Maximizing Oligonucleotide Therapeutic Development: How They Work

This is the first of three blog posts discussing best practices for developing oligonucleotides. Interest in oligonucleotide therapies, which are composed of short strands of DNA or RNA, is growing rapidly; there are at least 135 of them currently in development.1 Underscoring their proliferation, a PubMed search for “oligonucleotide therapeutics” generated more than 35,000 hits. … Continued

ICYMI: Highlights of the ASCPT 2021 Annual Meeting

The COVID-19 pandemic has upended all our lives in ways big and small with the ability to attend in-person scientific conferences being no exception. Fortunately, many conferences have become virtual events which have allowed participants to share the latest research findings and trends while maintaining safety for everyone. Last month, I virtually attended the annual … Continued

Effectively engaging KOLs & Stakeholders: An interview with Erin Duffy

Healthcare providers (HCPs) expect greater product education and information on the medications that they prescribe to patients. At the same time, data and scientific information relating to therapies continues to become more complex. Thus, the role of the Medical Science Liaison (MSL) has become more and more crucial in the key stakeholder and Key Opinion … 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

Simcyp Simulator Impacts 80+ Novel Drugs

250 Label claims using PBPK without the need for additional clinical studies “Clinical Studies and Model-Informed Approaches.”  This is the language typically used by the US FDA on drug labels to describe how clinical pharmacology decisions have been reached.  Much more detail can be found in the Office of Clinical Pharmacology (OCP) review that supports … Continued

How to Navigate the Increasingly Stormy Waters of Accessing US Managed Markets

The US reimbursement landscape for prescription drugs has been shifting rapidly over the last few years. Some of the major US access trends that have accelerated include: Payers increasing volume control over prescribed therapies, tightening formularies, and utilization management As the site-of-care landscape is consolidating, provider groups are incentivized to shift away from volume to … Continued

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