Regulatory & Safety Operations: Unlocking Additional Value of Your Marketed Products

Many marketed products bring in a large portion of revenue for a company, but are not necessarily drivers of growth. As organizations explore new ways to do more with less, the ongoing costs of regulatory and safety activities needed to keep products on the market globally are becoming a prime target, especially given the significant infrastructure and human resource costs for those activities. This webinar will help you understand how to increase efficiency, optimize decision making and ultimately improve profitability for maintaining your marketed products.

With pipelines diminishing and the cost of bringing products to market rising, operational departments (especially Regulatory and Safety) are under more pressure than ever to reduce costs and increase value. Additionally, new upcoming changes to international regulations and obligations are likely to lead to further escalating costs. In order to thrive (rather than just survive) in this new environment, companies must adopt more strategic approaches to product maintenance by introducing repeatable processes that are cost effective, adaptable to future changes and operationally effective. Developing scalable solutions for decreasing the long-term operational burden for multiple products in your portfolio can have a significant impact on the bottom line.

During this webinar, we will provide insight into primary cost drivers and explore key activities that can help make the biggest impact to improving profitability. We will also discuss strategies for outsourcing, as well as example process and technology approaches to improve efficiency and governance. These novel approaches can not only help you increase revenue for marketed products, but also improve strategic decision making.

Some approaches we will cover include:

• Core/Non-core Assessments (identification of activities that are critical to keep in-house,
  versus those that can be outsourced)
• Sourcing Strategies (decision criteria for determining what to outsource and how best to
  outsource effectively to achieve desired cost reductions or other key goals)
• Process and organizational optimization (development of repeatable processes or
  organization structures that improve efficiencies and reduce costs)
• Metrics and IT-enabled dashboards (identification of what to measure to make more
  informed decisions, as well as visualization tools to improve access to critical data)

Understanding these approaches will enable you to better explore your options, determine what akes the most sense for your product portfolio, and help you make smarter decisions about optimizing your business and improving profitability.

For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email [email protected]

Speakers

Geoff Garabedian, VP and Managing Director - Regulatory & Quality and Horizontal Capabilities, Quintiles

What he does: Geoff leads the Regulatory & Quality practice within the U.S., as well as the horizontal solution areas across Consulting (Process Optimization, IT Strategy & Implementation, Change Management and Program Management).

Areas of expertise: Over the past 21 years, Geoff has been delivering management consulting solutions to Life Sciences clients, with a mix of strategy development, process design, technology implementation and change management skills.  Geoff’s primary focus is helping companies improve operational performance and compliance through process and IT solutions, coupled with change management activities to help ensure sustainable change.  Geoff’s expertise has been mainly focused on the R&D, Medical Affairs, Regulatory Affairs and Pharmacovigilance areas.

Relevant project examples: During his career, Geoff has led numerous consulting projects, ranging from facilitation of strategic planning sessions for organizations to design and implementation of large-scale organization, process and technology transformations.  Geoff has worked with many large pharmaceutical companies, as well as various smaller pharmaceutical start-ups, biotech and device companies.

Prior work experience: Prior to joining Quintiles, Geoff was a partner at BusinessEdge Solutions within their Life Sciences industry group. He led the R&D practice, which encompassed Clinical Development, Regulatory Affairs, Medical Affairs and Pharmacovigilance. Prior to joining BusinessEdge in 2003, Geoff was at Accenture for 11 years, focusing on process and technology solutions within R&D, Regulatory Affairs, Medical Affairs and Compliance.

Education: B.E. and B.A. from Stevens Institute of Technology.

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Peter Lassoff, Pharm.D., Vice President and Head, Global Regulatory Affairs, Quintiles

What he does: Works with global clients in the pharmaceutical, medical device, cosmetic, nutrition and other industries on regulatory strategy and implementation to ensure their products are placed on the market in the fastest, least expensive manner.

Expertise: The development and worldwide registration of medicinal products, biotech products, ‘borderline’ products, medical devices, cosmetics and ‘cosmeceuticals’, nutritional supplements and other regulated health-care products.

Project examples: Has registered hundreds of products in Europe, the US and global markets, including joint NDA/Centralised EMA submissions. Provides regulatory strategies for the development of products for global markets from preclinical to post-marketing. Provide expert regulatory due diligence services for companies purchasing products or companies.

Experience: Has worked in the pharmaceutical industry for 30 years. Prior to joining Quintiles, was VP Europe for Parexel Consulting. Prior to that worked in BMS, ConvaTec and Stiefel.

Education: Doctor of Pharmacy (Pharm.D.) from the University of Southern California School of Pharmacy,1986

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Uwe Maennl, MD, Ph.D., MBA, Vice President and Global Head of Lifecycle Safety, Quintiles

Uwe is responsible for developing and implementing Quintiles’ integrated drug safety
and benefit -risk-management strategies. In addition, he works to develop initiatives
that bring forward innovations in all aspects of integrated lifecycle drug safety and
benefit- risk management services at global scale, both on operational level and under
the strategic aspect. Uwe specializes in the development of novel drug safety and risk
management delivery platforms as solutions for business support and outsourcing
purposes. In doing so, Uwe is following the paradigm that only holistic, consequent
and integrated management of benefit and risk information will maximize the value of
surveillance activities for improving the safety of clinical trial subjects and patients.

Previously, Uwe held senior global drug safety roles with major pharmaceutical
companies and CROs. He was also a practicing anesthetist in intensive care units in
Germany and the UK. Uwe is a UK GMC-registered specialist in anesthesiology. As
part of Interplast, Uwe provided medical services in Guinea, West Africa. He earned
his medical degree and doctorate in medical sciences from Johann Wolfgang Goethe
University in Frankfurt, Germany and later earned Masters of Business Administration
from Macquarie Graduate School of Management, Sydney, Australia.

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Jill Buckley, Pharm.D., Global Head of Safety Operations, Quintiles

What she does: Provide senior strategic leadership for Lifecycle Safety, Service Operations (SO), developing global, cross-functional integrated delivery plans for safety operations throughout all stages of product development.

Areas of expertise: Clinical Trial and Post Marketing Operations, Aggregate Reporting, Risk Management, Signal Detection

Industry leadership: Responsible for building the Drug Safety and Safety department at King Pharmaceuticals

Prior work experience: Jill has more than 25 years industry experience and came to Quintiles from King Pharmaceuticals, Inc.

Education: Doctor of Pharmacy from University of Michigan, Resident in Hospital Pharmacy at Duke University Medical Center, Drug Development and Clinical Research Fellowship from University of North Carolina, Chapel Hill

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