Results for 'Data'
Ashley Woolmore , Dirk Arnold , Jean‐Yves Blay , Christian Buske , Alfredo Carrato , Winald Gerritsen , Marc Peeters , Jesus Garcia‐Foncillas , David Kerr
The Oncology Data Network (ODN): Methodology, Challenges, and Achievements
The oncology data network, ODN
The Oncology Data Network (ODN) aims to create a collaborative infrastructure for precision medicine, established in over seven European countries with 124 cancer centers. The ODN collects concise data on cancer medicine use, adhering to EU GDPR regulations, and has a central European Data Wareho…
May 21st • 8 mins read
Jingjing Yu, Isabelle Ragueneau-Majlessi
In Vitro-to-In Vivo Extrapolation of Transporter Inhibition Data for Drugs Approved by the US Food and Drug Administration in 2018
In Vitro-to-In Vivo, Transporter Inhibition Data, Drug Approval, FDA, 2018
The analysis focuses on inhibition transporter data from New Drug Applications approved by the FDA in 2018, involving 42 drugs. Key points include: In vitro-to-in vivo predictions were available for nine recommended transporters. 29 parent drugs and 16 metabolites inhibited at least one transpor…
Jan 25th • 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
Robbe Saesen, Georgios Kantidakis, Ann Marinus, Denis Lacombe, Isabelle Huys
How do cancer clinicians perceive real-world data and the evidence derived therefrom? Findings from an international survey of the European Organisation for Research and Treatment of Cancer
real-world evidence, real-world data, oncology, cancer, survey, clinicians, randomized controlled trials, Europe
Real-world evidence (RWE) is increasingly being used in the development and decision-making processes for anticancer therapies, but clinician views on its use are unclear. A survey conducted between May and July 2021 involved 557 clinicians from 30 countries and 13 cancer domains. Most clinician…
Aug 1st • 45 mins read
Robbe Saesen, Mieke Van Hemelrijck, Jan Bogaerts, Christopher M. Booth, Jan J. Cornelissen, Andre Dekker, Elizabeth A. Eisenhauer, André Freitas, Alessandro Gronchi, Miguel A. Hernán, Frank Hulstaert, Piet Ost, Petr Szturz, Helena M. Verkooijen, Michael W
Defining the role of real-world data in cancer clinical research: The position of the
real-world data, real-world evidence, randomised, pragmatic trials, cancer, clinical research, add-on cohorts
Real-World Data (RWD) are increasingly used in cancer clinical research as an alternative evidence source. RWD studies primarily involve observational data, which offer insights into real-world conditions but may have quality limitations. Some research questions necessitate Randomized Controlled…
Mar 20th • 10 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
E.M. Ray, L.A. Carey, K.E. Reeder-Hayes
Leveraging existing data to contextualize phase II clinical trial findings in oncology
HER2, phase II trials, oncology, iDFS, EBC, early stage breast cancer
In the USA, over 250,000 women are diagnosed with early-stage breast cancer (EBC) yearly, with up to 30% having HER2 amplification. The standard care for HER2-positive EBC involves chemotherapy plus HER2-directed therapy for one year. The phase II Adjuvant Paclitaxel and Trastuzumab (APT) tr…
Sep 21st • 3 mins read
S.F. Oosting, J. Barriuso, A. Bottomley, M. Galotti, B. Gyawali, B. Kiesewetter, N.J. Latino, F. Martinelli, M. Pe, G. Pentheroudakis, F. Roitberg, H. Vachon, E.G.E. de Vries, M. Piccart, N.I. Cherny
Methodological and reporting standards for quality-of-life data eligible for European Society for Medical Oncology-Magnitude of Clinical Benefit Scale
Benefit Scale, MCBS, Quality of Life, Health Assessment, Oncology Scale, Cancer Guidelines, Treatment Evaluation, Medicine Scoring
The ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) was introduced in 2015 to standardize the assessment of clinical benefits from cancer treatments. ESMO-MCBS helps in health-technology assessment, especially given the increasing number of treatment options and rising cancer care costs. Ne…
Apr 1st • 30 mins read
Jamie Riley
The Talent Inflection Point in Pharma and Biotech: A Challenge to Companies — and a Call to Candidates
hiring, talent demand, job market
As pipelines advance and execution accelerates, pharma and biotech hiring may shift again in 2026, reshaping talent demand.
Feb 4th • 7 mins read
Michael Pietrack
Leadership Lab: How To Spot When Employees Are About To Walk Away
Employees rarely leave companies for one reason alone. In this column, Kaye/Bassman’s Michael Pietrack shares a framework that helps leaders identify when their team members are thinking about heading for the exit—and how to address it.
Oct 22nd • 7 mins read
Michael Pietrack
Leadership Lab: 4 Ways Biopharma Leaders Can Prepare for Media Interviews
Media coverage can help biopharma executives connect with, inform and inspire the public. In this column, Kaye/Bassman’s Michael Pietrack and three communications experts share how to make the most of these opportunities.
Aug 20th • 6 mins read
Michael Pietrack
Managing Emotions After Being Downsized
The biggest challenge a person faces after being downsized is the wide range of emotions that follow. Over the past 15 years, I’ve observed many individuals deal with this unfortunate circumstance, and I wanted to share what I’ve seen others do to cope. I genuinely hope this helps you or someon…
Oct 21st • 5 mins read
Michael Pietrack
Practical Advice for When You're Downsized. What Activities will Pay-off after a Lay-off?
Have you or someone you know recently been downsized, laid off, or RIF’d? If so, you’re going to want to watch and share this video. When one is downsized, there is a range of emotions. Some feel betrayed and carry hurt feelings, while others fight with the fear of uncertainty and the reality…
Sep 15th • 5 mins read
Michael Pietrack
Resume Advice: Tattoos and Breadcrumbs
Okay, Pietrack has finally lost it! What do tattoos and breadcrumbs have to do with resume advice? If you did a web search seeking resume advice, you would get pages of information about resume construction to format to length. So much of how a resume should be constructed is subjective or based o…
Jul 14th • 5 mins read
Michael Pietrack
How to Elevate Your Career: Go from Individual Contributor to People Leader
Have you ever wondered how to elevate from an individual contributor to a leadership position? Well, it's all about picking the right elevator. Imagine your current position as an elevator, and it has stopped at the seventh floor. Despite pushing all the buttons, that elevator just will not go …
Jul 24th • 5 mins read
Michael Pietrack
What Do Tennis and Job Interviewing Have in Common?
What do tennis and Job interviewing have in common? In a game of tennis, one person sends the ball over the net and the other person, sends it back, right? Well, when it comes to job interviewing, correspondence with the hiring manager is a lot like tennis. How? When you send the ball over the ne…
Apr 14th • 5 mins read
Michael Pietrack
Hiring Managers: What Should You Do During a Hiring Freeze?
As we begin 2023, many companies are experiencing hiring freezes. Some hiring managers have a sense of how long the freeze will be, some don’t, but all know that it’s temporary. So, what can hiring managers do during the freeze to stay competitive in the war for talent? Hiring is a competition…
Jan 26th • 5 mins read
Michael Pietrack
How to Know When to Make a Job Change
In career conversations, one of the most common questions I hear is: “How do I know if it’s time to move on from my company?” The real decision often comes down to a mix of factors that influence job satisfaction and long-term career growth. That’s why I use the CLAMPS framework. CLAMPS …
Aug 26th • 5 mins read
Michael Pietrack
The Great Resignation is Now The Great Hesitation
Over the last few years, the employment market has moved through dramatic swings. In 2021 and 2022, millions of professionals left their roles in what became known as The Great Resignation. Jobs were abundant, companies were aggressively hiring, and the perceived level of risk was low. If a new role…
Nov 19th • 5 mins read
Michael Pietrack
The Four Employment Agreement Questions Every Pharma Executive Must Ask
opinion, career advice, leaderhsip, legal
Clarity on employment terms is essential to protect careers. In this column, Kaye/Bassman’s Michael Pietrack speaks to employment attorney Howard Matalon, JD, partner at OlenderFeldman, on how to evaluate the fine print of an employment agreement.
Dec 18th • 6 mins read