The response from our members and the life sciences industry at-large to the COVID-19 pandemic has been amazing and is a testament to why Massachusetts truly is the State of Possible. We know that navigating this new reality is no easy feat, so we’ve compiled a set of helpful resources for our members: reopening guidance and best practices for life sciences workers returning to the lab, guidance from the FDA, information about donating supplies, ways to give back to the community, a list of current grant opportunities, and more. Keep up the amazing work you are all doing and we will get through this.Bob Coughlin, President & CEO, MassBio
Massachusetts Reopening Guidance / Best Practices for Life Sciences Workers Returning to the Lab & Office
On May 18, Governor Baker, through his Reopening Advisory Board (RAB), released a Reopening Massachusetts plan which outlines the gradual, phased reopening of the Massachusetts economy contingent upon the continued improvement of COVID-19 related public health data and increased testing and tracing implementation.
As more employees return to the lab and office, MassBio has consolidated employer best practices to keep those workers as safe as possible. These were developed with a primary focus on the safety and well-being of our industry’s employees, their families, and our community. Check out the best practices here.
Note: As part of Massachusetts’ Essential Services Order issued on March 31, 2020, the Baker Administration deemed the life sciences including R&D, manufacturing, distribution, warehousing, and supply chain essential and allowed its employees to continue to work on-site as necessary, while still encouraging all employees who could work remotely to do so.
PHASE I (listed below is guidance in Phase I that pertains to the life sciences industry operations)
May 18, 2020: Manufacturing activities allowed to resume starting May 18.
May 25, 2020: Non-essential lab space can reopen starting May 25. In addition, office space across the state for non-essential businesses, except for Boston, will be allowed to reopen starting May 25 at less than 25% capacity with Boston resuming on June 1.
New Mandatory Safety Standards
All businesses and activities, including those that have continued to operate as essential services, must comply as of May 25with new mandatory safety standards. All laboratories must follow sector specific workplace safety standards, as of May 25, even those labs which continued to operate as essential businesses.
Develop Written Control Plan
Businesses must also self-certify as meeting these mandatory safety standards by developing a written control plan outlining how the workplace will comply with the mandatory safety standards for operations. Control plans do not have to be submitted for approval but must be kept on-site. The state has developed a draft template suitable for use.
City of Cambridge – Face Covering Order
The City of Cambridge issued a revised face-covering order on May 25 which requires face coverings in public and at places of employment. However, this revised order allows for the removal of a face covering if the employee can always maintain a six-foot distance from others when at work.
Statewide Face Covering Order
Governor Baker issued an Order effective Wednesday, May 6 requiring face masks or cloth face coverings in public places where social distancing is not possible. This applies to both indoor and outdoor spaces.
Key Questions Answered About Life Sciences Industry Operations:
Does the 25% maximum capacity restriction for office space apply to essential businesses?
Yes, this restriction applies to all office spaces, including those of essential businesses. Essential businesses with office spaces have until July 1, 2020 to adhere to the capacity restrictions per the Safety Standards for Office Spaces.
In the case of facilities with dual or triple use (i.e. lab, office, and even manufacturing at the same site) does one guidance/safety standards cover all of that operation or do we need to treat each one differently? (all were previously covered under essential business)
If your business includes different workspaces in the same physical location (e.g. manufacturing space attached to an office space), each space should follow the specific standards for that space. For example, the office portion of the business should adhere to the safety standards for office spaces (including capacity limits) and the manufacturing or lab spaces should adhere to their respective safety standards.
The Cleaning & Disinfecting section of the manufacturing checklist states, “In the event of a positive case, shut down site for a deep cleaning and disinfecting of the workplace in accordance with current guidance.” Does “shut down site” intend to require a total shutdown of a manufacturing facility? Or could it be read to mean restricted access to the known and suspected infected area(s) and deep cleaning/sanitize there?
If a worker tests positive, any area of a facility that they work in or may have transited should be shut down and thoroughly cleaned and disinfected before reopening. This includes entryways, lobbies, restrooms, hallways, conference areas, cafeterias, their own and nearby workstations, etc.
Critical Savings for PPE, Office Supplies, and Services During COVID-19
All of our members are trying to find new efficiencies to do more with less and MassBio is here to help. Through the MassBio Edge, our members are able to purchase critical PPE, office supplies, and environmental and lab services and supplies at a discounted rate. See how you can reap the savings from our Preferred Partners, including Thermo Fisher Scientific, Veolia Environmental Services, Middlesex Gases, W.B. Mason, and IPP, among others, to aid in the transition back to the office and lab. Learn more here.
Massachusetts Life Sciences Companies Working to Address COVID-19
MassBio has compiled a list of all life sciences companies headquartered or that have a presence in Massachusetts that are working diligently to develop diagnostics, vaccines, and therapeutics related to COVID-19. View the list here.
Take Advantage of MassBio Virtual Benefits
As we say often, our members are constantly evolving, and MassBio is evolving right along with them. While we all get accustomed to working from home, practicing social distancing, and holding our events and meetings virtually, MassBio has been working on several new initiatives to engage our members in their new virtual settings. Learn more about these efforts and take advantage of our virtual benefits today.
Grant / Funding Opportunities
- Agency for Healthcare Research and Quality (AHQR)
- Amazon Web Services
- Biomedical Advanced Research and Development Authority (BARDA)
- Coalition for Epidemic Preparedness
- Defense Advanced Research Projects Agency (DARPA)
- Department of the Navy – SBIR/STTR
- Emergent Ventures – Fast Grants
- Engage – Transform Fund 2020
- Google Cloud Research Credits for Google Cloud Platform use
- Kaggle – COVID-19 Open Research Dataset Challenge (CORD-19)
- Massachusetts Life Sciences Center – Manufacturing Emergency Response Team Funding
- Medical Technology Enterprise Consortium (MTEC)
- NCI Serological Sciences Network for COVID-19 Research (SeroNet)
- The National Institute of Biomedical Imaging and Bioengineering (NBIB)
- NSF-U.S.-Israel Binational Science Foundation (BSF) Programs Dealing with the Coronavirus Disease: Call for Proposals
- Patient-Centered Outcomes Research Institute (PCORI)
- Peer-Reviewed Medical Research Program (PRMRP)
- Pfizer Global Medical Grants (GMG)
Community Giving – Immediate Opportunities
- Donate to the Massachusetts COVID019 Relief Fund, the Boston Resiliency Fund, and/or the City of Cambridge Disaster Relief Fund.
- Make a donation directly to the Life Science Cares COVID-19 Response Fund. 100% of donations go directly to those providing help on the front lines.
- Sign up for our Boston Area Hospital Volunteer Database (please fill out this survey).
- Donate a used Chromebook (or help purchase a new one) so Project Hope students can resume their classroom studies online.
- Provide games & activities to guests in isolation at Pine Street Inn.
- Help homeless shelters in Greater Boston supported by Circle of Hope obtain clothing, toiletries and other necessities needed.
- Support displaced, promising college students supported by the Wily Network with food and access to transportation.
- Give financially to these organizations, as well as other partners, including Boston Healthcare for the Homeless and CASPAR.
- Volunteer remotely and encourage your employees and network to do so.
FDA Guidance in Response to COVID-19
The FDA is regularly providing and updating recommendations, guidance, technical assistance, and other information in an effort to support COVID-19 response.
Of particular interest to the life sciences industry:
- “COVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs and Biological Products,”
- “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention,”
- “Development and Licensure of Vaccines to Prevent COVID-19“
- “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic”
- “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing – Guidance for Industry“
- “Investigational COVID-19 Convalescent Plasma; Guidance for Industry“
- “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products”
- “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers”
The FDA is requesting public input on practical steps and successful approaches relating to the start-up, implementation and sustainment of global clinical trials networks, including specific considerations for establishing such networks for a range of rare diseases: “FDA In Brief: FDA Requests Input on Rare Disease Clinical Trial Networks“
State Requests for Supplies
As the leading life sciences and healthcare organizations in the world, it’s incumbent upon all of us to do everything we can to address the COVID-19 pandemic and aid the first responders and healthcare providers who are putting their health on the line every day to help patients.
To that end, we’re asking every life sciences and healthcare organization to consider how they may be able to help, specifically in donating personal protection equipment (PPE), lab, testing, or diagnostics supplies, to combat COVID-19. Please fill out the state’s COVID-19 donation form here.
List of Supplies & Expertise Needed:
Personal Protection Equipment (PPE)
- Surgical/procedure masks
- N95/N99 masks (respirators)
- Face masks with integrated shield
- Protective suits/gowns
- Booties / shoe covers
- Hand sanitizer
- Sanitizing wipes
- Ventilators, PEEP
- Hospital gowns
- Endotracheal tubes
- Vital sign monitors
- UVT 3ML with flocked flex minitip
- 1.5ml swab microtiped flocked
- 6in swab Darcon
- Medium 2% FBS STD REFEED ML
- Sample collection supplies (sterile swabs, tubes, media)
- MicroAmp™ Optical 384-Well Reaction Plate with Barcode
- MicroAmp™ Fast Optical 96-Well Reaction Plate 0.1mL
- RNAse Away 6-pack
- RNeasy Mini Kit
- TaqMan™ Fast Advanced Master Mix
- BD Universal Viral Transport for Viruses, Chlamydiae, Mycoplasmas, and Ureaplasmas
- 0.2 mL PCR 8-tube Strip with Indiv. Attached Dome Caps
- QIAamp MinElute Virus Spin Kit
- Viral RNA Isolation Kits
- QIAamp® Viral RNA Mini Kits
- QIAamp® MinElute Virus Spin Kit or RNeasy® Mini Kits (QIAGEN
- EZ1 DSP Virus Kits (QIAGEN)
Diagnostics Supplies and Instruments
- Roche MagNA Pure Compact RNA Isolation Kits
- Roche MagNA Pure Compact Nucleic Acid Isolation Kits
- Roche MagNA Pure 96 DNA and Viral NA Small Volume Kits
- Roche MagNA Pure systems
- Roche 480Z
- ABI 7500DX
- Qiagen EZ1 Advanced XL
- QIAcube/QIAcube Connect
- cobas omni Wash Reagent 6997503190
- cobas omni Lysis Reagent 6997538190
- cobas omni MGP Reagent 6997546190
- cobas omni Specimen Diluent 6997511190
- cobas NHP Negative Control Kit 7002220190
- cobas omni Pipette Tips 5534925001
- cobas omni Processing Plate 5534917001
- cobas omni Amplification Plate 5534941001
- 6800 biohazard bags 7435967001
- Lab Tech
- Registered Nurse
- Physician/Medical Doctor
Boston University Survey – Disruptions in the Supply Chain from COVID
This survey has been prepared by a team led by professors David Weidman, Canan Gunes Corlu, and John Maleyeff in Boston University’s Enterprise Risk Management and Supply Chain Management MS programs. The aim of the project is to determine how COVID-19 has affected life science organizations. They are especially interested in how Research & Development (R&D) supply chains have been affected during the pandemic. Value will be created for biotechnology organizations engaged in R&D activities and results will be used to enhance the education of students and practitioners. The survey should take about 30 minutes to complete this survey. The results of the final analysis will be shared.
Click here to take the survey.