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Results for 'SAT&#39'

Browse oncology articles matching SAT&#39 — expert analysis, clinical perspectives, and industry updates from across drug development and care delivery. Use the tabs above for podcasts, press releases, partners, and people for the same search.

Single-arm trials supporting the approval of anticancer medicinal products in the European Union: contextualization of trial results and observed clinical benefit
OVN Avatar J. Mulder, S. Teerenstra, P. B. van Hennik, A. M. G. Pasmooij, V. Stoyanova-Beninska, E. E. Voest & A. de Boer
Single-arm trials supporting the approval of anticancer medicinal products in the European Union: contextualization of trial results and observed clinical benefit

single-arm trials, anticancer medicinal products, EU, trial, SAT's, oncology, European Medicines Agency, clinical benefit, contextualization

Between 2012 and 2021, 18 anticancer medicinal products for solid tumors were approved in the EU based on 21 SATs (single-arm trials). Pivotal SAT-based applications often included additional information for contextualization, such as supportive studies and external evidence. Thresholds for…

Apr 11th • 14 mins read

What decision-makers actually do when they can't evaluate reasoning directly
Partner Avatar Leon Rozen
What decision-makers actually do when they can't evaluate reasoning directly

Medical Strategy, Medical Leadership, Medical Affairs

There is a scene most advisory professionals will recognise. A recommendation that took weeks to produce — drawing on regulatory environment, market dynamics, scientific evidence, competitor positioning — gets four minutes in a senior forum. A question or two. A decision. The people in that roo…

Apr 12th • 5 mins read

The advice was good. It didn't matter.
Partner Avatar Leon Rozen
The advice was good. It didn't matter.

Medical Strategy, Medical Leadership, Medical Affairs

There is a particular kind of professional frustration that doesn't have a clean name. It isn't failure — the work was sound. It isn't incompetence. The reasoning was careful, the constraints were weighed, the recommendation was defensible. It is something more specific: the experience of having d…

Apr 12th • 5 mins read

Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years
OVN Avatar 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

Medical Affairs value isn't what you think it is
Partner Avatar Leon Rozen
Medical Affairs value isn't what you think it is

Medical Strategy, Medical Leadership, Medical Affairs

Medical Affairs functions have spent years building the case for their value. Frameworks, metrics, dashboards, impact stories, insight delivery. The work is real, the effort is genuine, and most of it misses the point entirely.

Apr 1st • 5 mins read

Why leadership teams become dependent on pressure and what it costs performance
Partner Avatar Jürgen Wiehn, Marian Duven
Why leadership teams become dependent on pressure and what it costs performance

leadership, career, performance

In many high-performing environments, pressure is not the exception. It becomes the operating baseline. Deadlines compress.Decisions stack.Communication tightens.Expectations increase. And over time, something subtle but important happens. Leadership teams begin to rely on pressure to function. …

Apr 13th • 5 mins read

Hiring Managers: What Should You Do During a Hiring Freeze?
Partner Avatar Michael Pietrack
Hiring Managers: What Should You Do During a Hiring Freeze?

careers

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

How to Know When to Make a Job Change
Partner Avatar Michael Pietrack
How to Know When to Make a Job Change

careers

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

Mastering the First Impression
Partner Avatar Tom Caravela
Mastering the First Impression

first impression, job interviews, professional communication, resume tips, LinkedIn profile

Why is a first impression so important? Mainly because it could also be your last, and only, impression on someone. Oftentimes, job seekers can fail at conveying a positive first impression, and they will unfortunately never get another chance to show who they truly are. This is an area that I feel …

Jan 29th • 2 mins read

“Extreme Interviewing” – MSL Interview Tips and Insights from Medical Affairs Leaders
Partner Avatar Tom Caravela
“Extreme Interviewing” – MSL Interview Tips and Insights from Medical Affairs Leaders

Extreme Interviewing, Medical Science Liaison, Emotional Intelligence, Hiring Process, Interview Tips

What is “Extreme Interviewing”? Is there such a thing? Does this term even exist in the dictionary? The short, and maybe obvious, answer is “No.” So perhaps I am guilty of coining a new term for the purpose of this article, but it is a concept that is very relevant and worth…

Jul 9th • 1 min read

MSL Retention – What Matters Most
Partner Avatar Tom Caravela
MSL Retention – What Matters Most

digital marketing, search engine optimization, keyword analysis, content strategy, online visibility

As the Medical Science Liaison job market continues to become more and more competitive, attrition rates continue to increase as a result. One of the most common questions I receive from MSL Directors and Medical Affairs leaders is, “What can we do to keep our MSLs loyal and motivated?” …

Mar 15th • 2 mins read

MSL Hiring and Recruitment: 5 Ways to Support Diversity and Inclusion
Partner Avatar Tom Caravela
MSL Hiring and Recruitment: 5 Ways to Support Diversity and Inclusion

Medical Science Liaison hiring, diversity and inclusion recruitment, diverse interview panel, employee referral program, diversity sourcing strategies

While the COVID-19 pandemic wreaked havoc on many industries, Medical Science Liaison hiring was steady throughout 2020 and continues to remain strong in 2021. The one change in hiring that has become evident is the increase in recruitment practices that support diversity and inclusion. While we may…

May 19th • 2 mins read

10 Ways to Make an Impact on a Phone Interview
Partner Avatar Tom Caravela
10 Ways to Make an Impact on a Phone Interview

phone interview tips, importance of phone screen, phone interview preparation, how to express interest in job, phone interview strategies

The phone interview, sometimes referred to by Hiring Managers and Talent Acquisition teams as the “phone screen,” is most often the first step in the interview process. While most job seekers are familiar with this concept and first step, some think of it simply as a formality or a way t…

Apr 9th • 1 min read

Transforming oncology: Five frontiers driving progress in cancer care
Partner Avatar iNIZIO
Transforming oncology: Five frontiers driving progress in cancer care

Thought Leadership, Oncology

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

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