Madhu Anant

WORK HISTORY

EDUCATION

SKILLS

ABOUT MADHU ANANT

Senior Pharmaceutical Professional with diverse experience in Research and Development, Clinical Research, Regulatory Affairs, Medical Affairs and Pharmacovigilance. Therapeutic area experience includes Cardiovascular, Endocrine and Metabolism, Pulmonary, CNS, Men\'s Health, Women\'s Health, Dermatology (including skin care and cosmetics/aesthetics), Immunology, Inflammation, Oncology, Ophthalmology, Pain, Over the Counter Products, Diagnostics and Biomarkers,Devices and Vaccines. In depth knowledge and experience in strategic and operational aspects of global drug development, including Health Authority Interactions and Registration Dossier Submissions.Leader with the ability to provide scientific contribution, influence negotiation and consensus building in a highly “ matrixed” global environment.Track record of Success in leading the development of novel compounds from candidate selection through product launch and lifecycle management. Program and Portfolio Management.Successful in enabling major international companies establish operations in the United States, including initiating clinical programs via interactions/discussions with the FDA, selection of contract research organizations for clinical research and contract manufacturers for clinical supplies. Expertise includes-Global Drug Development/Registrations/Regulatory Strategy/New Business Development-Strategic Clinical and Regulatory input towards new business development, licensing/acquisitions, joint drug development and Regulatory policy-Strong Pre-Clinical and Clinical Research Background-Phase and Phase IV, or post marketing studies-Advisory Committee meetings-Risk Evaluation and Mitigation Strategies (REMS)-Rx to OTC Switch Applications-PDMA Compliance-Advertisement and Promotional Review and Approvals/Interaction with OPDP