How can I accelerate the development of my oncology drug candidate?
Quotient understands the challenges associated with developing oncology drugs and has the expertise to successfully support biotech and pharmaceutical companies in accelerating development timelines from candidate selection through to commercial manufacture and supply.
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1. Pre-Formulation Assessment & Formulation Development
At Quotient, we emphasize the importance of data driven decisions in early development. Quotient prioritizes the key API characterization data required, which allows our scientific experts to recommend selection of the appropriate API form as well as informing a data-driven strategy for preclinical and clinical pharmaceutical development based on the Developability Classification System (DCS). With unparalleled biopharmaceutics experience, we factor in and anticipate clinical considerations as well as the in vitro performance of pharmaceutical formulations.
Early laboratory prototyping is performed on bench scale equipment, which mirror both small scale and mid to-large scale GMP manufacturing, in order to de-risk process scale-up and development should the molecule achieve its early clinical endpoints.
2. Clinical development: accelerating to POC
Our experts provide the full spectrum of manufacturing and supply paradigms, from traditional large batch manufacturing, through bright stock distribution and personalized manufacturing. There are compelling drivers for small batch sizes, such as conservation of API, and dose flexibility in order to meet individual subject needs and reduced stability needs. Fundamentally, with personalized manufacturing, the product is made on-demand, only when needed based on patient requirements. Overall, this alternative approach offers a reduction in waste and cost, while maximizing the potential for clinical success.
3. Formulation optimization and validation of product performance in humans
At Quotient Sciences, we have demonstrated that formulation flexibility in healthy volunteer trials can be used to develop “patient ready” formulations for oncology molecules in less than half the time of the industry standard. This is accomplished by the close integration of real-time manufacturing and clinical testing, also known as Translational Pharmaceutics, which uses a 14-day “make-test” cycle, enabling formulation decisions to be made based on emerging human data.
4. Process development, “scale-up” & clinical manufacturing for Phase II/III
Recognizing the need to move rapidly through clinical development, Quotient has the capability to efficiently scale-up drug product manufacturing processes from Phase I to meet the demands of later clinical trial requirements and ensure seamless transition to larger scale manufacturing and drug product commercialization.
5. Commercial manufacturing & supply
At Quotient, we work with our customers to configure a robust manufacturing and supply chain to meet their needs. We continue to invest in small-scale commercial equipment to broaden the technologies and product formats available and ensure seamless continuity throughout the development life cycle. We can accelerate development programs through registration and process validation and our manufacturing facilities support batch sizes ranging from less than 1 kg to over 500 kg for solid oral dosage forms and up to 350 L for liquid formats. Whether you are preparing for ANDA, NDA, MAA or Japanese NDA, Quotient has the expertise and regulatory approval to manufacture your registration and validation batches for the U.S., U.K., Europe and Japan. The Quotient team also has significant experience of supporting 505(b)(2) and all post-approval change filings.
As a fully integrated drug development, clinical testing and manufacturing organization, Quotient Sciences addresses the challenges associated with developing small molecule oncology therapeutics. We are dedicated to accelerating the development of new drugs for patients around the world providing individual services or fully integrated programs through our unique Translational Pharmaceutics platform.
Connect with us today to learn how we can help support the development and manufacturing needs of your oncology drug program by clicking here.
Accelerating the Development of Oncology Medicines
Oncology drugs dominate today’s research focus with over >5500 molecules in development, representing over 35% of the total industry pipeline. 10 new oncology drugs were approved by FDA in 2019, of which half had an orphan indication and all had been granted priority review. Given the number of molecules in development, there is increasing pressure on development teams to identify successful drug candidates as quickly as possible, and accelerate patient access, particularly where no effective therapies are currently available.
AAPS 2019 Poster- Applications and Benefits of Healthy Volunteer Trials to Accelerate Oncology Drug Development
Presented at AAPS 2019: Phase I drug development for oncology compounds is traditionally conducted directly in patient populations. Oncology molecules have historically been cytotoxic, meaning their safety and risk:benefit profile makes them unviable for dosing in healthy subjects. While this ensures reduced nonclinical requirements, rapid access to patient data and an earlier assessment of efficacious potential, it can also present challenges. For example, patients recruited in Phase I trials typically are at end of life care and will be taking multiple co-medications and have multiple co-morbidities (e.g. liver and kidney function may vary greatly among the recruited subjects). Practically, recruiting patients into Phase I studies can also be problematic, requiring multiple clinical sites and protracted recruitment times for what would traditionally be single site, quickly recruited healthy volunteer studies.
Rapid Development and Clinical Assessment of New Rectal and Oral Formulations for Ulcerative Colitis Using Real-Time Adaptive GMP Manufacturing and Supply
TOP1288 is a non-systemic kinase inhibitor (NSKI) being developed as a treatment for patients with ulcerative colitis. As a novel, locally-acting candidate, TOP1288 has low systemic bioavailability and therefore a dual-pronged formulation strategy was adopted with rectal and oral formulations being developed.
Adaptive manufacturing: a new paradigm to improve efficiency and effectiveness in early oncology development - AAPS 2014
There is an unmet need in the industry for a more efficient and flexible approach to provide drug product for early clinical studies. Presented here is an innovate approach to overcome these challenges by utilising a real-time, adaptive manufacturing and supply platform.
Flexible strategies for the conduct of human metabolism studies with oncology molecules - ISSX 2014
The key objectives of human ADME studies are to evaluate mass balance, determine the routes and rates of elimination and gain an understanding of the metabolic fate of the drug.
Conduct of clinical ADME study for Vosaroxin in oncology patients - AAPS 2015
Conduct of clinical ADME study for Vosaroxin in oncology patients via real-time adaptive manufacture of intravenous drug product.
Clovis Oncology has chosen Quotient’s drug product optimization approach for rociletinib, a promising oral candidate drug for the treatment of EGFR-resistant non-small cell lung cancer.