Each assessment for abuse liability is as unique as the molecule in question, reiterating the importance of early awareness, understanding the current regulatory landscape, and being able to plan your development and post-marketing accordingly.
In our previous blog post, we focused on the value of early drug abuse potential testing. In this blog, we’ll delve into important regulatory and market access considerations for abuse liability testing that can help drug developers maximize the potential of their molecule.
Clinical trials are becoming increasingly complex and competitive, so attracting the best investigator sites to participate in a trial is a crucial step in meeting patient enrollment targets.
Delaying approval by even one day can cost hundreds of thousands of dollars or more, depending on the drug. This means that timely trial implementation, including patient enrollment, may add significant value.
Meeting patient enrollment milestones in cooperation with investigators has traditionally been viewed as the responsibility of the contract research organization (CRO). Now, important new data show that a sponsor’s choice of a central lab impacts the willingness of investigators to work with a sponsor on clinical trials. Continue reading
Assessment of abuse potential of compounds in development is one of the most complex regulatory requirements and constitutes a critical exercise for sponsors and regulators. The strategy for the assessment of abuse potential cannot be customized and requires individual evaluation of the compound, its target indication and the entirety of the nonclinical and clinical safety database. In July 2016, the United States Congress passed the Comprehensive Addiction and Recovery Act (CARA) bill to address prescription opioid abuse and overdoses that have killed more than 165,000 people between 1999 and 20141.
Given this increased spotlight and focus on preventing opioid abuse and deaths in the US and abroad, it has become more critical than ever to better understand the abuse liability potential of a drug as early as possible in the development process. As part of the overall assessment of drug safety for a New Drug Application (NDA) in the United States or a Market Authorization Application (MAA) outside the United States, drug abuse potential testing is required – regardless of indication – on any drug that is active in the brain. This encompasses all properties of the drug (e.g., chemical, pharmacological, pharmacokinetic, clinical safety, etc.).
In the first of a two-part blog, we share important early considerations for abuse liability testing to help drug developers test the abuse potential of their molecule and better understand their path to viability in this changing landscape.
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.