Exploring Genome Editing Technologies in Drug Development

Conversations in Drug Development

Player FM - Internet Radio Done Right

הוסף לפני two שנים

תוכן מסופק על ידי Boyds. כל תוכן הפודקאסטים כולל פרקים, גרפיקה ותיאורי פודקאסטים מועלים ומסופקים ישירות על ידי Boyds או שותף פלטפורמת הפודקאסט שלהם. אם אתה מאמין שמישהו משתמש ביצירה שלך המוגנת בזכויות יוצרים ללא רשותך, אתה יכול לעקוב אחר התהליך המתואר כאן https://he.player.fm/legal.

All About Change

1
Eli Beer & United Hatzalah: Saving Lives in 90 seconds or Less 30:20

לפני 16 ימים30:20

הפעל מאוחר יותר

רשימות

לייק

אהבתי

30:20

Eli Beer is a pioneer, social entrepreneur, President and Founder of United Hatzalah of Israel. In thirty years, the organization has grown to more than 6,500 volunteers who unite together to provide immediate, life-saving care to anyone in need - regardless of race or religion. This community EMS force network treats over 730,000 incidents per year, in Israel, as they wait for ambulances and medical attention. Eli’s vision is to bring this life-saving model across the world. In 2015, Beer expanded internationally with the establishment of branches in South America and other countries, including “United Rescue” in Jersey City, USA, where the response time was reduced to just two minutes and thirty-five seconds. Episode Chapters (0:00) intro (1:04) Hatzalah’s reputation for speed (4:48) Hatzalah’s volunteer EMTs and ambucycles (5:50) Entrepreneurism at Hatzalah (8:09) Chutzpah (14:15) Hatzalah’s recruitment (18:31) Volunteers from all walks of life (22:51) Having COVID changed Eli’s perspective (26:00) operating around the world amid antisemitism (28:06) goodbye For video episodes, watch on www.youtube.com/@therudermanfamilyfoundation Stay in touch: X: @JayRuderman | @RudermanFdn LinkedIn: Jay Ruderman | Ruderman Family Foundation Instagram: All About Change Podcast | Ruderman Family Foundation To learn more about the podcast, visit https://allaboutchangepodcast.com/ Looking for more insights into the world of activism? Be sure to check out Jay’s brand new book, Find Your Fight , in which Jay teaches the next generation of activists and advocates how to step up and bring about lasting change. You can find Find Your Fight wherever you buy your books, and you can learn more about it at www.jayruderman.com .…

לפני שנה 23:44

MP3•בית הפרקים

In this episode, host Dr. Katherine Bowen, is joined by Harriet Edwards, Associate Director in Regulatory Affairs, to explore the fascinating world of genome editing technologies. Together, they delve into the ethical considerations of editing somatic versus germline cells and trace the historical progression of these technologies from agriculture to healthcare. Join us as we discuss the complexity of genome editing methods, the irreversible nature of genetic changes, and the associated risks.

19 פרקים

#Science #Biology #Fitness #Medicine #Drug Development #Boyd

Exploring Genome Editing Technologies in Drug Development

Conversations in Drug Development

published לפני שנה

שתפו

MP3•בית הפרקים

19 פרקים

#Science #Biology #Fitness #Medicine #Drug Development #Boyd

כל הפרקים

Conversations in Drug Development

1
Crystal Ball Gazing: What Does the Future Hold for Regulatory Affairs in Drug Development for 2025 32:57

לפני 8 weeks32:57

32:57

In this episode, Harriet Edwards from Boyds hosts a discussion on 2025 predictions in drug development and regulatory affairs. Joined by regulatory experts Dr. Katherine Bowen and Dr. Eric Hartder, the conversation covers the anticipated trends in the realm of cell and gene therapy, rare diseases, and the increasing role of artificial intelligence (AI). As we look ahead to 2025, Boyds' regulatory experts discuss the evolving regulatory landscape, legislative changes in the US and EU, and the importance of patient-centric approaches. Join us for this insightful journey as we uncover what 2025 has in store for drug development and regulatory strategies.…

Conversations in Drug Development

1
How to Effectively De-Risk your IND Process 52:58

לפני 13 weeks52:58

52:58

In this episode, Dr. Nick Meyers and Dr. Eric Hardter, discuss effective strategies for de-risking Investigational New Drug (IND) applications. Discover key insights on how to navigate the complexities of IND submissions, including the importance of pre-IND meetings, optimizing your non-clinical and CMC packages, and understanding FDA expectations. Gain valuable tips on engaging with regulatory agencies, addressing potential issues, and ensuring your IND is well-prepared to avoid clinical holds. Whether you're a seasoned professional or new to the field, this episode offers practical advice to help streamline your drug development process.…

Conversations in Drug Development

1
Understanding EU Medical Device Regulations: Key Insights for Developers and Innovators 24:03

לפני 18 weeks24:03

24:03

In this episode, host Harriet Edwards is joined by Eamonn McGowran, an expert in medical device regulations, to explore the complex and rapidly evolving regulatory landscape for medical devices, particularly within the EU. Eamonn highlights the challenges of developing combination products that integrate devices and pharmaceuticals, the roles of notified bodies and competent authorities, and the importance of early stakeholder engagement. The episode also covers the integration of artificial intelligence in medical devices and the evolving UK regulatory framework post-Brexit.…

Conversations in Drug Development

1
Patients as Partners: Advocacy's Role in Shaping Drug Development 27:24

לפני 27 weeks27:24

27:24

In this episode, host Harriet Edwards and Senior Clinical Project Manager, Chris Moore, discuss the vital role of patient and public involvement in drug development, particularly within clinical trials. The conversation covers the increasing significance of patient engagement, highlighting how the industry is recognizing the invaluable contributions of patients in shaping clinical trials and exploring the concept of "patients as partners," which is gaining traction among sponsors, ethics committees, and regulatory bodies.…

Conversations in Drug Development

1
Navigating the Future of EU Health Technology Assessments 29:10

לפני 30 weeks29:10

29:10

In this episode, host Dr Julie Warner is joined by experts from Decisive Consulting, Esther Nzenza, and Kevin Asher to discuss the upcoming joint clinical assessment (JCA) process set to begin in January 2025. The conversation covers the implications of the JCA for drug developers, particularly smaller companies, and emphasizes the importance of early planning and integrated evidence generation. Join us as we uncover the strategies and considerations essential for success in the ever-evolving world of health technology assessments.…

Conversations in Drug Development

1
A Guide to Marketing Authorization Applications in Europe 28:19

לפני 33 weeks28:19

28:19

In this episode, host Harriet Edwards is joined by Dr Katherine Bowen to explore the regulatory fundamentals for obtaining marketing authorization in Europe, focusing on the centralised procedure. Together, they unpack the intricacies of this pathway, comparing it to the FDA application process and emphasising the critical role of thorough dossier preparation and clear communication with regulatory authorities. Key topics include the importance of early engagement with regulators, navigating the challenges of Module 1, developing risk management plans, and addressing current regulatory issues.…

Conversations in Drug Development

1
Navigating the new EU Clinical Trials Regulation 28:26

לפני 39 weeks28:26

28:26

In this episode, host Harriet Edwards is joined by Dr Katherine Bowen and Shalini Gupta to explore the transformative changes in the European Union's clinical trial landscape. The focus is on the transition from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR) and its significant impact on the regulatory environment. Join us for an insightful discussion on how the CTR is shaping the future of clinical research in Europe and the positive impact it aims to have on patients.…

Conversations in Drug Development

1
Advances in Cell-Based Immunotherapies: CAR-T Cell Therapy vs TCR Therapy 28:10

לפני 42 weeks28:10

28:10

In this episode, host Harriet Edwards is joined by two regulatory experts from Boyds, Dr Patrick Ginty and Monica Pianella, to discuss cell-based immunotherapies, focusing on CAR-T cells and TCR-T cells. Patrick and Monica delve into these cutting-edge treatments, discussing their uses, the complexities of their production, and important safety considerations. They also highlight recent advancements and the exciting future prospects for these therapies in cancer treatment and other areas. Tune in for an insightful discussion on the future of cell-based immunotherapies, examining both the hurdles and the potential of these innovative treatments.…

Conversations in Drug Development

1
Demystifying Regulatory Designations in Drug Development 25:53

לפני 44 weeks25:53

25:53

In this episode, Dr Katherine Bowen and Dr Julie Warner delve into the world of regulatory designations, providing clarity on what these designations offer, the products that qualify, and the pros and cons of each. They discuss the history of regulatory designations, starting with the Orphan Drug Act of 1983, and explore various designations such as Orphan Drug Designation (ODD), Fast Track Designation (FTD), Breakthrough Therapy Designation (BTD), and Regenerative Medicines Advanced Therapy Designation (RMAT). Tune in to gain valuable insights from their experience and advice and learn how to navigate the regulatory landscape effectively.…

Conversations in Drug Development

לפני 1 year29:37

29:37

To celebrate Rare Disease Day, we are back with another Conversation in Drug Development, this time discussing the unique challenges of rare disease drug development. Dr Eric Hardter, Associate Director of Regulatory Affairs at Boyds, joins our host Harriet Edwards to explore the need for early stakeholder involvement, the complexities of pediatric clinical trials, including ethical considerations and regulatory requirements and to touch on FDA initiatives supporting rare disease therapeutics and the evolving landscape for cell and gene therapies. To discuss this episode of Conversations in Drug Development with a member of the team, visit www.boydconsultants.com.…

ברוכים הבאים אל Player FM!

Player FM סורק את האינטרנט עבור פודקאסטים באיכות גבוהה בשבילכם כדי שתהנו מהם כרגע. זה יישום הפודקאסט הטוב ביותר והוא עובד על אנדרואיד, iPhone ואינטרנט. הירשמו לסנכרון מנויים במכשירים שונים.

תקשיבו ל-500+ נושאים

Amazon eGift Card - Amazon Logo (Animated)

HP 67XL Black High-yield Ink Cartridge | Works with HP DeskJet 1255, 2700, 4100 Series, HP ENVY 6000, 6400 Series | Eligible for Instant Ink | One Size | 3YM57AN

Amazon eGift Card - Bright Balloons (Animated)

פודקאסטים ששווה להאזין

Conversations in Drug Development « » Exploring Genome Editing Technologies in Drug Development

Exploring Genome Editing Technologies in Drug Development

פודקאסטים ששווה להאזין

ברוכים הבאים אל Player FM!

Liquid I.V.® Hydration Multiplier - Lemon Lime | Electrolyte Powder Drink Mix | 1 Pack (16 Servings)

Apple iPad 11-inch: A16 chip, 11-inch Model, Liquid Retina Display, 128GB, Wi-Fi 6, 12MP Front/12MP Back Camera, Touch ID, All-Day Battery Life — Blue

Amazon Basics Micro SDXC Memory Card with Full Size Adapter, A2, U3, Read Speed up to 100 MB/s, 128 GB, Black

Walking Pad Treadmill with APP, 3 in 1 Under Desk Treadmill, 2.5HP Low Noise Walking Vibration Pad with Remote Control,Portable Treadmills for Home Office, Red

מדריך עזר מהיר

Conversations in Drug Development « »
Exploring Genome Editing Technologies in Drug Development