BioPharma EHS Forum ™

Please mark your calendars for the 2013 meeting of the BioPharma EHS Forum, Wednesday and Thursday, September 11 and 12, 2013 at Shire Human Genetics Therapies (HGT), 300 Patriot Way, Lexington, Massachusetts  02421.  The conference will be videocast at Shire, 11095 Torreyana Road, San Diego, California  92121, SD Video Conference.  This is a great time to catch up on CIH, CSP and ABSA continuing education points!  We hope that you will include this important meeting on your schedules.  A tentative agenda is attached; please register your attendance.

There is no cost for existing company members of the BioPharma EHS Forum to send up to three staff members; non-members pay $1800.00 for up to three attendees; and first-time guest companies may send up to three individuals to the meeting for a cost of $1500 (total).  Agenda items were chosen from suggestions on the 2012 Forum meeting evaluation forms and follow-up conference calls by the dedicated members of the Planning Committee: Dan Noberini (Bristol-Myers Squib, Elise Franklin (Bristol-Myers Squibb), Debora Van der Sluis (Solstice), Michael Landadio (Millipore), Tony Gemmellaro (Shire), Bill Gaylord (Allergan), Michael Schwartz (Immunogen), Tim Sullivan (Millennium), and Mark Thompson (Shire).

We are expecting an exhilarating and informative two days; as requested in the evaluation sheets from previous years, we are focusing on lessons learned, specific examples, and company experiences.  The following are speakers and topics being developed for the meeting, which will include time for group discussion of each topic:

1. Occupational Health Incidents & Trends – Reid Boswell, M.D., Occupational Medicine, Mt. Auburn Hospital will return to the BioPharma EHS Forum to provide attendees with the latest developments in these areas.
2. Green Chemistry for Manufacturing Plant Cleaning – The topic of switching from IPA to hydrogen peroxide will be explored.
3. Ergonomics Panel:  Lessons Learned –  Tony Gemmellaro, Shire, will discuss open workplace design; Susan Rera, Pfizer, will discuss Ergonomic Hazards and Corrective Strategies in Laboratories; Elise Franklin, Bristol-Myers Squibb will discuss the BMS Ergonomics Manual; Susan Medeiros, Millipore, will discuss Millipore’s Experience with Early Symptom Intervention, together with Greg Roth, an occupational therapist.
4. Disposables in BioPharma – Bill Gaylord, Allergan, will open the panel
   discussing the drivers for disposables.  An engineering manager will cover the technical aspect of small scale operations, and a process engineer will review the implementation of disposables.
5. Contractor Safety in R&D Settings – This issue continues to be requested on BioPharma EHS Forum meeting evaluation forms.  The Planning Committee is pulling together a panel to explore aspects of temporary help and compliance issues.
6. Massachusetts Process Hazard Regulation – The first compliance date is mid-2013 for this regulation which establishes five categories of hazards, with some BioPharma companies preparing for compliance with Category 4 processes by 1 June 2013.  A speaker will discuss the regulation and experience with compliance.
7. The Use of Disinfectants in Biologics Facilities – Companies are using
   disinfectants; Michael Schwartz, ImmunoGen, will discuss the results of the recent BioPharma EHS Forum poll, followed by a roundtable discussion with all participants.
8. 2014 Meeting Planning

If you have any questions please contact pstump@phylmar.com

Please mark your calendars for the 2012 meeting of the BioPharma EHS Forum, Wednesday and Thursday, September 12 and 13, 2012 at Pfizer’s La Jolla location, 10646 Science Center Dr., San Diego, CA 92121, Room 2249 of Campus Building 4 (CB-4).  The conference will be videocast at a Pfizer Cambridge location, 200 Cambridge Park Drive, Cambridge, MA 02140, Seminar Room, T-2003.  This is a great time to catch up on CIH and CSP continuing eduction points!  We hope that you will include this important meeting on your schedules.  A tentative agenda will be forwarded in the near future; please register if you plan to attend.

There is no cost for existing company members of the BioPharma EHS Forum to send up to three staff members; first-time guest companies may send up to three individuals to the meeting for a cost of $1300 (total). Agenda items are being chosen from suggestions on the 2011 Forum meeting evaluation forms and follow-up conference calls by the dedicated members of the Planning Committee: Dan Noberini (Bristol-Myers Squibb), Dan Shiel (Pfizer), Deb Martin (Pacific Biosciences), Tony Gemmellaro (Shire), Elise Franklin (Bristol-Myers Squibb), Betsy Gilman Duane (Pfizer), Michael Landadio (Millipore), Tamara McCammon-Tracy (Abbott Labs), Debora Van der Sluis (Solstice), Tim Sullivan (Millennium Pharmaceuticals), Jennifer Wright (Biogen Idec), and Tse-Sung Wu (Genentech).

We are expecting an exhilarating and informative two days; as requested in the evaluation sheets, we are focusing on lessons learned, specific examples, and company experiences. In response to requests, we are arranging for WiFi to be available at both locations. A tentative agenda will be issued in several months, but topics currently being developed including the following:

1. Root Cause Analysis Tools – after hearing from Rich DiBona, Shire Pharmaceuticals, each company in attendance will be asked to discuss its experience and lessons learned with implementing root cause analysis in R&D settings – please come prepared!

2. Roundtable discussion on effective use of safety committees.

3. Control strategies for isoflurane in vivariums.

4. Company experience with establishing a Green Chemistry program.

5. “Green Science” or “Green Biology” – What is low-hanging fruit in biology labs?

6. Life Cycle Assessment of Single-Use Bioreactors

7. The biosafety risk assessment process.

Day one will adjourn at 6:00 p.m. (East Coast time), 3:00 p.m. West Coast time, followed by a tour on the West Coast. Day two will begin with a tour at the East Coast location, and adjourn at 3:00 p.m. (West Coast), 6:00 p.m. (East Coast).

If you have any questions please contact pstump@phylmar.com

Re: NIOSH Hazardous Drug Alert: List of Examples of Hazardous Drugs

By: Debora Van der Sluis, Member, BioPharma EHS Forum

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) has updated Appendix A in the NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. This September 2010 list includes drugs reviewed by NIOSH up to June 2007. The current list of hazardous drugs can be found here:

NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010

http://www.cdc.gov/niosh/docs/2010-167/

The only High Molecular Weight Protein (HMWP) therapeutics included on the hazardous drugs list were alemtuzumab and gemtuzumab ozogamicin (an antibody drug conjugate, i.e., a HMWP therapeutic conjugated to a cytotoxin). Thanks to all of the companies that provided data and/or expertise to the BioPharma EHS Forum comments to NIOSH regarding the lack of occupational hazard when handling HMWP therapeutics, such as monoclonal antibody drug products, and following prudent chemical safety practices.

This achievement is critical since the NIOSH list of hazardous drugs is being referenced by other countries in guidance documents, such as the September 27, 2010 one published by the Canadian Working Committee on the Safe Handling of Hazardous Drugs established by the Association paritaire pour la santé et la sécurité du travail du secteur affaires sociales (ASSTSAS). In addition, OSHA has been approached about why OSHA is not developing a Standard for hazardous drugs. Here is a July 11, 2010 Q&A with Jordan Barab, Deputy Assistant Secretary of Labor for OSHA:

http://invw.org/chemo-osha-QA

Many thanks to everyone who participated in this year’s forum to make it our most successful year so far. Special thanks to our host teams at Genzyme and at Genentech for all your hard work and hospitality!

Please keep an eye on this website for updated news regarding the BioPharma EHS Forum – we are already planning the meeting for 2010, and hope you can all make it!  We have added an RSS feature on the right hand side of this website (below the search function) so that you can subscribe to the website and be notified when updates are made.

PDF copies of this year’s presentations will be available on our members-only website by the end of this week. Please contact scasey@phylmar.com if you need login information.

Thanks again!

On 10-11 December 2008, the fifth meeting of the BioPharma EHS Forum was held in Palo Alto, CA, graciously hosted by Deb Martin and Genencor.  The available presentations will be posted on the BioPharma EHS Forum members-only website.

Read the entire summary after the jump!

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