Summary: Dr. Andrew Lewis, Chief Scientific Officer at Quotient Sciences, discusses the integration of formulation design space with Translational Pharmaceutics® to enhance oral peptide development. This approach addresses challenges like low bioavailability by optimizing formulations based on clinical data. The platform combines drug product development, manufacturing, and clinical testing, enabling just-in-time manufacturing and efficient CMC packages. This innovative strategy minimizes investment and waste, ensuring successful oral peptide programs.

Recent advancements in drug discovery, peptide engineering and drug delivery have converged to address many of the challenges associated with oral peptide delivery. 

Technologies such as phage display can be used to create vast libraries of peptides that can be screened for properties of interest such as permeability and protease resistance, and numerous technologies – from permeation enhancers through to ingestible devices have been shown to be effective in promoting systemic absorption. 

Drugs entering clinical trials typically start with a Phase 1, first-in-human (FIH) program that includes a single ascending dose (SAD) study - starting with a sub-therapeutic dose and gradually increasing to predicted therapeutic levels before evaluating multiple ascending doses (MAD). 

As oral peptides usually have to be formulated with a drug delivery technology, multiple prototypes have to be developed with the knowledge that most of them will not be taken forward into later clinical development. Furthermore, given the many unknowns in oral peptide biopharmaceutics and poor correlation between preclinical models and humans, it is difficult to predict what the optimum formulation for performance in humans will be.

With this considered, a drug product strategy for oral peptide programs needs to be designed that enables the program objectives to be met whilst minimizing investment required and wasted API and drug product.  

How does a formulation design space work?

Using the Quotient Sciences Translational Pharmaceutics® platform, we offer an innovative solution that helps mitigate these development risks—especially when applied to molecules with known challenges such as low bioavailability.

Integrating drug product development and manufacturing services with clinical testing, we enable a just-in-time manufacturing strategy for drug products that are then dosed in the clinic as they are needed. The efficient CMC packages created as part of this platform are supported by a supply chain that Quotient Sciences controls from start to finish.  

With Translational Pharmaceutics®, formulations are optimized based on emerging clinical data, and using a formulation design space allows even greater flexibility. A formulation design space is a trusted concept that we have applied as part of RapidFACT® programs, an application of the Translational Pharmaceutics® platform, for almost two decades.  

To create a formulation design space, formulation variables are identified that are anticipated to be critical-to-performance (e.g. dose and the levels of a functional excipient). Demonstration batches are manufactured at the extremes of the design space, and batch analysis and stability data are obtained for submission to the regulatory agency to gain approval to dose any formulation within that design space. 

In the example shown, just four demonstration batches enable the clinical evaluation of many more formulation prototypes–without any regulatory amendments or notifications, as long as the compositions remain within the pre-defined design space.

Continue reading how we have applied the Translational Pharmaceutics® platform in the development of oral peptides, with case studies from pharma/biotech customers, in our latest whitepaper. 

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Thierry Van Nieuwenhove, CEO of Quotient Sciences, discusses the evolving landscape of Contract Development and Manufacturing Organizations (CDMOs).

Thierry emphasizes the shift in CDMO relationships with pharma and biotech clients from transactional models to more integrated, collaborative partnerships. This shift is not just about accelerating processes for speed but about creating a more controlled and responsive drug development process.

CDMOs that offer integrated services, and a collaborative approach are better positioned to help clients navigate uncertainty and use resources efficiently. Quotient Sciences uses its Translational Pharmaceutics® platform to enable greater agility by breaking down silos between traditionally separate functions.

Read the full article on the 247biopharma website.

Summary: Sue Sweet-Smith, Senior Director of Project Management at Quotient Sciences, explains how an integrated project management approach enhances drug development. Coordinating multidisciplinary teams and maintaining clear communication, Quotient Sciences' project managers ensure timely and high-quality project delivery. They help minimize risks and meet even the most aggressive timelines, ultimately expediting the delivery of new medicines to patients.  

Across the pharmaceutical industry, the R&D process is not getting any easier. 

Companies are faced with challenging budgets and economic pressures, all while aggressive timelines to get new therapies to market to meet patient expectations continue. This environment has led to increased reliance on partner CRO and CDMO companies to access the necessary services and scientific skills, knowledge, and innovation to remain ahead of competition—making the selection of a trusted, experienced partner even more important. 

Project management is central to every drug development program that we work on at Quotient Sciences. No matter where the project is performed—whether it is a clinical pharmacology program or an integrated Translational Pharmaceutics^® program that combines pharmaceutical sciences and clinical capabilities into a single program of work at either of our Phase I clinical units in Miami, FL or Nottingham, UK—our project managers help ensure customers have a consistent experience and maintain high standards of quality in project delivery. 

How Quotient Sciences approach project management for drug programs 

Our approach to project management is focused on the needs of our customers, and our project managers act as advocates to ensure an on-time and successful project delivery. 

Our delivery through high-performing multidisciplinary teams is fundamental to project success. Each project manager helps integrate services across scientific functions, facilities, and vendor partners to coordinate a program as it progresses from milestone to milestone. Each customer benefits from a single point of contact who will partner them from project initiation through delivery and reporting, facilitating seamless transitions to subsequent development stages. 

Our project managers are organized to lead cross-functional, multidisciplinary teams structure that provides consistency and accountability for the delivery of projects. Every customer has a dedicated project team, which provides continuity of interactions and accountability, direct peer-to-peer communication with technical experts, and program oversight to effectively manage time, cost, and quality.  

All project teams are assigned a lead team member from each of Quotient Sciences’ functions. This ranges from formulation development and manufacturing to analytical development and product release, clinical operations, regulatory and quality, and data sciences. Additionally, pharma project managers work closely with our business development and scientific teams to ensure a smooth handover to operations and continued scientific support throughout your study.  

They are also skilled at vendor management for third party services which may be required for the study, this takes some of the complexity and burden of managing multiple vendors off the customer and ensures a streamlined approach to clinical delivery.  

Our project managers are continually adapting to complex program requirements

Our agile, adaptive project managers embrace changing requirements while always looking ahead on how to best handle complex processes. For example, real time human PK data can sometimes take us in a direction we hadn’t anticipated. 

Our project managers can work with multiple functions such as formulation development, analytical, regulatory, manufacturing, screening, and clinical and medical teams to ensure that any amendments to the study design, formulations or exposure limits are managed in a smooth and compliant fashion with minimal impact to project delivery timelines. 

Through effective scheduling, forecasting, and risk management, we aim to successfully develop products and expedite the delivery of new medicines to patients.