MassBio News

Supreme Court Rejects Gene Patents

Thu, 13 Jun 2013 12:00:00 EDT

**MassBio is holding a Member Briefing on Thursday, June 20 at 3pm. Learn more & register here.***

The Supreme Court ruled today that human genes cannot be patented. The court’s unanimous decision in Association for Molecular Pathology vs. Myriad Genetics bars the patenting of naturally occurring isolated biological material, but rules cDNA is patentable.

Stay tuned for additional MassBio analysis of the decision.

Some other resources to check out:

BIO Statement On U.S. Supreme Court Review Of Isolated DNA Patents

From the New York Times: What Genes Can Be Patented (video)

FierceBiotech: In mixed decision, Supreme Court throws up a barrier around gene patents

Forbes: Supreme Court Rejects Human Patents - Sort Of

WSJ: Supreme Court Says Human Genes Aren't Patentable

BBJ: IP lawyers say Myriad ruling may lead to lower costs, but less innovation

BioPharm America™ 2013 program leads with plenary on drug development pipeline “The Chameleon Rubik’s Cube”

Fri, 07 Jun 2013 12:00:00 EDT

EBD Group’s BioPharm America™, hosted by MassBio, will kick off its 2013 program with an Opening Plenary entitled “Strategic R&D Planning: The Chameleon Rubik’s Cube” on Tuesday, September 17. The plenary features moderator Vaughn Kailian, Managing Director of MPM Capital and includes speakers James Hoyes, President of EMD Serono; David Meeker, CEO of Genzyme; and Roger Pomerantz, Senior VP and Head, Worldwide Licensing and Acquisitions at Merck. The panel will discuss long-term pipeline planning in drug development which can be likened to a Rubik’s cube that changes colors with its surroundings.

Other highlights of the 2013 program include a new spin on a conference favorite, Doug MacDougall’s “The Perfect Pitch: Do you have what it takes to win over investors?” and the workshop “Why can't big pharma invest in my company?” moderated by David Collier, CEO of Velocity Pharmaceutical Development.

“This year we have changed the program to include a full afternoon of roundtable discussions to engage conference attendees as well as the executive panelists,” said Carola Schropp, President of EBD Group. “The new roundtable format will promote discussion and interaction among discussion leaders and audience members, and therefore provide yet another networking opportunity for participants.”

Parallel roundtable discussions fall into four tracks:

The future of dealmaking;
External and internal drivers;
Therapeutic spotlight; and
Welcome to the digital age.

Sixteen roundtables are scheduled. An example is “Partnering: Thinking beyond the deal,” featuring Stephane Bancel, President and Founding CEO at Moderna Therapeutics; Christoph Pittius, VP, Strategic Partnering and Business Development, Cardiovascular/Metabolic at AstraZeneca; Jason Rhodes, Executive VP and CFO at Epizyme, Inc.; Ed Saltzman, President at Defined Health; and Andrew J. Schwab, Managing Partner at 5AM Ventures discussing the drivers for dealmaking with the audience.

EBD Group, the leading partnering firm for the life science industry, produces BioPharm America in collaboration with the Massachusetts Biotechnology Council (MassBio). It will be held in Boston September 17–19 at theWestin Boston Waterfront. The bio-pharma partnering event will welcome executives from big pharma, including AstraZeneca, Bayer HealthCare, EMD Serono, Janssen, Merck, Novo Nordisk, and Shire seeking to identify and enter into strategic relationships at the global level.

BioPharm America 2012 welcomed over 750 delegates representing 462 companies from 30 countries. Delegates in 2012 engaged in 1,846 one-to-one partnering meetings with 652 licensing opportunities.

One-to-one networking at BioPharm America™ is powered bypartneringONE ^®, the leading conference networking solution for the life sciences.

Register before July 19, 2013 to save USD 200 athttp://www.ebdgroup.com/bpa/registration/index.php. MassBio members receive an additional USD 200 discount by adding the code ‘MassBio’ in the comments field of the online registration form.

Presenting companies should submit an application by June 28, 2013 athttp://www.ebdgroup.com/bpa/presenters/index.php

Science Takes Center Stage for Hundreds of MA High School Students

Thu, 06 Jun 2013 12:00:00 EDT

400 students from across the state shadow scientists and industry execs on biotechnology Job Shadow Day

June 6, 2013 (CAMBRIDGE, MA) – Today, more than 400 Massachusetts high school students shadowed life sciences professionals across the Commonwealth during the fourth annual biotechnology Job Shadow Day organized by the Massachusetts Biotechnology Education Foundation (MassBioEd).

“When students see cutting-edge science and the connection between their high school curriculum and the life-saving work being done in company labs, it sparks their interest in STEM,” said Lance Hartford, Executive Director of the MassBioEd Foundation. “Job Shadow Day exposes students to a variety of careers in the life sciences and shows them that high school science can be the first step to an exciting future.”

This successful event, part of MassBioEd’s BioTeach program, aims to increase students’ interest in pursuing science, technology, engineering, and math (STEM) related careers as part of MassBioEd’s BioTeach program. Through BioTeach, MassBioEd works to bring lab equipment, teacher training, and student career exploration experiences to students throughout the state to educate and inspire future scientists.

“As a company committed to innovation and putting better outcomes in the hands of patients, Civitas Therapeutics knows it is critical to cultivate the next generation of scientific leaders,” said Glenn Batchelder, Founder and CEO of Civitas Therapeutics. “We are pleased to support the efforts of the MassBioEd Foundation in inspiring future scientists right here in Massachusetts by hosting students for Job Shadow Day.”

This year, 16 Massachusetts biotechnology, biopharmaceutical, life sciences companies and research institutions partnered with the MassBioEd Foundation to host 15 high schools for company tours and one-on-one mentoring.

“It’s been our privilege to host students on Job Shadow Day,” said Steven Richter, Ph.D., President and Scientific Director of Microtest Laboratories. “It’s difficult to get passionate about a field of interest with just textbook exposure- specifically science. And science- with the appropriate passion- can be an exciting, fulfilling and rewarding career on all levels. Job Shadow Day helps spark that passion.”

"It's critically important that we engage students at a young age so that science becomes understandable to them," said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. "Bringing students into our labs where they can wear lab coats and goggles while doing real experiments allows them to envision themselves as scientists, an important first step to support our innovators of the future."

Participants included:

Companies Schools

AbbVie (Worcester)	Millbury High School
AMAG Pharmaceuticals (Lexington)	Taunton High School
ARIAD Pharmaceuticals (Cambridge)	Assabet Valley Regional Technical High School
Civitas Therapeutics (Chelsea)	Everett High School
Cubist Pharmaceuticals (Lexington)	Malden High School
EMD Serono (Rockland)	Barnstable High School Sandwich High School
Foundation Medicine (Cambridge)	Hanover High School
Masy Systems (Pepperell)	Assabet Valley Regional Technical High School
Microtest Laboratories (Agawam)	Ludlow High School
Shire (Lexington)	Haverhill High School
Toxikon Corporation (Bedford)	Dracut High School
Vertex Pharmaceuticals (Cambridge)	Everett High School
Whitehead Institute (Cambridge)	Danvers High School

Three additional organizations will host Job Shadow Days later this month:

Biogen Idec

(*Cambridge on 6/11)

Pembroke High School

Massachusetts General Hospital (*Boston on 6/7)

Brighton High School

Thermo Fisher Scientific

(*Waltham on 6/14)

Bellingham High School

Governor Patrick & MLSC Announce $100M+ in Capital Grants for Western Mass

Thu, 06 Jun 2013 12:00:00 EDT

Governor Deval Patrick and the Massachusetts Life Sciences Center (MLSC) today announced over $100 million in grants for life-sciences-related capital projects in western Massachusetts, including $95 million for the University of Massachusetts (UMass) Amherst and $5.5 million for the Pioneer Valley Life Sciences Institute (PVLSI), a joint venture of Baystate Medical Center in Springfield and UMass Amherst.

“Our Life Sciences strategy is about choosing to shape our future - investing today to leave a better Commonwealth for the next generation,” said Governor Patrick. “These investments support the kind of innovation that propels our economy forward and prepares our citizens for the 21st century global marketplace.”

Through the MLSC, Massachusetts is investing $1 billion over 10 years in the growth of the state’s life sciences supercluster. These investments are being made under the Massachusetts Life Sciences Initiative, passed by the state Legislature and signed into law by Governor Patrick in 2008.

“A key strategy of the Life Sciences Center is to use our capital dollars to accelerate life sciences-driven economic development across the Commonwealth by engaging and building on regional strengths,” said Dr. Susan Windham-Bannister, Ph.D., President and CEO of the MLSC. “Our investments in UMass Amherst and PVLSI are great examples of that strategy. In addition to its role as a leading academic institution, UMass Amherst is an important catalyst for economic development in western Massachusetts. The MLSC’s investment in three new Centers at UMass Amherst: a Biosensors & Big Data Center, Healthcare Informatics & Technology Innovation Center and the Models to Medicine Center enhance the University’s ability to support both of these missions. The grant for PVLSI also will strengthen the region’s leadership in the expanding field of bioinformatics, building on the $4.5-million grant that we recently awarded to the Massachusetts Green High Performance Computing Center in Holyoke.”

The grant for UMass Amherst will fund construction to fit out and equip a substantial portion of the university’s new $157-million Life Sciences Laboratories. This building will house three new research centers led by faculty and will be dedicated to partnering with regional life sciences and precision manufacturing companies to develop innovative products and services. The three centers are as follows:

Personalized Health Monitoring, focused on developing nanotechnology and large dataset management to improve health care through low-cost, wearable, wireless sensors that analyze patient data continuously in real time. This center will bring bio-sensor technology, nanotechnology, new polymer and manufacturing techniques, “big data” and information technology together to design, develop and test the next generation of wearable bio-sensors and healthy lifestyle applications. Biomanufacturing firms, medical device makers, big data analysts and other health care industry partners will produce prototypes, test them and assess manufacturing feasibility.
Bioactive Delivery, focused on discovery and application of new drug, agricultural and “nutriceutical” compounds. It will draw on discoveries and research by UMass Amherst faculty who, for example, develop synthetic molecules that can fight infection in new ways and design all-natural formulations for delivering oil-soluble vitamins and other nutrients in food products.
Models to Medicine, focused on translating basic protein research by UMass Amherst experts into new therapeutic targets. This center will capitalize on an explosion of discoveries over the past 10 years that suggest a variety of protein dysfunctions play a role in Alzheimer’s, Parkinson’s, cancer and infectious diseases.

“This investment is an outstanding example of how world-class research at UMass, with support from the MLSC, can create a dynamic and prosperous future for the Commonwealth,” said Robert Caret, president of the University of Massachusetts. “The development of three new research centers in partnership with industry will enhance technology transfer and translate inventions into products and services that will make life better for all of us.”

“We are grateful to the MLSC for selecting UMass Amherst to be a catalyst for new advances in the life sciences,” said UMass Amherst Chancellor Kumble Subbaswamy. “This grant positions us for new directions in translational research and for increased engagement with industry and other educational institutions in western Massachusetts and throughout the Commonwealth. UMass is committed to growing these relationships to advance economic development as part of our land grant mission.”

“The UMass campus can have a large impact on local area businesses and has been working with regional groups connecting companies to new technologies,” said Ed Leyden, co-chair of the Advanced Manufacturing Collaborative and president of Ben Franklin Design and Manufacturing Company in Agawam. “I see the current life science initiative as another excellent means to engage local companies.”

The grant for PVLSI, located adjacent to Baystate Medical Center’s main campus in Springfield’s North End, will support the development of a new Center of Innovation in Health Informatics and Technology, focused on advancing public/private-sector partnerships and incubating innovative technology solutions developed by start-ups and larger, more established vendor firms in areas such as population health management, health care quality, “big data” analytics and mobile health.

“The assets we have in place in Springfield—beginning with a strong integrated health system in Baystate Health, and extending to the Pioneer Valley’s advanced high-tech manufacturing capabilities—provide a unique opportunity for our prospective start-up and vendor partners to accelerate and incubate their products here in western Massachusetts, benefiting our community’s health care and economy,” said Joel Vengco, vice president and chief information officer of Baystate Health.

“As a champion of the life sciences industry for nearly two decades, I am thrilled with today's announcement. In my opinion, the expansion of research and development in the field of the life sciences can improve the quality of health care, grow the economy and create jobs in the Pioneer Valley. These two major grants can be game changers for the life sciences and biotechnology communities in western Massachusetts,” said Congressman Richard E. Neal.

“The ripple effects of these investments will be enormously positive for western Massachusetts,” Massachusetts State Senate Majority Leader Stan Rosenberg said. “Not only will this funding help place our flagship campus exactly where it needs to be -- at the vanguard of life sciences research and development -- it will also help create good jobs and technological innovations that we can scarcely imagine today. This project, which is engaging the best and brightest from academia, government and the private sector, is an outstanding example of what can be accomplished when we work together in a spirit of partnership.”

“The growth of the life sciences industry is crucial to the continued health of the Massachusetts economy,” said Representative Ellen Story. “Equally important to the Western Massachusetts economy is our continued support for the University of Massachusetts, as it embarks on its most ambitious expansion in half a century. I am grateful that this investment in our economy has been made at the flagship campus of the University of Massachusetts.”

“MassBio was proud to support UMass in this process, and is thrilled to see investment in these key industry areas,” said Robert K. Coughlin, President & CEO of MassBio. “These grants enable UMass Amherst and the PVLSI to continue to anchor the life sciences industry in the Pioneer Valley and Western Massachusetts, underlining the fact that the industry truly reaches to all of our borders and the regions in between.”

The MLSC is a quasi-public agency of the Commonwealth tasked with implementing the Massachusetts Life Sciences Act. The MLSC’s mission is to create jobs in the life sciences and support vital scientific research that will improve the human condition. This work includes making financial investments in public and private institutions that are advancing life sciences research, development and commercialization as well as building ties among sectors of the Massachusetts life sciences community. For more information, visit www.masslifesciences.com.

Acceleron Named to the “Best Places to Work” List by The Scientist Magazine

Tue, 04 Jun 2013 12:00:00 EDT

Acceleron recognized among survey of more than 200 companies

Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases, today announced that it was named to the 2013 “Best Places to Work in Industry” by The Scientist magazine in their 11th annual survey. The survey included responses from 240 companies. Survey participants were asked to assess their work environment according to 43 criteria in eight different categories including research environment, integrity, management, communications, job satisfaction, and training and development. Other companies ranked in the top ten included Genos Ltd, Vitae Pharmaceuticals, OpenEye Scientific Software, Inc., Wyatt Technology Corporation, Genentech (a member of the Roche Group), Millennium: The Takeda Oncology Company, Integrated DNA Technologies, Regeneron Pharmaceuticals, and Monsanto.

“Acceleron is honored to be named by The Scientist as one of the 2013 Best Places to Work,” said John Knopf, Ph.D., Chief Executive Officer and Founder of Acceleron. “As we aspire to discover and develop therapies that will transform the lives of people suffering from cancer and orphan diseases, we remain committed to maintaining a culture that empowers our employees to thrive and take deep pride in their contributions to advancing science and improving the lives of patients.”

MassBio Appoints 51 Industry Leaders to New Advisory Board & Working Groups

Wed, 29 May 2013 01:00:00 EDT

May 29, 2013 (Cambridge, MA) -- MassBio has named 51 industry leaders to new advisory groups within the organization that will drive and oversee programming.

The new groups were named to support the new MassBio Forums, panel and networking sessions designed to meet the varied needs of the diverse life sciences community by providing the best, timeliest, most forward-looking and forward-thinking content possible. The effort has already led to the upcoming Adventures in Biotech program, a six-part series of discussions with industry leaders on building a biotech company in the current financial and regulatory environment. The first program, Dreams to Reality: Case Studies & Successes, will be held Thursday, June 13^th at 8 a.m. at MassBio. For more information and to register, visit www.massbio.org.

“Here at MassBio we strive for excellence and constantly seek opportunities to enhance our support of our members,” said Robert K. Coughlin, President and CEO of MassBio. “Working closely with our Board of Directors, we realized the way to bring the very best programming to the life sciences community was to look to industry leaders in helping shape and execute the programs industry needs to thrive.”

“The strength of MassBio is in the knowledge and network of its members,” said MassBio Board Chairman Geoff MacKay, President & CEO of Organogenesis, Inc. “We are thrilled to have so many industry experts stepping up to serve our new programming groups and share their expertise with our broader membership.” MassBio Forums are overseen by a Forum Advisory Board of 18 industry leaders with a breadth of experience. The Forum Advisory Board includes:

Debbie Benjamin, Director of Facilities & Lab Management, Celgene
Nils Bergenhem, Principal, NB R&D Consulting
Bob Bondaryk, President and CEO, KeraFast
Susan Boynton, VP, Global Regulatory Affairs, Shire HGT
Kathy Call,Senior Director & Head, Proteogenomics, Genzyme Corporation
Dalia Cohen, Founder & President/Science Entrepreneur, ALN Associates
Michael G. Donovan, Partner and Northeast Area Industry Leader for Biotechnology, Ernst & Young
Brian Fenton, Executive Director, Business Development, Shire HGT
Roger Frechette, Co-Founder and Principal, New England Pharm Associates
Mike Henry, VP, Business Development, Athena Diagnostics
George Hillman, Business Development, Bach Pharma
Jim Holmes, Partner, Deloitte
Joanne Kamens, Executive Director, Addgene
Chris Kennedy, Founder & CEO, SCM Advisers
Ralph Lambalot, VP, Biologics Development & Manufacturing Launch, AbbVie
Tsvetelina Lazarova, Co-Founder & Co-Owner, MedChem Partners
Imran Nasrullah, Head of Strategic Alliances, T1D Exchange
Larry Wittenberg, Co-Chair of Life Sciences Practice, Goodwin Proctor

The Forums are organized and planned by 10 volunteer Working Groups. Working Group Co-Chairs include:

Biostatistics / Data Management / Clinical Trials

John Balser, President, Veristat
Michelle Harrison, Manager, Clinical Data Management, Vertex Pharmaceuticals

Business Development & Finance

Chris Pereia, Senior Manager, Ernst & Young
John P. Reilly, VP Business Development, Tetragenetics, Inc.
Maude Tessier, Assistant Director, Strategic Initiatives & Business Development, Boston Children's Hospital
Paul Thibodeau, Director, Business Development & Strategy, Corporate Licenses, Sanofi

MA CRO/CMO

Peter Meltzer, President & CEO, Organix, Inc.
Bhavishya Mittal, Scientist II, Millennium: The Takeda Oncology Company
Ed Price, President, PCI Synthesis
Raj Rajur, Chairman & CEO, CreaGen Biosciences, Inc.

Drug Discovery

Masha Hareli, Founder & President, ATR, LLC
Steve Riesinger, Co-founder, MedChem Partners
Robert Suto, President and CSO, Xtal Biostructures Inc.

Entrepreneur's University

Steve Alteiri, Associate, Cooley LLP
Marc Cote, Co-founder & COO, Accellient Partners, LLC
John Hession, Partner, Cooley LLP

Formulation and Drug Delivery

Shikha P. Barman, Ph.D., CEO and CTO, Integral BioSystems
Angelos Dovletoglou, Executive Director of Preclinical Development Sciences, Epizyme
Alex Nivorozhkin, Director, Business Development, Neo-Advent

Human Resources

Patrick Marshall, Chief Business Officer/Co-Founder, StratAcuity
Eric Raichle, Vice President, Human Resources, Alnylam Pharmaceuticals
James Richardson, VP, Business Development, Marsh & McLennan Agency
Hewan Small, Senior Director, Human Resources, Selventa, Inc.

Legal & Regulatory

Mladen Bozic, Director, Global Regulatory Policy & Intelligence, Shire HGT
David Hoffman, Senior Counsel, Sunovion Pharmaceuticals, Inc.
Konstantin Linnik, Partner, Lawyer, Nutter McClennen & Fish LLP
Jayati Vaidya, Senior Consultant, Advisory Services, Deloitte

Marketing & Communications

Rob Goldstein, VP, Communications & Public Affairs, ALS Therapy Development Institute
Mike Walsh, Advocacy Development Manager, MedImmune, Inc.

Safety, Environmental and Facility Operations

Dick Aichelmann, Associate Director EH&S, Ironwood Pharmaceuticals
Denise Aronson, President, Safety Partners
Chris Gingrow, Senior Manager Facilities Operations, Amgen
Howard Lefkin, EH&S Manager, UMass Medical School

The MassBio Forums program kicks off with Adventures in Biotech, a six-part series that offers lessons and advice in starting and growing a company.

Upcoming Forums in the series include:

June 13, 8-10 am Dreams to Reality: Case Studies, Successes
June 27, 8-10 am Financing the Dream: Avenues for Raising Capital

September 2013

Executing the Dream I: Strategy & Models for Company Growth
Executing the Dream II: Science Tactics for Success

October 2013

Selling the Dream: Partners, Payors, & Patients
Lessons Learned: Nightmares?

All Forums are open free of charge to MassBio members and this special Adventures in Biotech series is open to non-members for a fee of $25 per session. Learn more and register at www.massbio.org.

MassBio Innovation Services Thriving

Wed, 29 May 2013 12:00:00 EDT

Just three years after the release of the 2015 Strategic Report, which identified the need to better align the research community with opportunities for commercialization, MassBio can report making significant headway. By introducing the MassCONNECT mentoring program and the popular Pharma Days, companies can capitalize on the state’s position at the forefront the life sciences industry and leverage the power of the MassBio network to enhance collaboration and accelerate innovation.

Building on MassCONNECT Successes

MassBio Innovation Services’ flagship program, MassCONNECT, is a unique mentoring program that connects entrepreneurs and founders with seasoned life sciences professionals to catalyze and commercialize innovation.

Since its inception in May 2010, MassCONNECT has graduated 40 companies. Despite an extremely challenging economic landscape, eight of those companies have already received funding following completion of the program.

“I see our experience with MassCONNECT as being a turning point in MindChild’s development process,” said Adam Wolfberg, MD, chief medical officer of MindChild Medical, a MassCONNECT graduate from 2010. “MindChild went from being a very early-stage, slightly naïve group of inventors and – I think because of the MassCONNECT program – turned into a startup company that is now very well-funded and well on its way to success.”

Most recently, MassCONNECT graduate Johannes Fruehauf, PhD, used connections made through the MassCONNECT network to secure partners for LabCentral, a new shared lab space designed to facilitate the creation of startup biotech companies in Kendall Square. Through MassCONNECT, Johannes met Charles Wilson, Vice President of Strategic Alliances at the Novartis Institutes for BioMedical Research (NIBR), which later signed on as a founding partner of LabCentral.

Scaling up Pharma Days

In 2013, MassBio is will host more of the popular Pharma Days programs than ever before, building on successes reported from past events. Pharma Days match pharma companies with biotech companies through invitation-only in-person meetings and events customized by MassBio. Pharma Days depart from traditional “speed-dating” formats and focus on tailored, optimal connections.

Pharma Days are designed to make partnering as smooth and productive as possible. For pharma companies, Pharma Days offer visibility and the chance to connect with biotechs in the number one life sciences cluster. For biotech companies, Pharma Days provide access to senior-level executives from pharma and critical information on pharma companies’ plans and strategies.

With new CBO John Hallinan at the helm and positioned in the heart of the thriving Massachusetts life sciences ecosystem, the MassBio Pharma Days program is on its way to becoming the industry-leading partnering program. To date, eight of the top 10 pharma companies have held Pharma Days. With six Pharma Days confirmed for 2013 and many more in process, MassBio aims to have held Pharma Days with all of the top 10 pharma companies by the end of the year.

To learn more about MassCONNECT or Pharma Days visit www.massbio.org/innovation or contact Rakhshita Dhar at 617-674-5100 or rakhshita.dhar@massbio.org.

"Golden Age" for Research

Wed, 29 May 2013 12:00:00 EDT

EARLY 400 INDUSTRY LEADERS GATHER FOR 2013 ANNUAL MEETING

BY MEAGHAN CASEY

Declaring it a golden age for biomedical research, FDA Commissioner Margaret Hamburg appealed to the nearly 400 biotechnology industry leaders gathered for MassBio’s 2013 Annual Meeting for an increase in collaboration, noting that more progress needs to be made to effectively translate scientific discoveries into therapies, prevention or cures.

“As a nation, we must take a serious look at everything from intellectual property and patent policy to economic policy, including such things as access to capital, incentives, and tax policy, how we invest in science, our reimbursement policies and, of course, regulatory policy and regulatory reform,” said Hamburg, who served as a keynote speaker at the two-day event held at the Royal Sonesta Hotel in March. “As a result of our dialogues with industry – including MassBio – we have heard loud and clear that you want increased clarity, certainty and predictability about the FDA’s standards and expectations. I think I can say that we are striving to do our part. Success will require regulatory flexibility, advancing regulatory science and true collaboration among health professionals, industry, government, academia, and our global health partners.”

Hamburg shared examples of Massachusetts companies who have successfully navigated approval pathways, including the new expedited approval pathway. Of the 47 novel drugs and biologics the FDA approved in 2012 – the most in more than a decade – one out of three received fast track designation, 41 percent received priority review, and 10 percent were approved under the accelerated approval program. Those developed in Massachusetts included: Iclusig, which treats two rare forms of leukemia and was approved in just 2.6 months; the orphan drug Juxtapid, approved based on a single clinical trial of 29 patients; Linzess, a drug for irritable bowel syndrome; and Kalydeco, the cystic fibrosis drug, which was approved in 3.5 months.

“The FDA was able to review and approve many of these new therapies quickly by communicating with drug companies early in the development process, allowing flexible clinical trial design, and using priority review and other drug approval mechanisms to expedite approval,” said Hamburg. “As a result, the majority of these important products were made available to patients in the U.S. earlier than anywhere else in the world.”

John Crowley, Chairman & CEO of Amicus Therapeutics, also served as a keynote speaker at the annual meeting, sharing his experiences as a biotech executive, father and patient advocate.

“So much of what we do is about selling hope – not just hope for everyone who is invested today, but hope for so many people who don’t even know that they need it, that they’re going to be sick and that their lives are going to profoundly change,” said Crowley.

Crowley and his wife Aileen’s lives changed abruptly in 1998 when they were told that their daughter Megan (then 15 months old) and Patrick (just a few days old) had a rare genetic disorder, Pompe disease. Crowley left his job at Bristol-Myers Squibb and invested himself and his life savings in Novazyme Pharmaceuticals, a start-up company that was conducting research on a new experimental treatment for the disease. In one year, Novazyme went from an endowment of $37,000 to $27 million and was quickly acquired by Genzyme. Crowley was named head of Genzyme’s global Pompe program. He left the company in 2002 and in January 2003, Megan and Patrick received the enzyme replacement therapy through an experimental trial, which Crowley credits with saving his children’s lives. Megan is now 16 and Patrick is 15.

“Much of what we do is about extending and enhancing life – making that hourglass a lot bigger,” said Crowley. “As humans, all we really have and all that we’re pursuing is time. It’s essential to keep taking risk, if in the next 20 years we want to deliver the dream of all these early-stage ideas.”

The annual meeting also included discussions on healthcare reimbursement, what’s next in oncology research, the future of biosimilars, rare disease therapies and research resources sharing.

“These conversations go to the very heart of what we do and how we as an industry will operate into the future,” said MassBio President & CEO Robert K. Coughlin. “We must understand our role in a shifting economic and regulatory environment and attempt to answer these big, complicated questions. Our only way forward is to address them together.”

Josef von Rickenbach, Founder, CEO and Chairman of PAREXEL International, received the Henri A. Termeer Innovative Leadership Award for his commitment and contributions to the biotechnology industry at the closing awards luncheon. Von Rickenbach co-founded PAREXEL as a regulatory consulting company in 1982 and soon grew the organization into a pioneer in clinical research outsourcing. To make clinical development more effective for clients, he conceived a multidisciplinary and systems-oriented approach to outsourced clinical development, bringing efficiencies, scalability, and standardization to the process. Thirty years later, PAREXEL is a $1.4 billion global company and one of the top biopharmaceutical service organizations in the world.

Gloucester High School was named this year’s Joshua Boger Innovative School of the Year by the Massachusetts Biotechnology Education Foundation (MassBioEd) for inspiring students to explore life sciences careers through progressive biotechnology education and exemplary science career programming. In 2009, Gloucester High was selected as a BioTeach school, and in four years, students and faculty have actively participated in both teacher professional development and biotechnology lab experiences. The school has also creatively adapted BioTeach labs and equipment to establish new biotech summer camp programs for high school students.

“This recognition is an important step forward for Gloucester High School, as we work towards our goal of becoming a leader in STEM-related high school education,” said Principal Erik Anderson.

To recognize its commitment to growing the life sciences supercluster in Massachusetts, Massachusetts Biomedical Initiatives (MBI) of Worcester was honored with MassBio’s Leading Impact Award. MBI is the second organization to receive this award. Last year’s winner was Pfizer’s Center for Therapeutic Innovation.

Q&A With Sen. Elizabeth Warren

Wed, 29 May 2013 12:00:00 EDT

Congratulations on your appointments to the Senate Health, Education, Labor and Pensions (HELP) Committee, the Banking, Housing, and Urban Affairs Committee, and the Senate Special Committee on Aging. As you delve deeper into your Committee work, would you share with us a few of yourpriorities for the coming months?

My top priority is working to build a future—a future for ourselves, our children and our grandchildren. I think that’s about making the right investments, about investing in education, infrastructure and research. I also believe we build a stronger field when we have a level playing field, when small businesses can compete against big businesses, and everyone who works hard and plays by the rules has a fair shot at success. I’m looking for every opportunity I can find to advance those goals.

The budget sequester and dramatic cuts to domestic spending present serious threats to our nation's ability to support cutting-edge research, bring new innovative therapies to market, and ensure patients have access to the treatments they need. How do we get Washington to understand that such cuts can have serious and long-term consequences for our nation's health and economic vitality?

Research is our future. Research is the foundation for innovation and for economic growth. The breakthroughs of today – in science, technology, and engineering – lead to the success stories of tomorrow: discoveries that cure disease; innovations that reduce the cost of power; prosthetic limbs for wounded warriors. I’m deeply proud to go to Washington to represent Massachusetts because we are leading the world in the research that produces new products and new industries - and creates the demand for new jobs at every stage. We are showing how investments in basic research and infrastructure create jobs and grow our economy. We can reduce our deficit and balance our budget in a balanced, sensible way by closing corporate tax loopholes, cutting agricultural subsidies, and finding strategic savings in our defense budget. Instead, we threaten our own future with mindless, across-the-board budget cuts. I will continue to fight for our priorities, to fight for the investments that will help us build a future here in the Commonwealth and across the country.

We often hear about the contentious political climate in Washington these days, and many observers lament the difficulty our political leaders have in making progress on important national issues. In your first several months as our Senator, what have you seen that presents cause for hope – for the life sciences and biotech communities and, more generally, for the American people?

I went to Washington to try to get something done for the people of Massachusetts. While there is a

minority of the minority in the Senate focused on playing hostage politics and blocking legislation,

I believe there are opportunities to make real progress on important issues. During my first few months as Senator, I have cosponsored bipartisan legislation to jumpstart reform of Fannie Mae and Freddie Mac, met with Republican Senators who are interested in working together to end Too Big to Fail, and passed an amendment with Senator Lisa Murkowski (R-AK) to support critical disaster assistance for fisherman. It’s not as much bipartisanship as I want, but it’s a good start. Support for the life sciences and biotech communities – and particularly for scientific and medical research – is widespread. People all around this country understand that innovations and breakthroughs in these areas will improve the lives of families and promote economic growth. But make no mistake – these problems won’t be fixed in Washington alone. Change is possible in the Senate when change is demanded outside the Senate. People are tired of gridlock in Congress, and they want to see us working to create jobs and rebuild our economy. But it will take people staying engaged in the process to get things done. I am optimistic that on life sciences and biotech issues people can and will stay engaged – and that we can make progress in supporting breakthroughs hat improve people’s lives.

Contact Sen. Elizabeth Warren at 617-565-3170 or visit www.warren.senate.gov

Celebrating Life and the Patient

Tue, 28 May 2013 12:00:00 EDT

By Meaghan Casey

Diagnosed with Pompe disease as a young mother of three active children, Deb Beaudette was originally told she would never live long enough to meet her grandchildren. That was 20 years ago. Today, she has a granddaughter who is nearly 2 years old and is treasuring every moment she has.

“The disease doesn't define who you are or what you can or cannot do,” said Beaudette. “You define who you are. You are in control of your quality of life. You can choose to feel sorry for yourself and sit quietly in a corner, or can choose to use the help and options around you and get up and enjoy everything before you can't get up anymore.”

Affecting about one in every 40,000 people in the U.S., Pompe disease is a rare, inherited disorder that disables the heart and skeletal muscles. Beaudette began noticing symptoms such as fatigue and the inability to move her legs. She described the feeling as “having heavy weights on her feet.” As her symptoms progressed, her primary care doctor tested her muscle enzymes, which were in the 1,000s, when they should have been in the 60s. From there she was sent to UMass Memorial Medical Center in Worcester and began the nine-month process towards diagnosis.

. After finally identifying a specialist, through his recommended regimen of diet and metabolic exercise, she was able to maintain her mobility and care for her children.

“I told him death wasn’t an option for me,” said Beaudette. “He saved my life.”

In 2010, when Genzyme began its trial for a medication that replaces a missing or deficient enzyme in people with late-onset Pompe disease, Beaudette was eager to participate.

“I thought, why not be a guinea pig and give my life some meaning,” she said.

The clinical trial was a randomized double-blind study and Beaudette had a 50-percent of being a test subject. Fortunately for her, she received the drug, not the placebo. By the third month, she reports that she was climbing hills without needing to rest, her lung capacity improved tremendously and the feeling of weights in her feet was gone.

Because of Genzyme’s trial – of which total of 81 of 90 patients completed – Beaudette also discovered a network of other Pompe patients, who have made an effort to remain connected.

“Genzyme gave me a community,” said Beaudette, who continues to remain vocal as a patient rights advocate.

That sense of support has fueled Beaudette in her journey. She still maintains an active life, with the help of a walker, and credits the combination of water therapy and Genzyme’s enzyme replacement therapy, which she has continued.

“Don’t settle; don’t accept that you’re disabled,” she said. “If you want to learn something or do something, do it. You have to keep moving.”

Beaudette served as a panelist at the 2013 BIO International Convention. She joined multiple sclerosis patient Ron Banks and moderator Kathleen Coolidge, Associate Director, Patient Advocacy – Rare Diseases for Genzyme in the Massachusetts Pavilion for a welcome session entitled “Celebrate the Patient.”

Policy Update

Tue, 30 Apr 2013 12:00:00 EDT

In March, MassBio announced that that our Chairman of the Board of Directors, Geoff MacKay, was named to the Health Policy Commission (HPC) Advisory Council. In his new role, Geoff Mackay will be joined by representatives from across the health care field to help guide the Health Policy Commission’s implementation of the state’s health care cost containment law. The Council will advise the HPC’s overall operations and policies, provide feedback on a grant program to support new system delivery and payment reform methods, and encourage public and stakeholder engagement in the HPC’s work. We look forward to our Chairman’s new role as he continues to bring insight and an industry voice to the health care reform implementation process.

On March 12^th and 13^th, MassBio participated in BIO Fly-In in Washington D.C., where biotechnology executives from across the country met to take part in legislative briefings and advocacy. MassBio had a strong presence at the event, meeting with Members of Congress and their staff to discuss important legislative issues facing our industry. One highlight from BIO Fly-In was MassBio’s Spring Reception event, where members of the Massachusetts Congressional Delegation and staff met with biotech leaders from the Commonwealth to engage in an active discussion on the current state and future of our industry. The reception proved to be a successful event and we would like thank everyone who attended for participating in such an important opportunity for our industry.

The Massachusetts Biotech Caucus has also been very busy this year. To kick off the legislative session, Senator Karen Spilka and Representative Joseph Wagner, co-chairs of the Biotech Caucus, held a Caucus event at the State House on Influenza Vaccination and Public Health. In the wake of the influenza outbreak this past winter, the event provided a timely review of the current vaccination options and what will be available for the next flu season. Legislators and staff alike attended to hear the discussion about innovative public health vaccination initiatives and steps that can be taken to improve public health in the Commonwealth.

In March, AstraZeneca welcomed members of the Massachusetts Biotech Caucus to their R&D Facility at Gatehouse Park in Waltham which is their headquarters for global infectious disease research and oncology drug research. In April, the Biotech Caucus continued its tour of the AstraZeneca facilities when it visited the Westborough manufacturing facility, where a sterile preservative free suspension used to treat bronchial asthma is produced. Biotech Caucus events continue to be great learning opportunities for Legislators and their staff, and MassBio looks forward to future Caucus events to come.

Return of BioPharm America™ 2013 to Boston will draw leading international life science dealmakers to northeast

Thu, 18 Apr 2013 12:00:00 EDT

Washington, DC; Carlsbad, CA and Boston, MA – April 18, 2013: EBD Group, the leading partnering firm for the life science industry, in collaboration with the Massachusetts Biotechnology Council (MassBio) announced today that BioPharm America™ 2013 will again be held in Boston September 17–19 at the Westin Boston Waterfront in Boston, MA.

Senior executives from big pharma are set to attend, including AstraZeneca, Bayer HealthCare, EMD Serono, Janssen, Merck, Novo Nordisk, Shire, and more. Program topics cover trends in healthcare and drug development and other timely issues for industry insiders. Spotlight panels and roundtables will also feature industry leaders in discussions on innovative partnerships, emerging markets and global drug development strategies. The 2012 edition welcomed over 750 delegates representing 462 companies from 30 countries. Delegates in 2012 engaged in 1,846 one-to-one partnering meetings with 652 licensing opportunities.

“Boston is a biotechnology innovation hub. There are more than 500 companies focused on pharmaceutical and biotech drug discovery located in Massachusetts, from small start-ups to large established pharmaceuticals,” said Carola Schropp, President of EBD Group. “This creates an ideal environment for partnering, and is what draws the global biotech sector to BioPharm America.”

“At MassBio, our focus is to promote world class biotechnology in Massachusetts, and BioPharm America is the forum that enables regional biotech companies to identify and enter into strategic relationships at the global level,” said Robert Coughlin, President and CEO of MassBio. “The partnering at BioPharm America, and particularly the process of meeting face-to-face to discuss novel assets, is a definite advantage in the culmination of any deal.”

BioPharm America 2013 will again celebrate the announcement of the Fierce 15, selected for their pioneering technology and innovative business models, with John Carroll, Editor-in-Chief of FierceBiotech, featured on a panel with several Fierce 15 CEOs to discuss the industry outlook for the life sciences.

One-to-one networking at BioPharm America™ is powered by partneringONE^®, the leading conference networking solution for the life sciences.

MassBio members receive an additional USD 200 discount by adding the code ‘MassBio’ in the comments field of the online registration form.

Presenting companies should submit an application by June 28, 2013 at http://www.ebdgroup.com/bpa/presenters/index.php

# # #

About BioPharm America 2013

BioPharm America is where biotech industry partnerships get started. Meet face-to-face with biotech and pharma executives from around the world to identify and enter strategic relationships. Equipped with partneringONE®, BioPharm America is the only event in North America based on the same reputable formula as EBD Group’s acclaimed European events BIO-Europe® and BIO-Europe Spring®.

Additional links and information:

Follow BioPharm America 2013 on Twitter: twitter.com/ebdgroup (hashtag: #BPA13)

Notes to Editors:

Entry to BioPharm America 2013 is free to members of the press, including full access to the partnering system, sessions, press conferences, workshops, and pre-arranged partnering meetings. Visit the BioPharm America conference website at http://www.ebdgroup.com/bpa/registration/press_reg.php for press registration details. In addition, Business Wire, the official News Release Distribution and Online Press Kit service for BioPharm America™ 2013, is offering services to enhance your public relations efforts.

About MassBio

www.massbio.org

MassBio, a not-for-profit organization that represents and provides services and support for the Massachusetts biotechnology industry, is the nation's oldest biotechnology trade association. Founded in 1985, MassBio is committed to advancing the development of critical new science, technology and medicines that benefit people worldwide. Representing over 600 biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and health care, MassBio works to advance policy and promote education, while providing member programs and events, industry information, and services.

About EBD Group

EBD Group is the leading partnering firm for the global life science industry. Since 1993, biotech, pharma and medical device companies have leveraged EBD Group’s partnering conferences, technology and services to identify business opportunities and develop strategic relationships essential to their success.

EBD Group’s conferences are run with the support of leading corporations and international trade associations and include:

BIO-Europe® and BIO-Europe Spring®, Europe’s largest life science partnering conferences, supported by the Biotechnology Industry Organization (BIO)
BioPharm America™, the fastest growing partnering event in North America
Biotech Showcase™, a unique forum in San Francisco for presenting to investors and business development executives, co-produced with Demy-Colton Life Science Advisors
BioEquity Europe, the investor conference co-organized with BioCentury Publications and BIO
ChinaBio® Partnering Forum, the first dedicated biotech/pharma partnering conference in China, co-produced with ChinaBio® LLC
EuroMedtech™, EBD Group’s partnering event for the innovative medical technology industry
Partnering for Global Impact®, a new partnering conference providing an innovative forum to partner, identify and generate social and philanthropic investment and funding opportunities

EBD Group’s sophisticated web-based partnering service, partneringONE®, is also used as the partnering engine at numerous third-party events around the world, and partnering360® is the open online community of life science dealmakers that enhances partnering experiences all year long.

Outside of the conference format, EBD Group’s consultants provide hands-on assistance for firms seeking to in- or out-license products and technologies.

EBD Group has offices in the USA and Europe.

For more information please visit www.ebdgroup.com.

# # #

Adrian Haber and Rahi Punjabi Selected as Massachusetts BioGENEius Delegates

Wed, 10 Apr 2013 12:00:00 EDT

Delegates Headed to Chicago for Prestigious Science Competition

April 10, 2013 (Cambridge, MA) — Adrian Haber of Boston Latin School and Rahi Punjabi of Advanced Math and Science Academy Charter School in Marlborough have been selected to represent Massachusetts at an international science fair competition in Chicago this month.

Haber, of Boston and Punjabi, of Northborough, will compete against students from across the country in the U.S. National BioGENEius Challenge at the BIO International Convention in Chicago on April 20, 2013.

“By highlighting the amazing research of these students, at such a young age, the BioGENEius Challenge promotes scientific excellence and curiosity. With more than 430 students competing in the Challenge each year, we hope to encourage these students – as well as others – to consider pursuing a career in biotechnology, said Tom Wiggans, Chairman of The Biotechnology Institute, which organizes the challenge.

The young scientists earned their spots through a competitive process based on cutting-edge research they prepared for the Massachusetts State Science & Engineering Fair (MSSEF), which will take place from May 2-4 at the Massachusetts Institute of Technology.

Tenth grader Haber's biochemistry-based project is titled “Testing the Effectiveness of Liposomal Nanoparticle Delivery of Oxybutynin to Reduce Bladder Spasms.” Through a novel method of using isolated pig bladders, the project tests the effectiveness of using liposomal nanoparticles to direct the delivery of medications for the treatment of overactive bladder and reduce side effects. With more than 39 million adults in the U.S. suffering from overactive bladder, Haber's project addresses a significant problem. He concluded that when oxybutynin is contained in liposomal nanoparticles it can diffuse into bladder tissue to reduce bladder spasms.

Punjabi is a BioGENEius Challenge veteran, having represented Massachusetts in the 2012 Challenge with a project exploring the antibiotic potential of garlic. This year, the eleventh grader entered another biology-based project called "Engineering a Novel Fusion Protein Therapy for Meningococcal Infection." The study looks at Neisseria meningitidis, a major and deadly cause of meningitis and sepsis worldwide. Punjabi concluded that fusion proteins show potential as a therapy for meningococcal infection.

As BioGENEius delegates, Haber and Punjabi will attend the 2013 BIO International Convention in Chicago (April 22-25), and participate in the national BioGENEius Challenge on April 20th. Based on their placement in the national competition, each delegate -- or both -- could advance to the international competition held on the following day. This is an all-expense-paid trip for the delegates and their chaperones.

The BioGENEius Challenges are national and international competitions for high school students that recognize excellence in original research in biotechnology. The Challenges, organized by the Biotechnology Institute, are prestigious science competitions with significant cash prizes awarded to the winners.

Selected winners of BioGENEius Challenges compete and present their research posters and oral presentations in front of a panel of biotech judges. The students are evaluated on their scientific merit and creative ability, project execution, and poster/oral presentation.

MassBioEd, a local partner of the BioGENEius Challenge, worked alongside MSSEF to recruit students as participants in the BioGENEius competition. MassBioEd was active in recruiting judges for both the National and International BioGENEius Challenges as well as coordinating with the MSSEF winners in preparation for the BIO International Convention.

“The BioGENEius Challenge is the premier competition for high school students inspired to excel in the field of biotechnology,” said Lance Hartford, Executive Director of the MassBioEd Foundation. “We are proud of the two Massachusetts students that will represent the state in the upcoming U.S. BioGENEius challenge and wish them the best as they compete and present their exciting research.”

MassBioEd Launches New Website MassBioEd.org

Wed, 20 Mar 2013 12:00:00 EDT

Comprehensive, dynamic site is new go-to resource for STEM stakeholders

March 20, 2013 (CAMBRIDGE, MA) - The Massachusetts Biotechnology Education Foundation (MassBioEd), a leader in STEM and biotechnology education, launched its new website on March 20, 2013. The site, www.massbioed.org, is designed to be the go-to resource for Massachusetts educators, students, postdocs, and life sciences industry professionals.

MassBioEd Foundation, which was established in 2001 by the Massachusetts Biotechnology Council (MassBio), is a nonprofit organization committed to supporting STEM through roots in biotech. MassBioEd supports biotechnology education through school programs, workforce training, and lifelong learning.

“MassBioEd is a proud leader in STEM education, but over time we realized our website could no longer serve the diverse and ever-evolving needs of the STEM community” said Lance Hartford, Executive Director of the Foundation. “We are pleased to unveil our new site which provides top-notch STEM and biotech resources and complements our programming and events.”

MassBioEd.org offers a comprehensive, user-friendly experience for a variety of audiences. From providing biotech career descriptions for students, to curricula materials for STEM educators, career resources for post-docs, and courses for industry professionals - the new and improved website is designed to cater to all individuals involved in STEM education and the biotech industry.

Alongside the new website, MassBioEd has launched a strong presence on social media. The nonprofit’s Twitter and Facebook pages serve as resources for STEM education stakeholders across the country.

MassBioEd invites the public to explore the new website and encourages STEM stakeholders to “Like” MassBioEd on Facebook and “Follow” @MassBioEd on Twitter.

MassBioEd partnered with Newburyport-based web development company iMarc on the website upgrade project.

About the MassBioEd Foundation

http://www.massbioed.org

The Massachusetts Biotechnology Education Foundation (MassBioEd), founded in 2001, is a nonprofit charitable organization committed to supporting science and biotechnology education in Massachusetts through school programs, workforce training, and lifelong learning. Serving as a link between education, industry, and government MassBioEd is working to ensure Massachusetts’ largest sector of the economy, biotechnology, has an appropriately trained work force to meet the growing employment needs. MassBioEd’s BioTeach program, which trains teachers in biotechnology curriculum and provides grants for lab equipment, has reached 185 schools across the Commonwealth. In addition, MassBioEd’s Biotech Learning Center offers professional development courses for employees in the biotech sector to advance their professional skills.

MassBio Welcomes 3 New Board Members: Olson, Pomponio & Roychowdhury to Join Board

Mon, 18 Mar 2013 12:00:00 EDT

CAMBRIDGE, MA (March 15, 2013) – MassBio members today elected three new life sciences executives to the organization’s Board of Directors at the 2013 MassBio Annual Meeting.

Joining the board this year are Lisa Olson, Divisional Vice President of Immunology Research & ABC Site Head at AbbVie, Alice Lin Pomponio, Leader of Americas Science Relations at AstraZeneca, and Debasish Roychowdhury, Head of Oncology at Sanofi.

“As an organization that aims to reflect the depth and breadth of our membership, we are thrilled to add three such prestigious names to our Board of Directors,” said MassBio President & CEO Robert K. Coughlin. “Lisa represents the new iteration of a long-time industry powerhouse, Alice brings a pure-play global biopharma R&D perspective, and Debasish represents one of our newest global players making a home in Massachusetts. We thank them all for their commitment to the industry here.”

Also joining the board is Renee Connolly, Vice President of US Communications for EMD Serono, who fills a seat on the board reserved for the Chair of the Board of the MassBioEd Foundation.

The 2013-2014 members of the MassBio Executive Committee are:

Chair Geoff MacKay, Organogenesis Inc.

Vice Chair Glenn Batchelder, Civitas Therapeutics

Treasurer Michael O'Hara, Deloitte

Clerk Abbie Celniker, Eleven Biotherapeutics

Past Chair Geoffrey Cox, Red Sky Partners

Counsel Lawrence Wittenberg, Goodwin Proctor

The 2013-2014 members of the MassBio Board of Directors are:

Caren Arnstein, Genzyme

Mark Bamforth, Gallus Biopharmaceuticals

Margaret Chu-Moyer, Amgen

Jeffrey Elton, Accenture

Scott Gillis, Onsite Therapeutics

Steven Gilman, Cubist Pharmaceuticals

Jose Carlos Gutierrez-Ramos, Pfizer

James Hoyes, EMD Serono

Edwin Kania, Flagship Ventures

Laurie Bartlett Keating, Millennium: The Takeda Oncology Company

Mark Leuchtenberger

David Lucchino, Semprus BioSciences

Lisa Olson, AbbVie

Deanna Petersen, Shire Pharmaceuticals

Alice Lin Pomponio, AstraZeneca

Steven Richter, Microtest Laboratories

Debasish Roychowdhury, Sanofi Oncology

Amit Sachdev, Vertex Pharmaceuticals

Frank Thomas, AMAG Pharmaceuticals

Kathleen Tregoning, Biogen Idec

Charles Wilson, Novartis

Lawrence Wittenberg, Goodwin Procter

Bill McDermott, McDermott, Quilty & Miller

Robert Gottlieb, RMG Associates

FDA Commissioner, Industry Leaders Gather to Discuss Most Pressing Life Sciences Issues

Fri, 15 Mar 2013 12:00:00 EDT

MassBio Annual Meeting Convenes Industry Stakeholders

March 15, 2013 (CAMBRIDGE, MA) — Nearly 400 biotechnology industry leaders gathered this week at the Royal Sonesta Hotel in Cambridge, right in the heart of the state’s biotech cluster, to participate in MassBio’s 2013 Annual Meeting.

The meeting took place across two days, and included discussions on healthcare reimbursement, what’s next in oncology research, the future of biosimilars and research resources sharing.

“These conversations go to the very heart of what we do and how we as an industry will operate into the future,” said Robert K. Coughlin. “We must understand our role in a shifting economic and regulatory environment and attempt to answer these big, complicated questions. Our only way forward is to address them together.”

The event’s keynote speakers included FDA Commissioner Margaret Hamburg and John Crowley, Chairman & CEO of Amicus Therapeutics. Commissioner Hamburg spoke on Friday and addressed industry concerns on time to approval, the threat of sequestration and other budget cuts, and recent successes in industry-FDA collaboration.

“I am committed to working with all of you—and many others—on the broad-based national strategy to advance biomedical product innovation that I believe is so very much needed at this critical time,” Hamburg said. “I think I can say that at FDA we are striving to do our part. Success will require regulatory flexibility, advancing regulatory science, and true collaboration among health professionals, industry, government, academia, and our global health partners.”

She shared examples of Massachusetts companies who had successfully navigated FDA approval pathways, and discussed the possibility of a new pathway in the future—one utilized for for “special limited use,” in cases where a population of patients may require additional methods of treatments than others in with the same disease or diagnosis.

“Such an approach – which would require working with Congress for the creation of a new drug approval pathway -- could permit a more appropriate risk-benefit evaluation for conditions such as serious, drug resistant infections or a chronic disease problem like obesity, where there is a significant range of patients and associated risks,” Hamburg said. “We are exploring this new pathway because we think it could enable potentially lifesaving medicines to be made available to patients in a more timely way.”

The full text of Commissioner Hamburg’s speech is online at http://www.fda.gov/NewsEvents/Speeches/ucm343949.htm.

Crowley delivered his address on Thursday where he shared his experiences as a biotech executive, father, and patient advocate.

"We didn’t pick to be here because ‘boy you can make a lot of money in this industry '. I’ve never seen a biotech plan where the vision was - last slide- we’re all gonna get rich. That’s not what we do. Most of us don’t because it’s just so hard in this business to make money. In some respects it may just be the hardest business there is. It’s a tall order to succeed, but to …[those]… in this world who have succeeded so very well, it is a remarkable example of why this is such a unique industry and the impact it can have on people’s lives.”

Josef von Rickenbach, Founder, CEO and Chairman, PAREXEL International received the Henri A. Termeer Innovative Leadership Award for his commitment and contributions to the biotechnology industry at the Awards Luncheon on Friday.

For inspiring students to explore life sciences careers through progressive biotechnology education and exemplary science career programming, Gloucester was chosen as the Joshua Boger Innovative School of the Year.

To recognize its commitment to growing the life sciences supercluster in Massachusetts, Massachusetts Biomedical Initiatives (MBI) of Worcester was honored with MassBio's Leading Impact Award.

18 companies and organizations sponsored the Annual Meeting including AT&T, Fisher Scientific, Pfizer and Sanofi.

Gloucester High School Named MassBioEd Innovative School of the Year

Tue, 12 Mar 2013 12:00:00 EDT

March 11, 2013 (CAMBRIDGE, MA) – Gloucester High School (GHS) has been named this year’s Joshua Boger Innovative School of the Year by the Massachusetts Biotechnology Education Foundation (MassBioEd) for inspiring students to explore life sciences careers through progressive biotechnology education and exemplary science career programming.

In 2009, GHS was selected as a BioTeach school. Over the past four years students and faculty have actively participated in both teacher professional development and biotechnology lab experiences. Gloucester has successfully utilized their BioTeach grant to create innovative programs and partnerships to ensure that students of all levels and academic achievement have the chance to experience biotechnology labs.

“Gloucester High School has done a remarkable job fostering STEM education and encouraging students to pursue careers in biotechnology as they look toward their futures,” said Lance Hartford, Executive Director of MassBioEd. “The judging panel was particularly impressed with the school’s commitment to building new partnerships to develop science outreach programs and their innovative use of BioTeach labs to give all students the opportunity to explore the world of biotechnology.”

GHS has also creatively adapted BioTeach labs and equipment to establish new biotech summer camp programs for high school students.

"This recognition is an important step forward for Gloucester High School, as we work towards our goal of becoming a leader in STEM related high school education,” said Principal Erik Anderson. “Thank you to MassBioEd for making the Innovative School of the Year Award available. All the credit for this honor goes to Mr. Eric Leigh, whose hard-work and selfless dedication to Gloucester High School students makes a difference every day. Way to go, Mr. Leigh and way to go Gloucester High School!"

“Gloucester High School is so excited to be named the Innovative School of the Year,” said Rachel Rex, Supervising Program Leader, Gloucester High School Science Department. “This is a wonderful opportunity for our students. The resources provided by MassBioEd continue to enable Gloucester High School students to see a real world connection between the classroom and industry. Who knows, an opportunity such as this could cultivate the next great Nobel Laureate.”

The award will be given at a luncheon ceremony at MassBio’s Annual Meeting on Friday, March 15th at the Royal Sonesta Hotel, 40 Edwin Land Blvd, Cambridge, MA. GHS will be represented by science teacher Eric Leigh and 10th grade students Morey Ronan and Jason Erwin.

The Joshua Boger Innovative School of the Year Award was established by the MassBioEd Foundation to honor a Massachusetts school that has distinguished itself through exemplary progressive biotechnology educational programming.

Gloucester High School is well-deserving of the prestigious award for its year round dedication to ensuring all of its students have the opportunity to explore the life sciences. The award will help the program continue to encourage students to pursue an education in STEM and biotechnology through the growth of partnerships and program expansion.

Worcester’s Massachusetts Biomedical Initiatives (MBI) to Receive MassBio’s Leading Impact Award

Tue, 12 Mar 2013 12:00:00 EDT

Honor recognizes commitment to strengthening the MA life sciences supercluster

March 12, 2013 (CAMBRIDGE, MA) – Massachusetts Biomedical Initiatives (MBI) will be honored for its significant contribution and commitment to improving the competitiveness of Massachusetts as a destination for the life sciences industry with the MassBio Leading Impact Award, the trade association announced today.

MBI President & CEO Kevin O’Sullivan will accept the award during MassBio’s Annual Meeting on Thursday, March 14^th at the Royal Sonesta Hotel, 40 Edwin Land Blvd, Cambridge, MA.

The Leading Impact Award was developed by MassBio’s Economic Development Advisory Group (EDAG) to annually recognize significant contributions made by innovative organizations within the industry, and in the arena of property development and local, regional, and state economic development, that have successfully worked to improve the ecosystem for industry growth in Massachusetts.

“MBI has fostered entrepreneurship and life sciences startups in MA for almost three decades, helping dozens of companies to become established and to grow,” said Mark R. Bamforth, EDAG Chairman and President & CEO of Gallus Pharmaceuticals. “It took foresight and courage to create a biotech hub in Worcester which complements the growth of the industry in Cambridge and around the Commonwealth. Kevin O’Sullivan has been a stalwart advocate for strong regional growth.”

Massachusetts Biomedical Initiatives (MBI) in Worcester, is a private, independent economic development organization dedicated to job creation and innovative healthcare throughout Massachusetts by promoting the growth of start-up biomedical companies. MBI operates three life science business incubator facilities in Worcester that are home to twenty companies with approximately 100 employees. Through its incubator facilities, MBI lowers barriers to success for emerging companies by providing cost-effective, high quality laboratory space and support services.

“The Leading Edge Award is a great tribute to our entrepreneurial MBI tenant companies - past and present, who commercialize their science by way of creating innovative companies and jobs while in turn helping to grow our Massachusetts economy,” said Kevin O’Sullivan, President & CEO of MBI. “We are grateful to MassBio for this recognition and look forward to continuing to work with them in fulfilling our economic mission.”

MBI was nominated for the award by the team at the City of Worcester.

“MBI was and remains instrumental in establishing Worcester as a premier biotechnology center,” said Timothy J. McGourthy, Chief Development Officer of the City of Worcester. “Under Kevin O’Sullivan’s leadership MBI has become a center for collaboration and innovation. MBI’s promotion of new start-ups, institutional partnerships, and tireless advocacy is transforming the future of healthcare worldwide as well as stimulating job growth in Worcester and throughout the Commonwealth.”

MBI is the second organization to receive this award. Last year’s winner was Pfizer's Center for Therapeutic Innovation (CTI) in Boston, MA.

PAREXEL CEO Josef von Rickenbach to Receive MassBio’s Henri Termeer Innovative Leadership Award

Thu, 07 Mar 2013 12:00:00 EST

Commitment to innovation, growth, and leadership in Massachusetts

March 7, 2013 (CAMBRIDGE, MA) – Josef von Rickenbach, Chairman and CEO of PAREXEL International Corporation (NASDAQ: PRXL), will be honored for his commitment and contributions to the biotechnology industry, the Massachusetts Biotechnology Council (MassBio) announced today.

Von Rickenbach co-founded PAREXEL as a regulatory consulting company in 1982 and soon grew the organization into a pioneer in clinical research outsourcing. To make clinical development more effective for clients, he conceived a multidisciplinary and systems-oriented approach to outsourced clinical development, bringing efficiencies, scalability, and standardization to the process. Thirty years later, PAREXEL is a $1.4 billion global company and one of the top biopharmaceutical service organizations in the world.

The company has forged long-standing strategic partnerships with the world’s largest biopharma companies as well as the next generation of industry innovators. For example, the PAREXEL® BioPharm Unit focuses solely on the unique needs of small and mid-sized companies and helps them achieve their development goals.

Today, PAREXEL employs nearly 14,000 people in 73 offices across 51 countries. The company employs 2,000 people across three Massachusetts locations, including its international headquarters in Waltham.

Under von Rickenbach’s leadership, the PAREXEL® Academy is committed to developing the future biopharmaceutical workforce with courses specifically tailored to meeting the growing talent needs of the clinical development job market. That commitment is evident in programs like PAREXEL’s new partnership with Salem State University to offer a Post Graduate Certificate Program in Clinical Trial Management.

Earlier this year, von Rickenbach was elected Chairman of the Association of Clinical Research Organizations (ACRO). He also serves on the Board of Directors of New England Healthcare Institute.

“Josef von Rickenbach has been an innovator since the moment he founded his company, shaping an industry that has become a vital piece of the drug development process,” said MassBio President & CEO Robert K. Coughlin. “We are thrilled to honor his commitment to the industry, to Massachusetts and to the next generation of life sciences workers.”

The award will be presented at MassBio’s Annual Meeting on Friday, March 15^th at the Royal Sonesta Hotel, 40 Edwin Land Blvd, Cambridge, MA.

The award recognizes an industry executive who has a strong presence and commitment to growth in Massachusetts, actively supports community-based organizations, contributes to science education to prepare the future workforce, and creates a positive work environment that fosters motivation and collaboration. It is named for longtime President and CEO of Genyzme, Henri Termeer.

“I am truly honored to be recognized by MassBio for this award,” said von Rickenbach. “I am proud of PAREXEL’s achievements, including the continued commitment of our employees worldwide to deliver on our goal to be a premier partner to the biopharmaceutical industry. We have maintained a clear focus on our mission to combine the strength of our expertise, experience and innovation to bring new medical treatments to market faster.”

Von Rickenbach is the fifth person to receive this award. Past recipients include former EMD Serono President & CEO Fereydoun Firouz, Cubist Pharmaceuticals President & CEO Michael Bonney, Millennium: The Takeda Oncology Company President & CEO Deborah Dunsire, and Vertex CEO Joshua Boger.

About PAREXEL

PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 73 locations throughout 51 countries around the world, and has approximately 14,000 employees. For more information about PAREXEL International visit www.PAREXEL.com.

About MassBio

www.massbio.org

New Online Tool Showcases Growing MA Contract Research & Contract Manufacturing Cluster

Mon, 25 Feb 2013 12:00:00 EST

February 25, 2013 (CAMBRIDGE, MA) -This morning, MassBio launched a new online portal to showcase the breadth and depth of contract research and contract manufacturing in Massachusetts. The MA CRO CMO Gateway is part of an initiative to market the complete continuum of services – from discovery through commercialization—available in Massachusetts.

A 2011 analysis by Tufts Center for the Study of Drug Development (Tufts CSDD) found a nearly four-fold increase in the number of contract research organizations (CROs) in the U.S. alone during the past decade. The market for contract services in the Greater Boston area alone has reached between $3.6 billion and $4.3 billion. There are 126 companies in Massachusetts providing contract non-clinical research, and 68 offering clinical research. Another 111 companies are providing CMC services for clients around the world.

The Gateway is powered by OnDeckBiotech, an online exchange for outsourced therapeutic R&D services. The OnDeckBiotech platform makes outsourcing faster, more secure, and more reliable. OnDeckBiotech was a 2012 MassChallenge winner.

The Gateway debuted in the opening session of MassBio’s second annual MA CRO CMO Symposium, a day of discussion on the role contract partnerships are playing in accelerating drug development. Visit the gateway here: http://www.massbio.org/economic_development/the_ma_cro_cmo_cluster

Not in it Alone: Diabetes Network Founder Finds His Voice

Wed, 20 Feb 2013 12:00:00 EST

A nonprofit leader, recognized social media author and passionate diabetes advocate, has lived with Latent Autoimmune Diabetes in Adults (LADA) since 2002.

Sometimes referred to as type 1.5 diabetes, LADA can be classified as a more slowly progressing variation of type 1 diabetes, yet it is often misdiagnosed as type 2.Hernandez was one of those patients incorrectly diagnosed with type 2 and sent home with a treatment of Metformin, diet and exercise. When that treatment proved to be unsuccessful, he was referred to an endocrinologist, tested positive for Glutamic acid decarboxylase (GAD) antibodies – a marker of type 1 – and put on an insulin treatment. He was formally diagnosed with LADA in 2007.

“When you are first diagnosed with diabetes, the amount of information you have to learn is overwhelming,” said Hernandez. “And in the educational materials that people with diabetes typically get presented with, the voice of the patient is frequently missing. When you incorporate the perspective of the patient, the realities of life with diabetes are uncovered.”

To provide others with that personal perspective, Hernandez began blogging about his experience shortly after his diagnosis. In 2007, he founded the social network TuDiabetes.org, and its Spanish sister site EsTuDiabetes.org. The network has more than 26,000 members.

“Nobody with diabetes should ever feel alone,” Hernandez said. “With the proliferation of online communities, you can connect with someone in India, the Philippines or just the other side of town. This facilitates a more open dialogue and a richer exchange, which empowers us and generates a positive impact within ourselves and the community.”

In 2008, Hernandez and his wife, Andreina Davila, cofounded the Diabetes Hands Foundation to further connect, engage and empower people touched by diabetes. He served as the foundation’s chairman between 2008 and 2012, developing the board from five members to 14 and supporting the organization’s growth to nearly $500,000 in annual revenue. As president of the foundation, he is responsible for program strategy, fundraising and partnership development. In addition, he has published books and is a frequent speaker at conferences on the topic of the intersection of social media and health.

Nationally, Novo Nordisk, the world’s leading diabetes care company, has announced a new partnership with the Diabetes Hands Foundation, to ask, “Do You Know Diabetes?” The cornerstone of the partnership is an interactive quiz to test consumers’ knowledge of diabetes facts, risk factors and statistics, and provide valuable education about the disease. You can learn more about diabetes by taking the “Do You Know Diabetes?” quiz today. Visit www.DoYouKnowDiabetes.com or join the conversation on Twitter using the hashtag #DiabetesFYI.

“Living with a chronic condition can make it difficult to relate to other people or allow others to relate to you because your condition doesn’t go away,” said Hernandez. “The ability for people to connect with each other, even at a very basic level, helps them get support.”

Born in Venezuela, Hernandez now lives in Palo Alto, Calif. with his wife and son. He earned his master’s degree from Cornell University and has more than 15 years of experience in team and project management.

Four Entrepreneurs Chosen to Catalyze & Commercialize Innovation

Tue, 19 Feb 2013 12:00:00 EST

MassCONNECT mentor program pairs new entrepreneurs with seasoned pros to advance ideas

February 19, 2013 (CAMBRIDGE, MA) —Entrepreneurs developing therapies using immune cells to kill cancer, software for cheaper and easier DNA sequencing, technology to provide personalized dosing in clinical trials and products to revolutionize treatment for atrial fibrillation have been chosen to learn from life sciences pros in the latest round of MassCONNECT.

These four ideas were chosen for inclusion in MassCONNECT, MassBio’s entrepreneur mentorship program, which kicked off its first cycle of 2013 today with a Technology Showcase. These entrepreneurs—chosen for their innovative technologies, products, or services—are paired with seasoned life sciences professionals for evaluation and advice as they work toward developing business plans, launching companies, and raising capital.

“MassCONNECT energizes the life sciences ecosystem and advances innovation by connecting inventors and entrepreneurs with the resources needed for success,” said John Hallinan, Chief Business Officer at MassBio.

The applicants chosen for the latest round of mentorship are:

Pattern Genomics, LLC - Daniel Fasulo, Ph.D.

Pattern Genomics has developed a novel software platform called Daydreamer that enables simultaneous pattern analysis and molecular assay design based on large-scale DNA sequencing data. The software forms the core of a robust, reproducible, and broadly-applicable process to assay design that is largely automated and far faster than traditional approaches, and hence much less expensive.

Boston 3T Biotechnologies - Meijia Yang, Ph.D.

Woburn, MA

Boston 3T Biotechnologies is developing genetically engineered T-cells as therapeutic for treating lymphomas and solid tumors. The therapeutic mechanism is based on the mobilization of the patient’s own immune cells, which will lead to the killing of the cancer cells. In addition, this technology trains the patient’s immune system to memorize this acquired ability in order to fight against the recurring cancer cells, resulting in a durable and effective control of the cancer.

LuminaCare Solutions - David Howe Ph.D.

LuminaCare Solutions is a Healthcare IT Company focused on patient data for optimization of clinical trials. LuminaCare’s lead technology is a platform that integrates patient characteristics, clinical data, and testing algorithms to provide personalized dosing for patients to maintain efficacy while reducing side effects. By repurposing technology that is currently being used to determine efficacious doses for the overall population from clinical trials, LuminaCare Solutions is able to determine an optimal does for a patient using a simple, minimally invasive test.

AblaCor Medical Corporation - Martin Sklar, M.S.

AblaCor Medical Corporation (www.ablacor.com) is a medical device company that is developing a revolutionary ablation product called the CircumBlator™ PVI Ablation System for the treatment of patients with atrial fibrillation (AFib). The CircumBlator’s comprehensive solution will provide safer, shorter, easier-to-perform, and more effective catheter ablation procedures. Unique from ablation devices on the market or in development, the CircumBlator technology will afford enhanced tissue contact and feedback. AblaCor believes the significant value the CircumBlator will bring to patients and physicians will be a mainstream, first-line treatment for AFib.

Each of these entrepreneurs is working with a team of mentors and an MBA student with expertise that fits their needs. The mentors and entrepreneurs will meet several times over the next two months to collaborate on a business plan for the proposed new technology or platform. The program culminates with entrepreneurs making their first pitch to a small group of venture capitalists and other possible investors. To date, approximately 12% of MassCONNECT graduates have received funding following their graduation from the program.

MassCONNECT is open to opportunities that involve the development of a new technologies, products, services, applications, or processes in the life sciences area. Typically, these will include new diagnostic tests, pre-clinical therapeutic molecules, platform technologies, and/or instrumentation.

For more information, or to apply to be a mentor, mentee, or MBA intern, visit http://www.massbio.org/innovation/massconnect.

2013 MassBio Annual Meeting Addresses the Business of Science

Tue, 19 Feb 2013 12:00:00 EST

The 2013 MassBio AnnualMeeting will be held March 14-15 atthe Royal Sonesta. Themed “The Business of Science,” the event will focus on the most timely and critical challenges facing the Massachusetts biotechnology industry today.

FDA Commissioner Margaret Hamburg will deliver the keynote address. A graduate of Harvard Medical School, Hamburg became the 21st commissioner of food and drugs in 2009. She is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health.

Through a series of presentations, panel discussions, interactive working sessions and extensive networking opportunities, the goals of the annual meeting are to discuss and debate the most relevant science and business topics driving industry’s innovation challenges; promote collaboration with industry scientists, CSOs and other life sciences leaders to enhance scientific and business understanding, augment deal flow and connections; forge new scientific and business relationships; and build the network of up-and-coming academic scientists.

Conference-wide panels will focus on overcoming barriers in translational drug development and the challenges and opportunities in research resource-sharing. Breakout session topics in the science track will focus on oncology, personalized medicine and companion diagnostics, neurodegenerative diseases, RNA therapeutics and antibody drug conjugates. The business track will include sessions on healthcare reimbursement strategies, rare disease therapies, antibiotics from a business perspective and the future of biosimilars.

Throughout the meeting and during the reception, posters will be on display to present data on groundbreaking discoveries, or on translational research that could lead to industry collaboration. MassBio Dollars will be distributed to attendees who can “invest” in the best science they see. The deadline to apply for poster presentations is February 14.

Sponsorship opportunities arealso available. Contact Elizabeth Steele at 617-674-5100 or
Elizabeth.Steele@massbio.org for more information.

2nd Annual MA CRO/CMO Symposium

Tue, 19 Feb 2013 12:00:00 EST

The second annual MA CRO/CMO Symposium, taking place Monday, Feb. 25 at the Boston Marriott in Newton, will shine a spotlight on the strength and success of the CRO and CMO communities in the Commonwealth.

The goal of the symposium is to bring together the biophamaceutical industry and the Massachusetts CRO/CMO cluster – which provides the scientific external resources required to support a virtual and semi-virtual company from conception through commercialization – and showcase the roles these types of partnerships are playing in accelerating drug development.

The event will allow attendees to evaluate the best alternatives that have evolved in shortening time to market. A series of case studies, interactive panel discussions and networking sessions will provide ample time to explore the various techniques and approaches being used by both virtual and established companies.

Keynote speakers will be Jose-Maria Fernandez, a researcher at the MIT Sloan Laboratory for Financial Engineering, and Janice Bourque, the managing director of Life Sciences at Hercules Technology Growth Capital – a specialty finance company providing secured loans and equity financing solutions to venture capital and private equity firms, and small-cap public life science companies at all stages of development. The company has committed $2.9 billion to more than 200 life science, technology and clean tech companies.

Bourque has more than 25 years of life science experience and focuses on emerging growth-stage life science companies. Before joining Hercules in 2010, Bourque provided strategic corporate investor fundraising for Commons Capital and Oxford Bioscience Partners to create a global health fund focused on innovative healthcare investments for emerging and developing countries. She also was senior vice president and group head-life sciences for Comerica Bank for four years and served as MassBio’s president & CEO for 12 years. She has been named one of Boston Magazine’s 100 most influential women and Newton Living’s 10 most influential women. She also serves as Emeritus Director of the MIT Koch Institute for Integrative Cancer Research.

Fernandez’s recent work has focused on the creation of new models to finance scientific research. More specifically, along with Professor Andrew Lo and Dr. Roger Stein, he has applied the principles of structured finance and portfolio theory to design a new type of biomedical investment vehicle
that issues research based obligations to finance the development of new cures for cancer. Prior to his work at MIT, he worked in debt capital markets for more than 10 years.

An exhibition area will connect attendees with companies that offer services from research to commercial manufacturing. The event will conclude with a networking reception.

For more information, contact Elizabeth Steele at 617-674-5100 or elizabeth.steele@massbio.org.

Focus on Biosimilars: 2013 Policy Leadership Breakfast Recap

Tue, 19 Feb 2013 12:00:00 EST

The introduction of biosimilars into clinical practice has become an increasingly hot topic, presenting new challenges that have not historically been present with small molecule generic medicines. In a lively panel discussion at MassBio’s 2013 Policy Leadership Breakfast, industry experts examined the role of biosimilars and the necessity for implementing sound public policies to ensure their safe and effective use.

Panelists included Dr. David Charles, Chairman of the Alliance for Patient Access and Chief Medical Officer at Vanderbilt University Clinical Neurosciences Institute; Professor William S. Hancock, Bradstreet Chair in Bioanalytical Chemistry, Barnett Institute of Chemical and Biological Analysis at Northeastern University; Fritz Bittenbender, BIO Vice President of Alliance Development/State Government Affairs; and Susan Nesci, Patient Advocate and Vice President of Public Policy & Advocacy of the Arthritis Foundation.

“It’s one of the hardest conversations as a health educator,” said Nesci. “Right now there’s no one-size-fitsall model. It’s trial-and-error with each patient. In a study last year, most patients stay on biologics for two years. We don’t want cheaper products that carry health risks. We want to see clear differences in the names of the products and patient providers should be notified if there is any change.”

Under the Biologics Price Competition and Innovation Act, a biological product may be demonstrated to be biosimilar if data show that, among other things, the product is highly similar to an already-approved biological product.

“As a dad, the idea of taking a generic drug – a pill – is one thing, but to inject a biologic is another,” said MassBio President & CEO Robert K. Coughlin, who moderated the panel. “Is it safe? And if there is a switch, it should be guaranteed that the physician is involved and the patient is involved, and that there’s some oversight and accountability.”

Bittenbender expounded on the fact that for biologics, the product is the process. Manufactured using living organisms, biologics are different and far more complex than most small molecule chemical drugs. Because the finished product cannot be fully characterized in the laboratory, manufacturers must ensure product consistency, quality and purity by making certain that the manufacturing process remains substantially the same over time. By contrast, a drug manufacturer can change the manufacturing process extensively and analyze the finished product to establish that it is the same as before the manufacturing change.

“The products are safe, but you want to know exactly what is being administered because a biosimilar may react differently in a person’s body,” said Bittenbender.

Because it is up to individual states to craft public policy around the approval of biosimilars, BIO has taken an active role in communicating with state lawmakers, making sure they are responsibly informed about the need to protect patient safety and preserve incentives to innovate.

“We’ve worked hard to develop principals for state policy discussions, focusing on access in the marketplace and patient safety,” said Bittenbender. “Patients need to be notified when they’re receiving a different product, and physicians need to be notified if a patient is receiving something other than what they prescribed. There also needs to be an increased standard for record-keeping at pharmacies.”

His fellow panelists agreed, and some called for even more accountability.

“Just receiving a notification is not acceptable” said Charles. “It should be a request – one that still engages the provider and patient in the decision process.”

While the debate regarding biosimilars will certainly carry on, one thing is certain – the availability of the products will continue to grow, affecting the treatment path of those with serious and life-threatening illnesses, such as cancer, multiple sclerosis, diabetes and HIV/AIDS, as well as many rare diseases.

“Thirty years ago, the first biologic came on the market, and today, they’re here to stay,” said Bittenbender. “Companies are absolutely going to make biosimilars, so this conversation is only going to take on more importance.”

The Policy Leadership Breakfast has become a must-attend annual event for policy makers, biotechnology, life sciences, healthcare and business leaders, and other key stakeholders. This year’s event was held on Jan. 23 at the Langham Hotel and attracted 220 attendees.

“As we enter a new legislative session, we are in the midst of some very, very significant changes,” said MassBio Board Chairman Geoff MacKay, who is President and CEO of Organogenesis Inc. “We are working with a federal government facing tremendous budget restraints, but committed to making healthcare accessible to all. This industry needs to have a voice among the new councils and committees forming and I implore you to join the conversation.”

To kick off the breakfast, MacKay was joined by Coughlin, who highlighted strengths of the Massachusetts biopharma industry, with industry employment reaching an all-time high, accounting for more than $6 billion in payroll and more than 1,000 drug candidates in development. Coughlin also presented Senate President Therese Murray with the MassBio Legislator of the Year Award for her efforts to foster innovation, forge global partnerships and enhance patient access.

“We need to keep working, building on the foundation we’ve put in place, and we have to continue to market the Commonwealth,” said Murray, who recently created the Northern Ireland Massachusetts Connection (NIMAC), a group dedicated to advancing business, research and clinical collaboration among Massachusetts, Northern Ireland and Europe.

“One thing is clear,” Murray continued. “Small connections make a very big impact. I’m committed to making these connections and ensuring that Massachusetts continues to be viewed as the leader in this industry.”

Throughout her career, Murray has been a driving force behind children’s health issues and health care reform efforts, and helped pass landmark legislation including Children’s Mental Health and the Health Care Reform Act of 2006. Last legislative session, she led an effort to allow patients to take advantage of rebates and discount programs made available to companies who manufacture complex and life-changing biologics. The Senate also passed minor changes to the Sales and Marketing disclosure law—also known as the gift ban— which brought it more in line with the federal law. Furthermore, she shepherded health care cost containment legislation through the process, resulting in Chapter 224, which is now in its implementation stage.

“We applaud Senate President Murray for her commitment to patients and ensuring that all aspects of health care, including the breakthrough therapies being researched, developed and manufactured right here in Massachusetts are available to the citizens that need them most,” said Coughlin.

Q&A With Mary Dunkle, Vice President for Communications at NORD (National Organization for Rare Disorders)

Tue, 19 Feb 2013 12:00:00 EST

What is Rare Disease Day? How has the day helped advance advocacy efforts for rare diseases?

Rare Disease Day is an international awareness day to bring widespread recognition of rare diseases as a global public health challenge. The day is celebrated on the last day of February every year. In 2013, it will be observed on Feb. 28.

Can you tell us a little bit about Rare Disease Day’s history and the Orphan Drug Act?

Rare Disease Day was established in Europe by 2008 by the European Organisation for Rare Diseases (EURORDIS). The following year, EURORDIS asked NORD to establish and sponsor it in the U.S. Since then, it has spread worldwide, and last year, Rare Disease Day was observed in more than 60 countries. Each country has a national sponsor, and the sponsors meet beforehand each year to plan an annual theme, shared messages and other activities so that people are celebrating in similar ways all around the world. This year’s observance of Rare Disease Day will have special significance in the U.S. because 2013 marks the 30th anniversary of the Orphan Drug Act. This is a law, enacted in 1983, that provides financial incentives that make it possible for pharmaceutical and biotechnology companies to make the necessary investment to develop products for small patient populations. Those incentives include, for instance, seven years of marketing exclusivity if a product is approved as an orphan.

What is the meaning behind this year’s theme “Rare Disorders Without Borders”?

The theme was selected by the global planning committee, and the intention is to demonstrate global solidarity of the rare disease community. We feel that it’s very important to have people all over the world promoting the same theme and messages each year. One of NORD’s consistent messages to our members is: Alone we are rare. Together we are strong. The same is true for the global rare disease community.

What opportunities are available for life sciences companies interested in getting involved?

Rare Disease Day celebrates the partnership among patient organizations, life sciences companies, academic researchers, practicing clinicians, NIH, FDA and all the other rare disease/orphan product stakeholders. We all share the same end goal — safe, effective treatments and cures for patients. Many companies will host events for their employees, and NORD is providing some resources such as a video from our president thanking company employees for the work they do on behalf of patients. Also, this year we are promoting State House events in other states, similar to the one MassBio co-hosts. Life sciences companies in those states may want to be involved in those events. The states where events are currently being organized are California, Connecticut, New Jersey and Texas, in addition to Massachusetts. Companies may also want to send out press releases in support of the day, and NORD is happy to make a press kit and/or sample release available for that purpose. We also have some pins, wristbands and notepads to make available to those hosting events.

How can individuals get involved in the day?

On the national website — RareDiseaseDay.US — we have posted suggestions for individuals. For instance, we have created suggestions for bringing Rare Disease Day into the classroom with elementary, middle school and high school students. We encourage teachers to use these resources and parents to make their children’s teachers aware of them. We also have a “Handprints Across America” photo gallery on the website where people can download a free flier with the Rare Disease Day logo and submit a photo of themselves holding it. We have some great photos already. And we’ll have a 24-hour advocacy campaign on Rare Disease Day through which individuals will be able to write to their elected officials. Individuals are planning special events in communities across the U.S. We’ll be posting those on the national website so that people can see if there is an event planned in their community.

MassBio will host a Rare Disease Day event at the State House

on Feb. 28 at 2 p.m. All are welcome — no registration

required. Visit www.massbio.org for more information.

MassBioEd Receives $250,000 Grant to Bring BioTeach to New Schools

Thu, 07 Feb 2013 12:00:00 EST

February 7, 2013 (Cambridge, MA) — The MassBioEd Foundation will expand its proven biotech education program, BioTeach, to eight new public high schools this year, thanks to a grant from the Massachusetts Life Sciences Center (MLSC).

MassBioEd will use the $250,000 from the MLSC’s Equipment and Supplies for Skills Training and Education Program to provide schools with professional development for teachers, curriculum for three biotech labs, and up to $16,000 for materials and equipment for school labs.

“The life sciences sector is critical to the Commonwealth’s economy and MassBioEd is excited to expand our BioTeach program this year to expose more students to the field,” said Lance Hartford, Executive Director of the MassBioEd Foundation. “By providing Massachusetts students with lab experiences in high schools across the state, we hope to inspire students to pursue educational opportunities and careers in the life sciences and biotechnology industry.”

“We at the Center are pleased to fund organizations like MassBioEd that enable schools across the Commonwealth to purchase top-of-the-line equipment, enhancing life sciences education for the next generation of our workforce,” said Susan Windham-Bannister, Ph.D., President & CEO of the MLSC, the agency charged with implementing Governor Patrick’s 10-year, $1 billion Life Sciences Initiative. “Life sciences companies continue to cite talent as a key reason for locating and growing their businesses in Massachusetts. MassBioEd’s programs are helping to train the workforce that will keep our life sciences industry strong in Massachusetts for generations to come.”

In February, teachers from the newly awarded school sites will receive professional training on the BioTeach labs and curriculum. The interactive labs are designed to pique student interest by exploring the opportunities in biotechnology.

Eight of the 15 schools participating in BioTeach through this grant are brand new to the program, bringing the total number of participating public schools in Massachusetts to 185. New schools include:

Bay Path Regional Vocational Technical High School
Barnstable High School
Fitchburg High School
Greater New Bedford Regional Vocational Technical
Haverhill High School
Montachusett Regional Vocational Technical School
Northeast Metropolitan Regional Vocational Technical School
Taunton High School

MassBioEd is one of 31 schools and programs to receive an award through the second round of the MLSC’s matching grant program, which totaled $3.2 million to support the purchase of life sciences training equipment and supplies at vocational technical schools and public high schools in Massachusetts' Gateway Cities, and workforce training programs across the state.

Learn more about MassBioEd and BioTeach at massbioed.org.

About the MassBioEd Foundation

http://www.massbioed.org

The Massachusetts Biotechnology Education Foundation (MassBioEd), founded in 2001, is a nonprofit charitable organization committed to supporting science and biotechnology education in Massachusetts through school programs, workforce training, and lifelong learning. Serving as a link between education, industry, and government, MassBioEd is working to ensure Massachusetts’ biotechnology sector, has an appropriately trained work force to meet the growing employment needs. MassBioEd’s BioTeach program provides professional development to over 500 teachers in their biotechnology curricula and provides grants and lab equipment to 185 schools across the Commonwealth. In addition, MassBioEd’s Biotech Learning Center offers professional development courses for employees in the biotech sector to advance their professional skills.

Inserm Transfert and MassBio announce a partnership to foster innovation, technology transfer and entrepreneurship between France and Massachusetts (USA)

Wed, 06 Feb 2013 12:00:00 EST

February 6, 2013, Paris (France) and Cambridge, Massachusetts (USA) – Today Inserm Transfert and MassBio announced a partnership aimed at facilitating scientific and commercial interactions between research laboratories and R&D companies in the field of Life Sciences both at Inserm in France and in Massachusetts.

Inserm Transfert will join MassBio programs such as MassCONNECT and the MassBio Innovation Exchange. Conversely MassBio members will have the opportunity to attend events sponsored or promoted by Inserm Transfert in France. The overall goal is to promote scientific collaborations and facilitate the translation of early stage innovation into commercial products for the benefit of patients.

The partnership was spearheaded by Dr. Bernard Malfroy-Camine, a French American biotech entrepreneur, formerly Inserm researcher and a Massachusetts resident for over two decades, who advises Inserm Transfert for US partnerships.

“When it comes to science and innovation, we believe it is extremely important to think international. Pairing our efforts with Massachussetts’ long standing track record in technology transfer was thus a tremendous opportunity, both for our scientists and our young companies” commented Cécile Tharaud, CEO, Inserm Transfert.

“Our new partnership with Inserm Transfert, developed through our Global Gateways initiative, will bring the vibrant clusters of innovation in Massachusetts and France together,” said Robert K. Coughlin, President & CEO of MassBio. “We are pleased to offer our members opportunities for collaborations and partnerships with top-notch early-stage companies from France as we continue to build the global life sciences network.”

###

About Inserm Transfert
Founded in 2000, InsermTransfert SA is the private subsidiary of the French National Institute of the Health and Medical Research (Inserm), dedicated to technology transfer (from invention disclosure to industrial partnership). InsermTransfert also manages European and International research projects, supports large scale projects in epidemiology and public health. Inserm Transfert runs a 2M€/year proof of concept fund. The company also supports entrepreneurs in the biotech sector, in partnership with Inserm Transfert Initiative, a € 39.7m life sciences seed investment company.
www.inserm-transfert.fr

About MassBio
http://www.massbio.org
MassBio, a not-for-profit organization that represents and provides services and support for the Massachusetts biotechnology industry, is the nation's oldest biotechnology trade association. Founded in 1985, MassBio is committed to advancing the development of critical new science, technology and medicines that benefit people worldwide. Representing over 600 biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and health care, MassBio works to advance policy and promote education, while providing member programs and events, industry information, and services.

MassBioEd Update: New Year, New Courses, New Instructors!

Tue, 22 Jan 2013 12:00:00 EST

MassBioEd is offering new courses in 2013 to meet the needs of MassBio members and the ever-evolving life sciences industry.

Biopharmaceutical Business & Corporate Development Executive Training

This two-day course will feature sessions on important business development topics and best practices with seasoned business professionals and Katrine Bosley, one of FierceBiotech’s “Top 10 Women in Biotech” in 2012, will be the seminar’s keynote speaker.

"Sell-side business development is the lifeblood of biotech yet there has never been a standardized way of practicing the art. Our course on best practices is practical from not just the strategic but also the tactics of successful deal making."

-Geoff Meyerson, Course Instructor, Co-Founder of Locust Walk Partners

Dates: Tuesday March 12 & Wednesday March 13
Times: 7:30 AM-7:30 PM/ 8:00 AM-4:30 PM
Cost: $1495 for MassBio Members; $1995 for non-members.

Cross-Cultural Biotech Presentation Skills

This seminar program will include two half-days and will provide interactive workshops around communication styles, perception and persuasion, cross-cultural communications, and public speaking.

“Science is a universal language but when you’re presenting to a cross cultural audience, it can easily get lost in translation. This course provides practical tips for anyone who works in the global biotech industry or is a non-native English speaker.”

- Kellyanne Dignan, Course Instructor, Associate VP of Rasky Baerlein Strategic Communications Inc.

Dates: Wednesday Feb 27 & Wednesday March 6
Times: 8:30 AM to 12:00 PM
Cost: $1295 MassBio Members; $1445 non-members

Biotech 101

This course, designed especially for non-scientists in the industry, will cover the basic science, techniques, applications, terminology, and issues in the biotech industry today.

“Whether you’re new to biotech, or haven’t taken a science class in a while, Biotech 101 will give you the background, and basic understanding of the “language” of Biotech.”

–Masha Hareli, Course Instructor

Dates: Thursday Feb 28 & Friday March 1
Times: 9:00 AM-4:30 PM
Cost: $1095 MassBio Members; $1245 non-members

Life Science Leadership & Management

This two day seminar program will teach scientists the leadership and management skills needed to take their careers to the next level. The course will be highly interactive and will involve small-group discussions of case studies using examples that are specific and relevant to the life sciences.

“As soon as a group of people must work together to achieve a goal, then management and leadership skills become important in ensuring they are as productive and effective as possible.”

- Dr. Gwen Acton, Course Instructor, CEO of Vivo Group

Dates: Wednesday March 13 & 20
Times: 9:00 AM to 5:00 PM
Cost: $1395 MassBio Members; $1545 non-members

All programs will be held at the MassBio Offices, 300 Technology Square 8^th Floor, Cambridge, MA. To view a full course listing and to register, visit www.massbioed.org/courses.

If your company has 50 or fewer employees you may be eligible to receive up to 50% reimbursement for the cost of training under the state's Workforce Training Fund Express Grant Program.

Contact courses@massbio.org to learn more.

Greater Boston Life Sciences Outlook Report

Fri, 18 Jan 2013 12:00:00 EST

Jones Lang LaSalle's Greater Boston Life Sciences Outlook Report complements the annual Global Life Sciences Cluster Report, while taking a closer look into what drives the local biopharma market. It explores market dynamics in East Cambridge, the Suburbs, as well as in the Seaport District and the Longwood Medical Area.

Download here.

http://www.us.am.joneslanglasalle.com/UnitedStates/EN-US/Pages/ResearchDetails.aspx?ItemID=10407