biopulse - week of 8/7/23
Bill Gadless
Founding Partner - ??emagineHealth, the Digital-First, AI-Powered Marketing Agency for Healthcare & Biopharma. emagineHealth.com
Welcome to?biopulse, your weekly briefing on key trends and insights in the biopharma sector. Every week, I (Bill Gadless) probe top stories, product launches, controversies, and marketing insights. I feature pivotal industry developments, innovative marketing tech, thought leadership and regulatory shifts reshaping healthcare engagement.
?? Most of all, I do my best to get you?thinking?about these topics.
? A quote (from me):
"The Inflation Reduction Act challenges the biopharma sector, especially small and emerging companies. We must innovate our way through this obstacle, embracing technologies like Decentralized Clinical Trials, to keep the lifeblood of medical discovery flowing without compromising affordability or quality."
Myself
? Another quote (from someone else):
"The time to adapt is now. Mid-market and emerging pharma companies can achieve their pivotal clinical trial milestones with a unified trial management system that offers a high-value solution, addressing the most pressing problems in the clinical trial development process."
Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics
?? Question for you:
How do you think emerging biopharma companies can best leverage technology to overcome the challenges posed by new price controls and continue driving medical innovation? What balance must be struck between patient affordability and sustained investment in R&D?" ??
?? What's Pulsing?
AI Detecting Breast Cancer as Well as Radiologists: A Game-Changer in Healthcare?
?? The deets:?A new study reveals AI's potential in detecting breast cancer, performing on par with experienced radiologists and even outpacing them by 20% in some cases. This technology could alleviate the workload of healthcare professionals, but implementation remains a future challenge. An exciting development with real promise.
????My two cents:?Isn't this something? We're talking about a machine that might soon be catching things even trained human eyes miss. Imagine AI being your co-pilot in the battle against breast cancer, not just speeding things up but maybe even spotting that critical 20% more. Of course, we've got to figure out how to get it into the hands of those who need it without tripping over ourselves. But hey, the future's knocking, and it's bringing hope and help in ways we might not have thought possible.
???Your turn:?AI is matching radiologists in spotting breast cancer. How could this advancement impact healthcare globally, particularly in regions facing a shortage of medical professionals? Is our healthcare system ready for this integration? Share your insights!
Neuralink Secures $280 Million: A Leap Forward or a Stumble in the Brain-Computer Interface Race?
?? The deets:?Elon Musk's Neuralink has landed $280 million in funding, led by Peter Thiel's Founders Fund, paving the way for its first human clinical trial. This comes after reports of rushed animal testing and some ethical concerns (according to Reuters.) A bold step into the future of brain-computer interfaces, but not without its shadows.
????My two cents:?$280 million in funding for Neuralink - that's a big leap forward! It's thrilling to think about the doors this could open in the world of brain-computer interfaces. Sure, there have been some concerns, but this step feels like a real game-changer. It's one of those moments where the future seems to be rushing towards us, full of promise and excitement. We're on the cusp of something that could redefine how we interact with technology, and I can't wait to see where it takes us.
???Your turn:?Neuralink's fresh $280 million funding heralds a new chapter in brain-computer interface technology. What do you think are the ethical boundaries that need to be established for such cutting-edge innovation? How can we balance the rush towards progress with responsible research? Share your thoughts.
FDA's Semiannual Regulatory Agenda Unveiled: New Rules on Labeling, Advertising, and Compounding Looming on the Horizon
?? The deets:?The US Department of Health and Human Services (HHS) has revealed the FDA's semiannual regulatory agenda, including 21 rules that cover areas like labeling, DTC advertising, and compounding. The proposed changes aim to enhance public health safety, simplify drug information, and align with international best practices. Several rules specifically target the COVID-19 pandemic and healthcare accessibility.
????My two cents:?Well, it seems like the FDA is rolling up its sleeves with this new regulatory agenda, and I think it's about time. It's not just about rules and red tape; it's about making things clearer and safer for everyone. I mean, who doesn't want to understand what's in the medications they're taking or know that the supply chain is reliable? And aligning with international best practices? That's a smart move. This is about looking at healthcare as a global community rather than in isolation. Some folks might grumble, but I think these changes could be a big win for consumers.
???Your turn:?The FDA's semiannual regulatory agenda paints a detailed picture of the upcoming changes in the healthcare landscape. How do you see these rules affecting the relationship between pharmaceutical companies, healthcare providers, and patients? Do you think the shift towards clearer communication and international alignment is a step in the right direction?
Biogen and Sage's Triumph and Setback: Postpartum Depression Drug Approved, Major Depressive Disorder Application Rejected
?? The deets:?Biogen and Sage Therapeutics received FDA approval for their postpartum depression drug Zurzuvae but were also dealt a blow with the rejection of the drug for major depressive disorder. The mixed result has caused disappointment for the companies, with Sage's stock dropping nearly 48% and Biogen's down 0.26%, and raised questions about future plans.
????My two cents:?Talk about an emotional roller coaster for Biogen and Sage Therapeutics. One minute they're celebrating FDA approval for Zurzuvae in treating postpartum depression, and the next, they're grappling with a rejection for major depressive disorder. That's like getting a high five and a slap in the face all in one day. And boy, did the market notice! Sage's stock taking a nosedive says it all. It's like a game of high stakes poker where the risks and rewards are monumental. It makes you wonder, though, what's the next move for these companies? Try again with new trials, or go back to the drawing board? I wouldn't want to be in their shoes, but I sure am curious about what they'll do next.
???Your turn:?The FDA's dual response to Biogen and Sage's new drug has shown both the triumphs and trials of pharma innovation. How do you interpret the implications of this mixed result for the broader industry? Does the rejection for major depressive disorder represent a setback for mental health treatments, or is it a necessary hurdle in ensuring only the most effective treatments reach the market?
Evolus Aims to Challenge Botox with Jeuveau Rebrand Targeting All Genders
?? The deets:?Evolus is rebranding its Botox competitor Jeuveau to broaden its appeal beyond millennial women, targeting all genders. Despite strong sales growth, Evolus is launching new branding to encourage all consumers to embrace their beauty. The rebrand includes a diverse range of models and a new website that emphasizes inclusivity and a youthful, vibrant aesthetic.
????My two cents:?Well, Evolus is stepping into the modern age with a rebrand that says, "Hey, beauty treatments aren't just for one demographic!" And why should they be? By shaking up Jeuveau's image to include everyone, they're not just chasing a trend; they're embracing the way our culture is evolving. It's like they've taken a good, hard look at the mirror and realized that beauty is a complex, multifaceted thing that doesn't fit into neat little boxes. And let's face it, in the cutthroat world of cosmetics, standing out from the crowd is everything. Will this rebrand make them a significant rival to Botox? Time will tell, but they're certainly making a statement, and it's one that resonates with a world where individuality and inclusivity are celebrated. Now that's something worth raising an eyebrow at - unless, of course, it's been recently treated with Jeuveau ...
???Your turn:?Evolus's rebranding of Jeuveau to target all genders represents a departure from traditional marketing in the aesthetics industry. How might this shift in branding impact the perception and use of neurotoxin wrinkle treatments in different demographics? What other industries could benefit from a more inclusive marketing approach?
J&J Partners with Influencers for Back-to-School Eye Exam Push
?? The deets:?Johnson & Johnson (J&J) is encouraging parents to add eye exams to their children's back-to-school preparations. Promoting its FDA-approved overnight contact lenses, Acuvue Abiliti, J&J has enlisted content creators, optometrists, and patients to share their experiences. The campaign highlights the importance of eye health and seeks to correct nearsightedness in children and young adults.
????My two cents:?Johnson & Johnson's campaign is an eye-opener in more ways than one. They've not just seen a marketing opportunity; they've honed in on a moment that matters to families all over the country - back-to-school preparation. And what's brilliant about this is that they're not just pushing a product; they're aligning it with the idea of taking care of your kids' health. By pulling in stories from real people, they're making it personal. It's not just a faceless corporation telling you to buy something; it's fellow parents and professionals saying, "Hey, this matters, and here's why." It's marketing with a message, and it's a message that could really resonate with parents who are all about doing the best for their children. The beauty here lies in the blend of smart branding and a genuine health reminder.
???Your turn:?Johnson & Johnson's back-to-school campaign for eye checks utilizes influencers to reach a wider audience. How do you think influencer marketing can impact healthcare awareness and product adoption? What are the ethical considerations that should be kept in mind when using influencers in the healthcare sector?
Kim Kardashian Showcases Medtech Company Prenuvo, Faces Backlash Over Costly MRI Scans
?? The deets:?Kim Kardashian promoted Silicon Valley startup Prenuvo on Instagram, showcasing the full-body MRI scan service that employs artificial intelligence. Kardashian praised the scan's ability to detect early-stage health conditions but faced criticism for promoting a $2,500 procedure most of her followers can't afford. Prenuvo's scans aren't covered by most insurers, and experts debate their effectiveness.
????My two cents:?Kim's endorsement of Prenuvo's full-body MRI scans brings a tricky issue into focus: accessibility in healthcare. While offering visibility to a high-tech medical procedure, it simultaneously highlights the vast disparities in access and affordability. It's a reminder that celebrity promotion in healthcare can spark interest but also stir concerns and debates about who gets to benefit from cutting-edge innovations. A complex conversation, wrapped in a single Instagram post.
???Your turn:?Kim Kardashian's promotion of Prenuvo's full-body MRI scans has stirred a debate about accessibility and the role of celebrities in medical technology promotion. How should companies weigh the benefits and potential downsides of celebrity endorsements, especially in the healthcare sector? What ethical considerations should be taken into account?
Dana-Farber's OncoNPC AI Helps Identify Origin of Hard-to-Diagnose Cancers
?? The deets:?Dana-Farber Cancer Institute's AI program, OncoNPC, can trace the origin of unknown primary cancers, finding the original malignancy site in cases that elude standard diagnostic techniques. Built using over 36,400 patients' medical records, OncoNPC accurately predicted about 80% of tumors’ origins and was 95% correct in high-confidence predictions. This could increase eligibility for precision treatments.
????My two cents:?OncoNPC's success in tracing the origin of unknown primary cancers is a game-changer in personalized cancer treatment. Unveiling the mystery in 3% to 5% of challenging cases, this AI tool could be the key to unlocking more precise therapies. It's not just about technology for technology's sake; this is about technology directly influencing patient care. This development puts a spotlight on the exciting intersection of AI and medicine.
???Your turn:?The OncoNPC AI tool by Dana-Farber Cancer Institute has shown potential in tracing unknown primary cancers back to their source. How can the integration of AI in diagnostic processes reshape the future of personalized medicine? What other areas of healthcare could benefit from similar AI-driven insights?
Nonprofit Naloxone Manufacturer Donates 200,000 Doses Following FDA Approval
?? The deets:?Nonprofit manufacturer Harm Reduction Therapeutics is donating 200,000 doses of its recently FDA-approved nasal naloxone spray, RiVive, to the Remedy Alliance. RiVive, aimed at reversing opioid overdose, will be sold over the counter for as much as 40% less than Narcan, the first FDA-approved naloxone product. The donation represents 10% of the nonprofit's expected annual production.
????My two cents:?Harm Reduction Therapeutics' move to donate 200,000 doses of RiVive isn't just a generous gesture; it's a strategic step toward making life-saving treatments more accessible. By offering a more affordable option for reversing opioid overdose, they're not only challenging the market but also directly addressing a public health crisis. This initiative could set a new precedent in the industry, putting lives before profits. It's an inspiring example of how business decisions can make real-world impacts.
???Your turn:?The nonprofit naloxone manufacturer, Harm Reduction Therapeutics, is making strides in increasing accessibility to life-saving medications for opioid overdoses. What other areas in healthcare could benefit from nonprofit innovations and how can the public and private sectors support such initiatives?
Obesity Drug Wegovy Shown to Reduce Risk of Stroke and Heart Attacks by 20%, Novo Nordisk Announces
?? The deets:?Novo Nordisk has revealed that its obesity drug Wegovy can reduce cardiovascular risks, such as heart attacks and strokes, by 20%. This is the first instance of a weight-loss drug being shown to have medical benefits beyond reducing weight. Wegovy's newly discovered benefits may impact insurance coverage for the medication, which costs over $1,300 monthly.
????My two cents:?The revelation that Novo Nordisk's Wegovy may reduce cardiovascular risks is not just a scientific advancement; it's a shift in how we might view weight-loss drugs. Instead of being seen only as a tool for weight control, Wegovy could become a significant player in heart health management. The potential for insurance coverage opens new doors for accessibility, but it also raises questions about where the line is drawn between lifestyle choices and medical necessity. This development signals a more holistic approach to treating obesity, recognizing its connection to other serious health conditions.
???Your turn:?The recent findings about Wegovy reducing cardiovascular risks challenge the conventional understanding of weight-loss drugs. What are some other areas of medical research that may benefit from revisiting current assumptions or biases? Could this foster innovations or uncover previously overlooked health benefits?
?? In Focus
Hey biopharma friends -
Trust and Transparency in our industry have never been more crucial, especially as we enter the second half of 2023. It's a time when trust has been challenged, and the demand for openness is at an all-time high.
I recorded a short video that dives into the subject, exploring:
This conversation fits right in with the top concerns on biopharma marketers' minds, such as:
... and evolving regulations.
But above all, it's about being transparent and accountable to those we serve: patients, HCPs, investors, employees, partners ... the public.
There's a comprehensive blog post on the trust issue as well (below the video)