Industry Research

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.

Are Oral Dose Manufacturing Projects Becoming More Complicated?

Has the complexity of oral dose manufacturing projects changed in recent years? Are CDMOs evaluated on the same metrics for simple and complex oral dose manufacturing projects? Data from ISR’s new report provides insight on these questions and more.

Preferred Provider Type By Clinical Research Phase

In a recent survey focused on clinical development outsourcing, respondents were asked which provider type they would choose if the choice were completely up to them.

Top Five Clinical Development Outsourcing Costs

In a recent survey focused on clinical development outsourcing, respondents reported that their companies outsourced, on average, 61% of their clinical development activities.

Interest In Hybrid Trials Increases

While outsourcing respondents currently hold mixed opinions on conducting hybrid trials, over two-thirds either currently use or plan to use them in the next two years.

Outsourcing Drivers For Small Molecule Manufacturing

ISR’s recent survey of small molecule outsourcers found that the majority of respondents outsource for one of two reasons: for all of their manufacturing needs, or to augment their internal manufacturing capacity.

Insights On How Outsourcing Decisions Are Made

How does your company’s approach to making outsourcing decisions compare with others in the industry? Data from ISR’s CDMO outsourcing models report highlights common practices that, when adopted, may improve outsourcing outcomes from drug innovators’ perspectives.

Sources For Clinical Outcome Reporting And Assessments

In a recent survey of respondents familiar with eCOA and ePRO systems, ISR asked about respondents’ past and projected use patterns regarding both the source of clinical reported outcomes and the source of clinical outcomes assessments (COAs).

CMOs Continue To Exceed Sponsor Expectations

ISR explains how the CMO Leadership Awards and the corresponding market research data can be used to make more informed CMO selection decisions and by contract manufacturers to optimize operational and marketing strategies.

Number Of EDC Systems Used — Current And Projected

In our most recent survey of EDC users, respondents indicated they are currently using 2.4 EDC systems on average to conduct their companies’ clinical trials.