Walter Houseman

Project Optimus is revolutionizing early oncology trials, aiming to ensure more effective and safer cancer drugs and improve patients' quality of life. Parexel experts have identified three strategies to help sponsors overcome challenges in achieving dose-optimization requirements. Here’s what we know works: 1️⃣ Design an integrated first-in-human study 2️⃣ Reach agreement with FDA at each step 3️⃣ Challenge guidelines with a compelling rationale Let me know your thoughts below and read more in our New Medicines, Novel Insights report! https://lnkd.in/dmYADu-n #ProjectOptimus #Oncology #NovelInsights

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In the fourth edition of our neurosciences blog series, Parexel expert and former regulator, Simona Stankeviciute, M.D., shares valuable insights on several best practices and creative approaches to assist biotech companies in developing effective trial design strategies and planning for successful regulatory submissions. Read the full article here: https://lnkd.in/gBnixZw2 #Alzheimers #Regulatory #ParexelBiotech

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In our latest Regulatory Navigator blog, we provide an overview of the proposed legislation in the BIOSECURE Act and outline ways that US-based developers – particularly those working on newer modalities such as cell and gene therapies – can mitigate associated risks.

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Accelerate regulatory submissions and lifecycle variations through automation and effective global-to-local collaboration on core packages. Learn how: https://bit.ly/3UdapLc #RIM #regulatory #submissions #biopharma

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I can highly recommend this free webinar with my amazing colleagues Marta and Harry around FSP Solutions for growth and transition. Hope to see you there!

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Get in touch, and learn how the team at TD2 can help streamline your next clinical trial!

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As a #leading #Data Services #FSP, Navitas Life Sciences specializes in providing high quality #Biostatistics, #Statistical #Programming and #Data #Management support across phases. #Speak to our #experts today to learn more about how our #global #FSP solutions can #augment your clinical trial. Navitas Data Sciences #biostatistics #dataprogramming #statistics #clinicaldataservices #functionalServiceprovider #biometrics #regulatorysubmissions

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What kinds of study changes and amendments need @IRB review? Check out Advarra's most recent #blog to get a refresher on the basics of what to send for review by the IRB.

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In our latest Regulatory Navigator blog, we provide an overview of the proposed legislation in the BIOSECURE Act and outline ways that US-based developers – particularly those working on newer modalities such as cell and gene therapies – can mitigate associated risks.

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Check out our latest article by Evan Hansberry that discusses reasons why biotechnology and pharmaceutical companies should consider establishing their Safety function earlier in the drug development process. Read the full article on our website: https://ow.ly/CaU550SohfA #drugsafety #pharmacovigilance #biotechnology #pharmaceuticals #prestigescientific

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Please stop by the booth if you are there and hear about what we can do to assist you in: 1) accelerating your regulatory filings, 2) relieving SMEs of the burden of technical writing (we write INDs, BLAs and NDAs from source documents) and 3) global regulatory strategy. Because we see so many INDs/BLAs/NDAs over the course of a year, we have a unique insight into what the regulatory authorities are focusing on and asking about today. We also do RTF and CRL remediation too but hopefully you will use us first so that remediation isn't needed!

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Learn how using Authorization Codes can help control protocol deviations in our latest blog post. https://lnkd.in/e4mj4mFX #AuthorizationCodes #RTSM

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My thoughts on Cell & Gene Therapy Deveopment from a CMC and regulatory strategy perspective captured in a vlog by Darwin Shurig.

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An IRB can review a "minor" study change via expedited review - but the regulations don't really define what "minor" means. Find out how IRBs navigate this grey area in our blog:

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In our latest Regulatory Navigator blog, we provide an overview of the proposed legislation in the BIOSECURE Act and outline ways that US-based developers – particularly those working on newer modalities such as cell and gene therapies – can mitigate associated risks.

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Attended an early session of today’s FDA conference where they discussed the new key elements sections for informed consent. This update is crucial for our ongoing projects and compliance efforts. For more information, check out the details. https://lnkd.in/gpBrM5Z6 #FDA #InformedConsent #Compliance #ClinicalResearch #ClinOptimaSolutions

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