• Global Opportunities and Requirements for Expedited Pathways

    This interview features insight from two leading industry executives, Bridget Heelan and Bhardwaj (Bob) Desai , on the complexities of expedited pathways in in the major markets of the US, EU and Japan and highlights expedited pathways with regard to significant benefit, clinical trials design and data, surrogate end points, orphan drugs, reimbursement and potential drawbacks to expedited pathways. Introduction Because of increased research and drug developme...
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    Expanded Access Programs: Making Compassion Work

    This article discusses issues and efforts related to expanded access programs aimed at providing patients with quicker access to new and experimental drugs, many of which are potentially lifesaving. The perspectives of health authorities, industry and patients are explored as well as the historical legal and ethical issues involved in ensuring expanded access drugs are safe and efficacious. Introduction In the late 1980s and early 1990s, the HIV/AIDS emergency prompted ...
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    Re-Designing Regulatory Capabilities

    Faced with growing regulatory burdens, Bristol Myers Squibb (BMS) and Halozyme each committed time and resources to connect regulatory functions from end-to-end with the goal of improving efficiency and transparency. This article describes how two very different companies made their business case, streamlined processes and managed change. The article also provides elements of what the two companies learned along the way. Introduction Life sciences companies are driving ...
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    Responding to the Challenges of Meeting the New EU Regulations Requirements: Insight from Three Global Regulatory Executives

    This article describes efforts to prepare Cook Medical and its partners for full implementation of European Union Medical Device Regulations in (EU-MDR) in 2020. It is based on interviews with Cook executives Jennifer Kerr, president of Cook Research Incorporated (CRI), April Lavender, senior vice president of regulatory affairs for Cook Medical, and Sinead Quaid, director, global regulatory affairs, at Cook Ireland. Introduction With the European Parliament's final app...
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    Implementing the New EU Medical Devices Regulations

    This article discusses the steps toward implementing the new EU regulations on medical devices with a focus on better pre-market control, establishing oversight and data systems. It is based on a presentation given by Salvatore Scalzo at the RAPS EU Regulatory Essentials Workshop held in Brussels, Belgium in July 2017. Introduction Provisions related to the European Union's (EU) medical devices legislation are currently explained in three directives. Directive 90/385...