Could genetic testing help thwart the opioid crisis?

Why some people become addicted to oopiods and some do not has become somewhat of a mystery in the medical community. But the story is familiar; patient gets prescribed an opioid pain killer, and by the end of their course of treatment, they have developed a dependency (knowingly or not). But what if a genetic test could signal whether a person is more likely to develop an addiction, and therefore at higher risk from the moment they enter the doctor’s office?

That’s exactly what the medical analytics company Prescient Medicine has set out to do with their LifeKit Test- a genetic test that determines within 97% sensitivity how addictive your genetic response to opioids will be. Using an algorithm they developed based on genes that signal addiction in neural pathways, they give each test subject a score out of 100, with anything 52 or higher showing an elevated risk of addiction.

WHY IT’S HOT

Perhaps LifeKit and advancements in genetic testing could be the preventative measure needed to stop this national health crisis, and even aid with substance abuse of all kinds. As genetic testing becomes cheaper and more ubiquitous, it may arm doctors with the knowledge to offer alternatives that could saves millions of lives.

SOURCE: https://www.fastcompany.com/40513391/is-genetic-testing-part-of-the-solution-to-the-opioid-crisis

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.

 

 

Breakthrough Bacterial “Live Ink” Developed For 3D Printing

ETH Zurich, a science & tech university, has announced the development of a new kind of ink that contains live bacteria. This ink has fantastic implications for several areas of science, including cleaning up environmental pollution and creating medical supplies.

For environmental pollution, the ink is key because it suspends bacteria in a polymer hydrogel, which keeps the bacteria alive and fed for a time. Once the bacteria eat all of the hydrogel, it can begin to process other materials – for example, toxins in water. ETH Zurich researchers printed a live ink grid embedded with bacteria that eat the hazardous chemical phenol, and then put the lattice in phenol-contaminated water. The water was completely purified in just a few days.

For medical supplies, this ink is important not because of the bacteria itself, but because of the strands of material that the bacteria create when they move: bacterial cellulose. Bacterial cellulose is pure, holds a lot of water, and is soothing to wounds on human flesh. And it’s a natural material, so human bodies generally don’t reject the cellulose. As a result, this material is perfect for materials like skin transplants and wound dressings. Until now, bacterial cellulose could only be grown in flat sheets, which isn’t conducive to the contours of bodies – but now with this 3D ink, researchers can print cellulose in the shape of someone’s elbow, or face, or ankle, etc.

Why It’s Hot: There are SO many possible applications of this technology. 3D printing is relatively easy to access, and there are a million kinds of bacteria (unscientific estimation) that could be used and modified to achieve a multitude of goals. For example, researchers are already eyeing bacteria that could be genetically modified to secrete medicine to speed wound healing, and before you know it we’ll all be buying bacterially enhanced Band-Aids!

Read more: The Verge | Science News

This video game is also an ADHD prescription medicine

Akili Interactive just announced incredible results from a pivotal study of their investigational digital medicine, AKL-T01, aka a VIDEO GAME, in treating pediatric ADHD. This sounds bonkers but it’s true, I swear.

In a randomized, controlled trial of 348 kids and teenagers with ADHD, AKL-T01 showed a statistically significant improvement compared to an active control on the primary goal of changing the subjects’ Attention Performance Index, a measure of ADHD symptoms. With these study results in hand, Akili plans to file AKL-T01 with the FDA for clearance as a novel treatment for pediatric ADHD.

AKL-T01 is built on Akili’s proprietary Project: EVO tech platform that “enables selective targeting and activation of specific cognitive neural systems in the brain that exhibit deficiencies from various medical conditions” (BusinessWire). Basically, the game uses algorithms to deliver stimuli that engage targeted neural systems in the brain, and the algorithms automatically adjust the level, aka dose, of stimuli depending on the particular patient. The treatment looks and feels like a video game, with art, music, storytelling, and rewards to keep kids engaged for maximum compliance.

Why It’s Hot: IT’S A VIDEO GAME THAT IS ALSO A PRESCRIPTION FOR CHANGING NEURAL PATHWAYS IN PEOPLE. That is bonkers. If the FDA approves this as a medication, and the platform is expanded to treat other brain/neurological disorders, the possibilities are endless.

Learn More: BusinessWire | Reuters

Pharma Trend Spotting for 2018

Going into the final month of the year, we should take a look at what could impact pharma marketers in 2018, and it’s identified half a dozen high-level trends for the year ahead.

Those trends range from maturing technology innovations to marketing around patient hero stories that inspire but also normalize people with chronic conditions. And they’re “changing the opportunities and focus for our clients,” Leigh Householder, managing director of innovation at inVentiv Health, said.

Some of the big-theme trends originated in 2017 or even earlier, but they’re just now maturing to opportunity status. For instance, technology innovations like artificial intelligence and augmented reality will begin to play a bigger role in healthcare next year as they move from novelty experiments to real-world tools. A pilot program by England’s NHS, for instance, uses AI as a first contact point for patients and puts a machine in the place of what would traditionally be a human healthcare provider, Householder noted. The NHS pilot actually incorporates another trend, too: the shifting front door to healthcare.

The shifting front door, whether a new kind of technology interface or pharmacists taking on a larger role in ongoing contact and care of patients, has been evolving for years, but it’s become more important for pharma companies to understand and incorporate it into their strategies.

Another trend she pointed to is the emergence of hero stories, in the past year showcased by individuals who broke through with poignant or meaningful tales of helping others, such as boaters in Texas who braved dangerous hurricane floodwaters to help victims. In healthcare and pharma, those can manifest as showing more real people who are living complex lives with chronic diseases, for instance—people who are simply “living normal,” Householder said.  MRM has partnered with WebMD to showcase how patients with bipolar depression live, and it’s very compelling.

Source:

WebMD presents Bipolar Disorder: In Our Own Words

“You can imagine why this is happening now when so many once life-ending diagnoses have become chronic diseases. Whether you’re talking about COPD or cancer, cystic fibrosis or AIDS, people are living for decades longer than maybe they ever expected,” she said, pointing to an outspoken advocate, Claire Wineland, who has cystic fibrosis. Wineland has talked to media outlets about “‘what happens when you have an illness and you’re never going to be healthy? Does that mean you’re never going to be anything other than the sick kid?’ We’re increasingly hearing from voices like that of people who just want to normalize disease,” Householder said.

Another example is the introduction of Julia, a muppet with autism, on “Sesame Street.” Julia helps kids understand what autism might look like in another child, and although she has differences, she’s just another one of the gang.

Householder is working on a follow-up white paper about what these trends mean for pharma, but she offered some initial thoughts about ways pharma can adapt. Understanding how people use technology and creating better user interfaces more quickly, for instance, is one area where pharma can improve. Another is at the new and shifting point of care.

“In the new journey in healthcare, how do we be relevant, useful and impactful at the new points of care? Whether that means an artificial intelligence interface, a call delivery of a prescription or a true care interaction with a pharmacist, how are we going to take the plans we have today and evolve them to the places that people are increasingly receiving care and making healthcare decisions?” she said.

Why It’s Hot

As pharma marketers, we need to evolve with how people interact with not only brands but more importantly, conditions.  Offering support in a variety of ways is a smart way to ensure that patients get as much help as they need.

 

Source: https://www.fiercepharma.com/marketing/pharma-marketing-trends-for-2018-include-hero-stories-technology-maturity-and-frontline

Apple Watch Gains Momentum as Key AFib Diagnosis Tool

Two developments this week are putting Apple Watch front & center in the ongoing search for better atrial fibrillation (AFib) diagnostic and management tools. AFib is a condition where your heartbeat is irregular, and it often has zero symptoms and goes undiagnosed. It’s currently the leading cause of strokes, and related deaths and hospitalizations, in the US.

First, the FDA has cleared the first EKG band as a direct-to-consumer – meaning, you don’t need a prescription to purchase or use it – Apple Watch accessory. The KardiaBand, a device made by startup AliveCor, can capture your EKG in 30 seconds. The band’s algorithms can then detect whether signs of AFib are present in the EKG. The band also makes use of the Apple Watch’s heartbeat sensors and will alert you if your watch is picking up fast or irregular heartbeats, and prompt you to complete an EKG test on the spot to further analyze any symptoms you may be feeling.

Second, Stanford has launched an irregular heartbeat study using the Apple Watch and an app available on the App Store called Apple Heart Study. Users just download the app and consent to participate, and then their data is automatically collected and analyzed by Stanford. If AFib is detected, the app will send you a push notification as well as provide a free consultation with a Stanford doctor and an EKG patch for further monitoring. With Apple’s recent release of HealthKit and ResearchKit, this study is another step toward positioning the Apple Watch as a versatile, reliable health monitoring device.

Why It’s Hot: These two developments are cracking the facade of a time-honored medical tradition of keeping information about your own body behind expert oversight. The KardiaBand being direct-to-consumer indicates a big step forward in companies being able to build hardware and software that rival medical technology to a level that the FDA will approve it. And the Stanford study is working directly with Apple Watch users, not requiring any subjects to go into a medical facility for testing and data gathering. Is this the first step toward breaking down the expert oversight firewall? But of course, on the other hand, what are the ramifications of people’s health data being shared and stored on their devices?

Learn More: EKG band | Stanford study

Brands Put Pressure on Agencies to Develop Alexa Capabilities

“As the Bezos behemoth continues along its unstoppable, disruptive path, brands are increasingly requesting Amazon-tailored services. Agencies have been ramping up their capabilities on the platform and even launching dedicated practices as a response.”

“Many marketers now view Amazon as a legitimate competitor to Facebook and Google, according to 22squared vp, director of media planning Brandy Everhart. ‘What they bring to the table is an extensive data set that you can’t get anywhere else,’ she said. ‘We’ve seen a lot of successful campaigns that are focused on driving conversions on the Amazon platform.’

Even brands that don’t sell on Amazon are asking questions due to the power of its search reach and the benefits of its data sets. ‘Clients want me to increase their engagement in every possible way,’ said Matt Bijarchi, founder and CEO of digital brand studio Blend. ‘We’ve learned ecommerce is also a brand-building opportunity.'”

Article here

Why It’s Hot

This is hot for 2 key reasons: data and customer engagement.

As VRT devices like Alexa and Google home start to infiltrate the home and the office, it will be increasingly important to understand what information users are asking these devices for, and what content people are consumers – making it a perfect addition to our SENSE offering.

For pharma specifically, Alexa and similar devices offer opportunities to support and engage both patients and HCPs in office and at home. Building relevant skills for these audience could help:

  • support physician discovery and work as a valuable sales resource
  • Provide guidance for patients when self-administering at home and track adherence
  • Help patients track symptom improvement
  • Improve infusion experiences at home and in-office with original and curated content tailored to patient’s interests/needs

Podcasts: Trust, Immersion & Convenience

Podcasts are far from new. However, they provide opportunities to reach and engage a very active group of consumers in an environment that they trust, for long periods of time during moments that are convenient for them.

Source

Why It’s Hot

Trust content is hard to come by these days. Additionally, consumers increasingly expect information that’s tailored to their needs and interests. Podcasts provide opportunities to engage these consumers around complicated topics for long periods of time when it’s convenient for them.

For pharma companies looking to engage and educate HCPs around new treatment options or opportunities in digital health, this could provide opportunities for content creation and/or partnership. The same can be said for B2B and technology.

FDA Approves First-Ever Digital Pill

The FDA has approved a pill called Abilify MyCite that can digitally track whether it’s been ingested, and when. The point of the medication is to increase patient compliance, the thought being that if the patient is being held accountable by their medication, they’ll be more likely to take their pills. Non-compliance is a huge issue – not only does it decrease patient outcomes, it’s also can create drug resistance, and in the case of overdosing, can create dangerous drug dependency.

The pill works via a sensor in the actual pill made of copper and magnesium that sends out an electric signal once the sensor hits the stomach acid. The patient wears a patch on their ribcage that receives the electric signal, and sends it along to an app that records the date and time of the pill digestion. The app allows for data sharing with doctors and family members (and sharing permissions can be revoked at any time).

Though the technology is promising, there are big ethical questions raised by this new pill. First, Abilify is an antipsychotic medication prescribed primarily to treat schizophrenia and bipolar disorder. The FDA’s approving of this particular kind of medication reflects a concerning disregard for the mental wellbeing of patients – Dr. Jeffrey Lieberman told The New York Times, “there’s an irony in it being giving to people with mental disorders that can include delusions. It’s like a biomedical Big Brother.” And his colleague Dr. Paul Appelbaum, Columbia’s director of law, ethics and psychiatry, pointed out that “drugs for almost any other condition would be a better place to start than a drug for schizophrenia.”

Second, the authority figures wielding this level of surveillance could easily manipulate patients. Imagine being told that your insurance company will cover 100% of your pill costs, but only if you take it on time every day. Or that you’re on parole and your freedom is contingent on taking medication. Or that your release from a psychiatric institution is predicated on your drug adherence.

Why It’s Hot: The technology itself is exciting – and the potential implications are fascinatingly broad, from improving patient outcomes to providing a whole new way for authorities to exert control over your physical being. (Yikes.)

Learn more: EngadgetNew York Times

 

Bye Bye Needles!

From a patient point of view, needles bring a wave of negative emotion. The pain, the fear of infection and the general phobia of something piercing your skin all combines to create a challenging experience. From a medical view, however, some of the most complex medications often need this delivery system to be effective. Of particular interest are large molecule biologics. These advanced therapies are manufactured in a living system like a plant, animal or human cells. By having a protein base, they are unable to survive in the harsh environment of the stomach, leaving injection as the only viable option

For patients on these life-changing therapies, over 50% end up dropping off, often due to injection challenges. These patients forgo the benefits merely due to the delivery device.

What if it didn’t have to be that hard? What if large cell molecule drugs could be delivered by a pill? Rani Therapeutics plans to find out.

Rani has been testing a new medical device that allows injectable medications to be delivered via a pill. Thier system leverages a swallowable auto-injector that launches in the intestine allowing the drug directly to be absorbed via the intestinal wall, allowing the drug to be inserted quickly into the bloodstream.

The sugar-based pill uses a reaction much like Alka Seltzer; the stomach acid dissolves the outer casing, causing a reaction and CO2 release that pushes “sugar needles” into the wall. These needles release their drug and then dissolve as well.

 

Mir Imran, Chairman, and CEO of Rani Therapeutics stated

Now, imagine eliminating injections altogether and delivering the drug through the oral route.  For patients, this could mean they no longer have to fear or dread the treatment plans designed to help them.

Why It’s Hot

The ability to remove the fear and administration burden of complex drugs will change the way patients access therapy. Combined with broader distribution and possible cost savings this evolution would fundamentally change the landscape of advanced therapies.