Immunovant’s Post

The Importance of Human Relationships in Medical Affairs During a recent meeting with my peers from the commercial areas, I was asked how I manage to speak so easily with everyone. Honestly, I laughed, as before working in the pharmaceutical industry, I considered myself rather shy and struggled to communicate with my fellow medical professionals. However, over these years in my career, I have grown confident in conversing with my colleagues and even with key opinion leaders who often have deeper expertise in certain medical topics. The key seems to be acknowledging their expertise, understanding my own position, and being clear about what I aim to achieve from each interaction. In Medical Affairs, this is particularly crucial. While there is an increasing need in the pharmaceutical industry to rely on evidence to make a difference and demonstrate the value of products and services, there are three essential points to focus on in Medical Affairs: Set Clear Objectives: Define your short, medium, and long-term goals clearly. Create a Scientific Strategy: Develop the scientific strategy and establish the tactics that will help you achieve the objectives within the timeframe set by you and your team. Play as a Team: The most important aspect is to play as a team. Seeking strategic allies both within and outside your comfort zone will take you further. Shared decision-making (SDM) is also vital in Medical Affairs. SDM is a collaborative process where a patient’s goals, values, and preferences are incorporated into informed health care choices. This approach ensures that the expertise of clinicians and the individual insights of patients are integrated into the decision-making process, which is especially important in multidisciplinary, team-based cardiovascular care. Today, more than ever, Medical Affairs is about teamwork, understanding the business needs, and supporting them from what drove us to study medicine in the first place: our love for science and care for patients. Incorporating the latest advancements in cardiometabolic and cardiovascular disease management, such as leveraging RAAS inhibition for conditions like chronic heart failure, diabetes, and ischemic heart disease, is key to our success. Embracing innovative technologies and evidence-based approaches ensures we stay at the forefront of the medical field. What do you think?#MedicalAffairs #CardiometabolicHealth #CardiovascularDisease #ChronicHeartFailure #DiabetesManagement #ScientificStrategy #TeamworkInHealthcare #RAASInhibition #EvidenceBasedMedicine #InnovationInPharma #SharedDecisionMaking #MultidisciplinaryCare

Researchers from the Parker Institute have been the primary drivers behind the evidence-driven and consensus-based guidelines regarding which contextual factors (CFs) to incorporate when conducting research in rheumatology. We already had evidence from the OMERACT Working Group on the importance of three important aspects/themes/concepts for CFs: (1) Effect Modifying Contextual Factors (EM-CFs), (2) Outcome Influencing Contextual Factors (OI-CFs), and (3) Measurement Affecting Contextual Factors (MA-CFs)) considered important within rheumatology, but we’re introducing a provisional list of things to consider. https://lnkd.in/dHXXuiik

Single-center randomized trials don't cut it. Clinical trials should use multiple sites whenever possible to increase generalizability. A 2023 systematic review of randomized controlled trials (RCTs) in critically ill patients found that of 19 single-center RCTs with a multicenter RCT follow-up, only ONE had successfully replicated results. This is so important in medical education, disease state, and therapy messaging. When describing a drug or treatment, looking at the trial design is crucial. There are many factors that contribute to the validity of a clinical trial, but seeing if it's multi-center or single-center is an easy check. #clinicaltrials #medicine #criticalillness Reference: 1.Kotani Y, Turi S, Ortalda A, et al. Positive single-center randomized trials and subsequent multicenter randomized trials in critically ill patients: a systematic review. Crit Care. 2023;27(1):465. doi:10.1186/s13054-023-04755-5 +++ 👋 I’m Chris, a medical strategist, writer, and founder of Quill Science LLC. We use accurate and engaging storytelling to amplify the benefits of cutting-edge scientific and medical advances. 🌐 Check out www.quillscience.com and book a free discovery call. 💡 Follow me for science and medical news, perspectives, and career posts.

Are your osmolality measurements made in time to inform patient care? We're thrilled to welcome Dr. Arian Gower, MD, a nephrologist at Renal Consultants Medical Group, to our Xtalks webinar for an in-depth exploration of osmolality testing and how it can be effectively utilized in medical diagnostics. 📅 Date: September 13th, 2024, at 3pm EDT | 2pm CDT | 12pm PDT Who Should Attend: This webinar is perfect for anyone involved in clinical laboratory testing, including nephrologists, emergency physicians, laboratory managers and medical technologists. Attendees will learn: • What osmolality testing is and how it can be used • The difference between calculated and measured osmolality • The osmolar gap to support the diagnosis of the ingestion of toxic alcohols like ethylene glycol • Why osmolality measurements must be performed quickly to inform the prompt treatment for patients who have ingested toxic alcohols •  The future of testing to evaluate possible toxic alcohol ingestion Register Now 👉 https://lnkd.in/dxwniYFB #XTalks #OsmolalityTesting #MedicalLabs #ClinicalDiagnostics

At a recent #workshop hosted by Ashoka University experts from esteemed organizations including the Indian Council of Medical Research (ICMR), World Health Organization (WHO), National Centre for Biological Sciences (NCBS), and partners of the #AllianceforPathogenSurveillanceandInnovation (APSI) underscored the urgent need for Unified Data Systems and Standard Operating Procedures (SoPs) for the surveillance of World Anti-Microbial Resistance Congress (AMR) in India. Distinguished attendees such as Dr. Kamini Walia, Senior Scientist at ICMR; Dr. Anuj Sharma, NPO – Technical focal point for AMR, Labs and IPC, WHO; Dr. Rakesh Mishra, Director, Tata Institute of Genetics Society; and Dr. (Brig.) Rakesh Kumar Gupta, Director, Government Institute of Medical Sciences (GIMS), among others, participated in the workshop. The event also welcomed scientists from CSIR-NCL, CSIR-CCMB & CSIR-IGIB, clinical partners of Ashoka University, representatives from funding bodies, and students and professors from colleges in Delhi-NCR. India currently faces an urgent need for precise estimates regarding the overall prevalence of AMR, with the #nation widely believed to carry one of the largest burdens of #drug-resistant pathogens globally. According to ICMR's Annual Report 2022, the misuse of #antimicrobials has led to a concerning rise in the prevalence of AMR in the country. Titled "#EnvironmentalSurveillanceofAntimicrobialResistance (AMR): Strategies and Implications," the workshop was part of an outreach effort by APSI, a multi-city consortium aimed at #developing advanced pathogen surveillance. APSI counts public and private institutions such as Ashoka University among its members. Prof. L.S. Shashidhara, Director of the National Centre for Biological Sciences (NCBS), Bengaluru, highlighted the unique nature of the APSI consortium, which brings together public and private academia, hospitals, R&D labs, and government departments to tackle the #AMRchallenge across four different regions of the country. He emphasized the vision of the consortium to provide evidence for framing public health policies and strategies at both national and state levels. A panel discussion during the workshop emphasized the importance of integrating surveillance data into #healthcare and environmental systems for informed decision-making and policy development. Key recommendations included addressing #challenges in real-time AMR surveillance such as data sharing and operator training, alongside advocating for digital systems to streamline data generation and allocation. Researchers associated with #APSI presented standard methods developed for AMR surveillance in various environments, including wastewater, milk samples, and clinics. #News #Medlr #Healthnews #Healthcare #Health

Clinical trials are not the only way to get phages to patients. An alternative is an approach that goes by a range of names: named patient use, expanded access, compassionate use… what they all cover is, to quote the European Medicines Agency, “a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies”. The extraction of useful data from such studies is heavily outweighed by the need to treat the patient, and in some cases even recording such data can be unacceptable. But it does get therapeutic phages to patients, and there are quite a few cases where there have been positive results. One excellent example was a case series pubished on treating diabetic toe ulcers, where some extremely nasty conditions were resolved through the use of phages, which was work explicitly intended to progress matters towards clinical trials. Fish R, Kutter E, Wheat G, Blasdel B, Kutateladze M, Kuhl S. Compassionate Use of Bacteriophage Therapy for Foot Ulcer Treatment as an Effective Step for Moving Toward Clinical Trials. Methods Mol Biol. 2018;1693:159-170. doi: 10.1007/978-1-4939-7395-8_14. PMID: 29119440. Sacher J and Zheng J, Phage Therapy Collaboration and Compassionate Use. ” in D.R.Harper, S.T.Abedon, B.H. Burrowes, M.L.McConville eds. (2021). Bacteriophages: Biology, Technology, Therapy (2 volumes). Springer Nature, Vienna. ISBN 978-3319419855 #bacteriophage #phage #compassionate_use #expanded­_access #named_patient #phagetherapy #thephageadviser drh@thephageadviser.com

Single-center randomized trials don't cut it. Clinical trials should use multiple sites whenever possible to increase generalizability. A 2023 systematic review of randomized controlled trials (RCTs) in critically ill patients found that of 19 single-center RCTs with a multicenter RCT follow-up, only ONE had successfully replicated results. This is so important in medical education, disease state, and therapy messaging. When describing a drug or treatment, looking at the trial design is crucial. There are many factors that contribute to the validity of a clinical trial, but seeing if it's multi-center or single-center is an easy check. #clinicaltrials #medicine #criticalillness Reference: 1.Kotani Y, Turi S, Ortalda A, et al. Positive single-center randomized trials and subsequent multicenter randomized trials in critically ill patients: a systematic review. Crit Care. 2023;27(1):465. doi:10.1186/s13054-023-04755-5 +++ 🔬 At Quill Science LLC, we use evidence-based scientific insight with top-notch strategic thinking to create and amplify accurate and impactful messages for biomedical and life sciences companies and agencies. Find out more about partnering with us at www.quillscience.com

Pain robs an individual of their life. A patient may become anxious or depressed and may even want to end their life because of pain. This mostly results from being unable to do many of the things they could do without the pain. It robs them of their relationships with others, their ability to maintain employment, and sometimes the joy they have when they are without pain. According to a WHO (World Health Organization) study, people with persistent pain are four times more likely to suffer from anxiety or depression than individuals without pain, and more than twice as likely to have difficulty working and concentrating. When someone is in constant acute pain, the last thing they want to do is attend a friend’s backyard barbecue, a company party, neighborhood meetings, or even small gatherings with their family members or close friends. This often leads to a downward cycle of social isolation, further deteriorating feelings of joy and happiness, and exacerbating loneliness. A PEMF approach towards pain management – specifically SofPulse – is being seen as a game changer. Effective pain management, less edema and swelling, reduced inflammation, and getting back to your life all with no adverse event risks – there is nothing like this in the market. SofPulse provides pain relief without narcotics or any drugs. Additionally, using SofPulse will address the underlying cause of pain - inflammation and edema. SofPulse is the only FDA-approved, technology-based, and patented pain relief product with a demonstrable ability to get you back to your life faster, with an improved quality-of-life benefit. SofPulse PEMF therapy treatment has been used in more than 20 thousand cases, including a large number of breast and other cancer surgeries,  to manage acute pain and edema in in-patient, outpatient, and home settings, offering patients a safe and effective pain management alternative. Contact us for more information. #painrelief #sofpulse #surgery #plasticsurgery #effectivepainrelief #painmanagement #edema #reducepain #veterans #veteranshealth #militarymedicine #seniors #seniormedicine www.sofpulse.com

Congratulations ! 🏆 🎉 Team QREC Clinical Research LLP (India-UAE) for successfully PUBLISHED the REAL WORLD Observational study on Cardiac Hemodynamic agent " Dihydropyridine calcium channel " with 100 KOL CARDIOLOGIST and 1000 patients PAN India. #cro #clinicaldatamanagement #medicalwriting #clinicaloperations #OBSERVATIONALSTUDY #statisticalanalysis #clinicalresearch #clinicaltrials #clinicaldata #medicalwriting #statisticalprogramming #contractresearchorganization #publications #submission #manuscripts #REALWORLDSTUDY #doctors #regulatoryaffairs #projectmanagement #qualitycontrol #sitemanagement #medicaldevices #pharmaceuticalsindustry #lifesciences