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Oncology

#ONcology

by Daniel Zamfir

With 26 years of experience in clinical operations, I have dedicated the last 16 years to oncology, with a specialized focus on cell and gene therapy for the past 6 years. My therapeutic area expertise spans a wide range, including CNS, dermatology, ophthalmology, cardiovascular, metabolic/liver, analgesia, and infectious diseases. Over the past 6 years, I have collaborated with over 200 biotech clients, developing operational strategies, implementing dozens of programs and managing as hand-on Ops lead, as well as program oversight. Expertise in trial design, feasibility, proposal development, budget negotiation, clinical operations, project management and more.

My oncology experience encompasses a balanced focus on both hematological malignancies and solid tumors. Within hematology, I have extensive experience in various indications, including follicular lymphoma (FL), chronic lymphocytic leukemia (CLL), multiple myeloma (MM), diffuse large B-cell lymphoma (DLBCL), B-cell non-Hodgkin lymphoma (NHL), acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), Fanconi anemia, and hemophilia. In solid tumors, my expertise spans a diverse range, including pancreatic, colorectal, breast (with experience in 3-4 subtypes), lung, adrenal, bladder, gastric, esophageal, neuroendocrine, head and neck, glioblastoma, and squamous cell/basal cell carcinoma. 

About 65/35 split between early Ph I-II and larger global Ph II-III
Ph I designs – direct experience in
  • 3+3, cohort, dose escalation/expansion with Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) methodology
  • Adaptive: Bayesian design, Bayesian Optimal (BOIN) with flexible cohorts and Continual reassessment (CRM), 3+3 backfill
  • Other nuances in design that I have been a part of over the years: optimal biological dose (OBD) instead of MTD, intra-patient escalation, parallel cohorts based on safety triggers; accelerated titration model; secondary expansion cohorts that allow a bridge between Ph I-II; overdose control design and interim dose levels; mTPI; control groups taken from other trial data;
Ph II designs
  • Single-arm, non-randomized to double blind randomized and stratified
  • Cohort and cohort expansion, Intra-patient escalation, Simon 2-stage design
  • Basket and Umbrella trials – mostly Ph III but some Ph II
Ph III designs
  • Open label, single blind, double blind, stratified for various factors (disease, age, mutation, etc.); time-to-event endpoints, non-inferiority, enrichment, rollover expansion open-label arm; long-term follow-up
Specialized Long-term FU up to 15 years post gene therapy administration
  • Basket rollover trial, Central site (brick and mortar), Virtual site, DCT components such as mobile nursing, telehealth, eCOA
 
MOA: My experience encompasses a wide range of treatment modalities, including small proteins, monoclonal antibodies (mAbs), bispecific antibodies (BsAbs), BiTEs, immune checkpoint inhibitors (PD1/PDL1, CTLA-4/6), targeted therapies (JAK3, FLT3), Antibody-drug conjugates (ADC), various small molecules and biologics, and oncolytic viruses. I have worked extensively with checkpoint inhibitors such as pembrolizumab, nivolumab, and atezolizumab. In the realm of cell and gene therapy, I have experience with both autologous and allogeneic approaches, including CAR-T (e.g., CD19/CD28), TCR T-Regs, CAR-NK, TILs, EVs, AAVs, LVs, ASOs, and naked plasmid. I am familiar with various administration methods, including IV, intrathecal, intracranial (using stereotactic devices), and intra-tumoral. Furthermore, I have experience managing the risks associated with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). In cell logistics, I have collaborated with internal and external resources to ensure Chain of Custody and Chain of Identity, and engaged with global cold-chain vendors to optimize value-chain analysis, shipping lane validation, and ultimately deliver cell therapies from CDMO back to the clinical site within 6-24 hours.

“In addition to my experience in North America, Western Europe, Eastern Europe, the Nordics, the UK, and Israel, I have a strong track record of managing and overseeing oncology trials in diverse regions. This includes experience in South Africa, Australia, New Zealand, South Korea, Singapore, China, and Taiwan. I have also had limited involvement in trials conducted in Mexico, Peru, Chile, Costa Rica, Brazil, and Argentina. Notably, I dedicated three years to working exclusively with APAC biotech companies aiming to develop global clinical programs, giving me valuable insights into the unique challenges and opportunities of this market.

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Drug Development Thought leader in Clinical Operations, Strategy, Trial Planning & Execution and Project Management within both Fortune 500 and smaller organizations

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