The transition of your molecule from research into development and the achievement of Proof-of-Concept (POC) are significant milestones for your new drug.
The early development process, encompassing the first-in-human clinical trial to the Proof-of-Concept study, can be complex, incorporating a range of clinical studies in healthy volunteers and patient groups. The type of drug product(s) employed in your early development program will often need to change to meet differing requirements. When you conduct a healthy volunteer trial in a tightly controlled clinical pharmacology unit, it has vastly different product requirements than an international, multi-center Proof-of-Concept trial.
In many cases, you’ll find the first-in-human trial reveals the new drug molecule to have suboptimal bioavailability — requiring an enhanced formulation to be developed prior to transitioning into subsequent clinical trials. Quotient Sciences has a proven track record of supporting early development programs in both the U.S. and the U.K. Clinical trial protocols either focus on single studies or have multiple parts, potentially spanning first-in-human through to Proof-of-Concept in a single clinical protocol. Quotient Sciences flagship Translational Pharmaceutics® platform for drug development allows your formulations to be modified in real time in response to emerging clinical data. We can help adapt your clinical trial manufacturing schedules and quantities to the precise requirements of your early development program, accelerating progress to POC while reducing costs.
The regulatory approval of your new drug requires a comprehensive package of clinical pharmacology information demonstrating that the drug product can be used safely in the intended patient population. You need a description of drug metabolism pathways, documentation of potential drug-drug interactions and an assessment of cardiac safety. Additional requirements can also include an understanding of the effects of age, gender, ethnicity and food on clinical responses.
The required information is unique to your molecule and is typically delivered from multiple healthy volunteer trials. Quotient Sciences designs the most appropriate program and delivers the associated trials. Our science and medical teams work with you to tailor a program to address the rigorous requirements of regulatory agencies. Your program is delivered on time by a single project manager. We also provide full-service data management and analysis as well as report writing to support your regulatory submission.
The majority of small molecules in the pharmaceutical R&D pipeline suffer from suboptimal biopharmaceutics properties that impede their bioavailability in the human body. To ensure that your molecule can exert its therapeutic effect when dosed to a patient, you typically must enhance or modify its formulation to maximize its delivery to the right place, at the right time, at the required concentration.
Quotient Sciences has over 30 years of experience optimizing the clinical performance of drug products. Our experience spans hundreds of drug molecules, including some of the most challenging conditions: poor solubility or permeability, short or long half-lives, and complex human drug metabolism. We will work with you to define a program that is unique to your molecule and that delivers a drug product formulation optimized to achieve the goals of your development plan.
Having locked the dosage strength and formulation composition for your product, it is critical to optimize the manufacturing process to ensure seamless scale-up for later stage development and commercial launch. We have a proven track record, having successfully formulated and manufactured more than 1,000 small molecules for oral, inhaled or topical delivery, and we have particular expertise handling highly potent molecules.
Our flexible approach to manufacturing can deliver batch sizes ranging from 1 – 1,000,000 units, allowing us to tailor product supply to your development program. For clinical trials in hard-to-recruit patient populations (e.g., oncology, rare disease, pediatrics), we manufacture and supply product on a per patient basis to dovetail with patient recruitment rates and global locations.
Patient and regulatory requirements have increased the focus on the development of new pediatric drugs. This can present new challenges to your development team regarding age-appropriate formulation design, taste masking and assessments, as well as the manufacture and supply of clinical and commercial products to serve your unique study and market needs.
Our comprehensive capabilities to meet your program requirements. We develop numerous pediatric product formats for different age ranges to help overcome aversive taste properties of drugs. Through our flagship Translational Pharmaceutics® platform for drug manufacturing, we can quickly perform integrated clinical studies to assess and optimize taste and PK performance based on human data. For simplicity and continuity, we manufacture and supply GMP drug products in real time to global clinical sites based on your protocol needs and serve as your long-term commercial manufacturing partner.