Understanding Regulatory and Market Access Considerations With Drug Abuse Potential

Each assessment for abuse liability is as unique as the molecule in question, reiterating Regulatory And Market Access Considerations With Drug Abuse Potentialthe 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.

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Important Early Considerations For Assessing Drug Abuse Liability

covance blog drug abuse

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.

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Fierce Innovation Awards Recognize Xcellerate® Trial Design As Best Data Analytics/Business Intelligence Technology

Covance is proud to announce that Xcellerate® Trial Design has been selected as the Fierce Innovation Awards Recognize Xcellerate® Trial Design 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 Importance of Stakeholder Research in Rare Disease Drug Development

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 Rare Disease Drug Developmentand 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

Clinical Outcomes in NASH: Choosing the Right Endpoints

Non-alcoholic steatohepatitis (NASH) can lead to serious conditions such as cirrhosis and its complications, liver cancer and hepatic transplantation. Many patients eventually die from liver-related problems or cardiovascular disease. The challenge in developing drugs for NASH is to demonstrate an improvement in clinical outcomes. Cirrhosis takes several years to develop, and it is impractical to perform such long studies to identify treatment benefits. Therefore, to expedite the process and deliver new drugs to patients, biopharmaceutical companies have to consider surrogate endpoints that are reliable, can be obtained within a reasonable amount of time and are associated with progression of the disease.

A range of liver-related outcomes

NASH patients face many potential disorders and complications. In addition to overall death and liver-related mortality, the following endpoints should be evaluated in a clinical Clinical Outcomes in NASHoutcomes study:

  • Portal hypertension. Chronic injury to the liver results in a wounding response that leads to fibrosis, scarring and ultimately replacement of normal liver architecture with regenerative nodules. As a result of these changes, portal hypertension develops.
  • The accumulation of fluid in the abdomen results from portal hypertension. Using diuretics and reducing sodium intake often helps, but some cases are difficult to treat.

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What Are the Emerging Noninvasive Biomarkers in NASH?

Novel biomarkers represent a promising means to improve diagnosis of nonalcoholic steatohepatitis (NASH). Currently, a definitive diagnosis requires a liver biopsy, a surgical Covance NASH Liver Disease Blogprocedure with many limitations. There are a variety of biomarkers that can assess liver status, but they do not always distinguish between patients with NASH and those with other disorders. Advanced imaging techniques, while useful for evaluating some liver features, can be impractical and costly.

The ultimate goal is to find noninvasive biomarkers that clearly show if the patient has steatohepatitis or liver fibrosis associated with nonalcoholic fatty liver disease (NAFLD). Recent studies suggest that nuclear magnetic resonance (NMR) spectroscopy, microRNA tests and genotyping may prove to be useful tools. Incorporating additional biomarkers into clinical trials can give biopharmaceutical companies an early indication of whether a compound is efficacious — and provide the confidence to move forward to the next phase of clinical testing. Continue reading

Advancing Rare Disease Drug Development: Four Key Considerations for Market Access

Our industry is witnessing increasing growth in the rare disease market, thanks to financial and regulatory incentives to develop orphan drugs. This has been good news for Covance Rare Disease Drug Development Market Access Blog. Photo of a man holding a pill. both sponsors and patients, but the fact remains that rare disease trials are inherently challenging to run. In addition, completing a complex study and reaching regulatory approval does not necessarily translate to market success.

John D. McDermott, Jr., Vice President of Covance Market Access Services, recently shared his insights on the market access challenges in rare disease drug development and discussed key considerations for sponsors and stakeholders.

  1. Provide early education about the disease

Even though rare diseases as a whole are getting more attention, sponsors cannot assume that their potential payers know much about the particular condition they are targeting and its importance to patients. Continue reading

How to Navigate Pre-Clinical Issues in NASH Development

The pre-clinical phase of development for non-alcoholic steatohepatitis (NASH) drugs faces many challenges. Biopharmaceutical companies have several options for rodent Pre-Clinical Issues in NASH Development - Covance Blog. Image of molecules.models, but they must weigh factors such as customization versus speed before deciding on the best approach.

Some of the challenges include:

  • Diet: There is no prevailing wisdom in the field suggesting that one induction diet is superior to another.
  • Duration of disease induction: Depending on the type of diet, it will take 6 to 9 months for models to exhibit NASH-like features.
  • Translation: Novel biomarkers used in human clinical trials need further validation in rodent models.

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Are you ready for ISO 15189:2012 to make a difference in your bottom line?

Is it possible to get more efficiency in your conventional and specialty tests while maintaining ongoing quality? ISO 15189:2012 accreditation answers this question by delivering a comprehensive approach to quality management in medical, central Covance ISO 15189:2012 accreditation blogand referral laboratories. Not only can these standards ensure quality, but they can reduce your risk of costly delays and ultimately save money in your trials.

“It’s no surprise that sponsors are concerned about the risk of regulatory findings and increasingly requesting ISO-accredited labs,” said Paul Kirchgraber, Vice President and Global General Manager at Covance Central Laboratory Services. “They need a demonstration of increasing quality—and savings—across their outsource vendors. Adopting ISO 15189:2012 is a powerful way to highlight our broad quality standards that meet or exceed their expectations.”

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Vaccine and Novel Immunotherapeutic Development: A Personal Quest

Like my colleagues at Covance, my work ultimately contributes to improving Vaccine and Novel Immunotherapeutic Development Covance Bloghealthcare and patients’ lives. Our efforts to accelerate fresh approaches towards effective treatments became deeply personal in 2007 when my oldest sister, Vicki, was diagnosed with advanced Triple Negative Breast Cancer (TNBC).

From her initial diagnosis, my sister was full of vitality and enjoyed a high quality of life due in part to several of the novel treatments that Covance had helped develop. She even participated in a long-term clinical trial involving an angiogenesis-inhibitor, in addition to traditional chemotherapy, during her early treatment.

Vicki became a student of her diagnosis, reading countless journal articles on the rapid advances in scientific understanding. When her health took a sharp decline, she asked for my support in helping her gain access to a new trial focused on the immune system. She wanted to do whatever she could to help others find a better treatment, or even a cure, for TNBC. Ultimately, she was too weak to make the journey to participate in a cutting-edge clinical trial. Vicki died on October 1st, 2013.

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