Covance is proud to announce that Xcellerate® Trial Design has been selected as the winner of the Fierce Innovation Awards: Life Sciences Edition in the Data Analytics/Business Intelligence category. The Fierce Innovation Awards: Life Sciences Edition recognizes outstanding innovations that are driving improvements and transforming the life sciences industry. Xcellerate Trial Design was recognized for its innovative approach to improving site selection, forecasting resource demand and optimizing of clinical trial design. Continue reading
The complexity of clinical trials continues to rise. New biomarkers for safety and efficacy continue to emerge, and new types of information – such as genomic profiles – have become critical to submissions for drug approval. Against this dynamic backdrop the central challenge facing trial sponsors remains the same: the need to bring together diverse data sets, draw meaningful insights from them and act quickly to maximize return on investment.
Covance and Global Specimen Solutions, Inc. (GSS) have announced a five-year strategic alliance that gives Covance clients access to a comprehensive and integrated solution that includes GlobalCODE®, snapTRACKTM and GSS wraparound services. This will enable near real-time data cleaning across clinical trial data sources which allow interventions to be made during the clinical trial, impacting overall trial execution and data validity. This also allows cross-protocol, cross-program analytics which provide context for data results, assuring robust clinical trial design and operational excellence. Continue reading
Overcoming Design Challenges
ICH E14 REGULATORY GUIDANCE 2005 AND 2015
It has been one year since the International Conference on Harmonisation (ICH) updated its 2005 cardiac safety guidelines. The 2015 update allows for specific QT interval analysis based upon concentration effect modeling up to supratherapeutic during Phase I as a reasonable substitute for a Thorough-QT (TQT) dedicated trial. These Phase I data along with preclinical results are submitted to the FDA prior to Phase III as a waiver request from a separate TQT study. This is good news! A dedicated TQT study involving time-wise comparisons of baseline corrected data is an expensive and lengthy endeavor. It typically takes place after proof of concept but before Phase III. Collection of QT information during an existing Phase I study costs substantially less and can provide go/no-go decisions much earlier. Continue reading
Over the last 10 years, clinical trials have changed substantially in response to increasing globalization and study complexity, along with new technological capabilities and industry guidelines,7. With these noticeable transformations, sponsors are increasingly revisiting their monitoring methods to uncover new efficiencies and develop more robust risk management processes that can enhance ongoing patient safety and data quality.
At the forefront of this movement is risk-based monitoring (RBM) – a broad term for a variety of clinical monitoring methods that combine people, process and technology, enabling project teams and Clinical Research Associates (CRAs) to focus on the most important risks in clinical trials.
Chances are you’ve been hit by the respiratory syncytial virus (RSV), which infects nearly everyone by the age of 2 and usually reinfects exposed people throughout their lifetimes. While most healthy people experience mild to moderate cold-like symptoms, RSV can also cause severe infections. It has earned notoriety as the leading cause of hospital stays for newborns, and RSV-associated infections in infants cause up to 200,000 deaths per year worldwide in developed countries.
With only limited, supportive treatments to help patients with RSV, scientists at Monogram Biosciences, Inc. (part of the LabCorp Specialty Testing Group) recently examined ways to help sponsors develop an RSV vaccine or antiviral medication that can treat or even prevent this illness. Continue reading
The approval of novel orphan drug designations continues to grow, while many existing rare disease therapies are receiving approval for expanded indications. With this increase and broadening class of products, including some that target the same mutation or molecular defect, sponsors face new and significant market access challenges in securing reimbursement.
Leading manufacturers increasingly employ stakeholder research early in development to better identify the needs of patients and providers. This strategy can build in compelling asset value during development, help avoid pitfalls and better inform go/no-go decisions earlier to avoid costly development delays or even dead-ends. Continue reading
Whether large or small, vaccine studies differ from standard drug development in many ways. Sarah Slette, Sr. Study Manager, Vaccines & Novel Immunotherapeutics at Covance, explains the unique challenges her team faces and their solutions to rapidly deliver customized vaccine kits to sponsors’ sites across the globe.
With its measurable impact on patient survival, there’s no denying that immunotherapy is already causing momentum in ways that cancer is treated. Drug researchers and developers are identifying new candidates in their growing pipelines and exploring combinations of immunotherapies, while regulatory agencies are providing expedited review and approval of these therapies for new indications at an unprecedented rate.
With checkpoint inhibitors from ipilimumab (Yervoy®) to nivolumab (Opdivo®) to pembrolizumab (Keytruda®) to the most recently approved atezolizumab (TecentriqTM), each breakthrough has provided new insights on how the immune system can be activated and manipulated to fight a variety of cancers. Continue reading
Q&A with Claudia Filozof, MD, PhD, Senior Medical Director in the Phase II-IV Cardiovascular/Metabolic Group and Richard Williams, PhD, JD, Executive Strategist, Global Regulatory Affairs
Is this a good time to develop a NASH drug, and if so, why?
Claudia: Yes, it’s a very good time. There are multiple companies starting NASH development, and there is a huge unmet medical need with no treatment approved so far. Health authorities also have shown a lot of interest in supporting companies to speed up development. If you have the right compound, there are multiple advantages to starting a NASH program.
Richard: The cost to society will be enormous if we can’t treat this disease. I think most pharmaceutical companies, big and small, see this as a substantial unmet medical need. With this unmet medical need, regulatory agencies can grant conditional approval (accelerated approval in the US), where the drug is approved for marketing with the condition that the company later shows it has a clinical benefit based on clinical outcomes. Continue reading
To enter the rapidly growing mobile health space, companies must overcome the crucial hurdle of validation. This process demonstrates that the app – in combination with the underlying technology platform / device – performs comparably to traditional products on the market, ensuring that patients and providers can rely on the output to make appropriate medical decisions.
Mobile health apps offer functions ranging from data collection to running algorithms, and underlying all of those features is the need for a quality system. To show that their product is reliable, developers need to take a variety of measurements, confirm that data transmission and analysis work correctly and test the app on multiple devices. Continue reading