Solstice

We're excited to launch Solstice's newsletter: "The Label Update". Here's what to expect: 1?? Solstice's latest product updates and platform developments to help marketers build and evaluate new content. 2?? Our vision of where we see AI currently fitting into existing workflows and how it will reshape the pharma marketing landscape. 3?? News about regulatory changes, market trends, and technological advancements in the life sciences commercial space. 4?? Must-attend events, either hosted by us or our partners, to meet industry peers and connect with other marketers, regulators, and technologists. Subscribe here if you're interested: https://t.ly/fEV94.

When brand labels change and new clinical data is released, a crucial part of a marketers job is to ensure that all prior-approved content accurately reflect the most recent data. Traditionally, teams were tasked to manually re-review hundreds of pieces that have already gone through the materials approval process and manually keep track of these changes. Solstice is excited to introduce a feature, as part of Fact Check Assistant, to ensure ensure that these changes are captured automatically and instantly. Fact Check Assistant keeps track of new data changes, notifies teams of the claims in all of the prior-approved documents that need to be updated, and provides justification to explain what exactly needs to be changed. The team and I are excited to see how this supports your work.

Solstice is excited to announce that we are sponsoring the 5th PRC Performance Optimization Summit on April 29-30 in Philadelphia. Join me in our panel "Determine Optimal Compliance Methods for New CCN Dual Modality Rules" where we will discuss how teams can leverage technology to align their content strategy with the dynamic regulatory landscape. Register with discount code SPONSOR324 at?https://t.ly/VOj9j. #DGEvents #PRCSummit

We’re excited to officially announce that?Solstice?has raised $3.5m in seed funding led by?Twelve Below?and?Virtue to accelerate life sciences commercial timelines. -- Solstice is the AI life sciences marketing engine. The platform connects marketing, regulatory, and commercial functions across biopharma, allowing teams to distribute better, more compliant content faster. The medical-legal-regulatory (MLR) review process is the bottleneck that keeps biopharma marketing in the stone age, where generic low-tech ads may or may not reach the relevant physicians or patients, and certainly will not resonate with them enough to catch their attention. This changes today. Solstice leverages secure generative AI models to streamline much of the manual work involved in regulatory review, speeding the development and distribution cycle so biopharma marketing teams can get their product to patients faster, shown through our two initial assistants: Fact Check Assistant and Regulatory Assistant. We have an exceptional team and are growing quickly. If you’re interested in transforming an industry with us, please reach out. We’re excited to meet you. Aris?and I would like to thank our wonderful investors, advisors, and customers for embarking on the journey with us. Together, we will reshape how the pharmaceutical industry brings life-saving drugs to the market. Read more about press release here: https://t.ly/xPV12 Read more about roles at Solstice here: https://t.ly/Zy8Pb

? Meet Arindam Sharma, our Head AI/ML Ops Engineer. 1. What excites you most about building AI/ML for life sciences commercial teams? "It's such an exciting space with new developments every day. I love experimenting and building logic in new models. In industries like the life sciences, AI is often misunderstood. I want to build tools that add true value to complex, manual workflows so that teams are able to operate more efficiently and achieve their mission to deliver critical drugs to patients who need them." 2. What has been your biggest learning since joining the team? "It was initially overwhelming to balance tasks I needed to prioritize. I felt like I would go into rabbit holes when I worked on specific tasks that I thought were interesting. What I learnt was that time is the biggest constraint. Although we want to build everything, it's important to perfect our current products right first before diving into subsequent endeavors." 3. You worked as an AI/ML researcher at Columbia prior to Solstice. How would you describe your experience working at Solstice? "Working in an academic setting was great, but it's slow. I like to think and experiment on my ideas quickly. Solstice is like a research project, just with the timelines being condensed by 100x. I'm like a kid in a candy store every day. With every single tool at my disposal, I'm able to come up a thesis, evaluate it, and repeat."

A key responsibility for life sciences marketing teams is to ensure that new published data is adequately reflected in existing pieces in a timely manner. One of the biggest bottlenecks in the content supply chain is the time required to update major pieces after new trial results emerge or label updates. Hundreds of pieces of content must funnel back into MLR, taking months to approve. In these scenarios, speed to market is of the essence. At Solstice, we're constantly looking at new ways to make it easier for marketing teams to review and approve content. An upcoming feature we are excited to incorporate to a new assistant addresses the challenge of updating and generating new information upon label updates and new published data. Teams will be able to incorporate new results to past content seamlessly, using existing templates already approved by their regulatory counterparts. In this example, we show a label expansion announced on January 16, 2024 for Sanofi & Regeneron's Dupixent (dupilumb) with new phase 3 data supporting its use in atopic dermatitis with moderate-to-severe hand and foot involvement. Solstice presents these changes and provides users with the option to update prior pieces to reflect the new data. Stay tuned for more updates! #pharmamarketing #regulatory #MLR #contentapproval

?? ?? ?? Introducing... Part 2 in our series of real-world case studies going through FDA Warning Letters issued to pharmaceutical companies, this time featuring Otsuka Pharmaceutical Co., Ltd. We'll show what issues were raised by the FDA and how Solstice would flag these issues prior to drug launches, helping teams avoid hefty fines. Let's dive in ?? On October 31, 2023, the FDA's Office of Prescription Drug Promotion issued a warning letter to Otsuka Pharmaceuticals for their TV advertisement campaign called “See The Signs” for Rexulti, an adjunctive prescription treatment of major depressive disorder (MDD) in adults. Specifically, the advertisement violated Sections 21 U.S.C. 352(a), (n); 321(a) & 21 CFR 202.1(e)(5) of the FD&C Act. In particular, the TV ad falsely stated that using Rexulti when taken in combination with an antidepressant reduced depression symptoms by 62%, as opposed to 11.9% as shown in clinical trials. The advertisement failed to take into account the difference between treatment and control groups. We show how Solstice's Regulatory Assistant is able to detect this regulatory misalignment, enabling marketing teams to make the necessary adjustments prior to promotional review discussions and ultimately avoid hefty fines. Read the OPDP Warning Letter: https://t.ly/_uOOH View the Rexulto Ad: https://t.ly/pSiba Learn more about Regulatory Assistant: https://t.ly/kZ4AT

?? ?? ?? We’re launching a series of real-world case studies to go through FDA Warning Letters issued to pharmaceutical companies. We'll show what issues were raised by the FDA and how Solstice would flag these issues prior to drug launches, helping teams avoid hefty fines. Here's Part 1 ?? : On August 29, 2024, the FDA's Office of Prescription Drug Promotion issued a warning letter to AbbVie for their TV advertisement campaign called “Escape the Migraine” for Ubrelvy, a prescription medication for migraine attacks with or without aura in adults, featuring the GOAT Serena Williams. Specifically, the advertisement violates Sections 21 U.S.C. 352(n); 321(n); 331(a) & 21 CFR 202.1(e)(5) of the FD&C Act. In particular, the claims “UBRELVY QUICKLY ELIMINATES MIGRAINE PAIN” and “ONE DOSE WORKS FAST TO ELIMINATE MIGRAINE PAIN” conflict with the efficacy endpoint from clinical trials of eliminating pain at two hours post-dose. In other words, it “misleadingly suggests that Ubrelvy eliminates migraine pain and symptoms more quickly than was demonstrated in the clinical trials.” Here we show Solstice rapidly raising these issues through Regulatory Assistant, allowing commercial teams to proactively identify potential regulatory misalignments prior to launch. Read the OPDP Warning Letter: https://t.ly/Fx8xJ View the Ubrelvy ad: https://t.ly/ie3GS Learn more about Regulatory Assistant: https://t.ly/kZ4AT

The Solstice team and I are excited to introduce Regulatory Assistant, a new way of evaluating promotional drug regulatory requirements and managing specific brand requirements. Last week, we launched a component of Regulatory Assistant called the SFB Score, allowing teams to navigate the subjective nature of interpreting fair balance in promotional documents. Regulatory Assistant provides teams with a series of agents, each assigned to specific rules, to evaluate content from multiple angles. Our agents are able to interpret rules with contextual reasoning capabilities and interact with team members who can provide feedback on their reasoning. This allows teams to conduct regulatory check at a fraction of the time while remaining compliant. We look forward to seeing how this will support your work. Read more about it here: https://t.ly/kZ4AT

?? We're excited to introduce the Solstice Fair Balance (SFB) Score, a novel approach of quantifying risk and benefit information present in prescription drug marketing material. The SFB Score acts as a guiding framework for marketing and regulatory teams to expedite review committee discussions. Our team understands the complexity involved in determining fair balance and have engineered the platform to take into account the many variables that must be considered in determining whether a piece of content meets this requirement. Providing this score is a crucial step in Solstice's ability to empower marketing and regulatory teams with the capabilities to perform and collaborate at the highest possible level. Learn more about it here: https://t.ly/ltrSk