Julia M. Markov, Pharm.D.

Science Specialist Buffalo

An experienced researcher and analyst of scientific issues, Julia focuses on product liability and health effects litigations, and serving clients involved in the medicalization of psychedelic therapies.

For over 15 years, clients and attorneys have relied on Julia’s evidence-based analyses of scientific literature, regulatory documents and medical records for the development of a scientific defense in product liability and health effects litigations.

Leveraging her deep knowledge of U.S. Food and Drug Administration (FDA) regulatory approval and compliance processes with her significant experience of critically evaluating scientific literature, Julia excels at producing risk management strategies for developers and manufacturers of pharmaceutical and medical device products.

A significant aspect of Julia’s experience includes having worked as part of the science counsel team for two major pharmaceutical companies, where she identified and evaluated relevant scientific data across multiple disciplines to assist in building a scientific defense in product liability matters involving antidepressants, antiemetics, antidiabetic medications, heartburn medications and hormone replacement therapies.

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Education & Admissions

Education
  • State University of New York at Buffalo, School of Pharmacy, Pharm.D., 2007
  • Vanderbilt University, B.A., magna cum laude, 2002

Experience

Representative Matters
  • For “helpline” team for a major pharmaceutical company, provided proactive risk-management analyses related to labeling and marketing claims for several prescription and over-the-counter therapies.
  • For defense team in a toxic exposure litigation, analyzed the epidemiological literature and evaluated the scientific basis for the alleged injury, examined disease state mechanisms and identified alternative risk factors.

Articles & Publications

Articles

  • Co-Author, “Major Milestone for Psychedelic-Assisted Therapy: Lykos Therapeutics Submits New Drug Application to the FDA for MDMA-Assisted Therapy for PTSD,” New York Law Journal, January 2024
  • Co-Author, “FDA Draft Guidance on Clinical Trials for Psychedelics: A Closer Look,” Microdose.buzz, July 2023
  • Co-Author, “APA Issues Position Statement on Psychedelics Use,” Microdose.buzz, September 2022
  • Co-Author, “Strategies For Improving Diversity In Psychedelics Research,” Law360, August 2022