Marc Wartenberger’s Post

A follow-up to a question from the webinar I participated in last week "Learning the Lessons of Failure: How to improve the economics of Life Sciences R&D". Here's my response to an attendee's question: "How will the IRA affect the economics of new drug development?" It’s a complicated question, but here are some areas that come to mind. Please reach out or add some comments in the chat to discuss this further.    With regard to pharma R&D and the IRA, companies must consider which indications and therapeutic areas will be impacted by the IRA’s direct negotiation. Specifics like the number of Medicare patients as a percentage of product market share, competitive products chosen for pricing negotiation and even potential biosimilar launches now have greater impact in market evaluations. With the IRA, companies really must evolve their R&D strategies and capabilities and be concerned about the likelihood of successfully recouping development costs. Thus, assets may not go forward in development, manufacturers may look to reduce R&D costs, and even look to increased use of AI (an area I spoke to on a previous Webinar).   To elaborate on a couple areas and some economic considerations:   1)        Stepwise Development Processes. In the IRA environment, indications and therapeutic areas with products that have an indication with a small initial addressable market before expanding into a larger market space may more years of peak revenue. Oncology and immunology TAs are far more exposed. This can impact asset development choices. 2)        Medicare Exposure. Indications with a greater percentage of patients over 65 are intrinsically more likely to be exposed to the IRA’s direct negotiation. The greater the share of revenues from Medicare, the larger the potential impact of direct negotiations. This impacts the eventual pricing of new products and can impact how much a company is willing to put up front into R&D. 3)        Baseline Rebating. When pipeline products in specific indication are in a TA that tends to be deeply discounted, like diabetes, the incremental risk of negotiation is smaller. However, assets in oncology can tend to be priced higher with less immediate discounting. Consequently, assets in development with indications that are already heavily rebated are less exposed to direct negotiation. Manufacturers with assets in development should monitor assets in the TA and watch the influence of the existing net Medicare pricing of negotiated products on existing therapeutic alternatives and soon to launch assets. These economics can again impact the R&D choices corporations make.   The IRA may cause manufacturers to adapt their R&D Strategy to decrease their cost base, increased use of AI/RWE, accelerate the timelines to launch, optimize trial design, look to decreasing time to indication expansions and explore launching in larger indications first. Will be presenting on the payer's views of the IRA at ISPOR too. The fun never ends!

In this article by ICON's Vesta Marciulioniene, published in Outsourcing Pharma, we give an update on the EMA's guideline on regulatory requirements for using computerized systems and electronic data in clinical trials, which went live in Sept 2023. How are sponsors, investigators and other parties coping? Find out here: https://ow.ly/VE2U50SoVAh

Did you crack the nut 🐿 🌰 when implementing the EMA Computerised Systems and Electronic Data Guideline 🤖 📅 in your companies and in investigative sites! Have a read on ICON's journey 🎯 , challenges faced 🎢 and steps 🐾 that can help you overcome those challenges. Thoughts on collaboration with sponsors 🤵, insights for investigative sites 🏥 and more...! #computerisedsystems #electronicdata #clinicaltrials #iconplc

Last day to take advantage of early bird registration for RECON 2025! 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐭𝐨𝐝𝐚𝐲!🎉 ➡ https://lnkd.in/gE6WZtuj 🔎 Explore the Agenda: https://lnkd.in/girYwv7j Our speaker lineup includes luminaries from the FDA, industry leaders, and academia. Over the course of the two-day conference, we will delve into: 1. 𝐁𝐢𝐨𝐦𝐚𝐫𝐤𝐞𝐫 𝐭𝐨 𝐄𝐧𝐝𝐩𝐨𝐢𝐧𝐭 𝐓𝐫𝐚𝐧𝐬𝐥𝐚𝐭𝐢𝐨𝐧 - Establishing surrogate endpoints. 2. 𝐆𝐥𝐨𝐛𝐚𝐥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐇𝐚𝐫𝐦𝐨𝐧𝐢𝐳𝐚𝐭𝐢𝐨𝐧 - Towards a streamlined global regulatory assessment. 3. 𝐏𝐫𝐨𝐣𝐞𝐜𝐭 𝐎𝐩𝐭𝐢𝐦𝐮𝐬 - R&D strategies, practicality, and collaboration between FDA and sponsors. 4. 𝐃𝐢𝐯𝐞𝐫𝐬𝐢𝐭𝐲 𝐢𝐧 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬 - Strategies and implications for enhancing clinical trial diversity. Spread the word among your colleagues- we can't wait to welcome you all there! #RECON #UniversityOfMarylandBaltimore #DrugDevelopment #Pharma #BioTech #FDA #ProjectOptimus #ClinicalTrials #RegulatoryStrategy #Biomarkers #Endpoints #RegulatoryHarmonization #VivproCorp #MorePowerToYou

Free Webinar Alert! ** What Sponsors need to know about the latest FDA Diversity plan guidance** Join Beatriz Rocha & Teresa Oblak from Fortrea on Nov 14th (10am EST) as they break down the latest FDA guidance on diversity in clinical trials. What you'll learn: • Key changes & impact on your work • Case studies & real-world examples • Future trends & how to prepare Perfect for: Pharma & Biotech professionals Register for FREE (TOPRA membership included!) https://lnkd.in/eWYb4t_R #Diversity #ClinicalTrials #webinar

🚀 Pharma Execs Alert! 🚀 Time's relentless march means one thing for pharma execs: the urgency of new launches to offset revenue lost to the patent cliff. Consider Humira, a global sales titan peaking at over $21 billion. Despite its success, it faced biosimilars in 2023, leading to a sharp decline. At Fierce Pharma, we've compiled the top drugs set to face this fate in 2024. From Bristol Myers Squibb to Novartis, these blockbusters are on the radar. Navigating legal and regulatory uncertainties, our report uses a mix of company filings and outside sources for reliability. Get ahead with insights from Corporate Pharmacy Services, Biospace, and OptumRx. See the full report👉 https://ow.ly/CPxf50QQBiR Stay updated on all our events by following Fierce Life Sciences Events #FierceBiotech #FierceLifeSciencesEvents #FiercePharma #WeAreFierce

We've shared general timelines for your FDA submissions, now see our breakdown of the internal steps, cross-center collaborations, and sponsor touchpoints of the FDA's formal review process here: https://lnkd.in/ggW5EkwM The "behind the scenes" regulatory answers in this ever-growing article are curated by two of SCI's former FDA Reviewers, Carolyn Dorgan and Courtney Evans. Keep reading in the weeks to come for more insider answers to questions like "What is the Reviewer doing in a review?" and "What training and tools does my Reviewer have at their disposal?" #fda #fdareview #regulatorysubmission #combinationproduct #drugdelivery #deliverydevice #deviceconstituent #pharma #biotech #medtech

Does working with your clinical partners sometimes feel like a massive slog? Do you ever think "why does it always have to be so hard"? What if I told you it doesn't? Join piet theisohn, VP, Clinical Development & Operations Bayer at the inaugural Clinical Partnerships and Outsourcing event this October in London as he shares "Bayer’s Optimized and Cost-Effective Outsourcing Strategy for Clinical Trials" to: - Understand the importance of working together with CROs for Pharma and Biotech, but also the frequent mutual frustration and surprises that come with it. - Explore Bayer's established collaboration model and discover several best practice approaches that you can apply to support on-time, cost efficient clinical trials of high quality. 📅 Download the agenda to find out more: https://bit.ly/4cRXMf3 👉 Book now: https://bit.ly/3XKH90u #ClinicalPartnerships #ClinicalOutsourcing #ClinicalTrials #ClinicalCollaboration #CROs #ClinicalSponsors #Pharma #Biotech

🚀 Virtual Pharma Regulatory roundtable: Navigating the Life Sciences regulatory jungle – challenges and opportunities 📅 Date: Thursday, 14 November 2024 ⏰ Time: 4:30–5:30pm (CET) 💻 Stay ahead in the dynamic life sciences sector by joining our exclusive virtual roundtable. Learn from top experts about the latest regulatory challenges and opportunities in the pharma industry. 👉 Register now to secure your spot and connect with industry leaders: https://lnkd.in/d4dpexSW #Pharma #Regulatory #LifeSciences #VirtualRoundtable #IndustryInsights

💊 Working in pharma and navigating relationships with CMOs amidst regulatory changes, sustainability pressures, and geopolitical shifts? THIS POST IS FOR YOU!! 📅 Join us at Pharma IQ’s annual Pharma Contract Manufacturing conference on March 26-27 2025! ✨ This year, we're shaking things up with interactive panel discussions, roundtables, and opinion pieces—no formal presentations! 📩 DM me for more info on how to attend or participate. The full agenda is coming soon! 👀 #Pharma #ContractManufacturing #CMO #PharmaConference #Networking