Category Archives: Healthcare Services

Diabeloop presents the results of the use of its Automated Insulin Delivery (AID) over the past 12 months by 4,162 patients

PARIS, 21-Sep-2022 — /EPR HEALTHCARE NEWS/ — Diabeloop, a leader in therapeutic AI applied to insulin delivery, reports today on 12 months of use of its hybrid closed-loop DBLG1 System on a large, multi-country patient cohort. While Time in Range (70-180 mg/dL) still shows constant improvement, time spent in hypoglycemia stays significantly low. Users share how these clinical results, combined with a growing trust in the algorithm has led to fewer interactions with the device and improved quality of life.

New data2: one year living with DBLG1 System
Cohort of over 4,000 patients in 5 European countries

The innovative company Diabeloop, which will be present this week at the EASD Annual Meeting 2022, shares new real-world data on its first Automated Insulin Delivery system use.

DBLG1 System reached the European market a little over a year ago with consistent utilization throughout this period, with merely 1% of users discontinuing use of the product3.

In line with previously presented data4, significant improvement in Time in Range is observed here on a much larger population. The cohort gathers 4,162 patients in five countries: Germany, Italy, Spain, The Netherlands and Switzerland. TIR gain is 17.6 percentage points over a year of real life use.

Pr. Pierre-Yves Benhamou, CMO and President of Diabeloop’s scientific committee and US advisory board, commented:

“When initiating a treatment with DBLG1, it can be expected that the recommended outcomes (i.e., a TIR>70%, a TBR<4% and a GMI< 7%) will be achieved in about half of patients. Currently in Europe, the rate of achievement with standard treatment is only 27%.”

Another significant result is that this improvement in time spent in the target range is combined with a still extremely low occurrence of hypoglycemia: 0.2% < 54 mg/dL, 1.1% < 70 mg/dL. For the patients’ clinical picture and for their overall quality of life, this means less than 20 minutes per day spent in hypoglycemia, whereas the maximum accepted in the international recommendations is 60 mins.

Andrea and Martin, users of DBLG1 System share the benefit they derived from DBLG1 System on their hypoglycemia:

“Before I started using the system, I always had restless nights, because I often got hypoglycemia at night. Now the nights are great, I have to say.”

“I feel safer knowing that I’m not going to start sweating at some point, somewhere, because I have a low. That always made me feel kind of weak. I used to work as a nurse in three shifts, so I wish DBLG1 had been available, because I didn’t really have a daily routine then, where DBLG1 would have supported me.”

Algorithm performance leads patients to entrust it with fuller meal management

In the current commercial version of DBLG1, thanks to the initial parameter (meal ratio) and intuitive food logging functionality, patients:

– have access to meal size pre-configurations (small – medium – large)
– can quickly declare their meal
– personalize the carb intake declaration.

Based on the declaration, the glucose trend at time of meal and incremental patient data, the algorithm will recommend the insulin dose to deliver and manage post-prandial time period.

Diabeloop has already announced it was working on new versions to allow optimal management without declaration. Testimonials and data5 of DBLG1 real-life use however tend to show that patients trust the currently available device’s performance enough to skip some meal declarations and/or to declare approximative carbs quantities, and still get satisfying results.

For example, for the three main daily meals (breakfast, lunch and dinner), the patients used the shortcut (small-medium-large) for half of the 45 million meals declared on DBLG1.

It has also been observed that the longer the patients use DBLG1, the less likely they tend to declare meals altogether and the system will regulate itself. On average, one less meal is declared per day after 6 months of use.

Throughout the first 12 months of commercialization, feedback from users has been tremendous, highlighting time-saving, mental load alleviation and overall quality of life improvement.

Eva shares:

“I would definitely say that the mental burden has become less, or that I have to put in less effort to get good values (…) My sleep in general has gotten much better. The blood sugar levels are much more stable. I remember when I would wake up at night or set my own alarm. That has become much better since I have the Diabeloop system. The nights are fantastic.”

Erik Huneker, co-founder and CEO of Diabeloop reacts to these new real-world data and users comments:

“There is nothing more fueling for us than seeing DBLG1 perform over many months while it contributes to people with diabetes various lifestyles and needs. We have now equipped 10,000 patients and look forward to providing more personalization, ever more simplicity of use and more choices…to more and more people with diabetes.”

DIABELOOP AT EASD, September 20-23:
Booth M06
Meet the Expert session, September 21, 10:00 – 10:30 am
Supporting patient empowerment and improving glycemic outcomes with connected pens and artificial intelligence – From DBLG1 to DBL-4pen.
Networking Hub – with Erik Huneker, Pr. Lutz Heinemann & Pr. Pierre-Yves Benhamou
Platinum sponsor of #dedoc voices program

SOURCE: EuropaWire

New AI-powered predictive algorithm offers unprecedented accuracy in diagnosing NASH and liver fibrosis staging

BOSTON, MA, United States, 18-Jul-2022 — /EPR HEALTHCARE NEWS/ — Metadeq Inc., a global NASH and metabolic diseases diagnostics company, today announced a breakthrough non-invasive blood test that utilizes two novel circulating proteins to accurately diagnose Non-alcoholic steato-hepatitis (NASH) and liver fibrosis, and can score the stages of both diseases, without the need for invasive liver biopsy. The study which details the new blood test – just revealed in Gut, a leading hepatology and gastroenterology journal published by BMJ – was led by King’s College London Professor Geltrude Mingrone, in collaboration with Metadeq.

Approximately one in four people worldwide, or approximately two billion people, have Non-alcoholic fatty liver disease (NAFLD) and therefore are at risk of developing NASH. NASH is the most severe form of NAFLD, a silent disease associated with fatty deposit build-up of the liver. NASH leads to advanced liver diseases such as liver fibrosis (scarring), cirrhosis, and liver cancer, and may ultimately result in death. The annual cost to the US healthcare system alone has been estimated to be over $100 billion per year.

Currently, the only way to diagnose NASH is through the standard of diagnosis, invasive liver biopsy, which is expensive and is associated with significant complications and discomfort. Until now, no reliable blood test has been developed for NASH, nor liver fibrosis. Most importantly, no available test can define the severity (stage), or monitor the progression, of either NASH or liver fibrosis.

Professor Geltrude Mingrone from the School of Cardiovascular and Metabolic Medicine & Sciences at King’s College London, who is one of the most widely cited and influential researchers globally for metabolic diseases and disorders, set out to discover a more accurate liquid biopsy test in support of patient care and in collaboration with Metadeq. The resulting study was published today in leading journal, Gut.

This study identified two novel protein biomarkers, PLIN2 and RAB14, to assist in the diagnosis of patients with NASH and/or liver fibrosis. The ability of these proteins to detect both diseases was tested in cohorts with either NASH and/or liver fibrosis that were confirmed with liver biopsy, the current standard of diagnosis.

“This blood test will allow researchers and clinicians to define the prevalence of NASH across populations, including children and adolescents, avoiding the need for invasive liver biopsy,” said Professor Mingrone. “Critically, it will allow care-givers to monitor the efficacy of NASH treatments over time, reducing screen failures and helping generate better drugs.”

“Since HEPAR-QTM is the only diagnostic modality that can diagnose NASH and fibrosis staging we expect it to be instrumental in the development of new therapeutics for the management of patients,” said Frank Jaksch, Chairman of Metadeq. “We believe that HEPAR-QTM will advance for the benefit of patients the problem of regular screening, that has resulted in late drug failures during clinical trials, since it is now possible to accurately measure the severity of disease in a non-invasive manner.”

 

The Metadeq predictive algorithm, which uses A.I., provided unprecedented sensitivity (88-95%), specificity (90-100%), and overall accuracy (92-93%) for NASH, and also has near-perfect sensitivity (99%-100%), specificity (90%-96%), and accuracy (98%-99%) for liver fibrosis.

The test results show that the proteins can provide rapid and cost-effective testing to combat the growing epidemic of NASH and liver fibrosis. This could be an invaluable tool in diagnosing and monitoring cases of liver diseases, allowing people to receive earlier treatment, from lifestyle adjustments to surgical and pharmacological interventions.

Currently no NASH drug has been approved by either the FDA or EMA, which may be a direct result of the lack of an accurate, reliable, and non-invasive test. More than 65% of patients who enroll in clinical trials for NASH-related therapies are found to be ineligible for the trial due to screen failure, which causes major monetary losses to companies developing and testing NASH drugs. The improved accuracy and ability to detect NASH staging will help in identifying and enrolling the appropriate people in clinical trials, speeding up the development of NASH drugs.

About Metadeq
Metadeq Corp. is a diagnostics company that provides innovative liquid biopsy solutions for liver and metabolic diseases. For the first time, Metadeq allows people to measure the whole spectrum of liver diseases – from NAFLD, to NASH, and liver fibrosis – with a blood test. www.metadeq.com

SOURCE: EuropaWire

Diabeloop, a high-growth health tech firm that automates the treatment and the management of diabetes, announces EUR 70 million funding

PARIS, 2-Jun-2022 — /EPR HEALTHCARE NEWS/ — Diabeloop secures 70 million euros to pursue its solid and sustained growth strategy.

The company, an Automated Insulin Delivery pioneer, develops machine-learning software for diabetes treatment. Its highly sophisticated algorithms are integrated into easy-to-use products helping facilitate chronic disease management impacting patients’ clinical outcomes and their quality of life.

Diabeloop has seen impressive growth in the last few years with two products on the European market, rapidly approaching 10,000 equipped patients one year after commercial launch and major developments with various device partners.

The first closed-loop solutions commercialized by Diabeloop offer personalized management for Type 1 (DBLG1) and highly unstable Type 1 diabetes (DBL-hu). By connecting a Continuous Glucose Monitoring device (CGM) and an insulin pump, Diabeloop’s world-leading algorithms analyze data in real time and automate insulin delivery. It transforms the lives of people with diabetes by taking over many of the therapeutic decisions that used to fall to patients.

Erik Huneker, founder & CEO of Diabeloop, declares: “Being able in 2021 to bring the benefits of our products to thousands of patients and hearing their enthusiasm, is why all of us at Diabeloop work so hard. The financing round announced today recognizes the team’s successes, and more importantly, the great opportunities ahead.”

The financing round is led by prominent private equity player LBO France. The Venture division of the sustainability-conscious private equity fund is a European leader in digital health, supporting young companies with ambitious projects showing international footprints.

“Diabeloop’s team has developed a unique data driven product that has the potential to revolutionize the daily life of millions of diabetic patients by taking away most of their daily mental burden and significantly improving the control of their disease. We are eager to join the investor base and help the company become a global leader in diabetes closed-loop software solutions,” says Valery Huot, Partner, Head of Venture at LBO France.

International healthcare leader Terumo Corporation also participates in Diabeloop’s Series C round. After entering into development agreements with one another in 2020, Terumo extended this to a comprehensive strategic partnership agreement with Diabeloop in 2021.

“We are excited that Diabeloop successfully completed this important milestone and the great opportunities will continue to expand for all corners of the world. Together with Diabeloop, we are committed that we will be able to contribute to all stakeholders by providing patient-centric and personalized solutions,” comments Hikaru Samejima, President of Terumo’s Medical Care Solutions Company.

Innovacom, a key player in the French and European startup community specialized in deep-tech and industrial projects, joins LBO France and Terumo Corporation as new investors.

Comforted by the commercial launch of Diabeloop first devices and the break-through potential of its projects to address a 10-million patients market in the mid-term, previous investors CERITD, CEMAG invest, Kreaxi, Supernova Invest, AGIR A DOM., Crédit Agricole, Odyssée Venture, UI Investissement (Sofimac) and Promontoires all have decided to reinvest.

Additionally, Bpifrance and the historical bank pool are supporting Diabeloop via debt financing.

“We are grateful for the confidence of our existing investors and proud of our distinguished new financial and industrial shareholders. I have full trust in the talent and commitment of the Diabeloop teams to pursue their groundbreaking value creation path for patients and become a trusted leader and partner in the highly reactive diabetes market,” concludes Catherine Dunand, Diabeloop’s Chairman of the Board.

In 2019, Diabeloop secured the highest recorded European financing round in Therapeutic Artificial Intelligence and went on to commercially launch two products, with several thousand patients equipped in less than a year. Their CE-marked data visualization platform accompanies healthcare professionals and patients as a telemedicine and remote patient monitoring solution. High-impact projects such as the adaptation of the core-algorithm to the multi-million users Connected Pen market and development of smart-watch devices also have contributed to Diabeloop’s tremendous momentum.

About Diabeloop
Diabeloop’s mission: Making innovation accessible to people living with diabetes, improving clinical results while relieving them of their constant mental burden.

Created in 2015, Diabeloop is a high-growth company that offers AI-based, personalized solutions to automate the treatment and the management of diabetes. DBLG1 System, Diabeloop’s first medical device for automated insulin delivery (AID) and DBL-hu, its solution for highly unstable Type 1 diabetes management, are both CE-marked and being deployed in Europe. Diabeloop just completed its Series C financing round, securing 70 million euros, to accelerate its commercial roll-out, support its sustained growth strategy and its high-impact projects.

Today, Diabeloop gathers the personality, passion, and skills of over 160 talented individuals who work hard to improve the quality of life for every person living with diabetes.

About LBO France
With €6.6 billion of capital raised since its inception, as a key player in private equity, LBO France is supporting growing French and Italian companies for more than 30 years.

Its investment strategy is based on five distinct segments managed by dedicated teams:

(i) Mid Cap Buyout through the White Knight funds, and Small Cap Buyout through the Small Caps Opportunities funds,
(ii) Venture capital through the Digital Health funds,
(iii) Real estate through the French White Stone funds, OPCI Lapillus, impact fund Newstone and the Italian management company Polis Fondi SGR
(iv) Debt, notably in Italy through the Vita Superbonus program to finance energy efficiency in real estate assets
(v) Public Equity through the France Développement fund

LBO France is 100 % owned by its management and employs nearly 70 professionals.

SOURCE: EuropaWire

European public-private project to advance precision psychiatry by introducing biology into clinical routine

PARIS AND MONTPELLIER, 30-Mar-2022 — /EPR HEALTHCARE NEWS/ — ALCEDIAG announces the launch of the EDIT-B Consortium, supported by the European Institute of Innovation and Technology for Health (EIT Health). This newly formed European public-private partnership aims at advancing precision psychiatry by introducing biology into clinical routine.

Around 300M people in the world are affected by depression. Studies show that up to 40% of them may be misdiagnosed and potentially bipolar. As a result, diagnosis is often delayed by an average of 7.5 years, worsening patients’ mental and physical conditions as well as their loved ones’ quality of life.

The EDIT-B Consortium aims to solve this diagnostic challenge by using specific RNA editing based biomarkers and artificial intelligence to validate and commercialize an accurate, reliable, and quick blood test to diagnose bipolar disorder.

The Consortium brings together prominent members from across Europe who will be working over the next three years to achieve this goal: Alcediag, Alcen, Capital Region of Denmark, Fundació Clinic per la Recerca Biomèdica, Fundació Sant Joan de Déu, GHU Paris Psychiatrie & Neurosciences, Hospital Clínic de Barcelona, Parc Sanitari Sant Joan de Déu, ProductLife Group and Synlab. With a total budget of € 5.2 million, EDIT-B is co-funded by the EIT Health (€ 2.5M) and the partners.

“This project will accurately separate bipolar disorder from unipolar disorder. This distinction is extremely important clinically, because the treatments are different. EDIT-B Consortium gathers all relevant expertise and as the principal investigator in the clinical trial, I hope we will be able to validate a test that will improve the lives of many people living with bipolar disorder”, says Prof. Eduard Vieta from the Hospital Clínic de Barcelona.

SYNLAB is the first diagnostic service provider in Europe, present in 36 countries in 4 continents and committed to developing high value solutions for patients  focusing on medical excellence and customer centricity.

Maurizio Ferrari, SYNLAB Italy Chief Medical Officer says: “innovation in healthcare is a key pillar for the customer centricity and  we are very proud to be part of this European research project that really may help patients with psychiatric disorders”.

“I am proud to see that the EDIT-B consortium led by our partner Alcediag – a subsidiary of Alcen – will tackle the challenge of improving the diagnosis of bipolar disorder. In doing so, they support EIT Health main mission which is to help citizens live healthier and longer lives and at the same time put the spotlight on mental health which is key to the proper care management and wellbeing of our communities”, adds Jean Marc Bourez, interim CEO of EIT Health.

“On this World Bipolar Day, Alcediag team is happy to announce its contribution to solving the bipolar disorder diagnostic issue.  We are proud and grateful to our partners and the EIT Health for this opportunity to advance science while having a positive impact on people’s lives”, said Alexandra Prieux, CEO of Alcediag.

SOURCE: EuropaWire

Cole & Van Note Announces Mon Health Data Breach Investigation

Oakland, California, USA, 2022-Mar-05 — /EPR HEALTHCARE NEWS/ — Cole & Van Note, a leading consumer rights law firm, announces today its investigation of Monongalia Health System, Inc. on behalf of its consumers/clients, arising out the company’s recent data breach. According to the company, the private information of a massive number of people may have been stolen in the hacking of its information network. It is currently unknown how many people have had their information used for criminal purposes.

If you received a notice of this alarming data breach and/or have transacted in any way with Monongalia Health System, Inc., your information may already be in the hands of cybercriminals, making your urgent attention to this situation very important.

Cole & Van Note is ready to discuss your options and can be contacted at (510) 891-9800, by email at sec@colevannote.com or through its  website by clicking below:

Cole & Van Note has been successfully handling consumer and employee rights matters since 1992. The firm has recovered compensation for millions of individuals and stands ready to help you get paid for your losses.

Attorney Advertisement. Our previous results do not guarantee or predict a similar outcome.

Full Name: Scott Cole
Organization Name: Cole & Van Note
Phone: (510) 891-9800
Email Address: sec@colevannote.com
Facebook Page
LinkedIn Page

Cole & Van Note Announces SAC Health System Data Breach Investigation

Oakland, California, USA, 2022-Mar-05 — /EPR HEALTHCARE NEWS/ — Cole & Van Note, a leading consumer rights law firm, announces today its investigation of SAC Health System on behalf of its consumers/clients, arising out the company’s recent data breach. According to the company, the private information of a massive number of people may have been stolen in the hacking of its information network. It is currently unknown how many people have had their information used for criminal purposes.

If you received a notice of this alarming data breach and/or have transacted in any way with SAC Health System, your information may already be in the hands of cybercriminals, making your urgent attention to this situation very important.

Cole & Van Note is ready to discuss your options and can be contacted at (510) 891-9800, by email at sec@colevannote.com or through its  website by clicking below:

Cole & Van Note has been successfully handling consumer and employee rights matters since 1992. The firm has recovered compensation for millions of individuals and stands ready to help you get paid for your losses.

Attorney Advertisement. Our previous results do not guarantee or predict a similar outcome.

Full Name: Scott Cole
Organization Name: Cole & Van Note
Phone: (510) 891-9800
Email Address: sec@colevannote.com
Facebook Page
LinkedIn Page

Via EPR Network
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Cole & Van Note Announces Logan Health Medical Center Data Breach Investigation

Oakland, CA, USA, 2022-Mar-03 — /EPR HEALTHCARE NEWS/ — Cole & Van Note, a leading consumer rights law firm, announces today its investigation of Logan Health Medical Center on behalf of its consumers/clients, arising out the company’s recent data breach. According to the company, the private information of a massive number of people may have been stolen in the hacking of its information network. It is currently unknown how many people have had their information used for criminal purposes.

If you received a notice of this alarming data breach and/or have transacted in any way with , Logan Health Medical Center your information may already be in the hands of cybercriminals, making your urgent attention to this situation very important.

Cole & Van Note is ready to discuss your options and can be contacted at (510) 891-9800, by email at sec@colevannote.com or through its  website by clicking below:

Cole & Van Note has been successfully handling consumer and employee rights matters since 1992. The firm has recovered compensation for millions of individuals and stands ready to help you get paid for your losses.

Attorney Advertisement. Our previous results do not guarantee or predict a similar outcome.

Full Name: Scott Cole
Organization Name: Cole & Van Note
Phone: (510) 891-9800
Email Address: sec@colevannote.com
Facebook Page
LinkedIn Page

Via EPR Network
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8-year follow up results revealed for the ELIOS® Excimer Laser Trabeculostomy procedure combined with cataract surgery

LOS ANGELES, CA, United States, 17-Feb-2022 — /EPR HEALTHCARE NEWS/ — Elios Vision Inc. announced today 8-year follow up results of its novel ELIOS® Excimer Laser Trabeculostomy procedure combined with cataract surgery.

Key study findings:

  • 161 eyes of 128 patients with glaucoma or ocular hypertension and cataract received Phaco-ELIOS, and were followed over an 8-year period
  • Significant mean IOP reduction from 19.3 mmHg at baseline to 15.4 mmHg after 8 years of follow-up (p=0.0040)
  • Significant reduction in medication requirements
  • Only 3.7% of patients required secondary surgical glaucoma intervention during the 8-year follow-up period
  • No serious intra- or post-operative events were observed

“This large cohort study provides encouraging evidence that the ‘implant free’ Phaco-ELIOS procedure causes minimal trauma, appears to show lasting IOP control with no serious intra- or post-operative complications, and low rate of incisional secondary surgical intervention over a period of at least 8 years,” said Thomas W. Samuelson, MD, founding partner of Minnesota Eye Consultants and an Adjunct Professor of Ophthalmology at the University of Minnesota. Dr Samuelson added that, “it is encouraging for patients that the number of topical medications required to control IOP was reduced significantly up to 4 years and remained below baseline levels across the entire 8-year follow-up period.”

About the ELIOS procedure:

  • The ELIOS procedure creates ten ‘microchannels (210µm)’ in the trabecular meshwork using an excimer laser.
  • The microchannels facilitate aqueous outflow into Schlemm’s canal, the eyes natural outflow pathway, reducing IOP2 and preserving the integrity, structure, and function of the trabecular meshwork.
  • Combining ELIOS with phacoemulsification is an ‘implant free’ minimally invasive glaucoma procedure with a rapid learning curve for ophthalmic surgeons.
  • The ELIOS procedure is approved in Europe for use in adults with glaucoma, with or without cataract, and is undergoing clinical trials in the US under an investigational device exemption (IDE).
  • Data on the ELIOS procedure has been published in 12 clinical studies2 with over 850 eyes treated showing an IOP reduction of 20-40% from baseline, a significant reduction of medication for up to 4 years, and up to 81% of patients ‘medication free’ at 1 year,3 and a favorable safety profile.

Over the past decade minimally invasive glaucoma surgeries (MIGS) have transformed the treatment of mild to moderate glaucoma and are an attractive alternative to more invasive incisional procedures such as trabeculectomy and tube shunts. Despite the growing popularity of MIGS, combining cataract and glaucoma surgery is not yet the preferred choice by most surgeons.

This clinical study shows that the ELIOS procedure is attractive to all ophthalmic surgeons for patients with glaucoma that are not controlled by medications or SLT because it reduces IOP to mid-teens for at least 8 years, minimizes postop inflammation, avoids intraocular implants, has a favorable safety profile, with or without cataract surgery.

Why are these findings relevant?

  • In 2022 it is estimated that around 29 million people globally will undergo cataract removal and around 20% also have glaucoma or ocular hypertension4.
  • These findings demonstrate a sustained reduction of IOP that is longer than any other currently available MIGS procedure.
  • Routinely combining cataract and glaucoma treatment is appealing since it can reduce the undesirable burden and side effects of drops and it can avoid patients undergoing two separate surgical procedures which also is more efficient for healthcare systems.

SOURCE: EuropaWire

EU Patients as Partners in Medicines Development conference to be held virtually on Jan 24-25, 2022

(PRESS RELEASE) New York, NY, United States, 5-Jan-2021 — /EPR HEALTHCARE NEWS/ — The Conference Forum announced the launch of the 6th annual EU Patients as Partners in Medicines Development conference to take place virtually on January 24-25th, 2022 GMT time.

​​This annual event, the first of its kind in Europe, will feature successful collaborations between patients and pharma where patient input directly impacted aspects of how a pharmaceutical company either designed or conducted a clinical trial.

Of the 20 sessions, half include a patient or patient advocate. This two-day program will demonstrate how patient-led research can improve the way pharma conducts clinical trials.

Examples include UCB developing new assessment tools to measure the effectiveness of novel treatments for Parkinson’s disease, changes in the design and implementation of an MS trial for greater patient engagement, and the development of a new toolkit to change the way patients are compensated for their contributions in clinical research.

“Patients have become more empowered,” says co-chair Michaela Dinboeck, Head, Center of Excellence for Patient Engagement at Novartis. “So patient engagement must be integrated into the DNA of how medicines are developed, approved, and used. Patients as Partners Europe will provide Pharma with valuable insights on how to achieve this.”

Participating pharma companies include Novartis, Pfizer, Merck KGaA, EMD Serono, Janssen, Johnson & Johnson, GSK, Ipsen, UCB, Takeda, AbbVie, Noema Pharma, Gilead Sciences, Regeneron, and Pierre Fabre.

Other topics to be addressed include: Scaling patient engagement activities company-wide, engaging patients in early clinical development, leveraging social media to gain patient insights, diversity and inclusion in research and updates on patient engagement activities in Eastern Europe.

To learn more, please visit Patients as Partners Europe.

SOURCE: EuropaWire

Origami and citoQualis will work together to help Medical Device startups get products to global markets faster

KFAR SABA, Israel, 9-Nov-2021 — /EPR HEALTHCARE NEWS/ — Origami, a leading provider of no-code business process automation software for Medical Device and other industries, and citoQualis, a regulatory and business advisory leader for EU Medical Device companies, are announcing a partnership to help Medical Device startups get products to global markets faster.

Medical Device startups face unique pressures due to numerous country-specific regulations. This new partnership will help companies efficiently manage their regulatory approval processes, and enable rapid business growth.

Origami’s medical device customers operate around the world. With recent EU regulatory updates, companies are seeking strategic regulatory and business guidance to help them get and maintain product approval in that geography. The new partnership will provide Origami customers with access to citoQualis expertise in business and complex regulatory landscapes.

The citoQualis team points out that Medical Device startups have global workforces that “expect to access their systems from wherever they’re located, and to use those systems to collaborate internally and with citoQualis” says Mr. Wolfgang Werner, CEO of citoQualis.

According to Mr. Werner, “As advisors, it’s our job to identify opportunities and share our insights. For startups, the faster a product moves from idea to production, the better. With Origami’s flexibility, we are able to give our clients a software option that works for them now and as they scale.”

Germany and other EU countries have strong medical device startup ecosystems, which citoQualis is well connected to. Origami is excited to work with citoQualis and the startups they advise, noting how both companies focus their solutions and teams on helping customers succeed in complex environments.

Yaniv Shimony, CEO of Origami says “startup CEOs recognize Origami’s business value, in that they always have the solution their company needs. When you create a new and innovative medical device, using inflexible software point solutions slows your business down. With Origami, information is instantly available about any part of your business such as sales, quality, design, product approvals, manufacturing, equipment maintenance, purchasing, supplier compliance, invoicing, complaints and more.”

Existing customers will be able to maintain and expand EU market access by working with local regulatory experts, facilitating hundreds of millions of Euros of revenue.

SOURCE: EuropaWire

Black-Owned FitTech Start-Up Aims to Fix Healthcare for African Americans

LOS ANGELES, CA, 2021-Sep-21 — /EPR HEALTHCARE NEWS/ — JunBugg Fitness Social Network, Wall Street’s “first and only luxury social media brand,” created by African American founder Louis Green, today announced the launch of its NextGen fitness website. Using computer algorithms, JunBugg integrate entertainment into health by sharing unique fitness solutions related to one’s body-type, that leads to better fitness results in least time — influencing success for a higher quality of life.

The start-up website boasts a sleek interface, vibrant logo, sophisticated font-type, and beautiful images, built on sophisticated software engineering. Through social engagement, members of similar health conditions and body-types share fitness strategies and medical solutions to get fit. JunBugg use algorithms that recommend relevant solutions to newsfeeds, the same technology that has allowed — TikTok, Netflix, and Amazon to be successful. The NextGen Search Database deliver relevant fitness matches for personalized training.

A personalized fitness solution, members engage, collaborate, and work as a team. Teamwork allows members to foster camaraderie, innovate, and better problem solve fitness and health obstacles. The bigger the network grows, the more cures that are created. Algorithms see patterns of successful fitness solutions, learns the most effective ones, and recommend them to newsfeeds. As solutions evolve and improve, the algorithm learns and thus recommend those.

The African American community was hit hard by COVID19, who stand to gain the most from JunBugg, for a higher quality of life. The platform is easily accessible and allows equal quality of health care while being affordable. The management of health conditions is the biggest benefit, and prevention of disease as opposed to disease treatment, by being fit through exercise and eating healthy. See boutique fitness solutions — https://www.junbugg.net

Unlike traditional social media services — TikTok, Facebook, Instagram, Snapchat, and Twitter, whose services are free, JunBugg’s boutique membership offerings range between $30 and $500 a month. Fees are comparable to other boutique studios and fitness services, such as — Equinox, SoulCycle, Peloton, and YogaWorks.

It’s all about fitness wealth and a higher quality of life. The first of its kind, JunBugg will forever change fitness and healthcare,” said Louis. “People are an amazing resource that’s never been used in this way — through the power of social media technology, to solve problems through entertainment.”

 

Via EPR Network
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University of Freiburg spin-off with strong preclinical evidence for significant breakthrough in curing prostate cancer

FREIBURG, Germany, 1-Jul-2021 — /EPR HEALTHCARE NEWS/ — Prostate cancer is the second most common cancer. According to the American Cancer Association, 1 in every 8 men will be diagnosed with it in their lifetime. In 2018 around 1.2 million men were diagnosed and there were 360,000 deaths. In Europe alone, 450,000 men are diagnosed with prostate cancer every year. But there could be a cure on the horizon.

B66, a new company in Germany and a spin-off from the University of Freiburg, Germany, has strong preclinical evidence that its research has made a significant breakthrough after 6 years of dedicated work. Professors Roland Schule, Manfred Jung and Dr Eric Metzger have pioneered research into inhibitors of the histone methyltransferase KMT9 that controls the growth of castration and enzalutamide resistant prostate tumours. These small molecular inhibitors are superior to current state-of-the-art Gold Standard drugs in preclinical models. This new treatment has the prospect of increasing survival in the normally fatal outcome of castration-resistant prostate cancer and becoming the universal therapeutic agent. In addition, the research team’s work shows that their new therapeutic agent has potentials in other cancers including colorectal, breast, bladder and the biggest of all killers, lung cancer.

Professor Roland Schule, one of the B66 founders, and a professor of Biochemistry in the University Medical Centre of Freiburg said “Our findings and approach to treatment is far in advance of anything that is going on in the world at the moment.”

Fellow founder, Professor Manfred Jung, added “many cancer treatments cause damage to the patient’s normal cells but the B66 inhibitor does not target normal cells indicating that our treatment will have minimum side effects”.

Although focused on prostate cancer right now, the B66 team’s long-term objective is to create a world-class development platform that will work on the defeat of many other types of cancer. The Freiburg region, thanks to the University, is a unique centre of leading medical knowledge. B66 will expand their work and draw in some of the skilled scientists from the area to help them work towards building a leading medical development hub.

The B66 team is already seeking commercial partners in order to forward their breakthrough work and advance as quickly as possible to defeat this major cancer.

SOURCE: EuropaWire

Palette Life Sciences unveils 4 international sites for its Deflux online presence

SANTA BARBARA, CALIF. / STOCKHOLM, 27-Oct-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences, a fully integrated global life sciences company dedicated to improving patient outcomes, today introduced valuable new online resources for healthcare providers in France, Germany, Italy and Spain. By expanding its Deflux online presence to international audiences, Palette Life Sciences demonstrates its commitment to supporting the global paediatric community.

Deflux.fr is a French-language resource for healthcare providers in France. Deflux.com/de is a German-language site serving practitioners in Germany. Deflux.com/es and Deflux.it are English-language sites serving physicians in Spain and Italy respectively. These new sites offer best-in-class online resources, important information and education about VUR, including symptoms, causes, risk factors and treatment options, such as Deflux®. All of the European sites provide physicians with access to the global Deflux Learning Center, a leading education platform that features information and training for paediatric urologists and their peers who treat VUR. The Deflux Learning Center includes clinical articles, educational videos, webinars, brochures, downloadable tools and The PedSpace podcast series, created for and presented by paediatric urology healthcare professionals.

The Deflux Learning Center for each respective country also provides downloadable educational materials for parents and caregivers managing children with vesicoureteral reflux (VUR).

“My personal long-term experience with Deflux has proven its effectiveness and safety in reducing VUR and preventing UTI recurrence in patients who fail medical management, thus avoiding use of long-term antibiotics. It is my hope that the new website initiative, which includes helpful resources for physicians, will help raise awareness of this treatment option in patients with primary VUR, troubled by recurrent febrile UTIs,” said Dr. Marie-Klaire Farrugia, Consultant Paediatric Urologist and Service Lead for Paediatric Surgery at Chelsea & Westminster and Imperial College Hospitals.

“We are excited to offer these new online resources to the healthcare community in France, Germany, Italy and Spain,” said Rich Low, Head of Marketing at Palette Life Sciences. “We are confident they will benefit the global paediatric urology ecosystem and serve as valuable resources by providing critical information and access to educational resources through the Deflux Learning Center.”

SOURCE: EuropaWire

CoapTech Raises $7 Million in Series B Funding Led by Hunniwell Lake Ventures

Baltimore, MD, 2020-Aug-28 — /EPR HEALTHCARE NEWS/ — CoapTech LLC (Baltimore, MD), a leading medical device start-up pioneering the world’s first and only ultrasound-based feeding tube placement system, announced today the closing of a Series B investment of $7 million led by Palo Alto-based medical device venture capital firm Hunniwell Lake Ventures. The financing will be used to fund CoapTech’s commercialization of its FDA-cleared PUMA-G System.

By simplifying gastrostomy procedures to the point where they can be conducted at the patient’s bedside with ultrasound, hospitals using PUMA-G benefit by freeing up surgical suites and personnel resources for COVID and other clinical priorities, minimizing cross-contamination, and improving efficiencies in care.

CoapTech was founded by critical care physician Dr. Steven Tropello and clinical innovation researcher Howard Carolan, to reduce unnecessary delays, harm, and costs for feeding tube placement, a vital therapy for millions of patients each year around the world.

Howard Carolan, CEO and Co-Founder, states: “We have been receiving fantastic feedback from hospitals in our initial launch program, which are using the PUMA-G System to revolutionize feeding tube placement. By using ultrasound at the patient bedside, rather than the conventional approach of orchestrating expensive and inefficient consults, critical care physicians are completing these procedures in minutes, on the same shift a feeding tube is first indicated. We’re seeing early indications those efficiencies result in patients leaving the ICU sooner, which saves hospitals many thousands of dollars per admission. A substantial portion of this new funding is from physicians who have seen the device and believe it can become the new default method for feeding tube placement.”

Dr. Steven Tropello elaborates, “the PUMA-G System is proving itself ready for standard-of-care adoption for safe and timely gastrostomy tube placement. It is also proving a powerful approach in the fight against COVID, by completely eliminating transport of patients, team members, and reprocessed tools throughout the hospital in favor of a sterile, disposable, bedside solution. I am also very excited about other clinical applications of the PUMA platform we are developing and aim to have for patients in the near future.”

This Series B investment was led by Hunniwell Lake Ventures, a Palo Alto-based medical device venture capital firm.

Daniel Teo, Managing Partner at Hunniwell Lake Ventures, further states “Coaptech’s PUMA System has the potential to transform gastrostomy and many other surgical procedures by allowing them to be performed using ultrasound at the bedside, in hospitals, ambulatory centers, skilled nursing facilities, and LTACHs (Long-term Acute Care Hospitals). This also benefits patients by bringing the procedure closer to the Point-of-Demand (PoD) and giving them more options with a larger community of medical providers capable of performing the procedure.

Via EPR Network
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Exclusive Interview on Addictiveness During the Coronavirus Pandemic with Dr. Henry Balzani, the “Addictiveness Doctor”

Fort Lee, NJ, USA, 2020-May-15 — /EPR HEALTHCARE NEWS/ — In an exclusive interview with Practicomm, nationally recognized addictiveness expert provides valuable update on controversial addiction issues.

Q1. In light of the Coronavirus pandemic, it appears that people who were not addicts could become addictive just from being quarantined? Do you think that would be a large number of new addicts?

Our “Basic Survival Thinking” is mostly negative and being quarantined produces increased life stresses such as, unemployment, financial loss, fear of death, forced isolation and mental illnesses. During the pandemic, there has been an increase in alcohol consumption (as well as other substances) to blunt the negative thoughts. Also, there was an increase in sugary-high carb “comfort foods” used to stimulate positive feelings through the increased production of neurotransmitters like dopamine and serotonin.

But in fact, almost all the Covid-19 deaths are directly related to our addictiveness to high carb, processed food and the abuse of drugs, alcohol, tobacco, especially high blood sugar, diabetes and high blood pressure, which compromise the immune system. In brief, “Yes”, there will be an increase in addictiveness to try to relieve the pressure and mental stress from this pandemic

Q2. Some people say that smoking is a worse addiction than alcohol and drugs. Is that true? If so, why?

Smoking leads to strong persistent cravings for more nicotine within minutes to hours of the last puff. Vaping allows nicotine to almost always “be in hand’ day and night, inside or out. Addiction to different substances varies with the substance and the individual, and is tempered by availability, legality, cost, social acceptance, the onset of health issues, age of user, and more. Smoking health issues usually develop later in life; products are readily available, and vaping is now cool and socially acceptable. Fortunately, tobacco products are banned in buildings and outside in parks, thus making it harder to use freely.

Q3. It seems that most addiction treatment centers have a high percentage of patients who are “cured” for only a small period of time before going back to the addiction. Is that a correct statement?

The LIFETIME tendency to relapse (recidivism) after treatment is still high. The “Post Treatment Cure” is, for most, a physiologic removal of the substance from the body; and, for a time, a psychologic re-education and respite for the client before entering the real world. The “Roots of Addiction” can start early in life and become deeply and unconsciously embedded over years, and can always be reactivated under stress. To achieve a lifetime cure, addicts must always be actively involved in their recovery, because life just doesn’t get easier. I have seen my clients relapse a number of times before being able to maintain sobriety; and, some who have relapsed after many years of sobriety.

Q4. Can addicts actually change the way they think? How would they do that if they could? Does this vary by the type of addiction?

Adult addicts can change the way they think if they have a strong Desire, Interest and Commitment to recover. But, being pushed into recovery usually doesn’t last long.

They must deal with the root causes of their addiction, as they can be reactivated during times of stress. For any addiction, they must fully commit and actively participate in their process of Detox, Treatment, Counseling, and follow up, remove people places and things, and have (or seek out) a strong support system which can help in stressful situations. The stresses of life will always be there and it’s the psychological aspect of addiction that can be persistent!

For more information on the root causes of addiction, visit  addictivenessdoctor.com and/or go to Dr.Balzani on Facebook.

Via EPR Network
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MEDIS expands into new areas of cardiovascular disease with the acquisition of Italian medtech company AMID

LEIDEN, Netherlands, 11-May-2020 — /EPR HEALTHCARE NEWS/ — MEDIS, a leading developer and supplier of software applications for image-based diagnosis and quantitative assessment of cardiovascular disease, today announced that it acquired Advanced Medical Imaging Development S.r.l. (AMID), a developer and supplier specialized in cardiovascular mechanics and innovative image processing in ultrasound and other modalities. The strategic acquisition will expedite MEDIS’ expansion in new areas of cardiovascular disease, and secure MEDIS’ access to key technologies to further enhance its innovative portfolio of post-processing solutions for X-ray, MR, CT, IVUS, OCT and US devices.

The acquisition of AMID, based in Sulmona (Italy), will further increase MEDIS’ share in the cardiovascular market. “This acquisition expands our product portfolio and brings in new sales channels. The combination of AMID’s products with our product and services portfolio will enable us to provide our customers a unique and more complete multi-modal offering for cardiovascular imaging analysis”, said Hans Brons, CEO of MEDIS.

“As part of MEDIS we will have significantly more leverage to position our portfolio of innovative technologies in the global market for cardiovascular imaging software,” commented Giovanni Tonti, CEO of AMID. “Our technology offerings will allow MEDIS to complement and further enhance its already impressive suite of clinical offerings and spur innovation.”

“MEDIS and AMID have already had an excellent cooperation for over five years, both commercially and in product development. I am very excited about our access to the unique know-how and innovative power of AMID’s founders and their technology, and to intensify the cooperation leading to new solutions that ultimately will benefit the patients“ says Hans Reiber, founder and CSO of MEDIS.

MEDIS will leverage AMID’s proprietary state-of-the-art software and know-how to provide even more sophisticated cardiac and cardiovascular imaging software solutions to its customers. “The integration of both companies will take place over the next months. We expect to significantly strengthen our power to innovate and are very excited about our new relationships with AMID’s existing OEMs and sales channels” added Hans Brons. “Our new customers will continue to receive the same high quality of service which they have come to expect.”

AMID, which will continue to operate under that name is now a wholly owned subsidiary of MEDIS.

Over the last 6 months Van Herk Ventures has made significant further equity investments in MEDIS with the aim to help accelerate the growth of the company and to enable the acquisition of AMID.

“With this investment, Van Herk Ventures enables us to further expand on our position as an independent vendor of high specialty software and a leader in this industry,” stated Hans Brons, CEO of MEDIS.

“We have been intrigued by the broad spectrum of innovations in the cardiovascular imaging domain that MEDIS has created and commercialized over the years, and in particular the more recent exciting and disruptive opportunities in the field of interventional cardiology.

MEDIS has been recognized worldwide as a company that develops high quality software, listening to the needs of the clinicians and researchers and supporting them with new and expanded applications. We believe that there is a great upwards potential in MEDIS and we like to stimulate these developments and see the company grow to the next level. We are therefore very excited about the MEDIS acquisition of AMID,” said Dharminder Chahal, managing director of Van Herk Ventures.

SOURCE: EuropaWire

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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Wilson Dental of McLean, a Veteran-owned Business Teams Up With Soldiers’ Angels to Collect Halloween Candy for Troops and Veterans

 

McLean, Virginia, 2019-Oct-30 — /EPR HEALTHCARE NEWS/ — Every year, millions of pounds of candy end up in the trash after Halloween. From over-buying, to kids collecting more than they can eat while Trick-or-Treating, candy is wasted across the country. This year, Wilson Dental of McLean is participating in a program that will help our community produce less waste after Halloween while also showing our support for our service members and veterans! Owner, Dr. Lois Wilson, is herself a Veteran who proudly served as an Army Dentist both here and overseas.

Soldiers’ Angels, a national 501(c)3 nonprofit, hosts an annual collection drive for excess Halloween candy. The organization ships the candy to deployed service members around the world for a sweet treat from home! They also utilize their “Angel” volunteers to distribute candy to veterans of all eras in VA Hospitals across the country.

Wilson Dental of McLean is proud to team up with the national organization to get our local community involved with giving back to the brave men and women who have sacrificed so much for our country. Our business has registered with Soldiers’ Angels to be an official drop-off site for Halloween candy. Once our collection drive is over, Wilson Dental of McLean will donate all collected candy to Soldiers’ Angels where it will be packaged and shipped to deployed or distributed in VA Hospitals.

“As a veteran of the US Army, I am excited to facilitate a donation for our service men and women who are deployed or currently in the hospital. I know first hand that being away from your family during joyful holidays is extremely difficult and I hope that this small token can help bring joy to those who sacrifice so much for our country.” – Dr. Wilson

The vision of Soldiers’ Angels is: May No Soldier Go Unloved. Although the gesture of handing out miniature candy bars may seem small, the impact that small gesture can have on troops and veterans is huge.

“When you are deployed to a combat zone, there are many comfort items you may go without for an extended period of time,” says Amy Palmer, President and CEO of Soldiers’ Angels. “Receiving care packages from home is a wonderful and unexpected surprise. The joy these service members get from opening a package of treats from home is immense and has a profound impact on their morale. The same can be said for veteran patients in VA Hospitals. Some patients have no family or regular visitors. When our Angel volunteers come in with treats like candy, the spirits of these patients are immediately lifted!”

Our collection drive will run from October 25th 2019 to November 18th 2019. Please call ahead before stopping by our location to drop off your candy:

Wilson Dental of McLean
1447-C Dolley Madison Blvd
McLean Virginia 22101

For more information on the program, or if you are interested in registering your business as a drop-off site, visit: www.SoldiersAngels.org/TreatsForTroops

Via EPR Network
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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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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