Personalised medicine is the topic at medical congresses and attracts the crowds. The hottest topics are cell & gene therapies and RNA therapies. 

The two approved cell therapies, Kymriah (Novartis) and Yescarta (Kite/Gilead) are so-called “CAR-T” therapies, which use autologous cells, i.e., the patient’s own T-cells. In the laboratory, the T-cells are modified using the gene scissors CRISPER to form the CAR surface protein, which is directed against the specific surface proteins of the cancer cell. As a result, after re-infusion of the “boosted” T-cells, the immune system reacts with a strong and sustained immune response against the tumour cells. CAR-T cell therapies are currently approved for ALL (acute lymphoblastic leukaemia), and DLBCL (diffuse B-cell lymphoma). So far, about 300 patients have been treated in Germany with excellent outcomes.

Currently, five gene therapies are approved for the causal treatment of monogenic hereditary diseases, such as Luxturna (Sparks/Novartis) for early retinal dystrophia due to RPE65 mutation, Zynteglo (Bluebird) for beta-thalassaemia and Zolgensma (Biogen) for spinal muscular atrophy SMA, SMN1 mutation.

In both approaches, pathogenic genes are altered; in cell therapy an ex-vivo (outside the patient’s body) process is used, and the “revised” cells are then re-infused. In gene therapy, the correction of the disease-causing gene is achieved in-vivo (inside the patient’s body) using viral vectors as vehicles.

Hypothesis 1:

With cell & gene, fantastic results can be achieved, reminiscent of biblical miracles when “the blind can see again”. However, the cost-intensive nature of these therapies and their disruptive character in terms of responsibility and business models pose major challenges to the health system.

In the context of cell and gene, RNA treatments should also be mentioned. RNA therapies, is an approach already discovered 20 years ago by Prof Tuchel, Göttingen. The idea is to deactivate pathogenic mRNA caused by mutation of the DNA and triggering a disease, with interfering RNA (RNAi), respectively silencing RNA (siRNA). With the development of organ-specific transport vesicles of siRNA therapies such as Onpattro, Glivaari and Oxlumo (Alnylam) are available today. Other very promising siRNA therapies are in development.

Likewise, more and more personalised medicines are becoming available through genetic testing (DNA sequence analysis). Companies like 10x Diagnostics, Illumina, even offer the measurement of active genes in single cells, in their spatial/spatial representation, through transcriptomics.

This makes oncological therapies in particular much more effective. Thanks to diagnostics, drugs can be administered specifically to patients whose tumour disease were caused by mutations in vital processes, such as the G12C mutations in KRAS3, and can now be treated causally with i.e., Lumakras (Amgen). Treating the root cause of diseases meets these patient’s biggest hope.

The use of drugs that have been on the market for a long time, such as ASA, can also be optimised through diagnostics. It could be shown, for example, that prophylaxis of arteriosclerosis is only effective in patients with the risk allele. Otherwise, the administration of ASA is counterproductive. (Hall, Kessler, Chasman, Schuckert, Eu. Heart J, 2019).

“precision medicine” could only be established with the development of molecular diagnostics. On the way to personalised medicine, precision medicine is a major milestone that sets the course away from “one medicine for all” towards specific therapies for defined subgroups. Precision medicine therefore usually goes hand in hand with the joint development of a companion diagnostic and targeted therapy. In recent years, more than 160 biomarkers have been approved in oncology alone. (McKinsey Oncology report 2020)

The benefits of gene-, transcript- and proteome diagnostics and precision medicine are evident for patients. But the benefits are also considerable for the companies that develop these therapies. Eventually, if the therapy is only used in identified target patients, it will be much more effective.  Robust evidence accelerates development and market approval as well as simplifies market access processes.

Could personalised medicine be described as the precise diagnosis of genes, mRNA and proteins and cell & gene therapies?  Well almost. The NIH defines personalised medicine as:

“Personalised medicine is a branch/field of medicine that uses information about a person’s genes, proteins, and living environment to prevent, diagnose, and treat disease.”

Cell- and gene-therapies are expensive with cost of several hundred thousand up to one million Euros. Getting data on genome, transcriptome and proteome also is also costly. Does this mean that personalised medicine is only restricted to severe diseases such as in oncology and orphan diseases? In these cases, necessarily, but exclusively?

The question is: Can’t personalised medicine be simpler? 

For example, do we need a genetic test to see whether we are a man or a woman? Well, mostly not. So-called gender medicine has been showing for many years that medicines affect men and women differently. Awareness of this is growing and has even been the subject of articles in the Public Press i.e., “Bunte” (No. 14, 2021). Nevertheless, almost all drugs in clinical development phases 1 and 2a are tested in men and thus “personalised” for men. It starts with the dose, as men are on average larger and heavier. But pharmacokinetics and pharmacology are also developed on the male system, except for women-specific drugs.

This continues in the training of doctors. In textbooks and even in practices, with the exception of gynaecology, there are anatomical boards depicting a man.

In the evaluations of clinical studies, sub-analyses are carried out in women and men, just as in different ethnic groups. Almost always, the percentages of adverse events are significantly higher in women than in men.

How might a better alternative look like? Differentiate between men and women? Sounds obvious and succinct, but it is far from being implemented everywhere. For example, according to the MELD score, the creatinine value plays a major role in organ allocation for liver transplantation. Since men usually have a higher muscle mass, they reach this value much faster.

Some companies have recognised the issue, and so the VfA can report initial progress in gender-specific development for some drugs: (https://www.vfa.de/de/arzneimittel-forschung/so-funktioniert-pharmaforschung/geschlechtsunterschiede-in-der-medikamentenwirkung.html )

Thesis 2:

Personalised medicine starts with the distinction between men and women!

As in the definition of the NIH, in personalised medicine the life circumstances factor plays just as big a role as genes, i.e., epigenetics, which is the reflection of lifestyle.

Age is certainly one of these life circumstances. Physical fitness, diet, smoking or not smoking, stress also determine “biological” age.

Age is often associated with “adjusted” medical norms. This leads to the question: how are norms formed? A value of a definitely healthy person?  According to Wikipedia, medical norms in medicine are empirically collected values of biological measurands that are obtained by examining a large number of “normal” individuals (“sample”), i.e., average values.

Normal is therefore not a targeted definition, but an empirical mean value. Does this mean, in the final analysis, that if the average person is ill, e.g., because he or she is overweight, the overweight becomes the normal value?  For a long time, type 2 diabetes was called age-related diabetes, but the weight factor plays a much stronger role than age.

Pulmonary function standard values are also adjusted to age. Athletic people are often up to 50 percent above their respective age percentiles.

General deductions from standard values to individuals can be fatal. For example, in the case of the athletic person, disease-related restrictions in lung function would not be recognised, since they are still in the age percentile.

Thesis 3:

Neither man, nor average, nor age can be the right basis for medical norms for all!

In the digital age, the solution in many cases could be the individual standard norm. Most patients are regularly examined by their family doctor, so that the family doctor knows the individual medical norm, i.e., the values in a healthy state. The electronic patient record (ePA) allows different doctors to access the individual norm values. It can therefore be life-saving. Why is it used so hesitantly?

Thesis 4:

Digitalisation supports individual medical norm!

Meanwhile, 16% of the population use fitness trackers (Statistika 2021), not counting smartphones. A wealth of health parameters such as ECG, heart rhythm or heart rate variability, blood oxygen saturation, mental activity and much more can be continuously recorded via smartphones and other devices.

The wide use of smartphones, the collection and reflection of data, encourages the use of digital health applications (DiGA). Already 15 DiGA are approved, can be prescribed and are reimbursed (diga. BfArM, May 2021).

Similar to diagnostics, precision medicine and new forms of therapy such as cell & gene, digitalisation enables an enormous leap in the quality of medicine on a broad basis. It allows patients to take on a new level of self-responsibility by tracking their lifestyle and compliance with medical recommendations themselves, noting progress and using this as motivation.

Thesis 5:

Digitalisation covers large parts of lifestyle and gives the patient a participatory role!

The Society for Personalised Medicine therefore supplements the definition of personalised medicine and describes it with the 4 Ps: Predictive, Preventive, Personalised and Participating. After all, it is about nothing less than taking medicine to a higher level with the available diagnostic and therapeutic options and thus achieving the noble goal of truly personalised medicine and doing so for the majority of patients, not just the few patients with severe diseases.

CONCLUSION

• New therapies such as cell and gene therapies are highly personalised and represent an enormous quantum leap in medicine.
• Advances in diagnostics make precision medicine possible. They set the course for specific therapy for identified subgroups, rather than medicine for all.
• More “personalised medicine” with all its benefits for a patient can also be achieved by redefining and individualising the norm.
• Digital tools give the patient a participatory role.
• Finally, clinical development or the use of medicines should be much more focused on subgroups, such as gender and genetic disposition.

With these 5 points, personalised medicine is feasible for all.

Abbreviations:

1. CRISPR: Clustered Regularly Interspaced Short Palindromic Repeats. This system forms the basis of the CRISPR/Cas genetic engineering method for creating genetically modified organisms.
2. CAR-T: chimeric antigen receptor T-cell
3. KRAS: Kirsten Rat Sarcoma is an oncogene that encodes a monomeric G protein that plays a crucial role in the proliferation of malignant tumours. It functions as a central element in a number of signal transduction pathways involved in the regulation of growth and differentiation.
4. The transcriptome is the sum of all genes transcribed at a given time in a cell, i.e. transcribed from DNA into RNA, i.e. the totality of all RNA molecules produced in a cell (Wikipedia).
5. The totality of all proteins in a living being, a tissue, a cell or a cell compartment, under precisely defined conditions and at a specific point in time, is called the proteome (Wikipedia).
6. Precision medicine Precision medicine is a medical model that proposes to adapt healthcare, tailoring medical decisions, treatments, practices or products to a subset of patients rather than a model that is appropriate for all. (Wikipedia)

Translated with www.DeepL.com/Translator (free version)

While even the Munich Oktoberfest with over 6 million expected visitors was cancelled due to the coronavirus, online conferences and virtual events are shooting up like mushrooms. What does this mean and what do you have to pay attention to as an organizer? 

Organizers are venturing new ways from presence to online events. Some things are bumpy at first, but the learning curves are steep once you get involved, as the following examples show.

A lightning start – in two weeks to a major virtual event

Paul Simms, Chairman & CEO of eyeforpharma, tells me on the phone that the decision to hold the 2-day conference in Barcelona, which is planned for the end of March with more than 2,000 expected visitors, as a virtual event was only made two weeks before. After the pharmaceutical companies had imposed travel bans, a series of cancellations of participants came in over a period of about 6 weeks. The mood at the organizer was increasingly clouded. But the decision to use video transmission was a real jolt for the almost 10-member event team. They worked day and night to get the virtual event up and running. 

All speakers and many sponsors were involved. Hotels and flights were cancelled and the speakers had to be familiarized with the new conditions. Since the tickets were refunded or were free of charge, the number of registrations could quickly be expanded to 15,000. The original 2-day conference with 7 parallel tracks turned into a 5-day video broadcast with many live presentations, panel discussions and interviews. ZOOM was chosen as the platform and the partly pre-recorded presentations and interviews were streamed via VIMEO. The individual sessions had an average of 1,000 listeners, reports Paul Simms.

From 150 to 15,000 participants – it works!

But online conferences don’t have to reach this size and the typical planning time is rather 6 weeks. I was booked as moderator for the 7^th MedTech Rheinland-Pfalz on 12 May. About 150 participants and over 20 exhibitors were expected in Mainz for this conference. At the end of March, the Ministry of Economics of Rhineland-Palatinate informed me that this event was also to be cancelled. Marlen Peseke and Daniela Arnold at the Ministry of Economic Affairs reacted curiously to my suggestion to transfer at least some of the content online. After all, the topic of artificial intelligence and robotics in medical technology, as well as an area such as Rhineland-Palatinate, are virtually predestined for innovative online formats.

We met with Michael Alf, an organizer of virtual events in a video chat to understand the technical requirements. When Alf was still living in Australia in 2015, he started organizing virtual events and is well acquainted with the different possibilities and platforms. We are now preparing the event on May 12^th in bilateral exchanges by mail and telephone and weekly video-jour fixes.

The MedTech Rheinland-Pfalz will be hosted on Hopin. This platform represents a conference and fair in a virtual world. After the participants have registered, they will arrive at the virtual reception area on 12 May from 12:30 pm. They will be able to visit more than 20 different exhibition booths and talk to the exhibitors in video chat and get information about their offers. Or they can go to the networking area to chat for a few minutes with another randomly selected participant – just like having a coffee at the trade fair reception – but in a private video room.

Networking & visiting the trade fair – it also works virtually

The presentations will start at 1 p.m. with a welcome by the Minister of Economics and a key note by Bart de Witte, followed by a panel discussion with four experts. After a virtual coffee break, which will once again provide an opportunity for a visit to the exhibition and networking area, the participants can go to one of the three parallel one-hour break-outs from 3 p.m. onwards, where topics will be discussed in greater depth. Afterwards there will be another break and the break-outs will take place again. Each participant can therefore attend two of the three sessions. During these sessions, listeners can ask questions or speak up via the chat – the moderator then opens the microphone for the questioner.

The preparation – What is different?

Preparation is similarly intensive as for analogue events, but it contains different facets. In addition to all content related program issues, which are comparable to those of a physical conference, virtual formats are not about room size, seating or catering, but about aspects such as the best web browser or pixel sizes for the virtual exhibition stands. Such technical details must be clarified with exhibitors and speakers in advance. Detailed briefings by Michael Alf and his team are available for this purpose. 

Virtual meetings – there is even more to it…

Alf observes how new online formats are constantly coming onto the market. He sees a future in playful applications in which participants are teleported into a virtual world with avatars and VR glasses. But in the life sciences and health industry, which still operates in a very traditional way, you don’t have to go as far as with avatars. Why not simply create an advisory board as an online meeting via video conferencing?

Virtual congresses – just get started & gain experience… 

From my point of view, virtual meetings as well as physical meetings enable knowledge transfer and exchange among experts. What if the wave of global solidarity that we have just witnessed in the efforts to combat the pandemic were not a one-off event. What if experts from all over the world were to exchange ideas in virtual formats and develop solutions together? What if global crowd-intelligence really became tangible? In the Healthcare Shapers network, we are already practicing this with our approximately 100 partners, and not just since we founded our chapter in the USA in 2019. Experimentation generates new ideas and innovation. This is precisely why I believe that virtualization should now be boldly pursued rather than cancelled. I am happy to support you in this.

The International Women’s Day is a global day celebrating the social, economic, cultural and political achievements of women; it also marks a call to action for accelerating women’s equality. International Women’s Day is celebrated annually for well over a century on March 8, with the first one gathering in 1911.[1] Hence, this particular day is deemed reason enough to put a spotlight on the strong women of the Healthcare Shapers network.

The individual partners of Healthcare Shapers, who are located in Germany, Switzerland and the USA, are consultants and interim managers with many years of practical experience in the healthcare industry. The diverse competencies of the partners enable the Healthcare Shapers to cover almost all areas of the healthcare sector in breadth and depth, and to develop tailor-made, forward-looking, pragmatic, feasible and effective solutions without overhead costs, supporting their clients in pursuit of success.

The currently 21 highly experienced women within the network (i.e. approximately one quarter of the Healthcare Shapers in total) cover a remarkable part of theentire healthcare value chain and reflect the diversity of the network. With deep expertise, optimized cross-market collaboration, seamless hand-overs and interfaces to accompany the client, they provide future-oriented solutions that lead to success.

Establishing a solid basis

Emerging healthcare companies need expertise and guidance in establishing a national or international footprint, gaining significant market traction that results in meaningful sales and becoming thought leaders and market standouts. Laura Carabello helps companies achieve this positioning through impactful public relations and marketing campaigns – growing companies that eventual get acquired, merged or conduct an Initial Public Offering (IPO).

The regulatory requirements for the development, testing, market access, as well as the continuous maintenance of an approved marketing authorization are complex, subject to quicker and quicker revision and depend on the respective type of product (e.g. medical device or innovative medicinal products). Their proficient implementation belongs to the essentials of a company and is often perceived as burden; however, it facilitates, if done properly, focusing on the development of effective and efficient medicines and medical devices.

Based on a proven track record in the respective area, the special focus of Dr. Monika Boos is on drug safety (pharmacovigilance). She supports pharma and biotech companies in setting up or improving the pharmacovigilance system and implementing legal requirements, acts as independent consultant and assumes interim management positions as responsible person for pharmacovigilance, e.g. EU QPPV. Her further activity areas concern medical devices (vigilance, clinical evaluation) and selected pharma law matters.

People at work and corporate culture

Kathy Letendre works with healthcare delivery organizations to create their excellence advantage. She guides leaders, teams, and healthcare providers to define excellence, in their terms, for the communities and patients they serve. Together they accelerate excellence in care delivery through transformative improvements, innovation, and translating strategy into actions.

What people can imagine and what they can do still drives the healthcare industry. From researchers to providers, from supply chain planners to social media experts, from IT-nerd to generalist leader. Brigitte D. Lippmann supports organisations in providing the people-related infrastructure, designing the processes and nurturing the culture they need to fulfil their strategy – from start-up organization to 130-year old Fortune 50. For that, she helps employees in this dynamic and global industry to define how to achieve their potential with improved presence, communication and (self-)leadership.

Social trends, new generations and the increasing complexity of our environment are changing companies not only from the outside, but also from the inside. In an intensive co-working process, Eva Zweidorf accompanies companies and their managers and employees into a new working culture. She strengthens change, responsibility and a new way of working together. In this way Eva enables inner growth, which is effective externally.

“Collaboration is my brand” Ellen Saltsman states. She designs and delivers interactive, engaging, creative programs of any size worldwide, transforming “offsite workshops” into meetings that drive divergent/convergent thinking and generate actionable, tangible results.  Ellen combines a creative environment with a consistent methodology to help organizations of every kind make effective decisions quickly.

Patient in Focus

Patient satisfaction affects clinical outcomes, patient retention, reimbursement, and medical malpractice claims. In today’s world of healthcare, your individual and collective success depends on patient satisfaction. Clinical outcomes alone are no longer the differentiator. Providing and achieving preeminent service outcomes, in addition to desired clinical outcomes, is what it takes to be a premiere provider.

Kim Wilkerson is known as a real-time, high impact consultant and coach who creates both dramatic organizational success and profound individual growth. She is recognized for achieving mission critical, high stakes results. Kim’s focus on “The Patient Experience,” includes patient centered services, patient engagement, communications, leadership, team dynamics and interaction, and provider shadowing and coaching… all in the name of being a premiere healthcare provider.

Dyan Bryson helps the healthcare industry finally put the patient at the center of their business as they have long promised. She develops and implements initiatives to help improve behavioral and health outcomes as well as medication adherence. Dyan does this with and without the use of technology designed specifically for the pharmaceutical/medical device company and healthcare institutions.

Digitization and digital transformation

Digital transformation has reached healthcare industries and opens new opportunities for data-driven patient journey. At the same time data privacy regulations worldwide and particularly in Europe build a serious obstacle for predictive analytics, real-world evidence and other data-driven models. Natalya Spuling supports healthcare companies to implement data privacy requirements in order to comply with EU General Data Protection Regulation (GDPR) and other healthcare privacy laws, so her clients can focus on their core business.      

“The digital transformation offers great advantages and opportunities for flexible companies” Serdil Dogan says. Serdil supports and accompanies the healthcare market in digitization and digital transformation – from the first idea over strategy development up to the successful and sustainable implementation. Her conceptional solutions unfold the digital potential of your company.

Dr. Ursula Kramer is working to ensure that patients and healthcare providers (HCPs) get access to digital innovations that generate value. With quality-assured information on quality, trustworthiness and security of health apps, Ursula supports health insurance companies, companies in the life science and MedTech industry and HCPs with the largest quality platform for health apps in Germany. She strengthens the Digital Health Competence of patients and HCPs with advanced training and help start-ups with the certification of their products as medical devices according to EU Medical Devices Regulation (MDR).

Dr. Elisabeth Siegmund-Schultze helps clients to design digitally augmented health programs with a focus on screening, delivery of care, and lifestyle improvement. As a physician and health economist with broad experience in health insurance, she takes into account various issues such as customer base expansion, reduction of spending, and adherence to prescribed medication. Elisabeth is always driven by the concept of value-based healthcare.

For organizations in digital transformation, Maike Dieckmann (re-)designs sound strategies, which help clients develop a viable service, creating value for patients and providers. She is a Hasso-Plattner-Institute-certified Design Thinking Coach with many years of sector-specific experience as an executive, especially in business development.

Strategic communication

Beatrix Benz is the partner for Strategic Communications and Public Affairs in Healthcare and Life Sciences. She has a passion for communication and supports start-up, biotech, medtech as well as pharmaceutical companies with a tailor-made approach to find the best solutions to deliver maximum impact and establish long-term success. Beatrix offers companies and individuals a holistic advisory approach – focused, concise and results-driven.

Today’s information overflow puts a strain on physicians. They have an important number of channels to consult. Pauline Millaard supports her clients in defining the optimal brand communication strategy with impactful tactics considering all possible on- and offline touchpoints as well as available customer data from CRM, CLM and other data sources. “My expertise in digital platforms, digital tools combined with the use of impact modeling are drivers of successful customer engagement outcome” Pauline says.

Marketing, sales and revenue

“What use is the best device without targeted and professional sales?” Corinna Ernst rightly asks. Products requiring explanation, that are meant for research and diagnostics ought to have a targeted sales strategy. Corinna’s customers can rely on receiving reliable feedback from future users about their medical devices. Reference centers becoming established and first sales will be realised within a short period of time. Corinna’s clients will also benefit from her excellent network, learn about the investment processes and save valuable time and resources.

Regina Shanklin helps healthcare clients become more customer centric to drive profitable revenue growth. She achieves this through driving the development of more powerful customer communications through better segmentation, targeting and value proposition development. 

Kristina Nix is an independent manager for synergistic healthcare marketing. She successfully establishes healthcare initiatives and educational programs in connection with healthcare products. Positioning and launching new drugs and treatments, developing communication strategies, as well as identifying and meeting customer needs are her core competences.

Added value – One step ahead

Due to the unique structure of personally networked consultants, the Healthcare Shapers are more than the sum of many consultants. Each partner of the network has outstanding skills and has qualified in an intensive selection process to become a member. Healthcare Shapers are recognized experts in their field; they have many years of professional experience and an excellent reputation. Only those who have qualified themselves professionally and personally in a multi-stage selection process can become partners in the network.

Like their clients, the Healthcare Shapers think and act as entrepreneurs. That’s how they find the form of collaboration that creates the most value for all parties involved, e.g., think tanks, workshops, events or projects. More information about the Healthcare Shapers’ strong women can be found in their individual profiles under www.healthcareshapers.com where you can also figure out how Dr. Angela Schremmer, Dr. Claudia Ulbrich and Frauke Wildvang may support you or contribute to make your business become more successful.

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[1] https://www.internationalwomensday.com/

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

• https://news.sky.com/story/pharmacists-preparing-to-stockpile-medicines-and-medical-supplies-for-no-deal-brexit-11441089
• https://deputyprimeminister.gov.mt/en/cpsu/Pages/News/Brexit.aspx
• https://www.theguardian.com/global/2019/aug/26/we-need-to-be-told-which-medicines-are-at-risk-in-no-deal-brexit
• https://www.pharmaceutical-technology.com/news/no-deal-brexit-medicines/

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)

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.

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

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.

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.

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[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