Immunotherapy Drug Development

Immunotherapy Drug Development

Advancing Breakthrough Treatments

Immunotherapy clinical trials offer the potential for new, targeted treatments to fight cancers. However, with their specialized nature, these trials may also require long, multi-step patient assessments, complex logistics, and regulatory considerations, to name a few.

At Synteract, we understand the unique challenges immunotherapy clinical trials pose. We were one of the first CROs to address this area, and today, draw on 14 years of expertise managing some of the most complex immunotherapy trials, across Phases I – III, with our specialized Center of Development (COD) in oncology. In the last five years alone, we have worked on more than 160 immunotherapy and oncology clinical trials, supporting dozens of sponsors, in multiple immuno-modulating treatments, including:

  • Cell/Stem Cell Therapy treatments – to repair diseased/dysfunctional tissue
  • Allergen and Vaccine Therapies – aimed at boosting immune systems, treating cancer, and preventing its return
  • Oncolytic Viruses – to infect and destroy cancer cells
  • CAR-T Cell Therapy – to remove, grow and return T cells to help increase immunity
  • Monoclonal Antibody (mAb)-Based Therapies, TCR Enhancers, and Small Molecules – targeting antigens

Regardless of Indication, Immunotherapy Trials Have Common Distinctions:

  1. Patient Screening
    • Typically a long, multi-step process due to number of assessments
    • Planning and site training are keys to success as well as proactive assessment of the process
  2. Logistics
    • Special equipment, long treatment preparation time and complex shipping and security procedures may be needed
    • Our experience with and knowledge of these logistic needs as well as our flexible process allow Synteract to manage the unique needs of these trials and support patient care
  3. Regulatory Process
    • Planning and Managing regulatory time-lines, as well as the unique considerations for certain types of therapy requires deep regulatory knowledge
    • Synteract's regulatory experience and expertise is essential to defining a proactive regulatory strategy, anticipating any unique needs, and planning accurate time-lines

First-Hand Immunotherapy Clinical Trial Expertise

Our Immunotherapy Experience Stats

Experience to Advance Your Breakthrough Drug Development

With disciplined, strategic assessment and decision-making skills, and the ability to pivot, we are structured to help smaller and mid-sized biopharma and biotech clients successfully navigate the continuum of drug development, often across multiple indications. When cross-integration and multiple disciplines are needed, we bring in specialists from our Centers of Development in general medicine, neuroscience, pediatrics, and rare and orphan disease to advance unique projects to bring new medicines to market. Our experience and processes enable us to navigate challenges and considerations and provide proactive risk management.

Discover how we can help advance your immunotherapy clinical trials to the cusp of innovation. Contact us today to find out how we can tailor an approach for you.

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