Megan Sutton, Dnp, Acnp-C Email & Phone Number

Boston, MA, US

New York, New York, US

• Lead the clinical development strategy for two innovative Adeno-associated virus (AAV) gene therapy programs at LEXEO Therapeutics, focusing on both early and late-stage development. Successfully advanced the.
• Led the HEROIC-PKP2 study from concept through execution, overseeing protocol design, IND approval, and study initiation, while achieving key milestones ahead of schedule; successfully secured fast-track and orphan.
• Directed comprehensive evidence-generation strategies, including natural history studies for both Friedreich’s ataxia cardiomyopathy and PKP2, to support pivotal trial planning and strengthen the regulatory submission.
• Established and cultivated partnerships with external experts, patient advocacy groups, and scientific advisors to shape clinical strategies, enhance trial designs, and ensure alignment with patient needs and.

• Acquired by Rocket Pharmaceuticals: December 2022As the founding leader of the Global Medical Affairs Department at Renovacor, I expertly researched and developed solutions in the field of Adeno-associated virus (AAV).
• Expertly managed a multi-million-dollar budget and a diverse team including independent contractors and project vendors, resulting in efficient budget management and successful execution of all medical affairs.
• Developed and executed effective Medical Affairs Strategies that positively impacted Renovacor's progress towards FDA IND filing, supporting the company's clinical trials and regulatory filing.
• Pioneered and led company initiatives, including:---A comprehensive Publications Strategy, Process, and Plan---An impactful RWE and HEOR Strategy, plan, and execution---A vital External Control Arm in Support of.

Lawrence Township, NJ, US

• A key member of the US Medical Affairs Cardiovascular Leadership Team. Developed and implemented the US medical strategy to support the launch of mavacamten (CAMZYOS ®), a first-in-class therapeutic agent for.
• Led the Integrated Evidence Plan (IEP) for US-relevant data generation and implemented data generation projects (IITs, RWE & HEOR, Observational Registry, Academic Research Partnerships, Phase 3b/Phase 4) to address.
• Led the medical strategy and co-led the BMS cross-functional core team for Institute for Clinical and Economic Review (ICER) review strategy and implementation, resulting in more favorable ICER review of the drug.
• Served as Medical Lead for all Market Access projects, including strategic planning on value strategy and content development for field market access team, resulting in successful reimbursement and coverage of the drug.
• Developed and executed robust scientific communication strategies, platforms, and plans, including publications, scientific content, congress scientific coverage, and internal training, ensuring alignment with Medical.

Brisbane, California, US

• Acquired by Bristol Myers Squibb: November 2020Led the design, development, and execution of real-world evidence generation, including studies to describe and quantify disease burden in patients with obstructive.
• Provided clinical subject matter expertise, guidance and direction to internal and external stakeholders, including: recommendations on health economic, RWE, and patient reported outcomes evidence needs for MyoKardia’s.
• Led study design, execution and conduction of rea-world evidence studies including collaboration cross functionally within the company and externally with thought leaders.
• Drove the development and implementation of US and global strategic research and for managing the planning, implementation and publishing of HEOR and RWE efforts focusing on observational epidemiologic studies in.

Brisbane, California, US

Founding member of MyoKardia's first field medical team. Led, developed, and implemented key internal/external processes to establish and demonstrate value in support of a first-in-class cardiovascular product for Hypertrophic Cardiomyopathy.

South San Francisco, CA, US

Developed and maintained strategic relationships with key clinician leaders in trauma, emergency medicine, cardiology, neurology, and pharmacy, resulting in successful delivery of clinical education and support for the launch of Andexanet alfa (ANDEXXA®)

Basel, Baselstadt, CH

• Key Highlights:
• Successfully led the launch of Sacubitril/valsartan (ENTRESTO®), a first-in-class Cardiovascular product, by conducting independent hospital profiling and building a new, self-sourced network of key opinion leaders.
• Developed and maintained strategic relationships with regional/national/global clinician leaders in Cardiology, Heart Failure, Internal Medicine, Critical Care, Emergency Medicine, Quality, Pharmacy, and Primary Care.
• Facilitated the success of Novartis-sponsored (phase II-IV) and investigator-initiated clinical/pre-clinical research activities by providing support for research site selection, study placement, and educational.
• Selected as MSL National Project Lead on key medical affairs initiatives and at multiple medical education symposiums.Awards and Recognition:
• Peer nominated member of the Medical Affairs Leadership Advisory Board - 2018.

Praha, Hlavní Město Praha, CZ

Founding member of the company’s first global telehealth provider team; Led, developed, and implemented key processes/polices to support a new team with global medical outreach responsibilities.

Chicago, IL, US

• Key Project Leadership: Created, designed, and implemented a Left Ventricular Assist Device (LVAD) database for 100+ patients to streamline workflow and improve continuity of patient care.

Chicago, Illinois, US

Strategic lead for the creation and implementation of process and quality improvement projects for the Cardiology Department in a community hospital setting.

Chicago, IL, US

• Assessed, diagnosed, treated, and managed all aspects of care for CVICU and Cardiac Telemetry patients recovering from Ventricular Assist Devices, Heart Transplant, and General Cardiac Surgery.

Chicago, Illinois, US

• Assessed, diagnosed, treated, and managed care for patients pre/post Heart Transplant and LVAD both in the CCU/SICU, step down unit and outpatient setting.

Bachelor'S Degree Of Science, Nursing

Master'S Degree Of Science, Nursing

Doctor Of Nursing Practice (Dnp) Degree