Here at CG Oncology we are thrilled to announce our recent hires who will join us on our quest of Attacking Bladder Cancer for a Better Tomorrow™.
Welcome to the team:
Allen Kou - Quality Control Manager
Anthony R. - Analytical Development Manager
Caitlyn Ainge - Director, Technical Accounting and SEC Reporting
Scott Tanner - Director, Finance & Accounting
Tracy Nazarchyk Pagnozzi - Senior Manager, Medical Writing
Jack Lin - Associate Director, CMC Small Molecules
Nexus Alliance is supercharging R&D in Oncology, CNS, and Rare disease:
1) A typical clinical trial protocol of investigator initiate trial takes about 150 hrs of preparation and medical writing.
2) A typical clinical trial of phase I/2b takes about 350 hrs of efforts.
3) The list for phase III protocols, aggregate reports, IND, NDA, EMA- MA, etc. range from 200-550 hrs. From shell to end.
What if our Gen- AI tools reduce it by 60%, and increase the consistency by 95% or better. What if, we assure documentation repository to offer reviews, Q/As, FAQ developments, etc. to 30% of the current expanditure? This reduces the cost of the R&D by 20% in total in our estimate just in submission, preparation, etc. We have similar proposals for collaborative associations to reduce the cost per patient per IND- NDA by about 55%. All with proven track record, alpha and beta POC, and to the penny of their case studies. We can reduce the labor cost by 20% in on shore model, 25% by hybrid of 50-50, and 45% across offshore labor assets.
For more information, ask for my latest innovation planetarium presentation at DIA- San Diego. A niche proposition value net in R&D.
Industry and centers of excellence collaborations wanted. Cost reduction, quality improvement, compliance 100%, and value net maximized.
🔬 Phase I: ERGOMED Clinical Trials Insights – Latest Oncology Whitepaper available for download!
Titled „Optimizing Backfilling Strategies for Phase I Oncology Studies“, read on as ERGOMED Medical Monitor, Assistant Professor in Oncology, & Biostatistician, Erard Gilles, MD,MSc, explores innovative strategies for Phase I oncology studies, focusing on determining the Recommended Phase 2 Dose (RP2D) for new biological drugs and targeted therapies.
💡 Discover the advantages of enrolling patients in lower doses deemed safe, maintaining enrollment momentum, and gathering more safety and efficacy data.
💡 Learn about statistical and non-statistical considerations in determining the RP2D expansion for new drugs and targeted therapies.
Download our comprehensive whitepaper now and stay ahead in the field of Phase I studies! Click the link to get your copy: https://okt.to/gKRvfh#ClinicalTrials#OncologyResearch#MedicalAdvancements#Pharma#DrugDevelopment#Biostatistics#MedicalResearch#ErgomedInsights
Are you looking to optimize your sales force in the Oncology sector?
Tegra Analytics partnered with a mid-sized Oncology company to determine the optimal size and alignment of their sales force based on indications and potential opportunities.
Discover how Tegra's data-driven approach and correlation analyses helped identify priority targets and optimize their sales force structure!
📚 Dive into the case study: https://bit.ly/3Hmfmdh
🌐 Contact Info@TegraAnalytics.com to unlock the full potential of your data! #TegraAnalytics#SalesOperations#LifeSciences
Happy International Pathology Day from the Connected-Pathology team!
Today, we are celebrating #InternationalPathologyDay, a day dedicated to honoring the vital contributions of pathologists both in the preclinical and clinical fields. In the preclinical area, pathology is the cornerstone of many types of studies, such as #Efficacy or #Toxicology, providing crucial insights into disease mechanisms, treatment efficacy, and safety assessments.
Accurate pathology assessments rely not only on the pathologist's expertise, which highlights the importance of pathology #trackandtrace workflow, including proper sample tracking systems, multiple quality control checks, and staining optimizations experiments.
At Connected-Pathology, we work hand-in-hand with researchers, united by a common goal: to enhance our understanding of diseases and help industry innovators develop novel therapies.
Read more about our pathology laboratory solutions here: https://lnkd.in/eaA4VBC6#PreclinicalResearch#EuropeanHistopathologyCRO#HistopathologyServicesEurope#HistopathologyTechnician#Pathology#ToxicologicPathology#VeterinaryPathologist#VeterinaryMedicine
Happy ASCO all:
This year close to 30K people gathered at ASCO. Companies had contingencies of more than 20-30 across individual top 20 companies. The small and medium size companies as well as about 30% are clinical practitioners, HCPs, etc. across the direct care Sphere. I pose a simple question to a top commercial lead of the oncology top pharma. He response was dead silence.
How many of your 35 attendees are trained oncologist(with minimal prior or current direct clinical care), HCPs in clinical care of oncology, or scientists with fellowship/post doc. credentials? The real number should surprise all of us!!! I suspect this chronic challenge is made across all top 100 attended biopharma.
Can we give the jobs to people who know it the best?
During one of the roundtable sessions at the ASHP Midyear meeting, an oncology pharmacist commented that his institution is considering creating an FTE for "knowledge management"
A person whose job is to keep on top of new information and disseminate it out to the teams 📚
Reminds me when we started seeing full time positions focused solely on drug shortages
When the work effort to keep up exceeds the number of work hours in the day, it's time to consider a separate role. It seems like we're coming up on that time in oncology 😳
Have you heard rumblings of this?
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📌 When you’re ready to work on your own knowledge management system, the Enjoy Learning Oncology (ELO) program can help you.
Start by getting the Oncology Insights Newsletter with oncology pearls and resources - sign up at the link in my profile or send me a DM.
#pharmacists#oncologypharmacistsKelleyCPharmD
𝐓𝐡𝐞 𝐅𝐃𝐀 𝐡𝐚𝐯𝐞 𝐥𝐚𝐮𝐧𝐜𝐡𝐞𝐝 𝐚 𝐧𝐞𝐰 𝐠𝐫𝐨𝐮𝐧𝐝𝐛𝐫𝐞𝐚𝐤𝐢𝐧𝐠 𝐩𝐢𝐥𝐨𝐭 𝐩𝐫𝐨𝐠𝐫𝐚𝐦, aimed to address long-standing regulatory challenges in oncology in-vitro diagnostics.
This program could pave the way for a more collaborative and efficient diagnostic landscape, not just in oncology but potentially in other therapeutic areas too such as neurology.
One of those hoping that this program will transform the landscape of diagnostic testing is Federico Goodsaid, SVP of Regulatory Affairs at Ariana Pharma.
Federico worked with the FDA for nearly a decade and now uses this wealth of knowledge to support clients across the life sciences industry. Together, we sat down to share some of Federico's insights on this new pilot program including:
👉 Streamlined regulatory pathways for in vitro diagnostics
👉 Enhanced collaboration among labs
👉 Reduced R&D costs
👉 Potential for global adoption
👉 A brighter future for personalised medicine
Read the full article via the link in the comments below 👇
#Oncology#LifeSciences#FraserDove#regulatoryaffairs
Shout out to all RaySearch Laboratories incredible inventors!
The patent ranking originally published by the European Patent Office (EPO) and also referred to by Digital Hälsa* (DigitalHealth) is evidence to your creative minds - bringing innovative oncology software solutions to patients all over the world. Keep up the great work!
#digitalhalsa#radiationoncology#advancingcancertreatment#raysearchlaboratories#medtech
*independent business-2-business news service
*NB! you need to subscribe to be able to read the article in Digital Hälsa
🚀 Second exit in less than a week! We are thrilled to announce the acquisition of JEITO’s portfolio company EyeBio by Merck (MSD) for a potential value of $3 billion.
The acquisition of EyeBio, a clinical-stage ophthalmology biopharma dedicated to delivering a new generation of therapies for sight-threatening eye diseases, follows the acquisition of HI-Bio by Biogen, and validates further Jeito’s unique and differentiated investment model.
JEITO's journey with EyeBio began in February 2022, with an initial investment just one year after its creation, as a co-lead investor in a $65 million Series A funding round. In November 2023, Jeito participated again in EyeBio’s $65 million Series A extension, aligning with Jeito’s refinancing strategy.
As a leading investor, JEITO fruitfully collaborated with EyeBio’s outstanding management team and has been a driving force in the strategic development of the company that led to faster development timelines.
This acquisition highlights the significant clinical progress achieved with Restoret™, EyeBio’s promising late-stage candidate for diabetic macular edema, as well as a robust preclinical pipeline targeting retinal diseases.
Congratulations to the EyeBio team for their tremendous progress over the past two years, offering new hope to patients with sight-threatening eye conditions 👏
Read more 👉 https://lnkd.in/e4XRdkc4#FasterForThePatient#privateequity#lifesciences#biopharma#ophthalmology
Great news!