AndrewPeterKrivoshikMDPhD

Pediatrics • Boston, MA

Pediatric Hematology/Oncology

President and Head of Development, Astellas Pharma Global Development

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Office
451 D Street
Boston, MA 02210
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Summary

Andrew Krivoshik, MD, PhD is a senior pharmaceutical executive with success in leading global multidisciplinary cross functional teams. Dr. Krivoshik and his development teams have successfully submitted BLA and NDA global submissions leading to the global approvals of new medicines. He is licensed both as a physician, and as a professional engineer, in multiple jurisdictions and has served as an invited speaker and session chair at international scientific congresses.

Education & Training

Duke University HospitalFellowship, Pediatric Hematology/Oncology, 2002 - 2004
Mayo Clinic College of Medicine and Science (Rochester)Residency, Pediatrics, 2000 - 2002
University of Illinois at Urbana-ChampaignPhD, Biophysics and Computational Biology, 1990 - 2001
Mayo Clinic College of Medicine and Science (Rochester)Internship, Pediatrics, 1999 - 2000
University of Illinois College of MedicineClass of 1999, MD
Princeton UniversityBSE, Electrical Engineering, Honors, 1986 - 1990

Certifications & Licensure

MA State Medical License 2023 - 2026
IL State Medical License 2004 - 2026
WI State Medical License 2018 - 2025
MN State Medical License 2000 - 2025
NC State Medical License 2002 - 2025
MI State Medical License 2017 - 2024
PA State Medical License 2004 - 2007
American Board of Pediatrics Pediatrics

Awards, Honors, & Recognition

Recipient of Global Medical & Development award for Operational Excellence through the Astellas Way Global Recognition Program 2014 Astellas, 2014
Recipient of APGD-LT Award 2013 Special Recognition as member of the data flow optimization project team Astellas, 2013
Recipient of GPRD President’s Award for contribution to the successful phase 1 evaluation of a stabilized lipid formulation of ABT-263 in healthy volunteers Abbott Labs, 2010
Service Champion Duke, 2003
Diplomate, American Board of Pediatrics – Board Certified General Pediatrics American Board of Pediatrics, 2002
Departmental Honors in Electrical Engineering Princeton University, 1990
Tau Beta Pi, National Engineering Honor Society Princeton University, 1988
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Clinical Trials

ABT-751 in Treating Young Patients With Refractory Solid Tumors Start of enrollment: 2002 Mar 01
Completed
Phase 1
A Study of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies Start of enrollment: 2006 Nov 01
Completed
Phase 1, Phase 2
ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment Start of enrollment: 2007 Jan 01
Completed
Phase 2
ABT-751 With Chemotherapy for Relapsed Pediatric ALL Start of enrollment: 2006 May 22
Terminated
Phase 1, Phase 2
A Phase 1/2a Study of ABT-263 in Subjects With Small Cell Lung Cancer (SCLC) or Other Non-Hematological Malignancies Start of enrollment: 2007 Apr 01
Completed
Phase 1, Phase 2
A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia Start of enrollment: 2007 Jul 25
Completed
Phase 1, Phase 2
Assess the Oral Bioavailability of New ABT-263 Formulations Start of enrollment: 2008 Aug 01
Completed
Phase 1
A Study Evaluating the Safety of ABT-263 in Combination With Etoposide/Cisplatin in Subjects With Cancer Start of enrollment: 2009 Oct 01
Completed
Phase 1
Safety Study of ABT-263 in Combination With Gemzar (Gemcitabine) in Subjects With Solid Tumors Start of enrollment: 2009 Sep 01
Completed
Phase 1
Safety Study of ABT-263 in Combination With Paclitaxel in Subjects With Solid Tumors Start of enrollment: 2009 Jul 01
Completed
Phase 1
Assess the Oral Bioavailability of a New ABT-263 Formulation in Subjects With Cancer Start of enrollment: 2009 Oct 01
Completed
Phase 1
A Study Evaluating ABT-263 With Erlotinib, ABT-263 With Irinotecan, and ABT-263 Monotherapy in Cancer Subjects Start of enrollment: 2009 Oct 01
Completed
Phase 1
A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax). Start of enrollment: 2010 Jan 01
Completed
Phase 1
Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female Subjects Start of enrollment: 2009 Oct 01
Completed
Phase 1
A Study to Assess the Effect of Rifampin on the Metabolism of Navitoclax Start of enrollment: 2010 May 01
Completed
Phase 1
A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy Start of enrollment: 2011 Dec 01
Completed
Phase 2
Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer Start of enrollment: 2012 Aug 01
Completed
Phase 2
A Phase 1, Dose Escalation Study to Assess the Safety and Tolerability of ASP9853 With Either Docetaxel or Paclitaxel in Patients With Advanced Non-hematologic Malignancies Start of enrollment: 2012 Aug 28
Terminated
Phase 1
A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide Start of enrollment: 2013 Sep 25
Completed
Phase 4
Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer Start of enrollment: 2013 Oct 31
Active, not recruiting
Phase 3
A Dose Escalation Study of ASP8273 in Subjects With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) Mutations Start of enrollment: 2014 Apr 09
Completed
Phase 1
An Open Study of ASP8273 in Patients With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) Mutations Start of enrollment: 2014 Jan 23
Terminated
Phase 1, Phase 2
A Study of ASP8273 in Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor-Naïve Patients With Non-Small Cell Lung Cancer Harboring EGFR Mutations Start of enrollment: 2015 Jun 25
Terminated
Phase 2
A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations Start of enrollment: 2016 Feb 11
Terminated
Phase 3
A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Start of enrollment: 2016 Mar 09
Active, not recruiting
Phase 3
A Study of ASP8273 in Subjects With Non-small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Mutations Start of enrollment: 2017 Mar 24
Terminated
Phase 1
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Publications & Presentations

PubMed

21 citations
Prognostic Association of Prostate-specific Antigen Decline with Clinical Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Treated with Enzalutamid...
Andrew J. Armstrong, Ping Lin, Celestia S. Higano, Peter Iversen, Cora N. Sternberg, Bertrand Tombal, De Phung, Teresa Parli, Andrew Krivoshik, Tomasz M. Beer> ;European Urology Oncology. 2019 Nov 1
A Phase 3, Randomized, Open-label Study of ASP8273 Versus Erlotinib or Gefitinib in Patients With Advanced Stage IIIB/IV Non-Small Cell Lung Cancer.
Kelly, R. J.,Shepherd, F. A.,Krivoshik, A.,Jie, F.,Horn, L.> ;Ann. Oncol.. 2019 May 10
5 citations
A phase I study of ABT-751, an orally bioavailable tubulin inhibitor, administered daily for 21 days every 28 days in pediatric patients with solid tumors.
Elizabeth Fox, John M Maris, Brigitte C Widemann, Wendy Goodspeed, Anne Goodwin, Marie Kromplewski, Molly E Fouts, Diane Medina, Susan L Cohn, Andrew Krivoshik, Anne E...> ;Clinical Cancer Research. 2008 Feb 15
43 citations
Development and validation of a prognostic model for overall survival in chemotherapy-naïve men with metastatic castration-resistant prostate cancer
Andrew J. Armstrong, Ping Lin, Celestia S. Higano, Cora N. Sternberg, Guru Sonpavde, Bertrand Tombal, Arnoud J. Templeton, Karim Fizazi, De Phung, E.K. Wong, Andrew Kr...> ;Annals of Oncology. 2018 Nov 1
624 citations
Enzalutamide in men with nonmetastatic, castration-resistant prostate cancer
Maha Hussain, Karim Fizazi, Fred Saad, Per Rathenborg, Neal D. Shore, Ubirajara Ferreira, Petro Ivashchenko, Eren Demirhan, Katharina Modelska, De Phung, Andrew Krivos...> ;The New England Journal of Medicine. 2018 Jun 27
42 citations
Radiographic Progression-Free Survival as a Clinically Meaningful End Point in Metastatic Castration-Resistant Prostate Cancer: The PREVAIL Randomized Clinical Trial.
Dana E. Rathkopf, Tomasz M. Beer, Yohann Loriot, Celestia S. Higano, Andrew J. Armstrong, Cora N. Sternberg, Johann S. de Bono, Bertrand Tombal, Teresa Parli, Suman Bh...> ;JAMA Oncology. 2018 May 1
25 citations
A Phase I, Dose Escalation Study of Oral ASP8273 in Patients with Non-small Cell Lung Cancers with Epidermal Growth Factor Receptor Mutations.
Helena A. Yu, Alexander I. Spira, Leora Horn, Jared Weiss, Howard West, Giuseppe Giaccone, Tracey L. Evans, Ronan J. Kelly, Bhardwai B Desai, Andrew Krivoshik, Diarmui...> ;Clinical Cancer Research. 2017 Dec 15
27 citations
Seizure Rates in Enzalutamide-Treated Men With Metastatic Castration-Resistant Prostate Cancer and Risk of Seizure: The UPWARD Study.
Susan F. Slovin, William R. Clark, Joan Carles, Andrew Krivoshik, Jung Wook Park, Fong Wang, Daniel J. George> ;JAMA Oncology. 2017 Dec 7
8 citations
Clinical Outcomes of Chemotherapy Naïve Men with Metastatic Castration Resistant Prostate Cancer and Low Baseline Prostate Specific Antigen Treated with Enzalutamide v...
Mary-Ellen Taplin, Andrew J. Armstrong, Ping Lin, Andrew Krivoshik, De Phung, Teresa Parli, Bertrand Tombal, Tomasz M. Beer> ;The Journal of Urology. 2017 Dec 1
8 citations
Risk Factors for and Incidence of Seizures in Metastatic Castration-Resistant Prostate Cancer: A Real-World Retrospective Cohort Study.
Charles Dharmani, Machaon Bonafede, Andrew Krivoshik> ;Clinical Drug Investigation. 2017 Oct 13
18 citations
Long-Term Antitumor Activity and Safety of Enzalutamide Monotherapy in Hormone Naïve Prostate Cancer: 3-Year Open Label Followup Results.
Bertrand Tombal, Michael Borre, Per Rathenborg, Patrick Werbrouck, Hendrik Van Poppel, Axel Heidenreich, Peter Iversen, Johan Braeckman, Jiri Heracek, Benoit Baron, An...> ;The Journal of Urology. 2018 Feb 1
65 citations
Radiographic progression with nonrising PSA in metastatic castration-resistant prostate cancer: post hoc analysis of PREVAIL.
Alan H. Bryce, Joshi J. Alumkal, Andrew J. Armstrong, Celestia S. Higano, Peter Iversen, Cora N. Sternberg, Dana E. Rathkopf, Yohann Loriot, J.S. de Bono, Bertrand Tom...> ;Prostate Cancer and Prostatic Diseases. 2017 Jan 24
75 citations
Neoadjuvant Enzalutamide Prior to Prostatectomy.
Bruce Montgomery, Maria S. Tretiakova, Anthony M. Joshua, Martin E. Gleave, Neil E. Fleshner, Glenn J. Bubley, Elahe A. Mostaghel, Kim N. Chi, Daniel W. Lin, Martin G....> ;Clinical Cancer Research. 2017 May 1
Reply to M.A.N. Sendur et al and J. Michels
David F. Penson, Andrew J. Armstrong, Raoul S. Concepcion, Neeraj Agarwal, Carl A. Olsson, Lawrence Karsh, Curtis Dunshee, Fong Wang, Kenneth Wu, Andrew Krivoshik, De ...> ;Journal of Clinical Oncology. 2017 Jan 1
16 citations
BATON-CRC: a phase II randomized trial comparing tivozanib plus mFOLFOX6 with bevacizumab plus mFOLFOX6 in stage IV metastatic colorectal cancer
Al B. Benson, Igor Kiss, John Bridgewater, Ferry A.L.M. Eskens, Carolyn Sasse, Sandra Vossen, Jihong Chen, Charles Van Sant, Howard A. Ball, Anne Keating, Andrew Krivo...> ;Clinical Cancer Research. 2016 Oct 15
221 citations
Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial
David F. Penson, Andrew J. Armstrong, Raoul S. Concepcion, Neeraj Agarwal, Carl A. Olsson, Lawrence Karsh, Curtis Dunshee, Fong Wang, Kenneth Wu, Andrew Krivoshik, De ...> ;Journal of Clinical Oncology. 2016 Sep 27
15 citations
ASP9853, an inhibitor of inducible nitric oxide synthase dimerization, in combination with docetaxel: preclinical investigation and a Phase I study in advanced solid t...
Jason J. Luke, Patricia LoRusso, Geoffrey I. Shapiro, Andrew Krivoshik, Robin Schuster, Takao Yamazaki, Yukinori Arai, Allam Fakhoury, Carl Dmuchowski, Jeffrey R. Infante> ;Cancer Chemotherapy and Pharmacology. 2016 Jan 25
13 citations
Studying navitoclax, a targeted anticancer drug, in healthy volunteers--ethical considerations and risk/benefit assessments and management.
Hao Xiong, Rajendra Pradhan, Adel Nada, Andrew Krivoshik, Kyle D. Holen, James W. Rhodes, Gary Gordon, Rod A. Humerickhouse, Walid M. Awni> ;Anticancer Research. 2014 Jul 1
310 citations
Tivozanib Versus Sorafenib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma: Results From a Phase III Trial
Robert J. Motzer, Dmitry Nosov, Timothy Eisen, Igor Bondarenko, Vladimir Lesovoy, Oleg Lipatov, Piotr Tomczak, Oleksiy Lyulko, Anna Alyasova, Mihai Harza, Mikhail Koga...> ;Journal of Clinical Oncology. 2013 Oct 20
10 citations
Preclinical discovery of candidate genes to guide pharmacogenetics during phase I development: the example of the novel anticancer agent ABT-751.
Federico Innocenti, Jacqueline Ramírez, Jennifer Obel, Julia Xiong, Snezana Mirkov, Yi-Lin Chiu, David A. Katz, Robert A. Carr, Wei Zhang, Soma Das, Araba A. Adjei, An...> ;Pharmacogenetics and Genomics. 2013 Jul 1
377 citations
Phase II Study of Single-Agent Navitoclax (ABT-263) and Biomarker Correlates in Patients with Relapsed Small Cell Lung Cancer
Charles M. Rudin, Christine L. Hann, Edward B. Garon, Moacyr Ribeiro de Oliveira, Philip Bonomi, D. Ross Camidge, Quincy Chu, Giuseppe Giaccone, Divis Khaira, Suresh S...> ;Clinical Cancer Research. 2012 Jun 1
5 citations
Evaluation of the oral antimitotic agent (ABT-751) in dogs with lymphoma.
M. Silver, Anthony Rusk, Brenda Phillips, E. Beck, M. Jankowski, J. Philibert, Kevin A. Hahn, E. Hershey, Evelyn McKeegan, J. Bauch, A. Krivoshik, Chand Khanna> ;Journal of Veterinary Internal Medicine. 2012 Mar 1
620 citations
Substantial Susceptibility of Chronic Lymphocytic Leukemia to BCL2 Inhibition: Results of a Phase I Study of Navitoclax in Patients With Relapsed or Refractory Disease
Andrew W. Roberts, John F. Seymour, Jennifer R. Brown, William G. Wierda, Thomas J. Kipps, Seong Lin Khaw, Dennis A. Carney, Simon He, David C.S. Huang, Hao Xiong, Yue...> ;Journal of Clinical Oncology. 2012 Feb 10
42 citations
Phase I/II Study of Pemetrexed With or Without ABT-751 in Advanced or Metastatic Non–Small-Cell Lung Cancer
Charles M. Rudin, Ann M. Mauer, Martin Šmakal, Rosalyn A. Juergens, Stanislav Spelda, Michael S. Wertheim, Andrew Coates, Evelyn McKeegan, Peter Ansell, Xiangdong Zhou...> ;Journal of Clinical Oncology. 2011 Mar 10
431 citations
Phase I Study of Navitoclax (ABT-263), a Novel Bcl-2 Family Inhibitor, in Patients With Small-Cell Lung Cancer and Other Solid Tumors
Leena Gandhi, D. Ross Camidge, Moacyr Ribeiro de Oliveira, Philip Bonomi, David R. Gandara, Divis Khaira, Christine L. Hann, Evelyn McKeegan, Elizabeth Litvinovich, Ph...> ;Journal of Clinical Oncology. 2011 Mar 1
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Journal Articles

Enzalutamide in Men with Nonmetastatic Castration-Resistant Prostate Cancer
Hussain, M., K. Fizazi, F. Saad, P. Rathenborg, N. Shore, U. Ferreira, P. Ivashchenko, E. Demirhan, K. Modelska, D. Phung, A. Krivoshik, C. Sternberg, NEJM 378(26):2465-2474, 2018
Wilms’ tumor and neuroblastoma
Morgenstern, B, A. Krivoshik, V. Rodriguez, P. Anderson, Acta Paediatrica Suppl 445:78-85, 2004
Force relaxes before the fall of cytosolic calcium in the photomechanical response of rat sphincter pupillae
Krivoshik, A., L. Barr, Am J Physiol (Cell) 279:C274, 2000

Other

The role of calcium in signal transduction: Kinetics and regulation of intracellular calcium during the photomechanical response of the albino rat sphincter pupillae s...
Krivoshik, ISBN 0-493-27444-8, UMI AAT 3017131
DAI-B 62/06, p. 2636, Dec 2001 - 12/2001

Authored Content

“Astellas C3 Prize focuses on challenges of COVID-19 for people with cancer”September 2020
Easing the Burden of Cancer Beyond Medicine through the Astellas Oncology C3 PrizeSeptember 2020

Press Mentions

Frontier Medicines lures Astellas exec to be its CMOMay 13th, 2023
Frontier Medicines Announces Appointment of Andrew Krivoshik, M.D., Ph.D., as Chief Medical OfficerMay 8th, 2023
Seagen and Astellas Complete Enrollment in EV-103 Trial Cohort K Combining PADCEV® (Enfortumab Vedotin-Ejfv) with Pembrolizumab as First-Line Treatment for Advanced Urothelial CancerOctober 12th, 2021
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Grant Support

US Public Health Service National Research Service Award for Post-doctoral Research Training in Cancer Biology and TherapyNational Institutes of Health2003–2004
The Jim Valvano Post-Doctoral Fellowship in Pediatric Cancer ResearchV Foundation for Pediatric Cancer Research Fellow2002
US Public Health Service National Research Service Award for Pre-doctoral Individual MD/PhD FellowsNational Institute on Drug Abuse, National Institutes of Health1993–1998
US Public Health Service Institutional National Research Service Award in Molecular BiophysicsNational Institutes of Health1991–1993

Research History

Pediatric Hematology/Oncology FellowResearch focus in cancer biology on vasomotor activity in skin fold window chamber tumor models under mentorship of Mark Dehwirst, DVM, PhD2002 - 2004
PhD CandidateResearch dissertation under mentorship of Lloyd Barr, PhD: The role of calcium in smooth muscle signal transduction: The kinetics and regulation of [Ca++]i and force during the photomechanical response of rat sphincter pupillae smooth muscle1990 - 2001