New Drug Approvals for Prostate Cancer

H&O  What are the most recent drug approvals for prostate cancer? IT  The most recent drug approvals for men with prostate cancer primarily consist of “me-too” […]

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 […]