Dr. Aruna Dontabhaktuni

Founder and CEO of PharmaPro Consulting

Dr. Aruna Dontabhaktuni, the Founder and CEO of PharmaPro Consulting, is a pharmaceutical professional with 24 years of experience, has built a notable career consulting with pharmaceutical and biotech companies as an expert in Clinical Pharmacology, DMPK, and Regulatory matters across all phases of drug development. Dr. Dontabhaktuni’s clientele includes prominent organizations such as Genentech, Roche, Daiichi Sankyo, GlaxoSmithKline, Mabion S.A. (Poland), ContraFect Corporation, SK Life Sciences, and Rafael Pharmaceuticals.

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In addition to this, Dr. Dontabhaktuni plays a crucial role on the DSMB & Scientific Boards of various pharmaceutical and biotech companies, where they offer expertise in Regulatory and Clinical Pharmacology. Over their career, they have supported more than 20 assets in a range of therapeutic areas. Their contributions include authoring and reviewing various eCTDs modules; 2.7.1 and 2.7.2, Biologics License Applications (BLA), Question-based Review (QbR), Clinical study protocols, Clinical study reports (CSR), Investigational New Drug (IND) applications, New Drug Applications (NDA), Pediatric Investigation Plans (PIP), Pediatric Study Plans (PSP), Orphan Drug Designation applications (ODD), Breakthrough Therapy Designations applications, Bio-similar applications, and briefing books.

Dr. Dontabhaktuni’s experience extends to interactions with various global regulatory agencies, including the FDA, PMDA, SFDA, EMEA, KFDA, through both face-to-face meetings and written responses. They have a broad range of experience in clinical drug development for biologics, small molecules, and antibody-drug conjugates, demonstrating proficiency both as an individual contributor and in leadership roles. Their expertise covers a wide array of therapeutic areas, notably immuno-oncology, oncology, immunoscience, and rare diseases.

Moreover, Dr. Dontabhaktuni has made significant contributions to academia, having authored over 40 peer-reviewed publications. They have also gained recognition as a keynote speaker at national and international scientific conferences, sharing insights on topics related to clinical pharmacology and regulatory submissions.

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