Nexavar Debuts Thyroid Cancer Indication at ASCO

By Nicole May,
Research Analyst

The ASCO abstracts are out!  Well most of them — some of the most exciting will be kept under wraps until the conference begins early next month.  One of those generating the most buzz is Abstract #4, “Sorafenib in locally advanced or metastatic patients with radioactive iodine-refractory differentiated thyroid cancer: The Phase III DECISION trial.” Continue reading

CDx Partnerships: What You Want and What You Don’t Want

For companies that don’t have an in-house diagnostics development program, especially those not focusing on therapeutic areas optimized for companion diagnostic (CDx) development, outsourcing to a diagnostic firm is a great solution.  There are many reasons why a drug manufacturer may need to outsource biomarker development.  A companion diagnostic (CDx) program is a valuable asset for any pharmaceutical or biotech company seeking to improve health outcomes and ensure that their products are provided to patients who are most likely to benefit from them.  Continue reading

Minimize Phase I Clinical Trials Delays with Early CRO Communication

Staying on schedule with planned timelines is both essential to maximizing a product’s potential and monstrously difficult to achieve.  New data that we’ve compiled in a recent study (see Figure 1) show an average of more than five months’ difference between planned and actual trial duration.  It’s clear that most of these delays are during patient enrollment, whether from low enrollment rates alone or amendments that companies end up making to the study protocol.  The exact problems that a clinical trial team runs into depend on the therapeutic area, the locations and abilities of the study sites.  But the clinical team should not discount the potential of its own expectations and communication methods to cause problems. Continue reading

Promising Oncology Drug Receives Third Breakthrough Designation from FDA

Pharmacyclics Inc. recently announced that the FDA granted an additional Breakthrough Therapy designation for its investigational oral agent ibrutinib as a monotherapy to treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with deletion of the short arm of chromosome 17. For those keeping score at home, this is ibrutinib’s third breakthrough therapy designation. In February 2013, the FDA granted breakthrough designations for ibrutinib’s use in relapsed or refractory mantle cell lymphoma (MCL) and Waldenstrom’s macroglobulinemia (WM). Continue reading

Phase IV Patients Are a Virtue

Finding patients in a very specific disease state is difficult enough, but in the shadow of Phase III, it’s nearly impossible.  In fact, next to Phase IV, Phase III patient enrollment looks easy.  Phase IV patient recruiters are stuck competing not only with their competitors’ large-scale Phase III trials, but also with their own company’s later-stage studies. Continue reading

Companion Diagnostics: A Growing, Beneficial Trend for Pharma

The drug industry’s reliance on companion diagnostics (CDx), particularly among large companies, has grown in recent years. According to the BasePair Group, CDx Partnerships with pharma have more than doubled between 2011 and 2012. Cutting Edge Information found in its study, “Companion Diagnostics and Biomarker Development: Partnership Strategies and Benchmarks” that 38% of surveyed companies had plans to launch a CDx in the next year. Continue reading

Local Expertise is Critical Ingredient, So Fully Vet CROs Before Signing Contracts

By Shaylyn Pike,
Senior Research Analyst

Pharmaceutical companies’ global clinical development strategies are diverse, but there are some points of agreement: clinical trials in emerging markets are more successful when companies hire local expertise. Generally speaking, this often means local vendors familiar with the markets they serve. But not all vendors — global or local — are guaranteed to own the knowledge they claim. For pharmaceutical and biotech companies looking to establish and expand their presence in emerging regions, lack of experience can result in being scammed by CROs and other vendors who promise to deliver regional expertise. Continue reading

Adaptive Clinical Trials: Three Challenges that Give the Pharma Industry Pause

By Elio Evangelista,
Director of Research

The promise of adaptive clinical trials leading to significant cost savings is attractive, and many drug companies have already put the strategy into practice. But most times, companies implement adaptive clinical trial design (ACTD) experimentally, mitigating risk by applying it only during early-phase trials. Since the FDA’s 2010 guidance on adaptive trial design, many pundits (including Cutting Edge Information) have predicted an increased use of ACDT moving forward. Continue reading

Understanding Culture is Crucial for Successful Emerging Markets Clinical Trials

By Shaylyn Pike,
Senior Research Analyst

The emerging markets are not the United States, nor are they the European Union. It seems like a simple statement, but in Cutting Edge Information’s latest research on clinical development in the emerging markets, one finding rose to the top: the life sciences industry consistently tries to run emerging markets clinical trials the same way they run them in more developed markets. They just expect more favorable timelines and resource figures. Continue reading