Schutz von biopharmazeutischen Assets - Warum Sie einen Online-Save und keinen Aktenschrank brauchen

White paper – Protection of biopharmaceutical assets  Paper 1/5 Protection of biopharmaceutical assets Protection of biopharmaceutical assets: why you need an online safe and not a filing cabinet The global economic conditions of the last few years have had a severe impact on many sectors of our economy. One sector that stands out is the pharmaceutical industry, which began to experience significant economic problems over 10 years ago. Compa- nies have been losing patent coverage on blockbuster drugs, have relatively few drugs from their own research laboratories, and have had to underwrite the rapidly escalating cost of developing drugs in the face of steadily declining revenue. Historically these companies have been insular with all critical processes controlled within the well-fortified buildings and corporate networks. Plus, paper was still king. This was combined with the misperception that firewalls offer the best security, and that their assets were in their large infrastructure and shrinking product line. These companies did not spend a lot of time and money on the electronic security of their real assets: their intellectual property, their clinical trial data and their due diligence documents for collaboration and licensing. While pharmaceutical companies were products from the biotechnology com- witnessing this downturn and searching panies to fill their pipelines, and are for ways to off-load expensive legacy purchasing smaller companies to gain systems, the biotechnology industry was access to people, technology and prod- blossoming and growing up. In contrast ucts. And they are using outside CROs to the pharmaceutical industry, biotech and CMOs to keep their overhead down. companies have a different infrastruc- The biotechnology companies, many ture and culture – they are smaller short on cash, are looking to the phar- organizations with low overhead and maceutical companies as licensing part- a culture of collaboration. Much of ners for the development of their the initial work at these companies is drugs. And because of the closed IPO done through close ties to the founders window they look to pharma for exit in academic institutions, and much of strategies. the development work occurs at outside All of these activities are based on use CMOs and CROs. of confidential assets in the form of Despite their different approaches and electronic documents and data – inclu- perceptions, both the pharmaceutical While companies have come to under- ding storage, editing and transmission. and biotechnology companies have stand the value of these assets, they If this confidential information is man- similar real assets. These assets are the have not focused on how these assets aged without a high security solution, backbone of valuation and investment can be lost – through lack of electronic just like in a bank, many costly mistakes in this sector prior to sales of products. security. are made, critical time is lost and the Today is a new era – the pharmaceutical documents can fall into the wrong and biotechnology companies are rein- hands through unintentional disclosure. venting themselves and evolving. The pharmaceutical companies are licensing White paper – Protection of biopharmaceutical assets  2/5 In light of the value of these assets, includes patents, trademarks, copyrights underlying value of all assets under their many companies have implemented and trade secrets. In life sciences a com- stewardship: to make sure that values secure, online collaborative work spaces pany’s IP is being generated every day, are maintained and the assets are effec- for safe filing, editing and distribution especially in the research and develop- tively exploited. Exploitation of IP can of these highly confidential life sciences ment (R&D) laboratories. take many forms, ranging from outright assets within, and between, organiza- These massive amounts of R&D data, sale of an asset to a joint venture or a tions. These web-based document records and audit logs are electronic licensing agreement. repositories, also called virtual data evidence of scientific intellectual pro- The value of the intellectual property, rooms, protect sensitive documents perty that one day could be called upon and ultimately a company, can be from unauthorized internal or external to support claims of first-to-invent and destroyed when intellectual property attacks, and document all activity in a ownership. Unfortunately, if one of security is compromised. To maintain the tamper-proof audit trail. these electronic records or data files is value, all intellectual property should be tampered with or stolen, the investment managed in a controlled way inside and Business processes requiring could be lost. Prior to patenting, this outside the company with a clear audit protection of electronic assets information is not protected in a secure trail detailing who has viewed and/or way – it is often covered only by confi- altered the information. This control and Intellectual property dentiality agreements which have signi- traceability can be achieved through use Patents are usually considered the ficant inherent risk. of secure online work spaces. most important intellectual property One of the key factors affecting a com- (IP) asset for life science companies. A pany’s success or failure is the degree to strong intellectual property portfolio is which it effectively exploits its intellec- of enormous value to life science com- tual property. Corporate executives panies because much of their value is need to know the value of the IP for the derived from them. Intellectual property same reason that they need to know the The value of the intellectual property, and ultimately a company, can be destroyed when intellectual property security is compromised. To maintain the value, all intellectual property should be managed in a controlled way inside and outside the company. White paper – Protection of biopharmaceutical assets  3/5 Clinical trials and regulatory filings Clinical research leading to regulatory filings is a major asset of the biopharma- ceutical industry. Developing the clinical trials and the clinical data is time consu- ming, extremely expensive and faces many hurdles including regulatory compliance (21 CFR Part 11, GCP, and HIPAA). Clinical trials can fail due to things outside of the sponsors’ control, i.e., the drug did not work. But they can also fail due to lack of proper security precautions, which is something that can be controlled. In life sciences it is essential to have security policies and SOPs that address the electronic security Licensing due diligence Companies in the industry are always in of the application, network, system With big pharma’s blockbusters going need of cash, and with big pharmaceuti- software, and databases. In order to off patent and their difficulty in new cal firms cash-rich and in desperate need perform clinical research at Yale Univer- drug approval, these companies have of pipeline drugs, M&A and licensing sity for example, companies must pro- turned to licensing technology from activity has been rapidly increasing. vide the following: biotechnology companies as a major Licensing involves the unveiling of all › Description of all sites where data will component of their business develop- of the intellectual capital of a company, be used or stored; ment activities.