NEWS

BREXIT: Deal or No-Deal

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Effects on Pharmaceutical Supply

The uncertainty of Brexit leaves millions in the UK and EU open to significant disruption in the pharmaceutical supply chain, creating severe shortages and impacting the availability of vital medicines. Governments answer to the possible fallout effects of Brexit on pharmaceutical supply, remains unclear, and inadequate.

Challenge

A lack of trust and insufficient information sharing, along any supply chain, causes inefficiencies, unnecessary costs, and missed opportunities for members. The pharmaceutical supply chain, is no exception.

The looming hard Brexit might turn this economic issue into a life-threatening tragedy for patients in the UK and across the European Union.

Situation Analysis

In a perfect world, even after a hard Brexit, pharmaceutical supply will follow market demands, and the supply of medical goods will remain uninterrupted. Unfortunately, the likelihood of this happening is rather small.

A smooth flow of products along any supply network requires each member to trust their suppliers to both receive and deliver on time. Otherwise, members begin to stockpile medicines and medical supplies “just in case”, so products end up stuck in transit. This leads to fundamentally higher costs for all participants, and in many cases, product shortages for the customer/patient. This problem is exacerbated by preemptive calls for a drug export ban after a no-deal Brexit. The pharmaceutical industry is worth £60bn to the British economy, and exports 45m packets of medicine to Europe every month, with 37m coming the other way (1).

Significant efforts have already been made in the UK to prevent the disruption of medicine supply after a hard Brexit, by creating vast stockpiles of drugs. While this may make intuitive sense, on closer examination, it becomes clear that these efforts might turn out to be counterproductive because one key element is missing: information sharing.

Lack of trusted information about stock levels and plans within the supply chain leads to market participants having no other option but to “play it safe” and stockpile. Despite this overstocking, manufacturers feel pressured to keep producing more and more, because the drugs aren’t actually being delivered to the patients that require them, so demand at the end of the supply chain grows more urgent.

This sequence is repeated until every supply chain member, including the pharmacies, are overstocked. While this does mean that, finally, sufficient amounts of drugs are reaching the patients, this is also the point where manufacturers still producing full stream ahead, suddenly see the demand drop out from under them. Now the manufacturers are caught between a rock and hard place, because with an export ban in place, there is no market opportunity for them and they are left holding the bag or pill bottle, in this case, and they are forced to dispose of their overproduction. As a consequence, production levels slow to a trickle until manufacturers feel the demand increase. With every buyer being overstocked themselves demand will stay dead low for a long time, until it will suddenly explode. The mechanics of theses inefficiencies have been investigated for decades and are well understood. Scholars have coined the term “bullwhip effect” for it, because of the shape of the resulting demand curve.

Solutions: Establishing a Trusted Information Flow Circuit

This issue can only be solved by establishing a flow of trusted information along supply chain members, giving them the opportunity for reliable long-term planning. But this information exchange means giving up trade secrets, which is a tough pill to swallow. So measures must be taken to facilitate the sharing of information.

We propose the following:

  • Incentivize the information sharing
  • Allow members full control over the flow of information they make available
  • Provide means for anonymous and automatic data aggregation with smart contracts

The PharmaTrace Network is being built to give companies along the pharmaceutical supply chain these capabilities and more. Although it is not yet production ready, it could be quickly deployed as a cloud-based solution to support these three measures.

In order for government to secure supply of vital pharmaceuticals to weather these scenarios, we recommend that a minimum of 10% of pharmacies in metropolitan areas, 50% in rural areas, all manufacturers of vital drugs, and industry wholesalers, be connected to the network. All sharing vital information within the common ecosystem. With a looming Brexit or other future causes of shortages, we must be prepared for supply chain disruption. It is not just a possibility but inevitable. We must work together to trace our path through.

Note: thanks to our contributors: Patrick Mccullough, Heisun Kim, Dr. Issame Outaleb

Study Benchmark Healthcare Movers

The international Healthcare Mover 2019 study by ConCeplus, headed by Beatus Hofrichter, partner of the Healthcare Shapers, highlights a new dynamic in investment and innovation behavior among leading healthcare stakeholders. The benchmark analysis sheds the light on three key business drivers which agile firms master significantly well in shaping their competitive future positioning.

A qualitative, international benchmark study across 6’800 Life Science companies, ICT firms and Healthcare providers in Austria, Canada, Denmark, Finland, Ireland, Norway, Sweden, Switzerland, and the UK revealed, that innovative and agile companies advance stronger in digitalization than their peers. We observe that the dynamics of the digital transformation in these markets differ significantly. In the forefront are the Scandinavian countries and Canada. Their companies deploy a strong digital offering already.

A total of +1’250 companies were validated (or 18.3%) and rank as “Healthcare Movers” (or HCM) in shaping the digital transformation. HCM players understand the importance of focusing their strategic investments across three key drivers, i.e. Data acquisition strength of the clinical, device, medical, and public data domains, Next-level technology strength, and Business model agility.

The Top 100 Healthcare Movers

Furthermore, the Top 100 HCM cohort outperforms the average HCM peer companies significantly. They shape and deploy highly aspiring integrative healthcare business models in combination to the other two drivers well ahead of the core industry. HCM leaders can often be associated with therapeutic fields such as Cardiology, Neurology, Oncology incl. Urology and Gynecology, Radiology, and Nutrition/Dietitian which scores high in the HCM ranking.

Today, healthcare stakeholders compete globally and fiercely for market shares in this multi-trillion USD industry. Traditionally, critical competitive edges were sought through incremental product-centric innovations. In the past years, innovative leaders pursued novel offerings applying integrated digital solutions. According to Mr. Hofrichter, founder of ConCeplus and author of the HCM report, “… tomorrows’ competitiveness in healthcare is founded on agile convergence innovation through combining adjacent technologies, cross-disciplinary competencies, ICT capabilities, and patient-centric offerings in order to establish higher value outcomes.”

Real World Evidence drives value

Today, it is evident, that “… healthcare is rapidly shifting to use Real world evidence to enrich medical data sets…”, according to Dr. Bürgi-Krishnamurthy, co-author of the report. Leading HCM players score high in Data acquisition strength (averaging 3.3 out of the 4 key healthcare data domains). They aim to maximize this driver throughout their daily operation and within established value chains. Here, they pursuit a strong competitive advantage, while traditional firms remain to acquire such data within their inherited technology field(s). (see Fig. 1)

Average data acquisition strength of HCMs across the four key data
domains in healthcare in 2019 [ in %]

Another essential contributing factor to tomorrows HCM winners are the Next-level technology strength, and Business model agility. Global Top 100 HCMs can be seen as avant-garde. They set a challenging benchmark score of business model agility (0.71pts) and next level technologies (0.69pts). This cohort outperforms the average HCM companies significantly (see Fig. 2), while traditional players will be more exposed to a widening competitive gap.

Strategic positioning of HCM companies in 2019

Partner for leading healthcare value chains

The report highlights the “…ICT players as partners to Life Science firms will even be more crucial in the advancement of deploying holistic integrated platforms. They are seen as the best facilitators for data acquisition across all healthcare domains. Therefore, such firms continue to advance as key partners for leading healthcare value chains, …” commented Beatus Hofrichter, initiator of the HCM report and partner of the Healthcare Shapers

Find out more about the Healthcare Movers 2019 Report on www.conceplus.com

“Real“ Leader Are Not Afraid Of Digitization!

In the old (pre-digital) world, roles were clearly defined. Leaders were managing and “leading” employees and gave them decision-making powers. This role – and also its power and the associated claim to leadership – was explained by the position within an organizational hierarchy, the privileges and status symbols associated with it as well as expert knowledge, leadership experience and networking (“Old Men’s Club”). The steps taken up the career ladder were reflected in budget responsibility and available resources and were framed in a top-down corporate culture.

One thing among many that the digitalization and the associated transformation of analog processes calls into question is the self-image of managers. According to Tim Holt’s[1] definition, digital transformation brings about the transition from an organizational structure based on performance and hierarchies to companies in which collaboration and co-creation are lived. Leadership therefore means helping the organization to become open to new forms of collaboration and goal achievement.

The concept of management and the understanding of leadership, which has developed and consolidated in companies over many years, is put to the test. How is management adapting to meet the demands of an increasingly digitalized work environment that is changing more dynamically than ever before?

When the importance of hierarchies, status and expertise changes, what will become of the leadership culture in companies? Does “management” by superiors still need to be provided at all? Or will only collaborative, self-organized teams act in the future? Is it enough to define roles and tasks? What does “leadership” mean in the digital environment?

The fact is that hierarchies represented in rigid organization charts are assigned to the old, predigital world. They are outdated.

Digital business models often require action across (organizational) boundaries and structures. Company boundaries disappear completely or increasingly dissolve. By working in networks, in different value creation systems and in cross-organizational collaborations, managers have to revive their claim to leadership: Anyone in a network who has nothing to offer to support success of  its members is seen as superfluous.

Moreover, the world is becoming more volatile, uncertain, complex and ambiguous: VUCA[2] sends its greetings. The early deceased psychologist Prof. Dr. Kruse[3] spoke of the complexity trap. Planning, e.g. of actions, resources, budgets, no longer works as it used to. Planning phases are becoming increasingly shorter, project responsibility is being shared. And this is an enormous challenge for managers. In the past, employees could expect concrete answers to questions and challenges from their bosses. For decades, experts have been fixed points of contact in companies due to their specialist knowledge. Today, with a radically shrunken half-life of knowledge, both are becoming increasingly unlikely. 

Where in an environment without permanent contact points is the framework located that creates identity? Who or what do people in companies identify with? Are corporate culture and boundaries still perceptible to the individual? Is it the conglomerate that finances the current “project”? Or is it the goal or result for which you are working? Is it the colleagues who are currently working in the “team”? The challenges to the structure and culture of the working world in the digital age are growing and changing the “new” definition of leadership.

Trust & Empowerment – still the two supporting pillars

What remains – even in the age of digitalization – are the two cornerstones of a successful corporate culture: trust and decision-making authority and thus the empowerment of employees, i.e. trust and empowerment.

Three very specific tips help corporate culture to grow in digitized working environments. In parts, these come from the so-called “agile manifesto”[4], which has massively changed complex development processes, such as software projects, in a results-oriented acceleration.

1 The customer takes it all,…

All understand the “why” and see in this one – namely their – meaning. In everything the team does, the customer takes center stage. Together established values support collaboration and interaction. The goals must be clearly understood and interpreted, so that alignment prevails and self-responsibility becomes possible. The teams build on diversity, i.e. they are composed of people who can differ and complement each other in age, professional qualifications, gender and cultural heritage. Transparency is the basis for trust and creates an atmosphere in which mistakes can be made in order to learn from them. This fosters courage, creativity and a willingness to take risks.

2. …we agree on resources and procedures…            

The group develops a common understanding of best practice. The self-discipline and self-organization of each individual ensures that skills are brought in and resources released when and where they are needed. A toolbox of methods, processes and techniques, mastered by all, supports collaboration.

3. …and practice effective communication across borders.

Communication is the key to effective collaboration. It must be made possible – the choice of the appropriate form, medium, language or technique is of secondary importance. Communication takes place in both directions, i.e. it demands sender and receiver qualities. It creates access to the information necessary for the work, motivates and mobilizes people to achieve common goals in teams. This also and above all includes personal communication and mutual inspiration.

Therefore: Don’t be afraid of digitalization!

Leaders who can not only cope with change, but also drive it forward, who communicate across structures – with open, outward-looking and inward-looking eyes – will absolutely be needed in the digital environment.

The successful executives in the digital age

  • develop tomorrow’s leaders
  • create an atmosphere of trust and security
  • formulate goals with the team, and the path to them
  • promote collaboration and experiments that can also fail
  • help to clear obstacles and difficulties out of the way
  • listen, coach, support, motivate, animate
  • allow people in the team to take responsibility
  • make mistakes themselves and talk about them
  • observe their working environment carefully, provide resources and open doors,
  • and together with their team they are looking forward to the successes

And very important:

  • They are self-reflective, open and curious about people and the environment.

Lippmann International LLC: Brigitte Lippmann helps with talent management and personnel problems, such as succession consulting, transition coaching, globalization support, diversity, leadership development, cultural expatriate training and talent pooling.

be@change beat schori managementberatung & coaching Ltd.: Beat Schori, the experienced consultant, guide and lecturer with many years of expertise in change management, culture change and integration projects, accompanies and supports companies in cultural change.


[1] Tim Holt, CEO Siemens Power Generation Services from Roland Dieser’s CFFO White Paper; Digital Transformation Challenges in Large and Complex Organizations, November 2018
[2] https://de.wikipedia.org/wiki/VUCA
[3] Peter Kruse: The leading power is shaken. Youtube Video, 2014
[4] https://de.wikipedia.org/wiki/Agile_Softwareentwicklung

Innovationsgetrieben und agil: Pharmaleader im digitalen Wandel

Pharma-, Medtech-, Biotech- und Diagnostic-industries are experiencing ubiquitouschange. Strong silo-mentality and tough regulatory forces in the healthcare sector create challenges for employees and leaders alike. In addition to that, trends such as reduced innovation in R&D departments and mounting digitalization of products and processes are increasing the complexity in the work environment. To solve the tension between the constant pressure to change on one hand and the rigorous structures on the other, organizations are looking for tools and methods that increase innovative thought and action.

How can this be successful without overtaxing the change readiness and ability of the organizational culture nor underestimating the impact of existing rules and regulations? Potentially one key to solving the riddle is a school of thought that came up during the beginning of the Internet-age: Ambidextrous Leadership[1]. In combination with clear expectation management, this leadership style can become a lever for high agility, which is needed by the innovation-dependent healthcare ecosystem.

The concept of „Ambidextrous Leadership“ is not new.
It dates back to the time when traditional “brick and mortar” companies were struggling to become operational in the online world at the advent of the Internet age: “Online” was not only new, but different: Changing strategies, new competitors, novel business models, adapted processes, diverse employee profiles. Companies that could manage these two worlds concurrently – as so-called two-speed organizations – were more successful than those who tried to run the emerging online business with the same structures and rules as their traditional business models.

Let sources of Innovation bubble up.
What does that mean in the context of pharmaceutical companies in the age of digitization?

Internal research departments are generating fewer innovations organically. More and more frequently university spin-offs, small research laboratories and start-ups are innovating through leaner organizations and cost structures, shorter reconciliation processes and fierce entrepreneurial drive. Since Big Pharma urgently needs these innovations for market growth, they acquire those smaller entities or forge partnerships.

In order to ensure that a newly identified source of innovation does not stall, it takes leaders who can master [read: foster, harvest and manage] the diversity of both worlds. To be agile means for Leader to do both:

  • co-create, think and act within the culture of the co-operation partners
  • keep an eye on how the idea, the prototype, the orphan drug becomes not only a marketable product gaining approval but also meets the commercial expectations of Big Pharma.

Successful leaders manage to achieve this “ambidextrousness” by a high degree of agility in their thinking and acting[2]when working withthe differences in e.g., the speed of processes or mindsets of employees.

Expectation Management: The “Knowing-Doing-Gap”
We all know that clearly communicated expectations greatly contribute to smooth operations. Nevertheless, many have a hard time communicating expectations of results to be achieved, lived values and, to some extent, behavior in clear, simple and open terms to our environment. Fixed processes and lengthy planning horizons are often ineffective in today’s environments and are replaced by a results orientation, which is guided by values and cultural norms. For this to work in the daily operations, [some] managers have to leave their comfort zone and express concretely, whatthey want to see achieved, without intervening too much in the technicalities of ‘howit is achieved’. Then innovation can unfold.

9 activities leading to more agility for [healthcare] leaders
Simple actions can help us to become more ambidextrous and hence create more nimble organizations – here a few ideas:

  1. Focus on a goal that the team develops, shares and tracks.
  2. Monitor the market continuously, recognize changes in time and respond promptly[3]
  3. Role-model changes with your behavior – do not just trigger change, [ie: do not stick rigidly to plans, but respond flexibly to suggestions and market changes]
  4. Demonstrate, promote and demand high-quality thinking [and thus achieve better results]
  5. Proactively and courageously ask for feedback [and build an effective feedback culture]
  6. Inspire and motivate others to bring their best self to work [Integrative management creates listen-up-speak-up cultures[4]]
  7. Accept that leadership exists throughout the organization [if you give employees the freedom to act so they feel engaged, empowered and committed]
  8. Be open to being influenced and persuaded by others [because those who are directly confronted with the problem often have the best solutions – regardless of title or status]
  9. Allow errors as long as they are used as a basis for improvement and learning processes [to get into the fast pace mode of testing-learning-change-testing]

Conclusion:Simple actions ofagility allow executives to be more innovative in highly complex work environments, bridge the gap between the “old world” and digital transformation, between traditional drug selling and patient focus, between clinical drug approval trials in mass markets to personalized and digitized therapies, all the way to individualized drug manufacturing with 3D printers.

Start today with being more explicit in your expectation setting around what needs to get accomplished!

 

Sources:

[1]https://hbr.org/2004/04/the-ambidextrous-organization

[2]Based on hypotheses of the Agile Business Consortium – Culture and Leadership Workstream April 2017 https://www.agilebusiness.org/resources/white-papers/culture-and-leadership-the-nine-principles-of-agile-leadership

[3]Pharma M&A: Agile Shouldn’t Mean Ad Hoc, McKinsey and Co., (Accessed Aug 2018) – https://www.mckinsey.com/business-functions/strategy-and-corporate-finance/our-insights/pharma-m-and-a-agile-shouldnt-mean-ad-hoc

[4]see also “Innovation, Diversity & Market Growth”, Center for Talent Innovation, 2013 – http://www.talentinnovation.org/_private/assets/IDMG-ExecSummFINAL-CTI.pdf

Market_Entry_Germany_Healthcareshapers_com

The day of rare diseases on February 28 focussed attention once again this year on the high unmet medical need in view of the 6,000 to 8,000 ‘rare’ or ‘orphan diseases’ for which there are until now no comprehensive therapies.1 The summary of the medicines newly approved in 2017 in Germany may mark an advance with 9 of 31 orphan drugs in this regard.2 The potential for innovative foreign companies, however, is evident – combined with the fact that a market entry in Germany is critical for success at the European level, it is logical for start-ups in particular to take the German market into consideration as their first choice for an expansion. A successful concept for this will include both organizational and market-specific aspects.

Orphan drugs, in addition to other therapeutic agents, provide a good example of business ideas with a potential for expansion. That’s because those who are working in the area of orphan diseases are researching at the forefront: many rare diseases are genetically determined, and scientists need to make use of molecular biology methods to clarify the disease mechanisms.3 The corresponding medicinal products are not infrequently developed by start-ups based in the USA.

After market launch in the United States, the second step is to develop markets in Europe. Due to Germany’s size as well as its relatively rapid reimbursement, many such companies consider the country an attractive initial target market. The lessons learned in Germany can then be transferred to other European countries.

Laying the foundations depending on company size and requirements: organizationally, structurally, close to the market

In a market expansion, foreign companies are confronted with numerous internal and external challenges. In particular, newly established companies lack the functional and specialist resources that an established player has from the outset. A network of competent, independent service providers with different specializations provides a powerful and at the same time cost-effective solution to creating the organizational and structural conditions for successful establishment in Germany and launch of the products.

At the company level, the first steps include searching for a suitable location and setting up a subsidiary, for instance a capital company. Decisions also need to be made on the topics of distribution and logistics. The latter can pose a great challenge in gene therapies. Besides regulations under finance and labor law, there are specific topics for the pharmaceutical industry when founding a company: for instance, establishing pharmacovigilance, appointing information officers, creating approval procedures, or generating a wholesale license.

The product-specific and market-specific challenges with which even established players are confronted when launching a product in Germany consist mainly of a profound understanding of the market when deriving a launch strategy, and bringing about a successful product launch. Once the market mechanisms, treatment guidelines and relevant stakeholders are known, it is easier for companies to develop market access and price strategies and address the right target groups – from medical specialist groups to patient organizations to public health policy.

The time required and the complexity of these tasks are often underestimated. At the same time, the individuals responsible are making decisions with a great scope, decisions are then difficult to revise. Whether for orphan drugs or other new products: for companies abroad of varying sizes, collaborating with cross-functional teams of local consultants is worthwhile for successful entry into the German market.

Sources:
1https://www.rarediseaseday.org/country/de/germany
2https://www.vfa.de/de/presse/pressemitteilungen/pm-028-2017-bilanz-2017-fortschritte-durch-neue-arzneimittel.html
3https://www.vfa-bio.de/vb-de/aktuelle-themen/orphans/immer-mehr-patienten-mit-seltenen-erkrankungen-behandelbar.html

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