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We speak to Graham Dutfield, professor of International Governance and author of That High Design of Purest Gold on the evolution of IP regulation in Pharma and how it could be transformed in the future. 

Patents are a historic tool, but have undergone an evolution. Patents started out in the 1470’s in Venice, and as an example Christoffer Columbus had a patent to explore the new world. Only in the late 18th century did patents become associated with exclusive rights to exploit an invention in return for disclosing the recipe for it. 

The purpose of patents is to incentivise companies to take on the considerable risk and heavy investment in researching and developing drugs. Without patents, competitors could replicate a successful drug without having to take on the investment and risk. 

But even though the intention behind patents is to ensure further innovation, it also creates perverse incentives in life sciences. This is mainly because new uses of existing drugs can also be patented as well as human genes and other biologics. 

We speak about how the biotech revolution changes the patent landscape by introducing complex technologies that require multiple patents to ensure protection to reap the benefits of the investment in their development. The industry is changing with a rise in the sheer volume of patents on both the drugs themselves, but also the manufacturing methods.  

The professionalisation of invention - the intententive pursuit of invention - was in fact the greatest revolution of the pharmaceutical industry. We look back to the history of the pharmaceutical industry and how the centre of gravity changed from originally being centred in Germany, but moving to the UK and eventually the US - shaped by the world wars. 

When turning to the future, we speak about the importance of biomarkers. They have the potential to transform medicine that works mediocre in the broad population to working exceptionally well in a specific subset of the population. There are also more approvals of novel drugs than in previous decades. 

But there is still an issue with a lack of research in diseases in underserved populations as well as rare diseases, where the market for the drug may be small. The potential for technology transfer is also still unutilized, and getting this right might help us prevent another pandemic. 

Graham envisions a menu of incentive structures for different kinds of disease areas that may differ for areas like chronic pain, antibiotics or rare diseases. That would be a more precise tool for getting the kind of i

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This week we dive into pharmacometrics as a discipline and the potential for replacing and augmenting clinical trials with modelling. We speak to Kristin Carlsson Petri, who is a Director of Pharmacometrics. 

Pharmacometrics modelling is a range of mathematical modelling techniques that can quantify our knowledge of drug biology and disease as well as trial information. The power of the methodology lies in the integration of knowledge across drug development and different compounds. 

Even though pharmacometrics modelling is coming of age in recent years, it is not a new discipline. Its origins trace back to work conducted in the ‘50s and ‘60s, and one of the modelling programs most commonly used today were built in the 1970s in the Fortran language. The development of computers and computing power has allowed the discipline to grow, since the modelling is highly dependent technology. 

Now the regulatory bodies request pharmacometrics analysis and the FDA has its own unit that conducts pharmacometric analysis on the data provided. Both the EMA and FDA encourage inclusion of pharmacometrics analysis especially for paediatrics studies. 

In paediatrics studies pharmacometrics modelling is especially powerful. This is an area where data is usually scarce and fewer patients. But this population should still be offered evidence based medicine. By drawing on existing data from adult studies, some of the gaps can be closed without additional burden on the patients. 

There are several examples of regulatory bodies accepting label expansion into paediatrics without the need to run clinical trials - relying solely on evidence from pharmacometric models. This is an opportunity - since it takes typically 10 years from a drug being developed for adults to it being approved for children. Closing this gap will increase access to evidence-based drugs for paediatric patients.   

The area could grow even faster if data sharing across especially pharma and academia could be accelerated, and AI and machine learning could be applied to it. This is difficult, since the legal challenges of sharing data blok an efficient exchange. 

We also speak about datasets collected continuously from wearables, and how they are challenging some of the techniques developed in decades past - and how these may need to be updated to the new technological possibilities. 

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For this episode we explore the evolution of the collaboration and partnership structure between sponsors, CROs and technology vendors in life sciences with Temitope Keyes, Executive Director of Encapsia. Temitope has had a front row seat to the digitization of the clinical trial process. 

We speak about the paper handling system that used to characterise clinical processes, and how “validation” that we now use to refer to systems validation used to refer to the validation of the printed paper. An entire ecosystem of vendors was required to make the paper ecosystem function, and the debate back then was whether to in-source or out-source, say, printing. 

The evolution away from paper was absolutely necessary to get an overview of what was actually happening in the trial. The safety issues with Vioxx is an example of how data buried in paper can endanger patients. Data submitted on paper also makes it prohibitive to find trends across trials and drug profiles. 

Temitope takes us through the digitization arc of the clinical process starting from the phone-based IVR systems to manage drug supply. Next came the development of the clinical database. Pharmaceutical companies attempted to build them themselves, but the complexity also forced specialisation in the industry and the creation of many of the technology vendors we work with today.  

Clinical operations is the most expensive part of a clinical trial budget, because it is human-intensive and humans are expensive. CTMS attempts to help provide an overview of the many people involved in a clinical trial. 

As more and more systems started supporting the clinical processes, the cost became prohibitive. CROs entered the space to offer pieces of systems to sponsors for a lower price, and in that way became technology companies themselves. 

We also speak about how we brought all the technology together to end-to-end solutions that allow decentralized clinical trials. 

Guest: 

Temitope Keyes: https://www.linkedin.com/in/temitopekeyes/ 

Encapsia: https://encapsia.com/ 

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We speak to Dr. Elin Haf Davies, CEO and founder of the technology company Apartito. We dive into the topic of designing trials with especially paediatric patients in mind. Elin shares with us her perspective on this topic from her background from healthcare, regulatory authorities, pharma and now also tech. 

Elin takes us through the mindset change the industry has undergone from believing that clinical trials in children were unethical, to regulatory bodies requiring life science companies to conduct trials in children to increase treatment options for this population. 

Finding ways to make clinical trials a positive experience for children requires that you think about how you design the administration of the drug - but also how you design the trial itself. Using endpoints that were designed for adults will leave you with inconclusive results in children. Designing endpoints that are age appropriate, disease specific, passive and pain free will make all the difference for your trial. 

What is missing from the equation is the tools for making paediatric-friendly clinical trials. Developing tools that will work for children will likely benefit the adult population too - because you are forced to reduce complexity and think about ease of use. 

Measuring endpoints in a passive fashion carries the promise to make clinical trials easier to participate in for both children and adults - with tools like analysis of video recordings and wearables. We also speak about how wearables and passive means of collecting data do not replace the human element of care - especially not in a paediatric setting. 

Guest: 

Elin Haf Davies: https://www.linkedin.com/in/elin-haf-davies-414b5211/

Aparito: https://www.aparito.com/ 

Links:

EMA on mandate to conduct paediatric trials: https://www.ema.europa.eu/en/documents/other/european-paediatric-initiative-history-paediatric-regulation_en.pdf  

FDA draft guidance on paediatric trials: https://www.fda.gov/news-events/press-announcements/new-fda-draft-guidance-aims-protect-children-who-participate-clinical-trials 

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Are pharmaceutical companies allowed to engage with patients and HCPs? Judging by how infrequent such interactions are, you might get the sense that it is strictly forbidden. Though such interactions are regulated, navigating these for the promise of understanding the perspective of the clinicians as well as patients is worthwhile. 

We speak to Andreas Dam, the founder and CEO of Daman, about patient empowerment in clinical trials and how pharma can come closer to patients and HCPs. 

Life sciences are impacted by two major trends: the larger consumerization trend and the shift of healthcare payer focus on outcomes. For the first, patients take greater ownership of their treatment. For the second, additional data about patients’ everyday lives are needed to determine how to prioritize the best treatment.

Patient reported outcomes are becoming an integrated part of clinical trials in part because regulatory bodies are requiring data on evaluating the value of the drug on the overall health of the patients. 

There are benefits of measuring patient health continuously rather than just at site visits. Ecological momentary assessment describes the difference between what you can measure in a controlled setting, and the actual reality. Our minds are programmed to forget the bad part of our lives and are influenced by the setting in the clinic when we recollect how the state of our health has been in the time period leading to the visit.  

Indirectly measuring the patient data from wearables rather than answering questionnaires is one of the ways that co-creating with patients creates trial design that fits more neatly into the lives of patients.  

Increased use of technology is challenging the predominant pharmaceutical business model with long lifecycles. Building software tools and wearables meant for patients require quick iteration and feedback from the end users. In this sense the digital transformation in pharma is not just about technology, but also a transformation in patient focus. 

Technology can help promote shared decision making between patients and doctors. The patient is the expert in living their life with their disease and the doctor is the medical expert. Looking at the same data can ensure a more equal conversation and improve collaboration.

Guest:

Andreas Dam: https://www.linkedin.com/in/andreasdam/ 

Daman: https://www.damandigital.com/ 

RheumaBuddy:

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The Life Science industry is both known for great leaps of innovation on the product side, and conservatism of process and practice on the other side. In this episode we dive into the actual state of innovation on the product side as we speak to Alexander Gray, the Chief Medical Officer of IDEA Pharma. 

The innovative potential of phase II trials in Life Sciences today is often lost, since the indication is locked in too early in the process. Instead we speak about how keeping the indication open might allow the asset to drive the research to more favorable uses. 

Especially in broad disease areas such as immunology, oncology and CNS it can pay to wait with settling on the final indication until well into the phase 2 trials. Allowing the asset to lead to the indication can lead to better asset-indication matches and better results in further clinical trials. 

We also speak about how it might be possible to keep the phase 2 trials open for longer - and the benefits of involving stakeholders from non-research areas in the development process. This can help expand the view of the asset’s potential and lead to more holistic decision making. 

That kind of holistic decision making can be difficult to achieve in especially larger companies, where the functional areas may be divided not only organizationally, but also geographically. Alexander also shares how the joining up of Commercial and R&D organisations have developed throughout the past 25 years, going from less to more collaboration - but also swinging back again occasionally. 

Specialization is both a gift and a curse in Life Sciences - leading both to highly knowledgeable people, but also makes cross-functional and cross-therapeutic thinking difficult. This sometimes means that the reasoning behind a molecule can also get lost in the mechanics of drug development later in the development process. Going back to the science can ensure a focus on the best use of the asset. 

Guest:

Alexander Gray https://www.linkedin.com/in/alexander-gray-934a653/ 

IDEA Pharma https://www.ideapharma.com/

Notes:

Link to the link between GLP-1 on addiction: https://pubmed.ncbi.nlm.nih.gov/34532853/#:~:text=Glucagon%2Dlike%20peptide%201%20(GLP%2D1)%20is%20released,a%20potential%20anti%2Daddiction%20treatment.  

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We speak to Dr. Jack Pearson and Sofie Askervall from Natural Cycles about digital contraception and clinical trials based on data science. We explore how an app can become approved by the FDA as a contraception and the benefits of being more involved with your own reproductive health. 

Besides being used by women as a hormone-free contraceptive, Natural Cycles can use the platform to collect additional data for research purposes. Self-proclaimed “nerds with PhDs” collaborate with academic institutions to answer questions such as “does the Covid vaccine influence the menstrual cycle?”  

Having access to users already engaging with your app on a daily basis lowers the barrier for assembling additional data for clinical research - whether related to women’s health or not. This increases the speed at which clinical research can be conducted.

Besides clinical research, curious stats can also be extracted from the app - such as what day users logged as the most stressful, and how the most frequent days to have sex varies across countries. 

We also speak about how interacting with your contraceptive method on a daily basis changes the relationship with reproductive health. Both in the sense of gaining more understanding for it, involving a partner or significant others or reaching out to the support team from Natural Cycles with questions. 

Users may find Natural Cycles easier to use in the future with the announcement of the new collaboration with Oura, taking the manual task of measuring temperature each morning out of the equation.  Besides being more convenient, this collaboration provides additional data that can be incorporated into future studies. 

Guests: 

Sofie Askervall: https://www.linkedin.com/in/sofie-askervall-ba311845/ 

Jack Pearson: https://www.linkedin.com/in/jack-pearson-6a8ab190/ 

Natural Cycles: https://www.naturalcycles.com/ 

References: 

Published Research by Natural Cycles: https://www.naturalcycles.com/research-library 

Association between menstrual cycle length and covid-19 vaccination: global, retrospective cohort study of prospectively collected data: https://bmjmedicine.bmj.com/content/1/1/e000297 

FDA 510(K) pathway:

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In this episode Sam and Ivanna dive into the topic of wicked problem solving in life sciences with wicked problem wizard Nechama Katan. 

To understand wicked problems we explore complex problems as a contrast. Examples of complex problems are a game of chess or a clinical trial data submission to authorities. Both have a lot of steps involved, but in the end you know whether you succeeded or not.

Unlike complex problems the rules and outcomes of wicked problems are ambiguous. The problem itself may not be agreed upon or can be seen from multiple diverging perspectives, and the problem does not end - it ends once no more resolutions are attempted.

We speak about how the breakthrough speed of modern trials is not translatable to other clinical studies. The teams working on the recent trials were achieved by people working long hours with clear focus and direction to save the world.

Transitioning to a model where we can conduct trials in 1/100th of the time it takes today requires that we pull the common model apart, and put it back together in a radically different way. This is hard, since the “right way” of solving problems that most leaders have been taught are fit for complex problems - and many are at a loss of what to do when a problem is wicked. 

We speak about how language and psychological safety are key to being able to solve wicked problems - but that it is hard to achieve when innovation moves at the speed of meetings in life sciences. We explore which maneuvers can be taken for wicked problems and how solutions may emerge. 

Guest: 

Nechama Katan: linkedin.com/in/nechama

Blog: https://nechamakatan.wordpress.com/ 

References: 

Wicked Problems & Social Complexity: http://www.cognexus.org/wpf/wickedproblems.pdf 

PMI Wicked Problem Solving Certification: https://www.pmi.org/wicked-problem-solving 

Cynefin model: https://thecynefin.co/about-us/about-cynefin-framework/ 

Amy Edmondsen on Psychological Safety: https://amycedmondson.com/psychological-safety/ 

Living your best year ever: https://store.darrenhardy.com/products/living-your-best-year-ever 

Innovation at the speed of trust:

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We speak to G.T. LaBorde, the CEO of IllumiCare about clinical trial recruitment at the point of care. Patients want to participate in clinical trials. Health care professionals are willing to refer patients. But there is a disconnect between point of care and clinical trial recruitment. 

“90% of providers say they feel comfortable talking to patients about clinical trials. Only 0.2 % actually do. That is an amazing disparity!”

• G.T. LaBorde 

G.T. talks to us about how this gap can be bridged at the point of care, making sure that providers can actually inform patients of the trials relevant to them in their geography. 

The current way of getting an eligible patient into a trial often requires heroics from the health personnel, manually reaching out to patients and remembering currently ongoing trials. 

Heroics may also be required from the patient side. For some patients, clinical trials can be the only treatment option. All existing courses of treatment may have been exhausted, and they are willing to embark on researching clinical trials on their own. 

G.T. walks us through how to embed information about clinical trials in the systems that clinicians already work in, without adding additional noise to the regular workflow. This type of seamless integration can simplify referral of the right patients to the right trials. 

This also means that patients can be recruited from a larger population base that may not search for a clinical trial on their own accord - yet the provider gets the final say. This is important to not taking patients thriving on current care off it just to participate in a trial. 

An analogy to the tool that IllumiCare built is a marketing platform at point of care to the provider who is taking care of the patient - like a marketing funnel. The study description would be like an ad, and referral would be analogous to a conversation event.

442 years of combined healthtech experience at IllumiCare is bringing this transformation to life.  

Guest:

G.T. LaBorde: https://www.linkedin.com/in/gtlaborde/ 

IllumiCare: https://illumicare.com/ 

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We speak to Savva Kerdemelidis and Nicholas Fiorenza, founders of Crowd Funded Cures about alternative financing models for clinical trials and drug development in general. 

Grants and especially patents have long been the predominant mechanisms for securing financing for novel treatment. IP law shapes the incentive structure of the life sciences industry - creating suboptimal behavior and leaving value on the table.  

We speak about unmonopolizable treatment and repurposing off-label and natural drugs. Since these do not fit into the predominant model, they do not undergo the same rigorous clinical research as patentable drugs. It is a market failure, since there are no incentives to conduct this research when no pathways exist for recovering the cost. 

The potential is large, since most of the drugs prescribed to patients are off-patent.  An example is ketamine, which is available off-label for treating severe depression and is currently more effective than it’s patented counterpart. 

Prizes, pay-for-success contracts, advance market commitments, social impact bonds and subscriptions have been debated and tested to a limited degree as alternatives to patents. 

The blockchain technology is showing promise in re-inventing IP with the emergence of Decentralized Science (DeSci) and IP Non-fungible Tokens (NFT). With blockchain technology the transaction costs are reduced and pay-for-success models are given scale.

We also speak about how the current model is disempowering for scientists, who are either forced to go into academia or join the industry. Both choices have significant drawbacks, especially considering that the low-hanging fruit for small molecules is likely already picked. 

Guests: 

Savva Kerdemelidis: https://www.linkedin.com/in/savvak/ 

Nicholas Fiorenza: https://www.linkedin.com/in/nicholascharlesfiorenza/

Crowd Funded Cures: https://crowdfundedcures.org/ 

Notes: 

DeSci  (DEcentralized SCIence) A Web3 (crypto) term for blockchain-based activities involving scientific research.

DAO decentralized autonomous organization is a system developed to distribute decision-making, management, and entity ownership.

Pay for success contracts: https://www.linkedin.com/pulse/pay-success-contracts-new-model-develop-therapies-from-/?trackingId=SKff3hMR

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