SME nonclinical regulatory toxicology

Keerthi Kumar Aavula

******************@*****.*** +1-506-***-**** New Brunswick, Canada

SUMMARY

A preclinical specialist to conduct & monitor nonclinical studies & to potentially serve as a representative to support INDs, and NDA. Addressing challenges from early discovery to late development & provide scientific leadership in the design, overall conduct of studies & integrate the findings from contributing scientists into reports that characterize the safety profile of drug candidates and draft nonclinical eCTD documents for regulatory filling.

Leadership – Develop and implement to drive operational excellence, client requirements. Demonstrated through efficient lab setup at GVK Bio, Vimta Labs and acted as IAEC Secretary. Awarded "Star Value" award at GVK Bio for customer-focused delivery. Represented nonclinical safety with a high level of independence in multidisciplinary development teams at Vyome. Represented the organization at industry conferences, meetings and events to promote visibility.

Teamwork – Proven ability to work as a team player with a professional research environment at R&D’s, CRO’s and collaborate with internal, external stakeholders. Recruit, mentor, and inspire a high-performing team. Establish performance metrics and accountability measures to ensure the organization’s success. Evaluate training needs and conduct performance reviews for direct reports.

Relationship Building – Skilled in developing relationships as demonstrated in the work and establish relationships with external partners. Cultivate a culture of innovation, collaboration, excellence by attending HR courses focused on Leadership, team building and communication.

Customer Focus – Dedicated to meeting the expectations of both internal and external stakeholders. By understanding the client needs, improvements have been made to projects. EXPERIENCE

Freelancer, Subject Matter Expert

Aug 2022 - Present

Design, analyze data from toxicological studies. Work cooperatively with scientists, researchers, and regulatory consultants to ensure adherence to safety standards and regulations. Prepare extensive reports and technical documentation showing toxicological finding and recommendations. Vyome Therapeutics Limited, Principal Scientist

Jul 2014- Sep 2021

Responsible for leading and managing nonclinical development activities, including strategic, scientific planning, and regulatory submissions to FDA. Generate high quality report writing, submitting, & tracking regulatory filings, developing project scopes, supervising, and managing resources. Performed risk management, communicate project expectations, and manage changes to project scope and schedule. In addition, collaborated with cross-functionally with CROs and consultants, organize key documentation, and conduct on-site monitoring and audit studies to meet GLP, FDA compliance. Served as a project coordinator and create workflow diagrams and SOPs. Key Responsibilities:

Oversees technical and provide scientific directions for the activities of the nonclinical safety assessment function covering preclinical program at the pre-IND stage through late-stage clinical programs spanning Phase 1, Phase 2b, Phase 3 enabling studies for FDA submission.

Oversees, evaluates CRO selection, study design, study conduct, operationalization, report preparation for toxicology studies.

Serve as the single point of control (Study Director/Study Monitor) on assigned acute through chronic general toxicology studies across all modalities.

Led a team of scientists to successfully complete a preclinical drug development project, ensuring adherence to regulatory guidelines and achieving project timelines by implementing efficient project management strategies.

Critically analyze, interpret data and collaborate with study monitor/director to generate high quality integrated nonclinical reports for inclusion in regulatory submissions and communicate.

Responsible for the quality and adequacy of the tabular and written toxicology summaries for submission (review of TSR received from the CRO, update or review of regulatory documents (IB, IND, briefing documents including Phase I protocol and CMC documents).

Potentially serve as a departmental representative on a product development team, overseeing the strategy and design of nonclinical safety studies and generation of regulatory strategies and communications with global regulatory agencies to support the development of drug candidates.

Provides strategic and operational direction ensuring that toxicology studies support the objectives of the program and are conducted in line with the appropriate regulatory guidelines.

Conducts investigations & supports all matters of Vyome’s business regarding toxicological testing and risk assessment. Develops strategies to ensure effective achievement of scientific objectives.

Consistently works on abstract problems across functional areas of nonclinical safety, and their relationship to human safety, clinical development, and regulatory submissions.

Identifies and evaluates fundamental issues and establishes strategy and operational plans for the toxicology elements of development projects.

Steered cross-functional teams to ensure technical transfer of new methods, while assisting in delivery status reports to stakeholders for budgeting and planning purposes.

Implement established & new regulatory guidelines in current & future development plans. Vimta Labs Limited, Senior Scientist

Mar 2010 – Jun 2014

Demonstrated leadership skills, supervised projects, coordinating with operations team, and served as Study Director in toxicology, pharmacology, and pharmacokinetic studies to provide support in early- stage and late-stage preclinical research. Routinely interacted with IAEC and QA to ensure full compliance with animal welfare and study protocol. GVK Bio, Research Associate

Feb 2008 – Mar 2010

Successfully designed and executed animal studies for drug efficacy in pain, inflammation, cardiac, and CNS diseases. In addition, identified requirements, executing studies, data interpretation, report writing. Sun Pharma Advanced Research Centre, Research Assistant May 2005 – Jan 2008

Coordinated with ancillary departments and team members to complete projects, and actively involved in screening NCEs for various therapeutic areas, pain and inflammation, CNS, metabolic disorders. EDUCATION

Crandall University

Master • Organizational Management • Sep 2021 - Aug 2022 Andhra University

PhD • Pharmacology • Feb 2014 - Aug 2018

Andhra University

Master • Pharmacy (Pharmacology) • Apr 2003 - May 200 PUBLICATIONS AND POSTER

A potent antibiotic-loaded bone-cement implant against staphylococcal bone infections. Ghosh S, Sinha M, Samanta R, Sadhasivam S, Bhattacharyya A, Nandy A, Saini S, Tandon N, Singh H, Gupta S, Chauhan A, Aavula KK, Varghese SS, Shi P, Ghosh S, Garg MK, Saha T, Padhye A, Ghosh S, Jang HL, Sengupta S. Nature Biomed Eng. 2022 Oct;6(10):1180-1195

Robust Potentiation of Known Antimycotic Agents with Molecular Replacement Therapy (MRTTM) for the Topical Treatment of Tinea Infections. S. Ghosh, R. S. Patel, S. P. Kaur, S. Sadhasivam, K. K. Aavula, M. Sinha, A. Bhattacharyya, A. Jain, S. Ghosh, S. Sengupta. ASM Microbe 2016.

“Timed Pentylenetetrazol Infusion Test: A comparative Analysis with scPTZ and MES Models of Anticonvulsant Screening in Mice”. Mandhane S, Keerthi Kumar Aavula, Rajamannar T. European Journal of Epilepsy Seizure 2007 Oct; 16(7): 636-44. SCIENTIFIC CONFERENCES AND MEETINGS

American College of Toxicology 40th annual meeting, Phoenix, 2019.

Preclinical development operations summit, Boston, 2017.

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