Kusuma Mallikaarjun

PhD, Senior Director, Clinical Regulatory Consulting, Market Access Consulting

Kusuma is responsible for developing the global regulatory strategy for Evidera projects. In addition to strategic regulatory leadership and input for the various programs, she provides tactical operational support for client programs at various stages of development. Kusuma also ensures effective communication with global health authorities, client leadership teams, and internal Evidera stakeholders.

Most recently, Kusuma was senior director of PPD Consulting where she was responsible for generating new client business for PPD and providing strategic regulatory oversight of key client portfolios. She also provided comprehensive, strategic, clinical regulatory guidance to clients from pre-IND through post-approval phases of development of drugs and biologics for adult, pediatric, and orphan diseases, including all FDA meetings and all expedited pathway submissions (i.e., orphan drug designation, priority review, accelerated review, breakthrough drug designation, and fast-track designation).

Kusuma has over 29 years of extensive regulatory strategy and pharmaceutical development experience across a broad range of therapeutic areas, both directly as a reviewer at the US FDA and in the US pharmaceutical industry, from pre-IND through approval and lifecycle management phases of development. She began her career at the US FDA as a clinical pharmacokinetics reviewer, where she supported multiple clinical review divisions (neuropharmacological drug products, antiviral drug products, anti-infective drug products, and pulmonary drug products, etc.). She returned to the FDA in 2010 to assume the pivotal safety project manager role in the Division of Psychopharmacology Products, where she was responsible for implementation of FDAAA safety processes and management of safety class actions, which included the successful implementation of the largest safety class action/labeling change for antipsychotics. During the industry phase of her career, Kusuma was responsible for the strategic regulatory management of the global CNS blockbuster antipsychotic, Abilify, from pre-IND through post-NDA approval stage, including the approval of four Abilify NDAs and more than 12 Abilify sNDAs, at Otsuka Pharmaceuticals. This included successful strategic and operational regulatory management of the Abilify global CNS Pediatric Exclusivity Program, from regulatory inception through two successful pediatric sNDA submissions, and the granting of six months of additional pediatric exclusivity by the FDA. She also managed the successful NDA review/approval/labeling negotiation and advisory committee activities for Otsuka’s oral hyponatremia product, Tolvapatan/Samsca. She has broad strategic industry experience in additional therapeutic areas such as oncology, cardiovascular, ophthalmology, gastrointestinal, endocrine-metabolism, and dermatology. Kusuma has extensive FDA and industry experience with managing all types of FDA/industry meetings – Type A, B, and C (pre-IND, pre-NDA, end of Phase II, 45-day Refuse-to-File) – including advisory committee meetings, clinical hold meetings, and pre-approval labeling negotiations.

Kusuma joined PPD Consulting in 2013 as director of regulatory consulting and subsequently assumed greater responsibilities as senior director of regulatory consulting in 2017. Kusuma has a PhD in pharmacokinetics from Virginia Commonwealth University and a bachelor’s degree in pharmacy from Bangalore University, India.