four (pharma marketing)

7/28/2019 Four (Pharma Marketing)

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LOGO Pharmaceutical marketing


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Pharmaceutical Marketing

Multicenter Trials: A multicenter research trial is a clinical trial conducted at

more than one medical center or clinic.

Most large clinical trials, particularly Phase III trials, areconducted at several clinical research centers.

The benefits of multicenter trials include a larger number ofparticipants, different geographic locations, the possibilityof inclusion of a wider range of population groups, and theability to compare results among centers, all of whichincrease the generalizability of the study.

In many cases, efficacy will vary significantly betweenpopulation groups with different genetic, environmental,and ethnic or cultural backgrounds ("demographic"factors); normally only geographically dispersed trials canproperly evaluate this.
http://en.wikipedia.org/wiki/Clinical_trialhttp://en.wikipedia.org/wiki/Clinical_trialhttp://en.wikipedia.org/wiki/Clinical_researchhttp://en.wikipedia.org/wiki/Clinical_researchhttp://en.wikipedia.org/wiki/Clinical_trialhttp://en.wikipedia.org/wiki/Clinical_trial


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Treatment studies Randomized controlled trial

Double-blind randomized trial

Single-blind randomized trial

Non-blind trial

Nonrandomized trial (quasi-experiment)

Observational studies

Cohort study Prospective cohort

Retrospective cohort

Time series study
http://en.wikipedia.org/wiki/Randomized_controlled_trialhttp://en.wikipedia.org/wiki/Double_blindhttp://en.wikipedia.org/wiki/Single_blindhttp://en.wikipedia.org/wiki/Open-label_trialhttp://en.wikipedia.org/wiki/Quasi-experimental_designhttp://en.wikipedia.org/wiki/Cohort_studyhttp://en.wikipedia.org/wiki/Prospective_cohort_studyhttp://en.wikipedia.org/wiki/Retrospective_cohort_studyhttp://en.wikipedia.org/wiki/Time_serieshttp://en.wikipedia.org/wiki/Time_serieshttp://en.wikipedia.org/wiki/Time_serieshttp://en.wikipedia.org/wiki/Retrospective_cohort_studyhttp://en.wikipedia.org/wiki/Prospective_cohort_studyhttp://en.wikipedia.org/wiki/Cohort_studyhttp://en.wikipedia.org/wiki/Quasi-experimental_designhttp://en.wikipedia.org/wiki/Open-label_trialhttp://en.wikipedia.org/wiki/Open-label_trialhttp://en.wikipedia.org/wiki/Open-label_trialhttp://en.wikipedia.org/wiki/Single_blindhttp://en.wikipedia.org/wiki/Single_blindhttp://en.wikipedia.org/wiki/Single_blindhttp://en.wikipedia.org/wiki/Double_blindhttp://en.wikipedia.org/wiki/Double_blindhttp://en.wikipedia.org/wiki/Double_blindhttp://en.wikipedia.org/wiki/Randomized_controlled_trial


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Registration Process of New Drug1) Step-One: Clinical trials (CT)

FDA approval process begins only aftersubmission of investigational new drug (IND)application.

The IND application should provide high qualitypreclinical data to justify the testing of the drugin humans. Almost 85% of drugs are subjected to

clinical trials, for which IND applications are filed.

The next step is phase I clinical trials (1-3 years)on human subjects (~100).


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The drugs safety profile and pharmacokinetics ofdrug are focused in this phase. Phase II trials (2years) are performed if the drug successfullypasses phase I.

To evaluate dosage, broad efficacy and additionalsafety in people (~300) are the main objective ofthe phase II.

If evidence of effectiveness is shown in phase II,

phase III studies (3-4 years) begins. These phaseIII concerns more about safety and effectivenessof drug from data of different populations,dosages and its combination with other drugs inseveral hundred to about 3,000 peoples.


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Step Two: New drug application (NDA)approval

A new drug application (NDA) can be filed onlywhen the drug successfully passes all three

phases of clinical trials and includes all animaland human data, data analyses,pharmacokinetics of drug and its manufacturingand proposed labeling.

The preclinical, clinical reports and risk-benefitanalysis (products beneficial effects outweigh itspossible harmful effects) are reviewed at theCenter for Drug Evaluation and Research by ateam of scientists.


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Generally approval of an NDA is granted withintwo years (on an average), however, this processcan be completed from two months to severalyears.

The innovating company is allowed to market thedrug after the approval of an NDA and isconsidered to be in Phase IV trials.

In this phase, new areas, uses or new

populations, long-term effects, and howparticipants respond to different dosages areexplored represents the new drug approvalprocess of FDA.


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Regulatory Authorities in the World:Drug Regulatory Authority (DRAP) Pakistan

Ministry of Health (MOH) Various Countries

Food & Drug Administration (FDA) USA

World Health Organization (WHO) World

State Food & Drug Administration (SFDA)- China

New Zealand Joint Therapeutic Products Agency

Russia Ministry of Health

Japan: Ministry of Health and Welfare

Australia's Department of Health and Aged CareIndustry Commission

Therapeutic Goods Administration
http://www.jtaproject.com/http://www.mednet.ru/main/http://www.mhlw.go.jp/english/http://www.health.gov.au/http://www.indcom.gov.au/http://www.tga.gov.au/http://www.tga.gov.au/http://www.indcom.gov.au/http://www.health.gov.au/http://www.mhlw.go.jp/english/http://www.mhlw.go.jp/english/http://www.mhlw.go.jp/english/http://www.mednet.ru/main/http://www.mednet.ru/main/http://www.mednet.ru/main/http://www.jtaproject.com/http://www.jtaproject.com/http://www.jtaproject.com/


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Marketing of Generic Drugs: Era before 1790 and 1790-1850

Generic Era: 1850-1920

Branded Era: 1921-1960

Increased acceptance of Generics: 1961-present

Advent of Branded Generic: 1970s

Pakistani branded Generic Market

There were only three manufacturing units in1947 in Lahore, Rawalpindi & Peshawar (UK)

Most of European Companies made distributionsset up in Pakistan (International & Local)

In 1954 Govt. forced to MNCs for plants


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Initially MNCs Collaborated with local companies But still bulk chunk of medicines were imported

In 1954 the pharmaceutical industrial units roseto 15 and in the following year came to 31 and

by the year 1959-60 the number reached 60 In the year 1951 Schazoo becomes one of the

first Pharmaceutical companies to setup amanufacturing facility

This attracts the eye of Multinational companieslike MERCK (Germany) and JANSSENPHARMACEUTICA (Belgium) which enter intolicense manufacturing agreements with Schazoo

in 1959.


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From 1961-1970 Schazoo expands its licensingagreements by adding to its portfolio NORDMARK(Germany), CHEMISCHE WERKE ALBERT(Germany), LEPITETE (Italy), DAGRA M.V.

(Holland), UPJOHN (USA) and HENRICH MACK(Germany)

In 1972 Government of Pakistan introduces thegeneric drug scheme under which the sale was

prohibited with brand names; this forced all ofSchazoos license partners to leave Pakistan.

In 1976 the government repeals the genericschema and introduces the Drugs Act 1976.


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Marketing of Branded Generic Productsin Pakistan

Research Interface & application submission

1. Product Selection2. Market Research

3. Primary Research

4. Secondary Research

5. Dossiers Making6. Submission of File

7. Approval & Marketing of drug


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Marketing of Branded Generic Productsin Pakistan

Market of Products

1. Test Marketing2. Teasers & preliminary stage

3. Relevant Promotional material distribution

4. Products availability

5. Launching of product in teaching hospitals6. Launching on KOLs

7. Launching at all the targeted doctors

Non-Prescription Products


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Drug Development Pipeline


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R&D & Launch of Pharma Product


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R&D & Launch of Pharma Product

Definition: In vivo refers to a medical test, experiment or

procedure that is done on a living organism, suchas a laboratory animal or human.

A study done in vivo looks at how the bodyresponds to a particular substance, in contrastto in vitro studies that are done in a test tube orlaboratory dish.

Multicenter Trials Regulatory Bodies (DRA, PPMA, MoH, FDA etc.)
http://lungcancer.about.com/od/glossary/g/invitro.htmhttp://lungcancer.about.com/od/glossary/g/invitro.htm


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Drug Registration


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