The life sciences industry is undergoing significant change on all levels – in terms of business model, global regulatory developments and management of processes. All of these changes pose both opportunities and challenges for companies, prompting them to consider what activities they should manage internally, how and where they should partner and how they should manage new developments.
By Katja Koesterke-Wagner, Sr. Manager, Life Sciences Business Process Services, CSC
Recently, my colleague, Dr Sven Jansen, spoke about the industry becoming more actively involved in the care management process and how this affects the activities related to the traditional role of managing products on the market.
Another ongoing issue for companies is managing the effects of mergers, divestments, product acquisitions, or integrating new business lines within a traditional pharma company, such as devices, combination products or generics. These changes bring with them the need for process and software alignment, and determining how best to manage those changes. Project support and gap analysis from a business process service (BPS) provider can help manage such challenges for the short or long term.
There are also significant submission developments taking place across global markets. Saudi Arabia has been excepting eCTD for some time and is now demanding eCTD baseline submissions for variations and renewals starting July 17, 2016. Going forward, companies will have to consolidate all previously sent submissions – those sent in NeeS or paper – into baseline eCTDs. This will be a major project for companies, requiring them to determine which is the latest version, how many variations there are (ensuring nothing is missing) and consolidate all of that information. With older products, that could be several years’ worth of submissions.
With China being the biggest emerging market, it remains to be seen when they will start on the eCTD bandwagon, especially with eCTD 4 development. The same is true for the other emerging markets such as Egypt, Turkey, the Middle East and Africa, as well as Latin America, to name but a few. While in theory, consolidation around eCTD should simplify processes for companies, each country will possibly have its own guidance, with some variations. Without the proper support internally or with partners, there is the potential for companies to simply copy and paste their eCTDs to other regions, which will inevitably result in errors. In my last blog, I spoke about the effect lean staffing is having on companies’ ability to respond to the rapid global move toward eCTD. Equally, the challenge is for companies to stay ahead of the curve, developing strategies on how to access emerging markets while they are still not on the eCTD format. Differing regulations require appropriate planning to allow submission in these markets.
Centralize while Following the Sun
There is also a growing push by companies to centralize a lot of their submission publishing activities, taking away responsibilities from a lot of affiliates in order to have better control over their data. That brings benefit but it also creates an enormous amount of work for companies. In fact, one company I spoke with is setting up to outsource most of their submissions through service providers.
Centralizing the submission process makes a lot of sense from a regulatory information management and IDMP point of view, but there are time considerations: How do you ensure you have enough hours in the day to get the work done? That’s where a combination of off-shore and even near-shore publishing capabilities is important, giving companies access to skilled regulatory people who are knowledgeable about the submission requirements, and at the same time able to provide security assurance and business continuity in the event of a systems collapse.
Most pharmaceutical companies are using service providers to help with some if not all these processes. But this can add another layer of complication: vendor management. Having multiple vendors support different parts of the process requires oversight of all those moving parts. A BPS partner that can also manage other parts of the process – from submission management, to gap analysis, to data center management, and key standardization activities such as adhering to CDISC standards – removes the complexity of vendor oversight.
Learn more about CSC’s BPS services and how these connect to other key capabilities, including follow-the-sun submission management, process development, IDMP and analytics and join our BPS webinar in August.