William McIntyre, PhD, currently serves as the Senior Vice President of Global Regulatory Affairs at Curemark, a biotechnology company focused on unmet medical needs in neurology and psychiatry. William has dedicated his career to drug development and has held a variety of senior executive roles in Pharma.
William has over 30 years of experience in Regulatory Affairs and drug development. He has been responsible for pre- and post-approval activities supporting almost a dozen NDAs, multiple BLAs, dozens of INDs, and hundreds of ANDAs, as well as devices. To accomplish these filings, William has built and maintained productive Regulatory Affairs groups in US, Europe, Latam, and Asia.
William’s therapeutic exposure and interaction with FDA/global health authorities includes analgesics, anti-infective, antihistamines, anti-inflammatory, anti-fungal, anxiolytics, blood glucose regulators, cardiovascular agents, depression, dermatological agents, neurodevelopmental agents and immunological agents. Recently, William’s team gained the approval (July 6, 2020) of Qwo® (collagenase clostridium histolyticum-aaes), as a first in class therapeutic product. The Qwo® BLA was a 10-month, first pass approval.
In addition to his traditional Regulatory Affairs roles, William has also held cGMP compliance roles. He has hosted dozens of cGMP, pre-approval, post-approval, “for cause”, DEA, and pharmacovigilance health authority inspections in US, Europe, Latam and Asia. He has also been the final reviewer of the responses to these respective health authority compliance groups and negotiated compliance outcomes, including multiple consent decrees and facility rehabilitations.
His manufacturing background includes virtually all dosage forms and the development of manufacturing processes that span the range from small molecules to complex fermentation products. He has also overseen the construction of manufacturing facilities around the world including a new Biosafety Level 3 manufacturing site for Aplisol® (Tuberculin Purified Protein Derivative) in US, as well as facilities for sterile, and solid oral products around the globe.
William lives in the New York Hudson River Valley with his partner Renée and their two dogs; Rembrandt and Rebel. William’s son is a musician and resides in Brooklyn, NY.