MassBio and Fisher Scientific are bringing their annual vendor expo on the road again this year! Fisher Scientific’s preferred suppliers and MassBio’s Primary Suppliers will showcase the latest technologies, equipment, supplies and services at four different locations throughout the Massachusetts area this summer and fall. Hope to see you there!
Dates & Locations:
July 24, 2014 11am – 1pm
Worcester Gateway Park, 60 Prescott St, Worcester, MA
August 12, 2014, 11am – 1pm
Cambridge Science Center- 245 First Street, Cambridge MA
August 28th, 2014, 11am – 1pm
One Kendall Square, Building 600/700, Cambridge MA
September 19th, 2014, 11am-1pm
500 Cummings Center, Room 221E, Beverly MA
No registration is required, just stop by during your lunch break and grab a slice of pizza!
Better Business Globally, LLC (BBG) is a unique firm that prepares employees and their families for corporate relocation abroad with Cultural Transition Advantage (CTA™) training. CTA™ eases the psychosocial transition of relocation by helping individual and/ or parents focus on the positive, growth-enhancing variables of their life abroad. Work-family balance is a key factor in the success of relocating executives and their families abroad. Discover how CTA™ can increase the success of your company’s relocation and expansion. BBG consults both privately and through human resources with comprehensive services assisting in pre and post transfer preparation and cross cultural adaptation. Services range from individual consultation to group trainings. Link
Solid Ventures is a biotechnology company focused on finding a treatment for Duchenne Muscular Dystrophy. Link
1) AbbVie and Shire come to terms on a $55B union – FierceBiotech, July 18, 2014 After months of semi-clandestine courtship, AbbVie and Shire have settled on a price: For $54.7 billion in cash and stock, the U.S. drugmaker will absorb its Irish target, securing a pipeline of promising rare disease treatments and a new address that should slash its tax rate. Link
2) Roche and Merck KGaA team on a multicancer companion diagnostic test – FierceDiagnostics, July 14, 2014 Companion diagnostics deals are an unstoppable train, and once again, Roche’s Ventana Medical Systems is at the center of another new partnership in the space. Ventana said it will develop a companion diagnostic test with Germany’s Merck KGaA that can be used for many different cancer types. Link
3) FDA Revises Policies on Obtaining Informed Consent in Clinical Trials – Regulatory Affairs Professionals Society (RAPS), July 15, 2014 As FDA explains in the draft guidance, Informed Consent Information Sheet, when most people think about the process of obtaining consent, they think of it as obtaining written consent from the subject to participate in a medical study. But FDA says this understanding—while technically correct—is not complete. Link
4) Seres Makes Push for First Drug, and IPO, of Microbiome Era – Xconomy, July 16, 2014 The first regulated therapy to emerge from the recent explosion of microbiome research is one step closer. And the company developing it, Seres Health, is stepping toward the first microbiome startup IPO. But what makes the update newsworthy, other than the growing body of clinical data, is that Seres is now planning a much larger trial by the end of the year. It will also apply to the Food and Drug Administration for special “breakthrough” status that would help speed up development and regulatory timelines for the product. Link
5) Massachusetts Life Sciences Firms Wary of Lower Device Costs – Medical Product Outsourcing (MPO), July 14, 2014
As the pressure to make health care more affordable mounts, Massachusetts biotech companies and medical device makers are warning that lower costs for consumers could be bad for business. Companies and investors in the life sciences cluster—a crucial part of the state’s economy—claim new restrictions on payments for drugs and other medical products will stifle innovation and harm patients. Link
Guest post by Jack Whelan, patient advocate from Andover battling a rare form of blood cancer and active patient and research advocate. His website is www.Jack-Whelan.com.
As state and federal lawmakers become more active in regulating healthcare policy, they need repeated infusions of information about state-of-the-art medical technology and update policies and regulations that encourage prudent cost savings and better healthcare outcomes. Patient advocates are often the most vocal, most effective voice in helping lawmakers understand the need to update regulations as their personal “real world” experiences often anticipate what many of us will face in the future, good healthcare enabled by good healthcare policy or poor healthcare because of out-of-date regulations.
When the topic of cancer or some other life-threatening illness comes up at your breakfast table and you begin to experience some regulatory hurdles and shortcomings in healthcare, you just might become a legislative advocate. For the past couple of years, several patient advocacy groups helped educate Massachusetts lawmakers encouraging them to enact smart legislation centered on emerging biosimilar technology. When Governor Patrick signed H .3734 the Biosimilars Bill, Massachusetts became one of several states to establish guidelines and clarification about when biosimilar medicines can be substituted. Biologics are complex medicines manufactured from living organisms which have been programmed to produce a desired therapeutic substance, for example to interfere with the proliferation of cancer cells. Biosimilars are biologic products that may have been manufactured by a third party company or comes from a different cell line that are substantially the same or “highly similar”.
The Food and Drug Administration is developing guidelines that will encourage approvals of biosimilars and interchangeable biologic products while the Affordable Care Act encourages substitution of lower cost therapeutics when possible. Issues of patient safety and efficacy of the therapeutic are far more critical than substitution for lower cost as often happens with generic drug substitution.
Corbus Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat life threatening (“orphan”) inflammatory-fibrotic diseases with clear unmet needs. Our lead product Resunab™ is a first- in-class oral anti-inflammatory expected to commence Phase-2a clinical trials for the treatment of cystic fibrosis and scleroderma pending FDA approval of INDs to be filed in the second half of 2014. Link
Intrinsic Imaging is an FDA audited, ISO 9001:2008, ISO 13485:2003 and ISO 22301:2012 certified, GAMP® 5 medical imaging core lab specializing in providing imaging core lab services for clinical trials. With its team of more than sixty board-certified diagnostic radiologists, robust and scalable clinical imaging technologies and our ISO certified and registered quality management systems, Intrinsic Imaging is ideally positioned to provide unprecedented imaging core lab services around the world. Link
Kaléo is a pharmaceutical company dedicated to putting a new generation of potentially life-saving personal medical products in patients’ hands. Our mission is to provide demonstrably superior medical products that empower patients and caregivers to confidently take control in potentially life-threatening situations. Each kaléo product combines an established drug with an innovative delivery platform with the goal of achieving superiority and cost effectiveness. Kaléo is a privately-held company headquartered in Richmond, Virginia. Link
Regulatory & Quality Solutions LLC is a team of regulatory and quality experts that provide your company with the best practices it needs to succeed. Our experts are experienced, knowledgeable, and scalable to whatever challenges your medical device business faces during its entire life cycle. R&Q has been built from the ground up to provide the solutions you need, when you need them, and where they provide optimum value. From strategic advice and guidance, to full spectrum, hands-on regulatory and quality engineering support, R&Q has the resources to ensure the success of your business. Link
Brandeis University supports an innovative and exciting program of learning that emphasizes an interdisciplinary approach to knowledge and the solution of real-life problems. Undergraduates, from the very first year, enjoy leadership positions and research opportunities typically available only to upperclass and graduate students. Link