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Table 2: Impact of new technologies in R&D value chain Discovery


AI/ML/NLP (including text mining), RWD, data validation and cleaning tools, Quantum Computing


Development


New development, eg virtual trials, AI/ML, Digital/Wearables, Blockchain, RWD


Medical Practice


AI/ML, Digital/Wearables, digitally-enhanced patient engagement, automatically produced PROs, intelligent home, RWD


Clinical Outcomes Regulatory Policy and Compliance Digital/Wearables, Blockchain, RWD


Predicting regulatory policy evolution and streamlining compliance to regulatory change, RWD


Business Development and Licensing


Augmenting search, evaluation and licensing with AI/ML, RWD


cated in different disease areas. For example, enterotype I and enterotype III bacteria were strongly associated with dementia31. By the early 2020s researchers were pursuing the potential of the microbiome and had moved beyond gut-related inflammation such as Crohn’s disease and colitis, to central nervous system and cardiovascular dis- eases. A greater understanding emerged in the early 2020s on how to balance the gut microbiome and test the effects on multiple disease phenotypes. However, researchers struggled to make headway due to the plethora of data sets published on microbiome experiments as enabled by the genomics era, until universal data and tools emerged on the molecular interactions between microbiome and host physiology.


These breakthrough treatments have been criti-


cised for being unaffordable – just as the cost of antibody-based cancer treatments in the 1990s were declared out of reach for most. However, experiments with new healthcare systems, includ- ing outcomes-based, annuity-based reimburse- ments26,27, aims to reward the biopharmaceutical industry for these new breakthrough drugs. Some companies have been prepared to accept


reimbursement in installments over three to five years or to provide discounts if a patient did not see specific benefits from the therapy. Where it became possible to measure pay for performance, many payers forced industry to accept pay for per- formance pricing paradigms. Furthermore, compa- nies were increasingly requesting tests to identify such genetic diseases to be added to mandatory newborn testing programmes28 in an attempt to develop these markets and, by doing so, improve health delivery and reduce per capita costs.


Microbiome: The human microbiome has an esti- mated 100 trillion microbes, the bulk of which live in the gut. Advances in genome sequencing tech- nologies and metagenomic analysis have greatly increased our understanding of the microbiome29. This had led to a whole new field of medicine with as much potential as genomics held 25 years ago. However, implementation was slower than antici- pated due to the sheer complexity of the mecha- nisms of action30. The microbiome had been impli-


44


Diagnostic pill: The paucity of knowledge about gut microbiota higher up the GI tract was resolved by researchers at Tufts University developing a ‘Diagnostic Pill’ which could be swallowed and recorded bacterial samples while passing through the gut32,33. Such ‘lab on a pill’ devices revolu- tionised understanding of the spatial diversity of the gut microbiome and its response to medical conditions and treatments. Today we are able to witness the benefits of


joined-up healthcare embracing the food industry. This had become a reality with health, welfare and social services combining in most economies to pro- vide wellness and prevention programmes for the population based on their individual needs. This change to focus on the public health agenda of dis- ease prevention34 had dramatically reduced the number of lifestyle-related illnesses, including can- cer. The reduction in obesity in the general popula- tion had seen the incidence of some cancers being reduced and while no specific causal link had been elucidated, obesity was seen as an important risk factor and the population had responded positively.


Skin microbiome: Skin micro-organisms have been discovered to have important roles in educating the cutaneous immune system. Some skin diseases had been associated with an altered microbial state of the skin. Reversion of this dysbiosis had helped prevent and/or treat the disease35. Indeed, some studies had indicated that bacteria in the skin microbiome could inhibit skin cancers36.


Skills for ‘R&D Technology’ Over the past decade, the relevant skills needed by the biopharmaceutical industry have evolved con- stantly due to the impact of new and emerging technologies (Table 2).


Drug Discovery World Winter 2019/20


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