With nine FDA-approved drugs today, 100+ in clinical development and several hundred in the preclinical stage, the market for bsAbs is projected to grow to >$30B by 2028. The distinct advantages of bsAbs, such as improved selectivity and specificity, increased efficacy, and lower toxicity, will result in measurable benefits for cancer patients. But bsAbs are … Continued
Do you remember the 1990s? The Soviet Union fell, Friends was the most popular TV show, and for some inexplicable reason, hammer pants were a viable fashion option. But while 90’s era political, entertainment, and fashion trends may have come and gone, many regulatory guidances from that time are still in effect. In my role … Continued
Physiologically-based pharmacokinetic (PBPK) modeling has proven invaluable in drug development, especially for pediatric populations, because of its ability to reduce and potentially eliminate the need to conduct clinical trials in this special population. However, much of the early research into pediatric PBPK models has concentrated on the North European and American populations. Growing interest in … Continued
Many drug developers have products that they want to submit for marketing approval in several regions like the US (NDA/BLA), Europe (MAA (Marketing Authorization Applications)), Canada (NDS (New Drug Submissions)), and elsewhere. But developing each submission independently can waste a lot of time and money. Fortunately, there are ways to maximize the reusability of your … Continued
Who would have thought when we completed work on the first submission for which we ever authored 3 or more documents and provided strategic support (our criteria for saying that we supported a client’s submission), that we’d be celebrating our 300th such submission just 12 years later. From that humble beginning, we’ve now supported more … Continued
The Institute for Clinical and Economic Review (ICER) is a US Health Technology Assessment organization. ICER’s mission is to conduct evidence-based reviews of healthcare interventions that help guide patients, doctors, and payers to high-value, cost-effective treatments using rigorous, transparent methods. ICER was founded in 2006 by Steve Pearson, a former fellow at the Americas Health … Continued
希少疾患の治療薬に関する規制状況は大きく変化しています。最近のいくつかの規制当局の諮問委員会の審議から、希少疾患の新薬開発の複雑性をあらためて垣間見ることができました。医療当局、医薬品開発者、オピニオン・リーダーたちは、臨床試験において意味のあるデータ・シグナルの帰属に苦慮しています。 つづく...
On 2022年8月16日, President Biden signed the Inflation Reduction Act of 2022 (IRA) into law. One key objective of the IRA is to shift healthcare costs from patients and the Centers for Medicare & Medicaid Services (CMS) to health insurers and pharmaceutical manufacturers. While the provisions allowing CMS to negotiate drug prices for select … Continued
As a pharmacologist, I’ve always been curious about how drugs work. A favorite time-killer while waiting at a doctor’s office is reading drug labels (also known as package inserts) contained within the pages of “lifestyle” magazines. Ever wonder what a package insert looks like? Ask a pharmacist. By law, pharmacies are supposed to offer that … Continued
Adverse effects of drugs pose potential harm to patients and can hinder or halt the development and intended therapeutic use of a drug. Such effects can arise from primary pharmacology (‘exaggerated pharmacology’, or unintended effects in non-targeted organ systems), secondary pharmacology (i.e., at another receptor, related or unrelated to the primary target), or from the … Continued
