It’s no lie the drug development model is in need of a drastic shakeup. With lengthy and costly approval processes, generic incursion, rising development costs and the need for novel adherence strategies, pharma and biotech, now more than ever need to initiate innovative formulation, delivery and development approaches in order to improve bioavailability and therapeutic performance.

Small and large molecule therapeutics urgently need to overcome drug formulation and delivery challenges in order to improve bioavailability and therapeutic performance. Because a majority of the drugs in development are hydrophobic (estimated at more than 40%), they need to be modified using chemical, physical, and biological methods to improve the aqueous solubility, and hence, BA. Optimization of drug solubility and BA of therapeutics stands as one of the top challenges faced by the pharmaceutical and biotech industry today.

Optimal bioavailability is important for high efficacy, but bioavailability can be poor in oral drugs. Some successful strategies for improving oral bioavailability of drugs include developing amorphous solid dispersions, nanoparticulates and self-emulsifying drying systems.

This week’s available deck is titled “Trends in Drug Bioavailability Enhancements and its Impact on Portfolio Strategy” from Linda Lohr at Pfizer. Linda was a previous speaker at our Global Drug Bioavailability Enhancement Summit. This presentation overviews discusses formularies, regulatory hurdles lead to focus on first in class across the industry, market drivers influence portfolio strategy, early clinical development: efficient de-risking and proof-of-mechanism / early signs of efficacy studies: concept and benefits. It additionally discusses focus on proof-of-mechanism (PoM) and early signs of efficacy (ESoE) studies increases success in delivering transformational medicines and determining the bioperformance & opportunities for modified release and conducting microdosing PK studies pre POC.