🔬 Meet the Makers | Stephanie Wickham, Ph.D.
Senior Director, Development - Syracuse Bio Campus

Clinical readiness doesn’t start in the clinic.
It begins with the decisions made during development.

Development may begin early, but its impact extends far beyond the early stages.

As Senior Director of Development at LOTTE Biologics’ Syracuse Bio Campus, Stephanie Wickham brings a perspective shaped by experience across development and MSAT—reflecting an end-to-end understanding from development through manufacturing.

Her experience highlights a critical reality:

✅ Development cannot happen in isolation.
Decisions made early, whether in process design or material selection, can significantly impact clinical timelines if not aligned with manufacturing and quality from the start.

✅ Risk in development scales with the process.
What may seem manageable early on can become a critical risk in clinical manufacturing. Aligning development, manufacturing, and quality from the outset is essential to reduce these risks and enable a smooth transition into clinical stages.

✅ Preparing for clinical stage is a coordinated effort.
Success depends on how well teams move together—sharing information, anticipating risks, and staying aligned throughout the process.

For clinical programs, delays originate from decisions made long before manufacturing. Development and manufacturing are not separate stages—they are continuously aligned to reduce risk and enable real execution.

“Clinical readiness isn’t just preparedness ; it’s the ability to scale with data, move with agility, act with speed, and communicate with absolute clarity.”