Larry Rosen Email and Phone Number

o Provide strategic guidance and hands on support to small and virtual biopharmaceutical companies on drug product development, from first-in-human formulation development through NDA/WMA approval and commercial launch.o Provide detailed reviews of CMC modules for regulatory submissions, identify potential gaps, and develop mitigation plans. o Advise on the selection of contract manufacturing organizations (CMOs) for drug product development. Provide technical oversight of CMOs.o Conduct due diligence of drug product development to support licensing and acquisition opportunities.

Led the drug product development activities for cefepime-taniborbactam injection and ceftibuten-ledaborbactam etzadroxil, investigational treatments for multi-drug resistant bacterial infections.o Reviewed and approved all Module 3 sections of company’s first NDA. Facilitated timely resolution of reviewer comments. Submission target date achieved.o Co-authored Module 3 sections of the company's first two INDs.o Collaborated with colleagues and external partners to develop manufacturing processes and analytical methods to produce drug product supplies for global Phase 3 clinical trial.o Identified external partners with the required manufacturing capabilities to support Venatorx’s programs. Developed strong relationships with external partners and worked collaboratively to address issues that arose. o Contributed to the authoring of multiple US government contract proposals (BARDA, NIAID) that provided non-dilutive funding to advance pipeline candidates.

Responsible for overseeing development of small molecule oral formulations and enabling technologies for poorly soluble drug candidates. Contributed to four NDA/WMA submissions. Supervisory responsibility for 10-22 scientific professionals. Provided scientific oversight for all programs assigned to direct reports. Served as co-chair of cross-functional oversight committee for small molecule programs in the Merck pipeline.

Directed group of scientists responsible for developing new life cycle management formulations for all Merck therapeutic areas. Supervised cGMP clinical manufacturing scientists and pilot plant staff. Nominated by senior management to participate on three teams supporting the integration of Merck & Schering - Plough. Represented functional area on company-wide Quality by Design Team.

Directed group of scientists responsible for new molecular entity (NME) and life cycle management (LCM) formulation development.

Directed team to complete late phase development, technology transfer, and filing of ISENTRESS (raltegravir tablet), the first in class integrase inhibitor for treatment of HIV.

Led process development team for VYTORIN (ezetimibe/simvastatin tablet) for treatment of hypercholesterolemia. Product was successfully scaled up and transferred to two international manufacturing sites. Supported CMC filing preparation and EU/US Pre-Approval Inspections for VYTORIN. Directed teams responsible for process development and technology transfer of JANUVIA (sitagliptin tablet) and JANUMET (sitagliptin/metformin tablet), first in class DPP-4 inhibitors for treatment of type 2 diabetes. Co-authored JANUVIA pharmaceutical development section of the NDA; presented overview of drug product development to the FDA as part of the FDA's Quality by Design pilot program. Represented Pharmaceutical R&D on two late state due diligence programs to support in-licensing opportunities.