What’s Inside: June Primary Highlights; FDA User Fee Legislation Passes House; New Bay Area Water Restrictions; San Diego County Proposes $618.7M Budget; and more.

The Latest on Midterm Elections
California’s “top two” primary system, which advances the top two candidates to the November general election without regard to party affiliation for federal and state offices, has led to intrigue and sometimes unlikely alliances as interests sometimes try to “help” candidates get to the second place slot because they are far less likely to win a general election, but this year’s June 7 primary election did not produce a large number of surprises for top candidates. Similarly, local races, many of which can be won in June without a runoff if a candidate wins more than 50 percent of the vote, played mostly to form this year, as well. Please click on the links below for more comprehensive looks at election results at the federal, state and local levels.

Federal Affairs

Congressional Primary Results in Newly Drawn Districts

On June 7, California held its top-two primary, in which the two candidates with the most votes advance to the general election regardless of their party. For the first time in its 171-year history, California lost one congressional district following the 2020 Census and will have 52 Representatives joining Congress in January. The change resulted is newly drafted districts and some incumbents moving to safer districts. All districts but five have incumbents. The current top two in the five open seats are: Kermit Jones (Democrat) v. Kevin Kiley (Republican) in District 3; Adam Gray (Democrat) v. John Duarte (Republican) in District 13; Kevin Mullin (Democrat) v. David Canepa (Democrat) in District 15, Sydney Kamlager (Democrat) v. Jan Perry (Democrat) in District 33; and Robert Garcia (Democrat) v. John Briscoe (Republican); in District 42. In the Senate, Sen. Alex Padilla will face Republican Mark Meuser.

User Fee Legislation Passes U.S. House of Representatives

On June 8, the U.S. House of Representatives passed the Food and Drug Amendments by a vote of 392-28. On June 14, the Senate HELP Committee marked up their version of the user fee agreement legislation and passed it by a 13-9 vote. Biocom California applauds the House for the timely passage of the bill and looks forward to working with the Senate as they move the bill to the floor. Biocom California will remain engaged in the user fee reauthorization process during the conference process.

Biocom California Receives Response to March-In Rights Letter

On June 2, Biocom California received a response from the National Institutes of Health (NIH) in regards to a recent letter we sent to Health and Human Services Secretary Xavier Becerra urging him to reject petitions to use the march-in rights provisions in the Bayh-Dole Act to control drug prices. In the response from NIH, Acting Director Lawrence Tabak stated they are still reviewing the current petition for Xtandi, outlining the criteria the petition must meet in law.

Biocom California Hires Zoe Bilis to Handle Regulatory Policy

Biocom California welcomed Zoe Bilis to the public policy team on June 6. Zoe’s focus is to respond to guidance documents, engage with federal agencies, lead Biocom California Regulatory Affairs Committee (RAC) and manage our Regulatory and Reimbursement Newsletter (R&R). Zoe has experience as both a biomedical engineer technician and a regulatory affairs specialist, and is based in our Washington, D.C. office. Zoe can be reached at [email protected].

Biocom California’s D.C. Office has a new location

We are pleased to announce that Biocom California’s Washington, D.C. office recently moved to 601 Pennsylvania Ave. NW, South Building, Suite 900. The move denotes a growing federal advocacy team dedicated to representing our members’ interests in our nation’s capital. We invite members to visit!

State Affairs

June Primary Highlights Mixed Results of State’s ‘Top Two’ System

Ten years after the state’s "top two" primary system was adopted following a late night budget compromise, the system continues to provide unpredictable results wherein two candidates emerge from the primary to continue to the November General Election, without any particular regard to their place on the political spectrum. The system was supposed to create a more moderate legislature but it is unclear if that has happened. Following the June 7 election last week, Gov. Gavin Newsom will advance against another Democrat, while two Democratic candidates for the State Senate will advance to November in a usually safe Republican district, guaranteeing a larger Senate supermajority. It remains to be seen how the process will work for a more moderate legislature in the future.

Regional Affairs

Local Elections Highlights

In Los Angeles County, there are still a high number of votes that need to be tallied (100,000 to 200,000) as of June 15. At the county level, Supervisor Hilda Solis will secure her third and final term in office, and State Sen. Bob Hertzberg and West Hollywood Councilmember Lindsey Horvath appear headed to the November runoff. In the race for LA mayor, Congressmember Karen Bass and developer Rick Caruso emerged as the top-two finishers and will face each other in the November runoff to replace termed-out Mayor Eric Garcetti. Initial counts had Caruso in first, but Bass moved to first place as more vote-by-mail ballots are counted.

San Diego County Board of Supervisors Member Nathan Fletcher won handily over Republican Amy Reichert, and incumbent Councilmember Dr. Jen Campbell will likely face off against Republican Linda Lukacs for the District 2 seat of the City Council. In Council District 6, Kent Lee and Tommy Hough advance to the general election with Lee leading Hough by a narrow margin.

In the Bay Area, Sylvia Arenas is leading in the race for Santa Clara County Supervisor, and Charles Stone and Ray Mueller have emerged as the top vote-getters for two seats on San Mateo County’s Board of Supervisors. Christina Corpus is holding a lead for San Mateo County Sheriff, and Eric Lucan and Mary Sackett are leading the race for available seats on the Marin County Board of Supervisors.

San Diego Tops Office-to-Lab Conversions

According to a report by CBRE, San Diego is second only to Boston in square feet of office-to-lab conversions in the U.S. Life science developers are increasingly opting to convert due to demand for flexible spaces following the COVID-19 pandemic, and the lower cost of converting buildings versus ground-up construction.

Construction Begins at Terminal 1 at San Diego International Airport

Travelers going through San Diego are bracing for increased congestion around the airport due to construction of the improved Terminal 1, set to be completed in late 2024. The Terminal 1 parking lot was closed to incoming traffic June 5 and will be permanently closed June 15.

County of San Diego Proposes $618.7M Budget, $1.8M for New Climate Action Plan

The proposed $618.7M 2022-23 budget for the County of San Diego Land Use and Environment Department includes $1.8 million for the County to develop a new Climate Action Plan (the one adopted in 2018 has been subjected to continued litigation) and $33 million to support climate action goals.

Proposals to Redevelop Midway District Include More Housing

Increased housing availability is at the center of all three proposals under consideration for the Pechanga (aka San Diego Sports Arena) site in the Midway District. The proposals all include a new arena, and each would add between 3,250 and 4,200 total housing units with a significant set-aside for affordable housing.

Alameda County Reinstates Indoor Mask Mandate

As of June 3, Alameda County has implemented an indoor mask mandate in most indoor public settings regardless of vaccination status or history of prior COVID-19 illness. The City of Berkeley, which sets its own health protocols, and the other eight Bay Area Counties are not considering reimplementing a mask mandate for their residents at this time.

California Farms, Bay Area Cities Ordered to Stop Diverting Water

The State Water Resources Control Board announced curtailment orders on June 7 for the City of San Francisco and farmers in the San Joaquin Valley to cease pulling water from area rivers and streams, including the Tuolumne River, due to worsening drought conditions. The order affects communities from Fresno to the Oregon state line and a total of 212 public water systems. Water that is already held in storage is not affected.

Water Wasters Could Be Fined Up to $10K in South Bay

Santa Clara Valley Water adopted a program to enforce restrictions on outdoor water use by residents and businesses by fining those who disregard repeated warnings on wasting water. SCVW customers could face fines ranging anywhere from $100 to $10,000 for not following rules for reducing outdoor water use.

Event Recaps

Roundtable with Rep. Lou Correa

On June 1, Biocom California hosted a roundtable meeting with Representative Lou Correa (D-CA-46) who represents Orange County and has been a great supporter of our industry. During the roundtable, he engaged Biocom California members on access to new medicines, supply chain, manufacturing, and IP protections.

IP Committee Meeting with UPSTO Official Steve Koziol

Biocom California hosted a meeting with USPTO Silicon Valley Office Acting Director, Steve Koziol, on June 2. During the meeting, he touched on the initiatives that recently confirmed USPTO Director, Kathi Vidal, is initiating, including efforts to make the patent system more accessible to all Americans. He also provided an update on the important outreach and educational activities of the USPTO Silicon Valley Office.

Meet the Team

Zoe Bilis
Associate Manager of Regulatory Policy
Washington, D.C.

Emily Cassel
Govt. Affairs Events & Project Manager
San Diego

Laure Clark
Sr. Director, Federal Policy & Govt. Affairs
Washington, D.C.

Melanie Cohn
Sr. Director, Regional Policy & Govt. Affairs
SD, LA, Bay Area

Fielding Greaves
Sr. Director, State Govt. Affairs
Sacramento

Jimmy Jackson
Senior Vice President & Chief Policy Officer
San Diego

Richard White
Associate Manager of Federal Advocacy
Washington, D.C.

Biocom California Advocacy

Biocom California is the largest, most experienced leader and advocate for California’s life science sector. Our public policy staff is strategically located in the Bay Area, Los Angeles, San Diego, Sacramento and Washington, D.C. We work with all levels of federal, state, and local governments to collectively pursue outcomes that benefit regional life science growth and contribute to a more innovation-friendly state. With over 27 years of experience, Biocom California works on behalf of more than 1,600 member companies statewide.

The Latest in Artificial Intelligence and Machine Learning

The technologies which make up artificial intelligence and machine learning are part of our everyday lives today from our emails and smart phones to Roombas darting across floors, and were even used to recreate Val Kilmer’s voice in the latest blockbuster. In life science, these advanced technologies are tools that can push the boundaries of innovation, drug and therapy development, and in finding cures for disease. John Melo, CEO of Amyris Inc., a synthetic biology and renewable company, recently shared this insight in an interview with The Motley Fool, saying these technologies are “the great enabler” and a workhorse that can do a lot of engineering for scientists. “The further on the edge information technology and AI and data science is pushed, then the better the science of biology and synthetic biology can grow,” he said.

Here are some examples of member companies that are harnessing the power of artificial intelligence and machine learning in their research and development.

What’s Inside: Mail-In Ballots Out for Primary Election; Biocom California Committee Meeting with USPTO’s Silicon Valley Director; State Considers Public Right to Know Act

Ballots are Out for the June Primary
County election officials across California started sending out vote-by-mail ballots to registered voters in early May. Every registered voter will receive a mail ballot because of new state legislation, AB 37, passed last year. Voters are sent ballots that can be returned by mail, at a secure drop box, or in person. Voters can track their vote-by-mail ballot by signing up at WheresMyBallot.sos.ca.gov to receive status alerts. Of course, you’re still welcome to vote in person on June 7.

Follow these links for primary guides in your area:

Federal Affairs

Biocom California’s Federal Policy Priorities

Biocom California is advocating before Congress and federal agencies on behalf of our members. Our 2022 top priorities include supporting advanced manufacturing and funding for COVID-19 products, increasing funding for the NIH and reauthorizing the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs, reauthorizing the FDA user fee agreements, encouraging the development of novel antibiotics, opposing international reference pricing and drug importation, lowering patient out-of-pocket costs, guaranteeing intellectual property protections, protecting the orphan drug tax credit, and supporting our agricultural and biobased economy, among others. View the full list of priorities here.

Biocom California Weighs in on Appropriation Requests

On May 4, Biocom California submitted letters to the House and Senate Appropriations Committees asking for funding increases for the FDA and its Center for Biologics Evaluation and Research (CBER), the NIH and its National Center for Advancing Translation Science (NCATS), the Centers for Disease Control and Prevention, and the National Pharmacogenomics Program (NPP). Biocom California will continue to engage with Congress as the government funding process continues.

Health Committee Approves User Fee Reauthorization

On May 18, the Energy and Commerce Committee approved the Food and Drug Amendments, the FDA user fee agreement reauthorization legislation, following its Health Subcommittee’s markup on May 11. The bill includes many provisions such as clinical trial diversity, supply chain improvements, cybersecurity of medical devices, supporting real-world evidence, and program changes to the Accelerated Approval Pathway. As amended, the bill is an improvement over what was initially offered but Biocom California continues to work on improving the bill as it moves through the legislative process.

Biocom California Sends March-In Rights Letter to HHS Secretary

On May 17, Biocom California sent a letter to Health and Human Services (HHS) Secretary Xavier Becerra discouraging the use of march-in rights to address the cost of a drug. In the letter, Biocom California notes that the use of march-in rights in this situation would go against the scope and intention of the Bayh-Dole Act. To date, no Administration has granted a march-in petition on the basis of cost and we encourage this administration to maintain that precedent. The use of march-in for this purpose would likely chill the innovation pipeline from federal research to private sector commercialization. Click here to view the letter.

Biocom California Creates Sustainability Award

Rep. Scott Peters (D-CA52) is slated to be Biocom California’s first “Sustainability Champion Award” recipient. The award recognizes elected officials for their support of policies protecting and advancing the environmental, economic, and social conditions that improve productivity and the stewardship of natural resources to accommodate the needs of present and future generations. Thank you to Genomatica for hosting our first ceremony on Monday, May 23, at 1 p.m. If you’d like to participate, please RSVP to Laure Clark by 12 p.m. on May 20.

Biocom California Advocates for SBIR/STTR Reauthorization

On May 9, Biocom California joined the Biotechnology Innovation Organization (BIO), AdvaMed, and many other state associations in sending a letter to Congress urging them to reauthorize the SBIR and STTR Programs as part of reconciliation of the U.S. Innovation and Competition Act (USICA) and the America COMPETES Act (COMPETES). The successful programs provide grants to small companies to carry out research projects and expire at the end of September 2022.

State Affairs

Judge Rules California Law Requiring Women on Corporate Boards is Unconstitutional

A Los Angeles judge ruled that California’s law mandating public companies have up to three board seats filled by women by this year is unconstitutional. Superior Court Judge Maureen Duffy-Lewis ruled that the law violated the right to equal treatment. SB 826 was signed into law in 2018 by then Gov. Jerry Brown.

Confidentiality At Risk: California Legislature Considers Public Right to Know Act

California lawmakers are considering a bill that would limit confidentiality involving defective products or allegations of environmental damage by banning protective orders and privacy terms in settlement agreements. The Public Right to Know Act (SB 1149) attempts to limit the ability of parties to enter agreements in product liability and environmental matters and was introduced this spring by California State Senator Connie Leva.

Regional Affairs

Biocom California Testifies at San Diego City Council Budget Hearing

On May 9, San Diego City Councilmembers held a series of public hearings on department budget proposals, with each department head outlining their budget needs. Biocom California Senior Director of Regional Policy and Government Affairs, Melanie Cohn, spoke in support of the Development Services Department’s proposal to fund additional staff both through outsourcing and permanent hires. Biocom California continues to work with the department, the city’s construction permitting entity, to address permit delays and initiatives to keep up with industry growth—including a workshop with DSD Director Elyse Lowe on May 19.

Citizens’ Initiative Aims to Raise Sales Tax

May 11 was the deadline for supporters to submit 116,000 signatures to place a citizens’ initiative on the November ballot that would raise sales taxes to fund transit, road, and highway projects in the San Diego region. A similar measure to fund SANDAG failed in 2016, but backers of the new measure tout a broader coalition of support and the 51 percent approval-to-pass threshold as reasons to expect passage of this year’s measure. The initiative asks voters to approve half-cent sales tax increases in 2022, 2024, and 2028.

San Diego County Releases Recommended Budget

The County’s $7.15 billion recommended budget was released on May 5. It includes funding for initiatives addressing mental health and substance use, homelessness and housing, justice reform, sustainability, and more. The Board of Supervisors will hear the budget overview in mid-May, and budget hearings will be held June 13 and 16. The next Regional Decarbonization Framework public meetings will take place on June 28 and July 26. The county’s revised Transportation Study Guide (TSG) for vehicle miles traveled (VMT) will be available for public review beginning May 12 until June 13. Staff will be conducting outreach to stakeholders and a public meeting will be held on May 24.

San Francisco Mayor London Breed Appoints Matt Dorsey to the Board of Supervisors

On May 9, Mayor Breed appointed Dorsey to serve as District 6 Supervisor, covering Mission Bay and Treasure Island. The seat was left vacant by Matt Haney after he won a State Assembly race. Dorsey has been the strategic communications director for the San Francisco Police Department since May 2020. Before that, he worked as the press secretary for former City Attorney Dennis Herrera for 14 years. He is the first self-identified member of the substance use disorder recovery community to serve on the board in a generation.

Water Restrictions and Possible Fines Approved for Customers in the East Bay

The East Bay Municipal Utility District has mandated a ten percent water use reduction districtwide. The vote declares a stage two drought emergency, which reinstates an excessive use penalty ordinance and updates restrictions on outdoor water use. The agency will also impose an eight percent drought surcharge on water flow, beginning July 1st, 2022.

San Mateo Exploring Further Restrictions on Natural Gas

San Mateo’s Infrastructure and Sustainability Commission expressed interest last month in pursuing new codes to require that all new construction is all-electric. It is currently required that specific building types be all-electric, including new residential construction and new office buildings. Opinions among commissioners were mixed, with some supporting a city staff recommendation that all new construction be electric to reach a city Climate Action Plan goal to limit carbon emissions. Others expressed worry about the burden of increased costs of switching to electric. This fall, the city will adopt new codes lasting three years, which start January 1, 2023.

LA & San Diego Lab-to-Office Conversions Outpace Other Markets

The conversion of office space to lab space is a rapidly growing trend for real estate developers across the country as demand for lab space continues to increase. San Diego has the second-highest growth nationwide with 1.6 million square feet of office-to-lab conversions in progress in Q1 of 2022 (behind Boston). Los Angeles could be called the “busiest” market based on the percent increase in projects with 667,000 square feet of conversions in Q1 in 2022, growing by 339 percent from Q1 2021.

Upcoming Events

DSD Workshop: Development Services Department

Thursday, May 19
Virtual

Join Biocom California for a workshop to share challenges and opportunities that the life science industry is experiencing with the City of San Diego’s Development Services Department (DSD). Our agenda will include: industry challenges, perceived and actual impediments in the building permit process, common submittal and inspection mistakes, and department updates.

IP Committee Meeting with UPSTO Official Steve Koziol

Thursday, June 2
Virtual

We will be hosting an Intellectual Property Committee meeting featuring Steve Koziol, Acting Director of the United States Patents and Trademarks Office’s (USPTO) Silicon Valley Regional Office. Director Koziol will discuss the USPTO’s strategic priorities following the confirmation of Kathi Vidal as the new USPTO Director last month, as well as the regional office’s role and services.

Meet the Team

Emily Cassel
Govt. Affairs Events & Project Manager
San Diego

Laure Clark
Sr. Director, Federal Policy & Govt. Affairs
Washington, D.C.

Melanie Cohn
Sr. Director, Regional Policy & Govt. Affairs
San Diego

Mitzy De La Peña Medina
Associate Manager
Public Policy
Bay Area

Fielding Greaves
Sr. Director, State Govt. Affairs
Sacramento

Jimmy Jackson
Senior Vice President & Chief Policy Officer
San Diego

Richard White
Associate Manager of Federal Advocacy
Washington, D.C.

Choose a location

Enter your location

What’s Inside: Biocom California Welcomes Miguel Motta; The Latest in Developing Treatments for Alzheimer’s; Berkeley Lab Creates New Class of Biofuels; and more.

What’s Happening at Biocom California

Welcome, Miguel Motta

Over the Airwaves

The Latest in Developing Treatments for Alzheimer’s

New Finding Could Identify Early Signs of Cognitive Decline

A Generous Gift to Help Find a Cure

Sanford Burham Prebys Launches Long-Term Alzheimer’s Study

Policy Perspective

Democrats Reach Drug Pricing Deal

Golden State Pathways Program

Community Planning Group Reform and New Climate Action Plan Advance in San Diego

Pasadena Selects New City Manager

Featured Premium Members

Biocom California

Celebrating Suppliers Devoted to Meaningful Change

Upcoming Events & Webinars

Featured Suppliers

Purchasing Group’s Endorsed Suppliers in the News:

Biocom California Purchasing Group

DE&I Pledge Spotlight: Cultura

The Power of Pride

ICYMI: A Recap of Asian American and Pacific Islander Heritage Month

Coming Up: National Hispanic Heritage Month

Share Your News 📣

Biocom California | Diversity, Equity & Inclusion Initiative

What’s Inside: June Primary Highlights; FDA User Fee Legislation Passes House; New Bay Area Water Restrictions; San Diego County Proposes $618.7M Budget; and more.

Federal Affairs

User Fee Legislation Passes U.S. House of Representatives

Biocom California Receives Response to March-In Rights Letter

Biocom California Hires Zoe Bilis to Handle Regulatory Policy

Biocom California’s D.C. Office has a new location

June Primary Highlights Mixed Results of State’s ‘Top Two’ System

Regional Affairs

San Diego Tops Office-to-Lab Conversions

Construction Begins at Terminal 1 at San Diego International Airport

County of San Diego Proposes $618.7M Budget, $1.8M for New Climate Action Plan

Proposals to Redevelop Midway District Include More Housing

Alameda County Reinstates Indoor Mask Mandate

California Farms, Bay Area Cities Ordered to Stop Diverting Water

Water Wasters Could Be Fined Up to $10K in South Bay

Meet the Team

Biocom California Advocacy

What’s Inside: Alameda Indoor Mask Mandate; Nominations Open for AgTech Innovators; Introducing Tyler Morris, Director of Capital Development; BIO 2022 in San Diego; Life Science Total Rewards Survey; and more

Biocom California | Bay Area

What’s Inside: Where to Find Us at #BIO2022; How AI and Machine Learning are Advancing Human Health; Amgen, Merck, and Provivi Win Green Chemistry Challenge; and more.

What’s Happening at Biocom California

See You at #BIO2022

National Biotechnology Month Proclamation

Full of Pride

The Latest in Artificial Intelligence and Machine Learning

Beyond the Family Tree

Modern Medicine

A Touch of Robotics

Epic Predictions

Policy Perspective

Drought Forces Water Restrictions

Alameda Masks Up

Featured Premium Members

Biocom California

What’s Inside: How GRAIL, DermTech, Cardiff Oncology, George Clinical, and PetDx Are Improving Oncology Outcomes; FDA Approves Dupilumab, and more.

What’s Happening at Biocom California

Representative Scott Peters is Our 2022 Sustainability Champion

Global Business Reports United States Life Sciences Report

The Latest in Oncology

National Recognition

Patch Test

Advances in Care

Help for Our Four-Legged Friends

Policy Perspective

Biocom California Sends March-In Rights Letter to HHS Secretary

Drought Worsening as Governor Urges Conservation

Biometric Privacy Legislation Stopped in the State Senate

Feedback Needed for SSF General Plan

San Diego Mayor’s May Revision to Proposed Budget

Featured Premium Members

Biocom California

Leverage Quality Benefits to Retain Top Talent