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Results for 'development in research'

New Book Unites Oncology’s Brightest Minds To Innovate Cancer Cures
OVN Avatar 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

12 Interview Techniques to Help Land Your Next Job
Partner Avatar Tom Caravela
12 Interview Techniques to Help Land Your Next Job

interview preparation, job interview tips, business etiquette, salary negotiation, follow-up after interview

Your next career move could very well be one interview away. Be sure to take every measure to prepare yourself and make the most of the opportunity. According to a recent Simply Hired survey of over 850 Managers, an overwhelming 89% said that “showing lack of preparation” will affect the…

May 12th • 1 min read

Job Search Checklist for Aspiring Medical Science Liaisons
Partner Avatar 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

7 High-Cost Interview Mistakes that are Easy to Avoid
Partner Avatar Tom Caravela
7 High-Cost Interview Mistakes that are Easy to Avoid

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

Is your job search taking much longer than expected? Have you gone on interviews and feel it went well, but you still didn’t get the job? Interviewing in a competitive job market can be more challenging than one might think. COVID-19 has not made the interview process any easier – instea…

Jul 28th • 1 min read

MSL People Skills: Top 10 Tips for Better Engagement
Partner Avatar Tom Caravela
MSL People Skills: Top 10 Tips for Better Engagement

Medical Science Liaison, relationship building, business etiquette, social awareness, emotional intelligence, professional interactions, Dale Carnegie, How to Win Friends and Influence People, professional brand, engagement tips, digital communication

The cornerstone of the Medical Science Liaison role is RELATIONSHIP BUILDING. In a nutshell, better engagement equates to better relationships. The purpose of this article is to address the importance of proper business etiquette and the impact of social awareness and emotional intelligence as it re…

Apr 20th • 8 mins read

Promotability: How to Land Your Next Promotion
Partner Avatar Tom Caravela
Promotability: How to Land Your Next Promotion

professional visibility, career advancement, promotion tips, career progression, networking strategies, mentorship benefits, resume upgrades, servant leadership, problem-solving skills, personal branding

“Promotability” may be defined as one’s suitability for being promoted. Is it your goal to obtain a promotion this year? If so, how suitable or promotable are you for that next step? Job-seekers and professionals often ask me what steps are necessary for advancement. I have broken …

May 5th • 10 mins read

Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years
OVN Avatar Emmanuelle Jacqueta, Ghania Kerouani-Lafayeb, Francoise Grudeb, Sergio Goncalvesb, Annie Lorenced, Florence Turcryb, Liora Brunelb, Laetitia Belgodereb, Adrien Monardc, Gaëlle Guyaderb, Lotfi Boudalib, Nicolas Albin
Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years

Innovation, Expanded access, Early drug access, Cancer, FDA, EMA

Cancer incidence is increasing globally, and while medical innovation significantly impacts patient survival, the drug development process is lengthy, often exceeding 10 years for marketing authorization (MA). France has implemented the ATU (Temporary Authorization for Use) program to facil…

Apr 7th • 12 mins read

Past, Current, and Future Cancer Clinical Research Collaborations: The Case of the European Organisation for Research and Treatment of Cancer
OVN Avatar Stefanie Broes, Robbe Saesen, Denis Lacombe, Isabelle Huys
Past, Current, and Future Cancer Clinical Research Collaborations: The Case of the European Organisation for Research and Treatment of Cancer

European organisation for Research and Treatment of Cancer, EORTC, clinical research

Collaborations between academic institutions and industry have led to significant scientific breakthroughs in pharmaceutical research, particularly in the discovery phase. The role of multi-stakeholder partnerships in the clinical development of anticancer medicines requires further clarification…

Aug 16th • 8 mins read

Quantitative Translation in Immuno-Oncology Research and Development
OVN Avatar Dean Bottino, Rachael Liu, Hojjat Bazzazi, Karthik Venkatakrishnan
Quantitative Translation in Immuno-Oncology Research and Development

Quantitative Translation, Immuno-Oncology, Research, Development, CIC

Exploring the therapeutic potential of the rapidly expanding field of immuno-oncology (IO) drug targets and diverse therapeutic modalities. Recognizing the need for principled decisions based on biologically sound quantitative translation in a competitive clinical research environment. High…

Jul 9th • 3 mins read

Publicly accessible evidence of health-related quality of life benefits associated with cancer drugs approved by the European Medicines Agency between 2009 and 2015
OVN Avatar Nicole Grossmann, Martin Robausch, Eleen Rothschedl, Claudia Wild, Judit Simon
Publicly accessible evidence of health-related quality of life benefits associated with cancer drugs approved by the European Medicines Agency between 2009 and 2015

Antineoplastic agents, Health-related quality of life, Clinical efficacy, Drug approvals, Patient-relevant outcomes

The study investigates cancer drugs approved by the European Medicines Agency (EMA) that initially lack Health-related Quality of Life (HRQoL) information. Data was collected for cancer indications approved between January 2009 and October 2015, using sources like the EMA website, clinical…

Feb 23rd • 12 mins read

Patient burden and clinical advances associated with post approval monotherapy cancer drug trials: a retrospective cohort study
OVN Avatar Benjamin Gregory Carlisle, Adélaïde Doussau, Jonathan Kimmelman
Patient burden and clinical advances associated with post approval monotherapy cancer drug trials: a retrospective cohort study

clinical advances, monotherapy cancer drug trials, FDA

Objective: The study investigates the efforts to extend the uses of new drugs by testing them for new, non-approved indications and examines the patient burden and clinical impact. Design and Setting: A retrospective cohort study focused on post-approval trials of anticancer drugs approved betwee…

Feb 17th • 7 mins read

EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for hematological malignancies
OVN Avatar Barbara Kiesewetter , Nathan I Cherny, Nicolas Boissel, Francesco Cerisoli, Urania Dafni, Elisabeth G E de Vries, Paolo Ghia, Nicola Gökbuget, Verónica González-Calle, Brian Huntly, Ulrich Jäger, Nicola Jane Latino, Jean-Yves Douillard, Luca Malcovati, Ma
EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for hematological malignancies

ESMO, hematological malignancies, Clinical benefit scale, EHA

The ESMO-MCBS v1.1 has not been previously validated for haematological malignancies, but it is being explored to avoid duplication of efforts. A feasibility test was conducted using 80 studies related to various haematological malignancies such as acute and chronic leukaemia, lymphoma, myel…

Jan 20th • 20 mins read

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
OVN Avatar Carrie Printz
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

Precision Medicine, pediatrics, clinical trials

Pediatric precision oncology faces challenges due to the rarity of pediatric cancers, which limits research and funding compared to adult cancers. Dr. Katherine Janeway highlights the need for more validated pre-clinical models and pharmaceutical interest in pediatric cancers. The RACE Act, effe…

Jan 9th • 2 mins read

New Realities of Phase I Clinical Trials in the Era of
OVN Avatar S.E. Abdullah, E. Oflazoglu, J.C. Soria, M.M. Dar
New Realities of Phase I Clinical Trials in the Era of

durvalumab, durvalumab experience, clinical trials, immunotherapy

The development of cancer immunotherapy, particularly durvalumab, has progressed rapidly due to innovative strategies, such as novel study designs. Durvalumab, an anti-PD-L1 monoclonal antibody, was developed by AstraZeneca starting in 2012, with initial trials leading to its accelerated appr…

Oct 7th • 5 mins read

Prediction of Drug Approval After Phase I Clinical Trials in Oncology: RESOLVED2
OVN Avatar Guillaume Beinse, MD, Virgile Tellier, Valentin Charvet, MSc, Eric Deutsch, MD, PhD, Isabelle Borget, PharmD, PhD, Christophe Massard, MD, PhD., Antoine Hollebecque, MD, PhD, and Loic Verlingue, MD
Prediction of Drug Approval After Phase I Clinical Trials in Oncology: RESOLVED2

clinical trials, RESOLVED2, FDA

  Challenge in Oncology Drug Development: The field is currently facing an increase in the number of antineoplastic agents (ANAs) entering phase I clinical trials (P1CTs) and a high attrition rate for final FDA approval. Objective: Development of a machine learning algorithm, RESOLVED2, to …

Sep 20th • 12 mins read

Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration
OVN Avatar Natansh D. Modi, BPharm; Ahmad Y. Abuhelwa, PhD; Ross A. McKinnon, PhD
Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration

IPD sharing, clinical trial transparency, FDA anticancer approvals, oncology trials, data accessibility, pharmaceutical industry

The study examines the eligibility for individual participant data (IPD) sharing from clinical trials that supported the FDA approval of anticancer medicines over the past 10 years. Of the 304 trials analyzed, 136 (45%) were eligible for IPD sharing, while 168 (55%) were not. IPD sharing rates v…

Jul 28th • 20 mins read

Association between control group therapy and magnitude of clinical benefit of cancer drugs
OVN Avatar Consolacion Molto, Ariadna Tibau, Aida Bujosa, Jose Carlos Tapia, Abhenil Mittal, Faris Tamimi & Eitan Amir
Association between control group therapy and magnitude of clinical benefit of cancer drugs

control group therapy, clinical benefit scales, ESMO-MCBS, ASCO-VF, randomized trials

The study investigated the impact of control group therapy on various clinical benefit scales like ASCO-VF, ESMO-MCBS, NCCN Evidence Blocks, and ASCO-CRC. Researchers analyzed cancer drugs approved between 2012 and 2021 using data from randomized controlled trials (RCTs) listed on Drugs@FDA. Sig…

Dec 9th • 20 mins read

Patient involvement: A must-have in medicine development, but is it being overlooked in a cost-constrained environment?
Partner Avatar Envision Pharma Group
Patient involvement: A must-have in medicine development, but is it being overlooked in a cost-constrained environment?

patient engagement in pharma, patient-centric drug development, life sciences industry innovation, patient insights in medicine, regulatory compliance in patient engagement, patient involvement in clinical trials, benefits of patient advocacy, patient-cen

The life sciences industry is in a constant state of advancement, bringing more and more groundbreaking medicines, cutting-edge technologies, and innovative solutions to market. Amidst these rapid changes, patients remain at the heart of these scientific developments. In recent decades, the l…

May 9th • 5 mins read

Preliminary Attainability Assessment of Real-World Data for Answering Major Clinical Research Questions in Breast Cancer Brain Metastasis: Framework Development and Validation Study
OVN Avatar Min Jeong Kim, Hyo Jung Kim, Danbee Kang, Hee Kyung Ahn, Soo-Yong Shin, Juhee Cho, Yeon Hee Park,
Preliminary Attainability Assessment of Real-World Data for Answering Major Clinical Research Questions in Breast Cancer Brain Metastasis: Framework Development and Validation Study

real-world data, preliminary attainability assessment, observational study, clinical data warehouse, PAR framework, brain metastasis, breast cancer

The study proposes the PAR framework for data attainability screening in clinical research, particularly useful for addressing unmet clinical needs in BCBM. A survey showed clinical questions had a mean score of 4.37, indicating the significance of these questions. RWE generation is crucial…

Oct 9th • 4 mins read

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
OVN Avatar Yafang Huanga, Weiyi Xiongb, Jingwei Zhaoa, Wentao Lia, Li Mac, Hao Wua
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

Early phase clinical trial, Dose-expansion cohort, Single-arm trial, Pivotal trial, FDA approved indications, Targeted anticancer drugs

Analysis of 188 FDA-approved indications for 95 molecular targeted anticancer drugs between 2012 and 2021. 59.6% of indications were approved based on Early Phase Clinical Trials (EPCTs). There was a notable annual increase of 22.2% in approvals based on EPCTs, compared to a 5.0% increase for ph…

Mar 9th • 10 mins read

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