Going with the Flow: Key Flow Cytometry Challenges and Solutions at CYTO 2017

When it comes to novel drug discovery and development, flow cytometry is known for Flow Cytometer blogbeing both a powerful and versatile technology. It can deliver valuable information to advance early biomarker development, tolerability, clinical studies and even companion diagnostics. But leveraging flow cytometry technologies to answer analytical questions and empower decision making from the research lab to the clinic requires a deep knowledge of cutting-edge approaches.

Virginia Litwin, PhD, principal scientist, hematology/flow cytometry at Covance and her team are examining current trends in rare event analyses assays to ensure that performance is well characterized and fit-for-purpose – particularly in regulated environments. They are also addressing the various hurdles associated with analyzing cellular biomarkers for immunotherapy and adoptive cell therapy. Continue reading

Rheumatoid Arthritis Biosimilars: Regulatory and Clinical Considerations

Three biosimilars for rheumatoid arthritis (RA) were approved by the FDA last year, Rheumatoid Arthritis Biosimilarsbut the regulatory pathway in the U.S. is still considered a new frontier, especially when compared to regulatory guidance in the EU. With our global industry’s growing interest in developing biosimilars, it’s critical that sponsors have a clear understanding of key clinical issues and develop a strategy for navigating today’s regulatory environment. Continue reading

ELISPOT Assay: A Powerful Tool in Vaccine Development and Immune Monitoring

Over the past several years, the scientific community has made tremendous progress in advancing our understanding of the immune system, from the basic functions of its various components to molecular pathways that operate within those components. With new, state-of-the-art tools and technologies, immunologists now have the ability to better understand the mechanisms of immune response to various antigens, thereby aiding them in the development of novel approaches to treat immune-system-related diseases and better design vaccines to combat infectious agents and cancer.

Currently, one of the most sensitive techniques available for the detection, measurement, and functional analysis of immune cells is the enzyme-linked immunospot (ELISPOT) assay. Covance uses the ELISPOT technique in applications such as evaluation of vaccine efficacy and immunogenicity of biological products.
ELISPOT Circles
Continue reading

Finding the Other 90%: Attracting Naïve Patients to RA Studies

A recent study by Tufts Center for the Study of Drug Development, based on a survey of 2,000 physicians and nurses primarily in the United States and Europe, found that 91% of physicians feel ‘somewhat’ or ‘very’ comfortable discussing the opportunity to participate in a clinical trial with patients, but actually refer less than 0.2% of their patients into clinical trials.1 In conjunction, more than 80% of patients Attracting Naïve Patients to RA Clinical Studies say they are willing to participate in clinical research studies, but only around 10% actually do so.2 It is further reported that while 85% of patients are generally comfortable presenting any clinical research information they find to their doctor, only 17% have actually done so.3 And what of those patients that are interested in participating in a clinical study only to find they are ineligible? When queried on next steps after finding out he/she did not qualify, 36% stopped looking for a clinical research study to participate in.3 This latter fact is a staggering waste of potential when you consider that there are currently >130 planned or ongoing industry-sponsored Phase II-III rheumatoid arthritis (RA) studies to choose from (>210 when you consider any type of study sponsor).4
Continue reading

Patient Centricity and the Role of the CRO

Biopharmaceutical companies both big and small have witnessed the shift toward patient-centric practices in the current healthcare landscape. As a result, many are now including or planning to incorporate the voice of the patient in their drug Patient Centricity and the Role of the CROdevelopment strategy.

How do clinical research organizations (CROs) respond and support this increasing focus on patient-centric practices? We recently spoke to Jonathan Zung, PhD, group president, clinical development and commercialization services at Covance to understand his view on the patient centricity imperative and how it impacts clinical development activities.
Continue reading

A Holistic View of the Biosimilars Landscape: Key Factors for Clinical and Commercial Success

Biosimilars have dominated the headlines in the U.S. with several FDA approvals, legal battles and questions around reimbursement, placing an increased focus on  Biosimilars Landscape: Key Factors for Clinical and Commercial Successhow to successfully navigate this relatively new pathway from end to end.

Starting with the regulatory environment to CMC bioanalytics and pharmacodynamics, learn how drug developers can understand regulatory differences and identify a fit-for-purpose program. We will also cover how to proactively identify key issues for both PK equivalence and Phase III equivalence studies, and initiate market access and commercialization approaches. Continue reading

Stepping Up the Game: Measles, Mumps, Rubella and Varicella (MMRV) Concomitant Testing Support for Vaccine Evaluation

The introduction of vaccines against Measles, Mumps, Rubella (MMR), and Varicella (the “V” in MMRV vaccines) led to a drop in the incidence of these diseases by 89% (Varicella) and 99% (MMR). These effective vaccines are a core component in most pediatric immunization programs across the world. Hence, every time a new pediatric vaccine is added to the existing immunization schedule, clinical evidence must be provided that the newcomer does not adversely influence the immunogenic response to the MMRV-licensed vaccines. These required non-inferiority studies when vaccines are co-administered (known as concomitant vaccine testing) come with their own challenges.

Continue reading

Hot Topics Discussed in Covance Spring & Summer Webinars

Unlock opportunities for your clinical research programs and deliver results that Covance Spring Webinars Video Nash Diabetic Heart Biomarkersmatter.
We’re excited to be on the cutting edge of drug development solutions. Take a look at our recent webinar topics and leverage our experience.

Going Virtual: Evolving Real World Evidence Study Design for
Speed, Flexibility and Lower Cost

Using a traditional clinical-site recruitment approach is no longer the only option in observational research. With the increased adoption of electronic informed consent methods by the FDA, it is now feasible to conduct real world evidence (RWE) studies using a virtual model that eliminates entirely the need for clinical sites.

Join us to learn how to lower cost and improve the efficacy of current, site-based RWE studies as well as:

  • The implications of electronic informed consent by the FDA
  • What is required to conduct a prospective virtual RWE study
  • How to use electronic data for a retrospective virtual RWE study

September 19, 2017 | 11 a.m. EDT | Register Now

 

Continue reading

Clinical & Research Excellence Awards Shortlist Xcellerate Medical Review

Covance is excited to announce that Xcellerate® Medical Review has been named a finalist in the Clinical & Research Excellence (CARE) Awards. As a finalist in the Best Sponsor-Focused Technological Development category, Xcellerate Medical Review is Clinical & Research Excellence Awards Shortlist Xcellerate Medical Reviewbeing recognized for its modern approach to improving the clinical trial process. The CARE Awards recognize excellence across the global clinical research enterprise.

The Xcellerate Medical Review informatics product provides a critical function to study sponsors to safeguard subject safety, increase the robustness and quality of clinical trial execution, improve the reliability of investigational data and ensure adherence to ethical standards. Xcellerate Medical Review is a part of the larger award-winning Xcellerate Clinical Trial Optimization® suite, a comprehensive informatics solution that can meaningfully reduce the cost, time, complexity and risk of drug development. Continue reading

Phase I cGMP Drug Manufacture at the CRU: 3 BIG Benefits

Using a cGMP pharmacy at your CRU for Phase I drug manufacturing yields benefits in quality and safety, timeline reduction and cost efficiency.

The regulatory environment continues to move toward requiring drug manufacturing cGMP pharmacy Covance Blogat current good manufacturing practice (cGMP)-compliant pharmacies. This trend and other factors make it increasingly attractive to use cGMP compounding on-site at your CRU for early development. Let’s look at Three Big Benefits for Phase I drug manufacturing:

  1. Quality and safety
  2. Timeline reduction
  3. Cost efficiency

Continue reading