Lisa Malandro

As the Founder and Principal Consultant of Lexmera Consulting, I provide strategic regulatory guidance to pharma and biotech organizations developing innovative therapies across global markets. I specialize in translating complex scientific and regulatory requirements into clear, actionable strategies that support efficient development, informed decision‑making, and successful interactions with health authorities. My work spans: • Regulatory strategy development • Global submission planning • Risk assessment and mitigation • Scientific and regulatory storytelling • Health authority engagement strategy I bring a blend of scientific fluency, strategic thinking, and practical experience — helping teams see the full landscape, anticipate obstacles, and move confidently toward approval.

Managed team of RA professionals responsible for directing the global development (both clinical and non-clinical aspects) of early and late-stage product candidates by providing strategic direction and senior-level regulatory expertise. • Approval of first enzyme replacement therapy administered via intracerebroventricular infusion for CLN2 based on data from a Phase 1/2 study in U.S. and EU simultaneously; • Combination product with priority review and breakthrough therapy designation in U.S. and first accelerated assessment reviewed under the new process in EU; and • Lead Advisory Committee preparations, prepared responses to questions (>500), supported inspection and commercial launch activities and facilitated multiple meetings and teleconferences with Health Authorities (HA). • Phase 3 start for treatment for achondroplasia following successful End-of-Phase 2 meetings with global HAs; • First CTA for Company’s first gene therapy product for treatment of hemophilia A; • Participated as member of the Clinical Regulatory Leadership Team with responsibilities for process development and improvement, resource allocation, and budget management; • Represented RA during routine FDA pharmacovigilance inspection; and • Managed Regulatory Project Management team responsible for developing and updating regulatory timelines and dashboards, tracking regulatory commitments and managing the budget process.

The OPC is a consortium of nine pharmaceutical companies with NDAs charged with developing and conducting studies to fulfill post-marketing requirements for ER/LA opioid products. • As Steering Committee Chair, provided program oversight and guidance, developed operating structure, managed interactions with CDER’s Office of the Center Director and facilitated meetings within OPC and between the OPC and FDA; OPC submitted 11 study protocols that were subsequently reviewed and agreed to by FDA and initiated according to aggressive FDA-stipulated timelines. • As Regulatory Sub-Team Chair, developed and implemented regulatory strategies with colleagues from other member companies, led preparations for two-day FDA public meeting and managed interactions with FDA Hyperalgesia Sub-Team and Observational Workgroup.

Accountable for developing regulatory strategies for portfolio of established products and authorized generics in Cardiovascular, Metabolic, Endocrine, Pain and Inflammation therapeutic areas (including Lipitor®, Celebrex® and Neurontin®), including assessment of Rx-to-OTC switch strategies and support of Tikosyn® Risk Evaluation and Mitigation Strategy (REMS). • Negotiated with FDA to reduce Tikosyn® REMS requirements (subsequently REMS was released); • Supervised regional and global regulatory strategists (3) with direct responsibility for talent and career development, planning and performance management; and • Served as a member of the Regulatory Strategy Extended Leadership Team and contributed to management and process improvement for the department.

Provided regulatory expertise and leadership for the assigned projects for a portfolio of abuse-deterrent Opioid analgesics (3/2011-4/2013) and for $3B growth asset (Lyrica®; 1/2008-5/2011) Conducted due diligence for business development opportunities within and outside therapeutic areas of expertise; participated in integration processes. As Global Regulatory Lead (GRL) for Opioid portfolio: • Integrated a portfolio of abuse-deterrent opioid analgesics acquired from King Pharmaceuticals into Pfizer processes; • Developed U.S. regulatory strategies [e.g., 505(b)(2)] and assessed global opportunities for opioid portfolio; and • Lead class post-marketing and REMS activities (see below). As GRL for Lyrica (pregabalin): • Supported global filings, review processes and meetings with HAs for neuropathic pain, epilepsy, generalized anxiety disorder and fibromyalgia including initial filings in EU (fibromyalgia), Canada (fibromyalgia), Japan and China and resubmission of generalized anxiety disorder in the U.S.; • Responsible for global regulatory lifecycle strategies including development of a long-acting formulation, expanded indications (e.g., sleep, restless leg syndrome) and pediatric development; and • Lead Pfizer U.S. Advisory Committee activities related to an evaluation of suicidality in anti-epileptics (total of 6 drug products), including worldwide communications.

The RPC is a consortium of ER/LA Opioid NDA and ANDA holders (>20 pharmaceutical companies, 30 NDAs and ANDAs) charged with developing and implementing a class REMS, which was part of Prescription Drug Abuse Prevention Plan by the Office of National Drug Control Policy (ONDCP) under President Obama. • As Regulatory Sub-Team Chair, facilitated development and review of initial REMS documents and subsequent revisions, provided regulatory guidance, strategies and processes to RPC and its sub-teams, and managed interactions with CDER’s Office of Safety and Epidemiology; RPC implemented one of largest and most comprehensive class REMS programs and improved communications between RPC and FDA (as noted by senior FDA officials).

Responsible for managing all stages of the regulatory review process for products under development to treat pain associated with neuropathies, rheumatoid diseases and for management of fibromyalgia, including more than 15 NDAs, 10 BLAs, and 150 INDs for drugs, biologics and botanical products. • Participated in additional projects, including as member of Standard Letters Committee, Late Duty Officer in Office of Counter-Terrorism, and DAARTS validation testing. • Presenter representing FDA for Pharmaceutical Education & Research Institute (PERI) and Temple University.