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NewYorkBIO News   
July 2016

NewYorkBIO Updates   *   New York Legislative Updates   *   Events   *   Member News

Notes from Nathan

First off, THANK YOU to all of you who joined us for the NewYorkBIO 2016 Annual Conference in May! By all measures, the Conference was a huge success and set a new standard in life science programming. Our panelists and speakers delivered stimulating, dynamic sessions on innovation, funding, investment, and health technology and translation. Thursday's sessions on microbiome, immune-oncology, and medical cannabis further demonstrated the innovative power of our life sciences where hard science meets industry.

Your feedback on our new programs, as well as on annual events that have evolved and grown, has been invaluable, and I am grateful for your continued enthusiasm. We received impressive feedback this year, with attendees particularly pleased by the high quality of the panels and PitchFest sessions representing the broad interests of life science industry in business, research, and technology.

Hard on the heels of our conference was the BIO International Convention in San Francisco. With more than 15,000 attendees, this is the largest bioscience meeting on the planet and New York was well represented with hundreds of attendees from all across the Empire State. I am especially proud that NewYorkBIO was able to partner with Empire State Development to provide underwriting grants to 12 emerging companies to help them attend the Convention and network with the world. We are already in planning New York's presence at the 2017 BIO Convention in San Diego--I hope you will help us!

And even though the Conference and the Convention kept us busy, we revved up advocacy activities. Our spring and summer legislative work has proved very successful, as we defeated two pricing and labeling bills that threatened our members and indeed threatened business development in New York. Moreover, we won some impressive victories to pass helpful legislation, including Provider Prevails and Step Therapy legislation. As we advocated for the industry, we really felt we spoke with and for our membership, as NewYorkBIO members took the opportunity to join NewYorkBIO staff in expressing concerns about important legislation.

I look forward to seeing you at the BioCruise and all our summer events!

Nathan Tinker
Executive Director

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NewYorkBIO Annual Conference 2016 Highlights Ideas
The 2016 NewYorkBIO Annual Conference explored the key issues of the life sciences community today, with panels and special sessions devoted to the science of health and disease, a guide to capital markets, investment tips for biotech startups, and the ins and outs of business development.  

This year's Pitch sessions featured a new twist, as s enior business development experts from Merck, Pizer, Eli Lilly, Sanofi, and Novartis were among a distinguished panel of judges for this event featuring over 40 companies.  Each PitchFest entrepreneur gave a 15-minute pitch to an investor panel, followed by 5 minutes of Q&A and 5 minutes of non-rebuttal feedback from the panel. Pitches were then evaluated and scored on a range of important business and scientific criteria. Leading scorers and winners were announced during the keynote program, and much was learned by all about the great state of innovation in New York life sciences.

Celgene CEO Mark Alles delivered the Keynote address, "Medical Innovation and Health: Today's Age of Great Hope, Challenges, and Opportunities" on Thursday, May 12th.   Alles thrilled attendees with an electric, inspiring talk.  NewYorkBIO's Executive Director Nathan Tinker said that he has gotten such an intense, positive response to Alles' dynamic presentation that NewYorkBIO will make it available on the organization's website this week.

Save the Date: May 10-11 for the NewYorkBIO 2017 Annual Conference @ the Time Warner Center.

Eli Lilly to Meet NewYorkBIO Talent
On July 12th in New York City, NewYorkBIO will host an invitation-only meeting and reception with a group of New York-area organizations, including academic institutions and investigators, companies, and patient and disease foundations.  This diverse group of life sciences professionals will meet with senior leaders from Eli Lilly as part of NewYorkBIO's Partnering programming.
Throughout the day Lilly will cover their areas of interested for innovation partnering and  will have teams within the following areas participating in one-on-one meetings: Oncology, Neuroscience, Diabetes, Autoimmune Disorders, Cardiovascular, Biotherapeutic Technologies, Emerging Markets, and Drug Delivery & Devices.

Additionally, NewYorkBIO will host a Plenary Session and Panel Q&A Discussion by Eli Lilly from 8:30 to 10:30 AM.  Lilly will offer presentations outlining the scientific areas they represent.  Anyone interested in attending this open session should contact Nathan Tinker for details.

NewX2 BioCruise 2016 Ready to Set Sail
Summer in New York life sciences always signals the launch of BioCruise. This unique networking event hosted by NewYorkBIO and BioNJ has become the top life science business and social event of the season.  On July 13th, the two organizations, along with their members and friends, will meet for a beautiful tour of our beloved New York Harbor. According to one regular participant, "the cruise offers me the chance to reconnect with my life science friends in a totally non-stress environment.  It's difficult for these busy folks to find time to socialize, and, ironically, I always seem to accomplish some profitable business here, merely by spending this quality time with industry friends."

Executive Director of NewYorkBIO, Nathan Tinker, explains, " Our annual voyage through New York and New Jersey waterways is always  THE  networking event of the summer, bringing together the life science communities of  BioNJ  and NewYorkBIO." Along with networking, the cruise features fine dining and live music, and it always includes Lady Liberty at sundown.  

Jason Park of Flagship Ventures to Breakfast with CEOs
The summer edition of CEO Breakfast Club features a talk by Jason Park, Flagship Ventures principal.  This popular NewYorkBio event offers life science executives an opportunity to share ideas with about 25 of their peers in life science leaders entrepreneurship and investment in an intimate setting at New York City's renowned Lamb's Club.

Jason Park is a principal at Flagship Ventures and leads the Flagship team administering the $150 Million City of New York Life Science Fund.   The co-investment partnership exceeded its initial funding goal by $50 million to launch with a total of $150 million, which includes $10 million in anchor funding from NYCEDC and leveraged with capital from industry partners and managed by leading venture capital partners. The Funding Initiative will identify and invest in the most promising research generated by the city's academic medical institutions and leading entrepreneurs, creating and growing companies working on the leading edge of life sciences advances.

The Early Stage Life Sciences Funding Initiative was initially announced in 2013 with the aim of deploying $100 million in public and private capital. The project leverages NYCEDC funding with capital from industry partners Celgene Corporation, GE Ventures and Eli Lilly and Company (Lilly). Two top tier venture capital firms, Flagship Ventures and ARCH Venture Partners, will manage separate investment activities within the Funding Initiative and will each establish a presence in New York City.

LifeSciTodayNew York Legislative Update


Now that the 2016 legislative session has concluded, the lawmakers have returned to their districts to begin campaigning. All 213 members of the Senate and Assembly must run for reelection this November. While there will be several key races to watch in the Assembly, no race in that house will impact the overall control of the Assembly by Democrats. 

The same cannot be said for the Senate. The races in the Senate will be watched very closely as the Democrats in the Senate seek to take the majority from the Senate Republicans. Right now, the Senate Democrats have the technical numerical majority, but several side alliances between Democrats and the Republicans allow the Republicans to maintain the majority. This November, the Democrats will seek to gain an outright majority, while the Republicans do the same. There will be a handful of very competitive races that will be watched closely. We will keep you posted on all of the developments with an election update in November. 

During the session, NewYorkBIO worked in Albany on over a dozen major legislative priorities, and we succeeded in strengthening and supporting biosciences across the state.  
  • NewYorkBIO and its supporters defeated efforts to mandate price controls on biopharmaceutical products. As one of the largest bioscience sectors in the country, New York bioscience could have been crippled by this legislation.
  • NewYorkBIO also succeeded in defeating legislation providing for the regulation of genetically engineered products, which would have imposed a set of new labeling requirements on products that contain food that has been modified by modern genetic engineering techniques. NewYorkBIO strongly opposed this unnecessary and expensive legislation, which threatened to undermine New York's leadership in the field of biotechnology. 
  • NewYorkBIO also strongly supported A.2834-A / S.3419-A an act to amend the insurance law in relation to the regulation of step therapy and first fail health insurance policies and contracts. The legislation requires clinical review criteria used to establish step therapy protocols be based on clinical practice guidelines endorsed by independent experts, based on high quality studies, and be created by a transparent process. It also requires that patients and health care providers have access to a clear and convenient process to request a step therapy exception determination, thus guaranteeing the health and safety of consumers by providing necessary patient protections. The legislation passed the Senate with strong support, and the Assembly unanimously!

Despite this being summer during an election year, there is still important bioscience activity in Washington DC. This week, the U.S. Senate moved forward on the Roberts and Stabenow GMO Labeling and Disclosure Bill. The bill now heads to the House. As detailed below, NewYorkBIO supports passage of a fair plan that clarifies the labeling process nationally.
  • NewYorkBIO, along with BIO, the Coalition for Safe and Affordable Food, and 18 other state life science associations, joined forces in support of the H.R. 1599, the Safe and Accurate Food Labeling Act. This bipartisan legislation will ensure that food labeling in the United States is uniform and science-based.  The proposed legislation also would improve clarity for foods carrying a GMO-free label and provide uniform rules by creating a national certification program for foods that have been produced without bioengineering.
  • We also worked closely with BIO to in support of H.R. 4139, the Fostering Innovation Act. The Fostering Innovation Act would support the growth of emerging biotechs by reducing the cost of burdensome regulations. Specifically, the bill would create a targeted five-year exemption from Sarbanes-Oxley (SOX) Section 404(b) for JOBS Act companies that are still pre-revenue when the IPO On-Ramp expires. The Fostering Innovation Act represents a move away from one-size-fits-all compliance burdens, and we believe it will sustain the growth of the biotech industry in New York and support the search for the next generation of medical breakthroughs.

EventsUpcoming Events

Monday & Tuesday, July 11-12, 2016
Meet with Eli Lilly

Wednesday, July 13, 2016
4:00 PM - 9:00 PM 
NewX2 BioCruise 2016
New York Harbor World Yacht at Pier 81

Wednesday, July 20, 2016
7:30 AM - 9:30 AM 
CEO Breakfast Club with Jason Park, Principal, Flagship Ventures
The Lambs Club
Wednesday, September 14, 2016
Buffalo BioCruise

Welcome New Members

A special welcome and thank you to our newest  Premier Members

Advaxis, Inc.
Alpha1 Biologics, LLC
American Laboratory Trading
Applied Biological Laboratories
ASC Biosciences
Aset Therapeutics LLC
Aurora BioPharma, Inc.
Axella Bioventures
BeyondSpring Pharmaceuticals
Biogelx, Inc.
Biotherapeutics Inc.
Concarlo Holdings
Cox Biosciences LLC
Cyclops Research & Development, Inc.
Efferent Labs, Inc.
ENB Therapeutics
Explorium Capital LLC
Foliage, part of the Altran Group
GenoPheno, LLC
HemoGenyx LLC
Highline Therapeutics, Inc.
iCell Gene Therapeutics
Kyras Therapeutics Inc.
Merck & Co., Inc.
Merck Research Laboratories
Mirna Analytics, LLC
Neurovation Labs, Inc.
NomoCan Pharmaceuticals LLC
OncGen Therapeutics
Pepper Hamilton LLP
Pulmokine Inc.
Quentis, Inc.
SkinAxis LLC
Syndax Pharmaceuticals, Inc.
Thymon, LLC
US Specialty Formulations LLC
Vertex Pharmaceuticals Inc.
Virtual SurgerySIM
Xaleron Pharmaceuticals, Inc.

CEO Breakfast Club 
with  Jason Park

Flagship Ventures
July 20

MemberNewsNewYorkBIO Member News

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AbbVie Inc.
AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved HUMIRA® (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis.

Acorda Therapeutics, Inc.
Acorda Therapeutics, Inc.  announced that Burkhard Blank, M.D. has assumed the role of Chief Medical Officer.
Read More 

Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. announced positive results from its Phase 1 Actimab-A trial in patients newly diagnosed with acute myeloid leukemia (AML) who are over the age of 60.

Advaxis, Inc.
Advaxis announced that it reached an agreement with the U.S. Food and Drug Administration (FDA), under the Special Protocol Assessment process, for the Phase 3 AIM2CERV trial evaluating the Company's lead Lm immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with high-risk, locally advanced cervical cancer.
Read More

Albert Einstein College of Medicine
Albert Einstein College of Medicine has named Kamran Khodakhah, Ph.D. chair of the Dominick P. Purpura Department of Neuroscience. 

Allovate, LLC
Allovate was featured on CBS New York.

Applied Biological Laboratories
Applied Biological Laboratories Inc. submitted form D announcing $3,000,000 equity financing.
Read More

BeyondSpring Pharmaceuticals
Beyond Spring Pharmaceuticals announced that it has filed two new method of treatment patent applications with the United States Patent and Trademark Office to cover methods of treating brain tumors as well as cancers expressing a mutant form of RAS protein through administration of the Company's lead compound, Plinabulin.

BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. announced the publication of data highlighting the efficacy of collagenase clostridium histolyticum (CCH) for the treatment of uterine fibroids in the May 2016 issue of the American Journal of Obstetrics & Gynecology.
Read More

Biotherapeutics Inc.
Jean-Frederic Colombel, MD, an internationally renowned clinician and researcher in inflammatory bowel disease (IBD) and gastroenterology, has been appointed to BioTherapeutics' SAB.

Bristol Myers Squibb
Cormorant Pharmaceuticals announced that Bristol-Myers Squibb has acquired all of the outstanding capital stock of Cormorant, a private, Stockholm, Sweden-based pharmaceutical company focused on the development of therapies for cancer and rare diseases.
Read More

Celgene Corporation
Celgene entered into four public-private collaboration agreements in which it paid a total of $50 million, $12.5 million to each of four NCI Cancer centers, for the option to enter into future agreements to develop and commercialize novel cancer therapeutics arising from the consortium's efforts.

Cellectis Inc. 
Cellectis Inc. announced that the Company has been selected as a 2016 World Economic Forum Technology Pioneer,

Celmatix, Inc.
Celmatix was featured in Genetic Engineering & Biotechnology News
Read More

Chembio Diagnostic Systems Inc.
Chembio Diagnostic Systems Inc.  announced the launch of U.S. sales of its Chembio-branded SURE CHECK® HIV 1/2 Assay.
Read More

Children's Tumor Foundation
CTF announced that it is participating in the Cancer Moonshot Summit
Read More

Cold Spring Harbor  Laboratory
The Pershing Square Sohn Cancer Research Alliance announced that Associate Professor Christopher Vakoc, M.D., Ph.D., of Cold Spring Harbor Laboratory is among seven winners of the third annual Pershing Square Sohn Prize for Young Investigators in Cancer Research.

Columbia Technology Ventures, Columbia University
Columbia Technology Ventures announced that it is one of four NCI Cancer Centers collaborating with Celgene.

Eli Lilly and Company
Eli Lilly and Company announced the promotion of Aarti Shah, Ph.D., to senior vice president and chief information officer effective July 1.
Read More

EpiBone was featured in Scientific American.

Harlem Biospace
Harlem Biospace announced the launch of Synaptic.

HHMI/The Rockefeller University

Intensity Therapeutics, Inc
Intensity Therapeutics, Inc.,  announced that it has secured $10 million in new capital from a Series A preferred stock financing.
Read More

International AIDS Vaccine Initiative
The International AIDS Vaccine Initiative and its partners have received a five-year cooperative agreement award with a US$160 million ceiling from the U.S. Agency for International Development (USAID).

Johnson & Johnson Innovation Center
Janssen Brazil and Johnson & Johnson Innovation, JLABS, announced that a research project from Alberto Luiz Coimbra Institute of Graduate Studies and Engineering Research, Federal University of Rio de Janeiro has been selected as the recipient of the QuickFire Challenge award in Latin America,
Read More
Lupus and Allied Diseases Association, Inc.
The Alliance for Lupus Research (ALR), the Lupus and Allied Diseases Association (LADA), Lupus Foundation of America (LFA), and the Lupus Research Institute (LRI) announced that a Lupus Patient-Focused Drug Development Meeting - Lupus: Patient Voices - will be held in spring 2017.
Read More
Merck & Co Inc.
Merck and Moderna Therapeutics announced a strategic collaboration and license agreement to develop and commercialize novel messenger RNA (mRNA)-based personalized cancer vaccines

New York Stem Cell Foundation
Yumanity Therapeutics, a company focused on transforming drug discovery for diseases caused by protein misfolding, announced a discovery collaboration with the New York Stem Cell Foundation (NYSCF) Research Institute
Read More

November Inc. announced the completion of a pair of successful commercial-scale rigid foam trials utilizing the company's unique Converge® CO2-based polyol blends.
Read More

Ophthotech Corporation
Opthotech announced that it has completed patient recruitment in Phase 3 Trial of Fovista in combination with Eylea or Avastin in Wet Age-Related Macular Degeneration
Read More

Merck KGaA, Darmstadt, Germany, and Pfizer announced the initiation of a Phase III study, JAVELIN Ovarian 100, to evaluate the efficacy and safety of avelumab* in combination with, and/or as follow-on treatment to, platinum-based chemotherapy in patients with locally advanced or metastatic disease with previously untreated epithelial ovarian cancer.

Provista Diagnostics, Inc.
Provista Diagnostics announced positive results from Provista 002, a large, multi-center trial for its diagnostic test, Videssa® Breast.
Read More

Purdue Pharma L.P.
Mundipharma Medical Company Limited and the independent associated company, Purdue Pharma L.P., announced that, following completion of Phase II studies, they have exercised their option and taken over full responsibility from Laboratorios Esteve, S.A.U. for the clinical, regulatory and commercial development of a potential first-in-class sigma-1 antagonist.  

Roche announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Tecentriq® (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma

SUNY Downstate Medical Center
New research led by SUNY Downstate Medical Center shows that mice devoid of PKMzeta, a molecule previously identified by SUNY Downstate scientists as essential to memory formation and storage, recruit a closely related molecule, PKCiota/lambda, to make up for the missing PKMzeta.
Read More

Symbiomix Therapeutics, LLC
Symbiomix Therapeutics announced positive results from the seond trial of Sym-1219 as a single-dose therapy for BV.  The company also announced a successful pre-NDA meeting with the US FDA.
Read More  

Syndax Pharmaceuticals, Inc.  
Syndax Pharmaceuticals, Inc.,  announced that it has entered into an exclusive worldwide license agreement with UCB for UCB6352, an IND-ready anti-CSF- 1R monoclonal antibody

Synthetic Genomics
Synthetic Genomics, Inc. announced that Anthony Artuso has joined its executive team as Chief Business Officer.

The Center for Technology Licensing
Cornell University's Center for Technology Licensing announced that one of its companies, Stealth BioTherapeutics announced the presentation of positive results from MMPOWER in patients with a genetically confirmed mitochondrial disease.
Read More
The Research Foundation of SUNY
The University at Buffalo has established a new international hub for addressing global health challenges through pharmacological research and drug and vaccine development, the Center for Integrated Global Biomedical Sciences.
Read More

University of Rochester Medical Center
The Center for Musculoskeletal Research at the University of Rochester Medical Center recently received renewal of a five year, $4 million grant from the National Institutes of Health.
Read More

Vertex Pharmaceuticals Inc.
Vertex Pharmaceuticals Inc and Moderna Therapeutics announced that the two companies have entered into an exclusive research collaboration and licensing agreement aimed at the discovery and development of messenger Ribonucleic Acid (mRNA) Therapeutics™ for the treatment of cystic fibrosis (CF).