Dr Ravi Kacchigere

Head – Techno-commercial Development

· Member of Senior Scientific Advisory Committee – On Advising the Management on the Implementation of New Scientific and Business Plans.

· Rendering Technical, regulatory, and commercial guidance to the clients for End-to-End Drug Development from Pre-Clinical Through cGMP Analytical testing to Clinical Trials.

· Change in the business strategy from Short-term (Retail) projects to long term (1-2 years) Programs (with IND enabling programs and 505(b)2 programs) to enable clients to land on best market landscape.

· Adding Value to the organization with more International Client base through technical inputs (22% Growth contribution from international clients Y-o-Y).

· Supported to Achieve the Track Record business target as on Past Business years of all the business verticals.

· Cross-functional advise to Analytical, Biopharma and Clinical Development divisions along with Core Business acumen enabling complete ecosystem of Organizational Business functions.

· On boarded Leading Global Pharma players with end-to-end support for their Development programs.

· Established Business association with new Geographies.

Marketing Support

· Designed and presented New Marketing Materials for Digital marketing

· Brought new Ideas to the Marketing team on sales navigation platform to improve the Brand value.

· Periodically updated the Corporate presentations based on vertical and Business associates requirements

· Speaker on 18 Technical webinars (Virtual) during the Pandemic time to keep the continued Technical and Business association.

· Author of 142 Standard Operating Procedures (SOP) on all the segments of GLP.

· Establishment of Complete GLP Test facility in Malaysia as Chief Operating Officer (COO) and Executive Board of Director.

· Participation, presentation and review all the proceedings of the Board and represent as Executive Board of Director.

· Supported Many NKEA – EPP-1 Programs for the Development of New Herbal formulations for varied therapeutic areas.

· Instrumental in making the Venture Capitalists to understand the Pre-Clinical Business and its Scope for Major Venture Capitalist both in India and Malaysia

· Instrumental in getting AAALAC Accreditation as Key Veterinarian

· Proven Experience in handling NKEA projects in Collaboration with MOA and CRO in successful registration.

· Offering End-to-End Service from Early Product Development to Registration in India, Malaysia, Thailand, Indonesia and Singapore Registration authorities.

· Presented on International Platforms on Drug Discovery, Development and registration requirements for Pharma, Herbal Cosmetics and Medical Device.

· Close association with

§ NGCMA of Malaysia (National Pharmaceutical Registration authority – NPRA – Previously called BPFK)

§ Medical Device Authority – Malaysia

§ Ministry of Health (MOH) – Malaysia

§ Malaysia Biotechnology Corporation (BIOTECHCORP)

§ Ministry of Agriculture (MOA) - Malaysia

§ Malaysia Trade Authorities (MALTRADE)

§ WHO/FDA – Indonesia

§ WHO - Singapore

§ ASTAR – Singapore

· More than 17 consecutive years of proven working experience in the field of Regulatory Pre-Clinical service (Technical and Techno-commercial Platform).

· Instrumental in Establishing a One Stop GLP Test Facility at Malaysia (MyBioScienceLab Sdn. Bhd).

Study Director

· Acted as Study Director for Sub-chronic, Chronic and Reproductive Toxicity studies.

· Standardized and executed many Toxicity studies to meet the regulatory requirements.

· Instrumental in getting AAALAC accreditations.

· Good knowledge and understanding of Global Regulatory requirements

· Author and Approved many system specific/study specific SOP’s

· More than 4 consecutive years of proven working experience as Study Director.

Veterinarian

· As a Veterinarian, responsible for the day – to – day activities of Animal Facility for the care and Management of Laboratory animals.

· Attending Veterinarian – Institutional Animal ethics Committee (IAEC) – Bioneeds India Pvt Ltd.

· Attending Veterinarian – Institutional Biosafety Committee (IBSC) – Bioneeds India Pvt Ltd.

Team Leader – Business Development and Project Management

· Instrumental in Bringing the Venture Capitalist (Can Ventures) to the organization.

· Streamlined the organization for the Robust Business Plan.

· Established effective Marketing material and improve the website with new look

· Established and executed the Digital Marketing plan with innovative ideas.

· Streamlined the Project Management plan and established the Project Management team for the timely deliverables.

· Study director for Acute, Sub-acute and Reproductive Toxicity Studies.

· Successful in Validation of Segment-3 Reproductive toxicity study in compliance with OECD GLP as per ICH and Schedule-Y requirements.

· Designated as Study Director – Record breaking duration (Within short term)

· Validated Juvenile Toxicity study in Rats.

· Validated Endocrine disruptor assays (Hershbergar and Uterotrophic Bioassays)

· Instrument in bringing Robust Ethical committee practice as Study Veterinarian.

· Helped the organization in “Prerana – A Corporate sustainability Initiative”

· Editor of “Symphony” Newsletter of Advinus therapeutics.