Shortcomings in the framework for clinical trials, little knowledge of intellectual property law and an awkward relationship between scientists and technology transfer offices are holding back science-industry collaboration, but work is in hand to change things
Medical researchers in Poland have plenty of good ideas and the intellectual capacity to pursue them, but they are having a hard time building effective drug discovery partnerships with industry.
In Poland, scientists show “huge resistance” when it comes to working with industry, said Duncan Holmes, head of Discovery Partnerships with Academia (DPAc) at GlaxoSmithKline. “But I come here open minded,” he told delegates at Pharma Day, a meeting held to highlight the barriers to effective collaboration between research and industry, in Warsaw last month.
The meeting of medical scientists, IP specialists and representatives of big pharma was organised by BASTION, an EU funded project that aims to reduce the time from scientific discovery to clinical application.
Poland has got great scientific heritage and Holmes said that is one of the reasons why big pharma is still looking for investment opportunities there. However, Polish scientists have got to be open to this interest. “Big pharma will not keep coming unless you are willing to stand up and talk about the research you are doing,” he said.
Overcoming this reticence would allow scientists to capitalise on the economic potential of their research and meet the industry halfway.
In recent years big pharma companies have put significant effort into setting up dedicated units with a brief to improve interactions with academics, Examples include the Johnson & Johnson innovation centres, Pfizer’s Centres for Therapeutic Innovation (CTI) and GSK’s DPAc programme.
GSK’s DPAc programme is looking around the globe for 10 to 15 partnerships with researchers that “undertake the best science” and “are focused on drug discovery,” said Holmes. These partnerships can be set up across any geography and in any therapeutic area, with the researchers sharing both the investment and the rewards with the pharma company.
Another example is Pfizer’s CTI. These centres are separate research units with a focus on entrepreneurship which, “serve as accelerators for projects in academic research,” said Olga Krylova, Senior Director for External R&D Innovation at Pfizer. Researchers can tap into Pfizer’s know-how in regulation and commercialisation. Since 2010, Pfizer’s CTIs have, “evaluated over 1,000 proposals of which two have already reached the clinical development phase,” Krylova noted.
For the moment, there are obstacles on the road to fruitful collaboration between science and industry in Poland, including an incomplete legal framework for clinical trials, little awareness of intellectual property law, and the awkward relationship between scientists and technology transfer offices.
Incomplete legal frameworks
“The Polish law on non-commercial clinical trials is very poor,” said Ewa Rutkowska, an expert in pharmaceutical law, healthcare law and product liability. “But there are sparkles of hope,” she said. The Polish government is in the thick of preparing an amendment to the pharmaceutical law that opens the door to non-commercial clinical trials.
Researchers complain about not being able to use equipment paid for by the EU in clinical trials sponsored by industry. This is sometimes prohibited by the rules of the funding. “These kind of situations block science-industry cooperation and the progress of science,” said Rutkowska.
Some of these obstacles could be avoided if Poland was more engaged in EU funding mechanisms and programmes such as Horizon 2020 and the Innovative Medicines Initiative, argued Janusz Bujnicki, head of Laboratory of Bioinformatics and Protein Engineering at the International Institute of Molecular and Cellular Biology. Poland, “Is not involved in designing EU funding mechanisms,” he said.
Another hole in the Polish legal framework is a lack of special provisions to ensure the transparency of science-industry collaborations. In healthcare, “cooperation is inevitable, but let’s do it in a fair and transparent way,” said Rutkowska. To achieve this, stakeholders should be more proactive and “encourage decision makers to implement laws that offer incentives and not obstacles,” Rutkowska recommended.
Last but not least, the Polish tax law lacks key provisions relating to the fiscal status of research grants coming from industry.
No IP, no commercialisation
Until last year the Polish IP law was not clear about who actually owns a patented invention, causing much confusion between scientists and research institutions. A new law, “is a good direction, but it’s still not perfect” said Rutkowska. There should be more flexibility, enabling scientists to earn money from their inventions.
In addition, a low level of IP awareness can be a barrier in the drug development process, said Magdalena Tagowska, patent attorney at PATPOL. Scientists in Poland overlook many important details. They “do not look into the patent database and many get heartbroken when they find out their ‘invention’ has already been registered,” said Tagowska.
At the same time scientists are drowning in paperwork and do not have enough energy to do their research and take care of the legal stuff as well, Tagowska said, suggesting this is a burden which could be relieved by technology transfer offices.
Piotr Kaminski, managing partner at Kaminski & Partners, warned scientists about the dangers of publishing research results before legally protecting the IP. Once the results are published scientists will not be able to find partners or investors from the industry. “Publish and be damned,” he said.
Kaminski echoed Tagowska’s view on the low IP awareness of scientists in Poland, arguing scientists must educate themselves about the importance of IP if they ever wish to commercialise their research results.
Technology transfer offices are waiting for scientists to catch up
Tech transfer offices have a crucial role in oiling the wheels of science-industry collaborations. They know about the expectations and the needs of the industry and have the ability to advise scientists on commercialisation opportunities.
However, as things stand “Most drug development projects are at an early stage and are not mature enough to show to investors,” said Maciej Wierzbicki, head of technology transfer at the BioTechMed cluster.
While early stage drug discovery projects in Poland have attracted interest from big pharma there are no successful spin out companies. “I hope that in a few years there will be this very famous Polish biotech company,” said Andrzej Kusmierz, founder & CEO, Idea2Business. Then, “We will be able to say this is the place to come for early stage drug discovery projects.”
A survey of scientists, experts, tech transfer officers and investors conducted by Idea2Business, suggested that to speed things up, Warsaw needs an independent biotech incubator. “Leaders of the best research teams said they have many ideas and would like to have a place where they can go freely without being defined collaborators of existing institutes,” said Kusmierz
How Poland can play to its strengths
“Poland should play to its strengths and find its competitive advantage” said Marcin Makowski, associate director for Centralised monitoring at AstraZeneca. “[Poland] has the capability to recruit a lot of patients in early phase clinical trials,” said Makowski. “Our biggest asset is the quality of human resources.”
To tackle the shortcomings in science-industry collaboration in drug development projects, Bujnicki suggested there should be more interchange with Polish scientists and business representatives from abroad.
This view was echoed by Duncan Holmes. “More dialogue between the different groups involved is really valuable,” he said. Big pharma companies will not invest in universities where there is no, “form of engagement to drug discovery,” said Holmes.