Gene Therapy Programs

Where bold science meets expert execution

Gene therapy has shifted from an emerging concept to a transformative reality. With over 3000 active programs and growing, the opportunity to change the course of medicine—and the lives of patients and families—is real. But complexity remains high, and the path forward isn’t always clear.

You need a team that’s been here before. A team that knows how to navigate the uncertainty, anticipate the obstacles, and lead with clarity and conviction.

Gene therapy is different. So are we.

While gene and cell therapies are often lumped together, gene therapy demands its own blueprint. That’s why we’ve built a team of gene therapy veterans—clinical leaders who’ve run their own programs, solved their own setbacks, and now bring that hard-earned insight to your side.

We’ve walked in your shoes. We’re ready to walk with you—from day one to approval.

Vision, creativity, and groundwork that lasts

Experience matters. But experience alone isn’t enough. Every gene therapy trial requires fresh thinking and a clear strategy to carve out space where none exists.
From natural history studies to endpoint development and site optimization, we co-create the roadmap that fits your program—not someone else’s playbook.

Cross-functional by design. Unified by purpose.

Gene therapy programs can’t thrive in silos. That’s why our team works as a seamless, full-service unit, aligning clinical, regulatory, operational, and medical functions from the inside out.
What makes us different? Autonomous flexibility. We adapt fast, collaborate deeply, and stay aligned—so your program doesn’t lose momentum.

Regulatory stewardship—rooted in excellence

It’s our business to know this business, and that’s why we don’t chase guidance—we anticipate it. Our regulatory experts bring the foresight and strategic alignment needed to move quickly and confidently, from IND to agency interactions to final submission.

With deep therapeutic and regulatory experience, we help you understand the milestones that matter—and how to reach them.

A team that stays with you

Gene therapy demands more than skill—it requires grit, passion, and trust. Through our proprietary resourcing approach, we handpick senior experts with the specialized mindset needed to lead in this space.
With an industry-low 6% turnover rate, your team stays intact—and fully invested in your program from start to finish.

Gene therapy, fully supported

  • Study design and protocol collaboration and development
  • Regulatory strategy and agency guidance
  • Accredited investigator and patient recruitment
  • Relationship-first site management and monitoring <link to RSM page>
  • Clinical documentation and submission
  • Global drug safety
  • Portfolio-wide strategic planning
  • Natural history study and subgroup planning

Let’s find the answers together

We don’t believe in gatekeeping knowledge that has the potential to change the world. Schedule a free one-on-one consulting call with one of our cell therapy leaders. No obligation, just informed discussion.

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