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KNOW WHERE YOU’RE GOING:
Set a Business Strategy Roadmap to Ensure Peak Sales
Bridging the Gap Between Business & Clinical Development:
How (and When) do you Engage and Collaborate with Commercial Colleagues in Strategic Planning for R&D Studies? There is an increasing awareness of the potential benefit of successful collaboration between the research and development and commercial divisions within industry. As the line between these divisions becomes blurred is it truly possible to gain a balance between the...
- Peter DiBiaso, Senior Clinical Operations Director, Clinical Research & Development, Shire Pharmaceuticals
How Can I Expedite Go/No Go Decisions in Clinical Development to More Efficiently Move Viable Compounds into Phase 3 Development
This session helps maximizing proof on concept potential for early phase studies and increase registrational potential in later phase...
- Keith Wilner, Senior Director, Oncology Clinical Development,Pfizer
Developing a Business Case for Clinical Improvements and Total Drug Valuation: Does Cost Impact Value Creation
How do you financially value your clinical investment and sourcing projects? How do you prioritize and select amongst a portfolio of... - Jeffrey J. DiFrancesco, Assistant Professor, Mayes College of Healthcare Business and Policy, University of the Sciences in Philadelphia
Expediting Trial Enrollment through Predictive Modeling
Too many companies leave enrollment to chance, despite knowing all too well the bottlenecks and obstacles that prevent on-time... - Roger Smith, Chief Information Officer & Vice President of Operations, Acurian, Inc.
| PARTNER FOR SUCCESS:
Maximize Key Stakeholder Relationships
How Payer Perspectives Might Shape the Future of Drug Development Strategies:
Health Economics, Patient Outcomes, & Proving Stakeholder Value To continue R&D investments at traditional levels, new products must succeed commercially, and industry must ensure the right products are being developed that will lead to market sustainability and peak...
Panelists: - Elizabeth Bewley, Vice President, Strategic Planning, Johnson & Johnson Health Care Systems, Inc.
- Gergana Zlateva, Director, Global Outcomes Research, Pfizer
- Suzanne McDonald, Vice President, government and External Affairs, Takeda Pharmaceuticals North America
- Helen Sherman, Chief Pharmacy Officer, Pharmacy Services, The Regence Group
How Can you Leverage Offshore Capabilities, Align your Strategy, and Maintain a Successful Global Partnership
How you structure your global alliance management structure can be the deciding factor between whether your trial fails or succeeds. You need confidence in your global partner for complete end to end information sharing to...
Panelists: - Julia Santos, Worldwide Associate Director, Strategic Outsourcing, Johnson & Johnson
- Robert Ward, Vice President, Alliance Management, NPS Pharmaceuticals
- Kendra Eager, Assistant Vice President, Global Business Development, Wyeth Pharmaceuticals
Alliance Management: An Opportunity for Turn Key Project Management
The management of projects in any industry is typically filled with challenges, however, based on the unique nuances of the contract pharmaceutical/clinical arena, effective project management can be... - Viq Pervaaz, Vice President, Global Project Management, MDS Pharma
Managing eClinical Technology: Avoiding the Trips, Traps and Gotchas
The use of eClinical technology is becoming the nrom. As Sponsors and CROs, you're expecting the use of this technology to improve efficiencies and data quality. Don't let the often overlooked "trips, traps and... - David Friend, Director of Key Account Management, MedNet Solutions, Inc.
| DO MORE WITH LESS:
Implement Metrics for Productivity Enhancement
What Can We Learn from the Small Pharma/Biotech Model of Clinical Development?
Smaller pharma and biotechs organizations are faced with limited resources in human and financial capital than large pharma, yet are acknowledged in the industry as the innovators- staying ahead of the curve in discovering new compounds and pushing...
Panelists: - Maria G. Rachelle, Director, Clinical Trial Management, Genentech, Inc.
- Rashieda Gluck, Head of Clinical Operations, Vifor Pharma
- Deborah Profit, Associate Director, Clinical Operations, Global Clinical Development, Otsuka Pharmaceutical Development
Maximizing Internal Resources on External Projects: Application of Project Management Principles to Outsourced Projects to Drive Efficient and Effective Delivery
Excellent Contract and Relationship Management are critical to successful outsourcing. However, to ensure performance meets the ever increasing business demands in terms of time, cost, and quality, a more rigorous... - Thomas P. Lawler III, Senior Director, Clinical Project Management, AstraZeneca Pharmaceuticals
Integrating a Metrics-Driven Approach to Subject Enrollment to Optimize Site Productivity
Understanding stakeholder objectives in order to develop appropriate metrics... - Christopher Sleat, Chief Operating Officer, Chief Technology Officer, Inclinix, Inc.
| SLASH TIME TO APPROVALS:
Design your Trial to Increase Speed to Market
How Can you Fully Enroll a Trial in One Day? Overcoming Patient Recruitment Bottlenecks
The biggest contributing factor to the success or failure of a trial is patient enrollement. Intelligent site identification and patient outreach can take months off clinical trial timelines and prevent...
Panelists: - Joseph Kim, Patient Recruitment Specialist, Merck & Co
- Gretchen Goller, Patient Recruitment/Compliance Specialist, Operations, sanofi-aventis
- Brad Allen, Clinical Trial Enrollment Optimization Consultant, Global Enrollment Optimization, Eli Lilly & Co
How Can I Design a Trial to Ensure It’s Positioned for Faster Regulatory Approval
An increase in the number of drug recalls has led to heightened safety concerns and consideration. Sponsors are diving deeper into how to integrate drug safety knowledge across the drug compound’s lifecycle, creating robust...
Panelists: - Ming Ji, Executive Director, Product Safety, Amgen
- Bruce Binkowitz, Senior Director, Late Development Statistics, Merck
| | | LOOK TO THE FUTURE:
Ensure you Thrive in the New Environment
Where Will we Find the Next Therapeutic Area Breakthrough and How Will it Impact your Clinical Trials
Advancements in science, R&D, genomics and individualized medicines hold the potential to make new drug development breakthroughs become a reality…
Panelists: - Perry Nisen, Senior Vice President, Cancer Research, GlaxoSmithKline (Oncology)
- Scott Patterson, Senior Director of Statistical Science, Vaccines and Infectious Disease, Wyeth (Infectious Disease)
- Marc Cantillon, Senior Director, CNS Clinical Research, Schering-Plough Research Institute (Oncology)
Where Will we Find the Next Big Global Site? Gaining Confidence in Expanding your Operations beyond China and India
While China and India have emerged to the forefront of globalization efforts, pharma executives must always be looking to find what’s next for global expansion. Evaluate key factors in each region, including getting in on the ground level to train and...
Panelists: - Chandrashekhar Potkar, Director, Clinical Research, Pfizer India
- Grace Woo, Director, International Clinical Operations, sanofi-aventis
- Murray Stewart, Vice President, Clinical Europe, GlaxoSmithKline
Why Social Media will Be A Key Element to Pharma’s Ability to Compete and Succeed in the Future
Engaging, interacting, and connecting will be a key element to pharma’s ability to compete and succeed in the future. Wikis, blogs, video streaming like YouTube, virtual worlds, and social networks like Facebook and MySpace have become mainstream and are accelerating... - Kristin Eilenberg, Global Customer Solutions, Explorer and Evangelist, Innovation and New Media, Eli Lilly & Co
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