Regional Availability of and Reimbursement Models for Biologic Therapies to Treat RA Patients with Moderate to Severe Disease

Rheumatoid arthritis (RA) is an autoimmune disease primarily affecting the musculoskeletal system with typical symptoms including swollen and painful joints, joint
stiffness and loss of function, ultimately leading to disability if untreated. RA also has significant systemic featureRA Patientss in many patients that appreciably impact upon their quality of life, including fatigue and depression. Prevalence varies between 0.3 – 1.0% and is more common in women and in developed countries.1

Modern RA treatment paradigms (i.e. “treat to target”) focus on achieving remission/low disease activity to minimize joint damage and disability. Biologic agents targeting key inflammatory mediators (TNF-alpha, IL-1, IL-6), key cells and activation pathways of the adaptive immune system such as B cells and T cell co-stimulation pathways, have revolutionized the treatment of RA and many other immune-mediated inflammatory diseases (IMIDs), and have rapidly been introduced into accepted treatment paradigms2,3 when earlier disease modifying anti rheumatic disease (DMARD) agents such as methotrexate (and others) are insufficient to reach these target goals. 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
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Establishing Control Over the Manufacturing Process and the Quality of your Biologic

101679_Large-Molecule_1575263331When a patient reads the label on their medicine bottle, he or she naturally relies on the medicine to contain the correct drug, be safe, work as intended and list the correct dosage. The pharmaceutical companies that produce these medicines similarly must rely on their internal manufacturing processes and quality control testing to generate the medicine responsible for this patient trust.

For the development of biologic medicines, the process of generating a quality product is less straightforward than that of a small-molecule medicine, like pain relievers such as aspirin. Selecting the right partner, such as Covance and its ‘Central GMP Testing Laboratory’ model, can smooth the path to validation and consistent manufacturing quality for your biologic.    Continue reading

CNS Drug Development: Impact of Biosimilars

neuro2The biologics sector continues to offer lucrative opportunities for future growth, but with relatively few contributions for the treatment of CNS indications. High-growth CNS market segments generally share one feature: biologics play a pivotal role in the treatment paradigm, or soon will. Neuromuscular-blocking biologics recently secured regulatory approval for chronic migraine. Alzheimer’s disease is a high unmet need indication currently addressed only by symptomatic treatments, with potential for disease modification biologic therapies to play an important future role.

The example of biologics’ success in the CNS market is highlighted largely by the success of therapies that target the multiple sclerosis (MS) disease process. This success has spurred some drug developers to increase their assets in this space and seek future opportunities for biologics in other CNS diseases. However, one important new reality that is slated to reshape the future landscape of this market is the introduction of biosimilars. Continue reading

How to Proactively Avoid the Common Pitfalls in Biologics Development

When developing a biologic, great science does not always translate into a great product. Doing the rights studies, the right way, is paramount to realizing the product’s potential. Knowing which studies to conduct, when to conduct them and interpreting the data in the context of the product’s development, can make the difference between success and failure.

oysterFor Biologics, “The Product is the Process”

Biological medicines, including therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins are large, complex molecules that cannot be fully defined by physicochemical analytical methods. They are manufactured from genetically modified living cells using processes that are usually complex. Biological medicines are often 200 to 1,000 times the size of small molecule drugs, and because of the biological nature of the starting materials, the manufacturing processes have inherent variability and product heterogeneity. Continue reading

Why Comparability Studies are the Key to a Biosimilar’s Success

Comparability Studies are the Key to a Biosimilar’s SuccessBiosimilars, which are new versions of innovator biopharmaceutical products that are marketed after expiration of patents, have emerged as one of the fastest growing development opportunities in the biopharmaceutical sector. In the U.S. alone, industry analysts estimate that biologics worth $80 billion are slated to go off patent by 2015.

Regulatory agencies evaluate biosimilars based on their level of similarity to, rather than the exact replication of, the innovator drug. In the U.S., recent guidance by the FDA says it will “consider the totality of the evidence” when assessing follow-on products. This approach requires sponsors to demonstrate robust chemical comparability to the innovator compound. Continue reading

Biotherapeutics and Immunogenicity Implications in Drug Development

Immunogenicity

In contrast to new chemical entities, biotherapeutic drugs are potentially immunogenic, and, in rare cases, treatment with such products can lead to severe and devastating illnesses in humans. Therefore, the importance in understanding how immunogenicity affects drug exposure, efficacy, and toxicity at all stages of the drug development process can not be overstated.

There are more than 200 biotechnology products currently on the market with 400-plus additional therapies in clinical trials targeting diseases such as cancer, Alzheimer’s, rheumatoid arthritis, multiple sclerosis, and HIV/AIDS. In 2014, it’s predicted that 50% of the top 100 drug sales will be biologics, an increase of 28% from 2008. Continue reading