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April 2017

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NewYorkBIO thanks our Sustaining Members
Pfizer





Notes from Nathan

March and April are busy legislative months for NewYorkBIO, and this year's Advocacy Days in Albany and Washington generated a record number of productive meetings, formal and informal, among legislators, staffers, and our members. 

Even while we follow up on our advocacy, our Annual Conference 2017 promises a deeper dive into the core issues and emerging trends for life sciences organizations. Our keynote, Malcolm Gladwell, is sure to get us looking at our community from a fresh perspective, and we have a plenary panel of life science leaders who will join him after the keynote for a freewheeling discussion of the state of our industry today.
 
The lively panel format also shapes our kickoff for day two, with "Innovation and Its Ability to Transform Healthcare," a discussion, moderated by John Sterling, Editor-in-Chief of  Genetic Engineering and Biotechnology News, focusing on how we must shift both our perspective and the incentives in the healthcare system to a encompass a longer horizon that can capture complete measures of cost, value, and patient outcomes.  New York is at the leading edge of a seismic shift in healthcare, and we must contemplate and adopt policies that support innovation.  

The plenary will explore the argument that we cannot base long-term policy initiatives on one-year snapshots of upfront drug costs and expect to solve any problems.  Whether it's exploring new models for more efficient R&D, piloting innovative pricing models, or working directly with patients to define desired outcomes and endpoints, our shared mission is to rid the world of disease.
 
After exploring where we stand as an industry, our Conference will focus on the future with our 2017 Pitchfest. At PitchFest, entrepreneurs will give a 10-minute pitch presentation to a panel of experienced investors and business development specialists, who will provide Q&A and feedback. Each presentation will be evaluated and scored on a range of important business and scientific criteria by a group of seasoned entrepreneurs, venture capitalists, professionals and investors, including representatives from Johnson & Johnson, Merck, Covington, and more. Top scorers and winners will be announced during the keynote program on Thursday, May 11. View the entire Conference program here.

I look forward to seeing you there!





Nathan Tinker
Executive Director
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Guest Feature

Let's not sugar coat it - managing risk across supply chains has always been complex but it's become more complex in recent years. Life science companies are expanding their supplier networks and increasingly outsourcing services, with each new connection point introducing new vulnerabilities.

While some companies simply fail to account for the financial losses that could occur in the event of a major supplier disruption, others believe they have sufficient insurance coverage to off set any setbacks. In too many cases, companies learn of vital gaps in their coverage after the damage is done.

Life science firms frequently fall victim to three insurance policy pitfalls related to their supply chain: Continue reading...
Gladwell, Plenaries Launch NewYorkBIO 2017 Annual Conference at the Tipping Point
The NewYorkBIO Annual Conference 2017 spotlights the world of ideas available to the innovators shaping the future of Bio science and industry. In a shift from traditional programming, the Opening Keynote by thought leader Malcolm Gladwell will transition into a jumping-off point for a no-holds-barred plenary panel made up of leaders from government, industry, and research-and including Mr. Gladwell--featuring key leaders of the industry:
  • Alicia Glen, Deputy Mayor of New York City
  • Judith Dunn, Roche
  • Richard Lifton, Rockefeller University
  • Robert Urban, Johnson & Johnson Innovation Center
  • Uwe Schoenbeck, Pfizer
  • Michael Aberman, Regeneron
Panelists will consider the concept of New York Life Science at a Tipping Point and what that might mean for the future of the industry.

Day 2 kicks off with a powerhouse roundtable discussion, Innovation and Its Ability to Transform Healthcare, exploring what Executive Director Nathan Tinker describes as "new models for more efficient R&D, piloting innovative pricing models, and working directly with patients to define desired outcomes and endpoints. All of this encompasses our shared mission: to rid the world of disease." Invited and confirmed speakers include:
  • Michael Sherman, Harvard Pilgrim Healthcare
  • Michelle Drozd, PhRMA
  • Maureen Japha, FasterCures
  • Matthew Hurlburt, Pfizer
  • John Sterling, Genetic Engineering and Biotechnology News (Moderator)


NewYorkBIO Hosts Advocacy Day in Albany
Albany Advocacy Day
2017 Advocacy Day in Albany was stunning in terms of the interest, energy, and, well, advocacy, exhibited by all the participants. Newyorkbio Executive Director Nathan tinker said, "legislators learned a lot about the current challenges and needs of the life science community throughout New York." 

Perhaps energized by the political zeitgeist, NewYorkBIO members and friends, including entrepreneurs and CEOs of emerging companies, academics, pharma representatives, and non-profit research organizations together demonstrated the powerful potential of joined voices that express the value, and values, of our industry.  According to one life science CEO attending, "Lawmakers heard our message and came away with an improved understanding of our unique industry."

In photo, above-right:  (l-r) Don Mazzullo (Harter Secrest & Emery), Prem Premsrirut (Mirimus), Nathan Tinker (NewYorkBIO) Cindy Green (Pfizer), Senator Marty Golden, Christie Hubbard (International AIDS Vaccine Initiative)



NewYorkBIO Delegation Joins BIO Fly-In 2017
Congressman Tonko
NewYorkBIO spent the first week of April leading the New York delegation--made up of leaders from emerging and established companies, from academic and research institutions, as well as from Pharma and non-profits--through the halls and tunnels of the Capitol to meet with legislators and to explain the needs and concerns of the industry in 2017 and beyond.
 
Executive Director Nathan Tinker underscored the importance of the event for advocacy: "The BIO Fly-in is a vital opportunity for the New York life science industry to meet directly with our legislative delegation. With 27 influential congressional districts, New York is one of the largest and most important in the US. NewYorkBIO's advocacy helps members inform, educate, and impact our congressional representatives and senators."
 
On April 4th, the evening before the formal Fly-In meetings, three members of Congress and a dozen Hill staffers joined members of the New York and New Jersey delegations at Bistro Bis for the first annual Joint Legislative Reception.  NewYorkBIO members enjoyed the opportunity to meet informally with their representatives in Washington and to introduce legislators to the companies and institutions that make up the life sciences throughout state.

Photo, above-right: (l-r) Don Mazullo (Harter Secrest & Emery), Nathan Tinker (NewYorkBIO), Congressman Paul Tonko, Bob Easton (Bionest Partners), Peter Robinson (University of Rochester)



Rockefeller's President Richard P. Lifton to Headline April CEO Breakfast Club
Following tradition, the Lamb's Club will be the setting for the next session of NewYorkBIO's CEO Breakfast Club, which features The Rockefeller University's President Richard Lifton. This popular event offers attendees the opportunity to enjoy relaxed, free exchange among leaders of New York's life sciences. Limited to 25 life science executives, the CEO Breakfast Club affords the space for leading life science thinkers, entrepreneurs and investors to share ideas.

A physician-scientist who holds M.D. and Ph.D. degrees from Stanford University, Dr. Lifton has pioneered the use of genetics and genomics to understand fundamental mechanisms underlying human diseases, including cardiovascular disease, neoplasia, kidney disease, and osteoporosis. He is especially known for research on hypertension and salt intake, work which has informed public health efforts and therapeutic strategies used worldwide.

Dr. Lifton is a member of the National Academy of Sciences and the National Academy of Medicine and served as a Howard Hughes Medical Institute Investigator from 1994 until assuming the Rockefeller presidency in 2016. He was the co-chair of the planning committee for President Obama's Precision Medicine Initiative in 2015.


LifeSciTodayNew York Legislative Update


NEW YORK CITY AND STATE
NewYorkBIO has been advocating for large-scale thinking and investment Nathan Tinker, NewYorkBIO Executive Director says, "New York is truly poised to build the world's foremost life science cluster, with a range of business, research, and patient assets unavailable anywhere else. NewYorkBIO has a wide array of experts within our membership who are enthusiastic about opportunities to strengthen our industry while helping the next generation of innovators to succeed. We look forward to to working with the governor, the mayor, and their administrations to make New York the premiere destination for life sciences innovation and research."


NEW YORK STATE

NewYorkBIO Opposes Effort to Mandate Price Controls on Biopharmaceutical Products
NewYorkBIO strongly opposes Part D of the Health and Mental Hygiene Article VII budget proposal. This
proposal would allow the state to impose draconian price controls on all pharmaceuticals sold in New York and  thereby disincentivize innovative drug makers from offering their products in the New York market. Most  importantly, it would stifle the development of innovative therapies that target some of the most challenging and  debilitating diseases in our lifetime.
 

New York Bioscience Advocacy Day
Once a year, NewYorkBIO hosts Bioscience Advocacy Day, inviting life science and health executives from across New York to come to Albany for a day of legislative briefings and advocacy.  For 2017, NewYorkBIO was host to delegations in one-on-one and small group meetings with legislators, agencies, and departments on  March 6-7, 2017. 

Our delegation included life science leaders from industry, academia, research advocacy organizations, and investment, who met with Members of the State Legislature and their senior staff on the most important legislative issues facing the biotechnology industry in New York, including fair pricing, economic development, and patient access to innovative therapies.



FEDERAL UPDATE
On April 4 and 5, 2017, NewYorkBIO led the New York delegation for t he BIO Legislative Day Fly-In. The annual Fly-In is a free event hosted by BIO as a benefit of membership. Attendees participated in a legislative briefing and networking reception on Tuesday, April 4. On Wednesday April 5 attendeesl visited congressional offices and participated in meetings with New York senators, representatives, and staff. Discussion focused on industry support, ACA reform, FDA reform, the regulatory landscape, and patent reform. 

EventsUpcoming Events

Thursday, April 20, 2017 
CEO Breakfast Club with Rick Lifton, President, The Rockefeller University
Details & Registration

Tuesday, May 2, 2017 
Clinical Trials in Oncology
Tuesday, May 9-13, 2017 
The Biology of Genomes

Wednesday and Thursday, May 10-11, 2017 
2017 NewYorkBIO Annual Conference
Details & Registration

Thursday to Friday, May 18-19, 2017 
9th Annual New York State Biotechnology Symposium



Richard P. Lifton 
President, The Rockefeller University


Thursday, April 20
7:30AM

Sponsored by

Welcome New Members


2X Oncology
New York, NY

Advanced Accelerator Applications USA, Inc.
Milburn, NJ

Albany College of Pharmacy and Health Sciences
Rensselaer, NY

Albany Medical Center
Albany, NY

AMRI
Albany, NY

Beagle Bioscience
New York, NY

Bioconnex
Albany, NY

Bioharmony Therapeutics Inc.
New York, NY

BioHealthWays, Inc.
Brooklyn, NY

Biotechnology Accelerator Commercialization Center (BACC)
Albany, NY

BioWorks Inc.
Victor, NY

Business Opportunities Management Consulting
East Greenbush, NY

Canget BioTekpharma
Buffalo, NY

Center For Aquatic Animal Research and Management
Wingdale, NY

Center for Biotechnology & Interdisciplinary Studies
Troy, NY

Clarapath
New York, NY

ConquerAb Inc.
Philadelphia, PA

Coté Orphan, LLC
Silver Spring, MD

DrinkSavvy Inc.
Brooklyn, NY

Exemplify BioPharma
Cranbury, NJ

FALATI
Albany, NY

FitBiomics
Boston, MA
GE Global Research
Niskayuna, NY

Halloran Consulting Group, Inc.
Boston, MA

Hudson Valley Community College
Troy, NY

Kinnos
Brooklyn, NY

Klus Pharma Inc. Biologics

Krackeler Scientific
Albany, NY

Lodo Therapeutics Corporation
New York, NY

Longfellow Real Estate Partners, LLC
Boston, MA

Lucerna, Inc.
Brooklyn, NY

Matritek, Inc.
New York, NY

Mosaica Therapeutics Inc.
Howard Beach, NY

Moses & Singer LLP
New York, NY

NangioTx
New York, NY

Nevakar, LLC
Bridgewater, NJ

New York Huaqi Bioengineering, LLC
Brooklyn, NY

Parkside Scientific Inc.
Brooklyn, NY

Sanofi
Bridgewater, NJ

Scilligence Corporation
Cambridge, MA

Skidmore College
Saratoga Springs, NY

Taithera, Inc.
New York , NY

Tri-Medix LLC
Larchmont, NY

TRUETOX Laboratories
Garden City, NY

University at Albany
Albany, NY

WRS Therapeutics
New York, NY


MemberNewsNewYorkBIO Member News

NEWS SUBMISSIONS
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Acorda Therapeutics, Inc.
U.S. District Court issues decision to invalidate four Ampyra patents; company will appeal ruling.
 
Advaxis, Inc.
Advaxis announced that the U.S. Food and Drug Administration has indicated the Investigational New Drug application for ADXS-NEO, a personalized neoantigen-targeted approach to cancer immunotherapy that is being developed in collaboration with  Amgen, can proceed.
 
Albert Einstein College of Medicine
Einstein researchers have developed and validated a method for accurately identifying mutations in the genomes of single cells. The new method, which can help predict whether cancer will develop in seemingly healthy tissue, is described in a paper published in the online edition of Nature Methods. 
 
Alexandria Center
Alexandria announced that S&P Dow Jones Indices will include the company in the S&P 500®
 
AMRI
AMRI  has been honored as part of the  Life Science Leader's 2017 CMO Leadership Awards in five categories
 
Astellas Pharma US, Inc.
Astellas Pharma US announced that John DeMay has been appointed president, Astellas US Technologies, Inc.

Bristol-Myers Squibb Company
Bristol Meyers Squibb Company announced that the U.S. Food and Drug Administration accepted a supplemental Biologics License Application that seeks to extend the use of Opdivo (nivolumab) to patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

Celgene Corporation
Celgene Corporation and Agios Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted Celgene's New Drug Application for enasidenib (AG-221/CC-90007).
 
Cellectis, Inc.
Servier, together with Pfizer Inc. and Cellectis, announced that the U.S. Food and Drug Administration has granted Servier with an Investigational New Drug clearance to proceed in the U.S. with the clinical development of UCART19, an allogeneic, gene-edited cellular therapy candidate to treat relapsed/refractory acute lymphoblastic leukemia.
 
Cold Spring Harbor Laboratory
The New York Chapter of The Children's Heart Foundation presented Dr. Michael Ronemus of Cold Spring Harbor Laboratory a $50,000 grant to pursue research into the genetics of congenital heart disease.
Read More
 
Columbia University
Under an worldwide exclusive licensing agreement with Columbia University and Memorial Sloan Kettering Cancer Center, Lin BioScience plans to develop the novel CDC7 inhibitor (LBS-007) against a wide range of cancers.
 
CUNY Graduate Center
The GC, in partnership with the University of Minnesota Press, has launched a demo of its new interactive platform for scholarly publishing, funded by a grant from the  Andrew W. Mellon Foundation,
 
Eli Lilly and Company
Eli Lilly and Company announced plans to invest $850 million in its U.S. operations in 2017, including research laboratories, manufacturing sites.
 
Frommer Lawrence & Haug LLP (Haug Partners LLP)
Effective March 1, 2017, Frommer Lawrence & Haug transitioned to its new name, Haug Partners LLP. 
 
GE Global Research
GE is planning to launch products based on what it calls a Digital Ghost, a combination of its digital twin efforts and industrial control technologies, to thwart cyberattacks.
 
Genentech
that the U.S. Food and Drug Administration approved OCREVUS™ (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. 
 
Gilda's ClubNYC
Gilda's Club New York City presented The 6th Annual Gildie Awards - A Celebration of Life, Laughter, and Courage
 
Harlem Biospace
Harlem Biospace announced its April Riverside Chat: Life Science Angel Investing, co-hosted by Columbia Engineering and Columbia technology Ventures.
 
HHMI/The Rockefeller University
The Howard Hughes Medical Institute (HHMI) announced that it seeks to appoint up to 20 new biomedical researchers through a national open competition.
 
Invest in Denmark
Invest in Denmark is organizing a by-invitation-only luncheon & roundtable discussion: "Clinical Trials in Oncology" on May 2nd  at the Consulate General of Denmark in New York City.
 
Kinnos
Kinnos announced the closing of $1 million in seed round funding.
 
Lauren Sciences LLC
Lauren Sciences announced the award of its second grant from Voices Against Brain Cancer. VABC grant will support Lauren Sciences continued development of LAUR-401, its novel V-Smart™ Nanomedicine for Glioblastoma Multiforme. 
 
Merck & Co., Inc.
Merck announced that the U.S. Food and Drug Administration has approved KEYTRUDA® (pembrolizumab), the company's anti-PD-1 (programmed death receptor-1) therapy, for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy.
 
New York Genome Center
New York Genome Center's next Five Points Lecture features Stanford's Jin Billy Li, PhD, on New Insights of RNA Editing Regulation.
 
New York Huaqi Bioengineering, LLC
New York Huaqi Bioengineering, LLC, was included in the latest update to Start-Up NY.
 
New York University
A global research team, led by NYU Langone geneticist  Jef Boeke, PhD, and a team of more than 200 authors, has built five new synthetic yeast chromosomes, meaning that 30 percent of a key organism's genetic material has now been swapped out for engineered replacements.
 
Pepper Hamilton LLP
Pepper hamilton announced the creation of a new  Health Sciences Department. The firm will combine several of its premier practice areas in order to better serve clients in the health sciences industry.  The new department will be led by Pepper's former chairwoman,  Nina M. Gussack
 
Pfizer Inc.
Pfizer announced a collaboration with the National Newspaper Publishers Association to raise awareness of and improve patient care for Sickle Cell Disease.
 
Regeneron Pharmaceuticals, Inc.
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration approved DUPIXENT® (dupilumab) Injection, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
 
Roche
Roche announced that the US Food and Drug Administration approved OCREVUS™ (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. 
 
Royalty Pharma Management LLC
Royalty Pharma announces $2.85 billion acquisition of royalty rights in multiple sclerosis drug Tysabri® (natalizumab) from Perrigo Company.
 
Sanofi
Sanofi and  Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration approved Dupixent® (dupilumab) Injection, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

SUNY Downstate Medical Center
Locked-in ALS patients answer yes or no questions with wearable fNIRS device created at SUNY Downstate.
 
Taconic Biosciences, Inc.
Tactic Biosciences has launched ExpressMODEL™ that reduces the timeline to first generation and experimental cohort by up to four months. 
 
Tonix Pharmaceuticals Holding Corp.
Tonix announced the pricing of an underwritten public offering of 1,800,000 shares of its common stock at a public offering price of $4.45 per share. 
 
University of Rochester Medical Center
Fabeha Fazal, Ph.D., assistant professor of Pediatrics and Neonatology at UR Medicine's Golisano Children's Hospital, has received a 4-year, $1.9M grant to identify viable therapies that will limit acute lung injury (ALI).

Vertex Pharmaceuticals Inc.
Vertex announced that it has signed a definitive asset purchase agreement to acquire CTP-656 from Concert Pharmaceuticals for the treatment of Cystic Fibrosis

Weill Cornell Medicine
Weill Cornell Medicine researchers will receive a grant from the Department of Defense to conduct an in-depth study of the molecular machinery driving the most aggressive form of prostate cancer.

Yiviva
Yale biotech startup Yiviva received an Innovation Award at the  US-China Health Summit in the fall.

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