Adina Stephens

Dynamic leader with extensive experience at in the clinical research industry at the CRO and sponsor level, excelling in clinical trial management and budget stewardship. Proven track record in driving strategic initiatives, enhancing operational efficiency, and fostering stakeholder relationships. Adept at risk assessment and team building, consistently delivering projects on time and within budget while mentoring junior staff for professional growth. Methodical director with several years of comprehensive experience overseeing daily operations of clinical research trials. Hardworking and versatile professional well-versed in executing business strategies, preparing and implementing business plans and overseeing financial performance. Thorough knowledge of market changes and trends paired with strong grasp of corporate finance and performance measures.

Adina Stephens, Project Director, Lincoln, NE, Ms. Stephens is a motivated and focused Associate Director/Director Level leader with over 20 years of experience in the clinical research and pharmaceutical industry. Her depth of experience resides predominantly in the biotech space managing clinical trials consisting of projects ranging from phase I, II, and III including the implementation of study protocols, transition of rescue studies, feasibility, site selection and activation, study start up, patient enrollment, clinical monitoring, quality, close-out activities across North America, Asia Pacific, Latin America, and Europe. Patient population and trial experience includes Adult, Adolescent, Women's Health, Healthy Normal Volunteer, Rescue Study, Cell Therapy, Immunotherapy, Double-Blind Trial Design, ADME, Microdose, Radiolabeled, and Radioligand Therapy.

Ten years of oncology experience includes:

• CAR-T, Immunotherapy, Radioligand Therapy
• Advanced Solid Tumors, Nerve Sheath Tumor, Non-Small Cell Lung Cancer, Urothelial Cancer, Prostate Cancer, Breast Cancer, NHL, Large B-Cell Lymphoma

Additional Therapeutic Area Experience:

• Hyperhidrosis, Vaccine, Asthma, Rare disease

Research Protocols:

• A Phase lb study of the safety pharmacokinetics, and preliminary antitumor activity of XXX in combination with YYY in patients with advanced solid tumors
• A double blind randomized placebo controlled phase lll study of orally administered XXX in subjects with pigmented villonodular synovitis or giant cell tumor of the tendon sheath
• A 3 part open label comparative single dose randomized 3 period study to assess the relative bioavailability and the effect of food on three new XXX formulations on the current phase l formulation when administered with or without a proton pump inhibitor in healthy adult subjects
• A phase l study evaluating the combination therapy with the receptor tyrosine kinase inhibitor XXX and YYY in patients with unresectable sarcoma and Phase ll study in malignant peripheral nerve sheath tumors
• A Phase lb Study of the Selective HDAC6 Inhibitor XXX in Combination with YYY in Patients with Unresectable Non-Small Cell Lung Cancer
• A Phase lb Dose Escalation Study To Assess Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of XXX in Subjects with Advanced Malignancies
• A Phase lll, Open-Label, Randomized, Study of XXX Compared with Gemcitabine, Cisplatin or Carboplatin for PD-L1-Selected, Chemotherapy Naïve Patients with Stage IV Squamous Non-Small Cell Lung Cancer
• A Phase lll, Open-Label, Randomized Study To Investigate The Efficacy and Safety Of XXX Compared With Best Supportive Care Following Adjuvant Cisplatin Based Chemotherapy in PD-L1-Selected Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer
• Phase lb Dose Escalation Study Of Anti-PD-L1 Antibody (XXX) plus YYY In Advanced Solid Tumors
• A Sequential 2-arm, Open-label Phase l Study to Evaluate the Effects of XXX in Combination with YYY on the Pharmacokinetics of Losartan, Midazolam, Caffeine, Omeprazole, and Dextromethorphan Administered in a Cocktail Approach and on the Pharmacokinetics of Rosuvastatin in Patients with BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors
• Multicenter, Open-label, Phase I, Dose Escalation, Cohort Expansion, First-in-Human Study of XXX administered as Monotherapy and in Combination with YYY in Adult Subject with Locally Advanced or Metastatic Solid Tumors
• An Open-label, Phase I Study of XXX in Combination with Avelumab in Adult Subjects with Locally Advanced or Metastatic Urothelial Carcinoma
• Multi-center, open-label, Phase 1 study of the safety, tolerability and feasibility of dosing patients harboring metastatic castration resistant prostate cancer (mCRPC) with genetically modified autologous T cells (CART-PSMA-TGFβRDN cells) engineered to express a chimeric antigen receptor (CAR) capable of recognizing the tumor antigen prostate-specific membrane antigen (PSMA) and activating the T cell
• Multi-center, open-label, first in human Phase 1 study of the safety, tolerability, feasibility, and preliminary efficacy of the administration of genetically modified autologous T cells (CART-TnMUC1 cells) engineered to express a chimeric antigen receptor (CAR) capable of recognizing the tumor antigen, TnMUC1 and activating the T cell (CART- TnMUC1 cells)
• An Open Label, Dose-Escalation, Phase I/II study to Evaluate the Safety, Tolerability, Preliminary Efficacy, and Pharmacokinetics of XXX in Adult Patients with Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies
• Phase I/II Study of XXX in Combination with Rituximab in Patients with Relapsed/Refractory CD30-Positive Non-Hodgkin Lymphoma, A Phase 2/3, Randomized, Double Blind, Placebo-Controlled, Multicenter Study of XXX Vs Placebo Following CD19-Directed CAR-T Cell therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma
• A Phase 2, Open-label Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of (isotope/radioligand therapy) XXX in Participants with PSMA PET-Positive Castration-Resistant Prostate Cancer
• An Open-Label, Single-Dose, 4-Way Crossover, Bioavailability Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Food Effect of XXX Capsules in Healthy Adult Subjects, A Repeat Dose Maximum Use Study to Evaluate the Pharmacokinetics of XXX Administered Topically as a Gel to Subjects with Hyperhidrosis
• A Phase l, Randomized, Partial-Blind, Placebo-controlled, sequential Dose Group, Ascending, Multiple Dose Study of the Safety, Tolerability and Pharmacokinetics, with Food Effect, of XXX in Healthy Subjects
• A Phase l, Randomized, Double-Blind, Placebo-controlled, Dose-ranging Trial to Determine the Safety and Immunogenicity of a Norovirus Vaccine (XXX) Administered Orally to Healthy Volunteers