Well-trained personnel are the backbone of successful and innovative therapy development. In this sector, where various disciplines converge, there is a need for an integrated educational offering focused on methodology, ethics, regulation and other crucial aspects of clinical research and therapy development. Here, Jeroen van Smeden (education director at Centre for Human Drug Research) and Stan van Belkum (director at Central Committee on Human Research) explain why the five-party education consortium is committed to doing just that. “The time has come to launch a broad curriculum. The three applications we have submitted to the PharmaNL Human Capital Growth grant program can contribute to that,” Van Smeden believes.

“If you want to be successful as a researcher in developing drugs, then, in addition to sound substantive knowledge, you also have to be aware of other aspects, for example, about the routes you have to go through on the way to market admission. We see that academic researchers do not always know enough about this. On the other hand, so much is happening that even the pharmaceutical industry and government organizations such as ethics committees find it difficult to keep up with all the developments. In short: there is a need for a broad curriculum that includes all aspects of drug and therapy development,” says Van Belkum. “Drug research is incredibly expensive, lack of clarity about rules or mistakes in applications does not make it more efficient or cheaper. Good education is going to help counteract this. In the end, the end result will be achieved faster and generally improve if knowledge is in good order at all parties,” adds Van Smeden.

Need for broad curriculum
There has long been a national need for education around therapy development. Back in 2018, a letter of intent was signed by a number of interested parties. “We were not always speaking the same language for a long time and there was too little coherence. With that declaration of intent, we expressed that we want to join hands and that a joint, interdisciplinary approach is the only way to go. We are pursuing the development of a complete curriculum: with education and training programs for graduates in (bio)medical and pharmaceutical sciences. A curriculum that covers all aspects of the therapy development process,” says Van Smeden.
Van Belkum continues: “When I entered the Central Committee on Human Research (CCMO) three years ago, I saw a great educational need among our staff and committee members of medical ethics review committees (METCs). There are many developments, in terms of content – think of gene and cell therapy – but also because of changing European laws and regulations. Reviewing research proposals has become more complex as a result. As far as I am concerned, it is a no-brainer that we are committed to broad and up-to-date education in therapy development with all relevant parties from across the sector through the education consortium.”

Parties educational consortium
The educational consortium has brought together the CCMO, the Center for Human Drug Research (CHDR), the Medicines Evaluation Board (CBG), the Dutch Association of Pharmaceutical Physicians (NVFG) and the Dutch Association of Clinical Pharmacology and Biopharmacy (NVKFB). And there are discussions with some other parties who want to get in, such as the Dutch Association of Hospital Pharmacists (NVZA) and the Dutch Association of METCs (NVMETC). FAST is involved as a facilitating party. “Anyone involved in therapy development and its review is welcome. To ensure independence, we will work with non-profit organizations. The European Medicines Agency (EMA) is also interested in what we are doing. They will not formally participate but want to cooperate with us. Because in Europe, too, there is a need for a broad integrated approach,” Van Belkum said.

From plans to actual implementation
“After the letter of intent, we started working on a first draft of the curriculum and looking for grants. But that proved difficult, also due to corona. We are in the starting blocks, have a lot ready to go – including students who are eager for it – but lack the resources to free up the people from the five parties who have to do the development work for it. In the meantime, we have developed a pilot online basic course on clinical pharmacology (‘Assessing an IB’) for the target group of all five parties. Now it is important to get continuity in this and that is why we have submitted three applications to PharmaNL,” Van Smeden explains.
The goal of the PharmaNL Human Capital Growth program is to develop pharmaceutical training offerings that contribute to ‘life long learning.’ Projects could be submitted within five prioritized themes from PharmaNL’s investment agenda. “If our project ideas submitted in January are approved we will submit the more detailed grant applications in May. In late September or early October we will hear whether the applications will be honored. Hopefully they will be and we can finally really get started,” Van Belkum stressed.

Serving 10,000 people
Van Smeden: “We want a broad curriculum and that is also what is reflected in all three applications. They are broad courses on therapy development, which includes preclinical research and monitoring once a drug enters the market and everything in between. The difference between the applications is in the themes; we focus the applications on prio 2, 3 and 4 of PharmaNL’s investment agenda: Drug delivery capabilities + Advanced & emerging therapies; Early discovery infrastructure and Molecular Diagnostics and Imaging. The basic knowledge is identical for professionals working in these three themes, and has great overlap. Therefore, we ultimately want to build our curriculum in a modular fashion. In addition, we want to offer the curriculum at three levels (see Figure 1). “These applications align 1-to-1 with what we stand for as a consortium. We made a rough estimate of how many people we could serve from our respective constituencies alone with the educational offerings. With an initial estimate of about 10,000 people, it’s a huge potential audience. And that’s not counting potential candidates from the pharmaceutical industry and Europe,” Van Belkum states.

Jointly from the same interest
“The cooperation between the knowledge-intensive organizations within the consortium is important for the future of innovative therapy development in the Netherlands. We are convinced that good training throughout the career contributes to better development of new and innovative therapies. With the goal of getting new therapies to patients faster and more efficiently. Everyone contributes their own knowledge and expertise. We condense all available knowledge into a curriculum and step one is to actually implement it. The next big task is to keep the curriculum up-to-date. In addition, it must be and remain virtually free,” Van Belkum explains.
“We don’t have a profit model. It is not the intention that 1,500 or 2,000 euros must be laid down to follow an educational component. Perhaps a small contribution to continue to break even, continue the education and keep it up-to-date. That the curriculum will be practically free to access is one of the things that makes it unique. Furthermore, the open and broad nature of the consortium is unique, and of course that the consortium is both the target audience and at the same time the expertise. We have expressed our commitment to move forward with the parties involved and signed a framework agreement. Above all, we are very much looking forward to getting started,” Van Smeden concludes.