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The US Sunshine Act and its equivalents

It has been raining for weeks. The plants on my balcony are divided in their enthusiasm. My fern, bleeding heart and shiso plants are happy, while the chiles, the sage plants, the basil plant and many others have not grown since the rains started, reminding me that plants like humans need the right conditions in which to thrive.  

In the past weeks I have worked on regulations that apply for engaging with customers in various markets, started reading a book on the gender data gap, and joined a Balint group that runs at 3am my time (7pm in Boston). Today’s newsletter draws from these experiences.

Today’s topics:

  • The US Sunshine Act and its equivalents
  • Do you speak my language?
  • Address bias to improve business
  • Leadership: Words, words, words

The US Sunshine Act and its equivalents
 
The U.S. Physician Payments Sunshine Act, which is part of the Affordable Care Act, went into effect on August 1st, 2013, with the aim make the financial relationship between healthcare professionals and healthcare organisations and drug, device and biological product manufacturers more transparent. Manufacturers track and report payments or transfers of value provided to healthcare providers.
 
Payments and transfers of value may include payments for speaking engagements, research activities, continued medical education and travel or physical items such as gifts or the provision of scientific literature, training materials etc.
 
The data reported by manufacturers is published annually on the US government’s open payments website and can be accessed by any interested party Link. The threshold for reporting of a payment or transfer of value in the US is 10 USD and failure to report accurately can result in heavy fines.
 
Many US companies expanding outside the US market are curious about the regulations governing pharmaceutical industry practice including transfers of value in other markets.
 
The situation outside the US is not uniform, while some countries have implemented a standalone Sunshine Act equivalent approach with a tracking platform, such as Belgium (Link), many other countries have instead integrated guidance on transfers of value between the pharmaceutical industry and physicians into their regulatory framework for medicinal products.
 
For markets where no specific legal framework exists for payments and transfers of value, such as Vietnam, Malaysia or the Philippines, the Codes of Practice of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and their Member £Associations provide important guidance (Link), which is helpful whether or not a company is a member of these associations.   
 
This short introduction to the topic highlights that there is a large degree of variation between markets and that it is important to note that both regulations and codes are specific to each market and can vary substantially.  If you are curious to know more please contact me. 
 
Key take-away:  
The world is complex, it is worth preparing before you venture out.

Do you speak my language?

Have you ever wondered about the language constraints the pharmaceutical industry operates under? Wondered what guidance or expectations regulators have for pharmaceutical companies operating in individual markets?

Have you worried about engaging French customers in French, providing Iranian customers with Farsi speaking Medical Science Liaisons, or thought about the budget implications involved in trying to provide each market with native-speaking health care professionals to answer questions on your medicines and devices?

If so, you are not alone. The decision regarding the language you use depends in part on the market you are in, and naturally on local regulations and local culture, but also on the size of your local operation, your current future portfolio and many other considerations. If this is an issue you struggle with let me know.

Key take-away: If you worry about language, you are not alone, but it is less complicated than you might think.

Address bias to improve business

At last months BOOM summit in Basel, I spoke with participant and entrepreneur Douglas Drake about AI, data analytics and biased data amongst other topics.

Douglas recommended I read the book “Invisible women – exposing data bias in a world designed for men” by Carole Criado Perez. I am only in the middle of the book; however, it is fascinating reading so far.

Some of the examples have stayed with me: prehistoric cave art was historically attributed to men, because men hunted, recent research highlights that this attribution was likely erroneous. For many, female warriors were unthinkable. Hence when a skeleton with a female pelvis was found buried with two war-horses in 1878 it was considered male until a recent DNA analysis in 2017 showed that the skeleton was in fact female “Guided by comprehensive genomic sequencing, archaeologists first revealed the unexpected findings of the woman warrior in a 2017 study published in the American Journal of Physical Anthropology. But as Live Science’s Laura Geggel explains, naysayers immediately unleashed a storm of criticism, alternately questioning whether the researchers had analysed the correct set of bones, overlooked the presence of a male warrior sharing the grave, or failed to consider if the grave actually belonged to a transgender man” Smithsonianmag.org.

While you might say this is irrelevant and that the gender of an ancient Viking warrior is not important, it does illustrate that when something is unthinkable it is changed to fit the acceptable narrative. When I examined a patient as a medical student she assumed I was a nurse. The German word for doctor is masculine. Most doctors at the time my patient was young were male and so her world view was that a doctor is male and a nurse is female. I was female consequently a nurse.

Over the ages, assumptions and societal norms have coloured the interpretation of data from many different research fields. Unless corrected this robs us of the image of the world as it is, and this in turn robs us of the ability to design solutions and products for the world as it is, to build businesses that serve today’s populations and in fact to develop new markets. Yet, revenue generation depends on discovering new target audiences.

And new target audiences are being discovered as witnessed by the pharmaceutical industry’s recent discovery of women’s health topics, and the ubiquitous newly emerged enthusiasm for women’s health and pledges to invest in research and rectify the wrongs of non-inclusive research past.

I receive many variations of the following message on a daily basis “AI will revolutionise healthcare, medicine development, drug dosing etc. etc.”

I am not saying that AI cannot do this. I am sure it can, but the tool is not the problem. The potential problem is that AI is trained on data, that represents the world as it was, with biases and flaws. To design solutions that are fit for purpose we need a significant amount of knowledge and awareness to unpick bias/missing attributes in the data. And sometimes the data just does not carry the information that is needed to address the task at hand. For an excellent example of this read about snow plough deployment in Sweden and why non-gendered commuter data is a perhaps surprising issue in this context: Link.

Key take-away: Question your training data, ensure you have broad population representation when questioning the data, and designing solutions to ensure you don’t miss something. And: if you do not do it for the people, then do it to improve your business outcomes.

Leadership: Words, words, words

I trained as an executive coach at the Tavistock Institute in 2019. Since then, I have participated in Group Relations Conferences which have a fascinating mind-expanding effect. I highly recommend you participate in one if you want to increase your self-awareness and understand how you follow and lead. I have also trained in various techniques such as using constellations in my coaching work.

The work I do in collaboration with others ranges from coaching executives and teams, often when the pressure is intense, to supporting global transformation efforts, to work around data, analytics and systems, to finally supporting medical affairs and medical information strategy and operations. It is broad and it is beautiful. I enjoy the breadth of what I do and I am always learning.

So, when a month ago I was asked if I’d like to apply to participate in a Balint-oriented consultation group by one of the facilitators, who is a friend of mine, which is being organised by the Center for the Study of Groups and Social Systems, the Boston Affiliate of the A.K.Rice Institute, I was excited.

I naturally said yes, despite the fact that the group meets for two hours every month at 3am my time. I am a night person but not an early morning person. Three am, is, I believe, a non-time. However, I signed up, and when I joined the first meeting, it was worth every minute.

The focus of the group: to provide confidential peer feedback on dilemmas of functioning in organisational role. Initially I remember the participants were asked by the facilitators to share a “case”, or a “problem”. No cases, or problems were forthcoming. There was silence.

However, then a facilitator said “How about, a dilemma? Anyone, have a dilemma they want to share. It may not be a problem?” Suddenly we had presenters.

This continues to fascinate me because it illustrates the power of the right words to unlock access to content. This is relevant both for people working across language barriers and cultures, because a word that resonates with you, may not resonate with those who speak another mother tongue, but also for anyone engaging with others in conversation.

If a question you ask doesn’t elicit a response, try a synonym. Beyond testing different words, it is important to be able to wait until a response surfaces.

Key take-away: when looking to understand and communicate with others, be aware of how you use language.

I hope my posts provide you with useful insights. If  you need support with a project, or are interested in coaching, why not give me a call to see how I can help. Find out what clients say about working with me here link.
My very best wishes

Isabelle C. Widmer MD

Image credit: Fabrice Prost, ICRC restrooms, ICRC, Geneva, Switzerland.

The future of healthcare, digitalisation and health equity

Sunny beautiful May, plants on my balcony are blossoming. It is almost summer. Almost a month ago, I went to the first BOOM summit, run by DayOne in Basel, and MC’d by the fabulously impressive DayOne Director of Innovation: Caoimhe Vallely-Gilroy.  The topic of the event? Igniting the Health-tech revolution. There were many fascinating presentations, however, a few things stayed top of mind which I wanted to share with you. A testimony to the fact that great things stay in our minds, even months after we hear them. 

Today’s Topics:

  • BOOM Summit takeaway 1: GenAI and sustainability
  • BOOM Summit takeaway 2: How to bridge gaps and build futures
  • BOOM Summit takeaway 3: Health equity and digital transformation in the WHO EU region
  • Leadership: The traits of an inspiring leader

BOOM Summit Takeaway 1: GenAI and sustainability

The BOOM summit had some stellar presenters, brilliant presentations, deep subject matter expertise and competent, engaging delivery. There was so much content that it is impossible to share it all here, but there are certain topics that were raised, that I think of every day.

The first topic was water and energy consumption of Generative AI.

Samantha Gordine, Sustainability Solutions Lead, Arcondis, Switzerland shared that

  • ChatGPT uses 0.5 litres for every 20-30 questions it processes and that by 2027 AI’s water demand could be 50% of the UK’s national demand
  • GenAI uses 4-5x more energy than a conventional web search and that within years, large AI systems are likely to need as much energy as entire nations.

I think about this every time I use GenAI, or read about companies adopting GenAI across the globe, and I wonder.

A nature article posted on Feb 20th, 2024, addresses this topic in more depth “Generative AI’s environmental costs are soaring – and mostly secret (Link)

Key takeaway: My personal take-away is to ask myself when I need GenAI and when a regular search will do.

BOOM Summit Takeaway 2: How to bridge gaps and build futures

In the session: Bridging gaps, building futures: The intersection of Health Tech,
Gender, Medicine, and Additive Manufacturing Naomi Nathan, Head of Medical, Mobility, Medical goes Additive e.V., Germany shared her thoughts.

What stayed with me from her talk was the exhortation to the audience to do the following:

  • Break silos: bring together experts from diverse fields, healthcare, technology, engineering and beyond to cross-pollinate and tackle challenges from different angles.
  • Co-Creation: patients, clinicians, researchers, industry partners should co-create new health tech products.
  • Share knowledge: create collaborative ecosystems and avoid reinventing the wheel
  • Scalable solutions: interdisciplinary teams enable the development of solutions that can be deployed across diverse healthcare settings and communities.

I readily admit that in my case Naomi was preaching to the choir and my enthusiasm for her suggestions stems from my not only wholeheartedly agreeing with everything she said, but my also having said the same things over the years, repeatedly. My first panel discussion on digital islands was a case in point, both panelists have a broad background, they code, they are data scientists, they understand data, data science and systems but they also understand business from fintech, to NGO, to pharma, to CRO, national intelligence and beyond. It is easier than ever to bring thinkers together, all it needs is the willingness to explore different ways of thinking and working and to take nothing for granted.

Hopefully, these ideas are now becoming mainstream.

Key take-away: Accelerate towards success by integrating ideas across industries, countries and cultures and making something new.

BOOM Summit Takeaway 3: Health equity and digital transformation in the WHO EU region

Clayton Hamilton representing the DATA, Digital Health and Evidence WHO Regional office for Europe spoke about health equity and provided the following definition of health inequities: health inequities are differences in health status or in the distribution of health resources between different population groups, arising from the social conditions in which people are born, grow, live, work and age.

He asked the following questions:

  1. What impact is digitalisation having on health equity?
  2. Why does this matter?
  3. What can we do to shape the future of digital healthcare that is available, accessible, and affordable for all – and make sure that we do not lose the humanity in medicine?

From a patient perspective it is easy to understand that a lack of digital literacy and digital access impacts health outcomes. In addition, underserved and marginalised populations, could benefit hugely from access to digital health tools.

An aspect I did not consider is that if underserved population data is not captured, any AI solutions that are built using the data that is captured, once again, only represents a subsegment of the population further impacting how underserved populations healthcare needs are managed.

While we focus on patients, thinking of the charity I volunteer for, there are also clinical officers around the world serving patients, these clinical officers also do not have the same access to internet and digital health information as their peers. Who has access to data, when and to what quality and volume, is relevant not only for patients but also for physicians.

About ten years ago I was doing some work to design a training course on market access, and I remember looking up a McKinsey or PWC report on smart-phone use worldwide amongst HCPs – the topic was – when and how do doctors consume information. At around the same time pharma companies were providing physicians in South America with access to international scientific publications because of the cost of these publications making them less accessible to physicians in certain populations.

We are so used to having access to everything online all the time that it is easy to forget that this is not a global reality.

There was so much more content that Clayton shared, and I cannot go into it here, however, he shared a link to a WHO Online introductory course on Ethics and governance for AI for health, you can find the link here.

Key take-away: If we don’t address digital health inequity, health inequities and social disparities will grow.

Leadership: The traits of an inspiring leader

Leadership,  is as much, if not more about managing yourself, than it is about leading others.

In a nutshell, if you can manage yourself—your emotions, your engagement, your energy levels—and if you know what you can and cannot do, bringing in others with complementary skill sets without begrudging them their abilities, then you are already in a great position.

If you can work with others who possess diverse skills, delegate effectively, temper any need to micromanage, can offer praise but also provide candid, fair, and constructive feedback, and communicate honestly about what you can change and what you cannot, your position is further strengthened.

Finally,  you need to be able to make difficult decisions, avoid blaming others when things go wrong, take accountability, and be honest and human to the point of recognising and accepting you have strengths and weaknesses. Know that it is easier, and I believe more sensible, to build on a strength than it is to fix a weakness. Whatever the topic of your end of the year review.

The traits described above, I believe, are those of potentially great leaders, who can inspire loyalty in others and the desire in them to follow you.

Naturally, you also need to be able to communicate effectively, set goals, have a meaningful vision, and manage all the business aspects.

Key take-away: learn from others but know you are a unique leadership instrument, and you need to find out who you are as a leader, of one, or of many, yourself.

I hope my post provides you with useful insights. If  you need support with a project, or are interested in coaching, why not give me a call to see how I can help. Find out what clients say about working with me here link.

My very best wishes

Isabelle C. Widmer MD

Image credit: Jason Dent @Unsplash

GenAI and regulatory document review and the role of loyalty in personal and professional growth

Many new experiences in the past weeks. I worked on a publication on social dreaming during the pandemic, did a 21km walk in preparation for a 50km event later in the year and ran my company’s first webinar/panel discussion on the topic digital islands. The experience was fun and attendance was good. Beyond participation on the day,  28 people have watched the recording since the event, which is excellent.

Today’s topics:

  • Marooned on a Digital island panel discussion reflections
  • GenAI and regulatory document review
  • Moderna rolls out GenAI
  • Leadership: The role of loyalty in personal and professional growth

Marooned on a Digital island panel discussion reflections
 
Last week I ran my first panel discussion with my company. It was not part of a larger event run by a conference organiser.  I was joined by two friends, data scientists and brilliant thinkers Wolfgang Schwerdt, who is a Data Science Manager at the ICRC and Peter Shone, who is Chief Technology Officer at iEthico. I am immensely proud that Krystal Ellison from 3Sided Cube,  volunteered to help me. Without her support I do not think this would have come to fruition.
 
Strangely, although I have known both Wolfgang and Peter for years, they still manage to impress me, when I talk to them, both share concrete examples from the work they have done.
 
Upon being asked why digital islands still exist, although we have technology, knowledge on how to avoid them, and theoretical ability, Wolfgang answered “I think it just happens organically and is unavoidable.”  He then shared an example of a startup he was in, where three years after the company was founded, there were five thousand systems across the entire organisation.
 
We covered topics including why organisations struggle, what to do about it, key drivers for change, infrastructure, data mesh/data lakes and, of course, AI.
 
If you missed it, and you struggle with marooned data, don’t know your mesh from your lake yet, and find pragmatic solutions more attractive than waffle, watch the “Marooned on a Digital island panel discussion” here: Link
 
Key takeaway: You are not alone, if you want proof, and better yet,  solutions, watch the discussion on the Link. We received some great feedback.

GenAI and regulatory document review a case study
 
Enthusiasm does not trump accuracy. AI reminds me of a puppy, I throw a stick, the puppy brings me a similar looking stick. If the puppy is super enthusiastic, I may not notice.
 
In the past week I have reviewed regulatory documents from many markets including Israel, India, and Hong Kong. Documents included pharmaceutical industry codes of practice, regulations on medicines for human use, GDPR and other data privacy related regulations, EU directives and regulations, legislation governing promotional activity or transfers of value and legislation on consumer rights.
 
Many of these documents are lengthy, and manually searching them is time-consuming.
Fortunately, I was looking for specific information in each document, I know the subject area intimately, and most of the documents are available in English. 
 
From initial manual reviews, my approach evolved to using AI to support with searching the documents, prompting it to provide the text in original language, where it was not available in English, with a translation directly underneath and the exact article number and page numbers. This approach enabled me to review the original text, which I can do well enough to spot inaccurate translations in Spanish, Italian, French, German and English. This approach was usually not needed, however, as documents are often available, in bilingual versions, e.g. Hong Kong, or else in English as non-legally binding copies. The one outlier was Israel, I was unable to find the regulatory document I was interested in in English, ChatGPT made up answers, possibly due to a hebrew challenge,  and the translation engine I gave the task to last night is still translating. 
 
What struck me repeatedly was how often, even when I had provided ChatGPT with a full-length regulatory document, and asked specific questions on that exact document, the answers I received were wrong. They sounded reasonable, they made sense in the universe I live in, but being a sceptical soul I checked each answer, and quickly learned to ask for the exact original text snippet and the precise location in the document to check the responses I had received. Invariably I ended up getting this answer again and again “I am but a lowly large language model, I shouldn’t make stuff up, but I aim to serve”
 
I submitted the above text to ChatGPT4 and asked for its opinion: its feedback was this “Your experience highlights that accuracy is paramount and the verification of AI outputs is critical. The “happy puppy” analogy illustrates the risk of AI delivering incorrect answers that seem plausible. While AI can enhance efficiency in managing vast data volumes, its outputs must be thoroughly checked. Underscoring the need for collaboration between AI users and developers to improve accuracy. The key takeaway: enthusiasm does not diminish the importance of verification to ensure accuracy.”
 
Key take-away: Beware the happy puppy. If you send your puppy into the woods after a stick you threw, it may bring you an old boot, instead. Make sure you check because enthusiasm does not trump accuracy.

Moderna rolls out GenAI

In light of my experience above, I found this recent article in the Wall Steet Journal fascinating “At Moderna, OpenAI’s GPTs Are Changing Almost Everything” (Source Wall Street Journal, Isabelle Bousquette, April 24, 2024,(Link). According to the article “Moderna employees have created 750 unique tailored versions of OpenAI’s ChatGPT, that are designed to facilitate specific tasks or processes across the business. Some of these GPTs help select the optimal doses for clinical trials and help draft responses to questions from regulators

This is an interesting approach.  

What I am curious about, but what the article doesn’t go into, is how the models are trained, how the accuracy and precision of the implemented tools is managed, how recommendations are verified by experts, what governance has been put in place to manage this approach and how the data that is used for training is prepared.

The basis of any good AI model is clean data, clarity on what is being put in, training and monitoring of the output, and this is important, quality control, in this type of situation where the stakes are extremely high, ideally by an uninvested third party.

Key take-away
: We live in interesting times.

Leadership: The role of loyalty in personal and professional growth
 
Loyalty is regarded highly. Having a sense of commitment to the organisation you work for, the country you live in, the background you come from, or your team provides stability and a sense of belonging.
 
However, sometimes a sense of loyalty holds us back. For example, when I was still an employee, I did not apply for a newly created position to head up our team, because I would have been competing with my manager. It felt disloyal to apply. I remember how astonished some people were. We are still close friends; we both have different jobs, and it was the right decision for me at the time.
 
In the above example I was conscious of my loyalties. However, sometimes they are hidden.
 
As a coach the thought that unreflected loyalties can inhibit progress fascinates me.

Some obvious examples are loyalties to organisational structures, which have been reimagined, or old ways of working. At a much deeper level, unidentified loyalty to previous familial generations can sometimes also inhibit progress. Examples might include individuals with enormous potential, who do not progress in organisations, or do not finish university, because on a subconscious level, successfully achieving these goals, would make them feel disloyal to a family member, who was unable or did not have the opportunity to realise their own potential.
 
Many coachees I have discussed this with have found the idea resonates and have shared personal examples.
 
Key takeaway: If you feel unable to reach a personal goal, or you keep delaying something, ask yourself “who or what am I being loyal to in not reaching this goal?” Or “who, or what would I be disloyal to, if I reached this goal.”

Reminder, watch the panel discussion on digital islands

Link

I hope my post provides you with useful insights. If  you need support with a project, or are interested in coaching, why not give me a call to see how I can help. Find out what clients say about working with me here link.
My very best wishes

Isabelle C. Widmer MD

Image credit: Krystal Ellison

Navigating the regulatory jungle – don’t advertise magic remedies

I have a busy week behind me with participation in the Boom Summit in Basel, which was great, and a busy work week coming up. Beyond work spring has sprung, the weather is beautiful and I have new strawberry plants on my balcony. I have also  soaked chilhuacle nero  chili seeds in tea, and a batch in water in order to compare performance,  before putting them onto a heating pad to germinate. 

  • BOOM Summit: Improving healthcare access and technology
  • Bad workman, bad tools or neither? Me, my bike and I 
  • Navigating the regulatory jungle – don’t advertise magic remedies
  • Leadership: Lessons from a consultant

BOOM Summit: Improving healthcare access and technology

Imagine you have no health insurance; no internet access and you cannot afford the bus fare to get to your nearest physician. Perhaps you are one of the 2.9 billion people, 37% of the world’s population, that has never used the internet (Source: United Nations Website, 2021).

How would technology help you? When I prepared for the panel discussion on improving health care accessibility through technology, that I took part in at Boom Summit last week, it became clear to me that I want to share my passion for technology and equitable access to healthcare, while remembering that 50% of the world’s population does not have access to the healthcare they need (Source) and that, depending on location, needs are dramatically different.  I realised I wanted to focus on healthcare access/intervention and context first, and modality, e.g. technology, second. Tech is fantastic, but it is not always the answer. Below my recommendations for how to approach improving healthcare access with and without technology.  

  1. Patients: Engage patients, involve patients. listen to all patients and don’t forget that patients are also doctors and nurses, physiotherapists, and computer programmers, molecular biologists, and lawyers. They know their disease, they know the science, they have programmed solutions where the industry has not provided what was needed.
  2. Identify the problem: the presenting problem is often, in fact, almost never in my experience as a consultant, the main problem you need to solve. Ensure you have understood the issue, and you understand the context, key stakeholders, and patient needs. Reality check this. A great example of what happens when you don’t understand the problem can be found in Ernesto Sirolli’s Ted talk: want to help someone, shut up and listen
  3. Identify the ideal solution in the context you are in:  For example, to provide stigma free access to mental health support, a psychiatrist rolled out friendship benches in Zimbabwe. Benches are placed in parks, they are staffed by community elders, who listen to and potentially triage individuals needing mental health support to practicing clinicians, thus lowering the barrier to ask for help, while implementing a cost-effective solution.
  4. Fast-track your approach: learn from other industries and others in your field. 
  5. Smart solutions can have a huge impact even if they don’t seem exciting:  Game changers that can save money and ideally support systems to reallocate funds where they are most needed, include: implementing better processes in managing the patient’s journey and health records and ensuring all treating physicians have access to the data. Allocating physicians to cases based on expertise and adapting on a case by case basis as a day in the clinic evolves. And AI supported diagnostic solutions.
  6. In many indications in the mental health arena the need is great: aging populations including patients in mental decline, and those who are confused and disoriented, will at some point overwhelm the available resources in healthcare systems in the Western world. I remember a patient I met while I was a medical student. He had dementia and he spent his day restrained in his chair. He seemed lonely. I drew a board game and got some buttons. I tried to engage him.  This was many years ago, but this man’s situation, and the situation of many others like him around the world,  still make me feel sad. Tech solutions like Paro the therapeutic seal, view a video: here.  can help patients feel more connected and less afraid. Another success story is the app Stigma, which “aims to foster a supportive community while breaking down societal stigmas associated with mental health”

My fellow panellists also shared many ideas including the following: 

Ventsislav Dobrev recommended you start small and develop your solution in increments, Brian Li Han Wong, stressed the importance of implementing solutions that match the environment you are operating in, sharing a story about failed healthcare initiatives when high-tech solutions were implemented in an environment unable to maintain them, and Sara Schmachtenberg spoke about the problem with too many apps which makes managing health difficult for multimorbid patients and that when tech investors are hesitant creative tech developers will stand out from the crowd. Julie Cheu led us through the panel discussion and was widely acclaimed afterwards as a fantastic moderator by audience members I spoke to. 

Key takeaway: Here, as everywhere, knowing what you are doing is critical: shiny, golden tech solutions have no legs if all they are is golden and shiny.

Bad workman, bad tools or neither? Me, my bike and I
 
There is an English saying: “a bad workman blames his tools.”  However, sometimes ensuring you have tailored tools for the job can be the difference between success and failure.
 
Last weekend, I cycled up a series of hills. The steepest incline was 16%, which, for me, is steep. In the past, I would not have had the ability or the desire to attempt it. However, last Saturday I really enjoyed the challenge and the satisfaction of cycling a difficult route.
 
So, what has changed? My fitness? A little, but mainly my motivation and my equipment have changed; I had my bicycle adapted to make hill cycling easier and I bought a bicycle computer that tracks where I am on an incline and collects data. When I started cycling, other cyclists often overtook me, whenever I cycled up a hill. I assumed it was because the cyclists were much better than me; I did not think to question my equipment. Then an avid cyclist looked my bicycle over and explained the issue.
 
Key takeawayYou may not always see key performance predictors if you are not well-versed in a subject. Properly equipping yourself and aligning with your personal motivators can improve performance more effectively than merely training harder.

Leadership: Lessons from a consultant

When I began consulting in 2013, I was tempted to manage every aspect of my business myself. It seemed manageable and sensible for someone just starting out. However, my father, who passed away recently, often told me, “Do what you are good at, delegate the rest.”

It took me a while to embrace his advice, but now I apply his wisdom in every area of my life. If someone else is better at a task, if the task is highly time-consuming and my time would be better spent elsewhere, or if I simply do not enjoy it, or the thought of doing it causes me anguish, I hire someone else to do it. The joy I get from seeing something taken care of well, and knowing I did not have to do it, is incredible.

In addition, this approach frees me up to focus on what truly matters to me: consulting, coaching, learning, participating in industry events, making new connections, engaging in charity work, cycling, hiking, spending time in nature and with my friends and family.

Key take-away: Energy is finite. Delegate where you can and focus your energies, the rewards are immense.

Reminder, Sign up for the panel discussion  on digital islands and AI on April 24th

Don’t forget to sign up for the panel discussion on digital islands I will be joined by Wolfgang Schwerdt and Peter Shone, both experienced data scientists. All information in the link below.

Sign up for the panel discussion on April 24th at 2 pm GMT, 3 pm CET, and 9 am EST: “Are you stranded on a digital island in a sea of data?”

I hope my blog provides you with useful insights. If  you need support with a project, or are interested in coaching, why not contact me to see how I can help. Find out what clients say about working with me here link.


My very best wishes

Isabelle C. Widmer MD

Image credit: Michelle Bridenbaker

Data dynamics in medical affairs and sign-up for the panel discussion on digital islands!

The world is a riot of colour, cherry blossoms, crocus, bluebells and daffodils, green shoots, blue skies, and  more hours of sunlight every day. There is a lot of promise in the air. Spring is here, greeted every year with a sense of joy and wonder.

Another event that occurs annually is in preparation: The DIA Medical Information conference, which this year will be held in September in London. Remember, the meeting stays relevant and interesting thanks to your participation. If you have an idea for a submission, please don’t hold back. If you need a pep talk, reach out!

And now some news, something that has not been here before: I will be running and hosting my very first panel discussion with my company. I have done many of these but none without the support of conference staff. Please find the link below!

Today’s blog topics:

  • Medical affairs: unlocking insights and exploring data dynamics 
  • Medical affairs: the benefits of collaboration
  • NEWS: Upcoming panel discussion on digital islands and AI
  • Leadership: Remember to lead with compassion

Medical affairs: unlocking insights and exploring data dynamics 

In 2019, I conducted a survey on the interconnectedness of all things, systems, knowledge, and people in medical affairs. I asked individuals how they manage data, communicate across geographies, and ensure that different teams in the medical affairs sphere, think medical managers, medical directors, medical science liaisons, medical information and beyond, are aware of key information about products, key clients, and services. The survey was global and shared with biotech, pharma, and device manufacturers. Eighty-five respondents shared their knowledge.
 
I asked questions about collaboration across teams and geographies. I inquired about processes, systems, and platforms, as well as whether regular meetings to share data are held and  all processes are described in SOPs and WIS. While almost 50% of respondents reported having meetings to share information across functions, these meetings were mostly on a case-by-case basis, and the approach to information sharing was not described in SOPs and WIS.
 
When asked to identify the biggest challenge to collaboration and data-sharing across teams, respondents selected the following (multiple responses were possible):

  • Lack of knowledge about potential data sharing areas (85% of respondents)
  • Lack of shared processes (90% of respondents)
  • Lack of common platforms (80% of respondents)

 
While AI is often discussed for analysing data within systems, it’s crucial to acknowledge that without proper processes in place to identify and manage data, capitalising on its potential becomes challenging. Furthermore, the absence of common platforms poses a technical obstacle, compounded by variations in taxonomies and ontologies.
In conclusion, many hours are lost in generating new information or reinventing the wheel. With constant reorganisations in the pharmaceutical industry, managing this situation is more important than ever across the board, teams, and geographies.
 
If this topic is of interest to you, stay tuned for a follow-up survey. I am curious to see how the field has evolved.
 
Also, consider signing up for my upcoming panel discussion on digital islands here.
 
Key take-away:
 You don’t know what you don’t know.

Medical affairs: the benefits of collaboration

In the survey mentioned above, beyond asking team leads how they collaborate, what they collaborate on and what processes are in place, I asked them to outline how collaborating across teams, e.g., Medical Directors/Medical Managers, Medical Information, and Medical Science Liaisons, had improved how they work. The precise question was: “What have been the benefits since you started collaborating with other teams?” The answers included: faster identification of issues/opportunities in the markets (65% of respondents), harmonised medical affairs strategy at a local level (63% of respondents), insights from other markets to help us anticipate market needs (58% of respondents), and also, especially relevant in these times of constrained resources, sharing resources has freed up capacity to do other work (41% of respondents).

One respondent said: “From a global perspective, the benefits are better alignment, more efficiency, more room for innovation,” and another stated, “Collaboration helps us anticipate our customers’ information needs.” It is easy to imagine the downstream benefits of these outcomes of better collaboration, for example, better resource management, better customer satisfaction as customers’ needs are anticipated, and enhanced in-field effectiveness, all of which have a positive impact on the business.

Key take-away: cross-team collaboration can add huge value in medical affair through  efficient resource utilisation, reduction of reduplication of efforts and the ability to address topics as they arise ultimately leading to better business outcomes. 

NEWS: Upcoming panel discussion discussion on digital islands and AI

So how about managing data on Jersey then?” a lawyer in the financial sector asked me at a panel discussion I hosted on digital islands last year. Jersey is an island located in the English Channel off the coast of Normandy. I suspect he was disappointed to discover that the islands we focused on were entirely virtual.

I am delighted to share today that I am finally hosting my first virtual panel discussion on digital islands, also virtual, with my company elytra – very real!

I have been speaking at conferences for years, and managed many panel discussions, in this context, but I have always had a hankering to host my own. Now, finally, thanks to Krystal Ellison, who supported me in all things technical, my first panel discussion is here!

I will be joined by Wolfgang Schwerdt and Peter Shone, both experienced data scientists and sailors, so perfectly placed for the subject matter.

Sign up for the panel discussion on April 24th at 2 pm GMT, 3 pm CET, and 9 am EST: Are you stranded on a digital island in a sea of data?”

Come prepared to have all your questions answered.

Key takeaways: My first panel discussion is upcoming, it would be fantastic to see you there.

Leadership: Remember to lead with compassion

During the pandemic, there were many discussions regarding how teams can function without face-to-face interactions and in a state of fear and lock-down. A friend said “I tell my team that not being ok, is ok”.

There were discussions about self- care, how to achieve balance and rituals people put in place to work remotely. The truth of the matter is that many teams work remotely, pandemic or not. However, now the world is back to normal, I anticipate that some of the great ideas people had about managing pressure, or insights about remote working have been lost and forgotten amidst daily work and busy lives.

During the pandemic I put this question to Medical Affairs Leaders  “What has this extreme experience taught you that you are grateful for? How will this knowledge serve you in the future as a leader, or in your personal life?

The five responses I share below are as relevant for today’s world as they were in 2020. regardless of how you are currently engaging with your teams:

  • “Support, empathy and understanding are essential as a manager and be real”
  • “Personal and professional life are intertwined. Each person will react differently as these pieces alter”
  • “To get the best out of people individual circumstances and personalities must be taken account of” 
  • “As someone who would have been a big proponent of a WFH model, I now understand the benefits of working together. I can now also see the importance of trusting your team and giving them flexibility as appropriate to work around their lives”
  • “Some of us may have placed work/company as our driving priority in life. This experience reinforces that professionalism is vital to career success, but relationships outside workplace provide a critical source of connection”

Key take-away: Communication, empathy and trust are crucial when leading teams, regardless of the set-up.  Beyond this, understanding your needs,  striving for balance and self-care are also essential for you to be a strong leader. 

I hope my post provides you with useful insights. If  you need support with a project, or are interested in coaching, why not give me a call to see how I can help. Find out what clients say about working with me here link.


My very best wishes

Isabelle C. Widmer MD

Upcoming Digital Islands and AI webinar, and Leadership: you are not a shark!

This week is the Medical Affairs and Scientific Communications meeting MASC in Orlando. Pre-pandemic I was a regular attendee.  I love the meeting, connecting with old colleagues, many of whom have become friends,  and hearing what everyone has been up to. I am sad that I will miss it this year, and up until Saturday, and even this morning; I was thinking I could just hop on a plane and fly to Orlando. However, having just emerged from a four-month long course on Artificial intelligence that absorbed most of my evenings and weekends, upon reflection, I decided to pause. Find out why in today’s last topic.  

Today’s topics:

  • Upcoming Digital Islands and AI webinar
  • The secret to unlocking the promise of AI
  • Pharma excellence and the rest of the world
  • Leadership: You are not a shark

Upcoming digital islands and AI webinar

A potential client recently asked me “can you find this data for me online or generate it? I think we may have it in system in house somewhere, however, I have no idea where to find it and I don’t have the time”. Unfortunately, many individuals in pharma companies face similar challenges even today. Luckily, often when I am asked to help with this type of challenge, I have a good idea of where and how to find the data that is needed.

When I joined pharma I remember being fascinated and frustrated by the plethora of systems: a clinical trial management system, a customer relationship management system, and as one person told me when I asked them how they managed physician interactions “outlook”.  KOL speaker engagements were managed in another system. Response documents were on SharePoint, as were documents on education and each affiliate used their own tools, standard response documents, customer engagement materials, sometimes based on global documents, sometimes, officially based on global documents but unofficially custom written for local markets “because the global documents won’t work in my market”.

Each affiliate had their own tools. standard response documents, educational documents, training documents etc. Large companies that have existed for many years developed systems organically with each market implementing tools and processes as needed. While we have moved from physical to digital storage, somehow, the mindset of keeping data in siloed systems and thus restricting access to certain teams, remained. Happily, in the past 30 years companies are overhauling the “data in silos landscape” the key driver has been to increase efficiencies.  However, teams faced with historical data in historical systems, still struggle with data marooned on digital islands.

If you want to make the most of your data, whether that is to identify key topics of interest to your customers, understand patterns of engagement, unlock opportunities, analyse customer engagement, identify great clinical trial sites or you want to generate insights across different systems and markets tune it to a complimentary webinar I will be running on the 24th of April at 3pm CET. 

I will be joined by two experts in the field, who can share insights across space, time, and industries:

– Wolfgang Schwerdt, Senior Data Scientist and Project Lead at the International Committee of the Red Cross (ICRC), who has a PhD in econometrics and has worked on predictive analytics at United Health Group’s Optum Analytics overseeing the development of health condition prediction tools, as well as  in Fintech and on the European Central Bank’s Centralized Securities Database infrastructure and who has been engaged in digital and AI projects for the past 20 years.

– Peter Shone, currently Chief Technical Officer at iEthico, who has been engaged in data science with a passion matching mine, for many years before the topic became fashionable. His knowledge is incredible, spanning decades and leadership roles across industries. He was Global Vice President at Rolls Royce and Chief Technical Officer at Parexel and was engaged in the intelligence sector.

I am a big believer in not reinventing the wheel. If you are too, then come learn from industry experts with experience spanning pharma and healthcare as well as other regulated industries such as banking and aviation. And the intelligence secto. Join us for a panel discussion and lively Q&A to explore how we can help solve your current challenges.

Key takeaway: Jumpstart your data analytics journey! Join my free webinar on April 24, 2024, at 3 pm CET to question cross-industry data science and AI experts.

The secret to unlocking the promise of AI

Spoiler alert – it is a very simple secret that I have been advocating for at least twenty years.

Four months ago, I signed up for a no code AI course. My weekends and evenings since then have mainly been dedicated to studying. My motivation? To experience MIT faculty in action, to engage with passionate peers, to acquire the ability to build my own models and to be able to intelligently discuss the difference between AI and Mary Poppins, as the two are frequently confused by hopeful individuals.

The course reminded me just how much I love data. After four months, many  video lectures, several models built, much frustration, and three project submissions for different AI topics, all with perfect scores, of which I am surprisingly proud, I have finally reached the end. While the course wasn’t at all what I had dreamed of it served its purpose. I have acquired new ways of thinking about data, modelling, and websites and which I can use to support teams to better profit from their data, cross-functionally.  

While I learned a lot – too much to pack into a simple text, I want to share just one simple secret to unlocking the promise of AI. Before you do anything with your data, understand its strengths, weaknesses, and gaps, try to identify complimentary data that could be useful, do a preliminary analysis and then identify the best approach to working with that data. It might be AI it might be something else. Either way, according to course trainers, and my extensive experience working with data, 75% of the time spent on any data project, and that includes AI model building,  is ensuring you start with sufficient, clean and well-prepared data.

Key takeaways: Considering AI? Ensure it’s the right tool for the right purpose at the right time. Verify data quality, secure necessary resources, and avoid rushing the process.

Pharma excellence and the rest of the world (ROW)

Anyone, who has worked in the pharmaceutical industry, will have come across the expression ROW (The rest of the world). In more recent years, a more universally acceptable synonym has been adopted: Ex-US or International.

Whatever your naming preferences are, it is important if you are planning to launch your products in markets outside the US, that you consider the local cultural and legal realities of Ex-US markets. These include understanding how country healthcare systems function, what the local regulatory requirements and expectations are, how best to engage with healthcare professionals (HCPs) and non-HCPs, and how international reference pricing works, which will influence country engagement and launch sequencing.

Then there is language, you cannot necessarily expect to engage HCPs in English in every market, or indeed one type of Spanish across different Spanish speaking markets. On the one hand language abilities vary from market to market and between physician specialisations, on the other there may be regulations requiring local language use. Cultural norms and market maturity play an important role when dealing not only with customers but with government healthcare bodies too as do the rules for engaging with patients ex-US.

Finally, if you are a company that is starting out, and you are planning to expand from the US, you need to consider appropriate resourcing levels to deal with the local specificities of the rest of the world. While in the US you may be able to work with a small footprint initially, thanks to homogeneity, in other parts of the world you will need more resources to navigate heterogeneous populations, with potentially more than one language per country, and different cultures. In this situation it is worth considering partnering with an organisation that already has a footprint.

Key takeaway: In conclusion,  what works well in one geographical region will not necessarily work well in another geographical region.

Leadership: You are not a shark 

Sharks die if they stop moving.

This is in fact not true. However, it is true, that humans don’t do well if they never stop to think, to breath to pause. 

I have learned that when I feel compelled to quickly do just one more thing, I stop instead. Hence, when I contemplated buying a ticket to go to MASC on Saturday morning for a quick there and back trip to Orlando, I stopped myself. Because I realised it wasn’t the best thing for me to do right now. 

When I feel the desire to make a fast decision, I will take a walk, read a book, make a phonecall, ride my bike and I will revisit the topic a few hours later or the next day. If someone is awaiting a response, I will let them know that I am reflecting. However, I have also realised that there is generally no need to feel pressure to respond immediately.  I have come to prefer a good answer to a fast answer.  I am always surprised at the many different solutions that present themselves as I mull things over, and at how effortlessly a final approach I am happy with takes shape.

Key takeaway Slower is often faster. And sometimes slower means stop.

I hope my post provides you with useful insights. If  you need support with a project, or are interested in coaching, why not give me a call to see how I can help. Find out what clients say about working with me here link.
My very best wishes

Isabelle C. Widmer MD

Image credit: Dating scout @unsplash.com

Navigating the digital landscape

I hope you have had a wonderful holiday and are back full of energy.

Today’s topics:

  • Content strategy: navigating the digital landscape
  • How to make it easy for your customers to access digital content
  • Google trends and beyond – why context is key
  • Leadership: coaching considerations

Content strategy: navigating the digital landscape

In today’s digital era, providing content digitally is a necessity. The challenge lies in providing content in a way that ensures it stands out, and is accessible.

To add complexity, customer expectations and needs, and market-specific governance vary by location and culture; different customer types—patients, pharmacists, general practitioners, etc.—have different content needs.

At the recent DIA Medical Information and Communications Meeting in Brussels Dana Weber, International Digital Marketer and Katie Lewis, Vice President, both at Transperfect, shared recommendations for digital content provision. Dana suggested asking yourself: “What are HCPs looking for and do I have that information on my website?”

  1. Search approach: unveiling customer insights
    Search and social listening tools identify the type of content customers access online, and frequently used platforms. Data collected on company and competitor products provides insights into preferences and behaviours which vary from country to country. Dana suggests: Checking whether your company FAQs align with the terms that clinicians are using in their online searches.
  2. Surveying customers: Bridging the online-offline gap
    The types of questions asked online often differ from those made in direct calls to Medical Information teams. Understanding the drivers behind these behaviours can help companies tailor their online/offline content strategy. Surveys with healthcare professionals (HCPs), and patients can be conducted to gain insights into their content access preferences.
  3. Strategic placement of content: making information accessible
    Once you have identified the type of content your customers require you must ensure that it is easily accessible in the right format and in the right location.

Susan Mohamed and a team representing the Medical Information Leaders Europe (MILE) published an article providing guidelines for Digital Information provision for Healthcare professionals in March 2023 (Link).

Beyond the above approach Dana Weber added that market insights and competitor analysis help refine content strategy.

Key take-aways: In the world of online content, understanding your clients’ needs, monitoring content use and performance, and tailoring your content strategy accordingly, is critical to be relevant.

How to simplify access to digital content for your customers

It’s universally acknowledged that product-related content should be tailored to different customer types and accessible through their preferred channels. In addition, diverse customer types may favour distinct channels, and various inquiry types may lead to different contact methods, as outlined in the previous post.

However, even when you have taken all this into account, and identified key topics, formats, channels, and strategic content placement, the battle is far from won. The performance indicator for the success of the digital content provision is whether your customers access your content. It helps if you make it easy for them.

Here are some considerations from my consulting practice:

  • Transparency: Clearly communicate to customers on the website what information they can expect to find online and for which information they should contact the Medical Information department directly.
  • Consistency: Having a consistent approach across the entire company and products and teams regarding the type of information that is shared, which channel it is shared by and a harmonised format. Remember, customers engage with your company as a whole, they don’t think in individuals, in products or in individual teams, consequently, an approach that is not harmonised does not look professional.
  • Professional and fast platform: having a good platform that enables fast, easy, and efficient navigation to search for content
  • Fast access to support: If customers cannot access content online, provide them with the option to submit the query directly, without retyping the entire content of their request, or to transfer to a live chat, a video call, or to leave a phone number for call back. Don’t make them have to change channels, i.e. pick up their phones to call customer service themselves.

There is nothing more frustrating than performing online searches only to discover that certain information is not available online or not available to certain customer types at all.

Key take-away: Make customer access to your content easy, you would be surprised how often it is not.

Google trends and beyond – why context is key

Discussing how Google Trends can provide insights into healthcare professional’s medical information search behaviour online, a presenter said “people put information online all the time, it is important to take inventory of this information, to understand the needs of different demographics, avoid the temptation to ‘boil the ocean’ by conducting initial assessments to verify hypotheses.”

She went on to share a surprising revelation based on her research regarding content searches for a certain product. According to Google Trends, most questions submitted in Germany were in English. Asked about this she smiled saying: “Google doesn’t lie”. Upon reflection she mused: “Does it?”. This experience highlights something important: data analytics are valuable, looking at trends is critical, but interpretation must always be context dependent.

Depending on the type of healthcare professional you are interested in, their area of expertise, geographical location, and international exposure, they may search for medical information and product-specific details in either English or their mother tongue. If you want to ensure you understand your target audience, understanding whether what you observe is the complete reality, a subset of available information, or something else entirely, is crucial.

Key takeaway: If you are analysing global trends for your products, cross-check your data with local teams, who know the local market, and who can potentially question your insights.

Leadership: coaching considerations

Most employees have had many assessments and have benefited from coaching. Typically, at the beginning there are the tests: Myers Briggs, Insights, Belbin, DISC etc. as well as 360° feedback from colleagues and superiors. The information gain from these activities is significant, but although each approach brings valuable information to the fore, most of these tests identify what is, what is seen, what the coachee knows and what others observe and experience.

While there is undeniable value in having the information these assessments provide I believe it is also important to explore what is underneath.

I find that taking verbal communication out of coaching enables coachees to access their emotions, their experience, and their situation differently.

We are raised in a culture of language. We think, we write, we communicate using words. When coachees work with drawings, constellations, and other non-verbal approaches to review the “what is” it is easier to strip away superimposed narratives and enables relatively access to what is at the core of a situation. Frequently, new insights and connections rapidly emerge, often to the surprise of the coachee.

Key take-away: Often a non-verbal approach to coaching can bring surprising insights.

I hope my blog provides you with useful insights if you have a project you need support with or are interested in coaching, please contact me to discuss whether I can support you. To find out what clients and coachees say about working with me, please follow this link.

I look forward to hearing from you,

Isabelle C. Widmer MD

Photo Credit: Errol Ahmed @unsplash