Michael Martinelli Email & Phone Number

Alameda, California, Us

San Francisco, Ca, Us

Responsible for all manufacturing, from early pre-IND phase through NDA/BLA for small molecules and large molecules. Team includes drug substance, drug product, analytical development, clinical trial supply and commercial supply chain. Reporting to the CEO, I serve as an active and engaged member of the executive leadership team handling chemical, antibody, formulation, and analytical development from preclinical to commercial manufacturing. I manage a team of 50, retaining accountability for CMC regulatory submissions and registrations, budget management, and strategy decisions.Negotiating commercial supply agreements with big pharma partners and serving on joint steering committees are part of my typical day. I lead worldwide technical development with a history of international regulatory success in the US, EU, JP, CN, including pre-approval inspections and have collaborated with WADA on testing protocols at international sporting events including the Olympics. Throughout my time here I’ve invented an extensive list of patents and maintained a strong publication and international presentations record. As a result of these actions my team and I have: - Shortened cycle time dramatically and rationalized inventories to balance commercial readiness and financial investments. - Generated hundreds of millions in revenue by commercializing a novel drug via NDA/MAA submissions and integrating collaboration partners AZ and Astellas in a near-simultaneous worldwide submission- Achieved regulatory approval by leading API and FDP process development and manufacturing for phase-three asset and rapid earlier phase programs, and- Built functional capability for a diverse portfolio of therapeutics by recruiting key talent and developing ambitious staff.

San Francisco, Ca, Us

Head of CM&C team. A major priority of this position involved the management of manufacturing facility construction occurring throughout Beijing and Tianjin, China, with on-time and on-budget project completion being non-negotiable. I directed the energies of a team of 15 in completing the conceptual and detailed design, budget justification, and construction of two facilities that were slated to serve as the only manufacturing centers for the commercial product. My team came together strongly to support and complete all regulatory inspections needed to achieve approval for this project to move forward according to plan. Some of the projects and contributions I am most proud of include delivering product IP expansion through novel formulation and new methods of drug delivery; establishing an internal commercial manufacturing asset from design through approval; and delivering eight years of additional revenue by extending product patent life.

I provided subject matter expertise to the CEO and CMO on all CMC matters for the advanced phase (pre-Ph III) portfolio of drug candidates, including API, formulations, and analytical control. Part of this function involved identifying and meeting with key CMOs to outline manufacturing agreements and establish registration and validation phase contracts. Additionally, I was charged with developing strategic options for advancing late-stage assets through pivotal trials with parallel product registration and conducting site visits and technical assessments.I also established phase-three clinical trial readiness by evaluating a portfolio of six unique and distinct small molecules in various clinical indications.

San Diego, Ca, Us

Head of CM&C team. I guided chemistry, pharmaceutical sciences, analytical development, technical operations, supply chain, and CMC PM with the support of a team of 85 in San Diego and dotted line responsibility for an NPI team of 75 in Zofingen, CHE. I directed API and FDP process registration and validation, NDA/eCTD filing, launch, and commercial supply chain for Lorcaserin while managing pre-approval inspection and planning across the entire CMC spectrum at multiple sites. With the incredible commitment of my team, we advanced the portfolio of earlier phase IND drug candidates in development, including API, drug product, and stability studies. Other achievements include: The successful product launch via on-time and in-budget renovation of a manufacturing site in Zofingen, CHE, before commencement of full-scale production operations, and winning a competitive partnership with Eisai.Most notably, I played key role in what ultimately led to a Pfizer acquisition of a CMC package for the lead drug candidate etrasimod, an S1P modulator for ulcerative colitis and Crohn’s disease and led the FDA approval of lorcaserin (belviq®).Senior Director (2007-2008) I provided chemistry R&D leadership over registration, validation, and NDA for the chemical process of Lorcaserin Hemihydrate Hydrochloride. I directed the efforts of a 120 person team while handling technology transfer chemical processes between Arena, Siegfried, and Cilag and additional tech transfer with intermediates manufacturers. My team reliably maintained a fully inspected cGMP facility for QC testing, API, and tablet manufacturing. Our efforts ultimately served to advance drug candidates into early phase clinical trials for a variety of indications, including ralinepag (pulmonary arterial hypertension), temanogrel (5HT2a agonist, vasoconstriction), an oral CXCR2 antagonist for neutrophil-mediated diseases, and Olorinab (APD371), a CB2 agonist for pain and pipeline diversification for CAR-T therapeutics.

Thousand Oaks, Ca, Us

Head of Process Chemistry, Analytical Chemistry & Automation Technologies. Here I retained full accountability as the chemical process and technologies executive responsible for the internal and external manufacturing organization for the small molecule pipeline, supporting early phase library synthesis through API starting material acquisition. I led the 130-person research and automation technology group that vetted and implemented innovative technology hardware and software. Together we automated routine operations utilizing commercial and custom-designed products and managed key interfaces for internally derived and in-licensed projects, and deployed millions to modernize GMP facilities with upgrades to fixed reactors, hydrogenation equipment, and material handling with high containment drug candidates. We worked diligently to achieve outcomes including shorter cycle time to IND, maintaining a fully cGMP compliant kilo lab facility to manufacture all drug candidates, delivering expansion in Cambridge, MA, and securing a valuable pipeline of over 20 new potential products. Under my direction we introduced new molecules into the pipeline by establishing the capability and capacity for chemical process R&D, improved pipeline speed and quality and optimized manufacturing methods by enabling state-of-the-art technology screening, established a catalysis laboratory providing RoA, CoA, and PAT, enhanced the product pipeline with a 10-fold probability of technical success by integrating R&D at an earlier and measured stage, and achieved market exclusivity for a $1.7 billion market. All in all the risks were calculated and the outcomes exceeded our wildest expectations.

Indianapolis, Indiana, Us

Head of Process Research & Development. Research, Fellow, Research & Development In this position I earned this promotion faster than anyone in the 125-year company history, onboarding as a scientist and excelling through multiple levels to the equivalent of vice president on the technical ladder, eventually reporting to the Executive Vice President. I had the opportunity to serve on many review and governance committees and as key representative on due diligence deals, corporate presentations, and scientific venues, and was honored to be invited to participate in a select CEO panel aimed at revolutionizing the company's approach to technology.

Nih Postdoc, Organic Chemistry

Postdoc, Organic Chemistry

Doctor Of Philosophy (Phd)

Bachelor Of Science - Bs, Chemistry