Overcoming Plasmid DNA Limitations in Advanced Therapy Manufacturing

Biologic drugs have dominated the biopharmaceutical market in recent years and show no signs of slowing. While there is no shortage of therapeutic targets for drug developers designing monoclonal antibodies (mAB), validating those targets for clinical efficacy in various disease models is growing increasingly difficult. Since IL-11 was recently identified as an essential cytokine for inflammation and fibrosis, Enleofen and Aldevron developed monoclonal anti-IL-11 and anti-IL11RA antibodies for the treatment of non-alcoholic steatohepatitis (NASH) and other conditions.

Virtual or “siteless” clinical trials allow trial coordinators and patients to conduct clinical study visits via online video calls and collect data via handheld or wearable devices. In addition, virtual trials increase the size and diversity of the patient pool, accelerate recruiting, and generate more informative, clinically-relevant data that is accepted by regulatory agencies. However, moving from traditional to virtual trials presents challenges as clinical trial sponsors learn how to design, execute, and complete effective virtual trials. To assure success, trial sponsors need to better understand the digital tools and platforms used in virtual trials, how to manage the data collection they enable, and the pitfalls to avoid. In this webinar, Bernard Munos, a pioneering pharmaceutical industry innovator, and Transparency Life Sciences co-founder Dr. Tomasz Sablinski will provide an overview of the strategies leaders are finding helpful in adopting and adapting to virtual trials.

Multi-omics approaches integrate multiple omics data generated from cancer patients to better understand the molecular and clinical features of cancer. Multi-omics technologies, including genomics, proteomics, and metabolomics, have also been included in clinical trials to understand the response to immunotherapy and the mechanisms of drug resistance.

Dr. Hurley will provide an overview of psychosocial challenges faced by patients deciding to undergo genetic testing. Her presentation will combine research findings from psychosocial research and case illustrations from twenty years of providing psychotherapy to genetic counseling patients. She will provide tips on communication strategies as well as common pitfalls to avoid, and discuss advantages of creating an “information plan” based on patients’ needs, preferences, and ability to absorb emotionally challenging information. Clinical examples will be drawn from Dr. Hurley’s specialty in hereditary cancer risk, with the discussion of how psychosocial issues in genetic testing are relevant across a broad range of conditions, from the prenatal setting to other pediatric- and adult-onset hereditary syndromes.