In this article by Manufacturing Chemist, Annabel Kartal-Allen and Thierry Van Nieuwenhove discuss the impact of next-generation oral dosage therapeutics, AI and the Quotient Sciences drug development platform on the pharmaceutical industry.

Thierry Van Nieuwenhove highlighted the surge in interest for oral dosage forms in treating obesity, noting the potential of GLP1 analogues and other incretin hormones to offer more therapeutic options. 

He also speaks about the transformative role of AI in drug discovery and how AI’s predictive capabilities could further expedite drug development, granting patients quicker access to necessary medications.

At the forefront of innovation, Quotient Sciences continues its strategic partnership with Charles River Laboratories, aiming to expedite the drug development process from candidate selection to IND application.

To read more, check out the full article here on the Manufacturing Chemist website.

In this Pharmafile Magazine article Nazim Kanji and Huw Jones explore the orphan drug development and the benefit of CRO/CDMO collaboration, specifically in terms of pediatric rare diseases.

The development of therapeutics for the treatment of rare diseases can present several challenges to drug developers. The number of rare diseases that impact children make it clear why there is a demand for more pediatric medications that are appropriately designed and optimized for young patients.

Nazim Kanji and Huw Jones discuss benefits of CRO/CDMO collaboration and address the unique challenges of developing treatments for orphan, rare, and pediatric diseases. These partnerships help in creating patient-centric dosage forms, speeding up clinical trials, and customizing manufacturing to meet patient needs. Regulatory incentives in the US and EU support these efforts, ensuring timely and effective treatments for conditions that predominantly affect children.

To read more, check out the full article here on the Magazine Pharmafile website.

Ensysce Biosciences, Inc. (NASDAQ:ENSC), a clinical stage pharmaceutical company developing innovative solutions for pain relief that reduce the potential for opioid abuse and overdose, recently announced the renewal of its collaboration with Quotient Sciences to undertake the study PF614-MPAR-102 to examine and evaluate the full commercial dose range of the PF614-MPAR drug product.

The Phase 1b study, PF614-MPAR-102, will evaluate opioid release following administration of PF614-MPAR at ascending doses. Quotient Sciences' Translational Pharmaceutics® platform for drug development will be again used to manufacture and test the PF614-MPAR drug product, providing expedited clinical study progress.

Read the announcement on Ensysce's website

Read the Ensysce Biosciences case study

In this piece with Pharmaceutical Outsourcing, Nazim Kanji, Executive Director of Pediatric Services, speaks on current trends in the pediatric dosage form market and offers insight on how these influence product development strategies.

Nazim discusses his experience working with sponsor companies, highlighting the growing interest in developing a wide and full range of liquid and solid dose formats, noting a common preference for a single formulation that can be flexibly dosed to a wide age range of children and in dosage forms such as solutions, suspensions, powder for reconstitution, minitablets, and sprinkles. He also addresses key factors in determining product development strategy.

Nazim discusses the major challenges faced by pharmaceutical companies in developing pediatric dosage forms, particularly concerning safety, efficacy, and palatability. He touches on important factors to consider in initial stages and after formulation development in order to develop an acceptable pediatric product that achieves clinical, regulatory, and commercial success.

He also speaks on the issue of dose accuracy and variability in pediatric formulations, considering the diverse age groups and physiological differences among children. Nazim says, "Dosing is generally done in bands that are based on age, weight, or body surface area, with oral liquid formulations and minitablets among the most popular choices for their acceptability and efficacy in younger patients. Modeling and simulation can also be used to aid dose extrapolation from adult data and predict the in-vivo performance of a dosage form in children."

To read more, check out the full article here on the Pharmaceutical Outsourcing website.

Dr. Andrew Lewis, Quotient Sciences’ Chief Scientific Officer, has been recognized by the Controlled Release Society (CRS) as a recipient of the 2024 Distinguished Service Award.

CRS established the award in 1994 to recognize CRS members who have exhibited exceptional commitment and service to the organization. Winners are selected by the CRS Board of Directors, composed of senior leaders and executives from academia and the pharmaceutical and biotech industry. An award ceremony will take place in July at the annual CRS global meeting in Bologna, Italy.

The Distinguished Service Award is not automatically given each year to a CRS member but only in cases where an exceptional member fits the criteria for having given sustained and outstanding service. Several factors determine a person’s eligibility for the award, including the person’s contributions to the development of high-impact, sustainable initiatives for the organization, the understanding and delivery of science and technology to various audiences, and the enhancement of the organization’s global membership and reach.

“Since its inception, the CRS has established itself as a world-leading organization for delivery science, providing forums for collaboration and knowledge sharing that have led to the development of many products that improve the quality of life of people globally,” said Dr. Lewis. “I am honored and humbled to be recognized for my contribution and thank the CRS for this award.”

Dr. Lewis has been a member of CRS for 20 years and has actively contributed to its development on a range of initiatives, including the Membership Committee, Scientific Advisory Board, and two tenures on the Board of Directors as Director-at-Large and most recently as Secretary.

Read the official announcement here.