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2015 EUROPEAN MEETING OF ISMPP 1
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
MEDICAL PUBLICATIONS FOR
BETTER PATIENT CARE:
INTEGRITY, INNOVATION,AND IMPACT
20-21 January, 2015
etc.venues, St. Paul’s - 200 Aldersgate London, UK
2015 EUROPEAN MEETING OF ISMPP 2
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
PUBLICATION PLANNING
FOR ‘MATURE’ PRODUCTS Joanna Hulme
Scientific Director
The Prime Medical Group
2015 EUROPEAN MEETING OF ISMPP 3
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
Joanna is an employee of The Prime Medical
Group
Any views and/or opinions expressed by the
presenter do not necessarily reflect those of
The Prime Medical Group
2015 EUROPEAN MEETING OF ISMPP 4
Outline
• Definition of ‘mature’ products
• Considerations for publication planning
• Inputs to publication plan
• Implementation
• Agency perspective
2015 EUROPEAN MEETING OF ISMPP 5
What is a ‘mature’ product?
www.pharmexec.com
2015 EUROPEAN MEETING OF ISMPP 6
Anticipated changes in drug spending
IMS Institute for Healthcare Informatics, 2014
61%
27%
12%
52%
36%
12%
2012
US$965 bn
2017
US$1200 bn
Branded Generic Other
2015 EUROPEAN MEETING OF ISMPP 7
Challenges in publication planning
for established products
Growth in volume and
diversity
Clinical evidence sources evolve
Regional diversity
Heterogeneity of stakeholders
Quality of data?
Changes in educational needs
Diversity of
product utilisation
Types of evidence change
Resource limitations
Lifecycle plans
Integrating market
feedback
Maintaining
quality and interest
Commitment to data
transparency Publication Planning
considerations
Global – local coordination
2015 EUROPEAN MEETING OF ISMPP 8
Inputs to publication plans
for established products
Long-range
medical strategy
Medical info
requests
MSL input
Treatment landscape
Franchise / lifecycle
plan
Clinical data (sponsored;
independent; RWE)
Local or regional needs
Global Publication plan • Breakdown of stakeholders and prioritised educational needs • Publication plan educational objectives
• Outputs to fulfil educational objectives
Regular, scheduled updates Ability to facilitate rapid responses to specific clinical issues / challenges
Publication landscape
External expert
guidance
Patient feedback
RWE
External environment Internal focus
Local / regional publication plan
Local / regional publication plan
Local / regional publication plan
2015 EUROPEAN MEETING OF ISMPP 9
Implementation of publication plans
for established products
• External focus
– Consider regional / local requirements
– Ensure publication plan is addressing genuine educational needs of different markets / stakeholders
• Publication planning processes
– Need for dedicated regional / local publication plans
– Global plan and processes must consider local needs and vice versa
– Use local expertise to understand cultural issues
– Identify and prioritise strategically important publications for global
and regional needs
• Integration
– Alignment within lifecycle plans, franchise plans
• Relationships
– Ensure relationships exist and are maintained with lead investigators from cooperative groups
– Support MSLs to talk to HCPs about publication plans
2015 EUROPEAN MEETING OF ISMPP 10
Agency perspective
• Increasing complexity
• Flexibility needed in level and type of support
–Consider strategic context and support required
• Increasing need for dedicated regional support
• Practical considerations
–Expertise / training
–Budget (cost-effective working processes)
–Prioritisation (internal and external)
–Where to publish
• Realities of journal selection
–Ensuring continued quality…
2015 EUROPEAN MEETING OF ISMPP 11
2015 EUROPEAN MEETING OF ISMPP 12
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
UNDERSTANDING THE IMPACT OF
PUBLICATIONS IN SPECIALIST
AREAS: GENERIC PHARMACEUTICALS
Angela Kaya, PhD & Debra Mayo Pharm D, MHA
Teva Pharmaceuticals
Wednesday, 21 January, 2015
9:00-10:35 AM
2015 EUROPEAN MEETING OF ISMPP 13
2 0 1 5 E U R O P E A N M E E T I N G O F I S M P P
Debra Mayo and Angela Kaya are employees of
Teva Pharmaceuticals.
Any views and/or opinions expressed by the
presenters do not necessarily reflect those of Teva
Pharmaceuticals.
2015 EUROPEAN MEETING OF ISMPP 14
Generics will Represent a Larger Share of
the Market in Volume and Value Terms
Source: IMS (2013), ‘The Global Use of Medicines: Outlook through 2017’, www.imshealth.com
2015 EUROPEAN MEETING OF ISMPP 15
Types of Regulatory Application US & EU US New Chemical
Entities/Biologics Hybrid Applications Generic
Legislative Title 505(b)(1) & 351(a)
NDA
505(b)(2) & 351(k) 505(j)
ANDA
Data
Requirements
Full NDA
Clinical Studies
Required
Full 505(b)(2) Submission
A combination of new studies/pre-
existing data
315K submission still unclear
Proof of BE
Benefits Exclusivity Exclusivity No exclusivity
(except for first to generic
market)
Additional exclusivity for
orphan drug status or
pediatric indications
Non-substitutable Substitutable
EU New Chemical
Entities
Hybrid Applications Generic
EU Directive Article (8) 3 Article (10) X* Article (10) 1&2
Data
Requirements
Full submission
Clinical Studies
Required
Full Hybrid Submission
A combination of new studies/pre-
existing data
Proof of BE
Benefits Exclusivity No Exclusivity
(except for Orphan drugs)
No Exclusivity
(except for first to generic
market)
Additional exclusivity
for orphan drug status
or pediatric indications
Non-substitutable Substitutable
* Types of Applications: Article 10a Well-established use; Article 10b Fixed dose combination;
Article 10c Informed Consent; Article 10(3) Hybrid; Article 10(4) Similar Biological
2015 EUROPEAN MEETING OF ISMPP 16
Generics – Clinical Studies/
Additional Studies
• Reference countries which may require as a part of their generics application a study conducted in the reference country
– China
– Japan
– South Korea
– Russia
– Mexico
– Brazil
– Others
• Studies may be conducted as a part of a clinical waiver (dependent on country’s guidelines/requirements)
2015 EUROPEAN MEETING OF ISMPP 17
Expectations for Publications
Branded
Data Manuscripts: All data from clinical
studies are published
Review Articles: Limited only by company policy
Meeting Presentations: Determined by # of
studies and subanalyses
Focus: Drug/TA
Publication Planning: Full plan
Hybrid
Data Manuscripts: All data from clinical studies are published Review Articles: Limited Meeting Presentations: Determined by # of studies/subanalyses and interest Focus: Technology/delivery system/innovations Publication Planning: Medium – full plan, timing may be shifted dependent on ability to discuss new technology/delivery systems/innovations
Generics
Data Manuscripts: All data from clinical
studies are published
Review Articles: Very limited
Meeting Presentations: Limited (region)
Focus: Bioequivalence (BE) in specific
populations
Publication Planning: Limited to regional
planning with possibility
of global perspective
2015 EUROPEAN MEETING OF ISMPP 18
Challenges for Publications Planning
Hybrid
Timing: Organizational
commitment to generate and disseminate NEW data Budget: May be limited Risk: Increased scrutiny by innovator product owner Audience: May have limited interest
Authors: There many be a conflict with innovator product owner for biosimilars, new combinations, etc Journal: May have limited interest Opportunity: Health
economics/market access may be a focal point Unanswered topics of interest
Timing: Efficient execution of clinical trials—available data Budget: Full budget
Risk: Regulatory, legal, and compliance risk assessment Audience: Very interested Authors: Very interested Journal: Very interested for first in market/limited interest in
“me-toos” Opportunity: New drug/new therapeutic area
Branded Generics
Timing: Dependent on
reference country and reference country regulatory timeline Budget: Very limited Risk: Very limited Audience: Very limited interest/may be local or
regional Authors: Local/regional only Journal: Local/regional only Opportunity: Dependent on life cycle may be able to wrap up all regional publications in a review
article
2015 EUROPEAN MEETING OF ISMPP 19
Conclusion
• Accurate, transparent and comprehensive reporting of all clinical trial data regardless of branding or type of regulatory filing
• Use good publication practice regardless of branding or type of regulatory filing
• Refer to ICMJE for guidance on authorship for the publication of clinical trial data – PASS and Phase IV
• Need a greater rate of acceptance and more journals who accept less than cutting-edge science /clinical publications for the good of the patient
2015 EUROPEAN MEETING OF ISMPP 20
Resources
• Handoo S; Arora V, Khera D, Nandi PK, Sahu SK. A comprehensive
study on regulatory requirements for development and filing of
generic drug globally. Int J Pharm Invest. 2012 Jul-Sep; 2(3): 99-
105.
• FDA type of applications:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDr
ugsareDevelopedandApproved/ApprovalApplications/
• FDA Guidance for Industry: Applications Covered by Section
505(b)(2)
http://www.fda.gov/downloads/Drugs/Guidances/ucm079345.p
df
• FDA (draft) Guidance for Industry: Reference Product Exclusivity
for Biological Products Filed Under Section 351(a) of the PHS Act
http://www.fda.gov/downloads/drugs/guidancecompliancereg
ulatoryinformation/guidances/ucm407844.pdf
2015 EUROPEAN MEETING OF ISMPP 21
• DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human use http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf
• EMA Procedural advice for users of the centralised procedure for generic/hybrid applications http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004018.pdf
• EMA Q&A on generics/hybrid applications: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000035.jsp&mid=WC0b01ac058002708f
2015 EUROPEAN MEETING OF ISMPP 22
• State Food and Drug Administration of the People’s Republic of China (SFDA): http://eng.sfda.gov.cn/WS03/CL0768/61645.html
• Pharmaceutical and Medical Device Agency, Japan: http://www.pmda.go.jp/english/service/outline_s.html
• Korean Food and Drug Administration: http://www.kfda.go.kr/eng/index.do
• Federal Commission for Protection against Sanitary Risks (Mexico): http://www.cofepris.gob.mx/Paginas/Idiomas/Ingles.aspx
• Brazalian Health Surveillance Agency: http://portal.anvisa.gov.br/wps/portal/anvisa-ingles/anvisaingles/Home/!ut/p/c5/04_SB8K8xLLM9MSSzPy8xBz9CP0os3hTQwNfRydDRwN_N2cjA08XVzOPUF8PL08jU6B8pFm8AQ7gaADS7evoYeRh6GzgbmHp4WbgaWTp62Rm4GxgYmAA0Y2QD_F3Aco7hjqbmfsZWhib09BuOujG4_JwUDjj9zlIHo_5fh75uan6BbmhQBBhkGXiqAgAh0l8iA!!/dl3/d3/L2dJQSEvUUt3QS9ZQnZ3LzZfTUFIMkgxQzBHODlIRjBJMjlNQjYwQzA0MDA!/?WCM_GLOBAL_CONTEXT=/wps/wcm/connect/Anvisa+Ingles/Anvisa/Home
• National Center of Pharmaceutical Products Expertise (Russia): http://pharmareg.ru/content/view/18/37/
2015 EUROPEAN MEETING OF ISMPP 23
Definitions
• Branded Drug
– A brand name drug is a drug marketed under a proprietary, trademark-protected name
• Generic Drug
– A generic drug is the same as a brand name drug
in dosage, safety, strength, how it is taken, quality, performance, and intended use
– By law, a generic drug product must contain the
identical amounts of the same active ingredient(s)
as the brand name product
– Drug products evaluated as "therapeutically
equivalent" can be expected to have equal effect and no difference when substituted for the brand
name product
2015 EUROPEAN MEETING OF ISMPP 24
Definitions
• Biosimilar drug
– Highly similar versions of biologics, those medicines made from living microorganisms found in plant or animal cells
• New Molecular Entity (NME)
– An active ingredient that has never before been marketed in the United States in any form
• New Therapeutic Entity (NTE)
– A new acronym to describe a model for combining APIs, reformulating them, or developing new delivery mechanisms
• Branded Generic
– Generic drug that has a trade name
2015 EUROPEAN MEETING OF ISMPP 25
Other Issues
• Comparators
• P-values ? (driving for statistical significance or
clinical significance)
• Different regulatory and access regulations
• Health Economic data v clinical data
• US v Europe v ROW access issues
• Ability to get results published
• Access to data? 2014 move toward
transparency…
2015 EUROPEAN MEETING OF ISMPP 26
Hybrid Sector Companies Company Portfolio Examples
Abbvie Androgel, Duodopa
Shire Lialda, Intuniv
Teva Pain, respiratory, hormonal contraception
Endo International Pain, sex hormones, contraception
Novartis Tobi
Sandoz Biosimilars
Johnson & Johnson ADHD, oncology, pain
Hisamitu Topical pain killers in Japan
Actavis GI, sex hormones
Mundi Pharma Pain, respiratory
Pfizer Pain, hormonal contraception
Chiesi Fostair
Celgene Abraxane
Source: IMS (2014). The Third Sector. A Growing Opportunity in the Pharmaceutical Market?
2015 EUROPEAN MEETING OF ISMPP 27
2015 EUROPEAN MEETING OF ISMPP 28
Summary
• Heterogeneity of audience
• Regionalisation
– Variations in educational needs across
markets
• Importance of strategic focus
• Maintaining interest
• Working in a resource-limited environment
– Budgets
– Author prioritisation