GLOBAL FORMULATION REPORT – Notable Technologies, Approvals, Transactions, Pipelines & Inflection Points

-10 Notable Drug Delivery & Formulation Approvals of 2015
-10 Notable Drug Delivery & Formulation-Related Transactions of 2015
-10 Notable Drug-Device Approvals of 2015
-10 Notable Fixed-Dose Combination Drug Approvals of 2015
-Drug Delivery & Formulation Pipeline
-Inflection Points

The Pharmaceutical Industry constantly moves forward, at times, one step, at others, it’s two steps, and on occasion, it’s three or more. But like walking up a down escalator, it seems there is little progress as rising expectations make it appear the Industry is standing still. That perhaps best describes 2015 from the perspective of Drug Delivery and Formulation.

Past years of technology development resulted in the approval of a variety of Drug Delivery Enabled/Enhanced Products using well-validated oral, injectable, and inhalation technologies, but there was no true breakthrough. And then there was the disappointment of Afrezza and the promise of a practical non-injection delivery route for the systemic delivery of macromolecules. In retrospect, it seems that Exubera’s failure almost a decade ago was not a simple issue of an unwieldy device, or poor execution. Afrezza’s challenges confirmed there are still many challenges ahead for Drug Delivery & Formulation Professionals if they are to effectively deliver the next generation of molecules. There remains much opportunity for novel technologies to deliver macromolecules and poorly absorbed molecules orally. There is also the challenge of site-specific delivery to improve the tolerability of effective but toxic drugs. The rewards will be there for those that succeed in developing better products as evidenced by the spectacular financial success of Gilead’s Harvoni. At the same time, 2015 made the point that me-too products, even those using unique technology platforms, but delivering unimpressive patient benefits, would fail to get physician, payer, and patient support.

Gene therapy showed itself to be an area of opportunity in 2015. Gene therapy is now at a similar stage as antibody therapies were three decades ago, promising but with significant technical challenges. Much needs to be done to make gene therapy a therapeutic reality, as there was for antibody therapy. The difference perhaps is that gene therapy will be even more dependent on delivery technologies to ensure the payload, a viral- or non-viral-based collection of DNA, is delivered in a manner so as to optimize efficacy and safety. With time, the demands of treatment will turn to convenience. The tools required to achieve optimal delivery of gene therapeutics will depend on both traditional drug delivery and formulation technologies as well as a full toolbox of genetic engineering capabilities. Future Drug Delivery & Formulation Professionals will need to have complete command of both classical and genetic-based delivery technologies to be successful.

This year’s Global Formulation Report Click here to download the current Global Formulation Report (50 MB) reviews the more interesting and formative events of 2015 related to drug delivery and formulation with the hope that it may stimulate a closer look at how these events might shape the future. It has been said that those who fail to learn from history are doomed to repeat it. The approach this year once again is to identify notable drug delivery and formulation events of 2015 with a series of articles that range from new product formulations to devices to combinations to transactions. Two new features this year include an update on the notable events of 2014 and Inflection Points 2015, where we identify five trends in the Pharma industry that have reached apparent tipping points.

The Report is a collaborative effort between the well-respected team at Drug Development & Delivery, and the information, analysis, and writing team of the delivery and formulation experts at PharmaCircle (Kurt Sedo, Tom DePaul, and Josef Bossart). The format is intended to provide an overview of what happened in 2015 and how these events are likely to shape the coming years. We hope you enjoy this issue. Please drop us a line if you have suggestions for how we can improve future issues.

For reference to last year’s Global Formulation Report covering 2014, please review the July/August 2015 issue at

Click here to download the current Global Formulation Report (50 MB)

Ralph Vitaro, Publisher & President
Drug Development & Delivery

Tugrul Kararli, President & Founder
PharmaCircle LLC