Interview with Reinerio A. Deza, M.D., Head Global Pharmacovigilance at Cubist Pharmaceuticals, Inc

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* Pharmacovigilance
* Pharma
* Drug Safety
* Rems
* Clinical Safety

* Biotech
* Event
* Medical

* Chicago - Illinois - US

April 19, 2012 - PRLog -- Reinerio A. Deza answered a series of questions written by marcus evans before the forthcoming 2nd Global Pharmacovigilance & Adverse Event Reporting Conference, May 22-24, 2012 in Boston, MA. All responses represent the view of Mr. Deza and not necessarily those of Cubist Pharmaceuticals, Inc.

Many pharmaceutical companies are facing budget cuts and also increased expectations to have a robust drug safety function. How does outsourcing play into this situation?

RD: Outsourcing can be leveraged to provide support for the common or ordinary business activities, allowing the company’s safety staff experts to focus and address critical or complex safety reviews/assessments/reports. Similarly if the company does not have the subject matter experts, outsourcing can fill the gap.

What can companies do to maximize their resources?

RD: Use of contractors or outsourcing balanced with workload demand. This works well with allocating specific tasks or projects with known or finite timelines and clear deliverables.

How do you come up with the best balance between in-house and outsourced projects?

RD: As a guide, we want to keep sufficient in-house staff to handle critical and urgent issues.  Select projects with well thought processes and systems in place to monitor project status, deliverables, and timelines. We need to take extreme care and be very thorough in selecting the outsource partner to ensure they meet our needs not only for the specific project but for the entire program and end result as a whole. The more confidence and trust we have in our selected outsource partner, the less in-house staff would be required to monitor and maintain the outsourced projects.  

In your 20+ years of experience, how has the pharmaceutical industry’s viewpoint of outsourcing changed?

RD: Outsourcing was initially viewed more as a tactical partner but has now grown to be an integral part of industry and has expanded in developing strategic roles with industry.

What role do you see outsourcing playing in the future?  

RD: The industry business operating models are dramatically changing especially with new regulations, competition, and demands to rein-in and reduce healthcare costs. As a result there will be more consolidation and innovations for drug development in the industry. Clearly outsourcing will be an important player in the development of the new models especially at the operational level.  

Dr. Reinerio A. Deza is currently Global Head of Pharmacovigilance at Cubist Pharmaceuticals.  Dr. Deza has over 20 years of experience in the pharmaceutical industry, which have been primarily in the area of Pharmacovigilance (PV) but has also included Medical Affairs.  Most recently, Rene was at Merck (Schering-Plough) as the Sr. Director of Medical Services and the Clinical Risk Management Group with responsibility for their strategic products.  

For more information please contact Michele Westergaard, Marketing/PR Coordinator, marcus evans at 312-540-3000 ext. 6625 or

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Source:Michele Westergaard
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Tags:Pharmacovigilance, Pharma, Drug Safety, Rems, Clinical Safety
Industry:Biotech, Event, Medical
Location:Chicago - Illinois - United States
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