Ashok P.
About Ashok P.
Current Role as Manager Global Biospecimen Lead at Bristol Myers Squibb
Ashok P. currently holds the position of Manager Global Biospecimen Lead at Bristol Myers Squibb, located in Hyderabad, Telangana, India. In his role, he manages biospecimens for CAR-T, gene therapy, and oncology trials globally. His responsibilities include interacting with global trial managers, central labs, R&D, and biomarker/analytical departments to ensure efficient biospecimen management and report availability. He also trains site teams on biospecimen collection and processing and defines operational setups for bio specimen flows, testing activities, and data flows for each study. Ashok acts as a subject matter expert for several processes within his team.
Previous Experience at Tech Mahindra
Prior to his current role, Ashok P. served as Team Lead - Healthcare & Lifesciences (Domain Consultant) at Tech Mahindra from 2022 to 2023 in Bengaluru, Karnataka, India. In this hybrid position, he leveraged his extensive background in the healthcare and life sciences domain to contribute effectively to the team. Ashok's experience included work on Veeva Clinical Vault eTMF systems and data migration. His tenure at Tech Mahindra underscored his capability to handle complex projects and his proficiency in clinical and bioanalytical monitoring.
Educational Background in Analytics, Data Science, and Pharmaceutical Chemistry
Ashok P. has a strong educational foundation with a focus on analytics, data science, and pharmaceutical chemistry. He is currently enrolled in an MBA program in Analytics and Data Science at Manipal University Jaipur, expected to graduate in 2025. He also holds a Postgraduate Diploma in Project Management (PGDPM) from the University of Hyderabad, completed in 2017. Further, Ashok earned a Master's degree in Medicinal and Pharmaceutical Chemistry from Acharya Nagarjuna University in 2010 and a Bachelor's degree in Pharmacy from Andhra University in 2008. This diverse academic background has equipped him with the skills necessary for his various roles in the pharmaceutical and clinical research fields.
Experience in Clinical Project Management and Research
Throughout his career, Ashok P. has accumulated significant experience in clinical project management and research. He worked as a Clinical Project Manager at Biocon Biologics and as a Project Manager at Biocon, where he was involved in clinical development and medical affairs. His role included the design, preparation, review, and finalization of Protocols, Investigator's Brochures (IB), Patient Diaries, Informed Consent Forms (ICF), and Case Report Forms (CRF/eCRF) as a PK scientist and medical writer. Additionally, Ashok conducted feasibility assessments of clinical studies, provided forecasts to management, and conducted periodic vendor/CRO qualification audits.
Expertise in Handling Bioequivalence Studies
Ashok P. has demonstrated significant expertise in managing bioequivalence (BE) studies across a variety of dosage forms including tablets, capsules, sprays, gels, suspensions, and liposomal injections at global CROs and hospital sites. He played a pivotal role in the formulation and strategy selection for BE studies and oversaw the quality of CROs through clinical and bioanalytical monitoring. His work also involved preparing and reviewing clinical overviews for EU submissions, extrapolating pilot study pharmacokinetic (PK) data to design pivotal studies, and addressing regulatory queries and deficiencies. Ashok's specialized knowledge in pharmacokinetics and clinical research has been instrumental in his various roles in the pharmaceutical industry.