The new scope of cleaning validations for the manufacturers of reusable medical devices is examined in a white paper available for download from http://www.microtestlabs.com/new-scope-cleaning-validation-paper.

“Cleaning validation for reusable medical devices is an important step in proving their safety. Available guidance documents now indicate that the traditional method of validating cleanliness, spore log reduction, will no longer be acceptable. Analytical assays capable of providing quantitative results will now be required instead,” writes white paper author Patrick Kenny, Manager of Analytical Services, Microtest Laboratories.

In the new white paper, “The New Scope of Reusable Medical Device Cleaning Validations,” Kenny notes that “although a new requirement for reusable medical devices, these tests are traditional analytical assays that are performed routinely on other types of samples.”

“An effective protocol and report that includes justifications for the test soil and assays chosen, as well as thorough documentation of all parameters used in the validation, will help ensure success for the device’s submission,” Kenny notes.

The paper discusses cleaning validation analytical assays as well as various methods and scenarios related to performing the validation. Recommendations are based on several key documents relating to reusable device cleaning validations that are either in draft or final form. They include AAMI document TIR30:2003, a comprehensive guide to medical device cleaning validations. TIR30 is currently in revision, and an updated version is scheduled for 2011 release.

Download the white paper, “The New Scope of Reusable Medical Device Cleaning Validations,” from the Microtest Laboratories website at http://www.microtestlabs.com/new-scope-cleaning-validation-paper.

Kenny holds a M.S. degree in Chemistry and has spent the past 13 years working in QC, R&D and manufacturing laboratories. At Microtest, Kenny leads the services group performing medical device and pharmaceutical analytical testing for companies worldwide.

Addgene, a non-profit organization focused on scientific sharing announced today that it is collaborating with The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to assemble a collection of plasmid DNA samples for use in Parkinson’s Disease (PD) research. This collection, the Parkinson’s Disease Plasmid Resource, will be curated and distributed by Addgene to life science researchers around the globe.

“Our mission is to make the scientific research process easier by providing access to useful tools for the functional characterization of genes. We are thrilled to work with MJFF to build this important collection for the PD research community and to play a role in the development of treatments for this devastating disease,” says Dr. Joanne Kamens, Executive Director at Addgene.

Addgene currently hosts a growing library of over 20,000 recombinant DNA molecules known as plasmids. Plasmids, a type of research tool, are widely used by life scientists to isolate and study genes to explore gene function in health and disease.  Addgene’

WorldCare Clinical, LLC (WCC), a leading CRO focused on maximizing the precision and accuracy of independent assessments in clinical trials, today announced its new Endpoint Assessment Committee (EAC) services for blinded independent central review (BICR) of clinical trial data. WCC’s EAC services include expert assessments by physicians drawn from multiple therapeutic areas for comprehensive efficacy and safety reviews.

The unique depth and breadth of WCC’s strategic relationship with Massachusetts General Hospital (MGH) allows it to pull world-class, subspecialty-trained physicians from across departments for reads. From radiology and dermatology to oncology, cardiology and neurology, WCC provides blinded independent assessments by subspecialty-trained, board-certified experts, who are trained by WCC under a uniform system to maximize the precision and accuracy of data interpretation.

“WorldCare Clinical is excited to unveil our Endpoint Assessment Committee offering to pharmaceutical and biotechnology companies conducting trials that depend on subjective endpoint assessments,” said Richard Walovitch, Ph.D., president of WorldCare Clinical. “Our long-standing, cross-department relationship with MGH allows us to draw from the best independent readers. Across multiple therapeutic areas, the FDA is increasingly requiring EAC review of critical data for registration trials. We believe our EAC offering will enable sponsors to maximize their chances of regulatory success, by providing a more accurate and less variable interpretation of critical trial data.”

WCC’s WorldPRO data management platform captures and consolidates all data, including images, pathology slides, pictures of skin lesions, patient feedback, and more, and organizes data for a digital central review and streamlined submission to the FDA. This unique solution facilitates fast turnaround time for reviews and presents data uniformly to multi-discipline reviewers to enable the first-ever completely digital central assessment of subjective endpoints for maximum regulatory impact. For both trials that include an imaging component and those that do not, WCC can execute a BICR of any type of clinical data.

To support the release of its new EAC service offering, WCC has released a white paper titled, “A ‘Second Opinion’ for Subjective Endpoints: The Case for an Endpoint Assessment Committee.” To download a copy, visit http://www.wcclinical.com/aboutus/eac-white-paper/. For more information on WCC’s EAC services, visit: http://www.wcclinical.com/our-expertise/#page-EAC-Services or call 1-(888)-816-4721.

Kendall Square Corporate Pumpkin Carving Challenge

BOSTON, MASS., (October 10, 2012) – The Boys & Girls Clubs of Middlesex County is holding a Pumpkin Glow in Kendall Square on October 18, from 4:00 p.m. to 7:00 p.m. Carved pumpkins created by corporate challenge teams from Cambridge will be lit at approximately 6:15 p.m. in the North Plaza – 300 Athenaeum Street – of Kendall Square, Cambridge.

Residents from Cambridge and surrounding communities are encouraged to come out and see the amazing array of carved and illuminated pumpkins, and to also participate in the fun by purchasing a pumpkin to carve or decorate on-site with their families. Carving implements and markers will be provided. Guests can also enjoy great food from Redbones Barbeque along with a cold beverage in the Kendall Square Beer Garden. Live music will be provided by Zac Mac.

Sponsors to date include BioMed Realty, Amgen, Eastern Bank, Pilgrim Parking, Wessling Architects, Cambridge Trust Company, United Security, Momenta Pharmaceuticals, Alexandria Real Estate Equities, DTZ, a UGL Company, Watermark Cambridge Apartments, Atlantic Elevators, Valley Crest Landscaping, and Redbones Barbeque.

“This is going to be a fun event for the whole family, with pumpkin carving or decorating, kids’ activities, plenty of great barbeque and music,” commented Tracy Perrelle, regional director, East Coast Property Management. “All funds raised will benefit the Boys & Girls Club of Middlesex County which includes clubs in Cambridge, Medford, Somerville, and Everett. More than 1,500 children are served every year in after-school programs, athletics and recreation opportunities, and skills building in health, arts, music, education and career.”

About Boys & Girls Club of Middlesex County

The Boys & Girls Clubs of Middlesex County is an independent 501c3 organization with Clubs in Medford, Cambridge, Somerville and Everett .Its mission is to inspire and enable all young people to reach their full potential as caring, productive and responsible citizens. Clubhouses are designed and operated to provide a safe, supportive haven during out-of-school time that fosters academic, creative, leadership, and health-minded skills in youth during critical periods of their growth. Each year, more than 1,500 youth build supportive relationships with adult mentors, participate in goal-oriented, life enhancing programs, receive educational support, and benefit from meaningful BGCMC collaborations and partnerships. These resources along with shared knowledge and experiences benefit the Club’s youth and communities.

GNS Healthcare, Inc. (GNS), the leading Big Data analytics company focused on enabling personalized medicine to improve human health, today announced the expansion of its senior management team, adding Hans Winkler, Ph.D., as Chief Scientific Officer. Dr. Winkler will promote the development of the Company's intellectual property, building out product infrastructure and fostering the overall scientific strategy for the Company's product offerings to the pharmaceutical and biotechnology industry as well as academia. He was most recently Senior Director and Global Oncology Biomarker Program Leader within Janssen Oncology Research and Development, a division of Johnson & Johnson.

"We are too familiar with the current paradigm in the pharmaceutical industry, which has not resulted in gains to productivity, efficacy rates or probability of success, despite an unprecedented ability to generate data," said Colin Hill, President, CEO and co-founder of GNS Healthcare. "Hans is an innovator and a longtime customer of GNS with over 13 years of experience in the discovery and development of new medicines. At GNS, he will help us bring about a new paradigm for pharmaceutical development, providing innovative medicines to the right patient subpopulations. Dr. Winkler will guide the development of computer models of human disease and therapeutic interventions. These models will match patients to treatments that work and will foster the discovery of better medicines faster, resulting in lower costs and improved patient outcomes."

"The quality of the GNS team and its state-of-the-art REFS™ technology platform set GNS apart as a creator of valuable knowledge at machine scale-generated from disparate data sources with various data types and categories," said Dr. Winkler. "To succeed in the future, the pharmaceutical industry will adopt these Big Data analytics approaches to turn data into knowledge and discover what medicines work, and for whom. This will reduce the time and cost necessary to get innovative new medicines to those patients for whom they actually lead to meaningful clinical benefit."

Dr. Winkler joined Johnson & Johnson in 2003 as the Director and Head of Functional Genomics and Bioinformatics. From 1998 to 2003, he was Director and Global Program Manager for Target Validation Technologies at AstraZeneca, where he was responsible for target validation technology assessment gaining experience in array based gene expression analysis. Before this, he was a scientist and instructor at Harvard Medical School's Beth Israel Deaconess Hospital, where he worked in endothelial cell biology and immunobiology. Dr. Winkler earned his Ph.D. in biochemistry from the University of Vienna and completed postdoctoral work at the Institute for Molecular Pathology. Prior to his doctoral work, he was awarded a Fulbright fellowship to pursue graduate studies, obtaining his M.S. in molecular biology from the University of Houston.

Mabbett & Associates, Inc. (Mabbett™) is pleased to announce that the firm has been awarded a five year, $6M, Industrial Hygiene and Environmental Services Contract from the U.S. General Services Administration (GSA), National Capital Region (NCR).

As the prime contractor, Mabbett will provide technical support services to GSA‐NCR, including industrial hygiene, safety, sanitation, asbestos and lead containing paint, environmental and occupational health and safety specialist consulting and engineering support services. These services are provided within approximately 200 Federally‐owned, occupied, or leased facilities throughout the District of Columbia metropolitan area. Mabbett’s services also include: long‐term planning and implementation of comprehensive programs on complex multi‐building projects; on‐call rapid response 24/7; and single‐day evaluations‐projects. Mabbett held one of the five previous GSA‐NCR Industrial Hygiene and Environmental Services Contracts from 2009 to 2012.

“We appreciate the opportunity to continue to serve GSA‐NCR on this important contract and GSA‐NCR’s confidence in Mabbett," commented Susan Smits, CHMM, TURP, CET, Mabbett Program Manager. “We look forward to continuing to deliver high quality, well managed, and responsive service in support of GSA’s mission and Federal customers.”

Arthur N. Mabbett, President further noted “Mabbett is most pleased to be selected as one of only two prime contractors for the new award. GSA’s vote of confidence in the past performance of the Mabbett Team is most gratifying. I am very proud of our firm’s and staff’s success”.

Mabbett provides integrated multi‐disciplinary environmental, health and safety and sustainability‐energy consulting and engineering services. For over 30 years, Mabbett has delivered value‐added professional services to industry, commercial enterprise and Federal, state and local agencies. Mabbett is a U.S. Department of Veterans Affairs (VA), Center for Veterans Enterprise (CVE), verified Service‐Disabled Veteran‐Owned Small Business (SDVOSB) headquartered in Bedford, MA with regional offices in Providence, RI; Alexandria, VA and Paramus, NJ.

www.mabbett.com

The ALS Therapy Development Institute (ALS TDI) announced today that its CEO and CSO, Steve Perrin, Ph.D., coauthored a paper with members from neuroscience-focused organizations which published in the October 11, 2012 issue of the journal Nature. The international, cross-sector group makes new recommendations for the bare minimum reporting to be adopted by funding and publishing groups.

The paper entitled, “A call for transparent reporting to optimize the predictive value of preclinical research,” resulted from a US National Institute of Neurological Disorders and Stroke (NINDS) meeting earlier this year and outlines how to improve the methodological reporting of animal studies in grant applications and publications, including recommendations for a core set of reporting standards for rigorous study design.

“We owe it to patients today to conduct our preclinical research both as rapidly and rigorously as possible. We can’t allow these to be seen as mutually exclusive aims. No matter what the financial costs, the human costs are always going to be great. We need to a take top-down as well as a grassroots approach in the scientific community if we are to make this the new norm,” says Dr. Perrin. 

The Institute published a set of standards (Scott, et al.) for the optimized preclinical study design of the SOD1 mouse model of ALS in 2007 which was the basis for two international consensus papers and recommendations on publishing results using that model. The ALS TDI model has also been used by funding agencies, such Prize4Life, as a guideline for seeking grants.

“Drug discovery and development takes 12-15 years and over $1.2B. The risk and cost is especially great for neurodegenerative diseases. A critical inflection point is proof of mechanism in animals, which determines whether a potential drug advances into humans. Given the significant current problems in the predictive value of animal studies, improving their quality is essential to mitigating the risk of translating drug discovery into clinical trials,” says Howard Fillit, M.D., executive director and chief scientific officer of the Alzheimer’s Drug Discovery Foundation.

About the ALS Therapy Development Institute (ALS TDI)

The mission of the ALS Therapy Development Institute (ALS TDI) is to develop effective therapeutics that slow or stop amyotrophic lateral sclerosis (ALS, Lou Gehrig’s disease) as soon as possible for patients today. Focused on meeting this urgent unmet medical need, ALS TDI executes a robust target discovery program, while simultaneously operating the world’s largest efforts to preclinically validate potential therapeutics; including a pipeline of dozens of small molecules, protein biologics, gene therapies and cell-based constructs. The world’s first nonprofit biotech institute, ALS TDI has developed an industrial-scale platform, employs 30 professional scientists and evaluates dozens of potential therapeutics each year. Built by and for patients, the Cambridge, Massachusetts based research institute collaborates with leaders in both academia and industry to accelerate ALS therapeutic development, including Biogen Idec, UCB, Aestus Therapeutics, MDA and RGK Foundation. For more information, please visit us online at www.als.net.

 About the Alzheimer’s Drug Discovery Foundation

The mission of the Alzheimer’s Drug Discovery Foundation (ADDF) is to accelerate the discovery and development of drugs to prevent, treat and cure Alzheimer’s disease, related dementias and cognitive aging. The ADDF has granted more than $54 million to fund almost 400 Alzheimer’s drug discovery programs in academic centers and biotechnology companies in 18 countries. For more information about the ADDF, please visit www.alzdiscovery.org.

Dynamic, multi-sector panel of Boston healthcare leaders discussed the impact of reform on their companies' strategies

October 1, 2012 – The Healthcare Businesswomen’s Association (HBA) Boston Chapter held its provocative panel discussion on the impact of healthcare reform on innovation, on Thursday, September 13, 2012 in Boston. Local healthcare business leaders discussed how their organizations are using new business models, novel partnerships, and out-of-the-box thinking to change how healthcare is delivered.

According to panelists, 2012 has already been a big year in the healthcare industry, with more changes anticipated. The recent Supreme Court ruling, new FDA regulations coming into effect and the upcoming presidential election are having an unprecedented impact on the state of healthcare – quality, cost and delivery.

All sectors of the healthcare industry are impacted – from pharmaceuticals to hospitals, health plans to medical devices. Panelists believe that the key to sustainable change is for the industry to work together to understand overall goals and obstacles, and then propose new solutions. They have already begun this collaborative effort, and they shared some of their strategies at the Forum.

Six senior Boston leaders from organizations across the spectrum of healthcare participated in a panel discussion about the impact of reform on innovation, sharing examples of how reform is driving novel initiatives within their organizations, the challenges they are facing, and what they are planning for the year ahead.

Martha Bebinger, WBUR Healthcare Reporter, moderated the following panel of distinguished speakers, discussing how they are handling the new challenges. The panel discussion focused on of delivering quality care in a cost-conscious environment. Panelists each had their own solutions from within their organizations.

Martha Bebinger, healthcare reporter at WBUR, guided the panelists into critically evaluating the implications of the Affordable Care Act (ACA) through a conversational question-and-answer format. Despite uncertainty caused by ACA reforms, the panelists spoke about each challenge as an opportunity to build more efficient healthcare processes and to continue innovation under an affordable healthcare model.

Justine Carr, MD, chief medical officer at Steward Health Care System
Dr. Carr has led multiple initiatives in clinical integration, including standardization of policies and best practices in clinical excellence and prevention of harm. She spoke about high quality, low-cost and reproducible models of care, including telemedicine (giving more cost-effective care in home), customer satisfaction feedback, and prevention methods such as use of “health coaches,” as well as defraying the cost of medical education. She focused on the concept of total healthcare costs versus incidental opportunities for savings that might be associated with fee-for-service thinking. 

Naomi Fried, PhD, chief innovation officer at Boston Children’s Hospital
Dr. Fried is building the innovation acceleration program, aimed at improving care quality and assisting the hospital in shaping the future of healthcare at Boston Children’s Hospital. The program focuses on integrative models of care such as using more cost-effective delivery of health (telehealth – remote delivery of healthcare, at home and at school); looking at the “whole patient” – a paradigm shift from sick care to health care; moving toward a service model with emphasis on quality, not volume; resourcing grass roots innovation; and identifying unmet innovation opportunities. She raised the concept of physicians being paid by outcomes instead of by volume. Fried also raised the issue of providing medical innovation for children (stocked products need to have varying sizes, as an example), and the challenge of providing care for an entire family when a child becomes critically ill.

Nancy Gagliano, MD, chief medical officer at CVS MinuteClinic
Dr. Gagliano is responsible for physician oversight and expansion of services and clinics,
as well as internal operations at the CVS MinuteClinic organization. She pointed out that 45 million Americans are expected to be insured at the same time as we are facing a 40,000 primary care physician shortage. She discussed the “medical home” concept in which a patient’s home base becomes the source of care. CVS’ MinuteClinic strives to be part of a less expensive option, the “medical neighborhood” concept. It uses nurse practitioners and physician assistants who see approximately two million patients annually at its 500+ locations, to increase community healthcare access in an environment of primary care physician shortage. At the same time, this program helps to reduce healthcare costs. The structure and delivery targets for the CVS MinuteClinics allow the organization to develop complete, standardized protocols for visits they are able to take care of, referring patients to physicians for the matters they cannot. Delivery in these circumstances can therefore be 40-70% less expensive that that provided by a typical physician practice.

Tamima Itani, PhD, vice president of global regulatory affairs and regulatory compliance at Boston Scientific Corporation
Dr. Itani’s responsibilities include strategic regulatory, clinical and quality systems leadership for a broad range of class II and class III medical devices, pharmaceutical products, and combination products. She stated that the Affordable Care Act is a unique challenge for the medical device industry due to the ACA being partially funded by manufacturers: a 2.3% medical device excise tax. Companies faced with this expense have the challenge to not slow down innovation and not to pass too much cost on to patients. She cited a shift to medical care delivery at home and a challenge to focus product development on decisive technologies that decrease patients’ costs.

Christina Severin, president of Network Health
Under Ms. Severin’s strategic leadership, Network Health has launched several new and competitive plans for healthcare delivery. Using modeling techniques to reduce expenses while providing better member service, Network Health has developed a social care management program that has become the Medicaid Managed Care Organization industry standard. Under her leadership, Network Health has earned top National Committee for Quality Assurance (NCQA) ratings, a result of “patient-centered and patient-directed” care. A large portion of her service base apparently consists of Medicaid patients and she discussed the challenges of providing anti-poverty and social justice programs in the current environment. She echoed the need for a focus on medical outcomes.

Samantha Singer, vice president of corporate strategy and portfolio management
at Biogen Idec
Ms. Singer is currently chief of staff for Biogen Idec’s CEO, leading corporate strategy and process. She said there should be an increased emphasis on value and adaptation in the face of healthcare reform. If value that is truly innovative can be provided, then the healthcare system is willing to pay for the product, according to Singer. Medical products companies face a challenge in cutting costs. Many companies have already pared down operations costs to a minimum and the only remaining place for discretionary cost-cutting is in R&D; cutting costs in R&D imposes challenges for the future of the company. Product companies therefore must look for true unmet need and provide the value.

Under Bebinger’s skilled guidance, panelists addressed topics and concerns which have arisen from the ACA and other changes taking place:

• Panelists appear to believe that the ACA will remain in place regardless of election outcomes; the difference between parties may be in the level to which provisions are monitored and enforced
• Panelists pointed out that the ACA prompts participating provider organizations to take ownership of a given patient population and promote savings in healthcare delivery. However, the organizations can only retain the savings if they meet the provisions of 32 measures provided by the act
• Value of care provided versus volume will become more important for providers
• Patient-directed care may become more important, and patient responsibility for follow-through with medical orders will gain more attention
• Changes from within healthcare provider organizations and product development organizations may evolve as frequent, subtle changes

Panelists discussed the main challenges they face under current healthcare reform: 

• For product manufacturers, the key challenge is to find savings within their organizations to pay for the increases in costs brought about by universal healthcare coverage
• Manufacturers must also strive to find and develop value in meeting true unmet medical need with their new product introductions
• Providers face a pending shortage of primary care providers in the face of increasing numbers of patients covered by health insurance. They must look for innovative ways to meet the need. Deploying service delivery across a range of healthcare providers, not just physicians can allow each provider type to function at the maximum capacity for which they are trained and not to be bogged down completing tasks which an alternative provider can complete
• Panelists cited a fear that the government could lose patience with the pace of change under reform and not allow changes to reach fulfillment
• To really impact outcomes, panelists cited, patients must have “skin in the game” and help to drive outcomes by taking responsibility for their own lifestyle and behaviors that impact health. Providers are challenged to implement education and guidance to impact such patient participation
• Providers and manufacturers must partner with payers for data and better understanding of outcomes. There needs to be a bridge between the different types of organizations to truly impact health outcomes

Ideas for constructing the bridge between different groups to help improve outcomes came forward in the discussion but it was clear that more work needs to be done in this area. Some of the ideas:

• Pay for performance and outcomes
• Look at the European models for health technology assessments
• Clinical trials for new products and services that have patient-reported outcomes
• Stating targets and holding healthcare costs to that target

Audience questions were equally provocative:

• Raising the issue of the costs for medical education: the panelists suggested ways of defraying costs, such as agreements to provide service in underserved communities, providing incentives for graduating physicians to go into primary care versus into specialties
• Raising the issue of potentially cutting costs for drugs and devices: the panelists cited their understanding that drugs are not the key cost of care and that sometimes paying more for drugs and using them in appropriately-suited patients can lower overall medical costs.   More data is needed on the outcomes of drug and device usage and how they impact quality of life, ability to return to work, and other measures. Risk contracts (between manufacturers and providers) have also been considered. Panelists lamented the fractionated healthcare system in the US that makes such innovations difficult and cited examples of team medicine which helps to overcome the fractionation
• Raising the issue of how to get information on changes to patients: panelists acknowledged this as a challenge, but also emphasized the importance of patients becoming involved in the changes. Panelists cited a low level of health literacy in our country and the complications of overcoming this. Shared decision-making (patients and providers) will become more important in the future

Topics and discussion continued on a variety of concerns specific to Massachusetts and its ability to move to the “next stage” of healthcare reform: setting target cost growth, helping or hindering the innovations companies are trying, payment reforms, challenges of dealing with home-bound patients.

Local sponsors supporting the forum represented a cross-section of companies and services in Boston's healthcare market: Alexion Pharmaceuticals, Alkermes, Biogen Idec, Blue Cross/Blue Shield of Massachusetts, Boston Scientific Corporation, Cubist Pharmaceuticals, Inc., Millennium: The Takeda Oncology Company, Ping Identity, Sanofi, Shire, Thermo Fisher Scientific, and Witt/Kieffer.

“We thank our panelists and moderator for an illuminating and very informative discussion, with a record turnout of members and others, the highest number of attendees in the chapter’s history. The national board has recognized the outstanding marketing efforts of the Boston chapter in
considering our nomination and award of Best Chapter for the year. A real feather in our cap!” said Keri Collette, President of the HBA Boston chapter.

About Healthcare Businesswomen’s Association (HBA) and the Boston chapter

Healthcare Businesswomen’s Association (HBA) is in its fourth decade as a global not-for-profit organization dedicated to furthering the advancement of women in healthcare worldwide. With 15 chapters throughout the US and Europe, HBA provides educational opportunities for women and men to develop cutting-edge healthcare industry knowledge and leadership skills, recognizes outstanding women and men in the industry, provides opportunities for networking, creates greater visibility for women in the industry, fosters mentoring relationships and serves as a conduit and sponsor for research on career advancement issues. HBA has nearly 6,000 individual members and over 130 corporate partners, and is widely recognized as a catalyst for leadership development of women in healthcare worldwide. The Boston chapter has over 700 members and a network of over 2,000 followers. The Healthcare Forum initiates the theme of “Being Equipped for Change” that will be carried through in Boston programs for 2013.

###

Publish Date: 09/20/2012

Two Boston area firms, contract research organization (CRO) Integral BioSystems, LLC and intellectual property (IP) law firm Patents Etcetera have joined forces in offering drug development services that start with an IP strategy review.

Instead of investing dollars and time in a lengthy approval process for a new chemical entity (NCE), many pharmaceutical companies are seeking to reduce risks and costs by finding new uses for existing drugs. Companies that take this approach fit naturally within the risk reduction model because they start with approved compounds with established history of use in humans. This approach to drug development, using repurposed, already-approved compounds, can make it possible for new drug formulations to enter the clinical development phase more rapidly and at much lower cost than when NCEs are used.

Companies taking this approach to "repurpose" drugs use one or a combination of the following strategies: (a) reformulating to “improve" efficacy, (b) discovery of new targets for old drugs, (c) reformatting an old drug with an established mechanism of action for another indication or (d) repurposing existing drugs to identify novel uses. While these approaches offer easier regulatory approval paths compared to the lengthy approval process for a New Drug Application (NDA) for a new chemical entity, new challenges have emerged in terms of gaining patent protection and product exclusivity for the new "repurposed" products.

Patent Attorney Dave Karasic (DBA Patents Etcetera) advises drug development companies about the patentability of their drug and its proposed clinical indication, suggesting ways to gain new patent protection for off-patent and/or repurposed drugs. The strategies and approaches are developed in collaboration with drug delivery/ drug development experts at Integral BioSystems.

 Integral BioSystems excels in the conceptualization and design of innovative drug delivery solutions for drug candidates that are unstable, intrinsically tissue impermeable, or incompatible with physiological fluids. With extensive experience developing sustained release systems incorporating microspheres, nanospheres, liposomes, depots, etc., Integral BioSystems specializes in the removing “roadblocks” preventing companies from leveraging the full potential of their proposed drug products.

Courtagen Life Sciences, Inc. today announced the expansion of their molecular diagnostics menu. The new genetic test, epiSEEK™, provides the complete sequence of 327 genes that have been reported in association with epilepsy phenotypes and nonspecific seizure disorders.

Courtagen’s epiSEEK™ test expands their current molecular diagnostics menu, which includes tests for mitochondrial disease.

The epiSEEKTM test is conducted at Courtagen Diagnostics Laboratory, a CLIA certified clinical laboratory, and test results will be delivered to clinicians within weeks, much faster than the typical industry standard delivery time of several months.

“Launching this assay is one more step in building a world class clinical sequencing facility using nextgeneration sequencing," said Brian McKernan, CEO of Courtagen. "The epiSEEK™ assay is the most comprehensive test on the market, and results include an interpretation in language that physicians understand and can use for the real benefit of their patients.”

Courtagen’s tests are highly sensitive, accurate, and efficient, and address the significant need for a
quicker, non-invasive, and more reliable diagnostic tool for this patient population.

Epilepsy is a common neurological disorder with a highly heterogeneous background that often prevents definitive diagnosis. Epilepsy has a strong genetic contribution, with an underlying genetic predisposition for approximately fifty percent of affected people. Knowing the genetic basis of a patient’s epilepsy is valuable for obtaining a definitive diagnosis, for estimating prognosis, and for determining recurrence risks. In many cases, the precise genetic defect is important in the therapy given, and at times this knowledge results in substantial improvements in patient outcome.

About Courtagen Life Sciences, Inc.
Courtagen Life Sciences, Inc. is a privately held global life sciences company that provides innovative proteomic and genomic products and services to the life sciences industry. Founded by innovators in next-generation sequencing, biological sciences, and information science, our company delivers tools that enable researchers and clinicians to make better decisions regarding drug and therapy development, as well as patient care. More information can be found at: www.courtagen.com.

GMP Storage in the US for a UK manufacturer

Pepperell, MA– Monday, October 29, 2012 -- Masy Systems, Inc., a leader in GMP storage, validation and calibration services is pleased to announce a storage and distribution agreement with Ludger Ltd., an Oxford, England company specializing in biopharmaceutical glycoprofiling.  The storage and distribution agreement is focused on Ludger manufactured biopharmaceutical characterization kits, with plans to increase distribution of products well into 2013.

Masy Systems, of Pepperell, MA operates a GMP repository offering storage across the range of temperatures needed for pharmaceutical products and medical devices.

 “I’m excited by our collaboration with Masy.  This will allow us to simplify shipment of Ludger products to our North American customers.  Masy are a superb company to work with.  We chose them because they really understand the GMP and regulatory requirements that our clients need to work to – and their systems for storing and shipping temperature sensitive materials are excellent.  They also have a deep commitment to customer service and have always been helpful to us. ” - Dr Mark Johnson, US Technical Sales Consultant, Ludger Ltd.

“Masy is very pleased to be partnering with Ludger in this new business venture.  The agreement gives Masy an opportunity to expand our distribution services, which includes both temperature controlled and standard shipping services.  GMP storage is so critical for products that are temperature sensitive and we are always enthusiastic to provide customers with any additional services they might need in order to facilitate their business success.”  – John Coolidge, Biorepository Manager, Masy Systems, Inc.

Ludger is a bioscience company specializing in technology for the measurement and control of biopharmaceutical glycosylation.  This technology is used in the quality control of FDA- and EMEA-approved biopharmaceuticals worldwide, and can be used to support IND submissions.  Ludger is ISO 9001 certified, and offers both glycoprofiling products as well as services. Ludger clients include leading pharmaceutical and biotechnology companies throughout the world.

Masy will also be opening a new 6,200 cubic foot -75°C Storage Facility in December 2012.  Masy is NVLAP accredited to ISO 17025 for calibrations, and ISO 9001 certified.  Masy provides validation and calibration services, equipment rentals, and GMP storage for the pharmaceutical and biotech industries. 

Contact:
Matt Dionne
Masy Systems, Inc.
978-433-6279
978-433-0442 Fax
mdionne@masy.com
www.masy.com

Nuclea Biotechnologies will officially open its new Bioinformatics and Imaging Center at the William Stanley Business Park this week and make major announcements about infrastructure upgrades, new research partnerships, and its vision for biotechnology in the Berkshires.

What:                  Nuclea Biotechnologies Official Opening and Press Conference

Who:                    Patrick Muraca, President & CEO, Nuclea Biotechnologies

Pittsfield Mayor Daniel L. Bianchi

State Senator Benjamin Downing

Dr. Mary Grant, President, Massachusetts College of Liberal Arts

Corydon Thurston, Executive Director, Pittsfield Economic Development Authority

When:                  Thursday, November 8, 2012 9:30 am

Where:                Pittsfield Economic Development Authority

81 Kellogg Street

Pittsfield, MA 01201

Photo and interview opportunities: After a speaking program, speakers will be available for additional comment and photos.  The site will be available for photographs as well.

Members of the press should please RSVP to Greg D’Agostino at (617) 695-0369 or Greg@libertysquaregroup.com. Images for publication are available upon request.

Nuclea Biotechnologies, Inc. is headquartered in Pittsfield, Massachusetts. Nuclea has three lines of business, each of which is operated by a separate wholly-owned subsidiary: Nuclea Diagnostic Laboratories (“NDL”) which has developed and is commercializing unique diagnostic tests for colon, breast, leukemia, lung and prostate cancer; Nuclea Biomarkers (“NBM”) which performs research leading to novel molecular oncology therapeutics and diagnostics for the pharmaceutical and biotechnology industries and performs services by analyzing and testing the efficacy and validating other indications of existing therapeutics utilizing a highly characterized and consented patient database; and Nuclea Biotherapeutics (“NBT”) which develops novel therapeutics..

Jones Lang LaSalle Construction has completed work as the general contractor for an interior renovation for Boston University in its Translational Synthetic and Medicinal Chemistry Laboratory at 590 Commonwealth Avenue Boston. The complex project, partially funded by a grant from the National Institute of Health, is valued at $7 million.

The 10,000-square-foot fourth floor renovation, designed by William Wilson Associated Architects Inc., features all new chemistry labs, faculty offices, and student workspaces. Other changes include: new mechanical and electrical systems, a roof top mechanical penthouse with supply and lab exhausts, roof top electrical penthouse and switchgear, roof top chiller, emergency power distribution, new lab systems, casework and fume hoods.

“Jones Lang LaSalle Construction did a fantastic job on the construction,” said Aaron Beeler, Assistant Professor of Boston University’s Chemistry Department. “These are the nicest labs I have seen. I’ve been involved in a number of construction projects over the years, and this has been by far the best organized and executed.”

According to Jones Lang LaSalle Senior Vice President and Construction Manager Larry Carpenter: “We ran mechanical systems through occupied labs on five floors of an existing, occupied science facility. This project required careful coordination and detailed communication with the entire team of Boston University, Wilson Architects, and Bard, Rao + Athanas Consulting Engineers to complete successfully.”

Joining Larry on the Jones Lang LaSalle Construction team was Project Executive Dana Griffin, Superintendents Joshua Blake and Steve Pizzuto, Assistant Construction Manager Laura Frailoli, and Estimator Chris Hardiman. The architect was William Wilson Associated Architects Inc.

About Jones Lang LaSalle Construction

Jones Lang LaSalle offers comprehensive services as a construction manager, general contractor and design/builder, completing over 500 diverse assignments annually. With a service reach throughout New England, the Mid-Atlantic, mid-West and the West Coast, Jones Lang LaSalle constructed $145 million in 2011. Delivering construction solutions to an extensive roster of Life Sciences, Higher Education, Government, Corporate, Industrial, Technology, Hospitality, and Residential/Retail clients, assignments range from smaller interior fir-outs to $100 million mixed-use developments. Their on line portfolio can be viewed at www.us.joneslanglasalle.com/boston/construction.

About Jones Lang LaSalle

Jones Lang LaSalle (NYSE:JLL) is a financial and professional services firm specializing in real estate. The firm offers integrated services delivered by expert teams worldwide to clients seeking increased value by owning, occupying or investing in real estate. With 2011 global revenue of $3.6 billion, Jones Lang LaSalle serves clients in 70 countries from more than 1,000 locations worldwide, including 200 corporate offices.  The firm is an industry leader in property and corporate facility management services, with a portfolio of approximately 2.1 billion square feet worldwide. LaSalle Investment Management, the company’s investment management business, is one of the world’s largest and most diverse in real estate with $47 billion of assets under management. For further information, please visit www.joneslanglasalle.com.

Jones Lang LaSalle’s Construction team has completed an interior renovation for Boston Medical Center in its Preston Family Buildings Center for Endocrinology, Diabetes, Nutrition and Weight Management on 732 Harrison Avenue Boston. The $2.5 million project provides the community with contemporary, state of the art patient care facility. Jones Lang LaSalle is the Construction Manager/General Contractor.

Patient treatment and common areas in the new 10,000-square-foot hospital clinic on the second floor have been significantly upgraded. Features include: upgraded HVAC and electrical systems, new finishes, comfortable check in and waiting areas, and other system upgrades and improvements on the existing floor. The construction work was multi-phased so as not to interrupt clinic operations.

“The construction for the second floor went extremely well and did not impact patient care during any of the phases,” said Anthony Lanci, construction project manager of Boston Medical Center. “Jones Lang LaSalle’s project superintendent Niles Carter did an outstanding job with communication back to the BMC project team for any potential shutdowns. The Preston building is one of the most difficult buildings on campus to work on because of the low ceiling to deck heights. Even with those difficulties Jones Lang LaSalle completed the project ahead of schedule and under budget.”

 “We are pleased to have delivered the project ahead of schedule with no impact on daily patient service,” said Jones Lang LaSalle Senior Vice President and Construction Manager Larry Carpenter. “This was achieved through careful planning, and a tight collaborative effort between our long-standing client Boston Medical Center and all contractors.” 

Joining Larry on the Jones Lang LaSalle Construction team was Managing Director and Project Executive Steven Wassersug, Senior Superintendent Niles Carter, and Senior Estimator Chris Hardiman.

About Jones Lang LaSalle Construction

Jones Lang LaSalle offers comprehensive services as a construction manager, general contractor and design/builder, completing over 500 diverse assignments annually. With a service reach throughout New England, the Mid-Atlantic, mid-West and the West Coast, Jones Lang LaSalle constructed $145 million in 2011. Delivering construction solutions to an extensive roster of Life Sciences, Higher Education, Government, Corporate, Industrial, Technology, Hospitality, and Residential/Retail clients, assignments range from smaller interior fir-outs to $100 million mixed-use developments. Their on line portfolio can be viewed at www.us.joneslanglasalle.com/boston/construction.

About Jones Lang LaSalle

Jones Lang LaSalle (NYSE:JLL) is a financial and professional services firm specializing in real estate. The firm offers integrated services delivered by expert teams worldwide to clients seeking increased value by owning, occupying or investing in real estate. With 2011 global revenue of $3.6 billion, Jones Lang LaSalle serves clients in 70 countries from more than 1,000 locations worldwide, including 200 corporate offices.  The firm is an industry leader in property and corporate facility management services, with a portfolio of approximately 2.1 billion square feet worldwide. LaSalle Investment Management, the company’s investment management business, is one of the world’s largest and most diverse in real estate with $47 billion of assets under management. For further information, please visit www.joneslanglasalle.com.

BOSTON, April 18, 2012— Jones Lang LaSalle has been appointed as exclusive leasing agent by Tufts University’s Cummings School of Veterinary Medicine on the development of Phase I of Grafton Science Park, a new 348,000-square-foot lab, research and office park on the school’s campus on Route 30 in Grafton, MA. All major permits have been secured including local master plan approval and a Massachusetts Environmental Protection Act (MEPA) Certificate by the state.

Construction of the Park’s first phase of infrastructure and public utilities is complete. The site is located on Route 30, in the western portion of the school’s 594-acre parcel abutting the Grafton MBTA commuter rail station. The approved campus master plan permits up to 702,000 square feet of three-story buildings, and allows for flexibility in actual building and building site areas. Water and public sewer are at the site.

Grafton Science Park is located within an Economic Target Area. Occupants will have the added benefit of close proximity to Tuft’s University’s faculty, students, and research infrastructure.

 “The location of Grafton Science Park, on the campus of New England’s only veterinary school, offers tenants a pre-permitted, convenient location ideal for life sciences and biotechnology,” said Deborah T. Kochevar, DVM, Ph.D., dean of the Cummings School. “The added benefit is the proximity to the school’s world-class faculty and translational research.”

According to Jones Lang LaSalle Managing Director Phil DeSimone: “We are excited to be working on this unique offering, and working with Tufts to market land sites for a build-to-suit. Tufts demonstrates a commitment to sustainable development. The project will reflect the quality of their reputation, as well as the innovation and excitement that makes Worcester County a growing and thriving area for technology and life sciences. Jones Lang LaSalle has teamed up with Kelleher & Sadowsky to co-market these land sites because of their reach into the Worcester market.”

About Jones Lang LaSalle

Jones Lang LaSalle (NYSE:JLL) is a financial and professional services firm specializing in real estate. The firm offers integrated services delivered by expert teams worldwide to clients seeking increased value by owning, occupying or investing in real estate. With 2011 global revenue of $3.6 billion, Jones Lang LaSalle serves clients in 70 countries from more than 1,000 locations worldwide, including 200 corporate offices.  The firm is an industry leader in property and corporate facility management services, with a portfolio of approximately 2.1 billion square feet worldwide. LaSalle Investment Management, the company’s investment management business, is one of the world’s largest and most diverse in real estate with $47.7 billion of assets under management. For further information, please visit our website, www.joneslanglasalle.com.

BOSTON, June 6, 2012 – Alexandria Real Estate Equities, Inc. (NYSE: ARE), the leading owner, operator, and developer of high-quality, sustainable real estate for the broad and diverse life science industry, is pleased to announce six recent lease transactions, aggregating approximately 187,000 square feet, at Alexandria Park at 128 in the heart of the Route 128 submarket of Greater Boston. These long-term lease transactions with high-quality life science and advanced technology entities, including 1366 Technologies, Inc., Cystic Fibrosis Foundation, Emerald BioStructures, Life Technologies Corporation, Microbia, Inc., and QD Vision, Inc. affirm Alexandria Park at 128 as the leading science and technology campus in the Route 128 submarket. Jones Lang LaSalle is Alexandria’s leasing agent at Alexandria Park at 128, 

Alexandria is the dominant life science owner, operator, and developer nationally, as well as in the Greater Boston cluster, in which Alexandria owns and operates approximately 3.5 million square feet of high-quality laboratory and office space proximate to world-renowned academic and medical institutions for approximately 100 client tenants including Abbott Laboratories, Biogen Idec Inc., Eisai Co., Ltd., GlaxoSmithKline plc, Massachusetts Institute of Technology, Novartis AG, Quest Diagnostics Incorporated, Thermo Fisher Scientific Inc., and University of Massachusetts Medical School. In the Greater Boston cluster, Alexandria’s submarkets include Cambridge, Longwood Medical Area, and Route 128. Alexandria’s Route 128 submarket offers approximately 580,000 square feet of state-of-the-art laboratory and office space in a convenient suburban location with easy access to the world-renowned academic and medical centers of Cambridge and Boston.

Alexandria’s flagship asset in the Route 128 submarket, Alexandria Park at Route 128, is an eight building science and technology park totaling approximately 345,000 square feet. The dynamic park is strategically located near Hartwell Avenue at the Route 128 and Route 4/225 interchange. The park is immediately adjacent to desirable residential areas as well as unique restaurants, shops, and convenient amenities. It is already home to a variety of leading life science and advanced technology firms including Celgene Corporation, Diversified Technologies, Inc., RainDance Technologies, Inc., Synta Pharmaceuticals Corp., and TIAX LLC.

The six new lease transactions total approximately 187,000 square feet at Alexandria Park at 128. 1366 Technologies, relocating and expanding from Lexington, will occupy 41,071 square feet at 6-8 Preston Court in Bedford. QD Vision, Inc., a nanomaterials products company, relocated and expanded from Watertown to 59,000 square feet at 29 Hartwell Avenue in Lexington. Microbia, Inc., a subsidiary of Koninklijke DSM N.V., renewed for 40,000 square feet at 60 Westview Street in Lexington, and Life Technologies renewed for 28,640 square feet at 35 Wiggins Avenue in Bedford. Cystic Fibrosis Foundation recently occupied a 6,633 square foot laboratory suite at 3 Preston Court, Bedford, and Emerald BioStructures leased 6,740 square feet of space in the same building. Alexandria’s occupancy rate in the Route 128 submarket is currently at 95.2%, while the market for laboratory is approximately 88%.

“Alexandria Park at 128 is the leading destination for life science and technology entities in the Route 128 corridor,” said Tom Andrews, Executive Vice President and Regional Market Director at Alexandria Real Estate Equities, Inc. “The announcement of these new and renewal leases with high-quality client tenants is a testament to the great location, state-of-the-art real estate, and our dedication to partnering with our client tenants to find the ideal real estate solution for their unique needs.”

Tamie Thompson of Jones Lang LaSalle added, “The lure of the park has been Alexandria’s strong brand in the life science real estate sector, access to Cambridge and Boston, the cluster of science and technology companies, and the flexibility of the space.”

About Alexandria Real Estate Equities, Inc.

Alexandria Real Estate Equities, Inc. (NYSE: ARE) is the largest and leading investment-grade real estate investment trust focused principally on owning, operating, and developing high-quality, sustainable real estate for the broad and diverse life science industry.  Founded in 1994, Alexandria has the first-mover advantage in every core life science cluster location, including Greater Boston, San Francisco, San Diego, and New York City. Alexandria’s high-credit client tenants span the life science industry, including renowned academic and medical institutions, multinational pharmaceutical companies, public and private biotechnology entities, U.S. government research agencies, medical device companies, clean technology companies, venture capitalists, and life science product and service companies.  As the recognized real estate partner of the life science industry, Alexandria has a superior track record in driving client tenant productivity and innovation through its best-in-class laboratory and office space, collaborative locations proximate to leading research institutions, unparalleled life science real estate expertise and services, and longstanding and expansive network in the life science community.  For additional information on Alexandria Real Estate Equities, Inc., please visit www.are.com.

This press release contains forward-looking statements within the meaning of the federal securities laws.  Actual results may differ materially from those projected in the forward-looking statements. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements is contained in our Annual Report on Form 10-K and our other periodic reports filed with the Securities and Exchange Commission.

About Jones Lang LaSalle

Jones Lang LaSalle (NYSE:JLL) is a financial and professional services firm specializing in real estate. The firm offers integrated services delivered by expert teams worldwide to clients seeking increased value by owning, occupying or investing in real estate. With 2011 global revenue of $3.6 billion, Jones Lang LaSalle serves clients in 70 countries from more than 1,000 locations worldwide, including 200 corporate offices.  The firm is an industry leader in property and corporate facility management services, with a portfolio of approximately 2.1 billion square feet worldwide. LaSalle Investment Management, the company’s investment management business, is one of the world’s largest and most diverse in real estate with $47.2 billion of assets under management. For further information, please visit www.joneslanglasalle.com.

BOSTON, August 22, 2012— Beal/Street-Works, the partnership between The Beal Companies and Street-Works Development to co-develop 50 acres of historic downtown Quincy, Massachusetts, have appointed Jones Lang LaSalle as the exclusive leasing agent for the office and medical office space at the new Quincy Center. This component represents 1.1 million square feet of the 3.5 million square foot mixed-use urban revitalization in the heart of downtown Quincy.

The new Quincy Center project is a model for cities across America. The $1.6 billion redevelopment plan is a historic private/public partnership with the City of Quincy. A neighborhood of offices in five buildings, comprising approximately 700,000 square feet of retail, two new hotels, 1,400 residential units, and multiple new parking garages providing 5,000 public parking spaces, will all be anchored by an expanded public space, called Adams Green, and a new visitor’s center that will more effectively highlight Quincy’s role as the birthplace of two American presidents.

The 1.1 million square feet of new state-of-the-art green office and medical office space will be a destination for health care, life sciences, higher education institutions, and other quality office tenants just eight miles from Boston. All permits for the 50 acre and 20 city block project are in place, infrastructure improvements are well underway, and groundbreaking will begin in mid-2013.

As Beal/Street-Works, The Beal Companies and Street-Works share a commitment to cities and bring a wealth of shared experience to the project. Street-Works has successfully completed mixed-use projects from California to Connecticut, including Santana Row in San Jose, California, Bethesda Row in Bethesda, Maryland and Blue Back Square in West Hartford, Connecticut. Currently, Street-Works is leading major urban redevelopments in Detroit and Dallas.

“The Quincy Center redevelopment is the right project at the right time,” said the Beal Companies Senior Vice President Stephen Faber.  “It represents a tremendous opportunity to give Quincy new life, and it is in our office program where we find the real exciting prospects for transformation. Rather than just putting up buildings, we plan to create an environment where medical institutions can utilize the latest in technology and consumer trends to redefine how they interact with patients. We look forward to working with Jones Lang LaSalle to realize this vision.

According to Street-Works Managing Partner Ken Narva, “Overall, our program will bring Class A office space to downtown Quincy, a market which has been underserved in the past. The possibility for connectivity between our two signature office towers will provide a potential floor plate of up to 60,000 square feet. We are excited to get this program underway with the expertise of Jones Lang LaSalle on board.”

“Jones Lang LaSalle is excited to be partnering with the visionary team of Beal Companies and Street-Works on this marque assignment,” Jones Lang LaSalle Executive Vice President Tom Kent said. “Beal Cos.’ long experience in building and managing large scale properties throughout Greater Boston, combined with Street-Works expertise in high profile urban strategies, positions new Quincy Center for a bright and successful future. They have made important progress toward creating a vibrant mixed-use destination, and making the City of Quincy truly a 24-hour city.”

Joining Tom on the Jones Lang LaSalle leasing and marketing team are: Managing Director Bill Barrack, Senior Vice President John Osten, Vice President Sean Lynch, Senior Vice President, Stephen Steinberg, and Junior Associate Jordan Yarboro. The agents for retail leasing are National Realty and Development Corp., and CBRE/Grossman Retail Advisors LLC.

About Beal/Street-Works

Beal/Street-Works is committed to creating the next generation of livable and sustainable downtowns.  We believe that by both honoring history and embracing innovation, we can combine the best of the past and the future to create exceptional urban spaces where people will want to live, work, play—and stay. We balance bold and original approaches to development with responsible financial stewardship. Together, Beal/Street-Works is re-imagining what is possible for development in the 21st century.  www.quincytime.com, www.bealco.com, www.street-works.com

About Jones Lang LaSalle

Jones Lang LaSalle (NYSE:JLL) is a financial and professional services firm specializing in real estate. The firm offers integrated services delivered by expert teams worldwide to clients seeking increased value by owning, occupying or investing in real estate. With 2011 global revenue of $3.6 billion, Jones Lang LaSalle serves clients in 70 countries from more than 1,000 locations worldwide, including 200 corporate offices. The firm is an industry leader in property and corporate facility management services, with a portfolio of approximately 2.1 billion square feet worldwide. LaSalle Investment Management, the company’s investment management business, is one of the world’s largest and most diverse in real estate with $47 billion of assets under management. For further information, please visit www.joneslanglasalle.com.

BOSTON, October 31, 2012— Veolia Energy North America, leading developer and operator of efficient energy solutions, and the operator of the country’s largest portfolio of district energy networks, has signed a 27,440-square-foot lease at 53 State Street in Boston. The firm will occupy first class office space on all of floor 14 to serve as its North American headquarters.

Jones Lang LaSalle Managing Directors Ben Heller and Brendan Callahan, and Senior Vice President Brian Connolly represented the tenant. The landlord was represented by Cassidy Turley FHO Senior Managing Director/Principal Glenn Verrette, and Vice President John McHugh.

“Veolia Energy is pleased to expand the size of its U.S. headquarters in Boston, which is the most progressive and vibrant energy services market in the country,” said Cyrille du Peloux, President and Chief Executive Officer of Veolia Energy North America. “Jones Lang LaSalle has been instrumental in helping us locate office space that supports our company’s commitment to environmental responsibility.”

Veolia Energy North America is moving from its current location at 99 Summer Street in Boston where it has resided since 2007. Its energy consulting and engineering subsidiary SourceOne Inc. will also relocate to the new headquarters from 132 Canal Street. Therefore, the move represents both a consolidation and expansion. Veolia Energy’s occupancy at 53 State is scheduled to begin in early 2013.

“Veolia Energy was committed to locating in a LEED, sustainable office building,” said Ben Heller, Managing Director of Jones Lang LaSalle. “The property fits its criteria by being in the midst of every downtown amenity, and easily accessible via highways and the MBTA. 53 State Street provides Veolia Energy with a headquarters location from which to grow its business.”

About Veolia Energy North America

Based in Boston, MA, Veolia Energy North America is a leading U.S. operator and developer of energy efficient solutions.  Veolia Energy operates and maintains the largest portfolio of efficient district energy networks in North America.  Veolia Energy Solutions operates and maintains commercial and manufacturing energy infrastructure with guaranteed savings; designs, builds, operates and maintains socially responsible, local energy production assets such as combined heat and power (CHP) and renewable energy plants; and provides energy consulting and engineering

services.   Visit the company’s Web sites at www.veoliaenergyna.com and www.veolianorthamerica.com.   

About Veolia Environnement

Veolia Environnement (Paris Euronext: VIE and NYSE: VE) is the worldwide reference in environmental solutions. The company has operations all around the world and provides tailored solutions to meet the needs of municipal and industrial customers in the complementary segments of water management, waste management, and energy management. Veolia Environnement recorded revenue of $38.4 billion in 2011.  www.veolia.com.

About Jones Lang LaSalle

Jones Lang LaSalle (NYSE:JLL) is a financial and professional services firm specializing in real estate. The firm offers integrated services delivered by expert teams worldwide to clients seeking increased value by owning, occupying or investing in real estate. With 2011 global revenue of $3.6 billion, Jones Lang LaSalle serves clients in 70 countries from more than 1,000 locations worldwide, including 200 corporate offices.  The firm is an industry leader in property and corporate facility management services, with a portfolio of approximately 2.1 billion square feet worldwide. LaSalle Investment Management, the company’s investment management business, is one of the world’s largest and most diverse in real estate with $47 billion of assets under management. For further information, please visit www.joneslanglasalle.com.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sanofi (EURONEXT: SAN and NYSE: SNY) and Genzyme, a Sanofi Company, today congratulated John Zawacki, MD, of UMass Memorial Medical Center in Worcester, Massachusetts, the recipient of the 2012 Schwartz Center Compassionate Caregiver Award, for his display of extraordinary compassion in caring for patients and families. Sanofi Oncology and Genzyme were the co-sponsors of the award, which was announced Thursday, November 8th, at the 17th Annual Kenneth B. Schwartz Compassionate Healthcare Dinner at the Boston Convention Center.

“As long as you share your feelings and have good intentions, the words will come. It [being a doctor] is not a scripted experience.”

Dr. Zawacki is a gastroenterologist who cares for patients with Crohn’s disease, ulcerative colitis and irritable bowel syndrome. He has also taught and mentored hundreds of medical students, residents and fellows, telling them, “As long as you share your feelings and have good intentions, the words will come. It [being a doctor] is not a scripted experience.”

The Schwartz Center for Compassionate Healthcare, a nonprofit organization dedicated to strengthening the relationship between patients and their healthcare providers, established the award in 1999 to honor healthcare providers who practice compassionate care, which includes effective communication, emotional support, mutual trust and respect, involving patients and families in healthcare decisions, and treating patients as people.

Debasish Roychowdhury, Head of Sanofi Oncology, and David Meeker, President and CEO of Genzyme, warmly praised Dr. Zawacki and this year’s other nominees for embodying Ken Schwartz’s deeply held belief that what matters most during an illness is the human connection between patients and their caregivers.

The Schwartz Center for Compassionate Healthcare (www.theschwartzcenter.org) was founded in 1995 by Ken Schwartz, a Boston healthcare attorney who died of lung cancer at the age of 40 and found that what mattered to him most as a patient was the compassionate care he received from his caregivers. He established the Schwartz Center just days before his death to ensure that all patients and families receive compassionate care.

About Genzyme, a Sanofi Company

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

About Sanofi Oncology

Based in Cambridge, Massachusetts, USA and Vitry-sur-Seine, France, Sanofi Oncology is dedicated to translating science into effective therapeutics that address unmet medical needs for cancer and organ transplant patients. Starting with a deep understanding of the disease and the patient, Sanofi Oncology employs innovative approaches to drug discovery and clinical development, with the ultimate goal of bringing the right medicines to the right patients to help them live healthier and longer lives. We believe in the value of partnerships that combine our internal scientific expertise with that of industry and academic experts. Our portfolio includes 10 marketed products and more than 15 investigational compounds in clinical development, including small molecules and biological agents.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Photos/Multimedia Gallery Available:http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50471694&lang=en

Highlights developments in generic drugs, impact of VC money, recruiting and outsourcing for pharma and biotech

PCI Synthesis, Inc. (www.pcisynthesis.com), a 12-year-old pharmaceutical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products, today announced a list of trends it thinks will impact the emerging biotech and generic drug industries in both Massachusetts and the U.S.

• Producing generic drugs will become more expensive in 2013.  The Generic Drug User Fee Amendments of 2012 (GDUFA), passed by Congress in July, has a worthwhile goal: “to ensure Americans have timely access to safe, high-quality, and effective generic drugs.” But the fees – estimated by the FDA “to cost the generic drug industry less than ten cents for the average generic prescription,” squeezes a lot of the smaller companies.  Companies will now have to pay for applications and Drug Master Files (DMFs) -- as much as $20,000 to $30,000 per DMF, which could have an adverse effect on the generic drug industry. GDUFA changes the risk profile for small companies applying for DMFs; companies need to be sure they can generate a better return to compensate that risk. In the long run, generics will become more expensive. The increased fees equate more inspections of foreign manufacturing and it remains to be seen if these efforts will truly shorten the FDA approval process.

• Foreign drug companies need to be held to consistent, high standards of the FDA. As prices for U.S.-produced generics increase, we can expect to see an increase in sales of foreign-made generics.  The FDA needs to step up inspections of foreign plants in countries such as India or China to ensure their quality control meets U.S. standards.

• More VC money will be available in 2013 to fund new companies and research.  The level of VC funding rebounded in 2011 (up from 2009 and 2010), and held steady in 2012. We expect that to continue in 2013. The structure of the investments has changed but money is still available. We continue to expect long-term trends to continue, for example: more virtual pharma companies that will outsource most of their work. This is good news for the Massachusetts CRO/CMO community.

• Recruiting will be a big issue.  One of the biggest risks that everyone has is the lack of qualified people. Unemployment is still an issue in general in Massachusetts and the U.S., but finding qualified people for the pharma industry is a challenge. Expect to see more remote hires as talented people use technology to telecommute rather than relocate. Some in the industry have seen the rise of “supertemps,” talented employees who move frequently from one company to the next, but this is a short-term solution that does not help companies or the industry.

• For its biotech hub to remain competitive, Massachusetts needs to do more to bring more pharmaceutical business to the state. Massachusetts has done a good job supporting its universities, and its R&D cluster is growing, but we’re seeing an increase of companies from outside the state trying to lure business away from here. The state should focus not only on research jobs, but also how to better promote manufacturing which could be an impetus for even more jobs for the state. Too often great research and development is done locally then moves elsewhere for manufacturing upon commercialization. From a historical perspective this is counter to the other leading industries that were previously developed in Massachusetts such as semi-conductors, computers, textiles, etc.

• Outsourcing research and development to other countries will make less sense in 2013.  The cost differential between U.S. R&D and foreign R&D is narrowing all the time. Labor costs in India and China continue to grow. Pretty soon the salary of a chemist in India and the U.S. will be more in line. Increased regulation may make it harder to bring new drugs into the country.

“This is a dynamic time for the industry – an increase in VC funding over a couple of years ago, which may spur additional development; new regulations and fees that make business more expensive. Over the past 12 years, we’ve provided our clients with insights into new trends to help them prepare and manage for the future. The biggest issue for the industry is the direction the FDA is going to take, and the continuing wage inflation affecting the Indian and Chinese economies,” said Ed Price, President of PCI.

About PCI Synthesis
PCI Synthesis is a 12-year-old custom chemical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products. A contract manufacturing organization (CMO), PCI provides emerging and mid-sized pharmaceutical companies access to the expertise needed to develop and manufacture complex small molecules and APIs used in generic pharmaceuticals. To learn more about PCI Synthesis, its proprietary NCE development activities and process R&D capabilities please visit www.pcisynthesis.com.

http://pcisynthesis.com/about-us/press-releases/pci-announces-2013-trends-and-predictions/