By gathering many of the functions needed for development of a potential pharmaceutical candidate under one roof, RISE offers a unique partnership in drug discovery and development to all instances, ranging from small university-affiliated start-ups to large pharmaceutical companies.
The development of new medicines requires both a structured process and access to specialists in several areas.
“Within RISE, we have the expertise to support our customers right through the process, from the development of a drug candidate drug through to clinical trials” concludes Håkan Hollmark, Sales and Marketing Manager at RISE.
Pharmaceutical development of a substance with the potential of becoming a novel medication encompasses, among other things, toxicological risk prediction and testing, bioanalysis, synthesis, crystallization, formulation and tests of the possibility to scale up production. Everything required for this is in place at RISE. And if the need arises, we have a comprehensive network in the academic community that we cooperate with for out-sourcing of specialized tasks.
“Much of this can also be performed individually in “budget” countries, but we have gathered everything “under one roof” and also offer added value in that we continuously guide our customers through regulatory discussions and decision-making and help them make smart decisions that ensure effective use of time and finances. We take responsibility for a project from start to finish, even if problems pop up along the way” remarks Håkan Hollmark.
Solid background in industrial research
The operations are performed mainly at AstraZeneca’s site in Södertälje. When AstraZeneca discontinued its research and development in the city in 2012/3, several of the researchers in Process Research and Development were recruited to RISE, which also took over some of the premises. This was further strengthened in 2019 by the addition of colleagues from the former Safety Assessment department of AstraZeneca, who provide considerable experience in both scientific and practical aspects of preclinical safety assessment of drug candidates.
Together this entails that current employees have an extensive industry research background and access to state-of-the-art production and test laboratories. Using our collective technical expertise and considerable experience of how pharmaceutical companies work, we focus on strengthening customers development projects, whilst the customer retains all IP rights.
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“When it is time to test up-scaling of production, we can build up a small “model factory” where everything is mobile and can be rebuilt for each project” explains Håkan Hollmark.
Biological medicines are the future
Today, pharmaceutical development is increasingly shifting away from traditional “small molecule” based therapies towards medicines based on biological molecules, such as antibodies, peptides and DNA/RNA-based molecules, that can provide a more effective and potentially individualized treatment for patients compared with traditional drugs. RISE has identified this as a future area of development and, among other things, has state-of-the-art expertise in formulation, drug delivery and controlled release of biological medicines. We have also good experience in safety assessment of these novel therapeutic entities
“We rely on a firm foundation and we are very strong in these areas,” Håkan Hollmark notes.
Since 1 January 2019, there has been a unit for safety testing and safety assessment of drug candidates in RISE. The unit with its own test laboratories has experts and staff with many years of experience from the pharmaceuticals industry.
We know how a pharmaceutical company works
At present, around 140 people, of whom two thirds hold PhDs, work with issues concerning pharmaceutical development in some form at RISE. Together, they currently work with more than 100 customers, both in Sweden and abroad.
“Among other things, major international pharmaceutical companies choose to use us as an extension of their own research and development operations. This is witnessed in the fact that they sign FTE agreements with RISE, which means that there is a full-time employee here with us who is at the company’s disposal during a pre-defined period, often over years,” says Håkan Hollmark.
“These companies essentially see us as a department within their own company. We know how a pharmaceutical company works” concludes Håkan Hollmark.