Cellular and Gene Therapy

Experienced CRO Partner for Cellular & Gene Therapy Clinical Development

Medpace has been a pioneer in the clinical development of cellular and gene therapies and offers Sponsors an experienced team of experts who take an active role in the field and are at the forefront of rapidly changing clinical and regulatory developments.

Medpace has global cellular and gene therapy experience across numerous therapeutic areas and global regions. Areas of expertise and specialty include malignant and benign hematology, oncology, cardiovascular, diabetes, neuroscience, nephrology, wound care, rare disease and orphan indications, ophthalmology, pediatrics, and medical device.

Medpace has contributed to over 130 cellular and gene therapy clinical trials.

Areas of Expertise

  • Hematopoietic Cell Transplantation
  • Gene Therapy
  • Gene Editing
  • Graft Versus Host Disease
  • Cellular Therapy
  • Tissue Therapy
  • Adoptive Immunotherapy
  • Tissue Engineered Products

The Medpace Difference for Cellular and Gene Therapy Studies

As an active CRO in this rapidly advancing area, Medpace offers numerous advantages:

  • Cellular and gene therapy physicians partnering with over 30 Medpace sub-specialist medical doctors to advise, design and execute clinical trials
  • Experience in the planning and management of cellular and gene therapy clinical trials with proactive solutions to the operational complexities inherent in these therapies
  • Integration with rare disease clinical team, including pediatrics
  • Regulatory experts with in-depth knowledge of the latest global regulations and developments related to cellular and gene therapy products in all major regions, including FDA and EMA processes linked to cell and gene therapy clinical development pathways
  • Network of globally trained investigators with the capabilities and experience to store, prepare and administer these unique products
  • Experience in designing and conducting medical device trials

Core Labs

Medpace Core Labs combines state of the art imaging services with Medpace clinical teams to provide efficiency through partnership. Medpace offers imaging for cohesive, streamlined and standardized trial management. Our imaging and clinical trial experience ensures that imaging components are seamlessly integrated into the complex structure of cell and gene clinical trials.

Central Laboratories

Medpace Central Laboratories provides customized, quality central laboratory services to pharmaceutical and biotech clinical development industries. Central Labs provide specialized product storage and delivery capabilities.

Active Member and Supporter

Active, long-term member of the Alliance for Regenerative Medicine,
a Washington, D.C.-based non-profit organization whose mission is to
educate key policy makers about the potential of regenerative medicine
and to advocate for favorable public policies—funding, regulatory,
reimbursement and others—to facilitate advances in the field.

Industry supporter of Rare Disease UK, an organization providing
a united voice for the rare disease community by capturing the experiences
of patients and families and working to raise the profile of rare diseases
across the UK, seeking to bring about lasting change offering better health
and quality of life for individuals and families affected by rare diseases.