Commercial considerations in early drug development
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Transcript of Commercial considerations in early drug development
Specialists in international B2B communications since 1998
Three sectors with a specific need to translate product features
into brand benefits
INDUSTRY
Alfa Laval Duni Ecophon Inwido NSK Microbas Sandvik Mining Perstorp Tetra Pak Thorn Lighting Trelleborg
TECHNOLOGY
Baldwin Cliniclands Comsys SCAN COIN Sovplym Sydantenn Wayne
LIFE SCIENCE
Grünenthal Lundbeck Norgine Novo Nordisk UCB Airsonett
W COMMUNICATION AGENCY
WHAT DO WE MEAN BY INNOVATION IN THE PHARMACEUTICAL INDUSTRY? INNOVATION IN THE RESEARCH ENVIRONMENT
SUNIL RAMKALI, ACCOUNT DIRECTOR,
W COMMUNICATION AGENCY 3RD MARCH 2016
CLINICAL DEVELOPMENT PROCESS: QUALITY, SAFETY AND EFFICACY ARE REQUIRED FOR REGULATORY APPROVAL
4
Phase 2 Phase 1
First human dose
50–100 volunteers
Dosage and side effects
First efficacy dose
100–1,000 patients
Long-term effects,
optimal dose and efficacy
Phase 3
Confirmatory trials
Up to 9,000 patients
Safety and efficacy
X years
CLINICAL DEVELOPMENT / REGULATORY PROCESS
5
Phase 4 Initiation Phase 1 Phase 2 Phase 3a Phase 3b
RESEARCH DEVELOPMENT COMMERCIALISATION
Manufacturing
Product up-scaling formulation
Non-clinical testing
Safety and tolerability
Clinical trials
Proof of clinical concept, safety and efficacy
Product registration
Global regulatory requirements
and product labelling Preparing for launch
Product communication and
market access
Research
Discovery and validation of
clinical proof of principle
Reaching the market
Product expands treatment options
for people with chronic conditions
Initiation: Average industry time to develop a new molecular entity in R&D = 10 – 15 years at an estimated cost of around $1 billion
Source: innovation.org - Drug Discovery and Development: Understanding the R&D Process, Feb 2007.
TRADITIONAL ‘ROAD MAP’ FOR BRINGING A
PHARMACEUTICAL PRODUCT TO THE MARKET
Need for the product
Identify the product
Develop the product
Study the product
Approve the product
Reimburse the product
Sell the product
3000 raw ideas
300 ideas worked
125 Concepts
9 Projects
2 Commercially ready
1 Commercial Success
THE PIPELINE – FOOD FOR THOUGHT!
Source: Dow Chemical Company
HOW DO WE DEFINE INNOVATION?
General definition
• Innovation is the application of new solutions that meet new requirements, inarticulate needs, or existing market needs (source: www.wikipedia.com)
Business definition
• The process of translating an idea or invention into a good or service that creates value or for which customers will pay (source: www.businessdictionary.com)
Healthcare definition?
• Scientific breakthrough in basic research or discovery and transforming them into marketable products that can be successfully launched into highly regulated markets.
HOW DO WE DEFINE INNOVATION?
General definition
• Innovation is the application of new solutions that meet new requirements, inarticulate needs, or existing market needs (source: www.wikipedia.com)
Business definition
• The process of translating an idea or invention into a good or service that creates value or for which customers will pay (source: www.businessdictionary.com)
Healthcare definition?
• Scientific breakthrough in basic research or discovery and transforming them into marketable products that can be successfully launched into highly regulated markets.
OBJECTIVES OF TODAY
The pharmaceutical landscape is rapidly changing and the pharmaceutical industry needs to adapt
Understanding the customer definition of brand value (innovation) is critical for achieving access to the market
The cost of delivering brand value (innovation) to the pharmaceutical industry
OBJECTIVES OF TODAY
The pharmaceutical landscape is rapidly changing and the pharmaceutical industry needs to adapt
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4
ACTION – GLOBAL TRENDS ARE RESHAPING THE
PHARMACEUTICAL MARKET PLACE*
• Increasing demand for health care services – cost containment
• Priority to serious diseases
• Increasing requirement that products prove:
• Incremental clinical benefits vs. SoC
• Cost-effectiveness
• Affordable / BI analysis
*PWC report (2008): Pharma 2020: Marketing the future. Which path will you take?
• The burden of chronic disease is soaring
• Increasing influence of policy makers/payers on prescribing decisions
• Increase in pay-for-performance
• Increased focus on prevention rather than treatment
• The regulators are becoming more risk-adverse
‘ACTION’ – PHARMACEUTICAL LANDSCAPE
Aging population leading to increase drug spending
Devolution of budgets from national to regional healthcare organisations, leading to cost containment
at a local level
Significant increase in the influence of health technology assessment bodies
Increased use & enforcement of prescribing guidelines / drug listings
Increased focus on drug development in niche therapy areas / non-trivial diseases
Increased use of generics = 2nd/3rd/ 4th line positioning for ‘new’ & branded products
‘REACTION’ – PHARMACEUTICAL LANDSCAPE
Reduced access to healthcare professionals
New customer groups to address – payers / healthcare technology assessment bodies
Down sizing of sales forces
Increased joint drug development between different companies – ‘reduced risk
Increased focus on drug development for more serious conditions
New drugs being positioned as ‘add-on’ (after generics)
Need for tailored marketing communications – specific value story for payers
INNOVATIVE BRANDS MUST FOCUS ON VALUE
DEMONSTRATION!
Value demonstration
• Delivering brand communications that are compelling, meaningful and relevant is mandatory.
Differentiation vs. the competition
• Communicating the incremental clinical benefit/s & value for money of your brand is critical.
Strategic & creative execution
• Executing brand communications via creative, relevant and motivating channels is a must, if we are to change prescribing behaviours (& funding decisions).
OBJECTIVES OF TODAY
Understanding the customer definition of innovation is critical for achieving access to the market
UNDERSTANDING STAKEHOLDER NEEDS IS CRITICAL
FOR COMMERCIAL SUCCESS
Budget
impact /
affordability
Quality Safety Efficacy P & R
Regulatory assessment
Marketing authorisation
Payer assessment
Value demonstration
‘4th hurdle’ ‘5th hurdle’
Pre
scri
bers
All parameters are critical for market penetration Adapted from Paul & Trueman (2001), Fouth hurdle reviews , NICE, and database applications, Pharmacoepidemiology and Safety, 10 (5), 429 - 438
Industry
perspective Innovation based on “novel“
pre-clinical capabilities “new mode of action“
“first in class“
“highly selective …“
Payer perspective Innovation based on “improves compliance“
potential and benefit for “health consequence of side effects“
patient management “improves health status“
“clinical important to the patient”
“reduced treatment costs“
Definition Attributes
Payers need to be convinced of the value for money
of the product
“INNOVATION” FOR THE PHARMACEUTICAL INDUSTRY
AND EXTERNAL STAKEHOLDERS ARE VERY DIFFERENT
TYPE OF EVIDENCE FOR TREATMENT INTERVENTIONS
Efficacy
Does it work in clinical trials?
Effectiveness
Does it work in clinical practice?
Efficiency
Does it contribute to more efficient use of
resources?
Expert Rev Pharmacoeconomics Outcomes Res 2007
OVERVIEW OF AUTHORITY FEEDBACK TO
REIMBURSEMENT APPLICATIONS FOR BRAND X
22
22
Country Lack of
comparative data Lack of long-term
data Modest effect
Lack of data
in subgroups No real life data
Country A X X X
Country B X X X X
Country C X X X X X
Country D X X X
Country E X X X X
Country F X
In addition to these points, the budget impact was frequently mentioned
INCREASING NEED TO DEMONSTRATE ‘ADDED VALUE’
DURING P&R NEGOTIATIONS
“We don’t simply expect to have more medicines, but rather to have medicines that heal better,
or at the very least as well as the ones that are already available”
- Xavier Bertrand, Minister for Work, Employment and Health, France (June 2011)
AMNOG healthcare reform, Germany (1st Jan 2011) – ‘early benefit assessment’
• Clinical benefit - quantification of the incremental clinical benefits vs. current German standard of care
The NHS (England & Wales) is considering ‘Value Based Pricing’ (VBP) model
• The reimbursed price of a new product will be determined based upon its incremental value vs. the relevant comparator
THE INDUSTRY IS ADAPTING TO THE CHANGING
LANDSCAPE (GSK)
Andrew Witty was quoted to have said to his senior R&D Managers
2
4
Andrew Witty,
CEO of GlaxoSmithKline
“you will receive your bonuses,
not on how products are approved by the regulators,
but on how many products are reimbursed by the payers”
Sources: Drug Discovery and Development: Understanding the R&D Process,
www.innovation.org;
CBO, Research and Development in the Pharmaceutical Industry, 2006.
DRUG DEVELOPMENT TAKES LONGER Developing a new medicine takes an average of 10–15 years; the
Congressional Budget Office reports that “relatively few drugs survive
the clinical trial process”
Sources: 1J. DiMasi and H. Grabowski, "The Cost of Biopharmaceutical R&D: Is Biotech Different?, " Managerial and Decision Economics, 2007; J. DiMasi et al.,
“The Price of Innovation: New Estimates of Drug Development Costs,” Journal of Health Economics, 2003.
THE COST OF DEVELOPING A NEW DRUG HAS
INCREASED
$100M
$300M
$800M
$1.3B
1979 1991 2000 2005
Cost to Develop One New Drug1
Bil
lion
s (C
on
stan
t D
oll
ars
, Y
ear
20
00
)
CONSEQUENCES OF GETTING WRONG!
• More than half of the costs are on clinical development, especially on multinational phase III trials.
• Failure of a drug during phase III is a significant expense to the industry.
• Pfizer is discontinuing a Phase III trial evaluating the investigational compound inotuzumab ozogamicin – the drug just isn't working as well as they hoped it would in this situation
• Eli Lilly reported that solanezumab had failed both primary endpoints in a large Phase III study for Alzheimer's.
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ADDRESSING THESE ISSUES - HOW DOES THE FDA ENCOURAGE INNOVATION?
• The FDA uses a classification process for NMEs for ‘fast tracking’ innovative products.
• Products are categorised:
• Priority Review
• Fast Track
• Accelerated Approval
• Priority Review – has the potentially provide a significant advance in medical care - review within 6
months, instead of the standard 10 months.
• Fast track – the product treats an unmet medical need.
• Accelerate approval – treats a serious or life-threatening illness that offers a benefit over current
treatments.
3
0
2012
HOW DO WE INCREASE THE COMMERCIAL
SUCCESS OF PHARMACEUTICAL BRAND?
- UNDERSTAND WHAT CUSTOMERS MEAN
BY BRAND VALUE
HOW TO DEFINE BRAND VALUE IN HEALTHCARE?
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7
Brand value = offers a clinical benefit / addresses a clinical need
HOW TO DEFINE BRAND VALUE IN HEALTHCARE?
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Brand value = offers a clinical benefit / addresses a clinical need
+ differentiation from standard of care
HOW TO DEFINE BRAND VALUE IN HEALTHCARE?
3
9
Brand value = offers a clinical benefit / addresses a clinical need
+ differentiation from standard of care
+ meaningful target population
HOW TO DEFINE BRAND VALUE IN HEALTHCARE?
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0
Brand value = offers a clinical benefit / addresses a clinical need
+ differentiation from standard of care
+ meaningful target population
+ competitive price
COMPANY CONFIDENTIAL – FOR INTERNAL USE ONLY.
GRAZAX®
THE INNOVATION IN ALLERGY TREATMENT
• Administration advantages:
• GRAZAX is a tablet-based immunotherapy
• GRAZAX is taken once-daily and without up-dosing
• GRAZAX allows home administration
COMPANY CONFIDENTIAL – FOR INTERNAL USE ONLY.
GRAZAX®
THE INNOVATION IN ALLERGY TREATMENT
• Formulation advantages:
• GRAZAX dissolves under the tongue within seconds
• GRAZAX provides optimal exposure of allergens
• GRAZAX can be stored at room temperature
GRAZAX® provides a convenient and safe immunotherapy
treatment for home administration
COMPANY CONFIDENTIAL – FOR INTERNAL USE ONLY.
GRAZAX®
THE INNOVATION IN ALLERGY TREATMENT
• Patients benefits:
• GRAZAX is a convenient and easy-to-use immunotherapy
• GRAZAX induces immunological tolerance to grass
• GRAZAX improves the quality of life of patients
GRAZAX® allows many more patients suffering from grass
allergy to benefit from immunotherapy
SUMMARY
The pharmaceutical landscape is rapidly changing and the pharmaceutical industry needs to adapt
Understanding the customer’s definition of innovation is critical for achieving access to the market!
R&D functions need to consider markets needs earlier the drug development process