The Challenge of Transforming Scientific Innovation into Commercial Success
Download
1 / 31

Healthcare is Changing Rapidly - PowerPoint PPT Presentation


  • 412 Views
  • Updated On :

The Challenge of Transforming Scientific Innovation into Commercial Success. Dr. Norbert Riedel Kellogg Biotech Symposium April 16, 2004. Healthcare is Changing Rapidly. Increasing age of world population Increased prevalence of life-threatening conditions

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Healthcare is Changing Rapidly' - arleen


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
Slide1 l.jpg

The Challenge of Transforming Scientific Innovation into Commercial Success

Dr. Norbert Riedel

Kellogg Biotech Symposium

April 16, 2004


Healthcare is changing rapidly l.jpg
Healthcare is Changing Rapidly Commercial Success

  • Increasing age of world population

  • Increased prevalence of life-threatening conditions

  • Cost-containment pressure from governments and other payors

  • Expanding patient knowledge and empowerment

  • More diverse sources of innovation

  • Personalized Medicine

  • Rapid technological change


Slide3 l.jpg

Predicted 2003 and 2007 sales in the top nine markets in Europe and the top five in selected other regions at ex-manufacturers’ prices using forecast exchange rates. Source: IMS Market Prognosis Global



Slide5 l.jpg

Leading Major Companies by Profitability First Six Months of 2003

(profit as % of sales) in 2002



Slide7 l.jpg

Major New US Product Approvals First Six Months of 2003


Slide8 l.jpg

BIO’s Biotech Drug Approval List First Six Months of 2003

Also approved in 2003 were 13 additional recombinant proteins, monoclonal antibodies, small-molecule products and selected tissue-engineered products. Biotechnology Industry Organization (BIO) considered relevant to the sector. With the exception of FluMist and Advate, all these products were transferred from the Center for Biologics Evaluation and Research (CBER) to CDER, but were not included on CDER’s list of NME approvals for 2003.


Slide9 l.jpg

Major new EU product approvals First Six Months of 2003


Slide10 l.jpg

With only 31 new active substances last year, the much-vaunted revolution in drug development still seems a long way off.


Increase in life threatening conditions presents major growth opportunities l.jpg

Blood, immune and autoimmune disorders much-vaunted revolution in drug development still seems a long way off.

Cancer

CNS Disorders

Infectious diseases, including biodefense

Tissue engineering

Surgical situations

Trauma

Increase in Life-Threatening Conditions Presents Major Growth Opportunities

Small molecules, biopharmaceuticals and vaccines for:


What s next in technology l.jpg

Bioinformatics much-vaunted revolution in drug development still seems a long way off.

Blood safety (prions)

Drug delivery

Homecare

Medication error prevention

Personalized Medicine

Internet-based clinical trials

Minimally invasive surgery

Nanotechnology

Proteomics

Stem cells

Cell therapy

Tissue engineering

Organ replacement

Telemedicine/remote patient monitoring

What’s Next in Technology?


Technological changes are creating new possibilities l.jpg
Technological Changes are much-vaunted revolution in drug development still seems a long way off.Creating New Possibilities

Contemporary

1920s

1950s

1980s

Major New Drug Classes

Combinatorial

small molecules,

designer peptides

Recombinant human

proteins, monoclonal

antibodies,

nucleic acids

Antibiotics

Cardiovascular drugs,

antihypertensives

psychotropics

Combinatorial chemistry,

combinatorial peptides

Genetic engineering,

tissue culture

New Drug Sources

Proteins

Genomics, proteomics,

functional genomics,

high-throughput screening,

transgenic/knockout

model systems,

transcript profiling

New Target Identifaction Tools

Molecular biology,

molecular genetics,

PCR, rDNA

Biotechnology, cell biology

Targets

Genes

Genes, genetic regulatory elements, signal transduction pathways, protein-protein and protein-macromolecular interactions

Human

subjects

Microorganisms, animal models

Enzymes,

receptors

Sources: Pharmaceutical Research and Manufacturers of America, ING Baring Furman Setz


Future mandate for r d l.jpg
Future Mandate for R&D much-vaunted revolution in drug development still seems a long way off.

  • Shorten discovery timelines

  • Strengthen development efforts

  • Increase research productivity


Slide15 l.jpg

Timelines in drug development much-vaunted revolution in drug development still seems a long way off.

Targets selected

Lead series

selected

Candidate leads selected

IND

approval

NDA

approval

Lead selection

Lead optimisation

(in vitro ADMET)

Target identification

Target selection

Preclinical evaluation

(in vivo ADMET)

Clinical evaluation

Safety/Efficacy

Marketing & sales

Monitoring-ADR

OLD PARADIGM

Lead identification

1.5-4 yr

1.5-1 yr

1-2 yr

1-2 yr

8-10 yr

0.5 yr

0.5 yr

1-1.5 yr

1-1.5 yr

7-9 yr

Increased efficiency in drug development

Technological drivers:

Genomics, proteomics, metabonomics, disease models, combinatorial chemistry, HTS, bioinformatics…

Increased lifecycle of new drugs

NEW PARADIGM

2-6 yr


Slide16 l.jpg

35% much-vaunted revolution in drug development still seems a long way off.

30%

35%

Even small improvements in compound selection will have huge effects on profits

With up to 70% of clinical trial spending wasted on trials of failed compounds…

Annual spending in clinical trials

…a 1 percent improvement in selection can save $7 million from each $1 billion of an annual development budget.

Total: $20 billion

$700 million potential improvement opportunity by improving selection process

Drugs that fall due to selection of wrong targets

For each $1 billion of an annual development budget…

Successful

drugs

…70% is spent on failed drugs

$70 million for a 10 percent improvement

Drugs that fall due to poor chemistry


Drug discovery in the 21st century l.jpg
Drug Discovery in the 21st Century much-vaunted revolution in drug development still seems a long way off.

High Throughput Screening

Genomics/Proteomics Novel Targets

Informatics

Therapeutic Areas

Informatics

Informatics

Combinatorial Chemistry


Slide18 l.jpg

Medicinal chemist much-vaunted revolution in drug development still seems a long way off.

Pharmacologist/

toxicologist

Clinical

researcher

Molecular biologist/

bioinformatician

Characterize

mechanism

of action

Prioritize

lead

compounds

Characterize

‘off target’

effects

Develop

surrogate

markers

Understand

clinical responses

Discovery Preclinical Clinical

Target selection Lead optimization IND NDA


Slide19 l.jpg

HIGH-EFFICIENCY PROTEOMICS much-vaunted revolution in drug development still seems a long way off.

(applied to small molecule drug discovery)

Informatics

Proteomics

Sorting of cells from tissue, in vitro cell culture

Affinity chromatography (MDLC)

Quantitation & Identification (LC-MS, MS/MS)

Genome sequence (identification & in silico triage)

INPUT:

Normal &

Disease

Samples

(+ in vitro)

Affinity

capture of

protein class

(in vitro/invivo)

Proteomic

profiling of

differences

Validate with

class-specific

inhibitors

(in vitro/in vivo)

Structure-

based drug

design

OUTPUT:

Optimised

lead

X-ray crystallography

Focused library (+ biology)

Class-specific agonists/antagonists

Activity-based affinity reagents

Chemistry


Slide20 l.jpg

QUANTITY much-vaunted revolution in drug development still seems a long way off.

Library Generation

Medicinal Chemistry

QUALITY

TARGET

VALIDATION

cell-based

SAR

Functional Genomics

Proteomics

LEAD

PROFILING

ASSAY

DEVELOPMENT

MET/TOX

Primary Screening

HIT

VALIDATION

cell-based


Key srategies for success l.jpg
Key Srategies for Success much-vaunted revolution in drug development still seems a long way off.

Industrialization of lead identification

Data warehousing and portals for knowledge access

Customer groups

Innovation

Commercialization

Internet-based clinical trials

Computer-aided trial design and simulation


Slide22 l.jpg

IBM’s New Business Model for Pharma much-vaunted revolution in drug development still seems a long way off.

Accurate Assessment of the Threshold of Innovation

Investment

New Products

Discovery

Marketing

Development

Manufacturing

Sales

Traditional

Products

High Density

Products

Targeted

Treatment

Solutions

New development approach

Adaptive trials and in-life testing

Rolling dossier

Outcomes – oriented marketing

EMRs

Smaller and smarter sales force

Integrated media

New disease-led approach

Multiple supply chain models


Integrating into networks of innovation is a key growth strategy l.jpg
Integrating Into Networks of Innovation much-vaunted revolution in drug development still seems a long way off.is a Key Growth Strategy

Areas of Strength

Areas of Weakness

Academia

Preferred Flows

Biotech Start-up Companies

Large Healthcare Companies

Regulatory

Marketing & Sales

Exploratory Research

Development

Manufacturing


Key business challenges for biotech l.jpg
Key Business Challenges for Biotech much-vaunted revolution in drug development still seems a long way off.

  • Create a strategic vision for “grown up” companies

  • Deliver earnings to support valuations

  • Structure value maximizing alliances with traditional pharmaceutical companies

  • Evaluate mergers and acquisitions

  • Build production capacity


Challenge define strategic vision l.jpg
Challenge: Define Strategic Vision much-vaunted revolution in drug development still seems a long way off.

  • What is the appropriate vision?

    • Fully integrated pharmaceutical company or pure discovery engine?

  • What therapeutic / technology focus should a company have?

    • Diagnostics, delivery or drugs? Technology Play?

  • What supporting functions, processes are needed?

    • Discovery to development to portfolio management to marketing


Challenge translate innovation into earnings l.jpg
Challenge: Translate Innovation much-vaunted revolution in drug development still seems a long way off.Into Earnings

  • How do companies maximize the value of their:

    • Technology platforms

      • Identify the appropriate targets and tools

    • Development candidates

      • Balance technical and commercial risk

    • Marketed products

      • Expand capacity and develop line extension strategies


Challenge structure value maximizing alliances l.jpg
Challenge: Structure much-vaunted revolution in drug development still seems a long way off.Value-Maximizing Alliances

  • Alliances between biotechs and pharma firms will become even more important

    • How do biotechs balance short-term funding needs with long-term value maximization?

    • What are the elements of win-win alliances?

    • What strategic frameworks and processes can shape future alliances?


Slide28 l.jpg

Some of the more significant deals signed between pharma and biotech companies last year. Valuations cannot be directly compared because

they have not been uniformly calculated.


Slide29 l.jpg

Biotech Disappointments biotech companies last year. Valuations cannot be directly compared because

  • Merck & Co drops Celltech compound

  • Novo Nordisk tries to stop Pfizer ending its hormone replacement therapy deal

  • Lilly drops Ono’s sivelestat

  • Lilly ends a deal to develop oral insulin with Generex

  • Biogen ends Icos deal

  • Bayer shelves key PPL project

  • Pfizer ends deal with Phytopharm’s P57 obesity project

  • AstraZeneca pulls out of a deal with NicOx

  • Cambridge Antibody Technology/Abbott deal goes sour

  • GlaxoSmithKline scraps its oral insulin deal with Nobex

  • Abbott scraps its diabetes deal with Karo Bio

  • Pfizer hands back Celltech’s antiheumatic

  • Pfizer returns product rights to Debiopharm


Challenge evaluate m a l.jpg
Challenge: Evaluate M&A biotech companies last year. Valuations cannot be directly compared because

  • The biotech industry is still highly fragmented, and more consolidation is inevitable

  • Successful companies will proactively evaluate:

    • When is the right time for M&A?

    • What attributes make a candidate attractive?

    • What synergies exist, and how quickly can they be realized?



ad