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Globalization of Drug Development : Stipulation and Perceptibility Dr Deven V Parmar MD,FCP

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Page 1: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Globalization of Drug Development : Stipulation and Perceptibility

Dr Deven V Parmar MD,FCP

Page 2: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Agenda

• Overview

• Regulatory Perspective

• Global trends in Drug Development/ Clinical trials

• Global Opportunities

• Global Challenges

Page 3: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Agenda

• Overview

• Regulatory Perspective

• Global trends in Drug Development/ Clinical trials

• Global Opportunities

• Global Challenges

Page 4: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov
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Globalization Works?

• Many economist & world leaders agree that globalization is supposed to create higher living standards, increased access to foreign markets, investments & open borders.

• However, according to JS, globalization is desperately failing the 80% of the world’s population living in developing countries & 40% that lives in poverty.

Page 6: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

The Third Place: HealthCare Everywhere

• Health Care Cost are becoming unsustainable, in large part due to chronic disease epidemic fueled by unhealthy lifestyles, aging populations & increasing standards of living.

• Health Care will become more patient centric & ubiquitous – delivered wherever the patient happens to be.

• Patients who have grown increasing comfortable with empowering technologies are taking more active roles in managing their health & are demanding a different model in the third place.

Page 7: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Move to evidence based, outcomes focused, behavior driven world

Progressions : Global Life Sciences, E & Y, 2012

Page 8: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Agenda

• Overview

• Regulatory Perspective

• Global trends in Drug Development/ Clinical trials

• Global Opportunities

• Global Challenges

Page 9: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Regulatory Perspective

Page 10: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov
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Trends in Attrition

Source: Nature June 2011 Cont’d…

Page 12: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Source: Nature June 2011

Page 13: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

IND application increased 16 fold…

Source: FDA : Globalization of Clinical Trials, 2001

Page 14: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Source: FDA : Globalization of Clinical Trials, 2001

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Accessed on 22nd Nov, 2013 Clinical trial.gov

Page 16: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Location of Registered Studies

Accessed on 22nd Nov, 2013 Clinical trial.gov

Page 17: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Location of Recruiting Studies

Accessed on 22nd Nov, 2013 Clinical trial.gov

Page 18: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov
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To Do List for a Regulator…

Douglas C. Throckmorton, Deputy Director for Regulatory Programs, CDER, FDA DIA April 18, 2012

Page 21: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Douglas C. Throckmorton, Deputy Director for Regulatory Programs, CDER, FDA DIA April 18, 2012

Page 22: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Douglas C. Throckmorton, Deputy Director for Regulatory Programs, CDER, FDA DIA April 18, 2012

Page 23: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Douglas C. Throckmorton, Deputy Director for Regulatory Programs, CDER, FDA DIA April 18, 2012

Page 24: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Douglas C. Throckmorton, Deputy Director for Regulatory Programs, CDER, FDA DIA April 18, 2012

Page 25: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

EMA & FDA Initiative

Page 26: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

EMA & FDA Initiative

Page 27: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Cont’d…

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Agenda

• Overview

• Registration Requirements

• Regulatory Perspective

• Global trends in Drug Development/ Clinical trials

• Global Opportunities

• Global Challenges

Page 30: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Global use of Medicines: Outlook throu’ 2016, IMS health, July 2012

Page 31: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Global use of Medicines: Outlook throu’ 2016, IMS health, July 2012

Page 32: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Global use of Medicines: Outlook throu’ 2016, IMS health, July 2012

Page 33: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Generics will continue to dominate growth in spending in pharma-emerging markets and will account for 63% of the total market at the end of the forecast period.

Page 34: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Global use of Medicines: Outlook throu’ 2016, IMS health, July 2012

Page 35: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Global use of Medicines: Outlook throu’ 2016, IMS health, July 2012

Page 36: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Global use of Medicines: Outlook throu’ 2016, IMS health, July 2012

Page 37: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Global use of Medicines: Outlook throu’ 2016, IMS health, July 2012

Page 38: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Nature Drug Discovery 2010 March; ( 9 ) : 211 - 213

Page 39: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov
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Agenda

• Overview

• Regulatory Perspective

• Global trends in Drug Development/ Clinical trials

• Global Opportunities

• Global Challenges

Page 41: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Evaluate Pharma: World Preview 2013 Outlook to 2018

Page 42: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

IMS Asia Pacific Insight Issue 2, 2012

Page 43: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Ref: Deloitte Report : The Future of LifeSciences Industry : Strategies for Success in 2015

Page 44: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Ref: Deloitte Report : The Future of LifeSciences Industry : Strategies for Success in 2015

Page 45: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Ref: Deloitte Report : The Future of LifeSciences Industry : Strategies for Success in 2015

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Rezaie et al. Health Research Policy and Systems 2012, 10:18

Growth in the emerging countries continues to outpace the developed countries.

Page 49: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Growth in pharma - emerging markets will increase from $26Bn in 2012, to $30-50Bn in 2017, primarily due to increased access to medicines as infrastructure and health systems evolve.

Page 50: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

The U.S., EU5, Japan and China account for just under 70% of total global medicine spending

Page 51: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Increasing numbers of innovative new medicines and orphan drugs are expected to be launched.

Page 52: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Agenda

• Overview

• Regulatory Perspective

• Global trends in Drug Development/ Clinical trials

• Global Opportunities

• Global Challenges

Page 53: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Global Challenges

• Regulatory approval

• Medical Infrastructure

– Addressing adverse events

– Access to healthcare system

– Access to specialists

– Training Investigators

• Culture & Language

• Geography

Page 54: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Global Challenges

Development process in 2020

Page 55: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

EMA Roadmap 2015

Page 56: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

EMA Roadmap 2015

Page 57: Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

EMA Roadmap 2015

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Progressions : Global Life Sciences, E & Y, 2012

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Moving Ahead.

• Innovation, the ultimate engine of growth for the global provision of medicines, will see a revival of activity through 2017, with increases in the number of global innovative launches since 2010.

• Growth in pharma-emerging markets will increase from $26Bn in 2012, to $30-50Bn in 2017, primarily due to increased access to medicines as infrastructure and health systems evolve.

• Patient-centric approach will transform clinical development, as deep insights allow for more efficient product development and a better understanding of patients’ needs.

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Thank you