Small biotech companies getting started with their first early phase clinical trials have particular characteristics and needs to be considered.
The structure, resources, necessities, and expectations of small biotechs are not the same as those of larger pharmaceutical companies that are already selling approved medications.
Emerging biotech with promising molecules have the potential to bring great game-changing compounds to the market but they need to surround themselves with strategic partners that can make the most out of their available resources and planned investments.
A common set of needs typically shared by many small biotechnology companies include the necessity for: (1) small-batch drug manufacturing for early phase clinical trials, (2) a dedicated and flexible CRO for clinical trial management.
In this article we are going to discuss these two aspects in more detail.
Small-Batch Drug Manufacturing for Early Phase Clinical Trials
Biotech firms working on their initial drug development stages normally need to manufacture small batches of drugs for their early-phase clinical trials (e.g. first in human, phase 1 studies needing 2,500 vials of an injectable compound).
Early-stage clinical trials typically recruit a small number of participants as phase 1 studies seek to evaluate drug safety in reduced sample sizes (i.e. around 15-20 patients). If a biotech company is focused on executing its first phase 1 trial, its management team will not be seeking to produce large amounts of drug.
However, manufacturing drugs in small amounts can be quite challenging depending on the type of production technology needed. Clinical trial sponsors usually get their drugs manufactured by subcontracted vendors known as contract development and manufacturing organizations (CDMOs). Externalizing drug manufacturing tasks is the general rule nowadays.
The main problem arises when CDMOs do not have the required flexibility to accommodate small manufacturing runs in their production lines. Different pharmaceutical compounds require different manufacturing techniques, machines, and methods, and not all CDMOs are capable or willing to invest in customer-specific configurations if the orders are not substantial.
Therefore, small biotechs frequently find difficulties to manufacture reduced amounts of drug in the required timelines, and they may have a very hard time to find the right partner that can offer them the flexibility and responsiveness they need.
How can biotech firms overcome this difficulty? After more or less search efforts, and after signing more or less CDAs with potential vendors, clinical trial sponsors will end up finding a convenient CDMO partner, but this search can get painful sometimes.
In front of this scenario, working with a clinical research organization (CRO) well connected with the CDMO space can be useful. Even though the core business of most CROs is to manage clinical trials, some of them collaborate with CDMOs that manufacture different types of pharmaceutical compounds. After knowing the type of drug the sponsor is seeking to produce, CROs can recommend the best CDMO partner in each case.
Sofpromed is a full service CRO having strong collaboration links with CDMOs around the world. We facilitate drug product manufacturing services (solid oral, liquid, semi-solid, and freeze-dried forms), with particular expertise in aseptic, non-aseptic, and high-potency fill and finish. We have partners with great flexibility to manufacture small batches for early phase clinical trials.
A Dedicated and Flexible CRO for Clinical Trial Management
Another major and very common need of emerging biotech companies is to count on the support of a dedicated and flexible CRO for clinical trial management.
Clinical trial sponsors have a variety of options when selecting the CRO they want to work with. Certainly, there are CROs of different sizes and all of them can do a great job, but there is a trend in the market that biotech companies should be aware of: small-sized CROs normally offer a closer service and more flexibility.
As it happens in other industries, the larger the size of a vendor, the bigger its internal structure, which often has an impact on service flexibility and bureaucracy. Large vendors may also tend to prioritize key bigger clients, giving them huge business. In addition, the prices offered by multinational companies are typically higher than those provided by smaller suppliers, as they have to cover the costs of heavier structures.
These realities are not different when we talk about the CRO market. Small-sized CROs are actually able to compete with global CROs by offering increased flexibility, more personal client support, and more competitive quotes, yet maintaining satisfactory quality standards.
Biotech companies immersed in their early stages of drug development should consider small-sized CROs in an intent to get a more responsive, agile, and cost-efficient service when conducting their initial phase 1-2 clinical studies. Small CROs are commonly a good choice for small biotech firms.
Sofpromed is a small-sized CRO with a good understanding of small biotech needs. Many of our clients are emerging biotechs getting started with their first clinical trials, and we provide them with the personalized support they need, at competitive prices.
Biotech startups can benefit from selecting small CROs.
By choosing small-sized CROs, clinical trial sponsors are likely to get more dedicated and personalized attention, flexible solutions, and the possibility of making the most out of their investments.
There are great big and small CROs out there but, at the end of the day, the best CRO for an emerging biotech is the one that is able to meet its specific needs.