On Dec. 20, Congress passed a sweeping overhaul of the tax code in the form of H.R. 1, the Tax Cuts and Jobs Act. While CLSA did not take a position on the overall legislation, we worked in close collaboration and coordination with BIO and our CLSA member companies to ensure that the Orphan Drug Tax Credit – a meaningful incentive for investment in rare disease therapy innovation – was preserved in the final bill passed by Congress. | READ MORE »
Los Angeles Take Back Legislation Rises Anew In 2018 | READ MORE »
The guide is the perfect accessory for navigating around San Francisco and getting the most out of the week, with insights into JPM Week 2018 concurrent events including Biotech Showcase and RESI, and predictions and advice from JPM Week veterans for conquering healthcare investing’s most impactful week of the year | READ MORE »
Bio-Link Depot Grand Opening in Oakland| 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.
President’s Corner – 2017 Year in Review
By: Sara Radcliffe
CLSA President & CEO
December 21, 2017
The California Life Sciences Association (CLSA), along with the California Life Sciences Institute (CLSI), would like to thank everyone – members, board members, national organization partners, strategic partners, academic partners and the California life sciences community – for your membership, support and participation throughout the year. As 2017 draws to a close, we’d like to share key milestones we accomplished as your trade association representing California’s life sciences sector:
- We are so proud that CLSA significantly expanded our advocacy teams in Sacramento and Washington, D.C., with the additions of 3 directors and 2 associates, including a new alliance development position to drive allied stakeholder engagement.
- CLSA helped shepherd the passage of the FDA Reauthorization Act, legislation that renews the FDA’s authority to collect user fees, and makes critical improvements for the agency’s medical device and prescription drug review programs. This bill was signed into law by the President in August.
- CLSA launched our Digital Advocacy Center to help members contact their elected officials, stay informed about CLSA’s advocacy efforts, view priority legislation, and more.
- Governor Brown signed a CLSA-sponsored bill into law to protect diabetes patients from counterfeit or improperly stored diabetes test devices.
- CLSA also successfully led the effort to defeat a harmful bill that would have restricted the life sciences sector’s ability to provide continuing education to physicians and discuss the clinical benefits of medicines.
- CLSA drove support for House repeal of the Independent Payment Advisory Board (IPAB), a controversial board that could harm biomedical innovation by reducing incentives for investment in new research and product development. Next up… the U.S. Senate!
- CLSA hosted its annual one-of-a-kind Life Sciences Academy, educating 18 state legislators and staff on life sciences policy and business matters.
- CLSA reached over 3 million readers in leading publications with 10 op-eds focusing on pressing life sciences sector policy priorities.
- CLSA released our 2018 California Life Sciences Industry Report with PwC, showing that California continues to outpace other states in life science-related economic growth, and is producing nearly 300,000 jobs and shepherding more than a thousand new therapies through the pipeline.
- CLSA held a mayoral roundtable with Los Angeles Mayor Eric Garcetti where he met with members, heard perspectives from the life sciences industry, and discussed the growth of the life sciences sector in the City and region.
- CLSA spearheaded the fight on drug and take back measures through direct advocacy to counties throughout the state as CLSA further forged its one-of-a-kind local advocacy.
- CLSA aggressively grew our “Protect Access and Innovation” public affairs campaign, generating 980 letters sent to legislators and over 1.5 million ad impressions, regarding priority state and federal legislation of importance to the industry.
- CLSA expanded our membership by nearly 200 new members in 2017 and helped those members achieve more than $250M in savings through our partnership with BIO and our Power Purchasing program.
- CLSA launched a new State of the Industry series and hosted more than 6,000 life sciences professionals at 70+ events this year.
- More than 600 life sciences professionals joined CLSA for our 14th Annual Pantheon Awards in November, honoring John Martin of Gilead and Jay Flatley of Illumina for their outstanding achievements, and recognizing organizations throughout the state for their contribution to our innovative life sciences ecosystem.
- CLSI launched an Innovation Series and a new monthly newsletter – CLSI Connections – to keep members informed of trends, challenges and news relevant to life sciences innovation.
- CLSI’s Fellow All Star Team (FAST) Advisory Program and CARB-X accelerator programs expanded our startup services to even more companies across the state, country and globe:
- 50 FAST graduates collectively raised over $317 million, 15 have Series A investments, 14 companies are generating revenue, 3 have successfully exited, and 9 have formed strategic partnerships.
- After a full year of operation and over 350 applications, CARB-X granted a total of $60M in nondilutive funding awards to 23 companies, with up to an additional $75.25M in awards if project milestones are met.
- CLSI’s STEM efforts celebrated some of the region’s most remarkable students during the Amgen Bay Area BioGENEius Challenge, connected thousands of students to industry professionals, created access to career pathways and industry-relevant experience for increasing numbers of underrepresented students, inspired young females of color to pursue science careers, and awarded $60,000 in science grants to “Giants of Science” Bay Area high schools.
- Due to significant expansion in 2017, we have outgrown our Bay Area office. After many good years in our E. Grand Avenue home, the Bay Area team is very excited to announce that we will start the New Year by moving to another South San Francisco location – a brand new, state-of-the-art office space just around the corner. Stay tuned for our new address and more information in the January Bulletin!
It has certainly been an exciting year, and we look forward in 2018 to supporting every organization here in California that contributes to our world-leading life sciences ecosystem.
President & Chief Executive Officer
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.
Congress Passes Tax Reform Legislation, Protecting Critical Orphan, R&D Tax Credits
Dec. 20, 2017
On Dec. 20, Congress passed a sweeping overhaul of the tax code in the form of H.R. 1, the Tax Cuts and Jobs Act. While CLSA did not take a position on the overall legislation, we did work in close collaboration and coordination with BIO and our CLSA member companies to ensure that the Orphan Drug Tax Credit – a meaningful incentive for investment in rare disease therapy innovation – was preserved in the final bill passed by Congress.
The California Congressional Delegation overwhelmingly opposed H.R. 1 when it was brought to the full House and Senate for a vote. In the House, the measures passed by a vote of 224 to 201. All present California Democrats voted against the bill (38 voted no, and Rep. Grace Napolitano (D-El Monte) did not vote) with 2 Republicans, Reps. Darrell Issa (R-Vista) and Dana Rohrabacher (R-Huntington Beach), also voting against the bill. Overall, 12 House Republicans opposed the measure, including the aforementioned 2 from California. No House Democrats voted for the bill. In the Senate, H.R. 1 passed by a vote of 51 to 48. The vote fell along party lines, with all Republicans voting for the measure, and all Democrats voting against it. Both of California’s senators – Sens. Dianne Feinstein (D) and Kamala Harris (D) – opposed the measure. (Sen. John McCain (R-Ariz.) did not vote.)
The bill now goes to the President’s desk for signature, where it is expected to be signed into law before the end of the year.
By way of background, in November, both the House and Senate passed their respective versions of H.R. 1. Notably, the House-passed bill eliminated the Orphan Drug Tax Credit (ODTC). By contrast, the Senate-passed bill retained the ODTC, but at a significantly reduced rate of 27.5% in order to meet the revenue targets necessary to pass comprehensive tax reform. (Note: Section 45C of the Internal Revenue Code currently provides eligible drugmakers a tax credit of 50% of the qualified clinical testing expenses incurred in a taxable year with respect to drugs designated as “orphan drugs” by the FDA.) Neither bill addressed the medical device tax, and both bills retained the R&D tax credit.
Over the past several months, CLSA has advocated vociferously for the Orphan Drug Tax Credit to be retained in the reformed tax code. Most recently, we sent a letter to the only conference committee member from California, Rep. Devin Nunes (R-Visalia), urging that he support the protection of the ODTC in the Conference Report. A copy of the letter we sent to him can be viewed here. CLSA also coordinated a California company sign-on letter to House Majority Leader Kevin McCarthy (R-Bakersfield) urging that the ODTC be included in the final tax reform package. Cosigned by 21 California companies invested in rare disease therapy innovation, a copy of that letter can be viewed here. We are pleased to see that our advocacy and engagement helped ensure the inclusion of a meaningful Orphan Drug Credit in the conference package. Click here to view the legislation.
It is worth noting that the R&D Tax Credit remains intact and was not altered by H.R. 1. Another tax-related provision of interest, the medical device excise tax, was not addressed in H.R. 1. Click here for an update on our efforts to repeal the medical device tax.
Questions? Please contact Jenny Carey, CLSA’s Vice President of Federal Government Relations & Alliance Development (email@example.com).
CLSA Urging Congress to Repeal Medical Device Tax by Year’s End
Dec. 19, 2017
We are pleased to share that on Dec. 18, The Orange County Register published an op-ed from CLSA President & CEO Sara Radcliffe and CLSA Board Chairman Don Bobo (Corporate VP, Strategy & Corporate Development of Edwards Lifesciences), on the need for Congress to repeal the medical device tax. You can view the piece via the CLSA website, OC Register or on Twitter.
This month, Reps. Erik Paulsen (R-Minn.) and Jackie Walorski (R-Ind.) and House Ways & Means Committee Chairman Brady (R-Texas) introduced new legislation to provide a 5-year suspension of the medical device excise tax (H.R. 4617). The current suspension of the 2.3% medical device excise tax expires Dec. 31, 2017, and has not been addressed this year due to healthcare and tax reform packages taking all of the oxygen out of the room.
CLSA, along with our national medtech trade association partners AdvaMed and MDMA, remain committed to a full and permanent repeal of the medical device tax. This bill provides an immediate and long-term reprieve of the tax (which is otherwise set to reactivate in the new year), offering an important intermediary step toward full repeal. CLSA issued a statement on the release of H.R. 4617, supporting the bill and urging swift action before the end of the year. The full statement is available here.
We are hopeful the bill will be advanced prior to year’s end, potentially as part of a government funding bill or Continuing Resolution. CLSA continues to urge our delegation to act on at least a long-term suspension (if not full repeal) before year’s end. Our understanding is that House Leadership has indicated a commitment to address the tax in January, even though they are aware of the significant burden that will be placed on companies having to pay the tax in the interim (the tax will reactivate effective Jan. 1, 2018 and will be paid every two weeks by affected companies). We continue to press on our House delegation members for more urgent action, and at a minimum are asking members to urge leadership to make a public commitment that the tax will be addressed as soon as possible.
Click here to visit CLSA’s Digital Action Center to urge your member of Congress to scrap the medical device tax on innovation. Questions? Please contact Adam Lotspike, CLSA’s Associate Director of Federal Government Relations (firstname.lastname@example.org).
CLSA Hosts End of Year Reception in DC, Celebrating Achievements in Life Sciences
Dec. 16, 2017
On Dec. 6, CLSA hosted our annual End of Year Reception on Capitol Hill in Washington, DC. Over 150 guests attended the reception, including California Reps. Tony Cárdenas (D- San Fernando Valley), Jimmy Panetta (D-Monterey), Jackie Speier (D-South San Francisco), and David Valadao (R-Hanford), and staff from more than half of our California congressional delegation’s offices.
CLSA would like to extend a heartfelt thank you to our sponsors for the generous support and making this event possible again this year:
Abbott, AbbVie, Amgen, Astellas, BioMarin, Celgene, Edwards Lifesciences, EMD Serono, Genentech, Gilead, Hogan Lovells, Horizon Pharma, McDermott+Consulting, Medtronic, Merck, Organogenesis, Retrophin, Shire, Vertex, VWR, W Strategies and BIO.
Click here to view more photos from the event.
Questions? Please contact Jenny Carey, CLSA’s Vice President of Federal Government Relations and Alliance Development (email@example.com).
PhRMA Files Suit to Stop SB 17, New California Reporting Burdens Law
Dec. 15, 2017
On Dec. 8, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the United States District Court for the Eastern District of California, seeking to have Senate Bill (SB) 17’s manufacturer reporting requirements declared unconstitutional and void.
Under SB 17, 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 (PBMs) if that drug’s price has increased 16 percent or more cumulatively over the previous two calendar years, including the current year’s increase.
California’s Office of Statewide Health Planning and Development (OSHPD) recently released its implementation plan for Senate Bill 17 (Hernandez), and the law’s advance notice provisions are set to take effect on January 1, 2018. Additional quarterly reporting by manufacturers to OSHPD would begin on January 1, 2019.
With the lawsuit, PhRMA seeks a permanent injunction from the Court to prevent the State from implementing or enforcing the law’s requirements related to manufacturer reporting and notices.
PhRMA’s complaint in the case states three central claims. First, SB 17 violates the Commerce Clause, which prohibits California from regulating out-of-state drug pricing. Second, it also violates the First Amendment by “compelling speech by manufacturers justifying their price changes.” Finally, it violates the Fourteenth Amendment’s due process clause on account of unconstitutionally vague language. A copy of the Complaint is available here.
Much of the attention has been paid to the alleged violations of the Commerce Clause, which generally has been interpreted by the United States Supreme Court to prohibit direct regulation of interstate commerce by a state. Thus, a central issue for the Court in the case going forward will be whether a 60-day advance notice of a change in a national list price is direct or incidental regulation of interstate commerce. PhRMA’s complaint argues it is direct regulation because, among other things, the notice effectively “imposes a 60-day nationwide ban on price increases,” which is analogous to other laws previously struck down by the Supreme Court.
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 (firstname.lastname@example.org) or Brett Johnson, CLSA’s Senior Director, Policy & Regulatory Affairs (email@example.com).
Los Angeles Take Back Legislation Rises Anew in 2018
Dec. 14, 2017
After a relatively quiet year in the County of Los Angeles regarding proposed take back legislation, activity has begun to percolate this month. In December, the expected leadership change from Supervisor Mark Ridley-Thomas to Supervisor Sheila Kuehl as President of the Board for 2018 took place which foreshadows a potentially more aggressive Board in putting the issue on the County’s agenda.
The County Public Health Department released a report in mid-December evaluating the potential take back ordinance. The document gives an overview of the policy proposed, the status and implementation of other local ordinances over the last several years, comments from outside technical experts, concerns with the May 2017 California State Auditor’s Report, and recommendations to move forward with the ordinance.
This report has been sent to each of the Supervisors. While it is currently not on the agenda for any upcoming Board hearings, we do expect newly installed President Sheila Kuehl to move quickly on the item. There is also expectation the County’s EPR Working Group, which previously handled all items related to the legislation, will contact the stakeholders again soon as the County prepares its next steps forward in the new year.
CLSA has been at the forefront of this issue in Los Angeles ever since the County’s early stakeholder meetings held in 2015. CLSA has continued its coalition work with national organizations to collectively organize around the ongoing legislative, political, educational, and other activities on take back in Los Angeles. The coalition meets weekly to share information, discuss strategy, and consider industry comments. Throughout 2017, while the legislation was not directly before the Board, the coalition has worked on opportunities for further educational outreach to the Members, the larger community, and through organizing take back events to show that the legislation is not necessary.
For more information on the proposed legislation, CLSA’s on-the-ground initiatives in Los Angeles, the coalition’s plans, or any questions, please contact Reese Isbell, CLSA’s Director of Local Government and Community Relations (firstname.lastname@example.org).
CLSA Hosts Congressional Briefing, Publishes Report to Raise Awareness of IBD
Dec. 13, 2017
During Crohn’s and Colitis Awareness Week – recognized annually in the U.S. between Dec. 1-7, CLSA hosted a congressional briefing on Dec. 6, in collaboration with Takeda Pharmaceuticals USA, on “Enhancing Patient Access to Therapies for Inflammatory Bowel Disease (IBD).”
More than 3 million Americans suffer from Inflammatory Bowel Disease (IBD),an umbrella term for two distinct conditions – Crohn’s disease and ulcerative colitis – both characterized by chronic inflammation of the gastrointestinal tract. IBD can significantly affect a patient’s quality of life and may impose tremendous public health burdens, including economic costs. There is currently no cure for IBD, and patients require chronic, long-term treatment. Major scientific advances within the fields of genetics, immunology, and microbiology have led to a greater understanding of the underlying mechanisms involved in IBD and an increase in the number of treatment options available for IBD patients.
CLSA’s informational briefing was an opportunity to for Members of Congress, their staff, and other stakeholders to hear from the patient’s perspective (Kate Detwiler – IBD Patient), issues that clinicians face in treating patients (Dr. Michael Weinstein – Gastroenterologist), and how Congress can help to improve access to necessary treatments (Laura Wingate – Crohn’s & Colitis Foundation, and Uthra Sundaram – Takeda Pharmaceuticals USA). The briefing also featured remarks from Reps. Raul Ruiz, MD (D-Palm Desert) and Brad Wenstrup, MD (R-Ohio), who serve as cosponsors of H.R. 2077, Restoring the Patients’ Voice Act, and from Rep. Ryan Costello (R-Pennsylvania), co-chair of the Crohn’s & Colitis Caucus.
To learn more about IBD and how Congress can help ensure patients receive access to necessary therapies, please check out our latest educational brochure, “Understanding IBD.” Questions? Please contact Adam Lotspike, CLSA’s Associate Director of Federal Government Relations (email@example.com).
Your Free Guide to Surviving JPM San Francisco 2018
By Erin Righetti
Your free copy of the J.P. Morgan Conference 2018 Survival Guide
The teeming influx of life science industry folk in San Francisco during the second week of January represents the zenith of the 36th annual J.P. Morgan Healthcare Conference pilgrimage. Concurrent events add to the draw for the who’s who of life science investing, from industry leaders and emerging fast-growth companies, to investors, innovative technology creators and biotech. For those well versed in the conference circuit, you’ll recognize the madness as just par for the course during JPM Week.
And man, is it hopping! I have never been so simultaneously energized and exhausted than during JPM Week. From the moment you arrive in the city, you’ll experience morning to evening activity. From keynote speeches with luminaries like Joe Biden, to panels and partnering meetings with pharma CEOs, to hundreds of parties ranging from circus performers to whiskey tastings, the best way to prepare is with the J.P. Morgan Conference 2018 Survival Guide.
The guide is the perfect accessory for navigating around San Francisco and getting the most out of the week, with insights into JPM Week 2018 concurrent events including Biotech Showcase and RESI, and predictions and advice from JPM Week veterans for conquering healthcare investing’s most impactful week of the year.
The guide is the perfect accessory for navigating around San Francisco and getting the most out of the week, with insights into JPM Week 2018 concurrent events including Biotech Showcase and RESI, and predictions and advice from JPM Week veterans for conquering healthcare investing’s most impactful week of the year.
There are lots of guides out there, and even a few for purchase. But the free J.P. Morgan Conference 2018 Survival Guide will demystify the week and help you turn the chaos into opportunities for successful networking. The guide features:
- Listing of the week’s conference landscape with maps
- Hot new restaurants where you might actually get a table
- Other local events and sightseeing
- Most accessible coffee spots
- Libations, entertainment options, and much more.
I recommend downloading a copy of the J.P. Morgan Conference 2018 Survival Guide to kick-start your game plan for JPM San Francisco 2018.
Fitbit Selected for National Institutes of Health (NIH) Precision Medicine Research Program with The Scripps Research Institute (TSRI)
November 07, 2017
By Jen Ralls
10,000 Fitbit devices to be used for research in national program
SAN FRANCISCO–(BUSINESS WIRE)– Fitbit (NYSE:FIT), the leading global wearables brand, announced today it has been selected as the first wearable for use in the national All of Us Research Program established by the White House in 2015. This project is funded by a supplement to a funding award from the National Institutes of Health (NIH) to The Scripps Research Institute (TSRI).
All of Us seeks to enroll one million or more participants to accelerate research that may improve the ability to prevent and treat disease based on individual characteristics. Researchers will use data gathered from the program to learn more about how individual differences in lifestyle, environment and biological makeup can influence health and disease.
As a subset of the All of Us Research Program, the Scripps Translational Science Institute (STSI) leads The Participant Center, a unit tasked with enrolling and engaging diverse populations across the country. Through this network, STSI will provide up to 10,000 Fitbit Charge 2™ and Fitbit Alta HR™ devices to a representative sample of All of Us volunteers for a one-year study. At the end of the study, the researchers will provide recommendations on how the devices could be more broadly incorporated into the All of UsResearch Program.
Additionally, the study will generate a data set that presents a unique opportunity to explore the relationship between health indicators such as physical activity, heart rate and sleep in conjunction with other critical health outcomes that will be captured as part of All of Us.
“As part of the global shift towards precision medicine, wearable data has the potential to inform highly personalized healthcare,” said Adam Pellegrini, General Manager of Fitbit Health Solutions. “Through this historic initiative, we will be able to see the role that Fitbit data can play on the path to better understanding how individualization can help to prevent and treat disease.”
Features of Fitbit Devices Are Vitally Important for Researchers
After evaluating consumer wearables in the market, the STSI team selected Fitbit based on its review of peer-reviewed validation studies and the fact that Fitbit devices are the most popular wearables in health research worldwide.
“The Fitbit devices selected track a combination of physical activity, sleep, and heart rate parameters,” said Eric Topol, Founder and Director of STSI. “The popularity of Fitbit devices among millions of Americans, combined with their ease of use, including multi-day battery life and broad compatibility with smartphones, made Fitbit a natural choice for this pilot program.”
An analysis1 published by the Federation of American Societies for Experimental Biology (FASEB) Journal found that Fitbit devices are the most commonly used tracker in biomedical research, including published work (89%), clinical trials (83%), and NIH-funded research (95%). To-date, more than 470 published studies2 have utilized a Fitbit device, which is more than any other consumer wearable brand3, including use of wearables in areas such as diabetes, cardiovascular health, oncology, mental health and post-surgery.
“Most of what researchers know is based on intermittent snapshots of health in an artificial setting or based on personal recall,” saidSteven Steinhubl, MD, Cardiologist and Director of Digital Medicine at STSI. “Through this research program, we’ll have access to comprehensive activity, heart rate and sleep data that may help us better understand the relationship between lifestyle behaviors and health outcomes and what that means for patients on an individualized basis.”
About Fitbit, Inc. (NYSE:FIT)
Fitbit helps people lead healthier, more active lives by empowering them with data, inspiration and guidance to reach their goals. As the leading global wearables brand, Fitbit designs products and experiences that track and provide motivation for everyday health and fitness. Fitbit’s diverse line of innovative and popular products includes Fitbit Surge®, Fitbit Blaze®, Fitbit Charge 2®, Alta HR™, Alta®, Fitbit Flex 2®, Fitbit One® and Fitbit Zip® activity trackers, as well as the Fitbit Ionic™ smartwatch, Fitbit Flyer™ wireless headphones and Fitbit Aria® and Fitbit Aria 2™ Wi-Fi Smart Scales. Fitbit products are carried in 46,000 retail stores across 78 countries around the globe. Powered by one of the world’s largest social fitness networks and databases of health and fitness data, the Fitbit platform delivers personalized experiences, insights and guidance through leading software and interactive tools, including the Fitbit and Fitbit Coach apps, Guided Health Programs, and the Fitbit OS for smartwatches. Fitbit Health Solutions develops health and wellness solutions designed to help increase engagement, improve health outcomes, and drive a positive return for employers, health plans and health systems.
Fitbit and the Fitbit logo are trademarks or registered trademarks of Fitbit, Inc. in the U.S. and other countries. Additional Fitbittrademarks can be found at www.fitbit.com/legal/trademark-list. Third-party trademarks are the property of their respective owners.
All of Us is a service mark of the U.S. Department of Health and Human Services.
Source: Fitbit, Inc.
Security Of Patient Data During Research and Pilots Programs
December 1, 2017
By Paola Bonilla
The option that patients have right now about participating in research or a pilot program sending health Information remotely to HealthCare Institutions, Providers, Payers and Pharma has shown tremendous benefits in improving patient treatments, including medication. But the more remotely devices usability to send health or medical data, the more vulnerabilities in the management, visualization and storage of that data.
Digital companies working on behalf of those Health Institutions have to be in compliance with HIPAA law and have to adopt best practices handling Protected Health Information and Personal Health Information.
Here are some guidelines provided by Wilson Jaramillo, VP of engineering and technology at esvyda Inc.:
Several challenges have to be faced while adoption of security strategies:
- Maintenance of software performance
- Management of data registries
- Management of security vs. latency of processes
- Security of data vs. execution time, while ensuring systems do not collapse
- Multithread administration to optimize hardware usage and provide traceability of every transaction done that involves data synchronization with mobile applications or third party systems.
- Disaster recovery policies that allow to keep a secure backup of the data in different locations along with standby instances of the databases that increase the availability of the data if something happens or any maintenance is being done
- Monitoring of user activities inside the application system, follow architectures like actor, action done, data modified, source of modification done, geolocation.
Combined strategies may improve security. Those may include but are not limited to: Encryption, Hardware Security Modules (HSM), Decrypted keys during a limited user session (validation without compromising security). Strategies to detect weird behaviors of user accesing data from other devices different from those usually used by him.
Among other strategies, the use of standards and security policies with internal control of the company may allow the correct adoption of the tools that maintain secure data, including systems that monitor the user activities, performance of the Operating System, and correct performance of data base, integrity of cache, load balancers, data base cluster sync and Firewall with real-time feedback of application software usage.
The encryption of data is also a good strategy. The implementation of AES 256 to encrypt data at rest with initilization vectores, store the decryption keys encrypted, usage of a master decryption key inside an HMS system which is independent of application software, generate a different encryption key for every patient and for every kind of data, avoiding dictionary attacks that facilitate the easy decryption beyond a database register, because the computational effort would be high. It is very important the communication of data transmitted between networks, using secure protocols and implementing strategies to avoid atatcks like the man in the middle. Protecting software deployment and data base to isolate the enviroment to only be accesible to authorized people and by the authorized applications using HTTPS implementations. To encrypt data at rest, access to the end user application always over HTTPS.
2017 Year in Review: Poised for Growth & Success
The California Life Sciences Institute (CLSI) is wrapping up another year on a high note, and would like to express our sincere gratitude to the outstanding companies, volunteers, students, educators, partners, sponsors and others who have joined us to further bolster our thriving California life sciences ecosystem.
During 2017, CLSI ‘s FAST and CARB-X accelerator programs allowed us to expand our startup services to even more companies across the state, country and globe. Our education programs celebrated some of the region’s most remarkable students, while continuing to create access to career pathways and industry-relevant experience for increasing numbers of students from underrepresented groups. And life science professionals built new management and other skills through CLSI’s multiple career development offerings.
Below are a few highlights from 2017.
- Quick Statistics:
- CLSI served a record 17 startups from the Bay Area and Davis, nine of whom presented their companies at a packed FAST Showcase on December 13.
- CLSI’s 50 FAST graduates have collectively raised over $317 million; and 15 with Series A investments.
- Fourteen companies are generating revenue, three have successfully exited, and nine have formed strategic partnerships.
- Over 240 new jobs have been created by FAST companies.
- Drawing from a generous advisory pool of over 250 professionals, FAST companies receive an estimated $25K in advisory services during the FAST program, with many continuing their advisory relationships well beyond FAST.
- Many FAST graduates have stayed in touch with the program, some serving on advisory teams, some providing best practice advice to new FAST companies in “pass-the-torch sessions”, and a few offering valuable FAST “Retrospectives” at the Closing Showcases.
- Earlier this fall, CLSI joined forces with the SENS Research Foundation (SRF) to launch the first “Rejuvenation Biotechnology Showcase” at the UCSF Mission Bay Conference Center with over 100 persons in attendance. The evening included presentations from four FAST companies as well as a snapshot of technologies at SRF that hold promise for addressing age-related disease. SRF and CLSI plan to seize on the significant interest generated in this launch event to embark on additional collaborations in 2018 designed to highlight innovation in the rejuvenation biology field
- Based on increasing demand in Southern California, CLSI is actively raising funds to expand FAST to San Diego in Fall of 2018.
After a full year of operation that included relationship-building, networking, discovering resources, making connections, participating in conference panel discussions, and providing substantive advisory services, CLSI and partners have launched a successful international CARB-X program. Since the beginning of its partnership with CARB-X, CLSI has created a diverse set of models to provide accelerator support for companies developing products to prevent, diagnose or treat serious bacterial infections.
- Quick Statistics:
- With over 350 applications, CARB-X has granted a total of $60M in nondilutive funding awards to 23 companies, with up to an additional $75.25M in awards if project milestones are met.
- CLSI has recruited over 75 remarkable advisors who have volunteered more than 575 hours, valued at over $171K of in-kind services to “Powered by CARB-X” companies, CARB-X applicants as well as future CARB-X prospects.
- In a stellar model of advisory services for Powered by CARB-X companies, CLSI hosted a three-day strategy session for Proteus IRC from Edinburgh, which drew 22 volunteer advisors to help the Proteus team plan the transition from a research consortium to a privately funded corporate entity.
- CLSI assisted with CARB-X pipeline development by creating a “CARB-X Track” within the FAST Program, including at least one company in the antimicrobial resistance (AMR) space in each cohort. Facile Therapeutics, BioAmp Diagnostics, and Inflammatix all have graduated from FAST’s CARB-X Track.
- CLSI helped to build the AMR community in a series of events this year:
- CLSI hosted an informational event at BioLabs San Diego in July, bringing together the local AMR community to hear from two San Diego-based CARB-X funded companies, Forge Therapeuticsand Cidara Therapeutics. (As testament to the vibrant AMR community in San Diego, two more San Diego-based companies joined the portfolio this Fall: InhibRx and Amicrobe)
- Earlier this fall, CLSI hosted Kevin Outterson at a networking event with local Bay Area therapeutics and diagnostics companies who were eager to meet the Executive Director of the CARB-X consortium.
- CLSI helped build awareness of the CARB-X program through numerous speaking engagements at AMR-related panels and conferences, notably the BIO Investor Forum in San Francisco, BARDA’s Industry Days in Washington, DC, and the One Nucleus AMR Leadership Seminar in Cambridge, England. Heather Shane, Executive Director of CLSI’s CARB-X accelerator, continues to share the CARB-X mission and to highlight the role of accelerators in providing and facilitating support for CARB-X projects and AMR innovation.
CLSI Innovation Series
In October of this year, CLSI launched a new Innovation Series focusing on issues most pressing for life science startups at early and more advanced stages of development. The inaugural panel – Reimbursement 101 – explored how provider groups and payers use value in their analysis of what technologies to adopt. Held at Verily, the panel included experts from Argenta Advisors, Sutter Health, Dignity Health and Verily. CLSI has several new panels lined up for 2018, including the upcoming Early Interactions with FDA: Developing the Value Story for Your Innovative Product at Hogan Lovells in Menlo Park this February.
I-Corps Bio-Entrepreneurship Workshop
CLSI helped secure industry mentors and access to the June BIO International Convention for the first I-CORPS Bio-Entrepreneurship Workshop, which included 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, who then applied evidence-based entrepreneurship concepts via customer discovery interviews at the BIO 2017 exhibition.
The Bio-Entrepreneurship Workshop coincided with BIO’s release of a set of principles on workforce development, diversity, and inclusion (WDDI). 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.
STEM EDUCATION & CAREERS
Amgen Bay Area BioGENEius Challenge
Mythri Ambatipudi, of Saint Francis High School in Mountain View, took first-place at the Amgen Bay Area BioGENEius Challenge in April and went on to represent the Bay Area in the International BioGENEius Challenge at the BIO International Convention in June. The Bay Area Challenge, held at Amgen in South San Francisco, included a keynote address by Ms. Daljit Bains, Deputy Director in the Office of Permit Assistance in the Governor’s Office of Business and Economic Development, as well as a Career Panel, lunch with Amgen scientists and a poster viewing and reception with Amgen employees.
During year three of the 4-year $6M California Career Pathways grant, CLSI and partners have stepped up work-based learning initiatives with high schools and credit recovery programs that have large numbers of underrepresented students, while increasing dual enrollment opportunities for all SFUSD students. Working closely with the Bay Area Bioscience Education Community (BABEC) to provide hands-on Genetic Engineering weeks for students, CLSI has connected industry volunteers with students, teachers and faculty to provide career talks, job shadows, internships resume review, etc, and in February 2018, a new speed networking initiative for high school and community college females with Young Women in BIO (YWIB) professionals.
NexGeneGirls Bootcamp and Internship Academy
CLSI partnered with NexGeneGirls to develop the 2017 NexGeneGirls Bootcamp and Summer Internship Academy. Over the spring, the program provided hands-on laboratory skills training taught by students in City College of San Francisco’s Stem Cell program to six high school females, helping them to master basic laboratory techniques such as pipetting, general biosafety, DNA extraction, and cloning and plasmid maps. Over six weeks in the summer, the NexGeneGirls interned three days a week in labs at UCSF, The Gladstone Institutes and San Francisco State University, and led hands-on science experiments with elementary- and middle-school females one day per week at the San Francisco Boys and Girls Club. A key element of the program’s success is the incorporation of a multigenerational teaching model, which reinforces learning and develops the confidence of the student “teachers,” while inspiring students with female role models who look like them.
The partnership is aimed at increasing diversity in STEM fields by tapping women leaders, students and industry professionals to mentor and inspire NexGeneGirl participants.
Giants of Science Competition
KNBR, CLSA and CLSI collaborated this year on a competition to expand science programming in Bay Area high schools. Three Bay Area schools in the North Bay, East Bay, and South Bay were awarded $20,000 each at the San Francisco Giants game on September: Abraham Lincoln High School, Northgate High School and Carlmont High School. Members of the life science community were eager to step forward to support the competition, and included Alexandria Real Estate, Celgene, Genentech, Gilead, Illumina, Nektar, Sutro Biopharma, Theravance, and Wareham Development. KNBR plans to run the competition again in 2018.
Professional Development Workshops
CLSI offered ten professional development workshops in 2017 on BioBasics, Drug Development, and Labs to Leadership, serving 230 life science professionals. CLSI will expand its offerings in 2019 to include workshops on Drug Pricing and Strategic Commercialization.
Coming Age of Genomics Documentary
CLSI has entered into a partnership with Wine Cow Productions to produce a documentary film on the past, present and future of genomics research and development. If funded, the National Human Genome Research Institute (NHGRI) will collaborate on the project. The goal is to portray science as a human enterprise with far-reaching social, cultural, economic, and political implications; and genomics, as a technical force capable of fundamentally transforming society and the human condition. The film will target outlets such as Discovery, HBO, National Geographic, Netflix and PBS.
Happy Holidays! We look forward to seeing you in 2018!
Fall 2017 FAST Closing Showcase Celebrates Eight Companies
CLSI celebrated key milestones at the Fall 2017 FAST Closing Showcase at Byers Auditorium in UCSF San Francisco on December 13, 2017. The Showcase marked the culmination of the Fall program and included presentations from eight graduating FAST companies: BioAmp Diagnostics, developing diagnostic assays that can detect antibiotics resistance directly in patient samples; Phi Therapeutics, developing a platform technology to enhance natural phage with payloads to improve bacterial targeting and neutralization; Pheronym, an Ag-biotech company developing green solutions for agricultural pest control; Oomni, developing drugs that simultaneously target two pathways of importance for inhibiting cancer growth and metastasis; Inflammatix, developing diagnostic tests based on ‘reading’ the immune system; DeviceFarm, developing a gas-based treatment to treat nail fungal infections; Siolta, developing microbial-based therapeutics for the prevention and treatment of inflammatory diseases, such as asthma; and STATegics, developing breakthrough new treatments for life-threatening rare neurodegenerative diseases.
The program also opened up with a retrospective from previous FAST graduate, Mary Ludlam, CEO of Cairn Biosciences, who discussed how the FAST program helped further their companies’ success, and closed off with the announcement of the PharmaDirections JumpStart Award given to Jeff Spencer of STATegics.
SPRING 2018 FAST Applications Open
Applications for the Spring 2018 program are open through January 26, 2018. Apply now. For information on the FAST program, contact Steve Karp at FAST@califesciences.org or Julie Harness at firstname.lastname@example.org.
FAST, Fellow and CARB-X Updates December
FAST & Fellows Round-Up
- STATegics (FAST Fall 2017) is announced winner of the PharmaDirections JumpStart award
- Purigen Biosystems (FAST Spring 2015) appoints life science industry veteran Barney Saunders as CEO Read More
- GigaGen (FAST Spring 2015) CEO David Johnson will be presenting at 2017 Antibody Engineering & Therapeutics Meeting Read More
- CLSA Fellow AnimalBiome wins $10,000 and is competing to win 2017/2018 Pet Care Innovation Prize Read More
- The AMR Centre is to collaborate with Russian science and technology organization, the Skolkovo Foundation in an effort to tackle the global problem of antimicrobial resistance Read More
- Powered By CARB-X company Oppilotech interviewed and featured in NB Herard article on Superbugs and how they plan on tackling the scientific challenges to combat antimicrobial resistance Read More
- Powered by CARB-X company Debiopharm Group announced the launch of their 2nd FDA cleared assay, GenePOC™ CDiff Read More
- Powered by CARB-X company Seres Therapeutics announces FDA Orphan Drug Designation for SER-287 in treatment of pediatric ulcerative colitis Read More
- Powered by CARB-X company Vedanta Biosciences announces initiation of Phase 1a/1b trial for new drug class of rationally-defined bacteria consortia derived from human microbiome Read More
Bio-Link Depot’s Grand Opening in Oakland
Donate Tax-Deductible Scientific Equipment and Supplies
Bio-Link Depot celebrated the Grand Opening of its new Oakland, California location last month with record numbers of educators and researchers in attendance. Since 2002, the Bio-Link Depot has connected educators and researchers with needed science supplies and equipment through its clearinghouse of biotech industry donations.
Because of the increasing demand for equipment and supplies from Bay Area teachers, the Depot is running low on donations from industry. Companies can make tax deductible donations of equipment, supplies and consumables – giving them a new life in cash-poor classrooms – through the Bio-Link Depot. The Depot accepts high-quality equipment and supplies from donating entities and makes them available to over 300 educators and researchers serving approximately 100,000 students in California high schools, community colleges, and universities.
As technology companies (pharmaceutical, bio-tech, etc.) restructure, move, or upgrade their equipment and supplies, the Depot is an alternative to equipment re-sellers, auctions, or landfills. Donors can arrange with Depot personnel to have their items picked up regardless of size or quantity. The Depot ensures that the Donor’s contributions are known to the recipients and thanks contributing companies on its website: http://biolinkdepot.org/
Please consider donating scientific equipment and supplies now to give those unneeded items a new life in schools.
To make a donation or learn more about the Depot and its upcoming events, contact Daniel Michael at: 510.686.3411, email@example.com or go to the Depot website’s donation page: http://biolinkdepot.org/index.php/donate/