He will also be explaining how the company is expanding its Translational Pharmaceutics platform into new therapeutic areas like mRNA, and using AI to optimize drug development. With a focus on compliance, innovation, and streamlining processes, he says the company continues to set itself apart in the pharmaceutical industry. We caught up with him before the event.
Can you provide insights into any regulatory changes or compliance issues that are impacting your business?
The industry is ever evolving, and our teams are mindful of staying ahead of regulatory and scientific policy changes to ensure that we stay current and in continued compliance. Internally, we are committed to knowledge sharing among our teams, continuous learning and improvement. A recent example is the implementation of new FDA guidelines for conducting clinical pharmacology studies, which we’ve been monitoring for more than two years to assess the impact on human ADME studies. The FDA’s guidance has described for the first time the agency's expectations for conducting these studies. Many of the expectations reflect the design and conduct of these studies over many years.
Quotient Sciences have evaluated the new guidance to ensure that our ADME programs can remain compliant with the new requirements, including recommendation to dosing increase to n=8 - to de-risk the likelihood of completing an ADME with an incomplete data set - and greater than 80% radioactivity in excreta to be identified which ensures compliance in our metabolite profiling and identification scope.
Can you discuss any plans for expansion or market growth in the pipeline?
Expanding our flagship Translational Pharmaceutics platform remains a key objective for us, and we are exploring ways to do this with both new geographies and applications into new modalities such as mRNA. Over the last 16 years, we’ve proven impressive time and cost savings for clients using the platform in the development, clinical testing, and manufacturing of small molecule and synthetic peptide therapeutics. The next generation of mRNA medicines is here, and Translational Pharmaceutics is a natural fit in this space that will allow companies greater speed-to-market and increased chance of success for new RNA-developed therapies.
Additionally, the impact of AI is being seen everywhere now. Leveraging our unique position that spans chemistry, pharmaceutical and clinical capabilities, Generative AI has the potential to deliver great benefits to business and to our client’s programs. By linking our history of drug development, including over 500 Quotient Sciences Translational Pharmaceutics programs completed over 16 years, we can see the progression of a molecule to a formulation to the clinical result from healthy volunteer trials. Undoubtedly, we will be able to use those learnings to optimize formulations and improve drug program outcomes.
What sets your company apart from competitors in the pharmaceutical industry, and what value do you offer to your customers?
A combination of CDMOs and CROs are usually required for drug development programs, with handovers at different points over the course of a program that can take time. Inherently, our Translational Pharmaceutics® platform helps streamline the outsourcing model, as we can offer multiple services directly from our organization and in many cases, from one facility.
There are major time savings for customers who choose to use our platform and its applications for streamlined drug product optimization, ADME studies, and first-in-human clinical trials. For example, we can greatly reduce the time that it takes to see clinical data and act based on their outcomes. Cost savings also come through API savings; we can make smaller drug product batches, just enough for what is needed to dose in our clinics and iterate drug product formulations based on real-time, emerging clinical data. Ultimately, these aspects and others attribute to greater process and product control.
Our commitments to partnership and collaboration are reflected in how we approach every client program. An example is recent work with Vasa Therapeutics, reaching a major clinical milestone with the first human subjects dosed at Quotient Sciences’ Nottingham, UK clinic for VS-041. VS-041 is in development as the first personalized medicine-based treatment of Heart failure with preserved ejection fraction (HFpEF), or diastolic heart failure.
The platform was selected to accelerate the drug into first-in-human (FIH) trials. We supported on-demand manufacture of an immediate release (IR) tablet that has allowed for recent dosing and will generate clinical data in a shortened time when compared to traditional methods of drug development.
Our approach to project management is also what helps make Translational Pharmaceutics successful. Project management is the lynchpin of integrating activities across scientific functions to complete work with our clients. Our Project Managers control activities across functions and sites more varied than almost any other provider in our sector. We’re providing a single partner for our customers. It is something we are very proud of.
