CLSA Bulletin

CLSA SpotlightThe Presidents Corner
ADVOCACY

CLSA Announces Expanded Sacramento & Washington Presence, Adds Three To Advocacy Team
CLSA recently announced a major expansion to its advocacy team, hiring three new government relations directors based in its Sacramento and Washington, D.C. offices, bringing its in-house advocacy staff count to 9 personnel. | READ MORE »

First Committee Hearings Indicate Tough Road Ahead On Major State Legislation In Sacramento | READ MORE »

CLSA Applauds Introduction Of New Bill To Improve Medical Device
Inspections
| READ MORE »

Bay Area Update: CLSA Works To Improve Commuting Options For Life Sciences Company Employees | READ MORE »

CLSA MEMBER NEWS & PROFILES

The Latest Diabetes Technology That Took A Team – And A Teenager
The MiniMed 670G is considered a breakthrough in diabetes management, but making it available to patients required strong partnerships and willing trial participants – like a 16-year old from California.| READ MORE »

How the IPO Environment Affects BioTech Growth | READ MORE »

The BIO International Convention is Coming to San Diego in June – Tips, Tricks and How to Maximize Your Time at #BIO2017 | READ MORE »
 

INSTITUTE

CARB-X
CARB-X is providing capital (up to $450M over 5 years) and strategic business support to companies with promising early-stage technologies to develop a portfolio of innovative products to address this critical threat to global health. | READ MORE »

CLSI Announces BioGENEius Winner | READ MORE »

FAST & Fellows Round-Up | READ MORE »

Biotech Primer: Promising Peptide Therapies | READ MORE »
 

APRIL 2017
ABOUT CLSA

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

Join CLSA

CLSA Launches Digital Advocacy Center to Connect Members with Legislators

 — New Digital Advocacy “Take Action” Center helps members stay informed about CLSA’s advocacy efforts, view priority legislation, contact their elected officials and more —

— Inaugural digital advocacy campaign urges members to contact U.S. Senators and Representatives to oppose the proposed $6 billion budget cuts to the National Institutes of Health (NIH) and lifesaving medical R&D —

April 25, 2017

California Life Sciences Association (CLSA) today announced their new Digital Advocacy Center. This innovative platform will harness the organization’s broad membership to engage on key legislation and public policies and help grow California’s life sciences sector.

CLSA’s “Take Action” digital advocacy tool helps CLSA members contact state and federal lawmakers to make their voices heard. Members can support life sciences priorities by sending letters, posting messages on Twitter or Facebook or using phone scripts to directly contact lawmakers. The new center also lets stakeholders view priority legislation, sign up for advocacy messages and alerts, lookup their elected officials and more. Learn more and check out the new digital advocacy center by visiting www.califesciences.org/TakeAction.

CLSA’s first digital advocacy campaign urges visitors to contact their U.S. Senators and Representatives to oppose the proposed $6 billion budget cuts to lifesaving medical research and development at the National Institutes of Health (NIH). Click here to learn more.

As CLSA continues to build strong ties in Sacramento, Washington and in municipalities throughout California, it is critical that policymakers understand the contributions innovative life scientists and CLSA member companies make to improved patient
care. This new resource will help CLSA shape federal, state and local policies that support life sciences research, investment and innovation in California.

To learn more about CLSA’s team of experienced government relations professionals, visit www.califesciences.org/advocacy.

Questions? Please contact Will Zasadny, CLSA’s Director of Communications (wzasadny@califesciences.org).

DC Reception on May 3, CLSA Welcomes 20 New Members, CA Pavilion at BIO 2017, BioGENEius Winners Announced, CLSA Team Growing Fast

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

April 26, 2017 

 

Welcoming New Members

CLSA’s Annual DC Reception on Capitol Hill, May 3
On May 3, CLSA will be hosting members of Congress, legislative staff, key government officials, life sciences industry executives, academic leaders, the patient community, and other sector stakeholders at our Annual Spring Reception on Capitol Hill, for an annual celebration of the state’s achievements in biomedical and life sciences innovation. This event in Washington D.C. fosters rich conversations about the issues that matter most to the continued success of California’s vibrant innovation ecosystem. Special thanks to our platinum sponsors: Gilead Sciences, Shire and PhRMA, and our gold sponsors: Abbott, AbbVie, Actelion, Amgen, Astellas, Edwards Lifesciences, Horizon Pharma, Johnson & Johnson, Medtronic, Merck, Pfizer, Theravance Biopharma, Vertex, VWR and AdvaMed. We hope you will join us on May 3! Click here to learn more and register.

CLSA Welcomes 20 New Members
Please join me in welcoming the 20 new CLSA members who joined us in the last month:
Ab Studio Inc., AM Chemicals, AOBiome, Assembly Biosciences, BioDuro, Context Matters, CTK Biotech, Endece, Life-Y Space Inc., Lin Biosciences, Meissa Vaccines Inc., MiraculeX Inc., Neurocrine Biosciences Inc., Novome Biotechnologies Inc., ONESKIN Inc., Quartz Therapeutics, Retrophin, Singlera Genomics, Sublime Biotherapeutics and Vault Bioventures Inc. Our membership portfolio grows ever more robust with the addition of these organizations, which add significantly to the expertise and resources available in the CLSA network. 

CLSA Debuts Powerful Digital Advocacy Tool to Connect Members With Legislators

I’m excited to announce the debut of CLSA’s “Take Action” digital advocacy tool, designed to help members stay informed about CLSA’s advocacy efforts, view priority legislation, contact their elected officials and more. Our Inaugural digital advocacy campaign urges members to contact U.S. Senators and Representatives to oppose the proposed $6 billion budget cuts to the National Institutes of Health (NIH) and lifesaving medical R&D. Learn more here or check out the new digital advocacy center at www.califesciences.org/TakeAction.

CLSA Op-Ed in San Jose Mercury News Calls for Repeal of IPAB

I recently had the opportunity to pen an op-ed in The San Jose Mercury News, urging Congress to repeal the Independent Payment Advisory Board (IPAB), a controversial advisory board enacted as part of the ACA, which threatens seniors’ care and could harm biomedical innovation by reducing incentives for investment in new research and product development. Repeal of the IPAB has been central to CLSA’s federal advocacy goals for a number of years and we are pleased at the opportunity to share our views in one of the largest papers in California. Learn more.

CP
Join CLSA in the California Pavilion during BIO 2017
June 19-22 in San Diego

BIO 2017 is rapidly approaching! Looking for a way to reach the thousands of leading biotechnology and pharmaceutical companies, contract research organizations (CROs) and contract manufacturing organizations (CMOs), key academic institutions, major research labs, government agencies, consultants, and service companies who will be attending the BIO International Convention in San Diego this June? Space is still available in the California Pavilion, an important resource for convention attendees and your opportunity to make contacts and create relationships. Contact us for more information.

Four CARB-X Grant Recipients Selected to Work with CLSI: Redx Pharma Plc

As the west coast accelerator for CARB-X, the California Life Sciences Institute (CLSI) is pleased to serve four of the first round of selected CARB-X companies: Forge Therapeutics Inc., Cidara Therapeutics Inc., Redx Pharma Plc and Proteus IRC. These companies join seven others who collectively will receive up to $48 million for development of innovative products designed to address the threat of anti-microbial resistance.

CLSI Announces Winners of Amgen Bay Area BioGENEius Challenge

In other exciting news, CLSI announced the winners of the Amgen Bay Area BioGENEius Challenge. First-place winner Mythri Ambatipudi of Saint Francis High School in Mountain View will go on to compete at the International BioGENEius Challenge at the June 2017 BIO International Convention in San Diego.

Gaeun Kim, from Stanford University Online High School, and Lekha Pillarisetti, from Doughtery Valley High School in San Ramon, took home second- and third-place, respectively. Sophia Sydir, from Leland High School in San Jose, Dipashreya Sur, from Notre Dame High School in Belmont, and Saurabh Narain, from Mission San Jose High School in Fremont, received Honorable Mentions. Learn more. 

 CLSA Team Enjoying Explosive Growth!

We’ve been hard at work expanding our teams in the Bay Area, Sacramento, San Diego, and Washington, D.C. over the last month. Please join me in welcoming these new additions:

Oliver Rocroi – Senior Director, State Government Relations: Oliver joins us as CLSA’s head in-house state lobbyist. He most recently worked for the Association of California Life and Health Insurance Companies (ACLHIC). Prior to ACLHIC, he worked for a public relations firm, the Assembly Republican Caucus, as a campaign manager for several legislative seats and the District Director for an Assemblymember. He earned his B.S. in Aerospace Engineering from California State Polytechnic University in Pomona.

Manny Heer – Director, Alliance Development & Advocacy: Manny is responsible for forging new relationships with various stakeholder groups, creating a grassroots advocacy program for our members and supporting the Sacramento team with policy research and lobbying. Most recently, Manny worked for the California Medical Association as their Associate Director of Political Operations. Prior to working in this capacity, Manny was a Health Law Information Specialist and a Paralegal. Manny received his B.S. from the University of San Francisco, SF and his Associate of Arts: Paralegal Studies from MTI College.

adam lotspikeAdam Lotspike – Associate Director, Federal Government Relations: Based in our Washington, D.C. office, Adam will support CLSA’s federal advocacy priorities through outreach, education and legislative advocacy activities with members of the California congressional delegation, as well as building and maintaining alliances with member companies, partner associations and other affiliate organizations. Prior to joining CLSA, Adam served as Manager of Federal Affairs at the American Psychiatric Association (APA). Prior to APA, he was a congressional campaign manager, and worked as a communications advisor on political and issue advocacy campaigns in California. He is a graduate of California Lutheran University where he earned both a B.A. in Political Science, and a Master of Public Policy & Administration in Public Policy and Administration.

Emily MorganEmily Morgan – Associate, Events: Emily is responsible for providing support in the planning, preparation, and delivery of events in California and nationwide. Prior to joining CLSA, Emily worked as an Account Manager in San Diego and was responsible for planning events, securing new business, and managing existing accounts. She is originally from Fairfax, Virginia and received a B.A. in Communication Studies from James Madison University.

Henrik OhrstromHenrik Ohrstrom – Salesforce Administrator: Henrik manages all CLSA databases as well as addressing the needs of employee workflows. Prior to joining CLSA, he worked as the Salesforce Administrator for a startup in the San Diego Area. Henrik studied Software Engineering at Cal Poly San Luis Obispo.

Annie LeeAnnie Lee – Administrative Assistant: Annie provides administrative support to the Business Development team, executive support to CLSA’s VP-level staff and day-to-day office management and reception for the San Diego office. Before joining CLSA, Annie was involved in the operations and management of her own startup restaurant.

The organization’s full-time staff spanning our five offices in San Diego, Sacramento, Los Angeles, Washington D.C. and the Bay Area is now over 30, including nine new hires in 2017 alone. In addition to these new hires, the CLSA management team now includes Jenny Carey, Vice President of Federal Government Relations & Alliance Development; Eve Bukowski, Vice President of State Government Relations; Kelly Bryant, Vice President of Business Development, and Elizabeth Gibson, Senior Director of Marketing & Programs.

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). for more information.

First Committee Hearings Indicate Tough Road Ahead on Major State Legislation in Sacramento

April 21, 2017

The third week of April marked the first policy committee hearings on the top two bills of interest for CLSA this year, Senate Bill 17 (Hernandez) and Assembly Bill 265 (Wood). These hearings, however, signify a difficult battle ahead for the life sciences sector in this legislative session.

SB 17 would require, among many other things, manufacturers of prescription drugs to submit a 90-day advance notice of a price increase to all California public agency purchasers, health insurers, and pharmacy benefit managers (PBM) where that increase would mean the wholesale acquisition cost (WAC) has exceeded 25 percent over the previous three calendar years. For specialty drugs, the price increase threshold is only 10 percent. A host of information must also be submitted on the effective date of the increase, and, after amendments in the recent hearing, similar information must also be submitted within 3 days of FDA approval of new drugs.

AB 265 was also amended in the recent hearing to explicitly remove biologics from the prohibitions on the use of copay assistance. The narrower bill now prohibits the use of copay assistance for small molecule brand drugs where a lower cost generic is covered by the insurer, as well as for drugs that combine multiple generic or over-the-counter active ingredients.

CLSA did not expect either bill of the committee chairs to fail in their own respective committees. Both bills were passed with only two “no” votes and a handful of abstaining committee members.  SB 17, in particular, also received statements in support from many of the almost 70 organizations on file as supporting the bill.

On AB 265, in response to concerns from committee members, the author and Chair of Assembly Health, Jim Wood, did commit to amending the bill to exempt drugs for which an insurer has approved a prior authorization, which address a number of the concerns voiced by CLSA.

On SB 17, while questions from committee members expressed concerns with the bill, the Chair and author, Ed Hernandez, set rigid guidelines for the hearing and witnesses in opposition to the bill, which included representatives from PhRMA and BIO, received a fraction of the opportunities to respond that were afforded to witnesses in support.

The next stop for both bills will be their respective appropriations committees in the coming weeks. 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.  Questions? Please contact Brett Johnson, CLSA’s Senior Director, Policy and Regulatory Affairs (Bjohnson@califesciences.org).

CLSA Applauds Introduction of New Bill to Improve Medical Device Inspections

April 24, 2017

CLSA is proud to endorse bipartisan legislation introduced on March 27 by Representatives Larry Bucshon (R-Ind.), Scott Peters (D-San Diego), Susan Brooks (R-Ind.) and G.K. Butterfield (D-N.C.) to improve the process for FDA inspections of medical device establishments and granting export certifications. California is home to over 1,700 medical device companies, providing approximately 75,000 jobs in vibrant medical technology clusters up and down the state.

CLSA strongly supports H.R. 1736, which will improve transparency, predictability, efficiency, and consistency around inspections of California’s medical device manufacturers and ensure timely patient access to life-saving medical devices. The bill, H.R. 1736, proposes four key improvements:

  • Risk-based inspections: Establishes a risk-based schedule for inspections to focus limited federal resources on the more significant risks to public health while reducing the burden on establishments with a strong history of compliance.
  • Improvements to inspections process: Standardizes and enhances processes associated with communications prior to, during, and after inspections. Also, proposes enhanced training opportunities for investigators to improve consistency and efficiency of the device inspection process.
  • Guidance: Requires the development of a draft guidance document that details the implementation process and requirements imposed by the legislation.
  • Export Certificates for Foreign Governments: Ensures devices that are lawfully marketed for United States patients will no longer be denied certification for marketing in other countries by requiring written justification for denial and summary of deficiencies if FDA refuses to issue an export certificate.

Working in collaboration with our member companies and our national trade association partner, AdvaMed, CLSA supported the inclusion of key elements of the legislation and secured California Representative Scott Peters, a member of the critical House Energy & Commerce Committee, as an original lead sponsor. We are working to secure additional cosponsors of the bill, and advocating for swift action on this legislation this year. A copy of our letter of endorsement of H.R. 1736 is available here.

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

Bay Area Update: CLSA Works to Improve Commuting Options for Life Sciences Company Employees

April 20, 2017

CLSA member companies have noted with growing urgency that transportation issues are a top concern for business. Many are concerned that their employees spend too much time in traffic. The ability to recruit and retain quality employees is made harder when experiencing long commutes and traffic jams. CLSA has taken the lead in working with many local and regional transportation collaborations to give voice to our industry’s perspective and seek solutions for our companies.

In South San Francisco, CLSA has banded together with member companies to develop commuting options for employees. As the life science community east of Highway 101 in South San Francisco continues to grow in population with new and expanded development, companies are seeking solutions. For employees seeking alternatives to long drives, the access to public transportation options like Caltrain, BART, or bus services has been limited. The distance between most of these public transportation stations and the office is what is called in transportation lingo as ‘the last mile’ and in SSF it is often impenetrable without an additional ride. While a private shuttle system exists in San Mateo County, there have been many impediments to its success.

CLSA continues working closely with City Hall to find new possibilities for our community. One of the latest commuting options is the establishment of a new carpooling app named Scoop. Scoop works in localities to provide a coordinated ride service for employees from work to home. It’s different from taxis or Uber/Lyft in that it is used only by fellow residents/employees of the area and the costs are lessened through government and private sponsorship. The City of South San Francisco recently put forward $50,000 to establish the project in SSF. Several other cities on the peninsula and in the Bay Area have invested similarly. More information about this option can be found at TakeScoop.com.

CLSA will continue to advocate for solutions to transportation gridlock to assist our sectors employees. For further information or questions on your company’s transportation concerns, contact Reese Isbell, CLSA’s Director, Local Government & Community Relations (Risbell@califesciences.org).

CLSA Announces Expanded Sacramento & Washington Presence, Adds Three to Advocacy Team

press-release-header-v1— Oliver Rocroi hired as Senior Director, State Government Relations —

— Manny Heer hired as Director, Alliance Development & Advocacy —

— Adam Lotspike hired as Associate Director, Federal Government Relations —

Staffing boost comes as CLSA grows robust footprint throughout California as the premier public policy and business solutions organization representing the life sciences sector —

SACRAMENTO & WASHINGTON – April 18, 2017 California Life Sciences Association (CLSA), the state’s premier public policy and business solutions organization representing California’s life sciences sector, today announced a major expansion to its advocacy team, hiring three new government relations directors based in its Sacramento and Washington, D.C. offices, bringing its in-house advocacy staff count to 9 personnel.

Oliver Rocroi has been hired as Senior Director, State Government Relations based in CLSA’s Sacramento office; Manny Heer has been hired as Director, Alliance Development & Advocacy based in CLSA’s Sacramento office; and Adam Lotspike has been hired as Associate Director, Federal Government Relations based in CLSA’s Washington, D.C. office. As CLSA continues to grow its robust statewide footprint, these hires bolster the organization’s government relations efforts in Sacramento, Washington and at the local levels to drive solution-oriented public policies and advocacy activities that sustain and support life sciences research, investment and innovation in California.

With these new additions to the advocacy team, the organization’s full-time staff spanning their five offices in San Diego, Sacramento, Los Angeles, Washington and the Bay Area is now over 30, including nine new hires in 2017 alone.

Oliver Rocroi Named Senior Director, State Government Relations – Sacramento Office

Oliver Rocroi has been named Senior Director, State Government Relations. Based in CLSA’s Sacramento office, Rocroi will conduct strategic lobbying activities to support and advance the organization’s state advocacy priorities on behalf of the life sciences sector and CLSA members. Rocroi comes to CLSA after two years with the Association of California Life and Health Insurance Companies (ACLHIC). Before ACLHIC, Rocroi worked for a public relations firm, the Assembly Republican Caucus, as a campaign manager for several legislative seats and as the District Director for an Assemblymember. Rocroi earned his Bachelor of Science in Aerospace Engineering from California State Polytechnic University in Pomona.

Manny Heer Named Director, Alliance Development & Advocacy – Sacramento Office

Manny Heer has been named Director, Alliance Development & Advocacy. Based in CLSA’s Sacramento office, Heer will support the organization’s state advocacy priorities by cultivating strong relationships with various stakeholder groups, creating a robust grassroots program for CLSA members and assisting with legislative policy, research and more. Heer will also assist in the development and implementation of direct legislative advocacy and education efforts with members of the California legislature, Governor’s office and various state and local agencies. Heer comes to CLSA after nearly two years with the California Medical Association (CMA) as Associate Director, Political Operations. Heer received his Bachelor of Science in Organizational Behavior & Leadership from the University of San Francisco.

Adam Lotspike Named Associate Director, Federal Government Relations – Washington Office

Adam Lotspike has been named Associate Director, Federal Government Relations. Based in CLSA’s Washington, D.C. office, Lotspike will support the organization’s federal advocacy priorities by assisting in the development and implementation of outreach, education and legislative advocacy activities with members of the California congressional delegation, as well as building and maintaining alliances with CLSA member companies, partner associations and other affiliate organizations. Lotspike comes to CLSA after serving as Manager of Federal Affairs at the American Psychiatric Association (APA). Prior to his tenure at APA, Lotspike served as congressional campaign manager and worked as a communications advisor on political and issue advocacy campaigns in California. Lotspike is a graduate of California Lutheran University where he earned both a Bachelor of Arts in Political Science, and a Master of Public Policy & Administration in Public Policy and Administration.

“Oliver Rocroi, Manny Heer and Adam Lotspike are exceptional additions to California Life Sciences Association’s team. Each brings a wealth of experience in government affairs and legislative advocacy, enabling CLSA to build and maintain stronger ties in Sacramento and Washington, so that policymakers understand the contributions that our innovative life sciences sector and member companies are making to drive gains in patient care,” said Sara Radcliffe, President & CEO of California Life Sciences Association.

“As CLSA continues to expand its broad membership and statewide reach, Oliver, Manny and Adam will bolster CLSA’s work in shaping solution-oriented public policy to support and sustain life sciences research, investment and innovation in California. I am delighted to welcome them to CLSA,” added Radcliffe.

Photos available upon request.

###


About California Life Sciences Association (CLSA)

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

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

Combining an Unparalleled AI Platform with a Seasoned Pharma Team, Evince Biosciences Reimagines Drug Discovery and takes on Cancer Immunotherapy

By Paulo Rangel
President & CEO of Evince Biosciences, Inc.

Evince Biosciences is a next generation drug discovery company, using a compelling machine learning approach to reimagining drug discovery. Our first program targets toll-like receptor 7 (TLR7) for cancer immunotherapy.

Simply stated, without a dramatic increase in R&D productivity, today’s pharmaceutical industry cannot sustain sufficient innovation to replace the loss of revenue due to patent expirations for successful products (Nature Reviews, March 2010). One highly promising way to close this gap, is the application of Artificial Intelligence. However, for all the buzz and promise, the application of artificial intelligence without accurate and complete information describing the molecules and targets to be evaluated will succumb to the axiom, “garbage in, garbage out.”

Our approach is called Autonomous Virtual Organism or “AVO.” The platform accurately predicts activity, toxicity and drug-like properties (ADME) simultaneously, transforming discovery into a parallel process in a virtual environment, rather than a sequential process in a laboratory environment. We have established a precise, calibrated series of in silico biological simulations that maximizes the informational content that is submitted for analysis by our machine learning approach. This approach to describe molecules is key to accurate predictions…and accuracy is essential for re-inventing drug discovery. Accelerating lead optimization is a key focus for our company. We start with the drug-like leads generated by AVO or our collaborator and apply medicinal chemistry principles to modify the molecules. AVO scores the new molecules to determine which changes were beneficial and which were not. In this way, we greatly enrich the pool of high-value molecules to be synthesized and evaluated in traditional biology. This smart in silico approach can dramatically decrease the number of medicinal chemistry cycles and reduce the cost and time required to successfully complete this stage.

We draw on Dr. James Appleman’s (Evince CSO) extensive experience in drug discovery, early clinical development and TLR7 for our first internal program – an orally administered TLR7 agonist for cancer immunotherapy. Stimulation of innate immunity is a current focus for immuno-oncology drug discovery, with STING (Stimulator of Interferon Genes) being one of the better known and accepted approaches. Our TLR7 agonist program compares favorably with STING as it stimulates innate immunity and the proliferation and activation of B-cells with an orally administered small molecule. Stimulation of the innate immune system is expected to increase the value of checkpoint inhibitors by augmenting the response rate, which is currently very low. We expect to identify a preclinical candidate in six months

We are optimistic about our future and the positive impact we can have on drug discovery and cancer immunotherapy. We are proud to be part of the San Diego biotechnology community and value collaborations with our colleagues in the pharma/biotech community worldwide.

About the author:

Paulo Rangel is President & CEO of Evince Biosciences, Inc. He can be reached at p.rangel@evincebio.com. To learn more about Evince Biosciences, visit www.evincebio.com.

The Latest Diabetes Technology That Took A Team – And A Teenager

How the IPO Environment Affects BioTech Growth

Going public was an appealing option as recently as three years ago. In 2014, total U.S. IPOs reached one of the market’s highest points, with 273 companies making their initial public offering. Biotech companies made up nearly 25 percent of total public offerings according to research compiled by Renaissance Capital.

IPOs in 2015, however, failed to live up to 2014’s highs. Only 169 companies in total went through an initial public offering in 2015. The froth in the market that had been there in 2014 dissipated with Federal Reserve concerns, increases in mergers and acquisitions and private market transactions, and for the biotech industry, the fallout from the Martin Shkreli price-raising controversy. When political leaders denounced the activity and started talking about the need for pharmaceutical price regulation, it had a chilling effect on the biotech market. The chilling effect continued into 2016, and when combined with other concerns such as the U.K.’s “Brexit” from the European Union and the presidential election, proceeds from IPOs fell to a 13-year-low. Offerings and filings also decreased significantly from 2015.

At the beginning of the year, at the J.P. Morgan conference, there was a lot of optimism that 2017 would hopefully be a better year for biotech IPOs than 2016 because of the new administration and a stronger U.S. economy. 2017 started with a big backlog of companies looking to go public, and year-to-date, very few of them have gone public. The first quarter had only four biotech IPOs. With that, companies right now are looking for other ways of raising capital.

The Impact of Poor IPO Market Performance

An IPO may be appealing to biotech companies because it offers an opportunity to raise additional capital for expansion and it creates an exit opportunity for current investors. A sluggish IPO market closes off the stock market as a means of an exit strategy, and it limits funding opportunities.

In the current climate, if biotech companies want to go public, their investors are forced to participate in the IPO to a greater extent than they’ve had to previously in order for the public offering to be successful. Another consequence of this is that because companies cannot go public, existing investors are forced to put more of their own money into their investments in order to keep them viable. Companies may also consider licensing one of their products to Big Pharma and using that money to fund research and development until the IPO market opens up. We’ve also seen some companies give up rights to their product in China in exchange for Chinese investments coming into the companies.

Alternative methods of going public have become more appealing.

Option 1: A Reverse Merger into a Public Shell

Companies considering a reverse merger have two methods from which to choose. One is to merge with a failed public company that has money in it. The other is to find a “clean shell”, which is set up with seed money that would allow a private company to merge into it.

Option 2: Form 10

A Form 10 is an alternative to a traditional IPO that resembles a Private Investment in Public Entity transaction. Companies looking to go public can register securities with the SEC after they raise their money. The registered securities are not publicly traded, but they will require the company to provide documentation normally required of publicly traded securities, including the Form 10-K.

The Form 10 opens up the potential to receive public equity funds, and the company may also use over-the-counter market exchanges for their securities. Once enough investors have come on board using the over-the-market exchanges, the company would enter a public exchange. Form 10 offerings may be of particular interest to biotech companies because they open up opportunities for additional capital.

Both the reverse merger and the Form 10 should only be considered if as the transaction is completed, an infusion of capital comes into the company that will be enough to ensure the company will be viable.

Option 3: Regulation A Plus Offering

With Regulation A Plus Offering (Reg A Plus) offerings, companies go through the SEC approval process for an IPO. Once approved, the company is permitted to use a broader pool of investors than the traditional pool of accredited investors, who must meet certain financial requirements. Crowdfunding an IPO is a relatively untested avenue, and to date, some biotech companies have tried the Reg A Plus offering but haven’t been successful in raising meaningful amounts of money.

Option 4: Overseas Exchanges

Some U.S. companies are looking to go public in overseas exchanges, including Brussels, Germany, China and Taiwan, and some have been successful. However, raising subsequent rounds of funding has been more difficult.

 Select the Best Method for Your Company

Meeting with your financial advisors can help companies evaluate the current marketplace and which route could best help the company achieve its capital objectives.


David Diamond is the Head of Capital Markets at CBIZ and MHM. He can be reached at ddiamond@cbiz.com or 858.795.2014.

FAST & Fellows Round-Up

Read the latest in FAST and Fellows news:

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

CARB-X

CLSI Supporting Four of First Eleven “Powered by CARB-X” Companies

What is CARB-X?

Launched in August 2016, CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical accelerator) is one of the world’s largest public-private partnerships devoted to combating anti-microbial resistance. CARB-X is providing capital (up to $450M over 5 years) and strategic business support to companies with promising early-stage technologies to develop a portfolio of innovative products to address this critical threat to global health. The consortium includes the California Life Sciences Institute (CLSI), the Wellcome Trust, BARDA, RTI International, NIAID, and MassBio, and is administered by Boston University.

What’s new?

On March 30, CARB-X announced funding of up to $48 million for the first group of 11 companies: $24M up front and potentially an additional $24M as milestones are reached. Four of these eleven companies will work with CLSI for strategic business and operational support.

As a partner in the consortium, CLSI is one of three CARB-X accelerators, along with MassBio in Boston and the Wellcome Trust in the UK. Since CARB-X’s launch in August 2016, CLSI has engaged with over 50 potential CARB-X companies. With the announcement of the first awards, CLSI will tap its extensive advisor network to continue with operational and strategic business advisory services to four companies: Forge Therapeutics, Cidara Therapeutics, Redx Pharma and Proteus IRC.

Meet our companies!

Forge Therapeutics Inc., San Diego, CA

Pioneering chemistry platform for first novel class of ‘superbug’ antibiotics in decades

Awarded $4.8M over 15 months, and potentially up to $4M in the following 18 months

Funded project: to develop novel antibiotics to treat infections caused by multi-drug resistant bacteria. With its proprietary chemistry approach, Forge develops small molecule inhibitors targeting metalloenzymes. Forge’s lead effort is focused on LpxC, a zinc metalloenzyme found only in Gram-negative bacteria, which is essential for bacteria to grow.

Cidara Therapeutics Inc., San Diego, CA

CloudbreakTM immunotherapy platform and CD201 offer new hope to treat serious multi-drug resistant bacterial infections

Awarded $3.9M over 13 months, and potentially up to $3M in the following 11 months

Funded project: to develop CD201 for the treatment of multi-drug resistant Gram-negative infections. CD201 is a bispecific, small molecule antibiotic possessing a Targeting Moiety that binds a conserved target on Gram-negative bacteria and an Effector Moiety that engages the immune system. CD201 was discovered using Cidara’s proprietary immunotherapy discovery platform called CloudbreakTM, which was designed specifically to create compounds that direct a patient’s immune cells to attack and eliminate bacterial, fungal or viral pathogens.

Redx Pharma Plc., Alderly Park, UK

Novel bacterial inhibitors target multi-drug resistant bacteria and hold potential for the treatment of serious hospital-acquired infections

Awarded $1M over 18 months

Funded project: to develop novel bacterial topoisomerase inhibitors against some of the most difficult-to-treat Gram-negative pathogens. Redx compounds from this series have demonstrated activity against a range of resistant bacterial species and have shown efficacy against a multi-drug resistant strain of A. baumannii in an animal model. With support from CARB-X, Redx aims to rapidly progress these compounds into clinical development with the goal of delivering to patients a new treatment for serious infections such as hospital-acquired pneumonia.

Proteus IRC, Edinburgh, Scotland

New optical imaging technology could allow rapid and accurate diagnosis of bacterial infection in the lungs, and help speed up access to life-saving treatment

Awarded $0.64M over 21 months, and potentially up to $0.48M in the following 20 months

The multidisciplinary Proteus team is developing technology to visualise bacteria and the host response in the deepest parts of human lungs in just 60 seconds, using bacteria-specific Smartprobes and fibre-based imaging. This potentially game-changing optical molecular technology will be used in critical care units, which are the largest consumer of antibiotics and an epicentre of antimicrobial resistance development in hospitals. Used at the bedside of patients who are mechanically ventilated and critically unwell, it will enable precision in diagnosing and prescribing, and has widespread applicability elsewhere in the human body for point-of-care bacterial detection and host-response monitoring.

Read the press release here.

For more information about CARB-X, contact Heather Shane, Executive Director, CLSI CARB-X, or visit CARB-X.

CLSI Announces BioGENEius Winner

CLSI Announces Winner of 2017 AMGEN Bay Area BioGENEius Challenge

On April 20, CLSI announced Mythri Ambatipudi of Saint Francis High School in Mountain View as the first-place winner in CLSI’s 2017 Amgen Bay Area BioGENEius Challenge, the annual competition that recognizes outstanding high school student research in the biosciences. As the Bay Area BioGENEius finalist, Mythri will advance to compete in the International BioGENEius Challenge, which will be held at the 2017 BIO International Convention in San Diego in June.

Gaeun Kim, from Stanford University Online High School in Stanford, and Lekha Pillarisetti, from Doughtery Valley High School in San Ramon, took home second- and third-place, respectively. Sophia Sydir, from Leland High School in San Jose, Dipashreya Sur, from Notre Dame High School in Belmont, and Saurabh Narain, from Mission San Jose High School in Fremont, received Honorable Mentions.

For the second year in a row, Amgen in South San Francisco hosted the signature competition. In addition to the judging of student poster presentations, CLSI’s Amgen Bay Area BioGENEius Challenge 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.

“Amgen is delighted to support the California Life Sciences Institute’s Amgen Bay Area BioGENius Challenge. Each year we are amazed with the caliber of these remarkable students, their scientific abilities, intellectual curiosity and boundless determination,” said Aarif Khakoo, Site Head and Vice President, Cardiometabolic Discovery Research, Amgen South San Francisco. “It’s energizing for our Amgen scientists to interact with the students, and to share in their enthusiasm for science and the excitement of discovery. Congratulations to all of the Challenge participants.”

Winners of the International BioGENEius Challenge will be announced during the Tuesday, June 20th keynote at the 2017 BIO International Convention. The winners will receive a $7,500 cash prize.

Read the full press release here.

FAST & Fellows Round-Up

Read the latest in FAST and Fellows news:

  • Paragon Genomics (FAST 2016) – dedicated to improving the critical upfront target enrichment and library preparation workflow for Next-Generation Sequencing – has launched its CleanPlex™ target enrichment solution at the 2017 AACR Annual Meeting. CleanPlex™ is a patented amplicon sequencing technology.
  • Encellin (FAST 2017), was the winner of the MedTech Innovator 2017: JLABS Pitch Event held at JLabs S. San Francisco on April 6. They were awarded a place in the MedTech Innovator Showcase, which includes one presentation slot and full access registration to AdvaMed 2017: The MedTech Conference. Additionally, this event serves as a critical step in selecting the MedTech Innovator Accelerator Class of 2017.
  • Of the four new companies accepted into Breakout labs this month, two are FAST companies. SciBac (Fall 2016) combats antibiotic-resistant infections with smart colonies of healthy bacteria, targeting Clostridium difficile (C. diff), a potentially fatal and often recurring gastrointestinal infection. LogicInk (FAST 2017) has designed a programmable temporary tattoo that changes shape and color to convey specific health information about the user. It’s free of electronics, instead tapping into the power of chemistry and biology as part of the larger digital health movement.
  • SyntheX (FAST 2016) – a therapeutics company that disrupts cellular communication pathways to target proteins that are inaccessible via canonical screening technologies – has been accepted into JLABS @ QB3, part of the QB3@953 incubator.
  • Whole Biome (FAST 2013)
    • is leaving QB3@953 to occupy its own space after a period of significant growth
    • Colleen Cutcliffe, CEO, was a featured speaker at the 3rd Annual Translational Microbiome Conference held this past month in Boston. She addressed two key questions: (1) Can we change an already existing microbial ecosystem in a predictable and desired way, and (2) Can we change a person’s disease or healthy state in predictable and desired ways?
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