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New Jersey Technology Council www.njtc.orgDecember 2013Vol. 12 Issue 4$3.50

EXPLORING THE TECHNOLOGIES THAT CHANGE THE WAY WE LIVE

Innovators in Science P4 Crowd Funding Legislation P11 Marijuana’s Legal Dilemma P18

Non-profit Org.U.S. Postage

PAIDNew Jersey

Technology Council

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The NJTC 2013 Awards CelebrationHonors the Region’s Tech Stars

GROW. WISELY.

At EisnerAmper, we understand that great ideas originate where

creativity is encouraged, where the entrepreneurial spirit is supported

by business professionals who share your vision and pursuit of the

innovative edge.

EisnerAmper’s Life Sciences professionals have the expertise, resources

and relationships to bridge the gap between business and science.

Combining expertise and experience with an understanding of how

your business really works, we roll up our sleeves to help you meet

these challenges.

Let’s get down to business.TM

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Steven Kreit212.891.4055 [email protected]

TechLifeSciNews | www.njtc.org | December 2013 3

PUBLISHERMaxine Ballen • [email protected]

VP OF PUBLICATIONSLeo M. Mennitt • [email protected]

CONTRIBUTING EDITORCarly Bohach • [email protected]

NJTC CONNECTIONS EDITORJudy Storck • [email protected]

GRAPHIC DESIGNERBonnie Jacobs • [email protected]

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Postmaster: Send address changes to: NJTC, 1001 Briggs Road, Suite 280, Mt. Laurel, N.J. 08054.

TechLifeSciNewsDecember 2013 • Vol. 12 No. 4New Jersey Technology Council

& The Education Foundation1001 Briggs Road, Suite 280

Mount Laurel, N.J. 08054 phone (856) 787-9700

fax (856) 787-9800www.njtc.org

contentsOn the Cover 12 The NJTC 2013 Awards Celebration

Honors the Region’s Tech Stars

NJTC Connections 4 PRESIDENT’S MESSAGE

20 NEW MEMBERS

21 PHOTO GALLERY

`22 CALENDAR

OF PROGRAMS

Features 4 Innovators in Science Series Highlights

Innovation and Technologies Discover how the Innovators in Science Series highlights cutting edge commercial

life science centered innovation and technologies.

16 Federal Contracting: Obtaining Non-Dilutive Funding Valuefor Necessary Research and Development Programs

By Christopher J. Schaber, PhD Learn how to obtain the appropriate level of funding to support key development

programs.

Columns 8 CORNER OFFICE Dr. Kenneth Blank By Carly Bohach Meet Dr. Kenneth Blank and find out Rowan University is having a positive

effect on the lives of its students and the citizens of all regions of New Jersey.

19 HUMAN RESOURCES HR Tech2.0 By Scott Feldman Here’s what you need to know about the talent management process.

5 EDUCATION Groundbreaking Rutgers Dual-Degree Program

Is Forging Tomorrow’s Health Leaders By Joseph A. Barone, PharmD, and Carol A. Terregino, MD Learn how Rutgers, The State University of New Jersey, is embarking on a

groundbreaking dual-degree program that will help train next-generation providers and health leaders.

18 LEGAL EAGLE Marijuana and its Legal Dilemma By Shahnam Sharareh This article addresses the prevalent issues regarding the passage of California

Proposition 215 and what should be considered by companies that operate in this space

Plugged In 8 ProCure Proton Therapy Center and the New York

Proton Center Expand Access to Proton Therapy Examine the benefits of proton therapy.

11 Crowdfunding Legislation: Providing new channels of investment for businesses and new investment opportunities for investors

By Taka Tanahashi New legislation is being proposed by New Jersey State Senators Ray

Lesniak and Joe Kyrillos and how it directly affects both entrepreneurs and investors.

10 BDO Biotech Briefing: Biotechs Continue to Invest More in R&D and Leverage the Capital Markets

By Ryan Starkes Explore how recent BDO analysis revealed research and development

spending at biotech firms and the utilization of capital markets to obtain the cash for R&D funding continues to rise.

CONNECT@NJTCNJTC TechWirehttp://njtcblog.wordpress.com

NJTC on @NJTC

NJTC Group on NJTC

GROW. WISELY.

At EisnerAmper, we understand that great ideas originate where

creativity is encouraged, where the entrepreneurial spirit is supported

by business professionals who share your vision and pursuit of the

innovative edge.

EisnerAmper’s Life Sciences professionals have the expertise, resources

and relationships to bridge the gap between business and science.

Combining expertise and experience with an understanding of how

your business really works, we roll up our sleeves to help you meet

these challenges.

Let’s get down to business.TM

NEW YORK | NEW JERSEY | PENNSYLVANIA | CALIFORNIA | CAYMAN ISLANDS

EisnerAmper LLPAccountants & Advisors

Independent Member of PKF International

www.eisneramper.com

John Pennett732.947.3628 [email protected]

Lori Reiner215.881.8853 [email protected]

Steven Kreit212.891.4055 [email protected]

TechLifeSciNews | www.njtc.org | December 20134

PRESIDENT’S MESSAGE

FOUNDER, PRESIDENT & CEO Maxine Ballen • [email protected]

CHIEF OPERATING OFFICER Joan C. Praiss • [email protected]

VP MEMBERSHIP Paul A. Frank III • [email protected]

VP PUBLICATIONS/BUSINESS DEVELOPMENT Leo Mennitt • [email protected]

EXECUTIVE ADMINISTRATOR Karen Lisnyj • [email protected]

MEMBERSHIP RELATIONS MANAGER Ellen Stein • [email protected]

OFFICE ADMINISTRATION/MEMBERSHIP SERVICES - CONNECTIONS EDITOR Judy Storck • [email protected]

EVENTS MANAGER Meredith Meyer • [email protected]

IT COORDINATOR Erwin Racimo • [email protected]

ACCOUNTING Peggy Reeve • [email protected]

NJTC CHARTER MEMBERS

DeloitteEdison Venture FundKPMG LLPMaloy Risk ServicesMorgan LewisPNC

NEW JERSEY TECHNOLOGY COUNCIL

www.njtc.org1001 Briggs Road, Ste 280Mount Laurel, NJ 08054856-787-9700

Council ConnectionsAs the year comes to an end, it’s not too late to get connected. On December 5, 2013 the NJTC and PA Bio will present the day long Regional Commercialization Summit. The Summit will bring together university tech transfer officers, entrepreneurs and investors to discuss technologies on the commercially-ready pathway at area universities. In addition, on December 12, 2013, the Data Summit will examine topics such as innovations in data center construction & DCIM, finding opportunities in the intersection of education, business and big data, Healthcare/Life Sciences and Big Data: a look back from 5 years and more. Close out 2013 with a new outlook on these important sectors.

Even though 2013 is almost over, the NJTC is looking forward to offering even more unique events in 2014. To start the New

Year off with a bang, be sure to attend the Technology Forecast on January 24, 2014. This exciting new event will highlight the dominant technology sectors of New Jersey including Digital Health/MedTech, FinTech, Cloud Computing, Data Analytics, Interactive Marketing, Mobile Communications, Energy Efficiency, and Imaging. Don’t wait; sign up now.

From everyone here at the NJTC; we hope you have a wonderful holiday season and we are excited to see what 2014 has to offer! n

— Maxine Ballen, President & CEO, NJTC

Visit our website at

ww.njtc.org

The Innovators in Science is an ongoing presentation and networking series that has been developed by the NJTC in collaboration with the Rita Allen Foundation, which is supporting the series. “This partnership amplifies an opportunity to showcase leading biomedical scholars and create new intersections with thought leaders and the broader technological community in New Jersey,” says Elizabeth Christopherson, President and Chief Executive Officer of the Rita Allen Foundation. “We are pleased to be able to present the series at the Institute for Advanced Study, one of the world’s leading centers for scientific research, in collaboration with the Institute’s Simons Center for Systems Biology.”

The series highlights cutting edge commercial life science centered innovation and technologies. The mission is to spotlight groundbreaking researchers and entrepreneurs as they share their work and discoveries with a multidisciplinary and diverse audience and network members of the regional technology and life sciences community. Christopherson explains, “From the Rita Allen Foundation’s earliest days, we have supported innovation to lead to breakthrough solutions to complex problems.”

Both Christopherson and December 10, 2013 speaker Arnold J. Levine, Ph.D., Professor Emeritus, Simons Center for Systems Biology, Institute for Advanced Study, and Professor, Pediatrics and Biochemistry Departments, Rutgers Cancer Institute of New Jersey weigh in on the importance of innovation and technology. Dr. Levine is a Past Chair and Emeritus Member of the Rita Allen Foundation Scientific Advisory Committee.

Innovators in Science Series Highlights Innovation

and Technologies

See “Innovators”. page 9


EDUCATION

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In the midst of ongoing, heated debates about health care reform, the vision of health care delivery in the future continues to evolve, but a picture of the type of practitioner who will be needed is beginning to emerge. These next-generation health care providers will have to be facile in multiple areas, comfortable with interdisciplinary training, have the ability to coordinate care from a variety of fronts, and even facilitate the translation of research to the bedside.

Rutgers, The State University of New Jersey, is embarking on a groundbreaking dual-degree program that will help train those next-generation providers and health leaders who will have the ability to inform health care advances on a national level.

Beginning this academic year, Rutgers’ Ernest Mario School of Pharmacy and Robert Wood Johnson Medical School are uniting in this effort to provide a dual-degree program that combines a doctorate in pharmacy with a medical degree. The 10-year program, available only to students enrolled in the PharmD program at Ernest Mario School of Pharmacy, will train an elite cadre of interdisciplinary practitioners and clinicians.

The ultimate goal: more comprehensive patient care, shaped by individuals who have a

more complete understanding of the diagnostic and treatment components of health care.

Leaders in Research, PolicyRutgers’ innovative program is indicative of the increasing interest in interprofessional healthcare and interdisciplinary collaborations in medicine as a whole. Teams comprising providers from different medical disciplines, patient-centered care, coordination of services—these concepts are driving many of the trends emerging in health care today. Interdisciplinary training can help develop the proficiencies needed to practice in this new environment.

PharmD/MD graduates will have unique skills that can be leveraged to create fascinating research. In fact, clinical research and clinical trial development will be the forte of a person with these skills, with their pharmacotherapeutic background giving them an advantage. They are advocates who can facilitate the translation of pharmaceutical agents to the bedside.

And, in the area of health care policy, these individuals will be in a great position to effect serious change. They will see issues from a drug therapy perspective and from the clinical perspective. Such an interdisciplinary

background can help individuals develop a much greater depth of understanding of critical health care policy issues.

Developing the New CurriculumRutgers’ new PharmD/MD program formalizes a working relationship that has been in practice for decades at the two schools—combined hospital rounds with pharmacy students and medical students being just one example of the close ties that formed the foundation of the new collaboration. Ultimately, the move to create the dual-degree program—believed by health-care educators to be the first of its kind—was made because it was the right thing to do.

The PharmD component of the dual degree consists of two pre-professional years and four professional years of training. Interested students apply for acceptance into the highly competitive program in the spring semester of their second professional year and undergo a rigorous review process by both the pharmacy and medical schools.

Practicing Interdisciplinary CollaborationsDuring the last two years in pharmacy school,

Groundbreaking Rutgers Dual-Degree Program Is Forging Tomorrow’s Health Leaders

BY JOSEPH A. BARONE, PHARMD, AND CAROL A. TERREGINO, MD

Joseph A. Barone, who has a doctorate in pharmacy, is dean of Rutgers Ernest Mario School of Pharmacy. Dr. Carol A. Terregino is senior associate dean for education (interim) at Rutgers Robert Wood Johnson Medical School.

Additional information about the PharmD/MD program is available online at pharmacy.rutgers.edu or by calling 848-445-6254.

See “Rutgers”. page 11

6

Dr. Kenneth Blank Vice President

for Health SciencesRowan University

Dr. Kenneth Blank was appointed vice president for Health Sciences at Rowan University, Glassboro, N.J., in December 2012. Blank, an esteemed molecular pathologist and cancer researcher with more than 30 years of experience in research program development, technology commercialization and regional economic development came to Rowan from Temple University in Philadelphia, where he served as senior vice provost for research and graduate education. He earned his Bachelor of Arts degree in biology from New York University, University College of Arts and Sciences and his Ph.D. in genetics from the Albert Einstein College of Medicine, Yeshiva University, New York City

How do you become VP of Health Sciences at Rowan? The short answer is that Dr. Ali Houshmand, the president of Rowan University, and I shared a vision about the role that research should play in an academic institution to create educational opportunities for students and economic development for the citizens of New Jersey. That shared vision and my extensive experience were assets when the position opened. My experience included building a successful research program with National Institutes of Health funding as a faculty member and creating large research programs and fostering economic development by commercializing technology developed as the product of research activity as an administrator.

When the opportunity to work with an innovative, forward looking, and passionate president like Dr. Houshmand became available, I was truly excited about the opportunity. Recently, the State implemented the New Jersey Medical and Health Sciences Education Restructuring Act, which designated Rowan University as the third State research institution and which integrated into the University a second medical school (now known as the Rowan University School of Osteopathic Medicine in Stratford). That Act created huge opportunities for southern New Jersey and the entire State.

For me, Rowan is the perfect place to be able to use my skills and background to innovate new ways that a university research enterprise can be built to develop solutions to critical societal issues and create economic development through interaction with industry and mission-oriented government agencies, such as the Departments of Defense, Transportation and Energy. What qualities do you feel you need to possess in order to be successful in your role? To be successful in this role, it’s important to be able to communicate well with people, be well versed in the local and regional healthcare environment, be creative in looking at new ways to approach healthcare education and research, and be able to listen to others and learn from others’ experience. Team building is an essential quality, especially in the complex environment that we refer to as healthcare. What do you want people to think about Rowan? Rowan University is an institution that has and will continue to have a very positive effect on the lives of its students and the citizens of all regions of New Jersey, but especially southern New Jersey. Rowan is a dynamic, innovative and growing institution that is committed to the four pillars of our strategic plan: access, quality, affordability and serving as an economic engine for our region.

During the next 10 years, we will double our


CORNER OFFICE BY CARLY BOHACH

part of our strategy to build new areas in life sciences education and research, Rowan will partner with several institutions in the City of Camden to develop a College of Health Sciences. The College will house new programs that will benefit the citizens of South Jersey in very tangible ways. How important are partnerships and how will you foster them? Partnerships are crucial for Rowan to achieve the goal of developing practical solutions to critical societal health issues. We need to work with industry and government partners to define the problems and tap into the innovative faculty at Rowan to develop solutions that can be implemented by those industry partners. The process of developing these solutions is critical to the healthcare needs of the citizens of New Jersey.

When it comes to the Life Science industry, what inspires you? The life sciences can impact our lives on a daily basis in so many ways. As a researcher, my goal was to understand how leukemias occur and use that information to find a way to prevent the development of this disease. Our life sciences industries are constantly innovating new approaches that prevent or cure diseases that affect many individuals and families or improve the access and delivery of healthcare to urban and rural populations. The life sciences industry is a major driver of economic development in New Jersey, and there are dedicated individuals who are starting new companies constantly to bring innovations to the market to benefit the public.

How do you encourage students to network within the industry? Most people do not have an intuitive understanding of the importance of networking. At Rowan University, we strive in many ways to educate our students about networking. We take our students to meetings and invite industry representatives to campus to provide students with the opportunity to interact with them. Many student projects at Rowan are funded by industry, which provides industry with the opportunity to cultivate the students as possible future employees. Our faculty members work with students to maximize their ability to present and discuss their work in manner that is consistent with networking with people who may not be experts in their fields. What is the main challenge for students entering the field and how does Rowan help them meet this challenge? It’s critical that universities prepare students to be productive members of the work force. Industry leaders too often find that new graduates from most universities are not prepared to step into a job and be productive

without further training provided by industry. Things are different at Rowan. When students leave campus with their new degrees, they also leave with real-world experience on their resumes. In all of our colleges, we focus on hands-on work on campus and off, in labs in our engineering and science buildings, at the South Jersey Technology Park at Rowan University and in our health-related programs. Students obtain internships in numerous companies in New Jersey and also out of state and abroad; we have many longstanding partnerships, and new firms seek collaborations every semester. Students work on College of Engineering clinic teams and in College of Science & Mathematics groups that address firms’ research needs, serving as de facto R&D arms. They focus on project-based learning in our Rohrer College of Business. I could go on, but the bottom line is Rowan students graduate ready to hit the ground running. Think ahead. Where do you see Rowan in the next five years? Five years from now, Rowan will be well on the way to meeting our 10-year goals of $100 million in external research expenditures from industry and government agencies and doubling our student body to 25,000 students. We will have built substantial new infrastructure at the South Jersey Technology Park at Rowan University that will house both large and small businesses and new companies that have licensed new technologies from the University. That will create demand for high-paying jobs in the life sciences, health care and related technology fields. We will have created a vibrant College of Health Sciences that will address health-related issues in the urban and rural areas of New Jersey.

Some things we can guarantee about the future of Rowan: We will remain committed to a strong undergraduate program. We will increase research that will focus on developing practical solutions to critical national issues. We will expand our involvement with business and community. Our health care professionals, including the physicians graduating from our two medical schools, will contribute their time and effort to helping the citizens of New Jersey.

In the last few years, Rowan, as an institution, has learned to seize opportunities. Five years ago, we did not envision having two medical schools. Now we have Cooper Medical School of Rowan University and the Rowan University School of Osteopathic Medicine. Five years ago we did not expect research institution status at this time. Five years ago, we laid the groundwork for Rowan Boulevard with the Borough of Glassboro and private developers, but we could not have envisioned the great success it has become, with housing, offices, retail outlets, a Barnes & Noble and a Courtyard at Marriott Hotel. Whatever the challenges during the next five years, Rowan University will step up for the benefit of southern New Jersey and the rest of the State and region. n

enrollment to 25,000, beginning in 2015 with doubling the number of students in the College of Engineering and Rohrer College of Business. Rowan’s students (and their families) should be excited about obtaining an exceptional — and affordable — education. Rowan’s partners – whether in government or industry — should believe that they are working with a strong organization and talented students.

The impact of increasing the student population and size of the research enterprise cannot be overstated in terms of the economy of South Jersey. For example, the College of Engineering already is attracting companies that require a work force of trained engineers who are considering relocating to areas such as Rowan’s South Jersey Technology Park. New companies will be created as technology produced at the University is licensed by startup companies that will hire not only engineers but accountants and others needed to run a company. People should think of Rowan as a premier institution that is doing all the right things for the citizens of New Jersey. Why should a student considering a career in life science pick Rowan? Students planning a career in life sciences, indeed in any STEM field, will find that they receive a first-rate education in the sciences and engineering at Rowan at a cost that will not result in substantial debt upon graduation.

Some of the greatest benefits for our undergraduates include our small class size, the ability to work on research projects with faculty and the opportunity to present the results of their work at University forums and off campus.

Rowan offers a wide variety of life sciences programs in our College of Engineering and College of Science and Mathematics. Opportunities also exist to work with faculty in Rowan’s two medical schools: Cooper Medical School of Rowan University and the Rowan University School of Osteopathic Medicine. Rowan is one of only two universities in the country to have both M.D. and D.O. degree-granting medical colleges.

How will you integrate and build the health sciences area of the University?We have several areas of existing strengths on our campuses, and we will build on those strengths by hiring new faculty, increasing external funding and applying our research to solve important health problems. As a few examples, some of Rowan’s present strengths are in the geriatric research performed in the New Jersey Institute for Successful Aging and the outstanding work on child abuse in the Child Abuse Research Education & Service Institute at the Rowan University School of Osteopathic Medicine. We will focus on building upon these areas of strength as well as look at areas of emerging strength where we can be a national and international leader. As an important

8 TechLifeSciNews | www.njtc.org | December 2013

PLUGGED IN

LEGAL

Q What is the Physician Payment Sunshine Act and How Does it Impact

Medical Device Companies?

A Effective March 31, 2014, manufacturers of drugs, medical devices,

biologicals and medical supplies must annually report payments to physi-cians and teaching hospitals to CMS. The obligation applies to payments made on or after August 1, 2013. The law requires reporting of a broad range of cash and in-kind payments, including (but not limited to) consult-ing fees; royalties; travel, meals and lodging; research grants; and charita-ble contributions. Reporting of certain ownership interests held by physicians and their immediate family members is also required. The data will be included in a publicly searchable data-base. Failure to submit a report can result in the imposition of significant fines on the company. Companies will be required to maintain and report detailed information about payment recipients, including the recipient’s NPI specialty and professional license number (among other things).

Beth Christian is a shareholder at Giordano, Halleran & Ciesla, PC, in the firm’s Healthcare practice area and co-author of the legal blog New Jersey Healthcare (www.njhealthcareblog.com). She can be reached at 732-741-3900 or [email protected]

ProCure Proton Therapy Center in Somerset, NJ, and The New York Proton Center (NYPC) - a consortium of five leading hospitals in New York City, have reached an agreement to expand access to proton therapy. The agreement will give the consortium’s patients access to a state-of-the-art proton treatment center in Somerset, NJ, one of only twelve such centers in the nation and the only center in the New York and New Jersey region.

Proton therapy is a unique form of precision radiation that directly attacks tumors while minimizing potentially damaging radiation to surrounding healthy tissues and organs. Recognizing the benefits of proton therapy for patients with specific tumor types, NYPC’s agreement with the ProCure Proton Therapy Center allows this therapy to be conveniently accessible for their patients. Under the agreement, patients receiving care at NYPC hospitals who need proton therapy will continue to have their treatments provided by their physicians who will now have treatment privileges at the Proton Center.

The ProCure Proton Therapy Center in Somerset, NJ, in affiliation with CentraState Healthcare System and Princeton Radiation Oncology, opened in March 2012. Meanwhile, the New York Proton Therapy Center (NYPC) is an alliance of five leading cancer treatment institutions in New York City and 21stCentury Oncology including Memorial Sloan-Kettering Cancer Center, New York University Langone Medical Center, Montefiore Medical Center, the Mount Sinai Medical Center, and Continuum Health Partners. The five institutions include many of the premier cancer treatment institutions in the world and together treat 19,000 new cancer patients every year.

Dr. Oren Cahlon, medical director of ProCure Proton Therapy Center in Somerset, NJ expands on this agreement and the latest developments with proton therapy:

Can you explain the benefits of proton therapy?Proton therapy is a precise form of radiation that directly attacks tumors while minimizing potentially damaging radiation to surrounding healthy tissues and organs. Traditional x-ray beams deposit a dose of radiation all the way through the patient’s body, but proton beams stop abruptly and do not deliver radiation dose beyond the tumor. This unique property helps to reduce the risk of secondary cancers and side effects, thereby improving the patient’s quality of life. For certain patients, especially those with solid tumors surrounded by sensitive tissue and vital organs, proton therapy is often the treatment of choice. Studies have shown proton therapy to be effective in treating many types of tumors, including pediatric cancers and selected tumors of the head and neck, brain, spinal cord, breast, gastrointestinal system, lung and prostate.

Can you discuss the importance of the NYPC agreement?The New York Proton Center (NYPC) is a consortium of five leading hospitals in New York City that includes Continuum Health Partners, Memorial Sloan-Kettering Cancer Center, Montefiore Medical Center, the Mount Sinai Medical Center and New York University Langone Medical Center. The consortium’s agreement with ProCure in NJ and our partners, CentraState Health Care System and Princeton Radiation Oncology will significantly increase patients’ access to proton therapy. Under the agreement, patients at any NYPC hospital who need proton therapy will now have treatment privileges at ProCure and will have their treatments provided by their current physicians.

What steps are you taking to make proton therapy available to more people?For many years, there were only two centers in the country that offered proton therapy. Many of our physicians learned about and witnessed the success of the treatment during their training and early years of practice, and they felt committed to build a center in their native territory, where so many patients are in need of cancer treatment and would benefit from proton therapy.

ProCure Proton Therapy Center and the New York

Proton Center Expand Access to Proton Therapy

8


We are the only facility in the New Jersey/New York metro region, but there are currently 12 proton centers in the country. The success of our center continues to help generate additional interest in building proton facilities and offering treatment to a wider audience.

In addition, members of our professional team also speak at local health and educational events. We strongly believe that joining forces with local organizations and advocacy groups will help to inform patients about treatment options and ultimately help increase access to proton therapy.

Where do you see proton therapy in the next 5 years?I believe that as proton technology continues to advance, the costs associated with offering treatment will decrease significantly. I also expect that as study results begin to unfold from the numerous clinical trials underway, proton therapy will increasingly be included as part of mainstream radiation therapy treatment. n

Christopherson explains:What is the importance of innovation?The Foundation’s first core program, the Rita Allen Foundation

Scholars program, has supported more than 100 young leaders in biomedical science at a critical time in their careers, allowing them to take more risks and explore new possibilities. This exploration has led to groundbreaking discoveries-Rita Allen Foundation Scholars have gone on to win numerous awards, including a Nobel Prize in Physiology or Medicine.

With recent new resources, we are now expanding to new areas of investment, supporting young leaders and pioneering organizations in society as well as science. In the spirit of the Rita Allen Foundation Scholars, innovation is a primary core principle guiding our vision for creating lasting change on some of the most challenging problems of our time. We are pleased to collaborate with the New Jersey Technology Council to highlight leaders at the forefront of innovation in the field of biomedical sciences, beginning with Drs. Levine and Robins, who are transforming the possibilities of medicine and bringing new hope to people who suffer from life-threatening illnesses.

Meanwhile, here are Dr. Levine’s thoughts on the importance of innovation:

I was convinced more than a decade ago that in the area of biomedical research, innovation through the development of fields such as systems biology, which can be described as research at the interface of molecular biology and the physical sciences, would be increasingly important. The complete sequence of the human genome, which became available in the year 2000, showed that all human beings are 99.9% identical in their DNA sequence. We still differ by 0.1% -- about 3 million nucleotide positions - in our genomes. These differences, called single nucleotide polymorphisms (SNPs) or when they are common enough in the population, mutations, are the very differences that make us individuals. They give us different chances of developing a disease, different responses to the drugs we take, and even different average life spans.

Since the completion of the human genome project, enormous databases of genetic and clinical information have been built that can be analyzed meaningfully only by using these innovative research approaches. Determining which genetic mutation or combination of mutations is associated with a particular trait or disease is difficult: there is a signal-to-noise problem, where the noise includes the random mutations that permit us to evolve and diversify, and the signal constitutes those forms of genes that may be beneficial or even detrimental (i.e., earlier age of onset of

cancer). Thus, there is a need for the mathematical and analytical tools typically used by physicists and astrophysicists to solve these signal-to-noise problems.

As one of the world’s leading centers for theoretical research in mathematics and theoretical physics, the Institute for Advanced Study was a natural place to set up such an innovative program, because it would be able to attract highly talented researchers from an array of disciplines including biology, physics, mathematics, and computer science. Through an innovative postdoctoral training program that the Center developed, these young scientists have been able to apply novel ideas to key areas of biological research. For example, Harlan Robins came to the Institute and applied analytical skills developed during his training in string theory to a number of biological problems.

Robins, another presenter in the series, is now an assistant professor at the Fred Hutchinson Cancer Research Center in Seattle, and co-founder of Adaptive Biotechnologies, which was featured not too long ago in press reports for its breakthrough in approaches to diagnosis and disease monitoring through “immune profiling” - using advanced sequencing technologies and algorithms to take advantage of the immune system’s B cells and T cells’ ability to shuffle their DNA in order to generate an enormous number of combinations, which allows T cells to recognize specific pathogens, and allows B cells to produce targeted antibodies against them. The diagnostic capabilities developed by Adaptive played a crucial role in the happy outcome for a six year old girl who had been close to death from leukemia, reported on by The New York Times in December 2012.

Overall, “with the Innovators in Science series, our goal is illuminate the exciting advances being made in the life sciences today to an even broader audience with diverse backgrounds and shared interests in scientific advancements. Entrepreneurs, leaders in technology, young scientists, and specialists in other disciplines, among others, will have the opportunity to hear leaders in the field and join them in conversation about the future of biomedical research and enterprise,” says Christopherson. “The series will focus on discoveries that have led to important clinical applications. It will also build on the remarkable resources available for biomedical innovation in New Jersey and the signature programs and leadership of the New Jersey Technology Council.”

The next event will take place on December 10, 2013 at the Institute for Advanced Study in Princeton, NJ from 8:30AM to 11AM. For more information regarding the Innovators in Science series, please visit www.njtc.org. and www. ritaallen.org. n

Innovatorscontinued from page 4


PLUGGED IN

As 2013 comes to a rapid close, much of the success of the biotech industry this year, particularly for New Jersey based companies, was foreshadowed by the financial results from the prior year. Not surprisingly, a recent BDO analysis revealed research and development spending at biotech firms and the utilization of capital markets to obtain the cash for R&D funding continues to rise.

The 2013 BDO Biotech Briefing found that companies spent an average of $54 million on R&D in 2012, up from $50 million in 2011 and $48 million in 2010. The spike reflects an eight percent jump in 2012, compared to a four percent increase the previous year.

Biotechs- particularly smaller companies- remain committed to R&D efforts. While smaller firms saw a nine percent increase in average R&D spending overall, average R&D spending as a percentage of revenue increased to 215 percent in 2012 from 143 percent in 2011. Small companies also spent more on R&D per employee. In 2012, these firms spent $342,000 per employee, 42 percent more than the overall average in the study, and 90 percent more than larger companies spent per employee in 2012.

The results of this increased R&D effort were recently identified in a report from the Pharmaceutical Research and Manufacturers of America (PhRMA), which noted that U.S. biopharmaceutical research companies are currently developing 452 new medicines and vaccines for the treatment of rare diseases, all of which are now in human clinical trials or under review by the Food and Drug Administration (FDA).

BDO’s findings also indicated that biotechs are driving job growth in the life sciences industry, with the number of employees increasing 13 percent from 2011 to 2012. A recent report from analyst EP Vantage confirmed these findings, revealing in fact that some companies reported staff increases of over 60 percent between 2007 and 2012. Overall headcount at large biotechs increased a notable 23 percent in 2012, with R&D professionals up seven percent.

The investment required to advance science to a marketable and approved product continues to be recognized. This year, New Jersey enacted two incentive programs that will help sustain the growth of life sciences companies in New Jersey: The Economic Opportunity Act and The Angel Investor Tax Credit Program.

The Economic Opportunity Act streamlines New Jersey’s economic development incentive programs into two categories: GrowNJ, which aims to attract and retain companies in New Jersey, and the Economic

Redevelopment and Growth Grant Program (ERG), which creates incentives for development and re-development in urban and other designated areas. The Angel Investor Tax Credit Program provides credits against New Jersey corporation business or gross income tax with the goal of stimulating investment in emerging technology businesses. The program offers tax credits for up to 10 percent of a qualified investment in a business (with a physical presence in New Jersey) that conducts research, manufacturing or technology commercialization in the state.

A vast majority of biotechs in BDO’s study (78 percent) raised capital in 2012, indicating that the industry continues to attract investment. Equity financing continued to be the most popular avenue, with 67 percent of biotechs looking to the equity markets. Companies raised an average of $56 million through equity financing, which was in line with the levels of the past two years. Biotechs seeking debt financing also found success, confirming the early signs of ease in the debt markets witnessed last year. The average amount raised jumped from $34 million in 2011 to $61 million in 2012.

The trend in utilizing the public markets to obtain the capital needed to fund the necessary R&D investment was prevalent throughout 2013. Studies indicate 45 life sciences companies raised over $6 billion from IPO’s this year – including six New Jersey based companies.

Biotechs also continue to prioritize prudent cash management: As companies continue to invest in product development, cash is critical to support their programs. Companies reported $134 million in liquid assets in 2012, up seven percent from 2011 and 17 percent from 2010. On average, biotechs held an equivalent of 2.49 years’ of R&D spending in 2012, which has remained consistent over the last three years, despite the growth in overall R&D expenditure. Smaller biotechs were even more strategic in cash management, holding 2.63 years’ worth of R&D spending, compared to 2.33 years worth among large companies.

Biotech is expected to continue to be one of the fastest growing sectors within the U.S. economy over the next few decades, and New Jersey based companies are poised to capitalize on this growth. Home to more than 350 biotech companies, record high concentration of scientists and innovative state incentive programs, New Jersey has the potential to contribute to significant job growth and continue to foster a healthcare sector that has created the “world’s medicine chest.” n

BDO Biotech Briefing: Biotechs Continue to Invest More in R&D

and Leverage the Capital MarketsBY RYAN STARKES

Ryan Starkes is a Woodridge-based partner and life sciences practice leader for BDO USA, LLP.


ACCOUNTING

Q:As a development stage entity, financial reporting costs are killing me. Can anyone help?

A: Yes…well, maybe. The Financial Accounting Standards Board (FASB) is on the case. They have now acknowledged that the cost

related to the expanded disclosures current required for development stage entities may not outweigh the benefits, and has released a proposal that if adopted, will eliminate all of them.

A development stage entity is one that devotes substantially all of its efforts to establishing a new business and for which planned principal operations not produced significant revenue. Current accounting rules require presentation of inception-to-date information about operations, cash flows, and equity transactions. The costs of these rules become particularly burdensome when a company remains in this stage for many years before engaging an accounting firm to audit those statements. The users of these financial statements have long been concerned about the cost and skeptical about the relevance of these additional requirements.

Many life Science companies do not plan on ever manufacture a single product, but rather, may periodically sell their IP. These businesses could remain in the development stage in perpetuity thereby continually bearing the cost of the expanded requirements.

The elimination of these additional reporting requirements has yet not been officially adopted. The FASB is seeking comments from interested parties through December 23, 2013. This is a rare opportunity to reduce complexity and unnecessary cost with limited downside for the actual users of the financial statements, so we think the FASB should adopt the proposal.

Jarrod Rhen, CPA, is a senior manager in the Princeton Office of WithumSmith+Brown, Certified Public Accountants and Consultants and is a member of the Firm’s Life Sciences Group. Rhen may be reached at 609.520.1188 or [email protected]

Crowdfunding Legislation: Providing new channels of investment

for businesses and new investment opportunities for investors

BY TAKA TANAHASHI

There is new legislation being proposed by New Jersey State Senators Ray Lesniak and Joe Kyrillos that directly affects both entrepreneurs and investors. It is a new crowdfunding legislation that will provide new channels of investment for businesses and new investment opportunities for investors.

Businesses will have access to funding beyond the traditional methods (loans, personal credit lines, etc.). The legislation proposes that investors will be able to invest up to $5,000 individually and $1 million in aggregate. Notably, investors do not need to be accredited. This means that anyone with capital to invest is able to participate rather than being restricted to the requirements of Regulation D of the SEC. This provides much greater access to capital for businesses than the SEC-proposed JOBS Act, which only would allow for accredited investors to participate.

For this specific legislation, only New Jersey residents and New Jersey-based businesses will be able to reap the benefits. Part of the proposed legislation will allow businesses seeking investors to fund their operations to advertise freely for the sale of their equity on Facebook, Twitter, billboards and many other forms of advertisement. This change to a law that is over 80 years old will significantly open up investment opportunities to many new investors.

As with all legislation, there are downsides to go along with upsides. The free form of advertising that would be given to businesses will open up plenty of opportunities for losses on investments for new, less experienced investors. This commercialization of security sales is the type of change to a long-standing rule that may or may not have consequences for the immediate and not-so-distant future.

The federal government is already in the process of providing similar legislation on this topic. The Jobs Act (Jumpstart Our Business Startups) is currently being prepared but is being set back due to debate over proper regulation to ensure that investors are not being directed into poor investments. A number of other states have also already passed similar laws in anticipation of the federal legislation.

The proposed legislation for New Jersey is seeking to provide NJ resident investors and businesses with new opportunities for investing capital and funding new businesses to stimulate the local economy. It has benefits and consequences inherently but with proper implementation has the potential to provide plenty of opportunities to both investors and businesses in New Jersey. n

PharmD/MD candidates will participate in joint programming with medical students in activities such as shadowing and collaborative research or service projects. They also may be assigned to specialized clinical clerkships emphasizing collaborative practice with medical students and physicians.

Once in medical school, students have the opportunity for specialized enrichment options that take advantage of their extensive knowledge of pharmacology, pharmacotherapy, and pharmacy practice.

Students also will develop and participate in seminar series, conceptualize and carry out research projects, and participate in a capstone leadership project that integrates their pharmacy and medical professional training, contributes to the literature on interdisciplinary health care, and makes a documented contribution to clinical practice.

As a trailblazing program—for Rutgers, as well as higher education in general—the full potential and broad range of career options and opportunities for individuals with this advanced, integrated training have yet to be realized. It is an exciting time, not only for the PharmD/MD candidates themselves, but also for Rutgers, which is seeing new opportunities in curriculum development and for additional partnerships. n

Rutgerscontinued from page 5

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NJTC AWARDS CELEBRATIONThe NJTC Awards Celebration Honors New Jersey’s Best and Brightest Stars

Photo 1: Trailblazer Award Blacklight Power - Dr. Randy Mills, Founder, President & CEO Presented by: Tom Conway, AmberRoad

Photo 2: Outstanding Technology Development Award Systech International – Robert DeJean, CEO & President Presented by: Sree Velicheti, CEO, EXP

Photo 3: Consumer Product Award Qualityhealth – Christopher Neuner, SVP Sales & Client Engagement Presented by: Stephen J. Muretta, Assurance Partner, Ernst & Young LLP

Photo 4: Beacon of Light Award Edge Therapeutics, Brian Leithner, CEO, (center) Presented by: L-R: Steven M. Cohen, Partner, Morgan Lewis, Judith Sheft, Associate VP Technology Development, NJIT and Jerry Creighton, Executive Director, NJIT

Photo 5: Rising Star Award HR Acquity Llc – Deborah Muller, President & CEO Presented by: Christina Giglio, Division Director, Robert Half Technology

Photo 6: Legislative Champion Award U.S. Congressman Frank Pallone, Jr. Presented by: Charlene Brown, RVP, AT&T External Affairs, AT&T

Photo 7: Innovative Technology Company Award Simeio Solutions Llc – Darren Calman, VP Business Development & Sorabh Chopra IAM Specialist Presented by: Ian Gallagher, Sr. Marketing Manager, Comcast Business

Photo 8: Impact Company of the Year Award Icims, Inc. – Adam Feigenbaum, COO Dan McGrath, COO, Maloy Risk Services

Photo 9: Legend of Technology Award Mario Casabona, Founder & CEO Presented by Brandyn Schmelzer, Manager, BDO USA

Photo 10: Private Company Award Premier Healthcare Exchange, Inc. – Todd Roberti, CEO Presented by Chris Downie, CEO, Telx

Photo 11: Public Company Award Stryker – Scott P. Bruder, M.D. Presented by Larry Irving, CFO – Synchronoss Technologies

Photo 12: John J. Martinson Technology Supporter Award Chris Sugden, Managing Partner, Edison Ventures Presented by David Sorin, Managing Partner, SorinRand LLP

Photo 13: Master Technology Company Award Universal Display Corporation – Steven Abramson, President & CEO Presented by: Jerry Passione, Strategic Alliances Senior Director, Juniper Networks - OPENLAB

Thank you to our 2013 Awards Celebration

Table Sponsors

Casabona VenturesStyker

McGladreyNew Jersey Institute of Technology

Susquehanna Growth EquityVerizon

131110 12

www.morganlewis.com©2013 Morgan, Lewis & Bockius LLP

We congratulate the nominees and

recipients of the 2013 New Jersey Technology Council Awards,

with a special salute to our clients and friends:

Universal Display CorporationMaster Technology Company of the Year

SevOneInnovative Technology Company

MD On-Line, Inc.Impact Company of the Year

Mario CasabonaLegend of Technology Award


For life science companies, in particular the smaller “biotech” companies, the approach to obtaining the appropriate level of funding to support key development programs has evolved significantly over the past three decades. In the 1990s and early 2000s, the opportunities for securing funding to support research and development were much greater than they are today. In today’s economic environment, developing sensible and productive funding mechanisms and relationships has become more and more challenging for corporate executives.

One pathway to facilitate meeting and overcoming this challenge is to evaluate the “cross-over” potential for your technology assets (e.g., drugs, devices, combination products).

By cross-over, we mean a technology that possesses:• the typical commercial interests and market potential (e.g., large

market, area of unmet medical need, etc.); and• the potential to address a need stipulated by the US federal government

in a current funding vehicle (e.g., a medical countermeasure).A product that meets these attributes of a cross-over product as

defined above will provide more opportunities to fund development programs and increase the resource bandwidth of an organization. Specifically, this product may meet an agency’s mission objectives (i.e. areas of interest) related to a federal funding opportunity including both grants and contracts. Federal grant opportunities are historically well-understood and a commonly utilized mechanism to obtain non-dilutive funding to support development programs; however, they typically do not provide sufficient funding to complete broad programs and many times are limited in scope. An alternative non-dilutive funding option available to support development programs are federal contracts.

Federal contracts provide companies:• a significant, often multi-million, multi-year influx of non-dilutive

funds including the direct reimbursement of funds spent on the program as well as application of the appropriate indirect rate and a negotiated profit/fee; it is worth noting that there is the possibility that several funded activities would be useful in supporting other development programs using the same product, thereby, indirectly

defraying the costs of additional programs; • the opportunity to expand the corporate team in all facets of

operations from research and development to finance;• the ability to move development programs forward, often while

completing key tasks that will directly and/or indirectly support other development programs involving the same product;

• public validation of the scientific and technical merit of your development program as well as confirmation that the team and corporate organization has the appropriate attributes to execute the detailed program.

Currently there are several departments and agencies within the federal government that offer solicitations for federal contracts that would be a fit for many life science companies including, but not limited to:

• the National Institutes of Health (NIH);• the Biomedical Advanced Research and Development Authority

(BARDA); and• the United States Food and Drug Administration (FDA).The first step to developing a successful federal contract proposal is

basic: READ THE SOLICITATION THOROUGHLY. Solicitations prepared by the government are often very specific and targeted. In order to determine if an open solicitation is a “match” for a company and/or program, the following questions should be answered affirmatively:

• Does the product/program clearly meet a specific area of interested noted?

• Can you/your team meet the process requirements and submission deadlines?

• Does the product/program meet the basic requirements (e.g., is your product at the appropriate technology readiness level or stage of development)?

Each solicitation will identify specific areas of interest. It is imperative that your product/program clearly meet a specified area of interest. If there are questions as to whether your product/program is a match for a

BY CHRISTOPHER J. SCHABER, PHD

Federal Contracting:

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Christopher Schaber, President & CEO, Soligenix

specific area or interest, it is highly recommended that the noted program officer be contacted prior to submitting any response. The agency issuing the solicitation often has a very specific intent to the wording of the areas of interest and engaging their representatives prior to submission will make for a more efficient process. It is strongly recommended that the “square peg-round hole” approach is not applied when determining if your program is a match. As you embark on the path of pursuing federal contracts, much like grants, you begin to develop a perception of your organization that is not served well by providing proposals that are not DIRECTLY responsive to the solicitation.

Question 2 above may appear obvious, but it is crucial to determining if you can successfully navigate the contracting process. All solicitations are not the same and, in many cases, even the basic process is different. Some solicitations take the form of a broad agency announcement (BAA) and have general objectives to be addressed by contractors submitting a pre-proposal (more commonly referred to as a “white paper”).

A white paper typically would include:• a one-page quad chart, summarizing the high-level goals/objectives,

target dates and budget for the proposed program;• a 10page “white paper” describing the technology and proposed

program; and• an appendix/attachment (in some cases used to describe key

personnel that will contribute to the program).Following submission of a white paper, the government agency will

review and determine whether or not to invite your organization to provide a full proposal (technical and cost proposal). There are open solicitations and BAAs that require submission of a full technical and cost proposal without the submission of a white paper. Accordingly, after you have determined if you have met a specific area of interest for a particular solicitation, it is extremely important to honestly evaluate

your capabilities prior to determining whether or not to respond to a solicitation. The resource commitment and capabilities necessary to generate a white paper is significantly less than the commitment and capabilities necessary to prepare a full contract proposal. A typical contract technical proposal will be approximately 150 pages (including appendices) while the cost proposal generally is not limited to a specific number of pages.

Once you have answered the questions above affirmatively and have determined to move forward with submission of a proposal, assembling the appropriate team members is of the utmost importance.

A typical team will include technical, operational, project management and financial representatives. Although all aspects of the proposal are important to the success of a submitted proposal, the most important aspect when submitting a proposal is the technical proposal. A proposal can only be as good as the science it is based on. The other components or volumes of the proposal clearly cannot be dismissed; however, if the science is not clear and feasible and the program is not progressive with regulatory potential, an invitation to enter contract negotiations will not be forthcoming. Once the technical aspects of the program are solidified, the project management and costing aspects of the proposal can be developed. It’s important to submit a budget within the ceiling or magnitude (if made known to the offerors) and identify best value solutions that are reasonable and advantageous to the government. The ideal and fundable contract proposal will be one that possesses a clear and scientifically/regulatory rationale approach balanced by a reasonable and accurate cost estimate.

Securing government grants and contracts is by no means an easy proposition, but when done right, it provides another effective mechanism to bring in non-dilutive capital to support development programs in today’s difficult economic environment. n

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Obtaining Non-Dilutive Funding Value For Necessary Research And Development Programs


LEGAL

Shahnam Sharareh, PharmD, JD, Partner, Fox Rothschild, LLP. Shahnam concentrates his practice on U.S. and international intellectual property, technology transfer and FDA regulatory issues

Since Dr. Sanjay Gupta’s documentary in CNN early in August on medicinal use of marijuana, the debate over medical marijuana has resurfaced. Since the passage of California Proposition 215 in 1996, some 20 States have now passed medical marijuana laws to implement programs to allow patient access to its medical use within a legal framework. However, there is much confusion as to the boundaries of these laws. The tension between the Federal or State jurisdictions has muddied the risk for the entities which function in this space. This article attempts to briefly visit some of prevalent issues for consideration by companies that operate in this space.

State LawsSince the passage of Proposition 215 in California, some 20 States have passed laws making marijuana plants available for a variety of medical conditions upon a doctor’s recommendation. These laws are inconsistent in their scope, do not generally include reciprocity provisions and could be more restrictive from one State to another; however, they have created a balance between the availability of the plant to the patients in need and the control over its distribution for medical use. The New Jersey Compassionate Use Medical Marijuana Act was signed into law on January 18, 2010 by Governor Corzine. Following certain delays and amendments, the mode and extent of patient access have gradually been set. In New Jersey, only certain physicians can prescribed it for medical use. Further, only certain patients meeting articulated criteria can qualify to receive medical marijuana. These criteria include a diagnosis of a “debilitating medical condition” that is “resistant to conventional therapy.” Such conditions include for example, seizure disorder, Glaucoma, Cancer resulting in severe or chronic pain, nausea, cachexia, or wasting syndrome, ALS, Muscular Dystrophy and Inflammatory Bowel Disease. More recently a change in the law allows access of edible medical marijuana to minors suffering from epilepsy.

States measures such as those in New Jersey, however, are inconsistent with Federal efforts to ensure that products intended to treat medical conditions undergo rigorous scientific scrutiny to substantiate their safety and effectiveness. As such dispensaries,

manufacturing and research companies in this space are not immune from Federal enforcement Actions.

Federal JurisdictionUnder the Federal Food, Drug, and Cosmetic (FD&C) Act, the U.S. Food and Drug Administration (FDA) is the Federal agency that evaluates the safety and efficacy of substances offered in commerce to treat or mitigate diseases before they enter the U.S. market. With respect to “new” products, FDA’s drug approval process requires an evaluation of necessary scientific data gathered during the Investigational New Drug Application (IND) period through trials conducted in humans. Preliminary animal data submitted by a Sponsor (the company seeking to offer the treatment) is first reviewed for potential risk of harm to study subjects and, if not objected-to, the Sponsor may begin studies in humans. Data compiled during such studies are then presented to FDA in a New Drug Application (NDA) to make the case for approval and labeling decisions. FDA sanctions companies that attempt to bypass its approval process because of the risk that their products may pose to potential users and patients. Marijuana falls under this regime as a “new” product offered to treat or mitigate disease.

DEA is another Federal agency that plays a role in regulating marijuana and tetrahydrocannabinol (THC)- derived substances. DEA is responsible for regulating controlled substances and enforcing the Controlled Substances Act (CSA). The CSA classifies controlled substances into five schedules, depending upon their approved medical use and abuse potential. Schedule I substances are those that have a very high potential for abuse, are not accepted for medical use in the United States, and typically lack accepted safety data for use under medical supervision. THC – the main psychoactive ingredient in marijuana plants – is currently listed as a schedule I substance. Schedule IV substances are approved for medical use but their potential for abuse is minimal.

FDA’s Office of Criminal Investigations (OCI) works closely with DEA to sanction the sale of products that may be obtained from marijuana plant. The criminal penalties related

BY SHAHNAM SHARAREH

Marijuana and its Legal Dilemma

to Schedule I controlled substances are much greater under the CSA than those available under the FD&C Act for the distribution of any unapproved controlled new drug. Therefore, it is the most likely the DEA that would take the leading role in enforcing irregularities in distribution of Schedule I substances.

FDA has already approved synthetic THC-based compounds – such as the Marinol tablet and Cesamet – as anti-emetic agents for use in the U.S. through the NDA pathway. However, FDA has not approved smoked or inhaled marijuana for any condition or disease indications. At least one hurdle in such approval is the difficulty in standardization of the potential formula in a well-controlled study. Thus, FDA, as the Federal agency responsible for reviewing the safety and efficacy of drugs and DEA, as the Federal agency charged with enforcing the CSA, do not support the use of smoked marijuana for medical purposes. Companies offering medical marijuana sector therefore are not immune from Federal enforcement action, even though they may operate in States that permit access to its medical use.

Historically, FDA issued warning letters implicating offenders for misbranding within the meaning of § 520(f)(1) of the FD&C. In such scenarios, marijuana plant-derived formulations are characterized as a new drug under section 201(p) for not being generally recognized as safe and effective when they are linked to a therapeutic claim.

Accordingly, seeking approval under the NDA path seems to be the FDA’s choice for evaluating marijuana-derived formulations.

Despite accessibility of patients to medical marijuana in some 20 States under respective State regulations, both FDA and DEA have Federal jurisdiction in limiting the distribution of any marijuana-derived products. Therefore, until well developed scientific basis for evaluating the clinical efficacy and safety of medical marijuana have been evaluated at the FDA level, State measures may not alleviate Federal scrutiny. In the meantime, FDA continues to require an approved new drug application before selling marijuana-derived products for the treatment of diseases and other medical conditions. n


Let’s start with a few numbers: 6,000,000, 33,000, 1,000 and 20. These numbers tell an intriguing story, and contain the secret to why the opportunity to build, operate or invest in human resource technology companies is so compelling.

6,000,000 – According to Cortera, there are 6,000,000 businesses on record in the United States that claim two or more employees. While most of the media’s focus over the last few years has been dominated by doom and gloom about rising taxes, layoffs and rising government spending, we think they are seeing the glass half empty. Look closer and you will see a very different picture: increasing revenues, 93%+ employment and the likely prospect of increasing job creation. These 6,000,000 businesses are the lifeblood of our economy.

33,000 – The combined total number of corporate customers claimed by WorkDay, LinkedIn, Taleo (prior to their sale to Oracle), Kenexa (prior to their sale to IBM), SuccessFactors (prior to their sale to SAP) and Cornerstone OnDemand. These are the modern day stalwarts of the HR technology landscape and, for the most part, they cater to the largest customers in the country. These six companies in aggregate have created over $45 billion of shareholder value over the last 15 years. Not bad for penetrating less than 1% of the target customer base!

1,000 – The number of US technology vendors developing solutions to help businesses manage their talent. These include applicant tracking systems, performance management solutions, learning management platforms, expense management systems, payroll, benefits administration, and incentives, to name just a few. These are the companies that help keep employees employed, motivated, trained and productive. If we want to remain competitive in the global economy, we need to increase productivity levels of our workforce and these technology solutions enable our businesses to do just that.

20 – There are nearly 200 million people employed in our country today and on a global basis our unemployment rates are exceptionally low. Our largest employer is Walmart, and they employ roughly 1% of our workforce with over 1,400,000 employees in the US alone. Our smallest employer has 1 employee. The average is 20 employees. We are a country dominated by small business: millions of small businesses with the same needs, desires, ideas and goals as the largest global enterprises.

Our country’s most important resource is our people and our employers’ most important asset is their employees. Yet only recently have solutions become available that enable businesses to manage talent effectively. Filing cabinets led to spreadsheets, which led to applicant tracking systems, which have now led to sophisticated work flow solutions managing massive amounts of personnel data covering both prospective and existing employees. With good intentions, many of the more mature solutions in the market were designed and developed for the largest of employers. These solutions were built on single-tenant architectures designed for on-premise use. Fast forward to today and we have multi-tenant software applications hosted remotely and served over the internet (software-as-a service or SaaS). The advantages are tremendous and provide for ease of access, implementation and use for even our smallest businesses. Talent management solutions in the cloud are now available to all, yet millions of customers still have not taken advantage of them.

To better understand the opportunity in HR technology we need to examine the talent management process in a bit more detail. Talent management begins with identifying a candidate, continues through the interviewing process, background screening, reference and assessment checking, hiring, onboarding, benefits administration, payroll, performance management, intra-company social connectivity, compensation management, succession planning, health and wellness management and so on. The lifecycle of an employee is riddled with multiple inflection points, any of which could positively or negatively impact the productivity of that employee or the profitability of the employer, or both. This is a complex process even for the largest employers. Imagine how inefficient smaller companies are without the right solutions in place to automate the different steps on the assembly line. Sure, some processes have advanced quite a bit even for small companies. Payroll is the best example, with the likes of ADP, Ceridian, Ultimate and Paychex delivering automated payment, direct deposit and other electronic compensation solutions to millions of employers. But candidate sourcing, performance management, wellness management and the like are all relatively new, formal parts of the talent management ecosystem, and accordingly they require adequate management information systems.

BY SCOTT FELDMAN

HUMAN RESOURCES

HR Tech2.0 The first generation of talent management solutions arrived in the 1990s with the mission to automate existing HR processes for large, horizontally integrated enterprises. We think of this group as HR Tech 1.0. A key driver of the shift in talent management technology is the maturation of the 1.0 leaders, which has caused a recent consolidation within the industry. This has left a tremendous opportunity for the next generation of talent management innovators, the 2.0 pure SaaS solutions. Greeting these innovators is a core marketplace that is both large and habitually under-served.

Talent management is undergoing a meaningful transition that will be driven by a variety of factors. First, traditional HR software systems are aging, which is causing most companies to begin the search for newer, more advanced technologies. Second, and very importantly, the Cloud has become more much accessible as a delivery platform. According to human resources technology expert Josh Bersin of Bersin & Associates, “Nearly every major HR software provider now offers their solution in the cloud…”, which has made it possible for HR departments to avoid upgrading software systems every year. Furthermore, since many companies employ cloud-based systems for their HR applications, it is now much easier to switch vendors. Put simply, the market for HR Technology is a buyer’s market, and the sellers have responded by broadening their product offering organically or through acquisitions to include all HR functionality in one package and creating better benchmarking and talent analytics systems. Finally, there has been a wide realization that talent is the most important factor of a business’ success.

If you run a small business and you are reading this article, you may be wondering “well, how much does it take to get one of these applications running?” iCIMS, one of our portfolio companies, is a great example. iCIMS is a talent management solution provider primarily focused on talent acquisition, or the pre-hire phase of talent management, for small, medium and large customers. Their small business offering is called iCIMS NOW and starts at a price point of $299 per month. iCIMS NOW has many functionalities, including candidate sourcing, allowing companies to aggregate potential candidates from multiple job boards. This platform offers CRM capabilities, allowing hiring managers to create records of candidates, communicate with them and carry them through the interviewing process.

See “HR”. page 21


NJTC NEW MEMBERS

CXOGeorge Mc Kevitt412 St. Marks Ave.Westfield, NJ 07090908-447-3702I worked for Albridge Solutions (now part of BNY Mellon) for the past 7 years. First as the Director/Managing Director of Software Development, Support and Architecture, then as the CIO since 2011 where I managed a team of 275. Prior to that, I was the VP of Software Development and Chief Architect for Starpoint Solutions as well as a National Enterprise Architect for Teradata. I also hold a PhD in Computer Science, an MS in Computer Science and a BS in Physics as well a BA in Business.

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IFS Technology Solutions500 Route 17SHasbrouck Heights, NJ 07504201-288-5599www.IFSTechnologySolutions.comMitch Kaufman, President - [email protected] develop and support custom software applications for desktop/web/mobile devices.

LAM Cloud Solutions1 Farr View DriveCranbury, NJ 08512888-936-5282http://lamcloud.comTom Ryan, Managing Director - [email protected] Cloud operates state-of-the-art data centers and facilitates, and offers scalable solutions including Business Continuity and Availability, Professional Services, Virtualization, Colocation, Managed Cloud, and Network and Internet Services.

Online Computers and Communications, LLC901 Route 10Whippany, NJ 07981973-929-2915www.onlinecomputers.comAndrea Dooley, Marketing [email protected] Computers and Communications is a Managed Service Provider supporting small to medium businesses throughout New Jersey. We provide all of our clients with outstanding service, as well as the most up to date technologies. We build lasting relationships with our clients and ensure they receive our undivided attention and care to guarantee the best possible technology which in turn creates the best possible business.

As of October 2013


TecEsq Knowledge Solutions LLC6512 Linden LaneDallas, TX 75230510-709-0240http://tecesq.comWendy Oliveras, Business Development Partner [email protected] is an Intellectual Property Consulting Company engaged in creating valuable business assets for our esteemed clients by helping and safeguarding their intellectual property.

salesforce.com4131 Michelle DriveTorrance, CA 90503-2410310-371-8096www.salesforce.comTodd Kyle, Sr. Account Manager [email protected] powers your Organization with cloud based engagement solutions to personalized service and build closer connections with your constituents.

Service ProviderPine Hill Group49 Winfield RoadSicklerville, NJ 08081610-456-9654www.thepinehillgroup.comStephen Nardi, Managing Director [email protected] Hill Group is a boutique finance and accounting consultancy that specializes in serving the financial, accounting and transactional needs of small- to mid-sized public and private companies.

Telecommunications/MediaArkados, Inc.211 Warren Street, Suite 320Newark, NJ 07103862-373-1988www.arkadosgroup.comTerrence DeFranco, CEO [email protected] Group, Inc. is a leading software and hardware design company focused on developing solutions that enable machine to machine communications for the Internet of Things (IoT). Our solutions support smart grid and smart home applications primarily in the areas of home and building automation and energy management. The Company’s solutions are uniquely designed to drive a wide variety of wireless and powerline communication (PLC)-based products, such as sensors, gateways, video cameras, appliances and other devices. By utilizing the Company’s solutions, Arkados’ customers can bring numerous sophisticated, full-featured products to market faster at a lower overall development cost. Arkados® is a registered trademark of Arkados Group, Inc. For more information about Arkados please visit the Company’s website: http://www.arkadosgroup.com

Joining the NJTCPaul Frank • Ext 222 • [email protected]

Membership ServicesJudy Storck • Ext 246 • [email protected]

Member Relations ManagerEllen Stein • Ext 228 • [email protected]


© 2013. Constellation Energy Resources, LLC. These materials are provided by Constellation NewEnergy, Inc. Any offerings described herein are those of Constellation NewEnergy, Inc., a subsidiary of Exelon Corporation. Brand names and product names are trademarks or service marks of their respective holders. All rights reserved. Errors and omissions excepted.

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It also provides social connectivity to multiple social and professional networks allowing for job posting and enabling candidates to apply for jobs right from the network. A company can be up in running on iCIMS NOW in less than a day with little to no integration with existing human resource systems, all for less than $4,000 per year. With the median salary in the US running around $60,000, a company can easily justify the cost even if they only make a few hires per year. More than a luxury, these systems are a requirement to stay competitive and position your business to gain access to, attract and retain the best talent. iCIMS has many peers in other areas of talent management including performance, benefits, wellness and many others. The opportunities are really endless for strong, pure SaaS, point solutions targeting the small and medium sized business market.

So now back to the title of this article – “HR Tech 2.0”. As discussed above, HR Tech 1.0 played out over the last 15 years, and its solutions were developed with less technological scalability and flexibility for only those that could afford the high implementation, integration and customization costs. 2.0 will play out over the next 15 years. It’s now all about having an affordable, scalable solution available to the masses, yet with all the same bells and whistles the incumbents have enjoyed over the last two decades. 2.0 is about leveling the technological playing field in corporate America. 2.0 is about small business and pure SaaS, cloud solutions, or whatever term you prefer that has come to define this dramatic shift in the market. And while the opportunity to take advantage of pure SaaS as an operator or investor manifests itself in many ways across multiple industry verticals, we put talent management at the top of the list. Talent management is a complex series of discrete processes that involve a company’s most prized asset: its employees. Proper care and consistency is required across these processes and is essential for the attraction, retention and growth of a stable and successful workforce.

If six companies can create over $45 billion of value in less than 15 years, just think what this new breed of entrepreneurs can do with 6 million customers over the next 15 years. We have never been more excited to invest our time, resources and capital into a sector and look forward to meeting the stars of this next chapter over the coming years. n

continued from page 19HR

Scott Feldman is a Managing Director with Susquehanna Growth Equity, an investment firm

that focuses on software, payments and information investments. Contact: [email protected].

RenewalsAgile Therapeutics www.agiletherapeutics.comAOS Thermal Compounds www.aosco.comATC Labs • www.atc-labs.comLeslie BilletBioClinica • www.bioclinica.comBusiness & IT Solutions Caliper Corporation www.calipercorp.comDelta Corporate Services, Inc. www.deltacorp.comDuane Morris LLP www.duanemorris.comEdison Ventures www.edisonventure.comEnixs Technology, LLC www.enixstechnology.comGeneral Network Service, Inc. www.general-network.comHS Design, Inc. • www.hs-design.comJCP&L/ A FirstEnergy Company www.firstenergycorp.comLightower Fiber Networks www.lightower.comLowenstein Sandler PC www.lowenstein.comMercer County Comm. College www.mccc.eduMiddlesex County College www.middlesexcc.eduMindshift Technologies www.mindshift.comOptima Global Solutions, Inc. www.optimags.comParmele, McDermott & Thomas www.parmelemcdermottthomas.comPrinceton Plasma Physics Laboratory www.pppl.govR² Associates • www.r2associates.comSimPhoTek Inc. • http://simphotek.comSorinRand LLP • www.sorinrand.comThe Philadelphia Trust Company www.philadelphiatrust.comTranSend IT • www.transendit.comTriNet HR Corporation www.trinet.comVidyo, Inc. • www.vidyo.comWayside Technology Group www.waysidetechnology.comYouGiveGoods, LLC www.yougivegoods.com

TechLifeSciNews | www.njtc.org | September 201322 TechLifeSciNews | www.njtc.org | December 201322

NJTC CALENDER OF EVENTS

Stay tuned for these great upcoming events in 2014

WHAT ABOUT WASHINGTON: TELECOM & ENERGY LEGISLATION IN 2014

January, 2014WeiserMazars LLP

Edison, NJ

Members: $25 • Non-members: $50

Reading the tea leaves in 2014 will be important – it’s an election year. Congress has a lot of issues to resolve. We hope you will join us in January to talk about some of the issues of importance to regional technology companies, including:• What if any legislative efforts will happen in

DC this year in relation to the Telecom and Energy industries? How will the new FCC chair handle releasing the great amount of spectrum needed? Will tax breaks be continued for wind and solar installations in the state, region and country?

• What would additional sequestration efforts (and possibly a second government shut-down) mean to the Energy and Telecom Industries and Academic Research in those areas

• What Intellectual Property changes are on the horizon in 2014?

Speakers will include some Washington experts. This program will introduce some topics for discussion when the NJTC delegation goes to Capitol Hill on February 11 -12.

NJTC TECHNOLOGY FORECASTJanuary 24, 2014

The Westin PrincetonPrinceton, NJ

MAKING CONNECTIONS: PARTNERING SESSIONS

February 6 • 4:00 PM - 6:00 PM Delta Corporate Services

129 Littleton Road Parsippany, NJ

Members $25.00 • Non-Members $60.00

TECH TREK TO WASHINGTON FEBRUARY 11, 2014

In collaboration with TECNA and CompTIA

MID ATLANTIC LIFE SCIENCE SYMPOSIUM

February 13, 2014Kean University

As part of this program, we are conducting a Life Science Survey to gather a sampling of people’s view of the industry and it future.

NJTC CIO CONFERENCE February 27 • 8:00 AM - 2:00 PM

Synchronoss 200 Crossing Blvd. 8th FL

Bridgewater, NJ

Members $150.00 • Non-Members $175.00 LUNCH ONLY NJTC Member $45.00 LUNCH ONLY Non-Member $90.00

Attendance at this event is exclusively for CIOs, CTOs, IT Directors, Senior IT executives, IT Managers, other senior business executives and sponsors/exhibitors.

SPONSOR / EXHIBIT OPPORTUNITIES AVAILABLE Contact Karen Lisnyj at 856.787.9700 or [email protected]

NETWORKSNJTC Industry Networks present programs about opportunities and challenges facing NJ technology companies by industry segment.

Electronics, Advanced Materials & Manufacturing

Patron Sponsors:EisnerAmper

Woodcock Washburn LLPContact:

Paul Frank • Ext [email protected]

Ellen Stein • Ext [email protected]

Enviro-Energy IndustryPatron Sponsors:

WeiserMazars LLPWoodcock Washburn

Contact: Paul Frank • Ext 222

[email protected] Stein • Ext 228

[email protected]

IT/SoftwarePatron Sponsor:

BDOContact:

Leo Mennitt • Ext 227 [email protected]

Judy Storck • Ext 246 [email protected]

Life Sciences & Health ITPatron Sponsors:Drinker Biddle

Fox Rothshild LLPMcGladrey

Contact: Leo Mennitt • Ext 227

[email protected] Johnston • Ext 244

[email protected]

Telecommunications/MediaPatron Sponsor:

Verizon New JerseyContact:

Paul Frank • Ext [email protected]

Judy Storck • Ext 246 [email protected]

CEO ForumPatron Sponsors:

Morgan Lewis • TriNet WithumSmith+Brown

Contact: Ellen Stein • Ext 222

[email protected]

CFO Peer NetworkPatron Sponsors:

Cresa NJ – North/Central LLC Ernst & Young, LLP

Contact: Martine Johnston • Ext 244

[email protected]

CIO Peer NetworkPatron Sponsors:

Oracle • telxContact:

Karen Lisnyj • Ext [email protected]

Government AffairsContact:

Karen Lisnyj • Ext [email protected]

Software Engineering LeadersPeer NetworkPatron Sponsor:Sparta Systems

Szaferman, Lakind, Blumstein & Blader, PCContact:

Leo Mennitt • Ext 227 [email protected]

For updated information or to register for NJTC events, visit www.njtc.org

NJTC Peer Networks bring together like-minded technology professionals to share common issues, learn best practices and gain perspective across all technology industry segments.


NJTC PHOTO GALLERY

NJTC Leadership Summit

The NJTC Leadership Summit assembled New Jersey’s best and brightest high-tech and life science executives for insightful discussions, engaging and successful speakers and practical advice for managing a more profitable company. Awards were presented to leaders from the private and public sectors. Honorees were selected based on their vision and leadership, corporate performance, innovative business achievements and social responsibility.

Photo 1: Welcoming remarks from Simon Nynens, President & CEO, Wayside Technology Group, Inc.

Photo 2: hilip Politziner, Chairman Emeritus, EisnerAmper LLP introduces Featured Speaker

Photo 3: Featured Speaker: Chuck Hanna, VP, Mid Atlantic Region, Constellation, An Exelon Company

Photo 4: Jeffrey Babin, Managing Director & Founder, Antiphony Partners, LLC - Case Study Presentation and Roundtable Discussions - Innovation on the Lean - A New Model for Efficient Product Development - A Dropbox Case Study

Photo 5: CEO Panel Discussion - Leadership 5.0 - The Story Behind the Story – Panelists L-R: Moderator: Andy Gilbert, Co-Managing Partner, DLA Piper; Tony Ellison, Founder & CEO, Shoplet; Bill Bartzak, President, CEO & Founder, MD On-Line, Inc.; Michael Carus, President & COO, RedVision

Photo 6: Congratulations to the CEO of the Year Award Winners L-R: Moderator: Kevin Pianko, Partner, WeiserMazars LLP; (Accepting on behalf of Ashraf Lotfi, Altera Fellow & CTO, Enpirion Power Businees, Ken SKen Sielatycki, CFO- Enpirion; Ali Houshmand, Ph.D., President, Rowan University; Marianna Rabinovitch, CEO, ECI Technology, Inc.; Stuart Peltz, Ph.D., Co-Founder & CEO, PTC Therapeutics; Adnane Charchour, President & CEO, Scivantage and Nariman Farvardin, Ph.D., President, Stevens Institute of Technology

Photo 7: Summit Sponsor & Moderator: Andy Gilbert, Co-Managing Partner, DLA Piper

Photo 8: Summit Sponsor & Moderator: Kevin Pianko, Partner, WeiserMazars LLP

Technology Tour - South Jersey Technology Park

NJTC visited the South Jersey Tech Park and we were able to tour several of the labs including the CAVE®, a room sized, virtual reality (VR) environment.

Photo: Shreekanth Mandayam, Associate Provost-Research, Director of the Tech Park, shared the university and region’s plans for growth and innovation.

Leading Forrester Analyst Presents the Software is the Brand

ObjectFrontier Software sponsored John C. McCarthy, VP and Principal Analyst, Forrester Research, Inc. who gave a presentation on the business implications and opportunities behind the software is your brand dynamic. Thank you to OFS for sponsoring this event along with the law firm Giordano, Halleran & Ciesla. Special thanks also to NJTC member Yorktel for hosting the event.

Photo: L-R John McCarthy and Rich Napoli, CEO, OFS

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FOR A NETWORK TO KEEP PACE WITH HIT INITIATIVES.Comcast Business Ethernet can help improve the quality of care of your organization. With speeds from 1Mbps to 10Gbps, telehealth from multiple locations can be a reality. And it’s flexible and scalable so it can grow right along with you while keeping costs in line.

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