013 Clinical Fellow, Divisions of Hematology-Oncology and Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina 2013-2017 Assistant Professor of Medicine, Divisions of Hematology-Oncology and Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina 2013Honorary Senior Lecturer, Department of Medicine, University of Malawi College of Medicine, Blantyre, Malawi 2017Associate Professor of Medicine, Divisions of Hematology-Oncology and Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina Honors 1993-1997 2001 2001 2004-2005 2012 2012 2012 2013 2013 Davie Scholar, University of North Carolina at Chapel Hill Hippocratic Oath Ceremony Student Speaker, Duke University School of Medicine Intern of the Month, University of Michigan Department of Internal Medicine Chief Resident, University of Michigan Internal Medicine-Pediatrics Residency Program Lineberger Clinical Fellows Award Fogarty Global Health Fellowship Fogarty International Research Scientist Development Award AIDS Malignancy Consortium Fellowship (inaugural year) North Carolina Cancer Hospital Endowment Fund Award Other Experience and Professional Memberships 1999-2000 Service Chair, Duke University School of Medicine Davison Council 2009Member, Infectious Disease Society of America 2010Member, American Society of Clinical Oncology 2010Member, American Society of Hematology 2011-2012 Invited contributor, US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents 2012Reviewer, AIDS Research and Human Retroviruses, PLoS One, Antiviral Therapy, Nature Reviews Clinical Oncology, Infectious Agents and Cancer, Journal of Clinical Oncology, Emerging Infectious Diseases, BMC Cancer, AIDS, Journal of AIDS, International Journal of STD & AIDS, Journal of Antimicrobial Chemotherapy, Journal of Medical Virology, Journal of Oncology Practice, International Journal of Cancer, Journal of Infectious Diseases, Leukemia & Lymphoma, Cancer Medicine, BMC Infectious Diseases, Journal of Global Oncology, Journal of the National Cancer Institute, Pediatric Blood & Cancer, BMC Infectious Diseases, Blood, Lancet HIV, BMC Health Services Research, Journal of Clinical Investigation 2012Member, Cancer Working Group, CNICS 2013Member, Cancer Working Group, IeDEA 2013Member, AIDS Malignancy Consortium Lymphoma Working Group, HPV Working Group, Kaposi Sarcoma Working Group, Non-AIDS Defining Cancer Task Force 2012Research mentor, Fogarty Global Health Fellows Program, Fulbright-Fogarty Fellowships in Public Health 2015 Reviewer, UNC Lineberger Developmental Awards 2016 Reviewer, UNC Gillings School of Global Public Health Innovation Lab Awards 2016 Reviewer, Thrasher Research Fund 2016 Reviewer, NCI/AORTIC BIG CAT grants program 2017 Reviewer, NCI Collaborative Consortia for the Study of HIV-Associated Cancers: US and Lowand Middle-Income Country (LMIC) Partnerships (U54), RFA-CA-16-018 2017 Lymphoma session co-chair, African Organization for Research and Training in Cancer biannual international conference C. Contribution to Science 1. HIV-associated lymphoma in the US. I initiated a large HIV-associated lymphoma study in the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) multicenter cohort. This led to a description of temporal trends in the US HIV-associated lymphoma population in the modern antiretroviral 2 therapy (ART) era. We demonstrated patients were less immunosuppressed with better HIV control at lymphoma diagnosis, with changing histologic distribution. We also found outcomes differed based on ART exposure at lymphoma diagnosis, suggesting tumor biology differs across varying immunologic contexts. We are now interrogating these findings through NCI-funded sequencing studies of pre-ART and post-ART lymphoma specimens drawn from CNICS and Malawi. Our work also demonstrated higher cumulative HIV viremia immediately after lymphoma diagnosis has adverse effects on survival, suggesting suppressive ART concurrently with chemotherapy improves outcomes. Additionally, we published the first description of the HIV-associated lymphoma immune reconstitution inflammatory syndrome. a. Gopal S, Patel MR, Yanik EL, Cole SR, Achenbach CJ, Napravnik S, Burkholder GA, Reid EG, Rodriguez B, Deeks SG, Mayer KH, Moore RD, Kitahata MM, Richards KL, Eron JJ. Association of early HIV viremia with mortality after HIV-associated lymphoma. AIDS 2013;27:2365-73. PMC3773290. b. Gopal S, Patel MR, Yanik EL, Cole SR, Achenbach CJ, Napravnik S, Burkholder GA, Reid EG, Rodriguez B, Deeks SG, Mayer KH, Moore RD, Kitahata MM, Eron JJ, Richards KL. Temporal trends in presentation and survival for HIV-associated lymphoma in the combination antiretroviral therapy era. J Natl Cancer Inst 2013;105:1221-9. PMC3748003. c. Gopal S, Patel MR, Achenbach CJ, Yanik EL, Cole SR, Napravnik S, Burkholder GA, Mathews WC, Rodriguez B, Deeks SG, Mayer KH, Moore RD, Kitahata MM, Richards KL, Eron JJ. Lymphoma Immune Reconstitution Inflammatory Syndrome in the Center for AIDS Research Network of Integrated Clinical Systems Cohort. Clin Infect Dis 2014;59:279-86. PMC4102912. d. Yanik EL, Achenbach CJ, Gopal S, Coghill AE, Cole SR, Eron JJ, Moore RD, Mathews WC, Drozd DR, Hamdan A, Ballestas ME, Engels EA. Changes in clinical context for Kaposi sarcoma and non-Hodgkin lymphoma among HIV-infected people in the United States. J Clin Oncol 2016;34:3276-83. PMC5024548. 2. Cancer diagnosis in sub-Saharan Africa. After joining the UNC faculty and moving to Lilongwe in 2012, I initiated efforts to improve diagnostic pathology services for cancer at Kamuzu Central Hospital (KCH), a national teaching hospital in the capital. This included implementation and expansion of immunistochemistry (IHC), and developing real-time telepathology involving clinicians and pathologists in the US and Malawi. This resulted in one of the first descriptions from the region of developing a de novo pathology laboratory with effective use of telepathology, description of pathologic disease burden in Malawi, and demonstration that telepathology plus limited IHC results in excellent diagnostic accuracy compared to US review, even after application of additional IHC stains and molecular diagnostic tools. a. Gopal S, Krysiak R, Liomba G. Building a pathology laboratory in Malawi. Lancet Oncol 2013;14:291-2. PMID: 23561742. b. Gopal S, Krysiak R, Liomba NG, Horner M, Shores C, Alide N, Kamiza S, Kampani C, Chimzimu F, Fedoriw Y, Dittmer DP, Hosseinipour MC, Hoffman IF. Early experience after developing a pathology laboratory in Malawi, with emphasis on cancer diagnoses. PLoS One 2013;8:e70361. PMC3737192. c. Montgomery ND, Graham T, Krysiak R, Kampani C, Liomba NG, Gopal S, Fedoriw Y. Comparison of eosinophil density in staging bone marrow biopsies from Malawi and the United States. Pathol Int 2015;65:671-3. PMC4668204. d. Montgomery ND, Liomba NG, Kampani C, Krysiak R, Stanley CC, Tomoka T, Kamiza S, Dhungel BM, Gopal S, Fedoriw Y. Accurate Real-Time Diagnosis of Lymphoproliferative Disorders in Malawi Through Clinicopathologic Teleconferences: A Model for Pathology Services in Sub-Saharan Africa. Am J Clin Pathol 2016;146:423-30. PMC5040876. 3. Lymphoma in sub-Saharan Africa. I am PI of the NIH-funded KCH Lymphoma Study initiated in June 2013. This is one of the first, large, prospective lymphoma cohorts from sub-Saharan Africa. All diagnoses are pathologically confirmed, and patients are longitudinally followed for five years after diagnosis, with transport reimbursements and active tracing to optimize retention, resulting in negligible loss-to-follow-up to date. All patients undergo systematic clinical, laboratory, and radiologic assessments while receiving care under local conditions. After initial diagnosis, tumor and plasma specimens undergo virologic, biomarker, and sequencing studies with basic science collaborators in the US. The study has resulted in the first descriptions of anthracycline-based treatment for pediatric Burkitt lymphoma in sub-Saharan Africa, and the first prospective study of CHOP chemotherapy for aggressive non-Hodgkin lymphoma among adults with and without HIV in the modern ART era. a. Stanley CC, Westmoreland KD, Heimlich BJ, El-Mallawany NK, Wasswa P, Mtete I, Butia M, Itimu S, Chasela M, Mtunda M, Chikasema M, Makwakwa V, Kaimila B, Kasonkanji E, Chimzimu F, Kampani C, 3 Dhungel BM, Krysiak R, Montgomery ND, Fedoriw Y, Rosenberg NE, Liomba NG, Gopal S. Outcomes for paediatric Burkitt lymphoma treated with anthracycline-based therapy in Malawi. Br J Haematol 2016;173:705-12. PMC4884132. b. Gopal S, Fedoriw Y, Kaimila B, Montgomery ND, Kasonkanji E, Moses A, Nyasosela R, Mzumara S, Varela C, Chikasema M, Makwakwa V, Itimu S, Tomoka T, Kamiza S, Dhungel BM, Chimzimu F, Kampani C, Krysiak R, Richards KL, Shea TC, Liomba NG. CHOP Chemotherapy for Aggressive NonHodgkin Lymphoma with and without HIV in the Antiretroviral Therapy Era in Malawi. PLoS One 2016;11:e0150445. PMC4775030. c. Westmoreland KD, Stanley CC, Montgomery ND, Kaimila B, Kasonkanji E, El-Mallawany NK, Wasswa P, Mtete I, Butia M, Itimu S, Chasela M, Mtunda M, Chikasema M, Makwakwa V, Kampani C, Dhungel BM, Sanders MK, Krysiak R, Tomoka T, Liomba NG, Dittmer DP, Fedoriw Y, Gopal S. Hodgkin lymphoma, HIV, and Epstein-Barr virus in Malawi: Longitudinal results from the Kamuzu Central Hospital Lymphoma study. Pediatr Blood Cancer 2016 Oct 26. doi: 10.1002/pbc.26302. [Epub ahead of print]. PMID: 27781380. d. Westmoreland KD, Montgomery ND, Stanley CC, El-Mallawany NK, Wasswa P, van der Gronde T, Mtete I, Butia M, Itimu S, Chasela M, Mtunda M, Kampani C, Liomba NG, Tomoka T, Dhungel BM, Sander MK, Krysiak R, Kazembe P, Dittmer DP, Fedoriw Y, Gopal S. Plasma Epstein-Barr virus DNA for pediatric Burkitt lymphoma diagnosis, prognosis, and response assessment in Malawi. Int J Cancer 2017;140:2509-2516. PMID: 28268254. 4. Kaposi sarcoma (KS) in sub-Saharan Africa. I am PI for the NIH U54 UNC-Malawi Cancer Consortium initiated in September 2014. The consortium builds on existing partnerships to address herpesvirusassociated cancers, specifically lymphoma and Kaposi sarcoma. In collaboration with the Malawi National Cancer Registry, we are conducting a national HIV-cancer record linkage study to assess trends in KS risk in the ART era. Through consortium activities, we are also undertaking studies to better understand clinical, virologic, and molecular correlates of KS outcomes. In particular, we are interested in potential contributions of other under-recognized diseases that are also associated with the KS-associated herpesvirus apart from KS itself, like multicentric Castleman disease, a condition for which our group has provided some of the first clinical descriptions from sub-Saharan Africa. a. Gopal S, Fedoriw Y, Montgomery ND, Kampani C, Krysiak R, Sanders MK, Dittmer DP, Liomba NG. Multicentric Castleman Disease in Malawi. Lancet 2014;384:1158. PMC4470481. b. Herce ME, Kalanga N, Wroe EB, Keck JW, Chingoli F, Tengatenga L, Gopal S, Phiri A, Mailosi B, Bazile J, Beste JA, Elmore SN, Crocker JT, Rigodon J. Excellent clinical outcomes and retention in care for adults with HIV-associated Kaposi sarcoma treated with systemic chemotherapy and integrated antiretroviral therapy in rural Malawi. J Int AIDS Soc 2015;18:19929. PMC4450240. c. Gopal S, Liomba NG, Montgomery ND, Moses A, Kaimila B, Nyasosela R, Chikasema M, Dhungel BM, Kampani C, Sanders MK, Krysiak R, Dittmer DP, Fedoriw Y. Characteristics and survival for HIVassociated multicentric Castleman disease in Malawi. J Int AIDS Soc 2015;18:20122. PMC4524888. d. Host KM, Horner MJ, van der Gronde T, Moses A, Phiri S, Dittmer DP, Damania B, Gopal S. Kaposi's sarcoma in Malawi: a continued problem for HIV-positive and HIV-negative individuals. AIDS 2017;31:318-319. PMC5180456. 5. Other cancers in sub-Saharan Africa. Finally, as the only medical oncologist in Malawi, and leader of our cancer clinical research program, I work with many collaborators and provide mentorship to US and Malawian trainees to address the most common malignancies in this environment. a. Gopal S. Moonshot to Malawi. N Engl J Med 2016;374:1604-5. PMC4871710. b. Gutnik L, Lee C, Msosa V, Moses A, Stanley C, Mzumara S, Liomba NG, Gopal S. Clinical breast exam screening by trained laywomen in Malawi integrated with other health services. J Surg Res 2016;204:61-7. PMC4963624. c. Liu W, Snell JM, Jeck WR, Hoadley KA, Wilkerson MD, Parker JS, Patel N, Mlombe YB, Mulima G, Liomba NG, Wolf LL, Shores CG, Gopal S, Sharpless NE. Subtyping sub-Saharan esophageal squamous cell carcinoma by comprehensive molecular analysis. JCI Insight 2016;1:e88755. PMC5053149. d. Kohler RE, Miller AR, Gutnik L, Lee CN, Gopal S. Experiences and perceptions regarding clinical breast exam screening by trained laywomen in Malawi. Cancer Causes Control 2017;28:137-143. PMID: 28097471. 4 URL of full published work: http://www.ncbi.nlm.nih.gov/sites/myncbi/satish.gopal.1/bibliography/43943250/public/?sort=date&direction=de scending D. Research Support Ongoing Research Support K01TW009488 Gopal (PI) 9/20/2012-6/30/2017 Developing a prospective lymphoma clinical cohort in Malawi This is an International Research Scientist Development Award to support my career development focused on lymphoma in resource-limited settings. The goals are to develop a large, longitudinal lymphoma cohort in Malawi with detailed characterization and embedded correlative sub-studies. Patients receiving treatment according to local standards are followed for up to five years to evaluate response to therapy, treatment-related toxicities, costs of treatment, and health-related quality of life. R21CA180815 Gopal (PI) 8/20/2013-7/31/2017 Molecular profiling of HIV-associated lymphoma in the US and Malawi This award is to perform the first large-scale genomic characterization of HIV-associated lymphoma using RNA sequencing. Tumor specimens are taken from ongoing lymphoma cohort studies in the US and in Malawi, for which I serve as PI, allowing correlation of all gene expression profiling data to robust clinical data. U54CA190152 Gopal (PI) 9/15/2014-8/31/2019 Addressing herpesvirus-associated cancers through the Malawi Cancer Consortium This award is to establish the Malawi Cancer Consortium, comprised of the University of North Carolina at Chapel Hill, Malawi Ministry of Health, and University of Malawi College of Medicine. The consortium is focused on Kaposi sarcoma and lymphoma. It includes three support cores (Administrative, Mentoring, Analysis) and three multi-institutional research projects: (1) a record linkage study between the Malawi National Cancer Registry and national HIV data to clarify changing patterns of cancer risk in the ART era; (2) a cohort study to elucidate HIV-associated Kaposi sarcoma subsets; and (3) a cohort study to develop riskadapted, response-guided treatment of HIV-associated lymphoma. A principal focus is to develop internal capacity such that Malawi can become a leading country for HIV-associated cancer research in the region. P20CA210285 Gopal (PI) 9/1/2016-8/31/2018 Planning for a national non-communicable disease center of research excellence in Malawi This anticipated award is for a two-year planning period to develop a Malawi Center of Research Excellence for non-communicable diseases (NCDs), focused on cancer, injury, and cardiovascular disease. The planning grant will engage every major group in Malawi with significant NCD programs, reflecting a commitment to a truly national agenda. The center will include administrative, developmental, clinical, laboratory, biostatistics, and implementation cores. Sustainability of the center and its impact will be ensured by strong scientific ownership from collaborating Malawian partners, including participation by the highest levels of the Malawi College of Medicine and Ministry of Health leadership. Active linkages to international institutions and networks outside Malawi will allow the center to leverage external relationships to achieve regional importance. P30CA016086-40S4 Gopal (PI) 3/24/2016-5/30/2018 Malawi Burkitt lymphoma project supplement award This supplement award to the Lineberger Comprehensive Cancer Center core grant is specifically for Burkitt lymphoma studies in Malawi. The included studies will focus on deriving and validating a diagnostic score to improve Burkitt lymphoma diagnosis, conducting a systematic methotrexate dose-escalation study, and increasing collaborations with regional partners during the supplement award period to establish a regional network for addressing this common pediatric cancer. UNC Lineberger Developmental Award Gopal (PI) 7/1/2013-7/31/2016 A pilot clinical trial of R-CHOP in Malawi The award is to conduct a single-center, non-randomized clinical trial of R-CHOP, using the Indian generic biosimilar Reditux. We will enroll 40 patients (20 HIV-infected, 20 HIV-uninfected). Patients will be followed for primary endpoints of toxicity and progression-free survival. 5