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CLSA Wire

CHI & BayBio Update from the President’s Desk

Posted by Sara Radcliffe, President & CEO
April 1, 2015

AN ACTION-PACKED FIRST MONTH!

Our new organization, the California Life Sciences Association, is well on the way to becoming California’s most influential life sciences advocacy and business leadership organization.

The merger between the Bay Area Bioscience Association (BayBio) and the California Healthcare Institute (CHI) closed on March 4 thanks to tremendous work from the BayBio and CHI teams, as well as numerous BayBio and CHI Board Members.

As the California Life Sciences Association wraps up its first month, I acknowledge with gratitude the extraordinary dedication of our combined team, which has managed to maintain a full range of programs, support services and advocacy efforts on behalf of the life sciences sector we serve — all in addition to our intensive ongoing work to integrate operations. We’re thrilled about the opportunities ahead of us to shape public policy, drive business solutions and grow California’s life sciences innovation ecosystem with our members, partners and supporters!

To get up to date on all we’ve been doing, please read on.

Please note that until we have developed unified branding and completed building our new website (which we expect to finalize in early May), we’ve chosen to continue communicating externally under the BayBio and CHI brands. Have questions? Click here for a list of frequently asked questions (FAQs).

Value of Medical Innovation Campaign Launch

A growing theme among many stakeholders (press, legislators, payors, etc.) is that medical innovations are often too expensive and/or of questionable value. To respond, we recently launched a campaign to recapture and reshape the public narrative away from the cost of innovation and toward the value of innovation by better communicating the role of biomedical innovation in driving improvements in patient care and near – and long-term benefits across our economy.

Click here to view our first infographic and click here to view my accompanying op-ed that was just published in The Sacramento Bee. Both pieces focus on HIV/AIDS medicines, the value they have brought to society, and the concerns with certain tactics by insurance companies to shift additional out-of-pocket costs onto patients by, for example, placing these drugs in specialty tiers. The SacBee op-ed also expands on the overarching message regarding the need to preserve and protect the value of and access to medical innovation. Over the next 12 months, we will be releasing 11 additional infographics centered on the theme of medical innovation. We’ve also created a microsite (www.chi.org/innovation) to host these along with the accompanying op-eds/blogs/other materials as they are published.

California Congressional Delegation New Member Orientation

On March 19, we convened a roundtable discussion in Washington D.C. to introduce the new members of our state’s delegation to the key federal policy issues that influence our continued leadership in life sciences innovation. Our event brought together the freshmen members of our delegation, along with board members and senior executives from across our organization’s membership. Discussion focused around the importance of science funding at NIH, intellectual property protections and tax policy, FDA regulatory processes and funding, and the role of coverage/payment/access/value policies in ensuring patient access to and continued innovation in new therapies and technologies. Participants in the roundtable included several board members and member company senior executives, and Reps. Mark DeSaulnier (D – East Bay), Steve Knight (R – Antelope Valley), Norma Torres (D – Pomona) and Mimi Walters (R – Laguna Niguel). Reps. Aguilar (D – Redlands) and Ted Lieu (D – Torrance) sent staff to observe the discussion.

Town Hall and Roundtable with NIH Director Collins

On March 6, we, Biocom, and UC San Diego hosted Francis Collins, M.D., Ph.D., Director of the National Institutes of Health (NIH) at the UC San Diego, School of Medicine for a roundtable discussion regarding the vibrancy of the California life sciences sector and a town hall on President Obama’s Precision Medicine Initiative. Learn more about the event here.

CALBIO 2015

A joint BayBio and Biocom event, the CALBIO2015 Conference, was held on March 2 – 3 in San Francisco, Calif., and provided an opportunity for frank and thoughtful discussions on how to turn today’s challenges into tomorrow’s opportunities. This statewide industry event brought together approximately 650 industry professionals and featured keynote presentations from Bob More, Bill & Melinda Gates Foundation; Gregory Simon, Poliwogg Healthcare Investments; and Patrick McNeillie, IBM. Approximately 20 educational sessions produced this year were focused on business strategy, partnering and funding, pricing and reimbursement, as well as regulatory and digital health issues. Attendance at this final BayBio event was 38 percent life sciences companies and 27 percent senior executives, as well as attendees from investment funds, patient foundations, university technology transfer offices, and media and industries supportive of the life sciences sector.

Engagement & Leadership on Key Federal Policy Priorities

We are leading efforts to encourage our California delegation’s support of and leadership on several key policy initiatives:

  • FDA User Fee Sequestration: We are supporting Reps. Anna Eshoo (D-Silicon Valley) and Leonard Lance (R – N.J.) in reintroducing the FDA Safety Over Sequestration Act, legislation to exempt FDA user fees from future threats of sequestration. The bill (HR 1078) was introduced last month and currently has 20 additional cosponsors, including 12 bipartisan cosponsors from the California congressional delegation. We are now leading efforts to increase stakeholder support for the bill. In collaboration with San Diego-based Biocom and our friends in New Jersey (HINJ, NJ Bio and Innovation New Jersey), we are leading a state and regional life sciences association letter of endorsement for the bill (a similar letter last congress was supported by 33 state and regional associations). We are also partnering with EveryLife Foundation for Rare Diseases to develop a patient advocacy and research organization letter of endorsement in support of the bill (a similar effort last congress was supported by 125 groups).‚óè       NIH Funding: Our efforts were successful in encouraging more than half of the California congressional delegation to support a bipartisan letter to House appropriators requesting at least $32 billion for the National Institutes of Health in FY16. In all, 33 members of our state’s delegation cosigned the letter, including two freshman members and four more senior members who had not supported similar efforts in the past. Overall, the letter was cosigned by 169 bipartisan members of the House. A similar letter in the Senate garnered support from 54 bipartisan cosigners, including both California Senators Barbara Boxer (D) and Dianne Feinstein (D).‚óè       Device Tax Repeal: We have been leading efforts to encourage our congressional delegation to support a repeal of the medical device tax, and are pleased that new cosponsors from our delegation have offered their support for legislation to repeal the tax (HR 160) this year – most notably Bay Area Rep. Jackie Speier (D – Hillsborough), who has not cosponsored similar bills in past years. We have also led efforts to secure three freshman members of our delegation to join as cosponsors of the bill: Reps. Pete Aguilar (D – Redlands), Steve Knight (R – Antelope Valley) and Mimi Walters (R – Laguna Niguel). Further, we are supporting Rep. Elise Stefanik’s (R – N.Y.) effort to send a bipartisan freshman letter to Speaker John Boehner (R-Ohio) calling for prompt consideration of legislation to repeal the device tax. We are pleased to report that all three of our freshman cosponsors of the bill have cosigned the letter. Click here to view my recently published op-ed in the U-T San Diego regarding the need to repeal the medical device tax.

    ‚óè       Patent Litigation Legislation: We have significant concerns with pending legislation (HR 9, the Innovation Act), which significantly alters patent litigation processes and procedures and would threaten the ability of life science innovators to enforce their patents and fund continued R&D by making it more difficult, time-consuming and expensive to enforce legitimate and important IP rights. We are working collaboratively with national associations like BIO, PhRMA, MDMA, NVCA, AAU and APLU to raise concerns with the proposed legislation, and offer alternative proposals that would protect life science IP rights. To this end, we have convened over a dozen meetings with key members of our congressional delegation (including the new members of Congress, with California members of the House Judiciary Committee, and members of the New Democrat Coalition of moderate, pro-business Democrats) to raise awareness to our sector’s concerns. The aggressive timeline for action on HR 9 has slowed, we believe in large part due to our advocacy and engagement. Click here to view an op-ed published in Roll Call by Todd Gillenwater, CHI’s Executive Vice President – Advocacy and External Relations, regarding HR 9.

Sacramento Update

  • Extended Producer Responsibility (EPR): We are watching two extended producer responsibility (EPR) bills: AB 45, Assemblymember Kevin Mullin (D – South San Francisco) Household Hazardous Waste and AB 1159, Assemblymember Rich Gordon (D – Menlo Park) Tire recycling: Incentive Program, currently a spot bill that will later be amended to address sharps and battery disposal. Both authors are requesting feedback from our industry as how to best address this complex matter. Our EPR task force continues to discuss next steps.‚óè        Drug Pricing and Patient Access: We have met with numerous legislators regarding drug pricing and access issues. Assemblymember David Chiu (D – San Francisco) introduced AB 463, legislation that would require companies to publish an extensive list of broad, undefined, and often impractical reporting requirements surrounding the development, manufacture and marketing of new therapies. We are actively opposing AB 463, as it seeks to impose expensive and burdensome reporting requirements with no real benefit to consumers or policy makers.‚óè       Biosimilars: We continue to build a coalition around the issue of biosimilars. Senator Jerry Hill (D – San Mateo) has introduced SB 671, which we support and which allows a pharmacist, under specified conditions, to substitute a biosimilar product determined to be interchangeable by the FDA. The bill is currently set for hearing in the Business and Professions Committee on April 13. We are meeting with members of this Committee as well as the Senate Health Committee.

    ‚óè       Speaker Series: Our Monthly Speaker Series in Sacramento provides our members the opportunity to engage with and educate key policymakers about issues of interest to the life sciences sector. Our 2015 speakers have included Assemblymember Rob Bonta (D – Alameda), Chair of the Assembly Health Committee; Assemblymember Jimmy Gomez (D – Los Angeles), Chair of the Assembly Appropriations Committee; and Senator Janet Nguyen (R – Garden Grove), Vice-Chair of the Health Committee. Our next Speaker Series on Wednesday, April 15 at 12:00 pm at the CMTA conference room at 1115 11th Street in Sacramento will include the Lesbian, Gay, Bisexual & Transgender (LGBT) Legislative Caucus. Assemblymember Susan Eggman (D – Stockton) chairs the caucus and is reaching out to her Caucus members to request their participation. For more information or to RSVP, please contact Christina Hwee, our state government affairs associate (Hwee@chi.org or 916-233-3497).

    ‚óè       PAC Events: Our PAC has been actively working to put on successful events for several legislators. We currently have four events planned around the corner including a wine reception with Senator Pat Bates (R – Laguna Niguel), Dinner with Senator Bob Wieckowski (D – Fremont), A Full Day in Wine Valley with Assemblymember Rob Bonta (D – Alameda), and an evening Los Angeles with Assemblymember Jimmy Gomez (D – Los Angeles).

Bay Area Update

  • Take-Back Ordinances in San Francisco and Marin Counties: In March, ordinances on drug take-back programs moved forward in San Francisco and Marin Counties. The San Francisco Board of Supervisors voted to establish a citywide drug take-back program, based on the similar Alameda County ordinance passed in 2012. The Marin County Board of Supervisors heard from its County Public Health Officer on recent stakeholders’ meeting recommendations for a drug take-back ordinance for their county. They directed county counsel and staff to work on crafting just such an ordinance for passage in the next few months. Movement is spreading to other Bay Area counties as well. These county ordinances require drug manufacturers to implement and fund programs for collecting and disposing of leftover drugs not used by consumers. We have actively opposed these proposals because they will not satisfy the supposed goals desired by the proponents on environment or public safety, they will not be workable in practice, and they place the entire burden of pharmaceutical waste on the manufacturers, ignoring the complex supply chain. Furthermore, the implementation of various local ordinances will do little more than create a patchwork of inconsistent regulations that will only confuse consumers and forestall conversations at the state and federal level around truly effective and equitable solutions. While we are disappointed in these county actions, our work continues, as we actively engage with other regional and state leaders and stakeholders to educate them on the adverse effects take-back proposals such as this will have on the life sciences innovation ecosystem. Click here for more information on San Francisco’s new ordinance, and click here to view Marin’s hearing.‚óè       Hearing on Specialty Tiering and Insurance Industry Practices: On March 25, the San Francisco Board of Supervisors held a hearing in the Budget and Finance Committee on insurance industry practices and specialty tier drug pricing. Recent trends by insurance companies increase co-pays for covered pharmaceuticals through a reclassification into specialty tiers have created a firestorm of controversy. Increasing the direct consumer costs for certain life-saving drugs, oftentimes at astronomical jumps in co-pay costs, effectively limits access to those drugs, including life-saving HIV/AIDS, cancer, and other treatments. Often patients end up forgoing adherence at the risk of their health and well-being. This hearing comes on the heels of recent news articles in the LGBT press in San Francisco about Kaiser Permanente’s tiering practices for HIV/AIDS drugs. Participants in the hearing criticized the insurance industry practices, but also raised concerns regarding the overall pricing of drugs and sought further information regarding drug pricing. Click here to learn more and view the hearing.

BayBio Institute Update

  • FAST: The BayBio Institute has announced the Spring 2015 FAST companies who have just entered into 10 weeks of team-based advising with industry experts before presenting to an esteemed audience on June 9 at Byers Auditorium in Genentech Hall at UCSF Mission Bay. The five companies represent two therapeutics, two tools, and one synthetic biology company. To date, the 15 companies that participated in the previous three FAST rounds have shown excellent progress, clocking in over 1300 advisory hours valued at over $350,000, collectively raising more than over $27 million and creating 37 new jobs.‚óè       Amgen Bay Area BioGENEius Challenge: The 2015 Amgen Bay Area BioGENEius Challenge, a high school science competition for some of the Bay Area’s most promising high school students, will take place on April 14 at the J. David Gladstone Institutes. The program includes a keynote address by Dr. Michael L. Penn, Jr. M.D., Ph.D., Vice President, Scientific Communications and Outreach at the Gladstone Institutes and CEO of the Gladstone Foundation, and a Career Panel led by Aarif Khakoo, Executive Director, Research and Site Head, Amgen South San Francisco. The first-and second-place winners will advance to the National and International BioGENEius Challenges at BIO 2015 in Philadelphia. The Bay Area’s finalists have taken first place in the International Challenge the last two years in a row. Our 2013 winner, Natalie Ng, was invited to the White House Science Fair on March 23, 2015.‚óè       Professional Development for Life Science Employees: The BayBio Institute launched its first professional development workshops of the year with a sold-out BioBasics, a two-day intensive course to help non-scientific staff develop a working knowledge of fundamental industry terms and applications, enabling more effective communication with colleagues and stakeholders — and a sold out From the Laboratory to Leadership, a four-day workshop developed exclusively for managers in scientific fields designed to help them develop the core management skills necessary become capable business leaders. Both workshops will run 2-3 more times this year. For more information, please contact Lori Lindburg, BayBio Institute’s Executive Director (Lori@baybio.org).

The California Life Sciences Association Team

Information regarding our team can be found at www.baybio.org/about/our-team/ and www.chi.org/about-chi/chi-management/. For more information regarding membership, please contact Jennifer Malloy (jmalloy@baybio.org, 650-871-3264) or Vita Blake (vblake@baybio.org, 650-871-3265). Our media contact is Will Zasadny (zasadny@chi.org, 858-456-8885).

Thank you for your continued support of California’s life sciences innovation ecosystem.

Best,

Sara Radcliffe
President & CEO