Michael Miller Email & Phone Number

Libertyville, Il, Us

Lake County, Illinois, United States

Global Development Lead (GDL) responsibilities (starting Sept '22) entailed overseeing the creation of the clinical development plan for high-priority, early stage COVID-19 direct-acting antivirals, along with long-range evidence generation strategies Oversaw, as well as actively contributed to, strategic aspects of direct-acting antiviral development, including but limited to FiH/ Phase 1 work, Phase 2 design and Phase 3 planning, and development strategy alignment to the Target Product Profile, as well as to the overall COVID-19 treatment landscape

Lake County, Illinois, United States

Co-led the Specialty Therapeutic Area Strategy Counsel (TASC), along with the Specialty Development TA VP and the Global Commercial Development VP; TASC represented core disciplines within AbbVie and served as TA strategy governance for Asset Strategy Teams Led staff of portfolio program managers who helped deliver on a diverse set of programs, ranging from virology (HCV, HIV, COVID, etc…) to general medicine (Women’s Health, Men’s Health, Cystic Fibrosis, etc…) Contributed as part of the PPM Leadership Team by driving initiatives, such as, implementing a new pipeline commercial model and team modelResponsible for leading Allergan integration on behalf of the PPM organization

Greater Chicago Area

Continuation of responsibilities following the Abbott/AbbVie split; responsibilities and contributions spanned AndroGel and oral testosterone undecanoate clinical development, medical affairs, business development, etc..., which later expanded to renal and pulmonology programs (e.g. atrasentan, Zemplar, CFTR triple combo modulator)Project Leader and Asset Strategy Leader roles for atrasentan and the CFTR triple combo modulator comprised leadership of cross-functional teams to deliver optimal asset strategies, inclusive of development, manufacturing, commercialization and access considerations

Led a combined Solvay and Alliance (CRO; Quintiles) partner team in successfully delivering pivotal Phase III start-up, execution, data delivery/interpretation and finalized clinical study report for eCTD incorporation as well as clinical sections of the eCTD for the NDA of AndroGel 1.62%. Provided clinical expertise and Clinical Development oversight on an oral Testosterone Undecanoate product that resulted in a successful in-licensing opportunity. Prepared clinical responses to FDA and Health Canada questions related to AndroGel and oral testosterone applications that resulted in advancing programs and/or finalizing labeling updates.

Supported all aspects of Men’s Health registration-level (FDA) clinical development plans, including Phase II – IV protocol development for AndroGel 1%, testosterone gel 1.62% and SLV 361 (oral testosterone undecanoate). Provide review for Clinical Pharmacology work (Phase I). Served as the liaison between NIA and Solvay Pharmaceuticals to ensure the fair-balanced review of AndroGel related data and the ultimate selection of AndroGel by the NIA Study Group’s Steering Committee. Successfully coordinated the support agreement between Solvay and the NIA Study Group of $15 MUSD (as part of the $40 MUSD total for the study) and clinical supplies (AndroGel). Supported global clinical development activities involving AndroGel (e.g. Solvay Canada, Solvay Europe). Participant in a varied depth and breadth of men’s health-specific initiatives (e.g. CDC lab standardization initiative, NIA Study Group activities, Class-Labeling Response Team, internal prostate safety standardization). Provided clinical support for numerous reviews and due diligence of candidate products for acquisition on behalf of New Business Development. Led the screening and selection of a qualified CRO to develop and validate a PRO tool for use in monitoring the treatment benefit of testosterone therapy in hypogonadal men. The program was part of a labeling (registration) strategy and HEOR effort to generate outcomes research data.Served as the spokesman for Men’s Health Clinical Development, specifically prepared to answer FDA Pediatric Advisory Committee questions related to the study design and results of a pediatric PK study and a longer-term safety and efficacy study completed for pediatric exclusivity.

Acted as an integral part of the management team as a medical liaison by working closely with other members of the team in marketing, medical operations, managed care and sales to achieve the company’s regional goals, as well as national objectives.Supported sales force education providing updates of the changes to the antihypertensive landscape and when necessary, meeting regional physicians with investigator-initiated study proposals. Identified and educated appropriate speakers for field sales initiated speaking engagements.Generated support for thought leader projects from Solvay Pharmaceutical’s Cardiovascular & Men’s Health Medical Services Division by acting as a company and thought leader advocate. Acted as a medical consultant to thought leaders in my region to help advance their work, while simultaneously obtaining their input on the best way to leverage our clinical data from trials. Worked closely with thought leaders with promising publications in development.

Pharm.D., Pharmacy

Cum Laude

Fellowship, Clinical Research And Drug Development

Focus was cardiovascular clinical research (e.g. lipids, interventional cardiology, BP, population-based risk assessments, etc...)