Ernst & Young LLP and YourEncore have formed a strategic alliance to provide offerings aimed at helping life sciences and consumer products clients accelerate product development, strengthen regulatory compliance, and improve productivity. The alliance combines EY management consulting, transaction advisory, and tax services with YourEncore’s range of services designed to help clients innovate, drive growth, manage risk, and comply with increasing regulatory challenges. 
 
The companies have developed the Customer Engagement & Safety Compliance (CESC) platform to help life sciences companies address patient safety and adverse event reporting challenges stemming from the rise of social media and other digital communication channels. The offering is designed to help clients capture, analyze, and monitor patient safety information in compliance with adverse event reporting requirements. 
 
The alliance will also introduce services that help companies comply with upcoming revisions to the EU Medical Device Directives, which will require enhanced supply chain traceability.
 
Lisa Arbogast, Vice President, Life Sciences at YourEncore discusses the alliance, major regulatory hurdles in today’s pharma/biopharma market, accelerating product development and productivity, and the main challenges associated with patient safety and adverse event reporting.  –KB

Contract Pharma: What was the strategy behind the EY/YourEncore alliance?
 
Lisa Arbogast: As the world get more complex, global, and regulated, we saw a need to serve clients differently. The strategy was to set a new standard in professional services by combining EYs world-class consulting capabilities with YourEncore’s industry and technical knowledge. Organizations have been disappointed in the quality of outsourcing and our alliance provides an alternative that looks very much like insourcing.
 
CP: What are some of the major regulatory hurdles in today’s pharma/biopharma market? How do you help clients overcome them?
 
LA: First and foremost, regulations are changing at a faster pace than ever before and the changes are global and implicate the entire value chain. The need for additional regulation is directly related to the patient; being able to deliver products that are represented with accuracy, safety and effectiveness on a timely basis anywhere around the world. The need for traceability and transparency has never been greater. Our alliance provides the means to interpret new regulations, strategize, assess our clients’ ability to comply with these regulations and finally, integrate the new regulations in a manner that is scalable and sustainable. 
 
CP: What are some key ways clients can accelerate product development and improve productivity?
 
LA: Staying abreast of the changing regulations and interpreting how to integrate them earlier within the development process increases time to market. Regulatory is a competitive advantage when viewed as a strategic driver.
 
CP: What services will the alliance provide to help clients innovate, manage risk, and comply with increasing regulatory challenges?
 
LA: Currently, the alliance is providing two solutions to the industry to innovate, mitigate risk, and comply with increasing regulatory challenges. EU Medical Device Regulations Solution – The existing EU rules date back to the 1990s and have not kept pace with the enormous technical and scientific progress in the past 20 years. Patients, healthcare professionals and other parties do not have access to essential information on how medical devices have been assessed, and what clinical evidence there is to show they are safe and effective. The need for greater transparency has been highlighted by recent scandals about faulty silicone breast implants and problems with some metal-on-metal hip replacements. It is not always possible to trace back medical devices to their suppliers therefore, new rules on identification and traceabilityof devices are being drafted. Our solution is a seven step approach to compliance change that begins with assessment of current state and working towards implementation and sustainability.
 
Customer Engagement & Safety Compliance – The life sciences industry is experiencing a significant shift from being product driven to focusing on patient outcomes in an environment of rapid regulatory change with significant regional variation. Manufacturers have placed a high priority on programs to enhance patient awareness, education and decision-making. To enhance these programs, the use of nontraditional engagement methods, such as social media, mobile health, and other digital technologies, has increased. As a result, there is increased regulatory scrutiny and greater penalties for non-compliance. Our alliance brings the necessary knowledge and experience to provide an adaptable end-to-end offering for customer engagement programs and safety reporting compliance. The solutions address the complex challenges in facilitating complete and accurate safety data capture and transfer from vendors to sponsors and in implementing effective cross-functional governance and oversight.
 
CP: What are the main challenges associated with patient safety and adverse event reporting? 
 
LA: Pharmaceutical manufacturers with the rise of social media and other communication channels are getting more creative in engaging directly with patients. These programs offer valuable platforms to exchange information, but with that also comes the responsibility to monitor those conversations for adverse events and report them to regulatory agencies. Failure to have proper adverse event reporting programs in place can impact patient safety and result in hefty regulatory fines. As companies are creating more customer engagement programs in more locations around the world, and are using more third party vendors, the complexity of managing adverse event reporting increases. 
 

Lisa Arbogast, YourEncore, Vice President, Life Sciences, leads YourEncore’s regulatory practice and the development of life sciences solutions. Lisa has spent 20 years working with Fortune 500 life sciences and consumer product companies. Her experience spans medical capital equipment, reusables, disposables, pharmaceutical and diagnostic products.
 

---

Kristin Brooks has been Associate Editor at Contract Pharma since 2004.