Therapeutic proteins (TP) – and more specifically monoclonal antibodies – are part of the therapeutic arsenal for the treatment of several diseases, providing effective and safe therapeutic solutions for patients. As part of the usual therapeutic practice, patients often receive drug combinations (TP/TP or TP/small molecules) and/or concomitant co-medications. Thus, drug-drug-interactions (DDIs) can be a … Continued
Drug developers often rush through the discovery process to get into human testing. Most are so curious about their new target or molecule that they may forget that the pharmaceutical formulation process that can easily make or break their program. Once in human testing, revisiting these formulations is often time-consuming. By then, depending on drug … Continued
In June 2022, the FDA published their first oligonucleotide clinical pharmacology specific guidance [1]. This is a welcome addition and clarifies the position of the agency on some key aspects regarding development of oligonucleotide therapies. Whilst the guidance still leaves a few open questions, it provides drug developers with a starting point and acknowledges that … Continued
Immunogenicity is the ability of a foreign substance, such as a drug or vaccine, to provoke an immune response. While provoking immunogenicity is a desired outcome for vaccines, the development of anti-drug antibodies (ADAs) can inactivate a biologic drug’s therapeutic effects and potentially cause safety issues. The issue of immunogenicity imposes both scientific and regulatory … Continued
Strategic consulting within drug discovery and development is an exciting career choice for many. Unlike a biotechnology or pharmaceutical enterprise, where the assets one typically works on are within that ecosystem, consulting offers the possibility of working on many different innovation pipelines. At any given time, you might be working on solving a problem for … Continued
Alzheimer’s disease (AD) is one of the most common forms of neurodegenerative dementia in the United States. In fact, the Alzheimer’s Association predicts that by the year 2050, the number of people age 65 and older with Alzheimer’s dementia is expected to double to comprise 12.4 million patients. AD is caused by a complex dysregulation … Continued
Monoclonal antibodies are now widely used in the treatment of several diseases, providing effective and safe therapeutic solutions for patients. Due to their molecular and biological specificities, their clinical and pharmaceutical development present some particularities and challenges in comparison to the development of new molecular entities. Thanks to three decades of experience in the development … Continued
抗体-药物偶联物（ADC）是清除肿瘤细胞的一种独特方法，也是肿瘤学中一种未得到充分利用的免疫疗法，无论是作为单一疗法还是联合疗法。FDA 首次批准 ADC 是在2011年，当时 Seattle Genetics 推出了 brentuximab vedotin（商标为 Adcetris）(1)。ADC development is inherently challenging because it … Continued
2021 年 6 月 17 日, Thu 11:15 AM EDT Learn about the role of clinical pharmacology and model-informed drug development in aiding the development and approval of drugs for rare and neglected diseases. Examples of applications of these principles to global health will also be presented.
Moderated by Early Career Community member Emily Cicali, PharmD (University of Florida), Patrick Smith, PharmD (Certara) discusses the ample opportunities for small biotech companies that has arisen from changes in regulations. This episode is a great listen for anyone interested in pursuing opportunities in consulting! “More and more compounds are being developed outside the walls … Continued
