Objectives of Dr Right in Y2011

Darren Hu MD

14th of June 2011

BSP Taiwan, General Management

2011 Medical Scorecard

Career Development

Shareholder / Financials Customer

增加能見度

Innovative processes to improve satisfactionAcute: infectionChronicHealth Maintenance

Leverage synergy of Ped/Family and Psy

Leadership / People

Career Development for Nurse and Doctor

Implementation of Health Consultant with competency model

Innovation / Effectiveness

• Perform co-monitoring activity to ensure the quality of our health care and critical issues have been addressed and escalated.

• Collaborate with cross- function to complete projects timely & effecively

• Provide efficient medical information service platform

1500 visits by Sep

BSP Taiwan, General Management

Widly Important Goal (WiG) of 2011

1. 領導者 ! You are a leader. Think and Act like a leader !

2. 健康顧問

3. Innovative processes to improve satisfaction

4. Provide efficient medical information service platform

5. Leverage synergy of Pediatric /Family Medicine and Psychology.

BSP Taiwan, General Management

Thanks

BSP Taiwan, General Management

Administrative

Objective – MeasuresNo. 1 增加新病患方法

1. 提供社區 ( 里辦公室、銀行 ) 生理監測服務 (Baby Box)

2. DM

3. 簡訊

4. 社區醫療保健座談 ( 里辦公室、銀行 VIP 客戶、衛生所 )

Challenges / Issues

1. Milestones are not clear set up for all studies.

2. Study status is tracked but not on weekly basis, so issue cannot be discovered earlier.

3. Contingency plan for critical issue is not completed in time.

Strategies

1. Magellan (12839): Coordinating re-monitoring activity and receive support from global team to ensure data accuracy and data lock timeline is met.

2. CHEST I&II (11348 and 11349) and PATENT I&II (12934 and 12935): complete re-feasibility and set up contingency plan to ensure recruitment for both studies are achieved in 2011.

1. Magellan (12839):

• All medical review queries closed by 30 Nov 10, Final queries closed 03 Dec 10, Last VRM queries answered 15 Dec 10, Database freeze 18 Dec 10 and Database lock 31 Dec 10.

• Have site close visits performed by 2011.

2. CHEST I&II (11348 and 11349) and PATENT I&II (12934 and 12935):

• Complete recruitment, 2 patients for CHEST and 8 patients for PATENT by 2011.

• Ensure Data entry and verification is completed within required time frame.

• Set up event dates in IMPACT and align with study timeline by Dec 2010.

• To ensure milestones are achieved in accordance with initial plan in IMPACT.

BSP Taiwan, General Management

健康顧問

Objective – Customer (1) MeasuresNo. 1 Objective

• Expedite MA process to support successful product launch

• Filing of Xarelto SPA

Challenges / Issues

• Ethnic sensitivity issue

- Low dose of Japan ROCKET study implying ethnic issue

- What’s the optimal dose for Taiwanese in SPAF?

- Taiwan ROCKET GCP violation

- Local data can’t be used to support registration

• New Non-CPP submission guideline for 2nd indication filing

Strategies

1. Gain support from global team to provide sufficient sub-group analysis report on ethnic issue

2. Plan the best timing for NDA filing & Taiwan ROCKET data submission

3. Collaborate with Pharma Association to push guideline announcement

• Filing of Xarelto SPAF in June 2011 to avoid conflicting with FDA/EMA NDA replying time

• Keep agility & fexibility in filing Taiwan ROCKET for GCP inspection to support 15/20mg is the optimal dose for Taiwanese in Q1 2012

• Quideline for new Non-CPP filing announced by Dec 2010

BSP Taiwan, General Management7

Physician

Objective – People Measures

No. 1 Objective

Align medical and business strategies with implementation of Health Consultant

Concept

Challenges/Issues

Unwillingness of job style change; form office-based to field-based

In need of comprehensive medical expertise to meet „peer-to-peer discussion“ requirement

Strategies

1. Provide incentives to motivate people to take on the job

2. Ensure suffient learning/development opportunities

3. Develop competence evaluation system for MSL

1. Adjust job grade and offer attractive compensation

2a. Organize bi-weekly or monthly journal club/ mini symposium / KOL lectures to build up medical expertise for MSL

2b. Provide opportunities to attend domestic/international academic congress/forum/workshop.

3. Setup and implement competence evaluation system to assess their qualification periodically.

BSP Taiwan, General Management

Medical Information

Objective - Customer MeasuresNo. 1 Objective

• Provide efficient medical information service platform according to BSP standard

Challenges / Issues

• Technical knowhow

• Gap between global/regional MI database

• Awareness/usage of MI database

• Shortage of dedicate FTE

Strategies

1. Implement MI 2.0 in 1Q.

2. Database introduction to all ETMS user in 1Q

3. Update FAQ according to global MI database (SHEROCK)

4. Additional FTE is required when monthly enquiries are above 50.

5. Cooperate with medial affairs to prepare local reply letter, especially the questions about off-label usage.

1. Implement MI 2.0 in 1Q

2. Training provided to all ETMS user in 1Q and new comer orientation

3. Monthly analysis of usage of MI 2.0

4. Number of official reply letter generated

5. Time to response< 3 working day

6. Total > 500 in 2011