It is important in the drug development process that marketers and researchers collaborate early to ensure that products being developed are truly innovative and deliver brand value to the different end users in a way that the product and the subsequent brand messaging is relevant, compelling and differentiating compared to the competition. T
In the market place that is heavily cost constraint, innovation is no longer about a unique mode of action or a new formulation, but more about the incremental brand value offered by new pharmaceutical products over existing treatments (standard of care) and how much healthcare systems are prepared to pay for these incremental benefits. My lecture at the Department of Innovation, Lund University, Sweden explored the importance of R&D functions getter closer to external stakeholders to really understand their needs, how they define brand value and the importance of considering this early in the drug development process.
New Product Planning in the Pharmaceutical IndustryAnthony Russell
Lecture presented in the Competitive Intelligence and Pricing course as part of the University of Southern California Master of Science in Healthcare Decision Analysis program. Presented on June 14, 2020 at USC via Zoom. The lectures gives an overview of what new product planning is in the pharmaceutical industry, what tools are used during new product evaluations, and the key elements of a new product business case. The lecture includes a couple of case studies to be worked on by the class.
Pharmacovigilanc: The science & activities relating to the Detection, Assessment, Understanding and Prevention of adverse effects or any other drug related problems
The Thalidomide Tragedy (Lessons for Drug Safety and Regulation)
CLASSIFICATION OF ADRS (RAWLIN AND THOMPSON CLASSIFICATION)
Why PV is Necessary?
Objective of PV
Outcomes of Drugs
Causal Relationship
Adverse drug reaction and causality assessment scales
Classification of AE
Serious Adverse Event (SAE)
Sources of Adverse Events (AE) reports
Sources of AE Reports(Solicited Reports)
What to Report?
Who to Report?
When to Report?
Individual case data flow
Carlos Langezaal - Eisai Inc, Speaker at the marcus evans Discovery Summit Fall 2011, delivers his presentation on The Importance of Developing a Global Regulatory Strategy towards the Goal of Registration
Fundamental concept of regulatory affairs in pharmaceutical & biotechnologyHitendra Singh
RA is a comparatively new profession which developed from the desire of governments to protect public health by controlling the Quality, safety and efficacy of products in areas including pharmaceuticals, Biotechnology, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Goals of Regulatory Affairs Professionals:-
Protection of human health
Ensuring safety, efficacy and quality of drugs
Ensuring appropriateness and accuracy of product information
New Product Planning in the Pharmaceutical IndustryAnthony Russell
Lecture presented in the Competitive Intelligence and Pricing course as part of the University of Southern California Master of Science in Healthcare Decision Analysis program. Presented on June 14, 2020 at USC via Zoom. The lectures gives an overview of what new product planning is in the pharmaceutical industry, what tools are used during new product evaluations, and the key elements of a new product business case. The lecture includes a couple of case studies to be worked on by the class.
Pharmacovigilanc: The science & activities relating to the Detection, Assessment, Understanding and Prevention of adverse effects or any other drug related problems
The Thalidomide Tragedy (Lessons for Drug Safety and Regulation)
CLASSIFICATION OF ADRS (RAWLIN AND THOMPSON CLASSIFICATION)
Why PV is Necessary?
Objective of PV
Outcomes of Drugs
Causal Relationship
Adverse drug reaction and causality assessment scales
Classification of AE
Serious Adverse Event (SAE)
Sources of Adverse Events (AE) reports
Sources of AE Reports(Solicited Reports)
What to Report?
Who to Report?
When to Report?
Individual case data flow
Carlos Langezaal - Eisai Inc, Speaker at the marcus evans Discovery Summit Fall 2011, delivers his presentation on The Importance of Developing a Global Regulatory Strategy towards the Goal of Registration
Fundamental concept of regulatory affairs in pharmaceutical & biotechnologyHitendra Singh
RA is a comparatively new profession which developed from the desire of governments to protect public health by controlling the Quality, safety and efficacy of products in areas including pharmaceuticals, Biotechnology, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Goals of Regulatory Affairs Professionals:-
Protection of human health
Ensuring safety, efficacy and quality of drugs
Ensuring appropriateness and accuracy of product information
These slides will help you to know about post marketing surveillance of drug. What are the major goals. Basic steps involve in post marketing surveillance of a drug. How to design a case stuty etc.
Part of the MaRS BioEntrepreneurship event series
Speaker: Wendy Hill, Gap Strategies
This event is available as an audio file:
http://www.marsdd.com/bioent/feb12
PAREXEL Principal Consultant Angela McGillivary discusses commercial considerations, clinical development, regulatory requirements, submission and post approval strategies in emerging markets
The sulfonylamide tragedy refers to a historical event that occurred in the 1930s, which resulted in the deaths of many patients who were treated with certain medications containing sulfa drugs.
Sulfa drugs were discovered in the early 20th century and were considered a revolutionary breakthrough in the treatment of bacterial infections. They were widely used during World War II and saved countless lives.
However, in the 1930s, the pharmaceutical industry was still in its infancy and drug safety regulations were not as stringent as they are today. This led to the production and distribution of poorly tested and inadequately regulated drugs.
One such drug was Elixir Sulfanilamide, which contained the sulfa drug sulfanilamide and diethylene glycol as a solvent. The drug was marketed as a safe and effective treatment for streptococcal infections.
Unfortunately, the solvent used in Elixir Sulfanilamide was highly toxic, causing severe liver and kidney damage. This led to the deaths of over 100 people, including many children.
The tragedy resulted in the passing of the Federal Food, Drug, and Cosmetic Act in 1938, which established new safety requirements for drugs and food additives. It also highlighted the need for thorough testing and regulation of pharmaceutical products before they are released to the market.
Today, sulfa drugs are still used in the treatment of bacterial infections, but they are much safer and undergo rigorous testing and regulation before being approved for use.
Speaker: Peter Pekos, Dalton Pharma Services. Part of the MaRS Best Practices Series.This session, led by seasoned industry experts, will explore how to effectively set up your pre-clinical POC studies, address pre-clinical safety requirements and issues, and give you an overview of the manufacturing standards required for Phase I studies
More information: http://www.marsdd.com/Events/Event-Calendar/Best-Practices-Series/ind-05132008.html
Presentation by NEPAD Agency on the African Medicines Regulatory Harmonisation made at the Euro-Africa Health Investment Conference, March 26 - 27, 2013, London, United Kingdom.
Scope of Pharmacy and Clinical ResearchMansi Pawar
By students of Sir Dr. M S GOSAVI COLLEGE OF PHARMACEUTICAL EDUCATION AND RESEARCH, Nashik
The ppt will provide wide overview of career opportunities in pharmacy and basic knowledge of clinical research.
Taking a Commercial Approach To Drug DevelopmentPharmacision LLC
Explore Target Product Profile development and commercially driven drug development strategies for early stage pharmas and drug development companies. See how to develop commercially compelling new drug candidates and increase future licensing opportunities.
These slides will help you to know about post marketing surveillance of drug. What are the major goals. Basic steps involve in post marketing surveillance of a drug. How to design a case stuty etc.
Part of the MaRS BioEntrepreneurship event series
Speaker: Wendy Hill, Gap Strategies
This event is available as an audio file:
http://www.marsdd.com/bioent/feb12
PAREXEL Principal Consultant Angela McGillivary discusses commercial considerations, clinical development, regulatory requirements, submission and post approval strategies in emerging markets
The sulfonylamide tragedy refers to a historical event that occurred in the 1930s, which resulted in the deaths of many patients who were treated with certain medications containing sulfa drugs.
Sulfa drugs were discovered in the early 20th century and were considered a revolutionary breakthrough in the treatment of bacterial infections. They were widely used during World War II and saved countless lives.
However, in the 1930s, the pharmaceutical industry was still in its infancy and drug safety regulations were not as stringent as they are today. This led to the production and distribution of poorly tested and inadequately regulated drugs.
One such drug was Elixir Sulfanilamide, which contained the sulfa drug sulfanilamide and diethylene glycol as a solvent. The drug was marketed as a safe and effective treatment for streptococcal infections.
Unfortunately, the solvent used in Elixir Sulfanilamide was highly toxic, causing severe liver and kidney damage. This led to the deaths of over 100 people, including many children.
The tragedy resulted in the passing of the Federal Food, Drug, and Cosmetic Act in 1938, which established new safety requirements for drugs and food additives. It also highlighted the need for thorough testing and regulation of pharmaceutical products before they are released to the market.
Today, sulfa drugs are still used in the treatment of bacterial infections, but they are much safer and undergo rigorous testing and regulation before being approved for use.
Speaker: Peter Pekos, Dalton Pharma Services. Part of the MaRS Best Practices Series.This session, led by seasoned industry experts, will explore how to effectively set up your pre-clinical POC studies, address pre-clinical safety requirements and issues, and give you an overview of the manufacturing standards required for Phase I studies
More information: http://www.marsdd.com/Events/Event-Calendar/Best-Practices-Series/ind-05132008.html
Presentation by NEPAD Agency on the African Medicines Regulatory Harmonisation made at the Euro-Africa Health Investment Conference, March 26 - 27, 2013, London, United Kingdom.
Scope of Pharmacy and Clinical ResearchMansi Pawar
By students of Sir Dr. M S GOSAVI COLLEGE OF PHARMACEUTICAL EDUCATION AND RESEARCH, Nashik
The ppt will provide wide overview of career opportunities in pharmacy and basic knowledge of clinical research.
Taking a Commercial Approach To Drug DevelopmentPharmacision LLC
Explore Target Product Profile development and commercially driven drug development strategies for early stage pharmas and drug development companies. See how to develop commercially compelling new drug candidates and increase future licensing opportunities.
New Drug Opportunity Assessments Strat Planning For Future SuccessPharmacision LLC
Pharmaceutical Business Development, Marketing and Strategic Planning Groups need an early read on opportunities, but oftentimes don’t have time or budget for extensive market research.
Pharmacision presents a step by step opportunity assessment and valuation process through a case study format.
Benefits of employing this process:
Quickly weed out projects with very low probability of commercial success,
Construct a framework for deeper dive assessments to validate and refine assumptions when greater market knowledge is needed before making go/no go decisions, Support clinical development and commercialization strategic planning, Reduce overall costs.
Presented by Dr. Tom Corr, CEO – Waterloo Research and Technology Park Accelerator Centre & Associate Vice President, Commercialization – University of Waterloo
Part of the Ontario Post Doctoral Fellowship Networking Event, October 6, 2008
TOPICS
Research Funding
Who Owns the Intellectual Property?
Commercialization Options
Dealing with VCs
Outcomes of Commercialization Efforts
The Tuskegee syphilis experiment was an infamous clinical study conducted between 1932 and 1972 by the U.S. Public Health Service to study the natural progression of untreated syphilis in rural African American men who thought they were receiving free health care from the U.S. government
This paper revisits some of the issues discussed in our 2013 presentation "Challenges in Visualizing Pharmaceutical Business Information," where we analyzed some of the unique challenges in visualizing competitive intelligence information for the pharmaceutical industry. A key challenge for pharmaceutical companies is to evaluate the competitive landscape for drug launches many years in the future, based on a combination of publicly available drug pipeline and clinical trials data and internal company knowledge. This information is often conveyed in hand-drawn PowerPoint slides, which are very time consuming to create and update as the competitive landscape changes. In this paper we'll discuss approaches to developing a toolkit to facilitate the analysis and visualization of competitive drug launch timelines, and then show how to apply the same tools to a different problem -- forecasting the patent expiration landscape.
This guide was prepared for the September 2015 Dpharm Conference in Boston as a catalyst for discussion around disruptive innovation in drug development.
The ideas transfer well to any industry and we invite you to use it next time you are needing fresh thinking.
Drug Development Life Cycle - Costs and RevenueRobert Sturm
Presentation explains the Drug Development Process in terms of time/costs from initial research to final manufacturing. It presents strategies for increasing profits/decreasing costs, shows the impact of generics and details how Information Technology fits into this equation. It uses research from DiMasi and Grabowski to identify drug costs and product revenue.
Flexible working: the competitive advantageHydrogen Group
Our recent research suggests that employers are missing a trick when it comes to flexible working.
Download the full report at www.flexibleworkingreport.com
its not my personal work presentation but taken from lecture ppt from university of San Diego, california.
Its about the drug discovery process, its development and its commercialization.
Real world data is no longer just for those trained in health economics and outcomes research — it can and will touch everyone in the pharma/healthcare space.
CBI asked industry's foremost RWD thought leaders a variety of questions to better understand how bio/pharmaceutical teams can collaborate and capture data in an aggregated form to continue to improve the value of products in development with real world, real-time data.
Real World Data - The New Currency in HealthcareJohn Reites
White paper published in June 2015 by CBI Life Sciences with interview insights from John Reites.
Real World Data (RWD) have become the bio/pharmaceutical industry’s treasure trove for information to inspire stakeholder decision-making. As an industry, professionals have increasingly been looking to RWD to not only assess the bene ts and risks of new medicines in clinical and real world settings, but also as a way to advise healthcare reimbursement decisions worldwide.
GetPersonalized! Pharma's perspective on the future, Claudia KarnbachSitra / Hyvinvointi
Pharma's perspective on the future, Claudia Karnbach, Head, Global Business Development and Licensing, Specialty Medicine, Bayer Healthcare Pharmaceuticals (USA, New York)
This is part of the MaRS BioEntrepreneurship series.
Speaker: Lynne Zydowsky, Ph.D., Managing Principal Zydowsky Consultants
* Explore the development of regulated drugs and devices
* Understand where and how value is generated in the pharmaceuticals industry
* Appreciate the interplay between science and business in a biotech company
To download a copy of the audio for this presentation, please go to:
http://www.marsdd.com/bioent/oct16
For the event blog and Q+A, please see:
http://blog.marsdd.com/2006/10/17/bringing-together-art-and-science/
Bridging the Gap between Clinical Development and Patient Access with Real-Wo...Covance
Real World Evidence (RWE) is defined by the FDA as 'clinical evidence regarding the usage and potential benefits or risks of medical products derived from analysis of Real World Data (RWD).' RWD is the data collected from sources other than traditional clinical trials. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Extended Real-World Data: The Life Science Industry’s Number One AssetHealth Catalyst
The life science industry has historically relied on sanitized clinical trials and commoditized data sources (largely claims) to inform its drug development process—an under-substantiated approach that didn’t reflect how a new drug would affect broader patient populations. In an effort to gain more accurate insight into the patient experience and bring drugs to market more efficiently and safely, the industry is now expanding into extended real-world data (RWD).
To access the needed breadth and depth of patient-centric data, life science companies must partner with a healthcare transformation company that has three key qualities:
A broad and deep data asset.
Extensive provider partnerships.
An outcomes-improvement engine to support the next generation of drug development.
Five Steps to Find your 'Beyond the Pill' Strategyexecutiveinsight
A short window of opportunity exists for pharmaceutical companies to establish indispensable beyond the pill services, which may even help them 'own' particular disease areas.
For those battling kidney disease and exploring treatment options, understanding when to consider a kidney transplant is crucial. This guide aims to provide valuable insights into the circumstances under which a kidney transplant at the renowned Hiranandani Hospital may be the most appropriate course of action. By addressing the key indicators and factors involved, we hope to empower patients and their families to make informed decisions about their kidney care journey.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
2. 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
3. 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
4. CLINICAL DEVELOPMENT PROCESS:
QUALITY, SAFETY AND EFFICACY ARE REQUIRED FOR REGULATORY APPROVAL
4
Phase 2Phase 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
5. CLINICAL DEVELOPMENT / REGULATORY PROCESS
5
Phase 4Initiation 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.
6. 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
7. 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
9. 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.
10. 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.
11. 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
12. OBJECTIVES OF TODAY
The pharmaceutical landscape is rapidly changing and the
pharmaceutical industry needs to adapt
13. To every action there is always
opposed an equal reaction.
Sir Isaac Newton, Physicist
14. 1
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
15. ‘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
16. ‘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
17. 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).
19. 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’
Prescribers
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
20. 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
21. 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
22. OVERVIEW OF AUTHORITY FEEDBACK TO
REIMBURSEMENT APPLICATIONS FOR BRAND X
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
23. 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
24. 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”
26. 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”
27. 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
Billions(ConstantDollars,Year
2000)
29. 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.
29
30. 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
31. GROWTH OF ORPHAN DRUGS
Source: Orphan Drug Report 2013, EvaluatePharma
32. HOW DO WE INCREASE THE COMMERCIAL
SUCCESS OF PHARMACEUTICAL BRAND?
- UNDERSTAND WHAT CUSTOMERS MEAN
BY BRAND VALUE
33. GENERATE THE ‘RIGHT’ CLINICAL AND ECONOMIC
EVIDENCE FOR ACHIEVING MARKET ACCESS /
REIMBURSEMENT
3
4
34. “FOREWARNED, FOREARMED - TO BE PREPARED IS
HALF THE VICTORY”*
*Miguel De Cervantes – Spanish Poet
35. HOW TO DEFINE BRAND VALUE IN HEALTHCARE?
3
6
Brand value
36. HOW TO DEFINE BRAND VALUE IN HEALTHCARE?
3
7
Brand value
= offers a clinical benefit / addresses a clinical need
37. HOW TO DEFINE BRAND VALUE IN HEALTHCARE?
3
8
Brand value
= offers a clinical benefit / addresses a clinical need
+ differentiation from standard of care
38. 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
39. HOW TO DEFINE BRAND VALUE IN HEALTHCARE?
4
0
Brand value
= offers a clinical benefit / addresses a clinical need
+ differentiation from standard of care
+ meaningful target population
+ competitive price
41. 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
42. 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
43. 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
44. 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