Flemming Ornskov, MD, MPH

Slides from the recent keynote "Biopharma Dealmaking: Time for a Re-Think" I delivered at the Swiss Healthcare Licensing Group meeting in Montreux in May are now available on the Lumanity website. https://lnkd.in/ePi9Vwse This data rich presentation is important viewing for anyone involved with or interested in biotech corp dev strategy but especially for those pre-commercial biotech "sellers" pinning their hopes on a large pharma partnership. The historically unprecedented increase in the number of biotechs reaching or surpassing clinical PoC stage (5 x or greater over past decade) coupled with a limited number of large pharma "buyers" means odds for vast majority of would be sellers are long. Many more of these biotechs should start to see self-commercializing, especially those pursuing advanced therapeutic modalities, such as cell and gene therapy, as more of a "Plan A" than B. And for many of these companies the time to get started is now, not when they are late in P3 or beyond.

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How to Prevent the Next Pandemic - by Bill Gates. Bill makes it clear that a lot of execution was badly done or in some cases not done at all. Clearly, the world needs a hard look at "Lessons Learned" from Covid. There is a lot of technology development around the world which will improve the reaction times of all of the phases (Recognition, Threat Definition, Diagnostics, Preventives, Amelioration, Treatment) of dealing with the next pandemic. Because everyone wants to do everything cheaper, better, faster, and get rich. Bill recommends adding some new (small) organization. I think this is very hard to put in place because politics is currently very partisan. I suggest; doing the hard work of Lessons Learned; running the technology development engines at full throttle; and lubricating the regulatory rules to bring advances to market safely, quickly, and economically.

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Roche announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, an automated multiplex real-time polymerase chain reaction (RT-PCR) assay on the cobas® liat system. Producing results in just 20 minutes on a compact analyser suitable for most healthcare settings, the test uses either a single nasopharyngeal or anterior nasal-swab sample to confirm or rule out infection with SARS-CoV-2, influenza A virus, influenza B virus and respiratory syncytial virus (RSV). “Diagnostics play a critical role in the fight against respiratory illness,” said Matt Sause, CEO of Roche Diagnostics. “We are proud to provide this innovative test to address the significant burden placed on healthcare systems. Now, healthcare professionals will be able to detect and differentiate these respiratory viruses within a single patient visit, enabling improved public health outcomes.” Introducing rapid multiplex PCR diagnostic tests into near-patient care environments such as emergency departments, urgent care facilities, and physician office labs has the potential to provide swift and precise results, expediting clinical decision-making processes. This approach can help reduce unnecessary antibiotic usage, facilitate targeted treatment strategies, and ultimately enhance patient outcomes and healthcare system efficiency. According to the U.S. Centers for Disease Control and Prevention (CDC), respiratory diseases in the United States reached high levels during the most recent autumn and winter seasons, with SARS-CoV-2 causing the most emergency department visits. Hospitalisations due to respiratory illness place a strain on hospitals and can result in delayed diagnosis and treatment for patients. In the 2023-2024 respiratory season, infants, children, and adults ages 65 and older were observed to have the highest rates of emergency department visits and hospitalisations caused by SARS-CoV-2, influenza, and RSV. Nationwide, the percentage of recent total deaths due to these respiratory viruses was highest among patients 65 and older. The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test authorised for emergency use further expands and complements Roche’s broad portfolio of single and multiplex tests intended to help diagnose and address the needs of patients presenting with symptoms of respiratory illness, including the following assays: cobas® SARS-CoV-2, cobas® Strep A, cobas® SARS-CoV-2 & Influenza A/B, and cobas® Influenza A/B & RSV for use on the cobas liat system. In 2025, Roche intends to seek FDA 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver in the United States for the new test, with plans for commercial launch in other markets worldwide following CE-IVDR approval. #diagnostics #respiratoryviruses #innovativetest  #RocheDiagnostics #Roche

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Exactly one year ago, Sandoz celebrated becoming the ‘oldest’ new company listed on the SIX Swiss Exchange. The spin-off from our parent company marked the start of a new era for Sandoz, a brand that dates back to 1886. A lot has happened since we rang that initial cowbell 12 months ago (the traditional ‘entry ceremony’ for new joiners at the SIX in Zurich). Sandoz today has clearly established itself as the independent global leader in off-patent medicines, with steady sales growth backed up by a string of strategic achievements, from key acquisitions to product approvals and launches. Most importantly, we are investing significantly to drive future growth, both in the rapidly-accelerating biosimilar segment and in key areas of our core generics business. We have a broad and deep pipeline including an industry-leading 25 biosimilars and more than 450 generics. If you've taken one of our medicines in the last year, you're in good company: our medicines provide more than 800 million treatments every year. So thank you for your trust in Sandoz. Together, we'll continue to push the boundaries of what's possible in healthcare! #PioneeringAccess

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What are the barriers to your personal development? We posed this question to our colleagues during a recent development workshop. See their insights below. When we start prioritizing our own #development, HOW do we actually learn? It often follows the 70/20/10 principle: 𝟳𝟬% 𝗢𝗻-𝘁𝗵𝗲-𝗷𝗼𝗯 𝗘𝘅𝗽𝗲𝗿𝗶𝗲𝗻𝗰𝗲𝘀 that are challenging, such as new job assignments or complex projects. 𝟮𝟬% 𝗥𝗲𝗹𝗮𝘁𝗶𝗼𝗻𝘀𝗵𝗶𝗽𝘀, including feedback from your supervisor and peers, mentors, and employee resource groups. 𝟭𝟬% 𝗘𝗱𝘂𝗰𝗮𝘁𝗶𝗼𝗻 and training programs. We grow through our daily experiences! Sometimes, we just need to take a moment to notice and reflect on them. #ProfessionalDevelopment #Growth #CareerDevelopment

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“Differentiate and Disrupt” In order for us to succeed, sustain, and survive, we need to differentiate, disrupt, and deviate from the main stream. This is the only way we can create an opportunity, stand out, and supersede other competitors. We need an atypical mindset totally different from others to disrupt an opportunity. This requires pushing beyond our threshold to make a mark in the industry. Enjoy achieving the impossibility by always differentiating from a possibility. It is the only way, we can succeed, sustain, and survive any competition. #differentiate #suceed #sustain #survive #disrupt

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This document in Nature Digital Medicine, provides valuable insights into the integration of Digital Therapeutics (DTx) within the German healthcare system, as facilitated by the Digital Healthcare Act. ​ It highlights the implementation of the Digital Health Application program (DiGA) and the criteria for inclusion in the BfArM DiGA directory. ​ The document also discusses the number of listed DiGAs and the pricing negotiations between manufacturers and public insurances. ​ It addresses the effectiveness, evidence requirements, patient access, and integration challenges of the DiGA program. ​ Additionally, it explores the evolution of the program over the past three years and upcoming legislative changes. ​ Overall, this comprehensive overview sheds light on the evolving landscape of digital therapeutics in Germany and its impact on healthcare delivery, offering valuable insights for healthcare systems globally. ​ #digitaltherapeutics #DiGA #DigitalHealth #reimbursement #pricing

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Worker absenteeism has soared since COVID. The following chart illustrates this new trend in Germany and similar charts have been produced for the UK and other developed economies. Long COVID is real and affects oral healthcare in several ways. 1. cancelled dental visits 2. more bleeding gums -- 29% of Long COVID patients complain about sore and bleeding gums. 3. an inability to tolerate and even afford invasive dental care. Long COVID sufferers often need more gentle, more accessible, less expensive oral healthcare. Think #Prevora.

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BIO-EUROPE: Panel Discussion "Pay The Price": Reimbursement - is there now a single HTA procedure in the European Union? With Niklas Hedberg (TLV / co-chair Member State Coordination Group on HTA), Sofia Heigis (Oncopeptides), Gry Stine Kopperud (Novartis), Alexander Natz (EUCOPE) and Fabian Berkemeier (IGES) Stockholm, 05 November 2024, 14:00, Exhibit Hall Stage In the European Union (EU), medicines are authorized centrally, but reimbursement is carried out at the national level: EU member states conduct national assessment procedures for this purpose, known as health technology assessments (HTAs). Harmonization of these procedures is one of the most important innovations in the regulatory framework for medicines in Europe. From January 2025, a common clinical assessment will come into force in the EU. This will be introduced gradually, starting with cancer medicines (including orphan oncology drugs) and ATMPs. A whole series of important EU regulations came into force in 2024. Currently, national regulations are being adapted to the new European procedure in the EU member states. And now, in the fall of 2024, many details regarding the implementation and execution of the new procedure are clarified (and others still open). This panel will discuss how small and large biopharmaceutical companies need to adapt to the new procedure to reach Europe’s patients quickly and successfully with their innovative therapies. Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV). He is the Co-Chair of the HTAR Coordination Group with special expertise in pharmaceuticals and the Chair of the Consortium Executive Board for EUnetHTA21 and was the Chair of the EUnetHTA JA 3, Executive Board between 2018 and 2021. Sofia Heigis, CEO of Oncopeptides AB (publ) - a biotech company focusing on research, development and commercialization of targeted therapies for difficult-to-treat cancers. Gry Stine Kopperud is Nordic Value & Access Head, Innovative Medicines Novartis. She is skilled in HTA strategy, submission and negotiation, Market Access, RWE and in Nordic tenders. Alexander Natz is the Secretary General of EUCOPE - European Confederation of Pharmaceutical Entrepreneurs and advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective.  Fabian Berkemeier, General Manager of IGES Institut GmbH will moderate the panel. As EU HTA stakeholders, the IGES Institute and IGES Group companies have been closely involved in the discussions and consultations of EUnetHTA21 and have prepared for the application of the regulation. In addition, the IGES Pharma division is represented by its Basel-based subsidiary Healthecon AG - Ein Unternehmen der IGES-Gruppe as a co-exhibitor at the Swiss joint stand (Booth 53) at BIO-EUROPE in Stockholm. #HTA #EUHTA #BIOEUROPE #IGES

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Novartis Ranked First in the 2024 Access to Medicine Index! 🌍💊   As #Novartis, we are proud to once again demonstrate our global leadership in access to medicines by securing the top spot in the 2024 Access to Medicine Index (#ATMI) report!   This achievement reinforces our commitment to ensuring access to medicines and our goal of providing equitable healthcare. At Novartis, we strive to reach more patients and improve lives with every step we take.   📌 Key accomplishments that led to our leadership in the 2024 Access to Medicine Index: - Integrating access as a priority in our research and development processes. - Developing innovative solutions to combat critical diseases like malaria, Chagas disease, and dengue. - Making a difference in healthcare by reaching 284 million patients in 2023.    While we celebrate this achievement, we recognize that there is still work to be done. As Novartis Türkiye, we will continue our efforts to increase access to medicines, particularly given the current 4% access level for innovative medicines*. This highlights the need for continued action to ensure equitable healthcare for all! Ranking first in the 2024 Access to Medicine Index is the result of the dedicated efforts of all our employees and the collective work we do together. I would like to extend my thanks and gratitude to all Novartis employees who contributed to this significant achievement. Together, we will continue to move forward with determination to increase access to medicines worldwide!   #Novartis #AccessToMedicine #HealthEquity #Leadership #GlobalImpact *https://lnkd.in/dqqETD2p

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Today, the European Medicines Agency recommended not granting a marketing authorisation for Leqembi (lecanemab). The main reason for that decision was, according to the EMA statement, that "the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious side events associated with the medicine, in particular the frequent occurrence of amyloid-related imaging abnormalities (ARIA), involving swelling and potential bleedings in the brain of patients who received Leqembi." You can see more details about the EMA statement at their website. At Ace Alzheimer Center Barcelona we believe this decision entails major concerns for the clinical, medical, and care community as well as for the field of research. First, the access of European patients to the same options and opportunities as the citizens from other countries. Secondly, the effect it can have in terms of research and investment in research. See more of our position in the open letter we sent to the EMA representatives: https://lnkd.in/d46T7fMt #Lecanemab #EMA #Leqembi #Alzheimers

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How Roche passed on a potential $14bn-a-year weight-loss pill In a notable missed opportunity, Swiss pharmaceutical giant Roche declined to acquire a weight-loss drug that could have positioned it at the forefront of the burgeoning obesity treatment market. The drug, now known as orforglipron, is being developed by Eli Lilly and is expected to generate $14 billion in annual revenue by 2032. This decision, made in 2018, highlights the challenges and uncertainties inherent in drug development, particularly in the weight-loss sector. Roche had the chance to secure orforglipron through its longstanding partnership with Japanese drugmaker Chugai. At the time, the drug, then called Owl-833, was poised to enter early-stage trials and was valued at a relatively modest sum. However, Roche chose not to exercise its "right of first refusal" on the drug, a move that allowed Eli Lilly to purchase it for $50 million. Since then, Eli Lilly has advanced orforglipron through clinical trials, and it is anticipated to be the first small molecule GLP-1 drug available as a weight-loss pill by 2026. The pharmaceutical industry is replete with stories of companies passing on early-stage drugs that later become blockbusters, and Roche’s experience with orforglipron is a prime example. The company had previously retreated from the obesity drug market after the failure of a GLP-1 drug, taspoglutide, in 2010. This setback, along with the side effects of an earlier obesity drug, Orlistat, led Roche to deprioritize obesity treatments in favor of its oncology pipeline. However, the soaring success of Novo Nordisk's Wegovy and the growing global demand for weight-loss solutions have reignited interest in this field. Roche has since re-entered the race, acquiring Carmot Therapeutics in 2023 for up to $3.1 billion. This acquisition has allowed Roche to develop its own weight-loss medications, although these are not expected to launch before 2028. Analysts predict that Roche's efforts will yield $4 billion in sales by 2032, far less than the projected earnings for Eli Lilly's orforglipron. Despite missing out on orforglipron, Roche's partnership with Chugai has not been without success. The collaboration brought forth Hemlibra, a $4.5 billion-a-year treatment for hemophilia. Even with orforglipron's success, Chugai stands to benefit through potential milestone payments, underscoring the complexity and long-term nature of pharmaceutical development partnerships. Source: FT 15.8.24 #biopharma #insights #diabetes

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The Abbvie vs Sanofi/Regeneron battle for Eczema is HOT - WHY? Here´s my take on the latest results of the last trial of Rinvoq vs Dupixent Also, I´m an eczema patient.... 1 - Rinvoq Clinically Superior (For Now): In the LEVEL UP trial, Rinvoq achieved near-complete skin clearance (with little to no itch) in 20% of patients with moderate-to-severe eczema after 16 weeks, compared to only 9% on Dupixent. This translates to a potentially significant improvement for patients. It's worth noting that this is the second time in four years #Rinvoq has bested Dupixent in head-to-head trials. 2 - Eczema Market Up for Grabs (With Data to Back It Up): Dupixent currently holds the dominant position in the eczema market, generating a whopping $11.6 billion in sales for 2023. However, Rinvoq's impressive results, especially considering it aced all secondary objectives in the trial, could lead to a significant shift. The key will be translating these trial results into real-world effectiveness and physician adoption. 3 - AbbVie's Strategy Validated (But Not Risk-Free): Rinvoq's success is a major win for AbbVie's strategy of diversifying its immunology portfolio beyond Humira's patent expiry. This cements their position as a key player in the lucrative eczema market, estimated to be worth over $15 billion by 2025. However, competition is fierce, and Dupixent still holds the upper hand in terms of broader age group approval (6 months and older vs. 12 and older for Rinvoq). 4 - Safety Concerns Mitigated (For Now): The previous safety concerns surrounding Rinvoq, which overshadowed their 2020 win, seem to be addressed in this trial. The researchers used a lower starting dose (15mg) with adjustments up to 30mg, and no new safety signals were identified. However, long-term safety data is still crucial, and investors should monitor any future developments. 5 - Dupixent Still a Formidable Foe, But Vulnerable: Let's not count Dupixent out. It boasts a broader age range approval and is on the cusp of potentially blockbuster sales in COPD (chronic obstructive pulmonary disease). Analyst projections estimate Dupixent's sales could reach over $20 billion by 2030. However, investors should be aware of the growing threat Rinvoq poses, especially if AbbVie can translate trial success into real-world results. What do you think about how the Eczema market will move after that? Leave a comment below Happy to answer any specific questions you may have about the biotech investment landscape #biotech #investment #investor #vc #drug #discovery #healthcare #market #business #patient #eczema _________________________________________________________________________________ Biotech investor or innovator? We assist investors unlock potential by assisting with due diligence and companies refine strategies for success and fundraising. Let's chat! Have you enjoyed this? Recommend Repost ♻️ if you find it useful Follow me, hit the 🔔 Adrian Rubstein

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Attending the Switzerland Stars Symposium and hearing from Roche Group CEO Thomas Schinecker was truly inspiring. Two key takeaways resonated deeply: 1. Always hire people smarter than you, trust them, cater them—they are the ones who will help you grow. 2. Drop the ego when working with your team—authenticity drives success. And one of his one statements I really liked. “American people, both republicans and democrats agree on two things; 1. China is evil and 2. Bib companies are evil” 🤪 Also fascinating was learning about Roche’s R&D-intensive business model—innovative and future-forward. Leadership insights from one of the world’s largest companies in person is a game-changer! #Leadership #Innovation #GrowthMindset #Roche #Stars #StarsAlumni #IamSrats

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Thoughtful commentary from my former Lumanity (Cello BioConsulting, Defined Health) colleague Joel Sandler, Ph.D. It will be very interesting to see how all this plays out in terms of therapeutic index, ease of use, manufacturing, and value (clinical benefit versus price) between CAR-T, cell engagers, cancer vaccines, next gen IO antibodies and maybe oncolytic viruses. #immunooncology #immunotherapy #cancer #oncology

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Let’s conclude this year’s Breast Cancer Awareness Month with some good news: new therapy methods are giving hope to more and more women. A promising clinical trial, conducted over the past ten years at Fresenius Helios in Germany and involving 1,500 breast cancer patients, explores the efficacy of "antibody-drug conjugates," which target cancer cells with greater precision, significantly enhancing treatment outcome, as initial results show.   Female breast cancer is the second most common form of cancer, with 2.3 million new cases every year and 670,000 deaths in 2022. However, while more women are developing breast cancer, the number of deaths has been falling for decades. Fresenius Kabi provides oncology drugs and biosimilars for the therapy itself as well as for mitigating side effects like vulnerability to infections. In our 21 breast cancer centers at Helios Kliniken GmbH and 50 centers at Quirónsalud, we have treated over 40,000 patients in the past eight years. Not all of them were women – 0.9 percent were in fact men.   Thanks to highly specialized medicine, 84 percent of patients are alive ten years after their diagnosis. The chance to receive a timely diagnosis and the right therapy varies significantly, however, depending on which country a patient lives in. According to the World Health Organization, one in 12 women living in a higher income country will be diagnosed with breast cancer in their lifetime – and one in 71 women will die from the disease. In lower income countries, the statistics are less favorable: just one in 27 women will be diagnosed and one in 48 women will not survive.   A breast cancer diagnosis is both a shock and a heavy burden for every woman, her family and friends. Our healthcare experts experience this difficult situation every day when treating patients with the disease. Mitigating side effects of cancer therapy and offering the right nutrition, specifically selected to meet the individual woman’s needs, is crucial for enhancing therapy success and preserving quality of life. Thus, it is no coincidence that Prof. Dr. Vesna Bjelic Radisic, Head of Senology and the Breast Centre at Helios University Hospital Wuppertal, has received numerous awards for her studies on quality of life in cancer therapy.   Currently the Helios Breast Center Wuppertal is one of the first clinics in Europe to take part in a study to find out whether an MRI examination of the removed tumor directly in the operating room can reduce the rate of follow-up operations. I truly admire the innovation that is driving today’s cancer therapies! #BreastCancerAwareness #GetChecked #HealthEquity #FutureFresenius #CommittedToLife

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𝗦𝘁𝗮𝗻𝗳𝗼𝗿𝗱 𝗨𝗻𝗶𝘃𝗲𝗿𝘀𝗶𝘁𝘆: 𝗔𝗿𝘁𝗶𝗳𝗶𝗰𝗶𝗮𝗹 𝗜𝗻𝘁𝗲𝗹𝗹𝗶𝗴𝗲𝗻𝗰𝗲 𝗜𝗻𝗱𝗲𝘅 𝗥𝗲𝗽𝗼𝗿𝘁 𝟮𝟬𝟮𝟰 "The 2024 Index is our most comprehensive to date and arrives at an important moment when AI’s influence on society has never been more pronounced. This year, we have broadened our scope to more extensively cover essential trends such as technical advancements in AI, public perceptions of the technology, and the geopolitical dynamics surrounding its development......." 𝗧𝗼𝗽 6 𝗧𝗮𝗸𝗲𝗮𝘄𝗮𝘆𝘀 1. AI beats humans on some tasks, but not on all. AI has surpassed human performance on several benchmarks, including some in image classification, visual reasoning, and English understanding. Yet it trails behind on more complex tasks like competition-level mathematics, visual commonsense reasoning and planning. 2. Industry continues to dominate frontier AI research. In 2023, industry produced 51 notable machine learning models, while academia contributed only 15. There were also 21 notable models resulting from industry-academia collaborations in 2023, a new high. 3. Frontier models get way more expensive. According to AI Index estimates, the training costs of state-of-the-art AI models have reached unprecedented levels. For example, OpenAI’s GPT-4 used an estimated $78 million worth of compute to train, while Google’s Gemini Ultra cost $191 million for compute. 4. The United States leads China, the EU, and the U.K. as the leading source of top AI models. In 2023, 61 notable AI models originated from U.S.-based institutions, far outpacing the European Union’s 21 and China’s 15. 5. Robust and standardized evaluations for LLM responsibility are seriously lacking. New research from the AI Index reveals a significant lack of standardization in responsible AI reporting. Leading developers, including OpenAI, Google, and Anthropic, primarily test their models against different responsible AI benchmarks. This practice complicates efforts to systematically compare the risks and limitations of top AI models. 6. Generative AI investment skyrockets. Despite a decline in overall AI private investment last year, funding for generative AI surged, nearly octupling from 2022 to reach $25.2 billion. Major players in the generative AI space, including OpenAI, Anthropic, Hugging Face, and Inflection, reported substantial fundraising rounds. https://lnkd.in/ez55g9Uw ==**== Connect with us to stay at the forefront of AI-powered GxP compliant solutions in life sciences. Your partnership in innovation begins here. 👇 Engage ➡️Like ➡️Share ➡️Discuss #ai #aitrends #artificialintelligence

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A new Danish study of adults with a #heartattack, reports that avoiding the dentist, raises the risk of second attack. https://lnkd.in/g7Qn3RKC So how do we get high-risk adults to go to the dentist? Make it affordable, painless, quick and convenient. In other words, introduce a new model of oral healthcare. Use #Prevora. Considered by high risk seniors to be very important, very acceptable, and very beneficial to overall health.

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Interesting Sloan Review post suggests FAST objectives are better than SMART objectives FAST (frequently discussed, ambitious, specific and transparent) not SMART https://lnkd.in/eG_z28Ai

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