Frontage
Accelerating IND Approval for Faster Time to Market

Drug development is undoubtedly one of the greatest achievements of humankind. However, despite its life-saving tendencies, it is no secret that drugs also bear certain risk in the form of drug-related side effects. To avoid such adverse outcomes and ensure the highest quality drugs, organizations like the FDA have made it mandatory for pharma and life science companies to submit extensive evidence regarding the safety and quality of life-saving drugs and therapies.

Although such regulations are put in place to ensure patient safety, pharma organizations might often find it difficult to traverse the formalities involved in the approval process. Take the FDA’s investigational new drug (IND) approval process for instance. Many of the IND approval applications don’t even make it past FDA’s regulatory ‘speed bumps’ owing to the lack of substantial evidence data to back up the drug’s safety. While the process of collating this evidence data and managing the overall IND submission program is relatively easier for established pharma organizations owing to their large, experienced teams, the same could be a daunting and resource-dividing task for startups and individual researchers. But no longer!

With the guidance of Frontage—a PA-based CRO with global acclaim—pharma and life science companies, and even individuals, can easily sidestep the common hurdles and achieve their drug development goals. Frontage is especially known for its integrated, science-driven product development services, ranging all the way from drug candidate evaluation to drug development. As a result, pharma and life science organization no longer have to depend on multiple vendors for different phases of product development. “Moreover, we help innovator, generic, and consumer health companies to file IND, NDA, ANDA, BLA, and 505(b) (2) submissions in global markets, ensuring successful development of important therapies and products for the patients,” says Song Li, CEO of Frontage.

Comprehensive Clinical Services that Ensure IND Approval

Li continues, “A crucial part of an IND or drug development program is the generation and collation of clinical data. Without evidence-backed data that proves the efficacy and safety of the drug, it is almost impossible to get FDA approval or investor backing.”

With Frontage, however, pharma organizations can accelerate the entire process and get their approval in no time. The CRO’s team of qualified project managers, study directors, and scientists coordinate seamlessly with innovators and pharma companies, assisting them through the entire drug candidate evaluation and clinical trials phase, while analyzing patient data and forming robust study reports for securing FDA approvals. Whether the clients are working on CNS, oncology, metabolic, or any other therapeutic programs, Frontage possesses the expertise needed to guide them through development to commercial launch on a global level.

The Gateway to a Successful and Sustainable Commercialization

A testament to Frontage’s capabilities is the role it played in assisting a cardiovascular specialist from Philadelphia to patent his unique method of combining different drug products, which not only reduced the original side effects but also improved the overall efficacy. However, since he didn’t have sufficient clinical evidence to back his claim, he was unable to secure approval from the FDA. That was when he sought the help of Frontage. Within a short period of time, Frontage generated additional evidence-backed data to support his claim, which not only enabled him to get FDA approval, but also secured him an investment of up to 19 million.

This is but one of the many instances where Frontage has guided innovators as well as pharma companies in getting their products through the FDA. In addition to these accomplishments, the CRO is also taking active part in mitigating the impact of COVID-19. Frontage’s bioanalytical and biologics teams are invested in supporting the development of assay kits designed to detect the COVID-19 virus as well as antibodies and deliver results within 15 minutes. The CRO is also developing and validating a 3-in-1 LC-MS/MS method for the determination of chloroquine, hydroxychloroquine, and azithromycin—three drugs that are under evaluation for treatment of COVID-19.

Propelled by such noteworthy contributions, Frontage is witnessing accelerated growth in the pharmaceutical sector. Having already secured its footprint in the U.S., China, and Canada, Frontage is on its way to establishing its presence in Europe and Japan as well. As it grows, the company will also set up new, compliant laboratories aimed at better assisting its clients. “We are committed to ensuring the highest quality and compliance. In months to come, we will assist our growing client base to advance hundreds of molecules through development to commercial launch in global markets,” concludes Li.