CLSA Bulletin

CLSA-BULLETIN-MAY SPOTLIGHT CLSA-BULLETIN-MAY-PC
ADVOCACY
CLSA Board Goes To Washington To Meet With Members Of Congress, Discuss Biomedical Innovation
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. | READ MORE »
U.S. Senate & House Markup FDA User Fee Reauthorization
Legislation
 | READ MORE »

CLSA Applauds Confirmation of Dr. Scott Gottlieb As New FDA Commissioner | READ MORE »

Sacramento Update: A Victory On Opioid Taxes, But A Growing Battle On Physician Payment Restriction | READ MORE »

Local Update: California State Auditor Releases Report on
Take Back
 | 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 »
Biotech Primer Article: Viruses Blasting Cancer | READ MORE »

Biotech Primer Article: Phage – More Than Just a Phase 
| READ MORE »


Biotech Primer Article: Decoding Your Genes
| READ MORE »

APRIL 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 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).

U.S. Senate & House Markup FDA User Fee Reauthorization Legislation

May 20, 2017

On May 18, the House Energy & Commerce Health Subcommittee unanimously voted to advance legislation that would reauthorize the U.S. Food and Drug Administration’s (FDA) authority to collect user fees for another five years.

User fees paid to the agency are intended to supplement (not supplant) congressional appropriations, and provide the vast majority of the agency’s financial resources for conducting drug and device product reviews. This user fee reauthorization legislation advanced last week notably includes a provision to improve medical device facility inspections, based on H.R. 1736, legislation led by Reps. Larry Bucshon (R-IN), G.K. Butterfield (D-NC), Susan Brooks (R-IN), and Scott Peters (D-CA). CLSA has endorsed the bill and is strongly supportive of inclusion of this measure in the broader package.

Additional amendments adopted included:

  • Kurt Schrader (D-OR) & Gus Bilirakis (R-FL): Expedites generic drug applications
  • Michael Burgess (R-TX), Gene Green (D-TX), and Leonard Lance (R-NJ) Strengthens drug supply chain
  • Patrick Kennedy (D-MA) and Marsha Blackburn (R-TN) Creates an FDA category for over-the-counter hearing aids

The Senate Health, Education, Labor & Pension (HELP) Committee marked up their version of the bill on May 11, by a vote of 21-1, with Sens. Rand Paul (R-KY) and Bernie Sanders (I-VT) voting against the bill. Only two amendments received a voice vote, one from Sens. Susan Collins (R-ME) & Al Franken (D-MN) that would expedite the review of some generic drug applications. The other, authored by Sen. Orrin Hatch (R-UT), would expand clinical trial criteria to allow sicker patients to participate. It would also make it easier for patients to use an FDA program to receive unapproved drugs when they don’t qualify for trials. Another amendment by Sen. Sanders regarding importation was tabled by a vote of 13-10, and will most likely be voted on when the bill reaches the Senate floor.

During the week of May 24, we are anticipating that the House Energy & Commerce full committee to markup the amended FDA user fee agreements. Neither chamber has announced a date for floor action. However, both chambers must pass identical legislation, and the President must sign it into law, well ahead of the current program’s expiration on Sept. 30, 2017.

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

CLSA Applauds Confirmation of Dr. Scott Gottlieb as New FDA Commissioner

WASHINGTON & BAY AREA, May 9, 2017 – California Life Sciences Association (CLSA), the state’s premier public policy and business solutions organization representing the California life sciences industry, today commended the U.S. Senate’s confirmation of Scott Gottlieb, M.D., as the new commissioner of the U.S. Food and Drug Administration (FDA).

As the key federal agency responsible for protecting and promoting public health by regulating drugs, medical devices, food safety and other health-related products, the FDA plays a vital role in the development of all biopharmaceuticals and medical technologies. As such, the FDA’s work heavily impacts the pace at which innovation is driven in California’s life sciences industry as well as the delivery of life-changing medicines and technologies far beyond the state of California.

“On behalf of the hundreds of life sciences organizations up and down the state we embody, California Life Sciences Association applauds the confirmation of Scott Gottlieb, M.D., as FDA Commissioner. Over the span of his distinguished career, Dr. Gottlieb has a proven track record as a strong advocate for both protecting public health and promoting biomedical innovation,” said Sara Radcliffe, President and CEO, California Life Sciences Association (CLSA).

“More recently, Dr. Gottlieb’s prominent and respected participation on several public health and policy committees, including the Federal Health IT Policy Committee and the National Coalition for Cancer Survivorship, further confirm the breadth and depth of his experience and commitment to bringing life-saving innovations to patients in need. During his previous time at the FDA as a deputy commissioner, Dr. Gottlieb was a strong advocate for policies that supported an efficient and streamlined drug development and approval process, including supporting development of the Critical Path Initiative. With his experience in regulatory matters, and understanding of agency and industry needs, we are confident Dr. Gottlieb will be an exemplary leader for the FDA. We look forward to working with him and his team at the FDA to meet our shared goals,” added Radcliffe.

Dr. Gottlieb previously served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs, a position he held from 2005 to 2007. He has also served as a senior policy advisor to the Administrator at the Centers for Medicare & Medicaid Services. He is a former member of the editorial staff of the British Medical Journal (BMJ), and a member of the editorial board of the Journal of the American Medical Association (JAMA). Dr. Gottlieb is currently a clinical assistant professor at New York University School of Medicine, and a resident fellow at the conservative American Enterprise Institute.

***

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.

Media Contact:
California Life Sciences Association (CLSA)
Will Zasadny
Director, Communications
wzasadny@califesciences.org
619-961-8848

Sacramento Update: A Victory on Opioid Taxes, but a Growing Battle on Physician Payment Restrictions

May 19, 2017

Taking a look beyond CLSA’s two most significant legislative battles of the year, Senate Bill 17 (Hernandez) and Assembly Bill 265 (Wood), CLSA notched a significant victory against opioid taxes, though the fight against state-level restrictions on physician payments has grown in intensity.

First, AB 1512 (McCarty) would have imposed a $0.01 per milligram tax on any “active opioid ingredient” to be paid by the manufacturer to fund opioid addiction prevention and rehabilitation programs. CLSA opposed the bill and fought aggressively with its partners, including distributors and wholesalers, to defeat the bill.

The bill failed in the Assembly Revenue and Tax Committee on procedural grounds.

Beyond the potential costs the bill would impose on the legitimate medication supply chain, CLSA was concerned with the precedent such a bill might set by targeting the industry as a funding source for such a broad, complex problem.

Second, SB 790 (McGuire) would restrict anything provided to physicians that might be considered a “gift” under the bill’s comprehensive definition. Much of the bill is modeled on a 2009 Vermont law, though it also duplicates much of what can be found in federal law. It does, however, go beyond federal law in several important ways, capping the value of meals to physicians at $250 and generally prohibiting anything beyond a salary to physicians conducting clinical trials.

CLSA and its industry partners vigorously opposed the bill on the grounds that it is unnecessarily duplicative of existing law and it will unduly restrict manufacturers from conducting critical education, outreach, and research activities. The author asserts the bill’s goal is to address the “direct correlation between pharmaceutical industry payments to medical professionals and the price of prescription drugs.” Organized labor and the Medical Board of California comprise the notable support behind the bill.

The bill was passed out of the Senate on May 18 on an essentially party-line vote (23-13) after another party-line vote in the Senate Health Committee (it was not required to be heard in the Appropriations Committee).

While CLSA is more optimistic regarding the Assembly, the bill has been wrapped up in the anti-industry narratives around SB 17 and AB 265 (both extensively discussed here previously) and may gain momentum as those bills move as well.

CLSA will continue working hard towards this legislation’s defeat and protect the life sciences sectors’ ability to discover new treatments and cures for patients. Questions? Please contact Brett Johnson, CLSA’s Senior Director, Policy and Regulatory Affairs (Bjohnson@califesciences.org).

Local Update: California State Auditor Releases Report on Take Back

May 18, 2017

The California State Auditor’s office released a report on home-generated sharps and pharmaceutical waste disposal as directed by the Joint Legislative Audit Committee. The official request was to gather data on relevant laws and regulations, consumer education, current programs and their efficacy, best practices from other jurisdictions, volume of waste and more.

The overall recommendation from the report encouraged the legislature to provide the California Department of Resources Recycling and Recovery (CalRecycle) with statutory oversight responsibility for such waste disposal and provide them with additional resources as necessary. Their conclusion that the lack of a lead state agency for oversight has left California consumers with conflicting guidance and a lack of adequate information about collection sites.

The report then encourages CalRecycle to focus on:

  • Public Education Campaign: The report argues that a current lack of education and coordinated guidance around proper disposal methods for consumers exists;
  • Public Listing of Locations: The report contends that about 89% of consumers live within a 20‑minute drive of sites for proper disposal;
  • Increase Access for Underserved Populations: The report documents around 4 million Californians live further away and would need great opportunities for access, including subsidizing mail-back options;
  • Review Other State Programs: The report specifically highlights New York State’s consumer education program as a possible model.

Other recommendations from the Audit include increasing in-state options for processing pharmaceutical waste through the authorization of municipal solid waste incinerators and adopting standard requirements for counties to follow if/when those localities implement extended producer responsibility (EPR) programs.

CalRecycle responded to the Audit with concerns regarding its potential designation as the oversight body due to lack of resources, expertise, and enforcement authority. They also were concerned that the Audit discounts the pursuit of EPR legislation. The Auditor rebutted by asserting its “disappointment with CalRecycle’s reluctance to assume leadership responsibility.”

For more information on the Audit and take back programs in general, please contact Reese Isbell, CLSA’s Director of Local Government and Community Relations ( risbell@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:

  • On April 27, BridgeBio Pharma announced the launch of Eidos Therapeutics, a CLSI 2016 FAST biopharmaceutical company developing a novel small-molecule treatment for transthyretin (TTR) amyloidosis. BridgeBio has committed $27 million and seasoned R&D executives to advance Eidos’ lead compound, AG10.   AG10 was discovered and initially developed by Eidos’ co-founders Isabella Graef, M.D., and Mamoun Alhamadsheh, Ph.D., through research funded by Stanford Medicine’s SPARK program. Read the press release here.
  • On April 20, Vyaire Medical, Inc., the healthcare industry’s largest pure-play “breathing” company, announced it has acquired Ciel Medical, Inc., of San Carlos, CA., a 2014 FAST company focused on solving unmet needs of medical professionals caring for intubated patients. Ciel Medical has developed innovative technologies that will strengthen Vyaire’s strategy to offer products that can help reduce the incidence of Ventilator Acquired Pneumonia for ventilated patients.  Vyaire management sees the acquisition of Ciel Medical as a step toward the company’s stated goal of becoming the global leader in the respiratory care market. Read the press release here.
  • On May 3, Angel Capital Association(ACA), the world’s leading professional association for angel investors, announced the winner of the coveted Luis Villalobos Award at the 2017 ACA Summit in [space] San Francisco.  ACA selected Magnetic Insight, a 2015 FAST graduate, as winner of the 2017 Luis Villalobos Award for ingenuity, creativity, and innovation among startups.  Based in Alameda, CA, Magnetic Insight has introduced Magnetic Particle Imaging (MPI), the first new diagnostic imaging technique since the introduction of CT, MRI, and PET over 30 years ago.

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.

AldenMC-Art-of-Science
MedTech Conference
BayBio

Premium Members

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Sustaining Members

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