Alan Lipschitz, M.D.

I am a physician-scientist committed to addressing unmet patient needs by maximizing the value of treatments for severe neurological and psychiatric illnesses.

I have demonstrated success in strategically positioning compounds to address unmet treatment needs, while driving cross-functional teams to generate and communicate the scientific evidence compelling to stakeholders, including regulators, prescribers, patient advocates, payers and guideline committees.

My leadership is grounded in building high-performing teams aligned around a shared vision of success and a disciplined plan for achieving it. I use targeted metrics to demonstrate the team’s impact on key stakeholders and patient care, reinforce its effectiveness, and secure sustained organizational support.

This combination of strategic vision and operational accountability has enabled me to lead a US Medical Affairs organization that is collaborative, innovative and recognized for its success, meeting both patient needs and business needs.

I would welcome the opportunity to apply my experience developing treatments for Alzheimer’s disease, Parkinson’s disease and other serious medical illnesses, to help progress the pioneering compounds in the Genentech/Roche neuroscience portfolio and strengthen the company’s leadership in neuroscience. 

My Teams

Over my twenty-five years leading US and global medical affairs and clinical development organizations in neurology, psychiatry, and ophthalmology, I have built and managed matrixed teams that deploy novel cross-functional techniques to identify unmet needs and evidence gaps to generate persuasive data for regulators, prescribers, patient advocates, payers, and guideline committees. 

These methods have transformed evidence generation across the enterprise. My teams address the evidence gaps with planning that collaboratively generates data through clinical trials, investigator-initiated studies, epidemiological research and real-world evidence. Initially composing and communicating data for launch readiness, our forward-looking strategic and tactical planning continues across the product life cycle. 

Collaborations with external scientific experts confirm the validity of these plans and the medical significance of the generated data. We show its impact through targeted metrics, tallying publications, digital analyses, guideline inclusions, health system adoptions, and other indicators reflecting the effective communication of compelling evidence to key stakeholders.

In the Vice President, US Medical Affairs role, I can deploy these processes to help Genentech/Roche maximize the value of its pioneering treatments for Alzheimer's disease and other neurological conditions. These techniques have served through decades of experience securing regulatory approvals and stakeholder acceptance for novel therapies, at launch and throughout their life cycles, and I am eager to apply that experience to advance the company’s leadership in neuroscience.

 

Achievements

  • Built the Merck global ophthalmology medical affairs organization following the 2024 Eyebiotech acquisition, assembling a multidisciplinary team that developed and implemented the ophthalmology medical affairs strategy while recruiting experienced retinopathy talent. Within five months, the team delivered the foundational medical affairs plan and the 2028 launch-readiness framework.

  • Pioneered an enterprise-wide integrated evidence-planning process that positions compounds to address unmet patient needs, closing data gaps by generating persuasive evidence that is communicated to prescribers, regulators, payers, and guideline committees.

  • Supported numerous NDA and SNDA filings; most recently the landmark Belsomra (suvorexant) sNDA incorporating the novel safety and efficacy data from a dedicated trial treating insomnia in vulnerable patients with Alzheimer’s disease.

  • Directly managed the pivotal clinical trials establishing Vraylar (cariprazine) treatment for depression indications while supporting its successful NDA filings for schizophrenia and bipolar mania.

  • Spearheaded the GSK landmark pediatric and adolescent suicidality data analysis leading FDA to recognize a class-wide antidepressant risk, mandating warning labeling for the entire class.

  • Campaigned to raise the standard of care for depression by championing full remission rather than simple treatment response, successfully aligning professional societies and patient advocacy groups behind this new therapeutic benchmark

  • Transformed modern emergency room protocols as Research Director for the American Foundation for Suicide Prevention, establishing foundational insights on acute crises and creating the scientific framework for the suicidality assessment scales now used globally.