Wednesday, September 14
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- Development of Global Standards for Contractor Safety – Discussion on the need for these standards and lessons learned.
- Roundtable: Cleaning Chemical Usage – BioPharma EHS Forum members are interested in company experiences with cleaning chemicals.
- 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.
- 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.
Here is the agenda of the recent Sep 16-17, 2015 BioPharma EHS Forum. Information about next year’s forum soon to come.
Wednesday, September 16
- Keynote: NIOSH Hazardous Drug Alert – New Format, Rationale for Monoclonal Antibodies Decision, State Activities – A presentation on the 2014 alert on hazardous drug exposures in health care settings. The BioPharma EHS Forum commented during the 2007, 2009, and 2013 updates of the NIOSH “List of Antineoplastic and Other Hazardous Drugs in Heathcare Settings.” NIOSH’s rationale for the changes made and state-level activity use of the list in regulatory settings will be of interest to attendees.
- Emerging Issues in BioPharma EHS, Product Stewardship – Emerging trends in Product Stewardship and Environmental Safety and Health for BioPharma companies.
- Management Systems: Maximizing the Value Proposition and Lessons from the Field – Experience on management systems and their effectiveness. The lessons learned should be particularly valuable as part of this interactive session.
- Management Systems: Biogen Idec’s Experience with EHS Management System
- Member Panel: Lessons Learned in the Evolution of Safety Cultures – Members appreciate hearing about the experiences of their colleagues. Different companies will share the evolution of their safety cultures.
- Managing Change: How to Navigate Different Company Governance Structures, Leadership Styles, and EHS Cultures – Considerable experiences with (1) how to focus on what is important; (2) how to leverage resources; (3) how to best present yourself; (4) how to meet your customer’s expectations; and (5) how change can come through many fronts.
- EHS Initiatives Roundtable – One person from each company will share 2015 EHS initiatives, or those underway or recently completed that may be of interest to other members.
Day one will adjourn at 5:15 p.m.; the No Host Group dinner will begin at 6:30 p.m. at the Colonial Inn after a walk around historic Concord.
Thursday, September 17
- 9:00 a.m. Tour – Please contact us for information.
- The Continuum of Enforcement: From Compliance to Criminal Enforcement – How an inspection goes from civil to criminal, from his informed perspective. Always good to hear about how to avoid criminal enforcement!
- Green Chemistry: Case Studies in Safety Chemistries – Case studies related to the use of safer chemistry.
- Member Panel: Emerging Topics in Biosafety – Emerging topics in biosafety that are of interest to members.
- BioPharma EHS Forum Member Sustainability Initiatives and Lessons Learned – This popular session is back, as requested by members for bi-annual discussion. Members are invited to share their ongoing initiatives and lessons learned.
- 2016 Meeting Planning – Do we want the focus of next meeting to be biologics, pharmaceuticals or biopharmaceuticals? Moving back to West Coast? Host volunteers? Planning Committee members?
Please let me know if you have any questions.
Phylmar Sacramento Office: P. O. Box 660912
Sacramento, California 95866; +1.916.486.4415