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 with Life Science Leader about whether the company size of a CRO has an impact on its therapeutic expertise, and by extension, an impact on outsourcing selection. Where does CRO size come into play? Size undoubtedly is a factor in an organization’s ability … Continued

Are Preferred Provider Agreements the Best Model For Outsourced Manufacturing?

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 manufacturing allocated to preferred providers over the past … 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

A Combination Of Reliability, Quality, Capabilities, And Expertise Add Up To Outsourcing Success

Vice President of Market Research at Industry Standard Research Kate Hammeke speaks with Life Science Leader about the CMO selection criteria deemed most important by experienced outsourcers. Similarly, when sponsors are outsourcing small molecule work, there are four common attributes deemed “most important” between drug substance and drug product manufacturing: the two previously mentioned attributes … 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

Services Marketing: You Can’t Build A Strong Marketing Strategy On A Weak Foundation

CEO of Industry Standard Research Kevin Olson explains how marketers can elevate their credibility, the credibility of their strategy, and the overall impact of marketing plans in their organization. Is your services marketing strategy constantly being questioned, critiqued, and disrupted internally? Too often, marketers lack vital information to create an effective marketing strategy and your … Continued

Study Startup Technology Investment Pays Off

Chief Editor Ed Miseta at Clinical Leader speaks with Industry Standard Research President Andrew Schafer about ISR’s custom research report eClinical Technology Adoption and Challenges in Study Startup. My advice, based on the data we collected, would be to make sure everyone is clear as to the goals of the technology implementation. For example, is the … Continued

Decision-making Responsibilities When Outsourcing Late-Phase Studies

VP of Market Research at Industry Standard Research Kate Hammeke explains the importance of conducting decision-making process research for sales and marketing outreach. Market research categorized as DMP/DMU (decision-making process/decisionmaking unit) studies may be conducted qualitatively, via in-depth interview, or quantitatively, via web-based survey. When it comes to outsourcing aspects of pharmaceutical development and commercialization, … Continued

Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations

Editor Anna Rose Welch at Biosimilar Development speaks to VP of Industry Standard Research Kate Hammeke about our recent report Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (4th Edition). Indeed, there are already 11 percent of respondents currently selling biosimilars to their own biologic. And of the 41 percent of respondents who are currently considering biosimilars … Continued

Time To Silence Capacity Alarms For Bioprocessing?

Chief Editor Louis Garguilo at Outsourced Pharma speaks with VP of Industry Standard Research Kate Hammeke about the non-appearance of a long-anticipated capacity crunch for bioprocessing services. One thing is certain: When considering overall outsourcing capacity, there are mitigating factors at work in the marketplace. The most important is that the bigger drug sponsors have in … Continued

A Hypothetical Question About Outsourcing Services Leads To … More Questions?

VP of Market Research at Industry Standard Research Kate Hammeke reviews some interesting findings which arose from comparing a theoretical question’s responses to other survey results. The five most common answers to this unaided question offer no real surprises on their own: quality (49 percent), price/affordability (41 percent), timelines (32 percent), expertise (29 percent), and regulatory compliance … Continued

Clinical Outsourcing Models: Still A Lot Of Churn And Uncertainty

Chief Editor Ed Miseta at Biosimilar Development discusses ISR’s recent report Clinical Development Outsourcing Models (3rd Edition) with President of Industry Standard Research Andrew Schafer. Being the third edition of this report, we can really see how the clinical development industry has both changed and not changed over the past five years. One point that really struck … Continued

What Makes It So Hard To Select A CMO?

VP of Market Research at Industry Standard Research Kate Hammeke answers why sponsors regularly struggle with CMO selection as one of the most difficult parts of their outsourcing manufacturing activities. In it we asked participants an open-ended question: “In your opinion, what is the most difficult part of outsourcing manufacturing activities?” The write-in responses, in … Continued

CRO Selection Taken Seriously

VP of Market Research at Industry Standard Research Rebecca McAvoy explains why sponsors need to give an appropriate amount of attention toward choosing their service providers. The remaining 35 percent at least slightly disagreed with the statement, meaning they anticipate some level of change to their organization’s mix of CROs over the next few years. Thirty-five percent … Continued

Brand Strength And The Contract Manufacturing Competitive Landscape

VP of Market Research at Industry Standard Research Kate Hammeke explains how important it is to know your business’ competitive landscape and how that impacts your buying audience, and then to use that knowledge to inform your marketing strategies. For example, if we look at brand strength, which measures the drop-off of potential customers at … Continued

Outsourcing Relationships Benefit From Aligning CMO Expertise With Sponsor Needs

VP of Market Research at Industry Standard Research Kate Hammeke discusses how both sponsors and CMOs can improve their understanding of the link between selection priorities and performance strengths, and how aligning these attributes can impact the client-vendor relationship. It’s more than just the absence of a “magic attribute” that leads to successful sponsor-CMO relationships; … Continued

Large Or Small Molecule: Drug Sponsors Share API Outsourcing Philosophy

Chief Editor Louis Garguilo at Outsourced Pharma asks “Are there strategic and tactical differences for [Large or Small Molecule] programs when outsourcing to CMOs?” In the small molecule report (SMR), 70% of biopharma companies that use “preferred provider lists” responded that 1 to 5 CMOs make up that list; 20% said it was between 6 … Continued

Don’t Let Insufficient Data Undermine Your CMO & CRO Selection Processes

CEO of Industry Standard Research Kevin Olson offers three tips to strengthen your selection process with third-party performance benchmarking. Selecting a CMO or CRO is stressful, expensive, and time-consuming. The complexity of these supplier organizations makes them difficult to evaluate. Far too often, decision makers lack vital information to support selection decisions. But the consequences … Continued

Is CRO Consolidation Good For Pharma?

Consolidation continues in the CRO space, with the acquisition of Chiltern by LabCorp being just the latest example of top CROs expanding and increasing their breadth of offerings. As large CROs continue to acquire smaller competitors, can sponsor companies expect to benefit from this development? I recently spoke to Andrew Schafer, president of research firm … Continued

Experiential Data Sheds Light On The CRO Selection Process

Vice President of Market Research at Industry Standard Research Rebecca McAvoy explains how our experiential user data can be used to pick the best service provider for your unique needs. From Life Science Leader: For decision makers whose companies have sophisticated outsourcing processes, using peer-based data can assist in evaluating CROs. Those at larger, more … Continued

Pharma Industry Lacks Consensus On Key Attribute Of A Sponsor-CMO Relationship

VP of Market Research at Industry Standard Research Kate Hammeke discusses how greater diversity in selection criteria leads to a cloudy decision-making process because no specific criterion dominates the CMO selection decision. To help Life Science Leader’s readers understand more about these industry peers, ISR asked participants in the research to prioritize a list of … Continued

CMOs need to increase awareness of offerings, ISR reports

A “new set of leaders” emerged in the contract manufacturing organization (CMO) industry over the past year, though many remain unheard of, according to a recent report. Kate Hammeke, Vice President, Market Research, Industry Standard Research, told us drug product outsourcers are consistent in their prioritization of CMO selection attributes. “The same three attributes topped … Continued

Two-thirds of pharmaceutical manufacturing is outsourced, ISR Reports

Only one-third of manufacturing is currently conducted in-house, from development stages to after commercial launch, according a recent report. The report, published by Industry Standard Research (ISR), explained that the majority of work is outsourced – and mainly to preferred providers, who are netting the largest portion of work. According to Kate Hammeke, Vice President … Continued

Best Practices in Study Feasibility

Successfully navigating the medical, clinical, logistical and regulatory challenges associated with establishing the feasibility of a clinical trial is not easy. Insights from sponsor organizations, CROs and sites have been compiled in ISR’s Best Practices in Study Feasibility report. A particular area of interest for readers of the report are the techniques and innovations proffered … Continued

eTMF market to grow sizably over next three years, ISR reports

The adoption of eTMF solutions is accelerating – with more than 50% of investigative sites expected to have access to a sponsor/CRO eTMF application within three years. This figure is according to a recent report published by Industry Standard Research (ISR), which assessed eTMF (electronic trial master file) application access to be around 20% today. … Continued

Use Peers’ Experiences To Make Educated CRO Selections

Director of Market Research at Industry Standard Research Rebecca McAvoy discusses with Life Science Leader about how you can use data from other decision-makers to have confidence in your own outsourcing decisions. Having access to performance data from CROs’ users is crucial in making an informed CRO selection. However, it is a lot of information … Continued

The Value Of Experiential Data In Making Informed CMO Selection Decisions

Director of Market Research at Industry Standard Research Kate Hammeke explains why experiential data is more important to CMOs and Sponsors than perception-based data when determining service provider quality. The change from perception-based data to experiential data is important because it shifts the focus of the awards from a CMO’s reputation — a product of … Continued

Clinical Outsourcing Market To See Continued Growth Through 2020

You often hear that this is a good time to be in the pharma industry.  I think that is especially true of the clinical trial sector.  Despite the onslaught of bad press pharma is receiving by both politicians and the general public, advancements in oncology and other serious diseases, coupled with the focus on precision … Continued

When are CMOs used? ISR Reports

While CMOs are currently engaged mainly through tactical outsourcing, this paradigm will shift as more companies begin outsourcing to preferred providers, says ISR report. https://www.outsourcing-pharma.com/Contract-Manufacturing/When-are-CMOs-used-ISR-reports

Orphan drug boom comes with a steady stream of outsourcing

With the FDA approving a record number of orphan drugs in 2014, sponsors weren’t the only ones to reap profits from their development. https://www.outsourcing-pharma.com/Clinical-Development/Orphan-drug-boom-comes-with-a-steady-stream-of-outsourcing

Triangle CROs adopt innovative methods to recruit clinical trial patients

Companies that help pharmaceutical and biotechnology companies conduct clinical trials are increasingly focused on unclogging what can be a major bottleneck – recruiting sufficient numbers of patients willing to test an experimental drug in a reasonable period of time. The stakes are high for these contract research organizations, or CROs – an industry that is … Continued

CRO Market Size: Growth in a Flat R&D World

ISR’s reports have been featured in numerous industry publications and news sources over the years. Below is a link to Appliedclinicaltrialsonline.com’s: CRO Market Size: Growth in a Flat R&D World https://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/Blogs/CRO-Market-Size-Growth-in-a-Flat-RampD-World/ArticleStandard/Article/detail/834426

ISR Reviews Report “Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing”

ISR’s reports have been featured in numerous industry publications and news sources over the years. Below is a link to Appliedclinicaltrialsonline.com’s: ISR Reviews Report “Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing” https://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/Blogs/ISR-Reviews-Report-Risk-based-Monitoring-Industry-/ArticleStandard/Article/detail/816364

What Does the Future Hold for Clinical Monitoring?

ISR’s reports have been featured in numerous industry publications and news sources over the years. Below is a link to Appliedclinicaltrialsonline.com’s: “What Does the Future Hold for Clinical Monitoring?” https://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=810203

ISR Reports Breaks Down: 2013 Late Phase Market Overview and Outlook

ISR’s reports have been featured in numerous industry publications and news sources over the years. Below is a link to Appliedclinicaltrialsonline.com’s: “ISR Reports Breaks Down: 2013 Late Phase Market Overview and Outlook” https://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/Blogs/ISR-Reports-Breaks-Down-2013-Late-Phase-Market-Ove/ArticleStandard/Article/detail/807543

Influence of Cost in the CRO Selection Process

ISR’s reports have been featured in numerous industry publications and news sources over the years. Below is a link to Appliedclinicaltrialsonline.com’s: “Influence of Cost in the CRO Selection Process” https://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/Influence-of-Cost-in-the-CRO-Selection-Process/ArticleStandard/Article/detail/808507

ISR’s “Social Media: Best Practices and Strategic Use in Patient Recruitment”

ISR’s reports have been featured in numerous industry publications and news sources over the years. Below is a link to Appliedclinicaltrialsonline.com’s: “ISR’s ‘Social Media: Best Practices and Strategic Use in Patient Recruitment’?” https://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/Blogs/ISRs-Social-Media-Best-Practices-and-Strategic-Use/ArticleStandard/Article/detail/802212

Benchmarking Investigator Payments

ISR’s reports have been featured in numerous industry publications and news sources over the years. Below is a link to Appliedclinicaltrialsonline.com’s: “Benchmarking Investigator Payments” https://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=799327

Selection of Phase I Service Providers

ISR’s reports have been featured in numerous industry publications and news sources over the years. Below is a link to Appliedclinicaltrialsonline.com’s: “Selection of Phase I Service Providers” https://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/Selection-of-Phase-I-Service-Providers/ArticleStandard/Article/detail/788581

Optimizing Investigator Fees

ISR’s reports have been featured in numerous industry publications and news sources over the years. Below is a link to Appliedclinicaltrialsonline.com’s: “Optimizing Investigator Fees” https://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/Data+Analysis/Optimizing-Investigator-Fees/ArticleStandard/Article/detail/800011 I’m not sure if it’s just me, but we still have some work to do on the automatically generated e-mails. I’ve provided DETAILED and SPECIFIC instructions I’d like to see … Continued

Access to patient population more important than price for Phase I outsourcing, says ISR

ISR’s reports have been featured in numerous industry publications and news sources over the years. Below is a link to Appliedclinicaltrialsonline.com’s: “Access to patient population more important than price for Phase I outsourcing, says ISR” https://www.outsourcing-pharma.com/Clinical-Development/Access-to-patient-population-more-important-than-price-for-Phase-I-outsourcing-says-ISR

Strong Link Between CRO Service Quality and Financial Performance

ISR’s reports have been featured in numerous industry publications and news sources over the years. Below is a link to Appliedclinicaltrialsonline.com’s: “Strong Link Between CRO Service Quality and Financial Performance” https://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=783320

ISR CUSTOMERS