Industry Articles

Tracking the Evolution of CDMO Selection Criteria for Biologic Drug Substance Manufacturing

Biologic drug substance developers face an ever-evolving slate of challenges related to CDMO outsourcing. As part of ISR’s CDMO Benchmarking research, respondents are asked to review a list of 28 selection attributes and to identify the one criterion most important…

Jenn Holloway

Manufacturing Supply Chain & Logistics

The Value of Strategic Outsourcing Relationships

The Evolution of Outsourcing Over the past few decades there have been considerable changes in the outsourcing environment; at the outset, pharmaceutical companies were primarily offshoring to lower-cost centers and used different contract manufacturers for different projects in a somewhat…

Kate Hammeke

Manufacturing

How Industry Benchmarks Can Inform CDMO Selection

Biopharmaceutical sponsor considerations when selecting a CDMO may include timelines, cost, regulatory requirements, capacity, quality, risks, and previous experience. To help sponsors better understand and prioritize development and manufacturing elements, ISR conducts four annual, manufacturing-specific benchmark studies that ask professionals…

Laura McWhinney

Articles

Decentralized Clinical Trials: Evolving Post-Pandemic

Decentralized clinical trials (DCTs) are studies in which some or all trial-related activities are conducted at a location separate from the investigators’ primary site. DCTs’ numerous benefits include convenience and flexibility for patients, greater opportunities for patient recruitment, increased patient…

Laura McWhinney

Articles

Sponsor Perspectives on Outsourced Clinical Trial Logistics

ISR consistently seeks to demystify the mystical, and there’s plenty of mystery regarding clinical trial logistics. How do sponsors select a provider? Which activities do they outsource the most? Where are these questions heading? To none other than ISR’s latest…

Brandon Allison

Manufacturing

Five Steps to CDMO Selection

Sponsors will see success in their CDMO partnerships by dedicating time and effort to establish a plan that identifies outsourcing drivers, to select a model that matches company needs and resources, to establish a decision-making process and group, and to…

Brandon Allison

Articles

Highly Potent API Manufacturing

Highly potent API manufacturing is a rapidly growing segment of drug development. Those familiar with HPAPI understand its specialized nature and the strict regulations surrounding it. A complicated and resource-intensive process, sponsors often find themselves in need of knowledgeable outsourcing…

Brandon Allison

Articles

Commercial Bioprocessing Market Outlook

Choosing an outsourcing partner for a commercial bioprocessing endeavor carries a gravitas that those outside that endeavor may not appreciate. Equally significant is the challenge facing CMOs in this space, many of whom are competing against larger, well-known manufacturers with…

Brandon Allison

Articles

Cell & Gene Market Outlook

I bet you can’t say “cell & gene therapies” three times fast. And by the time you do, you’ll have missed another article on your newsfeed discussing their intricacies and the headaches they can cause. Here’s one from Industry Standard…

Brandon Allison

Articles

CTMS Benchmarking & Market Dynamics

ISR’s CTMS Benchmarking & Market Dynamics (3rd Ed.) aims to tackle clinical trial management systems (CTMS) by helping providers and sponsors alike better understand current trends surrounding this technology and anticipate future ones. This report is the result of primary…

Brandon Allison

Articles

Six Questions to Ask About Your Market Research

How do you ensure the research products and services you buy will make you confident in the decisions you make? Here are six reasons why Industry Standard Research ensures you are getting the value you should expect from quality market…

Brandon Allison

Articles

2019 Year In Review – An Overview Of Insights in Pharmaceutical Manufacturing, Clinical Research and Technology

How Pharma, CROs, and CDMOs can prepare for 2020 ISR conducted approximately two dozen individual pieces of market research for syndication in 2019. This webinar summarizes many of the important learnings from these projects, providing attendees with real, usable data…

Brandon Allison

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