Medicine to Market Summits

What are the keys to a successful biopharma launch? Join in the conversation: we have nearly 40,000 professionals in our peer-powered community talking about it takes to prepare the people, product, and company for launch. Coming next week: member videos of our recent summit in Half Moon Bay, CA. You are welcome to view the session for the latest keys to launch. #pharmamarketing #payer #hcpengagement #telehealth #digitalpharma #productlaunch #biotech

From our CEO Frank F. Dolan...

The Novartis-Generate Biomedicines Deal: A Watershed Moment for AI in Drug Discovery The recent partnership between Novartis and Generate:Biomedicines marks a pivotal moment in the pharmaceutical industry's embrace of artificial intelligence (AI) for drug discovery. This collaboration exemplifies a broader shift towards AI-driven innovation in life sciences, promising to reshape drug development paradigms and accelerate the delivery of novel therapeutics to patients. At its core, the deal leverages Generate's proprietary generative AI platform in conjunction with Novartis' extensive expertise in target biology and clinical development. This synergy aims to revolutionize the discovery and development of protein therapeutics across multiple disease areas, potentially ushering in a new era of precision medicine. The financial structure of the agreement underscores the industry's growing confidence in AI-driven approaches. With an upfront payment of $65 million, including a $15 million equity investment, and potential milestone payments exceeding $1 billion, the deal reflects a significant commitment to AI's promise in drug discovery. This structure aligns with emerging trends in biotech partnerships, particularly those involving AI platforms, and sets a new benchmark for valuations in the sector. This signals a shift in traditional R&D models, with AI poised to accelerate drug discovery timelines, reduce costs, and potentially expand the scope of therapeutic targets. Industry projections suggest that AI could reduce preclinical development costs by 20% to 40%, potentially doubling operating profits in the pharmaceutical industry by 2030. This collaboration also exemplifies the evolving dynamics between established pharmaceutical companies and innovative biotech startups. It highlights a trend towards earlier-stage deals and the development of a more interconnected life sciences ecosystem. As half of the 50 largest pharmaceutical companies have already entered partnerships with AI companies, this deal may catalyze further collaborations across the sector. Looking ahead, the integration of AI into drug discovery processes is expected to have far-reaching effects on development costs, timelines, and the breadth of therapeutic research. The global AI in life sciences market is projected to reach $7.09 billion by 2028, with AI solutions in the pharmaceutical sector expected to achieve a CAGR of 21.94% by 2027. These projections suggest a fertile ground for further AI-focused collaborations and innovations. However, the promise of AI in drug discovery is not without challenges. Stakeholders must grapple with issues such as data quality, model interpretability, and the seamless integration of AI tools into existing workflows. Additionally, ensuring the ethical use of AI in healthcare and maintaining public trust in AI-derived therapies will be crucial as these technologies become more prevalent. #ai #drugdiscovery #healthcare #biotech #pdufa

News from Novartis and Generate:Biomedicines

"When a new CEO walks in, they’re not alone—they bring an army." The leadership change I mentioned? It’s never just one person. 👀 Expect a reshuffle—people are going to get swapped out. 👋 If you’re waiting for stability after a CEO change, don’t hold your breath. 😳 Every major leadership change creates a ripple effect across the organization, and here's a truth no one talks about: it’s rarely pretty. New leaders don’t come in to maintain—they come in to shake things up. Teams, strategies, even objectives are about to get flipped upside down. The worst thing you can do as a leader right now is to stand still, hoping everything stays the same. Spoiler alert: it won’t. ❌ Here’s what I’ve learned after seeing this happen across companies: it’s not just about a new face at the top. The rules of the game are about to change. KPIs? ✅ They’ll shift to match the new leader’s narrative. Goals? 🎯 They’ll be redefined. The game pieces are being moved around, and you better make sure your piece is in the right place. But here’s the real kicker: leaders know how to thrive in this chaos. Managers? They cling to old playbooks and hope things go back to normal. Newsflash—they won’t. The best leaders I’ve seen flip the script. When uncertainty spikes, they don’t waste time speculating on what might happen in a year. They condense the timeline, narrow the focus, and guide their teams toward short-term wins. You’re not going to fix a year’s worth of uncertainty in a week, but you can anchor your team to something real—and soon. Start measuring in sprints. Set milestones that your team can knock out in the next few weeks. Not only does it help drown out the noise, but it gives your team something to rally around. Small wins create momentum, and momentum builds confidence. In Part 3, we’ll talk about the universal truths of managing through uncertainty: high performance is the ultimate cure-all, and communication—done right—is your most powerful tool. Reminder: This is Part 2 of a three-part series on managing uncertainty. If you missed Part 1, check it out from Wednesday’s post. Stay tuned for the final part tomorrow.

"The moment you think uncertainty is over, you’re standing at the start of the next set of questions." A company I’m very familiar with just fired their CEO and brought in a new one. I’ve also noticed some other major leadership changes in the industry recently—and it’s shaking up entire organizations. Perhaps I'm thinking of Nike, Acadia Pharmaceuticals Inc., Axsome Therapeutics, Inc., Starbucks, or Crinetics Pharmaceuticals... ...or perhaps I'm thinking of different companies. Doesn't matter. If you’re dealing with something similar right now, I want to offer a few thoughts, especially for those leading teams through these massive shifts. Because make no mistake, when leadership changes, futures change. And here’s something you need to hear: I’m not talking to managers. 😕 This isn’t about checking boxes or maintaining status quo. ☑ Managers are stuck trying to execute the past. Leaders, on the other hand, are navigating the fog of the future. Those are my people. 👊👊👊 When uncertainty hits—whether it’s coming from external pressures or internal shifts—what matters most is how you show up as a leader. I’ve seen too many folks sit back, waiting for clarity. They want answers, they want certainty. But here’s the thing: by the time you get answers, you’re already facing the next wave of questions. You think the tough part is getting through the initial storm? Think again. Once the dust settles, the real work begins. Right now, a lot of people in your organization are spiraling. They're not just worried about their jobs—they’re juggling a thousand other personal pressures. It’s your job as a leader to recognize that and actually lead. Start by giving people grace. (credit: Angie Aldinger) You don’t know what they’re carrying, but you better believe the weight of work uncertainty just made it heavier. Your job isn’t to pretend you have all the answers. It’s to help people navigate the unknown. In Part 2, I’ll dive into the internal upheaval that comes when a new leader walks in the door and how it amplifies the anxiety across the team. Stay tuned. I'll drop that Thursday AM.

🚦 Green Light for Zevra 🚦 Zevra Therapeutics has secured FDA approval for Miplyffa, targeting Niemann-Pick type C disease, in collaboration with Johnson & Johnson's miglustat. This marks the first FDA-approved treatment for NPC, focusing on neurological symptoms in patients 2+ years. After a previous setback, Zevra Therapeutics is set to launch Miplyffa within 8-12 weeks, accompanied by the new AmplifyAssist support program. The approval followed promising trial results and an FDA advisory committee's favorable vote. This is a significant leap for NPC patients, with Miplyffa addressing a crucial unmet need. #RareDisease #FDAApproval #ZevraTherapeutics

Biotech IPOs have plummeted from 104 in 2021 to just 20 in 2023, marking a seismic shift in the life sciences funding landscape. Despite the downturn, standout successes like Acelyrin's $540 million raise prove that opportunities still exist for well-positioned companies. Economic uncertainties and shifting investor focus towards mature data points have reshaped the market dynamics. The "Series A cliff" is creating a financing bottleneck, challenging companies' readiness for public offerings. 2024 shows promise with 8 biotech IPOs in Q1, hinting at a potential market rebound driven by anticipated Fed policy shifts and increased M&A activity. Successful IPOs now hinge on robust clinical data, clear paths to profitability, and articulating long-term value beyond groundbreaking science. A diverse product pipeline and strong IP portfolio are crucial differentiators in today's competitive landscape. For biotech leaders navigating this complex terrain, meticulous planning, strategic partnerships, and expert guidance are more critical than ever.

🚨 BREAKING: House Passes Biosecure Act, Reshaping Pharma Supply Chains 🚨 The U.S. House of Representatives has passed the Biosecure Act with a 306-81 vote, potentially transforming the landscape for pharmaceutical manufacturing and R&D. Key highlights for pharma executives: • Bipartisan support: 111 Democrats joined Republicans in passing the bill • Target: WuXi AppTec, WuXi Biologics, and three genetic sequencing companies • Deadline: Companies must cut ties or restrict work with these entities by 2032 • Senate hurdle: The bill's future in the Senate remains uncertain 🔍 What it means for #pharma: • Supply chain disruption: Many companies rely on WuXi for manufacturing • IP protection: The bill aims to safeguard U.S. intellectual property • Timeline concerns: Senate version proposes a shorter 18-month transition Industry Impact: • BIO supports the House version with its 2032 timeline • Smaller biotechs may face significant challenges in finding new partners Stay tuned as we continue to monitor this developing story and its implications for the pharmaceutical industry. #Biosecure #clinicialtrials #biotech Summit Therapeutics, Inc. What are your thoughts on this legislation? How might it affect your company's operations? Share your insights below.

😰 subscription fatigue 🛠 $20 a month on OpenAI's ChatGPT Plus $20 a month for Anthropic's Claude Pro $20 a month for Perplexity That's just for me. Then I need to pay for our team users... Worth it? Yes indeed. Especially Perplexity. Saves time, helps speed up workflows, gives me contrarian views on important subject matter. There is a nice tool with much of the functionality at 0.25 of the price... worth checking out if you're having "subscription fatigue". What tools have you found that are saving on the monthly burn? Please share in the comments. https://gptandme.xyz/ #artificialintelligence #chatbots #subscriptions