CLSA Bulletin

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

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

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

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

MEMBER NEWS & PROFILES

MaxCyte and National Institute of Allergy and Infectious Diseases to Collaborate on Research for Ultra-Rare Disease Therapy
Researchers to explore the development of new therapies for X-linked chronic granulomatous disease (CGD) using MaxCyte’s gene-correction platform. | READ MORE »

Cloudian, ScaleMatrix and OnRamp BioInformatics Cut Storage Costs and Speed Human Genomic Data Analysis | READ MORE »

San Diego Union-Tribune: Life Scientists Share Connections and Innovative Ideas | READ MORE »

INSTITUTE
Spring 2017 FAST Closing Showcase Celebrates Seven
Companies 
| READ MORE »

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


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

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 »

JUNE 2017

ABOUT CLSA

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

Join CLSA

What Was Hot At BIO 2017 – Activity, Topics and Trends

16,123 attendees from 74 countries and 48 states, 1800 exhibitors, 800 speakers and 145+ presentations, and more than 41,000 partnering meetings – this is what BIO 2017 looked like last week in San Diego. Did you miss it? CLSA is happy to share an overview of what we saw, who we talked to, and what we can expect leading up to BIO 2018 in Boston next June.


CLSI Takes Center Stage

CA Pavilion - CLSI
Jeff Malin, Senior Business Development Specialist in GO-Biz CA Business Investment Services unit, greets International BioGENEius finalists at the CA Pavilion.

The California Life Sciences Institute (CLSI) hosted the International BioGENEius Challenge finalists, some of the country’s leading high school bioscience researchers, in a meeting with representatives of the California Governor’s Office of Business and Economic Development (GO-Biz) at the CA Pavilion.
CA Pavilion - CLSICLSI also assisted with the first BIO I-Corps Bio-Entrepreneurship Workshop featuring 25 early researchers from underrepresented groups from across the country who applied evidence-based entrepreneurship concepts via customer discovery interviews at the BIO 2017 exhibition. Peter M. Pellerito, BIO’s Senior Advisor for Federal/State Economic Development and University Relations (pictured), addressed the participants at the CA Pavilion reception and announced the new workforce development, diversity and inclusion (WDDI) principles adopted by BIO.

 

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

Finally, CARB-X – for which CLSI serves as the west-coast accelerator – was featured prominently in BIO 2017’s Infectious Disease track with speakers from BARDA and FDA, creating heightened awareness of the global threat of antimicrobial resistance (AMR).

CLSA, DLA Piper & HBA Recap Event

On June 28, CLSA hosted and broadcast three simultaneous California panels in conjunction with DLA Piper and the Healthcare Businesswomen’s Association (HBA) to summarize BIO 2017 and discuss the hot topics and emerging trends for the rest of this year and beyond.  Participants included:

San Francisco:

Joanne Duncan, Division President, BIO
Sara Radcliffe, President & CEO, California Life Sciences Association
Paul Hastings, CEO & Chairman, OncoMed Pharmaceuticals
Erica Pascal, Partner, DLA Piper, Intellectual Property & Technology
Shellie Williams, CEO, Artemis Staffing

Palo Alto:

Sarah Arth, Vice President of Education, BIO
Angele Maki, Director of Business Development, 23andMe
Neel Patel, Managing Director, inVentive Health Consulting, Commercial Strategy & Planning

San Diego:

Eric David, Chief Strategy Officer, Organovo
Chelsea Hewitt, Global Innovation, JLABS
Mandy Jackson, US West Coast Editor, Scrip Pharma Intelligence
Christina Waters, CEO, Rare Science

Here’s what they had to say:

BIO 2017 Overview

In San Francisco, Sara Radcliffe and Joanne Duncan gave a joint keynote addressing the state of the life sciences industry in California, as well as CLSA’s and BIO’s scope and priorities.  Within their panel, they spoke about increased interest in and concern for value, patient access, pricing, and commercialization, as well as reimbursement.  Paul Hastings noted that BIO 2017 put patients at the forefront, with 60+ patient advocacy organizations involved, a keynote address and book signing from Ann Romney related to her multiple sclerosis, and presentations that covered neurogenerative disease, infectious disease, rare and orphan diseases and others.

Hot Topics for 2017

Sarah Arth moderated the Palo Alto panel, who discussed hot topics at BIO 2017, predictions for 2018, and emerging trends.  Popular topics this year included:

  • The State of NIH Funding
  • Neuro-Degenerative Disease
  • The Trump Administration’s Effect on Trade
  • Digital Health & Big Data
  • Business Development & Finance Trends

Diversity was of particular interest to our participants, with multiple panel members remarking about the perceived increase in diversity at BIO 2017 – specifically that more women were visible in management positions and in partnering meetings.

Emerging Macro Trends

Neel Patel spoke about the fact that while 2015 is traditionally seen as a banner year for deals, his clients are seeing 2017 develop into the same robust environment.  Other macro trends they see:

  • Deal Volume: Large company deal volume is steadily decreasing, while funding for smaller companies is increasing.
  • Sellers’ Market: More buyers are looking to make deals and investors are investing more money, which means sellers have multiple options.
  • Factors Affecting Deals: External factors like US/EU policy, government change, ACA, pricing and tax policy scored lower with their clients than internal factors like cash value, debt or access to cash.
  • Outsourcing: Contract manufacturing is currently ~80% of outsourcing spend, contract research is ~55-60%, and commercialization is ~15% and growing.  They see commercialization as the fastest growing segment of outsourcing and anticipate it will eventually mirror contract manufacturing.

BIO 2018 – Boston, Massachusetts

After 2 years in California, the convention will move to Boston next June.  For 2018, our participants expect some carry over from BIO 2017 to drive these predicted areas of focus:

  • Diversity
  • US Policy, Tax Policy, and Climate Change
  • How Repatriation of Funds May Affect Mergers & Acquisitions
  • Cancer Immunology
  • CARB-X, Infectious & Neuro-Degenerative Diseases
  • Digital Health & Diagnostics

CLSA is already planning ahead for 2018.  If your organization is interested in participating in the BIO 2018 California Pavilion, contact us for more information.

CLSA Welcomes 25 New Members, BIO 2017, Roundtable with LA Mayor, Upcoming Open House and Pantheon 2017 Life Sciences Leadership Winners

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

June 29, 2017 

 

BIO2017-CAPavilionBIO 2017 – CLSA Success at the California Pavilion

As a regional host of BIO 2017 here in San Diego, the CLSA team was out in full force to welcome the life sciences community to our booth in the California Pavilion.  I hope you made it by to say hello!  It was a busy week, and our June spotlight provides an overview of the hot topics and macro trends noted by the team.  While at BIO, I enjoyed moderating an interactive drug pricing panel using a model developed by Celgene and introduced last December to our California delegation at CLSA’s Life Sciences Academy.  I also participated in a panel in the California Pavilion sponsored by the City of South San Francisco and moderated by City Manager Mike Futrell regarding how to create a Biotech-friendly city.  Other participants included California Assemblyman Kevin Mullin, South San Francisco Mayor Pradeep Gupta, Ph.D., and Nick Conley, Ph.D., CEO and Co-founder of EpiBiome.  Learn more here. The California Life Sciences Institute (CLSI) also hosted the International BioGENEius Challenge finalists in a meeting with California’s GoBiz, as well as the NSF I-Corps Bio-Entrepreneurship participants, who met with BIO’s Peter Pellerito, at the CA Pavilion.

 

CLSA Hosts Roundtable with LA Mayor to Support Life Sciences Growth in Region

CLSA Roundtable with LA Mayor

In 2016, CLSA expanded our presence in Los Angeles through strategic partnerships with LA Biomed and LabLaunch, and we remain committed to supporting and growing the Los Angeles life sciences community.

On June 13, we were pleased to host a roundtable discussion with Los Angeles Mayor Eric Garcetti focused on life sciences jobs, investment, and innovation.  CLSA Board Chairman Don Bobo from Edwards Lifesciences, as well as board members Wade Ackerman from Covington & Burling and Schlomo Melmed from Cedars-Sinai Health System, also participated in the discussion.  Learn more here.

 

My Los Angeles Daily News Op-Ed: State Must Keep The Life Sciences Healthy

LA Daily News

For generations, California has led the way in advancing innovations that drive the economy and create jobs. The Golden State plays key roles in developing therapies to extend life, reduce suffering and improve quality-of-life.  While California’s life sciences sector is doing well, there is always more that can be done. There are many unmet medical needs still to be addressed: cancer, Alzheimer’s, Parkinson’s, chronic pain, antibiotic resistance, rare diseases and more.

I recently penned an op-ed in the Los Angeles Daily News, calling attention to the great strengths of our sector as outlined in our 2017 California Life Sciences Industry Report. The piece also serves as a call to action to stakeholders and policymakers to continue nurturing the biomedical innovation ecosystem that has made the Golden State a life sciences powerhouse. Check out the op-ed here.

 

CLSA Celebrates Anniversary of CHI & BayBio Merge: A Collective 20-Year Legacy of Life Sciences Advocacy and Business Leadership

Legacy Lives On

In 2015, the California Healthcare Institute (CHI) and the Bay Area Biotechnology Association (BayBio) responded to the needs of our sector and the requests of their respective boards and merged to become the California Life Sciences Association (CLSA).  Since that merger, CLSA has become the strongest voice for life sciences in California, with five regional hubs in Sacramento, the Bay Area, Los Angeles, San Diego, and Washington, DC.  CLSA is proud to represent the interests of every life sciences organization in California through our local, state, and federal advocacy, our networking events, our publications and thought leadership, and through the Institute and our efforts to support innovation at every stage.

This summer, CLSA will celebrate the Anniversary of our CHI and BayBio merger with two jampacked Open House & Anniversary Celebrations in San Francisco and San Diego.  Join us for fun, networking, and these highlights:

  • Wine & Beer Tastings from Local Breweries & Wineries
  • Food Trucks & Gourmet Catering
  • Music/Local Bands
  • Power Purchasing Partner Programs
  • Photo Booths

If you haven’t been to a CLSA networking event yet, mark your calendars – these two events will fill up fast!

CLSA Open House SFOpen House & Anniversary Celebration
– San Francisco, July 26
250 E. Grand Avenue #26, South San Francisco, CA
Register Here

CLSA Open House SD
Open House & Anniversary Celebration
– San Diego, August 3
JLABS, 3210 Merryfield Road, San Diego, CA
Register Here

 

CLSA Welcomes 25 New Members

Please join me in welcoming the 25 new CLSA members who joined us in the last month:

Vir Biotechnology, Innovation Pathways, Kenjockety Biotechnology LLC, NeuroNascent Inc., Velox Biosystems, EAG Laboratories, Perfect Day, Combinati Inc., Carlsbad Technology, MatriSys Bioscience Inc., MedAborne Inc., Biocellection, Epalex Corporation, Corvus Pharmaceuticals, Encellin, Biotechnical Services Inc., Nvigen Inc., Sidecar Therapeutics, January Therapeutics Inc., Raydiant Oximetry Inc., BioSuperior Technology LLC, Evolve BioSystems, Vanguard Therapeutics Inc., AMMA Therapeutics Inc. and System1 Biosciences. 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 Events

Medtech conferenceEarly Bird Pricing Ends July 7 for the MedTech Conference
September 25-27 – 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.

Pantheon 2017
CLSA Announces Life Sciences Leadership Winners for Pantheon 2017
– November 10 in San Francisco!

Each year, CLSA brings together the life sciences community in California to recognizeBIO and celebrate those organizations and leaders who are advancing our sector with their fantastic work.  Last year more than 600 life sciences executives and leaders attended the event in San Francisco, and we are looking forward to a powerful program and a packed room again this year.  We are especially thrilled to announce that our Life Sciences Leadership awardees for 2017 are Jay Flatley, Executive Chairman, Illumina and John Martin, Executive Chairman, Gilead Sciences. Join us this year to support life sciences innovation and success in California.

Interested in becoming a sponsor or attending this year’s event?  Contact us for more information and learn more at www.clsapantheon.org

 

Regards,

Sara Radcliffe
President & CEO
California Life Sciences Association

PS – Have newsworthy items to submit for consideration for our monthly CLSA Bulletin? Feel free to send those tips to Elizabeth Gibson (EGibson@califesciences.org), Senior Director of Marketing.

 

 

CLSA Hosts Roundtable with Los Angeles Mayor Eric Garcetti

June 26, 2017

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

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

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

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

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

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

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

June 28, 2017

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

SB 17

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

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

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

SB 790

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

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

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

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

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

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

DC Congressional Briefing: Federal Investment in Biomedical Innovation

June 23, 2017

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

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

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

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

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

June 22, 2017

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

Independent Payment Advisory Board (IPAB)

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

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

Medical Device Tax

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

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

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

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

MaxCyte and National Institute of Allergy and Infectious Diseases to Collaborate on Research for Ultra-Rare Disease Therapy

–  Researchers to explore development of new therapies for X-linked chronic granulomatous disease (CGD) using MaxCyte’s gene-correction platform

MAXCYTE

Maryland, USA – 06 June 2017 – MaxCyte, Inc. today announces it has entered into a Cooperative Research and Development Agreement (“CRADA”) with the National Institutes of Health’s (“NIH”) National Institute of Allergy and Infectious Diseases (“NIAID”) to develop treatments for X-linked chronic granulomatous disease (“CGD”) using next-generation gene correction leveraging CRISPR/Cas9 and MaxCyte’s Flow Electroporation™ Platform.

 

CGD is an inherited genetic disorder that impairs the function of the immune system and leads to ongoing and severe bacterial infections. The disease affects approximately 1 in 250,000* people worldwide and is currently only treatable through high-risk treatments, such as allogeneic bone marrow transplantation.

 

NIAID will conduct pre-clinical research evaluating the effectiveness and safety of CRISPR-Cas9 gene editing on models of CGD by “correcting” the faulty gene that causes the disease. MaxCyte will supply mRNA molecules and focus on leveraging its Flow Electroporation™ Platform to develop robust and scalable processes that result in a clinically meaningful correction of mutated gene sequences.

 

Doug Doerfler, President & CEO of MaxCyte, said: “We are delighted to continue our collaboration with NIAID, one of the world’s leading infectious disease institutes, which is leveraging MaxCyte’s expertise in developing a new generation of genome editing therapy for CGD patients. We believe that this work will validate the use of our platform for developing gene-editing therapies via rapid, cost-effective manufacturing. This agreement, along with recent data announced from a research effort between MaxCyte and NHLBI of NIH in sickle cell disease, further demonstrates our commitment to deliver new therapies to patients where there is an extremely high unmet medical need.”

 

The MaxCyte/NIAID CRADA marks the latest step in the collaboration between the Company and the NIAID to advance new treatments for CGD, and reflects MaxCyte platform’s ability to be used in multiple fields of indication. MaxCyte received Maryland Stem Cell Research Fund grants in 2015 and 2017 to pursue its collaboration with the NIAID to develop preclinical processes and clinical-scale protocols for CGD and other rare diseases. MaxCyte also presented data generated in the collaboration at the 2015 American Society of Gene and Cell Therapy (ASGCT) annual meeting on the ability of genome editing in hematopoietic stem cells to restore oxidase activity. Earlier this year, MaxCyte shared data from the collaboration at the ASGCT’s annual meeting highlighting the achievement of therapeutic levels of gene correction in hematopoietic stem cells obtained from CGD patients.

 

References:

*MedScape

About MaxCyte

MaxCyte is a US-based global company dedicated to driving the acceleration of the discovery, development, manufacturing and commercialization of next-generation, cell-based medicines. The Company provides its patented, high-performance cell engineering platform to biopharmaceutical partners engaged in drug discovery and development, biomanufacturing, and cell therapy, including gene editing and immuno-oncology. With its robust delivery platform, MaxCyte’s team of scientific experts helps its partners to unlock their product potential and solve problems. This platform allows for the engineering of nearly all cell types, including human primary cells, with any molecule, at any scale. It also provides a high degree of consistency and minimal cell disturbance, thereby facilitating rapid, large-scale, clinical and commercial grade cell engineering in a non-viral system and with low-toxicity concerns. The Company’s cell-engineering platform is FDA-accredited, providing MaxCyte’s customers and partners with an established regulatory path to commercialize cell-based medicines.  MaxCyte is also developing CARMA, its proprietary, breakthrough platform in immuno-oncology, to rapidly manufacture CAR therapies for a broad range of cancer indications, including solid tumors where existing CAR-T approaches face significant challenges.   For more information, visit /

 

 

MaxCyte Inc.  +1 301 944 1660
Doug Doerfler, Chief Executive OfficerMadhusudan V. Peshwa, PhD, Chief Scientific Officer, Executive Vice President, Cellular Therapies

Ron Holtz, Chief Financial Officer

 US Media Contact                                          

PressComm PR, LLC

+1 410 299 3310jamielacey@presscommpr.com
Jamie Lacey-Moreira

Cloudian, ScaleMatrix and OnRamp BioInformatics Cut Storage Costs and Speed Human Genomic Data Analysis

July 18, 2017 by ScaleMatrix Marketing Team

The original press release can be viewed here

Life-sciences ecosystem cuts storage costs by 50 percent, reduces complexity and drastically speeds data analysis of DNA sequencing and interpretation

San Mateo, California – July 18, 2017 – Cloudian, Inc., a global leader in hybrid-cloud object storage systems, today announced it is working with ScaleMatrix and OnRamp BioInformatics to improve efficiencies of data analysis and storage for life sciences companies focused on human genomics.

ScaleMatrix, a hybrid-cloud services provider, operates a 14,000-square-foot life-sciences incubator that couples a CLIA-certified genomics laboratory with a state-of-the-art datacenter powering Cloudian object storage and OnRamp BioInformatics genomic analysis software. The incubator helps reduce the barriers to entry for early-stage companies in the fields of genomics, molecular diagnostics and bioinformatics. Using an on-site Illumina sequencer at the incubator, researchers and biologists can generate genomic data then use genomic software from OnRamp BioInformatics to rapidly process and interpret data in ScaleMatrix’s GPU-enabled high-density compute farm and efficiently store valuable insights and data to Cloudian object storage.

The Cloudian deployment enables researchers to store, tag, track and retrieve large amounts of data intelligently and cost-effectively, while the OnRamp BioInformatics software streamlines and simplifies genomic data analysis so that biologists, clinicians and drug developers can unlock valuable insights.

“Our cradle-to-grave experience helps break down major barriers in life sciences, which involve massive data storage and analysis requirements that often aren’t within reach of start-ups,” said Chris Orlando, co-founder of ScaleMatrix. “Cloudian’s petabyte-scalable storage is the ideal platform to quickly and cost-effectively accommodate the data volumes inherent in genomic research. OnRamp BioInformatics completes the solution with an intuitive user experience, workflow automation and comprehensive data and analysis tracking to increase storage efficiency and research productivity.”

By 2025, 40 exabytes of data will be generated annually by DNA sequencers as two billion genomes are sequenced. One human genome generates 250 gigabytes of raw data, which can expand by a factor of from three to five as it is processed by any of the 11,000 open-source applications currently available for genome analysis. This data creates incredible management challenges for the future of precision medicine. Cloudian scale-out storage allows labs to store information at 70 percent less cost than with traditional on-premises storage; it also eliminates the variable charges of public cloud storage.

“DNA sequencing is important for our future and for human longevity, but the cost of storing and analyzing genomic data is a significant hurdle,” said Tim Wesselman, CEO of OnRamp Bioinformatics. “Too often, storage costs and data analysis complexity become bottlenecks to scientific breakthroughs by obscuring insights or even by forcing researchers to delete data that may have real value. Unlike public cloud storage, Cloudian has no access charges and easily scales to genomic proportions, so researchers can stay within their budgets and retain the data they need.”

“Object storage is ideal for the scale and management of the large amounts of data produced in the life sciences, and particularly genomics,” said Michael Tso, CEO of Cloudian. “We’re helping power developments in human genomics that can ultimately lead to new discoveries in health, drug development and longevity.”

Media Inquiries

Cloudian@touchdownpr.com

Bio on the Bay with CLSA

Spring 2017 FAST Closing Showcase Celebrates Seven Companies

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

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

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

FALL 2017 FAST Applications Open

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

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

CARB-X Featured Prominently at BIO 2017

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

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

 

I-Corps Bio-Entrepreneurship Workshop Debuts at BIO 2017

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

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

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

BIO Adopts Principles on Workplace Development, Diversity and Inclusion

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

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

Read the CSU I-Corps press release here.

FAST & Fellows Round Up

Read the latest in FAST and Fellows news:

  • Medical device startup, Raydiant Oximetry Inc.(FAST Spring 2017) won first place at the 17th annual UC Davis Big Bang! Business Competition on Thursday, May 25 scoring a cash prize of $10,000! Read More
  • SyntheX(FAST Fall 2016) CEO, Maria Soloveychik is spotlighted in May SOSV. Maria has been fortunate to be surrounded by very strong women growing up who were a constant source of inspiration and support. SyntheX aims to “target the undruggable,” particularly cancers that are difficult to target. Read More
  • CEO of Shasqi (FAST Spring 2016), Jose Mejia Oneto, named one of “Seven Researchers … Changing the Face of Biotech” by San Francisco Business Times Read More
  • FAST Graduate GigaGen News
    • Grifols buys 44% stake in GigaGen for $35M Read More
    • GigaGen  CEO David Johnson talks with Dr. Moira Gunn on BioTech Nation about his company’s approach to achieving health with a compromised immune system. Listen on BioTech Nation Radio Podcast

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
MDMA
WVC West Coast

Premium Members

biomarincglifeDexcomEvaluateHorizonMedivationMoss AdamsVWR

Sustaining Members

AbbvieAgensysAlexandriaAllerganAmgenArcus BiosciencesArdelyxArmetheonastellasCedars SinaiCelgeneCity of HopeCodexisCymaBayCytomXDLA PiperDu PontEdwardsEYGenentechgenomic HealthGileadHogan LovellsJohnson & JohnsonJohnson & JohnsonKPMGLatham & WatkinsLeerinkMedtronicMerckNektarOncocyteOncoMedOrganovoPfizerProteuspwcSt. Jude MedicalStanford UniversitySutroTakedaTheravance BiopharmaUCSF