FDA Reviewing 3D Printing of Medication

The FDA’s Center for Drug Evaluation and Research (CDER) announced this week it is continuing to look into the feasibility manufacturing medications with 3D printing technology.

3D printing of pharmaceuticals allows for a unique approach for the manufacture of solid drug products in various shapes, strengths and spatial distributions of the active and inactive ingredients. Designs ranging from a single compartment to designs with multiple drug compartments can allow the release profile of the active ingredients to be tailored to meet the needs of specific patients.

Some of the advantages this manufacturing approach could include producing unique dosage forms such as the instantaneous disintegration of an active ingredient, and other complex drug release profiles. To date, one FDA-approved drug—Spritam®–is manufactured using 3D printing technology. Spritam® tablets, for the treatment of epilepsy, are designed so that a large dose of active ingredient (1000 mg of levetiracetam) disintegrates within seconds after taking a sip of water.

The Office of Testing & Research is examining questions such as

  • What are the critical process and component material parameters that affect printability of drugs?
  • What are the critical process parameters for each 3D printing technology?
  • How can a determination be made regarding when and how a given 3D geometric design is underperforming?
  • What are the critical characteristics of the component products for 3D printing including printers, filaments, substrate, and cartridges?
  • What are the critical factors in this method of manufacture that affect the drug release rates and MOA?

Of course, with any new pharmaceutical manufacturing process, there are also regulatory hurdles to be managed as well. CEDR is examining to what extent the process can be managed to ensure quality control across the multiple components associated with 3D printing processes, namely printers, substrate, and intermediate products and processes.

Why It’s Hot

In a word where we are expecting increasing levels of personalized service in almost every area of our life, pharmaceuticals as a produce lag due to legacy constraints in manufacturing.

3D printing offers the ability to manufacture drugs on demand for a unique individual’s physiological demands and can have a significant impact on quality of life.

 

 

Fitbit To Play Critical Role In New Study

The Scripps Translational Science Institute will be using 12 months of data collected from Fitbit devices worn by 10,000 participants for part of the All of Us research program, a National Institutes of Health project through which researchers are looking into how individual characteristics can affect health and disease treatment. Data to be collected will include health metrics such as sleep and heart rate.

The goal of the project is two-fold. The primary, initial goal is to better understand how wearables can support data collection with the secondary goal set at looking how participants engage with their devices over time.

Fitbit’s healthcare business strategy also includes working closely with health plans and health systems for remote monitoring in addition to developing relationships with employers for corporate wellness. Though more and more providers now have access to this type of data from wearables, there are still plenty of questions about the best way to leverage it, how to incorporate it into clinical practice, and whether it has a place in electronic health records.

Why It’s Hot

First, and most importantly, any time we can better collect and leverage data to improve both our overall health we, as a society, win in increased QoL and lower health care costs.

Second, the wearables field has been struggling to increase its relevance after a brief initial period of rapid adoption. Its role as a means of data collection, at least until we gain a better perspective on how to better leverage or merge with other technology, will keep it in play so that it can mature.

Hi Alexa. I need you to drop off my prescription.

Buzz, such as reports this week and last, around the increasing number of states in which Amazon has acquired wholesale pharmacy licenses, currently at 12, as well as forays into redefining other aspects of the healthcare experience, has been increasing.

The challenge is that these licenses lack an additional component, a Verified Accredited Wholesale Distributor (VAWD) Certification which is authorized by the National Association of Boards of Pharmacy (NABP) and officially permits companies to distribute pharmaceuticals. The current level of certification limits them instead only to distribution of medical-surgical equipment, devices, and other healthcare related equipment which they currently already offer.

Why It’s Hot

Current estimates state that only 10% of scripts are filed via Pharmacy Benefits Managers (PBMs) leaving plenty of room for expansion in that market with the vast majority of scripts being filled by local pharmacies.

The biggest potential benefit Amazon can bring is its core excellence in product distribution. Just as applying their infrastructure to Whole Foods offers people anywhere the opportunity to engage with the Whole foods brand, prescription drug distribution offers the opportunity for patients to experience the customer experience they expect with Amazon.

Even the biggest advantage the local pharmacy can offer, its ability to give the patient face to face access to their pharmacist, has the potential to be challenged. Considering Amazon’s significant investment in voice-activated tech, Alexa, or her virtual co-worker name TBD, can surely provide quicker, friendlier service with the ability to access a catalog of knowledge larger than any human pharmacist can manage.

It will also force significant portions of a US $440 billion market to rethink how it serves its customers. After all, why shouldn’t the process of having your Advair script refilled be just as simple as clicking your Bounty paper towel or Scott toilet paper Amazon Dash Button?

Any way you slice it, Amazon should be able to win in the pharmaceutical distribution experience.

Increased Use of Point of Care Tactics Offer Opportunity For Better In-office Experience

MM&M announced this week that “up to 20% of pharma brands are moving digital media spend to point-of-care tactics” which was grounded in a study fielded by ZS Associates. To a certain extent, this is unsurprising as many forms of digital media such as social and display continue to face increasing scrutiny around the topic of ad fraud.

This will have an impact on two key audiences in healthcare marketing – patients and providers – which if well thought through, should be overwhelmingly positive.

Phreesia Patient Intake Platform

Patients

Platforms such as Phreesia offer patients the opportunity to engage with content as part of the intake process. The biggest challenge here will be placements that are relevant to the specific patient as there is a potential to spend effort on poor placements. Case in point; when I took my son to the pediatrician for his flu shot this year, I was offered the opportunity to “Learn More” about a branded product. The only thing I can recall about the brand is that is had nothing to do with why I was there and wouldn’t be appropriate for my son. Contextual relevance will be critical to success in these moments.

epocrates advertising platform from athenahealth

Providers

HCPs, particularly PCPs, are the target of massive amounts of marketing. Overwhelming is an understatement here. When you consider the necessity of staying abreast of current trends and new therapies, to a certain extent, they need to be exposed to these messages. However, when it’s all said and done, the moment that matters is when the Rx decision is made. The opportunity to be a relevant part of that moment as part of the HCPs workflow in the EHR/EMR offers pharma companies an incredible opportunity. When you consider the number of drugs that don’t have the budget for mass DTC advertising, the HCP really is the decision maker in the therapy of choice.

Why It’s Hot

While contextual relevance for audiences is improving and offers plenty of potential, the real win will be when a brand can own the conversation across the moments in an office visit.

Consider a diabetes patient checking in for a check-up who is offered a message around potential therapy they may be eligible with a DTC ad based upon key factors pulled through from their EHR.

Then, at the end of the appointment, the HCP if offered a targeted message in the EHR with a savings offer the patient can print and take with them.

With brands doubling down on these POC channels, we have the opportunity to take the in-office experience to new levels.

FDA’s Digital Health Innovation Action Plan Targets Software – Not Hardware – For Regulatory Approval

A few weeks ago I posted an article that spoke to the value connected medicine dispensing could bring to healthcare.

What I neglected to mention is the plethora of HIPAA hurdles that the healthcare industry faces when it begins collecting patient-specific healthcare data on mobile devices such as phones, tablets or wearables.

Thankfully there may be a solution on the horizon that significantly circumvents this challenge.

In the past, if a client were to build an app that collected patient-specific medical data, the entire phone would then be considered a “medical device.” The challenge with this lies in the relative inability of a healthcare company to effectively to manage HIPAA compliance on a device they rarely have contact with.

However, the FDA’s new Digital Health Innovation Action Plan is looking at ways to view the software as the components of a tech solution that needs to be regulated. This effectively paves the way for healthcare companies and the companies to more deeply integrate mobile technology with healthcare.

As part of the plan, the FDA is seeking 9 that meet the following criteria for its pilot initiative;

  • Business is developing or planning to develop tools that meet the FDA’s definition of a device — one intended to be used to diagnose, cure, mitigate, treat, or prevent a disease;
  • Company has an existing track record in developing, testing, and maintaining software products use key performance indicators for quality control;
  • Must agree to provide access to performance measures during the pilot
  • Collect real-world post-market performance data and provide it to the FDA;
  • Availability for consultations and site visits from FDA officials
  • Provide quality management system information

So who did the FDA deem worthy this past week from the pool of over 100 applicants?

  • Apple
  • Fitbit
  • Verily (the health unit of Google parent Alphabet)
  • Samsung
  • Roche
  • Johnson & Johnson
  • Pear Therapeutics
  • Tidepool
  • Phosphorus.

“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices,” FDA Commissioner Scott Gottlieb said in a statement. “These pilot participants will help the agency shape a better and agiler approach toward digital health technology that focuses on the software developer rather than an individual product.”

The end goal of the program is to develop a regulatory framework for software as a medical device so that companies with established, tried and tested quality assurance protocols would be able to update their products faster.

Why It’s Hot:

in the past, mobile devices such as wearables, phone or tablets that collected patient data weren’t HIPAA compliant. This new FDA initiative opens up the potential to build technology that makes these devices HIPAA compliant opening up vast new opportunities for the healthcare industry.

Pillboxes May Not Belong in the “Internet of Things” After All

Many people working in the healthcare space have been excited about the potential of expanding device connectivity to medication administration in recent years. After all, pill bottles are “things” so why not incorporate them into the “Internet of Things,” right?

As a result, various private innovation firms, as well as major pharmaceutical companies, have been making significant investments in developing “connected” medication dispensing systems in an effort to combat poor treatment compliance.

Lack of compliance – a patient’s inability to take a given medication as intended by their physician – is estimated to cost the US healthcare system $100 billion to $300 billion dollars a year.

Take, for example, a therapy that is self-administered once daily that also needs to be titrated to meet the unique, metabolic needs of a particular patient. If the patient skips a few doses, goes in for a follow up and swears, “Scout’s Honor, Doc!” that he didn’t miss a day – but in fact only remembered to take it about 60% of the time – the dose adjustment the HCP gives him to meet his unique, but misrepresented, needs may trigger an adverse event – pharma-speak for “serious side-effect” – if he suddenly decides to take the medication as intended.

Now consider the value of a medication container that communicates with the patient’s Bluetooth equipped phone. It can remind the patient to take his medication, record the time it was taken down to the second, and, when paired with a wearable technology, could also record additional health related data that gives additional context. This additional context also gives the health care provider more context in which to manage chronic conditions.

When paired with a relevant app, it can also give an additional view into consumer behavior to help marketers better understand optimal cadence and content topics to increase performance in their marketing plans.

However, a recent study published in JAMA showed that a study of post heart attack patients who were provided electronic pill bottles, combined with financial incentives and social support for medication adherence, had the same outcome in terms of re-hospitalization rate, medication adherence, and total medical costs as those who were not provided these resources.

Why It’s Hot:

While making the health connection has been a major leap forward from a technological perspective, it hasn’t solved the challenge of reshaping human behavior. Yet.

Until this technology has a better rate of success in reshaping patient outcomes, broader adoption of this technology may be in question.