© Debiopharm Group 2012 Communicating Project and Portfolio Risks and Rewards 8th Annual Project &...

© Debiopharm Group 2012

Communicating Project and Portfolio Risks and Rewards

8th Annual Project & Portfolio Management, Nov 2012Debiopharm SA C. Deuschel V.P. Project and Portfolio Management

2 © Debiopharm Group 201219.04.23

Drug development efficiency!

PCAST, Report to the President, Sept. 2012

Cost per New molecular Entity


R&D Model to successfully discover and develop a single new molecular entity

24.3

80% 75% 85% 69% 54% 34% 70% 91%

19.4 14.6 12.4 8.6 4.6 1.6 1.1

Target to hit

Hit to leadLead optimization

Preclinal Phase IPhase II Phase III Submission

to launchLaunch

1

Capitalized cost for one NME launched: $ 1.8 billion

Source: Nature Review_Drug discovery_Volume 9_March 2010 : How to improve R&D Productivity: the pharmaceutical industry’s grand challenge?

Number of molecules per phase for one launch

Probability of successful transition from one stage to the next


Attrition rates: Main reasons

Reason why compounds undergo attrition and how this has changed over time

Source: Nature Reviews Drug Discovery 3, 711-716 (August 2004)) Can the pharmaceutical industry reduce attrition rates?

Copyright Nature


ValueValue

COSTCOST

Drug development challenges

Drug development is about the acquisition of information to reduce the risks and increase the value of the compound Studies/experiments are designed to answer questions related

to the compound efficacy/safety. There is a risk that any experiment will fail.

One of the main challenges of drug development is to reduce the risk of failures

Or to shift attrition to cheaper phases Risk management is key to identify critical information

POSPOSRISKSRISKS


Debiopharm Group™

Over 30 year of experience in drug development in collaboration with pharma

Two major marketed products Eloxatin ® Gold standard & blockbuster Decapetyl ® sustained release formulation (1, 3, 6 months)

About us Based in Switzerland Family owned Financial independent Team: staff over 300 Extensive international network of partners: over 400


Business model: a bridge to develop therapies

Fully fundeddevelopment of therapies

Discovery

Pharma

DEBIOPHARM GROUP™

Inlicensing Outlicensing

Market

Academic institutionsBiotechStart-upPharma


Our core business: Opportunity & risk management

7.5%Target to hit Hit to leadLead optimization

preclinal Phase I Phase II Phase III

SubmissionLaunch

from molecule to drug approval

Cummulative probability of success up to launch


Key Expertise from Search to Registration


Two development programmes have led to… …Five products currently commercialised internationally:

Eloxatin® / Elplat® / Dacotin® / Dacplat® Decapeptyl® / Trelstar® / Pamorelin® 1-month Decapeptyl® / Trelstar® / Pamorelin® 3-month Decapeptyl® / Trelstar® / Pamorelin ® 6-month Moapar® / Salvacyl® 3-month

Debiopharm Group’s achievements


Debiopharm Group™: marketed & late clinical

Prec

linic

al

Phas

e I

Phas

e II

Phas

e III

Mar

kete

d

Decapeptyl® / Trelstar® / Pamorelin® (1, 3, 6M) - GnRH agonist, Prostate cancer

Eloxatin® / Elplat® / Dacotin® / Dacplat® - Colorectal cancer

Debio 8206 CPP - GnRH agonist, Central Precocious Puberty

Debio 025 - HCV,Cyclophilin inhibitor (worldwide licence to Novartis except Japan)

Debio 8206 SC - GnRH agonist, Prostate cancer

G-SOX (oxaliplatin) - Advanced metastatic gastric cancer (Yakult, Japan)

Moapar® / Salvacyl® - GnRH agonist, severe sexual deviation


Debiopharm Group™ Pipeline: Early development

Prec

linic

al

Phas

e I

Phas

e II

Phas

e III

Mar

kete

d

Debio 0929 - Oncology, undisclosed target



Debio 0930 - Metabolic diseases, AMPK activator

Debio 025 - HCV , Cyclophilin inhibitor (Japan)

Debio 1036 - Autoimmune diseases, undisclosed target

Debio 1141 - Urothelial carcinoma, siRNA


Debio 0932 - Oncology, Hsp90 inhibitor

Debio 1144 - Oncology, tyrosine kinases inhibitor

Debio 1143 - Oncology, SMAC mimetic (pro-apoptotic)


Global development plan

Target Product Profile

TimeCost

RisksRisks

Risks and opportunity management shall be fully integrated in the global development plan


Opportunity Management

Assess all the key assumptions made for the drug development

Keep the risk assessment “emotion free”

Culture Value

creation

Risk assessment

tools


Project risk management approach and tools

Preclinical Phase I Phase II Phase III Filing Market

Risk landscape Impact /Probability Mitigation /Contingency

Risk landscape Impact /Probability Mitigation /Contingency Systematic Risk approach

“RADAR”

Systematic Risk approach“RADAR”

Decision Tree Decision Tree

Strategic Decisions

Operational Decisions

Probability of Success meetings

Risk management action plan and monitoring


Risk assessment tool: Risks Landscape

Mitigation Plan

GOAL Identify relevant risks of a project Assess impact and probability Establish Mitigations plan (if

necessary)

Neutralized examples

Risk # 1 Clinical: slow patient inclusion will dramatically delay human POC

Mitigation: increase trial centers

Risk#2 Business: Fierce competition at the same level of development

Mitigation: monitor advancement of competition and verify competitive advantage (USP)


Risk assessment tool: Consistent and Systematic approach RADAR Science

0.00%

50.00%

100.00%API

Process Chemistry

API supply

Formulation

Pharmacodynamics

General ToxicologyGenetic tox

Safety Pharmaco

Reprotoxicity

Metabolism

Kinetics

5

Science

Radar

A systematic approach: project risks are categorized into individual criteria which are scored Radar example: categories for preclinical project: Science Science All regulatory requirements are covered in a questionnaire (Pharmacodynamics, toxicology, reprotoxicity,…) Additional crucial criterias for the project development were added (formulation, API supply, …)

All these data provide a factual analysis of the strength and weakness of the product


Systematic approach RADAR allows follow up of project

0.00%

50.00%

100.00%API

Process Chemistry

API supply

Formulation

Pharmacodynamics


Safety Pharmaco

Reprotoxicity

Metabolism

Kinetics

5

0.00%

50.00%

100.00%API

Process Chemistry

API supply

Formulation

Pharmacodynamics


Safety Pharmaco

Reprotoxicity

Metabolism

Kinetics

5

0.00%

50.00%

100.00%API

Process Chemistry

API supply

Formulation

Pharmacodynamics


Safety Pharmaco

Reprotoxicity

Metabolism

Kinetics

5

Situation February 2011 Situation February 2012

Evolution 2011/2012


Systematic approach RADAR Economy

0.0

2.0

4.0

6.0

8.0

10.0Competition

Market.

Dev. Cost

Est. Sales

IP

COGs

Economy

Example of RADAR categories for preclinical project: EconomyEconomy

This questionnaire cover all topics impacting the economical viability of the project:

• Competition• Market • Development cost • IP protection (when launched)• …


Risks analysis: Systematic approach RADAR: Economy

0.0

2.0

4.0

6.0

8.0

10.0Competition

Market.

Dev. Cost

Est. Sales

IP

COGs

0.0

2.0

4.0

6.0

8.0

10.0Competition

Market.

Dev. Cost

Est. Sales

IP

COGs

0.0

2.0

4.0

6.0

8.0

10.0Competition

Market.

Dev. Cost

Est. Sales

IP

COGs

Situation February 2011 Situation February 2012

Evolution 2011/2012


Risk assessment tool: Decision tree

Attrition rates Phase I to market approval

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

2002(Buchanan

2002)

period 81-86(DiMasi2001)

period 87-92 (DiMasi

2001)

period 93-04 (Parexel2011/2012

p221)

period 93-04 (Parexel2011/2012,

p270)

2004 (Tuftsoct 2010,vol12, n° 5)

2004 (Kolaet al 2004)

2011 (Parexel2011/2012,

p265)

period 95-10(Paul et al,

2010)

average

Probability of Success Decision tree meetings are

performed at each project gate (Go/NoGo next project gate)

Outside expertise to ensure objectivity

Comparison with benchmark There is no unique benchmark!

Is the PoS of the project higher or lower than the benchmark? If yes, why?


Risks Analysis Overview per project

Risks Landscape• Risk 1: • Mitigation

• Risk 2:• Mitigation

Radar • Science• Economy

0.00%

50.00%

100.00%API

Process Chemistry

API supply

Formulation

Pharmacodynamics


Safety Pharmaco

Reprotoxicity

Metabolism

Kinetics

5

Science

0.0

2.0

4.0

6.0

8.0

10.0Competition

Market.

Dev. Cost

Est. Sales

IP

COGs

Economy

Probability of SuccessReflecting current development stage



Give confidence to everyone to ask right questions Strong involvement of project team Integrate opportunity and risk management into project lifecycle


Keep the risk assessment emotional free

Culture Value

creation

Risk assessment

tools


Drug development Stage Gate methodology

Preclinical Phase Phase 1 Phase 3Phase 2

GoFIM

Decision to

proceed in man

Go TOX

Decision to initiate

development project

Go POC

Decision to enter efficacy

trials

GoPIII

Decision to enter pivotal trials

Go Filing

Decision to

register

Level 1 (L1) project gate milestones


Differentiation of the level of responsabilities

L1: Top management needs a clear overview on the value creation milestones

L2: Project team is responsible for reaching the objectives/deliverables associated with the critical activities

L3: Team members are accountable for the detailed tasks to complete the critical network activities

L1 Project Gate

L2Critical

network activities

L3

Detailed tasksrisks

risks

risks

Risk assessment Relevant Go/NoGo and “what if scenarios” are discussed at each level



Give confidence to everyone to ask right questions

Integrate opportunity and risk management into project lifecycle


Keep the risk assessment emotional free

Report the relevant questions to the top management

Ensure approximately right decisions rather than precisely wrong decisions

Culture Value

creation

Risk assessment

tools


Project Review Committee

Project Review committee responsabilities Go/No Go for next phase Decisions on Portfolio composition and prioritization Risk management is key to identify critical information

Top Management

Project ReviewCommittee

Project Team

Reporting and escalation

Decision/feedback


Preparation for the Project review Committee

Risk analysis of

Go/NoGo criteria for decision making

Recommendation of the project team

Critical information for each L1 gate

Early Project•…•…•…

GoTox.•…•…•…

GoFIM•…•…•…

GoPOC•…•…•…

Project review committee

Clear decision criteria


PoS of projects within the portfolio

External diameter represents the estimated peak sales Internal diameter represents the cost of development

Portfolio analysis --- prioritization…

Debiopharm Portfolio NCE-Neutralized

0%

10%

20%

30%

40%

50%

60%

70%

80%

-9 -7 -5 -3 -1 1 3 5 7 9 11

Time to market and Data exclusivity

Pro

ba

bili

ty o

f S

uc

ce

ss

(P

OS

) %

2028

2028

2029

2028

2029

Debio XXXX

Debio XXXX

Debio XXXX

Debio XXXX

Debio XXXX


Value creation

Project risks are categorized into individual criterias which are scored

Project and portfolio metrics are based on risk and opportunity management

3 level of responsibilities (L1, L2, L3) are established to optimize project monitoring and management

Opportunity and risk management needs to be integrated into project lifecycle

Transparent view of risks and opportunities is shared through the whole organization

Focus on relevant risks which are escaladed to the top management

Check that the warning about the relevant risks and their associated opportunities are well understood by the top management


Change behavior toward risk : Look for opportunities

More anticipation… less problem resolution Be opportunistic focus by taking more acceptable risks to

improve profit expectation

Risk Management(Anticipation)

Issue Management(Firefighting)

Risk Management(Anticipation)

Issue Management(Firefighting)

Today

TomorrowEffort/ CostImprove profit

expectation



Special thanks to

Pierre Daram - Project Manager

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