Integrating risk minimization planning throughout the clinical development and commercialization lifecycle: an opinion on how drug development could be improved

Abstract

Pharmaceutical risk minimization programs are now an established requirement in the regulatory landscape. However, pharmaceutical companies have been slow to recognize and embrace the significant potential these programs offer in terms of enhancing trust with health care professionals and patients, and for providing a mechanism for bringing products to the market that might not otherwise have been approved. Pitfalls of the current drug development process include risk minimization programs that are not data driven; missed opportunities to incorporate pragmatic methods and market-based insights, outmoded tools and data sources, lack of rapid evaluative learning to support timely adaption, lack of systematic approaches for patient engagement, and questions on staffing and organizational infrastructure. We propose better integration of risk minimization with clinical drug development and commercialization work streams throughout the product lifecycle. We articulate a vision and propose broad adoption of organizational models for incorporating risk minimization expertise into the drug development process. Three organizational models are discussed and compared: outsource/external vendor, embedded risk management specialist model, and Center of Excellence.

Keywords:

• pharmaceuticals
• drug development
• risk management
• organizational design

Disclosure

Dr Morrato received no financial support for the conduct of this study or for the preparation of this manuscript. She has received consulting fees from the Consumer Healthcare Products Association, Merck & Company, and Janssen Pharmaceuticals. She has also received travel support from the Consumer Healthcare Products Association and Merck & Company. She has received research grant support from Janssen Pharmaceuticals. She is an advisor to the FDA and a former member of its Drug Safety and Risk Management Advisory Committee and current member of its Pulmonary-Allergy Drugs Advisory Committee. She has been an invited expert at the FDA REMS Assessments Public Workshop (June 2012), the Brookings Institution’s Expert Workshop “Strengthening Risk Evaluation and Mitigation Strategies” (September 2013 – paid travel), the CTTI-FDA Opioid Workshop (paid travel), and the Conjoint Committee on Continuing Education, Opioid REMS (no financial interest). She is a member of Benefit-Risk Assessment, Communication and Evaluation (BRACE) Special Interest Group (SIG) and International Society for Pharmacoepidemiology (ISPE) (no financial interest).

Dr Smith is a full-time employee of EMD Serono, Inc. and owns stock in Abbott Laboratories and AbbVie, Inc. Other than salary support, she received no funding for the conduct of this study or for the preparation of this manuscript. She is a former member of the Council on International Organizations of Medical Sciences Working Group VIII “Signal Detection in Pharmacovigilance” and Working Group IX “Practical Considerations for the Development and Application of a Toolkit for Medicinal Product Risk Management”. She has been an invited expert speaker at the US FDA Monthly Staff Forum, the FDA REMS Assessments Public Workshop (June 2012), and the Brookings Institution’s Expert Workshop “Strengthening Risk Evaluation and Mitigation Strategies” (September 2013). She is a member of the BRACE SIG and ISPE (no financial interest). She is a co-inventor of the US patent 12/237,853, title: System and methods for management of risk data and analytics (reference #: 241957.000019; Purdue reference: 07-BM-0014US02).

This manuscript represents the views of the authors and does not represent the views of EMD Serono, Inc. nor FDA policy or opinion.