Day Two

Thursday, 26th September, 2013

8.25 Registration, Coffee & Networking

9.00 Chair’s Opening Remarks

Stephen Barat, Senior Director, Toxicology and Operations, Forest Laboratories

Increased Efficiency In Safety & Toxicological Assessments

9.05 Leachables and Extractables – The Toxicologist’s Perspective

• Closer collaboration with toxicologists can lead to faster and more cost efficient PFS development

• A case study demonstrations of assessment excellence

William Beierschmitt, Associate Research Fellow, Pfizer

9.35 Current Approaches in the Safety Assessment of Leachables from Pre-Filled Syringes

• Overview on the need for safety evaluation of leachables from container closure systems

• Current thinking related to industry best practices for leachable safety assessment

• Case example to illustrate principles discussed

Stephen Barat, Senior Director, Toxicology and Operations, Forest Laboratories

10.05 Using ELSIE for Improved Toxicological Assessments

• Advancing principles of QbD by enhancing the prospects for identifying potential safety issues at the initial stages of the development process

Lee Nagao, Senior Science Advisor and Member of the ELSIE Board, Drinker Biddle & Reath

10.35 Morning Refreshments and Networking

Enhancing Formulation For Best Performance

11.00 Novel Advances in Silicone/Drug Interactions

• The latest on silicone oil-induced aggregation of proteins

• Minimize the impact of micro droplet related immune response for better drug performance

Ted Randolph, Gillespie Professor of Bioengineering, University of Colorado

11.30 Patient, Formulation and Device Considerations for Subcutaneous Delivery of Antibody Doses Greater Than 150mg

• Learn how formulation/device approaches can overcome increasingly important patient demands on comfort and ease of use

Bill Lambert, Fellow, Drug Delivery and Device Development, MedImmune

Getting The Right People To Ensure Success

12.00 Current and Future Challenges of Recruiting Injection Device Human Capital

• Learn why recruiting the best injection device developers is becoming increasingly difficult

• What does the future hold for recruiting in this space?

Kevin Kannady, Principal Talent Acquisition Specialist, Genentech

12.30 Mastermind Session

This session runs in a very focused format to promote collaborative discussion across topics and questions raised at the summit.

1.00 Networking Lunch

Understanding How To Work With Human Factors

2.00 Understanding Human Factors Standards and Guidances for Pre-Filled Syringes

• Overview of current Human Factors standards and guidances and what to begin preparing for

• Current implications on pre-filled syringe development

Edmond Israelski, Director, Human Factors, AbbVie

2.30 Understand the Implications of Needle-Stick Prevention Laws and How to Work With Them

• Legislation requirements and compliance issues will be covered

• Learn new Human Factor designs for pre-filled syringes to ensure device safety

Ron Stoker, Executive Director, ISIPS

3.00 Afternoon Refreshments and Networking

Overcoming Pre-Filled Syringe Manufacturing Challenges

4.00 Complying To Small Volume Syringe Standards

• The industry’s expectation pertaining to particle detection

• Understand modifications that are necessary to tune automated inspection equipment, qualify manual inspectors and automated inspection equipment

• Mitigating against adverse effects that can occur as a result of these modifications

Gabriel Anderson, Production Engineer, Novartis

4.30 Technical Approaches to Enhance Biodefense and Pandemic Response

• Explore challenges associated with current filling methods

• Modern technology to increase efficiency and reduce manufacturing time

Tim Lee, Industry Advisor, Formerly Sanofi Pasteur

5.00 Chair’s Closing Remarks