PPD’s Proposed IPO Comes Amid Growing CRO Market, Industry Expert Says

President of Industry Standard Research Andrew Schafer explains why the time may be right for PPD to re-enter the public market. “You have some big firms in there,” he said, referring to the sector. “Probably one of the reasons for the timing is that the CRO market does continue to grow, and Wall Street likes … Continued

IRB Performance and Best Practices in Site Start Up: Review of Two Recent Market Research Reports

ISR reviewed findings from two recent, high-profile pieces of market research in our October 29th webinar. One details the performance of specific IRBs in the clinical development space across such metrics as timeliness and responsiveness of protocol review and local IRB/regulatory knowledge. This report also highlights trends impacting how companies interact with IRBs—mainly the need … Continued

Report Projects Spending & Outsourcing To Drive CRO Market Growth

President of Industry Standard Research Andrew Schafer talks with Life Science Leader about the state of the CRO market, and why it has seen continued growth even as the S&P 500 fell by 6% in 2018. Most of this growth has and will continue to come from three areas, an increase in the number of … Continued

Areas Of Growth For Oral-Dose Outsourcing

Outsourcing growth is predicted across all sponsor groups Vice President of Market Research at Industry Standard Research Kate Hammeke discusses outsourcing trends from the results of a recent oral dosage survey with Life Science Leader. In fact, across all sponsor groups, respondents predict increases in the proportion of oral-dose manufacturing that is outsourced. For clinical … Continued

Improving Outsourcing Relationships

Vice President of Market Research at Industry Standard Research Kate Hammeke talks with Life Science Leader about the practices that can improve communication and trust between sponsors and CMOs. Sharing information doesn’t always come naturally in outsourcing relationships. This may be rooted in the early days of outsourcing, when there were more concerns about compromising … Continued

Outsourcing Motivations Should Guide One’s Outsourcing Approach

Vice President of Market Research at Industry Standard Research Kate Hammeke explains why outsourcers should focus on the reasons their company is outsourcing before considering selection criteria or specific companies. From Life Science Leader: Let’s say your organization has internal manufacturing capabilities, but not enough available capacity. As a result, your company engages a CMO … Continued

The Status Of mHealth In Clinical Trials: Trial And Error

President of Industry Standard Research Andrew Schafer speaks with Clinical Leader about how larger companies are forging ahead with mHealth implementations, but barriers are still preventing others from investing in mHealth use. “Trial-and-error” is how I would describe the current use of mHealth in clinical trials. We see pockets of companies that are fully “in” … Continued

Influence Of Size In CRO Selection

Vice President of Market Research at Industry Standard Research Rebecca McAvoy discusses whether the company size of a CRO has an impact on its therapeutic expertise, and by extension, an impact on outsourcing selection. CRO selection. Whether you’ve been in the business of clinical trials for two years or 20, this process often remains onerous, … Continued

Are Preferred Provider Agreements the Best Model For Outsourced Manufacturing?

PPAs are used by the majority of outsourcers Vice President of Market Research at Industry Standard Research Kate Hammeke discusses preferred provider agreements with Life Science Leader, detailing why they’re so popular with innovators. At the same time, ISR has observed an increased use of preferred provider agreements as well as a greater proportion of … Continued

Standing Out In The Crowded Biopharmaceutical Contract Manufacturing Market

Andrew Schafer (moderator), Kevin Olson, (interviewer) and Kate Hammeke (subject expert) from Industry Standard Research share data and insights from our CDMO Quality Benchmarking reports that will help CDMOs to better understand how to move their position in the competitive landscape. Here we’re showing some data on outsourcing drivers from our biologic API benchmarking study, … Continued

How Will mHealth Benefit Clinical Trials?

VP of Market Research at Industry Standard Research Kate Hammeke discusses how mHealth technologies are currently used in clinical trials, and why they could possibly make a larger impact in the near future. The mHealth experts with whom ISR spoke relayed several ways in which they believe mHealth will transform clinical development, from the ability … Continued

How Services Marketers Can Own Their Performance Measures

CEO of Industry Standard Research Kevin Olson describes how marketers can take control of the ways in which they are evaluated. Services marketers are often not evaluated on actual marketing performance. The lack of objective and relevant performance measures can limit respect for the marketing function and influence within the organization, and that’s problematic. Instead, services … Continued

The Evolving Landscape Of Medical Science Liaisons

Editor Anna Rose Welch at Biosimilar Development discusses the role MSLs play in the pharma industry, and how it will evolve. Quite often in this industry, we refer to education as a singular initiative put together by one organization or a collaborative effort amongst several stakeholder organizations. Each biosimilar company is no doubt involved in putting … Continued

For CRAs, There’s Less Turnover Than You Might Think

Editor Ed Miseta at Clinical Leader discusses CRA compensation and the CRA/RBM relationship. In 2015, risk-based monitoring (RBM) was making waves. That year Industry Standard Research (ISR) published an infographic which stated, “Increasingly sophisticated EDC capabilities, declining R&D productivity, and new regulatory guidance combined to create the ideal time to implement Risk-Based Monitoring.” Not everyone was … Continued

New Data And Analysis On Biopharma Capacity

Chief Editor Louis Garguilo at Outsourced Pharma speaks with Industry Standard Research VP Kate Hammeke about how the newly released Biologic API Contract Manufacturer Quality Benchmarking (4th Edition) data bear on the concern about bioprocessing capacity shortage. Among the remaining responders to this question about a concern for bioprocessing capacity at CDMOs, 37% answered “Maybe.” … Continued