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Would You Like To Expand Your Business Into China? Or Perhaps You Seek An Investor or Development Partner? Through our local partners in China, we can help you navigate this rapidly growing, but complex market. Indeed, China is a large and growing opportunity for Western life science companies, as: Life Science in China is Booming –Read More»
Lacerta Bio is seeking parenteral products for in-licensing on behalf of a US-based client. Key criteria are: Products which can be developed via the 505(b)(2) regulatory process in the US No specific therapeutic area Injectable could be infusion, prefilled syringe, or related presentation Products already approved outside the US are especially welcome Delivery / formulationRead More»
Lacerta Bio is looking to transact a business acquisition opportunity in the injectables manufacturing sector. We are seeking manufacturing facilities which have the following criteria: Based outside the US (Europe, Canada, LatAm, Australia, New Zealand preferred) FDA or EU approved manufacturing of parenteral products Could be a stand-alone company which manufactures its own products, or the divestmentRead More»
We recently learned about Bayer’s program. This program provides support to companies and projects involving “…novel software, hardware, technologies…contributing to improve health outcomes or pharmaceutical processes.”
But what exactly is “digital health”? And, how and where is it relevant to our industry?
This question would require an entire book to answer, and that book would be out of date the moment it was published.
Instead, we begin with this post, with the intention of editing and adding to it over time.
Here is our initial attempt to catalog just a few of the product concepts within the realm of digital health, with an emphasis on digital health as it applies to patient care.
Wellness, fitness, nutrition, and related apps will not be discussed here, nor will the application of digital tools to manufacturing, logistics, or other important aspects of the value chain.
“Around the Pill”
Pharmaceutical companies are looking at digital approaches to enhance patient compliance (and hence, efficacy), monitor side effects, and monitor disease conditions in real-time. All of these factors would enable prescribers to be much more informed about the effects their prescriptions are having on their patients.
This, in turn, could enhance patient-physician communications, and create physician brand loyalty towards pharma companies and their products.
For devices, this is a straightforward application of digital health. Indeed, the respiratory inhaler market is already embracing this concept through the use . These sensors transmit data to a smart phone app, enabling physicians to review compliance in real-time.
Oral solid dosage forms with ingestible sensors are also in development. For example, . This sensor detects and reports not only compliance data, but also physiologic responses. An NDA was filed in September, 2015.
This is interesting, for several reasons. First, the issue of FDA approval of apps and software as stand-alone products is an interesting one. How does one approve an app? What clinical trials are required, if any?
Second, the app will be for the diagnosis of Parkinson’s Disease. It’s one thing for an app to monitor disease, but diagnosis is a different matter. This is especially true for a rather . Can an app actually diagnose Parkinson’s? Will physicians simply ignore the app’s data and conduct their own assessment? Or, will the data be so rich and useful that they cannot be ignored by a physician?
Interestingly, . But this is for tracking symptoms during a clinical trial. On the surface, this is no different from a journal a clinical trial subject would keep during the course of the study. However, the digital element could add layers of data richness which are impossible with paper and pen.
Japan-based develops mobile apps to treat various conditions, including tobacco addiction. In Japan, mobile apps can be recognized as medical devices. Thus, after clinical trials, , and hence be eligible for health insurance coverage.
Increasing Access and Reducing Costs
Digital health can be used to increase access to physicians and specialists, while also reducing costs. For example, telemedicine is a concept which has been discussed for well over a decade. Today, the “doctor on your phone” concept is evolving into a “doctor in the app” model.
Companies such as are focused on physician access to areas of the world where this remains a challenge. Other examples include , , and . Telemedicine is already routinely used in the surgical setting, both during diagnosis and preparation, as well as during the surgical procedure itself.
From a pharma perspective, enhanced patient-physician interactions (either via video or quantitative data gathering) could provide companies with a far richer and more realistic data set compared to anything which could be gathered in a Phase IV study.
Conversely, open sourced observational studies could provide data which are less convincing than strictly-controlled Phase IV studies.
Speaking of reducing costs, is an online portal which enables patients to quickly compare prescription drug prices in a given location; the Uberization of prescription drugs, if you will. Similar sites include and .
One of the more progressive attitudes to be found in this space is elegantly captured by William Carson, President and CEO of Otsuka Pharmaceutical Development and Commercialization (OPDC).
Carson acknowledges that digital health has little to do with the current “pill” business. But, if Otsuka is a company which delivers health-related solutions, then digital health is an obvious market for investment, product development, and commercialization.
“We had to consistently remind employees that the mission of Otsuka isn’t to be a pill company, but to create new products for better health worldwide. We had to build a new mindset that the digital health system we were developing had little or no relationship to our existing business.” William Carson, OPDC
Indeed, the ability of , and hence eliminate the need for patients to buy their products, means that digital health could be a good way to diversify away from a business model which is characterized by high risk, high capital requirements, and long product development times.
Will Digital Health Backfire?
As patients continue to shoulder a greater proportion of drug therapy, it stands to reason that patients will use data access tools to shop for lower-priced options, such as generics and therapeutic equivalents.
This is obviously not new. But the question is, “How does pharma participate in this online discussion to enhance compliance, enhance physician brand loyalty, and drive sales?”
This is especially interesting when we consider that pharma companies do not control much of the data which goes into the drug selection decision, due to privacy, lack of access, or other reasons.
In other words, prescription decision-making is no longer the exclusive purview of the prescribing physician. Thanks to the Internet, we are all increasingly empowered to have some say in the prescribing process.
Pharma has countered this by having a greater presence both online and with DTC advertising.
But now there is the potential for patients to make even more informed decisions about prescription drug selection. For example, it is only a matter of time before patients take their own data (or the data from others) and post the results on social media. Some patients will come to the conclusion that the drug is ineffective, based on a social media post. How does pharma counter that?
Future of Digital Health?
As with most things digital, it is incredibly difficult to predict what lies ahead. But a few issues are fairly clear:
Regulatory – Digital health, especially as it interfaces with drug products, is a new paradigm for the FDA and other regulatory agencies.
Stickiness – Apps can be very easy to uninstall, or patients can become quickly bored with them. Design and ease of use will be critical in order to maintain compliance with the apps themselves.
Patents, IP, and Litigation – As we see in the mobile phone market, it is possible to craft patents which protect product attributes. But these can be readily mimicked. Is there a “composition of matter” or Paragraph IV equivalent when it comes to apps?
Creating an app or embedding a chip into a device is one thing. But adding value and improving patient health is another matter. As we often say in drug delivery, just because something can be done does not mean it should be done.
Ultimately, the decision to enter this area of digital health needs to be based on improving outcomes, reducing costs, and delivering value to patients, physicians, and shareholders alike.
This is a good question…a question which lacks a simple answer without quite a bit of analysis. We audit out-licensing processes, and there are times when the answer is an outright “No.” But sometimes, the answer is “Maybe,” provided some changes are made to the process, or provided additional data and details are added
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