Next-gen pharma manufacturing

Even with the rise in highly complex biologic drugs in development and on the market, when most people think of “drugs” they think of a little white or blue pill they take down the hatch with a drink of water. In technical jargon, a “pill” is also known as an “oral solid dose.” Fancy. Well, the little white pill itself is becoming a bit more complex. New technologies including 3D printing and continuous manufacturing are leading the way. Aprecia Pharmaceuticals is using a unique drug delivery technology (3D printing) platform to transform the patient and caregiver experience by reducing pill burden or simply making medicines easier to take. CONTINUUS Pharmaceuticals, a joint venture between Novartis and the MIT Center for Continuous Manufacturing, projects their plant can reduce COGS by >30-50%. So, be on the lookout for novel enhancements to the little red or blue pill.

The time is half past the QT interval

If that makes any sense to you, well done. If not, don’t worry, that’s what we’re here for. Earlier this week, Verily, a Google/Alphabet company, announced their Study Watch received FDA 510(k) clearance “as a Class II medical device for its on-demand ECG feature. Specifically, the FDA-cleared Study Watch as a prescription-only device intended to record, store, transfer and display single-channel ECG rhythms, and is indicated for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals.” According to Verily, “Study Watch has been used by thousands of participants in clinical research studies run by Verily and through our partners, such as the Project Baseline study, Aurora study, Personalized Parkinson’s Project study, and Parkinson’s Progression Markers Initiative.” This is big step and look kids, Big Ben, Parliament.

A warning from Novartis

May may or may not be able to pull off a Brexit deal prior to the country’s deadline. Novartis has looked into its crystal ball and told us what’s in store if there’s no Brexit deal. A statement released by Novartis warns that a no-deal Brexit “…will be hugely impactful for patients, particularly around the supply and safety of medicines.” To blunt the effects of potential difficulties importing drugs into the UK, Novartis is stockpiling supplies in the country ahead of the breakup. In addition, Novartis is pleading with pharmacists to not stockpile drugs and, instead, allow supply to be managed centrally by the company and avoid shortages around the country. Good luck. We’re all counting on you.

Sleep before you’re dead, not after

Scientists are sounding the alarm on a new public health crisis on the scale of obesity—sleep deprivation. Don’t hit snooze on these findings, because they suggest sleep loss may increase the risk of Alzheimer’s, strokes, and anxiety. Check out this TED Ed video about a kid who didn’t sleep for 11 days if you’re not scared yet. You’re supposed to get at least 7 hours of sleep every night, and according to the CDC over a third of Americans don’t. So yeah, the obesity comparison checks out. We don’t know a lot about sleep yet, even though we spend 33 years of our life in bed, so maybe this will serve as a wake-up call for research funding.

Sweat stickers

What that doesn’t sound appealing? Sure “Battery-free, skin-interfaced microfluidic/electronic systems for simultaneous electrochemical, colorimetric, and volumetric analysis of sweat” is more descriptive, but we’ll stay with sweat stickers. You could have your very own sweat sticker soon, which will tell you if you’re dehydrated, have low oxygen levels, or are at risk for cystic fibrosis. Recent (as in, Friday’s) advances in wearable tech have debuted a soft, light, battery-free patch which can monitor various biomarkers present in sweat and relay the info to a receiver. Companies like Gatorade and L’Oreal are hard at work developing their own sweat stickers, so expect to hear this throwback on repeat at their offices.

Oversight is over it

Taking direction from the White House’s recent and ongoing actions towards drug pricing, Congress has begun its latest investigation into prescription drug pricing. It starts with letters sent to 12 companies with products Congress views as either too costly or too price-hiked. As you might expect, that list is filled with blockbusters. Like America used to be. While the list is filled with pharma household names, three names you won’t see on the list—Amgen, Merck, and Gilead—were recently lauded by Health and Human Services Secretary Alex Azar for curbing drug prices. So maybe some progress is being made? The House Oversight Committee will hold hearings on Jan. 29 for experts and patients to weigh in, but no word on whether execs will be expected to make an appearance.

JP Morgan Healthcare Conference Recap

Well, one of the most important and well-attended healthcare conferences of the year wrapped up last week in San Francisco. The annual JP Morgan Healthcare conference is “the largest and most informative healthcare investment symposium in the industry, bringing together industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community.” ~9,000 attendees show up and ~450 public and private companies attend where people like Joe Biden and Bill Gates speak. For some of the better recaps go here for Day 1, here for Day 2, and here for day 3. The highlight? A contender would be Sage Therapeutics, as it saw its stock surge 43% on positive clinical trial news regarding their Sage 217 compound as it appeared to relieve symptoms of post-partum depression. Not bad. The opportunity to treat PPD is huge with 1 in 9 women experiencing the condition.

Did you check with Trump first?

“Our eventual goal is to add about 50 additional clinical reviewers to the group charged with overseeing the clinical investigation, development, and review of (cell and gene therapy) products” said FDA Commissioner Scott Gottlieb in a statement this week (the statement is a really good read). Sounds dandy and we assume that means there will be a wall too. The thing is, the FDA is hurting from the shutdown, but don’t worry, “the FDA will resume its inspections of high-risk food processing plants, using unpaid inspectors” – because all the good inspectors work for free. Back to gene therapy. In his statement, Gottlieb says “we anticipate by 2020 we will be receiving more than 200 INDs per year and by 2025 we predict the FDA will be approving 10 to 20 cell and gene therapy products a year.” Stay tuned.