Pramila Bakthavachalam

I am a seasoned toxicologist and biocompatibility specialist with nearly 20 years of experience in the medical device and toxicology field. Currently, I serve as a Senior Advisor at Eli Lilly Services India Pvt Ltd, where I lead initiatives in biological safety evaluation, extractable and leachable testing, toxicological risk assessment, and regulatory compliance. I am a European Registered Toxicologist.

My core competencies include the design and execution of preclinical toxicology studies in compliance with OECD, 21 CFR Part 58, ISO 10993, and ICH guidelines. I have played a pivotal role in establishing the GLP-certified Centre for Toxicology and Developmental Research (a sister organization of Sri Ramachandra Medical College and University), an achievement for which I was formally recognized. As a Study Director, I have led and overseen a wide range of toxicity studies, including cytotoxicity, acute systemic toxicity, dermal and eye irritation, skin sensitization, repeat-dose toxicity, carcinogenicity, and reproductive and developmental toxicity.

I am also experienced in coordinating with test facilities, interpreting study data, preparing regulatory documentation, and supporting MDR remediation efforts. My professional journey includes extensive collaboration with global medical device manufacturers such as Medtronic, Johnson & Johnson, Baxter, BD, Molnlycke, Nikkiso, Integra, and HillRom through service-based engagements. I have conducted biological safety assessments and toxicological risk assessments for a wide spectrum of Class I, IIa, IIb, and III medical devices, including those used in trauma, orthopedics, renal care, neurology, advanced surgery, wound care, drug delivery, and devices made from animal-derived materials.

I actively contribute to the advancement of industry standards through my involvement in global regulatory and scientific forums. I am an active member of AAMI and ADVAMED, where I participate in the development of ISO 10993 standards for the biological evaluation of medical devices. Additionally, I represent Lilly in BIOPHORUM, collaborating with industry experts to address shared challenges in biocompatibility.

I am also a Fellow of the Academy of Sciences (Animal Welfare), India.

Senior Advisor - Eli Lilly India Pvt Ltd

(2023-05)

• Preparation of Biological Safety Evaluation Plan and Biological Safety Evaluation Reports
• Preparation of Toxicological risk assessment of leachables and extractables
• Co-ordinating with Test facilities for conduction of Chemical characterization, E&L per ISO 10993-12, 18 and other Biocompatibility tests per ISO 10993-1 requirement
• Preparation and review of study plans and study reports of Biocompatibility assessments
• Identification of worst cases or representative products for Biocompatibility testing based on materials, processing aids, geometry and other characteristics
• Preparing documents for regulatory submission like FDA pre-submissions & submission, and NMPA submissions
• Addressing regulatory queries
• Strategic initiatives on Biocompatibility
• Training Resources on Biocompatibility
• Biocompatibility Expert representing Lilly in AAMI
• Biocompatibility Expert representing Lilly in ADVAMED
• Biocompatibility Expert representing Lilly in Biophorum

Architect / Subject Matter Expert Toxicology and Biocompatibility - L&T Technologies

(2021-10 - 2023-04)

• Preparation of Biological Safety Evaluation Plan and Biological Safety Evaluation Reports
• Preparation of Toxicological risk assessment of leachables and extractables
• Co-ordinating with Test facilities for conduction of Chemical characterization per ISO 10993-12, 18 and other Biocompatibility tests per ISO 10993-1 requirement
• Preparation and review of study plans and study reports of Biocompatibility assessments
• Identification of worst cases or representative products for Biocompatibility testing based on materials, processing aids, geometry and other characteristics
• Preparing documents for regulatory submission like FDA pre-submissions & submission, and NMPA submissions

Technical Manager / Subject Matter Expert Toxicology and Biocompatibility - HCL Technologies

(2018-06 - 2021-10)

• Preparation of Biological Safety Evaluation Plan and Biological Safety Evaluation Reports
• Preparation of Toxicological risk assessment of leachables and extractables
• Co-ordinating with Test facilities for conduction of Chemical characterization per ISO 10993-12, 18 and other Biocompatibility tests per ISO 10993-1 requirement
• Preparation and review of study plans and study reports of Biocompatibility assessments
• Identification of worst cases or representative products for Biocompatibility testing based on materials, processing aids, geometry and other characteristics
• Preparing documents for regulatory submission like FDA pre-submissions & submission, and NMPA submissions

Senior Toxicologist - Centre for Toxicology and Developmental Research

(2010-02 - 2018-05)

• Preparation and review of Standard Operating Procedures
• Designing of Studies and Preparation of protocols and reports pertaining to studies and activities
• Verification of Installation, operation and Performance Qualification of Instruments and Equipments
• Training of Study personnel on GLP and Toxicology
• Reviewing of Protocols for ensuring compliance with OECD, EPA, US FDA, ICH and WHO Guidelines
• Performing external audits of vendors and manufacturers and ensuring their compliance, and reporting of the same to the management Ensuring validation of computers and computerized system
• Coordinating with monitoring authorities during inspections. Preparation of application for submission to monitoring authorities. Preparation of Action Taken Report after inspection
• Interacting with Sponsors during facility visit and National GLP Compliance Monitoring Authority (NGCMA), India

Research Officer - Sun Agro Biotech Research Centre

(2006-08 - 2009-09)

• Conducting studies such as Acute (oral, dermal, irritation to mucous membrane, skin sensitization, repeat dose toxicity studies, reproduction toxicity studies)
• Conducting studies include preparation of protocol, communication with the clinical pathologist, pathologist, test item control officer, archivist and collection of raw data and interpretation of the results including pathology summary
• Interpretation of results of toxic studies such as pathology, blood chemistry, toxic signs

Study Scientist - International Institute of Biotechnology and Toxicology

(2004-08 - 2006-08)

• Conducting Toxicology studies based on OECD, ICH and EPA test guidelines
• Conducting studies such as Acute (oral, dermal, irritation to mucous membrane, skin sensitization, repeat dose toxicity studies, reproduction toxicity studies)
• Conducting studies include preparation of protocol, communication with the clinical pathologist, pathologist, test item control officer, archivist and collection of raw data and interpretation of the results including pathology summary
• Conducting of Reproduction Toxicity studies, Carcinogenicity studies
• Interpretation of results of toxic studies such as pathology, blood chemistry, toxic signs
• Study design and preparation of protocols and reports
• Preparation of Standard Operating Procedures for Conducting studies

Ph.D - Environmental Toxicology - Dr MGR Educational and Research Institute University (2010 - 2014)

M.Sc - Environmental Toxicology - Institute of Basic Medical Sciences, University of Madras (2002 - 2004)

B.Sc - Microbiology - University of Madras (1999 - 2002)