BioLines Weekender

Transcription

BioLines Weekender

BioLines Weekender
To Our New Jersey Life Sciences Community:
Welcome to the Weekender.
It's been quite a week for New Jersey, and for the BioNJ Team.
The good news included Bridgewater-based BioNJ Member Helsinn Group and Eisai
Inc. receiving Food and Drug Administration (FDA) approval AKYNZEO® and Morris
Plains-based BioNJ Member Immunomedics, Inc. announcing that the European Medicines Agency (EMA) has
granted orphan drug status for one of the company's solid-tumor antibody-drug conjugates.
Add to that the fact that on Monday and Tuesday BioNJ's 2nd Annual CEO Summit TOOK IT to the TOP with
250 participants, and maybe it was more than a pretty good week. Our great thanks to all who contributed to the
CEO Summit.
Enjoy the news below and your weekend.
Because Patients Can't Wait,
The BioNJ Team
Highlights include:
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BioNJ Calendar - Stay Tuned for Registration Information for the Annual Dinner Meeting
BioNJ News - Seeking Dr. Sol J. Barer Award Nominations; BIO 2015: The Road Leads through NJ
NJ Industry News - FDA Approves AKYNZEO®; Celator(R) Pharmaceuticals Announces Pricing of a
$12.9 Million Public Offering of Common Stock and Warrants to Purchase Common Stock; Advaxis
Appoints Chief Medical Officer; The Opening Of Paramesh Banerji Life Sciences Homeopathic
Medicine Manufacturing Facility in New Jersey; Bone Biologics Corp. Completes its Reverse
Merger; FluoroPharma Announces That Data From Its Phase II Clinical Trial of 18-F FCPHA
(CardioPET) Was Presented at the Annual Congress of the European Association of Nuclear
Medicine; Immunomedics Announces European Orphan Drug Designation for Isactuzumab Govitecan
for Pancreatic Cancer Treatment; TrialScope Appoints Chief Financial Officer; Law Firm Prepares for
Myriad of Virus-Related Questions; Horizon Blue Cross Blue Shield of New Jersey Creates Groundbreaking Patient-centered Program for Cancer Treatment; Cancer Genetics Inc. Granted Patent; New
Jersey Companies Make Donations in Fight Against Ebola ; StateBook International Signs Choose
Charter Members; Lexicon and Ipsen Enter into Ex-North America/Japan Licensing and
Commercialization Agreement; Detecting Cancer Earlier is Goal of Rutgers-Developed Medical Imaging
Technology; Article by James Golubieski for NMS Management
Funding News - Register Today for a Free Webinar About NCATS Small Business Funding
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Industry Events - NSF SBIR Program & 1-to-1 Appointments; IPT 2014 Pharma/Life Science Regional
SALT Seminar
NJ University/Institution News - Rutgers Business School Executive Education is Offering a MiniMBA
with a 10 Percent Discount Extended to BioNJ Members
BioNJ Business Solutions: Office Depot Offers HP OfficeJet Pro X Buy One Get One Offer; BioNJ's
Purchasing Consortium; Purchasing Consortium Highlighted at CEO Summit
Talent News - LSTN at BioNJ Job Leads; Rutgers University Camden - Internship Fair
BioNJ Tweets of the Week - A New Section Featuring Notable Tweets of the Week
BioNJ Calendar
BioNJ Legal Forum
November 18, 2014
NPS Pharma
Bedminster, NJ
By Invitation
Only
Drug Development
Primer
December 11-12, 2014
The Conference Center
at Mercer
West Windsor, NJ
Register Now
BioNJ Annual Dinner
Meeting
February 5, 2015
Hilton East Brunswick
East Brunswick, NJ
Registration Coming
Soon
BioNJ News
Seeking Dr. Sol J. Barer Award Nominations
BioNJ is seeking nominations for its most prestigious award, The Dr. Sol J. Barer Award for Vision
Innovation and Leadership.
Named for Sol J. Barer, Ph.D., the former Chairman of Celgene Corporation of Summit, NJ, the
Award recognizes outstanding biotechnology industry business leaders who have made significant
contributions to the growth and prosperity of the industry in New Jersey and throughout the
world. The Award will be presented on February 5, 2015 at the 2015 BioNJ Annual Dinner Meeting
at the Hilton East Brunswick in East Brunswick, NJ.
To submit a nomination, please describe in 250 words or less why the nominee should be
considered for the Dr. Sol J. Barer Award. Information provided in the nomination should address,
but is not limited to:
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Nominee's contribution to his or her company and/or organization, i.e., establishing an
innovative new organization, moving an established organization forward, mentoring
employees, etc.
Nominee's contributions to New Jersey's Life Sciences Community.
Nominee's contributions to the community on a local, State, national or global basis.
The final selection of the honoree will be based upon a review of applications by the BioNJ Board
of Trustees.
In making a submission, please indicate the Nominee's Full Name, Company, Title and Contact
Information. Please also include your Full Name, Company, Title and Contact Information.
Nominations must be submitted to BioNJ via email at BioNJ@BioNJ.org by close of business on
Friday, October 31, 2014.
If you have any questions, please contact BioNJ Headquarters by phone at 609-890-3185 or by
email at BioNJ@BioNJ.org.
BIO 2015: The Road Leads through NJ
BioNJ and Choose New Jersey have reserved premium space on the BIO 2015 trade show floor!
We are working to incorporate the New Jersey Story into our pavilion and want to see how we
might include you!
INTERESTED IN LEARNING MORE ABOUT THE NEW JERSEY PAVILION?
Please contact Debbie Mennito at BioNJ by phone at 609-890-3185 or by e-mail
atDMennito@BioNJ.org.
NJ Industry News
Make sure to send us your stories via BioNJ@BioNJ.org.
FDA Approves AKYNZEO® (netupitant/palonosetron) for the Prevention of
Chemotherapy-Induced Nausea and Vomiting
Bridgewater-based BioNJ Member Helsinn Group and Eisai Inc. announced on October 13 that the
Food and Drug Administration (FDA) approved AKYNZEO® for the prevention of acute and
delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy,
including, but not limited to, highly emetogenic chemotherapy. AKYNZEO is the first approved fixed
combination oral agent that targets two critical signaling pathways associated with CINV by
combining netupitant, an NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist,
in a single capsule for the prevention of CINV.
Please click here to read the full press release.
Celator(R) Pharmaceuticals Announces Pricing of a $12.9 Million Public
Offering of Common Stock and Warrants to Purchase Common Stock
Ewing-based BioNJ Member Celator Pharmaceuticals, Inc., a pharmaceutical company developing
new and more effective therapies to treat cancer, announced on October 23 the pricing of an
underwritten public offering of 6,611,150 shares of common stock and warrants to purchase up to
661,115 shares of its common stock.
Advaxis Appoints David J. Mauro, M.D., Ph.D., as Chief Medical Officer
Princeton-based BioNJ Member Advaxis, Inc., a clinical-stage biotechnology company developing
cancer immunotherapies, announced October 13 that it has appointed David J. Mauro, M.D., Ph.D.,
as Executive Vice President, Chief Medical Officer of Advaxis. Dr. Mauro brings to Advaxis more
than 14 years of experience in oncology drug development, clinical research, and medical affairs. In
his role as Chief Medical Officer, Dr. Mauro will oversee the Company's clinical immuno-oncology
programs that utilize bioengineered live attenuated bacteria, Listeria monocytogenes (Lm), to
actively suppress key components in the tumor microenvironment that contribute to the tumors
growth and protection from immunologic attack.
The Opening Of Paramesh Banerji Life Sciences Homeopathic Medicine
Manufacturing Facility in New Jersey, USA
BioNJ Member Paramesh Banerji Life Sciences, LLC held an opening event on October 14 to mark
the commissioning of their Advanced Homeopathic Medicine Manufacturing Facility in Notrh
Brunswick, NJ, USA. The company was founded by Dr. Paramesh Banerji of Kolkata (Calcutta),
India.
Bone Science Company Bone Biologics Corp. Completes its Reverse Merger
Bone Biologics Corp., which is developing a protein for use in bone regenerative medicine tied to
spinal fusion, announced on October 16 that the reverse merger that formed the company has
been completed.
Please click here to read the full article.
FluoroPharma Announces That Data From Its Phase II Clinical Trial of 18-F
FCPHA (CardioPET) Was Presented at the Annual Congress of the European
Association of Nuclear Medicine (EANM), October 19, 2014, in Gothenburg,
Sweden
Montclair-based FluoroPharma Medical, Inc., a company specializing in the development of novel
diagnostic imaging products that utilize positron emission tomography (PET) technology for the
detection and assessment of disease before clinical manifestation, announced on October 20 that
new Phase II data related to CardioPET (18-F FCPHA) for the assessment of myocardial perfusion
and fatty acid uptake in coronary artery disease (CAD) patients was presented by Dr. Fabian
Demeure, an author of the abstract, at the session: Cardiovascular System: Cardiac PET Imaging
on October 19th at the Annual Congress of the European Association of Nuclear Medicine (EANM),
October 18 - 22, 2014, in Gothenburg, Sweden.
Immunomedics Announces European Orphan Drug Designation for
Isactuzumab Govitecan for Pancreatic Cancer Treatment
MorrisPlains-based BioNJ Member Immunomedics, Inc., announced on October 20 that the
European Medicines Agency (EMA) has granted orphan drug status for one of the Company's
solid-tumor antibody-drug conjugates (ADCs), isactuzumab govitecan, or IMMU-132, for the
treatment of pancreatic cancer.
TrialScope Appoints Richard Guinaldo as Chief Financial Officer
TrialScope, a Jersey City-based provider of clinical trial solutions and services, announced on
October 21 that it has named Richard Aguinaldo its Chief Financial Officer.
Global Ebola Task Force: Law Firm Prepares for Myriad of Virus-Related
Questions
The law firm Reed Smith on October 21 launched a multidisciplinary Global Ebola Task Force,
headed by Patrick E. Bradley, a partner in the firm's Princeton office, to keep the firm abreast of
legal issues that arise from the Ebola crisis and to address the questions the firm has begun
fielding from clients across a wide range of industries.
Horizon Blue Cross Blue Shield of New Jersey Creates Ground-breaking
Patient-centered Program for Cancer Treatment
Horizon Blue Cross Blue Shield of New Jersey announced on October 21 that it has joined with
Regional Cancer Care Associates (RCCA) - one of the nation's largest oncologist physician groups
- to create an Episode of Care (EOC) program to deliver highly specialized care for breast cancer
patients. RCCA physicians, more than 100 specialists at 24 New Jersey locations, will be
compensated on the quality, not quantity, of care their breast cancer patients receive.
Cancer Genetics Inc. Granted Patent for Genomic Probe Set Used in
Proprietary Test for Cervical and Other HPV-Associated Cancers
Rutherford-based BioNJ Member Cancer Genetics, Inc., an emerging leader in DNA-based
diagnostics, announced on October 21 that it has received a formal Notice of Allowance from the
United States Patent and Trademark Office (USPTO) for its genomic probe set used to detect
biomarkers indicative of HPV-associated precancer and cancer of the cervix, anus, vulva, vagina,
penis, oropharynx, and pharynx. US Patent 8,865,882 covers the four-probe set used in CGI's
proprietary FISH-based HPV-Associated Cancer Test (FHACT®), which identifies genomic
aberrations associated with progression to cancer. The patent issuance underscores the
uniqueness of CGI's FHACT® test, which is currently available for clinical use in cervical cancer
screening, and benefits the product's positioning in the cervical cancer diagnostics market.
BioNJ Members Among New Jersey Companies to Make Donations in Fight
Against Ebola
As U.S. hospitals and airports confront the unfolding Ebola crisis, BioNJ Members are among the
companies with a presence in New Jersey that are making donations to help those stricken with the
disease in West African nations and providing funds to partners in Africa to combat the virulent
virus.
StateBook International Signs Choose New Jersey, East Kentucky Power
Cooperative and the Worcester Chamber of Commerce as Charter Members
On the heels of its partnership with SelectUSA, the federal level government entity charged with
showcasing the United States as the world's premier business location, StateBook International,
the first online marketplace to unite Economic Development Organizations, site selectors and
communities nationwide, today announced that Choose New Jersey, East Kentucky Power
Cooperative and the Worcester Regional Chamber of Commerce have all signed agreements to
utilize the StateBook International platform to plan and drive economic expansion and growth
across public, private and utility interests in 2015.
Lexicon and Ipsen Enter into Ex-North America/Japan Licensing and
Commercialization Agreement for Telotristat Etiprate
BioNJ Members Ipsen and Lexicon Pharmaceuticals, Inc. on October 22 announced that they have
entered into an exclusive licensing agreement for Ipsen to commercialize telotristat etiprate outside
of North America and Japan, with a focus on the treatment of carcinoid syndrome. Lexicon retains
sole rights to commercialize telotristat etiprate in the United States, Canada and Japan.
Detecting Cancer Earlier is Goal of Rutgers-Developed Medical Imaging
Technology
A new medical imaging method being developed at BioNJ Member Rutgers University could help
physicians detect cancer and other diseases earlier than before, speeding treatment and reducing
the need for invasive, time-consuming biopsies.
Mission-Related Investing: The Road from Bonds and Fixed Income to
Venture Capital - An Article by James Golubieski for NMS Management
In 1830, when Harvard College and Massachusetts General Hospital sued the Armories, few could
have imagined the evolution in investment policy that-over the next century and a half-would free
the not-for-profit community to expand its asset base and program reach to where it is today. A
quick look back illustrates how far we have come, and puts into perspective the breadth of
opportunities we now have to increase not only the financial, but the social impact of each dollar we
invest.
Funding News
Register Today for a Free Webinar About NCATS Small Business Funding
Register today to join NCATS and BIO on October 27 for a webinar on how NCATS can support
small businesses and technology transfer organizations as they develop and discover new
therapies and diagnostics to help move bench research to clinical practice and commercialization.
The webinar is free and open to BioNJ members and other interested small businesses, research
organizations, and venture-backed companies. Leaders from BIO and the NIH SBIR and STTR
programs will discuss:
Program overviews:
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Benefits of NCATS funding
Tips for submitting a successful application
Key NCATS focus areas to advance clinical research and patient care
Upcoming opportunities and deadlines
Other resources and programs, including the Therapeutics for Rare and Neglected
Diseases (TRND) and Bridging Interventional Development Gaps (BrIDGs) programs.
Register today to take advantage of this exciting opportunity!
Featured speakers:
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Cartier Esham, Ph.D., Executive Vice President for Emerging Companies, Biotechnology
Industry Organization
Lili M. Portilla, M.P.A., Director, Strategic Alliances, NCATS, NIH, U.S. Department of
Health and Human Services
Matthew Portnoy, Ph.D., SBIR and STTR Program Coordinator, NIH, U.S. Department of
Health and Human Services
Click here to Register for the webinar.
Industry Events
NSF SBIR Program & 1-to-1 Appointments
An NSF focused SBIR training program sponsored by the New Jersey Small Business
Development Centers and EisnerAmper LLP along with sponsoring organizations BioNJ, NJ
Technology Council and the Rutgers University Office of New Ventures & Entrepreneurship will be
held on Friday, October 31, from 8:30 a.m. to 1:00 p.m., at the NJIT Enterprise Development
Center, in Newark.
This half-day seminar is intended to provide participants with an introduction and overview of the
SBIR and STTR programs including how to search for solicitations and topics that may fit their
technologies and core technical competencies. The seminar will also include detailed instruction
intended to help attendees prepare competitive grant proposals. It will feature an introduction to
NSF's SBIR and STTR program by NSF Program Director Steven Konsek. Steven will also be
available for 1-to-1 appointments with attendees in the afternoon following a networking lunch.
The NSF SBIR program is very broad in its scope and is likely to be of interest to entrepreneurs
working in most of the science and engineering disciplines. It has large Biological and Biomedical
Technologies components, see http://www.nsf.gov/eng/iip/sbir/topicshome.jsp.
Please click here for more information.
IPT 2014 Pharma/Life Science Regional SALT Seminar
The Institute for Professionals in Taxation (IPT) will hold a Regional, State and Local Tax (SALT)
seminar on November 20 and 21 in Iselin, NJ, featuring BioNJ President and CEO Debbie Hart.
The life sciences industry faces a wide-array of industry specific challenges, including in the tax
area. From start-up, through commercialization, and including large, established, multi-national
companies, these industries are often impacted differently by tax laws than other industries. State
and local taxes are often the most significant, and most manageable, tax burdens faced by the
industry. This advanced two-day seminar is designed for state and local tax professionals involved
in the Pharmaceutical, Biotechnology and Life Sciences industries. The speakers, well-known
experts in the state and local tax field, will focus their presentations on current state and local tax
issues and how they specifically impact the life sciences industries.
A wide range of topics will be presented, including income/franchise taxes, sales/use taxes, and
unclaimed property. Issues to be addressed include nexus, apportionment, audit resolution, and
opportunities and pitfalls - all geared towards the special challenges faced by the life sciences
industries.
This special focused seminar provides an opportunity to hear some of the top SALT professionals
discuss current topics and their relevance to life sciences businesses, making it a "must-attend" for
those state and local tax professionals in these industries.
Please click here to view the full brochure.
Please click here to register.
NJ University/Institution News
Rutgers Business School Executive Education is Offering a MiniMBA:
BioPharma Innovation in Three Convenient Formats this Fall, with a 10%
Discount Extended to BioNJ Members!
You can choose between a week-long accelerated program, a 10-week evening program, or a
convenient online program. Seats for BioNJ members are still available.
The Rutgers MiniMBA: BioPharma Innovation educates clinicians and others in the life sciences
industry about business operations in the Pharmaceutical and Biotechnology sectors. It is the
perfect professional development opportunity for anybody who seeks a broader, cross-functional
understanding of the world in which new drugs, devices and technologies are developed and
brought to market.
For more information, contact Jennie Fine at 848-445-9418 or jfine@business.rutgers.edu, or
follow the links below.
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10-week evening program, starting October 13
12-week, self-paced online program, starting November 3
1-week accelerated program, starting November 17
BioNJ Business Solutions
Are Spending Issues Keeping You Up at Night?
BioNJ's Purchasing Consortium Can Help!
Take Advantage Of Member Savings On Overhead Spending Including Office Supplies And
Products, Shipping And .....Coming Soon...Health Insurance, Payroll And Event And Meeting
Planning!
From Fisher Lab Supplies to Business Wire Services, Insurance and IT Services and Scientific
Publications - why struggle with increasing costs?
Exploit your BioNJ Member Benefits and make sure you are using all the discounts that you are
entitled to!
For more information on your Member Benefits contact Linda Pontell at LPontell@BioNJ.org.
This Week's Featured Consortium Supplier
What's Your Appetite for Risk? Receive Member Discounts on the Chubb Group!
Business Insurance/Risk Management
For more than 20 years, the Chubb Group has provided cost-effective risk management and
insurance coverages tailored to the unique requirements of biotechnology companies.
* Clinical Trials Liability Insurance
* Products Liability Insurance
* Professional Liability Insurance
* Property & Casualty Insurance
Chubb's insurance professionals specialize in the biotechnology market; they understand your
issues and anticipate future insurance coverage challenges. To learn more about the program,
including coverages and premium rates, contact a Chubb appointed insurance agent or broker.
For more information on Chubb and all the savings available to you, contact Linda Pontell
atLPontell@BioNJ.org and 609-890-3185 x104.
BioNJ Purchasing Consortium Highlighted at CEO Summit
Dynamic Strategies, BioNJ's newest addition to the Purchasing Consortium awarded an IT security
Scan for a lucky attendee at the recent CEO Summit on Tuesday. Darek Hahn, of Dynamic
Strategies said the organization is pleased to be a part of BioNJ's Member cost saving program,
and thrilled to sponsor such a impressive meeting. Helen Cooke, an executive coach and founder
of Cooke Consulting, won Dynamic Strategies's prize of an IT vulnerability scan for her business.
Cooke Consulting Group, LLC, which specializes in guiding biotech and pharma leaders in
strengthening their people skills, has recently joined BioNJ as a Platinum member. Helen
commented, "The CEO Summit was impressive. Al Altomari, Jan Campbell, and the entire
committee delivered an educational and timely program. To then win Dynamic Strategies'
vulnerability scan was a lovely bonus!"
BioNJ Talent Network
Job Leads
BioNJ can help you find the perfect candidate for your open positions. Call us today!
Please click here to view all the job postings on the LSTN at BioNJ website.
Rutgers University Camden - Internship Fair
You are invited to participate in the campus-wide Internship Fair sponsored by the Career Fair of
Rutgers-Camden. The Internship Fair will give you the opportunity to meet and talk with students
from a wide range of majors in our College of Arts and Sciences and our School of Business.
These students are interested in gaining career related experience and will be eager to learn more
about your organization and internship opportunities.
Please click here for more information and registration.
BioNJ Tweets of the Week
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@YankeePR Tweeted #NPS #pharma Nader @BioNJ_Org CEO Summit: it's time to
declare war on #Alzheimers & #diabetes
@TFuller0 Tweeted @BioNJ_Org CEO Summit; Great culture starts w/ personal
responsibility for finding a way to make a significant contribution each/every day.
@MegTirrell Tweeted "Potentially a revolution in the treatment of Crohn's disease,"
$CELG COO Mark Alles says of '0301 at BioNJ CEO Summit
Please contact BioNJ at BioNJ@BioNJ.org
or 609-890-3185 with any questions.
Connect with us:

BioLines Weekender

Transcription

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