lecture_slides_ddc wse first lecture 2013
TRANSCRIPT
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Williams S. Ettouati, Pharm. D.Director, Industrial Relations & DevelopmentHealth Sciences Associate Clinical Professor, N.S.
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Lecture Objectives
Course Introduction
Pharmaceutical and Biotechnology IndustryLandscape
Global Outlook: What Will the FuturePotentially Look Like?
Patient Centric Discovery
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DDC Course Objectives
Drug Discovery Process From target to Investigational New Drug Application (IND)
Pharmaceutics & Life Cycle Strategic Plan
Clinical Development
- IND to New Drug Application (NDA) submission
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Clinical study design
Regulatory Requirements to File an IND and an NDA
Intellectual Property Strategy
Commercialization Strategies Marketing strategy; Managed markets
Strategic partnership and business development
Work in Multifunctional Teams
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Pharmaceutical & Biotechnology
Industry Landscape
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Pharmaceutical Market 2011
955 billion US $
Source: IMS Health
NorthAmerica
36%
Europe
25%
Japan12%
China7%
Africa, Asia& Australia
13%
LatinAmerica
7%
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CEO Short-Term Confidence in the Economy
1,258 CEOs from 60 countries shared their view with PwC in 2012
Q: How confident are you about your companys prospects forrevenue growth over the next 12 months?
Source: PricewaterhouseCoopers LLP 15th Annual Global CEO Survey 2012www.pwc.com/gx/en/ceo-survey/.../15th-global-pwc-ceo-survey.pdf
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Fundamental Changes
Capacity to innovate is at the forefront of priorities for CEOs
Patent expirations and low R&D productivity are leaving manypharma with uncertain revenue streams
Major Changes to R&D: 1/3 of CEOs in pharmaceutical and lifesciences, chemicals and technology industries
Pharma is shifting research resources to Asia
R&D spending in Asia has surpassed EU levels
A financial institution predicts R&D spending in Asia likely toovertake US levels before 2020
Source: PricewaterhouseCoopers LLP 15th Annual Global CEO Survey 2012www.pwc.com/gx/en/ceo-survey/.../15th-global-pwc-ceo-survey.pdf
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Pressure for Process & Radical Innovation
Q: To what degree are you changing the emphasis of your companysoverall innovation portfolio in the following areas?
Source: PricewaterhouseCoopers LLP 15th Annual Global CEO Survey 2012www.pwc.com/gx/en/ceo-survey/.../15th-global-pwc-ceo-survey.pdf
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New Molecular Entities Launched in
US 2002-2011
The Use of Medicines in the United States: Review of 2011Source: IMS Institute for Healthcare Informatics
34 New Molecular Entities launched in US, most in last 10 years
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FDA Approved
39*New Molecular Entities in 2012
Source: Bioassociate Consulting2012: The Winners and Losers of the Pharmaceutical Industry
FDA approved 39new drug in 2012
Almost twice the
number approvedin 2010
Highest numbersince mid 90s
Source: FDA
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Few Breakthrough Drugs Available
For First Time in 2012
Ivacaftor
First treatment that targets underlying mechanism of Cystic Fibrosis
Tofacitinib
First Rheumatoid Arthritis (RA) treatment in the new class of Januskinase inhibitors, and the first new oral disease-modifying anti-rheumaticdrug for RA in more than 10 years
Lorcaserin
First weight loss prescription drug to reach market in 13 years, aninnovative molecule, Lorcaserin, a serotonin receptor agonist
Source: Bioassociate Consulting2012: The Winners and Losers of the Pharmaceutical Industry
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80% Prescriptions Dispensed as a
Generic in 2011 Generics dispensed 94% of
time where a generic form isavailable
Patent expiries thatoccurred in late 2011; notyet impacted utilization or
spending by end of year
Majority of increase drivenby expiries in 2010 andearly 2011, including
Lovenox, AriceptandEffexor XR.
The Use of Medicines in the United States: Review of 2011Report by the IMS Institute for Healthcare Informatics
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Spending in Leading Therapy Areas
The Use of Medicines in the United States: Review of 2011
Report by the IMS Institute for Healthcare Informatics
Absolute spendinggrowth gains highest forantipsychotics,antidiabetes, respiratoryagents, autoimmunediseases and lipidregulators
Many generics in
leading traditionalclasses including lipidregulators andantipsychotics
Specialty classspending up > 10% in
multiple sclerosis,autoimmune diseasesand HIV antivirals,
< 5% in oncology
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Top Medicines by Prescriptions
Leading active-ingredients oringredient fixed-combinations, includesboth branded &
generics
Includes all
prescriptionsdispensed through allretail pharmacies
90-day & 30-dayprescriptions both
counted as oneprescription
The Use of Medicines in the United States: Review of 2011Report by the IMS Institute for Healthcare Informatics
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Global Outlook
What Will the Future
Potentially Look Like?
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Opportunities & Threats
Opportunities
Strengthening scientific base
A lot more to learn about thehuman body
Escalating demand for medicines
Trade liberalization Wireless health
Threats
Poor scientific productivity
Tighter regulation More difficult market conditions
Stronger price controls
Soaring healthcare costs
Patent cliff
Note: Figures for 2012 cover period up to 18 July 2012
Pharmas Financial Penalties in US
Source: PricewaterhouseCoopers LLChttp://www.pwc.com
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Challenges: Patent Expiration
Exposure & Impact - $127Bn
U.S.: $103Bn (44%) of 2011
Canada: 42% of spending
will be exposed
Other Developed markets23%
Patent expiration impact
- 13 of top 20 products
- 7 of the top 10 current
leading medicines such asLipitor, Plavix, AdvairDiskus, CrestorandNexium
Brand Spending Shift to Generics
Medicines Outlook Through 2016 IMS HealthSource: IMS Institute for Healthcare Informatics, May 2012
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2016 Global Spending Reach $1.2 Trillion
From 2006 to 2016 drug spending
Developed markets: 73% to 57%
U.S.: 41% to 31%
- Patent expiries & slower brandgrowth
EU5: 19% to 13%
- Slower economic growth
- Aggressive cost containmentmeasures
Pharmerging markets: 14% to 30%
- Millions of people gain access tobasic medicines
Japan: 10% flat
- Biennial price cuts expected in2014 and 2016
Medicines Outlook Through 2016 IMS HealthSource: IMS Market Prognosis, May 2012
Spending by Geography
*Pharmerging markets include China, Brazil, India, Russia, Mexico, Turkey, Poland, Venezuela,Argentina, Indonesia, South Africa, Thailand, Romania, Egypt, Ukraine, Pakistan and Vietnam.
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Spending Growth Driven By Innovation
Only anti-epileptics,contraceptives andantivirals (except HIVdrugs) grow fasterthan in the past 5
years
Specialty medicines
experience continuedgrowth in the mid-term, driven by:
Novel mechanisms
Improved efficacy
Relatively larger
patient populationsleading to increaseduptake
Medicines Outlook Through 2016 IMS HealthSource: IMS Institute for Healthcare Informatics, May 2012
Compounded Annual Growth rate (CAGR): business and investing specific term for thesmoothed annualized gain of an investment over a given time period
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By 2020, Pharma Will be Making
Much More Diverse Range of Products
New product types
More complex manufacturing & distribution processes
Different supply chains for different product types
Shorter product lifecycles
Source: PricewaterhouseCoopers LLChttp://www.pwc.com/gx/en/pharma-life-sciences/pharma2020/vision-to-decision.jhtml
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What is Pharma & Biotech Innovation?
A new drug
Researcher identifies scientific potential of a particular target and molecule
Investor backs belief with $$$$$
Company commits resources development and production of treatment
Regulator approves label
New innovative drug reaches the market, company commits promotionresources
Healthcare payer, provider and patient, respectively decide on the new druginnovativeness:
Healthcare payer by paying a premium price for it
Provider by choosing it over other therapies
Patient by taking it as instructed or even pressing for a prescription
T t t T f d b N d
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Treatments Transformed by New and
Existing Mechanisms
32-37 drugs expected to be
launched per year over the nextfive years
New mechanisms of action inAlzheimer's, autoimmune
diseases and various cancer,have the potential to transformdisease treatment
Not every therapy will becomeavailable or achieve its ultimate
clinical aims
Further developments in areas of
research where some therapiesalready exist like:
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Hepatitis C- Multiple sclerosis
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Prostate cancer
Have a potential to deliver better
efficacy, safety or convenientadministration
Medicines Outlook Through 2016 IMS HealthSource: IMS Institute for Healthcare Informatics, May 2012
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Patient Centric Drug Discovery &
Development
Tomorrows challenge to develop new medicines that can
Prevent
orCure currently incurable diseases
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Challenges in Drug Discovery & Development
R&D productivity has not improved drug approvals have not increased significantly,
while development costs have escalated
Linear: Drug R&D is conducted in a stepwise manner
Slow: Taking a compound or molecule from early research to approved producttakes over 10 years
Inflexible:Drug development process is also very rigid and highly regulated byFDA, EMEA and others
Expensive:On average, companies spend well over US$1 billion to bring anapproved drug to market (a number that includes the cost of products that fail
along the way)
Siloed: R&D process is highly fragmented. Driven by the need to protect theirintellectual property, companies fail to learn from experiences and the mistakesof others
Source: Beyond borders Global biotechnology Report 2012, Ernst & Young
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Source: PricewaterhouseCoopers LLCPharma 2020: Marketing the future: Which path will you take?
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Value Chains
Pharmaceutical and Biotech
Healthcare Provider
Healthcare Payer
Source: PricewaterhouseCoopers LLCPharma 2020: Marketing the future: Which path will you take?
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New Drug Development ParadigmInstead of a linear, slow, inflexible, expensive and siloed drug development paradigm
Pharma need one that is iterative, fast, adaptive, cost efficient and open/networked
HOLNet approach represents a vastly different and inclusive approach to R&D
HOLISTIC: Boundaries between drug development, product commercialization andhealth care delivery are blurred; Share data and connect dots across the entire valuechain of companies
OPEN: openness members pool their strengths and assets. Involve sharing anyresulting output e.g., creating open standards, making insights available to allmembers and often to nonmembers as well
LEARNING: Learning rapidly, in real time, by connecting data from across theecosystem. Allows constituents to quickly adjust their approaches from clinical trials
to standards of care saving time and money and potentially increasing success rates
NETWORK: Radically reinventing R&D and unleashing the transformative potential ofbig data requires the participation of diverse players from across the ecosystem
Source: Beyond borders Global biotechnology Report 2012, Ernst & Young
C f V l Ch i
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Convergence of Value Chain
Single Circular Value Chain: The Patient
Value Providers generatedepends on the revenuespayers raise and themedicines Pharma makes
Value Pharma generatesdepends on getting access tothe patients whom providers
serve and income from thepayers who fund thoseproviders
Relationship betweendifferent players is often quiteantagonistic and, while they
continue to clash, they arestruggling to retain theirrespective goals
Source: PricewaterhouseCoopers LLChttp://www.pwc.com/gx/en/pharma-life-sciences/pharma2020/vision-to-decision.jhtml
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Innovation!
Disruptive innovation
CURE a disease or PREVENT the disease and reduce mortality or morbidity
Incremental innovation
Reduce the cost of care
Improve the quality of life
Safer or easier to use
Improve patient compliance
Issue ME TOO drugs
Pharma race to develop new products, which all have the same mode of action
Maybe the third or fourth market entrant may be superior!
Payers are not going to pay a premium unless
Drug shows disruptive innovation
Demonstrate clear superiority in comparative trials with pharmacoeconomicbenefits
Breast Cancer
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Breast CancerUnderstanding Being Transformed
Every patient experience now generates rivers of data which, if pooled intelligently,can trace a detailed portrait of a patients health and, when aggregated with otherpatient data streams, can coalesce into deep reservoirs of knowledge about entiredisease states and patient populations. an industry marketer
Source:PricewaterhouseCoopers LLC: From vision to decision, Pharma 2020www.pwc.com/pharma2020
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Which Stakeholders Decide if a New
Product is Truly Innovative?
The Payer
Source: PricewaterhouseCoopers LLCPharma 2020: Marketing the future: Which path will you take?
B ildi C ll ti I t t C N t k
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Building Collective Intent Care Networks
to Change Health Care Delivery
Source: Beyond borders Global biotechnology Report 2012, Ernst & Young
Create disease networks leveraging the creativemodels that many health care systems are nowpiloting
From accountable care organizations andpatient-centered medical homes in the US toprimary care trusts in the UK.
Focusing on outcomes, patient-centricapproaches and preventive care, such programsalready provide some of the key building blocksof a HOLNet approach
HOLNets could supplement such modelsby bringing a broader spectrum of constituents
from across the ecosystem
Potentially bring disease-specific focus and,create collective intent to cure or radicallyimprove outcomes within that disease
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FDA Approves Computer Chip for Humans
Implantable computer chip approved in 2004 for implantation in a patientsarm for medical purposes
Can speed vital information about patients medical history to doctors andhospitals
Inserted under the skin
Silently and invisibly, dormant chip stores a code that releases patient-specific information when a scanner passes over it
Chip contains no medical records, just codes that can be scanned, andrevealed, in a doctors office or hospital
With the code health providers can unlock that portion of a secure databasethat holds that persons medical information, including allergies and priortreatment
June 2007, the American Medical Association declared that "implantableradio frequency identification devices may help to identify patients
Source: FDA approved VeriChip for medical applications 2004
VeriChip
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Thank you
Williams S. Ettouati, Pharm. D.Director, Industrial Relations & DevelopmentHealth Sciences Associate Clinical Professor, N.S.