Potent Compound Safe Use and Management
10:00am – 11:15am

Pharmaceutical companies are creating compounds that are more potent or have greater selectivity than ever before – therapeutic doses are continually getting smaller. While this increasing potency is of great benefit to patients, it can be equally unhealthful to employees who have to handle the compounds. A panel of industry experts will explore the facility management issues of safe potent compound handling and how they impact the various environments of research, development and manufacturing.

Panel Moderator:

Leslie O’Rourke-Garrett
Manager, Environmental Health and Safety, Cytokinetics

Panel Speakers:

Robert Bacci
Associate Director of Environmental Health and Safety, Nektar Therapeutics

John Farris
President & Chief Executive Officer, SafeBridge Consultants, Inc.

Jennifer Wright
Chemical Hygene Officer, Genentech

Planning for Lab Automation
11:30am – 12:45pm

The session on Laboratory Automation will explore the subject of Lab Automation for research from a variety of perspectives.

The goals and roles of lab automation equipment to support drug discovery in a research program will be discussed. What automation can and cannot do and the subject of compound storage and management will be presented.

Considerations and issues associated with selecting and purchasing automation equipment will also be discussed. Reliability of equipment, rate of equipment change, costs, consumables and maintenance of equipment are issues.

Planning and building research spaces and building systems for lab automation will also be considered. The flow of materials, designing flexible lab spaces around significant pieces of automation equipment, special levelness/vibration requirements, specialized systems to support automation and unique lab automation project management issues will also be discussed.

Panel Moderator:

Martin Gicklhorn
Partner, Gicklhorn Lazzarotto Partners

Panel Speakers:

Eric Ahlstrom
Project Manager, Amgen

Joe Barco
Applications Scientist, Velocity 11

Bill Gigante
Research Automation Engineer, Amgen

Challenging and Confirming the Facility through Process Modeling
2:00pm – 3:15pm

Facilities are designed to meet specific production requirements with some flexibility for the future. When those requirements change to incorporate new or additional products or to increase production the facility design, infrastructure and utilities are challenged. In biotech, the need to transition from one product to another or increase capacity quickly is a common occurrence. The use of process modeling to evaluate the support systems, utilities and even space within the facility enables one to ensure that increased production and/or implementation of a new or additional product will be successful. Facility capabilities are challenged quickly with multiple possible solutions explored. Risks and advantages for these solutions lead to providing the best option for the facility. Examples of how multiple facilities were challenged to implement production changes will be discussed.

Panel Moderator:

Sue Cost
Manager of Business Development, Western Region, Alfa Laval Biokinetics, Inc.

Panel Speakers:

David Himes
Principal Simulation Engineer, Alfa Laval Biokinetics, Inc.

Scott Silverness
Director of Process Engineering, Chiron

Amy Webb
Process Engineer, Chiron