Dr Asoke has had a uniquely broad 3 decade career at the FDA, serving in 5 divisions, including oncology, analgesic and anesthesia, rheumatology, respiratory and ophthalmology. His contributions at FDA resulted in approval of several break through products, including Relafen, Fluticasone, Tramadol, Latanoprost, Restasis, Uloric and Actemra. Prior to the FDA, he was engaged in cutting-edge research in academia and industry on diseases resulting from disturbed immune modulation, and has edited a textbook on the development of immunosuppressant products.

He is a strong proponent of early involvement in the drug development process of an experienced regulatory scientist. In the early 1990’s when Dr Asoke joined the FDA, he interacted early with a sponsor who proposed a nearly 20-fold higher dose of an agent for Phase I/II trials. His interactions with the sponsor resulted in the development of a drug with a materially higher therapeutic index.

Because of the breadth of his background, Dr Asoke is able to help a broad range of clients, including those engaged in product development of small or large molecules, drug-device combination products, in a range of therapeutic areas, including arthritis, asthma, pain, cancer, glaucoma, and treatment of substance abuse, at all stages of development, from preclinical development to IND to Phase I-IV clinical testing, including submissions of NDA/BLA/505(b)(2), and venture capitalists and other financiers in due diligence and product development assessment. 

Expertise
 Based on extensive small molecule and Biologic experience, Dr Asoke has deep understandingfor developing agreements with FDA review Divisions and Fast Track development of INDs. Dr Asoke\'s contributions to clinical development involve following:
• Phasel-3 studies in Biosirnilar, Autoimmunity, Respiratory, oncology, Pain, controlled substances and ophthalmics
• Extensive history of successful FDA negotiations (Pre-IND, End of Phase2, Pre-NDA, Types A, B and C meetings, Advisory Committee hearings) involving drugs and biologics
• Development and review of non-clinical protocols, study reports, Package Inserts according to PLR format and recent lactation guidelines
  

Selected Consulting Experience

• Analyzed pharmacological mechanisms for developing products for multiple indications and marketing advantage
• Advice on development strategies for multiple indications ensuring shortest development time
• Advice on orphan product designation, development and drafting clinical protocol synopsis.
• Non-clinical study requirements, gap analysis and review of data for all phases of clinical development and registration.
• First in human (FIH) dose selection criteria for oral, parenteral and inhalation delivery of drugs
• Drafting eCTD summary for pharmacology, toxicology, PK and updating Investigators\' brochures
• Advice industries on developing strategic questions for obtaining Pre-IND agreements with the regulatory body.
• Identify issues related to the development of biosimilar, patient-controlled self injection systems, generic equivalents, 505(b)(2) applications.
• Development of Botanical products in USA
• Assisted analysts from venture capital and investment firms on current needs and feasibilities for new business investment.