Susan Williamson

DGE's Transparency & Aggregate Spend Summit and Artificial Intelligence for Life Sciences Compliance Congress are coming up next week! Potomac Senior Manager Graham Rich will be speaking on a panel: "Discover Ways to Improve Documentation of Decisions and Reasoning." If you’re attending, we’d love to have you join in on the conversation.   #DGEvents #AIforLifeSciences #Potomac #Lifesciences #Compliance

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Don't let outdated tech hold your lab back. Our latest article explores '5 Clear Signs It's Time to Upgrade Your Laboratory Information System'. Is your LIS helping or hindering your lab's performance? Join the discussion. #LIS #MedicalLab #LabEfficiency #labos

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A big topic at the pricing and contracting conference here in New Olreans, we are optimistic that as the gather more information they will come to the same logical conclusion!

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Excited to be at #PwCExchange this week! This year’s theme is disruption driving reinvention, so let’s talk about what it will take for risk leaders to transform the future of business. What are some of the characteristics you think a modern risk leader should embody? Shout them out in the comments below!

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Attention, all hard-working friends out there! It's time to talk about the holy grail of workplace perks: Summer Hours! Who doesn't love having no meetings on Friday afternoons or getting out earlier on a holiday weekend? It's like the universe's way of saying, "Go ahead, have that extra scoop of ice cream...!" Our motto? "Work hard, play harder!" We have a lot going on and a lot to deliver this summer...that doesn't mean you can't have fun too. Whether you're hitting my favorite place, the beach, BBQing with friends, or just napping like a pro (aka my wife), you should feel encouraged to enjoy it. Many of us in pharma work in a data driven environment...and a satisfied workforce is closely linked to better customer satisfaction, especially in industries where employees directly interact with customers. So, fostering happiness within your team can lead to a positive ripple effect throughout your organization! Balance is key! So soak up some Vitamin D and some cocktails while you are at it, and recharge your batteries. #WorkLifeBalance #SummerHours #FridayFreedom #HolidayWeekendFun #RechargeAndRepeat #MakeREMSFunAgain

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Listen to BPM's Jessica Hekmatjah on the latest episode of the "MOVE Like This!" #podcast to learn about BPM's commitment to attracting and retaining more women and underrepresented groups. #DEIB #WomenLeadership

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Our latest thought leadership piece, "Compliance's Expanding Coverage: Current and Future Roles" explores the changing role of Compliance, emphasizing its increasing importance as a trusted advisor in preventing non-compliance. In a time where the role of Compliance is continually expanding, this piece offers invaluable insights on the growing areas of responsibility for Compliance. Click here to read it. https://bit.ly/3wGhFpZ

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Protocol amendment redlines are incredibly important for regulatory agencies, investigators, and ethics committees, but sometimes they're an afterthought... 😩 Make sure your redlines serve their intended purpose ✅ -- ie, displaying important changes from one version to the next -- with careful manual tweaks to make them more readable 👓 ----------------------------------------------------   Want to learn more about how a customized medical writing partnership can strengthen 🏋‍♀️ your team? Visit https://lnkd.in/gcScBpwg or email to set up an intro call: info@meaganeldridge.com ----------------------------------------------------- #medicalwriting #regulatorywriting #drugdevelopment #submissions #clinicaltrials #regulatory #clinicalresearch #pharma #protocols #clinicaldevelopment

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(Benefit-Risk Management / CBER / Procedures for Liaison Mtgs with Industry Group) In the event you were wondering how do stakeholder groups, not individuals, engage w/FDA, here's a published procedure from FDA/CBER to define exactly how that process may work. As mentioned previously, SOPP are CBER's SOPs that describe this special engagement process and what to expect. Group stakeholder engagement can move the needle in public health. Good detail to review especially for the medical and government affairs folks too. #fda #cber #biologics #stakeholders #biopharma #drugindustry #medicalaffairs #governmentaffairs

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20 things you should absolutely avoid saying to an FDA investigator: 1. “I think…” Uncertainty can raise red flags. Stick to facts and avoid speculation. 2. “I am not sure but [insert guess here]…” Guessing can lead to misinformation. If you don’t know, admit it and find someone who does. 3. “I told them not to do it this way…” Throwing colleagues under the bus isn’t professional and won’t help your case. 4. “You are wrong about this… you don’t know what you are talking about…” Arguing with an investigator is a surefire way to escalate tensions. 5. “During the last inspection, the FDA investigator saw the same thing and didn’t put it on the 483…” Each inspection is independent. Prior oversights don’t excuse current non-compliance. 6. “The last investigator was crazy” or “The last investigator didn’t know what they were doing…” Disparaging previous investigators doesn’t inspire confidence in your current practices. 7. “Well then how would you recommend we fix this deficiency?” It’s not the investigator’s job to solve your compliance issues. 8. “That is the way we have always done it…” Tradition isn’t a justification for non-compliance. Regulations evolve, and so should your practices. 9. “I probably shouldn’t say this, but….” If you feel the need to preface with this, it’s best left unsaid. 10. “If we followed those procedures, we would never get anything done.” Efficiency doesn’t trump compliance. Both are achievable with the right processes. 11. “We don’t have enough people or time to review all those complaints…” Resource constraints aren’t valid excuses for failing to meet regulatory obligations. 12. “The management of this firm is only concerned with profits and does not take quality seriously This kind of comment can trigger a deeper investigation into your company’s practices. 13. “I do it this way because our procedure does not make any sense Non-compliance isn’t justified by poor internal procedures. Fix the procedures instead 14. “I will change the procedure right away.” Sudden changes can appear reactionary. Show that you have a robust change control process. 15. “If you think that’s bad, you should see this Offering up additional issues isn’t advisable unless specifically asked. 16. “We fixed the problem by firing the person. Personnel changes don’t always address systemic issues. Show how processes have improved. 17. “That’s not my fault. It was the previous person who did that. Accepting responsibility reflects better on the organization than deflecting blame. 18. “That’s not my problem, that is quality assurance’s problem A fragmented approach to compliance is concerning. Demonstrate teamwork and accountability 19. “Write it on the 483 – that is the only way we will correct it Surprisingly common, but a poor approach. Strive to fix issues proactively. 20. “Are you going to shut us down?” or “Are we going to get a Warning Letter?” Prematurely asking about outcomes can seem defensive or defeatist. Focus on addressing the findings

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Optimize your #drugdevelopment strategy with these exclusively curate insights. Dive into unique perspectives on safety liabilities and competitive landscapes in our specialized webinar. https://okt.to/2MApgC

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There are endless barriers for patients to initiate and adhere to their specialty medications, from cost to insurance approvals and beyond. In our recent #blog, we break down some of these barriers and discuss the ways in which innovative technologies can help patients and providers accelerate enrollment and achieve better outcomes. ⚡ Check it out! #specialtypharmacy #digitalhealth #medaccess

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In the latest article from the "Ethics is Not a Dirty Word" series, The Compliance Concierge examines Paolo Macchiarini's story. It was a story of the betrayal of human trust when a thoracic surgeon deceived the medical fraternity with unsubstantiated operations, a betrayal that tragically resulted in the death of patients. He is the second inductee to the Dirty Dozed - Individuals, a list that highlights the severe consequences of unethical behavior. #Fraud #Deception #Ethics #Surgery #Doctors #Trust The article can be found at the link below: https://lnkd.in/gKjsxq73

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The Centers for Medicare & Medicaid Services (CMS) recent guidance on the Medicare Drug Price Negotiation Program exposes one of the numerous examples of the Inflation Reduction Act’s unintended consequences around patient access. Under the law, Part D plan sponsors must cover drugs selected for negotiation; however, the law falls short in facilitating full access to these drugs as there is no language to minimize utilization management (eg., prior authorization) or high out-of-pocket costs due to being placed on a higher tier. In this guidance, CMS stated they would employ its annual review of all submitted Part D formularies to protect access to these selected drugs. While this may sound heartening, it still falls short of ensuring or guaranteeing this access. This challenge is just one example of IRA’s unintended consequences. Earlier this week, I had a ton of fun talking about some of IRA’s unintended consequences with my friend and former colleague Kimberly Westrich at ISPOR 2024 (fun photo below). And, BTW, her team at NPC has done great work on this topic. As you plan for the Part D benefit redesign in 2025 and the start of the negotiation program in 2026, it is critical to explore how these changes will affect your patient population’s access to your products covered under Part D. At Cencora, we have engaged our manufacturer partners in helping them explore changes to their contracting and patient access strategies, and we would love to connect with you. Reach out to start a conversation!

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Jeff, as usual, you're spot on, but one key piece is missing. Scott's post politely commented that HEOR output is becoming more technical and complicated, and fewer consumers can understand (or use) it. Clearly, being able to communicate the "so what" is getting buried by methods. I am noticing the dissection of HEOR not only being pieced out to medical and managed markets but biostatistics as well. The inability to use the output promotionally or even to be clearly communicated upon request (by medical) contributes to the commercial belief that HEOR isn't adding value. I would guess that less than 20% of most HEOR/RWE teams have ever directly engaged a payer or clinician. The communication tree within organizations (even smaller ones) has become one way, with each branch (communications, training, the field) losing essential context to the study. I have repeatedly stated the need for a Chief Value Officer in organizations to ensure that the project's design meets corporate needs and that it is followed through to the promotional use of the data. This limits or eliminates the "so what" leakage and optimizes the potential for impacting the consumer. For decades, the industry has bemoaned the creation and negative impact of silos. Parsing out HEOR/Value talent (not technicians) will create more barriers. The utility of RWE was lauded for cross-functional value, including regulatory acceptance. Outcomes research should influence a broad audience of clinicians, payers, patients even government health agencies. Unfortunately, the industry is deciding that a project (and team) will only support a single consumer. Cross-functionally adept; strategic thinkers are more essential than ever. Innovation shouldn't be left up to AI. Thanks for the launch pad, Jeff!

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