Digital Biopharma 2.0

Digital health has converged with biopharma. It has happened because digital health technologies are making it easier for biopharmaceutical companies to discover, develop and launch new drugs faster and cheaper and improve the patient and doctor experience, in what is being labeled “after the pill”,

U.S. regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology. Some, however, are voicing concerns that there is no evidence that digital pills, prescription medications with ingestible wireless sensors, are beneficial to patients and, in fact, the technology poses a danger to the provider-patient relationship.

Increasingly, we are seeing the results of the intersection of digital health, biopharma and medtech. Here is an update on digital health pharma news.

What do the next stage of pharma and digital health collaborations look like?

Recent medical developments have gone towards personalized healthcare, meaning that patients get individualized treatments for their specific needs and also manage their disease.

Buzzwords that come to my mind in this context include big data, artificial intelligence, closed loop systems (not only for diabetes), and precision medicine.

Here are the results of a recent survey about the use of digital health in biopharma.

There are many applications:

1. Drug discovery and development using community based innovation networks
2. Better clinical trial recruitment, retention and execution that are more patient centric
3. Physician engagement at the community level as well as the academic research level
4. Patient engagement, compliance and adherence
5. Information and education

Here’s how digital health technologies are helping patients with diabetes and hypertension.

6. Remote sensing, data and analytics. For example, Pittsburgh-based UPMC Enterprises has made an equity investment in RxAnte, a predictive analytics and clinical intervention solution provider focused on inappropriate medication use.

RxAnte uses predictive analytics to improve prescribing practices and appropriate use of prescription medications.

7. Post market surveillance and pharmacovigilence

8. Sales and marketing

9. Personalized and precision medicine

10 Price and effectiveness transparency

11.Drug delivery

12. Smart pills

In addition, artificial intelligence, machine learning, the internet of medical things, remote patient monitoring, patient reported outcomes and blockchain technologies have the potential to improve the research quotient of biopharma drug discovery and development.

A recent HIMMS panel showcased the challenges:

The world is changing for Big Pharma. Driven by value-based care, reimbursement will increasingly be tied to drug effectiveness and outcomes. Competition is growing and market share slipping. To offset these challenges, pharma must forge new strategic alliances, drive efficiencies, speed up clinical trials, and develop targeted therapies as healthcare moves to more personalized care and precision medicine. Technology will drive this paradigm shift.

Here is how one company is rethinking how to engage with HCPs and digital health startups.

3 predictions for AI in pharma R&D in the year ahead:

Prediction 1: Drug discovery is being redefined by advances in technology. AI and machine learning software is expanding the universe of screenable compounds and will deliver higher hit rates as compounds move through the pharma value chain. The race is on for data. Consequently, BIG PHARMA will need to do a better job removing the barriers to collaboration with digital health (physician and patient) entrepreneurs.

Prediction 2: Within the next 10 years, a blockbuster-potential drug will emerge from a process that started with a computer, then to bench, then to clinic. We will see within the next few years promising compounds enter the FDA pipeline.

Prediction 3: Pharma companies will step up M&A, investment and joint venture activity this year and in 2019 as they look to the world of software AI startups for new drug discovery capabilities. The tailwinds are there for tremendous value creation.

Going beyond the pill will also require new business models and faces the challenges of precision medicine. Within the last few years the FDA has undergone a metamorphosis when it comes to digital health regulations. Though many of these are not yet solidified, a recent report by PricewaterhouseCoopers(PwC) predicts that these changes could open new doors for pharmaceutical companies looking to jump into the digital arena. The report spelled out four main regulatory changes that could give pharma a chance to accelerate digital product development.

First, the report points to the new digital health pre-certification program, which looks to allow certain companies that the FDA has deemed responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process.

Secondly, the agency proposed a new change that could make it easier for pharma companies to release medication companion apps. The report outlines that the proposal would allow digital tools, which supplement prescription drugs, to be regulated as labeling instead of going through their own process.

It also points to a newly published FDA draft guidance that applies to multiple function devices, which the FDA will “treat as separate the various functions of a digital health device, making it easier to have full-function products.”

Lastly, it highlights an over the counter (OTC) drug digital labeling regulations draft guidance, which allows the OTC drugs to be “approved based on evidence that consumers can use digital labeling to select a drug for treatment.”

Using digital tools to innovate has moved biopharmaceutical companies to create a new

position: chief digital officer and they are developing best practices.

All of these opportunities will challenge STEM graduate and medical school educators and leaders to create new learning objectives that provide the new and necessary competencies for graduates to compete in these evolving industries, particularly in the areas of data science, analytics, mining unstructured data and intelligence. Some universities and health systems, like the University of Colorado, are doing just that.

Digital health technologies are changing not only the face of clinical practice entrepreneurship, but medtech and biopharma as well. Given the pace of change, we are likely to see Digital Biopharma 2.0 and Digital Medtech 2.0 in the blink of an app. In fact, we might already have missed it.

Image by Arek Socha from Pixabay

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Arlen Meyers, MD, MBA is the President and CEO of the Society of Physician Entrepreneurs at www.sopenet.org and co-editor of Digital Health Entrepreneurship