Higher productivity, lower costs: The pharma industry meets for the DIA 2019
Main5 expert panel: Launch medications faster and at lower cost despite stricter formalities
The pharma industry is still facing increasing pressure. The age of blockbuster medication is over, while regulatory stipulations are becoming stricter. The annual conference of the DIA (Drug Information Association) is being held in Vienna from February 5 to February 7. The Main5 pharma expert panel (Stand B31) is focusing on processes and systems in research and development: "The market for pharmaceutical products is demanding faster development cycles at lower cost under increasingly strict international regulatory stipulations. As a result, the entire industry continues facing pressure to demonstrate productive and result-oriented work based on lower fixed costs," says Tore Bergsteiner, Partner of the consultancy firm Main5 which specializes in pharma companies.
Always aspiring for process excellence
Effectiveness, above all in research development, is increasingly under the microscope according to the team at Main5. "Value creation and a culture of performance in the R&D sector is being continually updated in a lot of businesses in order to guarantee that pharma companies are future-ready," says Tore Bergsteiner. However, successful research is not enough for overall success: By aspiring for "process excellence", and looking to optimize and modify existing structures, it is possible to create new impulses and energies that have not yet been utilized. "It's getting tight in the pharma industry thanks to digitalization and other innovations in healthcare. New job profiles are appearing, such as Data Scientists. Anyone who is not currently adapting their internal structures and ways of thinking will miss the exit before they know it," warns Dr. Adam Sobanski, Partner at Main5.
Therapy for people is the goal
The growth in regulatory requirements across all sectors is ensuring that intellectual riches are being represented in databases and documents. A focus on systems and processes for regulated data and document management in clinical development, approvals and more, is consistently contributing to compliance, efficiency and productivity. "In fact, an integrated data and document management system that will generate long-term value is already deciding the success or failure of new innovative developments in therapy. With solutions such as lab data management, clinical data management, and holistic document management, companies will enjoy significant benefits long-term," explains Bergsteiner.
New technologies on the road to success
There are plenty of opportunities for the pharma industry to make day-to-day business more efficient within the high-speed world of artificial intelligence development: The countless possibilities for digitalization range from more efficient lab work to the development and approval of effective therapies. Mental work automated using artificial intelligence is already speeding up and improving research, development and approval work. Main5 works as an adviser to leading technology providers with proven success.
AI brings big opportunities for pharmaceutical industry
Used correctly, digital media offers great opportunities for the future
The consultancy firm MAIN5 (www.main5.de) advises pharmaceutical companies on how they can get involved in the myriad possibilities of digital development. "It's above all lack of knowledge and vision that is often leading to people to view working with data with caution. But fear is a poor mentor because the future belongs to data. The pharmaceutical industry is lagging particularly far behind in terms of digital development and should take a leaf out of the books of digitally active industries like the automotive sector, banking and finance," says a convinced Tore Bergsteiner, Managing Director and Partner of consultancy firm MAIN5. The Frankfurt-based consultants have specialised in the analysis, flexibilisation and potential re-structuring of business processes in the pharmaceutical industry.
The three steps to digitalisation
The advantages of digitalisation are numerous. In fact, today nearly every research activity and interaction is based on data. This creates a premature gold-rush attitude amongst software manufacturers, investors and pharmaceutical companies. "Of course, companies need to be sure that they are managing growing quantities of data reliably and correctly and using these to create value. When we think of research, people's lives soon depend on this," warns Bergsteiner. Yet provided good research practice is followed, the possibilities are endless: it's all about reducing time in the laboratory, optimising the time aspect of clinical studies, improving management of side effects, and developing more effective therapies. Mental work automated using Artificial Intelligence speeds up and improves development during its regulated phases, and also allows you to establish if a medication is fit for purpose as quickly as possible.
According to MAIN5, there are three steps to successful digitalisation in pharmaceutical companies.
- In the first step, companies should define their own digital vision and implementation strategy.
- Then, in the second step, the maturity of the processes and of data management in the organisation should be assessed so that a digital implementation plan can be set up accordingly.
- The third and final step is then consistent implementation and analysis of the effective and efficient use of greater digitalisation in the isolated value-creation processes of the pharmaceutical company.
Solutions for optimal data assessment
Tore Bergsteiner, Managing Director and Partner of MAIN5, will be speaking at this year's Swiss Association of Pharmaceutical Professionals. The symposium is hosted every year by two Swiss professional associations. Around 140 experts are expected to attend on 28 November 2018. They all work in the pharmaceutical or biotechnology industry. "We want to use the symposium to show that technology offers great potential that can benefit humanity. There are of course countless challenges in the way here: for example, the further digitalisation progresses, the more data analysts and IT technicians with specific knowledge the industry needs. Success will be achieved as soon as the pharmaceutical world is in the position to set the regulatory standards that are so urgently required," says Bergsteiner.
Pharmaceutical industry: An informed patient demands "digital honesty“
MAIN5 takes stock following pharmaceutical and expert congresses: Companies will only win the trust of patients if they can guarantee the integrity of digital information
The more data the pharmaceutical industry uses, the more relevant it becomes to make clear the integrity of the digital material. Only then can research be successful and digitally informed patients convinced in the long term. This is the current message issued by the pharmaceutical consulting company MAIN5. "Many good discussions held in the environment of the German Quality Management Association e.V. (GQMA) have once again shown us how crucial the integrity of data is for the pharmaceutical industry. The performance to date and the vast knowledge of the pharmaceutical companies are undisputed. However, data material that is reliably collected and evaluated can and should be used by the pharmaceutical industry to support research and, through transparent performance, make what have to date been strictly regulated processes accessible to the general public with full transparency“, advised Tore Bergsteiner, Managing Director of MAIN5 (www.main5.de).
High hopes of possibilities
In the course of the GQMA pharmaceutical conference, MAIN5 presented two projects, which had been carried out in collaboration with Merck and Fresenius Kabi and which focus on the digital development of the industry. "The interest in the projects we presented was immense and we got some fantastic feedback. The thirst for knowledge proves that the numerous opportunities and problems within the industry, ranging from a fragmented research and quality culture through to criminally motivated drug counterfeiting, are clearly perceived. The basic rule states: The larger the mass of data, the more companies are compelled to realise that patient protection must always be put first time and time again instead of getting lost in the evaluation of exciting data material“, explained Bergsteiner.
Quality is a challenge for policies, economics and people
The issue of secure digitalisation is occupying the entire industry, as demonstrated at the Expopharm trade fair and the German Pharmacists' Conference. Here demands were made for the rapid introduction of electronic prescriptions and a clear timetable for the implementation of processes designed to ensure greater safety in drug treatments. Data protection is also a key issue for the European Union. For this reason the Falsified Medicines Directive (EU) will come into effect in February 2019. Prescription drugs must subsequently be distinguished with a unique security tag. Pharmaceutical companies are currently working on global standards in order to ensure efficient and uniform implementation.
GQMA Conference 2018: The Challenge of Central Digitalization in the Localized Pharma Industry
Main5 Experts at the GQMA Conference 2018: Pharma companies need to learn to be interdisciplinary
Digitalization is advancing and is at the forefront of the Annual Conference of the German Quality Management Association e.V. (GQMA) in Bonn (September 20-21, 2018). The association is Europe's second-largest quality management specialist for the chemical and pharmaceutical industry. "The pharma industry is in the midst of an upheaval and needs to consider fields that were previously far outside its business model. The challenge lies in the central digitalization of a historically localized sector," says Tore Bergsteiner, Managing Director of Main5 (www.main5.de). The specialist consultancy analyzes process chains within renowned pharma companies and adapts their business models and processes for the digital future.
Global Regulation and Patent Protection
Alongside decentralized production and sales processes in the pharma industry, quality management often engages in centralized work in order to find a sustainable solution to issues such as counterfeit medication or contamination. The pharma industry is subject to comprehensive global regulations and monitoring, however, European countries have different regulations compared to the USA, for example. Loopholes such as internet commerce are used by criminals and can be harmful to patients on account of counterfeit products, for example. "Counterfeit drugs are a problem that continues to grow and which the pharma industry's processes need to face. The protection of patients has to be the primary focus," explains Main5's Tore Bergsteiner. The Falsified Medicines Directive (EU) will come into effect in February 2019. Prescription drugs must subsequently be distinguished with a unique safety feature. Pharma companies are currently working on global standards in order to ensure efficient and uniform implementation.
Summit for Quality Management
The key issues for a digital future with centralized systems will be discussed and presented at the GQMA Conference. This will include two projects from Main5 that were conducted with Merck and Fresenius Kabi respectively. "The problem in the pharma industry lies in the highly complex processes and the necessary, and appropriate, international regulations. We use agile methods to bring processes, people and technology together on the projects. Pharma will take on a leading role in future models for many other sectors of the process industry," says Tore Bergsteiner.
Main5 (www.main5.de) was established in 2013 as a Management Consulting firm and focuses on strategy, process and solution consulting with international life science companies in the regulated R&D sector. The consultants at Main5 combine their methodical and systematic approach with years of experience in the pharma industry. The holistic approach, which places the primary focus of the route to the digital future on people, is also used to implement complex ideas from leading industry customers. The Main5 Institute supports specialists and management personnel in knowledge and research-intensive company sectors with a range of Seminars.
New seminars in MAIN5 Institute from the second half of 2018
One year after the establishment of the MAIN5 Institute for middle and upper management executives in the pharmaceutical industry under the direction of Armin Neises, the seminar program is essentially expanded with four further business seminars. As a part of an extensive customer survey and market study, the company has identified new focal points which should help the industry to achieve further success in the future. The diversified offer can be booked from September 2018 at selected venues in the Rhine-Main area. It seamlessly complements the two seminars on the successful handling of growing complexity in the pharmaceutical context and on the BPM - creating value in a GxP-regulated Environment.
Accompanied by the holistic approach of MAIN5, the new seminar topics of MAIN5 Institute are also aligned to the six poles Strategy, Processes, Structures, Systems, people and culture. With the topic "Self-reflection and Meditation for Professionals and Executives" MAIN5 Institute is the first company who does the market entry and offers a seminar with this topic especially for the pharmaceutical professionals and executives. The focus of the 2-day seminar is self-observation and self-knowledge as a basis for inner stability, so that managers remain focused and able to make decisions even in turbulent times. Changes are a continuum in our industry. Nevertheless, many companies are still challenged to implement basic principles adequately and safely in the change process. With the practical seminar "Change Management in the pharmaceutical environment - successfully shaping changes" the participants are shown ways how to react appropriately to changes in the pharmaceutical companies. With its focus on "Pharma Management Skills", MAIN5 Institute builds a bridge between a demanding professional and a humanly sensitive management level. Relevant socio-economic concepts for specialists and managers who are characterized by success in a scientific environment will be provided. From 2019 the fourth seminar "Digitalization in Life Science - Prepare yourself for the Future" will be bookable.
The special feature and the advantage of MAIN5 seminars lies very clearly in the exclusive orientation to the requirements of the pharmaceutical industry. MAIN5 reacts to the needs of the pharmaceutical industry with the contents of the further training courses offered, in which growing regulatory requirements prevail with a high change dynamics. With the expanded range of seminars, MAIN5 Institute is once again setting a course and continuing to focus on its corporate development in this selected niche.
Seeing the bigger picture: maximising DMS/ECM project success
It isn’t always easy to step back and take the broad perspective when a new document or content management system requirement is bearing down. But, until life sciences companies start taking an end-to-end view and appreciating the wider impact on people and processes, they risk compromising a successful delivery for the business, says Karsten Krüger of MAIN5 Management Consulting.
Pharmaceutical organisations do a great many things very well, but it can be easy to underestimate the demands and efforts of new information system projects – incurring a risk that these initiatives will fail.
Whether the motivation for a project is a company merger or acquisition, a harmonisation/rationalisation drive, a system refresh, or a specific new regulatory requirement such as IDMP or GDPR, life sciences companies still too often approach document or content management system (DMS/ECM) projects as targeted activities to achieve a specific single goal.
On top of this, they may set their parameters too narrowly in terms of the people they involve, the timeframes they allow, and the scoping of user requirements. This can lead to costly project overruns, poor user buy-in and – at some point down the line – disappointing results and even project failure. And the financial implications can run into hundreds of thousands (if not millions) of euros.
So it is surprising that the vast majority of pharma organisations continue to plan and deliver DMS/ECM projects in the same sub-optimal way, time after time.
Standing on the shoulders of others
It’s a subject we’ll explore in one of two sessions we’re running at AMPLEXOR’s Be the Expert meeting in June. Based on numerous electronic document/content management projects that we’ve helped clients plan, manage and deploy, we’ll be drawing together some of the major lessons companies are learning about successful delivery.
Some of it is about appreciating the need to include department heads and user representatives from across R&D – stakeholders from Regulatory Affairs, Clinical and Pharmacovigilance teams, as well as IT. This is critical to ensure that new systems serve the fullest purpose, work for everyone, and will have maximum application – as user requirements evolve and grow.
Whether companies bring in external help or not, the responsibility for delivering results cannot be passed off to a third party. Without internal ownership, and sufficient thought about how processes need to work, and the impact on individual roles, the best plans can go awry. A common mistake we see is project responsibilities being added to the workloads of already busy people who lack the capacity to expand the vision and review broader processes.
Another is to confine project parameters to a single use case in a single department. Not only does this limit the potential benefits; it also increases the likelihood of other, future projects in other parts of the business replicating much of the same groundwork – ad infinitum.
Planning for the unknown
In one of our two speaker sessions, we’ll be exploring what’s involved in taking a more holistic approach to content management. Not just inter-departmentally, reducing duplication and improving people’s line of sight across products and processes. But also in helping companies develop a more flexible foundation for absorbing and responding to future regulatory and user-driven information requirements that are not yet known. Although this approach to planning is currently the exception rather than the norm, it can pay dividends – allowing companies to adapt more swiftly and painlessly each time new requirements emerge.
Ultimately, this is about agility. There will always be ‘projects’: as one ends, another appears on the horizon – so that planning for each as a distinct entity no longer makes sense; not if the pharma business is to meet its long-term strategic and operational goals.
From engaging and increasing the awareness of business sponsors in the IT initiatives they have prompted, to building multi-disciplinary teams that can help influence the right kind of change, we’ll be providing practical advice on the most effective and efficient approaches to end-to-end DMS/ECM delivery, based on the real and recent experiences of a cross-section of our clients. We hope to stimulate a decent debate!
* Karsten Krüger and Gero Neidlinger are managing partner at MAIN5 GmbH & Co. KGaA in Germany. The company advises on and helps pharmaceutical firms to deliver organisational change, processes and systems in a successful way.
MAIN5 at the DIA Europe 2018 in Basel
The management consulting company MAIN5 with its exclusive focus on strategy, process and system consulting in the regulated value-added areas of the pharmaceutical industry will be exhibiting for the first time at DIA Europe 2018 in Basel from April 17 to 19, 2018 with booth number 3.
"During the three days at the DIA we will give an extensive insight into our methods and projects of the past months." comments Gero Neidlinger, Managing Partner at MAIN5 " Simply looking at past projects with selected case studies we have prepared ourselves for an active dialogue with interested specialists. We are ready to discuss our concepts for the analysis, selection and introduction of innovative business solutions and solutions from the areas of global labeling document management, training concepts for global quality processes, validation, introduction of international patient support programs, GDPR in life science and business process management in pharmaceutical R&D."
For MAIN5, the DIA exhibition is a great stage for the presentation of its holistic solution and project approaches specialized in the life sciences industry. Based on clearly formulated goals that support a project in the corporate context, MAIN5 focuses on the analysis and development of effective processes, as well as the introduction of suitable solutions. MAIN5´s uniqueness is clearly the exclusive orientation of its method- and expert-centered consulting approaches to the requirements of the pharmaceutical industry. In connection with its young business academy, the MAIN5 Institute, MAIN5 always moves at the pulse of time, - develops and imparts modern and practical methodology and leadership competence.
"Our corporate development in recent years clearly shows that hardly any other industry recognizes so much need for consulting and catching up as the pharmaceutical industry. Particularly with regard to process management and digitization, there are still considerable treasures buried that will provide the industry with further innovations and efficiency advantages in the coming years“, says Tore Bergsteiner, Managing Partner at MAIN5, "Our consultants and teams continue to educate themselves and gain valuable impulses from adjacent industries. In order to maintain and expand existing competitive advantages in an international comparison, we have already successfully distinguished ourselves in a large number of sensitive projects".
Armin Neises is taking over as head of the MAIN5 Institute
MAIN5 has recruited Armin Neises for the expansion of the MAIN5 Institute! With its ambitious business academy, the pharma management consulting company trains line managers and senior managers on how they can safely navigate their teams and initiatives in a competitive and rapidly changing environment. At the same time, the MAIN5 experts for organisational change in life science companies also envision their young institute as a think tank. The academy offers participants an inspiring space for exploring relevant topics outside of the everyday pressure and routine, to meet in an informal setting and to share experiences.
‘The current social and intercultural changes have also shaken up the pharmaceutical industry’, commented Tore Bergsteiner, Managing Partner at MAIN5. ‘The unprecedented insights that patients have in the information age, the disappearing clear structures in a network society and the noticeable progress of new digital players require an urgent review of and adjustments to management methods and strategies for success. We are all the more pleased to entrust the experienced and dedicated leader Armin Neises with the development of our institute.’
Neises is a certified General Manager and has already set up and run successful business academies. He has many years of experience in management consultancy and training. To date, he has trained or consulted more than 2,000 line managers and senior managers from several reputable industrial companies. As Director of MAIN5 Institute, he plans to expand the industry-specific curriculum in such a way that traditional, innovation-based companies in the pharmaceutical and medical devices industries will also be able to cope with internal and external challenges in the future. To start with, there will be a seminar program that focuses on areas such as the complexity in the pharmaceutical business and BPM as a management tool in pharma R&D. The goal is to bolster the business skills of scientists and doctors working within the context of the pharmaceutical industry.
One special aspect of MAIN5 Institute is that the method-oriented and value-driven curriculum for its training courses is focused exclusively on the specific requirements of the pharmaceutical industry. Another special aspect is that the young business academy imparts a firm, modern and practical understanding of management and leadership: What intelligently steered organisational changes can introduce valuable organisational flexibility? How can prudent management thwart the efforts of people resisting reforms; how can it involve employees in the process; and how can prudent managers be empowered so they can act with confidence?
‘Life scientists, physicians and engineers who are highly qualified in their respective disciplines and are entrusted with managerial functions in the life science industry are approaching us today with very specific requirements and problems regarding management and leadership’, explains Armin Neises, Senior Director of MAIN5 Institute. ‘They need modern, more subtle and dynamic forms of leadership in order to meet their need for self-monitoring and participation. Our trainers are extremely well-acquainted with this environment and they possess extensive experience working in the industry and up-to-date management know-how. They can also offer a change in perspective that points the way forward for management.’
22nd GQMA (German Quality Management Association e.V.) International Meeting, Maritim Hotel Würzburg
The German Quality Management Association e.V. (GQMA) is the largest expert association for quality management in the chemical and pharmaceutical industry in Germany and the second largest in Europe. Every year in the fall, the association holds its annual international meeting, which is attended by several hundred experts from industrial companies, contract research organizations, hospitals and public authorities. The wide array of topics discussed at the conference enables experts to be kept up-to-date with the latest developments, to take home important suggestions that can be incorporated in their daily work routine, and to make valuable contacts with representatives from other related industries.
Ms Verena Jachmann from Fresenius-Kabi in Oberursel and Ms Sabine Schmidt from MAIN5 in Frankfurt am Main will be giving presentations on the topic of "Roll out and implementation of a globally harmonized eQMS” during the Risk Management Session at the 22nd GQMA International Meeting (Friday, September 22, 2017 morning session).
Registration / Information:
Online registration is available through the event agency CSM:
Event organizer: GQMA, German Quality Management Association e.V.
After its Rebranding, MAIN5 Remains on Course for Growth
FRANKFURT AM MAIN, SCHAAFHEIM, GERMANY, July 25, 2017: After a highly successful four-year start-up phase, the management consulting firm MAIN5, which focuses exclusively on strategy and implementation solutions for the regulated added value sectors in the pharmaceutical industry, remains on course for continued growth. Last year, the firm was again able to increase its sales and earnings.
The consultancy firm made up of more than 20 consultants has built a solid customer base comprised of renowned TOP 50 global players and selective regional medium-sized companies, and today it is presenting itself more confident and optimistic than ever. The firm, which was founded in 2013, is currently making targeted investments in the advancement and expansion of its excellent network of consultants, the maintenance and development of its customer relations over the long-term, and in the development of a strong MAIN5 core brand.
New business relationships are increasingly being established on the basis of recommendations made by existing customers or as a direct result of the seminars run by the MAIN5 Institute. Tore Bergsteiner, one of the Managing Partners at MAIN5, explains, “The key decisive factor for companies in the pharmaceutical industry is being successful in their multifaceted endeavors. The trust we have received and the values our firm lives by are now incorporated in our brand identity and serve as an additional valuable impetus for our firm’s development.”
Some of the more obvious aspects that characterize the complexity of MAIN5’s activities include the increasing regulatory requirements that are associated with highly dynamic changes; the increasing pressure from the competition and the accelerating pace of innovation by international comparison; the growing pressure to curb costs by national healthcare systems; the unconstrained market consolidation taking place; and the ongoing digitalization of all business processes and interfaces. Alexander Tryba, another Managing Partner at MAIN5, sums up the firm’s position in the market in a nutshell: “There are many consultancy firms working in this field, but at the end of the day, having insider knowledge accounts for the subtle difference between top-notch experts and mediocre consultants.”
After its rebranding at the beginning of 2016, the young firm has put itself in an even stronger position. Its new brand identity and its disciplined process management enable MAIN5 to release new energies and to be focused on realizing further growth.