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NeoCardiogenesis- Celebrating The Birth Of Regenerative Cardiology
MRI Limited (Meta Reports), Nov 2008, Pages: 312
Regenerating the damaged human heart therapeutically is the new paradigm that was a heresy not too long ago. Regenerative cardiology is now a segment of one of the most heavily funded areas of medical research in human history. The initial euphoria of growing natural bypass to the blocked coronary arteries was dampened by the ghost of “placebo-effect” that resulted in less than desirable outcomes of the first wave of clinical trials. In its Second Coming the drug development industry is back with a vengeance to conquer the eluding dream. The rush to get a non-invasive heart repair drug is unprecedented. Despite no sign of success in any of the dozens of clinical trials already reported, we account for more than 80 companies in pursuit of the promised heart mender. Such a scale of drug development initiative for a single category of indication has no parallel or precedence in healthcare industry. It’s nothing less than the Gold Rush of 21st Century.
Although this research was intended as purely a “regenerative cardiology market analysis and business intelligence report”, the technology leaning of our research team in serendipity, discovered a breakthrough that has the potential to not only revitalize the currently active or on-hold neocardiogenesis programs, but also hold out a promise to revive and salvage hundreds of millions of dollars invested in those programs that were terminated for reasons of insufficient or no efficacy. This project culminated in at least three patents either filed or under preparation. The report, for the first time, identifies unique problems facing the neocardiogenesis clinical trials, and prepares the biotechnology industry for the Second Coming of regenerative cardiology.
This research report presents certain breakthrough findings that not only solve regenerative cardiology companies’ unyielding problem of translating positive pre-clinical animal data into successful human trials, but provides new clinical pharmacology insights that bear relevance to any life sciences research group involved in clinical development of therapeutics, whether in academia or in industry.
In the 70 year history of United States FDA 11,808 new drug applications were approved and 1,427 new molecular entities introduced in the healthcare market. It’s the rigors of the regulatory process of developing new drugs that pushed the industry and academia to evolve clinical pharmacology to an incomprehensible credulity that it enjoys today. Each one of an estimated 120,000 potential drugs that entered the clinical phase of the regulatory approval process in those 70 years ardently obeyed the laws of pharmacokinetics (PK) and pharamcodynamics (PD). But one clinical situation changed all of that. One therapeutic approach defied all efforts to translate the positive animal data to successful clinical trials. One indication defeated all the time tested principles of PK/PD Modeling and eluded success. Yet, that indication remains in hot pursuit by - Regenerative Cardiology.
Initiated purely as a market research project for providing business intelligence to biotechnology companies, this research became, what it was never intended to – A Treatise of Inventions. These new findings present an entirely new approach that could potentially end regenerative medicine industry’s most protracted efficacy stalemate. Whether stimulating coronary angiogenesis or inducing myocardial myogenesis to rebuild an ischemic or infracted heart, this report provides path breaking analyses and conclusions that are completely original, unprecedented, and have the potential to navigate any protein therapy, gene therapy or cell therapy approaches to repair / regenerate damaged hearts to the path of success. The report also covers about 90 companies that are of significant relevance to these new endeavors in regenerative medicine.
Reasons to purchase this report
-Find out why regenerative cardiology is a whole different ballgame.
-Find out what’s missing in the deployment of various stem cell therapy approaches or VEGF, FGF, HGF, PlGF protein / gene therapy approaches in heart repair treatment for coronary artery disease.
-Plug the holes in the clinical trial protocols that are confounding the clinical efficacy of the heart repair therapeutic trials.
-Companies can potentially revive the initial programs for regenerating vessels and heart tissue to compensate the effects of blocked coronary arteries and salvage their investments.
-Companies can potentially revitalize their current regenerative cardiology clinical development programs to ensure clinical efficacy of their therapeutic agents.
-Find out why the time tested PK/PD Modeling principles that are highly relevant to any drug development scenario need to make room for a new pharmacotherapy situation never encountered before.
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