pa biowatch - files.ctctcdn.comfiles.ctctcdn.com/a4698730301/8099b367-4a68-450a-b... · the future...

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PA Bio Watch PENNSYLVANIA BIO’S QUARTERLY NEWS SOURCE Q3 2014 T he membership of Pennsylvania Bio at the end of Q3 2014 included more than 625 members, regional, na- tional, and international partners, and financial support that allow the trade association to shape the great messages of the life sciences, and push them out to statewide, national and even global audiences. According to PA Bio president & CEO Christopher P. Molineaux, “the life sciences commu- nity in PA – companies of all sizes, universities and research organizations, pharma, biotech, medical devices, diagnostics, investment organizations – is now the tip of an economic spear that is leveraging huge change here in Pennsylvania and around the nation.” Data released in June report more than 2,200 life sciences establishments in PA; $7 billion in annual wages; 85,000 direct jobs and nearly 500,000 Pennsylvanians either directly or indirectly employed by life sciences work. According to Molineaux, “the most important result of the life sciences successes in Pennsylvania over the past few years is that they further strengthened our foundation and allow us to focus on the future.” With that renewed focus, the Pennsylvania Bio Board of Directors met in mid-July at the GlaxoSmithKline offices in Gulph Mills, PA to update the strategic plan of the organization, taking the planning to 2017 and beyond. While Board members acknowledged during the meeting the negative effects of the biopharmaceutical industry transformation and considerable job loss throughout the region, there was recognition and optimism grounded in recent data from the Pennsylvania Department of Labor & Industry indicating life science industry employment has been affected much less than other sectors of the economy. As the Medical Device and Drug & Pharmaceutical sub-sectors both saw decreases in establishments in the five-year period between 2008 and 2013 – losing 60 and 7 establishments respectively – the number of establishments in the Research, Testing and Medical Laboratory sub-sector continued to grow at a strong pace with 727 firms created – a 24% increase – during the same period. Today’s 85,000 direct jobs in the life sciences represent the greatest number since prior to 2007. Pennsylvania Bio Board Chairman, Rob Bazemore, Chief Operating Officer of Synageva Biopharma Corp., reiterated the cause for optimism for the community and emphasized the obligation of PA Bio, the only statewide organization for the entire life sciences ecosystem. “Pennsylvania Bio is a recognized leader, voice and resource for the life sciences community in Pennsylvania. e strategic plan developed today assumes significant change will continue in the industry and focuses on the core activities that Pennsylvania Bio members consider valuable…while also contemplating strategic growth in emerging areas of interest and opportunity. is plan will guide the annual development of working plans for the organization and Board of Directors, but also will be revisited annually due to the fluid nature of the industry.” Following is a summary of Pennsylvania Bio’s Strategic Plan for 2014-2017. Pennsylvania Bio Vision - 2017 Pennsylvania is considered the most attractive location in the United States for establishing a life sciences organization by life sciences leaders within the U.S. and by those outside the U.S. seeking to establish U.S. operations. Pennsylvania Bio Mission Pennsylvania Bio’s mission is to ensure Pennsylvania is the United States hub for the life sciences* by creating a business and public policy environment which fosters life sciences growth and success. THIS ISSUE Life Sciencs Future ............ 2 Locate in PA .................... 8 Membership News............ 9 Regional Events ............... 12 Advocacy Update ............ 15 Programs........................ 18 Q&A .............................. 20 President’s Column .......... 23 Mapping to 2017 Continued on page 14 e Pennsylvania Bio Board of Directors met in mid-July at the GlaxoSmith- Kline offices in Gulph Mills, PA to update the strategic plan of the organiza- tion, taking the planning to 2017 and beyond.

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Page 1: PA BioWatch - files.ctctcdn.comfiles.ctctcdn.com/a4698730301/8099b367-4a68-450a-b... · The Future of Life Sciences Comes to Pennsylvania OCTOBER 13 Keynote Speaker Jon Soderstrom

PA BioWatchP E N N S Y L VA N I A B I O ’ S Q U A R T E R L Y N E W S S O U R C E Q 3 2 0 1 4

The membership of Pennsylvania Bio at the end of Q3 2014 included more than 625 members, regional, na-

tional, and international partners, and financial support that allow the trade association to shape the great messages of the life sciences, and push them out to statewide, national and even global audiences. According to PA Bio president & CEO Christopher P. Molineaux, “the life sciences commu-nity in PA – companies of all sizes, universities and research organizations, pharma, biotech, medical devices, diagnostics, investment organizations – is now the tip of an economic spear that is leveraging huge change here in Pennsylvania and around the nation.”

Data released in June report more than 2,200 life sciences establishments in PA; $7 billion in annual wages; 85,000 direct jobs and nearly 500,000 Pennsylvanians either directly or indirectly employed by life sciences work. According to Molineaux, “the most important result of the life sciences successes in Pennsylvania over the past few years is that they further strengthened our foundation and allow us to focus on the future.”

With that renewed focus, the Pennsylvania Bio Board of Directors met in mid-July at the GlaxoSmithKline offices in Gulph Mills, PA to update the strategic plan of the organization, taking the planning to 2017 and beyond.

While Board members acknowledged during the meeting the negative effects of the biopharmaceutical industry transformation and considerable job loss throughout the region, there was recognition and optimism grounded in recent data from the Pennsylvania Department of Labor & Industry indicating life science industry employment has been affected much less than other sectors of the economy. As the Medical Device and Drug & Pharmaceutical sub-sectors both saw decreases in establishments in the five-year period between 2008 and 2013 – losing 60 and 7 establishments respectively – the number of establishments in the Research, Testing and Medical Laboratory sub-sector continued to grow at a strong pace with 727 firms created – a 24% increase – during the same period. Today’s 85,000 direct jobs in the life sciences represent the greatest number since prior to 2007.

Pennsylvania Bio Board Chairman, Rob Bazemore, Chief Operating Officer of Synageva Biopharma Corp., reiterated the cause for optimism for the community and emphasized the obligation of PA Bio, the only statewide organization for the entire life sciences ecosystem. “Pennsylvania Bio is a recognized leader, voice and resource for the life sciences community in Pennsylvania. The strategic plan developed today assumes significant change will continue in the industry and focuses on the core activities that Pennsylvania Bio members consider valuable…while also contemplating strategic growth in emerging areas of interest and opportunity. This plan will guide the annual development of working plans for the organization and Board of Directors, but also will be revisited annually due to the fluid nature of the industry.”

Following is a summary of Pennsylvania Bio’s Strategic Plan for 2014-2017.

Pennsylvania Bio Vision - 2017Pennsylvania is considered the most attractive location in the United States for establishing a life sciences organization by life sciences leaders within the U.S. and by those outside the U.S. seeking to establish U.S. operations.

Pennsylvania Bio Mission

Pennsylvania Bio’s mission is to ensure Pennsylvania is the United States hub for the life sciences* by creating a business and public policy environment which fosters life sciences growth and success.

THIS ISSUELife Sciencs Future ............ 2Locate in PA .................... 8Membership News ............ 9Regional Events ...............12Advocacy Update ............15Programs ........................18Q&A ..............................20President’s Column ..........23

Mapping to 2017

Continued on page 14

The Pennsylvania Bio Board of Directors met in mid-July at the GlaxoSmith-Kline offices in Gulph Mills, PA to update the strategic plan of the organiza-tion, taking the planning to 2017 and beyond.

Page 2: PA BioWatch - files.ctctcdn.comfiles.ctctcdn.com/a4698730301/8099b367-4a68-450a-b... · The Future of Life Sciences Comes to Pennsylvania OCTOBER 13 Keynote Speaker Jon Soderstrom

The Future of Life Sciences Comes to Pennsylvania

OCTOBER 13

Keynote Speaker

Jon SoderstromManaging Director of the Office

of Cooperative Research Yale University

Closing Speaker

Michael Sofia, Ph.D.President and Co-Founder

OnCore BioPharma

17 institutions will be participating:Join business development teams from the following companies:

Symposium: Partnerships in Science

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OCTOBER 13

Investment Organizations*

Symposium: Partnerships in Science

EDUCATION SESSIONS

All Sides of One Transaction – Case Study of Spark Therapeutics and The Children’s Hospital of Philadelphia (CHOP)Moderator – Elana Gordon, WHYYPanelists – Phil Johnson, M.D., CHOP; Tom Todorow, MBA, CHOP; Jeff Marrazzo, MBA, MPA, Spark; Katherine High, M.D., Spark

Alternate Sources of Funding for Your Lab – No More Business as UsualSpeaker – Russ Kaufman, M.D., Wistar Institute

The IP Perils of Alternative Funding SourcesSpeakers – Kathryn Doyle, Ph.D., Saul Ewing; Domingos Silva, Ph.D., Saul Ewing

The Art of the PitchSpeaker – Greg Coticchia, MBA, PC, University of Pittsburgh

Students Today – Entrepreneurs TomorrowModerator – Kenny Simansky, Ph.D., DrexelPanelists – Donna DeCarolis, Ph.D., Drexel; Keith Marmer, DTP, MBA, Penn; Steve Nappi, Temple

•Aisling Capital•Ben Franklin Technology Partners S.E.•Bio Motiv•BioAdvance•CapGenic Advisors•Fidelity Biosciences•JDRF•Johnson & Johnson Development Corp.•Keiretsu

•Life Sciences Greenhouse of Central PA•MedImmune Ventures•Merck•Mid-Atlantic Bio Angels•Osage University Partners•Pappas Ventures•Phoenix I.P. Ventures•Pittsburgh Life Science Greenhouse•SR One

*As of September 19, 2014

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OCTOBER 14Morning Speaker

Margaret A. HamburgCommissioner

U.S. Food and Drug Administration

Patient Spotlight Speakers

Collaborations at Life Sciences Future

2013

Christian Bermudez, M.D. University of Pittsburgh Phy-sicians UPMC Heart and Vas-cular Institute Chief, Division of Cardiothoracic Transplanta-tion, UPMC, Surgical Director,

ECMO Program, UPMC

Peter DeComoChairman & CEO

ALung Technologies

In November 2013, representing the Univer-sity of Pittsburgh, Thomas Smithgall, Ph.D., attended Life Sciences Future to display his scientific poster on the “Discovery and Devel-opment of a New Class of Antiretroviral Drugs for HIV/AIDS.”

Dr. Smithgall was introduced to Allen B. Reitz, Ph.D., CEO of Fox Chase Chemical Diversity Center, Inc. which led to a collaboration be-tween the two.

On January 5th, a Phase I STTR grant was filed which resulted in funding and on July 31st, the notice of an NIH award was issued. It is a $225K proof of concept grant, with the purpose of target validation to see if they can justify go-ing into the larger Phase II part of the program.

“Life Sciences Future is designed to provide opportunities to find partners and collabora-tors,” said Marc S. Malandro Ph.D., Associate Vice Chancellor for Technology Management and Commercialization at the University of Pittsburgh. “The story of Dr. Smithgall and Dr. Reitz demonstrates the significant connections that are made at Life Sciences Future.”

Dr. Christian Bermudez pictured with Jon Sacker, a double

lung transplant patient treated with the Hemolung.

Bring this coupon to Life Sciences Future and enter to win two seats for you and a colleague to Pennsylvania Bio’s Annual Dinner on March 12, 2015 at the Pennsylvania Convention Center in Philadelphia! *A $400 value

Name: Company: E-mail:

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www.PABIO.org | 5

OCTOBER 14

Breakfast in the C-Suite

Company Presentations

Funding Meet-Ups

Local Arts & Music

Partnering & Mobile App

Patient Spotlight

Scientific Posters

Short Takes

Conference Features:

SHORT TAKES SPEAKERS

“Solving the Payer Problem: Why most companies fall short, and putting forward a roadmap for getting it right—leading to larger revenue streams, larger partnering deals, and higher investor ROI”David Balekdjian, CEO, The Bruckner Group

“Human Biospecimens and Translational Research —Past, Present, Future”Thomas Bell, Director of Scientific Services, NDRI

“Update on the IPO Bubble – Has it Burst?”John Carroll, Editor-in-Chief, FierceBiotech

“The Scope of 3D Printing”Randy Haluck, Professor & Chief of the Division of Minimally Invasive Surgery and Bariatrics, Vice Chair in Surgery for Technology and Innovation, Penn State’s Hershey Medical Center.

“FDA guidance on the changing landscape of MD & D.”Janice Hogan, Partner, Hogan Lovells “Why does Amazon know me better than my own doctor?”Eric King, Founder & CEO, Grand Round Table

“Off-label Drug Usage”Daniel Kracov, Partner & Chair, FDA & Healthcare Practice Group, Arnold & Porter “The Ethical Challenges of Compassionate Use in the Era of Social Media.”Kenneth Moch, Former President & CEO, Chimerix, Inc.

“SBIR as a source of non-traditional funding.”Maureen Mulvihill, Ph.D., President and CEO, Actuated Medical

“Alternative Sourcing of Financing in the Biotech Industry.”Dennis Purcell, Senior Managing Partner, Aisling Capital

“Preparing for Due Diligence and Exit.”Steve Tullman, Managing Partner, NeXeption

“Innovation in minimally invasive cancer therapies: The past, current, and future of ablation tech-nology.”Steve Wagner, MD, Interventional Radiologist, Eastern Regional Medical Center

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6 | PA BioWatch, Q3 2014

Pennsylvania Bio Welcomes Ten New Board Members“On behalf of the Pennsylvania Bio Board of Directors, we are honored to welcome ten industry leaders whose leadership, expertise and dedication will be essential assets to the Board of Directors and the Association,” said Robert Bazemore, Chair of the Pennsylvania Bio Board of Directors and Chief Operat-ing Officer, Synageva BioPharma.

“The addition to the Board continues our ongoing effort as a trade association to build upon past successes and continue to ensure Pennsylvania remains a global leader in the life sciences industry,” added Pennsylvania Bio President and CEO Christopher P. Molineaux.

Armando Anido is the Chairman and CEO of Zyner-ba Pharmaceuticals. Prior to Zynerba, Mr. Anido was Chief Executive Officer and Director of NuPathe, Inc., a publicly-traded biopharmaceutical company focused on diseases of the central nervous system. Mr. Anido has more than thirty years of executive, operational and commercial leadership experience in the biophar-maceutical industry. He is currently a member of the

board of directors of Respira Therapeutics, Inc. Mr. Anido received his BS in Pharmacy and his MBA in Marketing and Finance from West Virginia University.

Stephen Allan is currently Vice-President of Market-ing and Communications of Unilife Corporation, a U.S. based developer and supplier of injectable drug delivery systems. Mr. Allan oversees activities relating to commu-nications, corporate and commercial marketing, public relations and government affairs. Mr. Allan has more than twenty years of public advocacy and marketing ex-perience in the U.S. and Australia. Mr. Allan received a

B.A. in Communications from Australia’s most reputable university for media professionals.

Matthew J. Gantz is the Executive Vice President, U.S. at BTG International and serves on the Board of Swedish Orphan Biovitrum, a publically traded spe-cialty biopharma company based in Sweden. Over twenty years of experience in the global biopharma-ceutical, life science and healthcare industry, Mr. Gantz has an entrepreneurial mind set, experienced in both startup operations and developing and implementing

strategies to build growing, sustainable multi-national businesses. Mr. Gatz received a BA in History from Princeton University and MBA from Harvard Graduate School of Business Administration.

Philip Hosbach currently holds the position of Vice President of Immu-nization Policy at Sanofi Pasteur. His responsibilities include oversight of im-munization policy development and coordination of Sanofi Pasteur relations with Federal and State Government offi-cials. Mr. Hosbach also serves as Chair-

man for Sanofi Pasteur’s Philanthropy Steering Committee and is Chairman for the Sanofi Pasteur Employee Political Action Committee. Mr. Hosbach acts as Sanofi Pasteur’s principle liaison with CDC, and coordinated Sanofi Pasteur’s global efforts in responding to the H1N1 pan-demic in 2009-10. Mr. Hosbach is a graduate of Lafayette College.

Dr. Philip Johnson currently serves as Chief Scientific Officer, Executive Vice President, and Director of the Re-search Institute at the Children’s Hos-pital of Philadelphia. He also holds the Edmond F. Notebaert Chair in Pediat-ric Research and is a Professor in the

Department of Pediatrics at the University of Pennsylvania School of Medicine. In his role as Chief Scientific Officer, Dr. Johnson oversees the research enterprise at Children’s Hospital that supports over 2000 faculty and staff engaged in a wide array of basic, clinical, and translational research activities with annual expenditures of over $325 M. Dr. Johnson received his undergraduate and medical degrees from the University of North Carolina at Chapel Hill, fol-lowed by a pediatric residency and infectious diseases training at Vanderbilt University.

Joseph W. La Barge is a seasoned ex-ecutive and legal advisor with over fif-teen years of experience counseling life science companies and healthcare institutions. Mr. La Barge was the vice president, general counsel and chief compliance officer at Tengion, Inc., a

clinical-stage, regenerative medicine company, where he oversaw legal affairs, compliance and quality assurance. While at Tengion, he helped raise over $150 million and led the company’s initial public offering in 2010. Mr. La Barge also played an integral role in developing Tengion's intellectual property strategies for their novel, first-in-class, cell-based therapies. Mr. La Barge was previously of counsel at Ballard Spahr LLP in Philadelphia where he advised bio-

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Robert Smith is an accomplished biophar-maceutical executive with over thirty years’ experience in a variety of academic, alli-ance management, business development, commercial, corporate, and research and development roles. Mr. Smith is currently responsible for leading and managing the Worldwide Business Development activi-

ties for Pfizer’s Worldwide Research and Development organi-zation. He is also responsible for leading and managing Pfizer’s Strategic Transactions team. Mr. Smith obtained a B.S. in Neuro-science from the University of Rochester and an MBA in Finance and Corporate Accounting from the William E. Simon Graduate School of Business Administration at the University of Rochester.

Perry J. Sternberg is Senior Vice President and Head, Neuroscience Business Unit at Shire which generates more than one-third of Shire’s nearly $5 billion in annual sales. Mr. Sternberg has over twenty years of industry experience holding positions at Merck and Co., Novartis, and Bausch & Lomb, Inc. Mr. Sternberg re-

Jennifer Strong is an audit partner in KPMG’s Pharmaceutical, Life Sciences practice in the Philadelphia office. Mrs. Strong has over seven-teen years of public accounting experience and significant experience with revenue recognition and debt and equity issues. Mrs. Strong spent much of her career working with entrepreneurs in various emerging growth and venture back

companies. She has been involved with initial and secondary public of-ferings as well as debt financings and private equity transactions. Mrs. Strong received her B.S. degree from Rutgers University.

Michael Yang is President, Immunology for Jans-sen Biotech, Inc. A dedicated and passionate business leader, Mr. Yang is committed to trans-formational medical innovation on behalf of pa-tients living with chronic autoimmune diseases. In his current role, he is responsible for the overall achievement of business objectives and accelerat-ing growth strategies for the U.S. Immunology

franchise. Mr. Yang serves as a member of the North America Lead-ership Team (NALT) and is based in Horsham, PA. Mr. Yang earned a B.S. degree in Marketing & Business Administration from San Diego State University.

Present your science in

multiple formatsMinisymposia,

ePosters, traditional

posters

Accelerate your professional

growth Numerous career

development sessions

Apply for travel awards or childcare

grants

A joint meeting of the American Society for Cell Biology and the International Federation for Cell Biology

www.ascb.org/2014meeting

facebook.com/ASCBiology @ASCBiologyConnect with ASCB:

Meeting registration, abstract submission open now!

The World’s Best Cell Biology

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PA BIO members receive a

10% discount off exhibit

booths!

technology companies in private and public financings, M&A and collaboration and licensing transactions. Mr. La Barge also served as the deputy general counsel to the Kennedy Health Sys-tem in New Jersey. Mr. La Barge received his J.D. from Temple University and a B.A. from Bucknell University.

ceived a B.S. in Animal Science from The Pennsylvania State University.

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8 | PA BioWatch, Q3 2014

The end of summer has heralded new beginnings for Penn-sylvania, bringing novel biotechs and fresh management

to the area.

Austrian biotech Nabriva Therapeutics recently announced the opening of a new U.S. subsidiary in Philadelphia, set to be the home of Nabriva’s clinical development team. The team, work-ing to develop a new class of antibiotics, will be led by newly appointed Chief Executive Officer, Colin Broom, M.D. When asked about the choice of the location, Broom and Denise Pollard-Knight, Ph.D, chairwoman of the Nabriva supervisory board, agree the new location was selected for the favorable funding environment for biotech companies. This positions the company for significant growth in the future.

Dr. Broom states that Nabriva was also drawn to the Philadel-phia area because it offers support to life science programs, and is known to be home to significant scientific research. Refer-ring to Philadelphia as a “biotech hub,” Broom notes his ex-citement for the abundance of talent and experience the city has to offer. He states, “My immediate attention is focused on establishing a world-class clinical development team in the Philadelphia area.”

In addition to Nabriva, Virtech Bio LLC, originally operated out of Delaware, is another exciting biotech company making waves in Pennsylvania. Virtech will be spending time at the University of Pittsburg Medical Center (UPMC) while they complete their IDE application, and prepare for their first clin-ical trial. Over the next few months, Virtech will be working on their organ preservation technology.

Paulo Fontes, M.D, became the Chairman of the Scientific Board Advisory at Virtech Bio LLC in 2014, and is no stranger to the Pittsburg area. He is an Associate Professor of Surgery at

UPMC and was the Director of the Liver Transplant Program at the Starzl Transplantation Institute, UPMC for almost ten years.

Nabriva and Virtech fit well into the scientific environment that Pennsylvania harbors. The supportive state government programs paired with the overwhelming amount of research talent found in this state are sure to foster growth, while en-couraging scientific advances.

Fall Brings a Breath of Fresh Air to Biotech Hub

Locate in PA

CSL Behring LLC, 1020 First Avenue, P.O. Box 61501, King of Prussia, PA 19406-0901 USA | www.CSLBehring.com

At CSL Behring, we are committed to saving lives and improving quality of life for people with rare and serious diseases. We research, develop, manufacture and market a range of plasma-derived and recombinant therapies that are used worldwide.

Biotherapies for Life ®

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50,000 Americans contract HIV every year. A total of 33 million people are infected across the globe. While highly active antiretroviral therapy can control HIV-1, this solution is far from perfect—a single interruption in treatment leaves patients susceptible to the virus once again. However, recent advancements from researchers at the Temple University School of Medicine could be the key to an HIV-free world.

The team, led by Kamel Khalili, PhD, Professor and Chair of the Department of Neuroscience at Temple and Wenhui Hu, MD, PhD, Associate Professor of Neuroscience at Temple, has developed a way to permanently eradicate integrated HIV-1 genes from a cell.

While the process is not yet ready to go to clinical trials, Dr. Khalili explains, “This is one important step on the path toward a permanent cure for AIDS.“

The technique involves deploying a combination of DNA-snipping enzymes and a targeting strand of RNA to seek out viral genomes. The HIV-1 DNA is removed, and the loose ends of the genome are repaired, leaving the cell HIV-free. Scientists

are hopeful that this therapy will result not only in a cure, but also in a vaccine, as cells that contained the nuclease-RNA combination were impervious to the virus.

Present challenges include devising a method to deliver the therapeutic agent to every infected cell, as well as creating individualized treatments for each patient’s unique viral

sequence. However, Dr. Khalili and his team remain undaunted by this task. “We are working on a number of strategies so we can take the construct into preclinical studies,” Dr. Khalili said. “We want to eradicate every single copy of HIV-1 from the patient. That will cure AIDS. I think this technology is the way we can do it.”

www.PABIO.org | 9

Temple University Tackles HIV

Membership News

Expanding Clinical Trial Solutions Provider DrugDev Moves Head-quarters to King of PrussiaWith 50 percent growth over the past year and similar growth projected for the coming years, DrugDev is moving its North American head-quarters from Audubon, PA, to new offices in King of Prussia.

A family of DrugDev technology driven solu-tions that help investigators, sponsors and CROs do more clinical trials together, the rapidly expanding DrugDev acquired CFS Clini-cal, the leading provider of global investi-gator payment, contracting and regulatory services, in October 2013, and TrialNet-works, developer of unified cloud-based platform for trial management apps and site tools, in May of this year.

The newly renovated 31,000-square foot facil-ity was chosen for its accessibility to customers. The proximity to major highways and its loca-tion squarely inside of the Philadelphia area’s

pharmaceutical sector will allow the company to continue its ongoing work supporting clinical research.

Recently named one of the region’s Best Places to Work for the third year running by the Phila-delphia Business Journal, DrugDev also chose the site for its convenience for employees. “It’s

important that we provide our employees with a welcoming and fun environment that will give us room to expand over the coming years,” says Kelly Morello, vice president of Human Re-sources and Administration. “Our new space offers great amenities like a fitness center with showers, a café in the neighboring complex, and

proximity to a bike trail. It’s also close to Weg-man’s, the King of Prussia Mall and many other local business providers.”

With the much larger facility, DrugDev is keep-ing eye toward a continuing and positive future in Pennsylvania. “Pennsylvania is a nexus of pharmaceutical industry innovation, with well

over 100 biotech, pharma and life sciences companies—many in and around King of Prussia,” Morello says. “We’re in the midst of remarkable people working in science, technology, academia, and business to im-prove healthcare for patients worldwide. As

a member of the Pennsylvania pharma commu-nity, we’re committed to helping trial sponsors around the world manage business and financial activities for clinical trials, to make it easier for sponsors, CROs and sites to do more trials to-gether.”

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10 | PA BioWatch, Q3 2014

In August, two Pennsylvania Bio member companies received approval from the United States Food and Drug Administration (FDA).

GlaxoSmithKline plc’s Arnuity™ Ellipta® (fluticasone furoate inhalation pow-der), a once-daily corticosteroid medicine for maintenance treatment of asth-ma in patients aged 12 and older. The dry powder, designed for use with the Ellipta inhaler, is indicated for prophylactic therapy only—not for relief of acute bronchospasm. “The approval of Arnuity Ellipta is significant for appro-priate asthma patients, because for patients 12 years and older, for whom ICS therapy is indicated, it provides sustained, 24-hour lung function improvement with once-daily dosing,” says Juan Carlos Molina, spokesman for GSK. “What’s more, Arnuity Ellipta represents the first treatment from our emerging portfo-lio to be approved for the treatment of asthma.”

Philadelphia-based Iroko Pharmaceuticals LLC’s Zorvolex® (diclofenac) cap-sules, a nonsteroid anti-inflammatory drug (NSAID), was approved for the management of osteoarthritis pain. The drug was previously approved by FDA in October 2013 for the management of mild to moderate acute pain in adults.

Designed to support FDA and professional medical organization recommen-dations that NSAIDs be used at the lowest effective dose for the shortest pos-sible duration as consistent with individual patient treatment goals, Zorvolex contains a proprietary technology with submicron particles approximately 20 times smaller than original size, allowing for increased surface area and faster dissolution. “By using this technology the dose can be lowered without delay-ing absorption. This allows for the treatment of patients with a low dose NSAID that results in lower overall systemic exposure,” says John Vavricka, President and CEO of Iroko Pharmaceuticals. “The use of NSAIDS is likely to increase as the United States population continues to age and experience painful condi-tions that are more common among older adults. There’s an unmet need in pain treatment for options that can be given at a lower dose to potentially reduce the risk of treatment-related adverse events.”

With its operating headquarters in the historic Philadelphia Naval Yard, Iroko is committed to staying and growing in the city. “We were drawn to the Navy Yard because of the appeal and advantages of being in a vibrant, growing cor-porate hub in Philadelphia,” Vavricka says. “The area is a wonderful place for the life sciences because of its talent and research infrastructure and its location allows for the unique ability to draw talent from the tri-state area. Our head-quarters in the Navy Yard, which opened in November 2012, represents our third buildout since coming to the Navy Yard and mirrors Iroko’s growth and progress.”

Two New Drugs Get FDA Approval

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TandemHeart Launches Clinical Trial for Innovative Heart PumpPittsburgh-based medical device company TandemHeart announced in August that the company is actively recruiting patients for a clini-cal trial, TandemHeart to Reduce Infarct Size (TRIS), to study how unloading the heart prior to reperfusion during an acute myocardial infarction affects the muscle. “We’ve developed this technology here in Pennsylvania and we continue to partner with the state’s major re-search institutions to see it through the pipe-line,” says John Marous, president and CEO of TandemHeart.

Today, Physicians must adhere to the “door to balloon time” rule and open the patient’s vessel within 90 minutes, but that therapy can do further damage to a stressed heart. “Too often, patients leave the hospital and are faced with a downward spiral of congestive heart failure because the heart attack has weakened their heart muscle,” Marous says. Given that con-gestive heart disease is responsible for 55,000 deaths a year and half of all people with that diagnosis die within five years, the trial’s implica-tions for patients are great, with the potential to reduce mortality and improve quality of life.

The pump was designed to allow the heart to rest during an acute event. “What the pump effectively does is take the workload out of the human heart and it allows the muscle to rest as therapies are applied,” Marous says. Previous animal studies have demonstrated that resting the heart while treating the heart attack resulted in a 50 percent reduction of dead tissue during the vessel blockage.

With up to 20 hospitals participating, includ-ing Temple University Hospital and Allegh-eny General Hospital, the clinical trial will look at the pump’s ability to reduce the work of the heart while the blocked blood vessels

are opened, minimizing tissue damage and the weakening of the heart muscle during the process.

TandemHeart is now in the final stages of planning additional trials for its products. Marous says the company, which already employs many graduates of University of Pittsburgh, Carnegie Mellon and Penn State University, has just expanded its manufacturing capabilities at its main facility in Pittsburgh, and anticipates creating more local jobs in manu-facturing, production and technology development.

Patent Created for an Eye-Catching Technology by Particle Sciences and Eyeon TherapeuticsPennsylvania-based Particle Sciences and Eyeon Therapeutics com-bined forces to align on one vision – finding a solution for dry eye. After a successful trial, a Notice of Allowance was received by the pair on a novel dry eye treatment based on a charged hydrophilic polymer.

Particle Sciences CEO Mark Mitchnick, MD, states, "This first set of claims around the polymer and its class will go a long way to moving this tech-nology into the commercial phase. We have been using it in several development projects, and we believe it has promise in many ocular formulations as well as in other areas. Helping Eyeon gain a pro-prietary position in this very important market is a great example of what Particle Sciences offers its partners."

Particle Sciences, a top drug delivery CDMO located in Bethlehem, Pennsylvania, developed the polymers used in this treatment. Eyeon Therapeutics advanced the product using these polymers, to now of-fer a clinically proven approach, applicable for improving several ocu-lar functions.

In upcoming months, Eyeon Therapeutics plans to expand partner-ships and security measures as the product advances. Due to the vari-ous uses of this dry eye treatment, Eyeon will commercially benefit in the market, while combining medicine and technology.

The partnership between Particle Sciences and Eyeon Therapeutics will continue to develop with equal con-tributions from both companies. Particle Sciences concentrates on BCS II/III/IV molecules, highly potent compounds, and biologics. Numerous technologies are put to use that comply with the FDA and the DEA associations. Particle Sciences

offers Eyeon Therapeutics a complete development solution that re-duces time and risk factors of the clinical studies. Although based in New York, Eyeon Therapeutics remains close to home in location and goals. With the development solution given to them, Eyeon focuses on improving early-stage technologies from beginning to end, result-ing in a thriving concept and product.

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University City Science Center Establishes New Facilities and Collaborations

Regional Events

12 | PA BioWatch, Q3 2014

The Innovation Center @3401, a collaborative effort of Drexel University and the University City Science Center. It is in the heart of Philadelphia’s Innovation Neighborhood and is home to the start-up and entrepreneurial community. Sci-ence Center President and CEO Stephen S. Tang hopes ic@3401 “makes the Phila-delphia region stronger and recognized as a successful and supportive innovation hub.”

“3737 Market Street and ic@3401 are much more than concrete and steel. They are links in the chain that connects our region’s innovation ecosystem. Bookending our campus, they bring together a diverse yet complementary group of residents that are conducting the groundbreaking work that will solve the problems of fu-ture generations to come,” said Stephen S. Tang, Ph.D., MBA, President & CEO, University City Science Center.

Developed jointly by Wexford and the Science Center, 3737 Science Center pro-vides approximately 334,000 square feet of premier laboratory and office space at the epicenter of Philadelphia’s renowned “eds and meds” community that is home to the University of Pennsylvania and Drexel University, as well as The Children’s Hospital of Philadelphia, University of the Sciences and The Wistar Institute. The new building, the 16th on the Science Center campus and the second by the joint venture between the Science Center and Wexford, cements the Science Center’s reputation as a world-class innovation center and enhances Wexford’s presence in University City.

James R. Berens, President of Wexford Science + Technology remarked “Along with our adjacent 3711 Science Center building, this world-class life science re-search complex exemplifies the vitality of this region’s health care and research sectors, bolsters University City’s reputation as a foremost innovation center.”

http://drexel.edu/now/archive/2014/July/IC3401-Opening/

https://www.sciencecenter.org/science-center-news/press-release-wexford-science-technology-and-university-city-science-center-officially-open-new-3737-science-center-building-in-west-philadel-phia

The University City Science Center continues to demonstrate passion and commitment to the life sciences, start-up and en-trepreneur communities by recently opening the Innovation Center @3401 in collaboration with Drexel University and the 3737 Science Center life science building developed jointly with Wexford Science and Technology.

Top: On September 12th Wexford Science + Technology and the University City Science Center hosted the grand opening ribbon cutting ceremony of the new 3737 Science Center life science building on the Science Center campus in Philadelphia.

Bottom The ceremonial garage door officially opened at Innovation Center @3401 on July 28, 2014. From L-R: Keith Orris, Senior Vice President for Corporate Relations & Economic Development, Drexel University, Stephen S. Tang, Ph.D., MBA, President & CEO, University City Sci-ence Center and John A. Fry, President, Drexel University.

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Golfing for Science EducationCelebrating a MilestoneOn September 19th, Pennsylvania Bio joined Rockland Immunochemi-cals, Senator John Rafferty, Representative Mark Painter, Representative Warren Kampf and other guests for a ribbon cutting ceremony and facility tour at their new laboratory in Limerick, PA.

“The global economy currently presents significant opportunities within the Diagnostic and BioPharma industry. Rockland’s new facilities consist-ing of clean rooms for cell culture, molecular biology suites and increased aseptic processing areas allows us to better support our clients in their Assay Development and Drug Discovery needs.” Explains Chief Executive Officer, Jim Fendrick. “In addition to tripling our lab space, we have cre-ated an atmosphere where biotechnology, IT and e-commerce are unified and cross-communication between departments is welcomed.”

Founded locally, this family business has found success for over 50 years working with leaders in ground-breaking medical research, such as the National Institutes of Health.

Rockland supports the academic, biopharma and diagnostic industries with antibodies and antibody based tools while working side-by-side with top biotech and biopharma companies to optimize future diagnostics and therapies that will deliver on the promise of personalized medicine.

Rockland employees in Pennsylvania manufacture over 10,000 products used by researchers around the world to study cancer, immunology, neu-roscience, and cell biology. This global reach and depth of capabilities gen-erates high-paying, green jobs important to Pennsylvania.

The PA Society for Biomedical Research (PSBR) held its 2nd An-nual Dr. Harry Rozmiarek Memorial Golf Outing on October 9, 2014 at the River Winds Golf Course in West Deptford, NJ.

The event honors a great man who contributed much to the field of laboratory animal science and supports PSBR’s programs. These programs teach students K-12, their teachers, and the general pub-lic about the process of biomedical research including the impor-tant role of animals in that research.

Congratulations to the winning team: Grant Wilkinson, Bill Cole, Jeff LeFrancois, and Dale Martin.

“Thank you to all who participated,” said Paula Clifford, Executive Director, PA Society for Biomedical Research. “We appreciate your support for science and education!”

For more information about PA Society for Biomedical Research please visit www.psbr.org.

The winning team from L-R: Jeff LeFrancois, Bill Cole, Grant Wilkinson, and Dale Martin.

Rockland Immunochemicals CEO Jim Fendrick is flanked by Senator John Rafferty, Representative Mark Painter, Representative Warren Kampf and other guests at the ribbon cutting ceremony for Rockland’s new laboratory facility in Limerick, PA on September 19, 2014.

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Member Companies Welcome Teleflex to the Neighborhood

14 | PA BioWatch, Q3 2014

Pennsylvania Bio Strategy

By leveraging the diverse and cohesive life sciences presence in the Commonwealth as our basis, Pennsylvania Bio will position Pennsylvania as the epicenter of the U.S. life science community – the only region in the world where all elements of today’s life sciences industry model can be found. Expertise across Pennsylvania includes pharmaceuticals, biotechnology, medical devices, diagnostics, research and investment, and spans the entire value chain – research & development, manufacturing and commercialization. Simultaneously, we will solidify Pennsylvania Bio’s role and reputation as the advocacy leader for the life sciences industry and the unequaled source of strategic connections and expertise for the industry and its stakeholders throughout Pennsylvania, offering unmatched value for our members and the life sciences community.

2014-2017 Strategic Plan Priorities

•Ensure a supportive business and public policy climate in Pennsylvania to support company formation and retention in the Commonwealth

•Facilitate partnerships between and among entrepreneurs, large industry, small companies, research institutions and funding organizations to advance company formation, innovation, job creation and success in the industry

•Promote and support strategic engagement between the Pennsylvania life sciences industry and other key healthcare industry stakeholders

•Provide valued services and access to cost-efficient resources for Association members to make informed decisions and grow their businesses

The Pennsylvania Bio Strategic Plan can be found in its entirety by visiting the Pennsylvania Bio website: www.pabio.org.

On July 10th, Pennsylvania Bio members gathered for a welcome reception for medical device company, Teleflex, at their new 84,000 square feet headquarters in Wayne, PA. Hosted by Pennsylvania Bio and AdvaMed, guests networked with one another while enjoying horderves and cocktails.

Pennsylvania Bio’s Chris Molineaux delivered opening remarks followed by Teleflex Chairman and CEO, Benson Smith, and B.Braun Chairman and CEO, Caroll Neubauer.

“Bringing the membership together to welcome a member company to a new location demonstrates the strong support the Association has for one another,” said Christopher P. Molineaux, President and CEO of Pennsylvania Bio.

*The life sciences is defined as a diverse group of industries and activities with a common link—they apply knowledge of the way in which plants, animals, and humans function. The life sciences industry sector spans different markets and includes manufacturing, services, and research activities. By definition, the life sciences industry cluster is constantly changing to incorporate the latest research and scientific discoveries. – adapted from Battelle/BIO State Bioscience Jobs, Investments and Innovation 2014 definition of “biosciences”

Strategic plan continued from page 1

At Endo International our specialty pharmaceuticals, generic products and medical devices play an important role in helping millions of patients lead healthier lives. Through our operating companies, we are dedicated to serving our patients, customers and shareholders as we continually search for new and better ways to do things while creating value.

Improving Lives,Creating Value.

TM

www.endo.com © 2014 Endo. All Rights Reserved.

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Advocacy UpdatePennsylvania Bio is always looking for

new ways to advocate for its mem-bers in Harrisburg and Washington, D.C. From our annual Advocacy Day in Harrisburg in the Spring, to the various Fly Ins for our national trade affiliates (PhRMA, BIO, MDMA & AdvaMed) and our numerous meetings with State and Federal legislators throughout the year, we work to present our members’ positions on many issues. This day-to-day advocacy is an important aspect to the relevancy of our trade association and its role in shaping public policy.

At the end of 2013, PA Bio surveyed its membership to review how our various events and activities are valued. One finding in the results of the survey was that a portion of our membership either did not know what PA Bio did in ad-vocacy or understood its value to their dues dollar. In an effort to address this lack of understanding or knowledge of our advocacy activity, we have initiated two new communication tools.

One Minute for Advocacy is a brief description of current legislative activ-ity and PA Bio Advocacy events. This e-newsletter is open to all, but requires the subscriber to pro-actively sign up for it. Published at least once a month, it provides the reader with a quick over-view of issues impacting the life sciences in Pennsylvania. If you are interested in receiving timely information on our

advocacy efforts and updates on impor-tant legislative activity, please email Ted Piper at [email protected].

A second communication tool was de-ployed in the 3rd Quarter of this year. The inaugural Life Sciences Town Hall Meeting was held on September 10th. This webinar featured two special guests, Representatives Scott Petri and Tim Briggs. Both legislators are Co-Chairs of the Life Sciences Caucus in Harrisburg. They discussed the importance of the Research and Development Tax Credit to life science companies both large and small. The webinar was attended by members of both policy committees and general members of PA Bio. The webi-nar concluded with a brief update of the 21st Century Cures effort in Washington and a general overview of the fall agenda in Harrisburg. We anticipate that two to three Town Halls will be held each year. The next Life Sciences Town Hall will be held after the election and will discuss the impact of the election results on our issues in Washington and Harrisburg.

New Communication Tools in Advocacy

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16 | PA BioWatch, Q3 2014

The inaugural Life Sciences Town Hall Meeting was held on September 10th. This webinar featured two special guests, Representatives Scott Petri and Tim Briggs. Both legislators are Co-Chairs of the Life Sciences Caucus in Harrisburg. They discussed the importance of the Research and Development Tax Credit to life science companies both large and small. The webinar was attended by members of both policy committees and general members of PA Bio. The webinar concluded with a brief update of the 21st Century Cures effort in Washington and a general overview of the fall agenda in Harrisburg. We anticipate that two to three Town Halls will be held each year. The next Life Sciences Town Hall will be held after the election and will discuss the impact of the election results on our issues in Washington and Harrisburg.

Pennsylvania Bio Members Participate in Inaugural Life Sciences Town Hall Meeting

Pennsylvania Bio and the Pennsylvania Biotechnology Center of Bucks County hosted Congressman Mike Fitzpatrick (PA-8) for a town hall and facility tour on Tuesday, August 19th. Several Pennsylvania Bio mem-ber companies were in attendance and spoke to Congressman Fitzpatrick about the importance of innovation and tax credits in the Commonwealth. They also expressed their gratitude for his consistent support of the indus-try in Washington DC. Congressman Fitzpatrick spoke of his legislation the "Fostering Innovation Act" which will reduce regulatory burdens on small public companies, allowing emerging biotech companies to focus on groundbreaking research rather than spending capital on bureaucratic red tape. After the town hall, Congressman Fitzpatrick conducted a number of stop in's to see first-hand the value the Biotech Center provides for emerg-ing companies. A special thanks to the Pennsylvania Bio member compa-nies below for participating:

Advanced Nueral Dynamics, Inc.ALS Biopharma, LLCAreon Biosciences, LLCAtrin PharmaceuticalsCallidus Biopharma, Inc.Enantigen Therapeutics Inc.FlowMetric, Inc.FORGE Life Science, LLCFox Chase Chemical Diversity CenterMid-Atlantic Bio Therapeutics, Inc.

Oncore BiopharmaOrthogenRx, Inc.Pennsylvania Biotechnology CenterPennsylvania Drug Discovery InstitutePharmabridge, Inc.PMV PharmaProduct and Educations Services, LLCTherimuneX

Bucks County Biotech Center town hall with Congressman Mike Fitzpatrick (PA-8)

TandemHeart, Inc. facility tour with Congress-man Keith Rothfus (PA-12)In late August, Pennsylvania Bio and TandemHeart, Inc. hosted Congressman Keith Rothfus for a facility tour and employee town hall in Pittsburgh. Attendees composed of employees and industry representatives heard from TandemHeart CEO, John Marous about the TandemHeart technology and the benefit it provides to patients. Pennsylvania Bio President and CEO, Chris Molineaux spoke about the economic impact of the life sciences industry in the Common-wealth and gave a warm welcome to Congressman Rothfus. Guests in attendance were given the opportunity to ask questions of the Congressman on a variety of topics to include the FDA, the medical device tax, and his priorities for the rest of the legislative session.

Pennsylvania Bio President & CEO Chris Molineaux welcomes Congress-man Keith Rothfus during a facility tour and employee town hall at Tan-demHeart, Inc. in Pittsburgh.

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Indiana, North Carolina Join Pennsylvania for Governors Innovation ForumIn mid-August, Pennsylvania Bio President and CEO Chris Molineaux, presented at a We Work For Health event titled "Biopharmaceutical Inno-vation – Driving Quality Care and Enhancing Local Economies" featuring Governor Tom Corbett (PA), Governor Mike Pence (IN), and Governor Pat McCrory (NC). The Governors and panelists discussed the importance of the life sciences industry on local economies in their respective states. The event was held at the Union League in Philadelphia and featured at-tendees from area life sciences companies, policy makers, and patient ad-vocacy groups. We Work for Health is a network of 50+ life science compa-nies, business and labor groups, and patient/community organizations that seek to educate our elected leaders, the news media and our communities about the important economic and social contributions of the life sciences industry.

tevausa.com

Teva Pharmaceuticals is working every day to make quality

healthcare accessible around the world. As a manufacturer of

specialty and generic pharmaceuticals, Teva provides both new

therapies and greater access to quality, affordable medicines.

We lead the way

Congressional Breakfast with Mike Kelly (PA-3)

In late July, Pennsylvania Bio and representatives from its member companies GlaxoSmithKline, Johnson & Johnson, CSL Behring, Endo, Teva, Shire, Merck, and Bristol-Myers Squibb hosted a life sciences industry breakfast with Congressman Mike Kelly (PA-3). Congressman Kelly, a member of the House Ways and Means Committee and Republican Study Committee, spoke to the group about the importance of innovation in the life sciences industry and protecting patient access to therapies. Congressman Kelly also addressed the dire need of a business friendly tax climate so Penn-sylvania businesses, who currently employ 85,000 direct jobs in the Commonwealth, can thrive. Pennsylvania Bio looks forward to continuing to work with the Congressman and his staff.

Left: Representatives from PA Bio member companies gath-ered for a life sciences indus-try breakfast with Congress-man Mike Kelly.

From L-R: Christopher P. Molineaux, Daniel M. Skovronsky, M.D., Ph.D., Eliav Barr, M.D., Theresa Brennan, Governor Tom Corbett (PA), and Governor Pat McCrory (NC).

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ProgramsFrom Personalized Medicine to Precision Prevention – What Will it Mean for You?

Top: Panelists from L-R: Dietrich Stephan Ph.D., Dr. David Nash Kevin Harter, and Jean Hemphill.

18 | PA BioWatch, Q3 2014

Supply Chain Summit attendees listen to seasoned supply chain experts on September 9, 2014.

On August 20th Pennsylvania Bio members gathered at the Crowne Plaza Val-ley Forge to hear experts in the area of personalized medicine.

The panel featured Kevin Harter, President & CEO, Saladax Biomedical, Inc., Jean Hemphill, Partner, Ballard Spahr, David Nash, Dean, Jefferson School of Population Health, and Dietrich Stephan, Chair, Department of Human Genet-ics, Graduate School of Public Health, University of Pittsburgh

Moderated by Matthew Cabrey, panelists discussed the implications of preci-sion prevention now, and in the future and if we can identify chronic, genetic-based diseases early, is it possible to catalogue a patient’s risk portfolio early while managing it in a proactive way. Panelists also touched on implications for the payer community as well as for the biopharma, medical device/diagnostics, academic research and investment communities.

“We will be able to answer questions we didn't even know we had,” said Kevin Har-ter when asked his perspective on the future of personalized medicine."Genetic testing will push us [physicians] and promote the growth of personalized medi-cine,” added David Nash.

Thank you to our generous sponsors, Ballard Spahr and Ernst & Young.

More than 110 individuals from over 60 organizations gathered on September 9th at the Burl-ington County College Enterprise Center in Mt. Laurel, New Jersey for the 3rd annual Supply Chain Summit hosted by BioNJ, Delaware Bio and Pennsylvania Bio.

Summit attendees heard from seasoned supply chain experts who have successfully met chal-lenges such as understanding the regulatory environment of every country a company plans to distribute products, to the protection of sensitive and valuable products throughout the supply chain. Panelists provided critical insights for creating a supply chain that is capable of meeting the global demands for life-saving products.

Thank you to the sponsors: UPS, APICS Brandywine Chapter, American Express Meeting and Events, BioSurplus, CSS, Fisher Scientific and VWR International.

BioNJ, Delaware Bio and Pennsylvania Bio Host 3rd Annual Supply Chain Summit

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Pennsylvania Bio Continues Tradition of C-Suite DinnersEach year, Pennsylvania Bio Bio hosts dinners for its C-Suite executives. In the third quarter, Pennsylvania held dinners for Chief Finance, and Chief Scientific Officers from its core member companies.

The Pennsylvania Bio annual Chief Finance Officer (CFO) and Chief Sci-ence Officer (CSO) dinner are an invitation-only event for the CFO and CSO of its Core member companies. These dinners provide an opportunity for the executives to connect with their peers in an informal atmosphere, as well as to hear industry leaders share their personal insights related to life sciences and the challenges executives face in this complex environment.

The CFO dinner took place on September 16, 2014 at the Philadelphia Cricket Club in Phialdelphia, PA and the Chief Science Officer dinner took place on July 16, 2014 at the Radnor Hotel in St. Davids, PA.

The CFO dinner speaker, Mike Docherty, is a leading innovation expert, entrepreneur and connector, with a variety of broad-based experiences from senior level corporate roles, start-ups, consulting and venture capital. He is author of the forthcoming book “Collective Disruption” to be published in November 2014. Mike is currently CEO of Venture2, a consulting and new ventures firm he founded in 2004.

The CSO dinner speaker, Bill Hait, M.D., Ph.D., is currently the Global Head, Research and Development at Janssen Research and Development. In this role, he leads the global R&D group in its mission to discover and develop innovative new medicines to address the world’s most serious unmet medi-cal needs. Dr. Hait is an internationally recognized expert in translational cancer research who shared his personal insight into today’s life sciences industry to over 50 chief scientific officers.

Hait

Docherty

On July 31st, Compliance Implementation Services (CIS) and Pennsylvania Bio held an educational event, Making the Decision to Outsource Commercial Activities – Building a Relationship that Saves Money and Meets Business Goals at BioClinia in Audubon, PA.

Industry veterans shared experiences imple-menting an outsourced model for regulatory-heavy commercial and government activities. Panelists included experts from CIS, Ferring, Otsuka, Emergent BioSolutions (formerly Cangene), and Valeritas.

“With the regulatory focus on Healthcare Re-form, the industry’s potential for compliance risks and financial liability has increased ex-ponentially. By outsourcing back-office com-mercial and government operations, compa-nies can improve processes, better manage risk, reduce technology investments, and gain access to highly specialized regulatory exper-tise,” said Tom Evegan, Vice President, Con-tracts, Pricing, and Account Management at CIS.

Thank you to our host, BioClinca.

In July, Pennsylvania Bio hosted BioBasics: Biotech for the Non-Scientist, a two-day, intensive course focused on concepts required for understanding biotechnology applications.

Building on this knowledge, the course uses healthcare-specific examples to explore biologic drugs, biosimilars, personalized medicine, stem cell and regenerative medicine, culminating in drug discovery and development.

Class attendees develop a working knowledge of fundamental industry terms and applications, enabling more effective communication with colleagues and stakeholders.

For more information about the Biotech Primer classes, please visit: http://biotechprimer.com/.

Educational Course for the Non-Scientist

Outsourced Model for Commercial Activities

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Q&A

20 | PA BioWatch, Q3 2014

The Commonwealth of Pennsylvania has a rich history in the life sciences industry. From research and inno-vation, to being home to the nation’s first hospital, medical school and col-lege of pharmacy, it is hard to ignore our deep roots in the natural sciences industry.

Sixty percent of the United States and Canadian populations are within a day’s drive of Pennsylvania. This in-cludes access to 60 percent of Canada,

six of the 10 largest markets, three ports, six international airports, a world-class highway system and a modern freight railroad. Given our deep history and rich geographic location, it should come as no surprise that Pennsylvania has become a national and global leader in the life sciences industry. The life sciences industry is a $40 billion industry employing over 79,000 people and supporting over 2,200 business establishments. Our highly skilled workforce contributes to the positive economic impact the life sciences industry has on our state. Over 40 percent of our workforce has a post-secondary degree, and four out of the top 50 universities are in Pennsylvania – which is a fact that has not been lost on National Institutes of Health (NIH) organizations. At $1.38 billion, Pennsylvania has the fourth largest amount of NIH funding, including two out of the top 10 highest funded NIH organi-zations. We rank fifth in the U.S. both in higher education and state agency research and development (R&D) expenditures. We rank fourth in the U.S. for life science-related patents, and have over 1,800 research, testing and medical labs. Lastly, eight of our universities are categorized by the Carnegie Foundation as having “very high” or

“high” research activity.Shortly after taking office in 2011, I directed my Administration to create a Life Sciences Leadership Advisory Council to develop a 10-year plan to strengthen our life sciences industry. This council in-cludes representatives from the Pennsylvania General Assembly, the academic community, the life sciences industry, investors and my Administration. Through our work together, the council identified the unique ad-vantages that makes Pennsylvania competitive nationally – and even globally – in the life sciences industry, in addition to spurring future job growth. My Administration has taken many of the recommen-dations from the council as a guide for future initiatives. We are continuing funding to R&D tax credits in the amount of $55 million while securing the ability to trade those tax credits for immediate capital for those companies that are not yet financially viable. We have also implemented a pro-business tax reform package to help Pennsylvania compete for growth of our life sciences industry. For corporations, we have raised the cap on corporate net income tax net operating loss deductions from $3 million (or 20% of income) up to $5 million (or 30% of income) in 2015, which will effectively attract technology, bioscience and research firms by allowing these job cre-ators to smooth the impacts of business investments over future tax years. 2016 will finally put an end to Pennsylvania’s role as one of a minority of states to tax both business income and assets. By con-tinuing the phase-out of this job-killing tax, we will finally eliminate this inhibitor to Pennsylvania’s growth. My Administration also supports our private sector partners and programs that are growing the life sciences industry in Pennsylvania. This includes the “Discovered in PA – Developed in PA” program that assists local organizations with the establishment and anchoring of their operations within Pennsylvania. It also includes our state’s three Life Sciences Greenhouses (LSGs), which advance biotech and

Continued on page 22

Pennsylvania’s life sciences industry directly employs more than 85,000 individuals, is home to over 2,300 life science business establishments, and has a $40 billion annual economic impact. It is safe to say the life sciences is a vital and leading sector across the Commonwealth. As the November elections are quickly approaching, Pennsylvania Bio wanted to identify both Pennsylvania gubernatorial candidates’ stances on the Common-wealth’s life sciences industry. Republican candidate, Governor Tom Corbett, and Democrat candidate, Tom Wolf, shared with BioWatch their visions for the life sciences in Pennsylvania.

Governor Tom Corbett

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I am running for governor because I want to give Pennsylvania a fresh start. I know capitalizing on the strengths of our life sciences sector is key to achieving this goal.

The life science sector in Pennsylvania is one of the biggest and most diverse sectors in the country. We are home to topnotch research institutions

that draw down a significant amount of federal research and development dollars, and Research, Testing and Medical Laboratory, and Drugs and Pharmaceutical sectors are major contributors to the state’s economy.

But in order to really grow this sector and Pennsylvania’s economy, the industry needs a partner in the Governor’s Office who will work with them to address challenges and take advantage of opportunities.

As governor, I will work with the life sciences community to make sure Pennsylvania has a pipeline of skilled workers, there is a bridge to move research to the private sector, State dollars are being used strategically, and the industry is able to capitalize on the extraction of natural gas. With this approach, I know we will be able to grow the sector and ensure that Pennsylvania is a keystone of innovation.

The life sciences industry provides the types of good paying, high wage jobs needed to grow Pennsylvania’s economy. The average wage for this industry is almost double the state’s average wage. In order to support the growth of these businesses, we must continue to produce an educated and skilled workforce. Governor Corbett has taken us in the wrong direction by cutting funding to our public schools and state supported colleges and universities.

As governor, I am committed to investing greater resources

in education and workforce development. In addition to appropriately funding education at all levels, I will work to expand our Science, Technology, Engineering, and Mathematics (STEM) programs by connecting colleges and universities with high schools, providing STEM enrichment grants to teachers, and creating a new 2+2 program that incentivizes students to major in STEM related subjects. I know this renewed focus on science, technology, engineering and mathematics is essential to keeping and growing life sciences businesses in Pennsylvania.

In addition to developing a pipeline of skilled workers, we must help the sector grow by strengthening the coordination between researchers at our colleges and universities with emerging life sciences businesses. In 2011, the University of Pittsburgh and the University of Pennsylvania collectively received almost $1.4 billion in federal funding for research and development. To make Pennsylvania the center for economic growth and innovation, it is time to focus our efforts on moving these theoretical ideas to the market place.

Through an innovation grants program using existing state resources, I will facilitate partnerships between colleges and universities and emerging life sciences firms that will allow us to capitalize on innovative research.

This program will help engage college students in the life sciences, lead to job creation and the production of new, innovative products, and drive additional research and development funding to our academic institutions.

Commercialization and technology transfer strategies based upon existing research are a great opportunity for the Commonwealth to start shifting its policies from those that promote special interests and favor political donors to a new approach that rewards small businesses and innovators that create good, sustainable jobs in Pennsylvania.

While transferring research to the private sector will help grow life sciences business, I know that the Commonwealth still

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Continued on page 22Continued on page 22

Tom Wolf

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22 | PA BioWatch, Q3 2014

needs to help this industry identify investment capital and ensure that State funds are used strategically. As governor, I will bring together key stakeholders to develop a plan around how to better invest State dollars in the industry. I believe it is essential that we take a long range approach and create a pathway to making Pennsylvania the keystone for life sciences in the United States.

This means we need to also work to support mature life sciences businesses so that they stay and grow in Pennsylvania.

Lastly, I believe the life sciences industry in Pennsylvania has an amazing opportunity to capitalize off of the extraction of natural gas.

The proposed Shell cracker plant in western Pennsylvania presents an opportunity for us to not just burn natural gas for energy but use it to it to make products and grow our economy.

The American Chemistry Council is already projecting that this new Shell plant could lead to more than 17,500 new jobs. Specifically, it is estimating Pennsylvania will gain 2,400 chemical industry jobs, 8,500 supply chain jobs, and 6,900 spinoff jobs. The ethylene produced in this plant will allow pharmaceutical and chemical manufacturer to make more products in the state, help rebuild our manufacturing sector, and attract more good paying, middle class jobs to the commonwealth.

I know the life sciences industry must be a key component in any plan for Pennsylvania’s future. I am excited about the opportunity to work with you to expand innovation, develop solutions to some of our most serious health issues, and revitalize our economy. Together, we can give Pennsylvania a fresh start.

Wolf Continued From Previous Page

Corbett Continued From Page 18

medical device startups by providing access to funding streams, investors and technical expertise. These LSGs have a proven record of success, including: an investment of over $67.8 million in over 194 projects since 2001; over $3 billion in private funds; and 175 life-saving patient care products brought to market. In just the last three years, LSGs have contributed to the creation of 32 new

bioscience firms, 156 new companies formed, 3,465 jobs created and 3,465 jobs retained. I am proud of my Administration’s commitment to the life sciences industry, and I truly believe we are in a better position today than we were four years go. I was honored to be presented with the Biotechnology Industry Organization’s 2013 Governor of the Year Award in recognition of my Administration’s leadership and devo-

tion to strengthening the biotechnology and public health sectors within Pennsylvania. By supporting initiatives that stimulate growth within the industry – from helping entrepreneurs quickly transform ideas into com-mercial products to supporting the establishment and expansion of biotech companies – we are ensuring the biotech economy will continue to grow and flourish in Pennsylvania. By working together, we have made Pennsylvania a leader in the life sciences. I am extremely excited in what we can do together to make our life sciences industry a leader not only over the next four years, but for generations to come. As your Governor, you have my promise that I will do all that I can to ensure that Pennsylvania continues to serve as a national leader on how to unlock the best of what the life sciences industry has to offer.

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The life sciences industry in Pennsylvania and around the world continues to transform as medical innovation reaches new heights and advances in science that were only in the imagination until recently – like precision prevention, companion diagnostics and the cure for Hepatitis C – are topics of daily conversation. Nevertheless, market, regulatory and pipeline pressures are straining industry resources, forcing the industry to create new models for research, discovery and development of life science products. Moreover, implementation of the Federal “Affordable Care Act” is well underway, creating uncer-tainty for innovator life sciences companies of every size, both as research-driven organi-zations and as employers of people.

Amidst this change, Pennsylvania is one of the few locations in the world where all dis-ciplines of the emerging life sciences industry model can be found. In Pennsylvania the life sciences sector includes companies in the fields of biotechnology, medical devices, diagnostics and pharmaceuticals, in addition to the growing category of Research, Test-ing and Medical Laboratories. Pennsylvania also boasts the other elements of the life sciences value chain: academic research, investment organizations, manufacturing capa-bility and commercialization expertise.

As the industry trade association for the life sciences in Pennsylvania, Pennsylvania Bio strives to marshal these elements to facilitate the new model and usher in a new industry, characterized by more streamlined companies that rely on multi-sourced expertise for much of their discovery and development efforts.

As the state-wide trade association for this important economic driver for the Common-wealth, Pennsylvania Bio is the sole organization that represents their common voice. Furthermore, Pennsylvania Bio’s affiliations with the national peer groups BIO, PhRMA, AdvaMed and MDMA provide it the strongest state presence with national and interna-tional reach.

The Strategic Plan described on the front page for Pennsylvania Bio for 2014-2017 as-sumes the tranformation of the industry will continue at its current rapid pace. It also assumes this transformation and uncertainty offer unprecedented opportunity for Penn-sylvania Bio to leverage its size and influence to attract, retain and grow the future drivers of the life sciences industry within Pennsylvania and beyond its borders.

Best wishes for the remainder of 2014.

Christopher P. MolineauxPresident & CEO

President’s Column

www.PABIO.org | 23

Pennsylvania Bio Team

Christopher P. Molineaux President & CEO [email protected] 610-947-6800 ext. 203

Advocacy

Craig L. Tucker Vice President, Policy and Public Affairs [email protected] 610-947-6800 ext. 205

Ted Piper Senior Director, Policy and Public Affairs [email protected] 610-947-6800 ext. 206

OperationsBetty Pike Accountant [email protected] 610-947-6800 ext. 207

Laura Nikorawalla Office Manager [email protected] 610-947-6800 ext. 201

ProgramsHeather Pritchard Programs Manager [email protected] 610-947-6800 ext. 202

MembershipKaren DeLone Vice President, Membership and Programs [email protected] 610-947-6800 ext. 210

Paul Kornblith Director, Western Pennsylvania [email protected] 412-770-1637

Anne Hart Membership Services Coordinator [email protected] 610-947-6800 ext. 204

Steffie Mongar Administrative Assistant [email protected] 610-947-6800 ext. 209

CommunicationsMolly Stewart Communications and Marketing Associate [email protected] 610-947-6800, ext. 211

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650 East Swedesford Road | Suite 190Wayne, PA 19087pabio.org

Special Welcome to Our Q3 New Members

American Association for Cancer ResearchAOI Communications

Cancer Treatment Centers of America at Eastern Regional Medical CenterCenter Point Clinical Services

CETICS Healthcare Technologies, Inc.Clinical RM

Cohera Medical, Inc.Emergent Biosolutions

Faber Daeufer Itrato & CabotKEM Holding

Scilex PharmaceuticalsThe Chemistry Research Solution LLC

As of September 22, 2014