Understanding Drug Safety Evidence at the Global and ... · •ICH E2B (R3) •Electronic Health...

Confidential DRAFT—NOT FOR EXTERNAL DISTRIBUTION

Understanding Drug Safety Evidence at the Global and National Level A Global Pharmacovigilance Perspective

Amrit Ray, MD

Chief Safety Officer

Janssen Research & Development LLC

Disclaimer

• Presentations are intended for educational purposes only and do not

replace independent professional judgment.

• Statements of fact and opinions expressed are those of the

participants individually and, unless expressly stated to the contrary,

are not the opinion or position of the Janssen Research and

Development LLC or its affiliates.

Global Medical Safety 1

Agenda

2 Global Medical Safety

Macro landscape and trends

Global patient safety responsibilities and systems

Key considerations for CADTH

Q&A

1

Why We All Care

• Adverse Drug Reactions (ADRs) are

among the leading causes of death in

many countries.

• The majority of ADRs are

preventable.

• People in every country of the world

are affected by ADRs.

• In some countries ADR-related costs

exceed the cost of the medications.

• No medicine is risk free.

3

Source: WHO Fact sheet N°293

Global Medical Safety

Macroenvironment is Tightening & is a Rapidly Moving Target

4

Source: Nielsen report, Q3’ 2011 *Source: Nielsen report, 2011

POLITICAL, Regulatory, Legal

• China SFDA

• DSUR—September 2011

• XEVMPD—July 2012

• New EU PV Legislation—July 2012

• PDUFA IV on REMS

ECONOMIC

• Need to focus on truly meaningful requirements in the context of our unrelenting global economic crisis

SOCIAL

• Patients share ADR experiences online—not using structured reporting tools—Americans spend more time on Facebook than any other single Website*—No FDA guidance yet

TECHNOLOGICAL

• ICH E2B (R3)

• Electronic Health Records

• Genomics, epigenetics, proteomics


Examples of current considerations in 2012:

5

E.g., Genomic biomarkers,

Pharmacogenomics (PGx),

pharmacogenetics (PGt),

proteomics and metabalomics

are being integrated into global

drug development and approval

processes

Science is Changing Rapidly

5

Source: EMEA ICH Topic E15

Most important, Patients are Evolving

We All Need to Better Understand the Impact

• Of patient needs and behaviors with high global

cross-flow of information

• Of patient needs and behaviors in an era where

data availability and transparency are high

• Of medicines in groups such as children,

pregnant women and the elderly

• Of chronic usage

• Of medicines in resource-poor settings

• Of interactions with other drugs

...and many other “real world-usage settings”


Agenda


2




Q&A

Global responsibilities are incumbent on global research organizations

• For global medical innovator organizations, there is a

wide-reaching business landscape for pharmacovigilance

– e.g., For Janssen: we comprise more than 60 Operating

Companies and do business in more than 100 countries,

including Janssen Inc. Canada

• We provide safety diligence for 1000+ products & variants

• We have over 200 pharmacovigilance agreements with

partners

• Globally, our organization takes pharmacovigilance

responsibility for one ICSR (individual case safety report)

every 2 minutes. Canada has the 2nd largest ICSR volume

for Johnson & Johnson

• Pharmacovigilance & Patient Safety are our top priorities

• In an environment of high complexity, the relevant

people, systems, processes and technologies must be in

place to enable effective delivery of global

pharmacovigilance responsibilities


Key Elements of a Pharmacovigilance system

9

Medical

Decision Making

Strong Scientific

and Medical Talent

Robust Operational

Pharmacovigilance Processes


Robust Operational Pharmacovigilance Processes: Safety Evaluation and Risk Management occurs in a methodical, systematic way


Large investment in

technology from early in

development—

toxicology, SOPs, IT

platforms, etc.

Medical Decision Making: Multidisciplinary SMTs are Crucial in the Risk Assessment Process


Example of Safety Management Team* (SMT)

Janssen has ~80 SMTs in place across the

pharmaceuticals portfolio

Examples of SMT Outputs

• Determination of adverse drug reactions

• Safety-related changes to company’s reference

safety information

• Risk management strategies

• Communication to health authorities as

appropriate

• Communication to Senior Medical Safety

Governance and Decision-making Board on a

regular basis [rapid or routine escalation pathway]

• Communication to clinical trial

patients/investigators as appropriate

*Source: Crowe, Brenda J. "Recommendations for Safety Planning, Data Collection, Evaluation and Reporting during Drug, Biologic and Vaccine Development: A Report of

the Safety Planning, Evaluation, and Reporting Team [SPERT – based on CIOMS- VI]." Clinical Trials, 2009. Web.

Benefit Risk Physician

(BRP)

Biostatistics

Epidemiology

Tech Ops (ad hoc)

Pre-Clinical Safety

Legal (ad hoc)

eCTL (ad hoc)

PV MM (ad hoc)

Regulatory Affairs

Regional Physician (ad hoc)

Cluster Head

Based on CIOMS-VI

Strong Medical, Scientific and Business Talent is our Strength


Pharmacovigilance is a highly

multidisciplinary science and art!

GLOBAL

TRAINING

PARTNERS

• Asia-Pacific

• EMEA

• Latin America

• North America

• Medicine

• Science

• Business

• Int’l studies

• Industry Partners

• Health professionals

• Hospitals

• Academia

• Project Management

• Process Excellence

• Health associations

• Global Health Org

• Government & Agencies

• Media

SKILLS • Biostatistics

• Epidemiology

• Clinical & pre-clinical

• Legal

• Information technology

• Alliance management

• Regulatory Affairs

• Pharmacovigilance

• Supply chain

Our Decision Making is Based on the Credo


Agenda


3




Q&A

Risk Management is a key driver for Proactive PV


Risk Management is an approach guided by principles of

scientific rigor, transparency and ethics.

CHANGING THE MINDSET

From:

“Do we have to do this?”

To:

“This is the right thing for patients.”

ARE YOU COMPLIANT? Train your staff and protect your

facility against costly litigation,

federal and state audits and fines.

Innovative Phased Drug Launches Could Deliver Long-term Insights and Solutions


Source: "Beyond Debacle and Debate: Developing Solutions in Drug Safety." Nature Reviews Drug Discovery (2009).

CURRENT

• Passive surveillance of

real-world usage

• Phase IIIb and IV trials

• Spontaneous adverse-

events reports

Kn

ow

led

ge o

f d

rug

safe

ty p

rofi

le

Stage 1

(pre-launch R&D)

Stage 2

(on-market

development)

Stage 3

(passive learning)

Time

• Spontaneous adverse-

events reports

• Minimal clinical trials

• Infrequent aggregate

safety reporting

• Fewer clinical trials than in

early stage 2

• Frequent aggregate safety

reporting First

marketing

approval

a FUTURE

• Inclusion of

special

populations

• Adaptive

trials

• Enhanced

signal

detection

processes

Kn

ow

led

ge o

f d

rug

safe

ty p

rofi

le

Stage 1

(pre-launch

R&D)

Stage 2

(phased

launch)

Stage 3

(active on-market learning)

Time

• Active

surveillance of

real-world usage

• Safety trials

First full

marketing

approval

b

Phased

launch

Enhanced drug safety model

Traditional drug safety model

• Appropriate usage

• Phase IIIb and IV trials

• Enhanced adverse-events reports

• Proactive epidemiology

• Periodic risk/benefit analyses

Key Considerations for CADTH to Protect Patients

1. Drive more effective partnerships between industry and health

authorities, e.g., through operational consolidation of meaningful

and comprehensive safety requirements

2. Outline strategy for risk communications and education to public

and external stakeholders

3. Use non-traditional data sources for signal detection

(e.g., EHR, web 2.0)

4. Develop real-time, proactive, risk-based, personalized

pharmacovigilance


On behalf of Janssen:

I wish to sincerely thank CADTH for your commitment to

patient safety—a commitment we share very deeply.

We look forward to the opportunity to lead and support initiatives

to protect and serve patients.


Understanding Drug Safety Evidence at the Global and ... · •ICH E2B (R3) •Electronic Health...

Documents

Transcript of Understanding Drug Safety Evidence at the Global and ... · •ICH E2B (R3) •Electronic Health...