FEATURED ARTICLES

Novartis: Pragmatic Clinical Trials & RWE Gain Traction Novartis: Pragmatic Clinical Trials & RWE Gain Traction

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.

  • Market Access Insight Commercial Considerations For Pharmaceutical Products

    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.

  • Clinical Leader Expands Editorial Advisory Board

    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.

  • Is The Sunshine Act Reducing Clinical Research Spending?

    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.

WHITE PAPERS & CASE STUDIES

  • Late Stage Clinical Research Services Brochure

    As a result of our holistic approach to Late Stage clinical programs and with our expertise in Product Life Cycle Management, INC Research/inVentiv Health is strategically positioned to collect real world, differentiating product evidence that can prepare our clients to more successfully go to market.

  • Commercial Regulatory Approval And Market Adoption Expertise Brochure

    We’ve invested in a strategic mix of proprietary services and infrastructure that offers each client customized solutions through a singular team to thrive in the new market reality.

  • Commercialize Oncology & Hematology Services Brochure

    At INC Research/inVentiv Health, we are reinventing the way our oncology clients commercialize products to optimize performance, reduce risk, and expedite the delivery of healthcare innovation to patients worldwide. In the last five years, we have conducted over 250 full-service oncology programs in more than 65 countries.

  • Commercial Regulatory Approval And Market Adoption Expertise Brochure

    We’ve invested in a strategic mix of proprietary services and infrastructure that offers each client customized solutions through a singular team to thrive in the new market reality.

  • Top 10 Questions To Ask Your Clinical Supply Vendor About Temperature Sensitive Drugs

    When conducting trials of biologics, the number of considerations to evaluate within the clinical trial supply chain can be daunting. Keeping investigational products at the right temperature and environmental conditions takes careful coordination of resources and, when required, tight integration with an experienced vendor.

  • InVentiv Health Late Stage Research Datasheet

    In today’s competitive landscape, getting a drug on the market is no longer about meeting clinical trial requirements, receiving regulatory approval and launching the drug. Drug developers need to generate evidence that shows whether a drug works in the real world and the benefit and value it provides to the healthcare system and patient.

SERVICES & PRODUCTS

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.

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.

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.

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.

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.

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.

NEWS