Upload
others
View
2
Download
0
Embed Size (px)
Citation preview
Emerging Trends in Healthcare and Drug Development
Kurt Nielsen, Ph.DSenior Vice President of InnovationNovember 15, 2010New Orleans, LA
2
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
3
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
4
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
5
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
6
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
7
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
8
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
9
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
10
Improving Drug Safety and ADME
• Reduction of Adverse Events
— Solubility enhancement
— CYP P450 enzymes
— Transporters
— Elucidate and reduce drug-drug interactions
11
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)
12
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
13
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
13
14