Experience. Integrity. IMPACT.
Experience. Integrity. IMPACT.

Why Choose IMPACT

From the Bench to the Clinic

IMPACT was asked to assist a clinician and researcher at a New York-based University, who had worked with IMPACT employees on prior projects, to develop 2 novel anesthesia products.  When approached, the University had completed early nonclinical pharmacology studies, but had not begun any formal toxicology work.

IMPACT’s staff created a virtual product development team for the University, led by an overall program manager, which consisted of nonclinical, CMC, and regulatory team members. This virtual team:

  • Worked with contract manufacturing companies to formulate the final intravenous drug products, assisting with the resolution of multiple issues regarding pH and solubility
  • Helped initiate appropriate stability work and label/store vials for clinical use
  • Set up formal safety pharmacology, toxicology, and toxicokinetic studies, monitored the conduct of these studies, and reviewed the draft study reports

Once these pieces were underway, IMPACT’s regulatory and medical writing group prepared a Pre-IND Briefing Package, prepared the client for the meeting, and attended the meeting to assist with regulatory questions. Following the successful and productive Pre-IND Meeting, IMPACT prepared and submitted the final IND in eCTD format to the FDA.

The process of drug development is not always straightforward; in fact, most programs are faced with various hurdles along the way.  It is imperative to have a dedicated, skilled, and experienced team assembled to tackle whatever issues need to be addressed – this has been essential for this program.

The result of the initial IND submission was a Clinical Hold due to concerns arising from rat toxicology results.  The virtual project team worked closely with the Agency to adequately address the hold issues in a strategic and efficient manner. The team went on to reformulate the drug product and conduct an additional rat toxicology study to demonstrate a higher safety margin, and a Clinical Hold Response was drafted and submitted.

The Clinical Hold was subsequently lifted, and the Agency allowed the University to proceed to first-in-human trials.  Following clearance of this IND, IMPACT has been responsible for all IND maintenance activities.

In addition to providing regulatory consulting and program management services, IMPACT managed and monitored the program’s first Phase 1 study and was responsible for overseeing all data management and biostatistics activities, which ultimately led to the production of a clean database and high-quality tables, figures, and listings. The writing of the final clinical study report by IMPACT’s medical writers was the culmination of years of hard work and dedication from this project team.

The end goal for this client is to out-license this drug. As a result, IMPACT has played an integral role in providing full development plans and cost estimates for potential investors, assisting with information/slide presentations, compiling information from multiples sources, authoring responses to due diligence questions, and coordinating/attending meetings with potential acquiring companies.

This drug development program has hit a number of bumps along the way, which IMPACT’s virtual team has had to circumvent. However, the end result has been an incredibly rewarding and positive long-term relationship with the University, and the successful work completed to-date has been critical in helping move an innovative new anesthesia product towards market.

“We have worked with IMPACT over the past three years, during which time we completed a Phase I trial of a neuromuscular blocking drug in human volunteers under general anesthesia. We are an Academic Institution with no experience or expertise in dealing with Regulatory Agencies. IMPACT provided all the service and organization required to ensure the completion of the study in a manner and format compatible with FDA guidelines. It was a great pleasure to work with IMPACT employees, particularly the Study Manager and Toxicologist/Pharmacologist, as well as several key consultants recommended by IMPACT. All I can say is that IMPACT has provided much more than excellent and timely service and expertise; we have certainly been completely satisfied with their work. Most importantly, IMPACT personnel have become not just extremely valued coworkers, but we look to them as highly respected professional colleagues and consultants. We anticipate that we will continue to enjoy working with and learning from the IMPACT team.”

– Inventor, Professor of Anesthesiology

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