AI/ML Powered Clinical Sciences

Oncology

Pharmaceutical and Clinical development in Oncology ranges from small molecule development (Taxanes, Epothilines), biomolecules (bi- and tri-specific mAbs) and cell therapies.

  • Vice President, Clinical Development, for Annexin receptor targeting peptides for Breast Cancer, FIH
  • Vice President, Late Clinical Development, targeting OX-40 pathway for atopic diseases and oncology targets
  • Clinical Development SME, for PD-1 x VEGF bispecific mAbs targeting solid tumors
    • Direct Principal Consultant leads to enhance strategic communications and client engagement
    • Provide oversight of client’s CRO including SOW compilation and long-term budgetary alignment
    • Drive change management to proactively mitigate financial risks and resolve realized risks
    • Mentor Project managers and Engagement managers to assure timely deliverables
    • Implemented AI integration to accelerate advocacy groups, KOL and regulatory engagement
    • Leverage ML to guide endpoint selection, optimize sample sizes and inform decision making
  • Immuno-oncology
    • Constructed differentiation strategies (versus SOC and mAbs in development such as Pembrolizumab (Keytruda) and Ivonescimab) for next generation of PD-1 x VEGF bispecific antibody incorporating the cooperative binding mechanism targeting solid tumors using Master Protocol (Platform Trial) design from FIH to Phase 3.
    • Designed single, overarching trial infrastructure designed to evaluate PD-1 x VEGF across multiple cancer types (sub-protocols) concurrently. Authored master protocol to define shared elements (safety monitoring, PK/PD, master ICF template). In parallel constructed sub-protocols for indication-specific sub studies (RCC, NSCLC, CRC) detailed eligibility, endpoints, specific schedules.
    • Utilized optimal biological dose (OBD) approach to identify indication-specific Recommended Phase 2 Dose (RP2D) including induction through maintenance phases
    • Compiled SAP incorporated Bayesian Adaptive Designs (BOIN2 / BOP2) statistical framework using accumulating trial data to enable timely decisions about the dose for the next Participant or cohort. Adaptive design with decision rules enabled understanding of dose-toxicity/efficacy probabilities as new Participant data comes in.
    • Advanced wnt/beta-catenin pathway bi-specific and tri-specific monoclonal antibodies for hepatic carcinomas.
    • Authored clinical trials protocols for Annexin targeted cancers targeting pulmonary, breast and colorectal tumors.
    • Led immune-histological assay designs for tumor margin assessments

Regenerative Medicine in Oncology

Clinical Development SME spearheading medical advisory board engagements with US and global medical institutions addressing post-mastectomy surgical reconstruction. Leverage immunology and oncology expertise to advance programs in breast cancer surgical reconstruction. Provided clinical leadership to transition regenerative tissue portfolio from 510k products to PMA/BLA assets.

Led high-stakes, late-stage regulatory filings and negotiations; transformed Real-World Data (RWD) into Real-World Evidence (RWE) to secure a Premarket Approval (PMA), confirming expertise in BLA/NDA-level regulatory execution.

Augment therapeutic/surgical area expertise with independent medical advisory boards to elucidate clinical equipoise. Guide regulatory authorities to align with surgical community and clinical strategy

  • Utilize insights into oncologist, surgical oncologist and patient experience to identify viable endpoints
  • Lead negotiations with FDA for SAP, endpoint determinations, outcomes measures (HR-QOL). Partnered with CDRH and CDER for joint PMA and Advisory Committee.
    • Formulated novel composite endpoints from the NIH sponsored nationwide study, Mastectomy Reconstruction Outcomes Consortium (MROC), to build a Premarket approval (PMA) strategy for the use of SurgiMend PRS for breast reconstruction.
    • Compiled statistical methodology and led dialogue between the FDA and Integra to design statistical analysis plans with FDA statisticians resulting in the first industry led statistical analysis plan (SAP) for the MROC data and establishing a framework for the FDA for the use of dermal matrices for surgical reconstruction.

Led Independent Surgical Reconstruction Medical Advisory to transform RWD to RWE resulting in PMA

  • Formulated novel composite endpoints from the NIH sponsored nationwide study, Mastectomy Reconstruction Outcomes Consortium (MROC), to build a Premarket approval (PMA) strategy for the use of SurgiMend PRS post mastectomy.
  • Compiled statistical methodology and led dialogue between the FDA and Integra to design statistical analysis plans with FDA statisticians resulting in the first industry led statistical analysis plan (SAP) for the MROC data and establishing a framework for the FDA for the use of dermal matrices for surgical reconstruction.

Ovarian and Liver Cancer

Led protocol development for confirmatory (Phase II, III) global clinical trials for the treatment of ovarian cancer (gene therapy) and liver cancer with gene therapies and novel drug delivery systems. Oversight of clinical development strategy, clinical program oversight, PI and site engagement, 3 direct reports

  • Led the clinical development strategy to evaluate the Phase I/II gene therapy for advanced epithelial ovarian, fallopian tube or primary peritoneal cancer of IL-12 plasmid with Neoadjuvant Chemotherapy (NACT) in patients.
  • Trained major cancer centers on dosing, safety, efficacy, and biological activity of IL-12 plasmid-based gene therapy
  • Oversight of Phase III study of thermosensitive liposomal doxorubicin in hepatocellular carcinoma (HCC)
  • Compiled statistical analysis plans, DMC charters and led interim analyses for Phase I/Phase II programs.
  • Led Orphan designation efforts for US/EU regulatory bodies
  • Led efforts for authoring, compilation, and submission of Pediatric Investigation Plans (PIP, EU)
  • Compiled submissions to Recombinant DNA advisory/ IBC committees.

Clinical Operations

  • Conducted site initiation visits, protocol training of site staff for gene therapy program
  • Screening log reviews and follow up with site staff
  • Weekly assessments of AEs/SAEs with Medical monitor(s)
  • Manage statisticians, medical monitors, data management staff (CRO).

Pfizer Clinical Affairs, Immunology and Oncology

  • Provided thought leadership for Interleukin-11 immuno-oncology asset to develop new indications for oral mucositis after radiation and chemotherapy and led Global Oncology advisory boards.
  • Leveraging advances in immunology and immunotherapy, designed novel clinical trials for the management of Asthma and Anaphylaxis. Conducted preclinical and non-clinical studies to support Phase 1-IV programs.

NIH Funded Clinical Development of Glioblastoma-Targeting Endofullerenes for Imaging Brain Tumors:

  • Principal Investigator in “Development of Glioblastoma-Targeting Endofullerenes for Imaging Brain Tumors” NIH grant. Built next generation biomarker molecular imaging franchise using more stable NCE’s. Proven ability to acquire external resources and funding to enable drug discovery efforts for NCE design (~ $1.0 MM SBIR/STTR).
  • Co-Investigator in “Development of Novel Cholesteryl-Derivatized Endohedral Metallofullerenes for Imaging Atherosclerotic Plaques” NIH grant. (~ $0.5 MM SBIR/STTR).
  • Attained three new corporate alliance partners to transition fullerene chemistry and functionalization potential into novel and safer biomarkers. Integrated internal synthesis programs for novel scaffolds into alliance R&D.
  • Executive Team Leader (5 Ph.D. senior scientists, 2 MS level) to lead NME design, synthesis, formulation and evaluation of novel fullerene biomarkers for targeted and non-targeted molecular imaging applications.

Oncology R&D and Preclinical Development

  • Implemented pre-clinical research biomarker methodologies in animal models for technology transfer to clinical settings for oncology targeted imaging agents. Validated Folate labeled agents that provided tumor targeting.
  • Executed tumor animal model studies for pharmacokinetics and pharmacodynamics (PK/PD) on NCEs. Developed imaging protocols to quantitate drug distribution in animal models to provide time dependent biodistribution data. Enabled animal model use optimization, drug PK/PD study improvements and drug targeting validation.
  • Enabled the first multiple-dose study with brivanib (BMS-582664), an oral VEGFR/FGFR tyrosine kinase inhibitor targeting multiple tumor types, including renal cell, hepatocellular, colorectal, NSCLC, breast. Resolved critical path issues leading to Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664, a VEGFR/FGFR inhibitor in patients with advanced/metastatic solid tumors. Facilitated clinical development of brivanib in markets covered by Vatalanib (NVS), SU11248 (PFE) and Avastin.
  • Enabled the design and synthesis of Epothilone Aziridines (BMS-753493, epothilone folate) for targeted folate conjugates. Led process synthesis for 12,13-aziridinyl analogues with advantages over natural oxiranyl analogues.
  • Led the development of BMS-505112, a small molecule inhibitor of the VEGFR-2 kinase domain with robust preclinical in vivo activity and a safety profile that is suitable for chronic dosing
  • Resolved critical path issues in the androgen receptor antagonist program preventing timely onset of multicenter phase I trials to evaluate BMS-641988, a potent nonsteroidal antiandrogen with transcriptional activity targeting hormone refractory prostate cancer.
  • Solved challenges in the clinical development of two lead panHER candidates in Signal Transduction Oncology program, BMS-599626 and BMS-690514 with superior HER1 and HER2 inhibition vs Tarceva and Iressa targeting breast solid tumor and ovarian cancer.
  • Designed, built and managed CADD, NMR and MRI facilities (solid tumor imaging). Developed oncology in-vitro and in-vivo biomarkers and screened new agents in animal models.