RECENT FACET SUCCESSES – JUST A FEW HIGHLIGHTS
FACET HELPS GOVERNMENT INVESTIGATE DEA DRUG OF CONCERN:
Facet champions IND preparation and submission to study PK and safety of widely available supplement. A large ex-US CRO and government agency jointly asked Facet to provide US regulatory affairs representation and support to investigate a DEA Drug of Concern under a US research IND. Facet conducted an extensive literature review and summarization of the information available on the drug, which served as the primary basis of evidence to support the IND. Facet also provided guidance and recommendations regarding the design of the IND-enabling clinical trial, including endpoint selection, safety evaluations, and schedule of assessments. The safe to proceed letter was issued 27 days after submission of the IND. Results from this study will provide the first controlled and systematic evaluation of the pharmacokinetics and safety of this supplement in humans.
COMMERCIAL IND FOR COMPLEX NCE CONTAINING CONTROLLED SUBSTANCE:
Facet prepares and submits IND to support participation in oncology basket trial. A 2-person ex-US company is developing a novel product containing 1 FDA-approved API and 1 controlled substance for the treatment of an oncology indication. After a successful pre-IND meeting, the company sought Facet’s help to prepare the contents of a commercial IND that would enable them to participate in a basket trial for an oncology indication. Over the course of several months, Facet summarized all the information collected to date on each API in the product, prepared the contents of the IND, and worked with the company to mitigate risks where gaps existed. Facet also worked with the CDMO that is preparing the drug product for clinical use. The IND was successfully submitted, and the company was allowed to dose patients with the NCE under the basket trial.
STREAMLINED STRATEGY FOR NEW INDICATION FOR RECENTLY APPROVED PRODUCT:
Facet uses strategic biometric support via partnership to set development strategy. A growing pharmaceutical company sought Facet’s help to design an aggressive pathway to a supplemental NDA for a new indication for their recently approved blockbuster product. Although the company had compelling preliminary efficacy data in a subset of patients under the new indication, there was a lack of information on how the product would perform in hard-to-treat patients. Facet helped this company secure the right statistical support to run simulations to confidently design a single pivotal trial with a formal interim analysis to improve the probability of success. Facet also prepared a meeting request and background package to seek FDA agreement on the sNDA strategy and clinical trial design. The FDA meeting was granted and is pending.