Interview: Quick learners
Quick to Clinic is an initiative offered by Patheon. Anil Kane, executive director, global head of formulation sciences and Alan Lahaise, senior director, Europe business development, spoke to EPM about what’s behind the offering, how it can be of benefit and how this version of the program has been finely tuned for improvement.
Tell us about Quick to Clinic - what is it and what sets it apart?
AK: The Quick to Clinic offering includes a month of clinical trial stability studies, provides customers access to six flexible dosage forms and decreases the wait time from receipt of API for clinical trial materials for First in Human trials by one month. The updated program offers customers the ability to meet their unique scientific requirements with capabilities spanning from formulation development and manufacturing to clinical packaging and distribution. Patheon is now the only CDMO to offer customers an accelerated 12-week clinical trial material program with stability data with a variety of flexible dosage forms. Patheon applies phase appropriate analytical method qualification and verification and the use of disposable equipment for manufacture where feasible, which allows us to speedily manufacture clinical material. Patheon uses standard templates for documents such as ‘manufacturing batch record’ thus enhancing the readiness of clinical supply manufacture
What prompted the move to update it?
AL: We received feedback from the market and from our sales team that our previous Quick to Clinic offering of four months was not considered quick and didn’t offer sufficient dosage form or geographic options. We have addressed all these concerns in our new Quick to Clinic refresh.
How has Patheon ensured no loss of quality now the scheme has a shorter time frame?
AL: Patheon has robust but flexible quality systems that allow us to manufacture GMP material for clinical supplies. We have an inventory of GMP released commonly used excipients that reduces the time required to make the material available for clinical batch manufacture. Use of trained operators, qualified equipment, pre-formatted documents and other quality systems ensures that quality is not compromised while bringing speed to the manufacture of clinical supplies.
What does the company have planned for the rest of the year?
AK: Quick to Clinic is only one of the many offerings and services available to customers from Patheon and is focused on faster results in the development phase. As a leading provider of contract development and manufacturing services to the global pharmaceutical industry, Patheon is responding to the needs of all customers with unique services and has recently expanded its overall capabilities by adding small molecule API and biologic drug substance capabilities to the broad array of solid oral and sterile dosage form capabilities. Additional offerings and capabilities will be announced in the coming months to help customers simplify their outsourcing needs and achieve their goals faster.