Over the past thirty years of working in Corporate Pharma (including Pfizer, Actelion/JNJ, and Bayer) I have launched, marketed and successfully managed many ethical pharmaceutical products/devices which have served millions of patients and generated billions in Sales. From LOPID to LIPITOR in cardiovascular disease, NEURONTIN to LYRICA in neuropathic pain, and TRACLEER to ADEMPAS in pulmonary hypertension, I have worked diligently to nurture many therapies from the Laboratory to the hands of patients with unmet needs. It has been my joy and passion to serve that Mission.
During those years, I have pondered what exactly the essence of launching new products in BioPharma is all about. Innovation in the BioPharma industry has never been higher; more than 20,000 compounds have been studied over the past two decades according to Clinicaltrials.gov. Due to the relatively low rate of FDA approval (approximately 14%), the Tufts Center for the Study of Drug Development estimates the cost of each marketed drug to be almost $3B. Certainly it behooves all responsible Stakeholders to look for ways to cost effectively bring their product to market to maximize investment returns while benefiting the most possible patients.
Launching new products successfully is not a given. Of all launched FDA-approved drugs, only 30% will see “commercial success”, according to Syneos Health. Those odds are not good! No one (especially patients!) is benefiting from those unfortunate launch failures.
Have spent the past 13 years working primarily in the therapeutic category of Pulmonary Hypertension, my expertise is in Cardiovascular and Pulmonary Rare Disease. Success in this area requires a unique approach to Centers of Excellence, Healthcare Providers, Specialty Pharmacies and Patient Advocacy groups. Understanding the unique subtleties of each of these important Stakeholders is paramount to building the proper Foundation for success.
I created the concept of BioAgility to help BioPharma companies break the launch paradigm with disruptive, innovative ideas that will transform the clinical options available to patients with unmet needs. It is especially challenging in any therapeutic category that is highly supported by larger players, to substantially modify the ecosystem that already exists. It not only takes a unique compound or device, but an approach to the marketplace which will truly get attention by the patients who could benefit from therapy. Launching new products is always a risky venture; success is never guaranteed. The Mission of BioAgility is to help push the odds of success in the right direction.