BioPharma EHS Forum ™

2021 was the quite a year for environmental, health and safety professionals.  The last few month particularly have felt a bit like déjà vu.  It is my fervent hope that each of you and your loved ones remain healthy.

In December, the BioPharma EHS Forum celebrated its 17^th Anniversary.  A few of you may recall that in December 2004, Genentech hosted the inaugural meeting of the BioPharma EHS Forum at its South San Francisco site.  The vision of Debora Van der Sluis, then-Senior Manager, Research & Development, EHS, Genentech, was to provide an opportunity for EHS professionals in BioPharma companies to exchange ideas, share best practices, network, and benchmark with other companies to help improve worker safety and health.  In 2009, the Forum held its first meeting in Massachusetts, at Genzyme, and videoconference was available for Western U.S. locations.  To minimize disruption and extended down times to accommodate lunches, early and late hours, Forum members voted in 2015 to hold the annual in-person meeting in a single location (rather than video cast in Massachusetts and California).  Gilead Sciences graciously hosted 43 participants at our last in-person annual meeting in Oceanview, CA in 2019.  Due to the global pandemic, there was no in-person meeting in 2020 or 2021. 

We appreciate your continued support moving forward into 2022.  Heartfelt gratitude to the faithful members of the BioPharma EHS Forum Planning Committee (Elise Franklin, BMS; Joe Hess, Gilead; Leo Njongmeta, AbbVie; Mike Cakouros, and Ginena Du, AZ; Nancy Kahl, MilliporeSigma; Jeff Hoogendyk, Takeda; Lori Medeiros-Nicholson, CRL; and Randy Boles, Vertex).  The Planning Committee will decide at a later date whether the annual BioPharma EHS Forum meeting will be held in 2022 as an in-person event or as a virtual conference.  The following is a report on activities during the past year:

Virtual Conference Call Series – During 2021, BioPharma EHS Forum held a series of 13 Conference Calls in lieu of the in-person meeting.  The calls consisted of the following:

Biden Administration USEPA:  The first call in the 2021 Conference Call Series was held on 10 March 2021. The speaker presented his perspective on “What to Expect from EPA in the Biden Administration” as the former Director of USEPA Enforcement.  He recommended an EHS “Thought Process” to be applied in the current political and activist environment, how to “protect the brand” and what EHS professionals need to think about moving forward.  

COVID-19:  View from NIOSH:  On 21 April 2021, our speaker discussed the latest developments, impact of the availability of vaccines, transmission, testing, second infection risk, natural immunity, vaccines, and variants.  As usual, there was an active Q&A session.

Spore-Klenz:  On 18 May 2021, an EHS professional discussed his experience Assessing Exposures & Industrial Hygiene Evaluation.  He discussed the effectiveness of Spore-Klenz® in comparison to other sterilants, the various forms Spore-Klenz® comes in, chronic effects of exposure, and sampling methods.  

Evolution of Federal OSHA’s COVID-19 ETS:  The Federal OSHA Emergency Temporary Standard (ETS) has been of interest to BioPharma members, and on 23 June 2021, we were fortunate to hear from an industry attorney on its scope, requirements, and projected timeframes.  His presentation was packed with information.  He also provided information on OSHA’s Updated COVID-19 Workplace Guidance, OSHA Organizational Changes, and Enforcement and Regulatory developments.  As usual, there was a robust Q&A at the end of the presentation.

What to Expect from Federal OSHA in the Biden Administration:  The fifth call of the series took place on 11 August 2021.  We were joined by an attorney who advises employers on workplace safety and health issues involving enforcement, compliance, workplace investigations, and emergency response matters.  He  provided an Overview of Key Regulations, Recent Developments, and opined on what may come down the road from Federal OSHA.  

Working from Home and Return to Work:  Lessons Learned:  When this call was scheduled for 2 September 2021, we had anticipated that employees would have been back to “in person”.  Surprise!  But the timing turned out to be excellent because BioPharma members were joined three EHS professionals.  Each speaker described their company’s approach, including processes for returning some workers to the site; new safety measures; the importance of teamwork, collaboration and communication; lessons from remote working; and various assessments of risk and benefit of various approaches. 

Virtual Training:  On 22 September 2021, the co-founder of a virtual training company, gave a fascinating presentation on virtual training and how it can be applied to workplaces with less investment than most people expect. 

Human and Organizational Performance (HOP):  The next call was presented by a panel on 28 September 2021.  They provided information on the theory as well as concrete examples of accomplishments from executing HOP as well as a discussion of the values, models, principles and methods their company has been successful in implementing it. 

September 2021 Executive Order On Vaccination:  The ninth Virtual Series call took place on 30 September 2021.  Members were joined once again by an industry attorney who discussed Mr. Biden’s Executive Order for a “hard” vaccine mandate for federal employees and contractors and the Directive to the Federal Occupational Safety and Health Administration (Fed/OSHA) to issue a COVID-19 ETS for a “soft” vaccine mandate for private employers with over 100 employees. 

CAR-T Cell Therapy:  On 10 October 2021, BioPharma members were joined by two BioPharma members. One member provided an introduction to CAR-T Cell Therapy including a discussion of cancer and therapies currently available to treat it. The second member discussed the application of NIH and CDC guidelines to CAR-T and Viral Vectors and provided a biology background.  

COVID-19:  Current Scientific Understanding:  We were joined again on 13 October by a member of  NIOSH, who discussed COVID-19 and employment trends, the state of the pandemic, vaccinations, Post-Vaccination (or “breakthrough”) COVID-19 cases, boosters, and Immune Response after Infection. A lively Q&A took place after the  presentation.  

Historical Exposure Assessment and Control Process and Industrial Hygiene Management Software Needs:  Our 12^th call took place on 4 November 2021. Our speaker reviewed the historical approach to exposure assessment and control, both qualitative and quantitative methods.  A review of his company’s previous industrial hygiene platform found it lacking in some important functionality.  He discussed the evaluation process for comparing various IH platforms to identify the one that would best serve their needs now and in the future.  He was joined by a Senior Director of EH&S in the San Francisco office. 

Electronic Reporting, OSHA Log Review and Thorny Recordkeeping Issues:  Our last call of the year took place on 2 December 2021 where our speaker discussed recordkeeping challenges.  She discussed some of the areas of confusion in the Federal OSHA Recordkeeping and Reporting rules for Occupational Injuries and Illnesses.  

In order to assure that the topics and speakers are relevant to BioPharma EHS professionals, Forum members volunteer to participate on the Planning Committee for every annual meeting as well as the quarterly conference calls.  For the past 15 years, Planning Committee members worked diligently to determine topics and select and acquire speakers for the conference calls in the Virtual Event Series; this has been especially challenging in 2021 with so many demands on their time.  If you would like to participate in the Planning Committee for 2022, please let me know at your earliest convenience.

More Background on the Forum – The BioPharma EHS Forum held annual meetings in 2005 (hosted by Genentech), 2006 (Amgen), 2007 (Gilead), 2008 (Genencor), 2009 (videocast-Genzyme in MA, Genentech in CA), 2010 (AstraZeneca in MA, Life Technologies in CA), 2011 (Biogen and Genentech), 2012 (Pfizer-MA and CA), 2013 (Shire- MA and CA), 2014 (Takeda and Genentech), 2015 (EMD Millipore), and without videocast in 2016 (Novartis), 2017 (Vertex), 2018 (AbbVie-Chicago), and 2019 (Gilead Sciences).  In both 2021 and 2020, the BioPharma forum was held as a Virtual Event Series.  The benefit for the attendees is not just in the breadth of industry representation but also in the depth of dialogue on EHS topics important to each member as well as a specific focus on biosafety.  Furthermore, it is a relatively small group, providing opportunities to informally network.  All topics on the agenda are relevant and of particular interest to EHS professionals in BioPharma.

In 2018, members of the BioPharma EHS Forum voted to adopt the following Statement of Purpose:

In biotechnology and biopharmaceutical industries where there is constant innovation, the BioPharma EHS Forum focuses on supporting EHS professionals, sharing best practices, networking and benchmarking to achieve excellence in EHS programs.

Based on company requests, the chair organizes conference calls for members on topics that may be of interest.  One call has already been scheduled for 2022:  WELL Building Standards on 13 January 2022.  Please contact Elizabeth Treanor (etreanor@phylmar.com) if you have topics you would like to volunteer to speak about or have a suggested topic and/or speaker. 

Benchmarking Polls – The Forum provides an easy network for members to share information with each other and to find out what other companies are doing to address particular subjects.  Members pose questions by sending them to staff, questions are distributed to members, and the results are provided to those individuals who respond (with company identifiers removed).  These polls have proven to be a very useful tool in information-sharing and benchmarking.  In 2021 a majority of the polls were related to COVID-19 and were sent to both BioPharma and the Phylmar Regulatory Roundtable- OSH Forum (PRR), with the results being updated daily.  The COVID-19 polls included the following:

• Onsite Vaccine Administration Clinics
• Vaccination Status
• Training Approaches and Platforms for COVID-19 training
• Lessons Learned in Post Pandemic Return to Work
• Mandates and Rollout
• Date of Vaccine Mandate Implementation
• Boosters
• PPE and Policies
• Tracking Vaccinations
• Company Protocols for Vaccinations
• Testing Programs
• Testing Options and Mandates

In addition, BioPharma members requested other company experiences on the following topics:

• Animal Bedding Disposal Stations
• Evaluation of Automated Pipette Tip Washers
• Defining Near Misses and Events
• EHS Tools and Next Generation
• EHSS Programs
• Handling of Occupational Exposure Limits
• Sustainable Vehicle Parking Programs
• Audit Applicability and Regulation Tracking Tools
• Screening Programs for Access to Vivarium Facilities
• Cal-EPA Notice of Compliance for Sharps 2022
• Modesty Curtains for Emergency Showers
• Lab Room Noise
• Engineering Firms for Noise Reduction in Labs

Finally, periodically, the chair distributed various Federal OSHA announcements and information that may be useful to members.

Web Sites – As requested in 2006 by the BioPharma EHS Forum, the members-only website is available to download BioPharma EHS Forum communications, polls, presentations, etc.  The public-facing BioPharma EHS Forum website, was created in 2009 and continues to provide minimal details for each annual meeting.  Concerns were identified several years ago about identifying individual names and the meeting locations on the website, so general information is provided on the current year’s meeting with a request that interested persons contact the chair. 

Comments – This year, no comments to federal or state regulatory agencies were submitted on behalf of the BioPharma EHS Forum.  Any filing of comments is a separate project, requiring additional funding from members.  In 2009 and 2013, the BioPharma EHS Forum submitted comments to NIOSH on its updating of the Hazardous Drug Alert, and comments were filed on the initial notice in 2007.  The major point was that bioavailability and route of exposure should be considered before designating drugs as “Hazardous Drugs.”  We stated that to be meaningful to the intended audience of healthcare workers, only drugs capable of harm in workplace situations and potential route(s) of exposure should be included in the list.

It has been another great year; thank you to all the members who help make the group valuable!   The annual fee was increased in 2021 to $2,250 per business unit for cash or check payments.  Costs have increased significantly, particularly for the website, poll compilation, and other administrative oversight.  Each member is entitled to have 10 individuals receive materials sent to the Forum.

We are currently uncertain whether there will be an in-person BioPharma EHS Forum in 2022.  In the meantime, please let me know if there is anything we can do to make the BioPharma EHS Forum provide more value to you.

Thank you.

Phylmar Sacramento Office:  P. O.  Box 660912

Sacramento, California 95866; +1.916.425.3270

https://biopharmaehsforum.com/ |  www.phylmar.com

What a year 2020 was for environmental, health and safety professionals!  It is my fervent hope that all of you and your loved ones are healthy.

In December, the BioPharma EHS Forum celebrated its 16^th Anniversary.  A few of you may recall that in December 2004, Genentech hosted the inaugural meeting of the BioPharma EHS Forum at its South San Francisco site.  The vision of Debora Van der Sluis, then-Senior Manager, Research & Development, EHS, Genentech, was to provide an opportunity for EHS professionals in BioPharma to exchange ideas, share best practices, network, and benchmark with other companies to help improve worker safety and health.  In 2009, the Forum held its first meeting in Massachusetts, at Genzyme, and videoconference was available for Western U.S. locations.  To minimize disruption, Forum members voted in 2015 to hold the annual in-person meeting in a single location (rather than video cast in Massachusetts and California), and that is what had been done until, for obvious reasons, there was no in-person meeting in 2020.    

We appreciate your continued participation as we move forward into 2021.  The following is a report on activities during the past year:

Conference Calls – The 2020 BioPharma EHS Forum meeting was scheduled to be held on 15 – 16 September in Cambridge, MA where members would normally network and attend two days of valuable presentations.  The Planning Committee decided instead to hold a Virtual Event Series consisting of six 90 minute conference calls. 

Call #1 – COVID-19:  The first call in the 2020 Virtual Event Series was held 17 June 2020 and featured John Howard, Director of CDC National Institute for Occupations Safety and Health.  Dr. Howard presented discussed (no surprise) “NIOSH Perspective on COVID-19 and the Workplace.”  He discussed the Background of COVID-19, Transmission, Testing, and Workplace Mitigation Measures.  A substantial Q&A session followed the presentation.  

Call #2 – Return to Work:  On 15 July 2020 three members of the BioPharma Planning Committee discussed the topic of “Return to Work Practices: EHS Role in Managing Returning to Sites.”  Each speaker reviewed steps to minimize transmission, the evolution of best practices at sites, reopening of amenities, managing the next wave (contact tracing), and re-densifying office sites.  An open discussion among speakers and attendees followed the presentations.

Call #3 – Environmental Sustainability:  The next call in the series was held 23 September 2020 provided an overview of one member’s R&D sites’ Environmental Sustainability Journey.  The presenters discussed the zero carbon ambition, highlighted where a few of their R&D sites currently are on the journey, and projected next steps.  Participant questions provided a lively discussion following the presentations.

Call #4 – Cell and Gene Therapy:  Members were lucky to hear a scientific presentation on Cell and Gene Therapy on 21 October 2020.  This therapy introduces new, healthy cells into a patient’s body to replace the diseased or missing cells.  Gene therapy involves treatments that use genetic material with the goal of changing the course of the disease accomplished through gene editing or gene addition. 

Call #5 – EHS Role in Corporate Security & FBI Stories:  On18 November 2020, members heard from FBI Special Agent Scott McGaunn and a Director of Corporate Security with a member company.  Agent McGaunn discussed various security threats and recent investigations, and encouraged call participants to become involved in InfraGard.  The role of the EHS professional in workplace security was also discussed.

Call #6 – Working from Home Ergonomics:  On 10 December 2020 BioPharma EHS Forum members were joined by a Principal Ergonomics Program Manager and a senior member of her staff on this important topic.  When shelter-in-place orders went into effect, there were many unknowns and little time to prepare.  Employees suddenly found themselves working at home, while balancing the needs of work and family and the Ergo Team was quickly inundated with requests for help.  Presenters shared their short- and long-term home office ergonomics tips and solutions to help employees work safely and comfortably.  

In addition to the six conference calls as part of the Virtual Event Series, six additional BioPharma conference calls were held on topics of interest, as follows: 

• Novel Coronavirus:  Benjamin Kim, Nixon Peabody – February 5, 2020;
• Inside View of EPA Enforcement:  Doug Parker, former US EPA Director of enforcement, and now Principal, RPO Strategies – February 11, 2020;
• OSHA Implications of COVID-19: Eric Conn, Founding Partner at Conn Maciel Carey, LLP – April 15, 2020;
• OSHA Implications of COVID-19 Part 2:  Eric Conn, Conn Maciel Carey, LLP –  June 4, 2002;
• NIOSH Perspective on COVID-19 and the Workplace Part 2: John Howard, Director of National Institute for Occupational Safety and Health – October 6, 2020; and
• Long-Term Legal Consequences of EHS and Management Decisions: Michael Cooper – December 8, 2020.

In order to assure that the topics and speakers were relevant to BioPharma EHS professionals, Forum members volunteer to participate on the Planning Committee for every annual meeting.  This year, the Planning Committee members went above and beyond the call of duty in determining topics and selecting and acquiring speakers for the six conference calls in the Virtual Event Series as well as the six regular conference calls scheduled in 2020.  

More Background – The benefit for the attendees is not just in the breadth of industry representation but also in the depth of dialogue on EHS topics important to each member as well as a specific focus on biosafety.  Furthermore, it is a relatively small group, providing opportunities to informally network.  All topics on the agenda are relevant and of particular interest to EHS professionals in BioPharma.

In 2018, members of the BioPharma EHS Forum voted to adopt the following Statement of Purpose:

In biotechnology and biopharmaceutical industries where there is constant innovation, the BioPharma EHS Forum focuses on supporting EHS professionals, sharing best practices, networking and benchmarking to achieve excellence in EHS programs.

Based on company requests, the chair organizes conference calls for members on topics that may be of interest.  Some calls have been scheduled for 2021:  Recordkeeping on 13 January; Dr. John Howard (NIOSH) on 10 February; What to Expect from a Biden Federal OSHA on 23 February; Developing World-Class Training and Effectiveness Survey, 2 March; and What to Expect from a Biden USEPA on 10 March.  Please contact Elizabeth Treanor (etreanor@phylmar.com) if you have topics you would like to volunteer to speak about or have a suggested topic and/or speaker. 

Benchmarking Polls – The Forum provides an easy network for members to share information with each other and to find out what other companies are doing to address particular topics.  Members pose questions by sending them to staff, questions are distributed to members, and the results are provided to those individuals who respond (with company identifiers removed).  These polls have proven to be a very useful tool in information-sharing and benchmarking.  In 2020 there were a total of 80 poll requests.  Sixty-six of these polls were COVID-19 related and results were updated daily.  

In addition, members requested information on Electronic Lab Notebooks and Risk Assessment; Evacuation Protocols; Recycling Silicone Tubing; EHS Reporting Line; Eyewashes and Emergency Showers; Lab Safety Shoes; Chemical Inventory Capabilities and RFI; Prevention of Potential Chemical and Biological Contamination; Safety Performance Management; Cellular Phones; On-site Healthcare Facilities; Cameras for Monitoring Body Temperature; Recognition Rewards for Manufacturing Personnel; and Driving Safety Programs.

Information Updates – Although not a formal part of the service, on occasion, summaries, memos, or notices are sent out to provide information on topics that may be of interest.  This year, information on the California emergency COVID-19 regulation was distributed, as well as other pertinent materials related to COVID guidance. 

It has been another great year; thank you to all the members who help make the group valuable!  As previously announced, the annual fee was increased for 2021 to $2,250 per company for cash or check payments.  Costs have increased significantly, particularly for the website, poll compilation, and other administrative oversight.  We hope you will continue to participate.

Please let me know if there is anything we can do to make the BioPharma EHS Forum provide more value to you.

Thank you.

Phylmar Sacramento Office:  P. O.  Box 660912

Sacramento, California 95866; +1.916.425.3270

https://biopharmaehsforum.com/ |  www.phylmar.com

Mark Your Calendars for the 2018 Meeting of the BioPharma EHS Forum on October 3-4 in Chicago. Agenda to come soon.

Wednesday, September 13

1. Keynote: EHS ties with the business function based on experiences in the executive suite – Will also describe impacts of EHS on the company over time.

2. National Fire Protection Association’s Industrial and Chemical Division – NFPA’s recent work, trainings they present, and how the NFPA writes, reviews, updates and revises its consensus standards.

3. EPA Enforcement Continuum: From Compliance to Criminal Prosecution – The continuum and the potential liability for EHS staff. The speaker will speak from his informed perspective on how an inspection goes from civil to criminal. Always good to hear about how to avoid criminal enforcement!

4. Company Experiences with Auditing Third Party Suppliers – BioPharma EHS members are interested in hearing about this topic, based on meeting evaluation comments. A panel will discuss their company auditing approach for 3rd party suppliers: waste vendors; managing acquisitions/ divestitures; contract manufacturing, pharmaceutical supply chain initiative. Each speaker will discuss their company’s approach, challenges, and lessons learned.

5. Industrial Hygiene Case Study: Paracetic Acid – A discussion of the use and monitoring of sterilizing agent (peracetic acid) exposures from cleaning operations and lessons learned will be provided.

6. Managing the Industrial Hygiene Program at GSK – GSK has launched a comprehensive industrial hygiene chemical agents risk management strategy (OH ChARM) which has enabled a clear picture of risk, competency, controls and continuous improvement in the chemical agent space across 70+ manufacturing sites.

7. Biogen’s Sustainability Journey – Biogen’s company experience and lessons learned as their program evolved.

Day one will adjourn at 5:15 p.m.; the No Host Group dinner will begin at 6:30 p.m.; details to be provided later.

Thursday, September 14

1. Mission/Vision for BioPharma EHS Forum – Attendees are invited to a working breakfast to discuss current member ideas about the future of the Forum, which was established in 2004 for senior level EHS professionals in biotech and biopharma to benchmark, share best practices, network, and exchange information in a private forum. Opportunities for continuing professional education are also provided. It seems appropriate to review the goals of the group, as membership has changed and perhaps priorities have changed as well.

2. Vertex Final Tablet Formulation Manufacturing – Overview of the operations – a one of a kind machine that validates in real time as the tablet is made. The machine takes the powder, blends it, takes all sorts of measurements to validate; output is total tablet. This machine is the first of its kind to be approved by the FDA.

3. Panel on Lessons Learned from Developing and Implementing EHS Information Reporting Systems – Each member will take a few minutes to discuss lessons learned that may be of interest to the full group. Discussion regarding experiences with CR 360, using the ULPURE Platform. EMD-Millipore worked with UL to develop the system which is maintained externally. Discussion of the need, how it works, and lessons learned in implementation. Lessons learned from an IH trying to pilot and implement IT systems within a corporate structure. How to plan for requirements and time commitments.

4. Sustainability in the Workplace: A New Approach for Advancing Worker Safety and Health – White paper about the importance of including worker safety and health in the push toward sustainability and corporate responsibility.

5. Containment and Control: Why Procedures Matter – Importance of clear, consistent and understood procedures. The Biopharma industry commits resources towards purchase and installation of control and containment systems including ventilated balance enclosures, chemical hoods, isolators, flexible containment, and custom units. Resources are also invested in facility design features such as once through air, gowning and degowning facilities, and room pressurization. With all of these controls in place, procedures are key to the proper operation of facilities and equipment. Data has been gathered to demonstrate key procedures that are critical to safe handling of potent compounds within the control and containment equipment. This presentation focuses on those procedures and provides data to back up the importance of the proper techniques.

6. Experiences with Workplace Violence Prevention Programs – Discussion on their journey implementing a workplace violence prevention program.

7. Leading Indicators and Correlation to Results – Providing information on member experiences.

8. Sharing Significant EHS Events – An idea to share lessons learned from incidents in a more structured way.

9. 2018 Meeting Planning – Do we want the focus of next meeting to be biologics, pharmaceuticals or biopharmaceuticals? Moving back to CA? Host volunteers? Planning Committee members?

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

Mark Your Calendars for the 2017 Meeting of the BioPharma EHS Forum on September 13 – 14 in Boston.  Agenda to come soon.

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.

Please mark your calendars for the 2016 meeting of the BioPharma EHS Forum, Wednesday and Thursday, September 14 – 15, 2016 in San Diego, CA.

Agenda soon to come.

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

1. 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.

2. Emerging Issues in BioPharma EHS, Product Stewardship –  Emerging trends in Product Stewardship and Environmental Safety and Health for BioPharma companies.

3. 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.

4. Management Systems: Biogen Idec’s Experience with EHS Management System 

5. 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.

6. 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.

7. 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

1. 9:00 a.m. Tour – Please contact us for information.

2. 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!

3. Green Chemistry: Case Studies in Safety Chemistries – Case studies related to the use of safer chemistry.

4. Member Panel: Emerging Topics in Biosafety – Emerging topics in biosafety that are of interest to members.

5. 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.

6. 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.

Thank you,

Elizabeth Treanor

Phylmar Sacramento Office:  P. O. Box 660912

Sacramento, California 95866; +1.916.486.4415

https://biopharmaehsforum.com/ |  www.phylmar.com