Dr Claes Wilhelmsson

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Dr Claes Wilhelmsson
Innovation and the life sciences

• Executive Director Research Development

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The challenges of new treatment paradigms
Increasing safety and delivery convenience Individ
ualised, coupled to diagnosis
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Tailored Treatment
The Ultimate Therapy Prevention or Cure
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1. Proteins 2. Antibodies 3. Gene therapy 4.
Xenotransplantation 5. Antisense 6. Vaccines
7. Natural products 8. Low molecular weight
synthetic drugs
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Multi-disciplincary teamworking - our key to
success
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Future scenario

• Increased need for drugs in 2000
• Increased elderly population è Cancer,
  Alzheimer, CV etc.
• Life style changes è Obesity, Diabetes, COPD etc.

• Treatment paradigms
• General è Individualised coupled to diagnostic
• Symptomatic è Disease modifying
• Established disease è Disease prevention
• Life threatening disease è Improved health and
  well-being
• Safety Delivery flexibility è Increasing
  Safety demands delivery convenience

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Capture more value from in vivo and in vitro
Towards in silico RD
Data integration mining
Pharmacome
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Discovery Development
Develop-ment for launch
Target Identification validation
Concept testing
Compound optimization
Compound Identification
Launch
Compound
Stringent Quality Criteria
Candidate Drug (CD)
Target
Product
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Guiding principles for RD organisation design

• Therapy Area led
• Project driven
• One RD organisation managed globally
• Critical mass to be leading in our chosen areas
• Strong portfolio management
• Team oriented culture
• Build and continuously improve Discovery

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AstraZeneca Global Discovery
Recruiting and investing
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Integrating Discovery, Development TAs
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AZ exploitation of the genomic revolution

• Great opportunities to understand disease
  mechanisms and to identify new drug targets
• Maximise internal activities with exploitation of
  genome collaborations
• Incyte, Affymetrix, Procardis/Oxagen, SNP
  consortium etc.
• Focus on building Target Validation strengths
• Genomics information widely deployed to AZ
  bioscientists via e-lab

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AZ way to external collaborations

• gt 300 collaborations with leading universities
  and Biotechs
• Clever use and timely adoption of breaking
  science technology
• Internal expertise to identify and closely
  monitor opportunities
• Full integration into drug-hunting

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Research Area collaborations - examples
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Technology Platforms - major alliance examples
High Throughput Screening
Chemical Libraries
Genomics
Informatics

• Incyte
• Oxford University
• GenomeTherapeutics
• OxaGen/Procardis
• Amersham Pharmacia Biotech
• SNP Consortium
• Affymetrix
• Molecular Dynamics/Nycomed Amersham

• Incyte
• EuropeanBio-informatics Institute
• Entelos

• Pharmacopeia
• Cambridge Combinatorial
• Griffith University, Brisbane

• AmershamPharmacia Biotech
• Cellomics
• Biosignal

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Exploiting AZ Bioinformatics e-lab

• Genome annotation and mining

• Protein classification

User-friendly accessand capturing value from
complex databases
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Balancing the risk in drug discovery
Do-ability of Target Classes
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AZ sources of chemical leads
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AZ natural product screening and isolation

• Many of top pharmaceuticals have natural product
  origin
• Exceptional chemical diversity - meet target
  explosion
• Unique Australian collection of rainforest
  plants, marine organisms, fungi, venoms etc.

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AstraZeneca Global Development
6 major Development sites
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Global Development
Global Regulatory
Global PRD
Global PARD
Global Clinical
RD
ISMO
US
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Organisation structure
Head of RD
February 1999
TherapyAreas
Cardiovascular Oncology Respiratory
Inflammation
Gastrointestinal CNS Pain Infection
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Up-front operating model decisions

• Complex balance between projects, functions, and
  sites

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RD Therapy Areas
Therapy Area
VP and TA Head

• Cardiovascular Hamish Cameron
• Respiratory Inflammation Colin Reddrop
• CNS Bill Bastain
• Pain Control Anders Ekblom
• Oncology Brent Vose
• Infection Aileen Allsop
• Gastrointestinal Hans Glise (reports to Head of
  GI Franchise)

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Global Product Team structure
Oncology
Pain
RespiratoryInflammation
GI
CV
Infection
CNS
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Activity phases
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Therapy Areas

• Organisation established functioning
• TAMT, TA Advisory Boards, GPTs and most
  cross-functional interfaces
• Close working relationship with PSL established
• TAs strategic plans prepared identifying areas of
  unmet medical need with commercial opportunities
• Brand strategies developed for all major products
• Alignment of TA RA strategy/opportunities
• TA project prioritisation body in place and
  operational

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High Therapy Area growth ambitions
Market position within 10 years

• Gastrointestinal 1
• Cardiovascular 1
• Respiratory Inflammation 2
• Oncology 1
• Pain Control 1
• CNS 10 share
• Infection Top 10

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Product Portfolio Management, key roles
SET
Across TA strategic direction, business
objectives and resource allocation
Portfolio Management Committee
Portfolio Management Team
TA Management Teams
Therapy Area Leadership
Global Brand(s)/Product(s) Leadership
Local Brand(s)/Product(s) Leadership
Marketing Company Product Teams
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Portfolio Shape - NCE Projects
NCE Projects (SPMT2)
Project Phase

• CD Pre-nomination 6
  
• Concept Testing 40
• Development for Launch 5
• Launch Phase 1

Total individual projects 153
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Distribution of projects - by priority
No of Projects
Priority 1
Project delay due to lack of resources not
acceptable
Source data Q1 Review, 2001
Priority 2
Resourced to deliver to plan
Priority 3
Project receive resources after availability
Priority 4
Terminated/halted
Ring-fence

• Special priority for early projects
• From CD pre-nomination to Proof of Principle as
  defined by TA/GPT
• Handled by functions as Prio 2
• Resources by Tollgate

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Portfolio management

• The Challenge is to Balance ...

against finite resources
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Quantitative targets
Contribute to doubling the value of the portfolio
RD Strategy
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AstraZeneca RD Culture Values
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To lead and not to lead.
Leading is more than Managing.
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Personal Leadership reflections

• Management by culture rather than by rules
• The managers role is of critical importance
• Open communication
• Strong empowerment and personal autonomy
• A number of policies define the corporate
  framework

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Leadership through Corporate culture is

• More efficient
• More flexible
• Faster
• Less expensive
• More fun
• (than the alternatives)

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AstraZeneca RD Culture Values

• Create high levels of employee loyalty and
  motivation, and provide the company with
  structure and controls without the need for an
  innovation stifling rigid bureaucracy