Genomics, Biotech, and Emerging Medical Technologies

Overcoming Challenges in the Emerging Biosimilar Landscape (2017 Spring Forum)

A biosimilar is a biologic drug that is developed to be highly similar, but not identical, to an existing biologic. The FDA looks at biosimilars as a biological product that is similar to a US licensed biological product not including minor differences in clinically inactive components, as well as having no clinically meaningful differences between the biological product and the reference product in terms of the safety, efficacy and potency of the product. Biologic agents have revolutionized the treatment of many diseases, including breast cancer, lung cancer, non-Hodgkin’s lymphoma, hepatitis, inflammatory bowel disease (IBD), rheumatoid arthritis, and many more. Now, with patents continuing to expire on these first biologics, biosimilar products are becoming available. These agents are expected to have a significant impact on healthcare but present a unique set of challenges for regulators, clinicians, payers, and consumers.
Physician, Nursing and CMCN credits valid to August 1, 2018

Overcoming Challenges in the Emerging Biosimilar Landscape (2016 Fall Forum)

Biologic agents have revolutionized the treatment of many diseases, including cancer, diabetes, hepatitis, inflammatory bowel disease, and rheumatoid arthritis. A biosimilar is a biologic drug that is developed to be highly similar, but not identical, to an existing biologic. Although there are minor differences in clinically inactive components, they cannot have a clinically meaningful difference between the biological product and the reference product in terms of the safety, efficacy and potency. Along with their sensitivity and size, biologic medicines are almost always injected into a patient’s body and the way a patient responses to that treatment can depend on how a biologic is made. Since the complexity of biologic medicines is well documented along with their complex production, biosimilars must be determined on the basis of analytical, non-clinical and clinical data to be similar to an original biologic in structural characteristics, safety and efficacy. Small differences with the active ingredient are expected and permitted so long as any such differences are demonstrated not to be clinically meaningful. Now, with patents continuing to expire on these first biologics, biosimilar products are becoming available. These agents are expected to have a significant impact on healthcare but present a unique set of challenges for regulators, clinicians, payers, and consumers.
Physician, Nursing and CMCN credits valid to January 31, 2018

Immunotherapy and Cancer

Cancer immunotherapy is the use of the immune system to treat cancer. Immunotherapies can be categorized as active, passive or hybrid (active and passive). These approaches exploit the fact that cancer cells often have molecules on their surface that can be detected by the immune system, known as tumour associated antigens (TAAs); they are often proteins or other macromolecules (e.g. carbohydrates). Active immunotherapy directs the immune system to attack tumor cells by targeting TAAs. Passive immunotherapies enhance existing anti-tumor responses and include the use of monoclonal antibodies, lymphocytes and cytokines. Advances in the understanding of the immune system are changing the way the interprofessional healthcare team manages cancer. As immunotherapies move to the forefront of cancer treatment, healthcare professionals will need to understand the immune system; know how cancer circumvents it; and be aware of the mechanisms of action, efficacy, and safety of current and emerging immunotherapies.

The development of immunotherapies to treat cancer has transformed the way clinicians think about managing their patients with many forms of malignancies. The speed, at which basic science and clinical trial information continues to emerge in this area, creates practice and/or educational gaps for busy clinicians who strive to maintain state-of-the art care for their patients with cancer. This field is one of the most clinically relevant and exciting areas of novel drug development in oncology.
Physician, Nursing and CMCN credits valid to December 31, 2017

Copyright permissions

To the best of our knowledge permissions for use of any copyright materials was received by each individual presenter. NAMCP/AAMCN does receive permissions to record, transcribe and publish materials (slides and audio) from each speaker. These permissions are on file at NAMCP headquarters.

For more information contact Jeremy Williams at 804-527-1905 or jwilliams@namcp.org.

 

Disclaimer

NAMCP and or this website does not provide medical advice, diagnosis or treatment. NAMCP does not endorse or imply endorsement of the content on any linked website. This website is to be used as an informational resource. With any health related concern, consult with your physician or healthcare professional.