Due to the uncertainty in the development, clinical testing, and regulatory approval of both biotech and medical technologies, which increasingly have to be viewed with the same competitive lens, investors have over the past few years shied away from seed stage or Series A stage company investment in favor of those nearer to market introduction. However, with the advent of a great number of new technologies and advances in the underlying science, there is enormous opportunity to identify companies and emerging sectors arising from these advances. The problem in identifying realistically promising companies is that it must be done so without falling prey to the bad investment practices in the past that ensued from a poor understanding of the technologies and their remaining commercial hurdles. Without careful consideration of remaining scientific development needed, the product’s target market, its competitors, and the sum total of the company’s capabilities to commercialize these technologies, investment in these areas will fall short of investment objectives or fail them outright.
While any of these considerations have the capacity to preempt a successful market introduction, a failure to understand the science behind the product and its remaining development hurdles to commercialization is likely to be the biggest cause of failure.
“We’ve already had one glaring example of a company, and its investors, learning the hard way that health and science advisors are important: Theranos.” (link)
Venture Capital has backed away from early stage investment
Earlier stage investment, with its higher risk, has higher potential reward, so there is a big need for more effective evaluation of potential early stage investments in order to (1) seize these opportunities that will otherwise potentially be lost with the shift to later stage fundings, (2) sort out those companies/technologies with overwhelming commercialization hurdles from those that will profitably tap an opportunity, and (3) gain the value of these opportunities before the innovation appreciates in value, driving up the price of the investment.
The Biotech Bubble
Biotech in the 1980s was enamored with companies pursuing “magic bullets” — technologies that had the potential to cure cancer or heart disease or other conditions with large, untapped or under-treated populations. With few exceptions, these all-in-one-basket efforts were only able achieve a measure of humility in the VCs who had poured volumes of money into them.
Here was evidenced a fundamental problem with biotech at a time when true scientific milestones were being reached, including successes in mapping the human genome: Landmark scientific milestones do not equate with commercial success.
As a result, money fled from biotech as few products could make it to market due to persistent development and FDA hurdles. By the late 1980s, many biotechs saw three quarters of their value disappear.
A Renewed Bubble?
The status of biomedical science and technology, with multiple synergistic developments, will lead to wild speculation and investment, potentially leading to yet another investment bubble. However, there will be advances that can point to real timelines for market introduction that will support investment.
Recent advances, developments and trends supporting emerging therapeutics
- Stem cells. A double-edged sword in that these do represent some the biggest therapeutics that will emerge, yet caution is advised since the mechanisms to control stem cells are not always sufficient to prevent their nasty tendency to become carcinogenic.
- Drug discovery models, such as using human “organoids” and other cell-based models to test or screen new drugs.
- Systems to accelerate the rapid evaluation of hundreds, perhaps, thousands of potential drugs before moving to animal models or preclinicals.
- Machine-learning algorithms
- Cell/tissue/organ models
- Meta-analysis, the practice of analyzing multiple, independently produced clinical data to draw conclusions from the broader dataset.
- Cross-discipline science
- cell biologists, immunologists, molecular biologists and others have a better understanding of pathology and therapeutics as a result of information sharing; plus BIG DATA (e.g., as part of the “Cancer Moonshot”). Thought leaders have called for collection and harnessing of patient data on a large scale and centralized for use in evaluating treatments for specific patients and cancer types.
- Artificial intelligence applied to diagnosis and prescribed therapeutics (e.g., IBM Watson).
- Examples of resulting therapies, at a minimum, include multimodal treatment – e.g., radiotherapy and immunotherapy – but more often may be represented in considerably more backend research and testing to identify and develop products with greater specificity, greater efficacy, and lowered risk of complications.
- Materials science developments, selected examples:
- CAR-T (chimeric antigen receptor T cell therapy)
- CRISPR/Cas-9. Gene editing
- Removal, insertion of individual genes responsible for disease
- Potential use for creating chimeras of human and other (e.g., pig) species in order to, for example, use pigs for growing human organs for transplant.
- Smart devices: smart biopsy needles, surgical probes to detect cancer margins, artificial pancreas. Devices using information
We sum this up with these prerequisites for investment:
Prerequisites for Early Stage Med/Bio Investment
- A fully understood and managed gap between scientific advance and commercial reality.
- Investment must be tied to specific steps (prototyping, preclinicals, clinicals, physician training, etc.).
- A management team qualified in commercializing medtech or biotech products.
- CEOs (and/or Chief Medical Officers, Chief Scientific Officers) with medical science backgrounds (MD, PhD) favored over CPAs or even JDs.
- Reimbursement strategy pursued as something more than an afterthought
- Technology development in sync with end-user acceptance and training to leverage the benefits:
- Easier to use
- Fewer complications
- Attractive physician revenue streams
- Broad competitive advantage pursued:
- Product benefits must stand up against all competition, irrespective of technology type (devices competing with drugs, biotech).
- Benefits of reducing the cost of care for an existing patient population are paramount.
- Competitive advantage must consider the trend in technology development to avoid being disrupted by other products soon to reach the market.
- Predefined exit strategy; selected examples:
- Positioning to add innovation to a mid-cap or large-cap medtech or biotech as acquirers.
- Development of platform technologies for licensing or sale.
Future investments are likely to track the historical focus on specific diseases and conditions:
Source: MedMarket Diligence, LLC and Emerging Therapeutic Company Investment and Deal Trends; Biotechnology Innovation Organization.
MedMarket Diligence, mediligence.com, tracks medical and biotechnology development to provide meaningful insights for manufacturers, investors, and other stakeholders.