Complex drug formulations, stringent regulatory standards, and a tough capital landscape are creating pressure for drug developers as they approach clinical trials. At this stage, a wrong decision could mean significant delays to a product’s timeline, increased costs, and even jeopardise the success of years of research.
More than ever, drug developers need strategic thinking and expert support to begin their in-human trials. During this critical early development stage, the right Contract Development and Manufacturing Organisation (CDMO) can be more than a valuable service provider—they can be a vital partner.
As Director Supply Chain and Project Management at Vetter, my colleagues and I have successfully partnered with various customers from large pharma to start-ups to bring their new molecules through the process of clinical manufacturing for their in-human trials. Up to this point, Vetter has successfully conducted over 1,000 batch fills at its two clinical sites in the U.S. and Austria. In this article, I will outline how drug developers can focus on their key competencies but also what they have to consider to start the challenging path through early clinical phases.
Begin by Finding the Right Outsourcing Partner
Most pharmaceutical and biotechnology firms have expertise in drug development but may lack the necessary infrastructure, specialised knowledge, experience, or resources to manufacture clinical trial materials (CTM) at scale. This critical step of drug product development requires precise formulation, packaging know-how, and regulatory documentation, all of which are essential to manage the integrity of the in-human trial.
Fill and finish CDMOs focus on providing the CTM, such as filled vials or syringes, in accordance with regulatory standards. The drug products and accompanying documentation are then provided to the drug developers, who use them in their clinical studies. The global clinical trial supplies market size was estimated at USD 2.58 billion in 2023 and is anticipated to grow at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2030. As this market grows, selecting the right filling CDMO becomes even more critical for supporting a successful clinical trial. Here are some steps drug developers can take to evaluate and select the best partner for their unique molecule:
Step 1: Conduct Comprehensive Research
Before starting the search for an outsourcing partner, it’s critical to thoroughly research potential partners that align with your criteria. Leverage resources such as online databases, industry publications, peer recommendations, and testimonials to gather insights. Check for important credentials like regulatory compliance. Gain an understanding of the different niches of potential partners, as some may have specific core competencies.
Step 2: Set Clear Objectives and Expectations
Having a solid understanding of your needs will help streamline the selection process and effectively communicate key requirements. Knowing your objective ahead of time will allow a potential partner to understand your needs.
Step 3: Assess Fit and Compatibility
After narrowing down your options, evaluate the compatibility of potential partners with your needs. This can be achieved through consultants, interviews, site visits, reference checks or even audits. It’s important to confirm that the partner’s culture, values, and vision align with your own.
Long-term partnerships are built on early alignment and strong relationships. We currently work with a wide range of customers from over 20 different countries. These include the global big pharma and biotech companies, as well as start-ups developing their first compound. Looking more closely at our early clinical business, around 70% of our clients have less than 200 employees. Each customer and their molecule require a different approach, making each project unique.
Pay attention to their communication style, transparency, and how they manage feedback and change. Trust, respect, and collaboration should also be key factors in your decision-making process. Even if they are a top-performing service provider, they may not be the right fit for every drug development company. There is no harm in passing on a five-star partner if they’re not suited for your specific needs. When exploring partnership options, remember to think beyond current requirements. Look for a CDMO that can help meet the immediate milestones and support throughout the entire product life cycle. Even better, look for a partner that is making investments in capacity now to allow room for expansion in the future.
