What CMOs Need to Know and Do When Preparing for Product Launch

John Yee MD, MPH, currently serves as Senior Vice President, Medical Affairs, at Apnimed, Inc., a company developing oral drugs for the treatment of obstructive sleep apnea. He has more than 25 years of leadership experience at leading biotechnology, pharmaceutical, and health care technology companies, and at a major academic medical center. Dr. Yee has expertise in all aspects of drug development and commercialization, including clinical development, medical affairs, pharmacovigilance, regulatory affairs, and patient advocacy. He has provided medical leadership for more than 10 new product launches and label expansions. Dr. Yee has served in senior medical leadership roles at Genzyme Corporation, AstraZeneca Pharmaceuticals, Intarcia Therapeutics, Vertex Pharmaceuticals, Flexion Therapeutics, and Sobi North America. Dr. Yee serves on the scientific advisory board for Comera Life Sciences, and previously served as a non-executive director on the board of directors. Dr. Yee earned an M.D. from Harvard Medical School, an M.P.H. in Health Care Management from the Harvard T.H. Chan School of Public Health, and an A.B. in History and Science from Harvard College. He completed his pediatric residency and fellowship training in rheumatology, immunology and health services research at Boston Children’s Hospital. Prior to joining the industry, Dr. Yee held leadership roles at Boston Children’s Hospital and served as a faculty member at Harvard Medical School.

Peg Crowley-Nowick is a well-respected expert in the pharmaceutical industry, bringing nearly 30 years of experience in medical affairs and clinical research. She has successfully led late-stage biotech and pharmaceutical companies through multiple product launches across several therapeutic areas, such as oncology, cardiovascular and diabetes. Dr Crowley-Nowick's patient-centric view and drive for improved patient care and outcomes have propelled her to shape Lumanity Medical Affairs based on not only scientific integrity but also continual collaboration with emerging medical stakeholders. Earlier in her career, Dr Crowley-Nowick held academic appointments, establishing her scientific credibility in the research and medical communities. Later she joined industry and gained valuable experience at all levels of responsibility within Medical Affairs, first at Berlex Laboratories, and then Bayer Healthcare Pharmaceuticals. Dr Crowley-Nowick founded Zipher Medical Affairs which was acquired by Lumanity in 2021. Dr Crowley-Nowick received a PhD from the University of Alabama at Birmingham in the field of immunology and an MBA from Simmons School of Management.

Lori leads the Medical and Scientific Affairs Practice at Putnam. Her expertise includes multi-stakeholder engagement, center of excellence profiling, organizational design, strategic medical launches, integrated medical evidence ideation, omnichannel strategy, and digital health platforms, including digital therapeutics, AI algorithms, and software as a medical device. Lori has experience in rare diseases including Duchenne muscular dystrophy, hemophilia, growth hormone deficiency, cardiac amyloidosis, acromegaly, sickle cell disease, and primary hyperoxaluria as well as oncology, infectious disease, cardiology, critical care, neurology, and endocrinology. Prior to Putnam, Lori had a Medical Affairs strategy consultancy, built the Medical Affairs division at CDM and later became President. Earlier in her career she gained experience in medical education and MSL training at Bayer, and clinical research at the University of Minnesota. Lori holds an RPh from the University of Iowa, a PharmD from the University of Minnesota, and completed a postdoctoral fellowship in critical care and infectious diseases at the University of Minnesota.

Susan Nemetz is CEO and founder of The NemetzGroup and Corval. A proven leader in the life science industry, Nemetz helps transform biopharma companies from early-stage to publicly traded with her ability to see strategic opportunities and cultivate talent and empower the team to achieve them.In 2003, Susan created The NemetzGroup, which helps companies successfully navigate the commercialization spectrum through a unique and flexible consulting model. Over the past 20 years, the company has been instrumental in guiding the evolution of hundreds of biopharma companies and the development of numerous assets, from targets to lifesaving approved medicines.Susan founded her second company, Corval, in 2018, which is built on her deep biopharma commercialization knowledge and vision to vastly improve how emerging companies define their path to market. The company’s disruptive technology platform enables early- mid-stage biopharma companies to self-navigate the complex commercialization planning process by building a validated map, headcount, and budget plan.

Jalpa Shah has worked in the healthcare space for 18 years and at ZS for 9 years; she leads the ZS Emerging Pharma Medical & Evidence practice. She focuses on bringing right-sized business and customer-oriented solutions to small and mid-sized pharma medical organizations, ensuring that medical leaders are connecting to create and deliver differentiated medical value. Her areas of expertise includes medical strategy, integrated evidence planning, organizational design and capability building, data strategy and analytics, and end-to-end scientific engagement. Ms Shah has worked extensively with pre-launch products, from phase 1 to phase 3 through to pre-launch, as well as with in-market products in the U.S. and partners with her colleagues across Europe and JAPAC across multiple disease states. Before joining ZS, she was a preclinical drug development scientist at organizations like GlaxoSmithKline, National Cancer Institute and a startup biotech, OncoMed Pharmaceuticals. Ms Shah holds an M.S. in Biotechnology from Johns Hopkin University and a B.S. with honors in Biomedical Science from the National University of Singapore.