Category: Advances in Drug Development
PROTAC Drugs in Cancer Care
H&O What are PROTACs, and how do they target proteins in cancer treatment? PF Proteolysis-targeting chimeras (PROTACs) are a new class of drugs that, in my […]
Coordination Between the FDA and the US Patent and Trademark Office
H&O What is the Executive Order on Promoting Competition in the American Economy and how does it relate to coordination between the FDA and the USPTO? […]
The Impact of Financial Toxicity on Cancer Care
H&O What is financial toxicity, and how does it impact cancer therapy? JP Financial toxicity is a term used to describe the burdens, barriers, and distress […]
Repurposing Drugs in Oncology
H&O What is drug repurposing, and how is it used in oncology? EV Drug repurposing describes the phenomenon of using drugs that are already approved or […]
Novel Sources of Funding for Clinical Trials in Oncology
H&O What are the traditional sources of funding for clinical trials in oncology, and how have they evolved over time? GS Traditional sources of funding for […]
Dosing of Nivolumab in India
H&O What factors determine the appropriate dose of nivolumab? VN The dosing of any drug is determined by multiple factors. Traditionally, drug dosing is initially determined […]
Factors Guiding Selection of Treatment in Metastatic Colorectal Cancer
H&O What factors guide selection of treatment in metastatic colorectal cancer? LS Metastatic colorectal cancer is a very broad area that requires an individualized approach to […]
Serving on the FDA Oncologic Drugs Advisory Committee
H&O What is the role of the Oncologic Drugs Advisory Committee (ODAC) of the US Food and Drug Administration (FDA)? PH ODAC is one of several […]
Variability in Global Drug Prices
H&O Why are drug prices in the United States so high? ASK Brand-name drug prices are on average approximately 2 to 4 times higher in the […]
Lessons Learned From the Accelerated Approval of Cancer Drugs
H&O What are the principles behind the accelerated approval pathway? BG The US Food and Drug Administration (FDA) introduced the accelerated approval pathway in the 1990s […]
Recent Advances in Understanding Glucocorticoid Receptor Function in Cancer
H&O Are there any new insights into the role of glucocorticoids and/or glucocorticoid receptors? SC There are several new insights into the role of glucocorticoids, […]
The I-SPY Approach to Drug Development
Clinical Advances in Hematology & Oncology October 2016, Volume 14, Issue 10 Laura Esserman, MD, MBA Professor, Departments of Surgery and Radiology Affiliate Faculty, Institute for […]
The Importance of Dose Optimization Prior to Initiation of a Registration Trial
Clinical Advances in Hematology & Oncology Volume 14, Issue 9, September 2016 Nam Atiqur Rahman, PhD Director Division of Clinical Pharmacology V Center for Drug Evaluation […]
Improving Clinical Trial Design Through Quantitative Pharmacology
Clinical Advances in Hematology & Oncology Volume 14, Issue 8, August 2016 Michael L. Maitland, MD, PhD Director of Therapeutics Inova Center for Personalized Health […]
Current Insights Into the Impact of Dihydropyrimidine Dehydrogenase Deficiency in Patients Receiving Treatment With 5-Fluorouracil
Clinical Advances in Hematology & Oncology Volume 14, Issue 7, July 2016 Robert B. Diasio, MD William J. and Charles H. Mayo Professor Director, Mayo Clinic […]
Novel Approaches to Delivering Value in Oncology Drugs
Clinical Advances in Hematology & Oncology April 2016, Volume 14, Issue 4 Steve Miller, MD Senior Vice President & Chief Medical Officer Express Scripts St Louis, […]
The Effect on Drug Development of the National Cancer Institute’s Cancer Therapy Evaluation Program
Clinical Advances in Hematology & Oncology March 2016, Volume 14, Issue 3 James Zwiebel, MD Chief, Investigational Drug Branch Cancer Therapy Evaluation Program National Cancer Institute […]
Casting Doubt on the Scientific Utility of Post-treatment Biopsies in Phase 1 Trials
Clinical Advances in Hematology & Oncology February 2016, Volume 14, Issue 2 Mark J. Ratain, MD Leon O. Jacobson Professor of Medicine Director, Center for Personalized Therapeutics […]
The Impact of Value-Based Insurance Design on Oncology Drugs
Clinical Advances in Hematology & Oncology January 2016, Volume 14, Issue 1 A. Mark Fendrick, MD Professor, Internal Medicine Director, Center for Value-Based Insurance Design […]
The Current and Future Applications of Immunopharmacogenomics
Clinical Advances in Hematology & Oncology December 2015, Volume 13, Issue 12 Yusuke Nakamura, MD, PhD Professor of Medicine Departments of Medicine and Surgery The University […]