Frequently Asked Questions

Life Science Leader and Outsourced Pharma's readers have told us about their struggles in efficiently vetting potential CDMO partners. In response to this input, the CDMO Leadership Awards were developed.

Based on research from Industry Standard Research’s Contract Manufacturing Quality Benchmarking annual online surveys, 72 contract manufacturing organizations were evaluated on more than 23 different performance metrics. Research participants were recruited from Pharma and Biopharma companies of all sizes and were screened for decision-making influence related to working with contract manufacturing suppliers. Respondents only evaluate companies with which they have worked on an outsourced project within the past 18 months. This level of qualification ensures that quality rates come from actual involvement with a business and that companies identified as leaders are backed by experiential data. CDMOs have an opportunity to win these awards in up to three groups of outsourcing respondents – Big Pharma, Small Pharma, and Overall (combined Big and Small Pharma).

ISR survey participants were asked to provide an expectation rating for each CDMO they have worked with in the past 18 months. Points were then totaled for a combined score for each attribute and a composite score for each core category was determined. Winning CDMOs were determined when comparing their overall score vs. the competitive set.

To learn more about ISR's industry reports, customized research, or to be included in future CDMO Quality Benchmarking annual surveys, visit isrreports.com or contact ISR at info@isrreports.com.

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Outsourced Pharma provides the biotechnology and pharmaceutical industry with unique analysis and exclusive content for the advancement of drug development and manufacturing outsourcing. Explore with us the business and personal relationships between drug sponsors and service providers, and our positions in the global biopharma industry, and healthcare systems.

ISR is a full-service pharma market research firm that delivers relevant and trustworthy insight into the complex and dynamic pharmaceutical environment. The high-quality market research enables confident tactical and strategic business decisions. ISR produces syndicated industry reports and offers custom research and consulting services.

Capabilities

1. All facilities fully owned
2. Complementary core competencies to in-house or other manufacturing contractors
3. Facility has most up-to-date manufacturing technologies
4. Full range of manufacturing for the dosage forms we require
5. Has capacity to meet our demands
6. Offers innovative solutions
7. Proven ability to manufacture API
8. Provides regulatory support for filing
9. Stability testing capabilities; storage capabilities

Compatibility

1. Access to desired markets
2. Accessible senior management
3. Complementary core competencies to in-house or other manufacturing contractors
4. Cultural fit
5. Financial strength/stability
6. Timely project communications
7. Well-regarded within the industry

Expertise

1. Ability to smoothly scale up manufacturing and transfer technology
2. Experience level of staff
3. Offers innovative solutions
4. Provides regulatory support for filing
5. Scientific knowledge
6. Strong regulatory track record

Quality

1. Right first-time measurements
2. Strong regulatory track record
3. Track record for meeting quality-performance metrics
4. Up-front contingency planning, risk management

Reliability

1. All facilities fully owned
2. Financial strength/stability
3. Flexibility to adjust schedule for special requests
4. Has capacity to meet our demands
5. Reliable on-time delivery
6. Timely project management
7. Up-front contingency planning, risk management

Service

1. Preformulation/formulation support
2. Process development and optimization
3. Analytical services, including stability and storage testing
4. Regulatory support

The survey for the CDMO Leadership Awards is conducted in the fourth quarter of the prior year.

Participants are recruited from biopharmaceutical companies of all sizes and are screened for decision-making influence and authority, as well as their areas of outsourcing expertise. Respondents only evaluate companies with which they have worked on an outsourced project within the past 18 months. ISR uses an “Industry-random approach.” Results are impartial because CDMOs do not have input on which customers evaluate their performance.  To be considered for inclusion to take the next available survey, please contact ISR directly at info@isrreports.com.

To be evaluated, a CDMO must manufacture API or drug product. CDMOs with commercial capabilities and those with development/ clinical batch sizes only are equally eligible for evaluation. Because evaluations are based on participant experience, CDDMOs must have been engaged in outsourced projects for at least the past 18 months. This level of qualification ensures that quality ratings come from actual involvement with a business. ISR works to maintain a current list of CDMOs and their services for inclusion in the survey. To be considered for inclusion in the next survey, please contact ISR directly at info@isrreports.com.

There is no cost to be included in the survey. For winning CDMOs, there is no cost to have a profile included in the awards supplement. The intention of this annual supplement is to provide Life Science Leader and Outsourced Pharma's industry readers with a resource they can use to vet CDMOs using feedback from other sponsor companies (their peers) who are utilizing outsourcing services.

Primary market research by Industry Standard Research (ISR) is the basis of the awards. ISR is able to identify outsourcing trends, CDMO selection drivers, and CDMO performance by molecule and stage of manufacturing. This is highly valuable to CDMOs – especially those with a diverse offering – that are able to gain insight into their performance on a granular level. For further details on your company’s performance in the survey that supports the CDMO Leadership Awards, please contact ISR directly at info@isrreports.com.

First of all – Congratulations! Please email cmoawards@lifescienceleader.com and we will be happy to send you all of the necessary information to promote your company’s hard earned achievement.

Yes! Digital copies are available for purchase at isrreports.com/reports. There are four reports in the suite – small molecule API, small molecule drug product, biologic API, and biologic drug product. Separating drug substance from drug product and small molecule from biologic manufacturing work enables an in-depth view of CDMO’s performance.

Each of ISR’s contract manufacturing quality benchmarking reports include seven major sections:

• Outsourcing philosophies and practices
• Provider perceptions and interactions
• Provider selection drivers
• Provider performance and scorecards across attributes
• Provider loyalty
• Company service quality profiles
• Study data

Company size plays a role in a sponsor’s service needs, budgets, and expectations when it comes to outsourcing. Therefore, participant responses are analyzed across three dimensions: big pharma ($1B + R&D), small pharma, and overall. By recognizing winning CDMOs in this way, the designations better serve sponsors in vetting potential partners.