- Joined on May 21, 2024
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470 items published
The Struggle With KOL Access in Todays World
<p>Carsten Schnatwinkel and Jeanna Cooper join Tom Caravela to discuss the evolving landscape of KOL access in medical affairs. They address challenges in securing KOL access and the role of AI ...
Surround to Succeed: Building a Motivational Network
<p>This week&rsquo;s guest is Sarah Snyder, MSL Recruiter with The Carolan Group who discusses the importance of surrounding yourself with a motivational network.</p> <div> <...
Social Media Listening Evolved
<p>In this episode, Tom Caravela, Conor McGladrigan, and Kevin Peterson discuss the evolving role of social media listening in Medical Affairs. They discuss the significance of social media list...
Culture, Context, and Care: The Role of Medical Anthropology in Medical Affairs
<p>In this episode, Tom Caravela, Sonika Garcia, and Suzi Fraze explore the intersection of medical anthropology and medical affairs. They discuss cultural competence versus cultural fluency, hi...
How to Silence Self Doubt And Create Unstoppable Confidence
<p>In this episode, Tom Caravela welcomes Allison Trucillo to discuss the journey of overcoming self-doubt and the inner critic. Allison shares her personal experiences and provides tools and st...
Over-Negotiation-How to Botch a Job Offer
<p>In this episode, Tom Caravela warns job seekers about over negotiation and making unnecessary mistakes in the offer process. Tom debunks common myths and provides essential strategies for Med...
Freedom: The Mid Year Check In
<p>In this episode, Tom Caravela reflects on the concepts of freedom and progress, providing a historical context for Independence Day and its relevance to personal goals. The discussion highlig...
How to Start Presenting Like a Pro
<p>In this episode, Tom Caravela is joined by Sarah Snyder and Patrina Pellett to share expert advice on how to become a master presenter. They explore and discuss the many ways Medical Science ...
Healthy on the Road-How to Avoid MSL Belly
<p>In this episode, Tom Caravela and Alex Palumbo discuss the challenges faced by Medical Science Liaisons (MSLs) to stay healthy with a crazy travel schedule and stay free from "MSL belly....
The State of the Job Market 2025
<p>In this episode, Tom Caravela and Bridget Rasmusson discuss the current state of the job markets and factors that are influencing it. They begin by discussing the economic factors influencing...
The Strategic vs the Scientific MSL
<p>In this episode, Tom Caravela is joined by Joy Morrell to explore the multifaceted role of Medical Science Liaisons (MSLs) in medical affairs. They discuss the critical importance of dialogue...
Be Brave-A Networking Tale that Led to Friendship
<p>In this episode, Josh Yoder and Kirsten Borbe to share their amazing story of how a networking message on LinkedIn led to a friendship. The discussion begins with insights into Josh and Kirst...
How Medical Affairs Professionals Should Engage with Digital Opinion Leaders
<p>In this episode of MSL Talk, Tom Caravela sits down with Paul Ward for an insightful conversation on the evolving role of Digital Opinion Leaders (DOLs) in Medical Affairs. Sponsored by Medic...
How to Leverage YOUR Unique Skills for Career Advantage
<p>In this episode, Tom Caravela sits down with Hahn-Ey Lee to discuss the importance of leveraging unique skills to advance the career of a Medical Science Liaison (MSL). The conversation delve...
Fierce Pharma Engage 2025 - RECAP
<p>In this episode, Tom Caravela and Patrina Pellett explore the highlights of the Fierce Pharma Engage 2025 conference. They discuss the conference's format, content, sessions, networking ...
ESCAPE from Ordinary in Pursuit of YOUR Passion
<p>In this episode, Tom Caravela welcomes renowned Entertainer, Magician, Escape Artist and Hypnotist Danny Zzzz who shares his journey from an unconventional background to GREAT success. The co...
The Power of Non Traditional KOL Engagement
<p>In this episode, Tom Caravela is joined by Lindsey Harrer to discuss the power of non traditional Key Opinion Leader (KOL) engagement for Medical Science Liaisons (MSLs). They explore the dif...
Medical Affairs- So Far to Come... So Far to Go
<p>In this episode, Tom Caravela and Mandy Krumnow explore the evolving landscape of medical affairs, highlighting its value and impact. They discuss what constitutes "true impact" wit...
2025 MAPS Conference RECAP
<p>In this episode, Tom Caravela and Patrina Pellett offer a full RECAP of the 2025 Medical Affairs Professional Society Meeting. The key themes from the meeting are examined, such as impact and...
How Should Medical Affairs Engage on Social Media
<p>In this episode, Tom Caravela and Sarah Snyder delve into the vital role of social media for Medical Science Liaisons (MSLs). They discuss its evolution in medical affairs, platforms for prof...
It Can be Lonely in the Life of an MSL
<p>In this episode, Tom Caravela welcomes special guest Trish Gorecki to share her insights and experiences as a Medical Science Liaison (MSL). The conversation delves into overcoming challenges...
The 3 “Knows” of Effective Scientific Communication
<p>In this episode, Tom Caravela is joined by guest Linda Traylor who discusses the 3 "knows" of scientific communication for Medical Science Liaisons (MSLs). She shares the framework ...
Finding MSL Success in Cross Therapeutic Transitions
<p>In this episode, Tom Caravela welcomes Mitch D'Rosario and Deanna Tucker to discuss the intricacies of switching therapeutic areas as a Medical Science Liaison (MSL). They share personal...
The Ideal Roadmap for New MSLs
<p>In this episode, Tom Caravela is joined by Sarah Snyder, MSL Recruiter at The Carolan Group and Co-Founder of MSL Mastery who discusses an ideal road map for new Medical Science Liaisons (MSL...
Is it Ever Too Early or Too Late
<p>In this episode, Tom Caravela is joined by Jeff Vaughn and Dean McAllister to discuss the critical timing of Medical Science Liaison (MSL) involvement in drug development. They explore miscon...
"TOO Busy….I Just DO NOT Have Time”
<p>In this episode, Allison Trucillo joins to discuss the challenges of balancing a demanding professional life with personal interests, such as fitness hobbies. The conversation delves into eff...
Utilizing Social Media and Digital Tools in Medical Affairs
<p>In this episode, Tom Caravela hosts Amanda Lally to explore the growing impact of digital tools and social media in medical affairs. Amanda shares insights on leveraging social media for MSL ...
AI in Medical Affairs
<p>In this episode, Tom Caravela and Patrina Pellett discuss insights from a recent AI in Medical Affairs conference. Tom highlights the lively atmosphere and key AI topics like efficiencies, pa...
What is Your Value?: Defining and Driving MSL Value Demonstration
<p>In this episode, Tom&nbsp;Caravela welcomes Cherie Hyder to discuss the critical topic of MSLs demonstrating VALUE. The conversation delves into defining value and effectively showcasing ...
The Amazing History and Evolution of Medical Affairs in 32 Minutes
<p>In this episode, Tom Caravela is joined by Ralph Rewers to explore the history and evolution of Medical Affairs. They discuss the origins and progression of Medical Affairs, including the sig...
How to Succeed in Any Area of Your Life
<p>In this episode, Tom Caravela explores the transformative power of self-commitment, focusing on the importance of making promises to oneself. He delves into the concept of promises and plans,...
Top 5 MSL Frustrations and How to Overcome Them
<p>In this episode, Tom Caravela and guests Sarah Snyder and Patrina Pellett discuss the common frustrations faced by Medical Science Liaisons, exploring the top challenges and offering practica...
Filler Words Fix the Problem You Didn't Know You Had
<p>In this episode, Tom Caravela delves into the significance of eliminating filler words in professional as well as personal communication. He highlights the impact of these verbal fillers on p...
No “D”…No Problem: Finding Success WITHOUT a Doctorate
<p>In this episode, Greg Auclair from Cytokinetics shares his journey into medical affairs and insights into the MSL role. He discusses his transition, the evolving career paths for MSLs, and th...
What is the ONE Word?
<p>This week is a solo episode, Tom Caravela, Founder and Managing Partner at The Carolan Group presents a special Thanksgiving episode on the ONE word. Tom introduces the concept of choosing a ...
Leveraging Real-World Evidence (RWE) in MSL Activities
<p>This week's guest is Elizabeth Pash, Medical Affairs Executive Leader who shares insights on how to leverage real-world evidence (RWE) in MSL activities.</p> <div> <h3&g...
All About Thought Leader Liaison
<p>This weeks guest is Jim Hahn, Senior Business Director, Thought Leader Engagement at EMD Serono who discusses the role of the Thought Leader Liaison and how it fits into the pharma world.<...
Product Safety and its Role in Medical Affairs
<p>This week's guest is Juan Daccach, MD, VP Global Product Safety at Merz Aesthetics who discusses Safety and its role in Medical/Product Safety and the interaction between safety physicia...
The Future of MSL Roles: Skills and Competencies for Tomorrow’s Challenges
<p>This week&rsquo;s guest is Stephanie Otis, Vice President Global Medical Excellence at Ferring Pharmaceuticals discusses future trends in the MSL field including the skills and competenci...
The Future of MSL Roles: Skills and Competencies for Tomorrow’s Challenges
<p>This week&rsquo;s guest is Stephanie Otis, Vice President Global Medical Excellence at Ferring Pharmaceuticals discusses future trends in the MSL field including the skills and competenci...
The Augmented MSL
<p>This week's guest is Nandini Sabharwal, Director, Migraine and Women's Health, Field Medical Group at Pfizer and we discuss the role of artificial intelligence in every day MSL life...
The Augmented MSL
<p>This week's guest is Nandini Sabharwal, Director, Migraine and Women's Health, Field Medical Group at Pfizer and we discuss the role of artificial intelligence in every day MSL life...
Unlocking Success: The Power of Continuous Learning
<p>This weeks guest is John Pracyk, Chief Medical Safety Officer, at Olympus who discusses the importance of continuous learning for professional growth and development</p> <div> &...
Practice in Private…Rewarded in Public
<p>This week is a solo episode, Tom Caravela, Founder and Managing Partner at The Carolan Group discusses the concept of what you practice in private, is rewarded in public.</p> <div&g...
Time Audit: YOUR Strategy for Time Management Success
<p>In this episode, Patrina Pellett joins Tom Caravela to dive into time management strategies for MSLs and medical affairs professionals. They introduce the concept of time audits, a practical ...
The Evolving Role of Clinical Educators for Pharma and Field Medical
<p>In this episode, Michelle Offner shares her journey from her previous roles to becoming a clinical educator. She delves into the responsibilities and importance of clinical educators, highlig...
The Value of Social Listening for MSL Success
<p>My guests this week are Vandana Grover, Sr Director, Head of Digital Strategy and Innovation at Eisai and Stevan Tomich, Lead Omni Channel Strategist at AbbVie who discuss the value of social...
How to Build Scientific Credibility for Continuous Career Development
<p>My guest this week is Ike Ogbaa, Vice President and Head of Medical Affairs who discusses How to Build Scientific Credibility for Continuous Career Development.</p> <div> <di...
Mindset: The ULTIMATE Key to Success in Your Life and Career
<p>In this episode, Amy Misnick joins to discuss the power of mindset in both personal and professional spheres. Amy shares her journey from a successful career to an entrepreneurial path, empha...
How AI Can Improve Patient Identification and Recruitment for Clinical Trials
Change Management: How Pharma SHOULD Handle Bad News
<p>In this episode, Tom Caravela welcomes Alicia Bullock to discuss change management within the pharmaceutical industry. Alicia shares her professional journey and insights on the key triggers ...
The ART of Excellence... How to be a Rock Star MSL
<p>In this episode, Cathy Andorfer joins Tom Caravela to discuss her new book and the journey of writing it. Cathy shares insights into her writing process, addressing challenges and the evolvin...
A Trip Around the MSL Insights Cycle
<p>In this episode, Patrina Pellett and Richard Swank join Tom Caravela to explore the intricacies of the MSL insight cycle. They delve into the growth and insights course, highlighting common m...
Demystifying and Unpacking Omnichannel Engagement
<p>In this week&rsquo;s episode, Donnie Wooten, PharmD, Head of Global Field Medical Excellence at Organon and Kelly Lo, Global Field Medical Excellence at Amgen discuss the Demystifying and...
Medical Affairs Fellowships: The What, the HOW and the WHY
<p>In this week&rsquo;s episode, Shani Park, Post Doctoral Fellow, Medical Science Liaison at Inizio Engage discusses her experience securing a Medical Affairs fellowship and what the opport...
Career Currency: The Key to Your Success
<p>In this week&rsquo;s episode, Rachel Couchenour, Vice President Global Medical Affairs at Travere Therapeutics, discusses the importance of building your internal and external network.<...
The Power of Purpose
<p>In this week&rsquo;s episode, Jill Donahue, Medical Affairs leader and author who discusses the power of purpose for MSLs and Medical Affairs professionals.</p> <div> <p&...
Top ASCO24 Abstracts That Could Revolutionize Oncology
The MSL Secret Weapon for Insightful Engagement
<p>In&nbsp;this week&rsquo;s episode,&nbsp;Mary Winkels, Global Director, Medical Affairs Training and Capability at Vertex Pharmaceuticals discusses the MSL secret weapon for insigh...
Enhancing Treatment Efficacy in Multiple Myeloma at ASCO24
Transforming the Lung Cancer Treatment Landscape
Never Split the Difference
<p>In this weeks episode, Linda Traylor, VP, Head of Medical Excellence at Acceleration Point and Josh Yoder, Sr Medical Science Liaison at Aurinia, discuss the book, Never Split the Difference ...
Layoff Ready... How to Plan and Prepare for Potential Career Transition
<p>Chad Schroer, Senior Director, USMA Field Medical Excellence at BeiGene, we discuss strategies to prepare yourself for career transition &ndash; whether it&rsquo;s to grow in your cur...
SUPER MSL: The Quest to Become the TOP MSL on Your Team
<p>Daniel Snyder, Senior Medical Affairs &amp; HEOR Leader, discusses the differentiators for MSLs that will make you stand out and become the top MSL on your team.&nbsp;</p> <...
From Medically Impossible to Medical MIRACLE
<p>Anthony Lee is the CEO of ZAP Mortgage, ex Military Special Forces and Best Selling author who tells his story of overcoming extreme odds to find unprecedented success in business and life.&l...
The Value of In-House Medical Affairs to the MSL E205 • May 14, 2024 • 29 mins
<p>Erlene Seymour, Medical Director, US Medical Affairs Hematology at BeiGene discusses the value of In House or HQ Medical Affairs to the MSL.</p> <div> <div> <p>Lear...
The Future MSL
<p>In this episode, Eddie Power joins to discuss the future landscape of the Medical Science Liaison (MSL) role. The conversation delves into emerging trends, including the integration of analyt...
Why Chasing Titles is Fools Gold
<p>In this episode, Tom&nbsp;Caravela welcomes Archie Stone, VP of Product Development at Aurinia Pharmaceuticals, to discuss the intricacies of titles in medical affairs. They explore the v...
The Increasing Complexity of TODAYS Interview Process
<p>In this episode,&nbsp;Nabhan Islam joins Tom Caravela to discuss the evolving landscape of the job market and its impact on MSL interviews. Nabhan shares his career journey and highlights...
Role of the MSL in launch preparedness for new products and indications
<p>Matt Goodwin joins Tom Caravela to discuss the crucial role of MSLs in drug launch preparation and leadership. Matt shares his career journey and insights from his experiences at MAPS. They d...
The MSL - 4 Years, 200 Episodes…What’s new, What’s not
<p>In this milestone 200th episode, Tom&nbsp;Caravela welcomes Sarah Snyder to delve into the evolving landscape of the Medical Science Liaison (MSL) role. Sarah shares insights from her exp...
Diagnostic MSL - More Similar Than Different E199 • Apr 2, 2024 • 23 mins
<p>In this episode, Keith&nbsp;Fairall joins Tom Caravela to delve into the unique and evolving role of the diagnostic MSL. They explore the distinctions between diagnostic and therapeutic M...
Oncology Pharmacology 2023: Today’s Treatments and Tomorrow’s Breakthroughs
Patient Education for Next-Generation Sequencing to Guide Cancer Therapy
Learn How Nurse Practitioners Use Biomarker Testing in Cancer Care
Address Knowledge Gaps in Evidence-Based Precision Medicine Care
3 Mantras of Cores Values and Leadership
<p>In this episode,&nbsp;Renu Juneja joins Tom Caravela to discuss the significance of core values and leadership in Medical Affairs. Renu shares her professional journey and introduces her ...
New Machine Learning Framework Uses EHR Data to Assess ICI Effectiveness, Toxicity
The PACE of Technology in Medical Affairs-Tools of the Trade
<p>In this episode, Matt Lewis joins Tom&nbsp;Caravela to delve into the evolving landscape of AI in medical affairs, focusing on its current state in 2024. They explore practical applicatio...
The VALUE of Management Skills
<p>In this episode, Angela Tom joins Tom&nbsp;Caravela to delve into the nuances of management skills versus leadership skills within the MSL field. They explore the significance of identify...
Anticancer drugs approved by the Food and Drug Administration for gastrointestinal malignancies: Clinical benefit and price considerations
<section id="cam42058-sec-0001"> <section id="summary"> <ul> <li>Drugs approved between 2006 and 2017 were analyzed.</li> <li>Clinical benef...
The ULTIMATE Checklist for New MSLs
<p>In this episode, Samantha Buckley discusses her journey from clinical pharmacy to becoming an&nbsp;MSL, highlighting the value of personalized cover letters and MSL certification. She del...
The OVERLOOKED KOL
<p>In this episode, Tom&nbsp;Caravela hosts Leticia Price and Dawn O'Reilly to discuss the critical role of Advanced Practice Providers (APPs) in the medical field. They explore the edu...
Good vs Great: What Makes a Rock STAR MSL?
<p>In this episode, Tom&nbsp;Caravela engages in a thoughtful discussion with Sanaz Cardoza on the nuances that differentiate good MSLs from great ones. They explore the critical role of att...
HOLD MY BEER… I’m Going to be an MSL
<p>In this episode, Lana&nbsp;Lucidi shares her journey from early career roles to becoming a Medical Science Liaison. She delves into her transition process, highlighting the importance of ...
MSL Burnout...The Struggle is Real
<p>In this episode, Jennifer Mohawk joins to discuss the prevalent issue of burnout among Medical Science Liaisons. She shares her insights on the common stressors, including&nbsp;overachiev...
The MSL Role - Big Pharma Vs. Small Biotech
<header></header> <p>In this episode, Sarah Ussery joins to discuss her career journey and the distinctions between working in big pharma versus small biotech companies. Sarah provi...
The Pros and Cons of Using AI for Your Job Search
<p>In this episode, Sarah Snyder dives into the&nbsp;transformative role of AI in the MSL job search process. She explores how AI tools can enhance resumes and assist in job applications, wh...
Camidge and Leland Discuss the Road to a Multifaceted Biotechnology Career
The Gamification of MSL Metrics
<header></header> <p>In this episode, Bart Brown joins Tom Caravela to explore the concept of gamifying MSL metrics. Bart shares his innovative point system designed to evaluate MSL...
MSL Visibility - How to SUCCEED in 2024
<header></header> <p>Tom Caravela welcomes Eleonora Goldberg to explore the evolving role of Medical Science Liaisons (MSLs) within organizations. They delve into the key attributes...
IMPOSTER: Why Do I STINK so much
<header></header> <p>In this episode, Tom Caravela delves into the pervasive issue of imposter syndrome, sharing personal insights and experiences. He candidly discusses his own enc...
The MOVE to Medical Excellence
<header></header> <p>In this episode, Tom Caravela welcomes Scott Thompson, CEO of Acceleration Point, to discuss the critical role of medical excellence in medical affairs. They ex...
The DARK Side of MSL-ing-What No One Tells YOU
<header></header> <p>In this episode, Kirsten Gurtowsky shares her experiences and insights as a Medical Science Liaison. She discusses her career journey, highlighting the balance ...
Job Leads: The Do's and Don't of Asking for Referrals
<header> <div></div> </header> <p>In this episode, George Lehman from&nbsp;Novo Nordisk joins to discuss the nuanced world of job referrals. George outlines his ca...
The Inside OUT Interview
<header> <div></div> </header> <p>In this episode, Kurt Grady joins Tom&nbsp;Caravela to discuss effective interview strategies and the importance of candidate fit...
How Job Seekers Can Stand out in a Crowded Market
<header> <div></div> </header> <p>In this episode, Sarah Snyder joins to discuss navigating the current job market&nbsp;amidst pharmaceutical industry changes. She...
Using Your VOICE as a Weapon
<header> <div></div> </header> <p>In this episode, Tom&nbsp;Caravela is joined by Matt Berthot to explore the significance of voice training in professional settin...
My Company has been sold, now what?!?”
<header> <div></div> </header> <p>In this episode, Tom&nbsp;Caravela welcomes Steve St. Onge to discuss the intricacies of corporate acquisitions within the pharma...
People First… Business Second
<header> <div></div> </header> <p>In this episode, Tom&nbsp;Caravela is joined by Mark Freebery and Rachel Pater to explore the vital role of team culture in the M...
Things will be HARD…but YOU can do hard things!
<header> <div></div> </header> <p>In this episode, Sarah Snyder joins Tom&nbsp;Caravela to share insights on navigating the current pharmaceutical industry landsca...
Rethinking for Success: Top 10 Lessons for Embracing the MSL mindset through insights from Adam Grant’s “Think Again”
<header> <div></div> </header> <p>In this episode, Tom&nbsp;Caravela is joined by Jeff Vaughn to explore the themes of Adam Grant's "Think Again". T...
The Importance of Social Media Monitoring for MSLs
<header> <div></div> </header> <p>In this episode, Tom&nbsp;Caravela welcomes Jason Howard to delve into the evolving role of a medical digital lead. Jason shares ...
G R I T – Surviving the Rocky Road of Pharma
<header> <div></div> </header> <p>In this episode, Tom&nbsp;Caravela welcomes CoraLynn Trewet to share her insights on navigating the MSL career path. CoraLynn rec...
Why Medical Affairs Needs More Leadership
<header> <div></div> </header> <p>In this episode, Scott&nbsp;Conry joins Tom Caravela to delve into the nuances of leadership within medical affairs. Scott shares...
Types of Conferences MSLs Attend & How To Prepare...
<header> <div></div> </header> <p>In this episode, George Lehman joins to discuss the strategic role of Medical Science Liaisons (MSLs) at conferences. The conversatio...
How Information is Consumed
<header> <div></div> </header> <p>In this episode, Tom&nbsp;Caravela is joined by Andrew Fariello from AstraZeneca to explore the evolving landscape of Medical Sci...
The Role of the Clinical Trials Navigator
Race in Research: From Subjects to Scientists, ONS Scholar-in-Residence Has a Career Commitment to Racial Equity
Job Search Mastery... How to WIN Your Dream Job
<p>In this episode, Tom Caravela introduces his new book, "Job Search Mastery, How to Win Your Dream Job," outlining its purpose and key strategies for effective job searching. He emph...
Addressing the Impact of Prior Authorization on Access to Cancer Treatment
The Value of Pharmaceutical Industry-Sponsored Patient Registries in Oncology Clinical Research
<p>Oncology patient registries are valuable for generating Real-World Evidence (RWE) due to:</p> <ul> <li>Prospective, primary data collection</li> <li>Character...
Diversity in Cancer Clinical Trials
Rise of Antibody-Drug Conjugates: The Present and Future
<ul> <li>Antibody-drug conjugates (ADCs) are designed for targeted cancer therapy by delivering cytotoxic agents specifically to tumor cells, minimizing harm to normal cells.</li> ...
CAR T-Cell Therapy for Hematologic Malignancies Requires Education and Navigation
Soft Skills & Leadership Advice for Introverts: In an Extrovert World
<p>In this episode, Tom&nbsp;Caravela is joined by Josh Kosnick to explore the intersection of soft skills and leadership for introverts. Josh shares insights from his coaching experience, e...
Prepare to LAUNCH: How to Build an MSL Team From Scratch
<p>In episode 152, Tom&nbsp;Caravela is joined by John Caskey to delve into the intricacies of assembling the ideal MSL team for a successful drug launch. The discussion covers strategic tim...
Barriers to Clinical Trial Participation for Transgender People
Value assessment of PD-1/PD-L1 inhibitors in the treatment of esophageal and gastrointestinal cancers
<ul> <li>Only a few treatment regimens showed clinical value in EC and&nbsp;CRC using ASCO-VF and ESMO-MCBS frameworks.</li> <li>Nivolumab met valuable threshold in resec...
How to Land an MSL Role as an International Candidate
<p>In this episode, Tom&nbsp;Caravela talks with Matteo Ottolini about the complexities of transitioning into an MSL role in the U.S. Matteo shares his personal experiences with work authori...
Single-arm trials supporting the approval of anticancer medicinal products in the European Union: contextualization of trial results and observed clinical benefit
<ul> <li>Between 2012 and 2021, 18 anticancer medicinal products for solid tumors were approved in the EU based on 21&nbsp;SATs (single-arm trials).</li> <li>Pivotal SAT-...
Mission Critical: Lessons from a Purple Heart
<p>In this episode, Tom&nbsp;Caravela welcomes Chris Warnes, a business and life coach, to discuss the journey of personal and professional growth. Chris shares insights from his military ba...
Evaluating External Validity of Oncology Biosimilar Safety Studies
<ul> <li>Biologics are the fastest growing medication class in the US, significantly contributing to healthcare costs.</li> <li>The Biologics Price Competition and Innovation...
Evolving Role of MSL Field Support for Clinical Trials
<p>In this episode, Tom&nbsp;Caravela is joined by Khalil Ahmed to explore the integral role of Medical Science Liaisons (MSLs) in clinical trials. Khalil shares his background and discusses...
Motivation Means NOTHING…
<p>In this episode, Tom&nbsp;Caravela delves into the crucial role of discipline for Medical Science Liaisons. He outlines a four-step process to help MSLs achieve their goals within Medical...
How to Start a Diversity Equity & Inclusion Program in Pharma
<p>In this episode, Tara Gonzalez joins to discuss the intricacies of establishing Diversity, Equity, and Inclusion (DEI) programs within organizations. She shares insights from her background a...
Defining the role of real-world data in cancer clinical research: The position of the
<ul> <li>Real-World Data (RWD) are increasingly used in cancer clinical research as an alternative evidence source.</li> <li>RWD studies primarily involve observational data,...
The BURN: How to Become a TOP Performer & Excel at the HIGHEST Levels
<p>In this episode, Tom&nbsp;Caravela is joined by Ben Newman, who delves into the concept of "the burn" and its role in maintaining motivation and purpose. Ben shares insights on ...
Early phase clinical trial played a critical role in the Food and Drug Administration-approved indications for targeted anticancer drugs: a cross-sectional study from 2012 to 2021
<ul> <li>Analysis of 188 FDA-approved indications for 95 molecular targeted anticancer drugs between 2012 and 2021.</li> <li>59.6% of indications were approved based on Early...
The Ultimate MSL Guide for an Impactful 30, 60, 90 Day Plan
<p>In this episode, Jay Van Horn joins Tom&nbsp;Caravela to discuss his extensive experience in the MSL field and share insights on effective planning and leadership. Jay delves into the imp...
3 KEY Factors that Altered the MSL Role Since 2020
<p>Join Mitchell&nbsp;D&rsquo;Rozario and Tom Caravela as they celebrate the podcast's 3-year anniversary by exploring three key factors transforming the MSL role since 2020. They d...
Value assessment of NMPA-approved new cancer drugs for solid cancer in China, 2016-2020
<ul> <li>This study is the first in China to comprehensively evaluate the value of new cancer drugs using&nbsp;ASCO-VF and ESMO-MCBS frameworks and investigate the correlation between...
The correlation between the costs and clinical benefits of PD-1/PD-L1 inhibitors in malignant tumors: An evaluation based on ASCO and ESMO frameworks
<ul> <li>Cancer drug innovation has significantly accelerated in the 21st century, with novel drug approvals and expenditures increasing notably.</li> <li>Assessment framewor...
13 Common Interview Mistakes Keeping You From Your Next Job
<p>In this episode, Sarah Snyder joins Tom&nbsp;Caravela to explore effective interview techniques for aspiring MSLs. Sarah shares insights on maintaining enthusiasm and professionalism, cra...
Paying it Forward (And Back)… Finding Medical Affairs Success as an Industry MD
<p>In this episode,&nbsp;Mena Boules shares his journey from a clinical background to a successful career in the pharmaceutical industry. He emphasizes the critical role mentorship played in...
US Government Payer-Funded Trials to Address Oncology's Drug-Dosing Conundrum: A Congressional Call to Action?
<div role="paragraph"> <div role="paragraph"> <ul> <li>Since the mid-20th century, cancer drug development has been driven by the "more is better&qu...
What is the weight of expectation bias in oncology trials?
<ul> <li>Expectation bias, also known as the&nbsp;Rosenthal effect, can distort experiment results due to the expectations of investigators or patients.</li> <li>Blinding...
Improving Transparency in Phase 1 Clinical Trials
Life After Medical Affairs: From MSL to M & A
<p>In this episode, Steve St.&nbsp;Onge shares his unique journey from traditional MSL roles to business development at Paratek. He discusses his background, transition to industry, and invo...
Biosimilar Basics for Oncology Nurses and Patients
Why Go ALONE? How 2 Aspiring MSLs Reached Their Goal TOGETHER
<p>In this episode, Tom&nbsp;Caravela is joined by Sierra Birch and George Lehman to discuss the power of collaboration in securing MSL roles. Celebrating a milestone of nearly 250,000 liste...
Professional Development: Why Consider an Executive Coach
<p>In this episode, Dana&nbsp;Paskalis, founder of Life Reset Labs, joins to discuss the pivotal role of coaching in personal and professional development. Dana outlines her career path lead...
New MSL: The 4 “Ts” to Prepare for and Overcome
<p>In this episode, Lauren Gardner shares her journey into the Medical Science Liaison (MSL) role, offering insights into effective time management and territory planning. She discusses the impo...
Application of Value Framework to Phase III Trials of Immune Checkpoint Inhibitors in Esophageal and Gastric Cancer
<ul> <li>Immunotherapy checkpoint inhibitors are FDA-approved for first-line metastatic esophageal and gastric cancer, but not all scenarios benefit from non-selective chemo-immunotherapy...
Factors associated with the uptake of biosimilars for breast cancer treatment from the perspectives of physicians and patients-Evidence from China
<ul> <li>In 2021, the&nbsp;trastuzumab biosimilar entered clinical use in the research setting with less than 20% uptake in China, significantly lower than in the EU.</li> <...
Twelve ESMO Congress 2022 breakthroughs: practicing oncologists' perceptions and potential application on presented data
<p>Background: At the&nbsp;ESMO Congress 2022, numerous clinical trial outcomes were presented, highlighting the importance of structuring data to weigh treatment burden against benefits.<...
Market Access and the MSL Role
<p>In this episode, Tom&nbsp;Caravela welcomes Ruchit Parikh to discuss the critical role of market access within the pharmaceutical industry. They explore the definition and significance of...
Medical Oncologists’ Knowledge and Perspectives on the Use of Biosimilars in the United States
<section id="abs-sec-1"> <section id="summary"> <ul> <li>Most oncologists (88%) treated patients with&nbsp;biosimilars, and 63% reported that biosimi...
How MSLs can WIN with Social Media in Medical Affairs
<p>In this episode, Tom&nbsp;Caravela is joined by Bruno Larvol to explore the intersection of medical science liaisons (MSLs) and social media. They discuss the importance of social media e...
The MSL in CANADA vs. the US MSL
<p>In this episode, Claudia&nbsp;Barube and Jeffrey Vaughn join Tom Caravela to explore the unique challenges and opportunities for Medical Science Liaisons (MSLs) in Canada. The discussion ...
Dx to Rx – Transitioning from Diagnostics to Pharma
<p>In this episode,&nbsp;Namratha Sastry shares her journey into the Medical Science Liaison (MSL) role, beginning with her first experience at Biodesics. She delves into the importance of n...
How to Break into a PEOPLE MANAGER Role
<p>In this episode, Tom&nbsp;Caravela welcomes Annette Ogbru to discuss her journey from an MSL to a leader in medical affairs. Annette shares her insights on leveraging social media and the...
Virtual Reality and Medical Affairs in the Metaverse
<p>In this episode, Bruno&nbsp;Larvol joins the discussion to explore the metaverse and its potential impact on medical affairs. The conversation delves into the significance and future appl...
Are the chronological age cutoffs used in clinical oncology guidelines biologically meaningful?
<div id="ABS1"> <ul> <li>Age is a significant risk factor for cancer, influencing&nbsp;tumour biology, treatment recommendations, and therapy response.</li> &l...
An Unscripted Fireside Chat w/ Tom Caravela
<p>In this episode, Sarah Snyder joins as guest host to delve into Tom&nbsp;Caravela's journey and the impact of MSL Talk. The conversation explores Tom's morning routine and produ...
Lack of Gender Equity in Oncology Clinical Trial Advisory Board Membership
MSL Talk Podcast Year in Review-Highlights to be Grateful For
<p>In this Thanksgiving episode, Tom&nbsp;Caravela is joined by Arthur Chan to explore a range of topics pertinent to MSLs and Medical Affairs professionals. Arthur shares his career journey...
How Will AI and Machine Learning Affect the MSL
<p>In this episode, Tom&nbsp;Caravela is joined by Dr. Sanjay Singhvi to delve into the transformative role of AI in medical affairs. They discuss AI's ability to address industry chall...
Off-label despite high-level evidence: a clinical practice review of commonly used off-patent cancer medicines
<ul> <li>Several 'old' cancer medicines remain off-label despite strong scientific evidence supporting their use in specific settings.</li> <li>Off-label prescripti...
Objection Handling for Field Medical Professionals
<p>In this episode, Linda&nbsp;Traylor joins Tom Caravela to delve into the art of objection handling for MSLs. They explore the nuances between MSLs and sales teams, introducing a structure...
Positive Mindset = Positive Outcomes
<p>In this episode, Don&nbsp;Sandel from Go Positive joins Tom Caravela to explore the power of a positive mindset. They delve into the science behind positivity, introducing the DOSE acrony...
Master Communication Skills to Improve Business Relations
<p>In this episode,&nbsp;MSL Talk hosts its first live broadcast with panelists Ruth Phillips, Michael Kahn, John Caskey, and Brian Bischel. The conversation centers on enhancing communicati...
Business Acumen: The Other MSL Currency
<p>In this episode, Tom&nbsp;Caravela is joined by Maria Abunto and Nabhan Islam to explore the critical role of business acumen in medical affairs. The discussion begins with the guests...
The Art of Story Telling for Impactul Engagement
<p>In this episode, Angela&nbsp;Valadez&nbsp;joins Tom Caravela to explore the power of storytelling in medical affairs. Angela shares her journey and emphasizes the critical role storyt...
Preliminary Attainability Assessment of Real-World Data for Answering Major Clinical Research Questions in Breast Cancer Brain Metastasis: Framework Development and Validation Study
<ul> <li>The study proposes the PAR framework for data attainability screening in clinical research, particularly useful for addressing unmet clinical needs in&nbsp;BCBM.</li> ...
Exploring the MSL role in IITs (Investigator Initiated Trials)
<p>In this episode, Gail&nbsp;Rosen Spahn joins to delve into Investigator-Initiated Trials (IITs) and their significance in the MSL landscape. The discussion covers the definition and under...
What I DO….How I BUILD Relationships
<p>In this episode, Bernadett Mamone shares her educational and professional journey in the medical affairs landscape. She highlights the secrets to becoming a successful MSL, emphasizing the im...
Secrets and pearls of wisdom for Field Medical success
<p>In this episode,&nbsp;Ravi Tayi shares his career journey and transition into medical affairs, emphasizing the key qualities that define successful Medical Science Liaisons (MSLs). He del...
Leveraging Creativity to Break into Your First MSL Role
<p>In this episode, Alec McCarthy shares his insights on breaking into the&nbsp;MSL field with a creative approach. He highlights the 70/30 rule for networking, emphasizing its importance fo...
Embracing Project Optimus: Can we Leverage Evolutionary Theory to Optimize Dosing in Oncology?
<ul> <li>Focus on tumor evolution, which leads to therapeutic failure and disease relapse.</li> <li>Emphasis on the effect of tumor evolution on the exposure-response (E-R) r...
Difficult KOLs: How to overcome challenges, find success and gain access
<p>In this episode, Andrea Johnson joins Tom&nbsp;Caravela to delve into effective strategies for Medical Science Liaisons. They explore the value of Key Opinion Leaders (KOLs), emphasizing ...
Skip Level Meetings: Prepare, Purpose, Pitfalls
<p>In this episode, Paul Ward, head of field medical at&nbsp;BeiGene, joins Tom Caravela to delve into the concept of skip level meetings. Paul shares insights on who should initiate these m...
Core Values: Foundation to Success and Fulfillment
<p>In this episode, Tom&nbsp;Caravela delves into the significance of core values in both personal and professional contexts. He explores the distinction between core values and goals, empha...
The MSL Execution Factor (Book Review)
<p>In this episode, Jihad &ldquo;JR&rdquo;&nbsp;Rizkallah joins Tom Caravela to delve into the core elements of success for Medical Science Liaisons through the lens of "The Exe...
Why is it so hard to get into oncology
<p>In this episode, Mary&nbsp;Miao shares her journey and experiences in the oncology field, offering insights into the unique challenges and strategies for breaking into this specialized ar...
Why and How to Build a “Community” MSL Team
<p>In this episode, Bobby&nbsp;Faison joins to discuss the concept and implementation of community MSL teams. The conversation highlights the importance of building these teams, their roles ...
What I Tell My Patients: Expert Insights into Patient Education on New Treatments and Clinical Trial Participation in Hodgkin and Non-Hodgkin Lymphomas
Why Companies Should Hire Aspiring MSLs (and How)
<p>In this episode, Alyson Evans joins Tom&nbsp;Caravela to discuss the evolving landscape of the MSL role. Alyson shares her career journey and offers insights on hiring practices, comparin...
The Role of MSLs in Achieving Health Equity
<p>In this episode, Ariel&nbsp;Katz, co-founder of H1, joins Tom Caravela to discuss the crucial topic of health equity. Ariel shares insights into his background and the mission of H1, defi...
Finding Success as a Rare Diseases MSL
<p>In this episode, Giovanni&nbsp;Passiatore delves into the complexities of working in the rare diseases arena as an MSL. Giovanni shares his extensive background and provides insights into...
The challenges and opportunities in using real-world data to drive advances in healthcare in East Asia: expert panel recommendations
<ul> <li>Recommend approaches to improve the use of Real-World Evidence (RWE) in healthcare decision-making in East Asia and beyond.</li> <li>Encourage large-scale collaborat...
Career Satisfaction and Growth: What factors MUST be considered
<p>In this episode, Tom&nbsp;Caravela is joined by Beth Kupferer to discuss career satisfaction and adaptation in the MSL field. Beth shares insights from her career journey, emphasizing the...
How to Emerge as an Everyday Leader and Top Performer
<p>In this episode, Mark&nbsp;McKern shares his extensive career journey and insights from the recent ASCO conference. He delves into the essential characteristics of effective leaders and t...
Field Medical Execution Despite Limited Resources
<p>In this episode, Ed Cunningham delves into his extensive background in Neurology&nbsp;MSLs and shares insights on managing MSL teams, including the role of outsourcing. He explores the im...
Increasing Clinical Trial Access for Blood Cancers
Effective Relationship Strategies for MSL Success with Commercial Counterparts
<p>In this episode, Tom&nbsp;Caravela hosts Rob Rosti to delve into the critical dynamics between Medical Science Liaisons (MSLs) and commercial teams. Rob shares his background and highligh...
Perceived, Probe, Reflect-KOL Engagement Model
<p>In this episode, Tom&nbsp;Caravela is joined by Cto delve into her innovative KOL engagement model. Amy shares her career journey and introduces her perceive, probe, and reflect approach....
KPIs: Why Quantitative WON’T Work Without Qualitative Outcomes
<p>In this episode, Linda&nbsp;Traylor and Rena Patel join Tom Caravela to share their insights on the evolving landscape of the MSL profession. They discuss the significance of networking, ...
Building a Healthcare Alliance for Resourceful Medicine Offensive Against Neoplasms in Hematology Added Value Framework for Hematologic Malignancies: A Comparative Analysis of Existing Tools
<ul> <li>Current Value Frameworks (VFs) have limitations and do not meet HARMONY's ambitions for assessing the therapeutic/clinical value of innovative health technologies.</li>...
Career Resiliency: How to Survive and Thrive After a Lay Off
<p>In this episode, Tom&nbsp;Caravela is joined by Carol Lawlor to discuss her career journey and the challenges faced in the medical affairs industry. Carol shares her personal experiences ...
Why MSLs Need a Personal Board of Directors
<p>In this episode, Tom&nbsp;Caravela welcomes Marieke Jonkman to discuss the concept of creating a personal board of directors for Medical Science Liaisons (MSLs). Marieke shares her career...
How to Architect a Presentation for an MSL Interview
<p>In this episode, Tom&nbsp;Caravela welcomes guests Kendra Peltz and Josh Yoder, who share their unique journeys from wrestling backgrounds to becoming Medical Science Liaisons. They delve...
Rationale, Strengths, and Limitations of Real-World Evidence in Oncology: A Canadian Review and Perspective
<p>Data obtained from real-world studies have an integral role in evidence-based medicine, serving as an essential source of safety information and a complement to efficacy data from RCTs. RWE i...
Digital Opinion Leaders: What You Should Know About DOLs
<p>In this episode, Tom&nbsp;Caravela is joined by Omar McMillan to delve into the emerging role of digital opinion leaders (DOLs) in medical affairs. They explore the criteria for identifyi...
Celebrating 100 Episodes: Top MSL Insights, Career Tips, and Community Gratitude
<p>In the milestone 100th episode of&nbsp;MSL Talk, Tom Caravela celebrates the journey of the podcast and extends gratitude to the supportive community. Reflecting on the podcast's evo...
From MSL to MSL Recruiter: A Career Transition
<p>In this episode, Sarah Snyder shares her journey from&nbsp;BioSplice to becoming an MSL recruiter at The Carolan Group. She emphasizes the value of networking and building a strong Linked...
How to Advance Your Career Through Informational Interviews
<p>In this episode,&nbsp;Joelle Martin joins Tom Caravela to explore the pivotal role of informational interviews in career advancement for MSLs. Joelle shares personal experiences and effec...
COMP: How HR Determines Compensation and Titles for Job Offers
<p>In this episode, Chris&nbsp;Castin joins Tom Caravela to delve into the intricacies of compensation and negotiation processes for MSL roles. They explore how to prepare for job offer nego...
The Use of Biosimilars in Oncology
The Misalignment of Clinical Development and Field Medical Affairs
<p>In this episode, Tom&nbsp;Caravela is joined by Carrie Caretta and Giancarlo Maranzano from Boehringer Ingelheim to explore the integration of clinical development and field medical affai...
Emotional Intelligence and the MSL: More Important than EVER
<p>In this episode, Doug&nbsp;Yau from Sanofi joins Tom Caravela to delve into the critical role of emotional intelligence in the MSL profession. They explore the definition, components, and...
TOP Interview Questions to Ask Hiring Managers
<p>In this episode, Tom&nbsp;Caravela and Charlie Cook delve into effective interview strategies for both hiring managers and candidates. They discuss essential interview questions, the impo...
Recent Advances and Real-World Implications in Multiple Myeloma
Recent Advances and Real-World Implications in Chronic Lymphocytic Leukemia and Lymphomas
Lead with Strengths… Develop Your Weaknesses
<p>In this episode, Tom&nbsp;Caravela explores the importance of recognizing and utilizing personal strengths in both professional and personal realms. He shares research on the benefits of ...
5 Ways to Survive and Thrive at MSL AND Mom Life
<p>In this episode, Sarah Snyder from The&nbsp;Carolan Group joins Tom Caravela to discuss strategies for MSL moms balancing work and family life. Sarah shares her expertise on leveraging Li...
From Pharmacy to MSL: How an Rx background can lead to industry
<p>In this episode, Tom&nbsp;Caravela welcomes Cassie James to discuss her transition from pharmacy to the industry and how her pharmacy skills have been invaluable in her MSL career. Cassie...
Do What Other Don't-Opportunity in a Saturated Market
<p>In this episode, Tom&nbsp;Caravela welcomes Kunal Ramani to discuss his inspiring journey from pharmacy school to a thriving career in medical affairs. Kunal shares his "do what othe...
Digital Therapeutics: Everything You Need to Know
<p>In this episode, Tom&nbsp;Caravela welcomes Madleine Makori to discuss her career journey and passion for the MSL role, with a particular focus on digital therapeutics. Madleine shares in...
Why Clinicians Make Great MSLs
<p>In this episode, Tom&nbsp;Caravela is joined by Dawn O'Reilly, who shares her journey into the MSL role and offers valuable insights for clinicians transitioning into this field. Daw...
Promotability: Top 10 Tips for Landing Your Next Promotion
<p>In this episode, Bridget&nbsp;Rasmusson joins Tom Caravela to explore the crucial topic of promotability for MSLs. They offer insights into understanding the target audience and recognizi...
INTENTION: How to Get What You Want and Achieve Your Goals
<p>E86 &bull;&nbsp;Jan 11, 2022 &bull; 26 mins</p> <p>In this episode, Tom Caravela delves into effective goal-setting strategies as the New Year approaches. He emphasiz...
External control arms in oncology: current use and future directions
<section> <section> <ul> <li>Considerations for using external controls in oncology clinical trials are complex and depend on their intended use.</li> <li>There...
Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application
<div id="14672757" data-section-parent-id="14672756"> <ul> <li>The FDA emphasizes early engagement and transparent protocols in Real-World Evidence (RWE) studie...
MSL Certification Programs: To Cert or Not to Cert?
<p>In this episode, Tom&nbsp;Caravela delves into the world of certification programs for Medical Science Liaisons (MSLs). He provides an overview of popular certifications like BCMAS and MS...
Mastering the Medical Affairs Professional Role: Inside and Out
<p>In this episode, Tom&nbsp;Caravela welcomes Kent Christofferson to discuss his career journey and insights into the MSL role. Kent shares his transition from academia to industry, highlig...
How and Why MSLs Bring VALUE to an Organization
<p>In this episode, Steven Stein, senior director of global field medical at Arena Pharmaceuticals, joins the discussion to explore the evolving role of&nbsp;MSLs. He delves into the concept...
Why and How MSLs Can Adapt the Mindset of a Lifelong Learner
<p>In this episode, Sarah Snyder shares her insights on lifelong learning for&nbsp;MSLs, emphasizing the importance of personal accountability and balancing different learning types. She dis...
CheckMate-067: Raising the Bar for the Next Decade in Oncology
<div role="paragraph"> <ul> <li>Historically, few effective systemic therapies were available for advanced melanoma, but recent advancements have led to significant progr...
Top 10 MSL Skills NOT always Taught by Leadership
<p>In this episode, Jeff Vaughn joins Tom&nbsp;Caravela to explore key skills essential for MSLs. Jeff shares his background and offers insights into effective territory management, becoming...
Recent Advances and Future Directions in Oncology
Gratitude: An absolute MUST for career advancement
<p>In this special solo episode, Tom&nbsp;Caravela, Founder of The Carolan Group, delves into the essential role of gratitude within professional relationships and career growth for MSLs. He...
How to Create a GREAT MSL Team Culture
<p>In this episode, Chad Fellers joins to discuss the crucial elements of team dynamics and leadership in medical affairs. Chad shares insights into his background, emphasizing the importance of...
Landing My First MSL Role: From the Inside
<p>In this episode, Amanda Vaughn joins the discussion to share her transition from academia to the industry and her new role as an&nbsp;MSL at Aglia. Amanda delves into the networking strat...
TEXT: Mapping Customer Journeys in a Digital World
<p>In this episode, Tom&nbsp;Caravela is joined by Mitchell D&rsquo;Rozario to explore the challenges and strategies in engaging with Key Opinion Leaders (KOLs). They discuss the importa...
Important TIPS for KOL Mapping
<p>In this episode,&nbsp;Keely Dahl shares her expertise on KOL mapping, offering valuable insights into identifying and ranking key opinion leaders. She outlines the importance of cross-fun...
What Makes KOLs Tick
<p>In this episode, Deanna Murray joins to delve into the intricacies of engaging with Key Opinion Leaders (KOLs). The discussion begins with understanding KOL motivations and the importance of ...
Estimated Medicare Spending on Cancer Drug Indications With a Confirmed Lack of Clinical Benefit After US Food and Drug Administration Accelerated
<ul> <li>Medicare Parts B and D spent at least $569 million between 2017 and 2019 on 10 cancer drug indications without confirmed overall survival (OS) benefit after accelerated approval ...
The HIGH FIVE Challenge
<p>In this episode, Tom&nbsp;Caravela delves into the transformative power of Mel Robbins' high five habit. He begins by introducing Mel Robbins and her background, then unpacks the con...
MSL People Skills-10 Tips for Better Engagement
<p>In this episode, Tom&nbsp;Caravela delves into essential people skills for Medical Science Liaisons. He outlines practical tips to enhance interpersonal interactions, such as focusing on ...
"You Cannot Teach Someone How to be an MSL"
<p>In this episode, Kathleen Bailey joins Tom&nbsp;Caravela to explore the essential skills for Medical Science Liaisons (MSLs). They highlight the importance of communication, trust-buildin...
Insight about INSIGHTS, and how they can help your MSL career!
<p>In this episode, Joe&nbsp;Liberman shares his journey from MSL to Associate Director, offering valuable advice on transitioning roles within medical affairs. He delves into the role of an...
Engagement Strategies: Crafting Your Story to Clinical Professionals
<p>In this episode, Ryan Norman joins Tom&nbsp;Caravela to discuss his journey into the pharmaceutical industry and how he successfully blended clinical expertise with business insights in h...
The ART of breaking out of your comfort zone
<p>In this episode, Cathy&nbsp;Andorfer joins Tom Caravela to discuss the unique challenges and advantages that introverts face within the medical science liaison (MSL) role. They explore th...
Implications of Research Biopsies in Clinical Trials
<ul> <li>Increased interest in noninvasive testing for treatment monitoring, tumor burden estimation, and disease recurrence prediction.</li> <li>Lower-risk research specimen...
Mentorship: Why it is SO important for MSLs
<p>In this episode, Tom&nbsp;Caravela is joined by Prashant Desai to delve into the pivotal role of mentorship in career development. Prashant shares insights from his career journey, emphas...
The Inclusion of Women in Global Oncology Drug Trials Over the Past 20 Years
<ul> <li>Women represented 77% of newly diagnosed thyroid cancer cases in 2020 but only comprised 51% of participants in related trials.</li> <li>Women accounted for 48% of g...
How Biomarker Testing Drives the Use of Targeted Therapies
How and Why Medical Affairs Can Support Diversity in Clinical Trials
<p>In this episode, Tom&nbsp;Caravela is joined by Brad Atkinson, Brian Wilson, and Christina Wright to explore the critical role of diversity in clinical trials and the MSL&rsquo;s part...
All about Job Offers and what to be aware of
<p>E66 &bull;&nbsp;Aug 17, 2021 &bull; 41 mins</p> <p>In this episode, Tom Caravela welcomes Anthony Greco to discuss job offer negotiations. Anthony shares insights on ...
Harnessing the Power of Registries to Understand the Impact of Treatment for Hodgkin Lymphoma on Fertility
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
<p>Six of 18 cancer drugs that initially received accelerated approval have indications that remain on the labeling and are recommended in clinical guidelines despite no improvement in the prima...
Report from American Society of Clinical Oncology Symposium 2020 and American Society of Clinical Oncology Gastrointestinal Cancer Symposium 2021
<ul> <li>Six out of 18 cancer drugs with accelerated approval still have indications on labeling and are recommended in guidelines despite not showing improvement in primary endpoints in ...
How to Transition from MSL to MSL Leader
<p>In this episode, Kathy&nbsp;Gann joins to discuss the transition from an MSL role to leadership positions. Kathy delves into personal development, goal setting, and the importance of life...
Payer perceptions of the use of real-world evidence in oncology-based decision making
<div role="paragraph"> <div role="paragraph"> <ul> <li>US payers find real-world evidence (RWE) useful for improving costs and outcomes in oncology, and ...
Job Search Jumpstart: 8 Simple Steps to Get More Interviews
<p>In this episode, Tom&nbsp;Caravela provides a comprehensive guide for those pursuing a career as a Medical Science Liaison. He outlines an eight-step process, starting with setting clear ...
New ‘Social’ Technology to Help Identify KEY Trends for Medical Affairs
<p>In this episode, Tom&nbsp;Caravela is joined by Tim Bialekki and Alec McCarthy to explore the intersection of Google Trends and the MSL role. The discussion delves into how Google Trends ...
Monoclonal Antibodies to Treat Cancer and COVID-19
Advanced Practitioners’ Role in Research
Career Q&A with Tom Caravela- His Story and other Stuff
<p>In this episode, Tom&nbsp;Caravela shares his personal journey from college to the pharmaceutical industry and eventually into MSL recruitment. He details the origins and evolution of The...
Power of Podcasts: 3 Surprising Ways MSLs can Level Up By Tuning In
<p>In this episode, Sarah Snyder,&nbsp;MSL Recruiter with The Carolan Group, joins to discuss the impactful role of podcasts in the career development of Medical Science Liaisons. The conver...
Advancing Clinical Trial Equity
Assessment of gender representation in clinical trials leading to FDA approval for oncology therapeutics between 2014 and 2019: A systematic review-based cohort study
<ul> <li>Gender representation in oncology clinical trials varies by cancer type, with women often underrepresented compared to national cancer incidence.</li> <li>Despite FD...
Metrics: Quality vs. Quantify and how the game has changed
<p>In this episode, Charlie Cook from&nbsp;Takeda joins Tom Caravela to explore the evolving landscape of MSL metrics before, during, and after COVID. They discuss the origins and strategic ...
How to “Manage Up” and work successfully with your supervisor
<p>In this episode, Tom&nbsp;Caravela is joined by Kathleen Quindon to explore the concept of managing up within the field of medical affairs. Kathleen shares insights from her career, empha...
MSL “GROWTH”…Within the role and BEYOND
<p>In this episode, Danielle Day, Senior Medical Director at&nbsp;Sobe North America, joins Tom Caravela to share her journey from academia to the MSL role. Danielle discusses her transition...
Canadian Regulatory and Health Technology Assessment for Malignant Hematology and Oncology Indications Compared With the US Food and Drug Administration Accelerated Approval Program
<ul> <li>Canadian regulatory approvals align with FDA decisions, but submission numbers to Health Canada (HC) and Health Technology Assessment (HTA) processes are lower in Canada.</li&...
KEYS to SUCCESS in small start-ups vs. big pharma
<p>In this episode, Tom&nbsp;Caravela is joined by Jim Morgan to explore the unique landscape of working in small pharma companies. Jim shares insights from his extensive background in large...
YAY! I'm an MSL…Now What?
<p>In this episode, Julie Chen shares her journey transitioning to an&nbsp;MSL role at Janssen, highlighting initial challenges and the significance of training and KOL engagement. She empha...
Biomarker Testing Improves Outcomes for Patients With Non-Small Cell Lung Cancer
Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration
<p>The study provides a crucial understanding of the role and impact of patient contributions in oncology drug development, focusing on their association with clinically impactful drug outcomes....
My GOAL is to be a Medical Science Liaison
<p>In this episode, Jeremy&nbsp;McLemore shares his inspiring journey from pharmaceutical sales to becoming a Medical Science Liaison (MSL). Jeremy discusses his transition into the MSL role...
From Data Disseminator to Trusted Advisor
<p>In this episode, Chad Fellers shares insights from his experience as an&nbsp;MSL, highlighting his team's success strategies during COVID-19. He discusses the evolving role of MSLs a...
Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors: A Systematic Review
<ul> <li><strong>Chiral Switching:</strong> A strategy where drug manufacturers develop a single-enantiomer formulation from a racemic one to extend market exclusivity, often ...
Use of real-world evidence for oncology clinical decision making in emerging economies
<p>Despite RWE being a relatively nascent concept in emerging economies, we have seen evidence of increasing use over the past 5 years growing at 11% per year. That said, barriers specific to em...
Patient-Reported Outcomes in Pediatric Cancer Registration Trials: A US Food and Drug Administration Perspective
<ul> <li>PROs have been feasible to collect from patients as young as 7 years old and were included in trials from 2013 onward.</li> <li>PROs were used as exploratory endpoin...
Revamping the ever-changing landscape of drug development processes in the midst of COVID-19 pandemic
<p>Oncology is the front-line of drug development. The current pharmaceutical pipeline is disproportional focused on oncology, where about 1/3 of all phases of development is in this therapeutic...
MSL Field Sanity: Top 10 Tips for Field Survival
<p>In this episode, Maria&nbsp;Urso joins Tom Caravela to delve into the challenges and strategies for maintaining health as a traveling Medical Science Liaison (MSL). They explore practical...
Model-Informed Therapeutic Dose Optimization Strategies for Antibody-Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration-Approved Antibody-Drug Conjugates?
<ul> <li>ADCs (Antibody-Drug Conjugates) are a promising area in oncology drug development, improving the therapeutic window of potent, nonspecific payloads by conjugating them to antibod...
From Clinical to Medical Device MSL and Beyond
<p>In this episode, Maria&nbsp;Abunto joins Tom Caravela to discuss her journey from clinical practice to becoming a successful Medical Science Liaison (MSL) in the medical device industry. ...
Updated estimates of eligibility for and response to genome-targeted oncology drugs among US cancer patients, 2006-2020
<section id="abssec0010"> <section id="summary"> <ul> <li>Recent studies have been conducted to update the estimates of eligibility and response rates to...
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
<section id="abssec0010"> <div id="abspara0010" role="paragraph"> <section> <ul> <li>The&nbsp;ESMO-MCBS is a tool used for scoring t...
MSL Career Options: The transition from Field Medical to Medical Director
<p>In this episode, Tom&nbsp;Caravela talks with Josh Corriveau about his journey from Medical Science Liaison to Medical Director. Josh shares insights into securing a medical director role...
Repackage what you have for what you want
<p>In this episode, Cherie&nbsp;Hyder shares her journey from the FDA to the industry, discussing the transition and how to enhance skills for a successful MSL career. She emphasizes the imp...
Cancer, Clinical Trials, and Canada: Our Contribution to Worldwide Randomized Controlled Trials
<p>This document reviews Canadian involvement in oncology randomized controlled trials (RCTs) from 2014-2017, comparing them to those from other high-income countries (HICs).</p> <ul&g...
ctDNA in DLBCL: A Blueprint for Better Clinical Trials?
Virtual Clinical Trials in Oncology-Overview, Challenges, Policy Considerations, and Future Directions
<p>The COVID-19 pandemic has significantly impacted clinical research, particularly in oncology, by accelerating the adoption of virtual clinical trials. These trials can address challenges such...
Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years
<section id="abssec0010"> <section> <div> <ul> <li>Cancer incidence is increasing globally, and while medical innovation significantly impacts patient survi...
The Path from Clinical Practice to Field Medical (MSL, CSL or CPL)
<p>In this episode, Jessica Johnson and Whitney&nbsp;Theiss from Neurocrine Biosciences join Tom Caravela to explore the transition from clinical roles to field medical positions, focusing o...
How Can We Expand Eligibility Criteria for Diffuse Large B-Cell Lymphoma Clinical Trials to Serve More Patients?
Advances in basic research in oncology in 2020: Bridging basic science and clinical care
<ul> <li>Cancer research is advancing with an understanding of the disease at the genetic level, facilitated by massive parallel sequencing.</li> <li>The pan-cancer analysis ...
Managed Care MSLs-Past, Present and Future
<p>In this episode, Todd&nbsp;Wandstrat delves into the intricate world of managed care and its intersection with the Medical Science Liaison (MSL) role. He offers a comprehensive overview o...
MSL Training: The Path of Continued Learning and Development
<p>In this episode, Michael&nbsp;Parisi and Marissa Polly from GuideMark Health join to explore the evolving training needs of Medical Science Liaisons (MSLs). They discuss the essential sci...
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
<ul> <li>Biosimilars are biologic drug products similar to reference drugs in various attributes, including safety and efficacy.</li> <li>Biosimilar epoetin was approved by t...
The Most Common (or NOT) Interview questions and How to Handle Them
<p>In this episode, Anita&nbsp;Carvalho joins MSL Talk to share invaluable interview tips for aspiring Medical Science Liaisons. Anita emphasizes the importance of thoroughly researching the...
How to create HIGH performing MSLs, teams and MSL leaders
<p>In this episode, Mike&nbsp;Penkethman delves into field medical development and the evolving role of MSLs. He emphasizes the importance of executive coaching, soft skills, and adapting to...
The MANY ways COVID-19 has made Medical Affairs and MSLs BETTER
<p>In this episode, JR&nbsp;Ryskala and Petrina Pellet join Tom Caravela to explore the evolving landscape of medical affairs amidst a shift to virtual engagement. The discussion covers the ...
Does biomarker use in oncology improve clinical trial failure risk? A large-scale analysis
<section id="cam43732-sec-0002"> <section> <ul> <li>Data from clinical trials across four oncology indications (breast cancer,&nbsp;NSCLC, melanoma, and colore...
Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval
<p>The study evaluates the acceptance and coverage of FDA-accelerated approved cancer drugs by the National Health Service (NHS) in England, focusing on decisions made by the National Institute ...
3 Things I wish I knew about being a MSL
<p>In this episode, Tom&nbsp;Caravela welcomes Mitchell D&rsquo;Rozario from Genentech Roche to share his journey into the MSL role. Mitchell provides three key insights he wishes he had...
FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs
<ul> <li>The FDA conducts independent reviews of scientific data to ensure the safety and efficacy of&nbsp;investigational drug products.</li> <li>FDA-approved product la...
Assessment of Food and Drug Administration- and European Medicines Agency-Approved Systemic Oncology Therapies and Clinically Meaningful Improvements in Quality of Life: A Systematic Review
<ul> <li>Recent oncology therapies approved by the FDA and&nbsp;EMA often lack evidence of clinically meaningful improvements in quality of life (QOL).</li> <li>Only 40% ...
Are Quality of Randomized Clinical Trials and ESMO-Magnitude of Clinical Benefit Scale Two Sides of the Same Coin, to Grade Recommendations for Drug Approval?
<ul> <li>The approval of new cancer drugs by the FDA and&nbsp;EMA is primarily based on positive results from well-designed randomized phase III clinical trials (RCTs).</li> &l...
How to ENGAGE and work with MSL Recruiters, and WHY!
<p>In this episode, Tom&nbsp;Caravela welcomes Daniel Herr to delve into the intricacies of recruitment within the medical science liaison field. Daniel shares insights on the different type...
How to overcome... "You don't have experience"
<p>In this episode, Mia Barnes joins Tom&nbsp;Caravela to discuss her journey from clinical practice to the MSL role. Mia shares insights on transitioning into the industry, highlighting the...
“Oncometabolism: The switchboard of cancer: An editorial”
<div id="p0005"> <ul> <li>Otto&nbsp;Warburg's discovery in the 1920s highlighted a unique bioenergetic phenotype in tumor cells, emphasizing their reliance on la...
Oncology approvals in 2020: a year of firsts in the midst of a pandemic
<p>Despite the global COVID-19 pandemic, 2020 was an active year for the OCE. In 2021, the OCE is engaging in Project 2025, an effort to envision the next 5 years in oncology drug development an...
The most difficult parts of being an MSL and how to overcome them
<p>In this episode, Tom&nbsp;Caravela speaks with Jonathan Horvath about his career journey and insights from the Rutgers fellowship program. Jonathan discusses the complexities and challeng...
How CAR and Other T Cells Are Revolutionizing Cancer Treatment
See One, Be One, Teach One…. How to be a Leader in Your Space
<p>In this episode,&nbsp;Abi Adenola shares her inspiring journey from pharmacy to becoming an MSL, detailing her experiences in medical information and the MSL role. Abi emphasizes the sign...
Top MSL Goals for the New Year and how to achieve tremendous success
<p>In this episode, Laurie&nbsp;Broman joins to share her expertise on effective strategies for MSLs in the current landscape. Laurie delves into the importance of pre-call planning and sett...
Diversity in Medical Affairs and the Power of Networking
<p>In this episode, Tom&nbsp;Caravela welcomes guests Rachel Kennedy, Lashondra Taylor, and Nirav Shah to discuss the formation and mission of DEMA. They explore the transformative power of ...
Nurse Innovators Increase Access to Biomarker Testing During ONS Hackathon
"The Road Less Traveled: Leveraging an Unconventional Career Path"
<p>In this episode, Tom&nbsp;Caravela is joined by Marc Bernarducci to explore the evolving role of Medical Science Liaisons. Marc shares insights from his educational journey and transition...
How a "Non Traditional" background can lead to success as an MSL
<p>In this episode, Robert&nbsp;Rosti shares his unique journey from medical information to becoming a Medical Science Liaison (MSL). He provides insights into the transition process, emphas...
Outcome measures for oncology alternative payment models: practical considerations and recommendations
<ul> <li>This paper focuses on synthesizing existing research on quality measures in oncology, particularly outcome-based quality measures which are underutilized.</li> <li>A...
Loose Regulatory Standards Portend a New Era of Imprecision Oncology
<ul> <li>Precision oncology aims to tailor cancer treatment based on genetic understanding, revolutionizing oncology.</li> <li>The FDA has been approving drugs under precisio...
LinkedIn: Why you need it. How to use it!
<p>In this episode, Jill&nbsp;Vanak joins the discussion to explore the transformative role of LinkedIn in career development. Jill shares her journey into career coaching and emphasizes the...
Gratitude: An absolute MUST for career advancement
<p>In this episode, Tom&nbsp;Caravela presents a Thanksgiving-themed discussion on gratitude and its impact on career advancement. He explores the significance of expressing gratitude in pro...
Safeguarding cancer research funding by European charities amidst the COVID-19 pandemic
<ul> <li>The COVID-19 outbreak has had a significant impact on cancer research and cancer care.</li> <li>European cancer charities are required to reassess their strategies.&...
The Evidence REVEAL Study: Exploring the Use of Real-World Evidence and Complex Clinical Trial Design by the European Pharmaceutical Industry
<ul> <li>The European Medicines Agency (EMA) should develop an RWE framework for premarketing authorization in Europe.</li> <li>EMA and the European Medicines Regulatory Netw...
Confounding factors in exposure–response analyses and mitigation strategies for monoclonal antibodies in oncology
<ul> <li>Dose selection and optimization is crucial in drug development to maximize benefits for all patients.</li> <li>Exposure&ndash;response (E-R) analysis is useful f...
Quantitative Clinical Pharmacology of T‐Cell Engaging Bispecifics: Current Perspectives and Opportunities
<ul> <li>The pharmacological response of&nbsp;TDBs involves complex interactions between T-cells, tumor cells, and TDBs, posing challenges in understanding pharmacokinetics, tissue di...
How I landed my first MSL role... what works, what doesn't, and what you need to know
<p>In this episode, Julie Chen shares her journey and insights into the&nbsp;MSL role, emphasizing the importance of confidence, preparation, and overcoming challenges in the job search. She...
Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016
<ul> <li>Data from 17 years of studies on novel cancer drugs show limited information available at market entry.</li> <li>Randomized Controlled Trials (RCTs) data are availab...
Compliance 101-Most common issues and MSL-related gray areas
<p>In this episode, Jessica&nbsp;McLin and Melody Davis explore the intricacies of compliance and communication in medical affairs. Jessica shares her journey into entrepreneurship and discu...
First person profile: William Sellers, MD
<div id="article__content" tabindex="-1"> <div> <article> <section> <section id="cncr33301-sec-0001"> <section> <ul> <...
Use of real-world evidence in cancer drug funding decisions in Canada: a qualitative study of stakeholders’ perspectives
<div id="abstract-1"> <div id="sec-4"> <div id="summary"> <ul> <li>The study emphasizes the need for a cultural shift, enhanced data inf...
How to Develop IDPs Individual Development Plans and Road Maps for Career Development
<p>In this episode, Tom&nbsp;Caravela is joined by Elaine Nadeau to delve into the realm of field medical excellence and the significance of Individual Development Plans (IDPs). Elaine share...
Top Ten Tips: Improving Business Etiquette and Emotional Intelligence to Advance Your Career
<p>In this episode, Tom&nbsp;Caravela and Bridget Rasmusson explore business etiquette and emotional intelligence. Bridget offers insights on first impressions, elevator pitches, and focused...
Inadequate and delayed characterization of cutaneous reactions for US Food and Drug Administration-approved oncologic drugs from 2011-2020 leading to medication discontinuation
<div> <ul> <li>Half of clinical trials lack detailed descriptions of rashes; over half discontinue therapy due to rash.</li> <li>There's a 1- to 2-year delay from...
The Future of KOL Engagement and new strategies that will emerge
<p>In this episode, Joan Cannon shares her journey into the&nbsp;MSL role and the operational shifts faced during the COVID-19 pandemic. The conversation covers adjustments in performance me...
Oncology Clinical Trials and Drug Development
Seven decades of chemotherapy clinical trials: a pan-cancer social network analysis
<p>Clinical trials are crucial in establishing cancer care standards, but the social dynamics among researchers in this field have not been extensively studied. A social network analysis of auth...
Improving Community Clinical Trial Participation
Best Practices and Creative Ways to Gain KOL Access During COVID-19
<p>In this episode, Tom&nbsp;Caravela speaks with Jason Demuth about his journey from retail pharmacy to the pharmaceutical industry. Jason shares his experiences engaging Key Opinion Leader...
Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States
<ul> <li>Regulatory agencies often have limited evidence on the clinical benefits and harms of new drugs at the time of market approval.</li> <li>There is frequent discordanc...
Career Longevity: What behavioral competencies will help you have career longevity and stability
<p>In this episode,&nbsp;Norwood Harris shares his extensive experience and career journey at Sandoz and Novartis, providing insights into career longevity and navigating mergers within larg...
Finding the Right Drug at the Right Dose the First Time: Has the Era of Personalized Formularies Finally Arrived?
<ul> <li>Many Americans take medications that are ineffective or cause adverse reactions due to genetic differences in drug metabolism.</li> <li>Pharmacogenomics, the study o...
Resume Writing and Editing for Medical Science Liaisons
<p>In this episode, Tom&nbsp;Caravela delves into the art of crafting a standout resume tailored for MSL roles. He begins with an overview of a resume webinar, offering insights into MSL job...
Leveraging existing data to contextualize phase II clinical trial findings in oncology
<div id="p0010" role="paragraph"> <div> <ul> <li>In the USA, over 250,000 women are diagnosed with early-stage breast cancer (EBC) yearly, with up to 30%...
Field MSL Leadership Panel - MSL QA Session PART ONE with Vanessa Jacobsen, Amy Misnik, and Sue Watson
<p>In this episode, Tom&nbsp;Caravela hosts a panel discussion with guests Sue Watson, Amy Misnik, and Vanessa Jacobson, who share their insights on the MSL role. Sue discusses the best indu...
Professional Medical Writer Assistance in Oncology Clinical Trials
<ul> <li>The use of professional medical writers (PMWs) in oncologic phase III randomized controlled trials (RCTs) has been historically low, but recent data on their usage is limited.<...
An Unexpected Journey From Novice MSL to Global Medical Excellence Leader with Tonya Johnson
<p>In this episode, Tom&nbsp;Caravela welcomes Dr. Tanya Johnson, who shares her inspiring journey from Newark to becoming a Medical Science Liaison (MSL). Tanya emphasizes the importance of...
Use of Real-World Evidence to Support FDA Approval of Oncology Drugs
<section> <div>Real-world evidence (RWE) has gained increased attention in recent years as a complement to traditional clinical trials. The use of RWE to establish the efficacy of oncolog...
Accelerated drug approvals in oncology: Pros and cons
<p>The summary of the content highlights the success of the accelerated approval process, especially for oncology drugs. Key points include:</p> <ul> <li>The rise of accelera...
Field MSL Leadership Panel - MSL QA Session PART TWO with Vanessa Jacobsen, Amy Misnik, and Sue Watson
<p>In this episode, Tom&nbsp;Caravela is joined by Amy Misnick, Vanessa Jacobson, and Sue Watson to explore a range of topics crucial for current and aspiring Medical Science Liaisons. The d...
Lessons learnt from scoring adjuvant colon cancer trials and meta-analyses using the ESMO-Magnitude of Clinical Benefit Scale V.1.1
<section id="as0010"> <section id="summary"> <ul> <li>Form 1 of the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS)...
Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies
<section id="as0010"> <section id="summary"> <ul> <li>The&nbsp;ESMO-MCBS is a validated value scale for assessing solid tumour anticancer treatments,...
Potential Cost Implications for All US Food and Drug Administration Oncology Drug Approvals in 2018
<p>The new, expensive cancer drugs approved by the FDA in 2018 could drastically increase U.S. healthcare spending if widely adopted, but industry forecasts suggest low-level market uptake, main...
Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration
<section id="sec1"> <ul> <li>The study evaluates the clinical benefits of immune checkpoint inhibitors using the&nbsp;ESMO-MCBS and ASCO VF scales.</li> <li...
MSL Interviews GONE WRONG... Shocking stories of what NOT to do Live or Virtual with Anita Carvalho
<p>In this episode, Anita&nbsp;Carvalho joins Tom Caravela to delve into the nuances of MSL interviews. Anita shares her experiences, highlighting both common and unusual occurrences during ...
The 2 Most Critical Elements of MSL Territory Excellence with Julie Montiel
<p>In this episode, Tom&nbsp;Caravela is joined by Julie Montiel to explore the nuances of MSL territory excellence and the critical role of scientific acumen. They delve into strategies for...
Past, Current, and Future Cancer Clinical Research Collaborations: The Case of the European Organisation for Research and Treatment of Cancer
<ul> <li>Collaborations between academic institutions and industry have led to significant scientific breakthroughs in pharmaceutical research, particularly in the discovery phase.</li...
A Field Test of Major Value Frameworks in Chemotherapy of Nasopharyngeal Carcinoma-To Know, Then to Measure
<ul> <li>The European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO) have developed frameworks to evaluate cancer treatments, particularly for na...
Pediatric Oncology Clinical Trials and Collaborative Research in Africa: Current Landscape and Future Perspectives
<section id="abs-sec-1"> <ul> <li>Current childhood cancer survival rates in African countries range from 8.1% to 30.3%.</li> <li>The review focuses on pedia...
The MSL Career Ladder…What options are available and how to position yourself for advancement with Davida White
<p>In this episode,&nbsp;Davida White shares her insights on the evolving landscape of Medical Science Liaison roles and medical affairs. She discusses her career journey and emphasizes the ...
A narrative review of biosimilars: a continued journey from the scientific evidence to practice implementation
<ul> <li>Biologic agents have significantly improved the management of serious health conditions over the last two decades, offering better treatment outcomes and quality of life compared...
Clinical benefit and cost of breakthrough cancer drugs approved by the US Food and Drug Administration
<section id="cncr33095-sec-0001"> <ul> <li>The study evaluates the clinical benefit and pricing of breakthrough-designated versus non-breakthrough-designated cancer drugs...
How to successfully recruit and hire MSLs VIRTUALLY with Paula Pearson
<p>My guest today is Paula Pearson, Senior Director, Field Medical at&nbsp;Apellis and we discuss how to successfully recruit and hire MSLs virtually.</p> <div> <div> &l...
Comparison of Access to Novel Drugs for Lymphoma and Chronic Lymphocytic Leukemia Between India and the United States
<ul> <li>The review examines the costs and access to novel drugs for treating chronic&nbsp;lymphocytic leukemia (CLL) and lymphoma in the United States and India over the last 5 years...
The transition from individual contributor to Medical Affairs leader with Gina Ferrari
<p>In this episode, Gina Ferrari shares her journey into the pharmaceutical industry and her progression to an&nbsp;MSL manager role. She provides insights on career advancement strategies, ...
Discordance Between Child-Pugh and National Cancer Institute Classifications for Hepatic Dysfunction: Implications on Dosing Recommendations for Oncology Compounds
<ul> <li>The FDA and European Medicines Agency recommend using Child-Pugh classification for&nbsp;pharmacokinetic evaluation in noncancer subjects with hepatic impairment (HI).</li...
How to leverage KOL relationships to achieve strategic objectives with Dr. Aoife O'Dwyer
<div> <div> <p>My guest today is Aoife O Dwyer, Founder of MSL Consultant, and we discuss how to leverage KOL relationships to achieve strategic objectives.</p> <p><...
Quantitative Translation in Immuno-Oncology Research and Development
<ul> <li>Exploring the therapeutic potential of the rapidly expanding field of&nbsp;immuno-oncology (IO) drug targets and diverse therapeutic modalities.</li> <li>Recogni...
How to Negotiate a Job Offer
<p>I have a special episode today by request. I&rsquo;m going to talk about how to negotiate a job offer. I&rsquo;m sincerely hoping that there's a lot of you out there that&rsq...
Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities
<ul> <li>Model-informed drug development (MIDD) has advanced rapidly in recent years, especially in oncology.</li> <li>The Prescription Drug User Fee Act (PDUFA) VI includes ...
Mechanistic Quantitative Pharmacology Strategies for the Early Clinical Development of Bispecific Antibodies in Oncology
<ul> <li>Bi-specific antibodies (bsAbs) are crucial in cancer therapy research.</li> <li>BsAbs offer advantages such as enhanced efficacy and reduced systemic toxicity.</l...
Comment on: Oncology research in Saudi Arabia over a 10-year period. A synopsis
<ul> <li>An article in the Saudi Medical Journal by&nbsp;Alghamdi et al reported on oncology research progress in Saudi Arabia.</li> <li>The study compared research quant...
IO Clinical Trials During COVID-19
Clinical development success rates and social value of pediatric Phase 1 trials in oncology
<ul> <li>Pediatric Phase 1 trials in oncology aim to assess social value, focusing on rates of approval, transition to further phases, and citation in research.</li> <li>The ...
Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions
<ul> <li>Randomized controlled trials (RCTs) are preferred by payers for health technology assessments and coverage decisions, but they may not reflect real-world clinical practice.</l...
Characterizing Exposure–Response Relationship for Therapeutic Monoclonal Antibodies in Immuno-Oncology and Beyond: Challenges, Perspectives, and Prospects
<ul> <li>Recent data from&nbsp;immuno-oncology clinical studies show that the exposure&ndash;response (E&ndash;R) relationship for therapeutic monoclonal antibodies (mAbs) is ...
The art of leveraging your strengths to be a Kick Ass MSL
<p>I&rsquo;m joined by Cathy&nbsp;Andorfer, who leads a national team of MSLs and has agreed to give us a leader&rsquo;s perspective on how to be great at your job.</p> <di...
Biosimilars in oncology: key role of nurses in patient education
<ul> <li>Biosimilars can reduce costs and improve access to cancer therapies, but unfamiliarity may hinder their adoption.</li> <li>Nurses, as trusted healthcare providers, a...
How to Prepare and Succeed on a Video Interview
<p>My guest today is Laura Wilson, MD --- Principal Consultant at&nbsp;BioStrategies Consulting LLC and we will discuss some ideas on how to prepare for a video interview.</p> <div...
How to maximize KOL engagement and MSL insights gathering at your next virtual congress with Patrina Pellet
<p>My guest today is&nbsp;Patrina Pellet. She is the Vice President of Medical Strategy at Kernel. We talk about how to maximize KOL engagement and MSL insights gathering at your next virtua...
The regulatory landscape of precision oncology laboratory medicine in the United States - Perspective on the past 5 years and considerations for future regulation
<ul> <li>The regulatory landscape for precision oncology in the United States is complex, involving multiple governmental agencies with varying jurisdictions.</li> <li>Since ...
The Oncology Data Network (ODN): Methodology, Challenges, and Achievements
<ul> <li>The Oncology Data Network (ODN) aims to create a collaborative infrastructure for precision medicine, established in over seven European countries with 124 cancer centers.</li...
Tips for landing your first MSL role…From a guy who just did with Kyle Householder
<p>My guest today is Kyle Householder, Medical Science Liaison at&nbsp;Teva Pharmaceuticals and we discuss how he landed his first MSL role and tips for anyone out there looking to do the sa...
How will COVID-19 affect the MSL role and what new skills may emerge as necessary to maintain value, access and future succes
<p>My guest today is Paul Ward. He is the National Director, Oncology&nbsp;MSLs at AstraZeneca, and MSL Society Advisory Board Member. We will discuss how Covid-19 will affect the role of th...
10 Tips for a Successful MSL Interview with Sue Watson
<p>My guest today is Sue Watson. Sue is the Scientific Director, Oncology Medical Affairs,&nbsp;Janssen Pharmaceuticals, Johnson &amp; Johnson. Our topic today is 10 Tips for a Successfu...
Sponsorship of oncology clinical trials in the United States according to age of eligibility
<ul> <li>The analysis focuses on the sponsorship of interventional oncology trials for patients under 18 in the U.S.</li> <li>There are fewer industry-sponsored trials for pe...
Sponsorship of oncology clinical trials in the United States according to age of eligibility
<ul> <li>The sponsorship mix of trials relevant to young people with cancer has not been well-documented, which may impact policies and regulations in pediatric cancer drug development.&l...
What's Next: Co-creating the next reality for Field Medical after a crisis with Craig Simms
<p>Today I have Craig&nbsp;Simms, CEO of Amplify Consulting Services and Former MSL Director of Astellas Pharma. Our topic for today is What&rsquo;s Next: Co-creating the next reality fo...
How to Prepare a Presentation for an MSL Interview with Kathy Gann
<p>In this episode, my guest is Kathy&nbsp;Gann. Kathy is a former MSL director of Mallinckrodt and Syneos Health and we talk about how to prepare a presentation for an MSL interview. Great ...
Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017
<ul> <li>The number of special regulatory programs for drug and biologic approvals by the FDA has increased since the introduction of the Fast Track designation in 1988.</li> <l...
Emotional Intelligence and why it is important for MSLs with Jessica Freund
<p>In this episode, Jessica&nbsp;Freund from Biogen shares her journey into the pharmaceutical industry, highlighting her transition from Sanofi and her current role. The discussion delves i...
Proportion of Patients in Phase I Oncology Trials Receiving Treatments That Are Ultimately Approved
<ul> <li>Phase I oncology trials are often considered a therapeutic option, but this claim is primarily based on surrogate measures like objective response rates.</li> <li>A ...
Top 12 Attributes of a Great MSL with Vanessa Jacobsen
<p>In this episode, my guest is Vanessa&nbsp;Jacobsen. Vanessa is the Strategic External Engagement Director - Janssen Oncology, US Medical Affairs. We are going to talk about the top 12 att...
MSL Onboarding, Training and the first 60 days with Maria Urso
<p>In this episode, my guest is Maria&nbsp;Urso. Maria is the Associate Director of MSLs for Exact Sciences. We talk about MSL onboarding, training, and the first 60 days as an MSL in additi...
The Importance of Networking for MSLs with Amy Misnik
<p>Today I have Amy&nbsp;Misnik on the podcast. She is the Director, Medical Science Liaisons, Hematology Oncology at The Janssen Pharmaceutical Companies of Johnson &amp; Johnson. Today...
FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019
<ul> <li>194 approvals were analyzed, with 64 (32.9%) relying on surrogate endpoints for the first time in a specific cancer type.</li> <li>Surrogate endpoints often have wea...
Publicly accessible evidence of health-related quality of life benefits associated with cancer drugs approved by the European Medicines Agency between 2009 and 2015
<section id="abssec0020"> <ul> <li>The study investigates cancer drugs approved by the European Medicines Agency (EMA) that initially lack Health-related Quality of Life ...
Patient burden and clinical advances associated with post approval monotherapy cancer drug trials: a retrospective cohort study
<ul> <li><strong>Objective:</strong> The study investigates the efforts to extend the uses of new drugs by testing them for new, non-approved indications and examines the pati...
The Use of Not-Negative Conclusions to Describe Results of Formally Negative Trials Presented at Oncology Meetings
<ul> <li>Out of 208 trials reviewed, 91 were formally negative.</li> <li>29% (26 trials) had "not-negative" conclusions.</li> <li>Reasons for "not...
In Vitro-to-In Vivo Extrapolation of Transporter Inhibition Data for Drugs Approved by the US Food and Drug Administration in 2018
<p>The analysis focuses on inhibition transporter data from New Drug Applications approved by the FDA in 2018, involving 42 drugs. Key points include:</p> <ul> <li><em>...
EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for hematological malignancies
<ul> <li>The&nbsp;ESMO-MCBS v1.1 has not been previously validated for haematological malignancies, but it is being explored to avoid duplication of efforts.</li> <li>A f...
Precision medicine for pediatric cancers lags behind that for adult cancers: Citing hurdles in clinical trial recruitment and drug development, researchers are exploring ways to close gaps
<ul> <li>Pediatric precision oncology faces challenges due to the rarity of pediatric cancers, which limits research and funding compared to adult cancers.</li> <li>Dr. Kathe...
Developing a framework to incorporate real-world evidence in cancer drug funding decisions: the Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration
<ul> <li>Oncology therapy is becoming more expensive, challenging the affordability and sustainability of drug programs globally.</li> <li>Health technology assessment organi...
The pitfalls and promise of liquid biopsies for diagnosing and treating solid tumors in children: a review
<ul> <li>Cell-free DNA profiling via blood samples is emerging as a non-invasive method for cancer&nbsp;genomic characterization.</li> <li>Liquid biopsies are set to be i...
Real-World Evidence in Oncology: Opportunities and Limitations
<ul> <li>Randomized controlled trials (RCTs) are traditionally viewed as the gold standard for evaluating treatment efficacy, but real-world evidence (RWE) is gaining traction in oncology...
Value assessment of oncology drugs using a weighted criterion-based approach
<ul> <li>The rising cost of anticancer therapy has led to efforts to quantify the overall value of new cancer treatments.</li> <li>Multicriteria decision analysis is used to ...
Biosimilars: what the oncologist should know
<ul> <li>As originator biologic medicines lose patent protection,&nbsp;biopharmaceutical companies are developing biosimilars.</li> <li>Biosimilars are similar versions o...
Biased by design? Clinical trials and patient benefit in oncology
<p>The study by Naci&nbsp;<em>et al.</em>&nbsp;raises numerous questions relating to the design characteristics, risks of bias and reporting of pivotal clinical trials in onc...
Access to Novel Drugs for Non-Small Cell Lung Cancer in Central and Southeastern Europe: A Central European Cooperative Oncology Group Analysis
<ul> <li>Treatment for non-small cell lung cancer (NSCLC) has significantly improved with the introduction of targeted and immune-oncologic drugs.</li> <li>Despite rapid deve...
Pivotal Considerations for Optimal Deployment of Healthy Volunteers in Oncology Drug Development
<section id="cts12703-sec-0006"> <section id="summary"> <p>The content discusses the challenges and opportunities in conducting oncology clinical trials, partic...
Pediatric Trials for Cancer Therapies With Targets Potentially Relevant to Pediatric Cancers
<ul> <li>The Research to Accelerate Cures and Equity (RACE) for Children Act was enacted in 2017.</li> <li>The Act authorizes the US FDA to require pediatric studies for new ...
Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation
<section id="sec1"> <section id="summary"> <h3>&nbsp;</h3> <ul> <li>The study investigates the publication status of clinical trials for...
Mandatory Research Biopsy Requirements Delay Initiation of Clinical Trials
<p>The study investigates the impact of requiring fresh tumor tissue biopsies for enrollment in clinical trials. Key findings include:</p> <ul> <li>Requiring biopsies signifi...
Clinical Trial Access in Rural Areas
First person profile: Supriya G. Mohile, MD, MS: A respected geriatric oncologist, Dr. Mohile has conducted innovative research on improving care for older patients with cancer
<section id="cncr32559-sec-0001"> <section id="summary-section"> <h2>&nbsp;</h2> <ul> <li> <p>Ms. Canin and Dr. Mohile collaborat...
New Realities of Phase I Clinical Trials in the Era of
<div id="p0010" role="paragraph"><br> <div> <ul> <li>The development of cancer immunotherapy, particularly durvalumab, has progressed rapidly due t...
Liquid biopsy in oncology: a consensus statement of the Spanish Society of Pathology and the Spanish Society of Medical Oncology
<p>&nbsp;</p> <ul> <li>The proportion of cancer patients with tumours that have targetable genomic alterations is increasing, which is crucial for tailored treatment and ...
Liquid biopsy in oncology: a consensus statement of the Spanish Society of Pathology and the Spanish Society of Medical Oncology
<ul> <li>The proportion of cancer patients with tumors having potentially&nbsp;targetable genomic alterations is increasing.</li> <li>Diagnosing these alterations can lea...
Prediction of Drug Approval After Phase I Clinical Trials in Oncology: RESOLVED2
<p>&nbsp;</p> <ul> <li><strong>Challenge in Oncology Drug Development:</strong> The field is currently facing an increase in the number of antineoplastic agen...
Association of National Cancer Institute-Sponsored Clinical Trial Network Group Studies With Guideline Care and New Drug Indications
<ul> <li><strong>Importance:</strong> NCTN groups are vital in identifying effective new antineoplastic regimens, but their clinical impact has not been systematically evaluat...
The rise of oncology biosimilars: from process to promise
<ul> <li>Biosimilars are biologic products that are highly similar to the approved originator molecule, with no clinically meaningful differences.</li> <li>They are expected ...
First person profile: Leslie Bernstein, PhD: An epidemiologist known for her groundbreaking discoveries about breast cancer, Dr. Bernstein continues to push the field forward
<section id="cncr32452-sec-0001"> <section id="summary"> <ul> <li>Dr. Leslie Bernstein is a renowned researcher in breast cancer risk and prevention at C...
Level of evidence used in recommendations by the National Comprehensive Cancer Network (NCCN) guidelines beyond Food and Drug Administration approvals
<div> <ul> <li>The analysis reviewed 113 NCCN recommendations, focusing on 44 off-label uses of drugs.</li> <li>14 of these off-label recommendations were later FDA-ap...
Median Survival or Mean Survival: Which Measure Is the Most Appropriate for Patients, Physicians, and Policymakers?
<div id="onco13022-sec-0002"></div> <div id="onco13022-sec-0003"> <div id="onco13022-sec-0017"> <div> <ul> <li>The average ...
Comparison of Long-term Survival Benefits in Trials of Immune Checkpoint Inhibitor vs Non-Immune Checkpoint Inhibitor Anticancer Agents Using ASCO Value Framework and ESMO Magnitude of Clinical Benefit Scale
<ul> <li><strong>Importance:</strong> Anticancer agents, especially immune checkpoint inhibitors (ICIs), have shown potential for long-term durable survival in some patients. ...
Dose Finding in the Clinical Development of 60 US Food and Drug Administration-Approved Drugs Compared With Learning vs. Confirming Recommendations
<ul> <li>This review evaluates the current practice of dose finding in the pharmaceutical industry and assesses the clinical evidence supporting the&nbsp;optimality of the label dose....
Advances and Challenges in Pediatric and Childhood Cancers
<ul> <li>Pediatric cancers, while uncommon compared to adult cancers, include leukemia, CNS tumors, lymphoma,&nbsp;Wilms' tumor, and retinoblastoma.</li> <li>Challen...
Addressing oncologists' gaps in the use of biosimilar products
<p>The study highlights significant gaps in knowledge, competence, and confidence among oncologists regarding biosimilars. Educational interventions notably improved clinicians' understandi...
Assessing cardiac safety in oncology drug development
<p>The Cardiac Safety Research Consortium (CSRC) highlighted the importance of addressing cardiovascular (CV) adverse effects in oncology drug development during a Think Tank meeting in October ...
Recent eUpdates to the ESMO Clinical Practice Guidelines on hepatocellular carcinoma, cancer of the pancreas, soft tissue and visceral sarcomas, cancer of the prostate and gastric cancer
<p>The following ESMO Clinical Practice Guidelines have been recently updated with new treatment recommendations for the ESMO Clinical Practice Guidelines on Hepatocellular Carcinoma, Cancer of ...
An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate
<p>Many cancer drugs come to market based on single-arm studies with modest RRs. Most of these drugs are tested in studies of over 100 patients prior to approval. Most (60%) of these approvals l...
Assessment of Whether the American Society of Clinical Oncology's Value Framework and the European Society for Medical Oncology's Magnitude of Clinical Benefit
<p>The ASCO-VF and ESMO-MCBS frameworks currently lack the ability to measure absolute survival benefit, which limits their effectiveness in comparing clinical benefits across different drugs an...
Association of Industry and Academic Sponsorship With Negative Phase 3 Oncology Trials and Reported Outcomes on Participant Survival: A Pooled Analysis
<p>In this study of trials published in 2016 through 2018, approximately 40% of negative phase 3 RCTs in oncology were conducted without supporting phase 2 trials, and such phase 3 trials were s...
Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs
<p>If FDA-approved checkpoint inhibitor drugs are universally available, we estimated that the proportion of US patients with cancer who could be eligible for such drugs is approximately 44%, wh...
Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration
<p>The aim of our analysis was to evaluate the quality of control&nbsp;arms in RCTs leading to anticancer drug approvals by the FDA.&nbsp;We found that, between January 1, 2013, and July...
Quantitative Mechanistic Modeling in Support of Pharmacological Therapeutics Development in Immuno-Oncology
<ul> <li>There has been significant growth in the development of&nbsp;immuno-modulating pharmacological treatments for various cancers following the approval of the first immune check...
Cancer drug development: The missing links
<ul> <li>Despite advanced science and technology, cancer incidence is highest in America and Europe.</li> <li>Science and technology alone are not sufficient for treating dis...
Biosimilars 2019 | Interview with Hope S Rugo, MD
Biosimilars 2019 | Interview with Gary H Lyman, MD, MPH
Biosimilars 2019 | Interview with Sanjiv S Agarwala, MD
Estimation of Study Time Reduction Using Surrogate End Points Rather Than Overall Survival in Oncology Clinical Trials
<ul> <li>The use of Response Rate (RR), Progression-Free Survival (PFS), and Overall Survival (OS) in clinical trials leading to FDA approval is associated with different study durations:...
Cancer experts point to new advances in research and treatment: A recent report by the American Association for Cancer Research highlights unprecedented successes as well as ongoing challenges in the cancer field
<p>Within the last few years, cancer research has made significant strides, leading to the approval of 22 new cancer treatments by the FDA between August 1, 2017, and July 31, 2018. Among these,...
The evolving landscape of precision medicine in primary liver cancer
<p>The field of oncology and cancer research is changing. As our understanding of the underlying biology of the disease improves, the one-size-fits-all treatment model has been exposed as inadeq...
Representation of Patients With Cardiovascular Disease in Pivotal Cancer Clinical Trials
<p>Heart failure (28%) was the most common exclusion criterion in clinical trials for FDA-approved anticancer therapies, followed by prior coronary disease and arrhythmias (27% and 23%, respecti...
Timing of first-in-child trials of FDA-approved oncology drugs
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Breaking Down Checkpoint Inhibitors
Value assessment frameworks in oncology: championing concordance through shared standards
<p>The ASCO Value Framework Net Health Benefit Score (ASCO-NHB) and the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS), introduced in 2015, are essential tools for assessing the relative b...
Industry Challenges Contribute to Financial Toxicity
How Washington Is Tackling High Prescription Drug Costs
The Case for Real-world Evidence in the Future of Clinical Research on Chronic Myeloid Leukemia
<p>In light of recently published guidelines from the US Food and Drug Administration (FDA) on the communication of real-world data (RWD) and real-world evidence (RWE) to support regulatory deci...
The Practical Side of Clinical Trials
Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016
<div> <div>Background: An overview was conducted of oncology products reviewed by the Office of Oncology Drug Products (OODP) at the FDA for marketing approval between July 2005 and Decem...
Challenges and Opportunities in Dose Finding in Oncology and Immuno-oncology
<ul> <li>Focus on optimizing oncology therapeutics through quantitative&nbsp;translational and clinical pharmacology.</li> <li>Emphasis on dosage precision to maximize pa...
Defining a Clinically Meaningful Benefit in Cancer Clinical Trials: From the Perspectives of the Clinical Trialist, Patient, and Society
<p>In value-based medicine, clinical trials must show both statistically significant and clinically meaningful improvements, such as ASCO's recommendation of a 20% relative improvement in o...
Opportunities and challenges in biosimilar uptake in oncology
<p>The U.S. has 10 approved biosimilars, including 3 for oncology, with many more in development, potentially increasing access to expensive biologics. Acceptance by healthcare providers and pat...
Early-drug development in the era of immuno-oncology: are we ready to face the challenges?
<ul> <li>The classical development of drugs is being replaced by a seamless drug-development process.</li> <li>First-in-human trials now often include large expansion cohorts...
Evolving Landscape of US Food and Drug Administration Drug Approval in the Era of Precision Oncology: Finding the Right Balance Between Access and Safety
<ul> <li>Balance is needed between enhancing drug access and ensuring patient safety.</li> <li>Accurate surrogate endpoints and sophisticated trial designs are crucial for pr...
Cancer research in the United States: A critical review of current status and proposal for alternative models
<ul> <li>Early research focused on tissue histology and animal models, with surgery and radiotherapy as primary treatments.</li> <li>1950s: Introduction of cell lines (e.g., ...
How Biosimilars Could Impact the Future of Cancer Care
Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development
<p>The article discusses optimizing oncology drug development, focusing on the impact of pharmacokinetic factors like food effects and drug interactions. It recommends early evaluation of these ...
Streamlining Adverse Events Reporting in Oncology: An American Society of Clinical Oncology Research Statement
<div role="paragraph"> <div role="paragraph"> <div role="paragraph">Monitoring patient safety during clinical trials is crucial to protect research pa...
New Guidelines for Managing Immunotherapy-Related Adverse Events
The Importance of Reading Clinical Trial Protocols Simultaneously With Published Studies
Clinical Trials in Oncology and Defining Benefit
<p>The article emphasizes the importance of defining efficacy and futility in oncology clinical trials from the patient's perspective, highlighting that what may be effective for one patien...
Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration
<ul> <li>Regulatory agencies assess drug safety and efficacy, but thresholds may differ from those accepted by clinicians .</li> <li>Only 43.8% of RCTs for FDA-approved drugs...