Courtney Zeni, PhD

SUMMARY

  • Medical Affairs (MA) leader with passion for therapeutic areas of high unmet, including CNS and psychiatry   

  • Experienced driver of cross-functional alignment of diverse points of view with internal and external stakeholders  

  • Strong knowledge of the psychiatry landscape, drug development, clinical practice, and pharmaceutical marketplace

  • Longstanding relationships with Key Opinion Leaders (KOLs) in psychiatry and drug development


PROFESSIONAL EXPERIENCE

Sumitomo Pharma America (formerly Sunovion Pharmaceuticals), Teaneck, NJ                                       November 2019– Present

Senior Director, Medical Affairs, (May 2022- present)

  • Global and US Medical Strategy lead for pipeline drug ulotaront (SEP-363856), Phase 3 investigational compound with FDA Breakthrough Therapy designation for the treatment of schizophrenia

  • Collaboration with key core team stakeholders within SMPA and with alliance partner at Global and Regional levels

  • Responsible for identifying critical data gaps, data generation opportunities, and planning and executing the publication plan for ulotaront in support of schizophrenia and future indications and LCM leading to successful co-development of a patent for methods of switching neuropsychiatric medications (under review): International Application no. PCT/US2023/079576, filed November 14, 2023

  • Author and presenter for various manuscripts, reviews, and conference presentations for ulotaront and disease state education

  • Reviewer for all Medical and Promotional materials, Regulatory submissions, and clinical protocols

  • Deep network of Key Opinion Leaders in Psychiatry; experience cultivating and maintaining relationships via scientific exchange and insight gathering, moderating and presenting at Advisory Boards, developing content for presenters, and fostering research and collaboration opportunities 

  • Responsible for the creation, review, and training of Medical Education materials for internal and external stakeholders

  • Reviewer for Medical Education Grants and Investigator-Initiated Research in support of critical education and data gaps needed to shift paradigm in well-established therapeutic area  

Director, Medical Affairs, Fort Lee, NJ, (November 2019 – May 2022)

  • Global and US Medical lead responsible for medical strategy for ulotaront (SEP-363856)  

Noven Pharmaceuticals, Jersey City, NJ                                                                                                            September 2013 – November 2019

Director, Medical Affairs (March 2019 - November 2019)

  • Head of Medical Affairs Department and sole strategist and contributor for all MA activities below

  • Medical lead for Commercial launch team for SECUADO® (asenapine) transdermal system 

Associate Medical Director, New York, NY (February 2015 - March 2019)

  • Head of Medical Affairs Department and sole strategist and contributor for all MA activities across  products and stages of development

  • Key player in all Business Development external discussions and partnering activities

  • Head of Medical Information Call Center; responsible for management of 2-person off-site team and call center

  • Head of Medical Education Grants and Investigator-Initiated Research Committees

  • Medical reviewer and contributor for Regulatory submissions and communications including NDAs, INDs, Briefing Documents, Investigator Brochures, Orphan Drug Applications, etc.

  • Member of innovation team responsible for identifying therapeutic areas of high unmet need that are suited for patch development

  • Additional responsibilities included KOL identification and engagement, patient advocacy, medical and promotional review, internal and external medical education, publication planning, Sales and Speaker Trainings, and Advisory Boards across therapeutic areas 

Medical Science Liaison, New York, NY (September 2013 - February 2015)

  • Acquired Northeast territory as entry-level MSL

  • Identified, developed, and maintained long-term relationships with top KOLs in Women’s Health

  • Integrated field insights to drive strategy for multiple Women’s Health franchises 

AlphaBioCom, King of Prussia, PA                                                                                                      May 2012 – September 2013

Scientific Communications Manager

  • Managed various large-scale pharmaceutical company accounts and developed their medical communications plans across a vast range of therapeutic areas

  • Developed scientific content including manuscripts, posters, oral presentations, and slide decks

  • Identified KOLs and recruited appropriately for Advisory Boards and other purposes

  • Built strong foundation in ICMJE and GPP Guidelines for Best Publication Practices 

Empirical Ink, LLC, Philadelphia, PA                                                                                              January 2009 – September 2013

Freelance Scientific Writer and Technical Editor

  • Co-founder and scientific writer specializing in editing non-native English manuscripts for successful publication in top-ranked scientific journals 

Temple University, Department of Biology, Philadelphia, PA                                                                November 2011 – April 2012

Post-doctoral Researcher

  • Managed research staff and trained both undergraduate and graduate students

  • Presented and published research at regional and national conferences and authored 2 publications in embryonic development and neural tube closure 

University of Medicine and Dentistry of New Jersey (UMDNJ), Piscataway, NJ                         May 2007 – November 2011

Graduate Researcher, Department of Biochemistry (May 2007 - November 2011)

  • Received prestigious NIH training grant to sponsor graduate research studies

  • Characterized 2 novel proteins in the non-canonical Wnt signaling pathway responsible for regulating neural tube closure in the vertebrate embryo

  • Authored 5 publications and was an invited speaker and award winner at scientific conferences

  • Gained extensive experience in laboratory skills and statistical analyses of data 

Licensing Consultant, Office of Patents and Licensing (September 2007 - September 2008)

  • Reviewed and assessed patent applications from UMDNJ pertaining to scientific innovations 

Rutgers University, Department of Neuroscience, Piscataway, NJ                                                                May 2005 – May 2006

Undergraduate Research

  • Characterized post-synaptic protein for its role in neural plasticity 

EDUCATION

miniMBA- BioPharma Innovation                                                                                                            February 2019- May 2019

Rutgers University, Rutgers Business School Executive Education 

PhD, Biochemistry and Molecular Biology                                                                             September 2006 – November 2011

Graduate School of Biomedical Sciences, Joint Molecular Biosciences Program, UMDNJ and Rutgers University, Piscataway, NJ 

Bachelor of Science, Biology

Minors in Psychology and Chemistry, The College of New Jersey, Ewing, NJ                                      September 2002 – May 2006

 

PATENTS

Methods of Switching Neuropsychiatric Medications (pending), International Application no. PCT/US2023/079576, filed November 14, 2023

HONORS

CEO Award, Sunovion Pharmaceuticals, 2022

 Rising Star Award, Healthcare Businesswomen’s Association (HBA), 2022 

Spotlight on Excellence: Individual Award, Sunovion Pharmaceuticals, 2020 

Gold Award: For Leadership, Dedication & Commitment to the Timely Submission of HP-3070 NDA, Noven Pharmaceuticals, Inc., 2019 

Spotlight: Standing Novation- Excellent Support in Launching Minivelle AGx, Noven Pharmaceuticals, Inc., 2018 

On-the-Spot Award- Successful IND Reactivation, Noven Pharmaceuticals, Inc., 2018 

Honorable Mention-Cover Image Submission, Society for Developmental Biology Conference, Chicago, IL, 2011 

Invited Speaker, International Conference on Neural Tube Defects, Austin, TX, 2011 

Best Poster Presentation, Biochemistry Department Annual Retreat, UMDNJ, 2007-2010 

NIH Training Grant Recipient, Biochemistry Department, UMDNJ, 2007-2009  

PROFESSIONAL CERTIFICATIONS

Drug Development, University of California San Diego and Coursera Course Certificates; License: 3KJC4ZE8X2SD, 2019

 Drug Discovery, University of California San Diego and Coursera Course Certificates; License: UGHSDHESD4L2, 2018 

Creative Writing: Craft of Character, Plot, Setting, Style and Description, Wesleyan University and Coursera Course Certificates; Licenses: VYNTD5ENK836, NJNVQ9ULSYAY, H5AP2JCRK93E, 9E4CTVCKXKPT, 2018 

Pharmaceutical and Medical Device Innovations, University of Minnesota and Coursera Course Certificates; License M2BV9NZ5WPFF, 2017 

Understanding Clinical Research: Behind the Statistics, University of Cape Town and Coursera Course Certificates; License N66VW5SAUA32, 2016 

Design and Interpretation of Clinical Trial- Passed with Distinction, Johns Hopkins University and Coursera Course Certificates; License VME7V5X7QF, 2015  

CURRENT MEMBERSHIPS, AFFILIATIONS, and SERVICE

Mentorship Program, Sunovion Pharmaceuticals/SMPA, since 2023

The International Society for CNS Clinical Trials and Methodology (ISCTM), Member, since 2022 

American Society of Clinical Psychopharmacology (ASCP), Member, since 2020 

Neuroscience Education Institute (NEI), Member, since 2020 

Schizophrenia International Research Society (SIRS), Member, since 2020 

Association for Women in Science (AWIS), Member, since 2019 

Healthcare Businesswomen’s Association (HBA), Member, since 2019 

International Journal of Clinical Practice, Peer Reviewer, since 2019 

SELECT PUBLICATIONS

For most up-to-date list, see PubMed