Jun 07, 2022
Leaderboard Branding Adds to Expert Drug Safety Division With Influential Hire: Former FDA DMEPA Evaluator
Max Straka, PharmD, FISMP, has extensive experience leading pharmaceutical and biotech proprietary name submission reviews and evaluating medication error reports.
CHARLOTTE, N.C. – Leaderboard Branding, a Fingerpaint company, the fast-growing global naming and branding firm that delivers strategic insights and world-class creativity to biopharma and healthcare companies as early as clinical phase 1, announced the hiring of Max Straka, PharmD, FISMP, a former FDA Division of Medication Error Prevention and Analysis (DMEPA) safety evaluator. As a Director of Leaderboard Branding’s Drug Safety Division, Dr. Straka adds to the broad experience of global leaders and innovators in this important area of drug development.
At the FDA DMEPA, Dr. Straka conducted and led the review processes to oversee and support the safe practices related to naming, labeling, packaging, and design of drugs. With evolving FDA guidance and recommended methodologies, Dr. Straka has first-hand experience and exclusive understanding of what is needed when developing proprietary names for submission.
“Max brings a unique end-to-end perspective of drug safety, as well as an insider’s understanding of the FDA,” said Brannon Cashion, Managing Partner of Leaderboard Branding. “His specific experience in proprietary name candidate review, reconsiderations, and final rejection or approval is invaluable as pharmaceutical companies around the world seek commercialization in the US through the FDA. From understanding what it takes to successfully move a therapeutic through the regulatory process to how it impacts real-world scenarios, Max has a clear grasp of the importance of naming and branding in drug safety.”
At the FDA, Dr. Straka assessed medication error reports submitted through the FDA Adverse Event Reporting System and drafted postmarket reviews to further evaluate a product’s safety. 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, Dr. Straka was a practicing pharmacist at a national retail pharmacy chain for nearly a decade, where his responsibilities included ensuring safety procedures and protocols were upheld to the highest standards.
“I’ve seen first-hand how the naming and branding of a therapeutic early on can set the successful foundation for the rest of its life cycle, from the regulatory process to how it is perceived on the shelf,” said Dr. Straka. “Having the opportunity to influence those decisions and taking the appropriate steps to support approval so early in the commercialization process is one of the reasons I’m excited to join Leaderboard Branding.”
While he was 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.