OptimizeRx的动态

Join Our Webinar: Data Agility in Biopharma - Strategies for Success. Tom Brohan and Eugene Olkhov will explore common challenges in biopharmaceutical laboratories, including data integration, volume, complexity, quality, standardization, security, compliance, and collaboration, with practical strategies for overcoming them. ?? Thursday, April 25 ?? 16:00 BST / 17:00 CEST / 11:00 EDT / 08:00 PDT ?? Register Now!?https://lnkd.in/ennBegfw #ResultsCount #LabWareBioPharma #LabWareLIMS #LabWareELN #LabWareAnalytics #datamanagement #biopharma #research #webinar #selectsciencewebinar

At CRIO, we're all about making a big impact in our industry. That's why we've been jumping into the FDA's public comment process on different draft guidelines. Most recently, we shared our thoughts on the FDA's draft guidance for Diversity Action Plans. With 136 comments from Pharma, CROs, industry groups, and other stakeholders, it's clear this is a hot topic! Read our comments here and below: https://lnkd.in/ehb8yrrn #FDA #DiversityActionPlans #eSource #Diversity #clinicaltrials Hannah Kulkarni

Last year AVS Life Sciences celebrated 25 years of excellence in the life sciences industry! From our humble?beginnings in 1998 focusing on biopharmaceutical projects to our global footprint today, we have?continually evolved to deliver top-notch engineering and validation services. Our recent acquisitions of?MWA Consulting and C&A Consulting further strengthen our capabilities, making us a leader in quality,?regulatory, commissioning, and validation services. Under the leadership of CEO Ruben Dario Taborda, AVS Life Sciences is committed to diversity and?inclusion, with 70% of our employees being minorities and women. We believe in creating robust?communities by hiring locally and investing in people. Our mission remains clear: to provide innovative?solutions from concept to care, advancing healthcare and enabling the successful development and?commercialization of life-changing products. Check out our latest blog article that discusses the last 25 years and what lies ahead:?https://lnkd.in/guT5tS7N #BioPharma #MedicalDevice #Validation?#Healthcare?#LifeSciences #HealthcareInnovation?#DiversityAndInclusion

?? Merck Leaders to Illuminate the J.P. Morgan Healthcare Conference! ?? Join us on January 13, 2025, at 4:30 p.m. PST / 7:30 p.m. EST as Merck & Co., Inc. takes center stage at the prestigious 43rd Annual J.P. Morgan Healthcare Conference! ?? Hear from key executives, including Chairman & CEO Robert M. Davis and Dr. Dean Y. Li, President of Merck Research Laboratories, as they engage in a fireside chat discussing: - Strategic initiatives - Ongoing research endeavors - Future plans in healthcare This is a unique opportunity for investors, analysts, media representatives, and the public to gain insights into Merck's commitment to innovation and excellence in biopharmaceuticals. ?? Tune into the live audio webcast for an engaging discussion that promises to shape the future of healthcare delivery! ?? Click on the link for more details! ??? #Biopharmaceuticals #General #HealthcareInnovation #JPMorganHealthcareConference #LeadershipInHealth #Merck #PharmaceuticalCompanies #MarketAccess #MarketAccessToday

If you are attending next week's Midwest Biopharmaceutical Statistics Workshop, make sure to attend the workshop on June 10th: "Open-Source Drug Development: ADAM, TLGs & Interactivity with R," led by my amazing colleagues Philip Bowsher and Richard Iannone. Philip Bowsher will also be leading a session on June 11th: "Making an Interactive Shiny App with GenAI…Five Ways"

The 2024 Future Pharma ?After the Event Report? is available: https://lnkd.in/evx_29te It's succinct, it's easy-to-digest, and it captures all the key insights from the live conference. There's no better way to get caught up!

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!

Sign up, and see you there! I will be part of a panel session, discussing common traps in Life Science contracting - and how to avoid them :-)

Happy #WorldQualityWeek! Take a look at this short, inspirational talk from Moderna's Jennifer White, and when faced with difficult decisions to improve and streamline Quality across your organization, ask yourself; "Why not?"

Because we wouldn't want anyone getting lost... ?? Here's a helpful guide for you to plan your travel to our event tomorrow. For those of you joining virtually please keep an eye out for the email invite with the link ?? We're looking forward to seeing you tomorrow for our first live Digital Pharma: Unlocked event of the year! There is still time for you to register your place - head over to our page where you can find the event details ? #pharma #pharmasales #pharmamarketing