New Data on Post-Pandemic Attitudes Reveals Opportunities for Eye Care Community
Eyenuk Announces $6.2 Million Financing to Accelerate Adoption of FDA-cleared AI Technology for Detection of Diabetic Retinopathy
NHS organisation wins ‘Inspiring Workplaces’ award
Digital Twin tech partnership delivers major solution to ‘COVID Delta’ variant
Bibliometric Analyses of Refractive Error, Dry Eye and Contact Lenses Now Available
Powermat Technologies to Develop Advanced Wireless Charging Technology for Cardiac Medical Devices
CMS Renews Bellese Technologies Contract for Medicare Cost Estimator
CooperVision Specialty EyeCare Announces Uniform Markings Across Blanchard Onefit Family of Scleral Lenses
CORE Summarizes BCLA CLEAR Guidance for Contact Lens Practitioners
John Rim, CEO of Samsung Biologics shares future plans at BIO Digital 2021
CORE and CooperVision Programs Win 2021 Silver Anvil Awards
The Public Relations Society of America has named five McDougall Communications-led, optometry-centered campaigns among the world’s best over the past year, recognizing the agency’s work with five 2021 Silver Anvil honors. Included were programs for the Centre for Ocular Research & Education (CORE) and contact lens innovator CooperVision. When erroneous reports of contact lens wear risks emerged during the pandemic, a rapid-response campaign from CORE set the record straight with healthcare professionals and consumers, generating more than 5,000 news stories and reaching 55 countries in only 30 days. Those efforts earned two Silver Anvil Awards in the highly competitive COVID-19 Crisis Communications (Healthcare) and COVID-19 Crisis Communications (Non-Profit) categories, and a Silver Anvil Award of Excellence for Global Communications. A related, highly-targeted program for CORE regarding the same issue also earned a Silver Anvil Award of Excellence in the Most Effective Campaign on a Shoestring Budget category. Other nominees across CORE’s categories include Carnival Corporation, the Alaska SeaLife Center, Meals on Wheels, Xavier University of Louisiana, and Johnson & Johnson Medical Devices Companies. The United States launch of CooperVision MiSight® 1 day, the first FDA-approved* soft contact lens designed for myopia control in children aged 8-12 at the initiation of treatment,1,2 was instrumental in building the category and helping eye care professionals embrace the breakthrough technology. The industry-focused campaign earned a Silver Anvil Award in the Marketing Business-to-Business Products category. A quantum computing program from Honeywell was the category’s Award of Excellence honoree. CooperVision’s companion MiSight 1 day consumer launch with partner agency EvolveMKD also earned a Silver Anvil Award in the Marketing Consumer Products (Packaged Goods) category. In addition, the American Academy of Optometry’s Academy 2020 at Home program earned a Silver Anvil in the Events and Observances (More Than Seven Days – Associations) category. Johnson & Johnson Vision’s Prioritize Your Eyes campaign received an Award of Excellence in the Public Service-Business category. “We’re not only privileged to work with organizations such as CooperVision and CORE who place a high value on strategic communications, but in a field that has incredible momentum and creativity. Our optometry and ophthalmology consulting now spans more than two decades. Never before have we experienced this degree of evolution and excitement among eye care professionals and consumers, plus new entrants to the sector. Clear, accurate and distinctive communications are more critical than ever to break through the noise,” said Mike McDougall, APR, Fellow PRSA, the firm’s founder and president. Of all Silver Anvils and Awards of Excellence presented this year, spanning corporate, academic, government and non-profit sectors, eye care programs represented a remarkable five percent of the total. Since 1944, the Silver Anvils have been presented to organizations that successfully address challenging issues with exemplary professional skill, creativity, and resourcefulness. They are widely considered the Oscars of the profession, owing to their stringent judging process and candidates from around the world. McDougall Communications won PRSA Silver Anvil Awards in 2015 and 2018, with members of the firm having earned another 10 Anvils and Awards of Excellence while in prior roles. McDougall Communications (mcdougallpr.com), founded in 2011, is focused on helping clients across the Americas, Europe and Asia-Pacific meet their business objectives through a range of communications services, including strategic planning, media and influencer relations, reputation and crisis counsel, and social media management. It is regularly looked to as an influencer shaping global communications advancements, and works with a range of ophthalmic clients such as CooperVision, CORE, the World Council of Optometry, the Contact Lens Institute, the International Association of Contact Lens Educators, Heliostatix and others.
CooperVision Specialty EyeCare Submits Educational Videos for ECPs to Vision by Design Virtual Bootcamp
Furthering its commitment to provide ongoing educational opportunities for eye care professionals (ECPs), CooperVision Specialty EyeCare has submitted several videos to Vision by Design’s year-long Virtual Bootcamp, which begins on Monday, June 14, 2021. The videos—which showcase the company’s broad portfolio of specialty lens designs from Blanchard, GP Specialists, and Paragon—focus on helping ECPs better differentiate their practices through expanded clinical knowledge of myopia management and scleral and advanced contact lens management. “CooperVision is deeply committed to advancing the profession through its ongoing collaboration with ECPs. We believe these videos will greatly enhance ECPs’ abilities to better understand the challenges of fitting specialty lenses and address the needs of hard-to-fit patients,” said Leah Johnson, OD, FAAO, Director of Professional Affairs, CooperVision Specialty EyeCare, Americas. “Ultimately, our hope is that these videos will empower the eye care community to drive growth and profitability to their practices, and enhance the industry as a whole.” Through the online product and training sessions, ECPs will have the opportunity to hear from other likeminded professionals and industry leaders on how they’ve leveraged CooperVision Specialty EyeCare’s portfolio of contact lenses to drive success in their practice. The full list of videos are as follows: Power Your Practice with Paragon CRT® Paragon CRT® Basic Training: Clinical Tips and Techniques for Success GP Specialists’ Portfolio for Ortho-K: iSee®, Paragon CRT®, GOV® and OrthoTool™ iSee® Ortho-K with the MM1 Retinal Defocus System Decoding Ortho-K Fitting Challenges: Moderate to Advanced Cases Ultimate Design Control for Ultimate Results, featuring Onefit™ MED and Onefit™ MED+ How to Design the Ideal Scleral Lens for Each patient with Onefit™ MED and Onefit™ MED+ To register for Vision by Design’s Virtual Bootcamp, visit https://aaomc.site-ym.com/events/EventDetails.aspx?id=1498264 CooperVision Specialty EyeCare develops, manufactures, and provides access to an unmatched portfolio of industry leading soft custom and rigid gas permeable lens designs, including orthokeratology and scleral lenses to address segments such as myopia management, scleral and irregular cornea and presbyopia management. Its ongoing research and innovative products and services play a leading role in expanding care worldwide. CooperVision Specialty EyeCare is comprised of industry leading companies including Blanchard, GP Specialists, Paragon, Procornea, Soflex and No 7.
CORE Announces 2021 BCLA Virtual Clinical Conference Presentations for June 13-14
The Centre for Ocular Research & Education (CORE) today announced its participation in the 2021 BCLA Virtual Clinical Conference, which will run from June 13-14 as a globally-available digital live stream. Even in the midst of the pandemic, CORE has continued to widely publish and present topics critical to the future of optometry and ophthalmology. Among the conference highlights will be Dr. Lyndon Jones’ COPE-accredited session on future applications for contact lenses, culled from the BCLA’s new Contact Lens Evidence-based Academic Reports (CLEAR) series. Contact Lens Technologies of the Future (Jones L, et al.) represents one of the most comprehensive reviews of advancements that will shape the category’s future, including novel biomaterials, nanotechnology progress, unique optical designs, biosensing discoveries, antibacterial agents, plus battery miniaturization and power transfer. “Since its initial publication only two months ago, the future technologies paper has captured the attention of our peers and from emerging entrants to the category. It has also drawn interest from mainstream news media in multiple countries, sparking dozens of stories and stimulating consumer interest in contact lenses. The opportunities for manufacturers, eye care professionals and of course the millions who will benefit from these innovations cannot be overstated,” said Jones. Dr. Chau-Minh Phan, a research assistant professor with CORE, was among the paper’s 14 co-authors. Six other CORE scientists contributed to the broader BCLA CLEAR Reports series, serving as co-authors on a variety of papers that cover anatomy and physiology, complications, evidence-based practice, and the effect of lens materials and design. Professor Eric Papas will chair an Alcon-sponsored session on contact lens comfort, with contributions from Professors Lyndon Jones, Jennifer Craig (New Zealand) and Greg Sawyer (USA) on the BCLA main stage, as part of the conference’s application track. They will review the complex interactions that occur between contact lens materials, ocular surface cells and the tear film, and how these interactions impact comfort and ultimately wearer retention. Professor Jones will also be one of four BCLA-designated North American hosts acting as chairs for the second half of day one. In addition, CORE researchers Jill Woods, Doerte Luensmann, Marc Schulze, and Sarah Guthrie are each presenting narrated posters regarding a multifocal contact lens clinical study, available as part of the conference’s extensive scientific program. BCLA anticipates that more than 1,000 United Kingdom and international contact lens professionals will attend the June 2021 conference over the course of its 30-hour live stream.
Early COVID-19 Whistleblowers Must Be Heard, says AHF
As the Geneva-based 74th World Health Assembly (WHA) meets virtually this week, AIDS Healthcare Foundation (AHF), the world’s largest provider of HIV/AIDS care globally, calls for the initial whistleblowers of the novel coronavirus outbreak in Wuhan, China to be made available for interviews immediately—preferably outside of China. China has been criticized since late 2019, at the onset of COVID-19, for attempting to cover up the origins of the outbreak by jailing and silencing whistleblowers for trying to warn colleagues and the world about a mysterious virus. Two doctors, Dr. Ai Fen and Dr. Li Wenliang, were among those censored by authorities. Dr. Li lost his battle with COVID-19 on Feb. 7, 2020, after contracting the virus from a patient the previous month. “We don't know if this outbreak was a lab accident, but we do know that its origin is being hidden and has been shrouded in secrecy since the beginning,” said AHF President Michael Weinstein. “With nearly 3.5 million COVID-19 deaths globally, China owes the world the truth about the outbreak’s origins. Doctors Li and Ai were only two of several individuals who first tried to sound the alarm on the novel coronavirus—they must all be free to tell their stories. The world deserves to know how this happened to help stop the current pandemic and prevent others in the future.” Dr. Li was one of eight people detained in Wuhan for “spreading rumors,” according to an article in The Lancet. Chinese citizen journalist Zhang Zhan was also jailed for her early COVID-19 reporting in Wuhan—another example of efforts by authorities to impede and obscure global investigations into COVID-19’s origins and its spread at the start of the outbreak. Since Zhang’s imprisonment, there have been reports of her continued protests in confinement. “Complete transparency is a must. The individuals who were detained, along with any others, including Ms. Zhang, who have firsthand knowledge of the origins of COVID-19, must be immediately allowed to speak—where they are free from the intimidation and censorship of Chinese officials,” added Weinstein. “Health care workers on the frontlines are the world’s first line of defense against infectious disease outbreaks. By not gathering and utilizing data from all their knowledge and experiences, the world is put at much greater risk—as we’ve seen all too clearly with this pandemic.” The more than 190 health ministers, who are members of the WHA, must raise their voices and demand that China be completely transparent, including providing all relevant information without interference. These actions would allow an independent panel to discover the truth about the origins of COVID-19, which has disrupted the lives of citizens across WHA member states and caused devastation to the health and economic systems in their respective countries. AHF echoes Dr. Li’s words just days before his death. “If the officials had disclosed information about the epidemic earlier, I think it would have been a lot better. There should be more openness and transparency,” said Li in an interview with The New York Times. In February 2020, AHF memorialized Dr. Li’s courage and sacrifice by naming its Asia Bureau office in Phnom Penh, Cambodia in his honor. ### AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.5 million clients in 45 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare
CooperVision DreamLite Ortho-K Lenses Gain European Approval for Slowing Progression of Myopia
CooperVision Specialty EyeCare’s Procornea DreamLite® night lenses have received European approval for slowing the progression of myopia in children and young adults. The popular orthokeratology contact lens is the latest CooperVision myopia control product to gain the CE Mark, joining EyeDream and Paragon CRT® ortho-k designs, MiSight® 1 day soft contact lenses, and SightGlass Vision Diffusion Optics Technology spectacle lenses. CooperVision has built the world’s largest portfolio of evidence-based myopia control interventions. This provides eye care professionals (ECPs) with multiple approved options for addressing the global myopia epidemic, helping them tailor the approach to each child and family. “Myopia’s increasing frequency and prevalence is one of the most discussed issues in eye health. But conversation without action will not change the lives of the hundreds of millions of children affected by the issue. That sentiment is echoed by the World Council of Optometry, which recently passed a resolution advising optometrists to incorporate a standard of care for myopia management within their practices,” said Dr. Juan Carlos Aragón, President, CooperVision Specialty EyeCare. “Our commitments to innovations such as DreamLite® night lenses, providing broader access to optical interventions with scientifically-demonstrated outcomes, and investing in widespread education for eye care professionals and parents are examples why CooperVision continues to lead the myopia management category. The latest CE Mark will help ECPs communicate with even more confidence about DreamLite® lenses’ ability to slow the progression of myopia.” DreamLite® night lenses can be used for myopia control with children who have a refraction of -0.75 D to -5.00 D and a cylindrical refraction with a maximum of -2.50 D. A two-year study showed that DreamLite® night lenses reduced axial length growth by 63% percent among high myopes compared to the single vision spectacle lens control group—a total reduction of 0.32 mm.1 The lenses are currently available across Europe, the Middle East, and China. CooperVision products are used by thousands of ECPs across the region for myopia correction and control. DreamLite® ortho-k lenses represent the leading design in the United Kingdom (under the EyeDream brand), and MiSight® 1 day soft contact lenses are available in multiple countries for daily wear. Commercialization plans are in progress for SightGlass Vision Diffusion Optics Technology™ spectacle lenses, which CooperVision acquired earlier this year. In November 2019, MiSight® 1 day became the first and only U.S. Food and Drug Administration-approved* soft contact lenses proven to slow myopia progression in children, aged 8-12 at the initiation of treatment.2** This pivotal development and subsequent adoption by thousands of influential ECPs has accelerated myopia management in the U.S. and other countries. Myopia is projected to affect the vision of approximately five billion people globally by 2050, more than doubling today’s numbers.3 High myopia raises the risk of vision-threatening eye conditions such as retinal detachment, glaucoma, early cataracts and myopic maculopathy, a leading cause of blindness world-wide.4 ### * U.S. indications for use: MiSight® 1 day (omafilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism. The lens is to be discarded after each removal. ** Compared to a single vision 1 day lens over a 3-year period.  Charm J, Cho P. High myopia-partial reduction ortho-k: a 2-year randomized study. Optom Vis Sci. 2013 Jun;90(6):530-9. doi: 10.1097/OPX.0b013e318293657d. PMID: 23645372.  Chamberlain P, et al. A 3-year randomized clinical trial of MiSight® lenses for myopia control. Optom Vis Sci. 2019; 96(8):556-67.  Holden et al, - Global Prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology 2016. 123(5):1036-1042  Tideman JW et al. Association of axial length with risk of uncorrectable visual impairment for Europeans with myopia. JAMA Ophthalmol. 2016;134:1355-1363.
PulPac granted support from Swedish strategic innovation program BioInnovation
The goal of the project is to develop radically new materials and evaluate application methods that enable the integration of more environmentally friendly hydro- or oleophobic barriers in dry molded processes (Dry Molded Fiber). The project is a collaboration between leading actors in chemical and material production in Sweden, where i.a. Nordic Barrier Coating will contribute with expertise in the development of non-woven materials, integrate pioneering chemistry and lamination of barriers on cellulose-based materials. A successful outcome of the project will enable the creation of several types of completely sustainable packaging products with high barrier properties with protection against, for example, grease and moisture. “The development of Dry Molded Fiber is progressing at a rapid pace and we see that there is an incredible amount of exciting happening in the market around sustainable chemicals, barriers and materials. We look forward to hypothesizing these leading innovative solutions in Dry Molded Fiber and are very positive regarding the possibilities of industrializing these.” comments Ove Larsson, Chief Technology Officer at PulPac AB Given proven hypotheses, the project will drive the uptake of Dry Molded Fiber in the most challenging packaging applications.
Toray Develops Biochip for High-Performance Multi-Item Allergy Testing
Toray Industries, Inc., announced today that it has developed an allergy testing biochip (see Glossary note 1) that can simultaneously measure multiple allergen-specific immunoglobin E (IgE) antibodies (see Glossary note 2) from trace amounts of blood. This breakthrough should help reduce stress on children and others whose blood is difficult to draw and enhance the accuracy of allergy diagnostics. Toray aims to undertake large-scale verifications of the specimens of allergy sufferers and swiftly apply for in-vitro diagnostic certification. Food, pollen, and other allergies afflict half of Japan’s population. Incidence rates are rising, particularly among infants and young adults. Infants often have multiple allergies. It is common in medicine to identify such ailments by using in vitro diagnostic products that measure allergen-specific IgE antibody levels in the blood. An issue with simultaneously measuring allergen-specific IgE antibodies from small blood samples to alleviate stress has been that proteins, cells, and other contaminants in the blood impede accurate measurements. Toray was able to attain high precision from measurements with small samples by combining the microarray technology of 3D-Gene®, a highly sensitive DNA chip that can simultaneously detect multiple genes, and a low-fouling polymer technology to prevent blood component adhesion that the company created in developing artificial kidneys for hemodialysis patients. In-house verification testing confirmed that Toray’s product, which simultaneously measures multiple allergy items from 20 microliters of blood, has a quantitative correlation exceeding 95% with existing in-vitro diagnostic products that measure single items. ### [Glossary] 1. Biochips are made of substrates on which DNA, proteins, sugar chains, and other bio-molecules are fixed to detect substances that interact specifically with these bio-molecules. Allergy testing biochips have allergens (proteins) on their substrate to detect allergen-specific IgE antibodies. 2. Allergen-specific IgE antibodies bind to allergens and cause allergic symptoms and are thus biomarkers for allergic ailments. Blood antibody measurements aim to identify causative allergens and select effective therapies.
TheOne Medical Introduces OneVet Veterinary Endoscope, A Versatile and Portable Device to Keep Your Pet Healthy
TheOne Medical is an innovative medical solution provider that specializes in medical imaging. To optimize the convenience and performance of diagnosis and treatment for veterinary practitioners, TheOne Medical will be showcasing its new imaging device, OneVet Veterinarian Endoscope, at various upcoming medical industry events in 2021. OneVet Veterinarian Endoscope is an ideal and cost-efficient solution for doctors seeking portable, easy-to-use, and versatile scope for various procedures. Equipped with a 3.5" IPS high-resolution screen, the 750mm length endoscope is easy to operate and suitable for examination, diagnosis, treatment, and biopsy. With a 2.8mm/4.8mm outer diameter (OD), a 1.2mm/2.6mm (ID) working channel, and suctioning function, the product is an effective imaging aid for the nose, ears, throat, stomach, intestine, and urinary tract practice in small and large animals. The 120° field of view (FOV) and 2-way deflection also facilitate the passage of the endoscope's tip to some hard-to-reach areas, reducing the damage and irritation to animals during the practice. By systematically integrating the software and hardware of medical imaging equipment, TheOne Medical is committed to developing easy-to-operate devices for physicians to optimize their practical applications. Competitive Advantages: • 100% made in Taiwan with warranty • Built-in battery lasts approximately 240 minutes • Snapshot and recording functions • Can be connected to external monitors, facilitating teaching and image preservation • Ergonomic handle for an easy, comfortable grip • Backup machines provided during maintenance for uninterrupted service
Techcarer Is Introducing The AI and Endoscope Diagnostic System Designing Services At MEDICA 2021
Techcarer, an innovative AI-powered diagnostic system service design company will be showcasing its new Techcarer AI and Endoscope Diagnostic system design services at the upcoming MEDICA 2021 (Nov 15 - Nov 18). With more than 4 years of experience in medical image and video for hybrid modalities applications, Techcarer designed diagnostic systems are currently used in over 60% of medical centers in Taiwan. Techcarer’s integration of AI technology into medical applications such as hyper-spectral intelligent identification systems (used for detection and analysis), allows the company to successfully capture unmet demands that currently exist with advanced infrastructure for medical distributors and solution providers. By leveraging its extensive experience in AI solutions, camera module system integration, and medical image and video integration, Techcarer is currently one of the leaders in AI service designers in the global medical industry. Competitive Advantages: • AI-powered hyper-spectral imaging • Ultra small endoscope camera (1.0mm) • Comprehensive video integration and recording system for medical facilities
Boehringer Ingelheim Expressed “Confidence in the Future” With Recording Positive Momentum in 2020 and Expanding R&D Investment
On the afternoon of the 24th, Boehringer Ingelheim held an online annual press conference and announced the progress of its 2020 annual results and business plans. The event was attended by Hubertus von Baumbach, Chairman of the Board of Managing Directors, and Michael Schmelmer, the Member of the Board of Managing Directors responsible for Finance and Group Functions.Currently, Boehringer Ingelheim is engaged in several projects aimed at finding medical solutions to treat COVID-19. In December 2020, the company announced together with Cologne University Hospital, the University of Marburg, and the German Center for Infection Research the initiation of Phase I/IIa clinical investigation of BI 767551. BI 767551 is the first SARS-CoV-2 neutralizing antibody administrated via inhalation as a potential new therapeutic and prophylactic option to block the virus at the site of infection. Other COVID-19 initiatives include the research and development of SARS-CoV-2 antibodies that can be combined with BI 767551, small molecules to inhibit its replication, and therapy development to prevent microcoagulation. ▲ Hubertus von Baumbach, Chairman of the Board of Managing Directors of Boehringer Ingelheim Hubertus von Baumbach stated that last year Boehringer Ingelheim drastically expanded its R&D investment by promoting the development of innovative medicines and treatments for diseases that do not yet have enough cures. In particular, the company accelerated efforts to research candidates for treatments related to COVID-19, and the total annual R&D investment in 2020 was 3.7 billion EUR, an increase of 7% from the previous year, the highest amount ever in the history of Boehringer Ingelheim for 136 years. Baumbach expressed his ambition, "2020 was a year that reaffirmed Boehringer Ingelheim's long-term R&D vision, and we try to move forward with greater confidence in the future."“The COVID-19 pandemic became an opportunity to find out what direction science is developing and how to contribute, and which field opportunities can be seized rather than risks. Recognizing the urgency of response to COVID-19, we started R&D on therapeutic candidates from the beginning of the first quarter of 2020. Research is underway with several partners around the world for patients,” Baumbach said. “Boehringer Ingelheim's executives and employees have continued to provide medicines and support medical staff to patients and animals. The achievements in 2020 are the result of our employees' efforts.”Besides, Baumbach emphasized the importance of partnership. “Looking back in 2020, Boehringer Ingelheim cannot help appreciating the support received from our partners. Funds and supplies have been provided in many countries around the world, helping COVID-19 patients and communities quickly and efficiently.” Also, “The recent partnership agreement between Boehringer Ingelheim and Google Quantum AI will be an opportunity to bring together all the necessary resources by combining our medical expertise with the algorithms of Google Quantum Computer.”Meanwhile, the Animal Health business of Boehringer Ingelheim is one of the largest providers of veterinary vaccines and medicines and has a strong presence in the livestock and companion animal segments. In 2020, the Animal Health business delivered a strong performance in a highly competitive market and grew by 5%, with net sales of 4.12 billion EUR. Baumbach explained, “Since Boehringer Ingelheim made a strategic decision to pay more attention to the field of animal health and veterinary medicine in 2016, we have continuously strived to develop synergies based on our knowledge between human and veterinary medicines.” ▲ Michael Schmelmer, the Member of the Board of Managing Directors responsible for Finance and Group Functions of Boehringer Ingelheim Michael Schmelmer gave a detailed introduction to Boehringer Ingelheim's performance in 2020, as well as business status including M&A and R&D. “2020 was a good year for Boehringer Ingelheim, although the effects of the COVID-19 pandemic were omnipresent. All of its businesses contributed positively to net sales and operating income. The company recorded net sales of 19.57 billion EUR, a 3% increase compared to the previous year. Foreign currency headwinds had a considerable impact; adjusted for currency effects, net sales rose by 5.6% year on year,” Schmelmer said. Also, “We met our ambitious targets, both in terms of our contribution to the wellbeing of humans, pets and livestock, and our business performance. This allows us to continue to invest even more in R&D, as well as in the long-term opportunities we have identified, most notably in the fields of oncology as well as digital and data technologies.”According to the presentation, operating income at the Group level rose to 4.62 billion EUR. One-time gains from divestitures supported the operating income. Income after taxes saw a 12.5% year-on-year increase to 3.06 billion EUR. Cash flow from operating activities increased by 619 million EUR to 3.96 billion EUR. At the end of 2020, the equity ratio stood at 47%. Moreover, the company invested 1.05 billion EUR in tangible assets in 2020, including the large-scale production facility for biopharmaceutical products (LSCC) in Vienna, Austria, and the new development center for biopharmaceutical medicines (BDC) in Biberach, Germany.Last year, Boehringer Ingelheim conducted several M&As to expand its portfolio through selection and concentration. In July, the company announced the acquisition of Global Stem cell Technology (GST), a Belgian veterinary biotech company, to develop and produce state-of-the-art stem cell products for horses and pets. In September, an equity stake in the China-based New Ruipeng Group, a company that specializes in providing medical care services for pets, was acquired. In December, the company announced the acquisition of all shares of NBE-Therapeutics, a clinical-stage Swiss biotechnology company focused on antibody-drug conjugates and advancing targeted cancer therapies derived from its immune-stimulatory iADC™ platform.Wrapping up the presentation, Schmelmer revealed the outlook for 2021. “2021 will be a year in which we continue to cope with the challenges posed by COVID-19. The difficult industry environment caused by increasing price pressures in several major markets is expected to affect 2021 earnings. Assuming that the approved vaccines and other medicines currently undergoing the approval process help curb the COVID-19 pandemic, the company expects strong general market growth for prescription pharmaceuticals. For 2021, Boehringer Ingelheim expects to achieve a slight year-on-year increase in net sales on a comparable basis.”
New Medical Ansats Will Be Equipped With Incubators For Saving Newborns
The Russian Helicopters holding company of the Rostec State Corporation will equip the updated Ansat medical helicopters with complexes for transporting newborns. The device has passed the necessary certification and received approval from the Federal Air Transport Agency. A new medical module, which is used in Ansat medical helicopters, has been supplemented with incubators for newborns. The module has a modified layout, adapted to unified stretchers, gurneys, and other equipment, thanks to which the patient's transportation has become more convenient: in the process of transferring a person on board, there is no need to shift and reconnect life support systems. Now it’s possible to load a patient into a helicopter by one person, the whole process takes less than 20 seconds. “When it comes to saving patients, including the kids, every minute can cost life. The incubators for newborns, which will now be equipped with the sanitary Ansats, will help to quickly deliver newborns to the hospital. The new version of the helicopter includes a ventilator, a condition monitoring unit, a respirator and an infusion pump. The new design makes it possible not to disconnect the patient from the life support devices during loading, which increases the speed and safety of transportation” said Oleg Yevtushenko, executive director of the Rostec State Corporation. The module is manufactured at the Kazan Aggregate Plant, it has passed all the necessary certification and is offered to customers as one of the options. “The approval of the Federal Air Transport Agency significantly expands the range of application of the new medical module MS-A for the Ansat helicopter, now it will be possible to transport patients of absolutely any age. The design bureau of Kazan Helicopters continues to work in this direction, in the context of a pandemic, the certification of an infectious box for a new medical module is especially relevant - this issue will also be resolved in the near future” said Andrey Boginsky, Director General of Russian Helicopters. Ansat helicopters carry out rescue services in various regions of the Russian Federation, the geography of their use is constantly expanding. The modern program for the development of sanitary aviation in Russia has been implemented since 2017 and is now part of the National Healthcare Project. On December 29, the upgraded Ansat-M helicopter took off for the first time with an increased flight range - up to 800 km with an additional fuel tank, which is especially important for medical evacuation, as it allows to perform work on a larger area of the region without refueling.
Intravacc’s Sabin Inactivated Polio vaccine (sIPV), out-licensed to LG Chem, receives WHO prequalification
Intravacc, a company specialized in translational research and development of vaccines, today announces the WHO prequalification for the Sabin-IPV (sIPV) vaccine Eupolio™, developed by Intravacc and out-licensed to South Korean LG Chem in 2014. The vaccine was developed by Intravacc for technology transfer to manufacturers in low- and middle-income countries in the context of the global polio eradication initiative. Eupolio™ received the prequalification status from the World Health Organization (WHO) by the end of December. LG Chem signed a contract with UNICEF to supply $80 million worth of polio vaccine Eupolio™ from 2021 to 2022. The company will supply the vaccine to 70 countries in the Middle East, Africa and Southeast Asia starting in January 2021. Intravacc will receive milestones and low single digit royalties for its considerable role in the development of this vaccine. In a phase III study completed in 2019 with Eupolio™ high neutralizing antibody titres were obtained against both wild-type and Sabin polioviruses, which will also protect against circulating vaccine-derived polioviruses (cVDPV) that make up the majority of polio cases in recent years. WHO prequalification of Eupolio™ is a major milestone in ongoing efforts towards global polio eradication, as it will help close the gap between demand and supply of safe and effective Inactivated Polio Vaccine (IPV) for millions of infants in need of immunization against poliovirus. To reduce the use of the virulent vaccine derived polioviruses, a switch to inactivated polio vaccines (IPV) was desired. Because of the limited supply and relatively high-cost price world-wide of IPV, Intravacc in collaboration with the WHO, initiated the development of a cost-effective manufacturing process for an inactivated poliovirus vaccine using attenuated (Sabin) poliovirus strains (sIPV) to be transferred to local manufacturers. LG Chem is the first manufacturer to bring the sIPV vaccine to the market. Dr. Jan Groen, Intravacc’s CEO, said: “This is a great example project in which Intravacc’s innovation and knowledge has been the basis of the development of an affordable vaccine that contribute to the reduction of infectious disease burden at a global level. We are confident that this joint effort with several of our license partners will significantly contribute to the polio eradication program.”
iMediSync debuts iSyncWave, a dedicated device for neuropsychiatric disorders, at CES 2021
iMediSync will showcase a groundbreaking EEG (electroencephalogram) brain mapping and LED-therapeutic device, iSyncWave™ at CES (Consumer Electronics Show) 2021. iSyncWave™ is a gel-free, portable EEG brain mapping device with LED photo-biomodulators. The device is especially designed for the early detection and supportive care of neuropsychiatric disorders such as dementia, Parkinson’s disease, TBI, PTSD, ADHD, depression, etc. iSyncWave™ will help neuropsychiatric patients to treat their illnesses at both clinics and homes. It will also allow for individuals to facilitate regular checkups to prevent degenerative neurological disorders. iSyncWave™ works with iSyncMe® – a mobile application that connects to iMediSync’s cloud platform, iSyncBrain®, the AI-driven EEG analysis platform for precision mental care. iSyncMe® also works as a telemedicine platform connecting iSyncWave™’s user to online doctors or mental care specialists. iMediSync has completed a basic framework for their virtual care platform by adding iSyncWave™ and iSyncMe® to their product line. An easy and time-saving EEG brain mapping and LED therapy device can be used not only in clinics but also at homes by individuals. This will enable healthcare providers to monitor their patients remotely, providing constant care that can be delivered at home. SeungWan Kang MD Ph.D, founder and CEO of iMediSync said “iSyncWave™ was created to provide an integrated service for both healthcare providers and individuals who want to understand their brain health with our comprehensive EEG analysis solution. At CES 2021, we look forward to meeting strategic partners who will pioneer the global market with iMediSync.” Visit www.imedisync.com for more information.
FDA Approves Liquid Biopsy NGS Companion Diagnostic Test for Multiple Cancers and Biomarkers
On October 26 and November 6, 2020, the Food and Drug Administration approved the liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test (Foundation Medicine, Inc.) as a companion diagnostic device for multiple additional biomarkers detected in cell free-DNA isolated from plasma specimens. The companion diagnostic indications in the October 26 approval are 1) to identify mutations in BRCA1 and BRCA2 genes in patients with ovarian cancer eligible for treatment with rucaparib (RUBRACA, Clovis Oncology, Inc.), 2) to identify ALK rearrangements in patients with non-small cell lung cancer (NSCLC) eligible for treatment with alectinib (ALECENSA, Genentech USA, Inc). and 3) to identify mutations in the PIK3CA gene in patients with breast cancer eligible for treatment with alpelisib (PIQRAY, Novartis Pharmaceutical Corporation). On November 6, FDA approved the FoundationOne Liquid CDx test as a companion diagnostic device to identify mutations in BRCA1, BRCA2 and ATM genes in patients with metastatic castration resistance prostate cancer (mCRPC) eligible for treatment with olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP). FoundationOne Liquid CDx approval as a companion diagnostic for rucaparib, alpelisib, alectinib, and olaparib was based on the retrospective testing with FoundationOne Liquid CDx of available plasma samples from patients enrolled in four clinical trials that supported the approval of associated therapeutics. Efficacy for rucaparib, alpelisib, alectinib, and olaparib was shown to be maintained in patients with confirmed BRCA1 and/or BRCA2 gene alterations, PIK3CA mutations, ALK rearrangement, and BRCA1, BRCA2, and/or ATM gene alterations, respectively, by FoundationOne Liquid CDx. If the specific mutations and alterations associated with these approvals are not detected in the blood, then a tumor biopsy should be performed to determine if the specific mutations and alterations are present.
Cell ageing can be slowed by oxidants
At high concentrations, reactive oxygen species – known as oxidants – are harmful to cells in all organisms and have been linked to ageing. But a study from Chalmers University of Technology, Sweden, has now shown that low levels of the oxidant hydrogen peroxide can stimulate an enzyme that helps slow down the ageing of yeast cells. One benefit of antioxidants, such as vitamins C and E, is that they neutralise reactive oxygen species – known as oxidants – which may otherwise react with important molecules in the body and destroy their biological functions. Larger amounts of oxidants can cause serious damage to DNA, cell membranes and proteins for example. Our cells have therefore developed powerful defence mechanisms to get rid of these oxidants, which are formed in our normal metabolism. It was previously believed that oxidants were only harmful, but recently we have begun to understand that they also have positive functions. Now, the new research from Chalmers University of Technology shows that the well-known oxidant hydrogen peroxide can actually slow down the ageing of yeast cells. Hydrogen peroxide is a chemical used for hair and tooth whitening, among other things. It is also one of the oxidants formed in our metabolism that is harmful at higher concentrations. Less food gives longer life The Chalmers researchers studied the enzyme Tsa1, which is part of a group of antioxidants called peroxiredoxins. “Previous studies of these enzymes have shown that they participate in yeast cells' defences against harmful oxidants,” says Mikael Molin, who leads the research group at Chalmers’ Department of Biology and Biological Engineering. “But the peroxiredoxins also help extend the life span of cells when they are subjected to calorie restriction. The mechanisms behind these functions have not yet been fully understood.” It is already known that reduced calorie intake can significantly extend the life span of a variety of organisms, from yeast to monkeys. Several research groups, including Mikael Molin’s, have also shown that stimulation of peroxiredoxin activity in particular is what slows down the ageing of cells, in organisms such as yeast, flies and worms, when they receive fewer calories than normal through their food. “Now we have found a new function of Tsa1,” says Cecilia Picazo, postdoctoral researcher at the Division of Systems and Synthetic Biology at Chalmers. “Previously, we thought that this enzyme simply neutralises reactive oxygen species. But now we have shown that Tsa1 actually requires a certain amount of hydrogen peroxide to be triggered in order to participate in the process of slowing down the ageing of yeast cells.” Surprisingly, the study shows that Tsa1 does not affect the levels of hydrogen peroxide in aged yeast cells. On the contrary, Tsa1 uses small amounts of hydrogen peroxide to reduce the activity of a central signalling pathway when cells are getting fewer calories. The effects of this ultimately lead to a slowdown in cell division and processes linked to the formation of the cells’ building blocks. The cells' defences against stress are also stimulated – which causes them to age more slowly. Could lead to drugs that mimic the positive effects of calorie restriction “Signal pathways which are affected by calorie intake may play a central role in ageing by sensing the status of many cellular processes and controlling them,” says Mikael Molin. “By studying this, we hope to understand the molecular causes behind why the occurrence of many common diseases such as cancer, Alzheimer's disease, and diabetes shows a sharp increase with age.” The fact that researchers have now come a step closer to understanding the mechanisms behind how oxidants can actually slow down the ageing process could lead to new studies, for example looking for peroxiredoxin-stimulating drugs, or testing whether age-related diseases can be slowed by other drugs that enhance the positive effects of oxidants in the body.
KÄÄPÄ Biotech launches the new Nordic Mushrooms product line and signs a distribution agreement to North America
The Finnish biotech company KÄÄPÄ Biotech announces the launch of the new Nordic Mushrooms product line. The product line has a distribution agreement to the North American market with the nutritional supplement supplier, Nutralliance. KÄÄPÄ Biotech is looking for partner opportunities also in other markets. KÄÄPÄ Biotech has invested in Ultrasonic Assisted Extraction technology to produce premium quality mushroom extracts. KÄÄPÄ Biotech specializes in mycological solutions for various industries, such as forestry and food supplement industry. KÄÄPÄ Biotech was founded in 2018 in Finland and the company has grown significantly in the past few years. KÄÄPÄ Biotech has launched the new Nordic Mushrooms wholesale mushroom extract product line, which includes Finnish grown organic chaga (Inonotus obliquus), reishi (Ganoderma lucidum), shiitake (Lentinula edodes), cordyceps (Cordyceps militaris), lion’s mane (Hericium erinaceus), maitake (Grifola frondosa) and turkey tail (Trametes versicolor). The product line includes mushroom extract powders and liquid extract ingredients for the health food and animal food supplement industry, for instance. KÄÄPÄ Biotech has signed a distribution agreement for the product line to North America with the nutritional supplement company, Nutralliance. “There is an increased demand for high-quality medicinal mushroom products in the North American market area,” says Eric Puro, the CEO of KÄÄPÄ Biotech. “The origin of the ingredients used in the food supplement industry is also getting more important all the time. Our products are 100% of Finnish origin, from the FSC or PEFC certified Finnish sawdust substrate, to growing of mushrooms as well as processing and manufacturing of the mushroom extracts. We have full traceability and transparency in our process from spore to shipment. Therefore we can guarantee premium quality mushroom extracts to the market.” KÄÄPÄ Biotech has invested in Ultrasonic Assisted Extraction technology which utilizes a combination of hot water and alcohol extraction. The method ensures the bio-availability of the desired bioactive compounds in each mushroom. This is important, because mushroom cell walls are made of chitin. Without an extraction process the compounds of interest are locked within the mushroom cell wall and pass through the human digestive system. “The fungi kingdom and especially members of the Basidiomycota phylum (mushrooms) hold tremendous potential for natural, safe and effective products that support a wide variety of health concerns as well as general well-being,” says Brian Salerno, CEO of Nutralliance. “To adequately fulfill modern North American consumers’ desires for superior quality in efficacy, safety and traceability as well as sustainability, we wanted to ensure our mycological expert source was able to put checkmarks in all those columns. KÄÄPÄ Biotech is that resource.”
Samsung Biologics Opens Its First Overseas CDO R&D Center in San Francisco
On 29th, Samsung Biologics (CEO Tae-han Kim) held an online opening ceremony for its San Francisco Contract Development Organization(CDO) Research & Development (R&D) Center. Samsung Biologics established the center that implemented the headquarters' CDO R&D platform to focus on meeting the demand for contract development services in the western United States. Moreover, by realizing the 'one-stop service' of CRO-CDO-CMO, the company has set a goal to become the best company in each of them. "In San Francisco, the mecca of the biopharmaceutical industry, there are about 2,500 life science companies. Also, since San Francisco is advantageous in terms of connectivity with the headquarters to successfully construct the initial global CDO R&D center, we chose San Francisco as the first destination," said Tae-han Kim, CEO of Samsung Biologics. "After 2020, the next 10 years will be the period for global expansion to Boston, Europe, and China. Through this expansion, we will endeavor to maximize customer satisfaction in the entire process of research, development, and manufacturing (CRO/CDO/CMO) of new biopharmaceuticals." ▲ Tae-han Kim, CEO of Samsung Biologics ◆ Full-fledged global expansion to become a Next Door CDO partner Samsung Biologics' San Francisco CDO R&D Center has the same state-of-the-art CDO service platform as the one at the Incheon Songdo headquarters. It was opened on a minimal scale initially, and it will be expanded in accordance with the increasing demand of clients in the future. Through this center, the company announced to become a 'Next Door CDO Partner' that supports clients' drug development process through closer and faster communication with local Big Pharma and Biotech. As a result, Samsung Biologics has resolved the parallax and low geographic access concerns raised by some overseas clients. Samsung Biologics plans to additionally build CDO R&D centers in Boston, Europe, and China at the major bio clusters where potential clients are concentrated to strengthen accessibility further. "We plan to open CDO R&D centers in the eastern United States and Western Europe in 2021. China is relatively advantageous in terms of the parallax and geographical elements, so the headquarters in Songdo, Incheon will manage for the meantime. However, as potential clients are rapidly increasing, we still have a plan to establish the CDO R&D center in China in the future," said Kim. On the other hand, securing more than 60 order contracts within two years since entering 2018, Samsung Biologics' CDO business grows fast with revealing its prominence in the global market. The company has successfully received both FDA & EMA regulatory approvals. Besides, GI Innovation Inc.'s drug candidate, which was consigned from the cell line development stage to Samsung Biologics, was exported for 900 billion won ($793 million) to Jiangsu Simcere Pharmaceutical Co., Ltd. In particular, Samsung Biologics is putting a lot of efforts in the CDO business to secure speed and price competitiveness with the slogan 'Faster & Better'. It drastically shortened the time required from cell line development to raw material drug production to 6 months and final product production to 7 months. This is about twice as fast as the 12-month development period of the same category currently promoted by major global companies. ▲ Samsung Biologics presented its vision as a one-stop CDMO service partner. ◆ Killing three birds with CRO-CDO-CMO end-to-end service Samsung Biologics has been proliferating since it entered the bio-industry in 2010 with its biopharmaceutical CMO business. Currently, it has three large biopharmaceutical production facilities, with a total of 364,000 liters. The 4th factory is scheduled to be ready for GMP operation from the end of 2022, and when it goes into operation, Samsung Biologics will have a total production scale of 620,000 liters. Samsung Biologics is more than the world's largest production CMO. It announced a strategy to maximize customer satisfaction through 'end-to-end one-stop service' system ranging from CRO (contract research), CDO (contract development), and CMO (contract manufacturing. For this, in succession to the CDO market advance in 2018, the company recently expanded its business to CRO. It has set a goal to establish itself as the best global CRO company in 2030, starting with a CRO business that includes antibody production service. The 4th factory was designed as the final edition of a one-stop service available within one factory from cell line development to end-product manufacturing. Based on this one-stop service, Samsung Biologics plans to secure 50% of the CMO volume through the CDO business by 2030. "Samsung Biologics started from a mudflat in Songdo, but achieved the CMO champion in 2020. We aim to achieve the CDO global champion by 2022, starting with the first overseas CDO R&D center in San Francisco. In the case of CRO business, Samsung Biologics will expand new bio drugs and antibodies production in earnest, and challenge the CRO global champion by 2030," said Kim. "Through the one-stop service, biotech clients could develop, produce, and manufacture new bio drugs with better efficacy and quality at a lower cost. Ultimately, Samsung Biologics aims to contribute to improving human health and the quality of life."