Evithé Biotechnology is on a ground-breaking journey to register a botanical drug for FDA-approved use. As a start-up company, Evithé was new to the GMP and drug development process.
Douglas CDMO provided their existing GMP infrastructure to support Evithe’s packing and labeling needs for investigational medicinal products in blinded clinical studies. Douglas CDMO also offered their experience in drug development and the requirements of regulatory bodies to progress Evithe’s botanical drug product to clinical trial.
The Challenge
As Evithé Biotechnology advanced their new botanical drug into Phase I clinical trials, they understood the importance of partnering with an experienced contract development and manufacturing company. Evithé Biotechnology required support in packing and labeling their product for a blinded Phase I trial in Wellington, New Zealand and chose to collaborate with Douglas CDMO to ensure compliance with regulatory requirements.
The challenge lay in adhering to strict GMP standards and blinding of clinical trial supplies, while ensuring efficiency and precision throughout the process, all while meeting target deadlines without delay.
Adherence to GMP is essential for a company to ensure their products are safe and effective for consumer use. Blinding investigational medicinal products (IMPs) and clinical trial supplies removes investigator and patient bias, limiting the potential placebo effect. Whilst Douglas CDMO was not involved in the manufacture of the product, they were responsible for detailing the packing procedures and protocols to meet GMP standards, maintain blinding of investigational medicinal products, and minimize risks that could affect product integrity.
As the product was a botanical tincture requiring cold chain storage and had a high alcohol content, classifying it as dangerous goods, extra considerations were needed to execute the project. Vina Komari, Programme Manager at Douglas CDMO, elaborates on how the team tackled these challenges.
“Our cross-functional team is solutions-focused, regularly consulting with our internal health and safety team, as well as our quality team, to develop a plan that is both suitable and cost-effective for our client.”
Vina Komari, Programme Manager at Douglas CDMO
The Approach
Vina explains how Douglas CDMO tailored its services to meet the needs of the client and the project.
“We make sure to align with the client on the scope of work needed. As Evithé was a start-up, we were mindful of the financial challenges these companies can face at critical points in the drug development process. In this particular case, we didn’t need to apply a full-blown commercial GMP set-up. Instead, we were able to identify what was specific and critical to the project and development stage, and create a pragmatic plan to execute it while upholding quality and regulatory requirements.”
Vina served as the primary point of contact throughout the project, overseeing the planning and execution from start to finish. She describes the approach of Douglas CDMO’s client services as bespoke and integrated.
“We have the existing knowledge; we have an established vendor network; we have the infrastructure; and we have quality and regulatory processes in place. This means we can manage each of these aspects of a project on behalf of our clients and do it in a way that keeps them engaged and involved throughout.”
The Douglas CDMO team’s coordination efforts for this project illustrate this concept. In addition to ensuring strict documentation to obtain GMP certification for packing and blinded labeling, extra efforts were made to collaborate with the clinical trial site and oversee freight logistics from the manufacturing site to the trial site, ensuring smooth supply to the trial site. Douglas CDMO’s integrated services are particularly valuable to companies undertaking clinical trials for the first time. By providing expert guidance and support, we help ensure the successful supply of your IMPs and ultimately commencement of your clinical trial. “Filling the gaps,” as Vina puts it, and doing whatever is necessary to achieve a successful outcome while meeting critical timelines. “We believe in our clients’ mission, and, ultimately, their success is a shared goal of ours,” says Vina.
The Result
Ultimately, Douglas CDMO was able to supply active and placebo blinded investigational products and issued GMP certification for the packing and labeling of Evithé’s IMPs, making it possible to commence the Phase I clinical trial.
Vina credits the open and transparent communication between the team at Douglas CDMO and Evithé for the success of this project. She also details the proactive risk management strategies that were put in place to ensure deadlines were met and progress did not stall. “Our team had backup plans for any possible equipment issues, foresaw and managed risks to avoid problems, and efficiently utilized our internal resources to remain cost-effective and on time for our client.”
Following on from the successful execution of this GMP packing and blinding project for the Phase I trial, Douglas CDMO and Evithé Biotechnology are looking to collaborate on the upcoming Phase II clinical trial for this novel botanical drug.
Cynthia Hunefeld, CEO at Evithé Biotechnology gave the following testimonial of her experience partnering with Douglas CDMO on this project.
“We are really grateful for your team’s support and for making it possible to commence clinical research in New Zealand. It is an honor to work with Douglas CDMO and learn from their extensive experience. We are blazing a trail for botanical drug development. Thanks again, Vina & Vazi, for your knowledge; your attention to detail is admirable. I’m looking forward to working with you again in the near future.”
Cynthia Hunefeld, CEO at Evithé Biotechnology