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CLSA Bulletin

2016 Federal, State and Local Election Roundup

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Nov. 10, 2016

CLSA is pleased to provide you with this exclusive 2016 federal, state and local election update, and what these results mean for California’s life sciences sector. With this week’s elections, and looking forward to challenging legislative environments at all levels in 2017, CLSA has already begun the work necessary to ensure our continued success — not only with our returning allies and champions, but with the many newly elected public officials as well.

2016 Federal Election Roundup

After a hard-fought, historically negative campaign, Republicans ultimately emerged victorious on Nov. 8, with President-Elect Donald Trump winning the Presidential election with 279 to 228 electoral votes over former Secretary of State Hillary Clinton. While Arizona (11 Electoral votes, leaning Trump), Michigan (16 Electoral votes, toss-up) and New Hampshire (4 Electoral votes, leaning Clinton) remain too close to call, Trump had already secured more than the 270 Electoral votes required to win the presidency.

Republicans also maintained their majorities in both the House and Senate for the 115th Congress, marking the first time since the 2004 election that Republicans will hold the White House and both chambers in the legislative branch. Republicans now control at least 51 seats in the Senate, losing two races (in Illinois and New Hampshire) and with one race still too-close-to-call (Louisiana, leaning Republican and pending a December run-off election). In the House of Representatives, Republicans will control at least 238 seats, representing a net loss of six seats and with four races still too-close-to-call (including two races each in California, one each leaning Democrat and Republican, and two races in Louisiana, with one leaning Democrat and the other pending run-off between two Republicans in December). Despite maintaining the Senate, Republicans will still fall shy of the 60-vote threshold needed to block a filibuster.

Of California’s 55-member congressional delegation, at least 47 incumbents will return to Washington, D.C. to serve in the 115th Congress. The last three election cycles have brought incredible change to the delegation, now with nearly half of the federal legislators in the state having served less than three terms on Capitol Hill.

2016 saw another wave of long-serving members announce retirements: Reps. Lois Capps (D-Santa Barbara), Sam Farr (D-Santa Cruz), Janice Hahn (D-Carson), Loretta Sanchez (D-Garden Grove) and Senator Barbara Boxer (D). Thus, the 115th Congress will usher in a new class of at least 6 New Member-Elects to the delegation, bringing the number of members in their first, second or third term to 25. Although the 2016 contest will not result in sweeping party changes for California at the federal level, the loss of institutional knowledge creates both significant challenges as well as opportunities to develop new champions for our state’s life sciences innovation ecosystem.

CLSA is well positioned to represent the life sciences sector in the upcoming Congress, having held numerous meetings and developed strong relationships with returning and newly elected members. We are excited for the opportunity to engage with these new legislators, to help them better understand and appreciate our state’s unique life sciences innovation ecosystem.

Below we have summarized some of the key changes in our delegation, and notable outcomes after Tuesday night’s election.

New Members

 California’s congressional delegation in the 115th Congress will include at least six new members:

  • CA-17: This race in the Democratic stronghold of Silicon Valley turned particularly negative in the closing weeks of the election, with 8-term incumbent Rep. Mike Honda (D) filing a lawsuit against repeat challenger Ro Khanna (D) alleging that the campaign had illegally accessed data on Honda’s donors. In the end, Rep. Honda was soundly defeated with 59.8% of the vote going to Khanna.
  • CA-20: In the upper Central Coast region, Monterey County Deputy District Attorney Jimmy Panetta (D) won 70.6% of the vote and defeated Pacific Grove Councilwoman Casey Lucius (R) in this race to replace retiring 23-year incumbent Rep. Sam Farr.
  • CA-24: Santa Barbara County Supervisor Salud Carbajal (D) won 53.8% of the vote and defeated small businessman Justin Fareed (R) in this Central Coast race to replace retiring 18-year incumbent Rep. Lois Capps (D).
  • CA-44: In South Los Angeles, California State Senator Isadore Hall (D) ultimately lost to Hermosa Beach City Councilwoman Nanette Barragan (D), with 51.2% of the vote. This is an open seat to replace retiring incumbent Rep. Janice Hahn (D), who was elected to the L.A. County Board of Supervisors on Tuesday.
  • CA-46: In East Orange County, former California State Senator Lou Correa (D) won 70.2% of the vote to defeat fellow former California State Senator Joe Dunn (D) to replace Rep. Loretta Sanchez (D), who stepped down to run for the open Senate seat vacated by Sen. Barbara Boxer (D).
  • California Senate Race: In the statewide race to replace retiring Sen. Barbara Boxer, Attorney General of California Kamala Harris (D) defeated Rep. Loretta Sanchez (D-Garden Grove) with 62.5% of the vote.

Races Too-Close-to-Call

  • CA-07: Ami Bera (D-Sacramento):
    • In a tightly contested race still too-close-to-call, two-term incumbent Rep. Ami Bera holds a narrow lead over Sacramento County Sherriff Scott Jones (R) with 50.6% of the vote.
  • CA-49: Darrell Issa (R-Vista):
    • Although this seat has typically been a safe race for Republican Rep. Darrell Issa – he won with 60% of the vote in 2014 – the 2016 election proved to be much closer than prior contests. With only 51.1% of the vote, 8-term incumbent Rep. Issa appears poised to narrowly defeat Ret. Marine Colonel and businessman Douglas Applegate (D).

Other Notable Races

  • CA-10: Jeff Denham (R-Modesto):
    • In California’s Central Valley, three-term incumbent Rep. Jeff Denham took 52.4% of the vote to narrowly defeat small businessman challenger Michael Eggman (D).
  • CA-21: Rep. David Valadao (R-Bakersfield):
    • First elected in 2012, incumbent Rep. Valadao held onto his seat in South Central California with 58.6% of the vote over civil rights attorney Emilio Huerta (D). Rep. Valadao was a 2014 recipient of CLSA’s Visionary Award, presented to federal legislators who have shown leadership and commitment to public policies that encourage biomedical research, investment and innovation in life sciences.
  • CA-25: Steve Knight (R-Simi Valley):
    • Going into Tuesday’s election, incumbent Rep. Steve Knight was ranked as one of California’s most vulnerable incumbents and the only remaining Republican congressman in Los Angeles County. Rep. Knight ultimately prevailed, holding 54.3% of the vote over challenger Bryan Caforio (D).
  • CA-31: Rep. Pete Aguilar (D-Redlands):
  • In San Bernardino, one-term incumbent Rep. Pete Aguilar held a narrow lead of 54.9% over Naval reservist challenger Paul Chabot (R).
  • CA-52 – Scott Peters (D-San Diego):
    • Since Rep. Scott Peters defeated incumbent Rep. Brian Bilbray (R) in 2012, the CA-52 race has been too close to call on election day. That changed on Tuesday when Rep. Peters soundly defeated small businesswoman Denise Gitsham (R) with 56.7% of the vote. Rep. Peters was a 2014 recipient of CLSA’s Visionary Award, presented to federal legislators who have shown leadership and commitment to public policies that encourage biomedical research, investment and innovation in life sciences.

Questions? Please contact Jenny Carey, CLSA’s Vice President of Federal Government Relations & Alliance Development (JCarey@califesciences.org).

2016 State Election Roundup

While a plethora of ballots remain to be counted, here is what we know at this time:

  • Supermajority:  Democrats in the Assembly achieved a supermajority, but fell short in the Senate.  This will allow Democrats to pass tax increases and procedural motions without the need for any Republican votes in the Assembly.  In the Senate, however, they will still need one Republican vote for tax increases.
  • Pro-business Democrats: Democrats considered to be “moderate” won in 4 seats over more liberal candidates.  However, one incumbent moderate Democrat lost to a more liberal candidate.
  • Republican Losses:  Incumbent Republicans in three Assembly districts with close registration margins lost to Democratic challengers.

In sum, the Assembly now consists of 55 Democrats and 25 Republicans, while the Senate has 26 Democrats and 14 Republicans.

KEY LEGISLATIVE RACES

In total, there were 33 legislative races.  Of those, 31 are newly-elected individuals who will be sworn in as Members of the Legislature on December 5th.  The remaining 2 races resulted in current members of the Assembly successfully winning election to the Senate. Each of these races are charted below.

OUTCOME OF BALLOT MEASURES

  • Priority #1

Proposition 61:  State Prescription Drug Pricing.  FAILED

Would have prohibited the state from buying any prescription drug from a drug manufacturer at a price over lowest price paid for the drug the United States Department of Veterans Affairs, and exempted managed care program funded through Medi-Cal.

Click here for the No on Prop 61 Campaign Press Release.

  • Other Ballot Measures

Proposition 52:  Medi-Cal Hospital Fee Program.  PASSED

Extends indefinitely an existing statute that imposes fees on hospitals to fund the Medi-Cal health care services, care for uninsured patients, and children’s health coverage.

Proposition 54: Legislature, Legislation and Proceedings. PASSED

Prohibits the Legislature from passing any bill unless it is published on the Internet for 72 hours before a vote, and requires the Legislature to record its proceedings and post them on the Internet.

Proposition 55: Tax Extension to Fund Education and Healthcare. PASSED

Extends by twelve years the temporary personal income tax increases enacted in 2012 (Proposition 30) on earnings over $250,000, with revenues allocated to K–12 schools, California Community Colleges, and, in certain years, healthcare.

Proposition 56: Cigarette Tax to Fund Healthcare and Tobacco Use Prevention. PASSED

Increases cigarette tax by $2.00 per pack, with equivalent increase on other tobacco products and electronic cigarettes containing nicotine.

Proposition 59: Corporations. Political Spending. PASSED

This is an advisory vote to ask whether California’s elected officials should use their authority to propose an amendment to the federal Constitution overturning the United States Supreme Court decision in Citizens United v. Federal Election Commission. Citizens United ruled that laws placing certain limits on political spending by corporations and unions are unconstitutional.

If you are interested in quantitative data related to the entire election in California, please click here.

Questions? Please contact Michael Bolden, CLSA’s Senior Director, State Government Relations (MBolden@califesciences.org).

2016 Local Election Roundup

Below are a key jurisdictions and measures of interest at the local and regional levels for the life sciences sector.

Los Angeles Board of Supervisors

Two new members will be sworn into the Board in December. Congresswoman Janice Hahn (D) will take the seat currently held by Supervisor Don Knabe (R), and Kathryn Barger, the current Chief of Staff for outgoing Supervisor Mike Antonovich (R) will take over her boss’ position on the Board. With this, the dynamics of the Board change from three Democrats and two Republicans to a larger Democratic majority of four to one. Following the recent hearing by the Board of Supervisors castigating industry over drug disposal plans, and overall drug pricing issues, we can expect the new Board to revisit and pursue a mandatory County EPR ordinance on pharmaceuticals and sharps takeback.

San Francisco Board of Supervisors

In San Francisco, all eleven members of the Board are Democrats—the internecine fights occur between differing factions called ‘moderates’ and ‘progressives.’ Currently, the Board of Supervisors has a one-vote advantage for the progressives while working with the more moderate Mayor. Three progressives were termed out and it looks as if they will continue to hold two of those seats, while one will be more moderate. This leads again to a relatively even split providing a one-vote difference between the two factions at the Board. While Supervisor Scott Wiener (from the moderate camp) has won his election to replace Senator Mark Leno in Sacramento, Mayor Lee will most likely appoint a moderate in his place, which should not further change the partisanship levels. Additionally, there were several measures on the ballot put on by progressives to take power away from the mayor that were all defeated.

Sonoma County Measure M

As noted in previous communications (GMO’s On the Ballot in Sonoma County), the Sonoma County Transgenic Contamination Prevention Ordinance (known as Measure M) went before voters. The measure to ban genetically modified organisms (GMO’s) in the County was supported by a group called the Citizens for Healthy Farms and Families and opposed by the Sonoma County Farm Bureau and a variety of agricultural life science technology companies, such as Bayer, Monsanto, Syngenta and others. Measure M passed with 56% of the vote.

Transportation Measures on the Ballot Around the State

Given the growing challenges for our life science companies attracting and retaining quality talent within the state’s largest regions, the sector has taken a keen interest in regional transportation issues. The following are a few propositions on transportation in particular localities and regions.

  • Los Angeles Region

While Los Angeles is known as the home of highways and cars, there are County planners working on creating alternatives to the never-ending process of sitting in traffic. With the passage of Measure M the region will expand rail/subway/bus systems via the local transit system known as Metro. It will also work on other traffic improvement projects and retrofitting for earthquakes. Measure M was heavily supported by the business community in Los Angeles.

  • San Francisco Bay Area
  • Regional

A key transportation resource in Northern California is the Bay Area Rapid Transit (BART) system. Covering several Counties around the Bay, the system is over 40 years old and an overall maintenance/infrastructure bond was placed on the ballot. Three Counties (San Francisco, Alameda, and Contra Costa) collectively passed the bond by over 2/3rds.

  • Santa Clara County

The business community heavily pushed for the passage of Measure B covering San Jose and Silicon Valley and it passed overwhelmingly. This half-cent sales tax will raise up to $6.5 billion toward the County’s bus/transit system known as VTA, as well as provide funding for BART extensions reaching into the County. Historically, Santa Clara County was not part of the original BART system built 40 years ago. Measure B will also improve connections and safety via Caltrain which runs from San Jose to San Francisco along the peninsula.

  • San Francisco County

While Proposition J was passed overwhelmingly to support San Francisco’s transit system (MUNI), Proposition K did not pass. Proposition K would have raised the city sales tax to fund Proposition J. Hence, the funds are no longer available for the proposals in Proposition J, although there will undoubtedly be other possible budgetary discussions.

  • Alameda County

Voters in Alameda County passed Measure C1 by 81% which extends the local parcel tax funding the County’s bus system (AC Transit) for another 20 years.

  • Contra Costa County

The Contra Costa Transportation Authority District placed Measure X on the ballot to collect up to $2.9 billion for more BART cars, shuttles, and road repairs. However, it fell just slightly under the 2/3rds required to pass.

For questions on these, or other local/regional elections from throughout the state, please contact Reese Isbell, CLSA’s Director of Local Government and Community Relations (risbell@califesciences.org).

CLSA Hosts CDC Director for Discussion on Pandemic Preparedness, Q&A with PaxVax CEO on Emerging Viruses; Welcoming New CLSA Members

RETBy: Sara Radcliffe
CLSA President & CEO
CLSA – California Life Sciences Association

July 20, 2016 

 

Welcoming New Members

Please welcome our newest CLSA members: Amaryllis, Nucleics, BioINK, Cepheus Biosciences, Inc., Igantia, Rex Animal Health, SeaSpine, SyntheX, and Veracyte, Inc.!  These organizations join our 750+ membership portfolio to add significant expertise and resources to the CLSA network.

CDC Director Joins CLSA for July 28 Program

Afternoon with Thought LeadersOn July 28, we’re excited to be hosting our Annual Afternoon with Thought Leaders program in San Diego, with featured videoconference keynote, Dr. Tom Frieden,  Director of the Centers for Disease Control and Prevention. This program will focus on Pandemic Preparedness: The Public-Private Research and Response Infrastructure.

As current and past experience has demonstrated, effective and timely responses to emergent public health emergencies and pandemic threats – Ebola, H1N1, SARS, Zika, etc. – require the coordination and collaboration of numerous governmental public health agencies, non-profits, private industry and other important stakeholders.  Our program, will serve to examine these critical partnerships, how our nation’s pandemic preparedness and response infrastructure functions, and how it can be improved, including the role of industry. Our esteemed panel following our keynote includes: Dr. David Ecker, Divisional Vice President of Abbott, Quita Highsmith, Genentech Franchise Head of Tamiflu, Dr. Bill Lee, Executive Vice President, Research at Gilead, Dr. Rekha Murthy, Vice President of Medical Affairs at Cedars Sinai Medical Center, and moderator, Dr. Penny M. Heaton, Director of Vaccine Development and Surveillance at The Bill And Melinda Gates Foundation. To RSVP or learn more, click here.

Following our Afternoon with Thought Leaders our third quarter CLSA Board Meeting will take place. Our Board members will discuss the current healthcare landscape and innovation in life sciences, and help shape CLSA’s agenda and organizational goals as we focus on our collective mission of helping grow and foster California’s world-leading life sciences sector. Our Board leaders and their respective organizations exemplify the depth and range of CLSA’s membership and what we stand for in advancing hope for patients and consumers in California, across our country, and around the world.

PaxVax CEO Nima Farzan sits down with CLSA for Q&A on Pandemic Preparedness

Nima Farzan, CEO & President, PaxVax
Nima Farzan, CEO & President, PaxVax

In recent years, a new round of terrifying viruses has emerged. Ebola, H1N1, SARS, Zika and other pathogens strike rapidly, may mutate without warning, and pose a major threat to public health.

As noted above, on July 28, CLSA will host a panel discussion in La Jolla, CA on Pandemic Preparedness: The Public-Private Research and Response Infrastructure, to examine how our nation’s pandemic preparedness and response infrastructure functions, and how it can be improved, including the role of industry. We recently chatted with PaxVax CEO Nima Farzan about how we can better unite government and industry to prepare for these dangers.

Click here to view CLSA’s discussion with PaxVax CEO Nima Farzan.

Update on Drug Pricing & Reporting Transparency Legislation in Sacramento

The legislative issue of “drug price transparency,” and the broader issue of prescription drug prices, continues to occupy center stage this year. Senate Bill (SB) 1010, authored by Senate Health Committee Chairman Ed Hernandez (D-West Covina), is this year’s primary legislation in this area.

While the bill has been significantly amended to address many specific concerns raised by CLSA, we remain steadfastly opposed to the bill and are working to amend it further. The bill would still require a manufacturer to provide public and private payers with 60 days’ advance notification of any price increase of 10 percent or more, or three days’ advance notice if it intends to market a new drug that will cost more than $10,000 per course of treatment. The bill also requires manufacturers to participate in a public hearing to “justify” such increases or costs, and to report certain proprietary information to payers.

The bill moved through the Senate after being amended in an effort to address some of CLSA’s concerns. The Assembly Health Committee then heard the bill on June 29 and passed it on a 12-4 party line vote after a lengthy and spirited hearing of the bill that consumed much of the four-hour proceeding. While we were disappointed by the Committee’s action to advance the bill, CLSA remains confident that once all the facts are known about the bill, lawmakers will agree SB 1010 is the wrong prescription for California.

The bill now heads to the Assembly Appropriations Committee, which will likely hear the bill in mid-August. During the recess, CLSA has been meeting with members of the Appropriations Committee in their home districts, while also refining and expanding our online social media campaign. Visit www.protectaccessandinnovation.org to view letters of concern and additional information on the pitfalls of SB 1010.

CLSA is Hiring!

We continue building our team to better serve California’s life sciences ecosystem. As the nation’s largest statewide public policy advocacy and business solutions organization, CLSA is expanding and seeking to fill the following positions:

Visit CLSA’s Career Opportunities center to learn more.

Be sure to stay connected with us at www.califesciences.org, and follow us @CALifeSciences, Facebook, Instagram, LinkedIn and YouTube.

Regards,
Sara Radcliffe
President & CEO
California Life Sciences Association

PS – Have newsworthy items to submit for consideration for our monthly CLSA Bulletin? Feel free to send those tips to Bianca Leveriza, CLSAs Associate, Marketing & Events (BLeveriza@CALifeSciences.org).

President Proposes Concerning Cuts to NIH, FDA in FY18 Budget Blueprint

March 20, 2017

On March 16, President Donald Trump released his budget blueprint for fiscal year (FY) 2018. The budget blueprint is high-level and doesn’t include detailed line-by-line specifics, and only covers discretionary, not mandatory spending. Greater detail will be offered later this spring when the Administration publishes its full budget request, including mandatory spending (including programs like Medicare and Social Security) and tax proposals, likely in May.

Notably, the blueprint released last week proposes deep cuts in funding for federal research at the National Institutes of Health (NIH), a proposal that stands in contrast to the bipartisan sentiment expressed by Congress last fall with enactment of the 21st Century Cures Act which reaffirmed the importance of federally-supported basic, clinical and translational research, and established a mechanism for significant increases to the NIH budget over several years. CLSA is strongly opposed to this (and any) proposal to cut funding for NIH.

CLSA released a statement expressing strong concerns with the proposal to cut NIH funding, available here, and CLSA President and CEO Sara Radcliffe was quoted in articles in the San Diego Union-Tribune and San Diego Business Journal on this issue.

Further, the budget blueprint proposes to cut federal funding to the U.S. Food and Drug Administration (FDA), with an increase in user fees. The proposal is short on details, but on its face, appears inconsistent with the pending user fee agreements that were carefully and recently negotiated between industry and the agency (under the previous administration).

The FDA’s current authority to collect user fees expires at the end of this fiscal year, and needs to be reauthorized swiftly for FDA to continue to rely on user fees to support its critical product review activities. CLSA is aligned with our national association partners and supportive of preserving the commitments reflected in the carefully negotiated user fee agreements, and ensuring that these vital programs are reauthorized in a timely manner.

While the President’s budget blueprint serves as an important statement of the Administration’s priorities for the coming fiscal year, it’s important to remember that the budget request is a non-binding document and Congress has the final say on how much and to which programs and activities federal funding will be allocated. In fact, Speaker of the House of Representatives, Paul Ryan (R-Wisc.), said that the president’s spending blueprint is just the beginning of a “very long, multi-stage progress of budgeting.” Specifically, on the question of NIH funding, Speaker Ryan said, “We just passed the [21st Century] Cures Act, just this last December, to increase spending in the NIH, because we really think we’re kind of getting close to some breakthrough discoveries on cancer and other diseases… in Congress you’ll see probably some changes.”

Nonetheless, the budget request provides a framework for discussion of our nation’s funding priorities.

Below is a summary analysis of the president’s budget blueprint’s provisions of importance to the biomedical and life sciences sectors. Questions? Please contact Jenny Carey, CLSA’s Vice President of Federal Government Relations and Alliance Development (jcarey@califesciences.org).

President Trump’s FY 2018 “Budget Blueprint” Highlights

On March 16, 2017, President Donald Trump released his “Budget Blueprint” for fiscal year (FY) 2018. Several of the budget’s many provisions of importance to the biomedical and life sciences sectors are detailed below.

Department of Health & Human Services: The blueprint proposes a total of $69 billion for the Department of Health and Human Services in FY18, representing an overall $15.1 billion (17.9%) decrease from the FY17 enacted level.

  • “Reforms key public health, emergency preparedness, and prevention programs. For example, the Budget restructures similar HHS preparedness grants to reduce overlap and administrative costs and directs resources to States with the greatest need.”
  • “Reforms the Centers for Disease Control and Prevention through a new $500 million block grant to increase State flexibility and focus on the leading public health challenges specific to each State.”
  • Increases opioid misuse prevention efforts by $500 million.
  • Eliminates $403 million in health professions and nursing training program, noting that such programs “lack evidence that they significantly improve the Nation’s health workforce.”

NIH: Reduces overall funding from $32 billion in FY17 to $25.9 billion in FY18 (a $6.1 billion reduction).

  • Proposes “a major reorganization of NIH’s Institutions and Centers to help focus resources on the highest priority research and training activities.” This includes eliminating the Fogarty International Center, which seeks to promote international medical research & collaboration.
  • Consolidates the Agency for Healthcare Research and Quality (AHRQ) under NIH’s umbrella.
  • Overall, the Budget “reduces administrative costs and rebalance[s] Federal contributions to research funding.”

FDA: The blueprint doesn’t specify a topline number for FDA.

  • FDA medical product user fees will be increased “to over $2 billion in 2018, approximately $1 billion over the 2017 annualized CR level.”
  • Without detailed budget tables, actual cuts/increases are difficult to ascertain. An analysis by CQ notes that FDA received approximately $1.96 billion in user fees in FY2016, $1.36 billion of which came from the non-tobacco drug and device divisions. A statement from the Alliance for a Stronger FDA notes that the budget proposal is “cutting more than a third of the agency’s appropriation and offsetting it with an enormous increase in medical product industry user fees.”
  • The blueprint also states: “To complement the increase in medical product user fees, the Budget includes a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products. In a constrained budget environment, industries that benefit from FDA’s approval can and should pay for their share.”

Read the full FY18 budget blueprint here.

Senator Hernandez Back with Legislation on Drug Price Reporting

March 18, 2017

Last August, State Senator Ed Hernandez (D-Asuza) pulled his drug price reporting legislation — Senate Bill (SB) 1010 — after the bill was amended in the Assembly Appropriations Committee. On March 15, he introduced SB 17, which is a somewhat modified version of last year’s bill.

At the press conference introducing SB 17, Hernandez, the chairman of the Senate Health Committee, was joined by Assemblyman David Chiu (D-San Francisco), billionaire activist Tom Steyer, and others, including representatives of Kaiser Permanente and the Pacific Business Group on Health. Comments at the press conference blamed the pharmaceutical industry for increases in health insurance costs and asserted more reporting from manufacturers would lead to lower drug prices.

The bill would require, among many other things, manufacturers of prescription drugs to submit a 90-day advance notice of a price increase to all California public agency purchasers, health insurers, and pharmacy benefit managers (PBMs) where that increase would mean the wholesale acquisition cost (WAC) has exceeded 25 percent over the previous three calendar years. For specialty drugs, the price increase threshold is only 10 percent.

This notice must also “include a statement of any changes or improvements to the clinical efficacy of the drug that explain the increase in [WAC].”

On the effective date of the increase, a host of information must be submitted to the state, including an explanation of “specific financial and nonfinancial factors used to the make the decision to increase [WAC],” the previous year’s marketing budget, any acquisition costs, the previous year’s sales volume, and any “documentation of increased clinical efficacy.”

For new specialty drugs, as defined under Medicare Part D, a manufacturer must notify the state three days before commercial availability regardless of FDA approval status. Within 30 days of this notice, the manufacturer must also submit a “description of the marketing and pricing plans” for the drug, the estimated number of patients to be prescribed the drug, the expected marketing budget, any acquisition costs related to the drug, and any documentation “showing increased efficacy of the drug compared to existing treatments.”

Finally, all the aforementioned information, for both new drugs and existing drugs with price increases, must be posted publicly on the internet by the state in a manner that allows identification of the information on an individual drug basis.

Unlike last year, Sen. Hernandez has not held any stakeholder workgroups or reached out to CLSA and others for input prior to introduction of the bill. We anticipate the bill being heard in the Senate Health Committee in mid-to-late April. Questions? Please contact Brett Johnson, CLSA’s Sr. Director, Policy & Regulatory Affairs (bjohnson@califesciences.org).

Gottlieb Nominated for FDA Commissioner; Senate Confirms Verma to Lead CMS

March 19, 2017

Leadership of key federal departments and agencies with oversight of issues of importance to California’s life sciences sector continue to take shape under the new Trump Administration with the recent confirmation of Ms. Seema Verma as head of the Centers for Medicare and Medicaid Services (CMS), and with the nomination of Dr. Scott Gottlieb to lead the Food and Drug Administration (FDA).

Verma Confirmed as CMS Administrator

On March 13, by a vote of 55 to 43, the U.S. Senate confirmed Verma as Administrator of the Centers for Medicare and Medicaid Services. Administrator Verma, who previously served as founder and CEO of SVC, Inc., a health policy consulting firm, has extensive experience in the Medicaid space having worked closely with former Indiana Governor Mitch Daniels (R) and Vice President Mike Pence on the “Healthy Indiana” insurance coverage reforms and Medicaid expansion. In addition, Verma was involved in Iowa’s move to enact Medicaid managed care and helped craft Kentucky Governor Matt Bevin’s (R) Medicaid expansion waiver. Verma is the first CMS administrator to gain Senate confirmation since Marilyn Tavenner in May 2013. Tavenner served in the role for approximately two years and was replaced by Andy Slavitt, who held the position on an acting basis until the end of the Obama administration.

Gottlieb Nominated to lead FDA

On March 10, the President announced his intention to nominate Scott Gottlieb to be commissioner of the FDA.

Dr. Gottlieb was FDA’s deputy commissioner for medical and scientific affairs from 2005 to 2007, and chief policy adviser to the CMS administrator in 2004, during implementation of Medicare Part D. Earlier he was a senior adviser and director of medical policy development at FDA, where he worked on issues like orphan drugs, and combination products. Gottlieb has long been a resident fellow at the right-leaning American Enterprise Institute. He also serves on the Federal Health IT Policy Committee, which makes recommendations to HHS’s Office for Healthcare Information Technology, and practices medicine at New York University where he is also a clinical assistant professor. His confirmation hearing has not yet been scheduled.

Questions? Please contact Jenny Carey, CLSA’s Vice President of Federal Government Relations and Alliance Development (jcarey@califesciences.org).

Assemblymember Wood Moves Forward on Effort to Ban Copay Coupons

March 18, 2017

Asm. Jim Wood (D-Healdsburg), Chair of the Assembly Health Committee, is preparing Assembly Bill (AB) 265 to be heard in his committee at some time in the next month.

The bill would prohibit a drug manufacturer from offering in California “any discount, rebate, product voucher, or other reduction in an individual’s out-of-pocket expenses, including, but not limited to, a copayment or deductible” if a lower cost and therapeutically equivalent brand or generic drug is “available.”

CLSA has taken an oppose position on the bill due to its potential negative impact on patients for whom a prescriber has determined a certain brand medicine is necessary, among other reasons. We anticipate significant amendments to the bill prior to its hearing in Assembly Health Committee.

To learn more about this legislation, view our February update here. Questions? Please contact Brett Johnson, CLSA’s Senior Director of Policy and Regulatory Affairs (Bjohnson@califesciences.org).

Northern California Continues Quest for Local Take-Back Ordinances

March 16, 2017

While the County of Los Angeles in Southern California deliberates over take-back legislation, the number of Counties in Northern California to pass take-back ordinances continues to grow.

Northern California Counties have led the way in pursuing take-back legislation in California. Seven Bay Area Counties (San Francisco, Alameda, San Mateo, Santa Clara, Santa Cruz, Marin, and Contra Costa) have all passed some form of take-back legislation. A potential eighth, Sonoma in the North Bay, is pushing hard to join them with plans to have a draft ordinance before their Board of Supervisors in early summer.

Sonoma’s County Board of Supervisors held a study session in late 2016 and directed staff to begin drafting drug take-back legislation while simultaneously conducting community research on the possible inclusion of sharps. Throughout 2017, County staff have pursued an ordinance methodically through conducting individual study sessions at each of the City Councils and other local government agencies within the County’s borders. These hearings serve to promote extended producer responsibility (EPR) throughout the County and to get localized feedback. Should the County pass an ordinance this summer it would cover the unincorporated areas of the County. County staff would then return to each of the Cities to push for localized ordinances that would cover their individual City jurisdictions and work collaboratively with the County’s language.

Much further north, rural Tehama County sits over two hours north of Sacramento with a population of only 63,000 residents. Tehama is the first County outside of the heavily populated areas along the Pacific Coast to study these issues publicly. County staff have held several study sessions in 2017 where they have been joined by Executive Director Heidi Sanborn of the pro-take-back California Product Stewardship Council. A local City Manager in the City of Corning in Tehama County serves as a member of their statewide Board of Directors and has been key to the rural push.

Sonoma and Tehama County will conduct further public meetings on their way to drafting legislation for their respective County Board of Supervisors in the coming months.

CLSA continues to be at the forefront of such local activities and speak on their impact of the industry. Questions? Please contact Reese Isbell, CLSA’s Director of Local Government and Community Relations at risbell@califesciences.org.

California Life Sciences Association Announces Winners of 2016 Pantheon Awards

For Immediate Release
Oct. 11, 2016
Media Contact
Will Zasadny, Associate Director, Communications
Tel: 619-961-8848
Email: Wzasadny@CALifeSciences.org

Esteemed Innovators to be Honored for California Life Sciences Contributions at 2016 Pantheon DiNA Award Program in San Francisco

SAN FRANCISCO – (Oct. 11, 2016) – California Life Sciences Association (CLSA), the state’s largest and most influential life sciences advocacy and business leadership organization representing California’s leading life sciences innovators, today announced winners of the 2016 Pantheon DiNA Awards, a distinguished awards program honoring innovation and excellence within California’s life sciences sector.

The annual program, now in its 13th year, brings together more than 600 industry pioneers – including innovators, investors and educators – and recognizes the achievements and excellence of those dedicated to enhancing California’s life sciences community. This year’s winners will be honored at the 2016 Pantheon Awards ceremony on Dec. 2 at the Westin St. Francis in San Francisco.

“California’s premier life sciences community continues to blossom and grow to new heights thanks to our innovators and entrepreneurs statewide who are hard at work producing the most advanced medicines, diagnostics and technologies in the world,” said Sara Radcliffe, President and CEO of California Life Sciences Association (CLSA). “At CLSA’s 2016 Pantheon DiNA Awards ceremony on Dec. 2, we will celebrate the great leaders, both individuals and companies, that have made extraordinary contributions to the California life sciences community this year.”

Winners of the 2016 Pantheon DiNA winners include, sorted by award category:  

Ticketing, event and sponsorship information is available at www.clsapantheon.org. The event will commence with a reception at 5:30 p.m. PT, followed by a presentation and dinner at 7 p.m. PT. Members of the press may obtain complimentary registration by RSVP’ing to Will Zasadny (Wzasadny@CALifeSciences.org or 619-961-8848).

To learn more about CLSA and its offerings, please visit: www.califesciences.org.

About California Life Sciences Association (CLSA)

California Life Sciences Association (CLSA) is the state’s largest and most influential life sciences advocacy and business leadership organization. With offices in Sacramento, San Diego, South San Francisco, Los Angeles and Washington DC, CLSA works closely with industry, government, academia and others to shape public policy, improve access to innovative technologies and grow California’s life sciences economy. CLSA serves biotechnology, pharmaceutical, medical device and diagnostics companies, research universities and institutes, investors and service providers throughout the Golden State. CLSA was founded in 2015 when the Bay Area Bioscience Association (BayBio) and the California Healthcare Institute (CHI) merged. Visit CLSA at www.califesciences.org and follow us on Twitter @CALifeSciences, Facebook, Instagram, LinkedIn and YouTube.

Contact:
Will Zasadny
Associate Director, Communications
Wzasadny@califesciences.org
619-961-8848

Opinion: Let’s not talk drug price, without value.

Peter J. Pitts

In medicine, it’s considered good practice to figure out what’s causing a patient’s illness before prescribing the cure.

When it comes to pharmaceutical pricing, politicians and special interest groups should do the same. Recently, politicians along with the nonprofit Public Citizen have slammed pharmaceutical firms for “needlessly high” drug prices. Public Citizen, specifically citing the $1,000-per-pill hepatitis C drug Sovaldi, have called for the government to step in and control prices in the drug industry.

The treatment plan? Very recently, Bernie Sanders has called for “wartime powers” to break the patents on drugs. Hillary Clinton has proposed regulating drug prices.

Unfortunately, while good intentioned, all these are responses to a symptom without understanding the underlying cause for the high cost of some drugs. And this prescribed treatment, price controls, has real side effects. When it comes to the price/value debate it’s important to look at the whole picture.

Some drugs are more expensive, but also more effective. Consider Sovaldi. A 12-week course of treatment costs $84,000, which is more expensive than past hepatitis C treatments — but it’s also more effective. Pegasys, one alternative treatment for Hepatitis C, requires one injection a week for 24 or 48 weeks. Sovaldi not only cures patients 2-4x faster than does Pegasys but also doesn’t cause the same severe side effects. That means patients are more likely to complete the regimen, rather than wasting money by dropping out of treatment prematurely, as many used to do.

Upfront drug costs prevent major expenditures later. High-tech pharmaceuticals prevent patients from developing more serious conditions that require expensive procedures, hospital stays, or doctors’ appointments. About one in five hepatitis C patients ultimately suffers cirrhosis of the liver. Sovaldi stops these patients from needing liver transplants, which can cost nearly $600,000.

Data recently published by the PwC Health Research Institute suggests that the use of Sovaldi will actually drive down overall spending within a decade.

Drug development is a lengthy, expensive undertaking. The average new treatment costs $2.6 billion and takes over a decade to develop. Even so, more than 88 percent of tested drugs fail to secure FDA approval. Today it takes about 10,000 new molecules to produce one FDA-approved medicine. This observation itself is disconcerting, but further, only three out of 10 new medicines earn back their R&D costs. If the government steps in and ratchets back the price of expensive medications, pharmaceutical innovation will grind to a halt. If the United States had implemented European Union-type price controls back in 1980, up to $256 billion worth of research would have been lost, according to one study.

Generics are a solution but also have hidden costs. “Mandatary generic substitution’ is a good way to save payers money in the short term (including our nation’s largest payer—Uncle Sam), but it often has a deleterious impact on patient care — an issue that is researched and quantified. This is even more important when it comes to medicines that have a narrow therapeutic index. A study fielded by the National Consumers League demonstrated that switching a patient to a generic medicine doesn’t always result in positive outcomes: only a third (34 percent) felt that the substituted medication was just as effective as the original medication.

When it comes to the price/value debate it’s important to look at the whole picture. The repercussions of choosing short-term savings over long-term results, of cost- based choices over patient-centric care are pernicious to both the public purse and the public health. Skimping on a more expensive medicine today but paying for an avoidable hospital stay later is a fool’s errand.

About the Author: Peter J. Pitts is a former FDA associate commissioner, current president and co-founder of the Center for Medicine in the Public Interest, and executive partner for YourEncore.

Emerging Themes in Personalized Medicine

The adoption of Personalized Medicine is being driven by the omnipresence of Next-Generation Sequencing (NGS), the fast pace of technological innovations in the field, and the President’s Precision Medicine Initiative. To date, however, only a relatively small fraction of the patient population has had their DNA fully sequenced, while a larger segment has undergone limited analysis related to an NGS-based diagnostics test, primarily in the area of oncology. It is expected that this picture will soon change though, as costs continue to drop and the value of NGS is further demonstrated thus driving this development.

NGS has tremendous value and potential in oncology for prognostic and diagnostic purposes. NGS data adds to the identification and application of biomarkers in different research areas such as cardiovascular disease, contributes to the understanding and characterization of the underlying biology of human diseases, and nowadays in the identification and characterization of new drug targets. Its wider-spread acceptance and applications bring with it a number of non-trivial challenges though, such as an increasing complexity in clinical trial design and patient selection, a potential to further increase drug development costs, and increased pressure to provide justification of clear clinical value to both payors and patients. Juxtaposed to this are the opportunities that come with improved computational and data management capabilities and the fast-paced technological achievements which are expected to address these challenges and further accelerate the transition into the clinic.

The 10th Personalized Medicine World Conference (PMWC 2016), held January 24-27 in Silicon Valley, will focus on these developments in a collegial setting that fosters scientific exchange, networking, and partnering. The broad array of topics covered span research and commercial applications and include NGS and its clinical utilization, prenatal diagnostics, data privacy and security, regulatory updates, and commercial opportunities. PMWC 2016 offers an environment that allows the dissemination and exchange of these relevant contents for researchers, clinicians, providers, and government and biotech representatives.

Follow us on Twitter: @PMWCintl

CSU I-Corps Partners to Offer Bio-entrepreneurship Workshop to Researchers Nationwide

Feb. 10, 2017 | California State University

The National Science Foundation (NSF) announced eight new Inclusive Entrepreneurship supplemental awards under the Innovation Corps (I-CorpsTM) program, including one to CSU I-Corps, a member of the National Innovation Network. The Inclusive Entrepreneurship grants are designed to “increase participation and promote inclusion of underrepresented populations in the National Innovation Network.”

The grant to CSU I-Corps, a program of the California State University Program for Education and Research in Biotechnology (CSUPERB), will support a June 2017 Bio-entrepreneurship Workshop for a diverse group of early-career researchers during this year’s Biotechnology Innovation Organization (BIO) International Conference in San Diego. Pete Pellerito, BIO’s Senior Advisor for Federal/State Economic Development and University Relations stated, “BIO welcomes this I-Corps initiative and its efforts to diversify the industry’s innovator pipeline. We look forward to having the Bio-entrepreneurship Workshop participants at BIO 2017.”

Susan Baxter, Executive Director of CSUPERB, said “We are looking forward to hosting life science researchers from universities nationwide at San Diego State University. The workshop will help unmask the skills, resources and networks needed to commercialize research-based ideas.” Stanley Maloy, Dean of the College of Sciences at San Diego State University, added “The unique perspectives of diverse teams can generate creative insights into important problems. This workshop will provide the tools for turning these innovative ideas into commercially viable solutions that lead to rewarding careers and economic growth.”

During the 2.5-day Bio-entrepreneurship Workshop, participants will learn about evidence-based entrepreneurship and value proposition design, pillars of the curriculum offered by I-CorpsTM sites and nodes nationwide. The workshop will pair participants and biotechnology industry experts in working teams.  After formulating value propositions, teams will test assumptions on the BIO 2017 exhibition floor.

CSUPERB will work with the E. E. Just Life Sciences Society, an initiative of the Center for Healthcare Innovation (CHI), and the Annual Biomedical Research Conference for Minority Students (ABRCMS) to recruit workshop participants nationwide.  “This bio-entrepreneurship workshop is ideal for our population of students,” said Avery August, ABRCMS Chair, Professor at Cornell University and CSU Los Angeles alum, “it complements our efforts to broaden access to career options as an integral part of the STEM learning experience.” Chad Womack, National Director of STEM Initiatives at the United Negro College Fund (UNCF), said “the purpose of the bio-entrepreneurship workshop is to empower participants with cutting-edge strategies for startup entrepreneurship in the life sciences.  We believe the workshop will also enhance diversity and inclusion while supporting the growth of the bio-industry.”

The Bio-entrepreneurship Workshop responds to a key finding of the 2016 California Talent Report co-authored by two BIO-affiliated organizations in California, the Biocom Institute and the California Life Sciences Institute (CLSI). The report sites concern from life science industry executives about “future talent from groups that are already unrepresented (i.e. African American, Hispanic and female) in STEM fields. Many recognize…the industry needs to do more to engage these underrepresented populations.” CLSI and the Biocom Institute will help with BIO conference coordination, helping to draw in industry experts and mentors from Biocom and California Life Sciences Association (CLSA) member companies and CSU I-Corps’ statewide mentor and alumni networks.

“We hope the Bio-entrepreneurship Workshop will become an integral part of BIO conventions in the future and help expand and diversify the ecosystem for life science innovation,” said Lori Lindburg, CEO/President of CLSI. “As we gain experience this summer, we want to work with BIO and the national Coalition of State Bioscience Institutes to better integrate activities into convention programming,” said Liisa Bozinovic, Executive Director of Biocom Institute.

The 2017 Bio-entrepreneurship Workshop will be held June 19-21, 2017, at San Diego State University.  The NSF grant will cover participants’ travel to and from San Diego, lodging and meals. Applications will be accepted starting in February.

International partnership established to tackle antimicrobial resistance

For Immediate Release:
July 28, 2016

The Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, brings together leaders with the aim of rejuvenating the antimicrobial pipeline

(LONDON/WASHINGTON, D.C.) – The U.S. Department of Health and Human Services (HHS), the Wellcome Trust of London, the AMR Centre of Alderley Park, Cheshire in the United Kingdom and Boston University School of Law today announced the establishment of one of the world’s largest public-private partnerships focused on tackling antibiotic resistance, an emerging modern threat to public health worldwide.

The Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, brings together leaders in industry, philanthropy, government and academia with the aim of rejuvenating the antimicrobial pipeline.

The Biomedical Advanced Research and Development Authority (BARDA), within HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR), will provide $30 million in research and development funding through CARB-X during the first year and up to $250 million over five years.

The AMR Centre, a public-private initiative formed in February 2016 to drive the development of new antibiotics and diagnostics, aims to provide $14 million to support CARB-X projects in year one and up to $100 million over five years.

The Wellcome Trust, a global charitable foundation focused on biomedical research, will contribute further funding and its expertise in overseeing projects of this kind.

CARB-X grew out of President Obama’s 2015 Combating Antibiotic Resistant Bacteria (CARB) initiative and will address several goals laid out in the U.S. Federal CARB National Action Plan.

“Our hope is that the combination of technical expertise and life science entrepreneurship experience within CARB-X’s life science accelerators will remove barriers for companies pursuing the development of the next novel drug, diagnostic, or vaccine to combat this public health threat,” said Joe Larsen, Ph.D., acting BARDA deputy director. “In the same way BARDA’s investment model has proven successful in advancing countermeasures through late-stage development, we believe this international partnership can identify promising candidates in the early stages of development that may offer treatment options for drug resistant bacterial infections.”

In 2014 the UK government and the Wellcome Trust asked economist Jim O’Neill to analyze the global problem of antimicrobial resistance and propose concrete actions to tackle it internationally. His final report, published in May 2016, called for concerted global effort to boost the supply of new antibiotics, and to develop rapid diagnostics to allow existing drugs to be used more sparingly. CARB-X will play a significant role in answering this call.

“Drug-resistant infections are already costing lives all over the world. Many drugs that we have too often taken for granted no longer work, presenting one of the biggest threats to our future global health and economic security,” said Dr. Jeremy Farrar, Director of the Wellcome Trust.  “A problem of this scale can only be tackled through coordinated international effort to curb our massive over use of existing antibiotics, and to accelerate the development of new ones. I hope our new transatlantic partnership marks the beginning of a wider global effort to prevent untreatable bacterial infections from claiming millions of lives.”

CARB-X aims to deliver a growing portfolio of promising new antibiotics, diagnostics and vaccines, to tackle the threat posed by untreatable bacterial infections. The international partnership will support a suite of products through early preclinical development to a stage where they can be taken forward by private or public investment.

“CARB-X is one of the most important steps yet in terms of rethinking how we deal with AMR and it will have an impact around the world,” said Dr. Peter Jackson, Steering Group Chairman of the AMR Centre. “At the AMR Centre we share the same goal of accelerating a new pipeline of treatments and diagnostics by working on new drug development programs in our own labs as well as with other collaborating organizations, in particular providing support to small and medium-sized businesses and research institutes which have exciting new approaches to AMR.”

Led by executive director and principal investigator Kevin Outterson, the N. Neal Pike Scholar in Health & Disability Law and Professor of Law at Boston University, the CARB-X partners will pool their broad scientific, technical, business and legal expertise to help grantees navigate the maze of regulatory steps, studies and data collection required for new drugs and other products to gain approval by U.S. and/or European regulators.

“The grant to establish the CARB-X project, with Kevin Outterson of the School of Law as executive director, is a major milestone for Boston University,” said Boston University President Dr. Robert A. Brown.  “That the leadership for this collaboration among very distinguished public and private entities comes from Boston University is testament to our range and depth as a research university.  Most of us understand the arms race that is ongoing between the natural evolution of bacteria harmful to humans and our development of the drugs that combat them. The CARB-X project will accelerate drug development in this critical race with nature.”

The CARB-X partners include:

  • The Biomedical Advanced Research and Development Authority (BARDA), within the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) who will draw on its extensive experience of successfully advancing promising medical countermeasures through late-stage development and provide $30 million during the project’s first year and up to $250 million during the five-year program;
  • Wellcome Trust is a global charitable foundation in London, UK. They are a major funder of biomedical research with significant experience in infectious diseases and investment in early stage antibiotic R&D. In addition to providing funding, Wellcome will bring expertise in overseeing high quality international research projects;
  • AMR Centre is a public-private initiative based in Alderley Park, Cheshire, UK that supports development of new antibiotics and diagnostics and will provide funding along with business mentoring and research support;
  • Boston University School of Law in Boston, Massachusetts, will host the CARB-X executive team which will include experts with decades of experience in antibiotic drug development, including John Rex, Senior Vice President at Astra Zeneca. Starting January 1, 2017, Barry Eisenstein (formerly of Cubist and currently at Merck) will join CARB-X;
  • The National Institutes of Health’s National Institute of Allergy and Infectious Disease (NIAID), which leads the U.S. government in determining the causes of infectious and immune-mediated diseases and developing better means of preventing, diagnosing and treating these illnesses. NIAID will provide in-kind services, including preclinical services, to projects that CARB-X supports. NIAID also is providing technical support for CARB-X from their internal subject matter experts in early stage antibiotic drug discovery and product development;
  • MassBio in Cambridge, as an extension of the successful MassCONNECT program, and California Life Sciences Institute (CLSI) in the San Francisco Bay Area will provide world-class business support and mentoring services to innovative product developers selected for funding. The two accelerators will also share best practices with the Wellcome Trust and AMR Centre, expanding the scope of business support services globally;
  • The Broad Institute of MIT and Harvard in Cambridge, Massachusetts will host a new inter-disciplinary Collaborative Hub for Early Antibiotic Discovery. This hub, aimed at early drug discovery, will work with multiple academic programs to advance promising antibiotic candidates that the CARB-X initiative can pursue;
  • RTI International will provide technical and regulatory support services to product developers in the partner accelerators as well as build and run the computing systems to identify, track and monitor all research programs, including a real-time dashboard management information system. RTI will evaluate all CARB-X operations to identify and share best practices across all partners and support continuous quality improvement.

Beginning in September, CARB-X will begin reviewing applications to determine the most promising products to fund. Decisions will be made by the Scientific Advisory Board, with input from the agencies, including BARDA and NIAID, and the funders. Applicants should check the website for updates.

###

Press Contacts:

HHS: Elleen Kane 202-205-8117, elleen.kane@hhs.gov

Wellcome Trust: Hannah Isom +44 (0) 207 611 8898, h.isom@wellcome.ac.uk

AMR Centre: Chris Hulme +44 (0) 7971 350116, hulme@thisisinfluential.com

Boston University: Tom Testa (617) 353-7628, ttesta@bu.edu

NIAID: Kathy Stover (301) 496-8864, kathy.stover@nih.gov

California Life Sciences Institute (CLSI): Will Zasadny (619) 961-8848,Wzasadny@califesciences.org

MassBio: Jessica Roche (617) 674-5146, jessica.roche@massbio.org or Sarah MacDonald (617) 997-8641, sarah.macdonald@massbio.org

The Broad: Lee McGuire (617) 714-7006, lmcguire@broadinstitute.org

RTI: Lisa Bistreich-Wolfe (919) 541-7340, news@rti.org

California Life Sciences Institute Releases 2016 Report on Economic Impact of Bay Area Life Science Startups

For Immediate Release:
June 7, 2016
Media Contact:
Will Zasadny, Associate Director, Communications
Tel: 619-961-8848
Email: Wzasadny@CALifeSciences.org

Report demonstrates that Bay Area life science startups are making significant contributions to local and state economy with public and private funding, job creation, and innovative discoveries. Almost half of surveyed companies have a woman in the C-suite.

SAN FRANCISCO – June 7, 2016 – The California Life Sciences Institute (CLSI) today released a report entitled “2016 Economic Impact of Bay Area Life Science Startups” at the BIO International Convention in San Francisco. This first-ever report measures the economic contributions of 137 pre-Series A Bay Area life science companies (a 30 percent sample of 450 companies contacted) in terms of funding, jobs, and patents. The report demonstrates that Bay Area life science startups are making significant contributions to the local and state economy with public and private funding, job creation, and innovative discoveries.

CLSI is the non-profit partner of the California Life Sciences Association (CLSA), and supports the foundations of innovation – workforce development, STEM education and entrepreneurship – that have made California home to the world’s most prominent life sciences ecosystem.

The genesis of the report came from a group of organizations that work with Bay Area life science startups – QB3, Stanford Office of Technology Licensing, Silicon Valley Bank and UCSF’s Center for Digital Health Innovation – all of whom saw value in trying to capture the impact of these early-stage companies, a large portion of whom operate largely under-the-radar.

Collected during the second quarter of 2015, the data demonstrates:

  • Over half (59 percent) of respondents’ companies are one-to-four years old, and 13 percent are less than a year old.
  • Therapeutics comprised the largest (36 percent) segment of respondents, followed by Medical Devices (19 percent), Research Tools (11 percent) and Digital Health (9 percent). Oncology is the leading indication in both Therapeutics and Medical Device companies.
  • Respondents have raised a total of $360 million in funding: 77 percent from private sources; 23 percent from public.
  • These companies are providing jobs for over 1200 people, either full- or part-time or consultants.
  • Respondents have filed 468 patents, with 158 of them granted.
  • Just under half of the respondents (47 percent) have a woman in the C-suite, significantly higher than the industry at large.

“While forced to navigate significant funding and regulatory challenges, our region’s earliest life science startups are still having a strong positive impact on our local and state economy,” said Lori Lindburg, executive director, California Life Sciences Institute (CLSI). “These startups need the help of the entire ecosystem – legislators, biopharma, investors, trade associations, and other stakeholders – to commercialize their innovative discoveries.”

Steve Karp, senior advisor to the California Life Sciences Institute (CLSI) who spearheaded the analysis said, “While these startups are on the leading edge of innovation in the industry, they often are not captured in traditional analyses, leaving uncovered the important economic and workforce contributions of our region’s youngest companies.”

The report is available at the 2016 BIO International Convention in San Francisco. The launch includes a panel discussion moderated by Todd Rufo, director of the San Francisco Office of Economic and Workforce Development, and features key leaders in the Bay Area entrepreneurial life sciences ecosystem from Bayer, Illumina, JLABS and QB3. The panel discusses the factors that underscore the region’s remarkable innovation engine.

An executive summary and full copy of the report can be found at: www.califesciences.org/EIR2016.

About California Life Sciences Institute (CLSI)
California Life Sciences Institute (CLSI) supports the foundations of innovation that have made California home to the world’s most prominent life sciences ecosystem. With a focus on the San Francisco Bay Area, CLSI’s mission is to maintain California’s leadership in life sciences innovation through support of entrepreneurship, education and career development. CLSI is an affiliate of the California Life Sciences Association (CLSA), which represents more than 750 life sciences organizations. The California Life Sciences Institute is a non-profit 501(c)(3), and was established in 1990 as the BayBio Institute. Learn more at http://califesciencesinstitute.org.

Media Contact:
Will Zasadny
Associate Director, Communications
Wzasadny@califesciences.org
619-961-8848

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