Results for 'access'
Emmanuelle Jacqueta, Ghania Kerouani-Lafayeb, Francoise Grudeb, Sergio Goncalvesb, Annie Lorenced, Florence Turcryb, Liora Brunelb, Laetitia Belgodereb, Adrien Monardc, Gaëlle Guyaderb, Lotfi Boudalib, Nicolas Albin
Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years
Innovation, Expanded access, Early drug access, Cancer, FDA, EMA
Cancer incidence is increasing globally, and while medical innovation significantly impacts patient survival, the drug development process is lengthy, often exceeding 10 years for marketing authorization (MA). France has implemented the ATU (Temporary Authorization for Use) program to facil…
Apr 7th • 12 mins read
Natansh D. Modi, BPharm; Ahmad Y. Abuhelwa, PhD; Ross A. McKinnon, PhD
Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration
IPD sharing, clinical trial transparency, FDA anticancer approvals, oncology trials, data accessibility, pharmaceutical industry
The study examines the eligibility for individual participant data (IPD) sharing from clinical trials that supported the FDA approval of anticancer medicines over the past 10 years. Of the 304 trials analyzed, 136 (45%) were eligible for IPD sharing, while 168 (55%) were not. IPD sharing rates v…
Jul 28th • 20 mins read
John Hair, Thomas Maryon, and Cristian Lieneck
Identification of Barriers Preventing Biosimiliar Oncology Medication Adoption
oncology, cancer, biosimilar, barriers, access, obstacles
Biosimilars are biologic medical products that are almost identical to original biologics but are produced by different companies. They are safe, effective, and can reduce costs for insurers and patients. Despite the benefits, barriers exist for oncologists and cancer centers in prescribing biosi…
Oct 27th • 30 mins read
Nicole M. Kuderer and Gary H. Lyman
Evolving Landscape of US Food and Drug Administration Drug Approval in the Era of Precision Oncology: Finding the Right Balance Between Access and Safety
FDA, trials, drug approval, access, safety
Balance is needed between enhancing drug access and ensuring patient safety. Accurate surrogate endpoints and sophisticated trial designs are crucial for predicting clinical benefits. Safety data before final approvals and postapproval assessments for vulnerable populations are necessary. Value…
Jun 20th • 3 mins read
Vishwanath Sathyanarayanan, MD, DM, Christopher R. Flowers, MD, MSc, and Swaminathan P. Iyer, MD, MBBS
Comparison of Access to Novel Drugs for Lymphoma and Chronic Lymphocytic Leukemia Between India and the United States
lymphoma, leukemia, India, United States, biosimiliars
The review examines the costs and access to novel drugs for treating chronic lymphocytic leukemia (CLL) and lymphoma in the United States and India over the last 5 years. Clinical outcomes for patients with hematologic malignancies have improved significantly due to immunotherapeutic and tar…
Jul 21st • 12 mins read
Tanja Cufer, Tudor E. Ciuleanu, Peter Berzinec, Gabriela Galffy, Marko Jakopovic, Jacek Jassem, Dragana Jovanovic, Zhasmina Mihaylova, Gyula Ostoros, Christiane Thallinger, Milada Zemanova, Christoph Zielinski
Access to Novel Drugs for Non-Small Cell Lung Cancer in Central and Southeastern Europe: A Central European Cooperative Oncology Group Analysis
Health Outcomes and Economics of Cancer Care, Lung Cancer, NSCLC, EMA
Treatment for non-small cell lung cancer (NSCLC) has significantly improved with the introduction of targeted and immune-oncologic drugs. Despite rapid development and European Medicinal Agency (EMA) registration, these novel drugs are not easily accessible in Central and Eastern European (CEE) c…
Nov 24th • 10 mins read
Nicole Grossmann, Martin Robausch, Eleen Rothschedl, Claudia Wild, Judit Simon
Publicly accessible evidence of health-related quality of life benefits associated with cancer drugs approved by the European Medicines Agency between 2009 and 2015
Antineoplastic agents, Health-related quality of life, Clinical efficacy, Drug approvals, Patient-relevant outcomes
The study investigates cancer drugs approved by the European Medicines Agency (EMA) that initially lack Health-related Quality of Life (HRQoL) information. Data was collected for cancer indications approved between January 2009 and October 2015, using sources like the EMA website, clinical…
Feb 23rd • 12 mins read
Envision Pharma Group
AI-powered real-world evidence: Strategically enhancing value and access
Oncology, Clinical Development, Targeted Therapy, Immunotherapy, Genomic Profiling, CAR-T Cell Therapy, Precision Medicine
Real-world evidence (RWE) complements traditional randomized controlled trials by providing insights from diverse data sources, helping healthcare decision-makers with coverage, reimbursement, and treatment guidelines. Artificial intelligence (AI) and natural language processing (NLP) are pivotal…
Aug 22nd • 5 mins read
Tom Caravela
12 Interview Techniques to Help Land Your Next Job
interview preparation, job interview tips, business etiquette, salary negotiation, follow-up after interview
Your next career move could very well be one interview away. Be sure to take every measure to prepare yourself and make the most of the opportunity. According to a recent Simply Hired survey of over 850 Managers, an overwhelming 89% said that “showing lack of preparation” will affect the…
May 12th • 1 min read
Bridget Rasmusson
6 Tips to Ace Your Next MSL Interview!
digital marketing, content optimization, search engine ranking, keyword research, on-page SEO
As a Medical Affairs-focused recruitment firm, we see MSL interview "wins" and slip-ups on a daily basis. From our experience working with candidates across all therapeutic areas and across the entire United States, I've noticed a few trends that might help you get that next interview "win" under yo…
Sep 28th • 1 min read
Tom Caravela
MSL Evolution: New Trends and Titles That May Emerge
digital marketing strategies, SEO best practices, content marketing tips, social media optimization, keyword research tools
The COVID-19 pandemic has clearly had a profound impact on Field Medical Affairs. Has the Medical Science Liaison role changed forever? What new titles, trends and opportunities might emerge as a result of the new age for Field Medical and the evolution of the Medical Science Liaison? Is virtual en…
Apr 5th • 1 min read
Bridget Rasmusson
Positioning Yourself to Become an MSL in 2022
MSL role, clinical background, academic background, research background, industry, MSL Society, conference, scientific expert, therapeutic expertise, pharma companies
After attending the MSL Society’s 9th annual conference in Vegas Last week, I have taken some time to reflect on inquiries our team received about how to effectively step into the MSL role from a clinical, academic, or research background. Industry is a tough nut to crack, but it is absolutely…
Dec 21st • 10 mins read
iNIZIO
Virtual Oncology MSL Team Increases KOL Engagement by 120%
Case Study (US) The Challenge Client needed comprehensive, scalable and innovative model. Goal: Cost-effectively supplement field based MSL team to provide national coverage. Objective: Share newly published guidelines with KOLs and gain key strategic insights. The Approach Highly …
Sep 3rd • 1 min read
iNIZIO
Transforming oncology: Five frontiers driving progress in cancer care
From biomarker-driven breakthroughs to AI-powered early detection and a renewed commitment to equity and patient centricity, the past 12 months have seen major strides across cancer research, treatment, and communication. At Inizio, we’ve had a front-row seat to this transformation, supporting…
May 16th • 5 mins read
B. Gyawali, E. G. E. de Vries, U. Dafni, T. Amaral, J. Barriuso, J. Bogaerts, A. Calles, G. Curigliano, C. Gomez-Roca, B. Kiesewetter, S. Oosting, A. Passaro, G. Pentheroudakis, M. Piccart, F. Roitberg, J. Tabernero, N. Tarazona, D. Trapani, R. Wester, G.
Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring
ESMO-MCBS, bias, clinical trial design, clinical trial implementation, clinical trial reporting, clinical trial analysis
The ESMO-MCBS is a tool used for scoring the clinical benefit of cancer medicines as reported in clinical trials, assuming valid research methodologies and quality implementation. The tool's effectiveness is compromised by studies with flawed design, implementation, or data analysis, w…
Apr 20th • 8 mins read
Pai, Rekha
Advances in basic research in oncology in 2020: Bridging basic science and clinical care
advances, research, oncology, PCAWG, 2020
Cancer research is advancing with an understanding of the disease at the genetic level, facilitated by massive parallel sequencing. The pan-cancer analysis of the whole genome (PCAWG) in 2020 documented genomic changes across 38 cancer types, involving 2658 cancer genomes. An average of four to …
Mar 24th • 1 min read
Charles L. Bennett , Sumimasa Nagai , Andrew C. Bennett , Shamia Hoque , Chadi Nabhan , Martin W. Schoen , William J. Hrushesky , Stefano Luminari , Paul Ray , Paul R. Yarnold , Bart Witherspoon , Josh Riente , Laura Bobolts , John Brusk , Rebecca Tombles
The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions
Epoetin, Biosimilars, Interchangeable, Substitution, Guidelines
Biosimilars are biologic drug products similar to reference drugs in various attributes, including safety and efficacy. Biosimilar epoetin was approved by the FDA in 2018 after previous non-approval letters in 2015 and 2017 despite positive reviews by the FDA's Oncologic Drugs Advisory Committee …
Mar 12th • 7 mins read
Cornelius F Waller & Adriano Friganovi´c
Biosimilars in oncology: key role of nurses in patient education
biologics, biosimilars, cancer care, nurse
Biosimilars can reduce costs and improve access to cancer therapies, but unfamiliarity may hinder their adoption. Nurses, as trusted healthcare providers, are crucial in educating patients about biosimilars. Biosimilars are highly regulated and offer benefits comparable to existing biologic…
Jun 15th • 10 mins read
Nidal Al-Huniti, Yan Feng, Jingyu (Jerry) Yu, Zheng Lu, Mario Nagase, Diansong Zhou, Jennifer Sheng
Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities
tumor growth, drug developement, drug approval, TGD, MIDD, PDUFA
Model-informed drug development (MIDD) has advanced rapidly in recent years, especially in oncology. The Prescription Drug User Fee Act (PDUFA) VI includes commitments to enhance MIDD. Tumor growth dynamic (TGD) modeling is a key MIDD approach used to accelerate drug development, support new dru…
Jun 26th • 18 mins read
Sean X Zhang, MSc , Dean Fergusson, PhD , Jonathan Kimmelman, PhD
Proportion of Patients in Phase I Oncology Trials Receiving Treatments That Are Ultimately Approved
cancer, biological markers, phase 1 clinical trials, drug approval, medical oncology, united states food and drug administration guidelines, adverse event, national comprehensive cancer network, American society of clinical oncology
Phase I oncology trials are often considered a therapeutic option, but this claim is primarily based on surrogate measures like objective response rates. A systematic search was conducted to evaluate the therapeutic value of phase I cancer trial participation, focusing on the likelihood of patien…
Apr 1st • 14 mins read