PRT Efficiency: Turbo-Charging Commercial and

Compliance Effectiveness

Benchmark Data Demonstrate PRT Impact on BusinessBenchmark Data Demonstrate PRT Impact on Business

3 Quantitative Conference Surveys

2010: FDLI – Oct; CBI – June; DIA – May

2 Podium Presentations2013: Compliance Congress – Jan; DIA – Feb

5,000 +Certification Test Scores

Center for Communication Compliance (CCC)Developed by former FDA officials (‘08-’12)

CIA and Warning Letter Analysis Input from industry experts

A Collaborative PRT Quantifiably Impacts Company Success

A Collaborative PRT Quantifiably Impacts Company Success

3

Reduce Waste

Deliver Metrics

Drive Collaboration

Create environment that protects AND grows the business

Reduce Risk(Compliance Effectiveness)

Increase Sales(Commercial Effectiveness)

Serving Patients and Public Health

Healthy Tension

A Collaborative PRT Quantifiably Fosters Healthy Tension

External ForcesRegulatory/Legal Risks•Known•Evolving•Emerging

Internal Forces

Key to Look Inside at What Makes Company VulnerableKey to Look Inside at What Makes Company Vulnerable

1. Rewrites2. Schism3. Relevance

• Reduce Waste• Create Metrics• Increase

Collaboration

The Cost of Knowledge and Process Gaps In the Millions The Cost of Knowledge and Process Gaps In the Millions

- Regulatory Knowledge Gaps

- Promotional Review Process Gaps

Intense Compliance Oversight

Promotional Review Rigor

$2M+

Hidden Vulnerability #1: Regulatory Knowledge GapsHidden Vulnerability #1: Regulatory Knowledge Gaps

40 hours lost monthly by Regulatory due to rewrites of promotional materials submitted by promotional agencies without proven acumen

More than 25% of one person’s time is lost to rewrites

● Doesn’t include time lost by Legal, Medical, Compliance or Marketing forced to handle rewrites

15 people combined from these functions =

$1 MM waste annually

Agencies spend $100K - $150K annuallyon rewrites of own noncompliant materials

Hidden Vulnerability #1: Regulatory Knowledge Gaps (con’t)

Hidden Vulnerability #1: Regulatory Knowledge Gaps (con’t)

● Based on the number of agencies, this can cost up to $1MM/brand or more annually

●Doesn’t factor in regular agency fees for material/campaign development

Why so much waste…

●Marketing and agency professionals (even senior executives) are not knowledgeable about basic regulations

● Communicating risk, reminder/disease state awareness ads, spokespeople

Vulnerability #1: Regulatory Knowledge Gaps (cont.)Vulnerability #1: Regulatory Knowledge Gaps (cont.)

● Marketing/agencies disagree with Regulatory on how to implement key initiatives within compliance● Digital and PR (media tours, releases)

● Promotional education (speaker’s bureaus, slide kits)

● Ad Boards

Brand Brand PlanningPlanningBrand Brand PlanningPlanning

Concept Concept ExecutionExecutionConcept Concept ExecutionExecution

PRCPRCPRCPRC

No opportunity to filter out

non-negotiable,

noncompliant elements

BEFORE submission

RevisionsRevisionsRevisionsRevisions Tactical Tactical ExecutionExecutionTactical Tactical ExecutionExecution

Rewrites increase

Slower output

Vulnerability #2: Agencies (& Marketing) Need Pre-ReviewVulnerability #2: Agencies (& Marketing) Need Pre-Review

Vulnerability #2: Not Every Reviewers is Seasoned (e.g., New Hires)Vulnerability #2: Not Every Reviewers is Seasoned (e.g., New Hires)

● Dozen plus review parameters can determine if piece is compliant (200+ queries = core)

● Review comprehensiveness/efficiency easily derailed:

■Typically go line-by-line during in-person review

meetings – would benefit from a “Heat map” to prioritize disagreements

■Spend time looking for government documents to prove their point – would benefit from easier access

■Experience redundancy/duplication of comments – would benefit tools that help reviewers “swim in own lane” without silos

■Level of review experience – new hire, junior

1. Leadership and commitment by senior management

2. Alignment between promotional regulatory compliance and marketing communications

3. Monitoring and auditing

4. Enterprise risk management

5. Disciplinary programs and corrective action protocols

Alignment Sustains Competitive Advantage in Compliant Culture

Alignment Sustains Competitive Advantage in Compliant Culture

Myths/Misconceptions Affecting Collaboration

Examples of Misaligned Beliefs

  Compliance thinks: Commercial thinks:

On goals and objectives

They don’t understand the implications of non-compliant materials

They doesn’t understand that my sales forecast is going to be really difficult for me to achieve this year

On being under pressure

I can be held personally responsible if we get in trouble, which can result in fines or even jail time 

I’ll get a bad review and no promotion if I don’t make my numbers

On adequate information

Some claims/promotional themes are simply not negotiable as they are emphatically violative

We are at a disadvantage when competitors promote in ways that we’re not allowed 

On communication

They think I can always give them an instant answer

They say no before they even listen to the idea

On moving forward

We seem to have the same conversation over and over

They don't give me alternatives

Increase marketing budget X% by converting wasted agency fees to production of more promotional materials

PRT Can Prove Its Value to Business With MetricsPRT Can Prove Its Value to Business With Metrics

Increase # of promotional campaigns/materials approved by team X% without compromising review comprehensiveness

Brand Brand PlanningPlanningBrand Brand PlanningPlanning

Concept Concept ExecutionExecutionConcept Concept ExecutionExecution

PRCPRCPRCPRC

Filter out non-negotiable,

noncompliant elements BEFORE

submission

RevisionsRevisionsRevisionsRevisions Tactical Tactical ExecutionExecutionTactical Tactical ExecutionExecution

Rewrites minimized

Faster output

Reduce Number of Non-Compliant Materials From Entering SystemReduce Number of Non-Compliant Materials From Entering System

Effective Collaboration is CrucialEffective Collaboration is Crucial

Needed to createenduring cultural change

Key for strategic thinking, listening, coaching, cross functional knowledge, softer skills

Critical to break down silos

Address root cause for collaboration challenges

The path forward requires a change in behaviors and attitude in order to successfully affect behaviors and cultures across functional boundaries to match the business objectives

Contact InformationContact Information

Ilyssa Levins, PresidentCenter for Communication Compliance (CCC)

ilevins@communicationcompliance.comp: 212-361-9868, f:212-980-3760

www.CommunicationCompliance.comwww.Twitter.com/ILatCCC