On Oct. 12, the National Institutes of Health (NIH) announced a new partnership with 11 biopharmaceutical companies aimed at accelerating innovation in new cancer immunotherapies.| READ MORE »
Several Significant Bills Impacting Industry Falter In The Homestretch | READ MORE »
Governor Signs Three Bay Area Regional Transportation Bills For Elections In 2018 | READ MORE »
More Than One Million Students Access Biology Content Each Month.. | READ MORE »
CARB-X Update October 2017| READ MORE »
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.
Giants of Science 2017
October 25, 2017
In May of 2017, the California Life Sciences Institute and CLSA partnered with KNBR to launch the Giants of Science grant competition for Bay Area high schools in support of innovation and developing the next generation of life sciences leaders. High schools from throughout the Bay Area completed an application and posted a video in order to be considered for one of three $20,000 science grants.
On a beautiful sunny day at AT&T stadium in San Francisco, at the same Giants game that saw pitcher Matt Cain throw his final pitch, CLSA and CLSI celebrated the winning schools from the 2017 Giants of Science grant competition:
- North Bay Winner: Abraham Lincoln High School
Abraham Lincoln high school will utilize the funds to continue offering Abraham Lincoln’s 2-year Biotech Pathway program. This program offers students a very unique window into a field that is massively important in the Bay Area for many reasons. The program is uniquely designed to allow all students who are interested to take part in the first-year class, giving them the ability to learn about various topics and the skills involved in modern research. The second-year class is designed for those who wish to explore further and often for those who wish to go into either academic or industrial research and allows them the chance to get more hands-on time with advanced applications and techniques. As such, the program is expensive to run and currently gets no money from SFUSD and very little the site (all site money comes from our wonderful PTSA). We would use all funds to order the reagents, supplies and technology needed to support the program for the next 2 years and allow students the chance to take part in a class that explores an important and interesting subject and field.
- East Bay Winner: Northgate High School
Northgate High School’s dream is to create an outdoor classroom. Northgate is transitioning to NGSS (Next Generation Science Standards) which puts more emphasis on inquiry and exploration. An outdoor classroom would go a long way toward helping students become scientists of the future. We want students to study geology by getting their hands dirty. We want them to understand chemistry applies to the ‘real world’ not just the pages of a textbook. Students need to experience photosynthesis, ecology, erosion, and populations in order to understand science. We want students to wonder about nature…and then question, experiment, analyze, etc. This space will allow students to experience science in a way they cannot when locked on to a screen. We have a space to create this outdoor science lab. We also have a very active PFC (Parent/Faculty Club) who is willing to partner with us on this project, but there is no way they can put up the capital to make it happen. We have a landscape designer who is willing to donate his time to help us design the space to meet our needs. And, we have a team of teachers, students, and parents willing to help with the labor to make this a reality.
- South Bay Winner: Carlmont High School
$20,000 will allow Carlmont High School’s Biotechnology Insititute (BTI) to offer each of its three cohorts equipment for advanced science experiments, cross-disciplinary curriculum, and access to biotech industry professionals. We would also be able to adequately fund the Biomanufacturing course that will launch this fall. During Biomanufacturing, students will develop an idea for producing a biotech product and pose their idea to a team of teachers and college professionals Shark Tank style. Once approved, students will manufacture their product while simultaneously working on how to advertise, bottle, and/or anything else needed for it to be released to the public. We would also use additional funding to enable the science, English, and history teachers in our program to collaborate, particularly between the staff teaching seniors. Currently, we have two semester-long cross-curricular projects, and we would like to develop new cross-disciplinary assignments. Additional funding would also make it possible for us to reach out to additional biotech companies for volunteers.
As the trade association for life sciences in California, CLSA and CLSI are committed to supporting and encouraging the development of the next generation of leaders throughout our great state. Alongside our partner KNBR, we would like to congratulate all of our winners on behalf of our sponsoring organizations – Alexandria Real Estate, Celgene, Genentech, Gilead, Illumina, Nektar, Sutro Biopharma, Theravance, and Wareham Development – for doing your part to develop life sciences acumen and leadership in the Bay Area.
If you have questions about participating in future Giants of Science programs, please contact Elizabeth Gibson at firstname.lastname@example.org.
CLSA 2018 Industry Report, Event Information, New Members and More!
By: Sara Radcliffe
CLSA President & CEO
October 26, 2017
Final Call for Tables at CLSA’s 2017 Pantheon Awards
On Nov. 10, we will gather with more than 600 professionals from our California life sciences community to celebrate another year of leadership, innovation, and overall excellence at CLSA’s signature event – the 14th Annual Pantheon DiNATM Awards. Don’t miss your chance to celebrate with us! Limited tables and individual seats are still available. Contact us to attend or learn more here.
Join CLSA & PwC on Nov. 15, 2017 for the 2018 California Life Sciences Industry Report Launch
Be the first to learn how California’s vibrant life sciences ecosystem is contributing to our state’s and nation’s workforce and economy – and, improving lives. Join us for the launch of the CLSA & PwC 2018 California Life Sciences Industry Report on Nov. 15. Our webinar presentation and discussion will detail the findings of the Report, including 350 new key data points and sector trends. Register here.
CLSA Panel at BioNetwork 2017
Earlier this week at BioNetwork 2017 in Laguna Niguel, I had the pleasure of participating in a panel discussion – The Current State of Pharma and the Policy Arena – with Marc Schwabish, U.S. Head, Pharma Business Development & Licensing, Bayer and Scott E. Goedeke, President, Viscadia. Our discussion covered federal and state areas of interest ranging from the 21st Century Cures Act and new FDA Commissioner Scott Gottlieb to the prospects for ACA repeal & reform, tax reform, and the current legislative environment in Sacramento.
CLSA Welcome 17 New Members This Month!
Please join us in welcoming the 17 new CLSA members who joined us in the last month: Ripple Foods, Antiva Biosciences, Alveo Technologies, Fixate IO, Telo Therapeutics, AbCyte Therapeutics, Kino Biosciences, Phanes Therapeutics, Jungla, Vision Infinitas, TarGead Sciences, aTyr Pharma, Mitokinin, Encodia, Optimal Tracers/Northern California PET Imaging Center, SeqMatic, and Impossible Foods. 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.
CLSI Launches Innovation Series
The California Life Sciences Institute (CLSI) launched a new Innovation Series focused on issues most pressing for life science startups from the very early to more advanced stages of development. The first event in the Innovation Series kicked off earlier this week with a “Reimbursement 101” panel at Verily in South San Francisco to explore how provider groups and payers use value in their analysis of what technologies to adopt. CLSI is planning additional panels in the Innovation Series for 2018. For additional information and sponsorship opportunities, click here.
CLSI CARB-X’s Heather Shane Speaks at BIO Investor Forum
Heather Shane, CLSI CARB-X’s Executive Director, spoke at this year’s BIO Investor Forum in San Francisco at a panel on “Antimicrobial Resistance: New Research and Funding Opportunities” on reimbursement models for AMR products, the need for expanded push incentives to de-risk early-stage AMR R&D, and the role accelerators play in developing the AMR community and corralling support for CARB-X projects and AMR innovation. For more information on the genesis, scope and mission, and portfolio priorities of CARB-X, or to get involved, click here.
BIO Survey: Share Your Drug Sponsor Experience Interacting with FDA
BIO is conducting a survey to gauge the effectiveness of FDA-sponsor interactions during the drug development process. This targeted survey focuses on key metrics of success for FDA-sponsor communications – including RPMs, communications channels, special designations, and the Enhanced Communications Team. You can sign up for the survey or log in to your account at fdasurvey.bio.org. There, you can provide basic info about your company and programs, and contribute vital feedback on your interactions with FDA via the survey’s clinical program journals. All data and feedback will be blinded and kept anonymous.
CLSA Expands Our Federal Advocacy Team in Washington, DC
We’re excited to welcome another new employee to the CLSA family this month:
Danielle Mitchell, Associate, Federal Government Relations & Programs
Dani joins CLSA’s Federal Government Relations team to support the implementation of strategy, member relationship development, and overall advancement of initiatives with federal policymakers and allied stakeholders. Prior to joining CLSA, Dani served as a government affairs intern & policy fellow in the Washington, DC office of Horizon Pharma, a CLSA member company. She previously interned for a DC-based policy and advocacy consulting firm, and in a Capitol Hill congressional office. Dani is a graduate of Middle Tennessee State University and is currently pursuing a Masters of Public Administration at American University (Washington, DC), where she also serves as a graduate assistant at AU’s Public Affairs and Advocacy Institute.
President & CEO
California Life Sciences Association
PS – Do you have newsworthy items to submit for consideration for our monthly CLSA Bulletin? Feel free to send those tips to Elizabeth Gibson (EGibson@califesciences.org), CLSA’s Senior Director of Marketing & Programs.
Two Major Bills Affecting Life Sciences Sector are Signed into Law
Oct. 24, 2017
Despite the best efforts of CLSA and its partner trade associations, both Senate Bill 17 (Hernandez) and Assembly Bill 265 (Wood) reached the Governor’s desk and were signed into law. At the signing ceremony for SB 17, Governor Brown said, “Californians have a right to know why their medical costs are out of control, especially when the pharmaceutical profits are soaring,” adding that there is “real evil when so many people are suffering so much from rising drug profits.”
First, SB 17 will require, among many other things, manufacturers 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 has increased 16 percent or more cumulatively over the previous two calendar years, including the current year’s increase.
Beginning on January 1, 2019, on the effective date of any price increase triggering the advance notice, the drug’s manufacturer must submit a host of information to the state, though the law allows any information not “otherwise in the public domain or publicly available” to be withheld. The information is then posted publicly by the state in a manner that allows for identification of the individual drugs.
California’s Office of Statewide Health Planning and Development (OSHPD) is tasked with implementing and overseeing the law’s requirements on manufacturers, and industry hopes to begin receiving guidance on how the law will be implemented soon. Guidance is needed on significant, pressing implementation questions, such as how manufacturers should interpret a requirement to provide 60 days advance notice on a law that is not legally on the books until January 1, 2018, and for which the official list of registered recipients for the notices may not yet be available.
Second, AB 265 will prohibit a drug manufacturer from offering in California “any discount, rebate, product voucher, or other reduction in an individual’s out-of-pocket expenses, including, but not limited to, a copayment or deductible” if a lower cost and therapeutically equivalent brand or generic drug is “available.” The law excludes biologics from this restriction and allows for exceptions when the patient has received a prior authorization or step therapy exception to receive the drug. Implementation questions remain, however, as to how and to what extent will pharmacies verify whether these exceptions apply when presented with a coupon or co-pay card.
CLSA is continuing to analyze the potential impacts of implementation of these laws on our industry, and any members who would like further information on these or any other new California laws are encouraged to reach out to Oliver Rocroi, CLSA’s Senior Director, State Government Relations (email@example.com) or Brett Johnson, CLSA’s Senior Director, Policy & Regulatory Affairs (firstname.lastname@example.org).
Several Significant Bills Impacting Industry Falter in the Homestretch
Oct. 23, 2017
In addition to Senate Bill 790 (McGuire), which was discussed in last month’s bulletin, several bills on which CLSA was active failed to become law this year. Unlike SB 790, these were bills CLSA had supported to varying degrees during the legislative process.
First, Assembly Bill 315 (Wood) initially would have required pharmacy benefit managers (PBMs) to report to the Board of Pharmacy, in addition to registering with the Board, on the amounts of rebates, discounts, and other price concessions passed through to health plan enrollees. As the bill moved into the Senate, however, regulatory authority was moved to the Department of Managed Health Care and reporting was only required to the PBMs’ clients upon request under confidentiality protections.
While CLSA maintained a dialogue with the bill’s author, our support remained contingent on amendments to the bill that would have consolidated industry reporting and ensured PBM information would inform the public’s understanding of drug costs. The author ultimately decided to withdraw the bill prior to it being brought to the Senate floor due to concerns about the appropriate regulatory structure for overseeing PBMs.
Second, AB 447 (Gray) would have explicitly included an FDA-approved continuous glucose monitor (CGM) as a Medi-Cal benefit if the CGM’s manufacturer had a rebate agreement with the state. The Governor unfortunately vetoed the bill, stating that the bill was unnecessary due to current Medi-Cal provisions already allowing the state to cover CGMs when deemed medically necessary. CLSA remained in strong support of the bill throughout the process.
Third, AB 1217 (Bocanegra) would have effectively established a charter school in Los Angeles County focused on science, technology, engineering, and mathematics (STEM) for grades 6 through 12. CLSA supported the bill due to our longstanding broad support of policies that would improve STEM educational opportunities in California. The bill unfortunately faced intense opposition from California’s teacher’s unions, and the author chose to withdraw the bill prior to a vote on the Senate floor.
Despite the failure of these proposals this year, they may return in one form or another next year. CLSA will continue monitoring these and other potential legislation as we head into the second year of this two-year legislative session.
Questions? Please contact Brett Johnson, CLSA’s Senior Director, Policy & Regulatory Affairs (BJohnson@califesciences.org).
CMS Withdraws Harmful Medicare Part B Demonstration
Oct. 22, 2017
On August 25, the Centers of Medicare and Medicaid Services (CMS) officially withdrew the proposed Center for Medicare & Medicaid Innovation (CMMI) Part B Demonstration, the “Medicare Part B Drug Payment Model” (CMS-1670-F).
The proposed rule, published in March 2016, proposed a two-phase nationwide mandatory “demonstration” to test new Medicare Part B prescription drug models, purportedly to test prescribing incentives (despite the fact that many of the impacted practices do not have alternatives to the drugs they administer). CLSA has strongly opposed the proposed rule since it was announced because of our concerns about the impact of the policy on innovation and patient access to needed therapies for critically ill patients.
Over the past year and a half, CLSA worked with the California congressional delegation and our partners at the national trade associations in calling for a repeal of the proposed rule. CLSA’s May 2016 comments to CMS asking for withdrawal of the proposed rule – sent in collaboration with California regional life sciences associations Biocom, CONNECT and SoCalBio – are available here. As a result of CLSA’s engagement and advocacy, a total of 31 bipartisan members of the California congressional delegation (12 Republicans, 19 Democrats) signed at least one letter expressing serious concerns or opposition to the CMMI proposed Part B rule.
For questions, please contact Jenny Carey, CLSA’s Vice President of Federal Government Relations and Alliance Development (email@example.com).
NIH Partners with 9 CLSA Member Biopharma Companies to Accelerate Cancer Therapy Innovation
Oct. 21, 2017
On Oct. 12, the National Institutes of Health (NIH) announced a new partnership with 11 biopharmaceutical companies aimed at accelerating innovation in new cancer immunotherapy therapies. We are very proud that nine CLSA member companies are participating in the initiative, which is demonstrative of the expertise and commitment of California innovators in driving groundbreaking research efforts that will lead to future treatments and cures.
The Partnership for Accelerating Cancer Therapies (PACT) is a five-year public-private research collaboration totaling $215 million, that supports the Cancer Moonshot goal of bringing immunotherapy success for more cancers to more patients.
PACT partners include CLSA members AbbVie; Amgen; Boehringer Ingelheim Pharma GmbH & Co. KG; Bristol-Myers Squibb; Celgene Corporation; Genentech, a member of the Roche Group; Gilead Sciences; Janssen Pharmaceutical Companies of Johnson & Johnson; and Pfizer, Inc.; as well as GlaxoSmithKline plc; and Novartis Institutes for Biomedical Research.
Additionally, NIH’s National Cancer Institute (NCI) recently awarded cooperative agreements to support four Cancer Immune Monitoring and Analysis Centers (CIMACs) and a Cancer Immunologic Data Commons (CIDC) with a total of $53.6 million in funding over five years. The four CIMACs and one CIDC will form a network of laboratory centers that will support both adult and pediatric immunotherapy trials. Researchers at the CIMACs will perform deep tumor and immune profiling. The resulting data will be collected in the CIDC database for exploration of biomarkers of immune response. This network will also provide a foundation for the core laboratory, assay development and database functions required by PACT. Notably, Stanford Cancer Institute (Palo Alto, CA), is among the cooperative agreement awardees. (Stanford University is a member of CLSA).
Congratulations to all participants in launching this landmark initiative! Click here to learn more about the announcement. Questions? Please contact Adam Lotspike, CLSA’s Associate Director, Federal Government Relations (firstname.lastname@example.org).
Governor Signs Three Bay Area Regional Transportation Bills for Elections in 2018
Oct. 19, 2017
Governor Jerry Brown signed three regional bills that will usher forward localized public votes in the 2018 elections to increase transportation funding and services in the Bay Area.
Senator Jim Beall’s (D-San Jose) SB 595 allows the Metropolitan Transportation Commission (MTC), in its role as the Bay Area Toll Authority, to put Regional Measure 3 (RM3) on the ballot in 2018. RM3 encompasses 9 of the Bay Area’s Counties (Alameda, Contra Costa, Marin, Napa, San Francisco, San Mateo, Santa Clara, Solano and Sonoma). Each of these Counties will vote as a region on whether to raise the tolls on the Bay Area’s seven-state owned bridge tolls by up to $3 to finance a $4.5 billion package of transportation projects. RM3 requires a majority vote of all 9 Bay Area Counties’ citizens combined.
Senator Jerry Hill’s (D-San Mateo) SB 797 allows for the Peninsula Corridor Joint Powers Board, which oversees Caltrain, to ask voters in the Countries of San Francisco, San Mateo, and Santa Clara to establish a one-eighth-cent sales tax. This would establish the first independent funding for Caltrain. The sales tax will need supportive votes from local transportation agencies, two-thirds majority votes from each of the three Counties’ Boards of Supervisors, and by another two-thirds vote of all three counties’ citizenry combined.
Assemblyman Kevin Mullin’s (D-South San Francisco) AB 1613 gives the San Mateo County Transit District the authority to put forward a potential sales tax measure, of no more than one-half percent, before the voters in San Mateo County to address transportation needs. With AB 1613 signed into law, the County will begin a community engagement process, which will include CLSA, to determine its expenditure priorities upon potential passage. It will require support from the County’s Board of Supervisors and approval from two-thirds of voters in the County.
CLSA will continue to work to address the concerns of our industry regarding Bay Area traffic congestion through regularly engagement with community leaders and elected officials on these and other infrastructure needs of our companies. For further information or questions, contact Reese Isbell, CLSA’s Director, Local Government & Community Relations (Risbell@califesciences.org).
Amgen Foundation Awards Khan Academy $3 Million To Support Development Of Free Comprehensive Biology Lessons
THOUSAND OAKS, Calif. and MOUNTAIN VIEW, Calif., Oct. 12, 2017 /PRNewswire/ — The Amgen Foundation today announced a three-year, $3 million grant to Khan Academy to develop comprehensive new biology lessons. The Amgen Foundation is the exclusive sponsor of Khan Academy’s biology content.
With the Amgen Foundation’s support, Khan Academy will create new biology lessons for students and teachers worldwide. New videos, articles and practice exercises for ninth-grade biology through Advanced Placement Program®(AP®) biology will complement existing offerings. Like all lessons from the nonprofit Khan Academy, biology lessons are available for free at KhanAcademy.org.
“The Amgen Foundation has demonstrated a deep commitment to science education for many years, and we’re honored by the renewed support of Khan Academy’s biology content,” said Khan Academy founder and CEO Sal Khan. “The Amgen Foundation’s funding allows Khan Academy to create new biology lessons that will enrich the classroom experience for students and teachers everywhere.”
The new Amgen Foundation funding builds on a 2015 grant partnership that supported the initial development of Khan Academy’s AP and other introductory college-level biology content. Khan Academy has grown its biology offering, with the Amgen Foundation’s support, to more than 300 videos, 80 exercise sets and 195 articles. Usage of Khan Academy biology lessons has increased to more than one million students monthly. In addition, Khan Academy is now the official practice partner for the AP Program and is partnering with the organization to create biology content that aligns with AP’s challenging academic standards.
“Khan Academy uses the power of technology to achieve meaningful scale and support learners around the world, particularly those who are low-income,” said Eduardo Cetlin, president of the Amgen Foundation. “With more than 10 million learners visiting the platform each month, we’re excited that students and teachers both in the U.S. and across the globe will have access to high-quality biology content through this partnership.”
According to Amgen Foundation research on biology classes, students ranked virtual learning and the ability to choose the topics they would like to explore further among their top preferences. The Khan Academy content supported by the Amgen Foundation can help students master scientific concepts taught in the classroom at their own pace, while allowing teachers to identify gaps in learning and provide tailored instruction.
Students who have used Khan Academy to study biology shared positive feedback on how it nurtured the STEM skills they need for college and career readiness.
“Khan Academy made me feel like I understood biology,” said Derek Wan, a student at the University of California, Berkeley, who used Khan Academy during his freshman year of high school. “The momentum from freshman year carried me on through junior year. That’s the feeling that Khan Academy gave me.”
“One of the great benefits of Khan Academy is that the videos are engaging and the information is easy to retain,” said Elizabeth Cass, a graduate student at Oregon State University. “The videos and exercises are an important resource for people who just want to learn more.”
Learn more about the new biology lessons by visiting khanacademy.org/science/biology.
About the Amgen Foundation
The Amgen Foundation seeks to advance excellence in science education to inspire the next generation of innovators, and invest in strengthening communities where Amgen staff members live and work. To date, the Foundation has donated over $250 million to local, regional, and international nonprofit organizations that impact society in inspiring and innovative ways. The Amgen Foundation brings the excitement of discovery to the scientists of tomorrow through several signature programs, including Amgen Scholars, Amgen Biotech Experience, and Amgen Teach. For more information, visit www.AmgenInspires.com and follow us on Twitter @AmgenFoundation.
About Khan Academy
Khan Academy is a 501(c)(3) nonprofit organization with the mission of providing a free, world-class education for anyone, anywhere. We use intelligent software, data analytics, and intuitive user interfaces to help students and teachers around the world. Our resources cover math, biology, chemistry, physics, history, economics, finance, grammar, preschool learning, and more. Khan Academy offers free personalized SAT prep in partnership with the College Board, and we are the official practice partner for AP. We provide teachers with tools and data so they can help their students develop the skills, habits, and mindsets necessary for success in school and beyond. Khan Academy has been translated into dozens of languages, and 10 million people around the globe learn on Khan Academy each month. For more information, visit khanacademy.org, join us on Facebook, or follow us on Twitter at @khanacademy. And remember, you can learn anything.
Advanced Placement Program and AP are registered trademarks of the College Entrance Examination Board.
Amgen, Thousand Oaks
Jennifer van der Borgt, 805-447-5597 (Media)
Barb Kunz, 650-429-8154
Kite’s Yescarta™ (Axicabtagene Ciloleucel) Becomes First CAR T Therapy Approved by the FDA for the Treatment of Adult Patients With Relapsed or Refractory Large B-Cell Lymphoma After Two or More Lines of Systemic Therapy
FOSTER CITY, Calif. & SANTA MONICA, Calif.–(BUSINESS WIRE)–Kite, a Gilead Company, (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted regular approval to Yescarta™ (axicabtagene ciloleucel), the first chimeric antigen receptor T cell (CAR T) therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL). Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.
CAR T therapy is a breakthrough in hematologic cancer treatment in which a patient’s own T cells are engineered to seek and destroy cancer cells. CAR T therapy is manufactured specifically for each individual patient.
“The FDA approval of Yescarta is a landmark for patients with relapsed or refractory large B-cell lymphoma. This approval would not have been possible without the courageous commitment of patients and clinicians, as well as the ongoing dedication of Kite’s employees,” said Arie Belldegrun, MD, FACS, Founder of Kite. “We must also recognize the FDA for their ability to embrace and support transformational new technologies that treat life-threatening illnesses. We believe this is only the beginning for CAR T therapies.”
“Today is an important day for patients with relapsed or refractory large B-cell lymphoma who have run out of options and have been waiting for new treatments that may help them in their fight against cancer,” said John Milligan, PhD, President and Chief Executive Officer of Gilead Sciences. “With the combined innovation, talent and drive of the Kite and Gilead teams, we will rapidly advance cell therapy research and aim to bring new options to patients with many other types of cancer.”
Yescarta has a Boxed Warning in its product label regarding the risks of cytokine release syndrome (CRS) and neurologic toxicities. A Risk Evaluation and Mitigation Strategy (REMS) has been approved by the FDA for Yescarta. The REMS program will inform and educate healthcare professionals about the risks associated with Yescarta therapy. Training and certification on the REMS program will be an integral part of the final authorization for centers offering Yescarta. Additional information about the REMS program can be found at www.yescartarems.com. Please see below for Important Safety Information.
Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive non-Hodgkin lymphoma (NHL), accounting for three out of every five cases. In the United States each year, there are approximately 7,500 patients with refractory DLBCL who are eligible for CAR T therapy. Historically, when treated with the current standard of care, patients with refractory large B-cell lymphoma had a median overall survival of approximately six months, with only seven percent attaining a complete response. Currently, patients with large B-cell lymphoma in second or later lines of therapy have poor outcomes and greater unmet need, since nearly half of them either do not respond or relapse shortly after transplant.
“With CAR T therapy, we are reengineering a patient’s own immune system to detect and kill cancer cells, and the results have been impressive,” said Frederick L. Locke, MD, ZUMA-1 Co-Lead Investigator and Vice Chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center in Tampa, Florida. “Many of the patients that received CAR T therapy had already relapsed several times with traditional treatments such as chemotherapy or hematopoietic stem cell transplant. Now, thanks to this new therapy many patients are in remission for months.”
“This therapy is a new option for patients with relapsed or refractory large B-cell lymphoma who have run out of treatment options and face a dire prognosis,” said Louis J. DeGennaro, PhD, President and Chief Executive Officer of The Leukemia & Lymphoma Society (LLS). “Early on, LLS recognized the potential of CAR T therapy and we are proud to be part of making this historic approval possible.”
“Engineered cell therapies like Yescarta represent the potential for a changing treatment paradigm for cancer patients,” said David Chang, MD, PhD, Worldwide Head of Research and Development and Chief Medical Officer at Kite. “Together, Gilead and Kite will accelerate studies of CAR T therapy in multiple blood cancers and advance other cell therapy approaches for solid tumors, with the goal of helping patients with diverse cancers benefit from this new era of personalized cancer therapy.”
Yescarta will be manufactured in Kite’s state-of-the-art commercial manufacturing facility in El Segundo, California. In the ZUMA-1 pivotal trial, Kite demonstrated a 99 percent manufacturing success rate with a median manufacturing turnaround time of 17 days, which is important to patients given the potential for rapid disease progression in this population.
In 2017, Kite established a multi-disciplinary field team focused on providing education and logistics training for centers. Upon Yescarta’s approval, this team will provide final site certification to 16 centers, enabling them to make Yescarta available to appropriate patients. This support is designed to assure the safe and effective use of Yescarta for patients and physicians. Kite is actively working to train more than 30 additional centers with an eventual target of 70 to 90 centers across the United States. The latest information on Yescarta authorized centers is available at www.yescarta.com.
In support of Yescarta therapy, Kite has developed Kite Konnect™, a program enabled by an integrated technology platform that focuses on providing information and assistance throughout the Yescarta therapy process, including courier tracking for shipments and manufacturing status updates. Kite Konnect also will provide information related to insurance benefits and third-party resources available for travel support. Healthcare providers and patients can reach Kite Konnect at www.KiteKonnect.com or 1-844-454-KITE (1-844-454-5483).
The list price of Yescarta in the United States is $373,000.
Yescarta has been granted Priority Medicines (PRIME) regulatory support for DLBCL in the European Union. A Marketing Authorization Application (MAA) for axicabtagene ciloleucel is currently under review with the European Medicines Agency (EMA) and potential approval is expected in the first half of 2018.
Yescarta (axicabtagene ciloleucel) Pivotal Trial Results
The approval of Yescarta is supported by data from the ZUMA-1 pivotal trial. In this study, 72 percent of patients treated with a single infusion of Yescarta (n=101) responded to therapy (overall response rate) including 51 percent of patients who had no detectable cancer remaining (complete remission; 95% CI: 41, 62). At a median follow-up of 7.9 months, patients who had achieved a complete remission had not reached the estimated median duration of response (95% CI: 8.1 months, not estimable [NE]).
In the study, 13 percent of patients experienced grade 3 or higher cytokine release syndrome (CRS) and 31 percent experienced neurologic toxicities. The most common (≥ 10%) Grade 3 or higher reactions include febrile neutropenia, fever, CRS, encephalopathy, infections-pathogen unspecified, hypotension, hypoxia and lung infections. Serious adverse reactions occurred in 52% of patients and included CRS, neurologic toxicity, prolonged cytopenias (including neutropenia, thrombocytopenia and anemia), and serious infections. Fatal cases of CRS and neurologic toxicity occurred. FDA approved Yescarta with a Risk Evaluation and Mitigation Strategy.
Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES
- Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving Yescarta. Do not administer Yescarta to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
- Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving Yescarta, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Yescarta. Provide supportive care and/or corticosteroids as needed.
- Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta REMS.
Cytokine Release Syndrome (CRS)
CRS, including fatal or life-threatening reactions, occurred following treatment with Yescarta. In Study 1, CRS occurred in 94% (101/108) of patients receiving Yescarta, including ≥ Grade 3 (Lee grading system) CRS in 13% (14/108) of patients. Among patients who died after receiving Yescarta, four had ongoing CRS events at the time of death. The median time to onset was 2 days (range: 1 to 12 days) and the median duration of CRS was 7 days (range: 2 to 58 days). Key manifestations of CRS include fever (78%), hypotension (41%), tachycardia (28%), hypoxia (22%), and chills (20%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
Ensure that 2 doses of tocilizumab are available prior to infusion of Yescarta. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 4 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab or tocilizumab and corticosteroids as indicated.
Neurologic toxicities, that were fatal or life-threatening, occurred following treatment with Yescarta. Neurologic toxicities occurred in 87% of patients. Ninety-eight percent of all neurologic toxicities occurred within the first 8 weeks of Yescarta infusion, with a median time to onset of 4 days (range: 1 to 43 days). The median duration of neurologic toxicities was 17 days. Grade 3 or higher neurologic toxicities occurred in 31% of patients.
The most common neurologic toxicities included encephalopathy (57%), headache (44%), tremor (31%), dizziness (21%), aphasia (18%), delirium (17%), insomnia (9%) and anxiety (9%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events including leukoencephalopathy and seizures occurred with Yescarta. Fatal and serious cases of cerebral edema have occurred in patients treated with Yescarta.
Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of neurologic toxicities. Monitor patients for signs or symptoms of neurologic toxicities for 4 weeks after infusion and treat promptly.
Because of the risk of CRS and neurologic toxicities, Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta REMS. The required components of the Yescarta REMS are:
- Healthcare facilities that dispense and administer Yescarta must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of two doses of tocilizumab are available for each patient for infusion within 2 hours after Yescarta infusion, if needed for treatment of CRS.
- Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense or administer Yescarta are trained about the management of CRS and neurologic toxicities.
Further information is available at www.YescartaREMS.com or 1-844-454-KITE (5483).
Allergic reactions may occur with the infusion of Yescarta. Serious hypersensitivity reactions including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in Yescarta.
Severe or life-threatening infections occurred in patients after Yescarta infusion. In Study 1, infections (all grades) occurred in 38% of patients. Grade 3 or higher infections occurred in 23% of patients. Grade 3 or higher infections with an unspecified pathogen occurred in 16% of patients, bacterial infections in 9%, and viral infections in 4%. Yescarta should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after Yescarta infusion and treat appropriately. Administer prophylactic anti-microbials according to local guidelines.
Febrile neutropenia was observed in 36% of patients after Yescarta infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids and other supportive care as medically indicated.
Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.
Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Yescarta infusion. In Study 1, Grade 3 or higher cytopenias not resolved by Day 30 following Yescarta infusion occurred in (28%) of patients and included thrombocytopenia (18%), neutropenia (15%), and anemia (3%). Monitor blood counts after Yescarta infusion.
B-cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with Yescarta. In Study 1, hypogammaglobulinemia occurred in 15% of patients. Monitor immunoglobulin levels after treatment with Yescarta and manage using infection precautions, antibiotic prophylaxis and immunoglobulin replacement.
The safety of immunization with live viral vaccines during or following Yescarta treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Yescarta treatment, and until immune recovery following treatment with Yescarta.
Patients treated with YESCARTA may develop secondary malignancies. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.
Effects on Ability to Drive and Use Machines
Due to the potential for neurologic events, including altered mental status or seizures, patients receiving Yescarta are at risk for altered or decreased consciousness or coordination in the 8 weeks following Yescarta infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.
The most common adverse reactions (incidence ≥ 20%) include CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias. Serious adverse reactions occurred in 52% of patients. The most common serious adverse reactions (> 2%) include encephalopathy, fever, lung infection, febrile neutropenia, cardiac arrhythmia, cardiac failure, urinary tract infection, renal insufficiency, aphasia, cardiac arrest, Clostridium difficile infection, delirium, hypotension, and hypoxia.
The most common (≥ 10%) Grade 3 or higher reactions include febrile neutropenia, fever, CRS, encephalopathy, infections-pathogen unspecified, hypotension, hypoxia and lung infections.
Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies. For more information on Kite, please visit www.kitepharma.com.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of the companies’ and members of their senior management team. Forward-looking statements include, without limitation, the risk that physicians may not see the benefits of prescribing Yescarta for the diseases for which it is approved; the ability of Kite to continue to manufacture Yescarta at the success rates experienced during clinical trials; the possibility of unfavorable results from additional clinical trials involving Yescarta; and the risk that other regulatory agencies may not approve Yescarta in the currently anticipated timelines or at all, and that any marketing approvals may have significant limitations on its use. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include risks and uncertainties detailed from time to time in the companies’ periodic reports filed with the Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements.
US Prescribing Information for Yescarta, including BOXED WARNING and Medication Guide, is available at www.yescarta.com.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Sung Lee, 650-524-7792
Amy Flood, 650-522-5643
HATCH Contributes to Los Angeles’s Bioscience Ecosystem
Building a Bioscience Cluster in East Los Angeles
October 2, 2017
East Los Angeles is shaping up to be one of the unlikely centers of southern California’s emerging bioscience industry. Bioscience has long had a presence in Los Angeles, given its collection of leading medical centers and universities. However, for years it has been overlooked as a destination for life science innovation and investment as San Francisco, Boston, and San Diego emerged as bioscience cluster powerhouses. Now, thanks to a shared vision among city and county leaders, local universities, and the bioscience industry, a concerted, cross-sector effort is activating a network of bioscience clusters across the region. East Los Angeles is one of those nodes.
The eastside cluster, known as the LA Bioscience Corridor, is anchored by the LAC+USC Medical Center and the USC Health Sciences Campus on the west, and California State University, Los Angeles (Cal State L.A.) and Grifols (a multinational pharmaceutical company) on the east. At the center of these university and research centers is a promising stretch of underused industrial land that is ready for redevelopment.
A key piece to cultivating bioscience innovation and industry depends on real estate—having lab space to operate and grow a life science startup. The LA Bioscience Corridor is home to some of Los Angeles’s last remaining industrial land. Unlike other parts of the region where industrial land is being rezoned for residential conversion, this East Los Angeles area is primed for hosting the next wave of manufacturing and production.
“We were looking for a particular building type in a more affordable neighborhood, when we came upon this building, which has great bones and is really beautiful. It quickly became important to understand how bioscience uses could fit within this type of building,” says Howard Kozloff, managing partner of Agora Partners.
The abandoned furniture warehouse was purchased and readied for adaptive use. The building, aptly named HATCH, will provide flexible working space to emerging bioscience companies that have outgrown their incubators and require purpose-built, dedicated lab and office space.
HATCH is regarded as a much-needed and valuable contribution to Los Angeles’s bioscience ecosystem. Part of the vision for this area is to create a place where companies can translate cutting-edge academic research into commercialized medical treatments and technologies that make it into hospitals and doctors’ offices.
Located within an industrial zone, HATCH will offer more than 17,000 square feet (1,600 sq m) of available lab space that can be configured for up to eight bioscience tenants. “HATCH is transforming a building that, in its prior iteration, had no more than four employees at one time into a dynamic hub of bioscience activity, accommodating over 50 people from all bioscience disciplines,” says Kozloff.
While Los Angeles has numerous research centers and a growing number of incubators, HATCH is its first privately funded, multitenant lab space. Being the local pioneers for this type of real estate product has come with some challenges. In particular, financing has been complicated.
Allan Glass, president and CEO of ASG Real Estate, says, “Being a first-mover requires us as developers to extract the emerging storyline between the industry and the real estate. Our research needs to be deeper than direct comparable sales and current market rents, which simply don’t exist. We need to understand who the stakeholders are, develop working relationships with them, take consensus of where priorities lie, and establish what is the most immediate missing need.”
The HATCH team has extrapolated a variety of data points to convey Los Angeles’s bioscience potential to capital investors. They’ve learned that there is also a catch-22 between buildout and tenant commitments. Bioscience startups typically do not commit to a space unless it is built out; however, funding a full buildout is challenging without tenant commitments. In addition, the extent of buildout for lab space can vary greatly, with costs ranging from $50 to $1,000 per square foot ($538 to $10,760 per sq m). To reduce risk and costs, HATCH has decided to allow specialty buildout to accommodate the range of company needs between creative office space environs and fully equipped wet labs and clean rooms.
Having overcome the hurdles of being a first-mover and seeing the opportunity of the LA Bioscience Corridor, the HATCH team continues to seek out additional opportunities for bioscience-focused development projects.
A stone’s throw from HATCH, Cal State L.A. has broken ground on LA BioSpace, an on-campus incubator that is scheduled to open next year. LA BioSpace is funded through a combination of county, federal, and philanthropic grants, and represents a cross-sector commitment that HATCH has successfully leveraged with private sector investors. LA BioSpace aims to be a launchpad for early-stage companies to take shape in the LA Bioscience Corridor.
“Our goal is to capture companies graduating from the academic and incubator environment and house them in HATCH, so that they can stay in Los Angeles and continue to grow locally,” says Glass.
In addition to its multitenant labs and offices for ascending bioscience companies, HATCH hopes to be a venue for bridging researchers, inventors, entrepreneurs, and venture capital firms. HATCH’s coworking environment and shared amenities will also serve as educational programming space to connect in-house companies, PhDs, and postdoctorates to young, local science, technology, engineering, and mathematics (STEM) students.
LA Bioscience Hub (LABH), a place-based nonprofit entity, is one of the local partners with which HATCH will organize its community programming. LABH focuses on shaping the LA Bioscience Corridor to become a thriving innovation center that creates good jobs for the local workforce. LABH brings an equitable economic development approach to the corridor’s growth through partnerships that can weave the benefits of redevelopment, like HATCH, into the fabric of the community. LABH’s core program, Biotech Leaders Academy, strengthens career pathways for diverse, East Los Angeles community college students through entrepreneurship training and internships in the bioscience industry. The nonprofit organization hopes to make HATCH’s future company tenants program partners.
“The addition of HATCH to the LA Bioscience Corridor is a catalytic development project for rooting more bioscience research and manufacturing enterprises in Los Angeles. The public and private investments coming into this area can lead to new, much-needed economic opportunity in East Los Angeles,” says Cecilia V. Estolano, executive director of LA Bioscience Hub.
Los Angeles is a wellspring of ingenuity with the right ingredients to flourish into a competitive bioscience force that continues to attract investors nationally and internationally. With ample space for new bioscience developments that can help local companies prosper, the LA Bioscience Corridor is on the cusp of becoming a center for leading-edge intellectual and commercial bioscience activity.
HATCH is a critical piece in writing Los Angeles’s bioscience story. Having state-of-the-art spaces for growing startup companies is crucial to the prosperity of the bioscience industry both in the LA Bioscience Corridor and in Los Angeles as a region. Los Angeles is home to talent, innovation, wealth, and land. The final ingredient is lab space, and the opportunity to create it awaits.
Bay Area Startup Bolt Threads Announces a New Partnership with Patagonia
Patagonia’s Next Jacket Will Be Made of Spider Silk
The material is ultra tough, durable, and lightweight, and it may be the future of outdoor apparel if Patagonia and a California startup have their way
by Sarah L. Stewart
Good news for gear junkies, bad news for arachnophobes: we’re now one step closer to swaddling ourselves in spiderwebs.
Earlier this month, Bay Area startup Bolt Threads announced a new partnership with Patagonia to develop goods made from its proprietary spider silk-inspired fibers and textiles. Along with the news that Bolt Threads has secured an additional $50 million in financing from investors, the collaboration indicates that the latest in a series of attempts to harness the powers of spider silk could prove to be the most successful yet.
“When a big brand like that steps up and makes this kind of commitment, I think it signals that people are really feeling that there’s some major improvement from this technology,” says Matt Powell, outdoor industry analyst for The NPD Group.
Scientists, entrepreneurs and big business have tried for decades to replicate spider silk, which is lauded for its superior qualities: ounce for ounce, it’s five times stronger than steel and three times tougher than Kevlar. So far none have succeeded on a commercially viable scale, but Bolt Threads is among a handful of companies worldwide racing to do just that. Using a fermentation process—much like brewing beer—Bolt Threads creates large quantities of silk proteins, then spins the raw protein into fibers. Since its founding in 2009, the company has moved from concept to reality, this summer transitioning into yarn manufacturing.
“We’re scaling up,” says Sue Levin, Bolt Threads’ chief marketing officer. “We’re going to be producing metric tons of material in the months ahead.”
Less clear is what exactly Patagonia will make from Bolt Threads’ Engineered Silk material; both companies have thus far declined to comment on specifics of the deal. But the earliest possible debut for a Patagonia-branded item would be in 2018, Levin says, due to the brand’s product lead time.
That doesn’t rule out the possibility of some other type of Bolt Threads product hitting shelves sooner, however. The company has previously predicted it would bring a product to market sometime this year and its website presently declares, “Stay tuned. We are planning to change your clothes in 2016.”
“We’re really not interested in talking about timelines,” Levin says. “What we’re trying to do is make textiles for the next century. It’s not really a question of if they’re going to be (available) in a month, or a year.”
Looking to the future, sustainability is a major selling point for Bolt Threads: sugar, water, yeast, and salts are the primary foundation of its fibers, as opposed to the petroleum used for most synthetics. These more environmentally sensitive practices make Bolt Threads a natural fit for an eco-conscious brand like Patagonia—and vice versa.
“Brands, especially in the outdoor space, are very interested in new technologies that are much more sustainable than previous ones,” Powell says. “I think we’ll see more of this kind of thing happening over the next year or so.”
CLSI Launches Innovation Series with Reimbursement Panel at Verily
October 24, 2017
The California Life Sciences Institute has launched a new Innovation Series that will focus on issues most pressing for life science startups from the very early to more advanced stage of development. The inaugural session – Reimbursement 101 – took place on October 24 at Verily in South San Francisco and was sponsored by Verify and Hogan Lovells.
Moderated by Jessica Holmes, Executive Director of Reimbursement at Argenta Advisors, the panel explored how provider groups and payers use value in their analysis of what technologies to adopt. For entrepreneurs to succeed in making a difference in human health, they need to design a path forward that will lead to adoption of their technology, with pragmatic considerations at every step. Panelists included John Hernandez, Head of Health Economics and Outcomes Research at Verily Life Sciences, Jennifer Kurkjian, VP of Managed Care and Dignity Health, and Kelvin Lam, MD, Chief Medical Officer at Sutter Health Bay Area.
CLSI is planning additional panels in the Innovation Series for 2018, including a Reimbursement 201 panel. Please contact Lori Lindburg for additional information and sponsorship opportunities.
CLSI Participates in Antimicrobial Resistance Panel at the 2017 BIO Investor Forum
Heather Shane, Executive Director of the CLSI CARB-X accelerator, spoke at this year’s BIO Investor Forum in San Francisco at a panel on the Antimicrobial Resistance: New Research and Funding Opportunities. The panel sought to explore the growing threat of antimicrobial resistance (AMR), the economic challenges in developing these products, and the incentives proposed to address these issues, and included David Puerta, COO of “Powered by CARB-X” company Forge Therapeutics, Ted Schroeder, President and CEO of Zavante Therapeutics, Ciara Kennedy, President and CEO of Amplyx, and Shelley Chu, Partner at Abingworth. Gregory Frank, Director of Infectious Disease Policy at BIO, moderated the panel.
Ms. Shane discussed how CARB-X is attacking the challenge of AMR by providing nondilutive funding and targeted advisory support, through its accelerators, to selected companies who are doing innovative work in the space. On the topic of reimbursement models for AMR products, Ms. Shane noted that success in prevention and conservation efforts is at odds with the current reimbursement regime, which rewards antibiotic use, as opposed to availability and preservation of effective antibiotics. She highlighted the need for expanded push incentives to de-risk early-stage AMR R&D, such as academic/industry partnerships through which companies can get access to sophisticated tools and deep expertise that are otherwise not available to them.
Ms. Shane further explained the role accelerators play in developing the AMR community and corralling support for CARB-X projects and AMR innovation. “The key to accelerating innovation,” Shane stated, “is for support to be flexible and customized to the individual company’s needs based on its development stage and management team.”
FAST & Fellows Round Up
Read the latest in FAST and Fellows news:
- Current FAST Fall 2017 company Inflammatix, FAST Grads HepaTx (Spring 2017), X-Therma (Spring 2017), Empire Biotechnologies(Fall 2016), SciBac (Fall 2016), Eidos Therapeutics (Spring 2016), and Magnetic Insight (Spring 2015), presented at BIO Investor Forum in San Francisco.
- FAST Grad Eidos Therapeutics (Spring 2016) initiates Phase 1 trial of of AG10, an orally bioavailable, small molecule stabilizer of transthyretin (TTR) Read More
- FAST Grad Sandstone Diagnostics (Fall 2013) was featured in Newsweek on the problem of declining fertility and what the Trak Male Fertility Testing System is doing to reverse the trend Read More
- Fellows member Synergys Biotherapeutics announced Phase 1 SBIR grant award from NIH for vasculogenic mimicry-blocking antibody fusion products for triple negative breast cancer Read More
To learn more about the CLSA Fellows program – the significantly discounted membership for life science startups – click here.
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.
Read the latest of CARB-X:
- CARB-X awarded its 20th project yesterday, funding Amicrobe to develop a new bioengineered antimicrobial designed for direct application to contaminated and infected tissues Read More
- Powered By CARB-X company Microbiotix and the AMR Centre announce co-development agreement targeting drug resistant P.aeruginosa in critically ill pneumonia patients Read More
- Powered By CARB-X company Achaogen awarded up to $18 million contract by BARDA to support development of orally-administered antibacterial candidate C-Scape Read More
- Powered By CARB-X company Spero announces positive Phase 1 clinical data from their Potentiator Platform Read More
- Powered By CARB-X company Visterra Closes $46.7 Million Series Financing to Advance Pipeline of Precision Antibody-Based Biological Medicines Read More
- Powered By CARB-X company Entasis Receives Second CARB-X Award, Providing up to $10.1 Million for Development of Non-Beta-Lactam PBP Inhibitor Program Read More
- Powered By CARB-X company Antabio Raises € 7.3M Series A Financing to Develop Novel Treatments against Drug-Resistant Gram-negative infections Read More
- Powered By CARB-X company Forge & Evotec Expand Strategic Alliance With Launch of BLACKSMITH Platform to Discover Novel Metalloenzyme Inhibitors Across Broad Therapeutic Areas Read More
- Powered By CARB-X company Cidara Announces Pricing of $20M Private Placement of Common Stock Read More