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]
Geoff Garabedian, VP and Managing Director - Regulatory & Quality and Horizontal Capabilities, Quintiles
Peter Lassoff, Pharm.D., Vice President and Head, Global Regulatory Affairs, Quintiles
Education: Doctor of Pharmacy (Pharm.D.) from the University of Southern California School of Pharmacy,1986Message Presenter
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.
Jill Buckley, Pharm.D., Global Head of Safety Operations, Quintiles
Who Should Attend?
Biopharma C-suite executives, EVPs, VPs, Directors, Heads, and other professionals in:
- Regulatory Affairs
- Safety/ Pharmacovigilance/Safety Surveillance/Risk Management
- Operational Excellence
- Medical Affairs
- Outsourcing Management
Quintiles helps you navigate the complexities of early-phase trials with scientific expertise, innovative approaches and flexible solutions to ensure smarter, faster trials. So you get the insights you need to confirm compound viability, identify risks and make go/no-go decisions with speed and confidence. Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of more than 20,000 engaged professionals in 60 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com/clinical-services/phase-i-iia/.