Pharmaceutical Regulatory Dossier Development
I have authored a total of 70+ regulatory submissions that have been filed in 17+ countries and led to the dosing of 1,000+ patients in Phase 1-3 clinical trials in oncology, cardiovascular, immunology, and neuroscience.
I develop regulatory submission content and strategy at Janssen Pharmaceuticals for global dossier submissions, investigator brochures, Health Authority responses, meeting requests, and briefing books for unprecedented platforms and processes including:
During my tenure as the Cell and Gene Therapy Dossier Intelligence Forum Leader at Johnson & Johnson, and while I supported the Regenerative Medicine and Advanced Therapies (RMAT) Global Regulatory Affairs group, I performed regulatory intelligence and policy activities to benchmark competitors’ regulatory approvals, clinical holds, and FDA RMAT designations using open-source intelligence methods.
By keeping our fingers on the pulse of Cell and Gene Therapy industry and by influencing health authorities, we positioned ourselves to bring advanced therapies to the patients as fast as possible with the best guidance and support from the health authorities.
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Brian has been DDO representative on SM ED Oncology team since its inception (CMC Lead: Jacalyn Clawson). This is a very visible team with many complex assets (e.g. KRAS, BTK, PRMT5) operating in a new fast-paced ED team paradigm. Brian has been successfully managing all his deliverables, sometimes exceeding the expectations by providing critical input on technical dossier content such as our approach to management of impurities for oncology indications, where Brian added significant value to the team by partnering with preclinical SMEs to examine key recent publications, HA guidelines, HA Question database in order to justify higher impurity qualification limits for KRAS and BTK programs, enabling the clinical programs to proceed with a higher max dose level.
Brian is a very impressive scientist. His drive and expertise are exactly what DPDS needs for continued success in the future. In the Cell & Gene Therapy DIF, Brian’s leadership is exemplary. Brian provided tremendous support to the PhRMA Working Group initiative addressing Patient-Centric Quality Standards by drafting a case study related to Impurities. This case study will be very helpful in the future.
By education and training, I am a Biomedical Scientist, graduating with a doctoral degree from the University of Central Flroida College of Medicine with expertise in antibody instability, as it relates to light chain amyloidosis. Also, I have extensive experience in the quantum mechanics of biological redox reactions and methods to increase expression yields of properly folded antibody domains. My work in these areas resulted in 8 publications, including articles in peer-reviewed scientific journals and book chapters in molecular biology textbooks. This work was funded by the National Institutes of Health and performed at the University of Central Florida College of Medicine.
I previously worked as a small molecule analytical scientist at Boehringer-Ingelheim Vetmedica, Inc. At BIVI, I supported the formulation development of Semintra®, performed stability assays for licensed products, conducted release and stability studies for a New Drug Application, as well as pharmcovigilance product quality studies.
Prior to Boehringer-Ingelheim, I worked at Nestle-Purina in the clinical laboratory as a clinical laboratory intern. I was responsible for cataloging, tracking, shipping, and maintaining over 1,200 biological samples as well as performing clinical laboratory blood and fecal tests.
I have Native/Bilingual/Working Proficiency in the following languages:
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