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title>Xtalks/title>
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title>Laser Vision: Pioneering Laser Innovations for Presbyopia ft. Ace Vision’s Dr. AnnMarie Hipsley/title>
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media:title>Laser Vision: Pioneering Laser Innovations for Presbyopia ft. Ace Vision’s Dr. AnnMarie Hipsley/media:title>
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media:description>In this episode, Ayesha spoke with AnnMarie Hipsley, DPT, PhD, CEO and founder of Ace Vision Group, an ophthalmic laser device company that is bringing touchless eye laser therapy to patients with age-related vision loss.
Dr. Hipsley is a vision scientist, inventor, entrepreneur, author and speaker on ocular biomechanics and the biomechanical rejuvenation of the aging eye.
She invented an innovative touchless laser system and a laser microporation system for the treatment of presbyopia.
Presbyopia is an age-related condition in which the eye gradually loses its ability to focus on close objects due to natural aging of the lens inside the eye. It typically begins to affect individuals around the age of 40 and continues to progress until around age 65.
Dr. Hipsley is passionate about educating the health care space on the global burden of uncorrected presbyopia, particularly the socioeconomic and quality of life implications of the condition.
Over the past 25 years, she has trained more than 100 ophthalmic surgeons worldwide in using near-infrared lasers for tissue microporation.
Tune into the episode to hear more about Dr. Hipsley and Ace Vision Group’s innovative solutions for presbyopia.
For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/
Follow Us on Social Media
Twitter: https://twitter.com/Xtalks
Instagram: https://www.instagram.com/xtalks/
Facebook: https://www.facebook.com/Xtalks.Webinars/
LinkedIn: https://www.linkedin.com/company/xtalks-webconferences
YouTube: https://www.youtube.com/c/XtalksWebinars/featured/media:description>
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yt:videoId>TDFvQe4N6Mk/yt:videoId>
yt:channelId>UCR0I-ZqmTd3pLuEQ5pomHbg/yt:channelId>
title>How Can Clinical Research Teams Use Data-Driven Approaches to Foster Diversity in Research?/title>
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name>Xtalks/name>
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published>2024-11-20T14:30:21+00:00/published>
updated>2024-11-20T14:30:21+00:00/updated>
media:group>
media:title>How Can Clinical Research Teams Use Data-Driven Approaches to Foster Diversity in Research?/media:title>
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media:thumbnail url="https://i1.ytimg.com/vi/TDFvQe4N6Mk/hqdefault.jpg" width="480" height="360"/>
media:description>More on this story: https://xtalks.com/how-can-clinical-research-teams-use-data-driven-approaches-to-foster-diversity-in-research-3940/
In this Xtalks Spotlight, we spoke with Ryan Brown, Regional Vice President of Sales for Trial Landscape at H1, about the need for a holistic, data-driven approach to inclusivity in clinical research.
From using technology to identify underserved populations to reimagining traditional benchmarks, Ryan discussed strategies that make clinical research more representative and accessible.
Receive weekly news and webinar updates right in your inbox: https://xtalks.com/register/
Listen live and interact with featured speakers on our upcoming Life Science webinars: https://bit.ly/2YRzAV0
#ClinicalResearch #ClinicalDevelopment #H1 #Diversity #ParticipantDiversity #PatientDiversity #DEI #HealthEquity/media:description>
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id>yt:video:QLpUGwkMijs/id>
yt:videoId>QLpUGwkMijs/yt:videoId>
yt:channelId>UCR0I-ZqmTd3pLuEQ5pomHbg/yt:channelId>
title>Diversity Actions Plans (DAPs) in Clinical Trials Are No Longer a “Nice-to-Have” — Are You Ready?/title>
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author>
name>Xtalks/name>
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published>2024-11-19T17:00:22+00:00/published>
updated>2024-11-22T08:32:21+00:00/updated>
media:group>
media:title>Diversity Actions Plans (DAPs) in Clinical Trials Are No Longer a “Nice-to-Have” — Are You Ready?/media:title>
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media:description>More on this story: https://xtalks.com/diversity-action-plans-daps-in-clinical-trials-are-no-longer-a-nice-to-have-are-you-ready-3969
In an engaging conversation with Xtalks, regulatory experts from Fortrea, Dr. Teresa Oblak, Senior Director of Regulatory Strategy, and Dr. Alicia McDowell, Head of Regulatory Strategy and Product Development, shed light on the critical role of Diversity Action Plans (DAPs) in shaping clinical trials and advancing health equity.
Drawing from their vast experience in regulatory strategy and clinical development, Dr. Oblak and Dr. McDowell explore how DAPs are breaking down barriers to inclusivity, enabling trials to better reflect real-world populations. They discuss the necessity of early planning, clear enrollment targets and adaptable trial frameworks to meet both FDA requirements and global diversity goals.
The conversation also dives into the human impact of DAPs, from bridging trust gaps in underserved communities to addressing logistical hurdles like transportation and scheduling. These initiatives aim to make trials accessible while ensuring data is reflective and actionable.
Discover how Diversity Action Plans are transforming clinical research, fostering inclusivity and paving the way for therapies that work for everyone.
Receive weekly news and webinar updates right in your inbox: https://xtalks.com/register/
Listen live and interact with featured speakers on our upcoming Life Science webinars: https://bit.ly/2YRzAV0
#DiversityInClinicalTrials #ClinicalResearch #Fortrea #FDA #ClinicalDevelopment #DiversityEquityInclusion #DrugDevelopment #PatientDiversity #HealthEquity #InclusiveResearch #MedicalTrials #FDACompliance #FDADraftGuidance #DiversityActionPlans/media:description>
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yt:channelId>UCR0I-ZqmTd3pLuEQ5pomHbg/yt:channelId>
title>Bringing the Tech Revolution to Medicine with Digital Therapeutics ft. Dr. Shaheen Lakhan/title>
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name>Xtalks/name>
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media:group>
media:title>Bringing the Tech Revolution to Medicine with Digital Therapeutics ft. Dr. Shaheen Lakhan/media:title>
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media:description>In this episode, Ayesha spoke with Shaheen Lakhan, MD, PhD, Chief Medical and Scientific Officer, Click Therapeutics, a company focused on developing software as prescription medical treatments for people with unmet medical needs.
Click Therapeutics is specifically developing Digital Therapeutics, which involve the delivery of prescription treatments to patient’s smartphones. These are being developed for indications in psychiatry, neurology, oncology, immunology and cardiometabolic diseases.
In collaboration with Otsuka, Click Therapeutics most recently developed the first prescription digital therapeutic authorized by the FDA for the adjunctive treatment of major depressive disorder symptoms.
Dr. Lakhan, is an inventive entrepreneurial physician-scientist who is board-certified in neurology and pain medicine with over 20 years of industry experience. As Chief Medical and Scientific Officer at Click Therapeutics and a Board Director at SpineThera, he spearheads AI-enabled clinical development and drug-delivery platforms.
Tune into the episode to hear more the cutting-edge new field of digital therapeutics and how they are shaping the industry.
For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/
Follow Us on Social Media
Twitter: https://twitter.com/Xtalks
Instagram: https://www.instagram.com/xtalks/
Facebook: https://www.facebook.com/Xtalks.Webinars/
LinkedIn: https://www.linkedin.com/company/xtalks-webconferences
YouTube: https://www.youtube.com/c/XtalksWebinars/featured/media:description>
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media:starRating count="3" average="5.00" min="1" max="5"/>
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id>yt:video:HnSkMcCRb28/id>
yt:videoId>HnSkMcCRb28/yt:videoId>
yt:channelId>UCR0I-ZqmTd3pLuEQ5pomHbg/yt:channelId>
title>Inside the Latest Advances in Hearing Tech ft. Envoy Medical CEO Brent Lucas/title>
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author>
name>Xtalks/name>
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published>2024-11-06T10:00:17+00:00/published>
updated>2024-11-12T17:03:48+00:00/updated>
media:group>
media:title>Inside the Latest Advances in Hearing Tech ft. Envoy Medical CEO Brent Lucas/media:title>
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media:thumbnail url="https://i1.ytimg.com/vi/HnSkMcCRb28/hqdefault.jpg" width="480" height="360"/>
media:description>In this episode, Ayesha spoke with Brent Lucas, CEO of Envoy Medical.
Envoy Medical is a medical device company focused on providing cutting-edge technologies across the hearing loss spectrum.
According to the National Institute of Deafness and Other Communication Disorders, 13 percent of people in the US 12 years of age and older have hearing loss in both ears, underscoring the importance of developing solutions to help this population.
Brent Lucas has been the CEO of Envoy Medical Corporation for the last seven years. Brent is a lawyer by training and as a Medical Devices Executive, he has extensive experience leading across enterprise functions. He has over 15 years of experience in active implantables in the hearing health industry. Brent has a Bachelor’s Degree from the University of St. Thomas and JD from the Mitchell Hamline School of Law.
Tune into the episode to hear more about the innovative hearing solutions Envoy Medical currently offers and some of the ones under development. Also hear more about hearing health, including guidance on how to protect hearing, where the industry may be headed in the next few years, as well as the Hearing Device Coverage Clarification Act and where it currently stands.
For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/
Follow Us on Social Media
Twitter: https://twitter.com/Xtalks
Instagram: https://www.instagram.com/xtalks/
Facebook: https://www.facebook.com/Xtalks.Webinars/
LinkedIn: https://www.linkedin.com/company/xtalks-webconferences
YouTube: https://www.youtube.com/c/XtalksWebinars/featured/media:description>
media:community>
media:starRating count="1" average="5.00" min="1" max="5"/>
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entry>
id>yt:video:T5OQ7YWu134/id>
yt:videoId>T5OQ7YWu134/yt:videoId>
yt:channelId>UCR0I-ZqmTd3pLuEQ5pomHbg/yt:channelId>
title>Advances in Heart Failure Treatment ft. Dr. Robert Perkins, VP, US Medical Affairs/Renal, Bayer/title>
link rel="alternate" href="https://www.youtube.com/watch?v=T5OQ7YWu134"/>
author>
name>Xtalks/name>
uri>https://www.youtube.com/channel/UCR0I-ZqmTd3pLuEQ5pomHbg/uri>
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published>2024-10-31T16:09:15+00:00/published>
updated>2024-11-07T00:27:59+00:00/updated>
media:group>
media:title>Advances in Heart Failure Treatment ft. Dr. Robert Perkins, VP, US Medical Affairs/Renal, Bayer/media:title>
media:content url="https://www.youtube.com/v/T5OQ7YWu134?version=3" type="application/x-shockwave-flash" width="640" height="390"/>
media:thumbnail url="https://i1.ytimg.com/vi/T5OQ7YWu134/hqdefault.jpg" width="480" height="360"/>
media:description>In this episode, Ayesha spoke with Robert Perkins, MD, Vice President, US Medical Affairs/Renal and Cardiovascular at Bayer who spoke about recent advancements in the heart failure (HF) treatment landscape.
This includes new Phase III trial data for Kerendia (finerenone) in patients with heart failure that was presented recently at this year’s European Society of Cardiology (ESC) Congress 2024.
At Bayer, Dr. Perkins leads a team of medical directors and field team members working to advance the care of patients with kidney disease and heart failure. Dr. Perkins has also led the development and implementation of innovative digital educational outreach campaigns for primary care physicians. Prior to joining Bayer, Dr. Perkins held leadership roles with Novartis and AstraZeneca. He obtained an MD at the University of Pittsburgh Medical School, a Masters of Public Health at Johns Hopkins University, Bloomberg School of Public Health, and a Bachelor of Arts in English Literature from Harvard University.
Tune into the episode to hear more about the latest trial data for finerenone in heart failure and the landscape of heart failure research.
For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/
Follow Us on Social Media
Twitter: https://twitter.com/Xtalks
Instagram: https://www.instagram.com/xtalks/
Facebook: https://www.facebook.com/Xtalks.Webinars/
LinkedIn: https://www.linkedin.com/company/xtalks-webconferences
YouTube: https://www.youtube.com/c/XtalksWebinars/featured/media:description>
media:community>
media:starRating count="0" average="0.00" min="1" max="5"/>
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entry>
id>yt:video:VAMMDMYDASU/id>
yt:videoId>VAMMDMYDASU/yt:videoId>
yt:channelId>UCR0I-ZqmTd3pLuEQ5pomHbg/yt:channelId>
title>How Are Digitized Protocols Accelerating Clinical Research Processes and What’s Next?/title>
link rel="alternate" href="https://www.youtube.com/watch?v=VAMMDMYDASU"/>
author>
name>Xtalks/name>
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published>2024-10-29T13:30:17+00:00/published>
updated>2024-11-17T13:54:49+00:00/updated>
media:group>
media:title>How Are Digitized Protocols Accelerating Clinical Research Processes and What’s Next?/media:title>
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media:thumbnail url="https://i3.ytimg.com/vi/VAMMDMYDASU/hqdefault.jpg" width="480" height="360"/>
media:description>More on this story: https://xtalks.com/how-are-digitized-protocols-accelerating-clinical-research-processes-and-whats-next-3834/
In this Xtalks Spotlight, we spoke with Matthew Herod, Director of Enterprise Data Strategy at the PPD Clinical Research Business of Thermo Fisher Scientific, to explore the impact of digitized protocols on clinical research and what lies ahead.
In his role, Matthew champions the drive for rapid adoption of AI in clinical research and provides expertise for applying technology innovations to the clinical product development lifecycle.
Watch the video with Matthew to learn how and why digitized protocols can lead to greater efficiency in clinical research.
Receive weekly news and webinar updates right in your inbox: https://xtalks.com/register/
Listen live and interact with featured speakers on our upcoming Life Science webinars: https://bit.ly/2YRzAV0
#ClinicalResearch #ClinicalDevelopment #ThermoFisherScientific #PPD #ProtocolDevelopment #Digitization #ScientificCommunications #Regulatory #RegulatoryAffairs #MedicalCommunications #MedComms #DigitizedProtocols/media:description>
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id>yt:video:siseb01d7fs/id>
yt:videoId>siseb01d7fs/yt:videoId>
yt:channelId>UCR0I-ZqmTd3pLuEQ5pomHbg/yt:channelId>
title>Transforming Clinical Research: A Conversation with Morgan Hanger, Executive Director of CTTI/title>
link rel="alternate" href="https://www.youtube.com/watch?v=siseb01d7fs"/>
author>
name>Xtalks/name>
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published>2024-10-23T09:01:02+00:00/published>
updated>2024-10-29T18:12:33+00:00/updated>
media:group>
media:title>Transforming Clinical Research: A Conversation with Morgan Hanger, Executive Director of CTTI/media:title>
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media:description>In this episode, Vera spoke with Morgan Hanger, Executive Director of the Clinical Trials Transformation Initiative (CTTI). CTTI is a public-private partnership dedicated to improving the quality and efficiency of clinical trials, aiming to transform the industry by 2030.
Hanger shares her career journey, from her roles at PatientsLikeMe and Memorial Sloan Kettering Cancer Center, to leading CTTI. She explains how her patient-centered focus has shaped CTTI’s approach to its Transforming Trials 2030 initiative.
Hanger addresses the major challenges in clinical trials today, including regulatory complexities and the need for better data transparency. She explains how CTTI is tackling these issues through collaboration and innovative trial designs, like decentralized and adaptive trials, which aim to improve efficiency and inclusivity.
Hanger encourages new clinical trial professionals to embrace innovation and stay patient-focused. She hopes her work at CTTI will influence the development of a clinical trial system that is more efficient, inclusive and better aligned with patient needs.
Tune in to learn how CTTI is leading efforts to reshape clinical trials.
For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/
Follow Us on Social Media
Twitter: https://twitter.com/Xtalks
Instagram: https://www.instagram.com/xtalks/
Facebook: https://www.facebook.com/Xtalks.Webinars/
LinkedIn: https://www.linkedin.com/company/xtalks-webconferences
YouTube: https://www.youtube.com/c/XtalksWebinars/featured/media:description>
media:community>
media:starRating count="4" average="5.00" min="1" max="5"/>
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entry>
id>yt:video:jZ3UE1_VezE/id>
yt:videoId>jZ3UE1_VezE/yt:videoId>
yt:channelId>UCR0I-ZqmTd3pLuEQ5pomHbg/yt:channelId>
title>Innovative Approaches to Antiviral Drug Development/title>
link rel="alternate" href="https://www.youtube.com/watch?v=jZ3UE1_VezE"/>
author>
name>Xtalks/name>
uri>https://www.youtube.com/channel/UCR0I-ZqmTd3pLuEQ5pomHbg/uri>
/author>
published>2024-10-16T09:00:43+00:00/published>
updated>2024-11-15T14:03:47+00:00/updated>
media:group>
media:title>Innovative Approaches to Antiviral Drug Development/media:title>
media:content url="https://www.youtube.com/v/jZ3UE1_VezE?version=3" type="application/x-shockwave-flash" width="640" height="390"/>
media:thumbnail url="https://i3.ytimg.com/vi/jZ3UE1_VezE/hqdefault.jpg" width="480" height="360"/>
media:description>In this episode, Vera spoke with Dr. Sam Lee, Co-Chief Executive Officer and President of Cocrystal Pharma, a clinical-stage biotech company focusing on antiviral drug development with a unique structure-based drug discovery platform.
With over 25 years of experience in anti-infective drug discovery, Dr. Lee brings a wealth of knowledge to the discussion on the urgent need for innovative antiviral therapies.
The conversation begins with Dr. Lee sharing insights on the mission of Cocrystal Pharma, which leverages Nobel Prize-winning expertise in the development of antiviral drugs.
Vera and Dr. Lee then discuss the recent emergence of a new strain of Avian flu, examining the potential risks and the current state of flu vaccines in providing protection against both seasonal and pandemic strains.
Dr. Lee delves into the challenges of pandemic preparedness and explains how broad-spectrum antivirals could offer a valuable tool in combating influenza outbreaks. He provides an overview of Cocrystal Pharma’s approach, particularly their focus on targeting viral replication proteins, which sets their platform apart from traditional antiviral discovery methods.
The discussion also covers the limitations of current antiviral treatments and highlights the unmet medical needs in influenza care.
As the conversation wraps up, Dr. Lee discusses his excitement for the future of antiviral drug development.
Tune in to gain an understanding of the evolving landscape of antiviral research and the cutting-edge innovations that could redefine treatment options for viral infections.
For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/
Follow Us on Social Media
Twitter: https://twitter.com/Xtalks
Instagram: https://www.instagram.com/xtalks/
Facebook: https://www.facebook.com/Xtalks.Webinars/
LinkedIn: https://www.linkedin.com/company/xtalks-webconferences
YouTube: https://www.youtube.com/c/XtalksWebinars/featured/media:description>
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entry>
id>yt:video:66T5rzgXF0A/id>
yt:videoId>66T5rzgXF0A/yt:videoId>
yt:channelId>UCR0I-ZqmTd3pLuEQ5pomHbg/yt:channelId>
title>Medical Device Safety: Navigating Regulations and Standards to Determine Non-clinical Requirements/title>
link rel="alternate" href="https://www.youtube.com/watch?v=66T5rzgXF0A"/>
author>
name>Xtalks/name>
uri>https://www.youtube.com/channel/UCR0I-ZqmTd3pLuEQ5pomHbg/uri>
/author>
published>2024-10-11T14:31:40+00:00/published>
updated>2024-11-11T14:02:39+00:00/updated>
media:group>
media:title>Medical Device Safety: Navigating Regulations and Standards to Determine Non-clinical Requirements/media:title>
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media:thumbnail url="https://i3.ytimg.com/vi/66T5rzgXF0A/hqdefault.jpg" width="480" height="360"/>
media:description>Register for this webinar: https://xtalks.com/webinars/medical-device-safety-navigating-regulations-and-standards-to-determine-non-clinical-requirements/?utm_source=youtube&utm_medium=videopromo&utm_campaign=24q2336
The process of understanding exactly what regulations and standards apply to engineered medical products is highly complex and based upon a system known as the ‘generally acknowledged technological state of the art’.
To understand the myriad of requirements, regulatory, technical, engineering and quality professionals have to navigate a complex network of regulations, standards and other documents that set out the key functional, performance, safety and user requirements. In an ever-changing world, this creates a high degree of uncertainty and often is based upon tribal knowledge rather than systematic and critical evaluation.
This webinar will focus on how the intended use, technological characteristics and risk classification of a medical device relates to standards. The attendees will gain insights into how a software tool like Element RegNav can increase speed and accuracy in identifying relevant requirements. This in turn creates the necessary trust and assurance in giving greater confidence in product development and regulatory submission, underpinned by robust non-clinical evidence.
This webinar will be particularly useful for attendees who are developing a medical product or have never interacted with a regulatory agency and/or conformity assessment body. Moreover, this webinar is of benefit to contract manufacturers who must follow a systematic process to ensure that medical devices meet specified requirements.
This webinar is Part 2 of Element RegNav’s medical device safety series. Part 1 – Medical Device Safety: The Next Frontier (October 23, 2024)
Register for this webinar to discover how medical device safety can be improved by streamlining the development and regulatory process for medical devices.
Register for this webinar: https://xtalks.com/webinars/medical-device-safety-navigating-regulations-and-standards-to-determine-non-clinical-requirements/?utm_source=youtube&utm_medium=videopromo&utm_campaign=24q2336
#MedicalDevice #MedicalDevices #Diagnostics #MedicalDeviceRegulation #MedicalDeviceManufacturing #LaboratoryTechnology #MedicalDeviceSafety #MedicalDeviceDevelopment/media:description>
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yt:channelId>UCR0I-ZqmTd3pLuEQ5pomHbg/yt:channelId>
title>A Unique Approach to in vivo CAR T Therapy and New Advancements in the Field/title>
link rel="alternate" href="https://www.youtube.com/watch?v=GcZuhZ7L5JE"/>
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name>Xtalks/name>
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published>2024-10-09T09:00:20+00:00/published>
updated>2024-11-08T14:05:18+00:00/updated>
media:group>
media:title>A Unique Approach to in vivo CAR T Therapy and New Advancements in the Field/media:title>
media:content url="https://www.youtube.com/v/GcZuhZ7L5JE?version=3" type="application/x-shockwave-flash" width="640" height="390"/>
media:thumbnail url="https://i4.ytimg.com/vi/GcZuhZ7L5JE/hqdefault.jpg" width="480" height="360"/>
media:description>In this episode, Vera spoke with Tim Culp, PhD, Vice President of Research and Development at Interius BioTherapeutics, a Philadelphia-based biotech company.
Their lead program focuses on an intravenous CAR therapy for B cell lymphomas. Additionally, the company is advancing a second program aimed at treating autoimmune diseases.
Dr. Culp joined Interius following a distinguished 14-year career with Merck Research Laboratories where he supported vaccine and oncolytic virus program development as a Senior Principal Scientist. His experience includes leadership of both early and late-stage development teams responsible for all Chemistry, Manufacturing and Controls (CMC) deliverables needed for clinical programs.
Dr. Culp completed a PhD from the Pennsylvania State University, College of Medicine for his research on human papillomaviruses. He then completed post-doctoral studies at Penn State developing chimeric papillomavirus vaccines. Dr. Culp holds a BS in Biology/Secondary Education from Christian Heritage College and had a 15-year high school teaching career prior to his graduate studies.
Tune into the episode to learn more about the promise of in vivo CAR T therapy and novel advancements in the field.
For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/
Follow Us on Social Media
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YouTube: https://www.youtube.com/c/XtalksWebinars/featured/media:description>
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yt:videoId>x_qEzY-WNdY/yt:videoId>
yt:channelId>UCR0I-ZqmTd3pLuEQ5pomHbg/yt:channelId>
title>How Is Prospective Data Differentiating Real-World Evidence (RWE)?/title>
link rel="alternate" href="https://www.youtube.com/watch?v=x_qEzY-WNdY"/>
author>
name>Xtalks/name>
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published>2024-10-07T13:30:37+00:00/published>
updated>2024-11-07T18:55:56+00:00/updated>
media:group>
media:title>How Is Prospective Data Differentiating Real-World Evidence (RWE)?/media:title>
media:content url="https://www.youtube.com/v/x_qEzY-WNdY?version=3" type="application/x-shockwave-flash" width="640" height="390"/>
media:thumbnail url="https://i1.ytimg.com/vi/x_qEzY-WNdY/hqdefault.jpg" width="480" height="360"/>
media:description>More on this story: https://xtalks.com/how-is-prospective-data-differentiating-real-world-evidence-rwe-3794
In an insightful chat with Xtalks, Dr. Kelly Brassil, Senior Director of Business Development at Pack Health, a Quest Diagnostics company, dives deep into how prospective data is transforming real-world evidence (RWE) and its impact on pharmaceutical research and patient care.
With vast experience in healthcare, Dr. Brassil explains how RWE is helping reshape drug labels, enhance clinical trial designs and streamline market access strategies. She discusses the critical importance of unified, population-based data sets, which are now essential in driving informed decisions from US Food and Drug Administration (FDA) approvals to personalized treatment plans.
Dr. Brassil also explores the unique value of prospective data in capturing patient-centered, real-time experiences — something retrospective data can’t fully achieve.
Discover how prospective data, with its real-world insights, is helping pharmaceutical companies develop more targeted therapies and drive better patient outcomes in today’s evolving healthcare landscape.
Receive weekly news and webinar updates right in your inbox: https://xtalks.com/register/
Listen live and interact with featured speakers on our upcoming Life Science webinars: https://bit.ly/2YRzAV0
#RealWorldEvidence #RWE #ProspectiveData #RetrospectiveData #PatientData #PackHealth #QuestDiagnostics/media:description>
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yt:videoId>1e4WCO8nOq4/yt:videoId>
yt:channelId>UCR0I-ZqmTd3pLuEQ5pomHbg/yt:channelId>
title>Promise of Epigenetic Therapeutics in Alcohol-Associated Hepatitis ft. DURECT CEO Dr. James Brown/title>
link rel="alternate" href="https://www.youtube.com/watch?v=1e4WCO8nOq4"/>
author>
name>Xtalks/name>
uri>https://www.youtube.com/channel/UCR0I-ZqmTd3pLuEQ5pomHbg/uri>
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published>2024-10-02T09:00:02+00:00/published>
updated>2024-11-07T17:49:55+00:00/updated>
media:group>
media:title>Promise of Epigenetic Therapeutics in Alcohol-Associated Hepatitis ft. DURECT CEO Dr. James Brown/media:title>
media:content url="https://www.youtube.com/v/1e4WCO8nOq4?version=3" type="application/x-shockwave-flash" width="640" height="390"/>
media:thumbnail url="https://i2.ytimg.com/vi/1e4WCO8nOq4/hqdefault.jpg" width="480" height="360"/>
media:description>In this episode, Ayesha spoke with James E. Brown, DVM, co-founder, President and CEO of DURECT.
DURECT is pioneering a therapeutic strategy by leveraging the potential of epigenetic modulation to alter the trajectory of severe and life-threatening conditions like acute organ injury and cancer.
The company is specifically focused on the development of an epigenetic modulator, larsucosterol (DUR-928) for the treatment of alcohol-associated hepatitis (AH). The therapeutic has shown promising results in human studies, including a Phase IIb trial in AH patients.
Dr. Brown co-founded DURECT in February 1998 and has served as President, CEO and a Director since June 1998. Dr. Brown has worked in various leadership positions, including as Vice President of Biopharmaceutical and Implant Research and Development at ALZA Corporation from 1995 to 1998 and various leadership roles at Syntex Corporation, now Roche. Dr. Brown holds a Doctor of Veterinary Medicine (DVM) from the University of California, Davis, where he also conducted postgraduate work in pharmacology and toxicology.
Tune into the episode to learn more about the promise of next generation epigenic modulators, including DURECT’s innovative epigenetic therapeutic approach.
For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/
Follow Us on Social Media
Twitter: https://twitter.com/Xtalks
Instagram: https://www.instagram.com/xtalks/
Facebook: https://www.facebook.com/Xtalks.Webinars/
LinkedIn: https://www.linkedin.com/company/xtalks-webconferences
YouTube: https://www.youtube.com/c/XtalksWebinars/featured/media:description>
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yt:channelId>UCR0I-ZqmTd3pLuEQ5pomHbg/yt:channelId>
title>Medical Device Safety: The Next Frontier/title>
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author>
name>Xtalks/name>
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published>2024-10-01T13:24:01+00:00/published>
updated>2024-11-07T15:25:28+00:00/updated>
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media:title>Medical Device Safety: The Next Frontier/media:title>
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media:thumbnail url="https://i3.ytimg.com/vi/jZL_16RSWmQ/hqdefault.jpg" width="480" height="360"/>
media:description>Register for this webinar: https://xtalks.com/webinars/medical-device-safety-the-next-frontier/ ?utm_source=youtube&utm_medium=videopromo&utm_campaign=24q287
During the COVID-19 pandemic, there was global demand for engineered medical devices and a shortage of critical products, including ventilators. Many countries, including the UK, resorted to developing new products or scaling up existing ones to meet their needs.
Given the critical urgency for products, regulatory processes and expectations had to be adapted. The expert speakers were involved in the UK Ventilator Challenge and one key challenge was understanding the non-clinical safety and performance requirements.
They observed first-hand the collaborative efforts of extraordinary individuals who had a broad range of backgrounds: Clinicians, Design Engineers, Test Engineers, Quality Engineers, Regulatory Affairs Specialists, Scientists and academics.
Element RegNav is a software solution designed to navigate these complex requirements, enabling the development and maintenance of safe and high-performing medical devices. This approach leverages the foundation of international safety and performance requirements and establishes state-of-the-art practices and user-defined characteristics derived from the intended use and technological features of medical products.
From defining product characteristics to understanding the performance, safety, usability and functional requirements, RegNav helps create comprehensive design and development plans. These plans ultimately facilitate submissions to regulatory authorities, notified bodies and stakeholders, providing evidence that all necessary requirements have been met.
This project represents not just a technological advancement but a profound commitment to improving the safety and efficacy of medical devices, ensuring better outcomes for patients and healthcare providers worldwide.
Register for this webinar today to discover how Element RegNav can improve medical device safety by streamlining the development and regulatory process for medical devices.
Register for this webinar: https://xtalks.com/webinars/medical-device-safety-the-next-frontier/ ?utm_source=youtube&utm_medium=videopromo&utm_campaign=24q287
#MedicalDevice #MedicalDevices #Diagnostics #MedicalDeviceRegulation #MedicalDeviceManufacturing #LaboratoryTechnology #MedicalDeviceSafety #MedicalDeviceDevelopment/media:description>
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title>What Do Patients Really Think About How They Are Being Paid During a Clinical Trial?/title>
link rel="alternate" href="https://www.youtube.com/watch?v=t5d5z_Ra9hg"/>
author>
name>Xtalks/name>
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published>2024-09-25T13:30:35+00:00/published>
updated>2024-11-07T17:40:15+00:00/updated>
media:group>
media:title>What Do Patients Really Think About How They Are Being Paid During a Clinical Trial?/media:title>
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media:thumbnail url="https://i1.ytimg.com/vi/t5d5z_Ra9hg/hqdefault.jpg" width="480" height="360"/>
media:description>More on this story: https://xtalks.com/what-do-patients-really-think-about-how-they-are-being-paid-during-a-clinical-trial-3806/
Discover how Medidata’s experts, Meghan Harrington and Alicia C. Staley, are transforming financial management for clinical trial patients.
Through research, Medidata gathered valuable insights from patients about real-world payment challenges, examining how these issues affect the patient experience and identifying technology-driven solutions to address them.
Learn how innovative technologies can address common payment pain points and enhance the patient experience.
Receive weekly news and webinar updates right in your inbox: https://xtalks.com/register/
Listen live and interact with featured speakers on our upcoming Life Science webinars: https://bit.ly/2YRzAV0
#ClinicalTrials #ClinicalResearch #ClinicalDevelopment #PatientEngagement #PatientRetention #ClinicalTrialPayment #ClinicalTrialReimbursement #Medidata #XtalksSpotlight/media:description>
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Xtalks
15.09.2024 11:04:05 Xtalks Webinars
1:: Laser Vision: Pioneering Laser Innovations for Presbyopia ft. Ace Vision’s Dr. AnnMarie Hipsley
20.11.2024 19:30:07 MiTTwoch 23.11.2024 18:03:28
2:: How Can Clinical Research Teams Use Data-Driven Approaches to Foster Diversity in Research?
20.11.2024 16:30:21 MiTTwoch 23.11.2024 18:03:28
3:: Diversity Actions Plans (DAPs) in Clinical Trials Are No Longer a “Nice-to-Have” — Are You Ready?
19.11.2024 19:00:22 Dienstag 23.11.2024 18:03:28
4:: Bringing the Tech Revolution to Medicine with Digital Therapeutics ft. Dr. Shaheen Lakhan
13.11.2024 12:00:25 MiTTwoch 23.11.2024 18:03:28
5:: Inside the Latest Advances in Hearing Tech ft. Envoy Medical CEO Brent Lucas
06.11.2024 12:00:17 MiTTwoch 23.11.2024 18:03:28
6:: Advances in Heart Failure Treatment ft. Dr. Robert Perkins, VP, US Medical Affairs/Renal, Bayer
31.10.2024 18:09:15 Donnerstag 23.11.2024 18:03:28
7:: How Are Digitized Protocols Accelerating Clinical Research Processes and What’s Next?
29.10.2024 15:30:17 Dienstag 23.11.2024 18:03:28
8:: Transforming Clinical Research: A Conversation with Morgan Hanger, Executive Director of CTTI
23.10.2024 11:01:02 MiTTwoch 23.11.2024 18:03:28
9:: Innovative Approaches to Antiviral Drug Development
16.10.2024 11:00:43 MiTTwoch 23.11.2024 18:03:28
10:: Medical Device Safety: Navigating Regulations and Standards to Determine Non-clinical Requirements
11.10.2024 16:31:40 Freitag 23.11.2024 18:03:28
11:: A Unique Approach to in vivo CAR T Therapy and New Advancements in the Field
09.10.2024 11:00:20 MiTTwoch 23.11.2024 18:03:28
12:: How Is Prospective Data Differentiating Real-World Evidence (RWE)?
07.10.2024 15:30:37 Montag 23.11.2024 18:03:28
13:: Promise of Epigenetic Therapeutics in Alcohol-Associated Hepatitis ft. DURECT CEO Dr. James Brown
02.10.2024 11:00:02 MiTTwoch 23.11.2024 18:03:28
14:: Medical Device Safety: The Next Frontier
01.10.2024 15:24:01 Dienstag 23.11.2024 18:03:28
15:: What Do Patients Really Think About How They Are Being Paid During a Clinical Trial?
25.09.2024 15:30:35 MiTTwoch 23.11.2024 18:03:28
16:: Enhancing Strategies for Effective Patient Engagement, Recruitment and Diversity in Clinical Trials
11.09.2024 17:05:05 MiTTwoch 15.09.2024 13:04:05
17:: Shifting Ophthalmology Retina Market: Proactive Planning for Late-Stage Clinical Success
10.09.2024 20:51:56 Dienstag 15.09.2024 13:04:05
18:: How Artificial Intelligence is Transforming Clinical Development
06.09.2024 23:19:15 Freitag 15.09.2024 13:04:05
19:: Criticality of STAT Osmolality Testing: Identifying Toxic Alcohol Ingestion
06.09.2024 15:56:11 Freitag 15.09.2024 13:04:05
20:: Coca-Cola x OREO Collab + New Proposed Price Gouging Ban
05.09.2024 11:00:03 Donnerstag 15.09.2024 13:04:05
21:: Value of In-Trial Interview Data for Regulatory & Health Technology Assessment (HTA) Decision-Making
04.09.2024 16:20:40 MiTTwoch 15.09.2024 13:04:05
22:: The Science of Sleep: Unmet Needs & Treatments for Narcolepsy ft Dr. Jennifer Gudeman, Avadel Pharma
04.09.2024 11:00:31 MiTTwoch 15.09.2024 13:04:05
23:: Clinical Data Analysis: Avoiding Obstacles to Success
03.09.2024 21:19:50 Dienstag 15.09.2024 13:04:05
24:: Enhancing NGS Sample Preparation from Sample to the Sequencer
03.09.2024 19:00:40 Dienstag 15.09.2024 13:04:05
25:: Why Authenticity and Patient Voice Are Critical When Driving Clinical Trial Diversity
03.09.2024 15:45:25 Dienstag 15.09.2024 13:04:05
26:: Leadership Insights from Regeneron’s Christine Enciso: Priorities, Projects and Personal Growth
03.09.2024 15:00:45 Dienstag 15.09.2024 13:04:05
27:: Transforming Pharma Access and Innovation: Insights from Moreno Perugini at Nestlé Health Science
03.09.2024 15:00:04 Dienstag 15.09.2024 13:04:05
28:: Mastering the Art of Developing a Successful Bispecific Antibody
30.08.2024 18:47:21 Freitag 15.09.2024 13:04:05
29:: Digital Health Tools That Will Transform Cancer Treatment
30.08.2024 16:39:20 Freitag 15.09.2024 13:04:05
30:: Strategic Advantages of Early-Phase Oncology Clinical Development Across Australia and the USA
29.08.2024 15:00:57 Donnerstag 15.09.2024 13:04:05
31:: Top 30 Pharma Companies in 2023: Statistics and Trends
21.08.2023 18:31:49 Montag 03.07.2024 17:40:29
32:: J&J Sues US Government Over Medicare Drug Price Negotiations
07.08.2023 18:00:16 Montag 03.07.2024 17:40:29
33:: Why is Prime Energy Drink Under Scrutiny?
31.07.2023 17:31:03 Montag 03.07.2024 17:40:29
34:: Xtalks Spotlight: How Can You Let Your Diagnostic Target Analyte Shine?
24.07.2023 12:30:15 Montag 03.07.2024 17:40:29
35:: Food Fraud: Urgent Measures Needed to Safeguard Global Food Supply
21.07.2023 20:31:53 Freitag 03.07.2024 17:40:29
36:: Biotech IPOs in 2023: Shaping the Future of Innovation
15.07.2023 18:00:45 Samstag 03.07.2024 17:40:29
37:: Discover the Top Three Fastest Growing Beverage Brands of 2023
05.07.2023 17:00:21 MiTTwoch 03.07.2024 17:40:29
38:: Top 10 Medical Device Companies in 2023 by Revenue Statistics and Trends
21.06.2023 18:00:35 MiTTwoch 03.07.2024 17:40:29
39:: World Hunger Day 2023 A Call for Sustainable Solutions
16.06.2023 18:00:29 Freitag 03.07.2024 17:40:29
40:: Arexvy Becomes World’s First RSV Vaccine
12.06.2023 18:00:05 Montag 03.07.2024 17:40:29
41:: Xtalks Spotlight: Cell & Gene Therapy Trials, Build Successful Partnerships with CRO Project Manager
08.06.2023 12:30:12 Donnerstag 03.07.2024 17:40:29
42:: After Daybue’s Approval Acadia Pharmaceuticals’ Next Steps for the Rett Syndrome Community
26.05.2023 20:14:35 Freitag 03.07.2024 17:40:29
43:: 5 Food Companies Working With Precision Fermentation Technology
19.05.2023 17:20:46 Freitag 03.07.2024 17:40:29
44:: FDA Encourages Tracheostomy Tube Reuse Due to Supply Shortages 4k
02.05.2023 21:28:53 Dienstag 03.07.2024 17:40:29
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