Companion Diagnostics Information

We are developing a new generation of companion diagnostics for safer and more effective drugs

CD_moreThe outlook for the drug industry continues to remain bleak in the context of productivity and success rates. In spite of ongoing increase in research and development (R&D) expenses and “technology revolutions” particularly in the post genomics area, nearly 92% of drug programs which enter clinical trial development die before reaching the market.

While industry R&D costs are increasing year after year, the number of new drugs entering the market is almost flat. Furthermore, the patent expiration of blockbuster drug products is alarming, opening the doors to generic companies. From 2011 to 2015, patent exclusivity will expire for a set of drugs that collectively generate more than $250 billion in sales.

Drug development is very costly with an average of 2.6 billion dollar to bring a drug to the market, including the cost of 92% of drugs that fail to make it. A number of drugs for all disease indications fall short at phase II or phase III clinical trial because they are unable to show undisputable efficacy to advance either to next phase III or gain market approval. This constitutes a severe set-back for developer companies for all endured expenses in development and clinical trials.

The high failure rates indicate that the currently used model of drug development and clinical trials are not adequate for making a Go no Go decision during the entire process. Early milestones for decision making are desirable.

It becomes obvious to the entire industry that the concept of medication “one size fits all” is no longer an option as it is making the cost spiral unbearable. This major problem opened the door to personalized medicine that targets a sub-group of the disease population rather than everyone in that disease. This new paradigm has become a necessity to control the outrageous cost of drug development.

The completion of the human genome sequencing and the cost reduction of sequencing technologies prompted several companies to engage in personalized medicine, with the hope to find genetic profiles that would predict better therapeutic targets or disease outcome.

There is tremendous genetic variations and polymorphism normally, which is exacerbated in diseased conditions.

Furthermore, there is extensive genetic polymorphism between and within individual tumors. Such variability precluded the discovery of better therapeutic, diagnostic and companion diagnostic for targeted therapy.

At Phenotype Pharmaceuticals, we have developed and integrated various sets of proprietary technologies to provide a reliable solution to this conundrum. Our aim is to discover and develop companion diagnostics primarily to facilitate the development of safe and efficient targeted therapeutics and to control the spiraling cost associated with drug development.

We apply our proprietary technologies to two distinct programs:

1.     Discover and develop companion diagnostics to our partners selected therapeutics to make their drugs safer and efficient and reduce their cost of drug development.

2.     Blockbuster drugs are falling from patent protection one after another. Despite their multi-billion dollars annual revenues, these drugs are often effective for a sub-group of patients, yet less for another. Phenotype Pharmaceuticals applies its proprietary technologies to discover, develop and commercialize companion diagnostics to these blockbuster drugs and remarket them jointly with companion diagnostics for safer and effective therapy, thus giving these products a new cycle of patent protection.

Related Publications

Stewart Bates. Progress towards personalized medicine. Drug Discovery Today ! Volume 15, Numbers 3/4 ! February 2010

David S Gibson, Michael J Bustard, Cathy M McGeough, Helena A Murray, et al.. Current and future trends in biomarker discovery and development of companion diagnostics for arthritis. Expert review of molecular diagnostics., Vol. 15, No. 2 , Pages 219-234. February 2015

Halard Seitz and Sarah Schumacher Biomarker validation. Technological, clinical and commercial aspects (Past and Future of Biomarkers). Book Editor, Wiley-VCH, 2015.

Dana Olsen and Jan Trost Jorgensen. Companion diagnostics for targeted cancer drugs – clinical and regulatory aspects. Front. Oncol., 16 May 2014 | doi: 10.3389/fonc.2014.00105

Stewart Bates. Progress towards personalized medicine. Drug Discovery Today ! Volume 15, Numbers 3/4 ! February 2010.

Irene Mancini, Pamela Pinzani , Lisa Simi, Ivan Brandslund , Pieter Vermeersch , Chiara Di Resta , Matthias Schwab , Janja Marc , Ron van Schaik, Mario Pazzagli . Implementation of a companion diagnostic in the clinical laboratory: The BRAF example in melanoma.Clinica Chimica Acta 439 (2015) 128–136…/Agenda-Workshop-Complexities-Personalized-Medicine_ FINAL-3-20-15.pdf

Complexities in Personalized Medicine: Harmonizing Companion……/150324-FDA-

AACR- ASCO%20workshop%20slides%20for%20web.pdf

Response to CDRH Priority Guidance…/CDRH.pdf…/CDRH.pdf…/Pages/Meetings-and-Events.aspx

A Blueprint Proposal for Companion Diagnostic Comparability ……/FDA-AACR-ASCO-Complexities-in-Personalized-Medicine- Blueprint-Proposal.pdf