AMPLEXOR recently staged its 19TH annual life sciences conference, BE THE EXPERT 2017. Across three days of debate, discussion and presentations in Budapest, delegates learned more about some of the issues facing the life sciences industry in 2017 and also about some of the technological solutions that are available to address these issues. Elvis Paćelat, Vice President, Life Sciences, AMPLEXOR, gives an overview of what was discussed and where he feels the industry is heading.
Every year for the last 19 years, AMPLEXOR has been lucky enough to attract some of the biggest names in life sciences to our annual conference. BE THE EXPERT 2017 was no different. A stellar line-up of speakers gathered in Budapest in May, to talk life sciences and outline their vision for the future.
Attendees enjoyed a fascinating series of presentations, and over the course of the event a number of themes began to emerge. First is that life sciences is an industry be set by ever-increasing regulation and struggling to manage and deploy the growing volumes of data that are generated. IDMP in particular was a key factor in this area, with a number of presenters focusing on elements of this.
But what also emerged, is that this industry can look forward to the future with confidence. This could be by deploying and benefitting from cutting-edge technologies such as Artificial Intelligence (AI) and Machine Learning (ML), using technology to make better use of the data it has at its disposal, or even changing the way many in the industry operate and work day-to-day.
The New Digital Workplace
Changing ways of working was the focus of our keynote speaker, Michael Woodbridge of industry analyst group Gartner. Michael presented on how the new digital workplace can help transform life sciences. The digital workplace is an over-arching strategy, defined by Gartner as a ‘business strategy to boost employee engagement and agility through a more consumerised work environment’, the digital workplace improves innovation, encourages collaboration and properly equips and prepares a workforce for modern working practices.
Although like other heavily-regulated industries, life sciences has been slower to adapt to these new ways of working, Michael discussed the potential for improving the way in which life sciences firms operate. A more effective workforce with access to tools that support and augment their decision making whilst unburdening them from the routine are far more likely to drive change and innovation that can be truly transformative. Michael mentioned initiatives such as digital R&D, lab of the future, Pharma 360 Development, all of which have the potential to be truly transformative and all of which require a strong digital workplace strategy.
A Grand Design
The potential of technology to improve the way life sciences firms approach business was a theme across the day’s presentations. Mark Cottingham of F. Hoffmann-La Roche spoke about ‘A Grand Design’, looking at automation and how organisations can move away from having data locked in documents and instead have data driving the documents.
More specifically he touched on how we can use data to drive the submission processes which will then benefit many other areas of the organisation - stakeholders in the submission process, compliance and process efficiencies, all of which feed into an overall objective of achieving right first time submissions, something of a holy grail for many organisations within life sciences.
AI and life sciences
Another glimpse into the future was provided by René Kasan. René outlined a future for life sciences where machines can take the industry into uncharted territory in terms of what can be achieved, especially in terms of how data is managed, analysed and deployed for business gain. Artificial Intelligence (AI) is defined as a ‘a broader concept of machines being able to carry out tasks in a way that we would consider ‘smart’, while Machine Learning (ML) is the capacity of a computer to learn from experience.
Both AI and ML can drive transformation across the industry, and René outlined benefits that included, productivity gains, GDP growth over achievement and business process automation rates of 30% and higher – all achievable goals and all highly desirable to most in life sciences.
SPOR – the NCA perspective
Nicolas VERVAECK of the federal agency for medicines and health products (FAMHP) provided an update on EMA’s SPOR program from the perspective of an NCA. The SPOR programme has been established to implement services that centralise management of the four domains of master data – substances, products, organisations and referentials.
EMA has established a EU IDMP/SPOR Task Force made up of representatives from the EU Regulatory Network (including EUNDB), members nominated by Industry Associations and other interested parties. The taskforce is responsible for advising on aspects related to planning, development, implementation and maintenance of the ISO IDMP standards in the EU and will deliver recommendations on the implementation strategy.
SPOR will bring about a number of changes and to enable these changes, EMA, NCAs and the overall industry will need to adapt their own systems and processes e.g. new process for maintaining synchronicity of local source systems with central SPOR data. Key to this is the right technology systems – an area in which AMPLEXOR is particularly strong.
Ready for IDMP?
After Nicholas touched on IDMP and its impact on the industry, Andrew Marr of Marr Consultancy looked at how life sciences firms have prepared for IDMP thus far, what they need to do ahead of the 2019 deadline and what the potential implications of Brexit might be, particularly for UK and European firms. What IDMP means for the European industry is increasing the level of data describing the product that will be submitted as part of the regulatory submission, and that the regulators will review and approve the data as part of the submission cycle. Andrew spoke of a significant change to the process, meaning an up-regulation in the amount of data that is needed and that additional data to be located within the organisation.
Organisations are all at different stages of readiness for IDMP and Andrew also spoke of how some are viewing IDMP as a stimulus to do something a little bit wider, or in some cases radical. Not just meeting compliance requirements, but improving how they manage their data.
IDMP and change management control
We continued the focus on IDMP, as Michiel Stam of eCTD Consultancy took to the stage to talk about IDMP as part of change management control and MA dossier maintenance. Providing this perspective on IDMP data governance in the context of change control, and showing the relationship with IDMP data maintenance and MA dossier maintenance helped us all think about the impact of IDMP on existing variation classification process.
Michiel advised the audience to ‘add additional “internal” change categories on top of official classifications’, to ‘consider product (group) specific templates’, to use change control numbers and to ‘integrate IDMP workflows with existing processes’, instead of on top of existing processes. To do this requires investment in process development, tools and workflow automation, but the benefits can be great for any organisation that does so.
Master Data Management and IDMP
The third in our trilogy of IDMP-focused presentations, was delivered by Jens-Olaf Vanggaard of HighPoint Solutions. Jens-Olaf spoke about Master Data Management, looking at what it was and how it relates to IDMP. MDM is so needed at present, because a lack of standardisation can lead to poor quality data, in-efficiencies and slower decision making.
ISO IDMP will provide standardisation by establishing definitions, concepts and describe data elements and their structural relationships, and the solution to this is MDM - the set of processes and solutions used to acquire, enhance and share master data across the enterprise. The benefits are many: timely data, increased efficiency, improved data quality and compliance, avoidance of costly data remediation and increased agility.
Like some of our other speakers, Jens-Olaf spoke of using data more progressively not just for IDMP. MDM technology can play a key role in that.
AMPLEXOR and the role of data
The theme of data was continued by Agnes Cwienczek, Senior Life Sciences Consultant at AMPLEXOR, in her presentation, in which she asked the question 'Best-of-Breed or All Inclusive?' Agnes discussed the case for both approaches for regulatory systems, and outlined her vision for the 'dream' - state-of-the art systems with defined interfaces, seamless data exchange and single source of truth for any data set and minimal data management efforts, combined with maximum data quality.
The reality is that with best-of-breed systems, data is duplicated which negatively impacts data quality and ultimately its reliability and the compliance. Agnes concluded that the most important aspect of a system is the overall ecosystems and its data and the data quality – get these right and you can achieve the ‘dream’ outlined earlier.
Improving Labeling Management
The next speaker was AMPLEXOR’s Romuald Braun, on how to take label management to the next level. Romuald presented on the importance of Structured Content Authoring in labeling management and how this allows organisations to reuse global information locally, and crucially, to do so driven by Product Master Data.
Romuald showcased the AMPLEXOR Life Sciences Suite™ which has become so important to many organisations’ labeling management, by automating structured content and reducing complexity. He outlined the product roadmap deep into 2018, with the Suite’s ability to reduce costs and improve compliance only set to grow in that period.
Regulatory Information Management (RIM) was the topic of our next speaker, with David Gwyn of Navitas, providing an update on how RIM-ready organisations were, what the requirements entailed and what were the main challenges.
Navitas’ rimnet benchmarking surveyed 10 organisations around RIM, and revealed some interesting finding. There are multiple systems and platforms in place supporting RIM, including a significant number still using Excel, and for most respondents, correspondence is managed separately from the submissions in two different systems.
It’s an interesting future with RIM though. David explained that there is no universally agreed industry definition of RIM and its scope and that regulatory information is both a compliance requirement and a commercial opportunity. This does mean that effective RIM can create significant competitive advantages, such as accurate and timely product registration information to all stakeholders, continuing the BE THE EXPERT 2017 theme of deploying data more effectively and strategically.
Delivering high quality medical content
The ability to deliver high quality medical content globally remains a challenge for many organisations, as AMPLEXOR’s Sandra La Brasca explained in her presentation. They are not content and multi-language experts, they need to expand but time and resource are scarce, while quality standards must not drop.
Sandra described the benefits to a centralised translation program - increased efficiency, cost management, improved quality assurance, reduced risk and increased transparency, before going on to explain how an organisation could implement such a program. It’s another example of how technology can be deployed within life sciences to add value and make operations run more smoothly.
Translation management in life sciences
Our final presentation was delivered by AMPLEXOR’s Karina Martinez Ferber and Siniša Belina, and focused on translation management in life sciences. This is increasingly important within the industry but also comes with a number of challenges, which is where AMPLEXOR X-Connect is such a big help to many in the industry.
It allows for automation, with no manual export/import of documents and their translations, relations between the original and translation(s) is maintained automatically, and all within a single user interface and in a fully online and collaborative environment.
Using technology to improve compliance and manage data better were constant themes through BE THE EXPERT 2017, and the whole atmosphere was one of positivity around what can be achieved. Life sciences is an industry that throws up a number of challenges, but we feel better equipped than ever to meet those challenges head on. We look forward to seeing you all again at BE THE EXPERT 2018 so we can look at progress made over the previous 12 months.