Industry Research

Outsourced Proportion Of Phase 2/3 Spend

ISR recently ran a survey to assess dynamics in the Phase 2/3 clinical development space. Survey respondents reported that, on average, two-thirds of their company’s spend on Phase 2/3 studies over the past year was outsourced.

Where Bioprocessing Outsourcers Stand On Capacity Concerns

Insights into bioprocessing outsourcers’ level of concern regarding current and upcoming avail-able capacity, whether they are currently facing limits, and what they plan to do about a potential shortage.

Volume Of Trials With Outsourced Clinical Logistics

ISR’s Clinical Logistics Market Dynamics report provides details on drug developers’ use of the various types of service providers available for outsourced clinical logistics.

Outsourcers Who Most Heavily Rely On CDMOs Often Lack CDMO Selection Resources

The 2022 iteration of ISR’s CDMO Outsourcing Models report relays similarities and differences in how outsourcing decisions are made at drug innovator companies of various sizes.

Predicted Changes In Outsourcing Rates For Highly Potent API

ISR’s latest research on highly potent API manufacturing asks participants whether they expect any change to the proportion of highly potent molecules in their portfolios, as well as any change to their outsourcing rate for high-containment manufacturing.

Phase 2/3 Service Provider Attributes Gaining In Selection Importance

In ISR’s recent CRO Benchmarking study, outsourcers of Phase 2/3 clinical development services were asked to identify attributes that have been rising in importance as CRO selection criteria over the past 12 months.

Preferred Provider Agreements For Phase 1 Services

Forty-two percent of respondents indicated their company has formal agreements in place, but there is a notable difference in preferred provider agreement (PPA) use when viewed through the lens of company size.

Outsourcers Send A Consistent Message In Phase 2/3 CRO Selection

Through two online surveys, one focused on the Phase 1 space and another focused on the Phase 2/3 space, recent customers have evaluated the performance of 50 CROs across 20+ attributes.

Outsourcing Differences By Company Size — Biologic Drug Substance Manufacturing

ISR split the data from its most recent Biologic API CDMO Benchmarking report by large and non-large respondents to highlight the differences in outsourcing preferences and practices.

Biologic And Small Molecule Drug Substance CDMO Selection Metrics Align

ISR’s annual CDMO Benchmarking research asks participants to identify the CDMO attributes that factor into their service provider selection decision.

Drug Product CDMO Selection Metrics Point Toward Pandemic-Induced Concern

ISR’s annual CDMO Benchmarking research asks participants to identify the CDMO attributes that factor into their service-provider selection decisions.

Medical Affairs Employee Attributes Critical to Success

ISR recently interviewed 15 individuals in Medical Affairs departments at Top 50 pharma companies to understand how they view their responsibilities, the challenges they face, and trends they are seeing in the Medical Affairs space.

Projected Growth In Commercial Biologics By Therapeutic Area

In a recent study on the market outlook for commercial bioprocessing, nearly half of respondents currently have marketed biologics to treat autoimmune disorders (47%) and cancer and related conditions (46%).

Cell & Gene Therapy Outsourcing Process Development

Half of respondents who outsource cell and/or gene manufacturing activities to CDMOs are outsourcing process development to ensure the ability to scale-up manufacturing should the therapy advance towards commercialization.

Sterile Injectable Product And CMO Volume

ISR asked respondents responsible for sterile injectable manufacturing outsourcing about the numbers and types of outsourced compounds they have in development and in marketing or foresee themselves having in five years.

Managing Trial Components: Hybrid Vs. Traditional Models

Respondents were shown a variety of trial functions and asked to opine as to whether management of each function was easier in a hybrid or traditional model or does not differ.

Experience And Capacity’s Influence On Outsourcing

ISR asked survey respondents, for each type of drug substance/drug product, select the reason that best fits your company’s capacity for, and experience with, manufacturing these components and products.

Hybrid vs. Traditional Clinical Trial Costs

In a recent survey about hybrid trials, over half of respondents reported that hybrid trials are currently more expensive to conduct compared to trials in the traditional model.

How Pharma Executives View Future Business Travel

In May Industry Standard Research (ISR) and Life science Leader asked biopharma executives about their travel expectations for the remainder of 2021. Some of that data and personal quotes is presented here.

Preferred Attributes When Selecting A Phase 2/3 CRO

Many factors come into play during the service provider selection process. One critical factor is undoubtedly the presence of preferred provider agreements.