In the below article, CELforPharma co-founder and expert faculty member Edouard Demeire outlines his view on how COVID-19 will force pharma companies to change some critical business practices.
Edouard is the author of KICCASS PHARMA – Keep it Customer Centric, Agile & Strategically Simple In Pharma & Diagnostic Management (2020), is Visiting Professor at CEDEP (INSEAD), and he teaches CELforPharma’s popular The Pharma Brand Planning Course.

1° Pharma needs to better understand patient journeys and develop holistic solutions that combine diagnostics, devices and pharmaceuticals

If we look at the patient journey of patients with COVID-19, simplifying somewhat, patients go through at least five phases. As outlined in the below table, each phase is at a different location, with different screening and diagnostic tools, and different medical needs.

Assuming that no vaccine will be available soon, no single product will bring a solution, calling for holistic solutions that combine diagnostics, devices and several classes of drugs.

The COVID-19 example can be extrapolated to diseases that can be impacted by NGS (Next Generation Sequencing), PHC/Biomarkers (Personalised Health Care), as well as to chronic diseases where early intervention can improve longer term outcomes.

This highlights the greater need to understand patient journeys and develop holistic solutions, including diagnostics, devices and drugs.

Ironically, Abbott separated into Abbott diagnostics and Abbvie. Roche operates in diagnostics and pharma, in two divisions, which are often located on different sites and have different reporting lines. Also, except for some exceptions in diabetes and asthma, few companies have drug and device departments inside an integrated structure that takes a holistic approach to the patient journey.

2° Annual financial budgeting exercises are even less valuable under extreme volatility

In the past, health care companies used a mix of bottom-up and top-down processes to budget for the next fiscal year, and then made quarterly revisions during the year. Nowadays, both on the revenue side and on the expense side, volatility is more of a rule than the exception.

As illustrated by the COVID-19 case, four factors make such annual budgeting exercises less valuable on the sales revenue side:

1. Brands in different diseases are impacted differently in terms of demand by COVID-19: some experience an increased need; others are temporarily less needed, and demand will spike again once hospitals are able to take on less urgent cases.
    
2. The timing of the impact of COVID-19 varies by country and is hard to predict, which makes financial forecasting more of a crystal ball exercise.
    
3. Bottlenecks in supply chain and operations are all over the place. Particularly diagnostics may be impacted by a scarcity of pre-analytics (swabs), kits, chemicals and finally, human resources which will impact drug use.
    
4. Finally, various payers in health care systems will have budget issues themselves, having to redirect their budgets on the fly.
    

On the expense side, pharma, devices and diagnostics companies need to be agile in order to be able to react immediately when market opportunities present themselves. Hence, organisations need to be highly sensitive to the market and be customer centric (rather than focused on pre-set KPIs). There needs to be a collective commitment to address customer pain points and finally, there needs to be resource fluidity across both functions and brand teams working in different disease areas (and business units).

3° The traditional product life cycle (PLC) concept will be even more challenged due to shorter and/or asynchronous multi-market PLCs

The pharma industry has been used to long life cycles with a decade of pre-clinical and clinical research, drug development and approval, followed by the launch phase years, then followed by the maturity phase … and finally ending with patent expiry and the post-patent phase. With LCM, pharma companies were able to repeat this sequence for multiple indications.

Below are two examples where this no longer applies:

1. Gilead’s entry into Hepatitis C has seen a staggering launch for their products, followed by rapid maturity and decline as newly diagnosed Hepatitis C infections dropped as the virus is eradicated in some high value developed markets. For these types of products, typical ‘frontloading’ strategies (i.e. spending more than you sell in the first years) may have to be revisited as the life cycle may not extend long enough to generate a return on the investment. Drugs in disease areas such as obesity have also seen much shortened ‘fashion’ life cycles. Acceleration in R&D and market need will also create market situations where life cycles become shorter and more volatile.
    
2. A second example is repurposing. Several drugs that were originally developed for HIV, regular influenza, Rheumatoid Arthritis, Lupus, … are now being evaluated in COVID-19. Hopefully, repurposing drugs will allow pharma companies to bring at least partial solutions more rapidly to the market than starting completely new R&D projects. As several drugs were viewed as mature drugs in their original indications, as in HIV for example, little medical/commercial activity and no more production investment was made. Now, companies are confronted with the question as to whether to invest in these older drug classes (seen as famous cash cows), based on the emergence of new, possibly much shorter and volatile life cycles for existing drugs in additional indications, in the same way that record companies are now wondering how much commercial and production resources to place on vinyl music records.
    

In certain areas, agile, scalable production capacity and dominance in supply chain may become a source of sustainable competitive advantage instead of patented molecules in R&D, similar to what one sees with Grifols, CSL Behring and Shire/Takeda in the fractioning market.

New business models may also emerge as several big pharma company leaders have been in contact to make, for example, biologic production capacity available to each other in case one of the researched drugs show benefits in COVID-19.

4° Pharma needs to further fragment interaction models as customers experience new ‘journeys’

Specialists in digital marketing claim that the confinement of sales reps due to COVID-19 will mean the death of the classic sales rep in favor of digital tools. Also, major congresses (e.g. ASCO, ACC, … ) are all going virtual, most of them however admitting they won’t be able to replicate the full benefit of face to face discussion sessions, satellite symposia, … proposing that the need for scientific exchange continues to exist even in these bizarre times.

The question is: What will happen with face to face communication once the pandemic is over, or at least reduced?

Will many scientists continue to participate digitally to major conferences (irrespective of time zones) and only travel for fully interactive meetings? Will they travel for multi-day conferences, but no longer for short advisory boards which can more easily be held digitally? Will sales reps stay in their home office instead of resuming visiting physician offices once confinement is over? Will prescribers prefer to call their familiar sales reps in their home office when a question comes up, or will they prefer to call a medical call centre?

Quality of the medical input is certainly of a higher standard with MSLs and medical call centres. But historically developed personal relations with sales reps means the interaction can be more easy going (and hence profound) .

What will future interaction modes look like? The answer is: “It depends”, and for sure the answer is: “There will be many more interaction modes, not a single one.” Which type of interaction will be most efficient and effective for one particular touchpoint depends on various aspects:

1. The issue the customer is facing (a question on dosing, combination of therapies, complexity of the disease area or novelty of the therapy)
    
2. What stage in the customer experience journey he/she is in, what they are doing, thinking, feeling,… (building up awareness of a medical issue, needing support to obtain funding,…)
    
3. Personal and cultural preferences of the customer (Latin versus Mediterranean, introvert vs extraverts,…)
    
4. Past experiences the customer has had with different interaction models (attended a boring web conference last month, or learned a lot in a Zoom session last week,…)
    
5. Whether the customer is ‘one’ or customers are ‘multiple’ stakeholders (need for sharing amongst decision makers and influencers or single decision making)
    

The key question is: how to synergize what looks like a fragmenting set of channels in an accelerating marketplace?

5° Pharma needs to explore contingencies to quickly recover from any potential disruption in clinical trials in the future

The normal running of trials is affected by three factors during the COVID-19 pandemic:

1. Some patients with chronic diseases are refraining from seeing their prescribers as they are afraid of contracting COVID-19, which is generally known to be riskier for patients with comorbidities. Trials which require regular follow-up of patients in chronic diseases may not be possible, which will disrupt data gathering. In France, in order not to overload prescribers with writing repeat prescriptions, the government has allowed pharmacists to fill a prescription which has already been filled a second time. Ironically, primary care physicians are seeing a 50 to 70% decline in patient visits, due to the fear of patients to contract COVID-19 in the doctor’s waiting area.
    
2. The regular functioning of hospitals is challenged due to reorganisation of certain wards. For example, one of the largest cancer centres in Paris (Institut Gustave Roussy) with 520 doctors and 950 research staff has converted part of its hospital to assist in the management of COVID-19 patients, resulting in staff having to be retrained etc. Prescribers and clinical researchers may feel it is not the time to enrol patients in trials as many HCPs are under time pressure. Additionally, a stressed and confined population may not react in the same way to medication. And, Medical Science Liaisons, who in many countries can support prescribers with information on patient enrolment in trials, will not be able to engage in regular face to face discussions.
    
3. Finally, trials which require substantial support from diagnostic labs may encounter difficulties getting a rapid service, as a lot of labs are focusing on rapid turnaround time of PCR testing for COVID-19. Just to give an idea of magnitude: the French health minister gave a speech on March 21st, proudly announcing that France had the capacity of performing 4000 PCR tests a day. Compare this with a cobas 8800 instrument that can process 4096 samples in 24 hours. In other words: The whole of France has PCR testing capacity equivalent to one single high throughput instrument! More rapid, lower throughput diagnostic instruments often require massive lab technician time, which reduces the time they can spend on other diagnostics. In general, supplies, reagents, masks, swabs,… are in scarce supply in many countries, which means staff is immobilised in less productive supply chain management challenges.
    

Pharma companies may need to set up contingency plans in order to attempt to catch up time by enrolling a greater number of patients once the pandemic retracts. There is plenty of room to do so: while in some cancers, many patients are in trials, in the US barely 4% of all cancer patients are included into trials. Valuable information resulting from 96% of the others might be lost, or needs to be recovered in observational studies. What would it take to double patient enrolment into trials to 8%?

There is a clear need for competitive intelligence in disease areas with small patient potentials. Some pharma companies may be tempted to continue enrolment, others will not want to challenge their relationships with trialists. Responses vary from recommending halting recruitment to others not starting new studies, and yet others acting as if nothing is happening, leaving the decision up to trialists.

But there is another perspective: The gold standard clinical trial is clearly the randomised, double blinded multicentre trial with sufficient number of patients to reach acceptable p-values. However, in times when a pandemic strikes, should society be willing to accept non-randomised smaller studies in order to initiate prescribing and then reconfirm as we go along?

In life threatening situations, should it not be up to prescribers to make the decision whether compassionate use is appropriate for patients not eligible for trials? And maybe authorities are even willing to support non-gold standard evidence?

Once NGS (Next Generation Sequencing) becomes mainstream in areas such as oncology, continuous, smaller scale trials will become a fact of life due to the much smaller patient populations with a particular set of genetic mutations. Beyond KRAS, HER2, EGFR,… markers, oncologists forecast there may be over a million types of cancers, classified according to mutations. This means that individual cancers may only have a few hundred patients annually worldwide. Small scale trials, ‘on the fly’ learning and adapting the allocation of patients across study arms as we learn, will have to become business as usual if we want to attempt to bring drugs to patients safely but also more rapidly. Unfortunately, the current public debate around hydroxychloroquine does not help the evolution which aims to bring hyper-personalised treatments to patients in an optimal timeframe and, beyond COVID-19, may unfortunately delay broad use of NGS which holds great promises in many diseases.

Last update: April 2020

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