Robert Johnson

About Robert Johnson

I’m a biopharma executive with extensive experience across all phases of clinical drug…

Experience

1. Vice President, Pharmaceutical Development

   X4 Pharmaceuticals

   Aug 2021 — Present

   Joined team in critical preclinical role and later assumed responsibility as head of Regulatory Affairs and Clinical Pharmacology, steering NDA submission, global regulatory submissions, and commercialization of its signature drug. Lead key modeling studies, as well as development of second drug for multiple indications. Report to the COO (formerly to the Chief Scientific Officer).• Played lead role and guided small team on NDA submission, including the clinical efficacy and clinical pharmacology (Module 2 summaries), achieving FDA approval; Xolremdi (mavorixafor) generated $3.5M in first 8 months.• Expedited 4 clinical pharmacology studies in support of the NDA submission, including completion of Clinical Study Reports (CSRs) and successful acceptance of the USPI drug label.• Spearheaded responses to 2 post-marketing requirements (PMRs), crafting and leading studies that were launched or completed on time or ahead of schedule, maintaining regulatory requirements (guidance practices).• Wrote detailed carcinogenicity waiver (WoE) averting requirement for lengthy and costly study; pending decision, if favorable, will save $4M+ in expense, plus costs of elapsed time and API depletion.• Steered toxicological analysis to address concern about manufacturing impurity (CMC regulatory affairs); argument accepted by the FDA with no follow up information requests (IRs).• Independently led IND readiness of novel backup drug for new indications, including CNS disorders.• Collaborated with Parexel accelerating clinical pharmacology studies, exceeding market expectations for FDA acceptance of NDA; partnered with Boyds preparing marketing application with EMA including substantially revised pediatric investigation plan (PIP) submitted to the paediatric committee (PDCO). • Led vital physiologically based pharmacokinetic (PBPK) modeling including pediatric, and supervised population pharmacokinetic (popPK) studies which served as key inputs to regulatory submissions.

Education

• Harvard Medical School

  Postdoctoral Fellow, Center for Blood Research

• Massachusetts Institute of Technology

  Research Affiliate (joint appointment)

• Cornell University

  Doctor of Philosophy (Ph.D.)

• Auburn University

  Bachelor of Science (B.S.), D.V.M.