Sanuwave confirms acting CEO Richardson as company head | Personnel Moves – December 12, 2018

Sanuwave CEO Kevin Richardson

Sanuwave said late last month that it lifted acting CEO and board chair Kevin Richardson to a permanent position in the corner office.

Richardson joined the Suwanee, Ga.-based company in 2009 as board chair, and has served as acting CEO since 2014. He also served as managing partner of investment management firm Prides Capital from 2004 to September 2018.

Sanuwave said that Richardson took over as the permanent CEO as of November 30, and that he will continue to serve as board chair alongside his new position heading the company, according to an SEC filing.

 Common Sensing lifts Schmid to CEO, White to board chair

Common Sensing said late last month it lifted COO and board member Kevin Schmid to the role of CEO, and that it appointed co-founder James White as its board chair.

Prior to joining Common Sensing, Schmid held “pivotal roles” at Insulet (NSDQ:PODD), Bose, JDS Uniphase and the Stevanato Group and served as a board member for Sorrel Medical.

“Kevin’s appointment to the chief executive role puts Common Sensing in a very strong position to scale Gocap injector monitoring platforms for insulin and beyond. As we transition from pilot level to commercial level operations over the next year, Kevin’s transformative leadership of the talented and growing Common Sensing team will evolve and drive the execution of our go-to-market strategies for our patented dose sensing technology. Our goal is to provide a smart dose sensing platform for patients, health care providers and payers to embrace injectable medicines for home use,” White said in a prepared statement.

During his time with Insulet, Schmid aided in the development, industrialization and commercialization of wearable, smart drug delivery pumps, Cambridge, Mass.-based Common Sensing said.

Common Sensing said that Schmid will lead top-level strategy, expansion and investor relations, while prez and co-founder Richard Whalley will focus on clinical, quality and regulatory functions.

“We are well underway with the development of our high performance, scalable, and commercial Gen 2 Gocap platform. This, combined with insightful user data from existing studies and patients, lays the foundation for Gocap technology to make a tremendous impact on wireless integrated health care. Gocap is an easy-to-use, cost-effective dose monitoring and reporting solution which will be accessible to millions of self-injecting patients,” Schmid said in a press release.

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 Glympse Bio appoints former Bristol-Myers exec Loew as prez & CEO

Glympse Bio said early this month that it appointed former Bristol-Myers Squibb (NYSE:BMY) exec Dr. Caroline Loew as its new prez & CEO.

Most recently, Loew served as R&D, strategy and planning VP at Bristol-Myers Squibb, the Cambridge, Mass.-based company said. She has also held senior roles with Merck and PhRMA, leading teams in drug development ,regulatory policy, market access and commercial fronts, Glympse Bio said.

“I’m excited to join Glympse and work alongside the exceptional and dedicated team here. Glympse’s powerful, tunable platform technology has the ability to transform how we detect and manage disease, and help both improve and save patients’ lives. I’m looking forward to building the company and fully realizing the potential of this platform for patients,” Loew said in a press release.

In connection with the appointment, Loew will also join Glympse Bio’s board of directors, which the company said it recently expanded. The expansion includes that appointment of co-founder Dr. Sangeeta Bhatia as head of the scientific advisory board and the appointment of Stanley Lapidus as board chair and Robert Langer as a board member.

“Caroline is an outstanding leader who brings a wealth of experience in life sciences, and we are thrilled she is joining Glympse. She is recognized for her acumen and operational execution, her ability to build talented teams and lead organizations, and for strategic development and commercialization of important products that change patients’ lives. We are also fortunate to have Sangeeta’s continuing scientific and clinical leadership on the Scientific Advisory Board,” board member & LS Polaris Innovation Fund partner Amy Schulman said in a prepared release.

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 NovaDip Biosciences taps former Argos CEO Abbey as chief exec

Regenerative medicine company Novadip Bioscences said today that it named former Argos Therapeutics prez & CEO Jeff Abbey as its new CEO, succeeding Jean-François Pollet.

Abbey spent 15 years at immuno-oncology cell therapy company Argos Therapeutics, holding the position of president and CEO during the past eight years, Belgium-based Novadip said. During his time with Argos, Abbey guided the company through a phase 3 trial and helped raise $250 million in equity financings which included an initial public offering.

“With his extensive experience in cell therapy combined with his expertise in equity financing, business development and strategy, Jeff possesses the skills necessary to lead Novadip through the next phases of its development. The board is highly confident that Jeff’s wealth of international experience and proven leadership will help Novadip in its mission to become a leading regenerative medicine company. As the founding CEO, Jean-François Pollet, along with co-founder and CSO, Denis Dufrane, has led Novadip through a number of important milestones and positioned the company in a strong position to succeed. The board would like to express its gratitude to Jean-François Pollet,” board chair Eric Pâques said in a prepared statement.

Novadip is developing an autologous three-dimensional cell therapy that is currently being studied in a phase I/IIa trial in spinal fusion patients, the company said. It added that it recently launched a second clinical program looking to enroll patients with non-healing bone fractures and that it is developing a regenerative skin product based on its cell therapy platform.

“I am excited to have the opportunity to join Novadip The technology platform and portfolio of products the company is developing offer tremendous opportunities to provide unique solutions to patients with catastrophic conditions in the fields of bone disease and skin regeneration. I look forward to working with the founders and the outstanding team of Novadip to bring truly innovative therapies to market and build a preeminent biotechnology company,” Abbey said in a press release.

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 Owens & Minor lifts interim CFO Snead to permanent chief finance officer position

Owens & Minor (NYSE:OMI) said today that it lifted interim CFO Robert Snead into a permanent role as chief financial officer and exec VP, effective December 6.

Snead has served as interim CFO since June, and will continue to report to board chair and interim prez & CEO Robert Sledd, the Richmond, Va.-based company said. He joined Owens & Minor in 2010 as corp dev VP and has held positions including treasurer and global solutions strategic biz unit finance group VP, the company added.

Prior to joining Owens & Minor, Snead served as Barclays Capital M&A group director in New York, the company said.

“We are very pleased Robert is taking on this important, strategic role for Owens & Minor. Robert’s eight years of service to Owens & Minor in a variety of finance and strategy roles have prepared him well for this leadership position. He brings valuable experience in working with the investor community, providing disciplined financial management oversight, and partnering with other leaders to help drive operating efficiency and profitability. Without question, Robert is the right choice for Owens & Minor as we prepare for the future,” board chair and interim prez & CEO Sledd said in a press release.

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FDA grants breakthrough status to joint Merck-Bayer AI program

FDA-logo-newMerck and Bayer have been granted FDA Breakthrough Device Designation for the collaborative Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Artificial Intelligence Pattern Recognition software.

CTEPH can be difficult to diagnose because its symptoms are similar to asthma and chronic obstructive pulmonary disease symptoms. CTEPH affects five people per million annually worldwide. Computed tomography pulmonary angiography and a ventilation/perfusion scan can be used to determine if thromboembolic occlusion is causing pulmonary hypertension in patients.

Get the full story on our sister site, Medical Design & Outsourcing.

The post FDA grants breakthrough status to joint Merck-Bayer AI program appeared first on MassDevice.

Study: Heat-stable drug formulation offers new option to prevent postpartum bleeding

Data from a collaboration between Ferring PharmaceuticalsMerck (NYSE:MRK) and the World Health Organization showed that a heat-stable formulation of carbetocin is as effective as oxytocin for the prevention of excessive bleeding following vaginal birth.

Millions of women are affected by postpartum hemorrhage every year, according to Ferring Pharmaceuticals. Traditionally, women are given oxytocin to prevent the deadly condition. But oxytocin has to be stored and transported at 2 – 8°C, which is not always possible in countries where adequate storage and distribution resources are scarce.

Get the full story at our sister site, Drug Delivery Business News.

The post Study: Heat-stable drug formulation offers new option to prevent postpartum bleeding appeared first on MassDevice.

OncoSec to combine ImmunoPulse device with Merck’s immunotherapy in breast cancer trial

OncoSec Medical (NSDQ:ONCS) expanded its relationship with Merck (NYSE:MRK) today, announcing a deal to combine its ImmunoPulse IL-12 device with Merck’s anti-PD-1 therapy, Keytruda, in a Phase II trial of patients with triple negative breast cancer.

The trial is slated to study the drug-device combination in patients with inoperable locally advanced or metastatic cancer who have failed at least one systemic chemotherapy or immunotherapy.

Get the full story at our sister site, Drug Delivery Business News.

The post OncoSec to combine ImmunoPulse device with Merck’s immunotherapy in breast cancer trial appeared first on MassDevice.

Mass. Supremes: Pharma Cos. liable for generic labeling issues

Merck (NYSE:MRK) and other large brand-name pharmaceutical manufacturers could be legally liable for injuries resulting not from the use of their brand name products, but from generic versions of those drugs made by other companies, according to a new ruling from the Massachusetts Supreme Judicial Court.

The court ruling could set the precedent that such brand-name pharma companies could be found liable for reckless behavior if they fail to update labeling for their products which are also used for generic versions, according to court documents.

Read the whole story on our sister site, Drug Delivery Business

The post Mass. Supremes: Pharma Cos. liable for generic labeling issues appeared first on MassDevice.

Appeal board to review Sanofi’s Lantus insulin injection patents

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    Here were some of the more interesting conversation points across a couple of the panel discussions I attended.

     Telemedicine, telehealth and the impact of 5G


    Most people don’t think of cancer treatment and telemedicine intersecting but as Rebecca Kaul, Houston-based MD Anderson Chief Innovation Officer noted, cancer center patients tend to have a varied geographical base. “We think telemedicine is highly important — two-thirds of our patients come from outside of Texas.”

    John Donovan, AT&T Chief Strategy Officer and group president for AT&T Technology and Operations, noted that 5G had the potential to improve the quality of virtual interactions between patients and physicians.

    5G will improve the quality of technology execution from telemedicine from near real time to real time, he noted. Donovan pointed out that healthcare is one of several industries hindered by slow technology. This advancement could help not only healthcare but other industries as well such as fintech.

    Coping with technology shortcomings

    Another interesting part was when the discussion tackled some of the shortcomings of technology, particularly when our expectations can’t be matched by the reality on the ground. Greg Simon, director of the Biden Cancer Initiative at the Biden Foundation, defended platforms like IBM Watson by noting that even the Hubble space telescope when initially launched had blurry vision. It took a team of scientists to correct that.  The computer platform is not a panacea because one of the challenges of new technology is that it takes time before it rises to its potential.

    “It’s not that surprising that Watson isn’t perfect,” Simon noted. “It is still a student. It reads everything but it doesn’t know everything.”

    Aman Bhandari, Merck executive director of data, sciences and partnerships, observed that there is dissonance between what we have the ability to do and what is actually happening in the healthcare delivery system.

    “So much great innovation is happening, yet our current health delivery system isn’t working to make those innovations available to everyone,” Bhandari said.

    Even immunotherapy, which is a hot area of investment for venture capital and is regarded as a promising new technology, has its own set of shortcomings. The problem with immunotherapy is that it can attack healthy tissue as well as unhealthy tissue.

    Big data and interoperability often rise to the surface as obstacles in healthcare and these sessions were no exception. In a lightning round for a panel moderated by Halle Tecco, who founded Rock Health and now teaches a class at Columbia Business School, she asked panelists what’s the biggest challenge they currently face. Bhandari noted data liquidity and Tecco’s husband Jeff Hammerbacher, the cofounder of Cloudera, called attention to the “Tower of Babel” around data.

    Every regulation at the FDA has been written in blood

    With speculation that President Donald Trump’s nomination to head up the U.S. Food and Drug Administration will champion deregulation, several of the panelists in one session feared what the consequences might be. Simon and Bhandari touched on the evolution of the FDA.

    “Every regulation at the FDA has been written in blood,” said Simon solemnly. “You will not hear from the cancer community that the FDA is slow and burdensome.”

    Bhandari added, “Every major regulation has happened because of a public health concern.”

    Simon expressed the hope that the administration would steer clear of cancer initiatives that have already been launched.

    Another panelist expressed the hope that providing better education support to patients about particular clinical trials would help with poor recruitment efforts.

    Simon was also frustrated by the way data from clinical trials is not released until one year after the clinical study was finished and hoped that would change.

    Advice for startups

    Tecco also asked her panel to offer some advice for startups. At some point in the conversation, Bhandari expressed some frustration with startups that make AI and machine learning claims without providing a more nuanced approach to how they are using these tools or even noting the slight differences between the two. Machine learning is one aspect of AI, which is a much broader term.

    Simon advised entrepreneurs to “immerse yourself in patients” and focus on their interests and priorities rather than investors, adding:

    “Don’t think about investors or the markets — if you immerse yourself in patients, you will figure something out.”

    Photo: xrisca30, Getty Images,