CLSA Bulletin

CLSA-BULLETIN-MAY SPOTLIGHT CLSA-BULLETIN-MAY-PC
ADVOCACY
CLSA Hosts Roundtable With Los Angeles Mayor Eric Garcetti
On June 13, CLSA hosted a roundtable with Los Angeles Mayor Eric Garcetti, CLSA Board Members, and other life sciences sector executives from the region to discuss life sciences innovation, investment and job creation. | READ MORE »
Take Action: Urge CA Legislators: Don’t Restrict Physician Education: Say “NO” to SB 790  | READ MORE »

Two Harmful Bills For Life Sciences Innovators Pass Out Of Assembly Health Committee In Sacramento | READ MORE »

DC Congressional Briefing: Federal Investment In Biomedical
Innovation
 | READ MORE »

CLSA Launches Grassroots Campaigns, Builds Momentum To Repeal Medical Device Tax & IPAB | READ MORE »

CLSA MEMBER NEWS & PROFILES

Evince Biosciences Reimagines Drug Discovery And Takes On Cancer Immunotherapy
Evince Biosciences is a next generation drug discovery company, using a compelling machine learning approach to reimagining drug discovery. Our first program targets toll-like receptor 7 (TLR7) for cancer immunotherapy.| READ MORE »

Festival of Genomics Returns to San Diego — Genomics Wonderland, June 26 – 27 | READ MORE »

CLSA Announces Bay Area “Giants of Sciences” Partnership with KNBR to Support Life Sciences Education | READ MORE »

Happy Hours with CLSA & Oracle Life Sciences in San Diego and the Bay Area. Register today! | SAN DIEGO » | BAY AREA » 

INSTITUTE
FAST & Fellows Round-Up
The FAST (Fellows All-Star Team) Accelerator provides select entrepreneurs with intensive team review and coaching to perfect their business model, product development plans, and to build a compelling commercialization strategy. | READ MORE »
Spring 2017 FAST Closing Showcase Celebrates Seven
Companies 
| READ MORE »

CARB-X Featured Prominently at BIO 2017 
| READ MORE »


I-Corps Bio-Entrepreneurship Workshop Debuts at BIO 2017 
| READ MORE »

JUNE 2017

ABOUT 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, LinkedIn, and YouTube.

Join CLSA

Executive Profile in BOSS Magazine: CLSA: Mission Driven to Cultivate Life Sciences Innovation in CA

Original Executive Profile & Content published at BOSS Magazine
May 2017 Edition

Exclusive Offer for CLSA Members: Interested in being featured in BOSS Magazine free of charge? Please contact Will Zasadny, Director of Communications at wzasadny@califesciences.org.
CLSA is a supporting nonprofit for the life sciences sector that focuses on biotechnology, pharmaceutical, medical device and diagnostics companies, research universities and institutes, investors, and service providers throughout the Golden State.

California’s incredible diversity in climate, geography, and race makes the state one of the most unique in the country. The state’s economy, the largest in the U.S., is just as diverse.

From tourism—which supported a record 251 million visitors and more than one million jobs in 2014—to Silicon Valley—the tech hub of the U.S.—California is on the cutting edge of just about everything.

The business environment in California garners an incredibly strong life sciences sector. There are more than 3,000 life sciences companies in the Golden State, employing more than 287,000 people and generating $147 billion in revenue.

With hubs in San Francisco, San Diego, and Los Angeles, California boasts one of the most influential life sciences communities in the world.

But past performance does not guarantee future results. This concept is the gasoline that fuels the California Life Sciences Association (which works to educate and unite business leaders, policymakers, academic researchers, patient advocates, investors, and many other players to ensure the sector’s future success.0

Combining Cultures

President and CEO Sara Radcliffe joined the organization in late 2014, when the California Healthcare Institute (CHI) and BayBio merged to become CLSA.

Radcliffe understands advocacy. Her position as Executive Vice President for Health at the Biotechnology Industry Organization (BIO), and her time with Pharmaceutical Research and Manufacturers of America (PhRMA) prepared Radcliffe for this undertaking.

“Leading CLSA was an intriguing proposition for me,” says Radcliffe. “BayBio and CHI had amazing achievements from their over 40 years of combined work on behalf of the sector, and it was up to me and my team to bring these two organizations together and make them one.”

San Diego-headquartered CHI concentrated on the policymaking side: helping local, state and federal governments devise sound policies and regulations to support and invigorate the sector. San Francisco’s BayBio was more focused on the business side: purchasing groups and other discount programs, science education, career support and public outreach.

Over the past three years, Radcliffe has united these functions into a significant and respected California-focused legislative and business nonprofit. CLSA has ramped up its business support, providing entrepreneur services, partnering events, and networking opportunities. The organization also offers technical training, career development, and other member benefits, in addition to robust public policy advocacy representation at the federal, state, and local levels.

“We realize that we have to meet sector people where they live,” says Radcliffe. “We are constantly asking ourselves: What does the CEO need to be successful? The procurement officer? The lab tech? And on and on. We try to customize our business services so that everyone has a home.”

Advocacy

Equally important, CLSA is committed to advancing sound public policy that supports California’s life sciences sector and ensures patients have access to groundbreaking medicines, diagnostics, and devices.

When the device tax was hurting small companies and stunting their ability to hire, expand, and innovate, CLSA joined forces with other organizations to lobby Congress to have it suspended. CLSA strongly supported the 21st Century Cures Act, which allocated more funding for the National Institutes of Health and the Food & Drug Administration to enhance research and accelerate the drug pipeline. Recently, CLSA activated its broad membership to bring awareness to and oppose the proposed 20 percent budget cuts to lifesaving medical research and development at the NIH.

CLSA also works on the state level in Sacramento, and in cities all over California, to help policymakers understand the nuances that can either help the sector expand or cause it irreparable damage. But more than anything, CLSA’s advocacy goals center on protecting patient access to care and promoting lifesaving medical innovation.

“The life sciences sector is an incredibly diverse and complex ecosystem,” says Radcliffe. “There are drug, device, and diagnostics companies, universities, research institutes, contract research organizations, wholesale suppliers; the list is virtually endless. Pull a string in one direction and the entire web vibrates.”

To help policymakers and stakeholders of all stripes understand the life sciences, CLSA provides a steady stream of industry intelligence and information, such as their annual California Life Sciences Industry Report, which takes the pulse of the sector’s economic and therapeutic impact in California.

CLSA Pres. & CEO Sara Radcliffe

The bottom-line mission for CLSA is ensuring that California’s life sciences community has the freedom to innovate and improve patient care.

“California companies have around 1,200 drugs in the development pipeline,” says Radcliffe. “Some of these are for rare disorders that have no treatments, or common disorders that need better treatments. With four fully staffed offices up-and-down the state and another in Washington, D.C., CLSA is laser focused on providing life sciences organizations the support they need to develop safe and effective therapeutics that help more patients.”

To learn more or join CLSA, visit www.califesciences.org or connect with us @CALifeSciences.

View the full profile at BOSS Magazine.

Editorial Note: CLSA members interested in being featured in BOSS Magazine free of charge may contact Chad Miller, Executive Director, who can be reached at 760-206-3196 or chad@thebnngroup.com.

CLSA Board Visits Capitol Hill, Annual DC Spring Reception, CLSA Welcomes 14 New Members, Events in June, CLSA Board and Staff Continues Expansion

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

May 25, 2017 

 

CLSA Board Goes to Washington to Meet with Members of Congress, Discuss Biomedical Innovation

As advocacy is a core activity critical to our organization’s mission, I was honored to join 19 CLSA board members on Capitol Hill on May 3 for a full day of meetings with key congressional policymakers discussing issues of importance to California’s biomedical innovation ecosystem. Over the course of the day, we had the privilege to sit down with 21 members of our California Congressional delegation – including all five of our state’s newly-elected House “freshmen” – as well as several members from other states in key policymaking roles.  In those meetings, we addressed topics such as:

  • CLSA’s support for predictable and sustained NIH funding for basic research;
  • The need for a full repeal of the medical device tax;
  • The importance of a transparent and predictable FDA regulatory environment, including swift reauthorization of the FDA user fee programs;
  • How public and private insurers can better value medical innovation through coverage and payment policies;
  • The importance of a patent system that preserves the ability for biomedical innovators to enforce their patents; and
  • The need for a timely repeal of the Independent Payment Advisory Board (IPAB).
CLSA Board of Directors
CLSA’s Board of Directors participate in a roundtable discussion, hosted by Rep. Eric Swalwell (D-East Bay), with all five new members of our California Congressional Delegation in the 115th Congress: Reps. Nanette Diaz Barragan (D-Carson), Salud Carbajal (D-Santa Barbara), Lou Correa (D-Santa Ana), Ro Khanna (D-Sunnyvale/Silicon Valley) and Jimmy Panetta (D-Monterey).

 

For more details about our Advocacy Day on Capitol Hill, click here.

CLSA Spring Reception & Dinner in DC

Following our productive day of meetings, CLSA hosted our annual Spring Reception in a tent on the grounds of the Folger Shakespeare Library, followed by a private dinner with our Board to welcome and recognize our state’s new delegation members.

More than 150 guests attended the public reception, and nearly 100 guests attended the private dinner. Attendees at the reception and/or dinner included several members of the California delegation, including: Reps. Nanette Diaz Barragan (D-Carson), Ami Bera, MD (D-Sacramento), Lou Correa (D-Santa Ana), Doug LaMalfa (R-Oroville), Jackie Speier (D-San Mateo/South San Francisco), and Eric Swalwell (D-East Bay), as well as legislative staff from numerous congressional, leadership and committee offices, including the House Committees on Energy & Commerce, Ways & Means, Appropriations, and Judiciary, and the Senate Committees on Appropriations, Finance, Judiciary, and Health, Education, Labor & Pensions (HELP).  At the dinner, Board Chair Don Bobo and I were pleased to welcome Dr. Marshall Summar, Chief of genomics and metabolism at Children’s National Medical Center (Washington, DC), head of the Children’s National Rare Disease Institute, and president of the Board of Directors of the National Organization for Rare Diseases and Disorders (NORD), for a keynote address about the incredible successes to date and challenges facing the future of rare disease therapy innovation and patient care.

CLSA Welcomes 14 New Members

Please join me in welcoming the 14 new CLSA members who joined us in the last month:
Agenovir Corporation, BioQuest LLC, Circularis Biotech, Evince Biosciences Inc., Evotec Inc., ImmunoActiva, J R Scientific, Labdoor, Naked Bone, Novol Inc., Oxford Finance LLC, Plex Pharmaceuticals Inc., Prime Genomics Inc. and Verrica Pharmaceuticals Inc.  Our membership portfolio grows ever more robust with the addition of these organizations, which add significantly to the expertise and resources available in the CLSA network.

CLSA Adds Board Members from Covington & Burling & Takeda Pharmaceuticals USA

We were all pleased to welcome two new members to the CLSA Board of Directors: Wade Ackerman, Partner at Covington & Burling LLP and Richard Ascroft, Vice President, Managed Market and Government Affairs at Takeda Pharmaceuticals USA, Inc.

As California Life Sciences Association continues to grow and expand our efforts and involvement statewide, we turn to our trusted board of directors to help guide us in the right direction to further enhance California’s innovative life sciences economy. Their insights will help bolster our efforts to drive solution-oriented public policies and advocacy activities that sustain and support life sciences research, investment and innovation in California. Learn more about Wade and Rick here.

Networking with CLSA in San Francisco & San Diego

Back-to-back networking events in San Francisco and San Diego allowed CLSA to host nearly 300 life sciences professionals last month.  Did you miss out?  Never fear – I’m thrilled to announce we’re serving up two more back-to-back opportunities for mixing and mingling next month, and we’d love to see you there.

 Bio On the beach
BIO on the Beach with Oracle – June 7th
Green Acres Campus Pointe, San Diego
Register Here

 Bio on the bay
BIO on the Bay with Oracle – June 8th
Foundry & Lux, San Francisco
Register Here

 

Alive After Five Happy HourCLSA & TriNet Host Alive After Five Happy Hour at BIO 2017
Looking for something to do after BIO’s opening reception on Tuesday, June 20?  Continue the fun at our Alive After Five cocktail reception for drinks, appetizers and a wildly scientific happy hour with your peers.  Learn more and register here.

Medtech conferenceDon’t Miss Early Bird Pricing on The MedTech Conference September 25-27th in San Jose, CA
Join CLSA and more than 2,500 attendees at The MedTech Conference powered by AdvaMed to network, gain access to capital and share insights in San Jose, Calif. from September 25-27. The conference features world-class plenary speakers, networking, and business development.  Our exclusive CLSA discount for The MedTech Conference registration is even better when paired with early bird rates! Register by July 7 to secure your spot in San Jose this fall: http://hubs.ly/H06K-H30.

 Mark Your Calendars for the First MedTech Meetup
In addition to taking advantage of early bird pricing, join the MedTech conference team for their first MedTech meetup in 2017!   Meet other MedTech attendees at Varian Medical Systems in Palo Alto on May 31from 4-6pm.  Learn more and register here.

 Akin Gump & CLSA Corporate Counsel Team Up for Webinar on Immigration Policies
Immigration reform was a focus of considerable debate during last year’s Presidential election, and continues to be a hot topic. President Trump has signed executive orders aimed at strict enforcement of current immigration laws, and proposed further regulatory and legislative actions that will dramatically change the US immigration system. Join CLSA’s Corporate Counsel along with Akin Gump for a webinar briefing on June 8 offering insights on how these changes could affect the life sciences sector and companies who hire foreign scientists or collaborate with foreign partners. Click here to learn more.

George ScangosFireside Chat with George Scangos, One of Biotech’s 25 Most Influential
Looking for an interesting event next month?  Join the Entrepreneurship Center at UCSF on the evening of June 6 for a Fireside Chat with George Scangos, the former CEO of Biogen and current CEO of Vir Biotechnology. George has been named one of the 25 most influential people in biotech, leading Biogen for six years before leaving at the end of 2016. During his tenure, he effected a turnaround by restructuring the company, divesting its Idec cancer drug division, refocusing research on neurology and hematology and presiding over the rollout of six new drugs including a blockbuster M.S. drug. Vir is his next challenge. Founded by Bob Nelsen/Arch Ventures, Vir is taking on infectious diseases with more than $150MM starting commitment from Arch and Gates Foundation and seeks to use breakthroughs in immune programming to manipulate pathogen-host interactions. Learn more and get tickets here.

 CLSA Team Still Growing!
We’re still expanding our teams in the Bay Area, Los Angeles, Sacramento, San Diego, and Washington, D.C. Please join me in welcoming our latest additions:

Jayne McNicolJayne McNicol
Jayne McNicol joined us as CLSA’s Chief Financial Officer (CFO) in the beginning of May, coming to us from her previous position as a Partner of Assurance Services at Ernst & Young LLP, serving life sciences companies primarily in the San Francisco Bay Area. As CLSA continues to expand its statewide membership roster and advocacy operations, Jayne’s financial acumen and wealth of experience in the life sciences industry will bring a fresh perspective to our financial processes, so that we can continue to deliver solutions for our members and California’s life sciences sector. Prior to this, Jayne served in positions of increasing responsibility at Ernst & Young and its predecessor, Arthur Young, initially in Bristol, England and later in the San Francisco Bay Area. Jayne is a Certified Public Accountant with the California Board of Accountancy and a Chartered Accountant with the Institute of Chartered Accountants in England and Wales. We are thrilled to have Jayne on board. View press release here.

leimmi zhangLeimmi Zhang
Leimmi Zhang also joined us in May 2017 as Digital Projects Associate from her previous position with Dexcom in San Diego. Her responsibilities include web and digital project management, marcom development, event logistics, inbound marketing and regional and national marketing projects.  Leimmi’s background is in Economics and User Experience Design from the University of California, San Diego.

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 Elizabeth Gibson (EGibson@califesciences.org), Senior Director of Marketing.

 

 

CLSA Hosts Roundtable with Los Angeles Mayor Eric Garcetti

June 26, 2017

On June 13, CLSA hosted a roundtable with Los Angeles Mayor Eric Garcetti, CLSA Board Members and other life sciences sector executives from the region to discuss life sciences innovation, investment and job creation.

CLSA’s Board Chairman Don Bobo, Corporate Vice President, Strategy & Corporate Development, Edwards Lifesciences, and Members Shlomo Melmed, EVP for Academic Affairs and Dean of the Medical Faculty, Cedars-Sinai Health System and Wade Ackerman, Partner, Covington & Burling LLP, were part of a group of 15 C-suite executives to share their thoughts with the Mayor and his staff inside his City Hall offices.

As part of the dialogue, Dr. Melmed alerted the Mayor to the fact that he has an overwhelming number of applicants who want to be part of Cedar Sanai’s Accelerator program. However, this positive news is shaded by the reality that many of these applicants simply cannot afford to live in Los Angeles with the lack of affordable housing options and long commutes due to traffic congestion.

Mayor Garcetti responded with a few updates on public infrastructure development, including a note on recent electoral support for public transportation funding through Measure M on the November ballot in which he took the lead in spearheading for passage. He also listed a few proposals of his own at the roundtable, including:

  • Preparing for the workforce needed in the region. Los Angeles leaders are concerned that while many bright students graduate from UCLA and other colleges in the region, seventy percent of these graduates leave Los Angeles to work in the Bay Area or San Diego for life science opportunities.
  • Supporting changes to local taxes seen as punitive to life science companies. Los Angeles has a gross receipts tax system on which San Francisco based its current transition plan.
  • Bringing forward a regional conversation among the County’s eighty-eight city mayors on public infrastructure, investment, and education.
  • Creating a ‘Biotech Park’ in Los Angeles to help build a life sciences cluster in the region. Los Angeles has land which could be developed for specific use by the life sciences.

CLSA was proud to host this roundtable with the Mayor of Los Angeles and another such event in 2016 with San Francisco Mayor Ed Lee. For more information on CLSA’s local advocacy programs, please contact Reese Isbell, Director of Local Government and Community Relations (Risbell@califesciences.org).

Two Harmful Bills for Life Sciences Innovators Pass Out of Assembly Health Committee in Sacramento

June 28, 2017

On June 27, two bills with significant negative consequences for the life sciences industry, Senate Bill 17 (Hernandez) and SB 790 (McGuire), were passed out of California’s Assembly Health Committee. Unfortunately, neither bill faces any serious obstacles prior to arriving on the Assembly Floor, which would be the last step prior to reaching the Governor’s desk.

SB 17

SB 17 would require, among many other things, industry to provide a 60-day advance notice of any price increase on a drug to all California public agency purchasers, health insurers, and pharmacy benefit managers (PBM) if that drug’s price increased 10 percent or more cumulatively over the previous two calendar years. On the date of the increase, the drug’s manufacturer would have to submit a host of information to the state, including proprietary information like expected marketing budgets for the drug. This information would then be posted publicly by the state in a manner that allows identification of the individual drugs.

Despite a valiant effort testifying in opposition by life sciences sector representatives and concerns from the committee as to why more industry amendments had not been accepted, the Senate Health Committee Chairman’s bill was passed on an 11-0 vote, with Republicans not voting on the bill.

Click here to add your voice and urge legislators to reject SB 17.

SB 790

SB 790 would restrict all “gifts,” as defined, from manufacturers to physicians unless it falls under one of the many, often confusing, exceptions under the bill. For instance, while meals provided as part of a third-party’s conference may be allowable under certain circumstances, meals as part of a group educational dinner would be subject to a limit of $250 per person, per year. Furthermore, while many expenses associated with research activities, including clinical trials, are permitted, things like equipment loans are not. It is also unclear the extent to which the distribution of investigational new drugs are permitted, as only FDA approved drugs are covered in the bill.

The bill passed by a single vote in committee, 8-3, with one Republican voting for the bill. CLSA’s own Oliver Rocroi, Senior Director of State Government Relations and Dr. Normal Lepor from the American College of Cardiology provided strong testimony in opposition.

We anticipate both bills reaching the Assembly Floor in August after the Legislature’s summer recess, though there is a possibility either could see votes in the first half of July.

Click here to add your voice and urge legislators to reject SB 790.

CLSA will continue to fight vigorously on behalf of California’s life sciences industry and to protect our ability to discover new treatments and cures for patients.

To make your voice heard on these on two pieces of legislation and other CLSA policy priorities, visit www.califesciences.org/TakeAction. Questions? Please contact Brett Johnson, CLSA’s Senior Director, Policy and Regulatory Affairs (Bjohnson@califesciences.org).

DC Congressional Briefing: Federal Investment in Biomedical Innovation

June 23, 2017

On June 5, CLSA hosted a congressional briefing on the importance of funding for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). The event, convened in collaboration with Reps. Leonard Lance (R-NJ) and Scott Peters (D-San Diego) as co-chairs of the Congressional Life Science Caucus, was co-hosted along with 15 other state and regional life sciences associations.

CLSA secured the expert panelists, including representatives from National Health Council, Alliance for a Stronger FDA, the Association of American Universities and United for Medical Research. The discussion was focused around how the agencies fuel biomedical innovation, work with private industry and academia to advance global human health, and give hope to patients in need. The event attracted a sizeable standing room-only crowd, and was very well attended by congressional staff and other stakeholders.

CLSA continues to support efforts to bolster funding for NIH and other science research agencies, as these agencies provide a critical foundation of the biomedical R&D ecosystem. Earlier this year (March 31), Rep. Susan Davis (D-San Diego) led a bipartisan House letter in support of $36 billion for NIH in the FY18 Labor-HHS Appropriations Bill. CLSA was strongly supportive of the letter, and due to our outreach efforts, the letter was cosigned by 35 other bipartisan members of the California congressional delegation. A copy of the final letter is available here.

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

CLSA Launches Grassroots Campaigns, Builds Momentum to Repeal Medical Device Tax & IPAB

June 22, 2017

CLSA continues to lead efforts to build support within the California congressional delegation for the repeal of two policies that harm life sciences investment and innovation: the medical device tax and Independent Payment Advisory Board (IPAB).

Independent Payment Advisory Board (IPAB)

CLSA is strongly supportive of a repeal of the Independent Payment Advisory Board (IPAB), a controversial advisory board enacted as part of the Affordable Care Act (ACA), which threatens seniors’ care and could harm biomedical innovation by reducing incentives for investment in new research and product development.

CLSA worked in close collaboration with the national trade associations and our member companies to support reintroduction of legislation to repeal the IPAB in the form of H.R. 849, the Protecting Seniors’ Access to Medicare Act. CLSA helped secure Rep. Raul Ruiz, MD (D-Palm Desert) as the lead Democratic sponsor of the bill in the 115th Congress, and to date, we have encouraged the support of 17 additional bipartisan California delegation cosponsors of the bill, including: Reps. Nanette Barragán (D-Carson), Ami Bera, MD (D-Sacramento), Julia Brownley (D-Thousand Oaks), Ken Calvert (R-Corona), Salud Carbajal (D-Santa Barbara), Tony Cárdenas (D-San Fernando Valley), Paul Cook (R-Yucaipa), Jeff Denham (R-Modesto), Doug LaMalfa (R-Oroville), Ted Lieu (D-Santa Monica), Devin Nunes (R-Fresno), Scott Peters (D-San Diego), Ed Royce (R-Brea), and Linda Sánchez (D-Cerritos). Norma Torres (D-Pomona), David Valadao (R-Hanford) and Mimi Walters (R-Irvine).

Medical Device Tax

CLSA has continued efforts to bolster support for the repeal of the 2.3 percent medical device excise tax that was enacted as a part of the Affordable Care Act (ACA). CLSA is proud that almost half of our congressional delegation is confirmed as cosponsors of H.R. 184, the Protect Medical Innovation Act, a bill to fully and permanently repeal the device tax.

Current California delegation cosponsors include Reps. Pete Aguilar (D-Redlands), Ami Bera, M.D. (D-Sacramento), Julia Brownley (D-Thousand Oaks), Ken Calvert (R-Corona), Tony Cárdenas (D-San Fernando Valley), Paul Cook (R-Apple Valley), Lou Correa* (D-Santa Ana), Jeff Denham (R-Modesto), Duncan Hunter (R-Temecula), Darrell Issa (R-Vista), Ro Khanna* (D-Fremont), Steve Knight (R-Simi Valley), Doug LaMalfa (R-Redding), Ted Lieu (D-Santa Monica), Tom McClintock (R-Roseville), Devin Nunes (R-Clovis), Scott Peters (D-San Diego), Dana Rohrabacher (R-Huntington Beach), Ed Royce (R-Brea), Raul Ruiz, M.D. (D-Pal Desert), Jackie Speier (D-Menlo Park), Eric Swalwell (D-Pleasanton), Norma Torres (D-Pomona), David Valadao (R-Bakersfield) and Mimi Walters (R-Irvine).

CLSA is supplementing our advocacy efforts on the ground in Washington, D.C. with digital advocacy campaigns to allow CLSA’s broad membership to engage on key legislation and public policies and help grow California’s life sciences sector. You can support the IPAB Repeal campaign here, and the Medical Device Tax Repeal campaign here.

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

CLSA Board Goes to Washington to Meet with Members of Congress, Discuss Biomedical Innovation

May 21, 2017

On May 3, 19 members of CLSA’s board of directors spent a full day on Capitol Hill meeting with more than two dozen key members of Congress on issues of importance to California’s life sciences innovation ecosystem.

The CLSA board met with a number of legislators, including: House Majority Leader Kevin McCarthy (R-Bakersfield), Reps. Judy Chu (D-Los Angeles), Anna G. Eshoo (D-Silicon Valley), Doris Matsui (D-Sacramento), Raul Ruiz, MD (D-Palm Desert), Jackie Speier (D-San Mateo/South San Francisco), Eric Swalwell (D-East Bay), David Valadao (R-Hanford), Mimi Walters (R-Laguna Nigel), and with the senior policy advisor to Energy & Commerce Health Subcommittee Chair Michael Burgess, MD (R-Texas). In addition, we participated in a roundtable discussion with members of the New Democrat Coalition, including: Reps. Ami Bera, MD (D-Elk Grove), Julia Brownley (D-Thousand Oaks), Tony Cárdenas (D-Los Angeles), Susan Davis (D-San Diego), Scott Peters (D-San Diego), and Norma Torres (D-Pomona), as well as Kathleen Rice (D-N.Y.), and Darren Soto (D-Florida).

We capped off the day with a roundtable discussion hosted by Rep. Eric Swalwell (D-East Bay), including all five of our delegation’s new members: Reps. Nanette Diaz Barragan (D-Carson), Salud Carbajal (D-Santa Barbara), Lou Correa (D-Santa Ana), Ro Khanna (D-Sunnyvale/Silicon Valley) and Jimmy Panetta (D-Monterey).

CLSA’s board members discussed issues including: the importance of a patent system that preserves the ability for biomedical innovators to enforce their patents; our support for predictable and sustained NIH funding for basic research; the importance of a transparent and predictable FDA regulatory environment, including swift reauthorization of the FDA user fee programs; the need for a full repeal of the medical device tax; the need for a timely repeal of the Independent Payment Advisory Board (IPAB); and how public and private insurers can better value medical innovation through coverage and payment policies.

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

Combining an Unparalleled AI Platform with a Seasoned Pharma Team, Evince Biosciences Reimagines Drug Discovery and takes on Cancer Immunotherapy

By Paulo Rangel
President & CEO of Evince Biosciences, Inc.

Evince Biosciences is a next generation drug discovery company, using a compelling machine learning approach to reimagining drug discovery. Our first program targets toll-like receptor 7 (TLR7) for cancer immunotherapy.

Simply stated, without a dramatic increase in R&D productivity, today’s pharmaceutical industry cannot sustain sufficient innovation to replace the loss of revenue due to patent expirations for successful products (Nature Reviews, March 2010). One highly promising way to close this gap, is the application of Artificial Intelligence. However, for all the buzz and promise, the application of artificial intelligence without accurate and complete information describing the molecules and targets to be evaluated will succumb to the axiom, “garbage in, garbage out.”

Our approach is called Autonomous Virtual Organism or “AVO.” The platform accurately predicts activity, toxicity and drug-like properties (ADME) simultaneously, transforming discovery into a parallel process in a virtual environment, rather than a sequential process in a laboratory environment. We have established a precise, calibrated series of in silico biological simulations that maximizes the informational content that is submitted for analysis by our machine learning approach. This approach to describe molecules is key to accurate predictions…and accuracy is essential for re-inventing drug discovery. Accelerating lead optimization is a key focus for our company. We start with the drug-like leads generated by AVO or our collaborator and apply medicinal chemistry principles to modify the molecules. AVO scores the new molecules to determine which changes were beneficial and which were not. In this way, we greatly enrich the pool of high-value molecules to be synthesized and evaluated in traditional biology. This smart in silico approach can dramatically decrease the number of medicinal chemistry cycles and reduce the cost and time required to successfully complete this stage.

We draw on Dr. James Appleman’s (Evince CSO) extensive experience in drug discovery, early clinical development and TLR7 for our first internal program – an orally administered TLR7 agonist for cancer immunotherapy. Stimulation of innate immunity is a current focus for immuno-oncology drug discovery, with STING (Stimulator of Interferon Genes) being one of the better known and accepted approaches. Our TLR7 agonist program compares favorably with STING as it stimulates innate immunity and the proliferation and activation of B-cells with an orally administered small molecule. Stimulation of the innate immune system is expected to increase the value of checkpoint inhibitors by augmenting the response rate, which is currently very low. We expect to identify a preclinical candidate in six months

We are optimistic about our future and the positive impact we can have on drug discovery and cancer immunotherapy. We are proud to be part of the San Diego biotechnology community and value collaborations with our colleagues in the pharma/biotech community worldwide.

About the author:

Paulo Rangel is President & CEO of Evince Biosciences, Inc. He can be reached at p.rangel@evincebio.com. To learn more about Evince Biosciences, visit www.evincebio.com.

Festival of Genomics San Diego

The Festival of Genomics San Diego (June 26-27, 2017) will bring together the genomics community with the collaborative goal to drive the benefits of genomics to patients, faster. The Festival will provide the big picture of what is going on within the industry. If you’re using genomics to drive forward R&D, drug development or the diagnosis and treatment of disease then this Festival is the place to get inspired and informed. We aim to create a memorable and enjoyable experience to connect with new, and old, colleagues.

Across two days, join over 1000 people, from academia, healthcare, pharma, technology providers and patient groups as we come together to celebrate and explore the advances taking place in genomics.

Hear insightful presentations including keynote sessions, covering 4 core themes at this year’s show: research & development, precision therapies, personalizing medicine and enabling data. Take advantage of our buzzing exhibition floor and newly added features for 2017 including: Silent Seminar Technology, Lunch and Learn Area, Launch Pads introducing some exciting innovations that are emerging and so much more…
To register for Festival of Genomics 2017 San Diego, book a booth, or learn about the various meeting access options, please visit: http://www.festivalofgenomicssandiego.com/register

 

San Diego Convention Center, 111 W. Harbor Drive, San Diego, CA 92101.

CLSA Announces Bay Area “Giants of Sciences” Partnership with KNBR to Support Life Sciences Education

giants of science

We are excited to announce that earlier this month several CLSA member companies, in conjunction with CLSA, CLSI and KNBR, launched the “Giants of Science” competition in San Francisco to award three $20,000 science program grants to Bay Area high schools who submit an application and video explaining why they need the grant and what the school would do with it.   Application information can be found at http://www.knbr.com/giantsofscience, and the three winning schools will attend a check presentation ceremony at a Giants baseball game in September.  CLSA would like to thank the companies who committed their support to the program:  Alexandria Real Estate, Celgene, Genentech, Gilead, Illumina, Nektar, Sutro BioPharma, Theravance, and Wareham Properties.  Sponsorship participation is still open, so if you are interested please contact us for more details.

FAST & Fellows Round Up

Read the latest in FAST and Fellows news:

  • Medical device startup, Raydiant Oximetry Inc. won first place at the 17th annual UC Davis Big Bang! Business Competition on Thursday, May 25 scoring a cash prize of $10,000! Read More
  • SyntheX CEO, Maria Soloveychik is spotlighted in May SOSV. Maria has been fortunate to be surrounded by very strong women growing up who were a constant source of inspiration and support. SyntheX aims to “target the undruggable,” particularly cancers that are difficult to target. Read More
  • CEO of Shasqi (FAST Spring 2016), Jose Mejia Oneto, named one of “Seven Researchers … Changing the Face of Biotech” by San Francisco Business Times Read More
  • FAST Graduate David Johnson, CEO of GigaGen talks with Dr. Moira Gunn on BioTech Nation about his company’s approach to achieving health with a compromised immune system.

To learn more about the CLSA Fellows program – the significantly discounted membership for life science startups – click here.

About FAST

The FAST (Fellows All-Star Team) Accelerator provides select entrepreneurs with intensive team review and coaching to perfect their business model, product development plans, and to build a compelling commercialization strategy. Experienced entrepreneurs, product and business experts (which may include clinical development, regulatory, reimbursement, and business development specialists) will advise selected Fellows during a ten-to-twelve week program, culminating in a Final FAST Showcase to a broad audience that includes potential investors and partners.

Spring 2017 FAST Closing Showcase Celebrates Seven Companies

Crystal Nyitray, PhD, Founder of FAST Spring 2017 graduate, Encellin, presents at the FAST Closing Showcase in June
Stephen Cary, Omniox CEO and FAST Fall 2013 graduate, offers FAST Retrospective

CLSI celebrated key milestones at the Spring 2017 FAST Closing Showcase at UCSF’s Byers Auditorium on June 13.  The Showcase marked the culmination of the Spring program and included presentations from seven graduating FAST companies: Encellin, an innovative ultra thin-film cell delivery platform company; LogicInk, developing programmable temporary tattoos that are electronics-free and transform to convey useful information about your body or environment; MicroSynbiotiX, developing a novel, patent-pending method of producing oral vaccines using transgenic microalgae; Raydiant Oximetry, developing a novel non-invasive medical device to better evaluate fetal well-being; X-Therma, developing state-of-the-art ice-blocking preservation solution; HepaTx, developing regenerative medicine solutions to address the need for better therapies for life-threatening liver diseases; and Facile Therapeutics, developing Ebselen for prevention of recurrence of Clostridium difficile infection. Raydiant Oximetry is a graduate of the FAST pilot in Davis, CA, which will continue this fall.

The program also included retrospectives from two previous FAST graduates, Stephen Cary, CEO of Omniox, and Anna Christensen, CEO of Magnetic Insight, both of whom discussed how the FAST program helped further their companies’ success.

FALL 2017 FAST Applications Open

Applications for the Fall 2017 program are open through July 17, 2017.  Apply now.

For information on the FAST program, contact Steve Karp at FAST@califesciences.org or Julie Harness at jharness@califesciences.org.

CARB-X Featured Prominently at BIO 2017

CARB-X
FDA’s Edward Cox and CARB-X Executive Director, Kevin Outterson, in panel moderated by Forge Therapeutics CEO, Zachary Zimmerman

The global threat of antimicrobial resistance (AMR) faces serious scientific and economic obstacles, both of which garnered significant attention on the Infectious Disease Track at BIO 2017 in San Diego. Multiple panels focused on these issues, including (1) new technologies to overcome AMR mechanisms, (2) partnerships that de-risk R&D of antimicrobial products (a panel featuring CARB-X Executive Director, Kevin Outterson, moderated by Zachary Zimmerman, CEO of Forge Therapeutics and one of first Powered by CARB-X companies) and (3) economic incentives to create a viable antimicrobial market (featuring Joe Larsen of BARDA). Push incentives such as CARB-X are spurring much needed innovation and early-stage development in the AMR space, but there is also a critical need to develop an infrastructure of economic incentives to create a viable market pull for products that diagnose and treat bacterial infections and save lives. This urgent need to build consensus amongst global stakeholders was the focus of an additional panel on building a sustainable model for developing medical countermeasures featuring BARDA Director Rick Bright.

 

 

I-Corps Bio-Entrepreneurship Workshop Debuts at BIO 2017

Peter M. Pellerito of BIO greets I-Corps Bio-Entrepreneurship Workshop participants at CA Pavilion

Twenty-five early researchers selected from 110 applications submitted from universities nationwide, helped kick off the first BIO 2017 I-Corps Bio-Entrepreneurship Workshop.  The researchers were undergraduates, graduates, post docs and assistant professors representing underrepresented groups from 18 institutions across the country. Organized by the American Society of Microbiology (ABRMS), Biocom Institute, California Life Sciences Institute (CLSI), CSU I-Corps, and the EE Just Life Sciences Society / United Negro College Fund (UNCF), the workshop paired participants with industry mentors to explore solutions to combatting antimicrobial resistance, then   applied evidence-based entrepreneurship concepts via customer discovery interviews at the BIO 2017 exhibition.

The workshop was made possible via an Inclusive Entrepreneurship supplemental award under the NSF I-Corps Program, which are designed to “increase participation and promote inclusion of underrepresented populations in the National Innovation Network.”

BIO Adopts Principles on Workplace Development, Diversity and Inclusion

The Bio-Entrepreneurship Workshop coincided with BIO’s release of a set of principles on workforce development, diversity, and inclusion (WDDI) – and the creation of a WDDI Committee – for the biotechnology industry. According to Jim Greenwood, BIO President & CEO, the Committee “will lead our efforts to attract the best and brightest talents from diverse backgrounds to biotech careers, foster an inclusive industry culture, and, most importantly, enable biotech companies and their employees to understand, interact with, and ultimately provide treatment to a diverse patient population with the cultural competency required for success.”

The partners are working with BIO to make the Bio-Entrepreneurships an integral part of the BIO International Convention to help expand and diversify the ecosystem for life science innovation, and will offer the workshop again next year at the BIO Convention in Boston. “Our hope is that this pilot and subsequent workshops will help to spawn research innovation and entrepreneurship in the life sciences from a diverse range of individuals and experiences,” stated Susan Baxter, Executive Director of the California State University Program for Education and Research in Biotechnology (CSUPERB).
Read the BIO press release on WDDI here.

Read the CSU I-Corps press release here.

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