Results for 'BLA'
Siddharth Agrawal, Nidhi Bansal
Advances and Challenges in Pediatric and Childhood Cancers
CNS, central nervous system, ES, Ewing sarcoma, MB, medulloblastoma, PTSD, post traumatic stress disorder, RB, retinoblastoma
Pediatric cancers, while uncommon compared to adult cancers, include leukemia, CNS tumors, lymphoma, Wilms' tumor, and retinoblastoma. Challenges in pediatric cancer treatment encompass late diagnosis, varied immune responses, preserving fertility, minimizing late effects, and considering lo…
Jun 27th • 2 mins read
Bhakti Arondekar, Mei Sheng Duh, Rachel H. Bhak, Maral DerSarkissian, Lynn Huynh, Kelsey Wang, John Wojciehowski, Melody Wu, Bryon Wornson, Alexander Niyazov, George D. Demetri
Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application
RWE, Biologics License, FDA, BLA, suplements
The FDA emphasizes early engagement and transparent protocols in Real-World Evidence (RWE) studies. Aligning RWE populations with pivotal trial populations is crucial, often achieved through criteria matching and propensity score methodologies. Major critiques include differences in tumor asse…
Jan 1st • 12 mins read
Forbes Books Press Release Official
New Book Unites Oncology’s Brightest Minds To Innovate Cancer Cures
Voices of Oncology, Cancer cures, Oncology Voice Network, Kirk V. Shepard, Ramin Farhood, Forbes Books, Cancer treatment innovation, Oncology collaboration, Patient engagement in oncology, Precision medicine cancer
Voices of Oncology: Fostering a Collaborative Community of Experts to Accelerate Cancer Cures is a book by Kirk V. Shepard, M.D., and Ramin Farhood, PharmD, M.B.A., featuring insights from 33 contributors in the oncology field. It is available on platforms like Amazon and Barne…
Sep 9th • 5 mins read
Tom Caravela
Mastering the First Impression
first impression, job interviews, professional communication, resume tips, LinkedIn profile
Why is a first impression so important? Mainly because it could also be your last, and only, impression on someone. Oftentimes, job seekers can fail at conveying a positive first impression, and they will unfortunately never get another chance to show who they truly are. This is an area that I feel …
Jan 29th • 2 mins read
Tom Caravela
Job Search Checklist for Aspiring Medical Science Liaisons
Medical Science Liaison, MSL role, MSL career tips, Pharmaceutical industry jobs, Break into MSL career
Tips to Help Break into Your First MSL Role The Medical Science Liaison (MSL) role, has become one of the most sought-after career paths in the Pharmaceutical and Biotech industry. What does it take to land a role as a Medical Science Liaison? As an MSL Recruiter, this is a question that I am…
May 17th • 2 mins read
Tom Caravela
MSL Hiring and Recruitment: 5 Ways to Support Diversity and Inclusion
Medical Science Liaison hiring, diversity and inclusion recruitment, diverse interview panel, employee referral program, diversity sourcing strategies
While the COVID-19 pandemic wreaked havoc on many industries, Medical Science Liaison hiring was steady throughout 2020 and continues to remain strong in 2021. The one change in hiring that has become evident is the increase in recruitment practices that support diversity and inclusion. While we may…
May 19th • 2 mins read
Tom Caravela
Combatting the “Summer Slow Down" – MSL Job Search Tips for Slower Months
Medical Science Liaison, Medical Affairs recruitment, job search strategies, networking in medical field, summer hiring trends
There is definitely a cyclical nature to hiring Medical Science Liaisons and Medical Affairs professionals. Typically, peak season for recruitment and hiring is from March to June, which is the time-frame in and around which MSLs collect their annual bonuses. However, Medical Science Liaison hiring …
Jun 23rd • 2 mins read
Gregory S. Calip, PharmD, MPH, PhD, Ivy P. Altomare, MD, Jenny S. Guadamuz, MSPH, PhD
Evaluating External Validity of Oncology Biosimilar Safety Studies
biologics, external validity, FDA, biosimilars, trastuzumab
Biologics are the fastest growing medication class in the US, significantly contributing to healthcare costs. The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway to make biological products more accessible. A phase 3 randomized trial of SB3, a trast…
Apr 6th • 2 mins read
Alison Betts, Piet H. van der Graaf
Mechanistic Quantitative Pharmacology Strategies for the Early Clinical Development of Bispecific Antibodies in Oncology
bispecific antibodies, mechanistic quantitative, pharmacology, strategies, bsAbs, immune cells, MABEL aproach
Bi-specific antibodies (bsAbs) are crucial in cancer therapy research. BsAbs offer advantages such as enhanced efficacy and reduced systemic toxicity. Early clinical trials face challenges with dose selection and predicting effective doses. Clinical variability is influenced by factors like fun…
Jun 24th • 18 mins read