LEAH ISAKOV
Data science

LEAH ISAKOV

Current position
PhD, Advisor at Pallantius Inc
Skills
Analytics
Business Strategy
Clinical Development
Biostatistics

Social

THE COURSES

  • Applied Statistics

About

Leah Isakov is a senior leader in the pharmaceutical industry with a unique combination of leadership and technical skills. She has worked in clinical trials for more than two decades and is known for delivering results. Leah has led NDA (New Drug Applications), PMA (Pre-Marketing Approvals) and BLA (Biologics License Applications) and have deep experience interacting with all the major regulatory bodies (FDA, EMEA, PMDA, Russian Ministry of Health, and Health Canada). She also has direct experience successfully managing cross-cultural international teams (USA, China, Japan and Canada). The recent therapeutic areas include Oncology, Infectious Diseases, Cardiovascular, Asthma, Renal Failure and HIV for Phase II-IV clinical trials in drugs and biologics.


As a leader, Dr. Isakov strives to be at the forefront of management practice. She incorporates data-driven decision making and quantitative risk management, and focus on building internal capabilities along with external collaborations. Leah believes that successful management comes from understanding the full organisational stack; that is, not only high-level strategy but also the technical aspects that enable success.

Experience

Global Head of BioStatistics, Data Management, Programming and Medical Writing Seqirus Oct 2016 – Present

Senior Director, Clinical Statistics / Biosimilars Statistical Lead
Pfizer
Feb 2014 – Oct 2016

Senior Director of Biostatistics, Statistical Programming and Data Management
Antigenics
2004 – 2014

Associate Director, Biostatistics
AAI Development (formerly MTRA) 1998 – 2004

Education

MIT Sloan School of Management, Cambridge, MA
MBA
Boston University, Boston, MA
PhD, Biostatistics

Selected Publications

  • Isakov, L., Jin, B., and Jacobs, I. A. (2016). "Statistical Primer on Biosimilar Clinical Development." American Journal of Therapeutics 0(1). DOI: 10.1097/MJT.0000000000000391
  • Musselli, C., Isakov, L., and Wentworth, K. (2011). “Chapter 11. Emerging clinical trial design concepts for therapeutic cancer vaccines.” Cancer Vaccines: From Research to Clinical Practice. ISBN 9781841848297
  • Wood, C., et al. (2008). “An adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen) versus observation alone for patients at high risk of recurrence after nephrectomy for renal cell carcinoma: a multicentre, open-label, randomised phase III trial.” The Lancet 372(9633). DOI: 10.1016/S0140-6736(08)60697-2
  • Jonasch, E. et al. (2008). “Vaccination of metastatic renal cell carcinoma patients with autologous tumour-derived vitespen vaccine: clinical findings.” British Journal of Cancer 98(8). DOI: 10.1038/sj.bjc.6604266

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