The Safety First Era


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Product Description

In the post-REMS world, pharmaceutical companies have an opportunity to differentiate themselves and positively impact healthcare delivery.

The classwide requirement for Risk Evaluation and Mitigation Strategies (REMS) for opioid products is likely to have a profound impact on the pharmaceutical industry and healthcare. While most REMS involve only a medication guide — which is likely to have little impact on the prescribing process — experts say the Food and Drug Administration’s classwide requirement for opioids opens new opportunities for companies.
“There is no doubt that more extensive REMS programs with more comprehensive ‘elements to assure safe use,’ such as registries, will definitely complicate — and in some cases potentially dissuade — prescribing and thus may limit the potential of many brands,” says Dan Bobear, executive VP, managing director of client service, at Palio. “In the case of a classwide REMS mandate, such as in opioids, healthcare providers will adjust and life will go on. I think it is really important to embrace the REMS mandate as, for some drug classes, it will most definitely…

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Prescription Drug Abuse and Misuse

Sound Bites From The Field
Jan-Anders Karlsson, Ph.D., is CEO of S*BIO Pte Ltd., which is focused on the ­discovery and clinical development of novel ­targeted small molecule drugs for the treatment of cancer. For more information, visit
Ilyssa Levins is President and Founder, Center for Communication ­Compliance (CCC), a ­centralized resource, ­training, and certification portal designed to support and enhance risk ­communication and regulatory compliance. For more information, visit
James R. Weston is Senior VP of Talaris Advisors LLC, ­which provides solutions for drug, diagnostic, and device ­development worldwide bringing significant flexibility and efficiency to clients through turnkey management solutions. For more information, visit

Experts on this topic
Karla Anderson. Managing Director, ­Pharmaceuticals and Life-Sciences Advisory Services Group, PricewaterhouseCoopers, which provides industry-focused advisory services. For more ­information, visit or e-mail
Dan Bobear. Executive VP, Managing Director of Client Service, Palio, a full-spectrum advertising and ­communications agency. For more information, visit
Jeff Fetterman. President, ParagonRx, which specializes in risk management. For more ­information, visit
Nayan Nanavati. VP and General Manager, ­Peri- and Postapproval Research, and Worldwide Head of Pharmacovigilance, Parexel, a global provider of consulting, clinical research, e-clinical technologies, and medical ­communications capabilities. For more information, visit ­
Scott Treiber, Ph.D. Executive VP, Clinical ­Development Solutions, inVentiv Clinical ­Solutions, a provider of clinical outsourcing. For more information, visit ­