Dr. Feussner, can you share from both your personal perspective as well as Vetter’s day-to-day experiences what the biotech environment looks like today? In particular, what are some of the key factors within this environment that small companies with drugs in early development are currently facing?
As we have seen over the last several years, drug development costs have continued to rise which has consequently led to higher risk, especially for small biotech companies with very limited budgets. Given the cost of bringing a drug through the development phases, even a minor error in their development process can lead to financial catastrophe for the company.
Therefore, smaller companies often find that they are most successful when they focus on their core competencies, which is drug discovery. Nevertheless, maximizing the value of the complete drug package is critical. Such a package is comprised of a combination of the compound itself, the drug-delivery system, and, of equal importance, the experience and trust the company places in its partners in the early stages of development. Therefore, early and careful planning for the future can usually offer a significant advantage and higher potential for the compound itself and, as a result, help enable the business success for all parties involved.
To answer your question succinctly, there are many factors that influence the ultimate success or failure of biotech companies when it comes to drug development. Therefore, a small biotech company today needs be as knowledgeable as possible about the process itself and, just as importantly, work closely with trusted partners to enable a positive outcome.
You refer to minor errors that can result in major consequences. Can you elaborate on this a little?
I would be happy to. To do this, however, it is helpful to have a look at the process of early drug development:
In order to navigate this process and to manufacture biotechnology drugs successfully, it is critical that every party involved have significant experience and process planning knowledge. For example, APIs that are based on biological processes consist of large, extremely complex molecules that are easily affected by outside environmental influences such as heat and light. Therefore, extremely high standards in their manufacturing and handling are required.
Because smaller biotech companies sometimes lack the necessary resources to successfully manage the manufacturing of the drug product, opportunities for better outcomes are often wasted, and suboptimal or negative outcomes are the result.
Is it safe to say that having positive cooperation with a single partner, or multiple partners, is a good way to increase the potential for successful drug development?
This is certainly the case not only for successful drug development, but also for overall “drug success.” In other words, having the right partner from the start can also increase the entire drug package’s value from development on through to market. This is an ideal that small biotech companies should strive to achieve.
Whether or not to partner is not really the question since any small biotech company needs to partner due to limited in-house resources. But choosing the right company to partner with is the critical decision. And small biotech companies have choices. They can either choose the “multiple partner approach,” or rely instead on just one partner that offers more of a “one-stop shopping approach,” such as that found with a Contract Development and Manufacturing Organization (CDMO).
Often, small biotech firms use a variety of partners. However, from our perspective and from what we have experienced in a lot of cases, such an approach is likely to increase overall costs and add additional risk to the entire development process, for example, in transfer activities associated with technology and expert knowledge.
If you were a small biotech firm, what would you see as the most important benefit for utilizing the services of a CDMO rather than a variety of service providers?
Overall, it can be said that keeping the number of service providers to a minimum is always a reasonable approach since it minimizes factors such as complexity, various interfaces, and daily handling efforts. There are, of course, other more specific contributing factors to be considered as well, including the retention of product and process knowledge, avoiding duplication of activities, and reducing overall timelines.
Partnering with a trusted CDMO early in the process will most likely offer a better opportunity of success since such organizations are acting in your best interests from the very start:
A trusted CDMO will act as both a guide and consultant given their ability to offer essential and important development support necessary for complex compounds, including fill and finish operations.
They can also act as a contributor to achieving an attractive, high-value drug package by lending their good reputation to the package and, therefore, to the biotech company itself. This only increases the likelihood of getting the attention of a large bio/ pharmaceutical company that might currently be following an acquisition or in-licensing strategy.
Finally, they can also act as an interface between a small biotech firm and its later bio/pharmaceutical counterpart, understanding the business situation of parties, as well as their targets and challenges.
From the other side of the table, what do you see as the key benefits of this type of cooperation for the large bio/pharmaceutical company following an in-licensing of a compound, or the acquisition of a small biotech company?
That is an excellent question. The advantages for the acquiring or in-licensing company are equal. That is because CDMOs, by their very definition, are adequately equipped and experienced to support the complete development of a drug product from early development on through, and including, launch and market supply. A development product’s handover from the small company to the large one with the help of a CDMO can run smoothly, avoiding the need for switching from one contractor to another, and thus, enable this project to continue as seamlessly and flawlessly as possible in its further execution.
Additionally, the hard-won knowledge and respective data that were gained regarding the compound and process experience are available and able to be applied for later processes. This is clearly a significant advantage for the larger company. Having these features already in place enables them to optimize processes, thus accelerating time-to-market.
In summation, it remains the choice of a small biotech company on which company or companies they wish to partner with in their drug development. We see our role here as sharing our company experiences with them and encourage them to make their decision with the final target in mind, and right from the start where the complex process of drug development really begins.
Dr. Claus Feussner, Senior Vice President, Vetter Development Service, Vetter Pharma-Fertigung GmbH & Co. KG, is responsible for the company’s development centers in both Ravensburg and Chicago. Vetter is an independent international contract development and manufacturing organization (CDMO), headquartered in Ravensburg, Germany, with a clientele that includes the world’s leading pharmaceutical and biotechnology companies.
Dr. Feussner’s responsibilities encompass the divisions of Chemical Analysis, Process Development and Implementation, Packaging Material Development, as well as the newly created department of Innovation Management. He joined Vetter in 2010 as Vice President, Quality Control. Dr. Feussner was named to his current position in September 2014.
Dr. Feussner began his career in 1997, and held a variety of positions of increasing importance at international pharmaceutical companies, including head of aseptic manufacturing, director of Quality Control, and Qualified Person. He holds a PhD in Natural Sciences from the Julius Maximilians University in Wurzburg, Germany.
Dr. Feussner is a board member of the German QP Association (GQPA), as well as a member of the German Pharmaceutical Society and the Parenteral Drug Association (PDA).