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Drug Development Drug Development and Discovery and Discovery Access to Essential Access to Essential Medicines De-Cal Medicines De-Cal Spring 2007- Week 3 Spring 2007- Week 3
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Drug Development and Discovery

Feb 01, 2016

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Drug Development and Discovery. Access to Essential Medicines De-Cal Spring 2007- Week 3. Roadmap. Evolution of the pharmaceutical industry Research & development pipeline: Identifying compounds Pre-clinical and clinical trials Production and distribution Marketing and sales - PowerPoint PPT Presentation
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Page 1: Drug Development and Discovery

Drug Drug Development and Development and

DiscoveryDiscoveryAccess to Essential Medicines Access to Essential Medicines

De-CalDe-Cal

Spring 2007- Week 3Spring 2007- Week 3

Page 2: Drug Development and Discovery

RoadmapRoadmap

Evolution of the pharmaceutical Evolution of the pharmaceutical industryindustry

Research & development pipeline:Research & development pipeline: Identifying compoundsIdentifying compounds Pre-clinical and clinical trialsPre-clinical and clinical trials Production and distributionProduction and distribution Marketing and salesMarketing and sales

The reality of PharmaThe reality of Pharma

Page 3: Drug Development and Discovery

Evolution of PharmaEvolution of Pharma Previously Previously

unregulatedunregulated Huge gains in Huge gains in

basic scientific basic scientific understanding the understanding the 1950s and 60s1950s and 60s

Modern drug Modern drug industry is industry is centralized in centralized in about ten major about ten major companiescompanies

Then

Now

Page 4: Drug Development and Discovery

R&D PipelineR&D Pipeline

The Players:

Basic research institutions

Small Biotech firms

Big Pharma

Contract Research Organizations

FDA

Page 5: Drug Development and Discovery

R&D PipelineR&D Pipeline

Step 1: Basic laboratory researchStep 1: Basic laboratory research Step 2: Preclinical testing after a Step 2: Preclinical testing after a

promising compound is foundpromising compound is found Step 3: Investigational New Drug Step 3: Investigational New Drug

filing with FDAfiling with FDA Three phases of clinical trialsThree phases of clinical trials

Step 4: New Drug Application (NDA)Step 4: New Drug Application (NDA) Step 5: SaleStep 5: Sale

Page 6: Drug Development and Discovery

Clinical TrialsClinical Trials

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Phase I Phase II Phase III

Non-blind experiments for

dosing

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Single blind experiments for

efficacy

Double blind experiments for efficacy

Page 7: Drug Development and Discovery

Less of a pipeline, more Less of a pipeline, more of a funnel . . . of a funnel . . .

Page 8: Drug Development and Discovery

Production and Production and DistributionDistribution

Developing Developing production production methods and methods and creating creating facilitiesfacilities

DistributionDistribution Enormous Enormous

marketing marketing expendituresexpenditures

Page 9: Drug Development and Discovery

Biologics- What are Biologics- What are they?they?

Biological products include a wide range of products such as vaccines, blood and blood components,

allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or

complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources - human,

animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge

technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of

medical conditions for which no other treatments are available.

Page 10: Drug Development and Discovery

And that means . . .And that means . . .

Traditional organic compound = Relatively

simple

Biologic compound = Significantly more

complex

Thalidomide

Hemoglobin

Page 11: Drug Development and Discovery

The $800 million pill?The $800 million pill?

Page 12: Drug Development and Discovery

Important conceptsImportant concepts

Generic drug manufacturersGeneric drug manufacturers New Molecular Entities (NMEs)New Molecular Entities (NMEs) BioequivalencyBioequivalency

Me-too drugsMe-too drugs Lifestyle drugsLifestyle drugs Second indicationsSecond indications Pharma companies are ruthless Pharma companies are ruthless

profit maximizersprofit maximizers

Page 13: Drug Development and Discovery

The Politics of PharmaThe Politics of Pharma

Organized into PhRMA Organized into PhRMA (Pharmaceutical Research and (Pharmaceutical Research and Manufacturers of AmericaManufacturers of America

Huge political lobby:Huge political lobby: In 2001 Name-brand pharma spent $75.4 In 2001 Name-brand pharma spent $75.4

million on lobbyingmillion on lobbying That same year generics spent $2.4 millionThat same year generics spent $2.4 million

The providers for a society that The providers for a society that increasingly relies on drugsincreasingly relies on drugs

Page 14: Drug Development and Discovery

The GoodThe Good

In 2004 name-brand pharmaceutical In 2004 name-brand pharmaceutical firms spent approximately $53 firms spent approximately $53 billion on R&Dbillion on R&D

New medicines generated 40% of New medicines generated 40% of the two-year life expectancy gain in the two-year life expectancy gain in 52 developed countries52 developed countries**

* F.R. Lichtenberg, The Impact of New Drug Launches on Longevity, National Bureau of Economics Research Working Paper No. 9754 (June 2003).

Page 15: Drug Development and Discovery

The BadThe Bad In 2001 an estimated 1.9 to 2.2 In 2001 an estimated 1.9 to 2.2

million Americans were driven in million Americans were driven in personal bankruptcy by health care personal bankruptcy by health care costscosts**

In 2004 pharma spent approximately In 2004 pharma spent approximately $1.25 billion per NME; in 1995 that $1.25 billion per NME; in 1995 that number was $317 millionnumber was $317 million++

* Health care costs main cause of bankruptcy, study finds, The New Standard, at http://newstandardnews.net/content/?action=show_item&itemid=1439

+R&D spending per NME Declines, Drugresearcher.com, at http://www.drugresearcher.com/news/ng.asp?id=61610-r-d-nme-spend

Page 16: Drug Development and Discovery

The QuestionableThe Questionable

Decline in the efficiency of R&D (Decline in the efficiency of R&D (i.e.i.e. less NMEs per R&D $ spent)less NMEs per R&D $ spent)

Mergers of big companies hurting Mergers of big companies hurting R&DR&D

The cost of marketing of The cost of marketing of pharmaceuticalspharmaceuticals

Direct to consumer advertisingDirect to consumer advertising The pipeline isn’t sustainableThe pipeline isn’t sustainableArrr! That be questionable,

matey