BioPharma EHS Forum ™

Wednesday, September 14

1. Keynote:

2. Risk Communication: Why Earning Trust Equity with Stakeholders Matters – The presentation will provide case studies and recommendations for companies needing to address risk with various audiences.

3. Federal Bureau of Investigation: Since the anthrax shipment disappearance, the FBI and its Weapons of Mass Destruction (WMD) unit, through its Coordinator of Personnel Reliability, are examining on-going threats to biosecurity.  The FBI has done significant outreach recently.

4. Company Experiences with CDC Select Agent Program – To follow on the previous discussion, CDC has increased its focus on its Select Agent Program. A discusscussion on experiences with the program and inspections.  Other Roundtable members will be free to share their familiarity as well.

5. Single Use Technology: Process Improvements and Waste Management– Proper handling of commonly used chemicals in bioprocessing is critical to maintaining a safe working environment, as well as operational efficiency.  Chemical mishandling can also lead to failed batch processes, quality issues, lost time and resources.  As new technologies designed to help mitigate these safety risks become available, biomanufacturers have more opportunities to ensure their production environments are safe.

6. Roundtable on EHS Initiatives Begun, Underway, or Recently Completed– Each member will take a few minutes to discuss projects and lessons learned that may be of interest to the full group.

Day one will adjourn at 5:00 p.m.; the No Host Group dinner will begin at 6:30 p.m.; details to be provided later.

Thursday, September 15

1. Tour–

2. Roundtable: Sustainable Practices and Lessons Learned – Water Conservation, Waste Management and Energy Conservation.   Each attendee is asked to bring three examples of practices to discuss with the group to make the discussion of most value.

3. Antibody Drug Conjugates (ADCs): The advent of ADCs has provided a new technology platform for the treatment of various cancers and other diseases.  In theory, ADCs allow for targeted delivery of exquisitely potent materials to tumors and other diseased organs, without the concern for off-target toxicity.  This has increased the need for the proper evaluation of the hazards of these new entities in order to provide the appropriate level of protection to individuals handling these materials in R&D as well as full-scale commercial facilities.   The discussion will be on the collaboration needed among biological and chemical experts within companies to address the risks of ADCs.

4. Contractor Safety: Trends in BioPharma Industry, Contractor Prequalification, Contractor Training and Other Issues:  An overview of trends being seen in the BioPharma Industry, processes used to prequalify contractors, evaluation metrics, and case studies/date on insurance and training.

5. Development of Global Standards for Contractor Safety – Discussion on the need for these standards and lessons learned.

6. Roundtable: Cleaning Chemical Usage – BioPharma EHS Forum members are interested in company experiences with cleaning chemicals.

7. Case Studies of Three-Factor Risk Assessment and Use as Metric for “Risk Reduced” –After hearing earlier in the day about ADC and risk assessment, we will discuss this type of risk assessment and how it can be used as a metric showing risk reduced for a facility or site. Traditional risk assessment looks at likelihood of occurring vs. potential damage, while three factor risk assessment looks at frequency of exposure, damage, and controls in place.

8. 2017 Meeting Planning – Do we want the focus of next meeting to be biologics, pharmaceuticals or biopharmaceuticals? Host volunteers?  Planning Committee members?

Day two will adjourn at 5:15 p.m.