I established Iridium Biosciences LLC in 2009 as an entrepreneurial organization that transforms biotechnology ideas into commercializable products. With over 20 years experience in creating discovery platform services ranging from start-ups to big pharma, my laboratories have always produced novel biologic drug candidates and reverse-engineered biosimilars- with successes documented in over 30 research articles and issued patents. Within contract and consultative services, I have directed over 800 research projects for DNA and protein biologic generation, and thus brought premium discovery expertise through Iridium Biosciences to many small biotechs. Wyeth, Pfizer and GSK were among the major pharmas served. Successful research projects included therapeutic antibody generation, bioactive peptides, vaccine generation, and molecularly evolved protein therapeutics.
Thoughts on Science, Biology and Biotechnology
Since the early 1980's Biotechnology has become a valid career path for academically trained scientists who wanted to apply biological or medical findings for commercial benefit. The intense motivation behind the rare entrepreneurial scientists to translate research discoveries into clinical therapies is the lifeforce in which Biotechnology is based. Unlike work funded in a rolling grant based or state sponsored research institution such as a university or National Institute of Health, biotechnology companies only exist with near term objectives (a few years) with highly defined goals. These goals are funded by the venture capital ecosystem, whose vested interest in biotechnology is founded on returning extremely high levels of returns to their investors. The fine dance between expected biological outcomes and investment return timelines has pressured biotechnology companies to attract individuals with a high-stakes mindset to enter this field. Although many people may see biotechnology as a different type of high technology (software, hardware, computers), biotechnology is a fundmentally different, more difficult area to enter and succeed. The funding requirements for biotech may be more than 10 x greater than software, and development cycles may exceed ten years, 20 x longer than many tech-based companies.
By the 1990's Biotechnology, had matured into an industry filled with companies seeking to apply novel ideas and therapies. The idealistic expectation of creating cures based on a researcher's favorite protein molecule eventually drove the premise of sequencing the human genome to uncover all the protein targets related to disease. The landslide of new sequences was thought to uncover new "druggable" targets. However, treating disease states is far more complex than identifying protein sequences. Biological systems are messy, intertwined with competing biochemical pathways. All drugs, including biotechnology drugs, risk being ineffective in humans, or worse, evoke "off target" responses in patients, since no therapeutic is 100% accurate in treating a disease. These side effects, if they become severe adverse events requiring hospitalization, doom potential drugs in the clinical trial process. Ineffectiveness and toxicity results in less than 10% success rate of drugs which enter FDA clinical trials.
By the 2000's the Human Genome was relatively complete, and the mad rush to identify and monatize new drugs was rapidly underway. Although the biotechnology industry continued to produce a small, stable number of new therapies each year, drugs based on the premise of genomic mining technologies failed to materialize and causing a collapse of a massive economic bubble within biotechnology. This collapse eroded confidence of fundable biotechnologies to venture capital has now made launching a biotechnology far more difficult than ever before. In addition, the cost of developing a drug and passing through the three phases of clinical trials is now in excess of 1 billion dollars, and is well out of the range of pure venture capital to fund. The biotechnology industry no longer aims for IPO which could fund clinical trials, and thus venture capital exits are solely based on corporate aquisition to fund costly human trials.
As the biotechnology industry faced growing pains, the large pharmaceutical companies that develop and market drugs also began encountering fundamentally challenging times. Namely- the ten year drug approval process simply takes too long, and the 90% risk of clinical failure is too high to sustain profitability. Even if a drug is approved, a therapeutic may only have 7-10 years to recoup the initial billion dollar investment. In addition, clinical trials generally produce a digital result- either the drug therapy is successful and is an IMPROVEMENT to existing standard of care, or the drug is deemed non-supeior or inferior to existing therapies and is considered a failure. As a result, large pharmacueticals have petitioned the government to extend the patent protection process, so marketed drugs would have longer profitability before generics are allowed to overtake market share.
Prospects for the future of Biotechnology
The seeds of biotechnology innovation rests with an visionary entrepreneurial scientist. Going forward, the economic climate change within the drug industry will fundamentally alter the course of commercializing biotechnology, and the entrepreneur will need to adapt to this environment. Biotechnology entrepreneurs must negotiate fundraising alongside cost containment to mitigate investment risk. The new models of biotechnology start-ups may rest on creating virtual companies which rely on multiple external contract partners to provide research services at all stages of technology development. The quality of the final data package would rest on finding and retaining the best quality relationships between the service providers and regulatory consultants.
Another avenue is to focus on non-therapeutic related biotechnologies. Start-ups based on diagnostics, medical devices, vetinary, or bacteriology .
It is my belief that vision alone is insufficient in producing fruitful drug discovery research. Even with the most talented scientific team, company assets are routinely lost or forgotten due to turnover, human error, and executive mismanagement. Transparency within a biotechnology discovery process is critical in successful execution, but typically lacking in most biotech start-ups due to data silos within different research and business development groups. Beyond understanding drug discovery, my sucess in creating discovery processes is by rendering transparent the material and data flow to all company stakeholders. This is accomplished by mapping the scientific discovery process and then building easy to use databases that mimics the process. In this way, no information is lost as complex biological data is accrued.
One major need in biologics contract research is a method to integrate client- based business objectives with the scientific bench work. To that end, I have collaborated with Avid Databases in developing Coronado, the first biotechnology database solution that captures and combines scientific information with business development activities (ELN - CRM hybrid). Coronado is currently available as beta-test version.
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