Biotech Event Brussels, 28th of June 206 - IBM · Biotech Event Brussels, 28th of June 206 ... an...

IBM Healthcare & Life Science Group

®

Biotech Event

Brussels, 28th of June 206

Juergen GoertlerDeepComputing and Infrastructure SolutionsIBM [email protected]

© 2004 IBM Corporation


Agenda10:00 - 10:30 hours Registration customers and welcome

10:30 – 11:15 hours Informatics tools to manage the data explosion and secure your corporate knowledgeSpeaker: Rene Simons of Waters N.V.

11:15 - 12:00 hours Software Tools for Data Analysis in R&DSpeaker: Benjamin Damien of BioXpr

12:00 – 12:45 hours LIMS Systems Speaker: Kevin Jones of Genologics

13:30 - 14:15 hours Underlaying IT architectures Speaker: Nicky Hekster of IBM

14:15 - 15:00 hours Newest Processor Developments, Speaker: Jan De Bondt of AMD

15:00 - 15:15 hours Break

15:15 - 16:00 hours How to approach a project Speaker: Luc Ducazu of Fit IT

16:00 - 16:45 hours LifeSciences and IBM, Speaker: Jacky Boonen of IBM

12:45 - 13:30 hours Lunch

16:45 hours Drinks


®

Biotech Event

Brussels, 28th of June 206

Jacky BoonenIBM Healthcare & Lifesciences Solution ExecutiveIBM BeNeLux [email protected]



Challenges in the Industry Integration, Collaboration, Data Mining, Speed to Market, Segmentation …

The change in customer demands,

technological innovations and

government regulations is

increasingly sudden and dramatic

Continuous Discontinuities

CompetitiveDarwinism

Due to increasingly transparent markets,

competitive intensity is growing in severity as existing players and

new entrants scramble to provide value to

customers



Challenges in the Industry Security, Efficiency, Cost Savings, Streamlining, Information Management ….

Unrelenting Financial Pressures

UnpredictableThreats

The growth and predictability of

revenues and margins becomes even more challenging due to

economic uncertainties and demanding

investors

Pervasive dangers become real and

prevalent as global firms see increased exposure to natural disasters, unstable

geopolitics and other market shocks

CAGR of 5.2%



Pharmaceutical Product Development Cycle

5,000–10,000Screened

5,000–10,000Screened

250Enter Preclinical

Testing

250Enter Preclinical

Testing

5Enter

Clinical Testing

5Enter

Clinical Testing

1Approved

by the FDA

1Approved

by the FDA

Net Cost: $802 million invested over 15 years

16

14

12

10

8

6

4

2

0Discovery(2-10 Years)

Preclinical TestingLaboratory andAnimal Testing

Years

Phase I20-80 Healthy VolunteersUsed to Determine Safety

And Dosage

Phase III1,000-5,000 PatientVolunteers Used to

Monitor Adverse Reactionsto Long-term Use

Phase II100-300 Patient VolunteersUsed to Look for Efficacyand Side Effects

FDA Review/Approval

Compound Success Rates by Stage

Source: Tufts Center for the Study of Drug Development

AdditionalPost-marketing

Testing



Targeted Treatment Solutions Will become the major revenue earners of the future but will requires re-invention across the value chain

Today

1980 1990 2000 2010 2020

Phar

ma

Rev

enue

s ($

)

Traditional Products High Density

Products

Gene-based Therapies

Targeted Treatment Solutions

Today

1980 1990 2000 2010 2020

Phar

ma

Rev

enue

s ($

)

Traditional Products High Density

Products

Gene-based Therapies

Targeted Treatment Solutions

SupportFunctions

Multiple Supply Chain Models with Increased Emphasis on

Biologics

New Disease-Led Approach with Focus on

Clinical Support Package

Adaptive Trials, Continuous Marketing

Application and In-Life Testing

Outcome Oriented

Marketing and Electronic

Medical Records

Smaller and Smarter Sales

Force with Integrated

Media

Human Resources, Finance & Accounting, Information Technology

Variable Service Levels, Process Outsourcing

DeliveryDiscovery Development Manufacture Marketing Sales

Information Based Medicine

Invest NewProducts

Traditional ProductsHi-density ProductsTargeted

Treatment Solutions

Accurate Assessment of the Threshold of Innovation



Building Disease, Target & Biomarker Knowledge

Transforming into a Biology Centric Discovery Process



Life sciences Ecosystem

Basic Research

Labs

Pharma Biotechs &

CRO

Analytical Instruments, Diagnostics & Medical Devices

Academic Medical Research Centers

Integrated Care Delivery Networks

Community Hospitals and Practices

Payers: Private, Government, Employers

Life Sciences

Healthcare Providers



Evolution of Medicine

Personalized Health Care

Translational Medicine

Health Care Today Digital Imaging

Episodic Treatment Electronic Health Records Artificial Expert Systems

Clinical Genomics

Genetic Predisposition Testing

Molecular Medicine

CA Diagnosis

Pre-symptomatic Treatment

Lifetime Treatment

Evolutionary Practices

Rev

olut

iona

ry T

echn

olog

y

Automated Systems

Non-specific (Treat Symptoms)

Information Correlation

1st Generation Diagnosis

Organized(Error Reduction)

Personalized(Disease Prevention)

Dis

trib

uted

Hig

h-Th

roug

hput

Ana

lytic

s

Data and Systems Integration



Storage needs are increasingPharma 2010 IT > Discovery > Data Volumes

Genebank has seen an exponential growth in data generated from new advances in laboratory automation and techniques over the last ten years

Data as at February 2003. Source: www.ncbi.nih.gov/genebank/genbankstats.html.Year

Exponential Increase in Base Pairs and Sequences

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

20,000

22,000

24,000

26,000

28,000

30,000

Year 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001

Bas

e Pa

irs (m

illio

ns)

0

2

4

6

8

10

12

14

16

18

20

22

24

Sequ

ence

s(m

illio

ns)

Base Pairs Sequences



Sequence assembly algorithms

Data miningand PatternDiscovery

Molecular modeling andStructure prediction

Complex celland organsimulation

# SEQLET # SEQLET 1 G..G.GK[STG]TL2 H.....HRD.K..N3 SGG[QEMRY]..R[VLIA].[IGLMV]R.L4 V.I.G.G..G...A6 G.GLGL.I...

Life Sciences Informatics drives High End Computing

HTS data

The Challenge: data complexity augments



Pharma IT funding trends : IT spending is on the rise…And is forecast to continue rising

$3.406

$3.879

$4.391

$4.877

$5.505

$3.015

$0

$1.000

$2.000

$3.000

$4.000

$5.000

$6.000

2000 2001 2002 2003 2004 2005

YearU

S Ph

arm

a In

dust

ry T

otal

Spe

nd (U

S$ m

illio

ns)

CAGR = 12.8%

Source: “US Pharmaceutical Industry: IT spending Forecast.”Gartner DataQuest, July 2001

IT Spend as % of Revenue

4,02%3,77%

3,34%

2,90%

2,58%

0,00%

0,50%

1,00%

1,50%

2,00%

2,50%

3,00%

3,50%

4,00%

4,50%

1997 1998 1999 2000 2001

© Copyright 2002 META Group



Drug discovery - summary of key features and implications

Pharma 2010 IT > Discovery > Key Features


IBM Healthcare & Life Science GroupIBM Organisation

SMEPublicSector

HealthHealth

DistribFinanceassurance

Telecom Industry

Systems Sales Material

Software Software

Personnal computing PC

IBM Global financing Financing

IBM Global Services infrastructure

IBM Business Consulting Services Industry skills

Life SciencesHealth

PharmaBiotech

Diagnostic

R&D CenterIBM



IBM’s Commitment to Healthcare & Life Sciences

Designated Life Sciences an IBM Emerging Business Oppty (EBO) Unit - Spring 2000

IBM Business Consulting ServicesPwC Consulting acquisition

Pharma 2010: The Threshold of Innovation

Strategic partnerships with industry leaders

Created IBM Healthcare & Life Sciences (2004)

Designated Information Based Medicine an IBM EBO in 2004



IBM Research: 8 sites, >3000 scientists,>38000 patents and …. 5 Nobels

Almadenemployees: 400computer science, database, user interface, web software, storage systems software & technology, physical sciences, materials science, nanotechnology, life sciences, DiscoveryLink, services research

Haifaemployees: 280VLSI design, verification technology, storage subsystems incl medical, e-business and security, computer systems, programming languages and environments, advanced applications, applied mathematics, multimedia, and service technologies.

Tokyo employees: 190software technology, systems technology, pervasive computing, Internet technology and applications, deep computing, 3D rendering

Beijing

employees: 90language processing, speech & handwriting recognition, pervasive computing, mobile computing, multimedia, and e-business technologies & solutions

Austin

employees: 40high performance/low power VLSI design and tools, system-level power analysis, and new system architectures

Watsonemployees: 1,680semiconductors, physical & computer sciences, life sciences and mathematics

Zurichemployees: 210communication systems, computer science, selected science and technology projects, and industry solutions and services research

employees: 70deep computing, bioinformatics, functional genomics commerce, media mining, fingerprint matching, speech recognition, weather forecasting and wireless networks

India

http://www.haifa.il.ibm.com/new_building_site.html

http://www.research.ibm.com/about/ykt.shtml



http://www.research.ibm.com/compsci/compbio/index.html



Distinctive Point of View on industry issues…

An Industrial Revolution in R&D

The Future of Clinical Trials-How Genomics, Proteomics and

Technology are Changing the Clinical Development Process

Silicon Rally:The Race to e-R&D

Realising the Full Rewards of EDC

Pharma 2010: The Threshold of Innovation

Pharma 2005Marketing to the

Individual

IBM Business Consulting Services continues to invest in research into the future of the pharmaceutical industry.

The Pharma 2005 series, published in 1998 and 1999, predicted the falling shareholder returns and consolidation of the industry that have occurred over the last few years.

http://www.ibm.com (search on “pharma 2005”)

We have recently published the follow up, Pharma 2010: The Threshold of Innovation, that forecasts a slow down in growth for the industry and describes a new industry model based on Targeted Treatment Solutions.

http://www.ibm.com/services/pharma2010

http://www.ibm.com/

http://www.ibm.com/services/pharma2010



IBM’s HC&LS focus is Infrastructure, Middleware and services

IBM and Partners provide hardware, software, and services that enhance discovery and development efforts

ADD OTHER LOGOS

e-business infrastructure

Industry specific applications

Content

Tools

IBM Life Sciences Framework

High Performance Information Infrastructure

Partners

Deep computing and storage/data management infrastructure

Service



A large panel of partners and scientific codes

© Copyright by IBM Corp.

Gaussian

DiscoverCHARMm

DMOL

Open Force Field (OFF)

Polymorph PredictorGamess

Spartan

AmberQ-Chem

Jaguar

NWChemetc.....

BLASTFASTA

ClustalW

Smith-Waterman

+ 220 applications

PSI-BLAST

BLAT



IBM supports WW standards…

… and open-source.



Scope of Pharma R&D Services

eDev

elop

men

t Stra

tegy

, arc

hite

ctur

ean

d Bu

sine

ss C

ase

Performance Improvement

Stra

tegy

Tech

nolo

gyPr

oces

s

DesignAdvise Build/Implement

Operate

Architecture and User Requirements Definition and Implementation eg EDC, e-Dossier, Archiving

Pro

cess

Re-

desi

gn

Organisation Re-design

Hos

ting,

Hel

p D

esk

and

Har

dwar

e D

eplo

ymen

t eg

EDC



Scope of Pharma R&D Services



High Performance Computing

Storage, Managed Storage Services

Integrated Technology Services

Tivoli

Services/e-sourcing

Bio-Grids

High Performance Integrated Information Infrastructure (HPIII) for drug discovery and research



IBM Websphere information integrator TM , DB2TM

Knowledge Management solution, Lotus

Services

Data and Knowledge Management solutions for scientific collaboration



Introduction into the IBM SCORE solutionIBM Solution for Compliance in a Regulated Environment (IBM SCORE) is a flexible and easy to configure regulatory compliancesolution

Provides the core information lifecycle and process management, security, and auditing functionality required to comply with regulations.

Allows the integration of document management and compliance systems with operational systems.

Collaborative and intuitive portal environment providing configurable out of the box functions. Flexible to support both regulated as non-regulated content.

Full blown eCTD solution, full lifecycle management of submissions and its content

Complete solution: combining best practices in software and services, allowing a fast track validated implementation including pre-configurations and accelerators

»»»» Collaboration

Application Integration

Business Process

Management

Data and Document

Management

eCTD Management



IBM SCORE: Ability to anticipate and respond on changing Life Sciences compliance business demands

SCORE is a life sciences focused solution which:

Supports key industry regulations and processes, such as GXP, 21CFR11

Flexible to support all processes across the Life Sciences value chain

Research SalesDevelopment MarketingManufacture

Electronic Submissions

Clinical Trial Management

Knowledge Management

GMP Documentation

Quality Management

Packaging & Labeling

Medical Information

Marketing & Promotion Materials

Web Content Management

Sales Enablement

New Disease-Led Approach

Increasing Collaboration

New Development

Approach, Adaptive and In-

Life Trials, Rolling Dossier

Multiple Supply Chain

Models

Improved Compliance

Outcome Oriented

Marketing, EMR


Force and Integrated

Media

Closer relationships between payers, providers and regulators

Research SalesDevelopment MarketingManufacture

Electronic Submissions

Clinical Trial Management

Knowledge Management

GMP Documentation

Quality Management

Packaging & Labeling

Medical Information

Marketing & Promotion Materials

Web Content Management

Sales Enablement

New Disease-Led Approach

Increasing Collaboration

New Development

Approach, Adaptive and In-

Life Trials, Rolling Dossier

Multiple Supply Chain

Models

Improved Compliance

Outcome Oriented

Marketing, EMR


Force and Integrated

Media

Closer relationships between payers, providers and regulators



IBM defines Information Based Medicine as the process of transforming existing medical and pharmaceutical practices with knowledge generated from the integration and analysis of diverseclinical and biomedical data

Biomedical

Image Data

Biobanks,AMRC’s

BioPharmaR & D

Healthcare Delivery

Clinical

Data

Genomic

Data

Epidemiological

Data

Phenotype Genotype Population

PersonalizedMedicine

Information Based Medicine

BRD PGx CDI BRD

PGx

CDI

Basic Research /Discovery

Pharmaco-Genomics

Clinical DecisionIntelligence

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