Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
While at the 2014 New York BIO Conference, I had the opportunity to interview Nathan Tinker, Executive Director at the New York Biotechnology Association, about challenges in early phase development. The New York Biotechnology Association is dedicated to the development and growth of New York State-based bioscience related industries and institutions.
Moe Alsumidaie: How is NYBIO Changing?
Nathan Tinker: When the organization was founded over 25 years ago, it was a biotechnology peer planning organization. However, it was clear that biopharmaceutical companies rapidly became a part of the equation. In the last two years, we have seen growth in the agricultural sciences industry, medical devices, combination therapies. Additionally, hospitals, clinicians, and payers/providers became more engaged in early-stage R&D development. Our objective is to take advantage of this culture and fully encompass what BIO has become on both national and policy fronts.
MA: There is a lot of interest in reform on reimbursement and medical product valuation. How is NYBIO getting involved with that concern?
NT: NYBIO has a Fellows Program for Life Sciences Entrepreneurs, which focuses specifically on companies with fewer than 10 employees, and less than $5 million in funding. We get entrepreneurs aligned with mentors, legal, and clinical support, and we help them identify what their real product opportunity is. The FDA is obviously becoming less and less interested in ‘me too’ products. Biopharmaceutical companies are also not interested unless the product is first or second in its class. So, trying to explain to an entrepreneur who has a great idea that it is not commercially viable can be a challenge, but, our role at the Fellows Program is to weed out unviable products and help align entrepreneurs’ vision with the needs of the industry.
MA: There is obviously a big gap between scientific entrepreneurs and venture capital firms, as VC firms are interested in quick ROIs, whereas the regulatory process for early scientific discoveries is quite complex, and severely impacts ROI outcomes. What are the challenges from bringing an idea from the lab into a successfully commercial product?
NT: The initial challenge is working with tech transfer offices at institutions, which have become more complicated. These offices are expecting more out of early-stage development, and often tend to want to own the majority of the license, which impacts investors. The financing is coming out of non-traditional sources; VCs are becoming less important in the early stage. However, strategic partners, patient groups, philanthropic funds, and family funds, that’s where there seems to be a new burgeoning of opportunity. The public markets have opened up a bit in the last few years, and it is becoming easier to bring a company public earlier in the lifecycle than it had been for quite a while. Additionally, there are alternative methods, such as reverse mergers, and special purpose acquisition companies are becoming more popular. Nonetheless, it is still a difficult road for a young company, especially if you’re getting into early and mid-stage trials, which cost hundreds of millions of dollars each without a promise of success.
MA: The White House indicated in one of its reports that the business and process of clinical trials is inefficient. How do these inefficiencies impact early stage companies? If clinical trials were more efficient and cost less, how will that impact innovation from early phase to commercialization?
NT: Big data is having a big impact on the way we run operations in clinical research, and using that sort of information to get from tens of thousands of candidates to a legitimate candidate more quickly without having to go through the same level of clinical work is going to be where things are headed. Efficiencies are going to come in preclinical and early clinical phases. It is easy to produce an enormous amount of data, but the next challenge is to parse the data and have it be useful. I don’t believe that the clinical trial model will disappear altogether; you have to have drugs in human bodies in order to reach levels of safety and efficacy. I remember when computers came in to aviation, and there was a lot of skepticism and resistance around using computers to fly planes; nowadays, most planes are kept in flight with computers. But, that’s not the same as the human body, which is a lot more complex.
MA: Is New York well-positioned to bring innovations in biotechnology?
NT: New York is well-positioned from the research innovation standpoint to take control of the changes and evolution in the industry, especially with the integration of IT, health data and clinical assessments.