What’s Inside: Recap of Our Inaugural USPTO & FDA Webinar; Senate Reauthorizes SBIR/STTR; Update on California Green Building Code; San Diego Receives Landmark EPA Loan; and more.  

Hundreds Tune In for Our Nationwide FDA & USPTO Webinar 

On September 8, Biocom California partnered with the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) to host a first-of-its-kind nationwide webinar to help entrepreneurs and intellectual property and regulatory professionals better understand how to navigate the patent application process and drug and device review and approval process. Participants heard presentations from the USPTO and FDA, followed by a discussion and Q&A on best practices and current topics moderated by Biocom California’s Sr. Director of Federal Policy & Government Affairs Laure Clark. The event “Strategies for Biotech and Medtech Startups: Successfully Navigating the USPTO and FDA” had over 700 hundred live attendees and over 1,500 registered, making it one of Biocom California’s largest and most attended events. Email [email protected] to receive a copy of the recording. 

Federal Affairs

Biocom California Advocates for SBIR/STTR Reauthorization

Yesterday, the Senate passed legislation to reauthorize the SBIR/STTR programs that would otherwise expire at the end of September. See our summary of new restrictions and changes made to the programs. We’ve been working closely with the committees of jurisdiction to prevent a lapse in funding and educating our California delegation about the importance of the programs. Last week, we joined the Rally for Medical Research and met with several members, including Rep. Lou Correa. We also urged advocates to send a letter to their Senators and Representative through our action center, asking them to extend the programs. 

Biocom California Responds to CMS & FDA Draft Rules 

Biocom California recently submitted comments on the CMS CY 2023 Physician Fee Schedule proposed rule and on two FDA draft guidance documents: Risk Management Plans to Mitigate the Potential for Drug Shortages and Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies. Thank you to our members for engaging on these important topics and providing feedback. Please contact [email protected] for future regulatory comments. 

Take Action |  Urge Congress to Reauthorize FDA User Fee Legislation

The FDA’s user fee programs are essential and raise revenue to support the review of medical products and advance key regulatory science activities. The Prescription Drug, Medical Device, Generic, and Biosimilar User Fee Agreements all expire on September 30, and require action from Congress to ensure these critical programs continue. Please help ensure that Congress passes the user fee reauthorizations by sending them a message today. To send a letter to your senators and representative, click here.  

Inaugural ARPA-H Director Tapped 

Former DARPA scientist, Dr. Renee Wegrzyn, will be appointed by the Biden Administration to lead the newly established Advanced Research Projects Agency for Health (ARPA-H). Dr. Wegrzyn will spearhead ARPA-H’s research portfolio and budget to support a variety of programs aimed at developing prevention, detection, and treatment capabilities for some of the most challenging diseases. 

State Affairs

The Latest on California Green Building Code 

The 2022 California Building Standards Code (Title 24) will go into effect on January 1, 2023. Title 24 is a broad set of requirements for energy conservation, green design, construction and maintenance, fire and life safety, and accessibility that apply to the structural, mechanical, electrical, and plumbing systems in a building. A summary of the code changes is available here.  

Cal/OSHA Hearing on Proposed Non-Emergency COVID-19 Standard 

The Cal/OSHA Standards Board held a hearing on a proposed non-emergency COVID-19 standard on September 15. Many representatives of the employer community raised serious concerns about the standard and the need for such a standard at all. Biocom California in written comments pointed out that life science companies provide access to testing resources that are above and beyond any requirements.

Regional Affairs

San Diego

Our Roundtable with San Diego City Council District 6 Candidates 

It’s not too late to register for Biocom California’s September 22 roundtable with Tommy Hough and Kent Lee, the candidates for San Diego City Council District 6. Following redistricting last year, the newly configured District 6 will contain a large portion of San Diego’s life science industry. 

Biocom California Supports Community Planning Group Reform Passage in San Diego 

Biocom California policy staff testified at a September 13 San Diego City Council hearing in support of Councilmember Joe LaCava’s proposal to reform the city’s Community Planning Groups. We have been working with a broad coalition to support LaCava’s efforts to bring CPGs in line with the city charter and increase participation and diversity in these groups that provide input to the city on land use decisions and construction projects. City council approved the reform proposal by a 6 – 1 vote.

City of San Diego Receives Landmark EPA Loan

Biocom California policy staff was one of a small handful of stakeholders on hand September 13 for the signing of a $225 million federal loan that will reduce flood risk for our members.  

Eric Dargan Named New San Diego COO 

On September 12, San Diego City Council approved Eric Dargan to serve as the city’s new Chief Operating Officer starting on November 1.

Food Waste Recycling Delayed in San Diego

The City of San Diego is targeting a January 2023 roll-out of its food waste recycling services, one year after the state’s 2022 deadline. 

Midway Redevelopment Inches Forward 

San Diego City Council voted on September 13 to enter into an exclusive negotiating agreement with the “Midway Rising” project to redevelop 50 acres including the Sports Arena.

Bay Area

Biocom California Testifies in Support of “Keep Innovation in Berkeley” 

On September 13, Berkeley City Council passed its “Keep Innovation in Berkeley” referral, which asks the City Manager and Planning Commission to return to council with zoning ordinance amendments and other actions to encourage the growth and retention of R&D firms. Biocom California’s policy staff spoke in support of the measure’s advancement at the council meeting.

San Francisco Policy Changes Aim at Adapting to Future of Work 

San Francisco Mayor London Breed outlined her vision to revitalize downtown; in the coming months her office will bring forward policy proposals in five areas of focus aimed at adapting to the future of work in the city. Additionally, San Francisco Planning and OEWD are working on a set of draft Planning Code amendments to support laboratories and light industrial activities. If you’d like to give input on the forthcoming proposal, contact Melanie Cohn.  

Caltrain Enhances Service for Commuters 

Caltrain announced it will increase service for commuters, including two hourly stops at the South San Francisco Station during peak commute times. 

Los Angeles

Heather Hutt Becomes New District 10 Councilmember in LA 

On September 2, Los Angeles City Council voted 12 – 2 to make political aide Heather Hutt the interim replacement for Councilmember Mark Ridley-Thomas. Hutt had been serving as the seat’s non-voting caretaker and Chief of Staff since October. She previously served as State Director for then-Senator Kamala Harris.

Biocom California “Spotlight on the Expo Line” 

Join us September 28 for the next installment in our Los Angeles region spotlight series—this time on the Expo Line Corridor which runs from Downtown LA through USC and Culver City, ending in Santa Monica. Assembly Member Reggie Jones-Sawyer will kick off a panel of speakers on one of the most interesting corridors on opportunities that exist along the Expo Line and how it can serve as a model for investments in other corridors in the region. 

Los Angeles Masking Recommendation Could Loosen as Cases Fall  

Public Health Director Barbara Ferrer announced on September 13 that the county could soon change its indoor masking guidance from “strongly recommended” to “individual preference”.

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