3 Takeaways from the FDA Oligo Guidance You Need to Know

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

Predicting and Taming Immunogenicity: Strategies for your Biologic Drug

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

A Day in the Life of a Clinical Pharmacology Consultant

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

Building a Robust Clinical Pharmacology & Model-Informed Drug Development Strategy for New Alzheimer’s Disease Drugs

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

What does the Clin Pharm Plan for a Biologic Look Like?

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

Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success

Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an underutilized immunotherapeutics option in oncology, whether as monotherapy or in combinations. The first FDA approval of an ADC was in 2011, with the introduction of brentuximab vedotin (trademarked Adcetris) by Seattle Genetics (1). ADC development is inherently challenging because it … Continued

5 Points to Consider When Designing an Immuno-oncology Clinical Pharmacology Program

Immunotherapy presents interesting and proximally viable therapeutic options in the growing armamentarium of treatment modalities to combat complex, multifactorial diseases. Indeed, its revolution within oncology is astounding. The field has witnessed rampant and clinically significant advances, with the approval of several checkpoint inhibitors. Clinical trials with these inhibitors suggest that there are more robust and … Continued

Episode 16 – Entrepreneurship and Consulting in Clinical Pharmacology and Pharmacometrics Part 2 with Patrick Smith and Emily Cicali

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

Episode 15 – Entrepreneurship and Consulting in Clinical Pharmacology and Pharmacometrics Part 1 with Patrick Smith and Emily Cicali

Moderated by Early Career Community member Emily Cicali, PharmD (University of Florida), Patrick Smith, PharmD (Certara) discusses the risks and rewards with entrepreneurship in the field of clinical pharmacology and pharmacometrics. Patrick talks honestly about the mistakes made early on and the differing needs of team members who are starting a business in varying stages … Continued

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