Core Therapeutic Expertise

A deep dive into our specialized, physician-led expertise in Oncology, Hematology, Rare Diseases, and Cell & Gene Therapies.

Our Approach: Understanding Complexity

Our deep therapeutic expertise aligns with the innovators we serve. We understand the intricacies of your science and the patients who need it most.

Deep Scientific Acumen

Our team is made up of oncologists and investigators who understand the culture, patients, physicians, and trial sites essential for success in complex studies.

Unwavering Patient-Centricity

We design and execute trials that reduce patient burden and incorporate the needs of people with rare diseases and their caregivers, especially pediatric patients.

Agility for Innovators

As a nimble, expert-led organization, we are built to support emerging and mid-sized biopharma, acting as a true extension of your team to navigate complexity together.

Deep Dive into Our Core Focus Areas

We provide integrated, end-to-end support tailored to the unique demands of each therapeutic area.

1. Oncology & Hematology

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    Comprehensive Understanding: We grasp the intricacies of oncology studies, from the ever-changing regulatory landscape and novel study designs to personalized treatment options.
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    Indication Experience: Solid Tumors
    • Advanced and early-stage solid tumors
    • Basal Cell Carcinoma
    • Bladder Cancer
    • Bone Cancer
    • Brain Cancer (incl. Glioblastoma)
    • Breast Cancer (incl. TNBC)
    • Cervical Cancer
    • Colorectal Cancer
    • Endometrial Carcinoma
    • Gastrointestinal Cancer
    • Head and Neck Cancer
    • Hepatocellular Carcinoma
    • Liver Metastases
    • Melanoma
    • Neuroendocrine Tumors
    • Non-Small Cell Lung Cancer (NSCLC)
    • Ovarian Cancer
    • Pancreatic Cancer
    • Prostate Cancer
    • Renal Cell Carcinoma
    • Sarcoma
    • Small Cell Lung Cancer
    • Squamous Cell Carcinoma
    • Thyroid Cancer
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    Indication Experience: Hematologic Malignancies
    • Acute Lymphocytic Leukemia (ALL)
    • Acute Myeloid Leukemia (AML)
    • Chronic Lymphocytic Leukemia (CLL)
    • Diffuse Large B-cell Lymphoma (DLBCL)
    • Hodgkin's Lymphoma
    • Multiple Myeloma
    • Myelodysplastic Syndrome (MDS)
    • Other Non-Hodgkin's Lymphomas
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    Supportive Care in Oncology: Specialized expertise in managing adverse events and treatment-related toxicities, including:
    • Cancer breakthrough pain
    • Cancer cachexia
    • Chemotherapy-induced toxicities
    • Tumor Lysis Syndrome
    • Immune-related Adverse Events (irAEs)
    • Cell & Gene Therapy toxicities (CRS, ICANS)

2. Rare Diseases & Pediatrics

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    Proven Track Record: Our team has successfully advanced over 210 rare disease studies with nearly 19,500 patients across more than 2,900 sites worldwide.
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    Navigating Unique Challenges: We address every challenge head-on, from designing protocols with appropriate inclusion/exclusion criteria to finding eligible patients in sparse populations and securing experienced sites.
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    Pediatric Rare Disease Focus: We have a dedicated focus on the unique needs of pediatric trials. We carefully examine the pediatric patient journey to balance ease of participation for children and their caregivers with the requirement to collect high-quality data.
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    Patient Finding & Retention: We leverage technology and our established relationships with KOLs and patient advocacy groups to find patients. We reduce patient burden through patient-centric practices to maximize retention.

3. Cell & Gene Therapy

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    Hands-On CAR-T Experience: Our leadership team has direct clinical development and BLA filing experience with approved CAR-T cell therapies, including playing a key role in the approval of AUCATZYL® (Obe-cel).
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    Expert Site Guidance & Logistics: Expert site guidance is critical for cell or gene therapies. We ensure sites can effectively handle complex study execution, logistics, and patient monitoring from leukapheresis to post-infusion follow-up.
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    Specialized Safety Monitoring: Deep expertise in monitoring and managing the unique toxicities associated with cell therapies, such as Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).

4. Additional Therapeutic Areas

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    Expanding Expertise: While oncology and rare diseases are our core focus, our deep clinical development and operational capabilities extend to other complex areas, including:
    • Dermatology
    • Cardiovascular
    • Ophthalmology
    • Immunological Rare Diseases
    • Rare Genetic & Blood Disorders
    • Rare Neurological Diseases

Led by Therapeutic Area Pioneers

Our expertise is embodied by our leadership, who have dedicated their careers to advancing therapies in these complex fields.

Dr. Ashok Srivastava

President & Chief Medical Officer

A "hands-on" global leader in oncology and hematology with 17+ years of experience. Dr. Srivastava has led over 130 trials and is an expert in cutting-edge modalities, including CAR-T, ADCs, and oncolytic viruses, with multiple successful BLA/NDA filings.

Elias Tharakan

Chief Executive & Technology Officer

A visionary technology executive who developed specialized solutions for complex oncology trials. Elias's platform provided real-time quality data for adaptive trials with thousands of subjects, contributing to dozens of approvals.