Cell and Gene Therapies

Global Advanced Therapy Experience

Medpace has been a pioneer in the clinical development of Advanced 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 cell and gene therapies experience of over 70 trials across numerous therapeutic areas and global regions. Areas of advanced therapy 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.

Areas of Expertise Include:

  • Hematopoietic cell transplantation
  • Gene therapy
  • Gene editing
  • Graft versus host disease
  • Cellular therapy
  • Tissue therapy
  • Adoptive immunotherapy
  • Tissue engineered products

The Medpace Difference for Advanced Therapy Studies

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

  • Advanced 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 advanced therapy clinical trials with proactive solutions to the operational complexities inherent in these therapies
  • 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
  • Regulatory experts with in-depth knowledge of the latest global regulations and developments related to advanced therapy products in all major regions, including FDA and EMA processes linked to advanced therapy clinical development pathways
  • Network of globally trained investigators with the capabilities and experience to store, prepare and administer these unique products
  • Integration with rare disease clinical team, including pediatrics
  • Central imaging for cohesive, streamlined and standardized trial management
  • Central laboratories with specialized product storage and delivery capabilities
  • Medpace Medical Device, exclusively dedicated to designing and conducting medical device trials
  • 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