Tags: app, apptomics, bbk worldwide, clinical trial, entrepreneur, neurologists, parkinson's disease, patient recruitment, patients, startup
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Firm client BBK Worldwide is partnering with Wellesley-based digital health app maker, Apptomics, as it prepares to launch a one-year clinical trial in September. Using a combination of apps (iMotor and MyPD), for monitoring patients with Parkinson’s disease, the trial will test the effectiveness of these tools in impacting the management of Parkinson’s disease and health outcomes. iMotor measures objectively patients’ motor function by combining several variables and MyPD focuses on collecting data related to symptoms, medications, side effects sleep quality, and emotional status. Data collected are transmitted in reports to patients’ neurologists.
BBK Worldwide is the foremost patient recruitment and engagement technology firm, providing a range of award-winning creative services and technology solutions to the world’s most innovative pharmaceutical and biopharmaceutical companies and their outsourced suppliers, such as CROs and eClinical providers. Apptomics works to achieve optimal management of chronic neurological conditions, including Parkinson’s, through scientifically validated mobile applications that allow collection of objective and patient reported data on disease progression. BBK Worldwide is now a minority investor in Apptomics, with BBK Principal Matthew Stumm serving on the Apptomics Board of Directors.
The two companies will work to develop a collection of apps aimed at monitoring patients with chronic neurological diseases and relaying the information to their doctors. Apptomics has already had success with the iMotor app through two studies that clearly demonstrated the scientific effectiveness of its data collection. The app also proved able to distinguish Parkinson’s patients from healthy individuals, and distinguished with high sensitivity the effects of treatment plans.
Congratulations to both companies on their new venture!
Tags: client, clinical study, ConforMIS, employment law, joint replacement implants, knee replacement, medical technology
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ConforMIS, Inc., a medical technology company that manufactures and sells joint replacement implants, received positive results from its iTotal CR study. The iTotal CR is a fully customized implant for use in total knee replacement, and the study found that 92% of patients were satisfied with the product in the year after receiving a knee replacement.
In developing, manufacturing, and selling joint replacement implants, ConforMIS uses its iFit Image-to-Implant technology, which allows for a customized implant specifically designed to fit an individual’s anatomy. The iTotal CR study included 300 patients in the United States, and is still ongoing. The interim study results were presented at the 2016 SICOT International Orthopaedic “Specialized Knee Surgery” Conference in Germany, which ran from June 30th to July 2nd.
The positive feedback is consistent with a previous study that showed that patients noted significantly higher satisfaction with the ConforMIS iTotal CR in their knee replacements, than with off-the-shelf implants. The positive results speak to the benefits of anatomically customized implants, and illustrate how ConforMIS’s products are making a positive and lasting impact in the joint replacement implant market.
To read more about the study and ConforMIS’s technology, read the full article.
Tags: acquisition, biologic, biopharmaceutical, biotechnology, blue stream, charles river laboratories, clinical development, merger, merger and acquisition, pharmaceutical
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MBBP client Blue Stream Laboratories, an analytical contract research organization supporting the development of complex biologics and biosimilars, was acquired by Charles River Laboratories. Charles River Laboratories is a provider of essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts.
According to Blue Stream, “The synergy of combining Blue Stream’s core expertise with Charles River’s existing broad portfolio of biopharmaceutical clinical development and supporting services creates a well-established services entity which can fully support biologic and biosimilar development.”
Morse, Barnes-Brown & Pendleton served as counsel to Blue Stream Laboratories and advised them in connection with the structuring, negotiation and documentation of this transaction. Shannon Zollo was the lead corporate attorney on MBBP’s team.
For more information, read the full news release.
PULSE@Mass Challenge Now Open in Boston! 06/10/2016Posted by Morse, Barnes-Brown Pendleton in Client News, Life Sciences, Medical Devices.
Tags: biotechnology, digital health, entrepreneur, entrepreneurs, innovation, Life Sciences, MassChallenge, research
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PULSE@MassChallenge officially opened in Boston last week, adding to the already increasing number of digital health companies in the area. MBBP’s Peter Barnes-Brown attended the ribbon cutting ceremony.
Read more about Peter’s thoughts on the growing digital health industry and about the company on our VCs & Startups Blog.
Tags: biotech, biotechnology, boston, employers, Life Sciences, medical labratories, medical research, patent, research
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The Boston Business Journal just announced that at the annual Biotechnology Innovation Organization meeting, Boston was recognized as the city with the largest number of employers in the field of research testing and medical laboratories. The BBJ explains that from biotech giants such as Biogen to Genzyme to research labs at the prestigious Harvard and MIT, the city is booming in life science employment and early stage development.
Furthermore, MassBio CEO and President Bob Coughlin explains how, “The research shows Massachusetts shines at the earliest stages of industry, with high levels of academic research, NIH and venture capital investments, as well as number of patents earned by our institutions…” Specifically, MA had $9.5 billion in VC investment in a three year term and ranked just behind California in the number of life science patents awarded.
MBBP is proud to represent life sciences companies throughout the greater Boston area (and beyond), in fields including biotechnology, pharmaceuticals and medical devices, along with institutions and investors in a wide range of sophisticated legal matters that arise in connection with the development, protection and commercialization of their diagnostic and therapeutic solutions.
Register Now! Laying the Firm Foundation for Growth: Entity & Equity – Life Sciences Series – Panel 2 05/31/2016Posted by Morse, Barnes-Brown Pendleton in Attorney News, Client News, Events, Intellectual Property, Life Sciences, MBBP news.
Tags: entrepreneurs, equity, Intellectual Property, Life Sciences, llc, llc formation, startup
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Join us at our Waltham office on June 22nd for the second panel in our Life Sciences Series, Laying the Firm Foundation for Growth: Entity & Equity.
Our expert panel will discuss whether a corporation or a limited liability company is more suitable for building an emerging company, and how to maximize the equity compensation of your team with restricted stock, stock options, or profits interests.
The event will take place from 7-9:30am. A light breakfast will be provided. Seating is limited – please register here.
Eric Lander of MBBP Client Whitehead Institute for Biomedical Research Receives MIT’s Killian Award 05/19/2016Posted by Morse, Barnes-Brown Pendleton in Client News, Life Sciences.
Tags: biology, client, Eric Lander, genome, MIT, President's Council of Advisors on Science and Technology, research, science, science and technology, Whitehead Institute for Biomedical Research
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MIT’s 2016-2017 James R. Killian Jr. Faculty Achievement Award was presented to biology professor Eric Lander. Lander, of MBBP client Whitehead Institute for Biomedical Research, is a renowned biologist recognized for his research in mapping the human genome. The Killian Award, established in 1971, honors faculty members who demonstrate extraordinary professional achievements.
Lander led the international Human Genome Project from 1990 to 2003, which included the development of techniques to map the human genome. He has taught his MIT introductory biology course for over 20 years. In addition to these achievements, Lander serves as co-chair of the White House’s President’s Council of Advisors on Science and Technology.
Lander joined the Whitehead Institute for Biomedical Research in 1986. The Whitehead Institute is a non-profit research facility that works to improve human health through biomedical research.
The Killian Award committee explained that “unlocking the information in genomes has been one of the defining scientific revolutions of the past quarter century. With the Killian Award, the committee acknowledges the transformative effect Professor Lander has had on the study of biology and medicine. We honor Professor Eric S. Lander for these extraordinary contributions, and for his roles as a gifted leader, teacher, mentor, and public advocate for science at the highest levels.”
In response, Lander stated that he is “tremendously honored, especially because this is an award conferred by my faculty colleagues at MIT. There is no higher recognition.”
Tags: entrepreneaurship, entrepreneurs, Germany, healthcare, investors, Life Sciences, science, Summit
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John Hession, Co-Chair of both the Corporate Department and the Life Science Task Force at Morse Barnes-Brown & Pendleton, PC, will be the Moderator of the prestigious Charité Entrepreneurship Summit 2016-Rethink & Transform Healthcare being held in Berlin, Germany May 26th & 27th. This is the 4th time John finds himself in this role, and he proclaims it as being one of his favorite and most rewarding “extra- curricular” activities.
Among the largest life sciences and health care industry conferences held in Western Europe each year, the Charité Summit brings together over 400 international entrepreneurs, scientists, investors and healthcare industry professionals. This year’s agenda features such diverse and relevant topics as the digitalization of health care, the prospects of genome editing, and the growing understanding of the compelling impact of gender differences on research and in the practice of medicine.
John says the role of Summit moderator is one he relishes with particular enthusiasm because it affords him the opportunity to interact with both the learned speakers and the diverse audience of life sciences and healthcare professionals. As he remarked, “The insights are scintillating and informative, the speakers animated and trenchant, and the networking before, during and after the program – in the Berlin beer halls- robust and gregarious.” Hession is the only American to repeat as Moderator in its 9 year history.
Tags: Intellectual Property, Life Sciences, patent
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Join us at MBBP‘s Waltham office on Wednesday, May 4th at 7:00am for a look at Building Your Product & Patent Strategy from the Ground Floor. This is the first of four events in the 2016 Life Science Panel Series.
This lively panel of experts will discuss how to structure a well-crafted intellectual property portfolio. They have all built and analyzed multiple portfolios and will share their experiences on the do’s and don’ts in both organically growing an IP portfolio and in-licensing key properties.
- William Edelman Social Entrepreneur and C-Level Executive, Paragonix Technologies, NewVert, VitaThreads, Flexicath, First Light Biosciences
- Molly Hoult Vice President, Fletcher Spaght Ventures
- Michael McDonald, Ph.D. Director of Intellectual Property, bluebird bio
Seating is limited. Register today!
Tags: decision, mayo, patent, petition, Prometheus Lab, scope, Sequenom, supreme court
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Late last month, Sequenom, Inc. filed a Petition for Writ of Certiorari requesting the United States Supreme Court to clarify the scope of its Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) decision, as applied to Sequenom’s claimed inventions. The Mayo decision, which held that a method correlating a drug dosage regimen and levels of the drug in the blood was an unpatentable law of nature, has had the profound effect of narrowing the scope of patent-eligible subject matter in the United States and has cast doubt on the validity and enforceability of previously-issued United States patents.
Sequenom’s discovery related to the discovery of cell-free fetal DNA circulating in maternal plasma, which was used to invent a test for detecting fetal genetic conditions in early pregnancy, and thereby avoid subjecting the mother to dangerous, invasive techniques such as amniocentesis. The Federal Circuit agreed that Sequenom’s invention combined and utilized man-made tools of biotechnology in a new way that revolutionized prenatal care; however, in view of Mayo, such inventions were deemed patent-ineligible as a matter of law, since their new combination involved only a “natural phenomenon” and techniques that were “routine” or “conventional” on their own.
Despite the Federal Circuit’s reluctant holding that Sequenom’s claimed inventions were not patent-ineligible, multiple judges wrote separately to explain that while this result was probably not intended by Mayo, that decision controlled and only the Supreme Court could clarify Mayo’s reach to prevent a “crisis of patent law and medical innovation.” Sequenom’s petition now asks the Supreme Court to clarify the scope of its Mayo decision in view of Sequenom’s claimed inventions, and to determine whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery.
If the Supreme Court grants certiorari it will have a compelling set of facts before it to clarify the scope of Mayo, and we patiently await its decision, which will have high stakes for the life sciences community.
For more information, contact Patent Attorney Stan Chalvire.
Tags: 2015, Intellectual Property, ip, patent, privacy, privacy shield, safe harbor, trademark
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2015 was another busy year in terms of intellectual property law, but luckily, MBBP has been carefully monitoring all of the important developments. There were many contenders for spots in our list, but only a select few could make the cut.
- Happy Birthday to All! – Marya v. Warner/Chappell Music, Inc.
- Google Books (Authors Guild v. Google, Inc.)
- Disparagement versus Free Speech: In re Tam
- Issue Preclusion & The TTAB: B&B Hardware, Inc. v. Hargis Indus., Inc.
- Patient Infringement Liability: Akamai Techs., Inc. v. Limelight Networks, Inc.
- Biosimilarity: Amgen v. Sandoz
- Patentability of Natural Phenomena: Ariosa Diagnostics, Inc. v. Sequenom, Inc.
- Computer Fraud & Abuse Act
- Safe Harbor Down, EU-US Privacy Shield Up
Tags: boston scientific challenge, caregiver, device, elderly care, health, medical device, technology, watchrx, wearables
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MBBP client WatchRx, is an early stage startup founded while trying to help aging parents manage their medications and health conditions remotely. Current solutions available in the market, like mobile apps and pill caps/bottles, didn’t fit the need and only added to the confusion. WatchRx provides a a simple dedicated reminder solution. From voice reminders to GPS tracking this device addresses so many needs. The watch can even send alerts to family and caregivers.
The Boston Scientific Connected Patient Challenge is an open competition focused on ideas and early-stage companies that improve patient care and/or drive down the cost of health care through the use of Remote Patient Monitoring using wearable, implantable or ubiquitous sensors. The top five ideas based on the online crowd voting and online judge scores were honored at a live event on February 25, 2016, where they presented their ideas to the Challenge Sponsors and fellow participants. Arun Buduri, Founder and Chief Product Officer, presented for WatchRx and walked away the winner! Watch the pitch (skip to 56:45) and award (skip to 1:53:00) here.
This isn’t the only thing the Greater Boston-based company is celebrating. Just yesterday WatchRx Founder and CEO Jayanthi Narasimhan was awarded 2016 Women to Watch in Science & Technology by the Boston Business Journal.
Congrats to WatchRx. If you aren’t a client to “watch” we don’t know who is!
Tags: biotech, innovation, Life Sciences, Massachusetts Life Sciences Center
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MBBP client, Selvita, recently announced an expansion into the Boston-area biotechnology and pharmaceutical market, as they open a fully-owned US subsidiary, Selvita Inc., headquartered in Cambridge, Massachusetts. Selvita is a leading global drug discovery company and the largest drug discovery company in Central and Eastern Europe. The new office, located at 485 Massachusetts Ave., will focus largely on expanding the company’s existing clients for its drug discovery services, as well as exploring and developing partnering opportunities.
“We are excited to celebrate the official opening of Selvita’s new office in Cambridge,” said Mike Kennealy, Acting President & CEO of the Massachusetts Life Sciences Center, a state-funded investment agency that worked closely with Selvita on their location decision. “The company’s presence here will enable Selvita to make important contributions to the Massachusetts life sciences community and to drug development, in the world’s leading ecosystem for life sciences innovation and growth.”
Read the full news release here.
Tags: Boston Tech, entrepreneurs, Team Tequila, Team Wine, TUGG, venture capital, Wine and Tequila Party
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On Thursday, April 16th, MBBP will be sponsoring the TUGG 9th Annual Wine and Tequila Party. Join 1,500+ of Boston tech’s entrepreneurs, venture capitalists, and philanthropists as we raise $400K+ to support six local nonprofits, while enjoying top-shelf wine and tequila. The non profits at this year’s party will consist of three returning favorites from the TUGG portfolio, and three new and promising ones. Meet and mingle with representatives from these nonprofits and hear their stories during the event. Then cast your votes for your favorite returning and your favorite new nonprofit. The winning non profit will be awarded up to $50,000.
Don’s miss out! Learn more and register for the TUGG 9th Annual Wine and Tequila Party.
Tags: biotechnology, Life Sciences, massbio, Trends in Science
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The MassBio Annual Meeting is a two day event that focuses on the most timely and critical challenges facing the Massachusetts biotechnology industry. As MassBio’s largest event, drawing close to 400 industry leaders, the meeting program is compiled by a Steering Committee and includes keynote presentations, plenary discussions, two panel tracks (Better Business and Trends in Science), and extensive networking opportunities.
For more information contact MassBio.
Tags: Amgen Inc., Apotex Inc., biosimilars, FDA, neupogen, Sandoz
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On February 18, 2015, Apotex Inc., announced that the Food and Drug Administration (FDA) had accepted its application for a biosimilar version of Amgen Inc’s Neupogen®. Apotex is second to Sandoz Inc. to propose a biosimilar version of Neupogen® (filgrastim), which is administered during chemotherapy to boost white blood cell counts and help fight infections. This is Apotex’s second biosimilar application, following Neulasta® (pelfilgrastim), a long-acting version of Neupogen®, filed last year. The approval of both Sandoz’s and Apotex’s Neuopogen(r) biosimilar applications could shed some light on the extent to which biosimilars will impact biologic sales.
Apotex hopes its biosimilar will be designated as an “interchangeable” product under the Biosimilars Act, which means that pharmacists filling prescriptions for Neupogen(r) could potentially substitute it without consulting the prescribing physician. However, it it is unclear whether it will benefit from the exclusivity period awarded to the first interchangeable product in view of Sandoz’s earlier filed Neupogen(r) biosimilar application. Even though Sandoz has publicly stated that it is not seeking interchangeability status for its Neupogen® biosimilar product, if the FDA nevertheless designates it as interchangeable Apotex would not be entitled to exclusivity for its Neupogen® biosimilar, and would have to wait until Sandoz’s exclusivity expired before the FDA would designate Apotex’s Neupogen® biosimilar as interchangeable. On the other hand, if the FDA does not designate Sandoz’s Neupogen® biosimilar as interchangeable, then Apotex’s biosimilar could be designated as interchangeable, as well as benefit from the exclusivity awarded to the first biosimilar to receive designation as interchangeable.
For more information on this topic, please contact David A. Fazzolare or Joanna T. Brougher.
Tags: alliances, licensing, Life Sciences, rights of first refusal, strategic partnerships, technology companies
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When entering into an exclusive licensing arrangement, the odds of success are against most companies. Typically within the first twelve months of an arrangement, 2/3 of all alliances crumble. If these ventures are so prone to failure, what preventative measures can a company employ to ensure success?
To learn how to achieve success when entering an alliance, read John Hession’s full article.