Timothy O. Email and Phone Number

•US strategic lead for UCB0022, an investigational new drug for the treatment of patients with advanced Parkinson’s Disease; assisted in the pre-IND meeting and initial IND application. •Supported sBLA for Cimzia for treatment of Polyarticulatar Juvenile Idiopathic Arthritis (pJIA), including a pre-sBLA meeting, sBLA initial application, as well as information requests from FDA.•Led drug-device combination development for Zilbrysq through agency interactions including leading a Type C meeting.•Zilbrysq pediatric investigational plan development and negotiations with the agency.•Distributed and implemented regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. (Member of the UCB Regulatory Intelligence Team)

•Primary contact for the FDA, EMA and MHRA for Zokinvy (Approved for treatment Hutchinson-Gilford Progeria Syndrome)•Assessed all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, HTA, etc.) and developed creative solutions to address anticipated obstacles in France regarding a cATU•Developed and updated global, regional, and multi-country regulatory strategy•Supervised regulatory operations functions to create and maintain regulatory information systems, that meet organization objectives.•Provided in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life- threatening medical conditions or that address unmet medical needs (e.g., orphan, conditional approval, breakthrough therapy).

Organized all regulatory and patient information to fit FDA GCP guidelines. Created three trial master files from scratch for investigator initiated trials over the span of 12 years. Led August 2020 FDA inspection, resulting in successful approval of Lonafarnib for first in market indication of Hutchinson Gilford Progeroid Syndrome and Progeroid Laminopathies. Compiled and quality controlled study reports and data for ongoing and previous trials. Served as liaison between the BCH team and FDA inspector during the audit. Updated and reviewed toxicology data, including medication diary review with patients and families. Trained interns on inspection readiness and GCP compliance. Updated IMP logs in accordance with GCP guidelines. Spearheaded the Phase 1 paper writing for Everolimus in combination with lonafarnib.

Intern for the Department of Critical Care

Handle all faculty relations, professional workshops, mental health seminars, and overall advance the quality of learning that happens beyond the classroom