Dr. Maximilian Straka, PharmD, FISMP
Director, Drug Safety
Maximilian ‘Max’ Straka, PharmD, FISMP, joined Leaderboard Branding from the Food and Drug Administration’s Division of Medication Error Prevention and Analysis (DMEPA). With his experience as a former FDA DMEPA safety evaluator and practicing pharmacist, Max brings a unique end-to-end perspective to Leaderboard Branding’s Drug Safety Division. From understanding what it takes to make it through the FDA review process, to how it impacts real-world scenarios, the FDA insider has a clear grasp of the importance naming and branding plays in drug safety.
At the FDA DMEPA, Dr. Straka conducted and led the review of proprietary name submissions, reconsiderations, and label submissions. In addition, Dr. Straka assessed and evaluated medication error reports submitted through the FDA Adverse Event Reporting System and drafted postmarket reviews. His depth of experience with the Division of Cardiology and Nephrology, where he was a primary reviewer, and the Divisions of Hematologic Malignancies and Non-Malignant Hematology provides further insight into these areas of rich innovation.
Prior to the FDA, Max was a practicing pharmacist for a national retail pharmacy chain for nearly a decade, where he was responsible for ensuring safety procedures and protocols were upheld in addition to providing medication consultation and ensuring medication compliance. He also led immunization efforts by providing in-store vaccinations as well as multiple off-site clinics.
While a Safe Medication Management Fellow at the Institute for Safe Medication Practices, Dr. Straka facilitated discussions and recommended solutions to labeling, packaging, naming, and device concerns for manufacturers, United States Pharmacopeia, and the FDA.