expectation from industries proposals from r&d head club · “part of multi-country . ......

1

Expectation from IndustriesProposals from R&D Head Club

Akihisa Harada MD., Ph.DExecutive Director, Clinical Research

Pfizer Japan Inc.

February 26, 2008Kitasato-Harvard Symposium

2

The changing pharmaceutical industry environmentin Asia

Japan’s capability in drug development in future

Japan needs R&D investment from inside and outside of Japan

The way forward for Japan’s pharmaceutical industry

Agenda

3

Asian countries Offer Advantage in Clinical Trials and Obtain Huge Investment from Outside

Asia offers unique opportunities for major pharmaceuticals.More and more outsource from Western countries to the regionThis has become a critical component for the countries’ bioscience infrastructure

4

Expansion of Global Companies Establishing Research and Development Bases in Asia

Established an R&D center in Shanghai

2007

2007Established an R&D center in Shanghai with an investment of 100 million dollars

2002Established a research base in Shanghai

2007R&D investment in ChinaEli Lilly

2005Pfizer

2006Established a research based collaboration in IndiaMerck

2004Established an R&D center in ShanghaiRoche

Set up an R&D center (CEDD) in neurodegenerative disease in Shanghai

GSK

Novartis

AstraZeneca

TimingDescriptionsCompany

Source: Becoming a More Competitive “Drug Discovery Venue” －The Current State of the Pharmaceutical Industry, and Problems Therein－ (May 2005, Office of Pharmaceutical Industry Research)

5

Pfizer、South Korea as one of core Research Sites in R&D

“Pfizer Inc. has decided on South Korea as a Center of Research excellence together with North America, France and Poland.”

“ Pfizer will not only develop drugs here but also invest in a center for PK/PD modeling.”

“ We are working closely with highly talented researchers for new candidates for early development.”

Mr. Armet GoksunCountry Manager in Pfizer Korea

- 朝鮮日報（Chosun News: Jan 21,2008）

6

Japan’s Drug budget: No increase Over the Past 10 Years

Source: MHLW published data

Japanese Medical Fee and Drug Costs

21.823.5

20.4

25.827.0

28.5 28.9 29.630.7 30.1

31.1 31.0 31.5 32.1

5.2 5.1 5.3 5.4 5.7 5.6 5.7 5.5 6.0 5.9 6.3 6.4 6.5 6.6

29.528.0 28.5

26.127.0

24.523.3

20.1 19.6 20.2 20.6 20.721.9 21.5

0.0

5.0

10.0

15.0

20.0

25.0

30.0

35.0

1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 20040.0

5.0

10.0

15.0

20.0

25.0

30.0

35.0

National Health Care Cost Drug Costs Drug Costs as a proportion of Health care costs

(in trillions of yen)

7

Japanese pharmaceutical market is large, but ….

0

10000

20000

30000

40000

50000

60000

Japan

Austral i

aChina

Korea

Taiwan

2004 2006

Source: IMS World Review

Market trend of Asian countries

10%24%US

D M

M

8

Which path are we going to take?

High

Low

Degree of globalizationLow High

Cap

abili

ty a

nd s

kill

in d

rug

deve

lopm

ent

“Some of EU countries”

1

2

Japan today

“Part of multi-country development center in specific disease area”

3

“ % of Japanese patients in the guideline “

“ regional approach “

Source: MacKinsey report

9

– Primarily focused on local programs with limited participation in global trials. Initiate global participation

– Regional leadership to plan and run the trials for Asian subject in global trials particularly Asian specific diseases such as liver cancer, hepatitis and gastric cancer

– Local expertise to operationally contribute to global trials

– Less initiation of clinical trials

1 Japan today

3

Part of multi-countryDevelopment Center

2

Some of EU countries

Which path are we going to take?

10

Comparison of the Science and Technology Budgets (Life Sciences) of Japan and the US

予算

額（日

本：億

円、

米国

百万

ドル

）

Source: Becoming a More Competitive “Drug Discovery Venue” －The Current State of the Pharmaceutical Industry, and Problems Therein－ (May 2005, Office of Pharmaceutical Industry Research)

0

5000

10000

15000

20000

25000

30000

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

US Japan

Budgets (units: Japan: in hundreds of

millions of yen; U

S: in m

illions of dollars

Japan has much less budget for life science

11

Source: Becoming a More Competitive “Drug Discovery Venue” －The Current State of the Pharmaceutical Industry, and Problems

Therein－ (May 2005, Office of Pharmaceutical Industry Research)

Japanese Companies are Also Pursuing Overseas-First Development Strategies

40.4 38.2 36.0

21.2 21.612.6

38.5 40.251.4

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2003 2004 2005

Overseas-first/only

Simultaneous

Japan-first/only

The percentage of approvals overseas or in Japan

12

Japan needs R&D investment from inside and outside of Japan

-The age of relying on the central government tofund growth is over

- Growth through innovation in R&D is needed- Partnership with the region

- Investment into Japan is the key for our future- Increase pipeline and initiate trials in Japan- Not by regulation but by incentives-“Drug lag” will be resolved

Environment

Investment

13

R&D investment in major companies (2006)

904

930144314661661

30673109

39024783

53495271

55606366

71257599

0 2000 4000 6000 8000

Otsuka

Eisai

Astellas

DaiichiSankyo

Takeda

BMS

Wyeth

AstraZeneca

Merck

Novartis

Roche

SanofiAventis

GSK

J&J

Pfizer

Million $Source： JPMA DATA BOOK 2008

15

Responding to the Increased Level of International Competition in the Drug/Medical Device Industry

New Health Frontier Strategy

Growth Acceleration Program

Innovative Drug/Medical Device Development 5-Year Plan

“Big-Boned” Structural Reform Policy 2007

Innovation 25

Economic Growth Strategy Policy (revised)

Drug Industry Vision/Medical Device Industry Vision

Cabinet

METI

Cabinet

Cabinet

Cabinet

MHLW

MHLW

Reference: Materials distributed at the July 2007 Silver & Health Care Business Academy Strategy Special Seminar

16

Three key components for future growth through Innovation- The Way Forward for Japan’s Pharmaceutical Industry

Japan todayInfrastructure

1Review and

approval

2Personnel

development

3

2

Part of multi-country development center

1

17

Competitive site performance in Asia• Rapid startup• The enrollment of large numbers• Data quality and subject retention• Cost effectiveness

- Issues in Japan• Low EDC usage and cost performance• Unclear role and responsibility between the sites/sponsors • The number of doctors is less• No understanding of Hospital management• Challenge in English protocols

1. Infrastructure


18

EDC is still not widely used in Phase 2/3 studies in Japan

EDC use in Phase II/III studies (including Phase I studies for patients) conducted in Japan (including multinational studies ) and only in foreign countries.

Source: R&D Head Club Internal Survey Results (2007)

0%100%20

75 <= % 50 <= ～ < 75 % 25 <= ～ < 50 % 0< ～ < 25 % 0 ％

Japan

0 0 0 02 3

0 0 0 0

1

2

0 0 02

1

5

2 36

4

8

6

16 1512 12

5

1

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2002 2003 2004 2005 2006 2007

Foreign

1 1 1

46

9

0 03

2

3

5

02

2

4

4

1

7

6

7

4

42

8 75 4

0 0

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2002 2003 2004 2005 2006 2007

19

Japan is still expensive

0 5000 10000 15000 20000 25000 30000 35000

Infectious disease

Maligant Tumor

Nuropsychiatric

Digestive/Metabolic

RespiratoryWest (U.S., Canada, Western Europe)

Japan

US $West: First Track 2006Japan: R&D Head Club 2006 Survey

Mean cost per patient in clinical trials by therapeutic area , 2000-2005

Exchange Rate $ 1=¥ 110.1

20

Sharing Sponsor’s expectation with clinical trial sites for more efficient way of clinical trial

i. Our expected level as global level in clinical trialii. Role and responsibilities between investigator/site and

sponsoriii. Expectation to investigator, CRC and clinical trial

administrative office

The document to clarify roles and responsibility between sponsors and investigator site is ready to go

21

• “Japan specific issues” still remain in review and approval process:

• Harmonization of preclinical data• Harmonization of post approval clinical trialsor survey for all cases?

• CTD content and revision request of dossier during the review process

- huge resource required both PMDA and industry• “Regional approach” rather than country??

2. Review and Approval


22

“Regional approach”The Need to Strengthen Ties in Asia

• Geographical Conditions• Rapid Economic Development• Utilization of Abundant Manpower• Similar Ethnic Characteristics

2. Review and Approval


23

Japan is losing “competitive edge”

• International personnel development- Share higher education in the region- Personnel exchanges - global employee- Competitive personnel

Japan’s ‘edge’ threatened bydrop in students abroad: expert Japan Times May 15, 2007

3. Personnel development


24

The changing pharmaceutical industry environment- Asian countries offers advantage in clinical trials

Japan’s capability in drug development in future- There’s no growth in drug budget in current Japan, but

which path are we going to take for future?

Japan needs R&D investment from inside and outside of Japan- Set up environment to encourage global Pharma to

invest in Japan

The way forward for Japan’s pharmaceutical industry- Infrastructure, Review and approval and Personnel

development

Conclusion

expectation from industries proposals from r&d head club · “part of multi-country . ......

Documents