Lakshmi Amaravadi

About Lakshmi Amaravadi

I am an accomplished and effective Pharmaceutical/Biotech R&D Leader. Experienced drug developer experienced in Program Leadership.I have a broad background/interests and experience in area of Translational Medicine across multiple therapeutic areas (Oncology, Neurology, Autoimmune and Inflammation, Cardio-Metabolic and Rare Diseases etc.) to support preclinical and clinical development of multiple modalities including biologics, small molecules, nucleic acids, gene therapy.I am an experienced strategic/operational leader with a scientific background which allows me to effectively lead teams by balancing the need to keep the focus on the big picture while being able to dive into the details that matter when needed. I am passionate about developing fit-for-purpose translational strategies that include Biomarkers, PK, Immunogenicity, DMPK, non-clinical safety and clinical translation components and execution. Skilled in establishing & leading functional capabilities, creating and executing novel biomarker driven translational strategies including CDx & diagnostics development. Identifying/developing innovative approaches/ technologies and implementing them to remain at the forefront. Experienced in developing multiple modalities (small molecules, Mabs, biologics, bi-specifics, ASOs, Gene therapy). Demonstrated experience in recruiting, building and managing high-performing functional teams. Served as Global Program Leader/Program Executive of development stage programs and led cross-functional program teams (functional members from Research, Translational, DMPK/Toxicology, Medical, Biostats, Clinical Operations, CMC, Commercial, Medical Affairs, Market Access and other) leading the team to achieve key program milestones. Contributed to >35 INDs, 10BLA/NDA, participated in regulatory interactions leading to successful filings/registrations. Successful support of post-marketing commitments. Proven ability to engage external KOLs, CRO partners to deliver successful results, Board Presentations, and representing company at external organizations and working corporate partners. Track record of success in building high performing teams, developing people to enable successful contributions to program milestones. Experienced Operational leader: Experienced in developing and managing functional and program level budgets, planning and managing resources, identifying and mitigating risks, negotiating trade-offs, collaborating with stake holders to create win-win situations.

Experience

1. Head of Oncology Bioanalytical Strategy Team Clinical Pharmacology and Safety Sciences

   AstraZeneca

   May 2024 — Present · Boston, MA, US

Education

• Acharya Nagarjuna University

  Master of Science - MS, Microbiology, General

• Indiana University School of Medicine

  Post Doctoral Research, Walther Oncology Center, Molecular Biology, Immunology

• Indiana State University

  Doctor of Philosophy (Ph.D.), Cell/Molecular Biology and Developmental Biology

Skills

• Pharmacology
• Lifesciences
• Pharmaceutical Industry
• Immunogenicity
• Drug Development
• Bioanalysis
• Biopharmaceuticals
• Glp
• Protein Chemistry
• Translational Medicine
• Biotechnology
• Immunoassays
• Validation
• Translational Research
• In Vitro
• Translational Science
• Life Sciences
• Antibodies
• Monoclonal Antibodies
• Immunology
• Assay Development
• Clinical Development
• Pharmacokinetics
• Drug Discovery
• Cell
• Biomarkers
• Oncology