Sunnyvale, California, United States
An excellent organic medicinal chemist with eight years experience in designing, developing and validating hit-to-lead generation of small molecules. Managed CMC preparation of SiemensMIBR radiopharmaceuticals for IND filings to enable phase I/II clinical trials. Over four plus years direct experience in regulatory filings, analytical method development/validations and QA/QC aspects of drug development and manufacturing with a proven success record in managing projects with strict timelines. A team player with an ability to easily integrate into interdisciplinary programs. Areas of expertise: • QA/QC/GMP/GCP/ICH • IND filings/Annual reports/IND Amendments • Authoring Investigator Brochures/CMCs and non-clinical reports/IMPDs • Project management/Microsoft project • US/Global radiopharmaceutical manufacturing site set-up • Analytical methods development and validations • SOPs, Deviation reports/CAPAs • PET Imaging biomarker discovery/Click chemistry/In-situ click chemistry • PK and Metabolism • Organic synthesis, medicinal chemistry and SAR • Experience in drug development across multiple stages from lead discovery through lead optimization to Phase I/II
Designed, synthesized and developed radiopharmaceuticals in discovery projects that lead to IND submissions and first-in-human clinical studies. Project lead with hands on experience for all formulations and analytical method validations for IND-enabling preclinical toxicology studies. Played a key role as the scientific liaison and point-person between chemistry, biology, radiochemistry and clinical groups. Regulatory: •Successfully Coordinated, authored and reviewed IND submissions, amendments and annual reports within strict timelines for 6 radiopharmaceuticals by interfacing with regulatory, quality, clinical and research personnel; prepared responses to the FDA’s questions and concerns as related to IND submissions. •Reviewed protocols, reports for non-clinical data, CMC sections and developed analytical methods. •Identified and solved impurity profile issues for several lead compounds at critical stages prior to IND filings while adhering to strict timelines Analytical/QA/QC: •Developed and transferred analytical methods and stability validations to contract laboratories in an effort to reduce CRO costs. •Developed HPLC and GC analytical methods; resolved analytical issues as they arose in a timely manner, especially during the manufacturing process. •Reviewed batch records including analytical data prior to release of products, resolved SOP deviations and prepared reports in clinical production with root cause analysis and CAPA implementation •Hands experience on analytical techniques including LC/MS, NMR, GC, HPLC. •Developed and implemented several analytical and quality control procedures (SOPs) using the Agile document control system; Performed experiments and authored reports for the in vivo metabolism of multiple radiopharmaceuticals for use in eIND submissions. •Point person for batch record reviews, quality control and fulfilling the on-site quality assurance role
Discovery / Translational Chemistry: • Involved in the design, synthesis and screening of amyloid plaque and Tau binding compounds in vitro and in vivo. • Involved in the design and development of radiopharmaceuticals specific for prostate specific membrane antigen (PSMA) and caspase-3 (Apoptosis) as PET imaging agents • Designed and synthesized cyclooxygenase-II (COX-II) inhibitors with nanomole inhibition in in vitro for imaging inflammation in vivo. • Designed, developed and synthesized highly potent Carbonic Anhydrase IX Inhibitors with excellent inhibitory activities; developed the lead compound as a PET imaging probe for CA-IX, a biological marker for tumor hypoxia. • Determined inhibitory activities of the possible drug candidates, conducted metabolism and PK studies using F18 labeled compounds
• Developed a solution phase combinatorial route for preparing aza peptides and un-natural peptides; synthesized larger quantities of these peptides and other unnatural peptide mimics as neurotoxin inhibitors. • Applied click chemistry to the development of peptidomimetic combinatorial libraries leading to the development of novel metalloprotease inhibitors • Extending the scope of In-situ Click chemistry in target assisted combinatorial screening for the development of novel inhibitors of enzymes and proteins