Pre-IND & Scientific Advisory Meetings
A strategy for success
Partner with the CRO that has been leading the way in Ophthalmology for over 50 years and fast-track your entry into human clinical trials with Ora.
Are you an early-stage biotech with a promising drug ready to advance beyond the benchtop?
Ora’s team of seasoned specialists are here to guide you through the critical Pre-IND (Investigational New Drug) or Scientific Advisory discussions, and ensure you are fully prepared for your meeting with the FDA, EMA, or MHRA.
- Global regulatory strategists
- Regulatory writers
- Toxicology experts
- Drug formulation / device design guidance for trials and more.
Accelerate your program with Ora
The Pre-IND or Scientific Advisory meeting marks a drug sponsor’s first formal interaction with regulatory agencies during the journey to bring a drug to market. This critical step allows sponsors to present their plans before submission, offering valuable feedback that can help shape the development process. Sponsors who integrate this feedback early are often able to minimize costly changes and delays down the road.
At Ora, we strongly advocate for these pre-alignment meetings with regulatory agencies to:
Gain critical agency feedback
This meeting offers an invaluable opportunity to understand regulatory agency perspectives on your drug’s development, align on key aspects, and potentially secure preliminary agreement on your program’s trajectory.
Ensure a complete application
By using insights gained from this meeting, you can avoid common pitfalls like clinical holds, ensuring your submission is comprehensive and well-received.
Build a collaborative relationship with the FDA, EMA, or MHRA
This meeting fosters trust and communication with regulatory agencies and key decision makers, helping you establish a strong foundation for the approval process ahead.
Ora consulting support for Pre-IND or Scientific Advisory discussions
Comprehensive, Expert Guidance
Complete Packaging of Development Work
We’ll organize all your work to date, including toxicology and safety data, ensuring a cohesive and compelling Pre-IND or Scientific Advisory submission package.
Program & Endpoint Analyses
We conduct in-depth analyses to assess your development program and identify potential predicates in the market, ensuring your drug is positioned strategically for success. This includes strategy both for initial program plans and future development plans to market.
Formulation & packaging recommendations
With a foundation of quality by design, the Ora team provides insights and strategic guidance on formulation, packaging, and other critical considerations. Ora leverages a global network of trusted CDMO (Contract Development and Manufacturing Organization) and laboratory partners to meet regulatory expectations and market needs.
First-in-Human Trial Protocol Synopsis
Ora will outline the best approach and protocol for your first-in-human trial, setting the stage for a smooth transition into clinical development.
Pitfall avoidance & risk mitigation
We guide you through potential challenges, identifying risks early to help you avoid common pitfalls and stay ahead of obstacles that could derail your timeline.
Comprehensive Regulatory Writing
Our regulatory writing experts will craft clear, detailed, and precise documentation that meets regulatory agency requirements and accelerates the review process.
With Ora’s expert consulting support, you can feel confident that your drug development program is on track for a successful regulatory path from the beginning. Our team is dedicated to helping you navigate every step of the process, ensuring a strong and streamlined submission across the globe.
At Ora, we don’t just help you prepare for your Pre-IND or Scientific Advisory meeting — we build a comprehensive strategy that covers every facet of your drug’s development.
By looking at all these critical factors, we guide you on how to present your best case during your initial discussions for all applicable regulatory bodies.
On average, Ora meets with regulatory agencies at least once a month on development discussions
Recent experience with Pre-IND meetings include
In two recent meetings we have learned of FDA regulatory shifts in nonclinical requirements.
In several recent studies, discussions led to early alignment of endpoints such as MD Slope as primary for Glaucoma or Multi-Luminance Mobility Test as primary for IRD trial.
Discussion and inputs led to acceptance of sham injection to control dosing frequency differences in IVT injection studies.
If you’re interested in how Ora can support your next Pre-IND or Scientific Advisory meeting, click here to schedule a conversation with one of our experts. We’ll work with you to make sure your strategy is as strong as possible.