 |
Printer Friendly
Printed from http://www.researchandmarkets.com/reports/1055719
Pharmaceutical Science Exellence: CMC Activities, Resources, and Performance
|
Description: |
This study was conducted to better understand resource and investment levels, expertise, and activities in global (pre-launch) Chemistry, Manufacturing and Control (CMC) operations in top pharmaceutical companies. This data-rich study provides numerous operational benchmarks around CMC facilities in terms of number/geographic locations, types of CMC activity performed, and FTEs by function and advanced degrees. The research also delivers benchmarks around number of projects, batches processed and timeframes for CMC activities. Other topic areas include capabilities & expertise and performance & measures. This study is intended to provide executives with data to assess the effectiveness and efficiency of their CMC operations and provide insights to improve drug development programs.
Note: Data for this study is presented in two segments – A Total Benchmark Class containing all participants and a Top 30 Segment, containing those companies that are among the Top 30 by revenue
KEY TOPICS:
- Scope of Operations - Activities - Facilities - Resources and Education Levels - Outputs and Development Timeframes - Capabilities & Expertise - Performance and Measures - Efficiency Ratios - Lessons Learned
KEY METRICS:
- Percent of Activities Outsourced - Number of Labs/Plants - Type of Labs/Plants - CMC FTE Data - Percent of FTEs Located at Central R&D Location - Percentage of FTEs in Each CMC Function - Percentage of FTEs with Advanced Degrees - Number of Drug Development Projects - Number of CMC Batches - Percentage of Work Completed by CMOs - Number of CMOs Used - CMC Development Timeframes - Organizational Capabilities - CMC Performance Measures
Additionally, a number of valuable Efficiency Ratios are included:
- CMC FTEs per $100 Million Revenue - Number of Projects per $100 Million Revenue - Number of FTEs per Project - Number of Batches per $100 Million Revenue - Batches per Drug Product FTE - Batches per CMC FTE - Batches per Drug Product, Clinical and Packaging FTE - Lab Error Ratio - Out of Standard Ratio - Total DP, Clinical and Packaging FTE - Percent of Outsourced Work per CMO |
|
Contents: |
STUDY OVERVIEW - Research Objective and Methodology - Data Visualization and Interpretation - Benchmark Class - Participant Qualification - Data Views and Benchmark Class Segmentation
BENCHMARK DATA - Scope of CMC Operations - Company Revenues (2007) - Percent of CMC Activities Outsourced
CMC ACTIVITIES - Percent of Companies Performing API Chemical - Percent of Companies Performing API Biologics - Percent of Companies Performing DP Activities - Percent of Companies Performing Packaging - Percent of Companies Performing Analytics - Percent of Companies Performing Other Activities
CMC FACILITIES - Number of Labs/Plants for CMC Development - Mean Geographic Breakdown of Facilities - Facility Type Breakdown by Geographic Area
CMC RESOURCES & EDUCATION LEVELS - CMC FTEs - Percent of Total Global CMC FTEs - Percent of FTEs in Each Function - Percentage of FTEs with Advanced Degrees
CMC OUTPUTS AND DEVELOPMENT TIMEFRAMES - Number of Drug Development Projects (2007) - Number of CMC Batches - Percent of CTM Work Completed by CMOs - Number of CMOs Used - CMC Development Timeframes (in months) - API Chemical Timeframes (in months) - API Biologic Timeframes (in months) - CTM Timeframes (in months)
CMC CAPABILITIES
CMC PERFORMANCE AND MEASURES
CMC EFFICIENCY RATIOS
CMC FTEs per $100 Million Revenue - Number of Projects per $100 Million Revenue - Number of FTEs per Project - Number of Batches per $100 Million Revenue - Batches per DP FTE - Batches per CMC FTE - Batches per DP, Packaging and Clinical FTE - Lab Error Ratio - Out-of-Standard Ratio - DP, Packaging, Clinical Supply FTE - Percent of Outsourced Work
LESSONS LEARNED - Improving CMC Operations
APPENDIX - Survey Instrument |
|
Companies Mentioned |
- Johnson & Johnson
- Daiichi Sankyo
- Pfizer
- Gilead Sciences
- GlaxoSmithKline
- Novartis
- Sanofi-Aventis
- Merck
- Abbott Laboratories
- Boehringer Ingelheim
- Baxter Healthcare
- Takeda Pharmaceuticals
- Astellas
- Eisai
- Alcon Laboratories
- Solvay Pharmaceuticals
- Biogen Idec
- Bausch & Lomb |
|
Ordering: |
Order Online - visit http://www.researchandmarkets.com/reports/1055719
Order by Fax - using the order form below
Order By Post - print the order form below and send to
 |
Research and Markets,
Guinness Centre,
Taylors Lane,
Dublin 8,
Ireland.
|
|
|
 |
Page 1 of 2 Printed 25/11/2009 14:03:02 |
|
Fax Order Form
To place an order via fax simply print this form, fill in the information below and
fax the completed form to
646-607-1907 (from USA) or +353 1 6849977 (from Rest of World). If you have any questions please email help@researchandmarkets.net
Order information
Please verify that the product information is correct and select the format you require.
|
|
|
Product Name: |
Pharmaceutical Science Exellence: CMC Activities, Resources, and Performance
|
|
Web Address: |
http://www.researchandmarkets.com/reports/1055719
|
|
Office Code: |
|
OC8HJNMPMSTQQ
|
Report formats
Please enter the quantity of the report format you require.
|
|
Format
|
Quantity
|
Price
|
|
Hard Copy (Hard Back)
|
|
€11,235.00 + EUR€ 50.00 Shipping/Handling *
|
|
Electronic (PDF)
- Single User
|
|
€11,235.00
|
|
CD ROM
|
|
€11,235.00 + EUR€ 50.00 Shipping/Handling *
|
|
Electronic (PDF)
- Site License
|
|
€33,705.00
|
|
Electronic (PDF)
- Enterprisewide
|
|
€56,175.00
|
* Shipping/Handling is only charged once per order.
Contact information
Please enter all the information below in BLOCK CAPITALS.
 |
|
First Name: |
Last Name: |
|
Email Address: |
 |
|
Job Title: |
 |
|
Organisation: |
 |
|
Address: |
 |
|
City: |
 |
|
Postal/Zip Code: |
 |
|
Country: |
 |
|
Phone Number: |
 |
|
Fax Number: |
 |
|
Please fax this form to: (646) 607-1907 or (646) 964-6609 (from USA) +353-1-481-1716 or +353-1-653-1571 (from Rest of World)
 |
Page 2 of 2 Printed 25/11/2009 14:03:02
|
|
Payment information
Please indicate the payment method you would like to use by selecting the appropriate
box.
|
|
|
|
American Express
|
|
Diners Club
|
|
Master Card
|
|
Visa
|
|
|
|
 |
|
Cardholder's Name: |
 |
|
|
|
Cardholder's Signature: |
 |
|
|
|
Expiry Date: |
/  |
|
|
|
Card Number: |
 |
|
|
|
CVV Security Code: |
 |
|
|
|
Issue Date: |
/ (Diners
Club only)
|
|
|
|
 |
Please post the check, accompanied by this form, to:
Research and Markets,
Guinness Centre,
Taylors Lane,
Dublin 8,
Ireland.
|
|
 |
|
 |
Please transfer funds to:
 |
|
Account number: |
83313083 |
|
Sort code: |
98-53-30 |
|
Swift code: |
ULSBIE2D |
|
IBAN number: |
IE78ULSB98533083313083 |
|
Bank Address: |
Ulster Bank,
27-35 Main St,
Blackrock,
Co. Dublin,
Ireland. |
|
|
|
If you have a Marketing Code please enter it below:
|
|
|
Marketing Code: |
 |
|
Please note that by ordering from Research and Markets you are agreeing to our Terms and Conditions at http://www.researchandmarkets.com/info/terms.asp
|
|
Please fax this form to: (646) 607-1907 or (646) 964-6609 (from USA) +353-1-481-1716 or +353-1-653-1571 (from Rest of World)
|
 |
 |
|
|