1、Look AheadTech&Trends 2024A look ahead at some of the most exciting innovations and movements that are changing the industry as we know it.Sponsored by2December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)Foreword and ContentsThe State O

2、f TechBio Going Into 2024 03How Boehringer,Lilly Are Taming The GenAI Dragon For Regulatory,Commercial Content 08Life Sciences Scaling Adoption Of New Metaverse,AI Tools 12What Next In Oncology?17The Power Of AI To Map The Patient Journey 23Step into the future of healthcare as we explore the key in

3、novations shaping our industry in 2024 and beyond.Read on as we discover how members of the Techbio community are already utilizing artificial intelligence(AI)to boost drug discovery and maximise clinical trial success.Next,leaders at Boehringer and Eli Lilly reveal how Open AIs GPT-4 is transformin

4、g regulatory and commercial content,helping overcome challenges and securing executive support.With more companies embracing newer digital technologies,we ask if 2024 will be the turning point for the adoption of metaverse,augmented and virtual reality applications.Then while the search for the next

5、 blockbuster drug unfolds,delve into the challenges and opportunities in oncology which still dominates the pharma sales and pipeline league tables.Conclude your journey by taking a look into the transformative power of AI in mapping the patient journey,and provide insights into current clinical pat

6、hways and the potential for predictive interventions.Embark on this exploration of 2024,where collaboration,innovation,and technology converge to shape a future marked by improved patient outcomes and enhanced healthcare experiences.3January 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citel

7、ine company(Unauthorized photocopying prohibited)These are exciting times for the TechBio community,from the pioneering start-ups and academics to their industry partners and investors.Generative artificial intelligence has now become part of everyday conversation through the success of ChatGPT and

8、other programs,raising awareness of some of the tools that underpin the technology aspect of TechBio companies.Meanwhile,biotech drug pipelines are as deep as ever with the validation of new modalities and patient data being generated at pace.For those companies operating at this interface,the use c

9、ases are maturing rapidly with real-world examples.The evolution of the TechBio community will impact the broader life sciences industry in a critical way.It will need to be integrated into the whole continuum of R&D.This includes AI-driven drug discovery,whereby algorithms are enabling the design a

10、nd optimization of novel small molecules and proteins with accuracy and scale that conventional drug discovery cannot match.Furthermore,existing treatments can be repurposed using AI-derived biological insights,with multi-factorial matching of patients to clinical trials that are designed to maximiz

11、ethe likelihood of success.Such processes will expedite the overall R&D process and drug development pipeline,lowering the degree of attrition during late-stage clinical trials,thus addressing key industry productivity challenges.Furthermore,expansion and integration of patient data into early R&D d

12、ecision making will be transformational for the future of health care.The broad adoption of multiomics tools The State Of TechBio Going Into 2024Luca Parisi,Daniel Chancellor and Lucie Ellis-TaittExecutive SummaryThe long-term success of TechBio is dependent upon the flow of investment and alliances

13、 with mature life sciences companies.This collaborative model has proven many times over to be an ideal framework to develop new treatments for patients.4December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)The State Of TechBio Going Int

14、o 2024is generating new insights into fundamental human biology and precision medicine.Diseases are increasingly viewed as a function of such biomarkers,which ultimately guide diagnosis,treatment and connected care in the real-world setting.Popular With InvestorsThe cost and complexity of drug devel

15、opment requires experienced and committed partners.Therefore,the long-term success of TechBio is dependent upon the flow of investment and alliances with mature life sciences companies.This collaborative model,long established between big pharma and emerging biotechs,has proven many times over an id

16、eal framework to develop new treatment options for patients.The broader state of TechBio can therefore be gauged through such deal-making activity.It is difficult to capture the totality and nuance of TechBio which sits at the intersection of many different disciplines within any standard industry d

17、ataset.Citeline tracks global deal-making activity in life sciences and assigns an AI classification to companies and deals where relevant,which can be used as a proxy for the TechBio universe.Exhibit 1 summarizes total financing and partnership activities involving AI.It is an understatement to say

18、 that TechBio Exhibit 1:Growth In TechBio Financing And Partnering Activities5December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)The State Of TechBio Going Into 2024deal-making is on the rise.Life sciences companies raised a record 9.4

19、bn investment in 2022 to further advance their AI platforms and assets,with this total having doubled every year since 2018.The number of alliances with biopharma partners is also following a similar trajectory,although their value is more volatile and heavily swayed by milestone components.Neverthe

20、less,263m in upfront payments was a record for 2022,spread across 81 separate partnerships.The first half of 2023 has not been able to sustain the incredible amount of global activity within 2022.Speaking to In Vivo,Ivan Griffith of BenevolentAI Limited explained:“Investment and growth have slowed d

21、own and people are waiting to see critical readouts and data that validate the thesis that AI can significantly benefit drug discovery and reduce attrition.”Deal values and volumes are down sharply as TechBio has not been immune to broader market uncertainties,although the UK has been an outlier.Her

22、e,TechBio companies are on track to exceed last years 161m in fundraising across 10 deals,with seven financings bringing in a total of 87m so far in 2023.This resilience is enabling the UK TechBio ecosystem to secure a prominent position in the global rankings.Across both financings and alliances,th

23、e UK is second only to the US for TechBio deal-making over the last 18 months(see Exhibit 2).Source:Biomedtracker,July 20236December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)The State Of TechBio Going Into 2024UK Companies Driving The

24、 AI RevolutionThe UK TechBio ecosystem contains a range of different technologies and business models.Companies such as Exscientia plc and BenevolentAI are at the vanguard,becoming fully fledged biotechs with a blend of strategic alliances,such as multi-year strategic partnerships between Benevolent

25、AI and AstraZeneca,out-licensed assets,and internal drug pipelines.Several others are bidding to make the transition from discovery science to clinical-stage candidate.Earlier in the lifecycle,there are a range of venture capital-backed service providers with specific capabilities in a particular R&

26、D step,therapy area or diagnostic tool.Having raised close to$500m from investors during its 2021 initial public offering and private placement,Exscientia has now progressed six assets into clinical trials,either through strategic alliances or as internal R&D programs.Three of these are under develo

27、pment by Sumitomo Pharma for CNS disorders,while the remaining programs target cancer and inflammatory diseases.Of note,the ELUCIDATE basket trial of a CDK7 inhibitor is underway,with broad potential application in a range of prevalent solid tumors.Exscientia also regained control of assets discover

28、ed in collaboration with Bristol Myers Squibb against the complex cancer targets LSD1 and MALT1.Prior to founding Exscientia,CEO Andrew Hopkins spent 14 years at Pfizer Inc.and in academia,pioneering projects using data mining and machine learning in the pharmaceutical industry.He expects the bigges

29、t gains for AI in biopharma to come from precision medicine.He told In Vivo:“The area,I believe,where we will see the greatest impact is truly making personalized medicine a reality.”In 2022,the company published results from the EXALT-1 trial.EXALT-1 was the first prospective interventional study o

30、f its kind.“Predictions made by the platform proposed which Source:Biomedtracker,July 2023Exhibit 2:Financing And Partnering Activity By Geography7December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)The State Of TechBio Going Into 2024t

31、herapy would be most effective for late stage hematological cancer patients based on testing drug responses ex vivo in their own tissue samples,”Hopkins explained.“When we looked at results,about 25%of the patients four years later were progression free.”London-based CHARM Therapeuticsis one of the

32、few TechBios to secure financing so far in 2023.New investment from Nvidia raises total fundraising to date to$70m and adds to an already impressive syndicate of venture capital firms.This investment will further fuel the development of Charms DragonFold platform that can identify novel molecules th

33、rough protein-ligand co-folding.In addition,Charm secured its first industry partner in Bristol Myers Squibb,leveraging DragonFold to discover novel molecules against targets of interest.BMS is able to exercise options to license and develop any compounds that arise from this collaboration.“Protein

34、structure prediction using deep learning has the opportunity to greatly impact biopharma,not just due to having the 3D structure of any protein,but also the related algorithms people will develop inspired by it(e.g.,folding a PROTAC,E3 ligase and POI all at the same time),”Laksh Aithani,CEO of CHARM

35、 Therapeutics,told In Vivo at the start of 2023.Also bucking the broader biotech downturn in 2023,BIOS Health received new funding from a range of investors,including the TechBio fund Selvedge Venture.BIOS is a trailblazer in combining AI technologies and precision neurology,and is providing its cap

36、abilities to the US National Institutes of Health as part of the REVEAL study.The ambition is to sequence neural biomarkers to elucidate the link to various disease states,much as genetic sequencing has resulted in significant breakthroughs for drug discovery in cancer and rare diseases.8January 202

37、3 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)Generative artificial intelligence(GenAI)is taking the world by storm it would seem,but the pharmaceutical industry has been relatively slow to adopt this new tool to create content,mainly on acco

38、unt of the regulatory scope within which it must function.Its high time.At a recent summit,Boehringer Ingelheim GmbHs global head of human pharma services(previously go-to-market services),Michael Kurr,went to the extent of saying“Im a true believer of thinking through this even if it hurts your cur

39、rent operating model,which youre proud of.But if you dont do this rest assured someone else will disrupt you,someone else will cannibalize you.”BIs Michael Schorpp,who heads knowledge management&AI,development biologicals,shared use cases at Indegenes Digital Summit 2023,saying“When we all do this r

40、ight,this technology can really play a big role in,for example,driving commercial successes and at the end,improving vendor/customer engagement.”While saying that companies which wait until regulatory agencies make guidelines on use of GenAI available,“will fail because then they did not learn what

41、others learned.So just having How Boehringer,Lilly Are Taming The GenAI Dragon For Regulatory,Commercial ContentOpen AIs GPT-4 A Hit Among UsersVibha RaviExecutive SummaryHeads of AI,global commercial services and human pharma services at Boehringer and Eli Lilly discuss at a recent summit ways to u

42、se generative AI like ChatGPT for commercial and regulatory content while tackling challenges like data protection,hallucination and CXO buy-in9December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)How Boehringer,Lilly Are Taming The GenA

43、I Dragon For Regulatory,Commercial Contentaccess to lets say a car doesnt mean that you can drive the car,right?You have to get experience.”At the same time,Schorpp pointed out that expectations around what AI can deliver should be realistic,with the“right areas”for application identified.Eli Lilly

44、and Companys SVP for global commercial services,Libby Driscoll,suggested companies should adopt a R&D mindset while implementing GenAI solutions,since“not everything is going to work right away given there is a huge learning curve here”.“There are going to be a lot of Phase I kind of projects,but no

45、t everythings going to make it through to Phase II or III.On the commercial side,sometimes we have less tolerance for failure or learning.the companies that can have that continuous learning mindset are those that are going to be able to use this as a competitive advantage because its going to take

46、us a while to really figure this out all out,”she pointed out.Driscoll was responding to a question posed by moderator Marc Valdiviezo,VP,strategy&applied digital transformation at Indegene,which offers R&D and management services to healthcare and pharmaceutical firms,during a panel discussion on t

47、he“Future of content in the biopharma industry.”(Also see“Life Sciences Scaling Adoption Of New Metaverse,AI Tools”-Scrip,2 Oct,2023.)Where To Use GenAI?BIs Schorpp said the company has been working hard to figure out where GenAI could have the biggest impact and it has been found“really effective i

48、n a few areas.”He outlined a few use cases Automate document checks for compliance to industry regulations or company guidelines.Create concise summaries from large amounts of text to understand main ideas or themes in research papers,clinical trials,regulatory documents.Sift through large documents

49、 to identify insights,patterns that might not be obvious.Glean relevant and actionable information to formulate better strategies.Improve knowledge retrieval and understanding for better problem solving,particularly when information is spread over multiple documents or sources including the internet

50、.Kurr expanded on GenAIs utility,talking about channel agnostic modules and toolboxes that could replace current production“because the sheer amount of individualized content you cannot recreate over and over again.So,you need to modularize it.”“Then you set up all these templates that are channelle

51、d specifically,you ideally put together machine-readable business routes,and all of this will be pre-approved,pre-configured and pre-coded.itll all be done in these content toolboxes which will then enable you to go to market very,very quickly.”Driscoll added Lillys approach is to think is not just

52、about efficiency“but about how do we be more effective with content,how do we deliver more of what really matters to our customers?And do that really timely.Thats whats been really exciting as weve made progress towards that modular content.And how do we turn that content into data?”Reinvent The Dig

53、ital FactoryWhile Kurr joked about cannibalizing himself while illustrating key phases of the content value chain where AI could bring significant change,he also urged the industry to get ready for this change early enough.10December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline comp

54、any(Unauthorized photocopying prohibited)“Lets start talking about the planning,I really believe smart technology will be able to provide the next best content.It will be able to feed which content performs how well in which markets and with this trigger a very rapid learning journey.And it will tel

55、l you which content to reinforce which content to expire,and probably where you also have content gaps,so that you can continue to evolve on your content.”Recently,Pfizer Inc.s global CMO Drew Panayiotou spoke about the role of creativity in marketing,remarking“You can have technology.But technology

56、 isnt innovation”at a Forbes summit.However,Kurr had a slightly different opinion.While theres a lot of auto-generated content today which is not genuinely new as it lacks original ideation,the technology is“so smart that it can do this in a way that the consumer is still surprised and it changes th

57、e perception of content quality coming our customers way,”he said.If companies modularize content,“I see a more immediate potential disruption.”Given its global scale,BI is running a digital factory with standardized inputs and outputs as otherwise it cant deploy content uniformly through regions it

58、 operates in.On the next step of content production,he said approval will mostly go on autopilot mode,with a final check to accommodate legal requirements.“But what does it mean when you have technology that can generate code,you train the machine to generate the code that is necessary to deploy stu

59、ff in your infrastructure.So again,the digital factory is at high risk,”he added.At the same time,“what gives me confidence to do this is that we now have a global environment,a global infrastructure that we can leverage in different contexts.So even if theres disruption coming,we will be agile enou

60、gh to adapt,to accommodate,to use what we have built,because this in itself was a journey.And I really believe this will give us a good competitive edge moving forward,”Kurr observed.Data Protection,Hallucination And MoreThe panelists also discussed challenges they addressed while preparing for GenA

61、I.BIs Schorpp had an interesting observation,saying even tech giants like Microsoft“really dont get how this neural network is working.There was this wonderful paper from Microsoft 150 pages long.And they had all this stuff on what GPT4 is capable of.And they concluded basically with“Well,this is al

62、l great.We have no clue why this works.”Besides large language models(LLMs)cant have record retention,which implies if you want to wipe data out of a LLM,you need to retrain it.“Permission rules are not possible with large language models,”he added.Hallucination,when an AI model generates incorrect

63、information but presents it as a fact,is another big concern.Schorpp shared BIs experience where post the launch of GPT-4,OpenAIs most advanced system,“people couldnt stop talking about this.So what happened is that people started playing with it.And of course,we encourage that big time.”As employee

64、s uncovered a completely new field of skills to differentiate from their colleagues,a community of users was built globally.With this community sharing their experiences and offering tips,BI found it had 1000 unique users and 1500 daily users in 70 countries in 108 departments,which meant“we were op

65、erating at scale in the blink of an eye and we had so many use cases.”However,hallucinations become a“really big issue when people play with it”without using the right,updated documents as the basis for a trusted source.“So we learned that people How Boehringer,Lilly Are Taming The GenAI Dragon For

66、Regulatory,Commercial Content11December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)need to understand the technologys nature and the limitation and that education is absolutely crucial and critical.”Kurr pointed out the importance of a

67、uniform message when a company operates in multiple countries.“To personalize a go to market approach,you need to have metadata.You need to have an agile and responsive global content infrastructure that allows your metadata and tags to travel with the content,so that your core claims and messages a

68、re not diluted when content travels from global to local,”he said.Apart from the digital production factory,BI has set up a“creative factory which will make this entire content journey completely seamless end to end,”he added.Eli Lillys Driscoll emphasized the data protection aspect.“Youd want the G

69、en AI model to have a continuous learning loop so that it gets better and better,but at the same time,you want your data to be secure.How do you then bring that external lens into your learning loop while keeping that learning environment firewalled so that your data doesnt get out?”Schorpp also hig

70、hlighted the importance of top management buy-in given that in recent years,they have been bombarded with high flying promises about what AI can do and this was leading to significant disappointments when such promises fell short.“If you want your executive leadership to invest in GenAI,start by dev

71、eloping an application using GenAI that tackles the specific challenges encountered by your executive leadership.They need to experience the difference themselves to become convinced,”he concluded.How Boehringer,Lilly Are Taming The GenAI Dragon For Regulatory,Commercial Content12January 2023 Copyri

72、ght 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)Leaders at life sciences companies appear to be embracing newer digital technologies such as the metaverse,albeit at a varied pace,and for those sitting on the fence,Apples entry into the area may perhaps

73、 provide a nudge.A wide-ranging study by Indian life sciences solutions provider Indegene on industrys future readiness,based on over 100 qualitative interviews with senior executives across the biopharma,biotech and medtech universe,indicated that 37%were scaling the adoption of augmented reality(A

74、R),virtual reality(VR),mixed-reality(MR)and the metaverse,with another 34%piloting use cases of these technologies.Importantly,7%of the leaders in the study,which covered large global companies as well as small and emerging biopharma firms,were already using these technologies“as a way of life”-thou

75、gh at the other end of the spectrum,22%hadnt tried them at all.The study also noted that life sciences companies are using cybersecurity(84%)and the cloud(75%)in a way of life manner.Tarun Mathur,Indegenes chief technology officer,told Scrip that 2024 will see an inflection point,with increasing dem

76、and for metaverse applications that“complement or fully integrate with non-metaverse applications,”giving users the option to switch back and forth between modalities.Life Sciences Scaling Adoption Of New Metaverse,AI ToolsWill Apples Move Nudge Undecided?Anju GhangurdeExecutive SummaryLife sciences

77、 firms are increasingly adopting new technologies like the metaverse and piloting use cases,although a“truly 3D immersive customer experience”may be some distance away.But2024 could see an inflection point with increasing demand for certain metaverse applications,says a senior Indegene executive.13D

78、ecember 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)Life Sciences Scaling Adoption Of New Metaverse,AI Tools“Apple.s entry into the space ignites interest and serves as a reinforcement for organizations that were undecided about investin

79、g in the metaverse.In fact,this brings the metaverse back to the discussion table for those organizations that had dismissed it as being too early,”said Mathur,a long-timer at the digital-first,life sciences commercialization company.Loosely put,the metaverse is seen as the next iteration of the int

80、ernet that encompasses and converges VR and physical reality in the digital space.Earlier this year,Apple unveiled its first mixed-reality headset,Apple Vision Pro,which experts say signals a shift in technology that could hasten the realization of the metaverse.Featuring the tech giants visionOS,th

81、e worlds first spatial operating system,Vision Prolets“users interact with digital content in a way that feels like it is physically present in their space,”Apple said at the time.Immersive InteractionIn the life sciences space,the huge potential of metaverse applications,while still in the early st

82、ages of development,is well recognized,though experts say that use cases will depend on how easily stakeholders are able to adapt these to their needs.(Also see“Using The Metaverse To Break Down Language Barriers and Improve Diversity In Clinical Trials”-Medtech Insight,3 May,2023.)Pharma leaders ha

83、ve recently noted the metaverse may still be at the hype stage,but is expected to convert into realistic applications“not that far in the future.”“The hype cycle is getting smaller and smaller because adoption is going pretty fast,”Agam Upadhyay,chief technology officer at GSK in the US,said at an i

84、ndustry event in India earlier this year.(Also see“GSK CTO,Boehringer Exec On The Metaverse And Pharmas Foot In The Door”-Scrip,9 Mar,2023.)Upadhyay highlighted at the time some of the early use cases for pharma organizations including GSK,which went into the“total experience”aspect of it,for instan

85、ce to improve the onboarding process for new employees in manufacturing or supply chain functions.For example,when a new operator is hired,creating a virtual“digital twin”could provide exactly the same immersive experience for training rather than having to use real and expensive machines,while also

86、 avoiding down time.GSK has been working with Siemens and Atos to develop such complete and real-time simulations of its vaccine manufacturing processes.Senior Indegene executives also touched upon the potential for metaverse-driven immersive experiences in other areas at a recent company-organized

87、summit event.Gaurav Kapoor,executive vice-president,pointed to significant interest around remote healthcare professional(HCP)/caregiver interaction with patients,for example.A senior Boehringer Ingelheimexecutive has similarly pointed to opportunities the metaverse might provide for emotional conne

88、ctions between patients and caregivers.On the commercial side,Kapoor said the technology is serving as a“compelling augmentation”to commercial engagement,providing a“unique/differentiated experience”to increasingly tech-savvy audiences looking for novel experiences.“Metaverse is poised to become a s

89、tandard component of the omnichannel experience,”he told Scrip.Nevertheless,Indegene CTO Mathur acknowledged the metaverse is still in its early days in terms of providing a“truly 3D immersive customer experience.”(Also see“Early Days For The Metaverse In The Life Sciences,But 14December 2023 Copyri

90、ght 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)Experimentation Is Happening”-Medtech Insight,19 Oct,2022.)“Todays technology is best suited for pilots and preparation for an inevitable future state where immersive online experiences will be the norm.T

91、he technology is also well-suited today for specialized use cases that target narrow audiences and use cases.”Other experts have underlined the need for proper pathways and regulations to be put in place before metaverse applications are deployed more widely for medical research collaborations or ge

92、nerating virtual patients.“This is expected to evolve as we start seeing gains from successful use case deployment using the metaverse,”a senior McKinsey executive told Scrip recently.(Also see“McKinsey Exec On Generative AI in R&D And Pharmacovigilance,Digital Twins”-Scrip,7 Aug,2023.)AI As A Way O

93、f LifeThe Indegene survey also indicated 95%of leaders are either using applied artificial intelligence(AI)as a way of life,scaling its adoption or piloting it,versus 89%for robotic process automation(RPA).Presidents,chief experience officers(CXOs)and EVPs of life sciences companies constituted 36%o

94、f the respondents.Indegene sees AI adoption happening in the commercial area and manufacturing,but Mathur signalled it has become critical across all functions,from R&D to post-commercialization activities.(Also see“AI In Drug Development:FDA Wants To Know How To Assure Data Integrity,Transparency,R

95、eliability”-Pink Sheet,10 May,2023.)The executive indicated that applied AI and RPA is seen being implemented in most functions within the pharma lifecycle.In some cases,Life Sciences Scaling Adoption Of New Metaverse,AI ToolsAbout 50%of life sciences leaders are yet to try applications that use Web

96、 3.0,quantum computing or blockchain technologies.(Also see“Indegene CTO On Pharma And Blockchains Promise Of Better Accountability,Trust”-Scrip,9 Sep,2022.)Whats behind the slow uptake and what can we expect going forward for these technologies?Indegene CTO Tarun Mathur:Web 3.0 has not been ratifie

97、d or adopted at scale with robust standards yet,so its understandable that leaders are hesitant to build applications on it at this point as the use cases and standards for it are unclear.There are metaverse applications that potentially benefit from it along with blockchain(which is typically ident

98、ified as a component in the Web 3.0 narrative),but its not clear at this point what the result would look like.For metaverse,going by first principles,we can only expect consumers to demand a seamless,more immersive digital experience in the future.Technology may not have caught up to that vision ye

99、t.But,were clear about one thing:we are increasingly moving into a world where digital experiences are increasingly collaborative,near real-time,deal with large and complicated data and information and experience that enhances the human/machine interface.So,pilots and programs that push along that v

100、ector are logical.Web 3.0 has not had as compelling a first principles argument,so reluctance to scale that investment is justified.Quantum computing(QC)is starting to break through and we believe that with 15December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized

101、 photocopying prohibited)this may be advancements to legacy systems such as basic document search being replaced with advanced search and retrieval systems that use AI to identify,extract and summarize information from multiple sources in response to queries.“In other cases,we have seen complete bus

102、iness processes re-engineered with AI unlocking automation and human expertise augmentation in novel ways,such as omnichannel commercial engagement.We are already seeing NLP natural language processing systems and AI-assisted translators used in commercial and pharmacovigilance use cases,”the execut

103、ive observed.Promising pilot schemes tend to be around taking these processes to the next level,possibly reducing the costs and timelines of current processes by“double-digit percentages,”Mathur said.The Indegene survey also ranked key challenges to embracing technology as follows:Top Challenges To

104、Adopting Technology Data(59%),clarity on returns(55%)and legacy technology(55%)challenge most leaders in adopting technology in their company.CXOs are challenged by data,while for SVPs and VPs its about justifying returns from technology investments.Small firms called out data as their top challenge

105、 Large companies struggle with the talent and skills to make the most of their technologyKapoor,meanwhile,added that in many use cases there are existing AI models in place and pilots being run to see if the performance utilization of the models can be substantially increased with smaller investment

106、s in shorter periods of time.“Generative AI GenAI is currently the hottest enabler for these kinds of pilots,”he declared.(Also see“ChatGPT Unleashed:Generative AI Use Cases Taking Off In Pharma”-Scrip,6 Jun,2023.)Theres been huge interest and growing endorsement of the potential of GenAI in the bio

107、pharma industry,concerns on data privacy and intellectual property issues notwithstanding.The recently concluded Indegene Digital Summit 2023 saw Matt Anderson,chief digital officer and managing director of digital at The Carlyle Group warn that firms that“fear overwhelming curiosity”could have a“re

108、al problem coming”given the ability of an organization to start to create competitive advantage using tools like GenAI.“Its one of those things where you begin to accelerate and your rate of acceleration can Life Sciences Scaling Adoption Of New Metaverse,AI Toolsrecent advancements pharma companies

109、 will look to partner with QC technology companies.As the cost of leveraging this technology goes down and with technology companies looking for real-world use cases,we expect to see QC play a bigger role in pharma going forward.Blockchain is used today in supply chain management and logistics.We do

110、nt think edge use cases such as Web 3.0 powered by blockchain will become mainstream standard any time soon,but could see it appear within the context of other systems that have federated data across disparate partners.I dont think pharma themselves will directly invest in these blockchain enablers,

111、but the IT and technology vendors designing solutions may adopt private and trusted blockchain technologies as a component of the overall solution.16December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)itself increase and that can cause

112、you to leave your competition in the dust,”Anderson said at the summit.The Carlyle executive said the global investment firm had seen“some extraordinary things”that AI and GenAI had been broadly able to do.Across some of its portfolio companies,Carlyle was seeing“business cases that are coming out i

113、n the tens and hundreds and millions of dollars EBITDA earnings before interest,taxes,depreciation,and amortizationranges depending on the company that youre talking to.”(There will be further detailed coverage of the Indegene Summit).Smaller Firms Prioritize Adopting Emerging TechnologiesMarkedly,t

114、he Indegene study saw financial resilience feature among the bottom three“future-readiness”attributes of a company overall,though leaders prioritize it the most.Large life sciences companies called out financial resilience as their top priority,versus smaller ones that prioritize adopting emerging t

115、echnologies.On whether that points to big corporations focusing on financials and return on investment rather than rapidly jumping on the technology train,Mathur explained that larger firms are feeling pressure to demonstrate growth and“stickiness”with their clients and solutions,but are not necessa

116、rily slow to adopt technology.“If it can be shown that the financial gains are viable with new technology,larger firms are able to adopt these technologies at enterprise scale and run pilots faster than many small firms as they have teams,processes and budgets to make it happen,”he observed.On the o

117、ther hand,smaller and new-generation firms,especially those seeking additional venture capital,are looking for differentiating technologies to separate themselves and increase their visibility.Their risk appetite is higher,but their ability to adopt enterprise-scale technology or integration that ul

118、timately yields long-term ROI is a bigger challenge.Kapoor indicated that much could boil down to leaders and their leadership styles:“People who are risk-takers tend to drive financial resilience through embracing technologies.”He added that a focus on financial results demonstrates a“maturity of t

119、hought and experience”and ultimately leads to the adoption of technology that is less likely to fail in delivering business value.Large firms have the advantage of experience,resources and data to execute diligence that smaller or emerging firms may not have.“At the end of the day,for businesses of

120、any size to adopt technology,the primary motivation should be that it enables a more effective and financially resilient organization.Larger firms are increasingly sensitive to rapidly adopting technologies without doing the diligence to make sure that the investment is in something that is likely t

121、o yield results.”Life Sciences Scaling Adoption Of New Metaverse,AI Tools17January 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)Cancer treatment has transformed over the last 25 years.Since the first genetically targeted treatments emerge

122、d in the 1990s and immune checkpoint inhibitors in the 2010s,oncology has consistently overshadowed other therapy areas.Cancer tops the approved drugs roster,the number and combined value of R&D programs,dealmaking numbers and venture capital investment.Total cancer drug sales of$180bn in 2022 eclip

123、sed other areas and will grow to over$340bn by 2028,according to Evaluate.Thats more than double the next-best placed category,neurology products.But the two most valuable cancer drugs,Merck&Co.,Inc.s Keytruda(pembrolizumab)and Johnson&Johnsons anti-CD38 antibody Darzalex(daratumumab)are approaching

124、 patent expiry.Genentech,Inc.s 25-year-old HER2 targeted Herceptin(trastuzumab)is already generic.The largest of the handful of cancer drugs expected to top$5bn in 2028 target the same mechanism:Keytruda,Opdivo,Tecentriq and Imfinzi are all immune checkpoint inhibitors that block the interaction of

125、programmed cell-death protein 1(PD-1)with PD-L1,unleashing T-cells on cancers.Checkpoint inhibitors alone will account for over$70bn in sales by 2028,a major growth driver for the entire sector.Keytruda is approved in over 40 different cancer indications,and,as a treatment mainstay,is being studied

126、in combination with dozens of newer drugs.Yet finding the next generation of cancer mega-blockbusters is challenging.Druggable and broadly relevant targets,like PD-1/PD-L1,are elusive.Cancer is a genetic disease;key culprits like the p53,MYC or RAS oncogenes have been known about for decades.But the

127、ir encoded proteins are difficult to drug,and they What Next In Oncology?Finding The Next Generation Of Cancer Mega-Blockbusters Is ChallengingMelanie SeniorExecutive SummaryOncology dominates pharma sales and pipeline league tables.But where is the next Keytruda?18December 2023 Copyright 2023 Pharm

128、a Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)What Next In Oncology?harbor many different mutations.Very few of these are critical drivers;target one,and dozens of others emerge.“We have leveraged most of the single mutational drivers for the benefit of patients a

129、lready,”says Kimberly Blackwell,CEO of Zentalis Pharmaceuticals,referring to drugs targeting mutations within more common families such as HER2,EGFR,RAS or ALK.Precision medicine has driven oncology R&D towards ever more personalized treatments and combinations,matching drugs to mutations and mutati

130、on sub-types that occur in just a tiny proportion of patients.Such targeted treatments continue to drive important advances,including in previously untreatable cancers.But they also mean smaller markets.Meanwhile,squeezed payer budgets are imposing increasingly rigid limits on how high prices can go

131、.The pendulum has swung from waging a nuclear war on cancer”with indiscriminate chemotherapy,to“precision medicine focused on ever-rarer mutations,”sums up Blackwell.Too Targeted?Targeted drugs can rapidly show trial efficacy in appropriately matched patient populations,and regulators are open to ex

132、pedited access in areas of unmet need.These factors have helped drive valuable deals such as Eli Lilly and Companys$8bn acquisition of Loxo Oncology,with chronic lymphocytic leukemia drug Jaypirca(pirtobrutinib),a small molecule inhibitor of Brutons tyrosine kinase used in patients resistant to earl

133、ier-generation BTK inhibitors,Bristol Myers Squibb Companys$4.1bn acquisition of Turning Point Therapeutics,whose repotrectinib for non-small cell lung cancer(NSCLC)targets ROS1,ALK and NTRK or,most recently,BMS$4.8bn acquisition of Mirati,with its KRAS-G12C targeting Krazati(adagrasib)for second-li

134、ne treatment of KRAS-mutated NSCLC.But some question whether such deals will pay off,given lackluster launches for some niche cancer products.Drugs targeting the rare NTRK gene fusion mutation,for instance,work only for a minority of patients and testing can be a hurdle too.Bayer AG doesnt break out

135、 Vitrakvi(larotrectinib)sales,and Roche Holding AG scrapped Rozlytrek(entrectinib,which also hits ROS-1)due to poor sales and handed back RET inhibitor Gavreto(pralsetinib)to Blueprint Medicines Corporationin February 2023 for similar reasons.(The Swiss group had,three years earlier,paid three quart

136、ers of a billion dollars up-front for Gavreto and,in 2017,$1.7bnfor Rozlytrek developer Ignyta.)Takeda in early October 2023 withdrew Exkivity(mobocertinib),its EGFR exon 20 mutation-targeting NSCLC drug.As for BMS prize:Miratis Krazati sold less than$20m in the first half of 2023,though a regulator

137、y setback for Amgen competitor Lumakras(2022 sales:$285m)may mean Krazati is first to win full FDA approval.These treatments“havent sold nearly as well as expected,”sums up Tim Opler,managing director at Stifel.The US Inflation Reduction Act adds another wrinkle:many of these assets are small molecu

138、les,and face a 9-year clock from first approval before Medicare price negotiations may kick in.That puts pressure on a fast ramp-up and will likely mean smaller indications such as rare cancers or other niche disorders are de-prioritized,rather than being used as early launchpads.The value of precis

139、ion oncology companies fell sharply after the pandemic,according to Stifel.Theyve recovered slowly over the last 12 months,but obesity,cardiometabolic diseases and immunology have stolen much of the limelight.With drugs like Novo Nordisk A/Ss Wegovy(semaglutide)or Lillys Mounjaro(tirzepatide)buildin

140、g markets that may comprise over 30%of US adults,niche cancer drugs that require complex genetic tests look a relatively less 19December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)attractive business proposition.Back To The MiddleHence

141、efforts by Zentalis and others to swing the nuclear-to-precision pendulum back to the middle.Zentalis is going after what it calls“fundamental”biological pathways that affect multiple cancer types.Its Phase II lead,azenosertib,is a small molecule inhibitor of WEE1,a cell cycle regulator and DNA dama

142、ge response protein that helps cancer cells repair and proliferate.Inhibiting WEE1 leads to cancer cell death as DNA damage accumulates.The approach builds on two other important cancer drug categories targeting core cellular mechanisms rather than a single mutation.PARP(poly-ADP ribose polymerase)i

143、nhibitors,including AstraZeneca PLCs Lynparza or GlaxoSmithKlines Zejula,target cells DNA damage repair mechanisms.Inhibiting PARP helps counter some breast,ovarian,pancreatic and prostate tumors but only in the minority of patients with mutated BRCA genes.Category-leader Lynparza sold$2.6bn in 2022

144、.Cyclin-dependent kinase(CDK)inhibitors like Pfizer Inc.s Ibrance,Novartis Kisqali or Lillys Verzenio hit proteins involved in the cell division cycle,which many cancer cells hijack in order to proliferate.Most of these drugs selectively inhibit the CDK4 and CDK6 subtypes and are used for some kinds

145、 of breast cancer.The top three CDK4/6 inhibitors each sold over$1bn in 2022(Lillys Verzenio topped$2bn).But tumors can become resistant to CDK4/6 inhibitors as other types of CDK protein(there are about a dozen in total)step in and compensate.Hence these categories,too,are limited in their applicat

146、ion,due to redundancies,toxicity and resistance.Since WEE1 works upstream of CDK proteins(it phosphorylates CDKs 1 and 2),Zentalis hopes that hitting it may overcome redundancy.But the more central the mechanism,the more likely the unwanted effects:AstraZeneca dropped its What Next In Oncology?Expan

147、ding CDKsEarly CDK inhibitors lacked specificity and efficacy and therefore came with severe side-effects.Scientists didnt fully understand the CDK family,nor did they have the tools to selectively hit one or the other.That changed in 2015 with the accelerated approval of Pfizers selective CDK4/6 in

148、hibitor Ibrance(palbociclib).Companies like G1 Therapeutics continue to hone and expand the approach:their CDK4/6 inhibitor Cosela is approved to reduce chemotherapy toxicity in small cell lung cancer patients and is being tested in other tumor types and combinations.Incyclix Bio,run by G1s founding

149、 team,selectively targets CDK2,believed to be one of main mediators of resistance to CDK4/6 inhibitors.Its going after tumors with intrinsic CDK4/6 resistance(due to amplified levels of cyclin E,a protein that facilitates cell cycle progression),and those that acquire resistance.Incyclixs lead progr

150、am is in a Phase I/II open label trial in estrogen receptor positive and HER2 negative breast cancer patients already taking a CDK4/6.“Cell cycle inhibitors have re-shaped the treatment paradigm in hormone receptor positive breast cancer,”says Patrick Roberts,Incyclix co-founder and CEO.“Targeting C

151、DK2 may have an even broader impact across patients”than CDK4/6 inhibitors,Roberts suggests,not least as cyclin E amplification is present across other tumor types.Blueprint Medicines also has a CDK2 inhibitor in Phase I/II for hormone receptor positive breast cancer and cyclin E aberrant tumors.Com

152、bining cell cycle-targeting drugs with other treatment mechanisms is another important research avenue.CDK and 20December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)WEE1 inhibitor in 2022 due to intolerable toxicity.Zentalis azenosertib

153、 is designed to have better selectivity and pharmacokinetics and is being tested as monotherapy in resistant ovarian and uterine cancers,and with chemotherapy and a PARP inhibitor,respectively,in platinum-sensitive and PARP-resistant ovarian tumors.The company has also optimized dosing to enable max

154、imum exposure while maintaining safety and tolerability:it raised$250m in follow-on financing in June on the back of strong objective response data from a 5:2(5 days on,2 days off)intermittent dosing schedule.Revolution Medicine is going after another frontier oncology target:the RAS cellular growth

155、 signaling pathway.Mutations in this pathway also deeply implicated in the cell division cycle-drive almost a third of all human cancers.RAS proteins include isoforms like KRAS,each with multiple oncogenic driver mutations(like KRASG12C).The KRAS proteins smooth,round shape makes it hard to drug,as

156、it lacks a nice binding pocket.Revolutions RAS(ON)inhibitor approach,designed to suppress multiple RAS mutations,use chaperone proteins to form a new ligand binding pocket.Their so-called tri-complexes may also block further oncogenic signaling.Revolution reported Phase I/Ib data for its multi-RAS c

157、ompound in patients with several different KRAS-G12 mutation subtypes at the European Society for Medical Oncology(ESMO)in October.Boehringer Ingelheims small molecule BI-2865,a collaboration with Memorial Sloan Kettering,is,similarly,designed to target multiple KRAS mutations.It was found in labora

158、tory studies to block over a dozen mutations beyond G12C.Black Diamond Therapeutics,Inc.raised almost half a billion dollars including a$230m IPO in 2020 on the back of its purported masterkey approach:therapies designed to hit clusters of mutations found across several cancer types,including allost

159、eric mutations(those found outside of kinase binding sites).A first clinical candidate,targeting a family of EGFR and HER2 exon 20 insertion mutations,disappointed,but Black Diamond,now with a new CEO,has another Phase I candidate hitting various EGFR mutations in non-small cell lung cancer patients

160、 resistant to EGFR-blocker Tagrisso.It raised a$75m follow-on in July.Blockbuster CombinationsWill any of these pan-cancer hopefuls become another Keytruda?“A pan-KRAS drug could be big,”says Darryl McConnell,SVP and research site head at Boehringer Ingelheim GmbHin Austria.But even for that if it e

161、merges standalone success is not guaranteed.“Theres a fundamental truth about cancer:its set up to work its way around monotherapies,”says Hamish Ryder,CEO of Therapeutic Innovation for Cancer Research Horizons,which helps translate Cancer Research UKs 300m research effort.Rapidly evolving standards

162、-of-care and therapy combinations set an ever-higher bar for newcomers and make it difficult to test the impact of any single drug old or new on a given cancer type and stage.Even pinning down cancer types is hard:basket trials now test drugs across multiple tumor types with shared mutations.Next ge

163、neration approaches,even if some become more widely applicable,will still be used within combinations.“The future of oncology therapy is about finding the right combination,”said Vittoria Zinzalla,global head of oncology translational medicine at What Next In Oncology?PARP inhibitors may work synerg

164、istically to induce cell cycle arrest and apoptosis of cancer cells;some cell cycle inhibitors like azenosertib may help predict chemotherapy response(though the precise nature of this interaction isnt yet fully understood).21December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline com

165、pany(Unauthorized photocopying prohibited)Boehringer Ingelheim at an October 2023 event in London.More mechanisms will feature in the mix.Antibody drug conjugates(ADCs)continue to make their mark:Merck recently committed$4bn up-front for three of Daiichi Sankyo Co.,Ltd.s;Pfizers$43bn Seagen deal ear

166、lier this year came with three marketed ADCs and a platform technology.Seagen/Astellas star ADC Padcev(enfortumab vedotin-ejfv)with forecast 2028 sales close to$3bn,according to Evaluate-is approved in combination with Keytruda for advanced bladder cancer and reported strong results in un-treated pa

167、tients ahead of the annual European Society for Medical Oncology meeting in Madrid.New generations of targeted protein degraders,which re-direct cells protein recycling system to target and destroy disease-causing proteins,are also attracting attention,including at companies like Kymera,C4 Therapeut

168、ics,Roivant or Arvinas.This approach allows chemists to“think differently about drug discovery,”says CRUKs Ryder.They can design small molecules that eliminate proteins without binding to a known functional site,accessing targets(such as transcription factors)considered un-druggable by conventional

169、means.Newer tie-ups marry ADCs with degraders to create degrader-antibody conjugates.Theres more to come from immunotherapy.Beyond checkpoint inhibitors,bispecific T-cell engager(BiTE)antibodies like Janssen Pharmaceutica Inc.s Tecvayli(teclistamab-cqyv)for multiple myeloma harness the immune system

170、 in a more targeted fashion.Tolerability has limited them to later-line therapy,though Amgen hopes its BiTE tarlatamab may be safer:recent Phase II data reported at ESMO showed a response rate of 40%in small cell lung cancer for the drugs low dose.Chimeric antigen(CAR)-T cell therapies,already an im

171、portant solution for some patients with severe blood cancers,also continue to evolve.But overcrowding within this and other corners of immuno-oncology,plus T-cell therapies manufacturing,delivery and pricing challenges,have triggered a cool-down.AbbVie recently scrapped its allogeneic CAR-T alliance

172、 with Caribou Biosciences,and business development executives at several biopharma players now single out cell therapy as one of few areas theyre not interested in.(AbbVies oncology cull also included Harpoon Therapeutics tri-specific B cell maturation antigen(BCMA)targeting T-cell engager program,a

173、nd ex-Chinese rights to IMabs CD-47 targeting antibody.)Some feel this that immunotherapy is more likely than any targeted medicine to generate another blockbuster,given the immune systems adaptive nature.But unpicking key mechanisms in immuno-oncology is arguably even tougher than pinpointing oncog

174、enes.Even Keytruda addresses only a minority of cancers,though it continues to expand its latest approval is in early-stage(peri-operative)NSCLC.Combining checkpoint inhibition with oncogene inhibitors may help widen the application of both.Oncogenes like KRAS do“more than speed up cell division,the

175、y also impact immune evasion,”explains BIs McConnell,pointing to preclinical work underway.Drugging“big”oncogenes and finding the right immuno-oncology partner would hit the jackpot,he continues.These approaches all face similar challenges:identifying key disease-causing targets whose elimination do

176、esnt cause other unwanted effects and overcoming resistance mechanisms.Tumors can escape CAR-T cells,work around ADCs,and re-wire downstream pathways to neutralize the impact of protein degraders.This is in part why,despite terrific advances in precision therapies and an ever-broader range of modali

177、ties,decades-old chemotherapy and radiation remain therapy mainstays.Yet these blunter instruments,too,are sharpening and What Next In Oncology?22December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)could help swing the oncology pendulum

178、 back to the middle.ADCs are a form of precision chemotherapy.Radiopharmaceuticals deliver radiation specifically to cancer cells,thereby limiting collateral damage.Radioisotopes such as radium,lutetium or actinium are linked to a directing molecule to deliver a more effective,selective punch;Eli Li

179、llys$1.4bn acquisition of Point Biopharma Global,RayzeBios$311m IPO,and a cluster of other recent deals signal increased popularity.Radioligands can be conjugated with therapeutic entities and combined,for instance with PARP inhibition,to knock out cancer cells DNA then prevent repair.Radiation and

180、immunotherapy could together mobilize the immune system to attack damaged tumor cells.Designing and testing combinations is easier with more in-house components.That along with the IRA-powered cap on any individual precision medicines value is why bigger players want a portfolio spanning as many mol

181、ecules and mechanisms as possible.Keytrudas may not come along every day,but given sufficient potential combinations,“I dont think its the last time well see a$20bn cancer drug,”says one CEO.What Next In Oncology?23January 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unautho

182、rized photocopying prohibited)Mapping the patient journey,the experience of a patient as they navigate through the various stages of care for a specific condition,provides a vital wealth of knowledge for health care providers,health systems and biopharmaceutical companies to assess the patient exper

183、ience from multiple angles.These insights create an invaluable window into the obstacles faced in delivering care,the effectiveness of patient-physician interactions,specific areas of concern for patients and the reasoning behind care-related decisions,all of which are critical pieces of the therape

184、utic and diagnostic development puzzle.It is a fundamental piece in improving the Triple Aim of healthcare;the improvement of patient experience,raising the health of populations and reducing health care cost.Patient journey mapping facilitates a continuous and comprehensive visualization of informa

185、tion while incorporating both quantitative and qualitative aspects.Critically,it encompasses the behaviors of patients,caregivers and healthcare providers,enabling a better understanding of the overall care experience.The patients journey begins with the onset of symptoms,followed by seeking medical

186、 attention for diagnosis.From there,the pathway involves initiating treatment to manage the diagnosed condition,which can ultimately result in a cure or long-term disease management.It may also involve the patients participation in a clinical trial.However,the patient journey is not The Power Of AI

187、To Map The Patient JourneyJo ShorthouseExecutive SummaryMapping the patient journey uncovers a wealth of insights into care,diagnosis and intervention.The onset of advanced analytics tools and sensors now augment the pharma industrys understanding of the challenges of traversing health care systems.

188、Layering AI into the mapping process not only has the power to provide insights into the current clinical pathway,it can be used to predict and intervene in clinical care.24December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)The Power O

189、f AI To Map The Patient Journeya straight line,and can highlight moments when individuals encounter frustrations or challenges such as uncertain diagnoses,misdiagnosis,additional evaluations and second opinions.Power To The PatientLooking at the pharmaceutical industry today,with the role of chief p

190、atient officer and patient centricity roles located within the C-suite,one would be forgiven for thinking that the importance placed upon understanding the patient journey had always been central to pharmas product development strategy.Not so.Anthony Yanni recalled a time to In Vivo,around 15 years

191、ago,when working as a physician and talking to a room full of executives at a large pharma and asking them why they werent talking to the patients.“That question was not well received,”he explained.“Now,you fast forward all these years,we have robust systems,and other companies are integrating the p

192、atient perspective into decision making,”said Yanni,now head of patient centricity at Astellas Pharma,Inc.In 2014,Sanofi was the first large pharma to create the role of chief patient officer.When the French major announced the appointment of Anne Beal to the position,it said that“interactions with

193、patients were a source of strength for the company,”with Beal adding that she would“infuse the patient perspective into Sanofis work that will advance our ability to deliver health care solutions that matter most to patients and those who care for them.”Nine years later,and patient participation in

194、decision making,both commercial and clinical is embedded within pharma.Disease foundations,patient advocacy groups,regulators,physicians and technology providers are connected to place the patient at the center of the pharmaceutical ecosystem.With the patient and their caregivers now placed at the h

195、eart of pharma strategic thinking,mapping the patient journey for better health outcomes and improving the patient experience takes on a greater significance.“What we try to do,and across industry,we include the caregiver,we include the provider,we understand the environment in which the patient liv

196、es in a real-world setting.All those things are critically important to understanding that group of patients that have similar experiences,so we can best understand not only what solutions they are looking for,but how do you deliver those solutions in their world,”said Yanni.Traditional Patient Jour

197、ney MappingTraditional market research methods,created through physician surveys,to map the patient journey would have consisted of the sequence in which a patient passes through a healthcare system,see Exhibit 1.This doctor-centered map would fail to show emotional or behavioral aspects to the jour

198、ney from symptom to treatment,and fundamental events that would happen outside the physicians environment such as pain and the variation of symptoms.Importantly,it did not include drug adherence,drug burden,age,culture,lifestyle,or the way in which caregivers were impacted.Anthony Yanni,Head Of Pati

199、ent Centricity,Astellas Source:Astellas25December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)It also failed to show the impact of payer decisions and oversimplified the process with which the patient entered and exited the healthcare sy

200、stem.Mapping a patients journey is a complicated undertaking,said Yanni,that should not use a one-size-fits-all approach.“The definition of a patient journey depends on the patient.This is why its important to talk to patients in different geographies,a diverse set of patients to understand their pe

201、rsonal experiences,and all the variables that impact it,”he explained.“There are different populations within a disease,we cannot map one Parkinsons disease patient and think we have completed the task,”he said.The importance of culture,age,and comorbidities all play a role in understanding the vari

202、ous cohorts of a population living with a specific condition,making it a fundamental undertaking to investigate and understand the journey as completely as possible.This is where modern digital means enter the situation.Advances within patient-owned technology,such as the smartphones and the use of

203、social media,coupled with wearable technology,connected electronic medical records(EMRs)and the increasing use of advanced analytics to make meaning from big data create a burgeoning environment in which to map the patient journey with detail never seen before.The Digital EraAny company developing a

204、 product needs to know their customer intimately,and a drug manufacturer is no different.Tools are now The Power Of AI To Map The Patient JourneyExhibit 1:A Sequential Patient Journey26December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited

205、)at hand for drug makers such as telehealth solutions,remote monitoring,blockchain for data security,data interoperability and Internet of Things devices such as sensors,wearables and apps.These elements continue to mature in sophistication and accessibility,and if brought together in a strategic an

206、d deliberate way can create a digital patient journey that is integrated within life science company decision making.Clinical and commercial decisions are made from qualitative and quantitative information gleaned from digital patient journey mapping and,increasingly,drug makers are using artificial

207、 intelligence(AI)and machine learning(ML)to find insights into patient behavior,often in real time.While understanding the real-world patient journey is complex because of big data,the lack of scalable solutions,and the personal nature of each patients journey,ML and advanced analytics can now be ap

208、plied to a crucial part of pharmas commercial toolkit.Companies such as Medidata Solutions Inc.,which provides cloud services to those involved in clinical research,are using AI to create a holistic picture of the patients journey.“One of the biggest changes in the mapping of the patient journey,esp

209、ecially in clinical trials,is more use of patient-reported outcomes,more use of sensors and wearables.That allows you to get a better understanding of the true condition of the patient at variable points in time,”said Fareed Melhem,head of AI for Medidata.With the incredible amount of data now being

210、 generated through sensors the only way to create insights,and to connect the patient reported outcome(PRO)data with physical data is to use AI,Melhem told In Vivo.“We capture and maintain all of that data and use a number of algorithms to pull out key events and correlate it with other data thats c

211、oming in,”he explained.If a patient is reported that they feel well in their PRO log,for instance,Medidata can correlate that with sensor data at that time.Data from sensors that record physical actions or states such as sleep,activity,or gait can be added to AI data to create a more holistic pictur

212、e of the patient journey.The journey through the health care system is fluid and dependent on many factors such as patient age and location.Product strategy,too,must respond to this mutability and take it into consideration within lifecycle management strategy.Not only can AI augment the patient jou

213、rney,but it can also create new approaches and alternative pathways.For instance,at the American Society of Clinical Oncology(ASCO)2022 meeting,Meditata presented research that showed using AI could predict adverse events at a patient level.In the CAR T-cell therapy space,cytokine release syndrome(C

214、RS)is the most common life-threatening adverse event.Medidata,alongside Michael Kattan of the Cleveland Clinic,compiled and analyzed the largest pooled clinical trial data set in existence from anti-CD19 CAR-T treatments,spanning more than 540 patients from multiple CAR-T clinical trials.The team us

215、ed big-data modeling techniques to quantify the relationship between patients lab measurements and the development of severe CRS.They analyzed common markers such as platelet counts,serum albumin concentration,creatinine,and neutrophil counts to spot changes or patterns occurring in the days followi

216、ng key milestones in CAR-T treatment pathways,which could lead to new approaches such as novel REMS for severe CRS.“Now a physician can intervene sooner when they see certain predictive markers and preempt those issues.So that way,AI moves the patient to a new branch of the patient journey,”explaine

217、d Melhem.“AI can go beyond just the mapping of the The Power Of AI To Map The Patient Journey27December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)journey to improve the patient journey and sometimes be integrated within the patient jou

218、rney,”he told In Vivo.Proceed With CautionAstellas Yanni sees the onset of digital capabilities as an adjunct to traditional patient journey mapping techniques,rather than a replacement.While advanced analytics approaches allow a broader understanding of the patient journey because of the large data

219、sets that were unavailable for analysis before now,this requires more discernment.The access to information is incredible,Yanni believes,but we need to ask vital questions.“Is the information were looking at accurate?Does it apply to the patient population and the questions we are asking?Is there hi

220、dden bias in the accumulation of that information youre looking at?There are so many things that we have to be cautious of because,in my view,more data does not necessarily mean more accurate information,”he said.“We need to be very careful in how we approach this so that we understand what were uti

221、lizing,what questions were asking,and how we are applying the information we find,”he warned.Yannis instinct seems to be echoed throughout the rest of big pharma.While the buzz around potential use cases of AI to innovate the development of new therapies has a long news tail attached to it,it has on

222、ly reached widespread adoption in activities such as site selection and enrolment modelling.Big pharma is,of course,exploring the potential for AI-powered innovation,in fact large pharma companies have agreed to more than 75 AI partnerships with institutions in recent years.Partnerships such as thos

223、e announced by Janssen Pharmaceuticals Inc.and MIT(which also facilitates the Machine Learning for Pharmaceutical Discovery and Synthesis Consortium),AbbVie Inc.and Calico and Sanofi and Exscientia plc have all grabbed the headlines.While Novartis AG said it has“applied AI broadly”to innovate across

224、 R&D to develop novel therapies and engage with patients,it concurrently published its commitment to the ethical and responsible use of AI.A recent ZS report,it cites barriers such as the need for high-quality data,navigating intricate regulatory landscapes,overcoming organizational resistance to ch

225、ange,developing AI algorithms that are interpretable and trustworthy,and bridging the talent gap between data science and industry-specific expertise.“Integrating AI demands significant workflow alterations and a workforce that possesses both data science proficiency and deep industry knowledge,”sai

226、d author Pranava Goundan.“There is this growing need for large data science centers that have GPUs which are very expensive,and take a lot of energy to run,”said David Hughes,graph practice director at Graphable.“Were starting to recognize is that there are significant barriers to operationalize mac

227、hine learning and large language models,the cost of running,retraining,fine tuning and then actually generating insights from trained models is going to be prohibitive to all but the top tier of tech company.”Visualization And ModellingHughes,having previously worked at the Seattle Cancer Care Allia

228、nce,All4Cure and Octave Bioscience Inc.,has an intimate knowledge of how the patient journey mapping process and the creation of a clinical pathway can be a powerful combination to capture a comprehensive view of the complex nature of a disease,its effect on a patient and the actions of a healthcare

229、 system,see Exhibit 2.The Power Of AI To Map The Patient Journey28December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)Graphable works with companies to make sense of data and is working with pharma on everything from drug discovery,nove

230、l protein development and synthesis,and patient journey mapping to better understanding disease progression.Hughes believes that by using graph science and databases within patient journey mapping,pharma can uncover meaningful clinical insights that will lead to a better understanding of a patients

231、journey and outcomes at scale.The image above depicts a digital twin of a single patients cancer journey.A digital replica of a patients healthcare journey within the system is formed by first inputting the patients clinical data into a clinical knowledge graph through graph models.This digital twin

232、 is then constructed with the aid of sophisticated schema-based clinical analytic systems.By mapping the patient journey,digital twins serve as valuable tools for uncovering real-world obstacles,care process gaps,and various challenges encountered by patients and their families.To gain insights into

233、 a patients clinical care,including aspects such as disease progression and cost analysis,a specialized graph schema is developed to facilitate these investigations.Exhibit 3,displayed below,illustrates the graph schema corresponding to the journey depicted in Exhibit 2.This schema represents a pati

234、ent(depicted as a red node)with a chronological sequence of clinical encounters(represented by yellow nodes).Each clinical encounter is intricately connected to an insurance claim event and further associated with the claims procedures,diagnoses,medications,imaging,clinical providers and other perti

235、nent facets of care.This comprehensive linkage offers a holistic perspective of a patients journey through the months and possible years of clinical interventions.The Power Of AI To Map The Patient JourneyExhibit 2:A Single Patients Clinical Oncology Journey Encompassing Insurance Claims,Imaging,Dia

236、gnostics and Medical Procedures Source:https:/www.graphable.ai/blog/patient-journey-mapping/29December 2023 Copyright 2023 Pharma Intelligence UK Limited,a Citeline company(Unauthorized photocopying prohibited)Source:https:/www.graphable.ai/blog/patient-journey-mapping/The use of schematics such as

237、that shown above may begin with the intention of finding ways to save cost within the health care system,but it can lead to epiphanies such as linking seemingly unrelated diagnoses given six months previously to a patients main diagnosis“That might lead researchers and pharma to start exploring the

238、mechanism of action,and better understanding what else is happening here in the patients world.They can then explore pathways,uncover insights,and even intervene earlier in a treatment,”Hughes told In Vivo.Graphs enable discovery opportunities which a company could then layer with machine learning,l

239、arge language models or generative AI to hypothesize on prevention,treatment,or care.“Graph data helps to ground hypotheses into truth,which makes it easier to decide on investment or clinical avenues because theres evidence that supports the decision,”Hughes said.The Digital Journey AheadThe rise o

240、f the digital patient,at the epicenter of their own health care journey,is now the expectation within modern health care and therapeutic choice.This is only the beginning of the future of digital patient journey planning,which will be characterized by increased personalization,the widespread use of

241、advanced technologies like AI and telehealth,and a strong emphasis on patient engagement and empowerment.These advancements have the potential to enhance the overall patient experience and improve healthcare outcomes.However,they also raise important ethical and regulatory considerations that will n

242、eed to be addressed as health care continues its digital transformation.The Power Of AI To Map The Patient JourneyExhibit 3:A Graph Schema Supporting Disease Progression And Cost ExplorationsCopyright 2023 Citeline,a Norstella company.Pharma Intelligence UK Limited is a company registered in England

243、 and Wales with company number 13787459 whose registered office is 3 More London Riverside,London SE1 2AQ.Citeline,a Norstella company,powers a full suite of complementary business intelligence offerings to meet the evolving needs of life science professionals to accelerate the connection of treatme

244、nts to patients and patients to treatments.These patient-focused solutions and services deliver and analyze data used to drive clinical,commercial,and regulatory-related decisions and create real-world opportunities for growth.Our global teams of analysts,journalists,and consultants keep their fingers on the pulse of the pharmaceutical,biomedical,and medtech industries,covering it all with expert insights:key diseases,clinical trials,drug R&D and approvals,market forecasts,and more.For more information on one of the worlds most trusted life science partners,visit C