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1、Pressing issues and critical imperatives that will shape the new model for the industrythe connected life sciences company.The future of life sciences Signals of changeFour strategic imperativesConclusionHow KPMG can helpForewordIn many ways,the response to the pandemic highlighted the life sciences

2、 industry at its best.The speed at which effective COVID-19 vaccines and treatments were identified,tested,developed,approved,and deployed on a global scale exemplifies the art of the possible when there is connectivity across all interestspublic,industry,and government.Today,however,public percepti

3、on of life sciences organizationsand pharmaceutical companies in particularhas largely settled back to pre-pandemic levels.Patients,providers,and payers have come to expect organizations to innovate at a faster pace to meet emerging clinical needs,be transparent about drug pricing,and demonstrate a

4、higher purpose than profits.Achieving these goals is,of course,complicated by current economic and geopolitical volatility.Some companies are hunkering down to weather the storm.Others are rethinking their operating models to ensure they can meet stakeholder expectations,anticipate and withstand thr

5、eats,and capitalize on data-driven insights to win in the marketplace.In this paper,we examine the four primary signals of change impacting the industry now.We also identify four strategic imperatives to help organizations seize opportunities in the current environment.We believe those who make the

6、most of these opportunities now will shape the future of life sciences.2 2023 Copyright owned by one or more of the KPMG International entities.KPMG International entities provide no services to clients.All rights reserved.Signals of changeFour strategic imperativesConclusionHow KPMG can helpWhats i

7、nsideSignals of change04Four strategic imperatives08How KPMG can help16Conclusion153 2023 Copyright owned by one or more of the KPMG International entities.KPMG International entities provide no services to clients.All rights reserved.Signals of changeFour strategic imperativesConclusionHow KPMG can

8、 helpSignals ofchangePharmaceutical companies and medical device manufacturers are evolving to become integral parts of the healthcare value chain.This means that increased connectivity and communication are expected by all stakeholders from payers to providers to patients.Precision medicine,digital

9、 health products,and lifestyle tools that incorporate machine learning and artificial intelligence now represent a greater percentage of life sciences companies portfolios than they did even a few years ago.And while these connectivity trends promise to improve both the patient experience and clinic

10、al outcomes,they also increase the potential attack surface for cyber-criminals,requiring a much more robust approach to cybersecurity and privacy.The following signals of change are the key drivers pushing the life sciences industry into the future and make up the most pressing issues for firms to

11、address and understand.4 2023 Copyright owned by one or more of the KPMG International entities.KPMG International entities provide no services to clients.All rights reserved.Signals of changeFour strategic imperativesConclusionHow KPMG can helpFour signals of changePrecision medicine changes the ga

12、me.1The life sciences industry has made major breakthroughs in precision medicine,which comprises treatments tailored to individuals unique genetic profiles and,in some cases,engineers a therapy from a patients own cells.Clinicians gain insight into molecular changes and personal characteristics tha

13、t can underlie disease in an individual patient and,in some cases,offer cures for previously untreatable diseases.1 In only the last two years,a number of new CAR-T drugs were approved by the U.S.FDA2,and companies are racing to build out their manufacturing capacity to meet rapidly growing demand.K

14、ey drivers of precision medicine are multiomic technologies,which,in the clinical setting,combine genomics,proteomics,and metabolomics-based diagnostics into one holistic picture of a patient,drawing on data from the whole body.While not all clinical diagnostics laboratories have the platforms to do

15、 this work,the industry is striving to overcome access challenges through meaningful connections between diagnostics and life science tool companies,testing centers,and reference labs.Autologous therapies require a“made-to-order”supply chain,challenging pharma companies to implement new capabilities

16、 around scheduling,logistics,and patient data management.Going forward,the U.S.federal government,through an ambitious program led by the White House Office of Science and Technology Policy,has made a commitment to increasing the manufacturing scale of cell-based therapies 10-fold.3Scaling precision

17、 medicine will require more than just increasing manufacturing capacity and furnishing clinical labs with new technologies.It requires connection and coordination across a variety of functions:The additional complexity of these therapies increases the onus on medical affairs resources to support Hea

18、lthcare Providers(HCPs).And certain therapies require formal Risk Evaluation and Mitigation Strategies(REMS)programs.No longer aspirational,precision medicine is real and is moving life sciences directly into the patient care continuum.As more therapies come to market,precision medicine manufacturer

19、s will be evaluated not only on the efficacy of their therapies,but also on their ability to seamlessly connect with HCPs and support them in care delivery.(See“Rethink the Supply Chain”)1 Source:Jill Collins,“5 Leading Healthcare Trends For 2023,”Forbes,February 16,2023.2 Source:Alex Smith,“The pro

20、mise of CAR-T therapy in cancer treatment,”News Medical,March 21,2023.3 Source:The White House Office of Science and Technology Policy,“Bold Goals for U.S.Biotechnology and Biomanufacturing,”March 2023.4 Source:Michael Timmes,“Millennials And Gen Z:Now Is The Time To Reshape Businesses To Harness Th

21、eir Power,”Forbes,June 27,2022.Digital health alters the landscape.2While the healthcare media has been talking about digital health for almost a decade,life sciences companies are only now breathing new life into existing technologies,and introducing new innovations at a breathtaking pace.Consumers

22、 expect better-connected healthcare experiences,which these technologies enable.Historically,healthcare and life sciences have lagged banking and retail in offering engaging digital experiences.Enormous bandwidth,extensive smartphone adoption,and a high level of digital fluency are converging to fue

23、l explosive growth in digital health offerings.Generation X,Y,and Z workers collectively make up 75 percent of the workforce as the Baby Boom and earlier generations retire.4 As digital natives,Generations Y and Z are the most likely to prefer the convenience of tailored connected experiences.With t

24、he burden of cost shifting to the individual,patients are taking more active roles in their own care with fitness devices,wellness apps,and easily accessible information online.Healthcare providers increasingly expect to have easy and convenient access to information and analysis and tools to help t

25、hem connect with patients and improve their clinical outcomes.With many healthcare provider systems struggling for talent at every level and the cost of care Global precision medicine market2022:US$83.43 billion 2023:US$95 billion(CAGR of 13.9%)2027:US$157.26 billion(projected)Source:March 2023,Prec

26、ision Medicine Global Market Report 2023,6241913.5 2023 Copyright owned by one or more of the KPMG International entities.KPMG International entities provide no services to clients.All rights reserved.Signals of changeFour strategic imperativesConclusionHow KPMG can help5 Source:Rebecca Pifer,“How t

27、echnology will shape healthcare in 2023,”Healthcare Dive,January 17,2023.6 Source:September 12,2022,Unpatched and Outdated Medical Devices Provide Cyber Attack Opportunities.7 Source:U.S.Department of Health and Human Services,March 30,2023,Cybersecurity in Medical Devices:Refuse to Accept Policy fo

28、r Cyber Devices and Related Systems Under Section 524B of the FD&C Act Guidance for Industry and Food and Drug Administration Staff.8 Source:Elizabeth Anne Wright,Jessica Koffel,and Edward Turtle,“Five potential EU regulatory changes impacting the life sciences industry in 2023,”European Pharmaceuti

29、cal Review,February 7,2023.becoming unsustainable,the potential for digital health tools to drive workflow efficiency and geographical reach is compelling.Many well-funded start-ups and tech giants are bringing their know-how in connected infrastructure,advanced analytics,and user experience to this

30、 opportunity.Over the past five years,many medical device companies have rebranded themselves as“MedTech”companies.Pharmaceutical companies are investing and forging digital health partnerships to supplement and differentiate their core therapies and help improve quality of care and patient experien

31、ce.Whether focused on the care provider or the patient,the plethora of innovative solutions being developed all have the following criteria in common:engaging user experiences,seamless integration,secure data,and real-time connectivity.As of November 2022,the FDA had already authorized more than 520

32、 medical artificial intelligence(AI)tools.5 Over the next five years,we expect to see a broad spectrum of new digitally enabled care paradigms that improve access,enhance quality of care,and lower total cost.(See“Design Tech-Enabled,Customer-Centric Experiences”)Artificial intelligence and machine l

33、earning are everywhere.3Artificial intelligence(AI)and machine learning(ML)have gone from novel experiments to the top of the C-suite agenda across most industries.Life sciences has been ahead of the pack,using AI in research and development and decision support long before the current excitement ab

34、out AI.Medical technology companies are leveraging ML in the development of devices and diagnostics,which has helped them realize accelerated cycle times,reduced costs,and improved quality.The resulting devices are perhaps the area of connected digital health with the most future growth potential.Fu

35、rther,using AI in the drug research process is allowing pharmaceutical companies to enhance discovery and innovation,connect with potential clinical trial participants worldwide,bring therapies to market faster,and shorten the time to realize return on investment(ROI)on new drugs.Although the power

36、of AI to detect patterns,synthesize structured and unstructured data,and predict patient outcomes is clear,it is important to consider the broader context.Getting full value out of AI tools requires robust data curation and an evolution of the extended operating model.In other words,“becoming digita

37、l”requires transformation beyond algorithms to include the operational processes and skills that can change“how work gets done.”It is important to note that,although technology advances such as AI and ML,as well as smart devices and digitalization of the supply chain,are critical to the growth and r

38、esiliency of the industry,this level of connectivity also introduces new security risks.There are both government-and industry-led efforts advocating for increased governance and oversight to ensure AI algorithms are unbiased,sensitive patient data is secure,and solutions dont create cybersecurity v

39、ulnerabilities.Although truly catastrophic medical device breaches have yet to occur,a September 2022 FBI report concluded that more than 50 percent of connected medical devices in hospitals have critical vulnerabilities.6 Worldwide,regulators expect industry to shore up the cybersecurity of AI-base

40、d devices.In December 2022,the U.S.FDA passed a law requiring medical device manufacturers to include cybersecurity plans along with their pre-market submissions.7 Although the FDA has said it wont start issuing“refuse to accept”notices right away,the law will be in full force by October of this yea

41、rputting pressure on life sciences companies to prepare more robust cybersecurity plans to accompany new innovations.For“high-risk”AI systems that perform a safety function within medical devices,there are new certification procedures out of the European Union that encompass data governance,record k

42、eeping,transparency,accuracy,and security to earn a CE mark.8(See“Develop AI partnerships for faster time to market”and“Manage Cyber Risks”)AIs expected impact on global economy:US$15 trillion by 2030 Source:Andrew R.Chow and Billy Perrigo,The AI Arms Race is Changing Everything,Time,February 17.202

43、3Digital Health Market2022:US$742.7 billion 2029:US$4.5 trillion(CAGR 29%+)Source:December 2022,Digital Health Market Size,Share&Trends Analysis,2029,FBI100227.6 2023 Copyright owned by one or more of the KPMG International entities.KPMG International entities provide no services to clients.All righ

44、ts reserved.Signals of changeFour strategic imperativesConclusionHow KPMG can helpCritical risks persist:Supply chain disruption,cyber breaches,and counterfeiting.4The pandemic shed light on the vulnerability of the life sciences supply chain to disruption,which caused shortages of critical medicati

45、ons including cancer drugs,sterile injectable products,pain killers,and even over-the-counter cold and flu medicines.The number of drugs impacted by shortages reached a peak of 295 in late 2022.9 Currently,nearly 80 percent of active pharmaceutical ingredients(API)manufacturers are located outside o

46、f the U.S.,10 highlighting the U.S.s reliance on foreign sources,which could pose a national security risk in the event of another crisis like the COVID-19 pandemic.Drug shortages did not start with COVID-19.A 2019 study U.S.Senate study identified concerning gaps in supply chain insight and the per

47、vasive inability to trace sources of supply.The ability to forecast and avoid or mitigate shortages depends on accurate data.Even long-term,loyal API suppliers can provide a false sense of security if many pharmaceutical manufacturers are using the same sources.If,for example,one of them is compromi

48、sed,it may be challenging to find an alternative supplier.Therefore,greater transparency is needed into supplier operations,which will require substantial investments in data integration and data protection.Life sciences supply chains are also vulnerable to both criminal cyber threats and counterfei

49、t products,as highlighted by the Organisation for Economic Cooperation and Development(OECD)in a recent study.11On the cyber front,patient data held by life sciences companiesas well as healthcare organizationsis particularly susceptible to cyber-theft,as this data purportedly sells on the black mar

50、ket for more than financial data.Compounding the problem is the increased dependence on foreign and domestic third-party suppliers with varying degrees of cyber maturity.If third parties are breached,their close connectivity to pharmaceutical companies could cause myriad impacts,such as:1.Allowing t

51、hreat actors to use the third-party as a gateway to the pharma companys systems to introduce a virus or access IP or sensitive patient data2.Driving life sciences companies to divert business from a breached supplier,potentially impacting the flow of drug supply and demand3.Causing long-term shortag

52、es of life-saving drugs if sole suppliers are compromised.When it comes to counterfeiting,the OECD is encouraging the industry and regulators to improve control over product distribution.12 In the early days of the pandemic,bad actors seized the opportunity of the huge spike in demand for drugs and

53、medical equipment to market counterfeit and substandard products from medical devices to ineffective hand sanitizer.Looking forward,the issue of counterfeit products is likely to be most acute in emerging markets,13 although it is a major concern in the U.S.as well.The final phase of the Drug Supply

54、 Chain Security Act(DSCSA),initially passed in the U.S.in 2013,goes into effect in November 202314 and seeks to ensure electronic records and traceability at the smallest saleable unit level.The data and insights generated by these efforts will provide valuable business insight well beyond regulator

55、y compliance.(See“Manage Cyber Risks”)9 Source:Marina Kopf and Catie Beck,As cancer drug shortages grow,some doctors are forced to ration doses or delay care,NBC News,May 26,2023.10 Source:Phillipe Drechsle,“Halting Europes essential medicines manufacturing exodus,”European Pharmaceutical Review,Feb

56、ruary 2,2023.11,12 Source:OECD,April 21,2020,Covid-19 crisis underscores need to address trade in fake pharmaceuticals,say OECD&EUIPO.13 Source:Hannah Balfour,“The latest on pharmaceutical counterfeiting,”European Pharmaceutical Review,May 3,2022.14 Source:U.S.Food and Drug Administration,“The DSCSA

57、 Implementation and Readiness Efforts for 2023 Virtual Public Meeting,”December 7-8,2022.Prime cyber targets:Life Sciences&HealthcarePrice on the black market for a medical record$250 USD Average financial impact of a security breach on a life sciences organization$7.13 million USDSource:Paul Nadrag

58、,“Industry VoicesForget credit card numbers.Medical records are the hottest items on the dark web,”Fierce Healthcare,January 26,2021.7 2023 Copyright owned by one or more of the KPMG International entities.KPMG International entities provide no services to clients.All rights reserved.Signals of chan

59、geFour strategic imperativesConclusionHow KPMG can helpFour strategic imperatives to take nowLife sciences companies seeking to differentiate themselves from the competition would be wise to accelerate their journey toward increased connectivity.“Customers”comprising payers,providers,patients,and,in

60、creasingly,employeesexpect the same convenient,accessible,engaging experiences from interactions with life sciences companies that they have come to enjoy in other aspects of their lives.When it comes to artificial intelligence,the life sciences industry is ahead of most others,using the technology

61、to enhance critical functions that help bring innovative,new drugs to market faster.The need to modernize and digitalize the supply chain became crystal clear during the pandemic,and life sciences companies are taking heed by fostering more digitalized processes,segmenting their supply chains to sup

62、port new innovations like precision medicine,and endeavoring to stay ahead of potential disruptions.Finally,as mentioned above,upgrading and bolstering cybersecurity and privacy protection programs have taken on new weight in this age of connectivity,requiring life sciences companies to bring securi

63、ty teams to the table as early as possible in the development of these new connected capabilities.To win in this new,highly connected healthcare marketplace,life sciences firms should act on the following four crucial strategic imperatives.8 2023 Copyright owned by one or more of the KPMG Internatio

64、nal entities.KPMG International entities provide no services to clients.All rights reserved.Signals of changeFour strategic imperativesConclusionHow KPMG can helpPayer communications should be centered around valuenot just for the payer,but for the patient and broader society.Value propositions for

65、new products,including digital health solutions,should be supported by compelling data and insights.Payers are interested in understanding whether products represent improvements over existing offerings,how they will impact the length and severity of the disease burden,how closely costs are aligned

66、with value,and whether there are new payment model options,such as outcomes-based agreements.The Centers for Medicare and Medicaid(CMS)in the U.S.have announced three new potential drug payment models that will be tested by the CMS Innovation Center.All three models will impact the price of drugs fo

67、r U.S.patients covered under Medicare Part D,Medicare Part B,and Medicaid.The three models include the“Medicare High-Value Drug List,”which comprises a standardized list of high-value,low-cost generic drugs;“Cell&Gene Therapy Access,”designed to provide Medicaid beneficiaries with access to high-cos

68、t cell and gene therapies to treat rare and severe diseases;and“Accelerating Clinical Evidence,”which provides manufacturers with incentives to complete confirmatory studies for accelerated-approval drugs in a timelier fashion.15For many industries,“customer centricity”has been the driving force of

69、business transformation.Retail,consumer goods,and banking have reimagined their businesses with“the customer at the center,”digitalizing their operations and designing next-level connected experiences.Ironically,life sciencesthe industry that adopted customer relationship management(CRM)technologies

70、 the earliestis among the furthest behind in putting the customer at the center of its decision-making.For most of the industry,the typical concept of“customer”doesnt fit.Still,there is a critical need to deliver intentional,connected interactions to meet the needs of the industrys three key stakeho

71、lderspayers,providers,and patients(and,to an extent,regulators).Delivering a great user experience requires listening to the unique needs of each stakeholder and delivering the appropriate products,services,and information in an accessible and sustainable way.Design tech-enabled,customer-centric exp

72、eriences115 Source:S.Lawrence Kocot,Tracey McKutcheon,and Ross White,“CMS announces model concepts to reduce prescription drug costs,”KPMG Center for Healthcare Regulatory Insights,February 17,2023.Life sciences stakeholders require differentiated experiencesProviders02 Do I believe my patient will

73、have a better outcome and/or fewer side effects with this therapy?Is this treatment easier to deliver,sustain,and manage?Patients03 Do I trust my doctors advice?Will my insurance cover this therapy?What have I heard about this therapy from other sources?Payers01 Does a new product significantly impr

74、ove the economics with comparable outcomes?Does it offer significantly improved outcomes at a higher cost?Does the therapy lower the total cost of care?9 2023 Copyright owned by one or more of the KPMG International entities.KPMG International entities provide no services to clients.All rights reser

75、ved.Signals of changeFour strategic imperativesConclusionHow KPMG can helpPatients need to be at the center of all life sciences decisionswhether individuals are highly knowledgeable about their disease,thirsty for knowledge,or only focused on access to medication.Developing a patient journey map is

76、 an effective way to understand the patient experience.While much of that experience lies in the healthcare delivery domain,life sciences companies should position themselves as a conduit between healthcare providers and patients to help patients manage their health and ensure they have exceptional

77、care experiences.For example,pharmaceutical companies can offer companion apps designed to improve patient health habits through services like gamification and real-time health indicator monitoring.Further,increasingly sophisticated smart devices are empowering patients and caregivers to connect to

78、each other to better manage chronic conditions and improve overall wellness.Smart watches have been prompting users to increase their physical activity for years.However,more recent improvements in sensor technology allow these devices to assess sleep quality,detect heartbeat irregularities,and moni

79、tor high blood pressure,with promising future features that include blood glucose testing.17Connecting all these stakeholders,we see a trend toward platform-based ecosystems(PBE)that offer omni-channel experiences allowing real-time troubleshooting between manufacturers and clinicians,tailored conte

80、nt delivery,personalized products and services,tele-health services,and patient support through patient-advocacy groups.Specifically,omni-channel has expanded as customers expect touchpoints across social media,email,video,portals,chatbots,forums,phone,forms,and face-to-face encounters.Examples of t

81、ransforming channels include AI-enabled chatbots that support patient screening prior to physician assessment,basic chat FAQ handling,and addressing procedure backlogs by separating care pathwayssuch as those related to COVID-19from business as usual.Healthcare providers(HCPs)are under significant s

82、tress due to:a hangover effect from the pandemic;significant staff shortages,particularly among nurses;inflation and supply chain disruptions;and increased demands from patients and healthcare systems.Life sciences companies should be mindful of these stressors and ensure that the products and servi

83、ces they offer lessen HCPs burden instead of adding to it.Further,since 70 percent of todays HCPs are digital natives,16 traditional sales representative and medical science liaison(MSL)support models are being used less often in favor of connected,ongoing digital interactions that can be delivered

84、on providers preferred timelines.Therapeutic breakthroughs are of little value if the healthcare system does not have the capacity to deliver them,so life sciences companies should consider whether the solutions they bring to market ease or add to the strain on healthcare systems.For example,with HC

85、Ps considering practicing precision medicine,life sciences companies would be well advised to provide support for the complex companion diagnostics and risk evaluation/mitigation strategies involved,lest delivery requirements become so great a burden that treatments never reach the patients.Similarl

86、y,digital health solutions should streamline HCP care coordination and connectivity with patients,as opposed to functioning as bottlenecks.Dont forget the fourth stakeholder:Employees The explosive growth in precision medicine,cell and gene therapy,biomanufacturing,AI,and data science is leading to

87、a huge demand for skilled workers in these areas.However,there are currently an insufficient number of potential hires to meet this demand.In AI alone,there are currently 1,5002,000 job openings across big pharma.Attracting and retaining these workers will require a laser focus on the employee value

88、 proposition,comprising a connected,digitally enabled enterprise;meaningful opportunities for training,reskilling,and advancement;commitment to environment,social,and governance(ESG);commitments to diversity,equity,and inclusion(DEI)and a strong corporate culture;and work/life balance,including the

89、appropriate mix of virtual,hybrid,and in-office work models.Life sciences companies that lose the war for talent will likely find that both innovation and growth will be hindered in the long term.Source:Brian Buntz,“What to expect from AI-enabled drug discovery in 2023,”Drug Discovery&Development,De

90、cember 13,2022.16 Source:Jan van den Burg,“Addressing the Need for Digital Engagement with Healthcare Providers,”The Journal of mHealth,January 22,2020.17 Source:Mark Gurman,“Apple Makes Major Progress on No-Prick Blood Glucose Tracking for Its Watch,”Bloomberg,February 22,2023.10 2023 Copyright own

91、ed by one or more of the KPMG International entities.KPMG International entities provide no services to clients.All rights reserved.Signals of changeFour strategic imperativesConclusionHow KPMG can helpCase study:Pharma firms physician-focused CX strategy drives ROI and organizational valueSituation

92、:A global pharmaceutical leader in pain management wanted to transition its approach to meeting the needs of its healthcare provider(HCP)clients from product-centric to customer-centric.This required a holistic understanding of the existing experience for HCPs.The KPMG team helped the client gather

93、and translate voice of customer(VoC)and voice of business(VoB)insights into the design and delivery of intentional HCP experiences.Approach:Developed a holistic view of the current HCP experience by assessing what factors constitute a great customer experience,identifying existing pain points,and pr

94、ioritizing areas of opportunity.Aligned on a CX vision,defined CX guiding principles,and leveraged current-state insights to identify strategic enablers of the future-state CX.Defined the processes to capture and operationalize customer feedback,quantify the impact of CX,embed CX excellence into the

95、 organizations operating model,and leverage the CX Playbook to pilot initiatives.Outcomes:Clearly defined CX reporting and escalation processes with initial ROI modelling to determine the impact of the CX transition.An enhanced CX governance hybrid model that embeds CX across the organization A deta

96、iled content strategy that allows for personalization based on advanced customer profiling and tagging CX Measurement Program Go-to-customer process evaluation for optimized data collection Replicable best practices for optimizing CX to drive ROI01020311 2023 Copyright owned by one or more of the KP

97、MG International entities.KPMG International entities provide no services to clients.All rights reserved.Signals of changeFour strategic imperativesConclusionHow KPMG can helpThe timeline for maximizing the return on investment for new innovative products has shrunk dramatically.Consider the followi

98、ng comparison:when Roche received FDA approval for the first personalized oncology treatment,Herceptin,in 1998,18 the company had nearly 10 years to maximize its returns on the product.It wasnt until 2010 that the second entrant in the classGSKs Tykerbwas FDA approved.19 In contrast,the March 2015 a

99、pproval of BMSs checkpoint inhibitor Opdivo for non-small-cell lung cancer20 was followed just six months later by a drug for the same indication,Mercks Keytruda.21Clearly,in todays faster moving drug development environment,life sciences companies seeking competitive advantage need to be more decis

100、ive and nimbler than their competitors from drug development through to market entry.This is especially important in areas such as oncology,as treatments target increasingly stratified patient populations based on biomarker status.This means that companies are competing for the same small patient po

101、pulations,not only from a commercial perspective,but also for recruitment into clinical trials,the latter of which requires connected technologies to make it possible to enroll participants from across the globe.To this end,pharmaceutical companies are looking to a future in which drugs will be brou

102、ght to market in a fraction of the current timeline,i.e.,under a year as opposed to the 10 or more years to which the industry is accustomed.22 Although the first AI-developed drug is still years away from approval,life sciences companies are forging partnerships with a range of AI companies,from fo

103、cused startups to Big Tech.These firms can already help pharmaceutical companies predict which existing drugs will work best in a particular patient,identify the most appropriate candidates and optimized dosing for clinical trials,23 unmask virus genomics,identify virus candidates prior to human tes

104、ting,and rapidly analyze clinical trial data to support speed to market.24 This is not to say that other advanced technologies will be completely eclipsed by AI.Robotic automation and ML models will continue to be used for applications like identifying small cellular changes so that multiple drugs c

105、an be tested simultaneously on patients with treatment-resistant diseases,like rare cancers.25 And we still do not see a future where laboratory-based science is completely eliminated.Develop AI partnerships for faster time to market 218 Source:Gina Kolata and Lawrence M.Fisher,“Drugs to Fight Breas

106、t Cancer Near Approval,”The New York Times,September 3,1998.19 Source:Press release:GSKs Tykerb receives accelerated approval for first-line combination treatment of hormone receptor positive,HER2+/ErbB2+metastatic breast cancer,GSK,January 29,2010.20 Source:Press release:March 2015 approval of BMSs

107、 checkpoint inhibitor Opdivo for non-small cell lung cancer,BMS,October 9,2015.21 Source:Press release:FDA Approves KEYTRUDA(pembrolizumab)for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1 with Disease Progression On or After Platinum-Containing Chem

108、otherapy,Merck,October 2,2015.22 Source:Kevin Dunleavy,“2023 forecast:An inflection point for biopharma,fueled by a flood of AI and machine learning products,”FiercePharma,December 21,2022.23 Source:Brian Buntz,“What to expect from AI-enabled drug discovery in 2023,”Drug Discovery&Development,Decemb

109、er 13,2022.24 Source:“Life Sciences:Thriving in an AI World”(kpmg.us)25 Source:Will Douglas Heaven,“AI is dreaming up drugs that no one has ever seen.Now weve got to see if they work,”MIT Technology Review,February 15,2023.12 2023 Copyright owned by one or more of the KPMG International entities.KPM

110、G International entities provide no services to clients.All rights reserved.Signals of changeFour strategic imperativesConclusionHow KPMG can helpFrom enabling a more connected,personalized customer experience,to supporting novel therapeutics and precision medicine,to finding ways to mitigate the ri

111、sk of disruption,there are many reasons that transforming the supply chain has moved to the top of the life sciences agenda.Rethink the supply chain 3The connected supply chain:Life sciences companies that invest in transforming their supply chains should do so with the goal of creating a dynamic,in

112、terconnected healthcare ecosystem to enable a more personalized patient experience.In the future,we envision an autonomous supply chain that self-learns,adapts,and focuses on continuously meeting the needs of value-chain customers,patients,and caregivers,while driving cost efficiencies and top-line

113、growth.Benefits may include autonomous and cognitive planning,predictive plant maintenance,automated re-stocking,and sensor-based replenishment and fulfillment to name a few examples.Data will be central to future supply chains,giving leaders a 360-degree view of their customers and other value chai

114、n participants.Advanced data analytics should enable life sciences organizations to proactively forecast demand,access insights into usage patterns,ensure business continuity by anticipating supply chain risks,address supply chain fragmentation to ensure consistency and connectivity across sites,bet

115、ter collaborate with internal and external partners,track product movement,and monitor end-to-end supply chain quality.Delivering on the promise of precision medicine:Pharmaceutical supply chain networks traditionally optimized for consistent,mass-market demand are increasingly being tasked with del

116、ivering precision medicine.This requires a shift to manufacturing low-volume,highly personalized,high-value products in a“make-to-order”versus“make-to-stock”model.To accommodate both traditional and precision models,supply chain strategies must evolve,and new capabilities must be developed and execu

117、ted at speed.Precision medicine supply chains need to create a digitally enabled operating model to manage the complexities that come with connecting to the right patients to deliver the right drug therapy at the right time and place.From planning to quality assurance to logistics,precision medicine

118、 therapeutics require not just a new set of processes,but also a new way of thinking.The very nature of precision medicine integrates the manufacturer into the care pathway and requires cross-functional connectivity and collaboration between the supply chain,commercial,and R&D organizations to align

119、 supply chain strategies around a deep understanding of patients and their health conditions.Modern technologies that foster connectivity BlockchainAIRobotic process automationCloud and edge computingThe Industrial Internet of Things(IIoT)5GDigital twinsSupply chain disruption:With todays increased

120、cyber-threats from foreign actors and complicated geopolitical landscape,data sharingbetween regulators and private industrywill be critical to creating a singular map of the entire pharmaceutical supply chain from API sources to distribution.26 These collaborative efforts should allow for more effe

121、ctive predictive analyses and proactive identification and mitigation of vulnerabilities.Transparency is a critical first step,as exemplified by New Zealands supply chain transparency model.27 The country has a publicly available database that houses information on the API sources and manufacturing

122、locations of all drugs on the market.Life sciences organizations should rethink existing operating models to improve supply chain resilience and continuity.Is there sufficient diversification to withstand disruption?Is demand data informing network planning?In general,organizations need to be more a

123、gile so they can make rapid adjustments to production levels,shift to alternate suppliers,and reroute shipments,when necessary.More specifically,it is becoming increasingly critical to re-think supplier strategies and collaboration,diversify and segment the supplier base,26 Source:Chairman Gary Pete

124、rs,“Short Supply:The Health and National Security Risks of Drug Shortages,”United States Senate Committee on Homeland Security&Governmental Affairs,March 2023.27 Source:Westpac NZ Government Innovation Fund,“Supply Chain Transparency,”February 2021.13 2023 Copyright owned by one or more of the KPMG

125、International entities.KPMG International entities provide no services to clients.All rights reserved.Signals of changeFour strategic imperativesConclusionHow KPMG can helpUnderstand the risks associated with digital and emerging technologies.While digital and emerging technologies like cloud,the In

126、dustrial Internet of Things(IIoT),AI,and ML can create marked improvements in manufacturing productivity and visibility,they introduce a new spectrum of cybersecurity risks,particularly when it comes to intellectual property and trade secrets.Further,although connecting factories to other factories

127、and to corporate information technology allow business analytics to drive actionable insights,these technological advances dramatically expose life sciences companies by exponentially increasing the attack surface.To get full value from advanced technologies,life sciences organizations should instit

128、ute more robust access-management protocols when,for example,digital supply chain data is used in the operational technology(OT)environment;engage with procurement during initial vendor discussions to identify potential risks and collaborate on appropriate adjustments;and educate the business on the

129、 value of evaluating and pressure testing products early in the technology integration process so the cyber team can institute compensating controls.Take responsibility for third-party risk.Since many life sciences suppliers are small businesses with a limited ability to invest in robust cybersecuri

130、ty programs,pharmaceutical manufacturers should ensure they conduct a thorough due diligence process before partnering with new suppliers.Third party risk management(TPRM)programs should specify the controls,systems,platforms,and security protocols approved suppliers must have in place.As pharmaceut

131、ical companies seek to wrap their arms around the spectrum of potential third-party cybersecurity risks,they should home in on priority suppliers that sell critical components,raw materials,and substrates for their products.Further,if third parties are reluctant to commit to adopting robust cybersec

132、urity protocols,then life sciences organizations should consider whether changing vendors is warranted.Manage Cyber Risks 4strengthen connections with top suppliers,institute intelligent platforms to quickly onboard new partners,and explore reshoring and onshoring.The security of the pharmaceutical

133、supply chain is receiving major attention by governments worldwide.The U.S.government is putting programs in place to foster biomanufacturing pathways that center around cost-effective domestic API production,as detailed in the recent White House publication,“Bold Goals for U.S.Biotechnology and Bio

134、manufacturing.”28“Fit for purpose”use of data/insight and advanced technologies will be crucial for operations teams as they seek to optimize the efficiency and security of the supply chain from source to end consumer across a diverse portfolio of products and platformsBy 2025,45 percent of global o

135、rganizations will be impacted by a supply chain attack.Source:Susan Moore,“7 Top Trends in Cybersecurity for 2022,”Gartner,April 13,202228 Source:The White House Office of Science and Technology Policy,“Bold Goals for U.S.Biotechnology and Biomanufacturing,”March 2023.14 2023 Copyright owned by one

136、or more of the KPMG International entities.KPMG International entities provide no services to clients.All rights reserved.Signals of changeFour strategic imperativesConclusionHow KPMG can helpConclusionFrom precision medicine to digital health to AI,the prevailing trends in the life sciences industr

137、y signal a period of astonishing connectivity and innovation that are poised to change the way patients and their providers understand,manage,and even cure chronic illnesses.Organizations that analyze where they stand on the maturity curve in relation to these trends should be well prepared to act o

138、n the imperatives that will help them shape the future of life sciences.That may mean developing tech-enabled connectivity between themselves and patients,providers,payers,and employees.Or it could entail accelerating time to market for breakthrough drugs through AI-enabled R&D,both in-person and vi

139、rtual clinical trials,and new modes of commercialization.Connected to both the above endeavors will be the need to reimagine and,in some cases,segment the supply chain so that different types of drug manufacturing can proceed on parallel paths.And,behind the scenes,life sciences cybersecurity and da

140、ta privacy efforts must remain in lockstep with the pace of innovation.This should ensure that organizations can limit the funds spent on threat remediation that would be better spent on offering patients connected customer experiences,tighter control of their conditions,and,ultimately,a much better

141、 quality of life.15 2023 Copyright owned by one or more of the KPMG International entities.KPMG International entities provide no services to clients.All rights reserved.Signals of changeFour strategic imperativesConclusionHow KPMG can helpHow KPMG can helpThe KPMG Life Sciences team has more than 4

142、,500 dedicated life sciences professionals with significant pools of experts in the largest healthcare and life sciences markets.Our team has depth in not only the business and technology,but also the science,of life sciences.Our team includes MDs and PhDs with deep experience in helping shape the f

143、uture of Precision Medicine and Digital Healthcare.We have deep practical knowledge of industry issues across payers,providers,life sciences,and intermediaries.We see the potential to improve outcomes and ensure equity and access to quality care.Passionate and purpose driven,KPMG delivers meaningful

144、 engagements to all the top 25 life sciences organizations and shares regular insights on trends,drivers,and key issues.Our ambition is to be deeply engaged with life sciences leaders as they seek to solve their most complex problems and achieve their aspirational goals.16 2023 Copyright owned by on

145、e or more of the KPMG International entities.KPMG International entities provide no services to clients.All rights reserved.Signals of changeFour strategic imperativesConclusionHow KPMG can helpKPMG member firms offer a wide spectrum of Connected Enterprise capabilities,detailed below,which can be a

146、pplied across a life sciences enterprise.These connected capabilities can allow life sciences organizations to respond to the drivers outlined in this paper and take advantage of the opportunities represented by the recommended actions.KPMG professionals can help organizations evaluate their maturit

147、y across these connected capabilities,shape their transformation agenda and plans,and deploy improvements in the capabilities across the enterprise with the aim of providing the greatest value.Insight-driven strategies and actions:We can help life sciences companies harness data and advanced analyti

148、cs to gain real-time understanding of their customers and businesses to shape integrated business decisions.Aligned and empowered workforce:The Connected Enterprises agile organizational structure allows life sciences companies to embrace change and recruit and attract the right talent at the right

149、time.Once they are part of the organization,individuals understand and are committed to the mission and understand their roles and responsibilities.Experience-centricity by design:Successful life sciences companies design consistent,effortless experiences,supporting customer value propositions to de

150、liver on key business objectives.Digitally enabled technology architecture:Intelligent and agile services,technologies,and platforms help life sciences companies meet patient needs with solutions that are secure,scalable,and cost-effective.Responsive operations and supply chain:Life sciences compani

151、es that operate their businesses and supply chains with efficiency and agility meet customers rising expectations consistently and profitably.Companies can effectively integrate front-,middle-,and back-office operations to capture competitive advantage.An integrated partner and alliance ecosystem:Th

152、e Connected Enterprise engages,integrates,and manages third parties to increase speed to market,reduce costs,mitigate risk,and close capability gaps.Our“Connected Enterprise”capabilities include:17 2023 Copyright owned by one or more of the KPMG International entities.KPMG International entities pro

153、vide no services to clients.All rights reserved.Signals of changeFour strategic imperativesConclusionHow KPMG can helpTransformation neverstops.Neither do we.At KPMG we believe that business transformation is too good an opportunity to miss.Combining the right tech and the best processes with people

154、 whose insight is as broad as it is deep,are essential ingredients to successfully transform.KPMG has worked at the heart of global businesses for many decades,helping our clients realize the full potential of their people and technology and working together to achieve real-world outcomes.Because wh

155、en people and technology are in harmony great things happen.Making a world of difference:KPMG people can make all the difference on your transformation journey.Together we can help you to orient your business around the customer,optimize functions for a new era,manage enterprise risk and regulation

156、for a safer future,rise to a new level of value creation,and create an environment for managing ongoing change.18 2023 Copyright owned by one or more of the KPMG International entities.KPMG International entities provide no services to clients.All rights reserved.Some or all of the services describe

157、d herein may not be permissible for KPMG audit clients and their affiliates or related entities.The information contained herein is of a general nature and is not intended to address the circumstances of any particular individual or entity.Although we endeavor to provide accurate and timely informat

158、ion,there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future.No one should act on such information without appropriate professional advice after a thorough examination of the particular situation.2023 Copyright ow

159、ned by one or more of the KPMG International entities.KPMG International entities provide no services to clients.All rights reserved.KPMG refers to the global organization or to one or more of the member firms of KPMG International Limited(“KPMG International”),each of which is a separate legal enti

160、ty.KPMG International Limited is a private English company limited by guarantee and does not provide services to clients.For more detail about our structure please visit home.kpmg/governance.The KPMG name and logo are trademarks used under license by the independent member firms of the KPMG global o

161、rganization.Throughout this document,“we”,“KPMG”,“us”and“our”refers to the global organization or to one or more of the member firms of KPMG International Limited(“KPMG International”),each of which is a separate legal entity.Designed by DAS Design.DASD-2022- Little Principal,Global Leader Connected

162、 Enterprise for Life Sciences Mike Ricci Managing Director,US Leader Connected Enterprise for Life Sciences Life Sciences Network contacts:Adrian Griffiths Partner,Life Sciences Leader EMEA Adrian.Griffithskpmg.co.ukLarry Raff Senior Partner,Global Head of Life Sciences,KPMG International US Peter Liddell Partner,Life Sciences Leader APAC .auSteve Sapletal Principal,Life Sciences Leader US Kristin Pothier Principal,Global and US Healthcare and Life Sciences Leader,Deal Advisory&Strategy US Colin Yu Partner,Life Sciences Leader China Alasdair Milton,Anastasia Miros,Caroline Rivett,Mary Rollman