The right outsourcing partner should open up access to expertise and technical capabilities in a broad range of dosage forms to ensure commercial success.
August 1, 2020
Volume 2020 Supplement, Issue 3
Page Number: s6-s9
By Felicity Thomas, Pharmaceutical Technology
As the need for innovation in drug development is increasing, so too is the requirement for companies to partner with a contract development and manufacturing organization (CDMO) early on in development. To find out more about the importance of considering the end-user and the role of an outsourcing partner in successful drug development, Pharmaceutical Technology sat down with a panel of experts, including Bora’s own Vice President of Business Development, Lonnie Barish
PharmTech: How are companies taking the end users’ opinions and preferences into consideration, in terms of drug dosage forms?
Barish (Bora): Patient compliance will dictate design of the dosage form. It must be integral/intrinsic to any drug development strategy because compliance and getting the desired effect is paramount. Each dosage form presents its own challenges and that is further complicated by the API. Drug developers should start with the ideal patient delivery for that form and then work on issues with the API to get as close as possible to that ideal delivery. Fortunately, new techniques and mechanisms have or are being developed to deliver challenging APIs towards those ideal forms.’
Role of the CDMO
PharmTech: What role can/does an outsourcing partner play in optimizing a drug dosage form?
Barish (Bora): It’s clear that one of the biggest changes to the pharma manufacturing industry is the increasing reliance on external partners. The shift has been positive for the entire pharma supply chain by promoting quality, innovation, and more efficient drug development and commercialization routes.
Pharma is also relying more on CDMOs to develop and manufacture increasingly complex drugs. It’s well known that more experienced project teams can help accelerate go-to-market schedules, and technical/operational mastery is a prerequisite. However, unlocking an API’s therapeutic value requires sound science, experienced technical expertise, and operational excellence to do it well and meet all commercial, financial, and regulatory expectations.
Companies have been engaging international manufacturing partners for a number of reasons. Some of the initial drivers have been access to lower-cost manufacturing and proximity to emerging markets. While managing costs has been a central theme, access to capacity, technical capabilities, and cutting-edge science have also prompted many partnerships, especially for more commoditized and high-volume products. Securing strategic experience and expertise is a big part of this trend.
F. Thomas, “Opening the Door to Successful Drug Development,” Outsourcing Resources Supplement (August 2020).