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PCMG 2018 – 50 SHADES OF OUTSOURCING

PCMG Annual Conference 201850 SHADES OF OUTSOURCING


A huge thank you to all our sponsors

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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.

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PCMG 2018 – 50 SHADES OF OUTSOURCINGwww.pcmg.org.uk 4

Please turn yourmobile phone to silent

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Richard Scaife, PCMG ChairGill Roberts, PCMG Vice-Chair

THE PCMG YEAR: A reflection…

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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 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 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 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


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


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

[email protected]

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


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


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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


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


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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


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


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Biotech Values and Motivators


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


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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


• 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?


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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


Platform Functionality


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?


Moderna’s vision: one platform enabling many drugs

mRNA platform

Many drugmodalities

Manydrugs

ProphylacticVaccines

Manydrugs

TherapeuticVaccines

Manydrugs

IntratumoralI/O

Manydrugs

LocalizedTherapeutics

Manydrugs

Liver


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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


Case Study: PPD and Moderna Strategic Partnership


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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


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


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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


Thank you


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Kindly sponsored by

Sessions resume at 11:15


Richard YoungChris MooreDermot Kenny

Time, quality, cost - the race tofaster, better & cheaper?

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Richard Young

TIME

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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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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


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


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


Chris Moore

QUALITY

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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?


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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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?


Blunt instrument solutions have‘masked’ the real problem

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StrategicOutsourcing

Vendorconsolidation

Technologyconsolidation

Offshoring

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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


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


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


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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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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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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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

www.pcmg.org.uk 103


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

www.pcmg.org.uk 104

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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

www.pcmg.org.uk 105


Popular Outsourcing Models #1:TypicalCRO use by small pharma/biotech

www.pcmg.org.uk 106

•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

www.pcmg.org.uk 107

•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


Popular Outsourcing Models #3: CROuse by both small/large Pharma

www.pcmg.org.uk 108

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

www.pcmg.org.uk 109


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

www.pcmg.org.uk 110

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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

www.pcmg.org.uk 111


Measuring success

•Cost

•Speed

•Quality (key partner satisfaction/GCP)

www.pcmg.org.uk 112

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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

www.pcmg.org.uk 113

Efficiency Metric =��

��


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

www.pcmg.org.uk 114

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Andrew Fried, IBM UK Ltd

LIFE v 2.0.18 - Artificial Intelligence: givingdata life

www.pcmg.org.uk 115

Emerging Integrated Platforms

artificial intelligence: giving data life

Andrew Fried | Life Sciences - Global Industry Leader | [email protected]

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Unified Cloud Based Platforms

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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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Kindly sponsored by



Do good relationshipsfacilitate projectdelivery?Facilitator: Carl EmersonPanel:Christian Buhlmann, PSICROAdrian Otte,Independent ConsultantHeather DiBenedetto,Moderna TherapeuticsChris Crucitti, BracketGlobal

132

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The 2018 PCMG LifetimeFellowship Award

Awarded by Richard Scaife and Gill Roberts onbehalf of the PCMG committee


Facilitator: Graham Belgrave, Advanced ClinicalRob Aitchison, ONO Pharma UKChris Moore, VeevaMark Bee, Covance

PCMG’s Room 101

www.pcmg.org.uk 134

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Results Board• Rob 78%• Mark 28%• Chris 46%

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Enjoy the Gala DinnerAnd that’s an Executive Order…..Meetin the hotel lobby at 19:15 for a VERYprompt departure.

Kindly sponsored by

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