Executive CV – Drug Development & Clinical Leadership

Ewa Carrier, MD

Executive Summary

Accomplished clinical development leader with over 20 years of global experience in oncology, hematology, rare diseases, and cellular
therapies. Recognized for pioneering translational research, biomarker-driven strategies, and innovative trial designs
(Bayesian/adaptive), delivering therapies from concept through pivotal trials and regulatory approval. Expertise spans solid tumors,
immuno-oncology, ADCs, cellular therapies, and global program leadership.

Clinical & Drug Development Leadership

  • Directed global clinical programs in NSCLC, pancreatic cancer (LAPC, mPDAC), hematology, and rare diseases, leading multiple Phase I–III trials to pivotal stages.
  • Led Phase III NSCLC FIH anti-sense TGFB vaccine trial, multi-phase pancreatic cancer programs, and IPF Phase III trials.
  • Developed and operationalized cellular therapy protocols for severe autoimmune diseases at UCSD
  • Secured INDs for novel oncology therapies (gal-9, ADCs) and collaborated with FDA on innovative trial designs, including Bayesian and adaptive protocols.
  • Oversaw China-based teams for Phase III trial execution and BLA submission support.

Translational Research & Biomarkers

  • Advanced programs including a-CCR8, gal-9, and a-CD46/MMAE ADCs with predictive biomarker strategies (e.g., a-CD46 PET imaging).
  • Collaborated with CTEP and NCCN to accelerate early-phase oncology trials, including Plk-1 inhibitor volasertib.
  • Pioneered translational integration in Phase I trials to optimize early drug development strategies

Industry Experience

FibroGen, Inc. (~400 employees)
Vice President, Clinical Development | 06/2015 – 10/2024

  • Lead solid tumor oncology and rare disease programs (4 Phase III trials, 3 early-stage IO/ADC programs).
  • Spearheaded global Phase III pancreatic cancer trial, exceeding timelines by 25% during COVID.
  • Partnered with FDA to design Precision Promise master protocol using Bayesian modeling.
  • Directed pipeline programs including anti-Gal-9, anti-CCR8 IO agents, and anti-CD46 ADC.

Boehringer Ingelheim (~44,000 employees)
Director, Clinical Development & Medical Affairs | 02/2012 – 06/2015

  • Directed global development of solid and hematologic tumors; advanced first-in-class Plk1 inhibitor to FDA breakthrough therapy designation.
  • Managed Phase I–III trials across international sites in collaboration with NCCN, ECOG, and other oncology networks
  • Led medical affairs and pre-marketing strategy for oncology programs.

NovaRx Corporation (~40 employees)
Vice President, Clinical Development & Medical Affairs | 01/2010 – 01/2013

  • Led global Phase III trial for Lucanix NSCLC cancer vaccine, including international recruitment and interim analyses
  • Directed BLA submission strategy and biomarker discovery for solid tumor populations.

Clinical Development Summary

Solid Tumor Oncology

  • Led Phase I–III programs in pancreatic cancer, NSCLC, and other malignancies, including cancer vaccines, monoclonal antibodies, ADCs, and small molecules.
  • Expert in trial design, regulatory strategy, and global program execution.

Hematology & BMT

  • Directed and participated in multiple Phase I–III hematology and BMT trials, including CTN networks.

Regulatory & Strategic Partnerships

  • Achieved FDA breakthrough therapy (AML/FIC Plk1 inhibitor) and fast-track designations for solid tumors.
  • Established global collaborations with partners including AstraZeneca and Astellas to accelerate oncology programs.

Medical Affairs Leadership

  • Developed and executed pre-launch and medical affairs strategies for solid tumor indications.
  • Delivered clinical data to KOLs and implemented global medical operating plans.

Academic & Research Leadership

  • NIH KO8 and R01-funded research in stem cell immunology; developed first murine model of prenatal transplantation; awarded U.S. Patent No. 8,703,487.
  • Achieved first-in-human prenatal transplant IND approval (inherited metabolic disorders, 2000).
  • Authored 100+ peer-reviewed publications and book chapters in oncology, hematology, and stem cell transplantation.
  • Conducted foundational lymphoma studies at Stanford (JCO, 1989) and established immuno-oncology and cellular therapy clinical protocols at UCSD.

Education

  • Medical University of Wroclaw, Poland – MD, Graduated with Honors (1976–1982)
  • Stanford University School of Medicine – Sub-Internship in Medicine; Pediatric Residency (1984)
  • UCSF, San Francisco, CA – Fellowships in Hematology/Oncology & Bone Marrow Transplantation (2001–2006)

Academic Appointments

  • UCSF, Associate Hematologist, Hematology & BMT Division (1997–1998)
  • UCSD, Associate Professor, Hematology & BMT Division (1998–2010)

Advisory Boards

  • America Stem Cells | Paul Burkett Foundation | LifeMax | Orchrist | Millennium
  • Global Institute of Stem Cell Therapy & Research | NovaRx Corporation | Targazyme | Calidi Bio

Peer Review / Journal Reviewer

  • Blood | Transplantation | Bone Marrow Transplantation | Haematologica | Experimental Hematology | Cell Transplantation

Grant Reviewer

  • GCRC – UC President Cancer Research Coordinating Committee
  • VA Merit Awards | NIH PO Awards | Moores UCSD Cancer Research Award

Publications

1. Horning S, Carrier E, Rouse R, Warnke R, Michie SL. Lymphomas presenting as histologically unclassified neoplasms:
Characteristics and response to treatment. J Clin Oncol. 1989;7(9):1281–1287.

2. Carrier E, Lee TH, Busch M, Cowan MJ. Induction of tolerance in non-defective mice after in utero transplantation of major
histocompatibility complex-mismatched fetal hematopoietic stem cells. Blood. 1995;86(12):4681–4690.

3. Carrier E, Lee TH, Busch M, Cowan MJ. Recruitment of engrafted donor cells postnatally into the blood with cytokines after in
utero transplantation in mice. Transplantation. 1997;64(4):627–633.

4. Carrier E. In utero transplantation. Gaucher Clin Perspect Mol Med Ther. 2000;8(1):6–11.

5. Burt RK, Brenner M, Burns W, Carrier E, Firestein G, Hahn B, Heslop H, Link C, McFarland H, Roland M, Territo M, Tsokos G,
Traynor A. Gene-marked autologous hematopoietic stem cell transplantation of autoimmune disease. J Clin Immunol.
2000;20(1):1–9.

6. Carrier E, Gilpin E, Lee TH, Busch MP, Zanetti M. Microchimerism does not induce tolerance post in utero transplantation and
may lead to the development of alloreactivity. J Lab Clin Med. 2000;136(3):224–235.

7. Bashey A, Corringham S, Gilpin E, DeFrancisco C, Santos-Ada O, Holman P, Carrier E, Lane TA, Ball ED, Law P. Simultaneous
administration of G-CSF and GM-CSF for re-mobilization in patients with inadequate initial progenitor cell collections for
autologous transplantation. Cytotherapy. 2000;2(3):195–200.

8. Carrier E, Burt R. Stem cell transplantation for autoimmune diseases: pros and cons. Curr Opin Organ Transplant. 2000;5:343–
351.

9. Donahue J, Gilpin E, Lee TH, Busch MP, Croft M, Carrier E. Microchimerism does not induce tolerance and sustains immunity
after in utero transplantation. Transplantation. 2001;71(3):359–368.

10. Donahue J, Gilpin E, Young D, Carrier E. Postnatal cytokines and boosts improve chimerism and hematological parameters in
β-thalassemic mice transplanted in utero. Transplantation. 2001;71(10):1491–1494.

11. Voltarelli JC, Ahmed H, Paton E, Stracieri AB, Holman P, Bashey A, Coutinho M, Simoes BP, Ball ED, Carrier E. Beneficial effect
of intravenous lidocaine in cutaneous chronic graft-versus-host disease secondary to donor lymphocyte infusion. Bone
Marrow Transplant. 2001;28(1):97–99.

12. Donahue J, Carrier E. Non-myeloablative transplants for congenital diseases. Cancer Treat Res. 2002;110:177–211. Review.

13. Francis K, Palsson B, Donahue J, Fong S, Carrier E. Murine Sca-1+/Lin- cells and human KG1a cells exhibit multiple pseudopod
morphologies during migration. Exp Hematol. 2002;30:460–463.

14. Sefriouri H, Donahue J, Gilpin EA, Srivastava AS, Carrier E. Tolerance and immunity following in utero transplantation of
allogeneic fetal liver cells: the cytokine shift. Cell Transplant. 2003;12(1):75–82.

15. Sefriouri H, Donahue J, Srivastava AS, Gilpin E, Lee TH, Carrier E. Alloreactivity following in utero transplantation of cytokinestimulated hematopoietic stem cells: the role of recipient CD4(-) cells. Exp Hematol. 2002;30(6):617–624.

16. Donahue J, Carrier E. Non-myeloablative transplants for congenital diseases. In: Bashey A, Ball ED, editors. NonMyeloablative Allogeneic Transplantation. Kluwer Academic Publishers; 2002:177–211.

17. Lane T, Carrier E, et al. Comparison of CD34 measurement on the product at the mid-point of leukapheresis versus peripheral
blood prior to apheresis to predict the amount of CD34 cells collected. Transfusion. 2003.

18. Tanner ML, Hoh CK, Bashey A, et al. FLAG chemotherapy followed by allogeneic stem cell transplant using nonmyeloablative
conditioning induces regression of myelofibrosis with myeloid metaplasia. Bone Marrow Transplant. 2003;32(6):581–585.

19. Srivastava A, Carrier E. Immunological factors that affect the in vivo fate of T7 phage in the mouse. J Virol Methods.
2004;115(1):99–104.

20. Srivastava AS, Oohara I, Suzuki T, Shenouda S, Singh SN, Chauhan DP, Carrier E. Purification and properties of cytosolic
alanine aminotransferase from the liver of two freshwater fish, Clarias batrachus and Labeo rohita. Comp Biochem Physiol B
Biochem Mol Biol. 2004;137(2):197–207.

21. Wang EH, Chen YA, Bashey A, Holman P, Ball ED, Carrier E. High-dose CEB vs BEAM with autologous stem cell transplant in
lymphoma. Bone Marrow Transplant. 2004;34(7):581–587.

22. Srivastava A, Chauhan DP, Carrier E. In utero detection of T7 phage after systemic administration to pregnant mice.
BioTechniques. 2004;37(1).

23. Lane TA, Bashey A, Carrier E, et al. Improving the efficiency of PBPC collection by pre-apheresis peripheral blood and midapheresis product measurements of CD34 cells. Cytotherapy. 2004;6(4):318–327.

24. Burt RK, Marmont A, Arnold R, et al. Development of a phase III trial of hematopoietic stem cell transplantation for systemic
lupus erythematosus. Bone Marrow Transplant. 2003;32:49–51.

25. Feng Z, Carrier E. A regulatory role of Wnt signaling pathway in the hematopoietic differentiation of murine embryonic stem
cells. Biochem Biophys Res Commun. 2004;324(4):1333–1339.

26. Moustafa M, Srivastava A, Nedelcu E, Donahue J, Gueorguieva I, Shenouda S, Minev B, Carrier E. Chimerism and tolerance
post in utero transplantation with ontogenically different sources of stem cells. Transplantation. 2004;78(9):1274–1282.

27. Chauhan DP, Srivastava AS, Moustafa ME, Shenouda S, Carrier E. In utero gene therapy: prospect and future. Curr Pharm Des.
2004;10(29):3663–3672.

28. Kamrava MR, Anderson EM, Kalunian K, Bashey A, Holman P, Medina B, Ball ED, Carrier E. T-cell depletion improves outcome
after autologous stem cell transplant in patients with systemic lupus erythematosus (SLE). Bone Marrow Transplant.
2005;35(3):321.

29. Burt R, Carrier E, et al. Hematopoietic stem cell transplantation for multiple sclerosis. Arch Neurol. 2005.

30. Burt RK, Cohen B, Oyama Y, et al. Hematopoietic stem cell transplantation for multiple sclerosis. Arch Neurol.
2005;62(6):860–864. Review.

31. Rizzia M, Gerloni M, Srivastava AS, Wheeler MC, Schuler K, Carrier E, Zanetti M. In utero DNA immunization: immunity over
tolerance in fetal life. Vaccine. 2005;23(33):4273–4282.

32. Bashey A, Liu L, Ihasz A, Medina B, Corringham S, Keese K, Carrier E, Castro JE, Holman P, Lane T, Hassidim K, Ball ED. Nonanthracycline-based remission induction therapy for newly diagnosed patients with acute myeloid leukemia aged 60 or older.
Leuk Res. 2006;30(4):503–506.

33. Srivastava AS, Shenouda S, Mishra R, Carrier E. Transplanted embryonic stem cells successfully survive, proliferate, and
migrate to damaged regions of the mouse brain. Stem Cells. 2006;24(7):1689–1694.

34. Srivastava AS, Kaushal S, Mishra R, Lane TA, Carrier E. Dexamethasone facilitates erythropoiesis in murine embryonic stem
cells differentiating into hematopoietic cells in vitro. Biochem Biophys Res Commun. 2006;346(2):508–516.

35. Srivastava AS, Nedelcu E, Esmaeli-Azad B, Mishra R, Carrier E. Thrombopoietin enhances generation of CD34+ cells from
human embryonic stem cells. Stem Cells. 2007;25:1456–1461.

36. Srivastava AS, Feng Z, Mishra R, Malhotra R, Kim HS, Carrier E. Embryonic stem cells ameliorate piroxicam-induced colitis in
IL10-/- KO mice. Biochem Biophys Res Commun. 2007;361(4):953–959.

37. Bashey A, Donohue M, Liu L, Medina B, Corringham S, Ihasz A, Carrier E, Castro JE, Holman PR, Xu R, Law P, Ball ED, Lane TA.
Peripheral blood progenitor cell mobilization with intermediate-dose cyclophosphamide, sequential GM-CSF and G-CSF, and
scheduled commencement of leukapheresis in 225 patients undergoing autologous transplantation. Transfusion.
2007;47(11):2153–2160.

38. Liu J, Malhotra R, Voltzrelli J, Stracieri AB, Oliveira L, Simoes BP, Ball ED, Carrier E. Ovarian recovery after stem cell
transplantation. Bone Marrow Transplant. 2008;41(3):275–278. Epub 2007 Oct 22.

39. Srivastava AS, Malhotra R, Esmaeli-Azad B, Lane T, Carrier E. Prospects of embryonic stem cells in treatment of hematopoietic
disorders. Curr Pharm Biotechnol. 2007;8(5):305–317.

40. Bashey A, Medina B, Corringham S, Pasek M, Carrier E, Vrooman L, Streicher H, Lowy I, Solomon SR, Morris LE, Holland K,
Mason J, Soiffer R, Ball ED. CTLA4 blockade with ipilimumab to treat relapse of malignancy after allogeneic hematopoietic cell
transplantation. Blood. 2009;113(7):1581–1588. Epub 2008 Oct 30.

41. Murphy MP, Wang H, Patel AN, Kambhampati S, Angle N, Chan K, Marleau AM, Pyszniak A, Carrier E, Ichim TE, Riordan NH.
Allogeneic endometrial regenerative cells: an “off the shelf solution” for critical limb ischemia? J Transl Med. 2008;6:45. Epub
ahead of print.

42. Han X, Meng X, Riordan N, Minev B, Carrier E, Patel A, Murphy MP, Min WP. Inhibition of intracranial glioma growth by
endometrial regenerative cells. Cell Cycle. 2009;8(4):606–610. Epub 2009 Mar 2.

43. Basak GW, Carrier E. The search for multiple myeloma stem cells: the long and winding road. Biol Blood Marrow Transplant.
2010;16(5):587–594. Epub 2009 Nov 4. Review.

44. Zheng X, Vladau C, Zhang X, Suzuki M, Ichim TE, Zhang Z, Li M, Carrier E, Barcia B, Jevnikar AM. A novel in vivo siRNA delivery
system specifically targeting dendritic cells and silencing CD40 genes for immunomodulation. Blood. 2009 Jan 22. Epub
ahead of print.

45. Basak GW, Srivastava AS, Malhotra R, Carrier E. Multiple myeloma bone marrow niche. Curr Pharm Biotechnol.
2009;10(3):345–346. Review.

46. Koos D, Josephs SF, Alexandrescu DT, Chan RC, Ramos F, Bogin V, Gammill V, Dasanu CA, De Necochea-Campion R, Riordan
NH, Carrier E. Tumor vaccines in 2010: need for integration. Cell Immunol. 2010;263(2):138–147. Epub 2010 Apr 3. Review.

47. Lin F, Josephs SF, Alexandrescu DT, Ramos F, Bogin V, Gammill V, Dasanu CA, De Necochea-Campion R, Patel AN, Carrier E,
Koos DR. Lasers, stem cells and COPD. J Transl Med. 2010;8:16. Review.

48. Koos D, Carrier E, et al. Hitting the right target. EBR – European Biopharmaceutical Review. 2010 Sep.

49. Venxue MA, Carrier E. Enhanced presentation of MHC class Ia, Ib, and class II-restricted peptides encapsulated in
biodegradable nanoparticles: a promising strategy for tumor immunotherapy. J Transl Med. 2007;5:45.

50. Didwania M, Didwania A, Mehta G, Basak GW, Yasukawa S, Takayama S, De Necochea-Campion R, Srivastava A, Carrier E.
Artificial hematopoietic stem cell niche: bioscaffolds to microfluidics to mathematical simulations. Curr Top Med Chem.
2011;11(13):1599–1605. Review.

51. Ma W, Smith T, Bogin V, Zhang Y, Ozkan C, Ozkan M, Hayden M, Schroter S, Carrier E, Messmer D, Kumar V, Minev B. Enhanced
presentation of MHC class Ia, Ib, and class II-restricted peptides encapsulated in biodegradable nanoparticles: a promising
strategy for tumor immunotherapy. J Transl Med. 2011;9:34.

52. De Necochea-Campion R, Carrier E, et al. Stem cell mobilization with HYC750. Biol Blood Marrow Transplant. 2010 Feb.

53. De Necochea-Campion R, Ghochikyan A, Josephs SF, Zacharias S, Woods E, Karimi-Busheri F, Alexandrescu DT, Chen CS,
Agadjanyan MG, Carrier E. Expression of the epigenetic factor BORIS (CTCFL) in the human genome. J Transl Med. 2011;9:213.
Epub ahead of print.

54. Karimi-Busheri F, Zadorozhny V, Carrier E, Fakhrai H. Molecular integrity and global gene expression of breast and lung cancer
stem cells under long-term storage and recovery. Cell Tissue Bank. 2012 May 18.

55. Giaconne G, Carrier E, et al. A phase III study of belagenpumatucel-L therapeutic tumor cell vaccine for non-small cell lung
cancer (NSCLC). Eur J Cancer. 2013 Sep.

56. Giaconne G, Carrier E, et al. A phase III study of belagenpumatucel-L, an allogeneic tumor cell vaccine, as maintenance
therapy for non-small cell lung cancer. Eur J Cancer. 2015 Aug.

57. Srivastava AS, Carrier E, et al. Generation of red blood cells from human embryonic stem cells (ES) with increased efficacy.
Biol Blood Marrow Transplant. 2012 Feb.

58. Picozzi VJ, Pipas JM, Koong AC, Giaccia AJ, Bahary N, Krishnamurthi SS, Lopez CD, O’Dwyer P, Modelska K, Carney M, Chou J,
Zhong M, Hemmerich S, Li D, Carrier E, Porter S, Neff TB, Valone FH. FG-3019, a human monoclonal antibody to connective
tissue growth factor, combined with chemotherapy in patients with locally advanced or metastatic pancreatic ductal
adenocarcinoma. J Cancer Clin Trials. 2017;2(1):123.

59. Carrier E, Mody K, Pishvaian M, Kouchakji E, Picozzi V, et al. Anti-CTGF human recombinant monoclonal antibody
pamrevlumab increases resectability and resection rate when combined with gemcitabine/nab-paclitaxel in locally advanced
pancreatic cancer. Ann Oncol. 2017 Sep.

60. Picozzi VJ, Pishvaian MJ, Mody K, Winter JM, Glaspy JA, Larson T, Matrana MR, Saikali K, Carney M, Porter S, Yu P, Kouchakji E,
Carrier E. Effect of anti-CTGF human recombinant monoclonal antibody pamrevlumab on resectability and resection rate
combined with gemcitabine/nab-paclitaxel in locally advanced pancreatic cancer. J Clin Oncol. 2018;36(15_suppl):4016.

61. Picozzi V, Carrier E, et al. Gemcitabine/nab-paclitaxel with pamrevlumab: a novel drug combination and trial design for the
treatment of locally advanced pancreatic cancer. ESMO Open. 2020;5(2):e000784.

62. Conolly A, Carrier E, et al. Pamrevlumab, a fully human monoclonal antibody targeting connective tissue growth factor, for
non-ambulatory patients with Duchenne muscular dystrophy. J Neuromuscul Dis. 2023 May 30

Books and books chapters/review papers

1. Carrier, E. In Utero Transplantation. Textbook “Hematopoietic Stem Cell Therapy, Eds. Ball ED, Lister J and Law P.
W.B. Saunders Publishing Company, Philadelphia, PA, 2000, Chap. 19, pp. 217-224.

2. Carrier, E. Murine Model of In Utero Transplantation. Eds. Ho AD, Marcel and Dekker Publishers, Inc., New York, NY,
pp. 195-222, 2000

3. Carrier, E, Heiju Ledingham: 100 Questions and Answers about Bone Marrow and Stem Cell
Transplantation. Jones & Bartlett Publishers, Incorporated. July 2003.

4. Carrier, E. and Richard Burt. Mobilization and conditioning regimens in stem cell transplant for autoimmune diseases.
Landes Bioscience. Book chapter in book edited by Burt and Marmont:” Stem cell transplant for autoimmune
diseases”.

5. Ball, E.D., Bashey, A., Carrier, E. Castro, J.E., Holman, P. and Lane, T.: Current Status of Bone Marrow Transplantation
for Treatment of Cancer. In Cancer Growth and Progression, 2nd Edition, Vol. 10, Cancer ManagementinMan:Biological
Response Modifiers,Chemotherapy, Antibiotics, Hyperthermia, Supporting Measures Neoplastic Prevention. [Volume
Editor: Minev,B., Series Editor: Kaiser, H.E.]

6. Thomas E Ichim, Neil H Riordan, Andre Alfaro, Samantha Halligan, Boris Minev, and Ewa Carrier MultipleMyeloma
Stem Cells: Therapeutic Implications of a Paradigm Shift. In: Cancer Management in Man: Chemotherapy, Biological
Therapy, Hyperthermia and Supporting Measures. Minev B. Volume Editor, Volume 10, Cancer Growth and Progression
Book Series, Springer, In Press, 2009