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
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The Challenge of Transforming Scientific Innovation into Commercial Success
Dr. Norbert Riedel
Kellogg Biotech Symposium
April 16, 2004
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
Top Ten Companies Worldwide in Prescription Sales for the First Six Months of 2003
Leading Major Companies by Profitability First Six Months of 2003
(profit as % of sales) in 2002
Leading Companies Ranked by Pharma R&D Spending in 2002 First Six Months of 2003
Major New US Product Approvals First Six Months of 2003
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.
Major new EU product approvals First Six Months of 2003
With only 31 new active substances last year, the much-vaunted revolution in drug development still seems a long way off.
Blood, immune and autoimmune disorders much-vaunted revolution in drug development still seems a long way off.
Infectious diseases, including biodefense
TraumaIncrease in Life-Threatening Conditions Presents Major Growth Opportunities
Small molecules, biopharmaceuticals and vaccines for:
Bioinformatics much-vaunted revolution in drug development still seems a long way off.
Blood safety (prions)
Medication error prevention
Internet-based clinical trials
Minimally invasive surgery
Telemedicine/remote patient monitoringWhat’s Next in Technology?
Major New Drug Classes
New Drug Sources
New Target Identifaction Tools
Biotechnology, cell biology
Genes, genetic regulatory elements, signal transduction pathways, protein-protein and protein-macromolecular interactions
Microorganisms, animal models
Sources: Pharmaceutical Research and Manufacturers of America, ING Baring Furman Setz
Timelines in drug development much-vaunted revolution in drug development still seems a long way off.
Candidate leads selected
(in vitro ADMET)
(in vivo ADMET)
Marketing & sales
Increased efficiency in drug development
Genomics, proteomics, metabonomics, disease models, combinatorial chemistry, HTS, bioinformatics…
Increased lifecycle of new drugs
35% much-vaunted revolution in drug development still seems a long way off.
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…
…70% is spent on failed drugs
$70 million for a 10 percent improvement
Drugs that fall due to poor chemistry
High Throughput Screening
Genomics/Proteomics Novel Targets
Medicinal chemist much-vaunted revolution in drug development still seems a long way off.
Discovery Preclinical Clinical
Target selection Lead optimization IND NDA
HIGH-EFFICIENCY PROTEOMICS much-vaunted revolution in drug development still seems a long way off.
(applied to small molecule drug discovery)
Sorting of cells from tissue, in vitro cell culture
Affinity chromatography (MDLC)
Quantitation & Identification (LC-MS, MS/MS)
Genome sequence (identification & in silico triage)
(+ in vitro)
(in vitro/in vivo)
Focused library (+ biology)
Activity-based affinity reagents
QUANTITY much-vaunted revolution in drug development still seems a long way off.
Industrialization of lead identification
Data warehousing and portals for knowledge access
Internet-based clinical trials
Computer-aided trial design and simulation
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
New development approach
Adaptive trials and in-life testing
Outcomes – oriented marketing
Smaller and smarter sales force
New disease-led approach
Multiple supply chain models
Areas of Strength
Areas of Weakness
Biotech Start-up Companies
Large Healthcare Companies
Marketing & Sales
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.
Biotech Disappointments biotech companies last year. Valuations cannot be directly compared because
Biotech companies are consolidating among themselves or being bought up by pharma