Learn how you can shorten the pathway to clinical development: Hear more from Quotient Sciences and Charles River leaders in our on-demand webinar.

Senior leaders from Charles River and Quotient Sciences discuss how this collaboration helps customers by bringing expert knowledge, removing obstacles from the critical path, reducing development risks, and shortening the pathway to clinical development. Through case studies they will demonstrate how an integrated program provides customers with the full set of deliverables required to be “clinic ready”, and how this seamless transition between providers can improve the chances of clinical success.

Combined, Charles River and Quotient Sciences have over 100 years of experience in the drug development space and across all stages of drug development, cementing them as trusted industry experts.

Key Topics

• The benefits of an integrated approach to accelerate to IND and beyond
• How this collaboration seamlessly delivers these integrated programs of work
• How technical transfers are achieved between organizations and how this can benefit clients in both time and cost saving
• A timeline overview for each stage of the development process
• Case studies that demonstrate the benefits of an integrated discovery to clinic approach

Featured Presenters

• Russell Scammell, Director Small Molecule Drug Discovery at Charles River
• Eleanor Row, Executive Director of Commercial

Learn how choosing an integrated service provider can help to accelerate your drug development timeline, featuring a customer case study presented by Ensysce Biosciences CEO, Lynn Kirkpatrick.

As the pharma and biotech industry looks to make drug development more efficient to achieve regulatory milestones faster, the outsourcing services sector has scaled to meet demand. In doing so, drug development activities have spread across multiple service vendors, creating siloes. In this presentation, Dr. Vanessa Zann, Senior Drug Development Consultant, and Lynn Kirkpatrick, CEO of Ensysce Biosciences, discuss the benefits of Quotient Sciences Translational Pharmaceutics® integrated drug development platform for decreasing the complexity of drug development for sponsors by providing integrated services under a single company.

Presentation Overview

Ensysce Biosciences' PF614-MPAR is a novel opioid combination product for the potential treatment of chronic pain that is designed to prevent both abuse and overdose. It is currently in Phase I trials. Quotient Sciences has supported Ensysce Biosciences with an integrated formulation development and Phase I clinical study program for PF614. 

In this presentation, Lynn Kirkpatrick, CEO of Ensysce Biosciences, discusses the reasons why Quotient Sciences was selected as an outsourcing partner. She highlights her company's experience working with Quotient Sciences, and how the Quotient Sciences Translational Pharmaceutics platform for integrated drug development is being used for their program.

You'll hear:

• How the Quotient Sciences Translational Pharmaceutics platform has accelerated Ensysce Biosciences' drug development timeline and what Ensysce hopes to achieve next through their partnership with Quotient Sciences
• How drug product formulations and doses can be adjusted and manufactured in real-time, often in response to emerging human data
• How the integration of drug substance, drug product & clinical testing activities under one organization can encourage close relationships between multidisciplinary experts and create a more agile approach to pharmaceutical development, which ultimately accelerates timelines towards IND and onwards to proof-of-concept.

Speakers

Lynn Kirkpatrick, CEO of Ensysce Biosciences
Lynn Kirkpatrick is the CEO of Ensysce Biosciences, a clinical-stage biotech company based in San Diego, CA. Her professional background is in medicinal chemistry, pharmacology, drug discovery, and drug product development.  She has co-founded two start up companies in her career and has developed three targeted small molecule oncology drugs from discovery to the clinic. She has experience in both private and public companies raising funds from private, public, and government sources.

Dr. Vanessa Zann, Senior Drug Development Consultant at Quotient Sciences
Vanessa has over two decades of industry experience providing biopharmaceutics support to discovery, development, and clinical programs. Before joining Quotient Sciences, Vanessa worked at AstraZeneca as a permeability expert in the Pharmaceutical Development department.

Meet Our Expert

Learn how choosing an integrated service provider can help to accelerate your drug development timeline.

Drug developers face many challenges and considerations in the preclinical and candidate development stage. They start with selecting the right molecule to take forward into clinical development and understanding the best drug substance and drug product development strategy to reach the clinic. 

To simplify and expedite this phase, developers can leverage an integrated biopharmaceutics, drug substance, and drug product development strategy to make science-led, data-driven decisions that greatly improve formulation performance and streamline the outsourcing process. 

The tight integration of these key activities under a single organization improves the supply chain by removing them from the critical path and allows for a seamless transition into clinical research with "clinic ready" deliverables.

Hear the benefits of integrating biopharmaceutics and drug substance activities in order to accelerate timelines to first-in-human studies, minimize risks, and improve the likelihood of downstream success.

Watch a discussion with scientific experts from Quotient Sciences in drug substance, biopharmaceutics, and candidate development. Moderated by Dr. Asma Patel, VP of Integrated Development Services, Quotient Sciences, our Quotient Sciences panelists include:

• Dr. Richard Castledine, Head of Drug Substance Operations
• Dr. Steve Byard, Principal Research Fellow
• Dr. Eleanor Row, Executive Director of Candidate Development

The journey of drug candidate compound from discovery to kilo-scale GMP manufacture is fraught with technical challenges, regulatory hurdles, and tight timelines.

Using case studies, our speaker, Richard Castledine, demonstrates how to manage the following factors in an accelerated timeline. You'll learn how working with an experienced partner from the earliest stages of development can avoid common pitfalls, such as late-stage modification of manufacturing processes requiring repeat toxicological studies or changes to the regulatory strategy. We also discuss how overall timelines to FIH can be reduced by integrating drug substance into drug product using our Translational Pharmaceutics platform.

This webinar is of interest to professionals responsible for the development of small molecule APIs and drug products, outsourcing managers, employees of biotechnology start-ups, small and medium pharmaceutical companies as well as drug development consultants. We discuss the critical phases of drug development, and strategies for risk mitigation and timeline acceleration, which can lead to successful completion of drug substance manufacture.

Presentation Overview

• How to select a synthetic route that is safe, regulatory compliant, and economically viable
• Batch or continuous manufacture, what are the pros and cons
• How to define GMP starting materials and establish suitable control points
• The importance of timely development of robust analytical methods
• Managing risks around process scale-up
• Material Sourcing
• Solid state considerations

About Richard Casteldine

Richard Castledine is Head of Drug Substance Operations at Quotient Sciences. He has 15 years of experience in the pharmaceutical and contract development industries. After completing a PhD in synthetic organic chemistry at the University of Nottingham he worked briefly as a medicinal chemist, before moving into process chemistry. He has led process development of over 25 programs at different stages of development ranging from pre-clinical and Phase I to process validation. In his current role, Richard is responsible for the Analytical Development, Process Research and Development, Solid State Chemistry, and Drug Substance Production Teams.