Transcript PL2_Dennis Wong_Asian Drug Development Catching

Asian Drug Development:
Catching-up, Leapfrog
Dr. Dennis A Wong
Shanghai/USA
Asia Pacific Development, Sanofi
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are not the opinions or positions of Sanofi.
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pect of projections and estimates and their underlying assumptions, state
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Asian Drug Development:
Contribution Small
Top 10 Fortune 500
https://en.wikipedia.org/wiki/Fortune_Global_500
Real Shift to EAST
Asia = 170
North America = 145
Europe = 110
https://en.wikipedia.org/wiki/Fortune_Global_500
BioPharma Unbalanced
http://www.pharmexec.com/2016-pharm-exec-50
Need to Develop Products
Drug Innovation Needed
Top Patent Generators Biotech
http://stateofinnovation.thomsonreuters.com/
https://www.statista.com/statistics/417986/
imports-and-exports-pharmaceutical-industry-in-asia-by-major-country/
Why is the West Ahead?
Funding? People?
http://www.insilicodrugdiscovery.com/wp-content/uploads/2014/09/
annual_research_and_development_expenditure_by_country.png
Autos vs Drugs
Focus?
http://europa.eu/rapid/press-release_MEMO-13-1000_en.htm
Currently US Pays: Therefore
Industry Tailors To Their
Needs and Regulations?
US Market Global Proportion 40%
http://the2x2project.org/big-pharma/
Generic US Use >85%
Breakthoughs or New Markets Needed
US Volume
Branded
Generic
http://www.pbs.org/newshour/updates/americans-spend-much-pharmaceuticals/
Growth of Orphan Drugs
More Drugs Serving Fewer People
www.evaluategroup.com/orphandrug2014
How Can Asia Catchup?
Leapfrog?
Academic
Key to Hub Formation
US Life Science Hubs (Blue Biotech)
• Boston and San Francisco Hubs
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NIH and Endowments Fund Academic centers
Intra and inter collaboration
Global recruitment at all levels
Entrepreneurial development of scientist/clinician
Strong industry interaction/support/exchange
• Train more scientist
http://comprendia.com/2012/11/09/which-life-science-hubs-are-the-biggest-analysis-of-linkedin-data/
Endowments
Regulatory
Globalization and Partnership
“Globalization has fundamentally altered the economic and innovation
landscapes. This comes at a time when many regulatory authorities
are already struggling to keep up with rapid advances in science
and technology as well as the growing complexity of medical products
and product development, manufacturing, and supply.
Additional pressures come from mounting economic and political
desire to manage public spending and product costs.”
Elias Zerhouni and Margaret Hamburg
Need to Harmonize drug regulations
• Can Asia harmonize?
• If there is “little to no difference”
in how East Asians handle drugs
then can there can be one approval
process in Asia
http://stm.sciencemag.org/content/8/338/338ed6
https://www.pmda.go.jp/english/rs-sb-std/rs/0002.html
Regulatory
Innovation: Sharing Risk
Ph III Alternatives
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Surrogate endpoints
Adaptive design
POC conditional approval
Limited use “registry”
http://reports.weforum.org/global-enabling-trade-2013/pharmaceuticals/
Eichler HG,et al From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients. Clin Pharmacol Ther. 2015 Mar;97(3):234-46
Payers/Patients
Set the Rules
“The way the patent system interacts with the FDA drug approval process skews what
kinds of cancer clinical trials are run. There’s more money to be made investing in
drugs that will extend cancer patients’ lives by a few months than in drugs that would
prevent cancer in the first place”
“for decades vaccines were a neglected corner of the drugs business, with old
technology, little investment and abysmal profit margins. Many firms sold their vaccine
divisions to concentrate on more profitable drugs.”
“Treating diabetes is far easier than
curing diabetes. If you are a
pharmaceutical company, it makes
more sense to invest money
in finding treatments when cures
are so much harder to find.
Companies have patients’ welfare
at heart; they are not intentionally
not pursuing cures because they
would lose money on drugs..”
http://www.nytimes.com/2015/12/29/upshot/why-preventing-cancer-is-not-the-priority-in-drug-development.html
http://www.theatlantic.com/business/archive/2015/02/vaccines-are-profitable-so-what/385214/
https://www.diabeteshealth.com/would-you-cure-a-profitable-disease/
Choi DW, et al Medicines for the mind: policy-based "pull" incentives for creating breakthrough CNS drugs. Neuron. 2014 Nov 5;84(3):554-63
Industry
Will need to Change
0.45 yrs or
32% of increase
due to new drugs
• Move towards “open innovation” sharing/contributing data and expertise
• academic/industry
• government/industry
• industry/industry
• Share the risk of drug development
• industry/regulatory/payer
• Contribute to developing the drug development infrastructure
• Training the people, academic/industry/clinical/regulatory
Lichtenberg FR. Contribution of pharmaceutical innovation to longevity growth
in Germany and France, 2001-7. Pharmacoeconomics. 2012 Mar;30(3):197-211.
Summary
Opportunity for Asia
• Biopharma has matured, tutored by US needs,
funding and regulations.
• Asia has the potential to accelerate the growth of
the industry here by learning from the West
• Cost constraints globally will force the industry
to change, Asians particularly collectively could
remodel the industry for the benefit of all
Thank You