In as little as 14 weeks from receiving your small molecule API, you can have your Phase I drug product manufactured, labelled, packaged and delivered to the clinic. That’s 1 month faster than most standard timelines, and includes a one-month stability study. Learn how Reneo Pharmaceuticals was able to get to clinic in 14 weeks from delivery of their API with the Quick to ClinicTM for Oral Solid Dose program.
Small and emerging companies face challenges related to limited funding and resources, such as technical expertise and capacity, making it imperative they find a competent partner to support them. Learn why 4SC selected Thermo Fisher Scientific Pharma Services as their CDMO partner to develop its lead asset, resminostat.
The Challenge: Given the rapid and widespread outbreak of this virus, researchers were urgently working towards a solution. In a significant breakthrough, a European-based manufacturer had successfully developed a test kit that enabled serological detection of the Zika virus. Getting these kits into the labs of the United States researchers became a critical priority.
A pharmaceutical manufacturer was working with Fisher Clinical Services in support of multiple clinical trials and protocols. Patients enrolled in these trials were occasionally unable to maintain an appointment at their respective investigator site. The circumstances were many and varied.
Poorly managed postoperative pain can have a significant impact on a patient’s recovery. Consequently, more patients relying in opioids furthers compounds the opioid epidemic. This case study discusses how Patheon and Pacira Pharma partnered to help curb this epidemic.
The Challenge: A top 20 global pharmaceutical manufacturer had worked with a parcel carrier for ten years to handle 1,700 monthly commercial sample product deliveries to Sales Representatives. Although the process had been in place for a considerable amount of time, it was not without its challenges.
In small pharmaceutical start-ups, you have to move fast with a limited amount of budget and resources to get your molecule to first-in-human, and then to proof-of-concept (POC). You keep headcount low and outsource wherever you can, often to multiple vendors. Working with multiple vendors means investing significant time to negotiate terms and conditions as well as to oversee the project.
The opioid abuse epidemic is a serious public health crisis that demands action on the part of many stakeholders. While abuse-deterrent opioids will not solve the opioid abuse epidemic alone, they play a critical role in the fight against it. While Collegium had come up with an innovative new approach to abuse deterrent formulations, it did not have the capacity or resources to manufacture its drug on a commercial scale.
As part of the FDA’s efforts to address opioid addiction, the agency put an opioid action plan into effect in 2011 to “reduce opioid abuse, dependence, and overdose in the United States.” Part of this plan included a call to pharmaceutical manufacturers to develop and expand access to abuse-deterrent formulations (ADFs) in order to discourage abuse among patients and promote innovation in the industry.