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CLSA Bulletin

ADVOCACY
Federal Update: Tax Reform & Impact on the Life Sciences Sector
Congress is currently advancing legislation in both chambers to significantly overhaul the U.S. tax code. Historically, CLSA has focused our tax-related advocacy efforts around…
State Releases Implementation Plan For Drug Price Reporting Law (SB 17)
Independent Payment Advisory Board (IPAB) Repeal Passes the House

Rezoning Proposal in South San Francisco’s Life Sciences Cluster
 | READ MORE »

MEMBER NEWS & PROFILES
Resourceful HR ranked #52 on PSBJ’s 100 Fastest-Growing Private Companies in Washington List
Resourceful HR ranked 52nd on the Puget Sound Business Journal’s (PSBJ) 2017 fastest-growing private companies list for Washington State… | READ MORE »
Riffyn Introduces First-of-Kind Scientific Development Environment to Address $100B of Lost Productivity in Scientific R&D | READ MORE »
The National Institutes of Health is Open for Business | READ MORE »
INSTITUTE
CLSI CARB-X Hosts Intensive Strategy Session for “Powered by CARB-X” Proteus IRC | READ MORE »
CLSI Participates in BARDA Industry Days and the One Nucleus Leadership Seminar – Addressing Infectious Disease Challenges | READ MORE »
FAST & Fellows Round-up November 2017 | READ MORE »

CARB-X Update November 2017| READ MORE »

NOVEMBER 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

CLSA 2018 Industry Report, 14th Annual Pantheon Awards, Upcoming Events, New Members and More!

RET

By: Sara Radcliffe
CLSA President & CEO

November 29, 2017 

 

 

New CLSA/PwC 2018 Life Sciences Industry Report Confirms California is #1 Leader in Life Sciences Innovation

On Nov. 15, CLSA and PwC unveiled the 2018 California Life Sciences Industry Report with a nationwide webinar and media launch. The 2018 report once again confirms that California continues to outpace other states in life science-related economic growth, including venture funding, National Institutes of Health (NIH) funding, digital health venture funding, and is producing nearly 300,000 jobs and shepherding more than a thousand new therapies through the pipeline. The report has garnered significant media attention so far, with articles published in the San Diego Union-Tribune, Los Angeles Business Journal, San Diego Business Journal and more. View the press release or download your copy of the report here.

 


Extraordinary Celebration of Life Sciences Excellence at the 14th Annual Pantheon DiNA™ Awards 

On Nov. 10, we brought together more than 600 professionals from California’s life sciences community for the Pantheon DiNA Awards at the Marriott Marquis in San Francisco, to celebrate the contributions and achievements of California’s leading life sciences innovators, and recognize the impact that California’s therapeutic, diagnostic, medical device, and biotechnology companies are making around the globe. Thank you to all our sponsors and attendees who made this event so successful!

 

Join CLSA’s Efforts to Repeal the Dangerous  Medical Device Tax on Innovation

CLSA is strongly opposed to the medical device tax because it harms job creation and impedes economic growth in California and deters innovation in new technologies that are so critically needed by patients. In recognition that the tax created devastating unintended consequences, Congress suspended the tax in 2015 – but only for two years. If Congress doesn’t act to repeal the tax by the end of the year, the tax goes back into effect in 2018.

Your voice is critical, and we need your help in urging Congress to repeal this tax for good. Click here to visit CLSA’s new digital action center to send a letter, tweet or call your member of Congress and tell them to finally eliminate the medical device tax.

 

CLSA Welcomes 17 New Members This Month!

Please join us in welcoming the 17 new CLSA members who joined us in the last month:  Alliance Forum Foundation, BioAmp Diagnostics, Bionano Genomics, Biospyder Technologies, C3Nano, Cutting Edge Solutions, Finless Foods, Fronthera US Pharmaceuticals, Full Spectrum Analytics, Hexagon, Humanigen, Prellis Biologics, Primmune Therapeutics, Public Library of Science, Rumi Scientific, The Scripps Research Institute and Zytogenex USA.  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 CARB-X Hosts Intensive Strategy Session For “Powered By CARB-X” Proteus IRC

Last month, the California Life Sciences Institute’s CARB-X team hosted Proteus IRC, a “Powered by CARB-X” company, for an intensive strategy session designed to help Proteus transition from a research consortium to a VC-backed entity. The three-day session drew 22 volunteer advisors from 20 different organizations across the U.S. who collectively donated over 230 hours to advising the Proteus team. Lynn Marks, MD, Senior R&D Advisor to BARDA and one of the members of the advisory group, noted that the experts around the table were “broad in skills, deep in level of expertise and highly engaged with free-flowing dialogue and excellent perspectives/advice.” For more information about CARB-X, contact Heather Shane, Executive Director of CLSI CARB-X, or visit CARB-X.

 

CLSI Advances CARB-X Mission

On Oct. 27, CLSI hosted national CARB-X Executive Director Kevin Outterson for a Bay Area meet and greet. With over 65 attendees, the event was described by one attendee as providing an “excellent collegial atmosphere with free sharing of ideas and advice.” CLSI CARB-X Executive Director, Heather Shane, presented on the CARB-X Model panel at BARDA Industry Days in Washington, D.C., on Nov. 8, and on Business Models of Infectious Diseases panel in Cambridge, UK, on Nov. 15.

 

Upcoming Events

FAST Closing Showcase & Reception
December 13 – San Francisco, CA

Nine FAST graduates from the Bay Area and Davis, CA, will present on their companies – the culmination of  twelve weeks of advising from an experienced team of industry experts at the Fall 2017 FAST Closing Showcase at UCSF Mission Bay on Dec. 13. For more information about FAST, contact FAST@califesciences.org.

DeviceTalks
December 11-12 – Costa Mesa, CA

Join us next month at DeviceTalks West in Costa Mesa, CA to gain powerful insight into the medtech community.  Register here to hear from some of the most influential leaders in the industry.

Redefining Early State Investments (RESI) Conference
January 9, 2018 – San Francisco, CA

Join us in the new year as we connect life sciences start-ups with active early-stage investors. For the past two years, RESI San Francisco reached capacity two weeks before the conference and had to close registrations, so sign up early! This conference offers early stage companies and investors an opportunity to get the most out of the wild JPM week. Register now to secure your partnering meetings with investors and strategic partners that are a fit.

 

Regards,

Sara Radcliffe
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.

Rezoning Proposal in South San Francisco’s Life Sciences Cluster

Nov. 25, 2017

In 2011, the City of South San Francisco approved a redevelopment plan for the Oyster Point area. The Oyster Point Specific Plan called for 81 acres east of Highway 101 to be developed with new life sciences companies, upgrades to the marina and a potential hotel.

In early 2017, the current developer attached to the project, Greenland USA, put forward an amendment to rezone a section that would allow for up to 1,200 residential units in lieu of research and development space. The City has since begun discussions regarding the first residential housing development directly within the life sciences cluster.

The City Council and City Planning Commission held a Joint Study Session in July to learn more about the concept. Several other commission hearings and public forums have also been organized. Currently, the City is in the midst of a Supplemental Environmental Impact Review (SEIR). Future meetings with final votes are expect in early 2018 before the City’s Planning Commission and City Council.

Residential housing has never been zoned in the East of Highway 101 region and it was not the intent of the original designers in 2011.

CLSA has spoken out in public hearings and in the community on the potential conflicting land use, residential neighboring manufacturing facilities, spot zoning, and increase traffic concerns. CLSA’s President and CEO Sara Radcliffe has also had comments on the issue in three recent publications, including the San Mateo Daily Journal,  San Francisco Business Times and the San Francisco Chronicle.

Given the increased need for affordable housing in the Bay Area, CLSA has regularly worked in coalitions to support the development of more housing throughout the region. However, CLSA has always supported the concept of more housing along transit corridors as the majority of regional planners do for the betterment of the Bay Area. Rezoning an area in the middle of the Life Sciences Cluster creates issues that must be considered and addressed.

For more information, please contact Reese Isbell, CLSA’s Director of Local Government and Community Relations (risbell@califesciences.org).

Federal Update: Tax Reform & Impact on the Life Sciences Sector

Nov. 28, 2017

Congress is currently advancing legislation in both chambers to significantly overhaul the U.S. tax code. Historically, CLSA (through our legacy organizations BayBio and CHI) has focused our tax-related advocacy efforts around: (1) calling for an update and making permanent of the R&D Tax Credit, (2) protecting the Orphan Drug Tax Credit (ODTC), and (3) opposing the creation of and later calling for a repeal of the medical device tax. To this end, below is a summary of activity in each chamber as of the publication of these materials:

  • House: On Nov. 16, the full House approved H.R. 1, the Tax Cuts and Jobs Act, by a vote of 227-205. All House Democrats voted against the bill, and were joined by 13 dissenting Republicans (including 3 California Republicans: Reps. Darrell Issa of San Diego, Tom McClintock of Roseville, and Dana Rohrabacher of Huntington Beach all voted no). With respect to the areas of priority advocacy for CLSA, the House bill protects the R&D tax credit, fully repeals the Orphan Drug Tax Credit, and does not address the medical device tax.
  • Senate: Also on Nov. 16, the Senate Finance Committee approved its version of tax reform by a party line vote of 14-12. The committee-passed bill similarly protects the R&D tax credit, and does not address the medical device tax. With respect to the Orphan Drug Tax Credit, however, the committee-passed bill includes a modified version of the Orphan Drug Tax Credit, which would allow a credit rate of 27.5% (reduced from 50%) and new reporting requirements.

Last month, CLSA cosigned a multi-state life sciences association letter in support of the ODTC, coordinated in collaboration with BIO’s Council for State Bioscience Associations (CSBA). Including CLSA, the letter was cosigned by 42 state and regional life sciences organizations. A copy of the CSBA letter is posted on our website here.

We continue to work with our broad membership, our national trade association partners, and other rare disease stakeholders to ensure that the Orphan Drug Tax Credit is protected in the final version of legislation passed by Congress.

CLSA also continues to urge that the final bill protect the R&D Tax Credit. CLSA also continues to urge Congress to act to repeal the medical device excise tax before the current reprieve expires at the end of this year. At the time these materials were prepared, the Senate Budget Committee is expected to mark up the Senate bill the week of Nov. 27, and then it will proceed to the Senate floor.

Questions? Please contact Adam Lotspike, CLSA’s Associate Director of Federal Government Relations (alotspike@califesciences.org).

Independent Payment Advisory Board (IPAB) Repeal Passes the House

Nov. 27, 2017

The Independent Payment Advisory Board (IPAB) is a controversial advisory board enacted as part of the Affordable Care Act in 2010, which threatens seniors’ care and could harm biomedical innovation by reducing incentives for investment in new research and product development. CLSA opposed the establishment of the IPAB since its inception and has called for its repeal ever since.

On Nov. 2, the House passed H.R. 849, the Protecting Seniors’ Access to Medicare Act, legislation to repeal the IPAB, by a vote of 307-111, with a total of 76 Democrats voting in favor of repeal. Click here to view CLSA’s press release applauding the House vote.

For the past few months, with all the discussion of healthcare reform at the top of legislators’ minds, CLSA’s DC office actively engaged members of the California Delegation offices to express our support for H.R. 849. Not only did CLSA issue a letter of endorsement of H.R. 849, we also joined over 760 other stakeholders to call for an immediate repeal of IPAB. This past April, an op-ed authored by CLSA’s President & CEO, Sara Radcliffe, was published by the San Jose Mercury News, urging repeal of IPAB.

The California Delegation overwhelmingly supported the measure, voting 30-20 for passage. Notably, the yea count included 17 Democrats from our delegation, representing almost 23% of the total number of Democrats who voted for the bill. We are proud to report that five out of our six freshman delegation members voted in support of the bill (Reps. Barragán, Carbajal, Correa, Gomez and Panetta). Three members of the delegation did not vote (Reps. Nunes, Peters and Speier). Rep. Scott Peters was unable to vote due to international travel on official business; he would have voted yes had he been present, and will be submitting a statement for the record indicating his views.

The bill now must be considered by the Senate for a vote, however, a schedule for action has not been announced.

On behalf of California’s life sciences innovators, a sector with over 3,000 firms employing nearly 300,000 people, California Life Sciences Association joins the rest of the biomedical innovation ecosystem in supporting the repeal of IPAB, which would have harmful and long-lasting effects on medical innovation. Visit CLSA’s Digital Action Center to send a letter to your Senator, urging repeal of IPAB. Questions? Please contact Adam Lotspike, CLSA’s Associate Director of Federal Government Relations (alotspike@califesciences.org).

State Releases Implementation Plan for Drug Price Reporting Law (SB 17)

Nov. 26, 2017

Shortly before Thanksgiving, California’s Office of Statewide Health Planning and Development (OSHPD) released its implementation plan for Senate Bill 17 (Hernandez). The bill was signed into law in October, and its advance notice provisions take effect on Jan. 1, 2018.

Under the law, manufacturers will be required 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.

OSHPD projects to have completed its registry of authorized recipients of the advance notice before Jan. 1, 2018, aiming to have a registration portal online by Dec.1.

CLSA and other industry partners, however, remain concerned regarding OSHPD’s standards for vetting whether the entities registering are valid recipients of the notice, as the pricing information is still considered incredibly sensitive across the industry. Any restrictions on recipients’ use of the information also remain unclear.

OSHPD has, furthermore, not yet provided any guidance as to how manufacturers should handle any price increases occurring less than 60 days after Jan. 1, 2018, which is the day on which the law is legally effective. The law states an intent not to hinder a manufacturer’s ability to price its product, suggesting manufacturers should not be expected to postpone any price increases to avoid being penalized under the law.

The quarterly reporting of manufacturers to OSHPD begins on Jan. 1, 2019. This reporting requires the drug’s manufacturer to submit a host of information on the drug and triggering price increase, 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. Information collection on triggering new prescription drugs will also begin in January of 2019.

OSHPD intends to commence a stakeholder process in January of 2018, which will inform its drafting of regulations to be effective Jan. 1, 2019. OSHPD, however, states that the “information reporting requirements and information collection format” will be released in the fourth quarter of 2018.

CLSA and our industry partners will continue to engage the state regarding SB 17 implementation. As we continue to analyze the potential impacts of implementation on our industry, any members who would like further information on SB 17 or any other new California laws are encouraged to reach out to Oliver Rocroi, CLSA’s Senior Director, State Government Relations (orocroi@califesciences.org) or Brett Johnson, CLSA’s Senior Director, Policy & Regulatory Affairs (bjohnson@califesciences.org).

Resourceful HR Ranked #52 on PSBJ’s 100 Fastest-Growing Private Companies in Washington List

By Laura Doehle

We are honored to announce that Resourceful HR ranked 52nd on the Puget Sound Business Journal’s (PSBJ) 2017 fastest-growing private companies list for Washington State, having made the list for the second year!

“Receiving this award for a second year represents not only dedication from our team, but also the strong commitment we share with our clients. Without their partnership, trust and collaboration, it wouldn’t be possible,” said Jennifer Olsen, CEO of Resourceful HR.

“We’re thankful to the Puget Sound Business Journal for the recognition and extend our congratulations to the other 99 companies on The List—we are privileged to be in such good company!”

The 100 companies being honored this year earned collective revenue of $4.89 billion, with a 140% increase in total revenue since 2014, according to the PSBJ. In addition to generating revenue, the 100 fastest-growing companies employ more than 36,000 people (21,800 in Washington State). This year other companies to receive the honor include Smartsheet, Oiselle Running, Inc., MOD Pizza, Glassbaby and HyGen Pharmaceuticals, Inc.

The annual PSBJ list ranks companies based on their growth over the past two years. To qualify for the list, a company must meet the following qualifications:

  • Be privately-held, with the headquarters located in Washington State
  • Recorded revenue of at least $500,000 in 2014, and
  • Demonstrated revenue growth through 2017

Again, we want to express appreciation to our client community for helping us reach this milestone: thank you!

Read the original article HERE.

Riffyn Introduces First-of-Kind Scientific Development Environment to Address $100B of Lost Productivity in Scientific R&D

Riffyn

Riffyn’s cloud-based R&D software connects previously siloed data to deliver reproducible science ready for machine learning

OAKLAND, Calif., Oct. 12, 2017 /PRNewswire/ — Riffyn, a global provider of R&D software, announced the release of its pioneering Scientific Development Environment (SDE). The Riffyn SDE is a cloud-based application designed to reduce experimental error and speed R&D in the biopharmaceutical, industrial biotech and food industries.

The Riffyn SDE empowers teams to design, execute, and share scientific experiments as visual, computable data sets for interactive analysis and machine learning. It reduces scientific data analysis timelines from weeks to minutes.

“Riffyn’s unique process-oriented architecture joins our experimental methods and results from collaborating teams on three continents, and aggregates it in real-time for structured data analysis. Riffyn data continuously feeds our data lake to support global R&D analytics,” said Søren Stenz Egestad, director of Scientific Data Management & Analysis at Novozymes. “We expect this setup to significantly reduce the time spent on basic data integration and manipulation—time that may be invested in further strengthening our ongoing research analytics.”

As scientific R&D grows more data intensive and more global, efforts are impeded by inaccessible datasets, excessive experimental noise, and constantly changing processes. The traditional data management approaches of Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELNs), and spreadsheet solutions have failed to address these problems. As a result, error rates in scientific R&D have escalated, costing more than $100 billion per year in lost productivity globally.

“Every day, extraordinary scientists around the world are impeded by cumbersome spreadsheets, inaccessible data stuck in ELNs, and excessive experimental noise,” said Dr. Timothy Gardner, CEO and founder of Riffyn. “Our ground-breaking SDE is a culmination of a 20-year scientific journey to address the problems of scientific data quality and analysis. We are gratified to see the transformative value it is delivering to our customers.”

About Riffyn
Riffyn delivers software and training to global R&D organizations to help them achieve more productive science. Its cloud-based Scientific Development Environment (SDE) integrates previously siloed experimental methods and data to resolve the root causes of error, deliver repeatable outcomes, and right-first-time technology scale-up. Riffyn was founded in 2014 with offices in Oakland, CA and Boston, MA. Visit: www.riffyn.com.

Media Relations
Katie Brashear
Allison+Partners
riffyn@allisonpr.com
(480) 330-0872

Read the original article HERE.

The National Institutes of Health is Open for Business

The National Institutes of Health (NIH) is the largest basic science research institute in the world. They are the epicenter for discoveries around the fundamental nature of living things. Their research protects and improves health. They develop drugs. Through their extramural program, they fund research around the world in the causes, diagnosis, prevention, and cure of human diseases; in the processes of human growth and development. With the largest number of hospital beds in the country, patients treated at the Clinical Center receive unique care, available nowhere else, at no cost.

All this is true. But, if this is all you know about NIH, then you don’t know NIH.

NIH’s more than 100 technology transfer professionals help their thousands of researchers – from basic to translational (and yes) to clinical – file patents on their discoveries so that the Bayh-Dole Act of 1980 can help move them towards the patient and – concurrently – towards the marketplace. It is well known that Bayh-Dole related to intellectual property directly resulting from federal government-funded research. It is well known that Bayh-Dole allows for a university, small business, or non-profit to obtain patent rights from such funding. It is not well known that NIH is part of this revolution.
Long thought of as the go-to place for academics to work with a thought-leader and publish in a top-tier journal, NIH’s technology transfer offices are establishing themselves as open for business – as one of the go-to places for the healthcare industry to work with a thought-leader, overcome a technology or knowledge gap, and get their products to market.

Translational and clinical innovators across 27 Institutes and Centers cover nearly every disease and disorder imaginable – and marketable. They develop drugs – as well as devices, diagnostics, wearable and digital health solutions, and software.
They are not merely the largest provider of direct support in the world – almost $30B this fiscal year.

They are the largest provider of in-kind support in the world. Research tools – mice, cell lines, antibodies – are provided at little or no cost. Their largest clinical center in the world? They work with companies to run dozens of clinical validation studies where each side pays its own way. When it comes to being competitive, there are thousands of technologies available for licensing that require little or no up-front equity. Their royalty rates compare favorably with the other world-renown places; as a federally funded agency, they seek fair market value – not maximum returns. An array of cooperative agreements is successfully executed at a rate of more than 10 a day.

Look again at their mission statement. Surprise: it includes accelerating and promoting economic development. That means working with companies to positively impact your chances as an equity investment, a M&A target, an active employer. They might not be the first place your company thinks of to bolster their pipeline or solve that development problem – but perhaps they should be.

CLSI CARB-X Hosts Intensive Strategy Session for “Powered by CARB-X” Proteus IRC

The CLSI CARB-X team – Heather Shane, Steve Karp, and Amy Xu – hosted Powered by CARB-X company, Proteus IRC, for an intensive strategy session designed to help Proteus transition from a research consortium to a VC-backed entity. The three-day session drew 22 volunteer advisors from 20 different organizations – from as far as Washington, DC – who collectively donated over 230 hours to advising the Proteus team, some for all three days.

Proteus IRC is an interdisciplinary research consortium based in Edinburgh, Scotland, and is the largest healthcare focused biophotonics project in the UK. The team consists of researchers who are developing novel technologies to image and sense within the human body with the goal of providing immediate ‘bedside’ detection of infections in patients in intensive care units.

CARB-X is funding the application of Proteus’ technology to a bronchoscopic sensing and imaging system capable of rapidly detecting the presence of harmful bacteria in the lungs. However, Proteus’ range of technologies – including highly flexible, disposable optical fibers, molecular optical sensing and imaging probes and single photon counting detectors – have numerous potential applications. Part of the purpose of the strategy session was to dive deeper into Proteus’ unique optical fiber technology and explore alternatives for its utilization. The discussions also included paths to commercialization of the fiber, as well as IP implications and resource needs.

Lynn Marks, MD, Senior R&D Advisor to BARDA and one of the members of the advisory group, noted that the experts around the table were “broad in skills, deep in level of expertise and highly engaged with free-flowing dialogue and excellent perspectives/advice”.  In addition to the rich and valuable discussions brought to the meeting table, the advisors and experts got to know the Proteus team, and each other, through informal networking during breaks and lunch.  David Davidovic, Founder of pathForward LLC and serial entrepreneur, who volunteered on two of the three days stated, “I thoroughly enjoyed the experience and felt quite invigorated. It was great to meet and hear so many brilliant and experienced minds”.

CLSI Participates in BARDA Industry Days and the One Nucleus Leadership Seminar – Addressing Infectious Disease Challenges

Heather Shane, Executive Director of the California Life Sciences Institute’s (CLSI) CARB-X Accelerator, spoke in November on two occasions about CARB-X and CLSI’s role in helping to move companies that are addressing the problem of Antimicrobial Resistance (AMR) through the product development pipeline. Her first appearance was at BARDA Industry Days in Washington, DC, where Ms. Shane spoke about “The CARB-X Model” on a panel that also included Tyler Merkeley, BARDA CARB-X Program Manager, Zachary Zimmerman, CEO of “Powered by CARB-X” company Forge Therapeutics, and John Mueller, Chief Development Officer of “Powered by CARB-X” company Entasis Therapeutics.

Ms. Shane discussed how the CLSI CARB-X accelerator model is flexible and customized to address the needs of each portfolio company based on its stage of development, individual circumstances, and management team. As with its very successful FAST Accelerator, CLSI provides this customized and swift support to portfolio companies in overcoming technical hurdles and business challenges through access to an extensive network of subject matter experts and resources. She also described the benefits of being a Powered by CARB-X company, which include non-dilutive funding, making companies more attractive to investors and downstream partners, validation of their technology, international press recognition, and being part of a global community focused on combatting AMR.

Subsequently, Ms. Shane appeared at One Nucleus’ Leadership Seminar on “Addressing Infectious Disease Challenges” in Chesterford Research Park, Cambridge, UK.  She spoke on the topic of “New Models to Incentivize and Support Early Stage R&D in the AMR Space” along with Peter Jackson, Executive Chairman of the AMR Centre, Alderley Park, UK. Ms. Shane provided background on the genesis of CARB-X, describing its unique structure, and CARB-X’s progress 15 months after its launch. She outlined the 22 projects in the portfolio, seven of which are developing novel classes of antibiotics. These companies are working on ten new targets and ten of the projects represent non-traditional approaches, including bifunctional immunotherapy, recombinant lysin proteins, antibody-drug conjugates and microbiome modulation. CARB-X has announced $60M in awards since launch, with an additional $75M committed if all future milestones are met.

As at BARDA Industry Days, Ms. Shane described the role of accelerators in providing access to a network of subject matter experts and resources within a decentralized framework. She discussed the ways in which CLSI is fueling the CARB-X pipeline by including prospective AMR companies in CLSI’s FAST accelerator program, and how the Institute is strengthening the AMR community by building support for CARB-X projects and AMR innovation.

FAST & Fellows Round Up

November 2017

Read the latest in FAST and Fellows news:

  • Encellin’s (FAST Spring 2017) insulin-releasing implant for Type-1 Diabetes featured on NPR Read More
  • LogicInk (FAST Spring 2017) announced their first product, LogicInk UV, an electronics-free temporary wearable powered by programmable ink Read More
  • Eidos Therapeutics (FAST Spring 2016) initiates Phase 1 trial of AG10, an orally bioavailable, small molecule stabilizer of transthyretin (TTR) Read More
  • EpiBiome (FAST Spring 2015) featured in The Economist on understanding how the microbiome is helping medicine Read More

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.

CARB-X Updates November 2017

  • Powered by CARB-X company Spero plans for $75M IPO for November 2nd (SPRO) Read More
  • Inhibrx Wins CARB-X Award of up to $6.0M to Accelerate Development of its Novel Antibody, INBRX-111, to Treat Pseudomonas Infections Read More
  • CARB-X backs Integrated Biotherapeutics to accelerate the development of a novel toxoid-based vaccine to prevent drug-resistant MRSA infections Read More
  • CARB-X awards up to $5.4M to Vedanta Biosciences to accelerate the development of a novel human microbiome-derived treatment for deadly C. difficile bacterial infections Read More
  • CARB-X awards Seres Therapeutics $2.5M and possibly $3.1M more to develop a microbiome therapeutic to prevent serious bacterial infections Read More

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