Skip to main content

Strategies for Achieving Regulatory Milestones Faster Using Quotient Sciences Translational Pharmaceutics®

On-Demand Webinars , Translational Pharmaceutics

Strategies for Achieving Regulatory Milestones Faster Using Quotient Sciences Translational Pharmaceutics®

19 April 2023
Overview

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

Watch
Date
19 April 2023

Reach the Clinic Faster: Integrated Biopharmaceutics & Drug Substance Strategies

On-Demand Webinars , Drug Substance

Reach the Clinic Faster: Integrated Biopharmaceutics & Drug Substance Strategies

27 July 2023
Overview

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
Watch
Date
27 July 2023

Quotient Sciences supports YourChoice Therapeutics with Phase I trial of novel hormone-free male birth control pill

Customer Milestone , News & Announcements

Quotient Sciences supports YourChoice Therapeutics with Phase I trial of novel hormone-free male birth control pill

Logos for YourChoice Therapeutics and Quotient Sciences

YourChoice Therapeutics, Inc., a pioneer of hormone-free family planning products, began dosing male volunteers in a Phase I study of YCT-529, a drug candidate designed to offer the first hormone-free birth control pill for men.

Quotient Sciences is supporting the development of YCT-529 with YourChoice Therapeutics. YCT-529 is a drug candidate designed to offer the first hormone-free birth control pill for men.

YCT-529 is a retinoic acid receptor-alpha (RAR-alpha) inhibitor that prevents sperm production by blocking access to vitamin A. This was first discovered in the 1930s when researchers found that depriving mice, rats, and monkeys of vitamin A caused infertility. Researchers validated the discovery in men and advanced their understanding in nearly 100 published papers in the decades that followed. Initial preclinical studies, funded in part by the National Institutes of Health, showed YCT-529 was 99% effective and 100% reversible with no side effects. 

Quotient Sciences is conducting the Phase I study from its Nottingham, UK clinic. The Phase I study will investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending oral doses of YCT-529 in 16 participants (2 cohorts of 8 subjects). Cohorts 1 and 2 will be dosed in the fasted state in Periods 1 and 2. Each cohort will receive two doses of study drug separated by a washout period. One cohort will then return for a third dose of study drug under fed conditions in Period 3 to study the effect of food on YCT-529.

Read the press release from YourChoice Therapeutics

Read coverage of the news in a recent article with STAT

Subscribe to