Regulatory Focus™ > News Articles > 7 > Innovative Technologies, 3D Printing, Accelerated Pathways, Biosimilars and an Update on Brazil

Innovative Technologies, 3D Printing, Accelerated Pathways, Biosimilars and an Update on Brazil

Posted 02 July 2018 | By Gloria Hall 

Innovative Technologies, 3D Printing, Accelerated Pathways, Biosimilars and an Update on Brazil

Articles posted throughout June featured various innovative technologies, including the increased use of artificial intelligence in the healthcare industry and the challenges of adopting 3D printing or additive manufacturing to develop products in the pharmaceutical industry. Other articles focused on the FDA’s Emerging Technology Program, critical technologies for conducting global clinical trials, complexities of global accelerated pathways in EU, US and Japan, innovative approaches to expediting biosimilar drug development and efforts to improve the drug regulatory environment in Brazil.

Innovative Technologies

Artificial Intelligence (AI) has been used extensively by various industries, such as finance, aviation and marketing. Although its use is relatively new in healthcare, there are three areas for the use of AI in which healthcare providers make decisions: screening, diagnosis and treatment planning. Experienced regulatory professionals, Samyukta Rajkumar and Stephen F. Amato, recommend potential approaches for resolving regulatory challenges that may arise with the use of new technologies and discuss the variety of FDA initiatives aimed at helping to solve AI regulatory challenges. “Regulatory Challenges for Artificial Intelligence Applications in Healthcare” addresses the regulatory challenges associated with using AI and explores challenges in regulating “digital health” and review various pathways to gain regulatory approval for artificial intelligence applications.

An important step in FDA’s mission to support pharmaceutical innovation and modernization to protect and promote the public health was the publication of the final guidance, “Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization.” Accomplished regulatory specialists, Monika Jain and Shilpa Rana, discuss important aspects of FDA’s “Emerging Technology Program” with a focus on emerging technology, such as continuous manufacturing and 3D printing, and detail what information is to be included in drug submissions. “Emerging Technology Integration in FDA’s Drug Approval Process” highlights a number of benefits of the program, including the synergy created between FDA and the pharmaceutical industry.

A candid interview with Terry Murphy, Vice President of Janssen Research and Development describes problems experienced with the company’s critical technologies for conducting global clinical trials, how the decision was made to replace them and what new technologies were implemented. “Unifying the Clinical Landscape to Drive Efficiency and Compliance,” reviews the benefits gained after the replacement was completed and also explains how the company maintains data security while they are “watching the marketplace and the evolution of technology.”

3D Printing

The healthcare industry is on the precipice of a new wave of innovation, encompassing medical devices, medications and the generation of human tissues using Additive Manufacturing (AM) or 3D printing to manufacture products. Former CDRH policy advisor and regulatory expert, Sugato De, discusses the value, potential and challenges of using 3D printing to develop products for use in the pharmaceutical industry. “FDA Releases Novel Technical Framework for 3D Printed Medical Devices” reviews the FDA’s guidance on AM in terms of design as well as manufacturing and device testing considerations. Emphasis is placed on the evolutionary aspects of providing final guidance on 3D printed products as well as the need for manufacturers using AM to establish early and frequent engagement with FDA through the AM product development process.

Medical device manufacturers are using 3D printing to create devices that were previously impossible to make, personalized to the patient or both. Hear from regulatory veteran, John Lincoln, as he shares his experience with “3D printing” or “additive manufacturing” for the manufacturing of medical devices, including replacement body parts. His article, “Additive/3D Printing Manufacturing: Regulatory Concerns,” reviews a new US FDA guidance document and discusses the unique issues posed by this technology, key concerns due to radically different features of such manufacturing and various ways to address the resulting FDA quality and regulatory concerns relative to ultimate patient safety.

Accelerated Pathways

Drug development traditionally involves long clinical trials and exposes thousands or tens-of-thousands of patients before health authorities can accept applications for market authorization. For serious life-threatening diseases with limited treatment options, global health authorities have recognized a need to offer programs and designations that can offer drug developers expedited routes to bring products to the market. All three major International Council for Harmonisation (ICH) regions, including the US, European Union (EU) and Japan offer accelerated pathways to enable expedited launch of life saving medicinal products and technology which represent a true shift in the clinical standard of care in the respective disease area. Three executives from AstraZeneca, Victoria Marsh, Jonathan Jazayeri and Priya Govekar, provide a high-level overview of the available accelerated pathways. “Accelerated Pathways in the US and EU for Expedited Marketing Authorization Approval” includes a case study on Tagrisso and focuses on the sponsor’s journey through the accelerated pathways in US and EU to deliver a vastly improved drug development timeline.


The biosimilars market continues to expand with $19 billion of current biotech spending predicted to be exposed to biosimilar competition for the first time in 2018. With at least 240 biosimilars in development, further growth is forecast. IQVIA experts, Raymond A. Huml, Jill Dawson, Oxana Iliach, Charu Manaktala and Nigel Rulewski, discuss innovative approaches to expediting biosimilar drug development in “ Trends in Biosimilars: Innovative Approaches to Expediting Development.” As sponsors of biosimilars seek additional efficiencies to get to the market more quickly, it is important for regulatory professionals to become aware of the different tactics and options that biosimilar drug developers can employ to bring copies of expensive biologics to the global market not only more quickly, but more broadly and less expensively.

Brazil Update

The global pharmaceutical industry considers Brazil a promising market. With new regulations and the Brazilian Health Regulatory Agency’s (ANVISA’s) efforts to improve regulatory processes, the drug regulatory environment has been moving toward shorter review timelines for Marketing Authorization Applications (MAAs) and post-marketing changes which prior approval is required. Hear from regulatory experts, Helio Jeng and Vitor Kimura, as they discuss changes to Brazilian law regarding its pharmaceutical industry. “ Brazilian Regulatory Timelines for Drug Applications” explains how ANVISA is overhauling and improving regulatory processes, streamlining the time to drug approval and impacting the public’s health and welfare.

What’s Coming in July

July feature articles will focus on nutrition in health and disease management and cover a wide range of topics including policy and regulatory framework, the changing healthcare paradigm, new opportunities for food (health) and drug (disease) systems and historic pharmaceutical and nutrition “models.” Other topics will include combination products, regulatory challenges of additive manufacturing and precision medicine. Look for these topics and more in July. Have a suggestion for a feature article? Contact me at

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