Q4 PA BioWatch Newsletter, Winter 2014
Transcription
Q4 PA BioWatch Newsletter, Winter 2014
PA BioWatch P 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 Q4 2014 Celebrating 25 Years of Life Sciences Leadership In December, 1989, leaders from Pennsylvania's burgeoning biotech industry came together to form Pennsylvania Bio. The trade association now represents the entire life sciences community of the Commonwealth - biotech, pharma, medical devices, diagnostics, academic research, investment organizations and the wide range of service organizations which call Pennsylvania home. On December 10, 2014, more than 200 members gathered at the Merion Cricket Club to celebrate Pennsylvania Bio’s Founders Reception, an event which recognized the 25th anniversary of the trade association and honored its founders – men and women who banded together to form an organization that now boasts 651 members. THIS ISSUE Locate in PA..................... 4 Membership News.. ........... 6 Regional Events. . ..............10 Advocacy Update.............12 Programs.. .......................15 Q&A. . .............................16 President’s Column. . .........19 Pennsylvania Bio’s founders are: Jeff Davidson, Mike Dougherty, John Enders, Mickey Flynn, Maria Maccecchini, Gwen Melincoff, Jim Shillenn, Jim Sharpe and Bill Wunner. Also honoring the Association that evening were Life Science Caucus co-chairs Representative Warren Kampf and Senator Andy Dinniman who presented citations from the State House and Senate. The 25th Anniversary celebration will continue at the premier event of the season, Pennsylvania Bio’s Annual Dinner, on March 12, 2015 at the Pennsylvania Convention Center in Philadelphia. For more information about the Annual Dinner and to register, please visit www.pabio.org. Photos on page 18 The Future of the Life Sciences Comes to PA More than 650 life science industry professionals from 14 states gathered at Life Sciences Future on October 13 and 14 at the Sheraton Downtown Hotel in Philadelphia. Jon Soderstrom Ph.D. of Yale University and Muz Mansuri, Ph.D. of Gilead Sciences, Inc. kicked off the Symposium: Partnerships in Science as the opening speakers on October 13. Reverse Pitch Presentations featuring business development representatives from 10 major pharma/biotech/medical device companies and a variety of panels took place throughout the afwith faculty and students representing 17 research ternoon. Michael Sofia Ph.D. of OnCore Biopharma institutions. closed the day along with a scientific poster session Continued on page 2 "Life Sciences Future was one of the most productive, informative and educational events I have been to in a while,” said Marc S. Malandro Ph.D., Associate Vice Chancellor for Technology Management and Commercialization, University of Pittsburgh. “The format and content of the conference was spot-on." October 14 opened with U.S. FDA Commissioner Margaret A. Hamburg. The second day of Life Sciences Future consisted of short takes, company presentations, funding meet-ups, partnering meetings and the Patient Spotlight story. This year's Patient Spotlight featured the story of Jon Sacker, a University of Pittsburgh Medical Center (UPMC) patient who at 33 years old was too sick for a second double lung transplant. Dr. Christian Bermudez, chief of UPMC's Division of Cardiothoracic Transplantation, and Peter M. DeComo, chairman and CEO of ALung Technologies, a University of Pittsburgh start-up company, revealed how an ALung device helped prepare Sacker for the lifesaving double lung transplant. MARK YOUR CALENDARS: Life Sciences Future 2015 will take place October 29 & 30 at the Sheraton Downtown Hotel in Philadelphia. “Life Sciences Future 2014 was a fantastic opportunity to meet with a wide range of contacts and potential partners in the Pennsylvania Life Sciences industry. We look forward to continuing to benefit from the great networking opportunities afforded by Pennsylvania Bio.” -Kevin Elliott, IDA Ireland "The location, the layout, the right mix of people and the timing were all well thought out. I thought the conference was great." -Rudy Treichel, Director of Graduate Programs, Widener University “I found the Life Sciences Future Partnering System extremely beneficial and useful organizing more than 9 meetings with life science professionals throughout the day. Equally outstanding was the support from the PA Bio team.” -Renay A Ebelle, President & CEO, Ebelle D’Ebelle Pharmaceuticals, Inc. FORGE Life Science and Shifa Biomedical Corporation Awarded JumpStart Grant at Life Sciences Future New Perspectives and Pharma Directions, in partnership with Pennsylvania Bio, awarded two Pennsylvania Bio member companies with service grants, each valued at $50,000 at Pennsylvania Bio’s annual fall event, Life Sciences Future. Symposium: Partnerships in Science attendees listen to Jon Soderstrom Ph.D. of Yale University and Muz Mansuri, Ph.D. of Gilead Sciences speak about developing commercialization strategies on October 13. According to Chris Morrison, VP of Business Development for PharmaDirections, “We designed the JumpStart Grant so two early stage drug development companies could reach the next milestone into their development. The Grant caters to privately held, early-stage therapeutic companies that are located in Pennsylvania and we are proud to be working with two great companies.” The Jumpstart grant winners are Shifa Biomedical Corporation (Shifa) and FORGE Life Science. Shifa is a structure-based drug discovery company. It is a privately held biopharmaceutical company dedicated to the rapid, cost-effective development of drugs for the treatment of cancer and cardiovascular diseases, and the development of vaccine technology. “This Grant represents a great opportunity for a small company like Shifa to quickly advance its program in areas of drug development and commercialization using the expertise and help of the two outstanding organizations, PharmaDirections and New Perspectives,” said Sherin S. Abdel-Meguid, Ph.D., President of Shifa Biomedical Corporation. “My colleagues and I look forward to working with PharmaDirections and New Perspectives to generate an investor-ready drug development and commercialization plan.” Michael Yang, President, Immunology at Janssen Biotech, Inc. sits down for a fireside chat with U.S. FDA Commissioner Margaret A. Hamburg. FORGE Life Science, a drug discovery company located at the Pennsylvania Biotech Center in Doylestown, is developing broad-spectrum host-targeted antivirals based on technology licensed from Princeton University. The company is funded by SBIR grants and private investors. “The JumpStart Award is invaluable for a company like FORGE,” said Lillian Chiang, CEO of FORGE Life Science. “It will significantly improve our pitch to attract further investment and pharma partnering while providing actionable focus in our path to actualize university innovation into realizable products serving patients in need.” Dr. Julia Shaklee Sammons, Medical Director of the Department of Infection Prevention and Control at CHOP speaks on Ebola: Threats, Challenges and Preparedness. PharmaDirections focuses on the preclinical drug development and is currently working with a number of early stage companies in Philadelphia and Pittsburgh. New Perspectives provides strategic and implementation leadership for marketing, commercialization and business development aspects of therapeutic development. For more information, please follow the links below: http://newperspectives-us.com/ http://www.pharmadirections.com/ Locate in PA Novartis Leases Building in King of Prussia Pennsylvania is getting their welcome wagon ready for the big move of global pharmaceutical company Novartis. The company will call 151 S. Warner Road home for the duration of its lease at King of Prussia. The 88,000 square foot purchase will be used to accommodate space needed for the company’s growth after the acquisition of a local business. This move brings a revitalized market to the King of Prussia, filling the vacated building and bringing in economic development for the area. Pennsylvania to create the Center for Advanced Cellular Therapies, a new research and development center on the university’s campus. The center was established after an agreement with GlaxoSmithKline (GSK), with Novartis acquiring GSK’s Oncology division in return for the sale of all vaccines, aside from the flu. GSK holds operations in the city of Philadelphia, and their recent collaboration has been rumored to be the cause of Novartis’ move. The people of King of Prussia should be eager for the company’s move to agreement was made between the two groups the suburbs of Pennsylvania and for the exto work on cancer treatments together. pected growth Novartis will bring to both This union between UPenn and Novartis their marketplace and to the field of pharmaNovartis is no stranger to Pennsylvania. Just builds on their growing Pennsylvania pres- ceutical medicine. last year, they worked with the University of ence. In April 2014, Novartis completed an Precision Therapeutics Transforms into Helomics™ Corporation Pittsburgh-based Precision Therapeutics, Inc. announced they will be known as Helomics™ Corporation, a privately held comprehensive personalized healthcare company that develops innovative next generation diagnostics for the oncology field. The name change reflects the company's new strategic vision, growth strategy and in-depth approach to characterizing patients' lives and archived cancer cells. Helomics will offer a more comprehensive set of services to help physicians individualize treatment options for their patients. “The marketplace for individualizing medicine is rapidly growing,” said Neil J. Campbell, President and CEO of Helomics. “With an even greater strategic vision and new management team, we believe Helomics is uniquely positioned to be the next-generation in personalized healthcare for patients with cancer and their physicians.” Helomics will offer an expanded platform of Precision Cellular Analytics, genomics and proteomics as well as bioinformatics & personal- Helomics will remain in Pittsburgh and will receive $60 million of ized analytics, contract research & development and biorepository & financing provided by Healthcare Royalty Partners. banking in addition to the company's core products, ChemoFx, BioSpeciFx® and GeneFx®. 4 | PA BioWatch, Q4 2014 PROFESSIONAL SCIENCE MASTER’S PROGRAMS at the College of Science and Technology BIOINNOVATION The skills to succeed in today’s most exciting industries, including pharmaceutical, technology transfer and public health BIOTECHNOLOGY Hands-on training and an interdisciplinary curriculum to take on today’s toughest scientific challenges • Curriculum developed by CST and the Fox School of Business • Human health, environmental or bioinformatics options • For professionals in science, business, communications and law • Advanced skills and real-world independent research projects • Work with bio-industry professionals, including physicians, lawyers, managers and journalists • Partnerships with Philadelphia’s industry and government leaders • Combine core, electives and projects tailored to industry or career goals Information at cst.temple.edu/ academics/bioinnovation • Includes responsibility and ethics in research and policy Information at cst.temple.edu/ academics/biotechnology Membership News York’s Unilife Signs Massive Commercial Supply Agreement with Sanofi Unilife Corporation, located in York, Pennsylvania, recently became the sole provider of cartridge-based wearable injectors for Sanofi. The worldwide Master Services and Commercial Supply agreement, which has a 15 year minimum, provides cartridge based wearable injectors used for all of Sanofi’s large volume drugs that apply. Not only will Sanofi be using Unilife’s cartridge based wearable injectors, but they will also be making them available to all of their partners. Unilife is anticipating to receive approximately $50 million from customization programs relating to Sanofi, in addition to the upfront payment and the device sales. On top of that, joint collaborations with Sanofi’s partners are expected to bring in even more additional revenue. In this agreement, Unilife granted Sanofi non-exclusive access to the wearable injector technology. This allows Unilife to enter into agreements with other pharmaceutical companies. This is good news as the market for wearable injectors is rapidly growing. Mr. Alan Shortall, Chairman and Chief Executive Officer of Unilife, said of the deal, “Unilife continues to advance our lead position in the fast-growing market for wearable injectors, a market which is expected to generate $8 billion in sales at an average $25 per unit by 2025.” With the fast growing market, Unilife’s wearable injectors are positioned to generate substantial amounts of revenue. Unilife will begin generating revenue from Sanofi this fiscal year. In addition to the lucrative commercial supply agreement, Unilife and Sanofi will also be collaborating to develop new technologies. They will be working together to address unmet or emerging needs for the delivery of large dose biologics. 6 | PA BioWatch, Q4 2014 Pennsylvania Organizations Partner to Combat Influenza and Antibiotic Resistant Bacteria The Defense Advanced Research Projects Agency (DARPA) has awarded $12.2 million for a collaborative study that will be conducted by scientists from the Perelman School of Medicine at the University of Pennsylvania; Inovio Pharmaceuticals; and MedImmune. Together, the three organizations will develop and assess the DNA mAbs in preclinical studies using technology developed by Penn and licensed by Inovio. The collaboration will focus on three disease areas – influenza virus, Pseudomonas aeruginosa and Staphylococcus aureus. "Monoclonal antibody technology has already achieved multiple market-proven product successes, and we believe DNA-based mAb technology could significantly extend the medical benefits and efficiency of this concept,” said Dr. J. Joseph Kim, President and CEO of Inovio Pharmaceuticals, Inc. “In previous preclinical studies our DNA-based mAbs demonstrated robust virus neutralization and protected treated animals challenged with a lethal virus. We look forward to working with our globally recognized collaborators to advance this potentially paradigm shifting technology." DARPA is an agency of the U.S. Department of Defense that creates and supports novel technologies important for national security. Successful completion of the initial preclinical activities under the DARPA grant aims to lead to clinical studies on selected product candidates to be funded under a future increment to the award. University of Pennsylvania Joins Forces with March of Dimes to Establish Research Center for Pre-Term Births The Perelman School of Medicine and the March of Dimes Foundation unveiled plans to create a $10 million research center devoted to uncovering the unknown causes of pre-term births, the leading killer of newborn babies in the U.S. Nearly 500,000 babies were born prematurely last year, and in Pennsylvania alone that number totaled 16,000—10.7 percent of all births. Preterm babies often face ongoing health challenges such as cerebral palsy, learning difficulties, vision and breathing problems, and higher rates of hospitalization and illness. Penn Medicine established its Prematurity Prevention Center in 2010, and now the Philadelphia-based health system will house leadingedge research in identifying and mitigating the risk factors associated with early birth. “We’ve been working on this area for a decade, but having this center allows us to accelerate that work and expand it,” says Dr. Deborah Driscoll, chairwoman of Penn’s department of obstetrics and gynecology, and principal investigator of the new center. “From a patient standpoint, we can develop strategies to reduce or eliminate preterm birth,” Dr. Driscoll says. “And from a biotechnology standpoint there may be new detection methods and new tests that can help us get to that goal.” btgplc.com While there will be no physical building, the March of Dimes Prematurity Research Center at Penn will use the funds to spur cross-discipline research by matching investigators who have not previously collaborated on such issues. Spanning the fields of physiology, genetics, microbiology, nutrition, pediatrics and gynecology, the center will also draw from research being conducted at Children’s Hospital of Philadelphia, Penn Engineering and the Wharton School. In total, the center, led by Deborah Driscoll, MD, chair of the department of Obstetrics and Gynecology at Penn, will comprise the work of more than 40 scientists, physicians, faculty and staff. “Including all of these areas of expertise will bring a very fresh perspective and allows us to gain new insights to identify the causes and mechanisms for preterm birth,” Dr. Driscoll says. Some of the topics to be studied include Bioenergetics, Mitochondria and Genetics, or identifying abnormalities in mitochondria function and mitochondrial DNA; Cervical Remodeling; and Placental Dysfunction, all of which may play a role in preterm birth. March of Dimes has invested millions of dollars elsewhere to create research centers at Stanford University School of Medicine, The Ohio Collaborative and Washington University in St Louis. Penn’s center will join these other institutions as part of an emerging national network. Focused on developing innovative products in specialist areas of medicine to better serve doctors and patients. Imagine where we can go. www.PABIO.org | 7 With $225,000 SBIR Grant, Rockland Immunochemicals Will Develop Synethic Antibodies for Modified RNA Detection Limerick-based Rockland Immunoceuticals received a $225,000 phase 1 Small Business Innovation Research grant (SBIR) from the National Institute of Health to develop synthetic antibodies for detection and quantitation of modified RNA. With a core competency of developing and manufacturing antibodies and other life science tools, Rockland is pioneering new capabilities for advancing scientific discovery, and this new grant promotes more groundbreaking study. “The grant enables Rockland to perform proofof-concept experiments using RNA aptamers to isolate and examine nucleic acid modifications in neuronal defects to the central nervous system development,” says Assistant Laboratory Director David Chimento, PhD. “Our goal is to generate a broad set of affinity reagents to profile RNA modifications in mouse mod- els of neurological disorders. The new reagents and tools developed will enable and advance research involving RNA editing in the central nervous system and other under-studied research areas.” The synthetic antibodies can be This is Rockland’s second grant from SBIR— used for discovery or as biosensors in applied in September, the company received $224,473 research for the diagnosis of diseases. from the NIH’s National Heart Lung and Blood Institute to develop an antibody-based device The research promises to shed light on previ- to diagnose sickle cell disease. ously difficult targets. “In this project we will design, engineer and produce RNA aptamers Chimento expects that Rockland’s grant-fundthat complement and supplement the func- ed work will help advance research, diagnostics tionality of antibodies,” Chimento says. “For and therapeutics, and in so doing, will help supexample, certain cellular targets do not respond port the greater regional economy. “The RNA to existing antibody reagents. RNA aptamers, aptamer and antibody technology will pay a therefore, hold the promise of extending the central role in the technologies researched and ability to study disease. Working together, an- developed by the biotech community in and tibodies and RNA aptamers expand the depth around Philadelphia, resulting in more discovand quality of the data we can gather about ery and more jobs.” neuronal defects and more.” University City Science Center Receives $1 Million Grant for Phase 1 Ventures Program The first and largest urban research park in the United States, the University City Science Center (UCSC) in Philadelphia is dedicated to fostering regional economic growth through innovation. A recently announced $1 million grant from the U.S. Economic Development Administration (EDA) will help with this effort. “As the first investment of Phase 1 Ventures, the EDA’s support is critical to getting this new program off to a running start,” says Christopher J. Laing, MRCVS, PhD, VP of Science and Technology at the UCSC. Phase 1 Ventures is a brand new, cross-institutional commercialization initiative that works with new technology companies to launch their products. “A comprehensive turn-key approach,” Phase 1 identifies already-proven technologies and works to secure financial and management resources needed to get their businesses off the 8 | PA BioWatch, Q4 2014 ground, including expertise in obtaining Small ten enough traction to Business Innovation Research (SBIR), Small attract management Business Technology Transfer (STTR) and oth- and investment.” er funding for new companies. All told, the Science With participation from academia, venture cap- Center’s graduates and ital, enterpreneurs and industry, Phase 1 helps Port business incubacompanies position themselves for greater suc- tors have created more cess. “With funding, management and other re- than 15,000 jobs in sources, Phase 1 Ventures helps ‘road test’ the the Greater Philadelphia region and contribute business feasibility of new ventures for their more than $9 billion to the regional economy suitability for independent investment or cor- every year. Laing believes Phase 1 Ventures will porate partnerships,” Laing says. “Phase 1 Ven- only further benefit the region. “The Science tures is starting with a focus on life sciences, de- Center’s mission is to support innovation, comvices and healthcare.” mercialization and entrepreneurship in our region. Phase 1 ventures hits all three of these butPhase 1 will work in tandem with the Center’s tons. We’re honored by EDA’s endorsement of QED Proof-of-Concept Program which re- what we do, and we take that partnership very ceived a $1 million grant from EDA in 2011. seriously. We’re looking forward to making a These are technologies that are “ready to leave real impact.” the university,” Laing says, “but have not yet got- Integral Molecular Awarded $3.5 Million To Study Ebola And Hepatitis C Virus The onset of potential Ebola cases in the U.S has caused a sense of fear in many Americans. As of early December there are 129 people in Pennsylvania being monitored for Ebola. Though the U.S has only seen two Ebola related deaths, there are many precautions being made to prevent an outbreak, one being a donation to Integral Molecular, Inc. in an attempt to study the Ebola and hepatitis C viruses (HCV). The National Institute of Health (NIH) recently awarded Integral Molecular a fiveyear, $3.5 million contract to study how the human immune system reacts to Ebola and hepatitis C. One of the goals of the research is to gain a better understanding of how human anti-bodies succeed or fail in protecting against these viruses. This is the second contract the NIH has awarded Integral Molecular for epitope mapping. The first contact they were awarded involved using Shotgun Mutagenesis to map over 280-antibody epitope binding sites for the dengue virus, Chikungunya virus, and HCV. Integral Molecular surpassed their goals by providing some of the largest data sets for viral pathogens. Integral Molecular will again be using its Shotgun Mutagenesis Epitope Mapping to have an understanding of the effect antibodies have on the Ebola and hepatitis C virus. Dr. Benjamin Doranz, President of Integral Molecular. “High resolution epitope maps that describe how the most effective antibodies bind and neutralize these viruses will increase our understanding of how these viral proteins function and how they can be inhibited.” “With this contract we will isolate and characterize new human antibodies against Ebola and HCV envelope proteins,” said Helping Those Who Have Helped Us Not all heroes come in capes and costumes. In fact, some can look like the person sitting next you on a bus or in front of you on line in the grocery store. For David Pernock, Chairman and Chief Executive Officer of autologous cell therapy company Fibrocell, that person is his father. Inspired by his father’s service in the U.S. Marine Corps during World War II and other veterans like him, Pernock and Fibrocell are looking to give back to these everyday heroes. Fibrocell Science Inc. wants to help wounded warriors who have suffered amputations. Some amputees suffer from prosthesis abandonment due to skin disease but with autologous fibroblasts, Fibrocell plans on strengthening the skin on the stump of the amputated area. The skin would have similar properties to the palm and sole and reduce pain and skin break down. The approval of the investigational new drug by the FDA will allow the “first-in-class” treatment for those who suffer from serious or rare skin conditions using the fibroblasts. With an invited application to the Peer Reviewed Orthopaedic Research Program Clinical Trial Award Grant, Fibrocell, in collaboration with Lt. Col. Jon Meyerle, MD of the Uniformed Services University of Health Sciences, the program will able to start treating the amputees and lessen the rates of prosthesis abandonment for our countries heroes. “We are proud and hopeful to play a role to develop a treatment that could potentially reduce the rate of prosthesis abandonment for those who have so honorably served our country,” Pernock said. “Prosthesis abandonment among amputees is due in large part to skin disease,” explains Lt. Col. Meyerle. “We are working with Fibrocell on a clinical study to develop a novel treatment of amputee stump skin that could advance the quality of life of service members by improving the ‘wearability’ of their prosthetic devices.” www.PABIO.org | 9 Regional Events Recognizing Health Care and Life Science Leaders The Philadelphia Business Journal, in conjunction with Comcast, Pennsylvania Bio and UnitedHealthcare, recognized health care and life science leaders in the Philadelphia region at the 2014 Innovation Awards on October 22, 2014 at the Crystal Tea Room, Wanamaker Building. Following the awards, the program featured a panel titled "Future of Health Care" with expert speakers and innovators who are pushing our medical community forward. Panelists included: Dr. Divya Dhar, Co-Founder of Seratis; Jean-François' Beaule, EVP, Health Plan Innovation at UnitedHealth Group; Dr. Stephen K. Klasko, President & CEO at Thomas Jefferson University and Jefferson Health System; and Roy Rosin, Chief Innovation Officer at Penn Medicine. Moderated by John George, Sr. Health Care Reporter at the Philadelphia Business Journal, the panel focused on how technology can help you lead a healthier life. Congratulations 2014 Innovation Award Winners Early Stage Company Chemo Cozy Patient Safety Award ERT Educator/Researcher of the Year Magid Abou-Gharbia, Temple University, Moulder Center for Drug Discovery Sustainability Award Cancer Treatment Centers of America, Culinary and Nutrition Teams Lankenau Medical Center, Main Line Health Emerging Executive of the Year Jeffrey Hatfield, Vitae Pharmaceuticals Health Care CEO of the Year Alan Miller, Universal Health Services, Inc. New Media Award Independence Blue Cross 10 | PA BioWatch, Q4 2014 Technology Transfer of the Year Temple University and Futura mHealth Partnering for scientific leadership Lifetime Achievement Award Winner Don Reed, Crozer-Keystone Health System astrazeneca.com/partnering Penn State Hershey Celebrates Spirit of Innovation Chester County Chamber Honors Award Recipients at Annual Dinner Faculty, staff, students, partners and the community gathered to celebrate the fourth annual Penn State Hershey Innovation Awards on October 29, 2014 at the University Conference Center in Hershey, PA. The Innovation Awards recognize members of the Penn State Hershey community whose ideas moved forward through execution of a license agreement, starting a company or earning a patent between July 1, 2013 and June 30, 2014. The keynote address was given by Charles Smith, Ph.D., founder and CEO of Apogee Biotechnology Corporation, Inc., entrepreneur-in-residence at Penn State College of Medicine and professor within the Department of Pharmacology. Following the address, 25 individuals were recognized for their achievements. For a complete list of award recipients and photos visit: http:// innovationcafepsu.wordpress.com/. On October 22, the Chester County Chamber of Business & Industry held its 2014 Annual Dinner at Longwood Gardens. This Chamber tradition celebrates the accomplishments of the Chamber over the past year as well as looks ahead to the future. Complete with expanded networking and award presentation, dinner guests gathered for an eventful evening. The Chamber honored two individuals for the Citizen of the Year and the CEO of the Year. Congressman Jim Gerlach was awarded the Citizen of the Year. This award goes to an individual who has taken on a community initiative or has had a major impact on their industry through professional and community involvement. Christopher P. Molineaux, President and CEO of Pennsylvania Bio received the CEO of the Year award. The award is given to a C-Level Executive Leader of a company who has had a significant impact during the year or who has shown steadfast leadership to their company and the community on an ongoing basis. Keynote speaker, Charles Smith, Ph.D., addresses attendees at the fourth annual Penn State Hershey Innovation Awards. The Chester County Chamber of Business and Industry held their 2014 Annual Dinner on October 22, 2014 at Longwood Gardens in Kennett Square, PA. www.PABIO.org | 11 Advocacy Update Pennsylvania Faces a Tough Budget in 2015 It hasn’t been fun watching Pennsylvania legislators craft the Commonwealth’s annual budget over the past few years. Budget holes seemingly grow month to month to a crescendo in June – then disappear in a blink of an eye as the witching hours of the final day of the month close in. It’s almost like magic. A strange annual magic show on the Susquehanna. The Commonwealth’s new chief executive, Tom Wolf, comes to this situation with the experience of being the Secretary of Revenue under former Governor Rendell. That experience should provide him a keen understanding of the process and the challenges. He has pulled one page out of the Corbett playbook and has begun a full throated “look at the mess I inherited” chant. Estimates of a $2 billion shortfall and promises by the new Governor to increase spending on education present a conundrum to the Republican appropriators in the House and Senate. They are, after November’s election, in a stronger position and are not ideologically inclined to enter- 12 | PA BioWatch, Q4 2014 tain his personal income tax proposal, but in weaker moments maybe for the shale tax if the deal is good. Think liquor privatization or an honest attempt at public pension reform. The Governor presents his version of the budget in early March. It will be a tall order and just the opening salvo, as every budget address is. Pennsylvania Bio is already working to protect the important tax credits that support innovators and companies, large and small. The Research & Development Tax Credit (R & D) and the new funds from Innovate in PA play a large role in company creation and sustainability. Eighty four (84) Pennsylvania Bio member companies were awarded R & D tax credits in 2013 to the tune of over $22 million. This support from the Commonwealth is very important and must stay in place. Pennsylvania, after all, competes each and every day with 49 other states and several highly competitive life sciences hubs who would love to steal these companies away. Post-election Town Hall The Life Sciences Town Hall meetings premiered in 2014 as an easy and convenient avenue for the general membership of Pennsylvania Bio to partake in the advocacy activity of the organization. A post-election Town Hall featured Alan Novak and TJ Rooney, two of Pennsylvania’s most successful political operatives. Alan Novak served as state GOP Chair under Governor Ridge and TJ Rooney led the Democratic Party during Governor Rendell. Even with two very different perspectives and backgrounds, the pair were united in their analysis of the November election. The national Republican wave did have some ripples in Pennsylvania, but it was not enough to aid the listing campaign of Governor Corbett. He fell to York businessman Tom Wolf by a wide margin. The Republicans gained eight house seats and three Senate seats in Harrisburg. The majority in the House was the largest for the GOP since the 1950’s. The election also saw little change in the congressional delegation as it welcomed two newcomers – Ryan Costello (R-6th) and Brendan Boyle (D-13th). Pennsylvania Bio welcomes the newest members of the State House and State Senate and urges them to join the Life Sciences Caucus. State Senators Art Haywood (D-4th) Tom McGarrigle (R-26th) Pat Stefano (R-32nd) Ryan Aument (R-36th) Carmera Bartolotta (R-46th) Michele Brooks (R-50th) State Representatives Barry Jozwiak (R-5th) Tedd Nesbit (R-8th) Parke Wentling (R-17th) Peter Schweyer (D-22nd) Brett Miller (R-41st) Jason Oritay (R-46th) Ryan Warner (R-52nd) Chris Dush (R-66th) Harry Lewis (R-74th) Judy Ward (R-80th) Rich Irvin (R-81st) Jeff Wheeland (R-83rd) Paul Schemel (R-90th) Kristin Phillips-Hill (R-93rd) David Zimmerman (R-99th) Russ Diamond (R-102nd) David Parker (R-115th) Aaron Kaufer (R-120th) Craig Staats (R-145th) Thomas Quigley (R-146th) Jamie Santora (R-163rd) Kate Klunk (R-169th) Mike Driscoll (D-173rd) Jack Rader (R-176th) Jason Dawkins (D-179th) Leslie Acosta (D-197th) CSL Hosts Expert Panel on Flu Vaccine CSL Behring and bioCSL hosted the Life Sciences Caucus at its King of Prussia offices in mid-October to listen to an expert panel on the importance of influenza vaccine and the latest innovations for its delivery. State Representative Scott Petri, Tim Briggs & Warren Kampf took in the presentation by Robin Rothermel - Director of the PA Bureau of Communicable Diseases, Diane McGowan - Founder of MARTIN Flu Foundation, Dr. Marie Mazur – President of bioCSL, Dr. Charles Altman – Head of Medical Affairs at bioCSL, and Dr. Andrew Bernstein – Senior Director of Medical Affairs Managed Markets for AstraZeneca MedImmune. 131 Pennsylvanians lost their lives to the flu. There were 28,000 cases in the Commonwealth and it is a real public health threat as vividly described by Diane McGowan. Founding MARTIN Flu Foundation after her son got the flu and quickly died from it, she stressed the need for very young children to be vaccinated. The legislators peppered the experts with questions about adequate funding from the CDC for low cost or free vaccinations in Pennsylvania. All three were impressed with the innovations in both disseminating the vaccine by local flu volunteers and community activists and the improving delivery methods for those who do not like needles. The panel stressed that with the outbreak of Ebola, public health awareness was now at the forefront in the news and the real dangers of the The event ended with flu shots being made available to attendees. flu can be discussed with a renewed effort to raise awareness. Last year www.PABIO.org | 13 Q&A WITH CONGRESSMAN PAT MEEHAN Patrick Meehan represents Pennsylvania’s 7th Congressional District in the United States Congress. Congressman Meehan recently shared with BioWatch his thoughts and views of the life sciences in Pennsylvania. What is the first action the 114th Congress can take to support the life sciences industry? I think there are a number of policies with broad bipartisan support that Congress can focus on right away. Making the research and development tax credit permanent is one. Congress needs to get away from repeated, short-term extensions of tax provisions and instead give life sciences companies the certainty they need to invest by making provisions like the R&D credit permanent. I’m also hopeful that we’ll be able to repeal the Affordable Care Act’s Medical Device Tax. There are more than 600 medical device companies across Pennsylvania -- the tax raises costs for manufacturers and consumers and it threatens jobs. Repealing the device tax will have attracted support from both Republicans and Democrats. Another issue in need of reform is our out-moded patent system. Modernizing our patent system will help protect intellectual property in the life sciences industry. Congressman Meehan With the International BIO convention coming to Philadelphia in June, what do you hope will be accomplished? Southeastern Pennsylvania is already a global center of life sciences research and education, but the International BIO convention is an opportunity to showcase what our region has to offer to life sciences companies from around the world. We have a first-rate workforce, world-class educational institutions, and our location at the heart of the Boston-Washington corridor gives us easy access to one of the world’s largest markets. I’m confident that when life sciences leaders from across the country and the globe come to Philadelphia in June, they’ll recognize the tremendous potential and opportunities we have to offer. Given your recent appointment to the Ways and Means Committee what is your position on corporate tax inversions and what is the appetite of the committee to address this issue? As a champion for the life sciences, what do you see as the industry’s value for the Commonwealth? We need to make sure our businesses and job-creators are competing with overseas rivals on a level playing field. Our workforce can compete and win against any nation in the world – we just need to ensure that our own tax code isn’t giving overseas competitors an unfair advantage in the global marketplace. The Delaware Valley is a national center for understanding and curing conditions that ail millions of Americans. Almost 80,000 Pennsylvanians go to work every day in the life sciences. We also benefit from countless small, start-up biotech companies that are creating jobs and expanding every day. Our corporate tax rate is the highest in the developed world and our tax code is almost 70,000 pages long. Ultimately, what we need is top-to-bottom tax reform that simplifies the code, broadens the tax base and lowers rates. The Ways and Means Committee will be central to this effort, and I look forward to being a part of it. We’re blessed to have world-class medical institutions like the University of Pennsylvania and CHOP. Research done at companies like Merck and GlaxoSmithKline is paving the way for the next wave of life-saving drugs. The industry is a crucial part of our regional economy, and I’m proud to fight every day for the thousands of hardworking employees in the life sciences. 14 | PA BioWatch, Q4 2014 Programs Gaining Insight from Global CEOs On November 20, Pennsylvania Bio members gathered at the Desmond Hotel and Conference Center for a unique opportunity to hear area CEO’s, who lead global organizations, share stories of challenges and successes at different turns in their career paths. acting with potential partners, the value of face to face communication, and their biggest failures throughout their career. “I’ve learned more through failure than winning,” said Micheal Yang of Janssen Biotech. “Many of our failures were the best things that could The panel featured Christophe have happened,” added Alan Shortall Dardel, President & CEO of DSM of Unilife Corporation. Biomedical; Alan Shortall, Chairman & CEO of Unilife Corporation; “You can only succeed by being surand Michael Yang, President, Immu- rounded by the best people,” said nology of Janssen Biotech, Inc. Christophe Dardel of DSM Biomedical. “Coming to Pennsylvania, we Moderated by Chris Molineaux, knew there was talent.” President & CEO of Pennsylvania Bio, panelists discussed various Thank you to our generous sponsors: ways in which small companies can Ballard Spahr and Ernst & Young. engage with large companies, inter- Pennsylvania Bio Hosts CEO Dinner Each year, Pennsylvania Bio hosts dinners for its C-Suite executives. In the fourth quarter, Pennsylvania held a dinner for the Chief Executive Officers from its core member companies. Steven M. Altschuler M.D., Chief Executive Officer of The Children's Hospital of Philadelphia (CHOP), was the 2014 Annual Chief Executive Officer (CEO) dinner speaker on December 2 at the Merion Golf Club in Ardmore, PA. Dr. Altschuler is a recognized expert who shared his personal insight into today’s life sciences industry to more than 75 chief executive officers. The Pennsylvania Bio annual Chief Executive Officer dinner is an invitation-only event for the Chief Executive Officers of its Core member companies. The dinner provides 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. Thank you to our generous sponsors: Liberty Property Trust, Medidata, and Morgan Lewis. Optimizing Your Drug Delivery System On November 10, West Pharmaceuticals and Pennsylvania Bio held a breakfast event, “Start with the End in Mind” at Shire Pharmaceuticals’ Chesterbrook Conference Center in Wayne, PA. Panelists included Graham Reynolds, VP of Marketing and Innovation at West Pharmaceutical Services, Inc., Sherry Martin-Moe,PhD, Executive Vice President at Enterprise Catalyst Group, and Yen-Huei Lin, PhD, Head of Drug Product Sciences, Global CMC Biologics at Teva Pharmaceuticals. Moderated by Robin Gasloli, Vice President and Managing Director at SmartAnalyst, panelists discussed how early decisions on containment and delivery systems can be instrumental to success, alternative containment materials that can help limit surprises like unexpected chemical interactions and improve time to market, and key advantages provided by advanced, flexible, customizable delivery options that may improve patient adherence and quality of life. Dr. Steven M. Altschuler addressed more than 75 chief executive officers at the Merion Golf Club on December 2, 2014. Thank you to our site host, Shire Pharmaceuticals. www.PABIO.org | 15 Q&A In December, 1989, nine leaders from Pennsylvania’s burgeoning biotech industry came together to form Pennsylvania Bio. The trade association now includes 651 member organizations across the entire life sciences community of the Commonwealth - biotech, pharma, medical devices, diagnostics, academic research, investment organizations and the wide range of service organizations which call Pennsylvania home. BioWatch recently spoke with three founders, Jeff Davidson, Maria Maccecchini, and Jim Schillenn about the history and first milestones of the Association. Where did the idea to begin a life sciences trade association stem from? JD: As a part of establishing the Penn State Bioprocessing Resource Center which was housed in the Penn State Biotechnology Institute, I and others explored the needs of the biotechnology community in Pennsylvania, seeking to understand some of the challenges the industry faced. Several important issues emerged that were not being met by existing programs or organizations, and it was thought that a new organization – a Pennsylvania Biotechnology Association – might meet these needs. JS: The development of a statewide trade association was one of the initiatives of the Bioprocessing Resource Center (BRC) at Penn State University. The BRC was established in 1988 under a grant from the Industrial Resource Center (IRC) Program through the Pennsylvania Department of Commerce (now the Department of Community and Economic Development) to support the development of the evolving biotechnology industry in Pennsylvania through research and development support, training support and the establishment of a statewide industry network. The Pennsylvania Biotechnology Association was developed by BRC staff members Jeff Davidson and myself under the leadership of Jean Benchley, Ph.D. the Director of the Penn State Biotechnology Institute and Bioprocess Resource Center. PA Bio was officially launched on December 6, 1989 when the board of directors met for the first time at Penn State’s Great Valley Campus and Jeff Davidson became the first Executive Director. What was the original mission for the Association? JD: Early on there were three principal missions for the Association and it was thought that they mutually reinforced each other: 1. Legislative and representational – seeking to help PA legislators, the Governor, and the economic development community better understand biotechnology companies. 2. Networking – connecting companies together more deeply at 16 | PA BioWatch, Q4 2014 several levels enabling them to learn from each other, and work together more effectively. 3. Education – helping public audiences to understand biotechnology topics in a more meaningful way. MM: The original mission was to help startups get organized, grow and raise money. JS: The original mission of the PA Bio was to help Pennsylvania companies succeed in the competitive, rapidly changing biotechnology arena. What was the long term vision? JD: The vision was to enhance biotechnology in Pennsylvania. This vision was pursued by building the association and by launching programs to serve the missions. MM: We saw Pennsylvania as having a lot of potential for becoming a hotbed of biotech startups and we wanted the industry to grow. Our mission was to prepare a fertile ground for the sprouting and growth of innovative biotech companies JS: It was recognized that to be successful in biotechnology companies would need to combine efforts to establish responsible biotechnology regulations, build public understanding of biotechnology and form business partnerships for the development and launch new biotechnology products. You faced many challenges over the years keeping the idea alive, can you tell our readers a story or a disaster that was averted that could have ended the Association? JD: Moving the organization out of its initial home at Penn State could have been a disaster and required more members to spend more money – they did. Our first annual meeting could have debuted to no one – but didn’t. Our first joint annual symposium with Bio NJ could have become a new war between the states – but didn’t. MM: As far as I remember we never had any disasters. However, in the beginning I was Chair of the Program Committee and we decided to have our first Annual Meeting. I spent an inordinate amount of time on putting the program together. The meeting was held at the Belleview and we invited everybody we could think of. Until the very last moment, I was petrified imagining the whole ball room being empty except for us organizers. Thankfully we had 112 people register and over 100 showed up – it was a great success. Ever since the Pennsylvania Biotechnology Association has always hosted an annual meeting and it has always been well attended and successful. Was there a catalyzing moment that propelled things forward? JD: The initial board of directors grabbed the idea of the association and propelled it forward. They consistently threw themselves into building programs and identifying ways the Association could meet its mission. After a formative time, the board also sought to separate the Association organizationally from its founding within Penn State and to have it become more autonomous. MM: Just like for disasters, there were no real “aha” moments. We just grew pretty steadily. What really propelled the growth of the organization was the attendance of a few Pharma people, who were working in biotech. That first step was followed by a number of Pharma people joining, whether they were biotech or not. This is how the Association grew from a few startups to a respectable membership of all therapeutic companies in the area. JS: In the beginning PA Bio was very dependent on financial support from the BRC to include offices in Wartik Lab on the Penn State University Park Campus. The catalyzing moment was when the Executive Director, Jeff Davidson became a full-time employee of PBA, moved off-campus and no longer dependent on funding through the IRC program. It was a “sink or swim” time for PBA and Jeff ’s energy and leadership was key to PBA’s success. Any other fun anecdotes/stories you’d like to share? JD: I think there are several ways the Association created some great successes in spite of our diminutive early size. Some of my favorites are: Hosting our first BIO meeting in Philadelphia was exciting and connected PA Bio with BIO, and to the various organizations that played an important role in supporting an international biotechnology community. We were pleased to help BIO grow the meeting to 3,000 (now it’s closer to 15,000). with state organizations with similar missions. The previous Biotechnology organizations (ABC and IBA) had limited connections with state organizations and had little ability to connect with state political leaders. This was transformed by PA Bio and the other young biotechnology associations. PA Bio served on the Emerging Council Board of Directors of BIO very early pulling BIO beyond Washington D.C. Working with other state associations and BIO (MBC, WA BIO, NYBA, NJ BC, etc.) to create a Council of State BioScience Associations allowing the organizations to learn from each other. It was important to get smart, thoughtful, creative people in the room and give them permission to work together, to borrow good ideas from each other, and generally to build better senses of what could be done at the state level. JS: Jeff Davidson always said we had to position PA Bio for success and our first major challenge was to make sure that the first annual symposium was successful. It was held in the Spring of 1991 at the Bellevue in Philadelphia and Jeff wanted to make sure that anyone who came through the door was counted to include support staff, invited speakers, vendors and, of course, actual registrants. The post-symposium headline in the PA Bio Newsletter was that it “attracted 175 people”. . . A true success!!! Any other thoughts we have not covered that you would like to share? JD: So many volunteers from young biotechnology enterprises gave so freely of their time and talent it was extraordinary and a highlight of my life. I enjoyed working with them to create something new! JS: In the late 1980s, before the establishment of PA Bio, Pennsylvania was not considered a national player in Biotech. The San Francisco Bay Area and the Boston Area were always mentioned with North Carolina and the Washington, D.C. areas as emerging players. PA Bio was a catalyst for communicating the message that Pennsylvania, especially southeastern PA, is as one of the top areas in the country for the development and commercialization of biotechnology products. Working at the formation of BIO to connect it much more firmly www.PABIO.org | 17 25th Anniversary Founders Reception December 10, 2014 | Merion Cricket Club Special Welcome to Our Q4 New Members American Liver Foundation Arent Fox LLP Argo Navis BioPharm Advisors COVIS Pharmaceuticals Dechert Exponent Formula Pharmaceuticals inVentiv Health Clinical 18 | PA BioWatch, Q4 2014 KP Interface Nabriva Therapeutics US, Inc. Omni Bio Pharmaceutical Oncoceutics, Inc. PharmaCadence Rare Genomics Institute RegDesk Inc. Regulatory & Quality Solutions RomAnalytics, LLC Spruzzo Skin Care Stephano Slack LLC The Webb Law Firm Veritable Zenith Technology Zynerba Pharmaceuticals Pennsylvania Bio Team President’s Column Think you know how Pennsylvania Bio was created…and why? Pennsylvania Bio, the statewide trade association for the entire life science industry in PA, celebrated its 25th anniversary in Q4 of 2014 and honored the men and women who “were there at the beginning.” This quarter’s newsletter features a Q&A with three of the Association’s founders who, together with six other pioneering biotech leaders, banded together a quarter-century ago to form what has become a nationally-recognized trade organization with more than 650 members. Think you know how Pennsylvania Bio was created? Think again…and read the story as told by Jeff Davidson, Jim Schillenn and Maria Maccecchini. It’s a story of vision, persistence, courage and growth, which has led to a life sciences community with a campus as big as Pennsylvania itself. We will continue to celebrate Pennsylvania Bio’s 25th anniversary this quarter and through the 2015 Annual Dinner in March. But we’re not only reflecting on the history of your trade association. Our focus is squarely on the future and how recent successes position Pennsylvania well for the continuing evolution of the life sciences community. This quarter’s newsletter features an ever-increasing list of mergers, acquisitions, licensing deals, IPOs, product approvals and other significant milestones that make Pennsylvania the envy of other regions in our vibrant life sciences world. It also reflects its continuing transformation. As the composition of our community changed, so did many of the company names on its roster. For those concerned about having lost “anchor tenants” like ViroPharma as attractants to PA, look at companies like Marinus Pharmaceuticals, HbO2 Therapeutics and Nabriva Therapeutics who announced in 2014 they were relocating their corporate headquarters to Pennsylvania from outside the Commonwealth – from Connecticut, Massachusetts and Austria, respectively. But change and opportunity were not confined to the life sciences marketplace in 2014. Pennsylvania also saw significant change in the public policy and political arenas. Although our delegation to the U.S. Congress remained essentially unchanged – Democrat Brendan Boyle replaced Democrat Allyson Schwartz and Republican Ryan Costello replaced Republican Jim Gerlach – the State House and State Senate both saw Republican gains, extending their majority in both chambers. And, of course, Pennsylvania elected Tom Wolf as the Commonwealth’s 47th Governor, returning the former Revenue Secretary to Harrisburg at a critical time in the State’s financial health. The team at Pennsylvania Bio, with the strong support and direction of our Policy Committees and Board of Directors, is already working with our re- and newlyelected State and Federal officials. You’ll also notice in this quarter’s newsletter that Pennsylvania Bio continued to change. As the theme of the Association’s 2013 Annual Report released in March suggests, we invited the world to “share our common wealth.” With the BIO International Convention in Philadelphia just six months away Pennsylvania Bio continued to set the stage by once again presenting Life Sciences Future, adding “Partnerships in Science,” a new half-day symposium on the front-end of our annual conference that brought together academia, industry, investors and our blossoming entrepreneur community. By all accounts, Life Sciences Future was again a great success and our willingness to take a leap paid off. We are able to try new concepts and make bold moves because of the support of our members. Our Board members – industry leaders who understand the value of trying new approaches – threw unanimous support behind our plans to shake things up. Our sponsors and presenters also appreciated the new ideas and goals. In the end, our planning committees, Board members and all conference registrants proved their willingness to try new approaches to meet the changing demands that face our community. Pennsylvania Bio finishes 2014 with more than 650 organizations in its membership, representing companies in biotechnology, medical devices and diagnostics, pharmaceuticals, healthcare IT, contract research or- ganizations, research institutions and the investment community. Our diverse membership reflects the changing nature of the life sciences and healthcare industries. Think you know how Pennsylvania Bio was created? Hopefully now you know why. Christopher P. Molineaux President & CEO cmolineaux@pabio.org 610-947-6800 ext. 203 Advocacy Craig L. Tucker Vice President, Policy and Public Affairs ctucker@pabio.org 610-947-6800 ext. 205 Ted Piper Senior Director, Policy and Public Affairs tpiper@pabio.org 610-947-6800 ext. 206 Operations Betty Pike Accountant bpike@pabio.org 610-947-6800 ext. 207 Laura Nikorawalla Office Manager lnikorawalla@pabio.org 610-947-6800 ext. 201 Programs Laura Markley Programs Manager lmarkley@pabio.org 610-947-6800 ext. 208 Membership Karen DeLone Vice President, Membership and Programs kdelone@pabio.org 610-947-6800 ext. 210 Paul Kornblith Director, Western Pennsylvania pkornblith@pabio.org 412-770-1637 Anne Hart Membership Services Coordinator ahart@pabio.org 610-947-6800 ext. 204 Steffie Mongar Administrative Assistant smongar@pabio.org 610-947-6800 ext. 209 Communications Molly Stewart Communications and Marketing Associate mstewart@pabio.org 610-947-6800 ext. 211 Christopher P. Molineaux President & CEO www.PABIO.org | 19 650 East Swedesford Road | Suite 190 Wayne, PA 19087 pabio.org Innovative Technology. Transformative Research. Medidata’s industry-leading cloud platform of innovative technology and data analytics is transforming clinical development today. Our solutions help life science organizations conduct their clinical trials with less risk, faster and with lower costs. And this means better treatments reaching waiting patients sooner. info@mdsol.com | mdsol.com | +1 866 515 6044