Category Archives: Biotech

American Hemp Processing To Roll Out Mobile Extraction Units

Sacramento, California, 2019-Dec-10 — /EPR HEALTHCARE NEWS/ — American Hemp Processing (AHP) is excited to announce the design completion of their Mobile Hemp Extraction Unit (MEHU). This is a key step in AHP’s expansion to increase production to 400,000lbs of hemp per month that will be completed 1st quarter 2020. The mobility of the MEHU reduces overall processing costs, mitigates many of the risks associated to transportation, and increases transparency with farmers.

The MHEU units bring significant benefits to the farmer from both a financial and risk mitigation perspective. “Most hemp farms are not close to processing facilities. Transportation is a large cost and increases the risk of degradation and contamination. On top of that, farmers still have to deal with legal issues in states that aren’t familiar with hemp and mistake it for marijuana,” says Andrew Alvarez Co-Founder and Chief Technology Officer “Additionally, it increases transparency with farmers and helps educate them along the way to build synergistic relationships”.

“The design of the MHEU was Phase 2 of our strategy,” says Shick Park Co-Founder and Chief Operations Officer, “Phase 1 was developing a scalable extraction and remediation process enabling us to create high quality and compliant CBD oil, and Phase 3 is the roll-out of the mobile extraction units on to farms fall of 2020.”

“This caps off a 12 month design process by our engineers and now we go to the assembly phase. These units will take approximately 120 days each to build, and we plan to initially build 3,” says Co-Founder and CEO Tom Richardson. “This has been a very rewarding journey for us, from meeting farmers all over the country, to government legislators, to fine tuning the extraction process, to meeting other processors and sharing ideas, we feel very confident about the Cannabinoid Sector business.”

Via EPR Network
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Parenteral Drug Association’s “ICH Q7 GMP for APIs” online training module is now endorsed by ICH

BERLIN, 22-Nov-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) is proud to announce that its “ICH Q7 GMP for APIs” online training module is now endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use as an “ICH Recognised Training Programme.”

The training module received the distinction after PDA demonstrated to ICH that it meets the twelve eligibility criteria for the program. Among these are its mission to serve as a neutral convening platform to engage expert stakeholders from industry, academia, advocacy groups, non-profits, and/or regulatory agencies on critical regulatory topics, and its promotion of regulatory convergence to accelerate innovation and improve healthcare globally.

The free “ICH Q7 GMP for APIs” training module introduces and improves understanding of the ICH quality guideline, Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. The webinar is intended for pharmaceutical professionals working with APIs. More information on the webinar is available here: https://www.pda.org/global-event-calendar/ich-q7-gmp-for-apis.

SOURCE: EuropaWire

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First Rhenium-SCT® (Skin Cancer Therapy) treatment in Germany done by Dr. Lutz-Hendrik Holle

HANAU, Germany, 4-Oct-2019 — /EPR HEALTHCARE NEWS/ — OncoBeta®, a Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today, that Dr. Lutz-Hendrik Holle, Medical Director of the interregional professional association for nuclear medicine in Hanau, has accomplished the first Rhenium-SCT® (Skin Cancer Therapy) treatment in Germany. This state-of-the-art technology of local radionuclide therapy offers a painless and non-invasive treatment option for patients with basal cell carcinoma and squamous cell carcinoma (BCC and SCC) and the interregional professional association for nuclear medicine Hanau is the first center in Germany that offers the Rhenium-SCT®.

With approximately 50.000 outpatient examinations annually, the interregional professional association for nuclear medicine Hanau is one of the biggest nuclear medicine service providers in Hesse. The offered services include a variety of different modern treatment and diagnostic methods. The key argument for the expansion of the spectrum was that the Rhenium-SCT® is a new, painless and highly efficient treatment option that also delivers excellent cosmetic results. Besides being a painless alternative to other procedures, the Rhenium-SCT® also allows the treatment of numerous NMSC lesions consecutively in a single session, which was already realized during the first treatment in Hanau. This has also attracted international attention so that an American patient travelled to Hanau for the treatment.

“This therapy is particularly suitable for tumor localizations where good cosmetic results are to be achieved. The fact that the treatment is completely painless and can be performed in just one session is a great advantage”, says Dr. Lutz-Hendrik Holle, Medical Director of Nuclear Medicine in Hanau.

“We are very happy and proud to be able to offer our revolutionary treatment to patients in Germany now. The interregional professional association of nuclear medicine in Hanau is an excellent partner for NMSC patients in the fight against NMSC”, said Shannon D. Brown III, CEO and Managing Director of OncoBeta® GmbH. “Unfortunately, Germany is one of the countries that has experienced a drastic increase in newly diagnosed NMSC cases in recent years. Our highly qualified team strives to provide physicians and patients with a non-invasive and affordable solution to treat NMSC, while focusing on the needs of the patient.”

The global incidence of non-melanoma skin cancers has been drastically increasing over the past decades. Depending on the source, it is estimated that there are over 5 million non-melanoma skin cancer cases reported globally each year. In certain analyzed areas of Germany there was an increase in the incidence between the year 2005 and the year 2014 by about 30%1. To serve the increasing medical need for innovative therapies in this field and to improve the quality of patients’ lives, OncoBeta® GmbH has developed its innovative Rhenium-SCT® which only require a single application in most of the cases, applied in one single session with excellent aesthetic outcomes.

Via EPR Network
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CoapTech and Fidmi Medical to Collaborate on Groundbreaking G-Tube Systems

Baltimore, MD, 2019-Sep-18 — /EPR HEALTHCARE NEWS/ — CoapTech LLC (Baltimore, MD) and Fidmi Medical, Ltd. (Caesarea, Israel) announced today that they will be collaborating on bringing to market a set of next-generation products for the initial placement and long-term maintenance of gastrostomy tubes (G-tubes). The collaboration between CoapTech and Fidmi will focus on integrating the company’s two technologies and expanding their collective market opportunities.

Gastrostomy tubes, which help patients receive long-term nutritional support, are typically placed endoscopically and need to be replaced every 3-6 months.

CoapTech’s PUMA-G System allows initial gastrostomy tube placement by non-surgeons/ gastroenterologists, outside of the endoscopy suite, using point-of-care ultrasound at the patient bedside. This novel approach can be performed in the ICU, emergency room, and eventually outside of the hospital setting, substantially reducing costs for tube placement.

Fidmi Medical’s innovative low-profile gastrostomy system is unique in that it can be utilized for both initial placement and replacement and has several features which make it more durable and comfortable for patients. Gastrostomy tubes very often get dislodged, clogged, or infected, and need to be replaced frequently. Fidmi’s improved low-profile gastrostomy tube is placed just like any standard PEG tube but has an easily replaceable inner tube which can be changed by patients without the need to re-enter the healthcare system for replacement procedures. This will result in fewer complications with patients’ g-tubes, therefore potentially reducing healthcare costs for payers and healthcare systems; as well as providing a substantial improvement in quality of life for patients and their caregivers.

Fidmi Medical Chairman, Lloyd Fishman, commented, “We are excited to collaborate with CoapTech in development and marketing. Both companies have developed cutting-edge technologies that will improve patient care and contribute to the ease, efficiency and confidence of clinicians’ work in the gastrostomy field.”

Dr. Steven Tropello, CoapTech’s founder and CMO said, “In combination these systems will be compatible with Push or Pull methods, be implantable in a wide variety of clinical settings, and require minimal readmission to the hospital and fewer visits to the ER. The synergy will reduce both front and back-end costs for hospitals and payers, and make care safer and more patient-centered.”

Via EPR Network
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2019 PDA Europe Biomanufacturing Conference in Munich: new speakers announced

2019 PDA Europe Biomanufacturing Conference in Munich: new speakers announced

BERLIN, 14-Aug-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) today announced representatives of seven health authorities have been invited to speak at the 2019 PDA Europe Biomanufacturing Conference, 3-4 September 2019 in Munich, Germany. The following health authorities have confirmed speakers:

  • Danish Medicines Agency
  • Dutch Medicines Evaluation Board
  • European Medicines Agency
  • European Directorate for the Quality of Medicines & Healthcare (EDQM)
  • Swedish Medicines Agency

Mats Welin, Medical Products Agency, Sweden, and Dolores Hernan, European Medicines Agency, will provide an opening plenary talk on Accelerated Access and discuss the results of a 2018 EMA/FDA workshop on quality considerations for early access approaches. Those intrigued by Accelerated Access can learn more in the follow-up session, moderated by Martjin van der Plas, Dutch Medicine Evaluation Board. Welin and Hernan will participate in a panel discussion ending that session.

After a the first-day luncheon, Nanna Kruse, Danish Medicines Agency, will peel away some of the mystery surrounding the forthcoming International Conference on Harmonization (ICH) Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. In a parallel track, the Austrian Agency for Health and Food Safety (speaker TBD) will intrigue the audience with a review of challenges regulators routinely face with the advent of new vaccines and innovative biologics.

Bright and early on 4 September, the EDQM’s Gwenael Cirefice and the Dutch Medicines Evaluation Board (speaker TBD) turn the attention to ICH and advances in test methodologies. In a parallel track, Martjin van de Plas returns to the podium to review regulatory ideas regarding quality by design and control strategies. Hernan takes the mic as the conference’s last speaker to discuss EMA’s 2025 regulatory science strategy.

The meeting will close with a panel discussion including all the regulatory representatives participating.

Learn more about the topics that will be examined in-depth and/or to register. https://www.pda.org/global-event-calendar/event-detail/biomanufacturing-conference

Members of the press are welcome to apply for a press pass. https://www.pda.org/about-pda/press-pass-request-form

SOURCE: EuropaWire

2019 Red Herring North America Top 100 Winner: New recognition of OncoBeta’s success in developing and providing an innovative therapy for non-melanoma skin cancer patients

Pasadena, CA, U.S.A., 6-Jul-2019 — /EPR HEALTHCARE NEWS/ — OncoBeta®, a Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today, that it was honored as a Red Herring Top 100 North America Award winner recognizing the continent’s most exciting and innovative private technology companies. After being recognized with the Red Herring Top 100 Europe Award earlier this year, this is now the second recognition obtained by Red Herring.

The winners, celebrated at a special awards ceremony at the Westin Pasadena hotel, have been chosen from thousands of entrants, whittled down to hundreds making the trip to California. The ceremony, led by Red Herring chairman Alex Vieux, was preceded by two days of keynote speeches, discussions and finalist presentations.

Companies were judged by industry experts, insiders and journalists on a wide variety of criteria including financial performance, innovation, business strategy, and market penetration. Winners ran the gamut of verticals, from FinTech and Marketing to Security, IoT, and many more industries.

Red Herring’s editors have been evaluating the world’s startups and tech companies for over two decades. It gives them the ability to see through the industry’s hype to pick firms that will continue on a trajectory to success. Brands such as Alibaba, Google, Kakao, Skype, Spotify, Twitter and YouTube have all been singled out in Red Herring’s storied history.

“2019’s crop of Top 100 winners has been among our most intriguing yet,” said Vieux. “North America has led the way in tech for so many years, and to see such unique, pioneering entrepreneurs and companies here in California, which is in many ways the heartland of the industry, has been a thrilling experience.”

“What has excited me most is to see so many people forging niches in high-tech and cutting edge sectors,” added Vieux. “Some of the technical wizardry and first-rate business models showcased here at the conference has been fantastic to learn about. We believe OncoBeta® embodies the drive, skill and passion on which tech thrives. OncoBeta® should be proud of its achievement – the competition was incredibly strong.”

“Being named as one of the Red Herring’s Top 100 North America award winner in addition to the Top 100 Europe is a great honor for us.” states Shannon D. Brown III, CEO of OncoBeta®. “The spirit of the award aligns perfectly with our team’s mission in the fight against non-melanocytic skin cancer (NMSC) with the Rhenium-SCT®.”

The complete list of the 2019 Red Herring North America Top 100 Winners can be found here in alphabetical order: https://www.redherring.com/2019-rhna-top100-winners/

Red Herring’s press release is available online at https://www.redherring.com/red-herring-2019-top-100-north-america-winners-press-release/

SOURCE: EuropaWire

EMA, MHRA and U.S. FDA among regulatory agencies participating at PDA’s 4th Annual European Meeting in Amsterdam

BERLIN, 10-Jun-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) is excited to host its 4th Annual European Meeting: Global Healthcare of the Present and the Future, June 25-26 in Amsterdam, The Netherlands, the new location of the European Medicines Agency, where industry and regulatory agencies will present their perspectives on the transformation unfolding in the pharmaceutical sector regarding the digitalization and automation of manufacturing processes.

From the Max Planck Institute for Human Development, Felix G. Rebitschek will deliver the keynote speech, “Decision-Making Under Uncertainty.” Following him, the opening plenary “Regulatory Updates – Current Situation” will discuss understanding regulatory frameworks in an atmosphere of rapid change and provide the opportunity to participate in conversation with regulators and industry representatives.

Regulatory agencies sharing industry updates include the European Medicines Agency, U.S. FDA, WHO, MHRA and HPRA, PIC/S.

A series of parallel tracks will offer the chance to learn about topics ranging from virtual reality, data quality management, manufacturing technologies and much more.

Learn more about the topics that will be examined in-depth.

Registration (https://store.pda.org/Meetings/Login.aspx?ID=4520) can be completed until June 24.

Bona fide members of the press are welcome to apply for a press pass.

SOURCE: EuropaWire

2019 PDA EU Advanced Therapy Medicinal Products: Cell and Gene Therapy – From Promise to Cure Conference

BERLIN, 28-May-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) is pleased to announce the speaker lineup for the 2019 PDA EU Advanced Therapy Medicinal Products: Cell and Gene Therapy – From Promise to Cure Conference, in Vilnius, Lithuania, June 4-5. Expert speakers representing industry, government and academia will cover the full breadth of scientific and regulatory considerations for successfully launching and manufacturing cell and gene therapies.

Lithuanian University of Health Science professor Romaldas Maciulaitis will get the meeting off to a quick start with his presentation, “Development and the Use of ATMPs in EU/Lithuania.”

Following him in the opening plenary session is Alistair Gibb from the UK Medicines and Healthcare Products Regulatory Agency, presenting “ATMPs System-wide Challenges from Innovation to Uptake – Pragmatic Supportive Regulation and Standards.”

The Paul-Ehrlich Institute’s Isabelle Bekeredjian-Ding takes the podium after her British counterpart with, “From Individualized to Standardized Microbiological Quality Control in ATMP Manufacturing.”

The PDA EU ATMP Conference comes just a month after PDA’s successful Cell and Gene Therapy Conference in Long Beach, Calif., May 6 – 7. That conference drew 200 participants. Earlier this year, PDA published Technical Report No. 81: Cell-Based Therapy Control Strategy.

Go here to see the full speaker lineup.

Press passes are available here to bona fide members of the press.

SOURCE: EuropaWire

The interregional professional association for nuclear medicine in Hanau has become the first treatment center in Germany to offer the Rhenium-SCT® (SCT= Skin Cancer Therapy)

GARCHING N. MUNICH, Germany, 13-May-2019 — /EPR HEALTHCARE NEWS/ — OncoBeta® GmbH, a commercial stage Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), is pleased to announce that the interregional professional association for nuclear medicine in Hanau now offers the Rhenium-SCT ® (SCT= Skin Cancer Therapy) as the first treatment center in Germany.

With approximately 50.000 outpatient examinations annually, the interregional professional association for nuclear medicine Hanau is one of the biggest nuclear medicine service providers in Hesse. The offered services include a variety of different modern treatment and diagnostic methods which are state-of the art in science and technology.

“Offering NMSC skin cancer patients a highly efficient, painless, innovative therapy with excellent aesthetic results was the driving reason to establish this treatment method in our clinic,” says Dr. med. Lutz-Hendrik Holle, Medical Director of Nuclear Medicine in Hanau.

“We are delighted that our innovative skin cancer therapy Rhenium-SCT® is now being offered by the Nuclear Medicine in Hanau and we are looking forward to this collaboration”, states Shannon D. Brown III, CEO and Managing Director of OncoBeta® GmbH. “For us, this is an important step to offer the treatment method in addition to Italy, South Africa and Australia now also in Germany. In order to provide our treatment to as many skin cancer patients as possible, it is of course our goal to offer the availability of the therapy nationwide in Germany in the future.”

The global incidence of non-melanoma skin cancers has been drastically increasing over the past decades. Depending on the source, it is estimated that there are over 5 million non-melanoma skin cancer cases reported globally each year. In Germany the number of newly diagnosed patients is about 200,000 annually and it is assumed that this number increases within the next years. To serve the increasing medical need for innovative therapies in this field and to improve the quality of patients’ lives, OncoBeta® GmbH has developed its innovative Rhenium-SCT® which only require a single application, applied in one single session with excellent aesthetic outcomes.

If interested, patients and doctors can either contact the interregional professional association for nuclear medicine in Hanau directly or OncoBeta® GmbH.

SOURCE: EuropaWire

Mr RICHARD GUILLAUME IS APPOINTED TO THE DIAFIR BOARD OF DIRECTORS

RENNES, FRANCE, 2019-Apr-08 — /EPR HEALTHCARE NEWS/ — DIAFIR, a medical technology company focused on the development, manufacture and sale of innovative diagnostic solutions in nonalcoholic steatohepatitis (NASH) and septic arthritis announces today the appointment of Mr Richard Guillaume to its Board of Directors.

Mr Guillaume has a wide experience of over 30 years in international management and operations in the pharmaceutical industry as well as in the medtech. Drawing on his experience and knowledge in the field of medical devices and diagnosis, Mr Guillaume will advise and help the Company in its development.

Alongside his role at Diafir, Richard Guillaume has been the General Manager of Echosens from 2008 until 2013. He was previously Executive Vice President Global Sales and Marketing at Blatchford, a UK medical device company. He was also member of the board. Prior, he held various positions such as Director Global Marketing of Abbott International in Chicago and Director Category Development Europe of Mead Johnson. Richard holds a Master in Business Administration from Poitiers University and a DESS in Marketing from Paris Dauphine completed by a general management program at INSEAD.

 

Via EPR Network
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The LentiGlobin application for cMAA at the EMA from bluebird bio still in review process by CHMP

LONDON, 27-Mar-2019 — /EPR HEALTHCARE NEWS/ — The LentiGlobin application for Conditional Marketing Authorization (cMAA) at the EMA from bluebird bio is still in the process of being reviewed by CHMP during their 25-28 March 2019 meeting. An opinion for the cMAA is expected to be released soon.

SOURCE: EuropaWire

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University of Pretoria Prof. Mike Sathekge is First in South Africa to Treat Non-Melanocytic Skin #Cancer Patients with Rhenium-SCT®

Garching n. Munich, Germany, 26-Nov-2018 — /EPR HEALTHCARE NEWS/ — OncoBeta® GmbH, a commercial stage Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today that Prof. Mike Sathekge from the University of Pretoria, Steve Biko Academic Hospital Nuclear Medical department and his clinical team has treated the first non-melanocytic skin cancer patients in South Africa with the innovative Rhenium-SCT® skin cancer treatment System. This next-generation radionuclide therapy technology applied by the nuclear medicine physician offers a new singles session, painless treatment for patients suffering from Basal Cell – and Squamous Cell Carcinomas (BCCs and SCCs).

The global incidence of non-melanoma skin cancers has drastically increased over the few past decades. Depending on the source, it is estimated that there are over 5 million non-melanoma skin cancer cases reported globally each year. Approximately 80% of non-melanoma skin cancers are basal cell carcinomas or squamous cell carcinomas with South Africa having one of the highest incidence rates in the world.

Prof. Mike Sathekge and his team at the University of Pretoria, Steve Biko Academic Hospital are focused on providing patients with personalized care using state-of-the-art technology that can deliver high-precision therapy and diagnostics with minimal side effects. The specialized team of experts in the nuclear medicine and medical physics, work closely with other disciplines within the university hospital, referring physicians, and other institutions, to ensure patients receive the best possible treatment for their specific type of cancer.

Martin Magwaza, CEO of Tautomer (PTY) LTD Oncobeta®’s distribution partner for the Rhenium-SCT® in Africa, is dedicated to providing South Africans with new innovative and effective therapies across the continent, coordinating with representatives from all levels of government and state for the health care landscape.

“The start of the Rhenium-SCT® in South Africa is a significant milestone in the international expansion of our ground-breaking treatment for BCCs and SCCs.,” said Shannon D. Brown III, CEO and Managing Director of OncoBeta® GmbH. “Our vision of bringing a revolutionary affordable skin cancer therapy to physicians and patients all over the world has come one step closer today”.

SOURCE: EuropaWire

Dr. Christina Marrongelli chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to moderate their 2018 conference in Paris

Dr. Christina Marrongelli chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to moderate their 2018 conference in Paris

Marrongelli selected for her expertise in Botanical Drug Development

LONDON, Jun-16-2018 — /EPR Healthcare News/ — As a leading expert in her field, Dr. Christina Marrongelli, PharmD has been chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to moderate their 2018 conference: Exploring New Trends & Innovations in Pharmacology and Natural Compounds. The conference is being held in Paris, France on June 18, 2018.

Dr. Marrongelli, who is an adjunct professor at the Medical University of South Carolina in the department of drug discovery and biomedical sciences will also present “Developing and Marketing Botanical Drugs in the United States”.

The United States, which has the largest pharmaceutical market in the world, demonstrates a strong demand for the use of botanicals as medicine. However, to date only two prescription botanical drugs are currently approved for use in the USA: Veregen® (sinecatechins) and Mytesi™ (crofelemer).

Marrongelli attributes this disconnect between supply and demand to hidden barriers. She notes that with the worldwide herbal drug market is expected to reach nearly $86.74 billion by 2022, businesses must identify and address these barriers so that heterogeneous botanical drug products can obtain the approvals necessary to meet the consumers growing expectations and demands for botanical medicines.

To further explain the barriers to regulation of botanicals, Marrongelli points to the Botanical Drug Development Guidance for Industry from the U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER) that was last updated in 2016. According to publication, regulation of botanicals in the U.S. is different from regulation in the rest of world. The U.S. does not have a separate regulatory category for traditional or herbal medicines: A botanical product may be classified as a food (including a dietary supplement), drug (including a biological drug), medical device, or cosmetic under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Whether an article is a food, drug, medical device, or cosmetic depends in large part on its intended use.

To learn more about the issues and barriers to the development of botanical drugs, please contact Dr. Marrongelli at Marronge@musc.edu or DrM@pharmD.expert.

SOURCE: EuropaWire

Health Innovation Centre of Southern Denmark, Fraunhofer Institute Portugal and ProjectRay named the winners of the European Silver Economy Awards 2018

Winners of the first European Silver Economy Awards: Boaz Zilberman (ProjectRay), Anne Friis Hansen (Health Innovation Centre of Southern Denmark) and Ana Vasconcelos (Fraunhoder Institute Portugal)

BRUSSELS, Belgium, 20-May-2018 — /EPR Healthcare News/ — On Thursday May 3, the first edition of the European Silver Economy Awards has celebrated its winners under the patronage of Mariya Gabriel, Commissioner for Digital Economy and Society, and Markku Markkula, First Vice-President of the Committee of the Regions. The ceremony took place at the Committee of the Regions in Brussels and has been designed as an event that brings together key speakers and innovators from both the public and private sector.

The first prize in the category Public Authorities has been awarded to the Health Innovation Centre of Southern Denmark (Denmark) for their Generic Telemedicine Platform. The Fraunhofer Institute Portugal (Portugal) submitted a tool for fall prevention and detection (GoLive Solutions) and was the winning Non-for Profit Organisation. Introducing a smartphone solution (RAY Solutions) for visually impaired people, ProjectRay (Israel) has won in the category For Profit Organisation.

The Silver Economy Awards have been launched to recognise and reward innovative ICT solutions from all sectors, to raise awareness of the potentials of this section of the economy and to bring together European stakeholders under a common goal: supporting and improving the quality of life of older persons in society. On behalf of Commissioner Gabriel, Cabinet Member Manuel Mateo Goyet described the first Silver Economy Awards as representing a “milestone on our way towards becoming a truly age-friendly Europe”, and promoted the ceremony as “a unique occasion to send a very positive message on how we see the future of ageing” showing “the true value of collaboration in Europe”.

Celebrating the nine finalists and their dedication to making Europe an age-friendlier place, Markku Markkula, host and moral patron of the Silver Economy Awards, declares his acknowledgement: “I want them in my region”. More than 95 applications coming from 22 countries have been submitted for consideration in three awards categories referring to the type of organisation. Over 40 Silver Economy experts were involved in the three-staged evaluation process to determine Winner, Second and Third.

For more details on the winner entries and an overview of the final ranking of the first European Silver Economy Awards 2018 edition please visit www.silvereconomyawards.eu/sea/2017/awards#Winners.

SOURCE: EuropaWire

FINALLY, A REAL INNOVATION IN DENTAL CARE – THE ONLY DUAL MODE LIGHT THERAPY ELECTRIC TOOTHBRUSH LAUNCHES ON KICKSTARTER

Los Angeles, California, 2018-Mar-26 — /EPR HEALTHCARE NEWS/ — Bristl combines proven science of light therapy with sonic vibration to improve oral care. The company also offers a subscription service to replace brush heads, so having the best oral health is also convenient.

Available on Kickstarter on Monday, March 26th at 9am (PST)

The combination of Bristl’s features, convenience, and style make for true market disruption:

Gum Health
Visible Red light (620–750 nm in wavelength) has been clinically proven to heal gum tissue and prevent inflammation. The same technology is often used in skincare; Bristl is bringing it to the everyday tooth brushing routine.

Kill Bacteria
Visible blue light (450–495 nm in wavelength) has been clinically proven to kill and prevent oral bacteria that causes gingivitis and other gum disease. This safe and natural blue light is proven to be effective, and Bristl is proud to bring it to market.

Get Rid of Plaque
Bristl has three sonic vibration modes: regular, gentle, and off. Sonic vibration is recommended by dentists as it has the highest cleaning ability without damaging gums. The brush head is also particularly designed to reach in crack and crevices while letting light pass through the bristles.

A Few Stats
According to a study published in the Journal of Periodontology and Implant Science (Vol. 44: pp. 280-287), Bristl’s technology (even with only red light) was effective in achieving the following:

  • 86% reduction in bacteria that causes destruction of tooth supporting tissue
  • 117% improvement in PPD (Periodontal Pocket Depth) which indicates gum health
  • 80% improvement in CAL (Clinical Attachment Level) which is another metric for gum health

Why Us?
The Bristl Science team consists of a group of innovators and scientists looking to use advanced technology to improve everyday lives. While we of course wish to build a successful business, we are doing so responsibly; Bristl has committed to donating a percentage of every sale to America’s Toothfairy to provide underserved children with dental care. Whether a customer or an underserved child, we’re on a mission to maximize oral health everywhere.

This is just the beginning. The Bristl Science team will work tirelessly to innovate and build products that improve lives, maximize health, and promote good. The Bristl light therapy toothbrush is just the first step toward a healthier future.

Clinical backing, photos, founders quotes, and more information can be found in our Media Kit:
http://bit.ly/2HtKTJ8

Campaign Preview: https://www.kickstarter.com/projects/574806194/565862801?ref=450743&token=dbd4feaa

Via EPR Network
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Alliance Life Sciences to present expanded portfolio of pricing & market access services at the World Pharma Pricing and Market Access Congress 2018

SOMERSET, N.J. / LONDON, UK, 19-Mar-2018 — /EuropaWire/ — Alliance Life Sciences, a leading global life sciences consulting, pricing data and technology provider, announced that it is a sponsor at the World Pharma Pricing and Market Access Congress 2018 taking place March 20-21 in London, United Kingdom. As part of the largest pharmaceutical commercialization organization that services more than 300 of the industry’s top pharmaceutical, biotech and medical device companies, Alliance will present its expanded portfolio of pricing and market access services. The focus will be on pricing and reimbursement data managed by PricentricOne and pricing governance, reference and tender pricing software manage by PriceRight.

Now in its 12th year the World Pharma Pricing and Market Access Congress brings together the most innovative leaders and organizations to discuss all aspects of evidence, access and pricing. This year’s event will feature over 150 speakers and a greater range of topics being covered including Big Data & AI, rare diseases, advanced therapies and other emerging, innovative areas.

Alan Crowther, President of Global Markets noted “Alliance Life Sciences is pleased to be a sponsor of the World Pharma Pricing & Market Access congress, particularly this year. We have made a number of investments in our people and infrastructure in Europe. Our acquisition by Water Street partners in 2017 allowed us to offer enhancements in our Market Access offerings too. Europe continues to be our focus market and World Pharma Pricing & Market Access congress is a great venue to showcase our expended capabilities”.

SOURCE: EuropaWire

Prof. Lucien Abenhaim: There is an incredible challenge for the sustainability of health systems across the world

Prof. Lucien Abenhaim

LONDON, Dec-3-2017 — /EuropaWire/ — On December 5-6, 2017, 200 high-level experts from government, academia, biopharmaceutical developers and patient organisations convene in London (UK) to address the mounting challenge of accessibility and patient access to high-value, high-cost medical therapies.

The not-for-profit executive forum is organised by the London School of Hygiene and Tropical Medicine and analytica|LASER, a global research consultancy, to investigate topical questions around drug policy, global health systems sustainability and innovation funding through a combination of case studies, panel sessions, and roundtables. Delegations are registered from over 70 public and private organisations, including the World Health Organization, as well as health systems representatives from Belgium, England, Estonia, Croatia, France, Germany, Italy, Norway, Sweden, the United States and Wales. Multiple patient organisations support the meeting to ensure that the patient voice is reflected in all deliberations.

“Access to life-saving drugs is not a new challenge. The paradigm of accessibility was changed completely in the face of the deadly HIV epidemic. This time, however, accessibility concerns almost every domain of medicine such as cancer, auto-immune diseases and rare diseases. We must act now,” says Prof Peter Piot, Director of the London School of Hygiene & Tropical Medicine and former head of UNAIDS.

“There is an incredible challenge for the sustainability of health systems across the world”, says Prof. Lucien Abenhaim, London School of Hygiene & Tropical Medicine and Chairman of Analytica Laser. “It is critical that drug developers and health system engage on actionable proposals that address concerns around value, cost and overall access to innovation for the patients who need it. We are at an inflection point – the paradigms of the 1990’s can no longer guide us,” he adds.

The main plenary on December 6th features scheduled remarks by over a dozen authorities in the field, including Professor Baron Peter Piot (Director, London School of Hygiene & Tropical Medicine and former Head, UNAIDS), Dr. Olivier Brandicourt (Chief Executive Officer, Sanofi), Dr. Sarah Garner (World Health Organization), Prof. Dominique Le Guludec (President, French HAS), Sir Andrew Dillon (Chief Executive, National Institute for Health and Care Excellence UK) and Dr. Harold Paz (Chief Medical Officer, Aetna). The plenary is preceded by a scientific seminar on December 5th which gathers globally renowned academics to explore new frontiers on the methodology for the appraisal and valuation of high-value medicines.

Please contact the organisers for more information on the programming and media access, or refer to www.accessibility-symposium.org

SOURCE: EuropaWire

MEDLAB Series Europe, 13-15 Sep 2017, will cover Point of Care Testing (POCT), Histopathology, Lab Management, Microbiology and Haematology

Spain, 04-May-2017 — /EuropaWire/ — After many years of operating successful MEDLAB events around Africa, Asia and the Middle East, Informa Life Sciences Exhibitions, the worlds leading publishing and exhibitions company, has announced that the MEDLAB Series will be expanding its presence into Europe. Taking place at the Barcelona Congress Centre in Barcelona, Spain, from 13-15 September 2017, more than 3,000 industry professionals are expected to attend Europe’s leading event for laboratory management and diagnosis.

With the European In-Vitro Diagnostics (IVD) market expected to reach USD 15.5 billion by 2024, a platform such as MEDLAB presents a huge opportunity for global laboratory industry leaders, including manufacturers, dealers and distributors, to make inroads into the European market. Housing international exhibitors and covering 2,000 sqm of exhibition space, MEDLAB Europe will give visitors from across the world an opportunity to access cutting-edge laboratory products, next-generation technology, innovative services and world-class educational content.

According to Tom Coleman, Group Exhibition Director, MEDLAB Series: “The launch of MEDLAB Europe is in line with our global expansion strategy for our MEDLAB series of events. The increasing prevalence of chronic diseases, rising geriatric population coupled with the rising awareness towards early diagnosis, has positioned the European IVD and medical laboratory market as a critical market for manufacturers, services providers, and dealers and distributors from across the globe. MEDLAB Europe will generate substantial value for our customers and partners by driving further product innovation and deeper engagement in these specific markets.”

Over the four-day event, MEDLAB Europe will also offer a multi-disciplinary congress tackling current challenges and developments key to the European market, and leveraging the true potential of laboratory testing to dramatically improve patient outcomes across the continent.

The conference programme covers five main tracks including Point of Care Testing (POCT), Histopathology, Lab Management, Microbiology and Haematology. From new methods of effective lab management to the development of techniques in detecting diseases, the conferences will also review the expanding role of the laboratory medicine and discuss partnership between a clinician and a lab professional in providing delivery of care to every patient.

“The scientific programme at MEDLAB has been carefully designed in collaboration with some of the brightest minds in the medical laboratory industry in order to have a real impact on improving the health and wellbeing of patients across the region,” said Coleman.

For more information about the MEDLAB Europe Exhibition & Congress, please visit: www.medlabeurope.com.

SOURCE: EuropaWire

Global leader in serialization solutions Systech to attend the annual pharmaceutical congress CPhI Worldwide in Barcelona, 4 – 6 Oct 2016

systech_international_slogo_europawireBRUSSELS, 28-Sep-2016 — /EuropaWire/ — Systech International, a global leader in brand protection technologies, will partner with Sharp Packaging and SINEL SYSTEMS, part of the Autajon Group, at CPhI Worldwide, the annual pharmaceutical congress held in Barcelona from 4 – 6 October 2016.

Systech will be part of Sharp’s panel discussion addressing delegates on the theme of “Serialization: Optimizing Your Supply Chain Means Optimizing Your Partners.” The presentation will explore the critical path to supply chain readiness, risk assessment, benchmarking and serialization risk mitigation options. The briefing will take place in the Pharma Insight Briefing room on Tuesday, 4 October 2016 at 11:30am CEST.

Systech will also showcase its UniSeries™ serialization software offered as an integrated solution within Autajon’s exhibit booth #2P16 (Hall 2).

CPhI Worldwide, together with co-located events ICSE, InnoPack, P-MEC and FDF, will host more than 36,000 visiting pharma professionals from 4-6 October at the Fira Gran Via, Barcelona, Spain. More than 2,500 exhibitors from 150+ countries gather at the event to network and take advantage of more than 100 free industry seminars. Every sector of the pharmaceutical market is represented under one roof, this year in a new location in Barcelona.

With thousands of implementations across the globe, Systech is the world’s most trusted brand protection expert, and its UniSeries offering is the industry standard for serializing products. UniSeries is offered as an integrated solution with both Sharp Packaging and Autajon Group’s hardware. Systech’s patented, configurable software offers manufacturers the flexibility to adapt to new regulations without extensive reworking or revalidation, thereby reducing implementation, training and support costs.

“We are recognized as the world leader in serialization and brand protection,” states Manfred Voglmaier, Senior Director Sales Europe, Systech International. “With more than 30 years of experience in providing highly configurable solutions for serialization across a variety of industries ― along with our partners Sharp Packaging and Sinel ― gives us a unique insight for this panel.”

Systech’s products are in greater demand than ever before since it is estimated that over 15,000 production lines for prescription medication in Europe must be fitted with a serialization system over the next three years. The European Commission adopted a regulation on October 2, 2015, under which the serialization of prescription medicine packages will become mandatory in all EU countries by 2019.

Show exhibit hours are on Tuesday, 4 October – Thursday, 6 October. Systech representatives will be available in the Sharp Packaging booth #3L56 (Hall 3) during the event, as well as in the Autajon booth #2P16 (Hall 2). They will showcase Systech’s software solutions on sample packaging lines and via live demos throughout the event.

SOURCE: EuropaWire

Sway Medical’s app for sports concussion exam received European CE Mark as Medical Device

sway-concussiontest-is-a-validated-ios-app-based-concussion-management-system

TULSA, OK, 08-Sep-2016 — /EPR HEALTHCARE NEWS/ — Sway Medical is a US medical device company who’s software turns an iPhone or iPad into a mobile medical device that provides immediate medical grade, objective concussion measurement to medical professionals.

Sway Medical LLC (Sway) would like to announce its official availability in all European Union Countries. Sway was issued its CE Mark after being marketed in the United States and Canada for two years. This is significant because European sports organizations ranging from youth through pro level now have an affordable and convenient sideline assessment tool supporting concussion related medical decision making. Medical professionals and trained coaches can obtain a concussion assessment via an Apple mobile device (iPhone or iPad) and the Sway Balance™ System web-portal. Acute objective measurements are obtained by performing a 1.5 minute balance and reaction time test protocol. Licensed athletic trainers, physical therapists and athletic therapists are able to join physicians in acutely managing the underserved market of youth sports, ages six and older.

Concussion injuries are very common in sports, often going un-reported or ignored until the obvious symptoms have incapacitated the athlete or draws the attention of a parent or coach. Second Impact Syndrome (SIS) is a serious medical condition with published mortality rates of up to 50%. SIS occurs when an athlete returns to play while still recovering from an initial concussion injury. During this time, the brain is highly susceptible to additional injury and complications. The Sway Balance™ System is able to accurately assess and track the acute and chronic outcome related to an athlete’s balance, motion reaction time and concussion symptoms. The Sway Balance™ System provides a graphical representation comparing suspicious injury event tests against a pre-injury “normative” or baseline score. The comparison of event tests against an established baseline is a common measurement for traumatic brain injury diagnosis and recovery tracking.

The Sway Balance™ System is available for purchase by licensed medical professionals involved in school, occupational or sports medicine through www.swaymedical.com. Additional protocols are available to assess an individual’s “Fall Risk” or “Functional Status”.

SOURCE: EuropaWire