Emerging Trends in Healthcare and Drug Development Kurt Nielsen, Ph.D Senior Vice President of Innovation November 15, 2010 New Orleans, LA
Emerging Trends in Healthcare and Drug Development
Kurt Nielsen, Ph.DSenior Vice President of InnovationNovember 15, 2010New Orleans, LA
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The Drug Development Challenge
Reduce Cost
138318
802
1318
1975 1987 2001 2006
Year
Dev
elop
men
t Cos
t fo
r N
CE
Exceed Standards forRegulatory Approval
$600 Billion In
vested
Improve Safety & Efficacy
The results so far…
No substantial increase in NME approvals.
No substantial increase in R&D productivity in the last 60 Years!
Increase Speedto Market
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People over 65 are living longer
• Cost of therapy and increasing quality of life are important to patients and payors
• 30 % increase in cardiovascular deaths (24MM) and 63% increase in incidence of diabetes expected (450MM) by 2030
20 20
40
80
1920 1940 1960 2004
Year
• 1920: only 20% of the increase in life expectancy was over the age of 65
• 2008: 80% of the increase in life expectancy was over the age of 65
% increase in LE over the age of 65
Chronic Disease is an Ever Increasing Burden on Global Healthcare Costs
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Big Challenges Remain in Many Therapeutic Areas
• Chronic and Infectious Disease
• Dramatic increases in Diabetes and Cardiovascular Disease
• 1.3 Million New Cases of Tuberculosis to be treated in next 5 years
• Malaria remains endemic
• 50% increase in new cancer cases to 16MM by 2014 with 70% in developing world
Need for therapies that Improve Quality of Life and are cost-effective
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Cost is Important to Payors and the Patients
• Healthcare Costs has Outpaced GDP growth for 30 years
• Comparative Effectiveness Research (CER)
— CMS & NICE0
1
2
3
4
5
1977 1990 2000 2007
Index
of
Exp
enditure
s FederalStatePrivateGDP
• Cost of Medical Benefit vs. Drug Benefits may lead to increased scrutiny of outcomes from pharmacotherapy
• Tiered Co-pays and co-insurance provide incentive for patients to participate in healthcare decisions
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Pharmaceutical Market Growth
• Global market growth from $800BB to $1.1trillion in 2014
— 15%+ growth in biologics and emerging markets
• 2.5x growth in population age range from 65-70 thru 2050
— 60% increase in developing countries
• Chronic and infectious disease burden will grow
• Improvements in adherence and compliance
• Increasing utilization at lower cost
Growth will be Driven by
Demographics and Cost of
Therapy
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The Role of Pharmaceutical Sciences
ConsumerHealth
Increase overall success rate from 1 in 100 and improve clinical success above 15%
Prescription
Rx
Devices and Diagnostics
PharmaceuticalSciences
Biologics or Small Molecules
Drug Development
Drug Discovery
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In vitro and In silico Prediction Tools are Critical to Success
• Tools for ADME and Clinical Pharmacology will grow in importance for safety and efficacy
• Structure Activity Relationships (SAR) can drive improvements in safety and efficacy
• Predictive In silico tools reduce cost and increase speed of development
• More computing power is affordable
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Optimize Bioavailability Using Particle Engineering
• Discrete set of technology levers for drug developers to optimize bioavailability
• API form, size and habit thru structured particles in a wide variety of dosage forms
Optimize BA
ImproveSolubility
Improve Permeability
API Synthesis / Salt Formation
Softgel
Liquid filled capsules
Melt Extrusion
Nano particles / Nano crystals
Spray Drying
Particle milling /micronization
Novel Excipients/ Surfactants
Absorption & permeability
Enhancer
Lipids
API DESIGN / SELECTION & ENHANCEMENT
API SIZE REDUCTION
SOLID DISPERSION
LIQUID – LIPID SYSTEMS
• Several companies are perceived by the marketplace as being technology leaders
• Technologies applicable to oral, sterile and inhaled dosage forms
Technology Leader in Class Others
Particle Milling / Micronization Micron Several
Melt Extrusion / Melt Dose / Melt Granulation Bend
Rottendorf, Lifecycle Pharma
Misc. Lipid Systems / Self Emulsifying
N/A PHARES, Eurand, Liposine
Liquid Filled Capsules / Systems Capsugel and Qualicaps Swiss Caps,
PharmaForm, SOLIQS
ISP, Hovione, Agere
Banner
Elan
Bend
Catalent
Nanoparticles
Spray Drying
Softgels
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Improving Drug Safety and ADME
• Reduction of Adverse Events
— Solubility enhancement
— CYP P450 enzymes
— Transporters
— Elucidate and reduce drug-drug interactions
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The Symphony of the Genome, Proteome and Transcriptome
• Availability of Data will help drive Innovation
— In less than 30 years Genbank has over 98 Million sequences
— Over 64,000 searchable protein structures
— Genome Wide Association Studies (GWAs)
— Single Nucleotide Polymorphism (SNPs)
— Increasing Importance of Gene Regulation
• Recent Articles on Genomics
— “Association of Risk Reducing Surgery in BRCA1 or BRCA2 Mutation Carriers with Cancer Risk and Mortality” (JAMA)
— “Melanoma: An Unlikely Poster Child for Personalized Cancer Therapy” (NEJM)
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Areas to Watch Over the Next 5 Years
• Oral delivery of vaccines and complex molecules
• Global emergence of complimentary, preventive and integrative medicine
• Payors and patients demands for better outcomes at lower cost
• R&D focused on predictive tools to increase long term productivity
• Early attention to minimizing product COGS
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To Patients, We Can Make a World of Difference
At Catalent, we:
• Focus on the patient experience through better medication delivery
• Produce products in rapidly growing areas of unmet need, from cystic fibrosis to vaccines to pain management. We are at the intersection of patient therapy
• Innovate to meet our customer’s unique market needs
Innovating to meet patient needs drives our thinking
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