Nancy Martin Email & Phone Number

Chicago, Il, Us

Clinically meaningful started out in 2017, where I provided consultation services to Pfizer including a successful delivery of a positive FDA Oncologic Drugs Advisory Committee Vote for the first US Epoetin Biosimilar (May 25, 2017). Served as the primary presenter and defended the nonclinical and clinical data package in support of a positive benefit/risk assessment at the FDA ODAC for Retacrit (epoetin biosimilar). In 2024, my consultation services are again available to companies in support of efficient solutions to a broad range of pharmaceutical product development and health authority engagement needs.

Deerfield, Illinois, Us

Reporting to the Chief Executive Officer, I served in an executive leadership capacity as a management partner leading the strategic and operational excellence of the medical affairs, clinical development, pharmacovigilance and regulatory affairs disciplines of TerSera Therapeutics.

Reporting to the Senior Vice President, Development Therapeutic Areas, I serve in an executive leadership capacity to drive medical strategic direction for the medical team in Medical Specialties, Medical & Development. In this role, I am responsible for overseeing the design and delivery of the medical strategic elements of development programs across a variety of primary focus areas and platform modalities. My role is accountable to ensure that medical expertise and scientific excellence is incorporated into holistic evidence generation plans from preclinical candidate nomination through all phases of clinical development across a multitude of therapeutic areas including rare diseases with the promise of advancing transformative medicines to patients. As a leader through leaders, my role is to strategically coach, mentor and facilitate the success of the medical directors on my global team. In this capacity, I also lead integration efforts of new inorganic growth in Astellas including the integration of cell therapies (AIRM) and gene therapies (AGT) development portfolios as part of the broader development organization. In addition, I drive strategic medical leadership in the evaluation of potential acquisition targets through risk-mitigating diligence contributions, ensuring high quality and timely medical review of in-licensing opportunities, out-licensing and/or multi-track activities.

Deerfield, Illinois, Us

Reporting to the Chief Science and Technology Officer and member of the R&D senior leadership team, I served in an executive capacity to lead a transformation of the clinical and preclinical R&D organization, optimizing development strategy and operational excellence culminating in $10 million savings for the organization while enhancing scientific rigor, development acumen and R&D governance. In this role, I lead a global team of >150 colleagues in clinical and preclinical development including the disciplines of clinical strategy, global clinical operations, data sciences, medical writing, preclinical model development, regulatory toxicology and biocompatibility sciences. I was accountable to the CSO, CEO and Management Committee for growth through innovation with a highly diversified portfolio of drug, drug/device combination and device assets across six global business units including overall product development strategy, oversight of evidence generation plans, clinical and preclinical development technical expertise, and delivery of programs on budget and plan.

Seattle, Wa, Us

Reporting directly to the Chief Executive Officer, I served in an executive capacity leading a global clinical, regulatory, quality and medical affairs organization with focus on women's heath in genitourinary and gastrointestinal conditions. In this role as CMO of a Frazier Portfolio Company, I was accountable to the CEO and Board of Directors for value creation with a portfolio of assets including overall development strategy, clinical, regulatory and quality expertise, oversight of development plans, an delivery of development programs on budget and plan while maintaining key opinion leader relationships for ongoing medical affairs activities.

New York, New York, Us

Reporting directly to the Chief Medical Officer, Global Established Products R&D and member of the CMO leadership team, I lead a clinical development organization with focus o the biosimilars portfolio. In this role, I was accountable for a portfolio of multiple biosimilar assets for development strategy, clinical expertise, oversight of clinical development plans and deliverly of clinical programs on budget and plan. I was responsible for advancing key decisions collaboratively with multiple functional lines (commercial, clinical operations, safety, regulatory, pharmaceutical sciences, medical affairs, QA, legal) in the biosimilars franchise. My role included coaching and mentoring physicians and allied health care professional clinical staff. Governance appointments included: Chair of the GDP technical review committee, core member of the GEP R&D executive strategy committee, core member of the R&D biosimiars portfolio segment team, member of the Pfizer Global Clinical Leadership Team, and Member of the CMO Leadership Team.

New York, New York, Us

As Vice President, Global Clinical Development at Hospira, A Pfizer Company, I reported directly to the Chief Medical Officer and lead a global cross function clinical development organization comprise of medical development, clinical pharmacology, statistics, data management, and clinical programming supporting all phases of development and life cycle management. In this role, I build the in house capability/ bench strength with a lean resourcing model to drive clinical, clinical pharmacology and data sciences deliverables for multiple INDs, sNDAs, MAAs, 351(k) BLAs and biosimilar MAAs. The scope of this portfolio included proprietary innovative drug products, specialty injectable generic products and biosimilars. Hospira was acquired by Pfizer in 2015 where I served as the R&D integration leader in the M&A activities where I successfully found placement for the 1500 R&D colleagues at Hospira in the broader Pfizer organization.

In this role, I lead the Urology Astellas Scientific and Medical Affairs team to ensure launch excellence for Myrbetriq/Betmiga, a first in class, novel therapeutic for overactive bladder. I was accountable for the medical affairs strategic plan for product approval and launch preparation activities for Myrbetriq (mirabegron) and ongoing medical affairs leadership for VESIcare (solifenacin). I co-lead with my commercial colleagues the design of the strategic plan for the global urology franchise. In this role, I ensured key partnerships for product support with internal and external stakeholders for LCM planning and execution, publication support, lead medical support for regulatory inquiries, and provided medical oversight to Phase 3b/4 trials as well as IIS activities.

I served as Global Medical Lead for Myrbetriq/Betmiga where I was accountable for the medical strategy and delivery of the mirabegron development program to support global registrations, defenses and approvals. In this role, I provided medical leadership to the team which achieved simultaneous submissions in advance of goal for the EU-MAA and US-NDA in August 2011. The product obtained first cycle approval in various regions submitted with successful negotiations with multiple health authorities (FDA/EMA/PMDA/HC/TGA). The product enjoys its successful approval in over 81 countries and successful launch across the regions.

I provided medical leadership for the global Phase 2/3 development program for mirabegron in overactive bladder, delivering a 41 study global clinical development package. I also served as medical lead for various GI programs in Phase 2 development in this role.

Paris, France, Fr

In this role, I was responsible for driving DMPK interdepartmental drug development programs (Ph 1-3) for new chemical entities (M100240, carioride, exubera) through the use of multidisciplinary matrix teams. I was responsible for the development and implementation of clinical pharmacology programs in support of NDA/MAA submissions including strategy and clinical trial execution.

Switzerland 🇨🇭 , Ch

In this role, I implemented the clinical pharmacology/clinical pharmacokinetic program including authorship of the clinical pharmacology sections of the NDA/MAA submission for PEGASYS (pegylated interferon alfa-2a). I served as the lead clinical pharmacologist for product labeling for this product. In addition, I was a major contributor to the clinical pharmacology dossier for the global NDA/MAA submissions for Tamiflu (olseltamivir phosphate) with a significant role in conducting the 22 clinical pharmacology studies in support of a rapid EIH to NDA submission in 2.4 years. Additional program support included clinical pharmacology characterization of an endothelin antagonist, Zenapax and Lenercept.

Doctor Of Medicine - Md

Doctor Of Pharmacy - Pharmd

Residency In Ophthalmology

Internship/Residency, Department Of Internal Medicine At Memorial Sloan Kettering Cancer Center, Internal Medicine

Post Doctoral Fellowship In Clinical Pharmacology

Pre-Pharmacy Curriculum