Phase IV Featured Articles

1. Novartis: Pragmatic Clinical Trials & RWE Gain Traction 8/28/2017

   In this Q&A, Sameer Tandon, head of strategic alliances and customer transactions in U.S. medical affairs for Novartis, shares some of the challenges of his job and what trends will shape the future of the medical affairs group. Tandon discusses real-world evidence, FDA, payers, working with CROs, procurement costs, and more.

2. How Pfizer Uses Patient Video To Improve Sickle Cell Trials 12/16/2016

   Sickle cell disease is a red blood cell disorder where patients have abnormal hemoglobin in those cells. In this interview Brenda Cooperstone, VP and chief development officer for the specialty care business unit at Pfizer, discusses the efforts made to understand sickle cell patients, their condition, and how the company should interact with them during visits to the emergency room.

3. With RE-VECTO, BI Investigates Clinical Use Of PRAXBIND 8/18/2016

   Boehringer Ingelheim Pharmaceuticals has announced the launch of a global program designed to evaluate the use of its PRAXBIND medicine, which received FDA approval in October 2015. The program, titled RE-VECTO, will gather data to better understand the actual usage of PRAXBIND in clinical settings.

4. Market Access Insight Commercial Considerations For Pharmaceutical Products 6/23/2016

   Understanding the clinical and technical factors surrounding a product during development is critical for downstream success. John D. McDermott, Jr., Vice President, Covance Market Access Services, discuses approaches to maximize a product’s commercial value.

5. Clinical Leader Expands Editorial Advisory Board 12/17/2015

   Clinical Leader relies on the feedback of pharma industry professionals and consultants to guide its focus and direction. The website’s editorial advisory board, composed of consultants and executives from the pharma and bio industries, help guide the direction and focus of the site’s editorial content. Clinical Leader has announced that in 2015 it added 17 distinguished individuals to that board, including representatives of Eli Lilly and Company, Pfizer, The Avoca Group, PatientsLikeMe, BMS, Novartis, Shire, and more.

6. Is The Sunshine Act Reducing Clinical Research Spending? 8/24/2015

   The intentions behind the passing of the Physicians Payment Sunshine Act were good. The Act required manufacturers of covered drugs, devices, biological products, and medical supplies to annually report to the Centers for Medicare & Medicaid Services (CMS) information regarding payments, ownership, investment interests, and other transfers of value to physicians and teaching hospitals. The intent was to reveal any conflicts of interest that might exist, with the end goal of hopefully bringing down healthcare costs. But even the most well-intentioned acts can have unforeseeable negative results. And it now seems the well-intentioned Sunshine Act may be having the unintended consequence of cutting down on the amount of investment making its way into clinical trials.

7. Improve Clinical Sites By Bringing Together Pharma, Biomedical R&D and CROs 2/18/2015

   How do you take pharma, and other biomedical R&D, as well as CROS, which for years have operated as separate entities, and get them to come together and create standards and an accreditation process to benefit the entire industry, indeed, the entire enterprise of a complex of multiple stakeholders, including regulators and the public? 

8. Four Ways To Avoid Clinical Monitor Burnout 8/2/2013

   Anyone involved with clinical research knows the world of drug trials can be demanding, especially for trial monitors. These individuals spend long hours on the job and are generally required to travel extensively. Lynn King, AVP of clinical operations for contract research firm Rho, understands the stress all too well. King has been involved in clinical research for more than 20 years and has spent some of that time working as a trial monitor. She now works closely with monitors, spending time on-site with them and discussing the challenges they face.

9. Pharmacovigilance Trends: Getting To Know The DSUR 4/15/2013

   In 2010, the International Conference on Harmonization (ICH) rolled out its E2F Development Safety Update Report (DSUR) guideline. The DSUR is similar to the US’s Investigational New Drug Annual Report (IND-AR) and the EU’s Annual Safety Report (ASR) in that its purpose is to provide a brief overview of safety for a project on an annual basis. By Malarkodi S. Moorthy, M.Sc., M.Phil., Medical Writer

10. Pharma Merger Trends - Insights From An Industry Consultant At Rondaxe 3/26/2013

    Just three months into 2013, several merger announcements have already crossed the wires. I spoke with Joel Lirot, VP of business development for consulting firm Rondaxe, about merger and acquisition trends he sees in the pharmaceutical industry.