“[Brian] Was a central figure and driver to complete documents on time. Although this is his role, thought he was efficient and pleasant to work with, considering this was an off-platform molecule. Did a good job organizing the documents and keeping the team on task to meet submission goals. Very responsive and flexible to repeated requests for edits. Think he can take on more responsibility or more challenging projects as he was very organized, responsive, and worked well with team members.”
Dominick Vacante – Senior Director DPDS
“Brian worked across boundaries and collaborated with many groups to collect SME input for the responses and did it in a timely way to gather responses, reviews and approvals all within a compressed timeline. Brian has in-depth knowledge about the large-molecule products so he does not have difficulty following the content which are being included in the dossier. He is quick at catching key points. Brian also has good relationship with his customers. It has been very easy to work with Brian thanks to his openness and nice character.”
Jason Mattis – Director Regulatory Affairs
Brian contributed a lot with our team assessing the CMC part of a draft regulation about Advanced Therapy Products (such as CAR-T). He was open to discuss, exchange ideas and contact other stakeholders to provide the most complete assessment. In fact, for us, he exceed our expectations (usually we don´t receive this kind of support from Global teams).
Laura Affonso – Brazil Regulatory Affairs Manager
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.
Tom Schultz – Senior Director Regulatory Affairs
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.
