Téa Romero, MPsy, MBA

Next week, Dinesh De Alwis, PhD, Senior Vice President of Clinical Drug Development, will join Certara’s inaugural Certainty event in Philadelphia. This unique event invites industry leaders to discuss the latest innovations that will bring us closer to “certainty” in drug development.     Dinesh will join a panel discussion about the potential of model-informed drug development (MIDD) to accelerate each phase of the process. Alongside fellow panelists Lisa Hendricks of Novartis and John Davis of Regeneron, Dinesh will share how we’re leveraging MIDD to maximize efficiency and precision across the development continuum.     Learn more about the panel, which will be moderated by Karen Rowland Yeo and Mirjam Trame of Certera. https://lnkd.in/dReXZyVt    #GenerativeBiology I #GenerativeAI

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IQVIA’s Early Phase Oncology Network (EPON) is a global network of qualified Phase I oncology sites. By utilizing pre-identified experienced sites, site selection timelines can be reduced, and operational efficiencies increased. Learn more about what makes us different. https://bit.ly/4cruPGv #EarlyPhaseOncology #CancerResearch #ClinicalTrials #OncologyResearch

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Syneos Health #AXS24 panel recap: true health system & biopharma collaboration takes time, trust, and equal investment and risk to be successful. Sara Sasso-Rubin shares her key takeaways from the session. ⬇️

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Join us for a free webinar, part of our Background Screening 101 series! Demystifying Drug Screening Wednesday, June 12 at 11am PT Register here: https://lnkd.in/gJUgdgXw Join us for an essential overview of what you need to know when it comes to drug screening: ➡️ What is drug screening? ➡️ Why is drug screening done? ➡️ What kind of drug, clinical or medical tests can be done? ➡️ Which industries or job profiles need drug screening? ➡️ How much does it cost?  ➡️ ... and more!! Let's clear up the confusion and make drug testing less overwhelming.  Sign up here: https://lnkd.in/gJUgdgXw Navin Chugh #hr #backgroundscreening #backgroundcheck #drugtesting #drugscreening

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Biotechs face funding, inflation, and milestone pressures that necessitate prudent cash flow management, especially during clinical manufacturing. CDMOs need to be willing to take a strategic approach that helps sponsors extend their cash runway. 👉 Learn more about lean clinical manufacturing in our new blog post: https://lnkd.in/g78XfvRM

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🧬CIRS held a multi-stakeholder workshop to discuss challenges and opportunities in the current regulatory and #HTA landscape for #raredisease. Regulators, HTA agencies, companies, payers, patient groups and academia were brought together to produce recommendations on how regulatory and HTA frameworks can improve to better support the next generation of rare disease treatments.   The workshop recommendations centred on three key areas: 💰 Evolving incentives 💡 Improving evidence development ❓ Better managing uncertainty Take a look at the workshop report >> https://lnkd.in/evdcqYgV #RegulatoryScience #reimbursement #orphandrugs #HEOR #orphanmedicine

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Secure your streamlined mAb development with SUREmAb. We proactively de-risk your program by eliminating the risk of coming to the end of your CLD program with invalidated clones, enhancing the DNA profile consistency from parental to daughter cells with secured testing reproducibility. Learn more: https://hubs.la/Q02cy7080

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📢 It's finally Day 1 of #ASCO24! Today's feature is the RadicaL Study for patients with metastatic kidney cancer. Swipe to learn more! American Society of Clinical Oncology (ASCO) PI: Rana McKay UC San Diego Bayer Alliance for Clinical Trials in Oncology

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If you work in the life sciences industry, you should know EXACTLY what statistical calculations are doing for the clinical trial. I want to help you understand this at its most basic level: Clinical Trials are tools used to show that a new drug is efficacious and safe. Statistics is the tool within the clinical trial that allows us to make these claims objectively. Specifically, statistics is used in a Proof By Contradiction where we first assume something to be true, and we then use data to show that the assumption we made cannot be true. We are using statistics to answer this question: - If there is no difference between two populations, what this the probability of randomly selecting samples with a difference as large or larger than actually observed? Braking this question out in simple steps: 1. Assume no difference between the two treatment samples 2. Collect data on the two treatment samples 3. Calculate the actual difference between the two treated samples 4. Use statistics to calculate how likely we are to get the result we actually got in step 3 if the assumption in step 1 is true (if there truly was no difference between the two groups - what is the chance we randomly sampled and got the difference we got) 5. If the probability is low enough (meaning there is a very low chance we would have been able to get the result we got if the assumption in step 1 was true) we can reject the assumption made in Step 1 and say there is a difference between the two treatment populations If that is not super clear (I don't blame you), here is a more detailed example: 1. I assume the population I give my drug to and the population I give placebo to will have the same systolic blood pressure result at week 2 of the trial 2. I treat the two populations accordingly and I measure the systolic blood pressure at week 2 and I calculate the average blood pressure at that time 3. My calculations of the average systolic blood pressure at week 2 is DIFFERENT at week 2 4. I USE STATISTICS TO CALCULATE THE PROBABILITY OF GETTING THE RESULT I GOT IN STEP 3 ASSUMING THERE ACTUALLY IS NO DIFFERENCE BETWEEN THE TWO POPULATIONS 5. If the calculated probability (also known as a P Value) in step 4 is less than 5% (typically) I can claim that my assumption in step 1 is NOT TRUE It's step 4 where statistics is applied and I have a course coming out in the near(ish) 😎 future that will break down how you actually do step 4 in concert with all the other steps. Until then, I recommend you check out my website (link in Bio) for a ton of free material around biostatistics, statistical programming, and how these two functions work in the regulated industry of the life sciences. Happy Reading and Happy Tuesday.

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Where do IRBs stand today? And, how should they evolve to better meet the needs of modern clinical trials while protecting research patients? Julie Blasingim of Univo IRB discusses. #clinicaltrials #clinicalresearch

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What is the current status of #IRBs? As the industry evolves, what changes can we implement to better meet the needs of modern #clinicaltrials while ensuring the protection of research participants? Our CEO, Julie Blasingim, addresses these questions in a recent article in Clinical Leader.

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Accelerate Your Drug Approval with FDA’s Expedited Programs Seeking fast track, accelerated approval, priority review, or breakthrough therapy designation for your drug? We're here to help! DSI's resources delve deeper into expedited drug development – ready to discover more? Check it out here: https://bit.ly/4aUjY6K Fast-track your knowledge of drug development with us! Let's unlock new possibilities together! #DSIInsights #DrugDevelopmentJourney

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Last month, Medpace infectious diseases and vaccines experts attended ESCMID Global in Barcelona, Spain. Dr. Slobodan Ilic, Senior Medical Director, and Dr. Christiane Bonde, Director, Clinical Trial Management, share key takeaways from the recent ID&V conference in this new blog. Click to learn more: https://lnkd.in/gsrd2qpQ #InfectiousDiseases #ESCMIDGlobal #ECCMID2024

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Building a strong TMF that is reliable, credible, and inspection-ready at all times is crucial for the reconstruction of any clinical trial. Successful TMF trial management can be facilitated by: 1) Standardizing Processes: Implementing SOP’s for filing or QCing a TMF document ensures your team is consistently delivering the same quality of work. Read more here: https://bit.ly/4e1wnbE * * * #TrialMasterFile #eTMF #ClinicalResearch

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Join Taylor Lipsich from PatientWing as she explores 'How Building Trust with Rare Disease Patients Accelerates Trial Enrollment' at the 20th Biopharma Clinical Trials Nexus in San Diego. Don't miss this insightful discussion! #NEXUSconference #Patientwing #BioPharmaNexus #raredisease

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Hear what one of our most recent TMF University (TMFU) graduates had to say about their experience! Learn more about TMF University here: https://bit.ly/3MmP9ip * * * #TrialMasterFile #eTMF #ClinicalResearch #LifeSciences #NeverStopLearning

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Invitae Generation is our rigorous, evolving approach to clinical genetic testing. Since 2020, we’ve seen a 40% reduction in rates of variants of uncertain significance (VUS) with Invitae Generation technology. Learn more about how to get the answers you need for your patients when you need them: https://invit.ae/3KMoJEG

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