Nikki Kandola’s Post

The Compliance Architects team is gearing up to attend the upcoming FDLI Annual Conference and Pharma Manufacturing World Summit. Stay ahead of industry trends and best practices by reading our latest article on the upcoming events. https://lnkd.in/eq-8vuht #compliancearchitects #conference #pharma #complianceprofessionals

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 Most recently, we shared our thoughts on the FDA's draft guidance for Diversity Action Plans.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

From the hurdles that new FDA regulations present to the medtech sector to the continued funding challenges for biopharma companies, RSM's 2024 life sciences industry outlook explores what's ahead for middle market business leaders. https://rsm.buzz/3xSu4Yx

We’re just two weeks away from the API Innovation Center’s 2nd annual plenary event, "A Bold Goal: Pathway to Build U.S. Drug Supply Chain Resilience," hosted at Washington University's Charles F. Knight Center in St. Louis on November 13, 2024! Join us for a gathering of stakeholders, industry leaders, and subject matter experts who are committed to strengthening the U.S. drug supply chain. We look forward to expanding on our discussions from last year's plenary event. Take a look at the key themes that our panel discussions will cover: - Designing a Sustainable, Long-Term Drug Supply Chain: Strategies for building a resilient drug supply chains. - Advanced Manufacturing Technologies for Domestic API Production: How innovative technology is shaping the future of API manufacturing. - Public-Private Partnerships and Collaboration: The importance of strengthening collaboration across sectors to build a stronger pharmaceutical industry. - Regulatory Affairs and Policy Considerations: Navigating policies to support supply chain resilience. If you haven't registered yet, there's still time! RSVP here: https://lnkd.in/e5zMhnww. We are also offering a virtual option for those who can’t make it in person. If you are traveling for our event and need to make accommodations, a hotel block has been reserved for guests of the conference at the Charles F. Knight Center. Please reach out to us at nweatherly@apicenter.org for more information on how to reserve your room as part of this hotel block. #SupplyChainResilience #PharmaceuticalManufacturing #APIInnovation #HealthSecurity #EconomicGrowth #FutureTech

Tomorrow, Friday, June 28th - Don't miss out on the opportunity to learn how Pfizer is using Digital Twin technology in modern facility management. Explore the transformative power of Digital Twin technology in this insightful webinar - register here: https://lnkd.in/egZrGHjp Through real-world examples and expert insights, Austin Brown from Pfizer and Nick Armstrong from CAI will show you how virtual replicas of physical facilities can revolutionize operations, maintenance, and strategic planning across various industries. If you can't make the date, no worries - by registering you will get a link to the recorded webinar so you can watch it on-demand. #pharmaceuticalmanufacturing #pharmaceuticaloperations #facilitiesmanagement #digitaltwin Ideal event for IT, Supply Chain, Manufacturing, Quality, Digitization SMEs at Merck, Novartis, Amgen, Eli Lilly and Company, Thermo Fisher Scientific, Catalent Pharma Solutions, Bayer, Boehringer Ingelheim, Corden Pharma - A Full-Service CDMO, Scorpius BioManufacturing, Inc., Teva Pharmaceuticals, Regeneron, ISPE, PDA - Parenteral Drug Association, ISPE Boston Area Chapter, ISPE Greater Los Angeles Area Chapter, ISPE Midwest Chapter, ISPE-CaSA, ISPE CaSA Women in Pharma, PDA Italy Chapter, ISPE United Kingdom Affiliate Ltd, ISPE United Kingdom Pharma 4.0 COP, FDA, PCI Pharma Services, Berkshire Sterile Manufacturing, Grand River Aseptic Manufacturing

From the hurdles that new FDA regulations present to the medtech sector to the continued funding challenges for biopharma companies, RSM's 2024 life sciences industry outlook explores what's ahead for middle market business leaders. https://rsm.buzz/4cO0nqx

From the hurdles that new FDA regulations present to the medtech sector to the continued funding challenges for biopharma companies, RSM's 2024 life sciences industry outlook explores what's ahead for middle market business leaders. https://rsm.buzz/3LvPIos

Interested in learning more about the challenges and risks related to the packaging and filling of high-value drug products? Register for our webinar in two weeks featuring West expert, Jim Thompson and Cytiva expert, Brent Lieffers! https://bit.ly/4byjdAT

From the hurdles that new FDA regulations present to the medtech sector to the continued funding challenges for biopharma companies, RSM's 2024 life sciences industry outlook explores what's ahead for middle market business leaders. https://rsm.buzz/4cUPDa0

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!