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Oncology

#ONcology

by Daniel Zamfir

With 24 years of experience in clinical research, I have dedicated the last 14 years to oncology, with a specialized focus on cell and gene therapy for the past 4 years. My therapeutic area expertise spans a wide range, including CNS, dermatology, ophthalmology, cardiovascular, metabolic/liver, analgesia, and infectious diseases. Over the past 4 years, I have collaborated with over 200 biotech clients and developed operational strategies for more than 120, with 70% focused on oncology. This includes expertise in trial design, feasibility assessments, proposal development, budget negotiation, and resource allocation. I have led over 20 bid defenses, kickoffs, and governance programs, while maintaining operational oversight and executive sponsorship for a diverse portfolio of clients.

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
 
PI Modalities: 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.

Below with more details around the size of trials. List not exhaustive
Therapeutic Indication Phase # of Patients # of Sites Countries (NA, WEU, EEU, Nordics)
Neuroendocrine tumors (3 trials) II & III 100-120 22+ 10-12
Follicular Lymphoma (several trials) I 18-36 1-5 1-2
FL, NHL, MDS, DLBCL, MZL, MCL (3+ trials) I & II ~100 12 3-5
Advanced Solid Tumors (several trials) I & II 80 ~12-15 5
Pacreatic Cancer (3 trials) II & III 500 50+ 12+
AML (several trials) I 30 3-5 2
Various other Heme & solid tumor indications (includes GVHD, glioblastoma and surgical component trials) I - III >100 >12 >5
Neuroblastoma (radiotherapy) I 24 3 1-3
@Allucent - Oversight of 10+ client CGT portfolio (included mostly oncology and Rare but also cardio, derm, CNS, ortho/pain) Mostly Ph I & II 12-48 1-3 1-10
@Labcorp - Oversight of 15+ client CGT portfolio for oncology (glioblastoma, various heme and solid tumors, CAR-T, TIL, Stem cell transplant, CAR-NK, EVs, Oligos, RNA based therapies, etc.) Mostly Ph I & II, some Ph II & III. LTFU 12-120 Various up to 24 3-9
@Premier - Oversight of all CGT portfolio 10+ (oncology, rare disease, CNS) Mostly PH I & II, some PH II & III. LTFU Per above Per above Per above

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