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1、THE WORLD LEADER IN SERVING SCIENCE1Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.THE PULSE 2023Global R&D Insights in Pharmaceuticals Methodology&Profile 3Executive Summary 8Industry Trends&Challenges 16Hot Topics 24Outsourcing 28Ap

2、pendix 32THE WORLD LEADER IN SERVING SCIENCE2Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.About The PulseThe future for drug developers is defined by how effectively they adopt innovative strategies and new technologies,while naviga

3、ting industry challenges and complexities.Thats why the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders at biotech and pharmaceutical organizations around the globe to assess trends in drug discovery and development.Respondents shared the therapeutic areas in their pi

4、pelines,barriers to bringing drugs to market,innovations that are driving transformation,and attitudes toward key topics such as outsourcing,patient recruitment,diversity,decentralized trials,and more.In our second annual report,youll go beyond the data to learn what these insights mean for drug dev

5、elopers across the globe,and how you can prepare to successfully navigate the evolving drug development landscape.Discover what industry leaders are facing today,and how their outlook on pharmaceutical research and development is pushing the industry forward.Copyright 2023 by Pharmaceutical Product

6、Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.This report,including the information contained herein and commentary associated herewith(“materials”),is provided as a service of PPD.TheseMaterials,basedon publicly available information,market research conducted on behalf of

7、PPD,as well asthe knowledge and experience of PPDsemployees,have been prepared solely for informational and educational purposes and should notbe relied upon for professional advice.Anyfurther use of these Materials requires the express written consent of PPD.THE WORLD LEADER IN SERVING SCIENCE3Copy

8、right 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.3METHODOLOGY&PROFILETHE WORLD LEADER IN SERVING SCIENCE4Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.150 participants were

9、surveyed in March/April 2023The online survey was conducted on behalf of the PPD clinical research business of Thermo Fisher Scientific by Life Science Strategy Group(LSSG)using its proprietary panel of more than 70,000 life science stakeholders and biopharma/biotech industry outsourcing decision ma

10、kers and its affiliated APAC partners respondent panel.Participants were provided an honorarium for their time.Methodology&ProfileParticipants were screened to ensure they met the following criteria:Industry:Pharmaceutical,biopharmaceutical,or biotechnology companyLevel:Director level or higher with

11、 drug development decision-making responsibilityRole:Work in a role related to drug development Company:Have at least one compound in developmentGeography:Asia,Europe,US/CanadaTHE WORLD LEADER IN SERVING SCIENCE5Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scient

12、ific.All rights reserved.SegmentationRESPONDENTS WERE CLASSIFIED INTO THE FOLLOWING SEGMENTS.Statistical DifferencesThroughout the report,letters are used to indicate statistically significant differences between segments at the 90%confidence level.GeographyUS/Canada(n=65)Europe(n=48)Asia/Pacific(n=

13、37)Company SizeSmall/Mid-Sized Companies:Annual R&D spend$1 billion*(n=85)Large Companies:Annual R&D spend$1 billion*(n=65)*Ranges in China were adjusted to reflect market conditions Small/Mid=annual R&D spend Greater use of RWD/RWE Patient diversity Small/Mid-Sized Companies Top 2:Innovative trial

14、design New approaches to investment and fundingTop 5 Key Initiatives:Large CompaniesTop 5 Key Initiatives:Small/Mid-Sized CompaniesTHE WORLD LEADER IN SERVING SCIENCE11Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Top 5 Strategies fo

15、r Removing Barriers to Patient ParticipationPatient RecruitmentKEY TAKEAWAYS:+Optimism around recruiting qualified patients has increased from where it stood in 2022;in 2023,38%feel more positive about their ability to recruit patients versus just 26%who felt this way in 2022.Negativity around recru

16、iting qualified patients has dropped from 42%to 28%.+Top patient recruitment/participation strategies include establishing or improving relationships with patient advocacy groups,building inclusion criteria into protocol designs,and patient assistance resources.THE WORLD LEADER IN SERVING SCIENCE12C

17、opyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Decentralized TrialsPast,Current,and Expected Future Use of Decentralized Clinical Trial ElementsKEY TAKEAWAYS:+The prevalence of decentralized trial elements continues to grow with about

18、40%of trials currently using DCT.+DCT growth is expected to continue,and in two years over 90%of participants expect to be using DCT in at least some of their trials.THE WORLD LEADER IN SERVING SCIENCE13Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All

19、rights reserved.OutsourcingKEY TAKEAWAYS:+More participants have upped their use of FSP outsourcing(41%)than say they have increased their use of full-service outsourcing(27%).+Full-service outsourcing makes up about 40%of clinical work that is outsourced,with FSP and Hybrid models each used for abo

20、ut 25%,and the remainder(13%)going to insourcing or temporary staffing.+Patient recruitment and clinical laboratory&diagnostic services are the top drug development activities likely to be outsourced.Top 5 Activities Likely to OutsourceTHE WORLD LEADER IN SERVING SCIENCE14Copyright 2023 by Pharmaceu

21、tical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Large Small/Mid Segment:Key HighlightsCategoryLarge Company ResponsesSmall/Mid-Sized Company ResponsesLeading Therapeutic Areas Oncology Immunology/Rheumatology Metabolic/Endocrine Rare Diseases Cardiovascular Onco

22、logy Immunology/Rheumatology Rare Diseases Neurology Infectious DiseasesClinical Development Timelines Reduced timelines Increased timelinesChallenges Patient diversity FundingTransformational Trends Use of RWD Leveraging new drug development technologies(e.g.,mRNA,CRISPR,gene-editing)Innovative tri

23、al designTop Strategies Pursued Patient diversity Personalized/precision medicine Genetherapy Innovative trial design Creative approaches to funding/investmentPatient Recruitment More optimistic about recruiting qualified patients vs.2 years ago Less success in affecting patient diversity vs.2 years

24、 ago More likely to utilize patient advocacy groups and patient education to increase diverse enrollment Less optimistic about recruiting qualified patients No change in ability to affect patient diversity vs.2 years ago Using inclusion criteria in protocol designs and patient assistance resources t

25、o increase diversityOutsourcing Increasing FSP use,decreasing full-service use Increasing FSP use,maintaining full-service useTHE WORLD LEADER IN SERVING SCIENCE15Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Geographic Regions:Notab

26、le Differences*Meaningful,statistically significant differences between regions at the 90%confidence level.CategoryUS/CanadaEuropeAsiaLeading Therapeutic Areas(Drug development in TAs higher than other regions)Infectious diseases HepatologyClinical Development Timelines Increased timelines Increased

27、 timelines Reduced timelinesChallenges Increased trial complexity Talent/staff shortages Increased trial complexity Keeping up with technology innovationTransformational Trends Innovative trial design Greater use of RWD/E Innovative trial design Personalized/precision medicineTop Strategies Pursued

28、Innovative trial design Innovative trial design Personalized/precision medicinePatient Recruitment More say it is too soon to see impact from patient diversity efforts compared to Asia More say it is too soon to see impact from patient diversity efforts compared to Asia Lags other regions in DCT use

29、 More optimistic about recruiting qualified patients More say their ability to affect patient diversity has worsened over last 2 yearsOutsourcing Prefer full-service and hybrid More likely to outsource lab/diagnostic services compared to Asia Prefer full-service More likely to outsource lab/diagnost

30、ic services compared to Asia Prefer and most often use FSP More likely to outsource for post-approval support,product registrationTHE WORLD LEADER IN SERVING SCIENCE16Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.1616DETAILED FINDING

31、S:INDUSTRY TRENDS&CHALLENGES+Leading therapeutic areas for drug development+Clinical trial timelines+Challenges+Transformational trends+Strategies pursuedTHE WORLD LEADER IN SERVING SCIENCE17Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reser

32、ved.Therapeutic AreasOncology significantly outpaces all other therapeutic areas for drug development,particularly among large companies.+Immunology/Rheumatology and Rare Diseases are the next most common development areas.+In addition to Oncology,large companies are also more likely than small/mid-

33、sized companies to be developing therapeutics for Metabolic/Endocrine,Cardiovascular,and Dermatology.Leading Therapeutic Areas for Drug Development(TAs selected by 10%or more*)YOY Top 10 TAs in 2023 are the same as in 2022.REGIONAL NOTES Infectious Disease drug development is highest in US/Canada.As

34、ia outpaces other regions for Hepatology.Letters indicate statistically significant difference between groups at the 90%confidence level.Base:All respondents,n=150;Large:n=65,Small/Mid:n=85Q2.Which therapeutic areas are leading your organizations drug development pipeline today?Please choose up to 5

35、.THE WORLD LEADER IN SERVING SCIENCE18Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Clinical Development Timeline Total MarketAcross the industry,somewhat more participants indicate that clinical development timelines are extending.+

36、For those whose timelines have increased,most say they have lengthened by less than a year,but 2 out of 5 indicate their timelines have stretched out by more than 12 months.+Those who have experienced shorter development timelines say the reduction has primarily been in the range of 1 to 11 months.C

37、hange in Timeline to Produce a Drug Compared to 2 Years Ago(from first-in-human trials through regulatory submission)YOY The lengthening timeline trend may have plateaued;only 41%say timelines are longer vs.52%in 2022.Base:All respondents excluding“dont know,”n=140Q6.Compared to two years ago,how ha

38、s the average timeline to produce a drug(from first-in-human trials through regulatory submission)changed at your organization?THE WORLD LEADER IN SERVING SCIENCE19Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Clinical Development Ti

39、meline by Company SizeChange in Timeline to Produce a Drug Compared to 2 Years Ago(from first-in-human trials through regulatory submission)Letters indicate statistically significant difference between groups at the 90%confidence level.Base:All respondents excluding“dont know,”Large:n=62;Small/Mid:n

40、=78Q6.Compared to two years ago,how has the average timeline to produce a drug(from first-in-human trials through regulatory submission)changed at your organization?The longer clinical development timelines for the industry are driven by small/mid-sized companies.+Half of participants from small/mid

41、-sized companies indicate their timelines are longer than they were two years ago;however,the situation is nearly reversed in the large company segment,where almost 50%say timelines are shorter.THE WORLD LEADER IN SERVING SCIENCE20Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of T

42、hermo Fisher Scientific.All rights reserved.Clinical Development Timeline by RegionLetters indicate statistically significant difference between groups at the 90%confidence level.Base:All respondents excluding“dont know,”US/Canada n=62;Europe n=41;Asia n=37Q6.Compared to two years ago,how has the av

43、erage timeline to produce a drug(from first-in-human trials through regulatory submission)changed at your organization?Participants in US/Canada and Europe report their trial timelines have tended to lengthen over the last two years,while the majority in Asia have seen theirs shorten.Change in Timel

44、ine to Produce a Drug Compared to 2 Years Ago(from first-in-human trials through regulatory submission)THE WORLD LEADER IN SERVING SCIENCE21Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Biggest ChallengesLetters indicate statisticall

45、y significant difference between groups at the 90%confidence level.Base:All respondents,n=150;Large:n=65,Small/Mid:n=85Q3.What are the biggest challenges your organization is currently facing?Please select your top 5 biggest challenges.Q3b.Listed below are the top challenges you indicated your organ

46、ization is facing.Please rank these top challenges your organization is facing,with Rank#1=Biggest challenge.As in 2022,patient recruitment and trial complexity continue to be the largest organizational hurdles.+A notable proportion are also quite concerned with maximizing ROI.+Respondents at small/

47、mid-sized companies are especially challenged by a lack of funding and talent,while addressing patient diversity and keeping up with technology are of more concern for those at large companies.YOY Supply chain disruptions(17%)are less problematic in 2023,down from 32%in 2022.REGIONAL NOTES Talent/st

48、aff shortages are a bigger challenge in US/Canada than elsewhere.Keeping up with technology&innovation is the biggest challenge in Asia.Pharmaceutical Companies Biggest Challenges(Challenges selected by 25%or more*)*See appendix for additional demographic detailTHE WORLD LEADER IN SERVING SCIENCE22C

49、opyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Top Transformational TrendsSee appendix for full trend descriptions provided in the survey.2023 wording:“Innovative trial design(e.g.,adaptive,synthetic arms,umbrella,etc.)”2022 wording:“A

50、daptive trial design”the broader context provided in 2023 may have led to the jump from 2022.Letters indicate statistically significant difference between groups at the 90%confidence level.Base:All respondents,n=150;Large:n=65,Small/Mid:n=85Q4.What are the top five trends that are driving transforma

51、tion in clinical trials?Please select your top 5 trends.Q4b.Listed below are the top trends you indicated are driving transformation in clinical trials.Please rank these top trends that are driving transformation in clinical trials,with Rank#1=Most impactful trend.While innovation in trial design to

52、ps the list of clinical development trends(especially among small/mid-sized companies),there is little consensus within the industry about which trends are most impactful.YOY Strengthening in 2023:Innovative trial design Artificial intelligenceSoftening in 2023:New technologies in drug developmentRE

53、GIONAL NOTES US/Canada&Europe:Innovative trial design is#1.Asia:Personalized/precision medicine is#1.US/Canada more apt to name RWD as a top trend than other regions.Trends Driving Transformation in Clinical Trials (Trends selected by 30%or more*)*See appendix for additional demographic detailTHE WO

54、RLD LEADER IN SERVING SCIENCE23Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Key InitiativesSee appendix for full trend descriptions provided in the survey.Letters indicate statistically significant difference between groups at the 9

55、0%confidence level.Base:All respondents,n=150;Large:n=65,Small/Mid:n=85Q5.Which specific innovations,strategies,and/or technologies are your organization currently pursuing?Please select all that apply.Reflecting the dispersion of opinions about leading transformational trends,a wide variety of stra

56、tegies,technologies and innovations are in use across the industry chief among them overall are innovative trial design,RWD/RWE,patient-centricity,and big data.+Many in large companies are also focusing on patient diversity,personalized medicine,cell and gene therapy,decentralization,and digitalizat

57、ion.+Given that respondents from small/mid-sized companies cite lack of funding as a top challenge,it is not surprising that implementing new investment and funding approaches is a key strategy for them,second only to innovative trial design.+As with innovative trial design this year,adaptive trial

58、design was the top strategy pursued in 2022.YOY Digitalization has slipped down the list compared to other strategies/technologies.REGIONAL NOTES Participants in Asia are significantly less likely to be pursing innovative trial design than those in US/Canada or Europe.Innovations,Strategies,and Tech

59、nologies Employed by Pharmaceutical Companies(Pursuits selected by 40%or more*)*See appendix for additional demographic detailTHE WORLD LEADER IN SERVING SCIENCE24Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.DETAILED FINDINGS:HOT TO

60、PICS24+Patient recruitment+Patient diversity strategies+DecentralizationTHE WORLD LEADER IN SERVING SCIENCE25Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Patient Recruitment+Almost all participants are tracking patient diversity,and

61、 there is more positivity than negativity about progress being made in this area among those who have been monitoring long enough to see results,but for about 1 in 5 it is still too early to tell.Large companies have a higher proportion than small/mid-sized companies who say their ability to affect

62、patient diversity has worsened over the last two years.In total,compared to how they felt two years ago,participants are slightly more optimistic than pessimistic about their ability to recruit qualified patients however,this is driven by those at large firms;for those in small/mid-sized companies,i

63、t is roughly an even split.Ability to Recruit Qualified Patients Compared to 2 Years AgoAbility to Affect Diverse Patient Enrollment Compared to 2 Years AgoLetters indicate statistically significant difference between groups at the 90%confidence level.Base:All respondents,n=150;Large:n=65,Small/Mid:

64、n=85Q17.How would you describe your ability to recruit qualified patients for your studies compared to two years ago?Q18.What type of change,if any,has your organization seen in its ability to affect diverse patient enrollment into your studies compared to two years ago?(Excludes dont know;Total:n=1

65、43;Large n=62;Small/Mid:n=81)YOY Optimism is up from 2022 when only 26%indicated they were more optimistic.REGIONAL NOTES Optimism about patient recruitment in Asia exceeds levels in US/Canada&Europe,but they believe their ability to impact patient diversity has worsened.THE WORLD LEADER IN SERVING

66、SCIENCE26Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Patient Participation StrategiesMultiple strategies are used to enhance patient participation and meet diversity goals.+Large Companies:Building relationships with patient advoca

67、cy groups is the leading strategy,followed by remote monitoring and patient education.+Small/Mid-Sized Companies:Protocol designs that incorporate inclusion criteria and patient assistance resources are the top two strategies,perhaps because they are less resource-intensive than other strategies.Top

68、 Strategies Used by Sponsors to Remove Barriers to Patient Participation and Meet Diversity Targets(Strategies selected by 40%or more*)Letters indicate statistically significant difference between groups at the 90%confidence level.Base:All respondents,n=150;Large:n=65,Small/Mid:n=85Q19.What strategi

69、es to remove barriers to patient participation in clinical trials is your organization currently employing to meet diversity targets?(Select all that apply.)THE WORLD LEADER IN SERVING SCIENCE27Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights re

70、served.Decentralized Trial ElementsParticipants indicate they have increased their use of decentralized clinical trial(DCT)elements from a year ago,and this trend is expected to continue,with about half of clinical trials estimated to be using DCT in 2025.+The proportion of those using DCT in more t

71、han 50%of their trials is similar among large and small/mid-sized companies.Past,Current,and Expected Future Use of Decentralized Clinical Trial ElementsAverage%of Clinical Trials Conducted with DCT ElementsProportion of Clinical Trials Conducted with DCT ElementsLetters indicate statistically signi

72、ficant difference between groups at the 90%confidence level.Base:All respondents,excluding“NA/Dont know,”n=138,138,141;Large:n=64,64,64,Small/Mid:n=74,74,77Q7.One year ago,what percentage of your companys clinical trials would you estimate were conducted with decentralized elements?Q8.What percentag

73、e of your companys current clinical trials would you estimate are being conducted with decentralized elements?Q9.Finally,what percentage of your companys clinical trials would you estimate will be conducted using decentralized elements in two years(2025)?YOY Participants are more bullish about DCT t

74、han they were in 2022,when they predicted that 36%of trials would be using DCT in two years(2024).REGIONAL NOTES DCT usage is growing in all regions,but its adoption in Europe significantly lags other regions.THE WORLD LEADER IN SERVING SCIENCE28Copyright 2023 by Pharmaceutical Product Development(“

75、PPD”),part of Thermo Fisher Scientific.All rights reserved.DETAILED FINDINGS:OUTSOURCING28+Outsourcing model:usage and trends+Drug development activities likely to outsourceTHE WORLD LEADER IN SERVING SCIENCE29Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientif

76、ic.All rights reserved.Outsourcing ModelsThe full-service model is used for the greatest share of current clinical development work,and it is most preferred.+FSP and Hybrid models also account for a substantial share of clinical development work and are preferred by many.Outsourcing Models:Share of

77、Current Clinical Development WorkMost Preferred Outsourcing Modelfor Clinical DevelopmentLetters indicate statistically significant difference between groups at the 90%confidence level.Base:All respondents,n=150;Large:n=65,Small/Mid:n=85 Q12.For the areas in your company with which you are familiar,

78、what percent of current clinical development work that is outsourced is accomplished via the following outsourcing models?(question modified in 2023)Q13.Which outsourcing model for clinical development work do you most prefer?YOY The general pattern of outsourcing model usage in 2023 is consistent w

79、ith 2022.REGIONAL NOTES US/Canada&Europe:Full-service is the most common model.Asia:FSP is most common and most preferred model.THE WORLD LEADER IN SERVING SCIENCE30Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Outsourcing TrendsFSP

80、outsourcing is growing faster than full-service outsourcing,and this is the case across the industry,regardless of company size.Change in Use of Full-Service and FSP Models Compared to 2 Years AgoLetters indicate statistically significant difference between groups at the 90%confidence level.Base:All

81、 respondents,n=150;Large:n=65,Small/Mid:n=85Q14.Over the past two years,how has your company changed its full-service clinical trial outsourcing behavior?Q15.Over the past two years,how has your company changed its functional service provider(FSP)outsourcing behavior?REGIONAL NOTES FSP outsourcing i

82、s increasing faster than full-service outsourcing in all regions surveyed.THE WORLD LEADER IN SERVING SCIENCE31Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Outsourcing of Drug Development ActivitiesOutsourcing is expected to encompa

83、ss a wide variety of drug development activities in the next two years;at the top across both large and small/mid-sized segments are patient recruitment,clinical lab and diagnostic services,and clinical trial management.+Not surprisingly,those in small/mid-sized companies expect to use outsourcing m

84、ore extensively than their large company counterparts,particularly for RWD,biostatistical analysis,post-approval support,data management,and safety analysis.Likelihood to Outsource Drug Development Activities in the Next 2 YearsLetters indicate statistically significant difference between groups at

85、the 90%confidence level.Base:Excludes“NA/dont know,”varies by activity statement.All respondents:n=143-150;Large:n=62-65,Small/Mid:n=79-85Q16.Using the scale provided,please indicate how likely your company is to outsource each of the below drug development activities in the next 2 years.5-point sca

86、le:Not at all likely to Extremely likely.(question modified in 2023)YOY Increase in 2023:Post-approval support Study designDecrease in 2023:Data managementREGIONAL NOTES Asia is less likely to outsource clinical lab&diagnostic services,but more apt to use it for product registration and post-approva

87、l support.THE WORLD LEADER IN SERVING SCIENCE32Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.APPENDIX32THE WORLD LEADER IN SERVING SCIENCE33Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.

88、All rights reserved.Survey participant screening criteria+Currently work for:Biopharmaceutical,biotechnology or pharmaceutical company+Geography:Asia Australia Europe Middle East/India US/Canada+Drug development phases:Decision-making responsibility in at least one of the following:Drug discovery Pr

89、eclinical Phase I Phase II Phase III Phase IV+Pipeline:Company has at least one(1)unique molecule/compound in development pipeline+Job level:Director or higher+Decision Maker:Highly or somewhat involved in outsourcing services to vendors/CROs(e.g.,deciding to keep activities in-house vs.outsource,ve

90、ndor selection,vendor management,etc.)in support of clinical trials+Primary functional area:Pre-trial/preclinical development(preclinical/toxicology,translational medicine)Clinical development(clinical development,clinical operations,clinical data management,clinical research,feasibility,patient rec

91、ruitment,biostatistics/statistical programming,safety/pharmacovigilance(PV),other R&D)Peri-/post-approval/registries/HEOR(medical affairs,market access,HEOR)Quality and regulatory(regulatory affairs,quality assurance/control(QA/QC)and compliance)Business services(alliance management/partnering,finan

92、ce,procurement/vendor management,purchasing)Executive management/C-level Commercial/Marketing+Compensation:Participants were compensated according to their agreement to participate in the Life Science Strategy Group(LSSG)panel.THE WORLD LEADER IN SERVING SCIENCE34Copyright 2023 by Pharmaceutical Pro

93、duct Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Participant Demographics(1 of 3)Company Size*Ranges in China were adjusted to reflect market conditions.to USD Conversion at time of data collection:Under 350M=Under$50M,350M to 700M=$50M to$100M,700M to 3.5B=$100M to$500M,

94、Over 3.5B=Over$500MLetters indicate statistically significant difference between groups at the 90%confidence level.S10.Which of the below ranges most closely represents your companys annual R&D spend?S9.What is the size of the organization you work for in terms of employees?Your best estimate is fin

95、e.S8.How many unique molecules/compounds are in your companys development pipeline?THE WORLD LEADER IN SERVING SCIENCE35Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Participant Demographics(2 of 3)Location/Job Level/Primary Function

96、Letters indicate statistically significant difference between groups at the 90%confidence level.S3.In which of the below regions is your company headquarters located?S2.In which of the below regions is your office located?S4.What is your job level?S5.Which of the following best describes your curren

97、t,primary functional area?THE WORLD LEADER IN SERVING SCIENCE36Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Participant Demographics(3 of 3)Drug DevelopmentLetters indicate statistically significant difference between groups at the

98、90%confidence level.Q1.In which categories is your organization/company developing or commercializing products?Please select all that apply.S6.In which development phase(s)do you have decision-making responsibility?Please select all that apply.S7.Over the past 2 years,what is your level of involveme

99、nt with outsourcing services to vendors/CROs(e.g.,deciding to keep activities in-house vs.outsource,vendor selection,vendor management,etc.)in support of your clinical trials?THE WORLD LEADER IN SERVING SCIENCE37Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scient

100、ific.All rights reserved.Transformational Trends+Accelerated development/approvals in rare/orphan disease+Artificial intelligence(e.g.,to enable recruitment,advanced analytics,RWD)+Big data and analytics(data science)+Data collection through wearables/connected health devices+Digital and decentraliz

101、ed trials+Digitalization(e.g.,cloud computing,APIs,digital platforms)+Expansion of development to emerging markets(e.g.,China,Latin America)+Greater use of RWD/RWE to complement data from clinical trials+Increasing focus on patient diversity+Innovative trial design(e.g.,adaptive,synthetic arms,umbre

102、lla,etc.)+Leveraging new technologies in drug development(e.g.,mRNA,CRISPR,gene-editing technologies)+Patient-centricity(e.g.,patient participation in protocol design,partnering with patient advocacy groups,etc.)+Personalized/precision medicine(e.g.,companion diagnostics)+Reducing research site burd

103、en+Risk Based Quality Management(RBQM)programs with technologies that address surveillance,identification and reportingQ4.What are the top five trends that are driving transformation in clinical trials?Please select your top 5 trends.Q4b.Listed below are the top trends you indicated are driving tran

104、sformation in clinical trials.Please rank these top trends that are driving transformation in clinical trials,with Rank#1=Most impactful trend.FULL DESCRIPTIONS PROVIDED IN THE SURVEYTHE WORLD LEADER IN SERVING SCIENCE38Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fishe

105、r Scientific.All rights reserved.Innovations,Strategies&Techniques+Artificial intelligence(e.g.,to enable recruitment,advanced analytics,RWD)+Big data and analytics(data science)+Cell and gene therapy+Data collection through wearables/connected health devices+Decentralized,digital and remote trials+

106、Digitalization(e.g.,cloud computing,APIs,digital platforms)+Greater use of RWD/RWE+Innovative trial design(e.g.,adaptive,synthetic arms,umbrella,etc.)+New approaches to investment and funding+Patient diversity+Patient-centricity+Personalized/precision medicine(e.g.,companion diagnostics)FULL DESCRIP

107、TIONS PROVIDED IN THE SURVEYQ5.Which specific innovations,strategies,and/or technologies are your organization currently pursuing?Please select all that apply.THE WORLD LEADER IN SERVING SCIENCE39Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights

108、reserved.Leading Therapeutic Areas for Drug DevelopmentLetters indicate statistically significant difference between groups at the 90%confidence level.Q2.Which therapeutic areas are leading your organizations drug development pipeline today?Please choose up to 5.THE WORLD LEADER IN SERVING SCIENCE40

109、Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Biggest ChallengesLetters indicate statistically significant difference between groups at the 90%confidence level.Q3.What are the biggest challenges your organization is currently facing?

110、Please select your top 5 biggest challenges.Q3b.Listed below are the top challenges you indicated your organization is facing.Please rank these top challenges your organization is facing,with Rank#1=Biggest challenge.THE WORLD LEADER IN SERVING SCIENCE41Copyright 2023 by Pharmaceutical Product Devel

111、opment(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Transformational TrendsLetters indicate statistically significant difference between groups at the 90%confidence level.Q4.What are the top five trends that are driving transformation in clinical trials?Please select your top 5 trends

112、.Q4b.Listed below are the top trends you indicated are driving transformation in clinical trials.Please rank these top trends that are driving transformation in clinical trials,with Rank#1=Most impactful trend.THE WORLD LEADER IN SERVING SCIENCE42Copyright 2023 by Pharmaceutical Product Development(

113、“PPD”),part of Thermo Fisher Scientific.All rights reserved.Innovations,Strategies&Techniques Currently PursuingLetters indicate statistically significant difference between groups at the 90%confidence level.Q5.Which specific innovations,strategies,and/or technologies are your organization currently

114、 pursuing?Please select all that apply.THE WORLD LEADER IN SERVING SCIENCE43Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Patient Participation StrategiesLetters indicate statistically significant difference between groups at the 90%

115、confidence level.Q19.What strategies to remove barriers to patient participation in clinical trials is your organization currently employing to meet diversity targets?Copyright 2023 by Pharmaceutical Product Development(“PPD”),part of Thermo Fisher Scientific.All rights reserved.Go deeper at ahead of the curve with our experts takes on how these insights will influence the future of the drug development industry.