NewYorkBIO thanks our Sustaining Members
Notes from Nathan
Happy New Year from NewYorkBIO!
2017 is off to a VERY FAST start, with large-scale industry incentive program announcements from both NYS Gov. Cuomo and NYC Mayor de Blasio (totaling over $1.1 Billion); expansion announcements from NY life science companies, especially Regeneron; and signature by Gov. Cuomo of the New York Step Therapy Reform Bill.
Of course, the life science business year officially kicks off next week with the JP Morgan Healthcare Conference in San Francisco. NewYorkBIO will be there in force, with over 30 NewYorkBIO member companies presenting in the JPM and satellite conferences, and over 1,000 attendees registered for our joint networking reception on Sunday (registration is closed, by the way, due to the overwhelming response!).
But there is much more going on throughout the year, as we prepare for important events like the BIO International Convention in June, and (most importantly) our own Annual Conference in May. Even while we work on these upcoming engagements, we continue to provide members and friends with regular
opportunities to meet, to partner, and to network as we expand our programming portfolio. In total, we have some 25 events scheduled throughout the year: The CEO Breakfast Club will deliver exciting speakers; our oversold networkers continue to crowd the calendar; and our special seminars, partnering programs, and bootcamps will again attract diverse members of New York's life science community.
Key among them is, as I mentioned, the NewYorkBIO 2017 Annual Conference, May 10-11. With the changing times in mind, we have chosen a conference theme that speaks to our moment in NY;'s life science history: New York Life Science at a Tipping Point. Over the past several years, the New York life science ecosystem has seen huge growth in industry development, venture investment, commercial expansion, and patient relations. But it has taken a long time to get this point, and the industry has had to recover from some significant set backs along the way.
The 2017 Annual Conference will be a frank and open discussion of the issues--I call it
the good, the bad, and the ugly
--of New York's life science scene as it exists today and what may be the strengths, weaknesses, opportunities, and threats to it. What have we done right? What have we done wrong? What lessons can be learned and applied? And I invite YOU to help us explore this topic in depth: propose a panel session before January 20th for consideration.
While the New Year offers change, it also renews, and we here at NewYorkBIO are excited about what the year holds.
I look forward to working with you and making 2017 the Year of New York Life Science!
Edgar H. Haug, Founding Partner of Frommer Lawrence & Haug, and Joel Marcus, CEO of Alexandria Real Estate Equities, Join NewYorkBIO Board
At the quarterly NewYorkBIO Board Meeting in December, NewYorkBIO welcomed two new Directors to the NewYorkBIO Board.
Ed Haug is a founding partner of Frommer Lawrence & Haug LLP, where he has served as
Partner since 2005. Mr. Haug is a nationally recognized intellectual property trial lawyer and consultant specializing in protecting his clients' intellectual assets in complex technical fields, including pharmaceuticals and biotechnology. He ensures that clients such as Shire Pharmaceuticals and The Medicines Company obtain full patent protection for their life science innovations while complying with all regulations, and, if needed, he defends their intellectual property from infringement. Mr. Haug has extensive experience both trying cases to courts and juries and arguing appeals in the United States, including before the U.S. Supreme Court. He has also defended cases in the United Kingdom, Germany, and Japan. He also regularly counsels clients in due diligence investigations. Currently, Mr. Haug serves as the Immediate Past President of the Federal Circuit Bar Association, a national bar association that represents approximately 3,000 lawyers, judges, and academics, that helps shape national legislation affecting intellectual property. In addition, Mr. Haug is a prolific lecturer, frequently sharing his knowledge about trial advocacy in patent litigation around the world.
Joel S. Marcus is the Chairman, Chief Executive Officer, and Founder of Alexandria Real Estate Equities,Inc. (NYSE:ARE), an urban office REIT uniquely focused on collaborative science and technology campuses in AAA innovation cluster locations. Mr. Marcus co-founded Alexandria in 1994 as a garage startup with a business plan, and $19 million in seed capital and has led its growth into a publicly traded, investment-grade REIT. Alexandria has a total market capitalization of approximately $13 billion and significant market presence in key locations, including Greater Boston, San Francisco, New York City, San Diego, Seattle, Maryland, and Research Triangle Park. In 1996, Mr. Marcus also founded Alexandria Venture Investments, the company's strategic venture capital arm, which he currently leads with a focus on novel, breakthrough discoveries in biopharmaceuticals, diagnostics, research tools, agtech, digital health, and technology.
NewYorkBIO Builds Presence at JP Morgan 2017
Members and friends of NewYorkBIO will enjoy some valuable benefits, including a popular wine reception and free meeting space, when they attend the JP Morgan Healthcare Conference in San Francisco.
Sponsored by Fitzpatrick Cella and hosted by NewYorkBIO, MichBIO, BIOCOM, AZ Bio, SD Bio and Life Science Washington, the reception attracts hundreds of conference-goers from around the US and internationally.
With quiet meeting space at a premium at this busy San Francisco event, NewYorkBIO members also enjoy the benefit of Member Meeting Space, whether for 1-1 meetings or larger group conferences. Space is still available: contact Nathan Tinker for reservations or details.
Executive Director of NewYorkBIO, Nathan Tinker, described the programs as a real plus for members. "We are
thrilled to offer our membership these conveniences of home when we visit this important west coast event. Enjoying a space to relax and network at our popular wine reception, combined with the opportunity to actually get real meetings accomplished in our quiet, professional space, NewYorkBIO is helping our members to make the JPM "circus" more comfortable and more productive.
Annual Conference 2017 Seeks Proposals
The NewYorkBIO 2017 Annual Conference will take place May 10-11, 2017, at 10 on the th
Park@ Time Warner Center in Columbus Circle. This year's theme is
NewYork Life Science at a Tipping Point
, and NewYorkBIO
invites our member and sponsor organizations to submit proposals for panel sessions at the conference.
Each year the event draws over 1,000 participants from New York and across the Northeast, as well as a global audience including attendees from Europe and Asia.
This year's theme refers to the strengths,weaknesses, opportunities, and threats facing growth of the life sciences in New York. In spite of setbacks, recent years have brought
growth to our industry, including venture investment, commercial expansion, and patient relations. Successful
proposals will take a thoughtful, creative, even provocative look through this lens at industry issues in these four categorie
- Technology and Biotechnology
- Academy/Industry/Government Partnership and Leadership
- The Science of Business and the Business of Science
- Policy, Legal, and Regulatory Challenges
NewYorkBIO Member companies and Annual Conference Sponsors will receive priority consideration. There are a limited number of panel slots available for panels that will enhance the Annual Conference program and provide both information and insight for our attendees. The Annual Conference Committee will review submissions and decision announcement will be made in February. Please contact Joe Tortorice at (212) 433-2623 or firstname.lastname@example.org for sponsorship opportunities.
Government Relations Committee Sets Priorities and Goals Post-Election
NewYorkBio's Government Relations team led a meeting of NewYorkBIO members on November 11th to analyze the impact of the federal and state election results on New York's life sciences industry
This important update was held in the NewYorkBIO offices in Midtown and included a conference call and webinar event.
Among the issues at stake: P
residential choice and its impact on FDA and other key agencies;p
arty control of the New York State Senate;
congressional races across the state.
Executive Director Nathan Tinker said that interest in the event was very strong, and the feedback from the event is shaping the team's upcoming work. NewYorkBIO's Government Relations Committee (GRC) is designed to better serve members with an interest in local, state, and federal public policy and a desire to advocate on behalf of the New York biotechnology industry.
Membership on the Government Relations Committee membership is open to any NewYorkBIO member in good standing whose organization is actively engaged in biomedical research.
The committee will meet in-person in New York City (with a teleconference option) once per month. The committee may meet more often when the New York State Legislature is in session.
New York Legislative Update
NEW YORK CITY AND STATE
NewYorkBIO applauds Governor Cuomo and Mayor de Blasio on the announcement of two major investment initiatives totaling over $1 Billion in New York's life science ecosystem!
announcements totaling over $1.15 Billion in investment
came in unusually quick succession
According to the Governor's announcement, the initiative will
- Make Capital, Operating Support and Tax Incentives Available to Life Science Companies to Support the Growth of Research and Development
- Make More Than 3.2 Million Square Feet of Innovation Space and 1,100 Acres of Developable Land Available Tax Free at 45 Colleges and Universities Statewide
- Create New Programs That Will Help Develop the Research and Entrepreneurial Talent Necessary for Growing New York's Life Science Sector
Just a few hours later, on Tuesday morning, NYC Mayor Bill de Blasio appeared at the Alexandria Center for Life Science to announce LifeSci NYC, a "ten-year, $500 million investment to vault NYC to the forefront of research and innovation."
The Mayor's announcement unveiled ten strategic initiatives to spur an estimated 16,000 new, good-paying jobs and establish New York City as a global leader in life sciences research and innovation.
According to the announcement, the program will strengthen the life sciences ecosystem in NYC through strategic initiatives and public-private partnerships in three key areas:
- Connecting Research to Industry, Creating Jobs, and Advancing Health Care and Technology
- Unlocking Space for Companies to Grow and Employ New Yorkers
- Building a Pipeline for Diverse Life Sciences Talent
Mayor de Blasio described the State and City programs as "complimentary." Together, they expect to create over 25,000 new jobs in New York.
NewYorkBIO has been advocating for this kind of large-scale thinking and investment and we applaud the vision put forth by both Governor Cuomo and Mayor de Blasio to grow this vital industry.
NewYorkBIO executive Director said "New York has all the ingredients necessary to build the world's foremost life science cluster, including a range of business, research, and patient assets unavailable anywhere else. The initiatives launched this week by Governor Cuomo and Mayor de Blasio offer a roadmap to engage these assets in exciting ways. NewYorkBIO is eager to work with both the Governor and the Mayor to ignite New York's life science potential."
For more information:
NEW YORK STATE
Step Therapy Reform Comes to New York
New York Governor Andrew Cuomo closed out 2016 by signing the Step Therapy Reform bill (S.3419C/A.2834D) on New Years Eve. In doing so, New York joins seven other states who have passed similar legislation in recent years. The bill was a top priority of patient advocates in New York who made hundreds of calls, held in-person meetings, and posted to elected officials social media pages in a grassroots effort to drum up support for the bill. NewYorkBIO has been a strong advocate for the bill.
Known as "fail first," step therapy policy are a form of utilization management that health plans may use as a mechanism to control the order in which patients take certain therapies. Step therapy protocols require that patients must try at least one medication selected by their insurer before the plan will grant coverage for the drug originally prescribed by the healthcare provider. Through this method, insurers often require a patient to try a lower-cost drug or service, before they will cover a more expensive option.
Step Therapy Reform, which took effect January 1st, will regulate insurance companies, health maintenance organizations (HMOs), and utilization review agents who impose step therapy protocols on patients, and will provide an expedited appeals process for patients and their health care professionals to override such protocols.
The law will expedite the process of step therapy and specifically:
- Require health insurance companies to provide patients and health care professionals with specific written information on their clinical review criteria relating to a decision made to utilize a step therapy protocol.
- Define key terms such as "step therapy protocol override determination" and "Step therapy protocol."
- Requires a utilization review agent to utilize evidenced-based and peer reviewed clinical review criteria that is appropriate for a patient's medical condition when establishing a step therapy protocol.
- Provide an expedited process for patients and health care providers to override a step therapy protocol. A determination must be made within 24 hours of the receipt of all information from the patient and/or health care provider in emergency cases.
- Establishes standards for an override determination. Upon a determination that the step therapy protocol should be overridden, the health plan must authorize immediate coverage for the prescription drug prescribed by the patient's treating health care provider.
- Provides that if an insurance company or utilization review agent fails to respond within the required timeframes, the appeal shall be deemed granted in favor of the patient.
New York Delegation Sends Letter to PTO Regarding IPR Reform
In November, NewYorkBIO, in cooperation with member companies and BIO, encouraged members of the New York federal delegation to support a letter, co-authored by Reps. Nidia Velasquez and Chris Collins, to the Patent and Trademark Office to "
express our concern with the continued abuse of the inter partes review (IPR)
system by financial speculators and other third parties with no legitimate interests in the patented
The signers particularly urged PTO to
"fully embrace your statutory discretion to curb abuse of the IPR system by hedge
funds and other non-practicing, third party petitioners. Indeed, it is ironic that a system that was
designed to address legitimate concerns about "patent trolls" who abuse their patent rights is now
being used to attack patent owners for similarly illegitimate reasons - a form of reverse patent
trolling. If left unaddressed, we believe these abuses risk upsetting the carefully crafted balance
of procedures that were designed to ensure that the IPR system provides patent owners with a
fair and predictable process for defending their intellectual property rights."
21st Century Cures Act Becomes Law
Over two years of hearings, hundreds of meetings to gather input from patients, agencies, industry, institutes, and with broad bi-partisan support from across the political spectrum, both the US House and US Senate have overwhelmingly passed the 21st Century Cures Act! This vital legislation was signed by Pres. Obama on Dec. 13.
NewYorkBIO is very proud to have been an active advocate for the Act, working closely with BIO, other state associations, and the New York legislative delegation throughout the process.
Nathan Tinker, Executive Director of NewYorkBIO, stated "The 21st Century Cures Act is the most important life science innovation legislation to come along in many years. By encouraging research, expanding access to therapies and promoting collaboration among stakeholders, the Act is a clear and important win for New Yorkers in innovation and research. But most importantly, it is a huge win for the millions of patients in New York (and beyond) waiting for a cure."
The 21st Century Cures Act reforms the current standards and appropriations for biomedical research, provide $1.75 billion annually for the National Institutes of Health (NIH) and $110 million for the Food and Drug Administration (FDA). Along with an increase in NIH and FDA funding, the Act reduces regulations on access to medical research and expedites the testing processes of new drugs.
Among its most important aspects, the Act will break down barriers to collaboration in research, provide funding for important research initiatives including the Cancer Moonshot and the Precision Medicine Initiative, and strengthen the FDA's ability to engage with patients throughout the regulatory process.
Thursday, February 2, 2017
CXO Bootcamp 1: JP Morgan Recap / Biotech Financing and Valuation
Monday, February 13 - Tuesday, February 14, 2017
BIO CEO & Investor Conference
The Waldorf Astoria New York
NewYorkBIO is proud to be the Local Co-Host of the BIO CEO & Investor Conference.
Registration is now open for the
BIO CEO & Investor Conference
, one of the largest investor conferences focused on established and emerging publicly traded and select private biotech companies.
Complimentary registration is available for qualified investors.
NewYorkBIO members receive a special discounted registration:
Early registration: $2,050
Late registration: $2,250
Use registration code: BIOCEO11
Welcome New Members
Special welcome to our newest Sustaining Member
Applied Biological Laboratories Inc.
Aurora BioPharma, Inc.
Center For Aquatic Animal Research and Management
New York, NY
Garwood Medical Devices, LLC
Klus Pharma Inc. Biologics
New York, NY
New York, NY
Raadysan Biotech Inc.
SCINSPIRE Holding & Consulting GmbH
New York, NY
North Brunswick, NJ
New York, NY
New York, NY
|NewYorkBIO Member News
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announced that it was entering into five-year collaboration agreements in oncology research with Johns Hopkins and with Northwestern University.
Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. announced
that Jeannine Larrieux, Ph.D. has been appointed Director of Analytical Development.
Advaxis announced that it was participating in a major collaboration focused on neoantigens, involving researchers at 30 academic, research and industry organizations.
AfriVax supported the Harlem Community Forum on Ebola in December.
Albert Einstein College of Medicine
Albert Einstein College of Medicine announced that
Investigators at Albert Einstein College of Medicine were awarded more than $160 million from the National Institutes of Health in federal fiscal year 2016
The ITL Group
announced a partnership with Applied DNA Sciences to marry Applied DNA's revolutionary SigNature
DNA forensic marking system with ITL's printed fabric care labels to support global apparel and footwear brands and retailers against product counterfeiters.
Argon Medical Devices Biocoatings Corp.
Argon announced that the company has received
clearance from the US Food and Drug Administration to begin marketing the CLEANER XT™ and CLEANER 15™ Rotational Thrombectomy Systems.
Astellas announced that it has completed the acquisition of Ganymed Pharmaceuticals AG.
Brooklyn Borough President Eric L. Adams announced that BioBAT will receive $1 million in Fiscal Year 2017 (FY17) for the outfitting of infrastructure for life science and technology companies occupying BioBAT's laboratory and manufacturing space.
Cold Spring Harbor
Northwell Health and Cold Spring Harbor Laboratory have recruited Robert G. Maki, M.D., Ph.D., an internationally-renowned sarcoma cancer physician and researcher, to join the leadership of the Northwell Health Cancer Institute.
Columbia University Medical Center
Columbia University Medical Center researchers have created a computational tool that can rapidly predict which genes are implicated in an individual's cancer and recommend treatments.
announced that it has been granted a $2.1 million Technology/Therapeutic Development Award through the US Department of Defense Peer Reviewed Medical Research Program
Eli Lilly and Company
Eli Lilly and Company
and AstraZeneca announced a worldwide agreement to co-develop MEDI1814, an antibody selective for amyloid-beta 42 (Aβ42), which is currently in Phase 1 trials as a potential disease-modifying treatment for Alzheimer's disease.
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has approved Avastin ® (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Gilda's Club NYC
Gilda's Club NYC presented its Heart of Gold Award to former NewYorkBIO chairman Robert J. Easton on November 10, 2016. CONGRATULATIONS, BOB!!
HHMI/The Rockefeller University
The Breakthrough Prize Foundation announced that Howard Hughes Medical Institute (HHMI) investigators
of Brigham and Women's Hospital,
of Stanford University, and
of Baylor College of Medicine are among scientists awarded this year's Breakthrough Prizes in Life Sciences.
Johnson & Johnson Innovation, LLC
Johnson & Johnson Innovation LLC and Janssen Research & Development, LLC announced multiple recipients of U.S. $500,000 grants and offers of residency at Johnson & Johnson Innovation | JLABS in the World Without Disease QuickFire Challenge.
Lupus and Allied Diseases Association, Inc.
The Lupus Agencies of New York State won a victory with the signing of the Lupus Education and Outreach Bill by Governor Andrew Cuomo.
MatriTek, Inc. announced the launch of commercial production of novel extracellular matrix (ECM) biomaterials for biomedical research.
Merck & Co Inc.
Merck announced that the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application for KEYTRUDA® (pembrolizumab), the company's anti-PD-1 therapy, for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or for patients who have relapsed after three or more prior lines of therapy.
Attorneys from Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. completed a $24.5 million financing in a private placement of common stock and warrants exercisable for common stock on behalf of Neutotrope, Inc., a company focused on developing drugs to treat neurodegenerative diseases including Alzheimer's disease.
New York Blood Center, Inc.
New York Blood Center announced that researcher
Dr. Sara Lustigman
, Head of the Laboratory of Molecular Parasitology at
NYBC's Lindsley F. Kimball Research Institute
, led the first-ever effort to generate a high-quality genome assembly of Onchocerca volvulus, the filarial parasite that causes onchocerciasis, also known as river blindness.
New York Genome Center
The New York Genome Center (NYGC) has
received conditional approval from the New York State Department of Health to offer
clinical constitutional whole-genome sequence (WGS) testing in its Clinical Laboratory
Evaluation Program (CLEP)-certified laboratory.
New York Medical College
BioInc@NYMC hosted a grand opening ribbon cutting event on December 6 to welcome its anchor client, Philips Healthcare Research.
New York Stem Cell Foundation
Susan L. Solomon, NYSCF CEO, and Dr. Michael Yaffe, NYSCF Vice President of Scientific Programs, contributed eleven new definitions and an editorial on the importance of harmonizing terminology in the industry to the third edition of the Cell Therapy Glossary.
NYU's Dr. Nicola Partridge Awarded $1.9 M to Further Osteoporosis Drug Research and Development.
announced that it has completed the acquisition of the development and commercialization rights to AstraZeneca's late-stage small molecule anti-infective business.
Population Diagnostics, Inc.
Population Diagnostics - a global leader in gene discovery for complex disease - announced that it is changing its corporate name to Population Bio.
Regeneron Pharmaceuticals, Inc. and
Geisinger Health System announced that
has published their study finding that a life-threatening genetic disorder known as Familial Hypercholesterolemia (FH) is both underdiagnosed and undertreated.
RespireRx Pharmaceuticals Inc.
RespireRx Pharmaceuticals Inc. announced
positive results of the PACE (Pharmacotherapy of Apnea by Cannabimimetic Enhancement) trial conducted by Dr. David Carley and colleagues at the University of Illinois at Chicago and Northwestern University.
announced that data from three Phase III studies of its investigational medicine OCREVUS® (ocrelizumab) were published in the 21 December 2016 online issue of the New England Journal of Medicine (NEJM).
esearchers at The Rockefeller University have developed an automated technology that combines imaging with digital analysis and machine learning to help physicians detect melanoma at its early stages.
SUNY Downstate Medical Center
Brooklyn Borough President Eric L. Adams announced that BioBAT will receive $1 million in Fiscal Year 2017 for the outfitting of infrastructure for life science and technology companies occupying BioBAT's laboratory and manufacturing space.
Syndax Pharmaceuticals, Inc.
Syntax Pharmaceuticals, Inc., announced that it has entered into a Cooperative Research and Development Agreement
with the National Cancer Institute for intramural preclinical and
Synthetic Genomics, Inc., announced that it has appointed Tina Nova, Ph.D., and William McKee to its board of directors.
Tonix Pharmaceuticals Holding Corp.
announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to TNX-102 SL* for the treatment of posttraumatic stress disorder (PTSD).
UniFirst Corporation has been named a bronze winner in the Film or Video of the Year category by the Best in Biz Awards.
University of Rochester Medical Center
A University of Rochester study has found that older adults with excellent memories have more efficient connections between specific areas of the brain-findings that could hold promise for the prevention of dementia and cognitive decline.
Bayer AG and Versant Ventures plan to establish a stem-cell research company to develop new and innovative drugs by joining with venture capital and biotechnology firms.
Vertex Pharmaceuticals Inc.
Vertex Pharmaceuticals, Inc.,
announced it has reached a pricing and reimbursement agreement for ORKAMBI® (lumacaftor/ivacaftor) with the German Federal Association of the Statutory Health Insurances
Weill Cornell Graduate School of Medical Sciences
Conor Liston, M.D. '08, an assistant professor of neuroscience in the Feil Family Brain and Mind Institute and an assistant professor of psychiatry at Weill Cornell Medicine, has identified biomarkers in depression by analyzing more than 1,100 functional magnetic resonance imaging (fMRI) brain scans of patients with clinical depression and of healthy control.
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