USE AND PRESENTATION OF EVIDENCE WHILE LAUNCHING AND MARKETING PRODUCTS

Dr Piyush AgarwalDGM-Clinical Development Support

Glenmark Pharmaceuticals Ltd

Most Important Question?After exhaustive clinical development of new product what is that company (marketing) looks forward most? • Product becomes blockbuster in the market• Good market share, profit, and early return on investment

What a Clinical Researcher look during development plan?• First In Class product for that disease• Better and safe product for next in class development

But why practicing physician will change his prescription?• Patient benefits• May not be happy with available therapy due to any reason• Academic person and prefer to use available new therapy

MOST IMPORTANT MESSAGE

A clinical trial data which is not

communicated well is as good as trial

not done

Patient

CLINICAL RESEARCHERPresentations in major international congresses

Publications in peer-reviewed journals with high impact factorTrial becoming a hot topic for opinion leaders

Increased awareness among doctors

PHYSICIANBetter patient care

Newer available therapies

MARKETINGShould be able to generate market share

More number of prescriptions and increase profitDifferentiated product with distinct advantage over

existing therapy

WHO IS THE ULTIMATE USER OF CT DATA?

Physician

CLINICAL TRIAL DATA PRESENTATION

• Data should be clear and concise• Simplify the data presentation

structure, and length• Better to present data in table and

graphs• Always remember that he can

distinguish between “solid” and “weak” clinical reports

• Provide valid information only• Develop content according to audience

Process

Analyse Market and Devise Strategy

Develop the Content

Layout, Designing, Diagrams and Charts

Using Images and Illustrations

Be more resourceful

Study the regulatory and legal requirement

Do’s and Don’ts of Developing Content

DOs• Understand real market need• Accurate interpretation of data• Look for competitive advantage• Work from all angles• Seek investigator help• Create a simple, clear and

concise message • Communicate explicit benefit• Know statutory requirement

DON’TS• Irrelevant messages• Hiding any information• Misleading information• Misinterpretation of data• Showing content without

any valid reference• Using jargons or excess

words• Lack of transparency

adhere to both

Scientific research

with the spirit and

the letter of

applicable industry

codes Respect the privacy

and personal

information of

patients

Promotion must be

ethical, accurate,

balanced and must

not be misleading.

Accurate,

balanced, and

scientifically

valid data

Ethical, appropriate

and professional

with Stakeholders

Confer high

standards of

quality, safety and

efficacy

Well being of

Patient

Adhere to both the

spirit and the letter

of applicable

industry codes

2012 IFPMA* Code

*International Federation of Pharmaceutical Manufacturers & Associations

Information Available from Clinical Development Plan

• Study the IB and TPP of the product• Take out important milestone development

Clinical Development Plan

• Identify the objective• Study the efficacy data and take the message• Study graphs and charts used in the study• Use any other data collected

Efficacy Data

• Define incidence of adverse events reported in study

• Compare it with available treatment options in market (with clear references)

Safety Data

What is Physician’s Interest From the Data?

Mechanism of action of new drug

What is the safety profile of the drug compared to the available product in market?

The cardiovascular safety profile

The common adverse events with available treatment compared with new product

What is the efficacy profile and compare to available treatment?

How is the interaction with other concomitant drugs used in treatment of

the targeted indication

Preparing The ContentSeek the answer to the following questions:• What does the data mean to a doctor?• How do the data relevant to doctor?• Which conclusion can you draw for practice of medicine?

In order to achieve this:• Inspect• Examine• Scrutinize

Develop Message to answer:• What is core message?• What you want to communicate?• What is the story and value addition with this product?

Communicate Explicit Benefits

Different about the trial design

Efficacy advantage

Duration of treatment advantage

Dosage administration advantage and therefore better compliance

Cost advantage

Comparative data of other products in same class or advantage over

other available treatment

Educating Final Stakeholders

SALES FORCE

• Need gap analysis• Start with product

pharmacology• By showing more

comparative data in graphs and tables

• By organizing CMEs with more insight on recent development and role of new drug in patient management

PHYSICIAN

• Explaining product concept• Need gap analysis• Explaining the product in

detail and brief about disease

• Explaining about the terms and meaning of CT results and comparative data

• Data capture that is self explanatory

• Cost of the product

COMET Study Results*

Study: Carvedilol Or Metoprolol European Trial (COMET),

Indication: Heart Failure

Sample Size: about 3000 patients with heart failure were enrolled to receive either twice daily Carvedilol or Metoprolol for five years.

Results:• yearly mortality rates with carvedilol is 8.3% as compared to 10%

with metoprolol. • The all-cause mortality was 34% (512 of 1511) for carvedilol and

40% (600 of 1518) for metoprolol (hazard ratio 0.83 [95% CI 0.74-0.93], p=0.0017)

*Lancet. 2003 Jul 5;362(9377):7-13

Message

Results of the COMET study suggested that

beta blocker Carvedilol offer substantial

survival benefit over another widely used beta

blocker (metoprolol)

CARVEDILIOL in Heart Failure

Carvedilol patients lives longer, on the average

of 1.4 years (Lancet. 2003 Jul 5;362(9377):7-13)

ACTION Study Results*

Study: A Coronary Disease Trial Investigating Outcome with Nifedipine gastrointestinal therapeutic system (ACTION)

Indication: Clinical outcomes in patients with stable, symptomatic coronary disease

Sample Size: about 3825 patients were enrolled to Nifidipine GITS arm and 3840 to placebo arm.

Results:• Deaths reported in Nifedipine GITS were 310 as compared to

291 with placebo (p=0.41). • In the Nifedipine arm the event rate per 100 patient year was 9.32

as comapred to 10.5 in placebo arm (p=0.0012)

*Expert Rev Cardiovasc Ther. 2008;6(8):1055-1062

Message

ACTION study suggested addition of Nifedipine GITS

to the conventional treatment of angina pectoris

has no effect on major cardiovascular event free

survival. However Nifedipine GITS reduces need of

coronary angiography and interventions

Nifedipine GITS in Angina

Unique study design, size and scientific validity

Proven safety and improved outcome: 11%

additional risk reduction

Some Examples

Some Examples

Some Examples

Some Examples

Mupirocin Ointment Microsphere Adapelene

Case StudyStudy: Efficacy and Safety of new drug assumed to have immunity boosting property (OTC), a non-comparative study

Sample Size: 75

Study Type: Marketing

Endpoint: Mean change in count and percentage for primary efficacy parameters at the end of study

Results: The mean change in the efficacy results did not show substantial advantage as compared to baseline

Next Steps• Study the other efficacy endpoint data and evaluate

results• Do subgroup analysis and prepare shift tables to see

change from baseline• Study each case and see the result and prepare your

talking points• Prepare the graphs and tables to highlight the results• Prepare to have explanation of activities done