Angela Lee’s Post

Looking forward to leading Thursday's webinar with Today's Clinical Lab on how cancer labs can best navigate FDA's final rule. https://lnkd.in/gRc-9mmA There is significant concern about FDA's 2024 final rule to regulate laboratory-developed tests (#LDTs). Oncology labs that previously developed their own LDTs may now be unsure of how to proceed in terms of costs, filings, and data collection. During this webinar, attendees will: - Learn how the final rule applies to oncology LDTs. - Find out what the FDA's action means for precision medicine efforts in cancer diagnosis and treatment. - Become familiar with upcoming timelines tied to the final rule.

Yet another reason to ensure clinical trials have adequate patient demographic representation. Regulatory bodies should consider providing accelerated review times for studies that meet this important criterion; alternatively, the FDA can expand the priority review voucher programs to applications that include trials meeting specific criteria.

The FDA has granted the withdrawal of Infigratinib (Truseltiq) for the treatment of cholangiocarcinoma, a rare bile duct cancer. This decision comes after a comprehensive review of the clinical data and reflects the evolving landscape of treatment options and regulatory standards. This withdrawal highlights the importance of ongoing research and the need for robust clinical evidence to support treatment approvals. Let's continue to support and advocate for innovative research and patient-centric approaches. Read More: https://lnkd.in/exSzxcDn #FDA #MedicalNews #Research #MedicalResearch #Oncology #PatientSafety #BiohackingVillage #BHVConnect #ClinicalTrials

Join us for our upcoming webinar where our expert speakers will delve into the latest data from ASCO and recent conferences, highlighting opportunities to escalate treatment for high-risk populations across tumor types and treatment settings. Key data includes insights on breast cancer, gastroesophageal cancer, bladder cancer, head & neck cancer, and colorectal cancer. Highlights you can expect: - In the MonarchE study, ctDNA+ in the adjuvant setting was highly prognostic of clinical outcomes in breast cancer. - A multi-institutional analysis revealed that ctDNA-positivity impacted the care plan of 91% of patients analyzed. - In gastroesophageal cancer, ctDNA results in the peri-operative setting correlated with long-term outcomes. - Patients with bladder cancer who remained MRD-negative on serial testing showed exceptional outcomes. - MRD-positive Signatera patients in head & neck cancer had inferior PFS post-treatment. - Results from the MD Anderson INTERCEPT program showed promising outcomes in colorectal cancer treatment. Don't miss out on the topline results expected later this year from the Phase III ALTAIR trial. Save your spot and register!

Interesting study that supports it can be done! Diversity without delay! No doubt in takes proactive planning and methodologies that are emerging as good practices. #communityengagement #diversityequityinclusion #drugdevelopment

Have Your Voice Heard! Through 25 June 2024, you can comment on FDA's draft guidance Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications. This guidance is deals with the eligibility criteria for cancer clinical trials and how selection is intended for patient populations and to reduce potential risks to trial participants. However, eligibility criteria are sometimes more restrictive than necessary, and expanding eligibility criteria to be more inclusive is one trial design consideration that may improve the diversity of clinical trial populations. This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs or biological products regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions. This guidance is intended to assist interested parties, including sponsors and/or institutional review boards, who are responsible for the development and oversight of clinical trials. #fda #cder #oncology #clinicaltrials #gcp

If you are a sponsor conducting oncology clinical trials, this is for you. Here is a summary of the top 5 key points from this new FDA guidance. 1. U.S. Population Representativeness in MRCTs: Sponsors should ensure that the trial population enrolled in MRCTs is representative of the U.S. population to support a robust assessment of the drug's safety and effectiveness in U.S. patients. 2. Considerations for U.S. and Foreign Site Selection: Trials should be conducted across major geographical regions rather than predominantly in a single country or region. Sponsors should justify the selected regions and sample size allocation, considering patient, disease, and healthcare system-related factors. 3. Disease, Available Treatment, and Medical Product Considerations: Sponsors should consider regional differences in disease characteristics, available treatments, and standard of care to ensure trial results are applicable to the U.S. population. 4. Considerations for Analyses of Data from MRCTs: The analysis plan should include regional treatment effects and subgroup analyses, particularly focusing on the U.S. population. Safety assessments should also be conducted across subgroups to identify potential safety signals. 5. Early Consultation with FDA and Other Regulatory Authorities: Sponsors should consult with FDA early in clinical development and seek input from other regulatory authorities to ensure the trial design meets their requirements and promotes efficiency in drug development.

(Benefit-Risk Management / Cancer Studies / 3 NEW FDA Draft Guidances) If your teams are involved in the design or oversight of cancer/oncology studies, please PAUSE, REVIEW, and SHARE these 3 new draft guidances as follows: (1) for lab values - https://lnkd.in/eMjR5QwR, (2) for performance status (how well can they perform the activities - https://lnkd.in/ebD-B3qw, (3) for washouts/concomits - https://lnkd.in/eSTArQ6S. #fda #drugs #biologics #cder #cber #cancerstudies #cancer #oncology #clinicaltrials #clinicalstudy #clinicalresearch

Want to know what the last six months have looked like for our team? The first half of the year has been a period of significant progress and milestones for BiVictriX, and we’re pleased to share our unaudited interim results for the period ended 30 June 2024. Key Highlights:   💊 Advancing BVX001 to clinic: Our lead candidate shows promising preclinical safety and efficacy data, positioning it well for clinical trials. With an FDA Orphan Drug Designation for acute myeloid leukaemia (AML), we're moving towards final IND-enabling studies with confidence. ✅ FDA progress: A successful INTERACT meeting with the FDA paves the way for an efficient IND submission process. 💰 Funding boost: Thanks to an Innovate UK grant, we’re accelerating our second drug candidate, BVX002, which targets solid tumors. 🔍 Expanding discovery: Our Bi-Cygni® platform has uncovered new target pairs in over ten cancer types, including lung, breast, and bladder cancers. 📈 Financial update: We maintain a strong cash position with £1.7 million in cash and cash equivalents as of 30 June 2024. Stay tuned as we continue to drive innovation in cancer therapeutics with our proprietary Bi-Cygni® ADCs! #CancerTherapeutics #ADCs #Pharma #Biotech #CancerResearch #DrugDiscovery

AdvaMed Praises CMS Draft Rule Improving Access to Alzheimer’s, Cancer Diagnostics: AdvaMed commended CMS for its July 10 proposed rule that includes separate payments for diagnostic radiopharmaceuticals are used to diagnose and treat diseases such as Alzheimer’s and cancer. #fda #financial #lifesciences