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PCMG 2018 – 50 SHADES OF OUTSOURCING
PCMG Annual Conference 201850 SHADES OF OUTSOURCING
PCMG 2018 – 50 SHADES OF OUTSOURCING
A huge thank you to all our sponsors
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PCMG 2018 – 50 SHADES OF OUTSOURCING
Please note:
To avoid breaching any competition legislation, participantsare reminded not to engage in any discussion which couldbe considered potentially anti-competitive. These include(but are not limited to) information regarding pricing,market shares, terms of sales, investment plans, individualterms of business or any other action which may restrictcompetition. Participants are also reminded to adhere totheir company polices and should inform the organisersabout any discussion which could breach their policies orthe competition legislation.
www.pcmg.org.uk 3
PCMG 2018 – 50 SHADES OF OUTSOURCINGwww.pcmg.org.uk 4
Please turn yourmobile phone to silent
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PCMG 2018 – 50 SHADES OF OUTSOURCING
Richard Scaife, PCMG ChairGill Roberts, PCMG Vice-Chair
THE PCMG YEAR: A reflection…
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PCMG 2018 – 50 SHADES OF OUTSOURCING
Let’s get INTERACTIVE!
The Greyest Shade of Outsourcing isunderstanding:
1. GDPR Changes?
2. Balanced Scorecards
3. How RFIs are used?
4. Where new CRO names come from?
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PCMG 2018 – 50 SHADES OF OUTSOURCING
PCMG MilestonesWhat did we achieve in the last 12 months?•Mission Statement•Workshops•Webinars•Training course accreditation•Membership high•Q&A examples•Website
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PCMG 2018 – 50 SHADES OF OUTSOURCING
PCMG Mission Statement Updated
•Unique
•Member-led
•Peer-2-Peer
•The ‘P’ word
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PCMG MilestonesWorkshops
October 2017: Outsourcing, Operations andOversight
February 2018: Operationalising Mergersand Acquisitions
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PCMG MilestonesM&A Sensitivity uncovered?What happened in February & Why is it soimportant to PCMG’s existence?
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Challenge of increased corporate compliance, confidentially andreluctance to share potential strategic business plans
Created opportunity for members to have open dialogue of‘real’ issues and brainstorm solutions
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PCMG MilestonesTraining Accreditation – the way forwardApril 2018 – First fully accredited OutsourcingInduction Course:• Competency-based training• Numbers proved the valueNext steps• Oct 2018 course• Advanced course in the planning for late 2019
An industry need
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PCMG 2018 – 50 SHADES OF OUTSOURCING
PCMG MilestonesMembership NumbersCorporate – updates to the corporatemembership implemented 2017Associate Membership cont. - to attract smallBiotechs and members from other regions withlimited access to workshops and conference (USand Asia)Current membership numbers are at an all timehigh
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PCMG Milestones
New PCMG Website:
•Where are we up to:•Site mapping completed; PCMG Committeereview;content currently being uploaded;
•Next steps:•UAT and launch. Planned for later this year!
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The Outsourcing Environment:Trends and Influences
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ARE WE MISSING SOMETHING?
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2018 Pharma Profitability: MixedPicture
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www.axios.com Q1 2018 vs Q1 2017
-1%
14%
22%
-53%-38%
-82%
63%
12%
-6%
-43%
-100.00% -80.00% -60.00% -40.00% -20.00% 0.00% 20.00% 40.00% 60.00% 80.00%
JOHNSON & JOHNSON
PFIZER
NOVARTIS
MERCK
GLAXOSMITHKLINE
SANOFI
ABBVIE
ELI LILLY
AMGEN
BRISTOL-MYERS SQUIBB
GILEAD SCIENCES
Q1 Profit % Change
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Politics Matter – US Tax ReformUS Pharma consolidates while EU fragments?
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Winners (Projected % DECREASE in tax)
• GSK 1.2%• Sanofi 1.5%• Gilead 1.5-3.5• Roche 3-6.6%• Lilly 2.5%• Pfizer 3%• Amgen 3-4%• Regeneron 8-12%• Abvie 9.9%
Losers (Projected % INCREASE in tax)
• Allergan 1.4%• Teva 1.7-3.7%• Novartis 1.9%• AZ 2-6%
Vs. 20% in 2017 = $2.5b US
infrastructure investment?
FiercePharma 14 Feb 2018
PCMG 2018 – 50 SHADES OF OUTSOURCING
Smartening up or Dumbing Down?
•Dec 2016: 21st Century Cures Act?• $8.4b from 25m barrels of oil reserve• Use of summaries and observational data• Removal of consent - ‘non interventional’ (IRB
unchanged)• Stimulating RWE investment into development?
• Is the ‘Right to Try’ Act a risk to development?• ‘Price Gouging’ risks broader intervention
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Pharma Top 10 (2017 revenue / growth)
1. Pfizer 52.54b
2. Roche 44.36b (12.3%)
3. Sanofi $36.66b (4.2%)
4. J&J $36.3b (8.3%)
5. MSD $35.4b
6. Novartis $33b (1.35%)
7. Abbvie $28.2b (10.4%)
8. Gilead $25.6b (-14%)
9. GSK $24b (7%)
10. Amgen $22.8b
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Pharma Top 10 (2017 revenue / growth)
1. Pfizer 52.54b
2. Roche 44.36b (12.3%)
3. Sanofi $36.66b (4.2%)
4. J&J $36.3b (8.3%)
5. MSD $35.4b
6. Novartis $33b (1.35%)
7. Takeda (+shire) $31.2b
8. Abbvie $28.2b (10.4%)
9. Gilead $25.6b (-14%)
10. GSK $24b (7%)
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Mergers Inevitable?..... BMS?
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The $$$ Pharma Acquisition ‘Fail trail’
• May Lilly + ARMO Biot. 41.6b• May J&J + BeneVir Biot. $1.1b• Feb Roche Flatiron Oncology
RWE $1.9b• Feb BMS Nektar co-dev $1.8b
up-front Opdivo• Feb Merck & Co.>Viralytics
£0.4b• Jan Sanofi > Bioverativ $11.6b
• Pfizer garage sale afterR&B/GSK go home
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‘Killer’ Acquisitions threat to Biotech?London Business School and Yale School of Mgt.
• Overlapping acquisitions
• Protection of market
• ‘Conservative estimates indicate 7% insample of 60,000 projects affected’
• ‘5% reduction in drug continuation
• Synacthen (Questor/Malincrodt $100msettlement Jan 2017)
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http://faculty.som.yale.edu/songma/files/cem_killeracquisitions.pdf?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosprorata&stream=top
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A (relatively) quiet CRO year?
• May - Eurofins Astellas alliance
• May - WuXi AppTec $353m IPO
• Mar - Accellovance + Linical
• Mar – WCT+ Continuum RWE
• Feb – CRL + MPI $800m (x2 5yrs?)
• Dec - CTI+Eurotrials
• Dec - ERT + iCardiac
• Nov - Bracket mProve Health BYOD?
• Nov – Bioclinica (PE) + MDDXimaging
• Sept - ERT + Biomedical systems
• Aug - Evotec Aptuit $300m
• Aug – PRA + Symphony $530mData/Analytics
• July - ICON + Mapi Clin Outcomes
• July - Eurofins+India Preclin $650m
• July – Labcorp + Chlltern $12.1b
• Jun – PXL PE buyout $5b
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Is choice of CRO shrinking?
•Polarisation to continue?
• IQVIA, SYNEOS, Covance… PPD? ICON? PXL?
•Consolidation of Tech e.g. ERT, Medidata, Bioclinica
•Do CRO alliances work?• ‘Align Clinical CRO’ open tech standards.
(ICON, Medpace, PPD, PRA, Syneos, UBC)
•Small/Niche CROs consolidation to survive?
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Smarter not bigger?
• Aetion $50m funding for RWE• Pfizer joins CROs in TriNetX real-time data access deal• Apple launch health records consolidation• M-T & Hitachi AI enabled trial planning• Novartis + Science 37 ‘virtual trials’• Tufts eClinical landscape study
• 87% Db STILL after FPV• Protocol redesign• Late system changes?
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Backup to The Future?AI – More artificial than intelligent?
• It can’t always explain its decisions
• Bias can be built into programs?
• Patient isolation with AI vs humans?
• Control of data privacy and security?
• Supervision… or surveillance.
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Nuffield Council on Bioethics
Remember ‘Theranos’, anyone?
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THE PCMGYEAR
Presentation close
27www.pcmg.org.uk
• Politics impact on insourcing
• Biotech funding & smaller,specialised CRO
• Big CROs are acquiring studydesign and execution tools toimprove outcomes
• Tech will have an impact –eventually
• Consolidation bigger & better???
Summary Points
PCMG 2018 – 50 SHADES OF OUTSOURCING
Dan O’Connor, OncoSec Medical
The Biotech journey from start-upto exit: the importance of outsourcing
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Targeting the Tumor Locally™May 2018 | NASDAQ:ONCS
Converting immunologically “cold” tumors toimmunologically “hot” tumors through the
intratumoral administration of interleukin-12(IL-12)
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THE ONCOSEC OPPROTUNITY IS MASSIVE60-90% of Patients Have No Anti-PD-1 Response
Checkpoint inhibitors dramatically increase survival inpatients with HOT tumors but is largely ineffective in
COLD tumors
1 ASCO 2017, KEYNOTE-086 Study; 2 Awad and Hammerman, JCO 2015; 3 Ferris
et al., N Engl J Med. 2016; 4 Seiwert et al., Lancet Oncl. 2016; 5 Rosenburg et
al., Lancet 2016; 6 Muro et al., Lancet Oncl. 2016
ImmunoPulse® IL-12
Tumor Type % Non-Responders
Melanoma ~60-80%
Triple Negative Breast ~95%1
Renal Cell Carcinoma ~71%2
Lung Carcinoma ~79-83%2
Head and Neck ~68-86%3,4
Bladder ~85%5
Gastric ~80%6
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The Three D’s
• Dollars
• Data
• Dynamics
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Dollars
• Where does the money a biotech raises go?
• Approximately 75% of dollars raised by abiotech company are spent with the CRO
• Why? Data!
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Data
• When you’re a pre-revenue biotech company,data is how you raise money, do deals, etc.
• Data is the life blood of a biotech company
• Without data, you’re toast!
• CRO’s generate the data
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• What constitutes your success in service business?
• Attracting, securing and retaining business
– Full backlog reports equals more revenues equal more profit
• How is this done? What do clients need? Want?
• Regardless of what they tell you and how they behave, first and foremost,sponsors are looking for their CROs to be their partners
• Think about the times you have had a good partner
– What did that look like? Feel like?
– Did you want to work with that partner again?
Partners
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Dynamics
• People don’t remember what you said or did,only how you made them feel
• When deciding to hire / rehire a CRO, people willcite facts, proposals and numbers, but ultimatelythey will decide on feelings
• Feeling that we are partners … not just anotherclient
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What Makes a Good Partner
• They prioritize communication
• They are straightforward and/or uncomplicated
• They are reasonable
• They are optimistic
• They take responsibility for themselves
• They are generous with their time and/or resources
• They are dependable
• They are supportive
• They put consistent effort into the relationship / partnership
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• People don’t care how much you know, unless they know how much you care
• You have to mentally decide that you are going to actually care
• Do you want the project to win badly?
• Are you up at night thinking about it?
• Are you thinking about ways to help optimize the chances for success
– What is going sideways in the project
• Don’t just identify problems – identify solutions
• You care about their needs
• Ask them what they need
• Observe their behaviors as signs of what they need
• Be knowledgeable, you have studied their business and know what drives it
Examples
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• Understand the science deeply
• Give them info on related to their science and competition
• Understand their business
– Pre-revenue companies fund their business by selling their stock or selling licenses
– Data is the lifeblood
• Communication effectively 5WH
• Never surprise
• Offer to make intros
• Invite them to speak at events
• Increase their network
• ALWAYS make them look smart to their boss, in control and delivering results
Examples
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• Understand the science deeply
• Give them info on related to their science and competition
• Understand their business
– Pre-revenue companies fund their business by selling their stock or selling licenses
– Data is the life blood
• Communication effectively 5WH
• Never surprise
• Offer to make intros
• Invite them to speak at events
• Increase their network
• ALWAYS make them look smart to their boss, in control and delivering results
Examples
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• What you respect will come to you, what you don’trespect will leave you
Final Thought
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Thank YouContact
855.662.6732
oncosec.com
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Heather DiBenedetto,Moderna Therapeutics
Strategic outsourcing applied in asmall Biotech
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A New Frontier:Outsourcing with Platform-based Biotechnology
PCMG Annual Conference,Valetta MaltaJune 6-8, 2018Heather DiBenedetto, Head of Therapeutic OperationsModerna Therapeutics
Copyright © 2018 Moderna
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Discussion Points
• Emerging Biotechnology & Their Unique Needs
• Platform based companies
• Introduction to Moderna
• How does this differ with a platform based company?
• Partnering Case Study
Copyright © 2018 Moderna
Sources say as much as 75% of current drug developmentwork comes from emerging biotechnology companies
____________________________________________
Between the 2 big US bio hubs (San Francisco & Boston)-thereare ~350 biotechnology companies1
How important is Biotech?
1 www.thebalance.com; Biotech Industry, August 14, 2017
Copyright © 2018 Moderna
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In Boston Area alone there are >1800 potential newcompounds in clinical trials or development1
In 2016, more than $3.5 billion went in funding tobiotechnology companies2
What is the impact of current Biotech work?
1 MassBiotechnology 2017 Industry Snapshot2 PwC Biotech Deal Values
Copyright © 2018 Moderna
CRO Solutions to Working with Biotech
Large CRO
Stand alonedivisions within
Large CROfocused on
biotech
Acquiresmall niche
CRO asstandalone
division
CRO with focusedconsulting groupable to support
biotech
Large CROacquires nicheCRO to bring
in biotechbusiness
Niche CRO
Large CROacquire smaller
technologyfocused services
to help bridgeneeds of smaller
biotechs
Copyright © 2018 Moderna
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The CRO Model
Nic
he
CR
Os
• Specific therapeutic expertise
• Geographic focus
• High Touch
• Fit with company values &culture
• Flexibility
• Small teams with focusedapproach
• Less layers
• Resource stability
Glo
bal
CR
Os
• Global reach
• Training & Process
• Resourcing
• Experience acrossindications
• Full service
• Rapid scale up forprogram expansion
• Continuity of Support
Copyright © 2018 Moderna
The shades of Biotech
START UP
‘Handful of people’
Virtual
Often 1 compound enteringclinic
Supported by Equity/VC
TRADITIONALBIOTECH
At least 1 drug nearingapproval/marketed
Other products earlier inpipeline
May be public or a divisionof larger pharma
Building resources
PLATFORMBIOTECH
Small companies withtechnologies allowing broad
therapeutic applications
Ability to leverage reuse orcross reference
Multiple source funding
Fast paced separate teams
SMALL –MIDSIZEPHARMA
Smaller scale butstructure similar to
pharma
More process andframework
Specialized groupsworking together
Copyright © 2018 Moderna
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Biotech Values and Motivators
Copyright © 2018 Moderna
Biotech versus pharma:VERY different
Biotech
• SPEED
• Lean teams
• Innovation
• Flexibility
• Sensitivity to cost
• Access to data for additional funding
• Continuity of CRO resources
• Support to lack of infrastructure
• Fast to escalate
• Ability to pivot quickly
Pharma
• Longer planning time
• Extension of Resources
• CRO ability to work with Sponsor’sprocess
• Formal Governance
• Global Reach
• Less risk tolerant
• Dedicated budget for duration of work
Copyright © 2018 Moderna
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How does Biotech find the right fit?
• Everyone wants the ‘A’ team
• Criticality of CRO understanding structure and strategy of biotech
• Executive sponsorship on both sides
• Preferred / Strategic partnerships
• Frequent and open communication
• CRO experience in early phase
• Program mindset versus study
• Flexibility and Nimbleness
• Ability of CROs to react and grow with Biotech
Copyright © 2018 Moderna
• Backbone of the technology is similar across products
• Reuse or cross reference
• Ability to accelerate multiple steps in drug development process
• Ability to explore diverse disease areas
What is a Platform Based Company?
Copyright © 2018 Moderna
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• Shorter cycle times
– In cycle learning
• Multiple programs in parallel
• Standardization is critical
• Need to monitor ‘horizontally’ as well as ‘vertically’
• Multiple Collaboration Partners
• Frequent Data Cuts and Monitoring
• New Concept / Technology
Platform Impact to Clinical Development
Copyright © 2018 Moderna
Platform Functionality
Copyright © 2018 Moderna
Preclinical PackageCompatibility &
SupportingPackage
Clinical
PreclinicalCross
ReferenceCompatibility
Clinical
Pre-clinical
CrossReference
SupportingPackage
Clinical
Acrossplatform
Frequent changes in early phase have high impact
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• 6 year old Biotechnology Company based in Cambridge, MA
• Exclusively focused in mRNA therapies
• These therapies use the body’s own innate cellular mechanisms totranslate the mRNA sequence into a protein
• The therapies can be used with different cell types
• Ability to combine mRNA sequences in one drug
• Multiple therapeutic areas of interest are being studied at the sametime
What is Moderna?
Copyright © 2018 Moderna
Moderna’s vision: one platform enabling many drugs
mRNA platform
Many drugmodalities
Manydrugs
ProphylacticVaccines
Manydrugs
TherapeuticVaccines
Manydrugs
IntratumoralI/O
Manydrugs
LocalizedTherapeutics
Manydrugs
Liver
Copyright © 2018 Moderna
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Moderna today
– 19 Development Candidates,10 in clinical trials
– Multiple therapeutic areas
– 600+ employees
– Company in sustained high growthphase
– Investing in infrastructure,manufacturing & digital technology
– Strong financing
Copyright © 2018 Moderna
Case Study: PPD and Moderna Strategic Partnership
Copyright © 2018 Moderna
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PPD and Moderna Strategic Partnership
• Entered into a Strategic Partnership from ‘the beginning’ (2015)
• Companies creatively streamlined costing model as well ascontracting process
• Scale and growth necessitated CRO with global footprint
• Ability to flex quick decisions and support for few internal resources
• Early Engagement access for work to start without a scope
• Partnership guide for both PPD and Moderna team members
• Regular views into Moderna pipeline and progress
Copyright © 2018 Moderna
Partnership Oversight
• PPD Functional Team Leads identified across the partnership
• Moderna and PPD have relationship level oversight to monitor theoverall portfolio of work
• Project and Portfolio Finance Meetings
• Joint Operating Steering Committee meeting to solve operationalissues across therapeutic areas promoting efficiency and consistency
• PPD/Moderna Steering Committee meets face to face to discusscurrent and future programs, partnership health and opportunities
• Transparency about decision making
Copyright © 2018 Moderna
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Key Factors for Success (to date)
• Fast turnaround times/streamlining timelines
• Strong Executive sponsorship
• Therapeutic oversight directorship
• Ability to challenge sponsor and creative thinking
• Willingness to work outside of procedures
• Retention of CRO team members on >1 study
• Collaborative problem solving
• VERY frequent communication
• Maturing relationship and growing with Moderna
Copyright © 2018 Moderna
Thank you
Copyright © 2018 Moderna
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PCMG 2018 – 50 SHADES OF OUTSOURCINGwww.pcmg.org.uk 65
Kindly sponsored by
Sessions resume at 11:15
PCMG 2018 – 50 SHADES OF OUTSOURCING
Richard YoungChris MooreDermot Kenny
Time, quality, cost - the race tofaster, better & cheaper?
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Richard Young
TIME
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PCMG 2018 – 50 SHADES OF OUTSOURCING
Database Build Timelines
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Average Time to Build and Release a Study Database for PhaseII and III Clinical Trials
61.1
74.9
71.4
60.2
72.8
73.4
52.8
68.3
Other EDC
Industry Leading EDC
High Trial Volume
Medium Trial Volume
Low Trial Volume
Sponsor
CRO
Overall
CoV = .48
CoV = .45
CoV = .46
CoV = .40
CoV = .62
CoV = .43
CoV = .37
CoV = .59
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PCMG 2018 – 50 SHADES OF OUTSOURCING
Database Build Timelines
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Protocol Database Design First Patient First Visit
4 ?
10.2
20 Site Initiation Visit
Time measured in weeks
PCMG 2018 – 50 SHADES OF OUTSOURCING
Top Causes of Database Build Delays
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Percent of Total(N=257)
*Time from LPLV toDBL
Coefficient ofVariation
Protocol Changes 45.1% 31.8 Days .73
User Acceptance Testing (including reviewand approvals)
16.7% 34.2 Days .90
Database Design Functionality 15.2% 50.4 Days 1.15
Study Database Move from Developmentinto Production
8.2% 39 Days .57
Standards Management 4.3% 37.5 Days .51
Ethics Approval Delays/Changes 1.2% 33.3 Days .46
Overall 100% 36.3 Days .91
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Data Entry Timelines
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Patient Visit Transcription fromSOURCE to EDC
Monitoring and SourceData Verification (SDV)
5 ?
8.1
18*
Time measured in days
PCMG 2018 – 50 SHADES OF OUTSOURCING
EDC Release after FPFV
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Downstream Cycle Times for Phase II and III Clinical Trials
Incidence* PercentTime from Patient
Visit to Data Entry**Coefficientof Variation
Time from LPLV toDBL***
Coefficientof Variation
Never(N=39)
15.2% 5.4 Days .87 31.4 Days .72
Rarely(N=135)
52.5% 7.8 Days .89 34.4 Days 1.06
Often(N=70)
27.2% 10.1 Days .94 41.7 Days .75
Always(N=7)
2.7% 10.2 Days .66 53.8 Days .58
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What Comes Next ?
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YES
TER
DA
Y/
TOD
AY
Design
Collect
Decide
Act
TOM
OR
RO
W
Streamlined
Connected
Engaged
Collaborative
TOM
OR
RO
W
Patient-Centric
Personalised
Adaptive
Unified
PCMG 2018 – 50 SHADES OF OUTSOURCING
Chris Moore
QUALITY
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PCMG 2018 – 50 SHADES OF OUTSOURCING
QualityHave we really advanced the cause?
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1. Do our systemshelp us to findinformation or
mask our failings?
2. Has outsourcinghelped or harmed?
3. Do our processesand choices reflectour needs or our
egos?
4. Do we applyquality by design or
sleep walk intoquality by comfort?
PCMG 2018 – 50 SHADES OF OUTSOURCING
Quality Pre, or Post iPhone
• iPhone• Data consistent
across all devices• A common consistent
interface with theability to search
• Ability to query, useand interact withdata using multipleapplications
• Pre-iPhone• Data entered on
multiple devices….if Ican be bothered
• Consistentinterface???
• Applications exist bydevice with theirown data and nohope of interfacing
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PCMG 2018 – 50 SHADES OF OUTSOURCING
Dermot Kenny
COST
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Clinical Trials – A burning platform ?
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20 years ago ?
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How far have clinical trials come in 20years?
PCMG 2018 – 50 SHADES OF OUTSOURCING
Blunt instrument solutions have‘masked’ the real problem
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StrategicOutsourcing
Vendorconsolidation
Technologyconsolidation
Offshoring
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PCMG 2018 – 50 SHADES OF OUTSOURCING
What would transformation look like ?
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Stop:
• connecting disparate systems in a clunkymanner
• collecting more data than we need tosatisfy protocol requirements
• data and subject cleaning interventionsthat have no impact on trial objectives?
Start
• standardizing in a truly meaningful way
• creating better connections with our mostcritical stakeholders (doctors and patients)
• Looking outside our industry forinspiration
PCMG 2018 – 50 SHADES OF OUTSOURCING
Antje HindahlMartin Robinson
Achieving Operational Excellence:Are YOU Competent?
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Presentation Content
•How and why PCMG and IAOCR came together
•Competence as a business imperative
•Professionalizing the role of R&D Outsourcing
•Do the right thing - check competence
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PCMG & IAOCR
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PCMG IAOCR
• Foster a consistent,professional approach tomanaging R&D outsourcing
• Generate standards for themanagement of pharmaR&D outsourcing
• Develop the skills ofPharmaceutical R&Doutsourcing professionals
• Align people and businessstrategies
• Enable organisational andindividual excellence
• Expertise in competencebased approach
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Quick poll
Please respond if you hold a position inoutsourcing, procurement or vendormanagement function
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Does your function have a career path/careerladder/career development document inplace?
A. Yes
B. No
C. Not sure
87
A. B. C.
23%
17%
60%
Voting system sponsored by
PCMG 2018 – 50 SHADES OF OUTSOURCING
Concept of a competence based approach
•Competence can be defined as “the ability ofan individual to demonstrate knowledge,skills and behaviours”.
•Competence based learning focusses onoutputs•What new knowledge, skills, behaviours havethe learners acquired?
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Competence?
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Competence as a Business Imperative –Some Examples
•Pharmacovigilance department (leading CRO)• Reduced major errors by 83% in 12 months• Client attraction and retention, due to confidence in drug safety
team• Staff recruitment, engagement and retention – staff feel
“invested in” and more confident in their roles
•Project Management (Global Life ScienceCompany)
• Reduced project timelines• Increased customer satisfaction
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Competence as a Business Imperative –Outsourcing
Outsourcing requires high range of competencies
PCMG 2018 – 50 SHADES OF OUTSOURCING
Outsourcing Competence Areas
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Financial Skills
Compliance/Risk Mgmt
Business Acumen
GCP
Stakeholder +Supplier Mgmt
Communication
Clinical ProjectDelivery Support
NegotiationSkills
IT SkillsLegal
Drug Development
Sourcing Processes
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Professionalizing the Outsourcing Role –Aims
Maximizing value from externalization of drug development activities
Ensuring quality and compliance through appropriate governance
Optimizing trial startup and delivery
Competent outsourcing professionals
Better outcomes for both customers and suppliers
….and ultimately patients
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Professionalizing the Outsourcing Role – Methods
Competency Framework forOutsourcing Professionals
• Derived from core activities ofan Outsourcing Professional
• Sets professional standards• Knowledge
• Skills
• Behaviours
• Objective measure ofperformance
Accreditation of PCMGOutsourcing Essentials Course
Course materialsreviewed by IAOCR
Feedback to PCMG
Course aligned withCompetency Framework
Learning Methods fit forPurpose
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Accreditation success
•April OE course was oversubscribed
•Participant feedback highly positive
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PCMG 2018 – 50 SHADES OF OUTSOURCING
Training courseParticipant voices
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„I really enjoyedthe mock
negotiations thatwere held“
„Very intense days.Getting an insight to
CRO world andnetworking was very
useful“
„Great way to getintroduced to the
area and fornetworking“
„It was a big 2 days andI enjoyed hearing theexperiences of others
and discussing thechallenges they faced“
„very useful, Iwould have likedanother hour on
this topic“
„These trainers wereexceptional, very
engaging and wereable to answer in very
good detail everyquestions asked“
„…great experience duringthe course. The instructors
and presentations werewell structured and madelearning all of the different
aspects of outsourcingvery enjoyable“
„Very goodintroduction to
OutsourcingManagement as a
discipline and whatit includes“
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PCMG 2018 – 50 SHADES OF OUTSOURCING
Do the right thing – check competence
Competent people enable you to:
•Outsource effectively and efficiently
•Execute trials on time and in budget
•Ensure quality
•Protect patients and data integrity
•Achieve operational excellencewww.pcmg.org.uk 97
PCMG 2018 – 50 SHADES OF OUTSOURCING 98www.pcmg.org.uk
•Core competency framework for outsourcingmanagement available
•Accredited foundational training course“Outsourcing Essentials” at least 1x/year
Competence is key to success
Summary Points
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Questions?
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Sessions resume at 14:00
PCMG 2018 – 50 SHADES OF OUTSOURCING
Dr Adrian OtteIndependent Consultant
Strategic choices when choosing anoutsourcing model
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Agenda
• Operating principles for clinical outsourcing• Outsourcing models• Popular options(3)….from very difficult to just difficult to
manage/oversee• Preferred options(2)- standardized and easier to
manage/oversee• Measuring success• Conclusions
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Operational Conduct of DrugDevelopment Programs: Key Principles• Quality data
• Standardized systems and processes• Effective and consistent oversight
• Cost effective• Flexibility
• Ability to change suppliers easily
• Ease of implementation/management• Key relationship management• Speed
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PCMG 2018 – 50 SHADES OF OUTSOURCING
Outsourcing Models
Full Service Outsourcing• Most popular industry model• Varying definition of ‘Full’ but can
include design to analysis• Extensive use of vendor
systems/processes and resourcealgorithms
• Typically involves hand-offs tosponsor systems or individualsinvolving duplication
• Relatively inflexible as it is hard tochange vendors mid trial
Functional Service Provider• Varying functions outsourced but
mainly include monitoring/ datamanagement and programming
• Typically uses sponsorsystems/processes and resourcealgorithms
• Cost advantage from lack ofduplicated roles
• Vendors replaced fairly easily• Requires sponsor to build or maintain
systems and processes
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PCMG 2018 – 50 SHADES OF OUTSOURCING
Popular Outsourcing Models #1:TypicalCRO use by small pharma/biotech
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•Monitoring CRO A, Data Mgt CRO B, Stats/programming CRO C
•Monitoring CRO D, Data Mgt CRO A, Stats/programming CRO E
•Full Service CRO F
•Full Service CRO G with stats and programming at CRO C
StudyA
StudyC
StudyB
StudyD
A variety of CROs are used within and across drug programs
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Popular Outsourcing Models #2: CROuse by Large Pharma
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•Monitoring/Data Mgt/Stats/Programming all in-house
•Monitoring FSP, Data Mgt/Stats/Programming all in-house
•Full Service CRO A
•Full Service CRO B with Stats/programming in-house
StudyA
StudyC
StudyB
StudyD
A variety of options are used including a combination of in-house, FSP and full service
PCMG 2018 – 50 SHADES OF OUTSOURCING
Popular Outsourcing Models #3: CROuse by both small/large Pharma
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CRO A/in-house
•CRO B/in-house
CRO C/in-house
TA/Product
X
TA/Product
Y
TA/Product
Z
Preferred vendor outsourcing model popular but implementation remains problematic
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Fundamental Challenges withOptions # 1-3
• Lack of standardization and continuity causes operationalinefficiencies
• Difficulties with quality oversight• Higher costs due to low volume per vendor and lack of leverage• Challenging environment for both vendor and sponsor staff due
to lack of consistency• Difficult operational oversight because of the lack of ‘one
source of truth’ for management information• Duplication of effort
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PCMG 2018 – 50 SHADES OF OUTSOURCING
Preferred Option #1: Full Service toSingle Provider
Ad
van
tage
s • Standardization ofsystems/processes
• No need to maintain or buildsystems or processes atPharma company
• Cost leverage/focus at singleprovider
Dis
adva
nta
ges
• Reliant on single supplier
• Reliant on CRO systems foroversight
• Reliant on CRO for innovation
• Hard to change supplier midstudy
• Hard to get level of oversightright
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PCMG 2018 – 50 SHADES OF OUTSOURCING
Preferred Option #2: Functional ServiceProvider with Standardization of Systemsand Processes
Ad
van
tage
s • Standardization
• Cost competitive
• No duplication of effort
• Real time oversight
• Cost transparency through algos
• Flexibility to change vendor mid-study
Dis
adva
nta
ges
• Currently requires sponsor tomaintain/build systemsprocesses
• Process Improvement withsponsor
• Potentially more suppliers
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PCMG 2018 – 50 SHADES OF OUTSOURCING
Measuring success
•Cost
•Speed
•Quality (key partner satisfaction/GCP)
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Clinical Operations Efficiency Metric
• CRO costs= FSP and Full Service
• Investigator spend= Patient grant costs, Investigator meetings, Labs, Imaging
and IRB
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PCMG 2018 – 50 SHADES OF OUTSOURCING
Conclusions
• Tools to allow systematic integration of information frommultiple vendors are appearing but are so far under utilized
• Therefore standardization is essential to ensure effectiveoversight and cost efficiencies
• Standardization can be achieved with a single vendor or an FSPmodel
• Single vendor model has a ‘single point of failure’ risk• FSP with common systems/processes simplifies oversight,
management of vendors, flexibility and lowers costs/risk
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Andrew Fried, IBM UK Ltd
LIFE v 2.0.18 - Artificial Intelligence: givingdata life
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Emerging Integrated Platforms
artificial intelligence: giving data life
Andrew Fried | Life Sciences - Global Industry Leader | [email protected]
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©2018 IBM Corporation117
©2018 IBM Corporation118
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©2018 IBM Corporation119
Unified Cloud Based Platforms
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©2018 IBM Corporation121
©2018 IBM Corporation122
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IBM Clinical Trial Transformation
Discussion Topics
Clinical Trials are Essential to Pharma, Bio-tech & Med DeviceCompanies
Clinical Trials are Essential
• Randomized Clinical Trials (RCT) are thegold standard for regulatory approval andproduct launch
• Generate evidence on safety andefficacy for the life of the product
• Results directly impact market value ofthe product
Clinical Trials are Expensive & Time Consuming
• Clinical development can take over 5-8years, and can cost over $1Billion insome cases
• Delays can cause substantial revenueerosion
• Failures in clinical development have amaterial impact on shareholder value
Watson forDrug Discovery
IBM ClinicalDevelopment
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Key hurdles in clinical trials
Desire toredesign entireprocess
Frustration
Getting doneon time andwithin budget
Time
Gathering,organizing,analyzing andreporting
Data
Right protocol to guide studysmoothly and effectively
Protocols
Right subject,right time,right place
Patients
What do thosehurdles mean tous?
Fully capitalized cost ofdeveloping and
launching a new drugin 2016
Percentage of annualR&D costs attributed to
clinical trials
Percentage of time spent indrug development attributed to
clinical trials
Percentage of clinical trialsthat experience delays
Potential cost of each day ofdelay in drug development
1
SOURCES:
1. DiMasia, J. et al. “Innovation in the pharmaceuticalindustry: New estimates of R&D costs.” Journal ofHealth Economics, Vol. 47 (2016), pp. 20-33.
2. Ibid.3. Ibid.4. Christel, M. “New approaches to speeding up clinical
trials – What works and what doesn’t,” Applied ClinicalTrials. May 27, 2015.
5. Morgan, C. “The need for speed in clinical studystartup,” Clinical Leader. July 9, 2015.
2 3
4 5
BILLION
MILLION / DAY
60%-70%
$8
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trans·form
/ˈtran(t)s’form/
verb
1. Make a thorough or dramatic change in theform, appearance or character of.
⌃
Transformation in clinical trialsmeans moving away from linearprocesses and incremental changes.
Current
Clinical development value chain
Marketplaceassessment
and moleculedevelopment(preclinical)
Clinical trialprotocol
development
Site selectionand patientrecruitment
Studyconduct,
datacollection
andoperations
Studyanalysis,
clinical studyreport andsubmission
Postmarketingand real-world
evidence studies(postmarket
requirements andcommitments)
Safety andpharmaceutic
alvigilance
Research CommercializationDevelopment
Cognitivetechnology
Dataassets
Emergingtechnology and theInternet of Things
(IoT)
Cloud
mHealth
Protocoloptimization
Patientsafety
Improvingpatient and site
selection
Transformed
Data analytics and aggregation
Patient-centric
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129Watson Health © IBM Corporation 2017
Opportunities forWatsonto transform the clinicaltrials
Watson for Drug Discovery
Watson for Patient Safety*
Watson forReal World Evidence*
Today’s capabilities
Watson Platform for Health
Watson Health Consulting
* In development
IBM Clinical DevelopmentProprietary
datasets
Transformation opportunities forIBM Clinical Development
from site-centric to patient-centric
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PCMG 2018 – 50 SHADES OF OUTSOURCINGwww.pcmg.org.uk 131
Kindly sponsored by
Sessions resume at 16:15
PCMG 2018 – 50 SHADES OF OUTSOURCING
Do good relationshipsfacilitate projectdelivery?Facilitator: Carl EmersonPanel:Christian Buhlmann, PSICROAdrian Otte,Independent ConsultantHeather DiBenedetto,Moderna TherapeuticsChris Crucitti, BracketGlobal
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The 2018 PCMG LifetimeFellowship Award
Awarded by Richard Scaife and Gill Roberts onbehalf of the PCMG committee
PCMG 2018 – 50 SHADES OF OUTSOURCING
Facilitator: Graham Belgrave, Advanced ClinicalRob Aitchison, ONO Pharma UKChris Moore, VeevaMark Bee, Covance
PCMG’s Room 101
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PCMG 2018 – 50 SHADES OF OUTSOURCING
Results Board• Rob 78%• Mark 28%• Chris 46%
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PCMG 2018 – 50 SHADES OF OUTSOURCINGwww.pcmg.org.uk 137
Enjoy the Gala DinnerAnd that’s an Executive Order…..Meetin the hotel lobby at 19:15 for a VERYprompt departure.
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