Simon Bruce Email & Phone Number

San Diego, California, United States

Dublin, Ie

Drug Development Services and Consulting

Harpers Ferry, West Virginia, Us

Kinexum TRANSLATIONAL RESEARCH & STRATEGIC SERVICES - "Kinexum guides, designs, and manages strategic and operational solutions to the regulatory, manufacturing, nonclinical, clinical development, and business challenges necessary to take scientific discoveries to proof of concept and through the product life cycle" - kinexum.com

Led clinical development of orphan drug indication in hypoparathyroidism for a calcium-sensing receptor antagonist including through CRADA with NIH intramural investigators. Developed innovative Phase 1/2 trial accepted by FDA and NIH for streamlined dose-finding and proof-of concept. Worked with small cross-functional team of veteran drug developers and collaborated with experts from NIH and top academic medical centers in preparation of integrated development plan.

Lyon, Fr

San Diego, California, Us

Basel, Baselstadt, Ch

Executive Director in the Metabolics Clinical Science Unit - Supervise physician and clinical scientist in a small team acting as main interface from late-stage clinical development with colleagues across all metabolic programs in translational medicine. Acting as a liaison to help bridge the perennial potential gaps between early development and full clinical development. Leveraging close working relationships and influence to advocate for protocol and program design and strategy to fulfill proof-of-concept goals while also maximally informing or mitigating risk for subsequent milestones. work with teams located in Cambridge and San Diego, providing input and guidance on clinical development strategy to global project teams. Serve as Global Program Medical Director and Medical Lead on projects transitioning to Phase 2 in the metabolic/endocrine indications. Work extensively with business development and in-licensing looking at program and portfolio opportunities to enhance and leverage Novartis ability to help impact diabetes and obesity epidemics.

San Diego, Ca, Us

Increasing levels of responsibility including managing team of PhD's in Health Economics and Outcomes Research, Pharmacometrics, safety surveillance, investigator initiated trials programs, and a group of scientists responsible for clinical/pre-clinical interface including key assays for development program biologics. Initiated and designed an IND trial in collaboration with regulatory and safety and put together a team to prosecute the orphan drug application for leptin for lipodystrophy. Mentored and developed physicians in medical affairs and in development to take over the leptin program. Key contributer to Bydureon ISS including extensive collaboration with safety and crafting discussions with FDA related to oversight and investigation of emerging potential safety signals.Led an initiative to obtain high level buy-in from senior management of large pharma partner on initiating a large CV outcomes trial and facilitate approval through their own governance processes to galvanize and realize the start of the cardiovascular outcome study in collaboration with Duke and Oxford.Worked with medical affairs team to support cardio-metabolic initiative looking at emerging information suggesting that GLP-1 and/or metabolites may have beneficial effects on cardiovascular and endothelial system and how best to provide appropriate access and compliant materials for education to medical professionals on current state of the art. Advocated through bi-partner reviews for strategy of clinical trials to forward understanding potential role of GLP-1 in blood pressure control, fatty liver, PCOS, and other. Advocated for upgrade to IIT systems to address chronic compliance issues at a time of extreme cost-cutting which was ultimately successful.

Basking Ridge, Nj, Us

Medical Lead for novel fructose 1,6 bisphophatase inhibitor designed to block overactive gluconeogenesis which is recognized to be a fundamental pathophysiology in type 2 diabetes. Soon after joining a concurrent clinical pharmacology study revealed a propensity for lactic acidosis when combined with metformin. Negotiated directly with FDA medical reviewer a plan to voluntarily stop ongoing outpatient trials and conduct an expert review with key opinion leaders. Expert input was unanimous that the underlying hypothesis needed to be tested and could be/should be ethically conducted. Designed a protocol with additional safety monitoring and features accepted by FDA to conduct definitive 3-month proof of concept which was successful although mechanism did not deliver efficacy better than metformin allowing a clean no-go decision. Innovated a safety system for that trial based on J-review and pre-specified signal-noise markers based on input from biostatistics which was later adopted and run by the safety department. Designed phase 3 plan and wrote initial phase 3 protocol for a novel PPAR-gamma compound and presented to FDA at end-of-phase 2 meeting.

Lawrence Township, Nj, Us

Medical Lead for DPP4 inhibitor, Saxagliptin, from pre-IND stage through to Phase 3.Initially worked as medic on Phase 3b/4 portfolio of studies supporting the first oral combination pill for type 2 diabetes, Glucovance. Managed multimillion clinical development budget. Worked in close alignment with medical affairs and supervised a team of up to 15 clinical scientists working on 4-5 trials including an sNDA for triple combination therapy, a new dose strength and duplicate trials to support the superiority of the first initial combination therapy indication in diabetes. Participated in review of efficacy/safety and contributed to ISE and ISS for NDA for follow-on combination with metformin/glipizide.Designed and completed international pediatric study on time under budget to qualify for 6-month patent extension. Write and publish manuscripts. Present data at US and international diabetes meetings. Convened and worked with experts in the field to design and conduct a hyperglycemic clamp and tracer study to demonstrate and support an increase in beta-cell function associated with the novel rapid release of the sulfonylurea component of the metformin/glyburide tablet which allowed increased efficacy with about half-maximal sulfonylurea doses. Worked extensively with early discovery and translational medicine advocating and clinical planning for SGLT2 inhibitor program. Promoted to medical lead for internal DPP4 inhibitor program from pre-clinical phase through to Phase 3. Crafted a white paper to vet with regulatory proposing that an accelerated straight to 3-month phase 2 strategy was appropriate and met one-one with the PRI chief scientific officer who accepted the proposal which allowed BMS to gain second to market for this novel therapeutic class. Co-Lead with Regulatory on Transition To Phase 3 Team; Designed and vetted phase 3 strategy.

Board Eligible In Endocrinology, Endocrinology

Bs, Neuroscience