Podcasts about Parexel

Investigative sites have shared that one of their top frustrations  with the clinical trial process is with the poor communication flow and overall lack of responsiveness from sponsors and CROs.  In this episode of ‘Enabling Successful Sites', Karen McIntyre, Vice President, Global Site Alliances  sits down with Jakub Jedrzejewski, Global Project Manager at Future Meds, Iwona Tongbhoyai, Chief Client Solutions Officer at Future Meds and Heidi Juncher-Benzon, Senior Director Clinical Operations for EMEA East at Parexel to discuss the biggest communication challenges facing sites and strategies to resolve them.

About Sasha Tyndale:Sasha Tyndale is a seasoned leader in the pharmaceutical industry with over 20 years of experience spanning oncology, immunology, neuroscience, and more. As Director of Diversity and Patient Inclusion at AbbVie, she drives patient-centric strategies and innovative clinical operations. With expertise in precision medicine and personalized healthcare, she collaborates cross-functionally to enhance patient engagement and future-proof organizations. Previously, she held key roles at PAREXEL and Johnson & Johnson, specializing in strategic patient recruitment and clinical innovation. Sasha holds a Master's and Bachelor's degree in English Literature from Rutgers University. Passionate about advancing equitable healthcare, she is committed to transforming research and improving patient outcomes.Things You'll Learn:AbbVie is making clinical trials more inclusive by ensuring they represent diverse populations affected by the diseases being studied.Through programs like ADMIRE, AbbVie is expanding research access by involving underrepresented healthcare providers in clinical research.AbbVie is simplifying participation in clinical trials by making study materials clearer and designing studies that minimize patient burden.Patient voices are essential in humanizing research, providing valuable insights into real-life disease challenges, and encouraging greater participation in clinical trials.AbbVie is taking bold action to challenge traditional research practices, collaborate with community partners, and improve healthcare access and representation.Educating individuals about clinical trials empowers communities to make informed decisions about participation in medical research.Resources:Connect with and follow Sasha Tyndale on LinkedIn.Discover more about AbbVie on their LinkedIn and website.Sign up for the ADMIRE program here.If you are considering participating in AbbVie's clinical research program, click here.

Patient recruitment continues to be a major cost driver and top challenge in clinical research. More than half of sites have to pay recruitment expenses out of their own funds, as sponsor budgets won't cover some of necessary education and recruitment practices that sites must perform in order to meet enrollment goals and stay in business. This ‘Enabling Successful Sites' podcast episode, moderated by Karen McIntyre, Vice President, Global Site Alliances  with insights from Steve Sattik, recently retired, former EVP at Flourish Research and Leslie Ives, Senior Director, Patient Recruitment at Parexel, discusses the challenges sites face with patient recruitment, the need for close collaboration between sites, sponsors and CROs,  and flexible options that satisfy all parties.

AI is becoming increasingly prevalent in the healthcare industry and clinical research. For clinical trial recruitment, AI can be extremely helpful in finding potential patient volunteers as well improving overall retention rates.  In part two of this ‘Enabling Successful Sites' podcast episode on improving patient recruitment and retention, Karen McIntyre, Vice President, Global Site Alliances, Steve Sattik, recently retired, former EVP at Flourish Research and Leslie Ives, Senior Director, Patient Recruitment at Parexel, discuss how we can leverage AI today to improve patient recruitment and retention and how they see AI evolving recruitment practices in the future.

This episode is a discussion of the paper entitled, "Catheter Ablation versus Advanced Therapy for Patients with Severe Heart Failure and Ventricular Electrical Storm." https://www.hrsonline.org/education/TheLead https://doi.org/10.1016/j.hrthm.2024.09.045 Host Disclosure(s): W.Sauer: Honoraria/Speaking/Consulting: Biotronik, Biosense Webster, Inc., Abbott, Boston Scientific, Research: Medtronic   Contributor Disclosure(s): R. Kerley: Nothing to disclose. A. Desai: Research: Novartis, Bayer Healthcare Pharmaceuticals, Abbott Medical, AstraZeneca, Honoraria/Speaking/Consulting: Novartis, Abbott, AstraZeneca, Regerneron, Alnylam Pharmaceuticals, Bayer Healthcare Pharmaceutricals, Cytokinetics, AxonTherapies, Avidity Biosciences, Medpace, Merck, New Amsterdam Pharma, Parexel, Roche Diagnostics, GlacoSmithKline, NovoNordisk, Veristat, Verily/Google, Zydus, River2Renal, Membership on Advisory Committees: BioFourmis

Dr. Andreas Lysandropoulos, Senior Vice President and Global Therapeutic Head of Neurosciences, and Wyatt Gotbetter, Senior Vice President, Worldwide Access Consulting, join Bev Hope, Parexel's Marketing Strategy Director, in a podcast discussion of how sponsors can build a value proposition and market access strategy for novel neurological and psychiatric treatments. Neuroscience disorders present significant challenges, including incomplete scientific understanding, patients' unequal access to accurate diagnosis and prognosis, payers' focus on short-term clinical outcomes, a relative lack of patient-relevant endpoints, and collecting high-quality real-world evidence, to name a few. Our experts offer examples and insights on how to overcome obstacles and de-risk sponsors' access strategies.

The ESMO Congress yielded another win for cancer immunotherapy target TIGIT, but the readout resurfaced worries about the mechanism's past failures to turn positive earlier stage data into Phase III success. On a special edition of the BioCentury This Week podcast, BioCentury's editors deliver their takeaways from this year's meeting, including analysis of data for TIGIT blocker belrestotug from iTeos Therapeutics, a colorectal cancer readout featuring J&J's Rybrevant and an antibody-drug conjugate from Genmab. The BioCentury team is joined by Gwyn Bebb, who is global franchise head for oncology at podcast sponsor Parexel. Bebb discusses what's changed in the oncology landscape in the 10 years since the approval of the first immunotherapies, observations that COVID-19 vaccines might have a role in treating cancer and developments in the radiopharma field. This episode of BioCentury This Week was sponsored by Parexel Biotech.View full story: https://www.biocentury.com/article/65368100:01 - Sponsor Message: Parexel BioTech01:55 - iTeos' TIGIT Data04:56 - Rybrevant Colorectal07:22 - Gwyn Bebb's Take21:38 - More ESMO HighlightsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

New Pulse of AI podcast is live! Season 6, episode 145. To be notified about future conversations with the leaders of the AI revolution sign up for our newsletter at www.thepulseofai.com  AI Pioneers: Andrew Maas on Pioneering Retrieval Systems and Deep Learning Join host Jason Stoughton in this exciting episode as he welcomes Andrew Maas, the visionary co-founder and CEO of Pointable. Andrew shares his journey through the world of artificial intelligence, from his groundbreaking work on data-centric deep learning at Apple to his pivotal role in founding roam Analytics, a natural language extraction platform acquired by Parexel. In this episode, Andrew delves into the innovative technologies behind Pointable, a startup revolutionizing retrieval systems for RAG-LLM workflows. He offers valuable insights for AI practitioners and founders, drawing from his extensive experience and academic background, including his PhD from Stanford University under the mentorship of Andrew Ng and Dan Jurafsky. Tune in to hear about Andrew's transformative work in AI, the future of retrieval systems, and what's next for Pointable. Whether you're an AI enthusiast or an aspiring entrepreneur, this conversation is packed with knowledge and inspiration!

On this episode, Danilo Branco (Director, Central Monitoring Operations, Fortrea), Cris McDavid (Director, Global Clinical Operations, RBQM, Parexel), and Valarie McGee (Senior Director, Clinical Systems Optimization, the PPD Clinical Research Business of Thermo Fisher Scientific) join the podcast to discuss insights from 5 years of data on industry RBM/RBQM adoption collected by ACRO's RBQM Working Group has and how industry can drive further RBQM adoption.They dive deeper into ACRO's annual RBQM landscape survey findings, challenges and opportunities presented by the growth of centralized monitoring and reduced SDR/SDV, and the role that RBQM can play in the future of clinical research.

On this episode, Dr. Tala Fakhouri (Associate Director for Data Science and Artificial Intelligence Policy, FDA) and Stephen Pyke (Chief Clinical Data & Digital Officer, Parexel) join the podcast to discuss how the FDA and regulators around the world are thinking about the use of AI in clinical research.They dive deeper into the FDA's evidentiary standards for AI, what organizations should consider about methodological transparency in submissions, and AI's potential as a tool that can help bring medicines to market more efficiently.For more information on ACRO's AI/ML Principles Statement, visit ACRO's website: https://www.acrohealth.org/initiatives-hub/ai-ml-in-drug-development/

ACRO's Good Clinical Podcast is back! This week, Stacy Hurt, Chief Patient Officer at Parexel, and Alicia Staley, Vice President, Patient Engagement at Medidata joined the podcast to discuss how we can turn patient centricity from “buzz words” to action. They discuss how their own experiences as patients have informed their approach to clinical research and the important role that an upstream patient voice plays in reducing the burden on patients.

BioSpace's Lori Ellis and Chantal Dresner are bringing live updates from #DIA2024 in San Diego this week where the first day kicked off with an inspiring story from Tom and Emily Whitehead of the Emily Whitehead Foundation, setting the tone for patient-centric discussions. The following panel featuring Emer Cooke, Chair, ICMRA an Executive Director, European Medicines Agency; Peter Marks, Director, CBER, FDA; Carsten Linnerman, CEO, Neogene Therapeutics, AstraZeneca Group; Dean Kamen, Founder, DEKA; and Stacy Hurt, Chief Patient Officer, Parexel emphasized the imperative of collaboration to improve outcomes, between regulatory bodies as well as with patients. Tune in this week to hear more from the event!

The site feasibility and initiation process can be a frustrating one for investigative sites due to lengthy questionnaires, duplication in data requests, and unrealistic recruitment targets and start-up timelines. In the first episode of our Enabling Successful Sites podcast Parexel's Karen McIntyre, VP of Global Site Alliances and Marta Leon, VP of Launch Excellence are joined by Mohammad Millwala, CEO of DM Clinical Research to discuss solutions to help improve the feasibility and start- up process.

The latest episode of Preparing for a Cell and Gene Future features a discussion between Jamie Pierson (Program Lead within Parexel's Cell and Gene Center of Excellence) and Kim MacDonnell (Associate Director for Rare Diseases). They consider uses of surrogate markers as endpoints in rare disease development and look ahead to positive directions established by FDA's current initiatives.

Karen McIntyre, Vice President of Site Alliances at Parexel, shares the impact and initiatives that contributed to their earning of the coveted SCRS Eagle Award in 2023. Hear valuable advice for industry organizations aspiring to build successful relationships with sites through the power of communication, trust, and shared goals. Karen also sheds light on Parexel's strategies to continually enhance and expand its site-focused efforts. 

William H. Sauer, MD, FHRS, CCDS, of Brigham and Women's Hospital is joined by guests Akshay Suvas Desai, MD, MPH of Brigham and Women's Hospital, and Sunil Kapur, MD of Brigham and Women`s Hospital to discuss how the Resynchronization–Defibrillation for Ambulatory Heart Failure Trial (RAFT) showed a greater benefit with respect to mortality at 5 years among patients who received cardiac-resynchronization therapy (CRT) than among those who received implantable cardioverter–defibrillators (ICDs). However, the effect of CRT on long-term survival is not known. We randomly assigned patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of 120 msec or more (or a paced QRS duration of 200 msec or more) to receive either an ICD alone or a CRT defibrillator (CRT-D). We assessed long-term outcomes among patients at the eight highest-enrolling participating sites. The primary outcome was death from any cause; the secondary outcome was a composite of death from any cause, heart transplantation, or implantation of a ventricular assist device.  https://www.hrsonline.org/education/TheLead https://www.nejm.org/doi/full/10.1056/NEJMoa2304542 Host Disclosure(s): W. Sauer: Honoraria/Speaking/Consulting: Biotronik, Biosense Webster, Inc., Abbott, Boston Scientific; Research: Medtronic Contributor Disclosure(s): A. Suvas Desai: Honoraria/Speaking/Consulting: Abbott, Novartis, AstraZeneca, BioFourmis, Regeneron, Alnylam Pharmaceuticals, Bayer Healthcare Pharmaceuticals, Cytokinetics, AxonTherapies, Avidity Biosciences, Medpace, Merck, New Amsterdam Pharma, Parexel, Roche Diagnostics, GlaxoSmithKline, NovoNordisk, Veristat, Verily/Google, Zydus, River2Renal, Research: Bayer Healthcare Pharmaceuticals, Abbott Medical, AstraZeneca, Novartis  S. Kapur: Honoraria/Speaking/Consulting: Medtronic, Novartis, Abbott, Biotronik This episode has .25 ACE credits associated with it. If you want credit for listening to this episode, please visit the episode page on HRS365 https://www.heartrhythm365.org/URL/TheLeadEpisode53

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials.  In today's episode, Fierce Pharma's Angus Liu talks with Parexel regulatory experts Mwango Kashoki, M.D., Senior Vice President, Global Head of Regulatory Strategy, and Steve Winitsky, M.D., Vice President, Technical - Regulatory Strategy, to understand the rationale behind the FDA's decision and to discuss its implications for CAR-T candidates and their developers down the line.

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials.  In today's episode, Fierce Pharma's Angus Liu talks with regulatory experts Mwango Kashoki, M.D., SVP, Global Head of Regulatory Strategy at Parexel, and Steve Winitsky, M.D., VP, Technical, Regulatory Strategy at Parexel, to understand the rationale behind the FDA's decision and to discuss its implications for CAR-T candidates and their developers down the line.   To learn more about the topics in this episode:  FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe Amid high-profile CAR-T safety probe, FDA's Peter Marks offers first glimpse at data under review  See omnystudio.com/listener for privacy information.

Born into a family steeped in military heritage, David initially broke the mould and began his career with the NHS. He soon realised his role wasn't challenging enough, so he joined the Queen Alexandra's Royal Army Nursing Corps, before specialising in blast & ballistic injury. David deployed overseas numerous times, unfortunately picking up injuries that would develop over time, resulting in him becoming a wheelchair user. Since leaving the Army, David has continued in the medical field, with the clinical trials & biotech consulting firm Parexel. Outside of work, David has gone on to achieve sporting world records, and is a highly respected figure in the business & start-up space. Follow This Podcast To Be Notified Of New Episodes, Visit Our Social Media Platforms & YouTube Channel For More Bonus Content, And Listen Live To Our Radio Station: Listen Live: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.forceradio.live/⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Visit Our YouTube Channel: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@forceradiohq

Hello and welcome to this special episode of Let's Talk Rare: The Life Science Podcast as we celebrate 5 years of bringing you the podcast that is now the number one life science podcast across all platforms. We at Partners 4 Access want to thank every single one of our 35,000 subscribers and all the guests who have graced the podcast from the bottom of our hearts, we would not have gotten here without you.  A special episode calls for special guests, and joining us today are our in-house expert and Managing Partner at P4A, Sophie Schmitz, our host from 2018-2021, Aparna Krishnan, and Prasan Subedi, Access Strategy Team Lead at Pfizer. Together, we walk down memory lane and relive the high points and challenges of the past five years, and share insights on rare diseases and cell and gene therapies. Aparna Krishnan Bio: Aparna has over 10 years of experience in the pharmaceutical and healthcare industry. As part of the senior leadership team, her primary focus is on strategic corporate engagement, legal, financial operations, and human resources. She has previously worked as Manager of Life Sciences at IHS Markit and as Consultant at Parexel's Commercialization unit, among others specializing in market access, pricing, and reimbursement. Sophie Schmitz Bio: Sophie is the managing partner at Partners 4 Access, a company that believes in a sustainable rare disease world, which means helping our clients unlock the true opportunity of orphan drugs and ATMPs. Her 20+ year career spans various disease areas and medical devices, successfully supporting the strategy development and operationalization for orphan drugs. She brings a wealth of commercial and access experience across orphan and cell and gene therapies to the benefit of clients. She plays an active role in advising clients on price and market access strategies, with the ultimate goal of optimizing fair access for all stakeholders in rare diseases.

On this episode of ACRO's Good Clinical Podcast, host Sophia McLeod is joined by Cyndi Verst (President, R&DS Design & Delivery Innovation, IQVIA) and Peyton Howell (Chief Operating & Growth Officer, Parexel). Peyton and Cyndi sat down to discuss the changes they have seen in the representation of women in clinical research throughout their careers, from trial participation to the board room. They dive deeper into how the clinical research industry can make trials more accessible for women and the role that many women play as healthcare decisionmakers in their families.

On this episode of ACRO's Good Clinical Podcast, host Sophia McLeod is joined by Lisa Moneymaker (Chief Technology Officer & Chief Product Officer, Saama Technologies) and Stephen Pyke (Chief Digital & Data Officer, EVP Clinical Data & Digital Services, Parexel). Lisa and Stephen dive into how AI and ML are currently being used in the clinical research industry and opportunities for further utilization in the future. They discuss misconceptions about AI and how regulators and policymakers are responding to its potential use in drug development.

William H. Sauer, MD, FHRS, CCDS, of Brigham and Women's Hospital is joined by Kolade Muchaili Agboola, MD, and Akshay Suvas Desai, MD, MPH, of Brigham and Women's Hospital to discuss the results and implications of the CASTLE-HTx trial.   https://www.hrsonline.org/education/TheLead   Host Disclosure(s): W. Sauer: Honoraria/Speaking/Consulting Fee: Biotronik, Biosense Webster, Inc., Abbott, Boston Scientific; Research (Contracted Grants for PIs Named Investigators Only): Medtronic   Contributor Disclosure(s): K. Agboola: No relevant financial relationships with ineligible companies to disclose.  A. Desai: Honoraria/Speaking/Consulting Fee: Abbott, Novartis, AstraZeneca, BioFourmis, Regeneron, Alnylam Pharmaceuticals, Bayer Healthcare Pharmaceuticals, Cytokinetics, AxonTherapies, Avidity Biosciences, Medpace, Merck, New Amsterdam Pharma, Parexel, Roche Diagnostics, GlaxoSmithKline, NovoNordisk, Veristat, Verily/Google, Zydus, River2Renal; Research (Contracted Grants for PIs Named Investigators Only): Bayer Healthcare Pharmaceuticals, Abbott Medical, AstraZeneca, Novartis

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Graham Wylie, Executive Chairman at the Medical Research Network (MRN). Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Graham, covering: Transitioning from Pfizer's in-house R&D team to a senior commercial BD role at Parexel The brutal experience of leading an MBO deal and why you should go into any deal with ‘your eyes open' How the fast-paced CRO world has evolved over the last 20 years, and what the future may hold for the clinical trials space How Graham built an entrepreneurial, family business with a view on the long term plan that includes his wife and kids How being used to fast growth as a specialist CRO better prepared MRN for the impact of C19 and 90% growth Dr Graham Wylie graduated in pharmacology in 1982 and then in medicine in 1987. He moved into the Pharma industry in 1989, spending 10 years at Pfizer and 5 years at Parexel in many different forms of clinical trial management before joining Healthcare at Home to create a trials division. He led an MBO to make this a separate company in 2006 and was CEO and majority owner for 16 years, until September 2022, when he passed over the CEO role to one of his (younger) co-founders, and became Executive Chairman. Through that period MRN enjoyed an average growth rate of 35% through feast and famine and continues to be one of the fastest-growing founder-led businesses in the UK. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.  

In part two of this podcast, “ePatients” Dave deBronkart and Stacy Hurt (Patient Advocacy Ambassador, Parexel) discuss new opportunities in the future of patient engagement in clinical research and care with DIA GAM 2023 Patient Engagement track chair Pujita Vaidya. “This advent and acceleration of artificial intelligence (which should be augmented intelligence) and digital biomarkers should not replace the physician-patient relationship but enhance it,” Stacy explains. “Lastly: If you want sustainable patient insights, don't only ask a patient, but invest in and hire patients as internal subject matter experts and full-time employees of your organization.” Listen to part 1.

DIA GAM 2023 Patient Engagement track chair Pujita Vaidya discusses the definition, history, and current state of patient engagement in clinical research and care with cancer survivors and “ePatients” Dave deBronkart and Stacy Hurt (Patient Advocacy Ambassador, Parexel). “Many people were trained for generations to think of patients as poor people who just don't understand how to save their own lives. I'm here to tell you, we are not only eager to help but we're tired of being treated as crash test dummies,” Dave says. “Engagement doesn't just mean invite me into your process. It also means listen to me as a thinking, intelligent person who might have some ideas that you haven't thought of.”

There are an estimated 1.6 million transgender people in the U.S. alone, with about 25% identifying as nonbinary. However, based on our research for the Beyond the Binary: Navigating Gender Diversity in Clinical Research report, we found that of the 141,000+ articles published on PubMed (a database of biomedical and life sciences literature) reporting interventional clinical trial results from 2018-2022, fewer than 1% reported study participation of transgender and nonbinary patients. We then set out to determine why this patient population is not being accurately represented in clinical research.      In this episode, Parexel subject matter experts – Rosamund Round, Vice President, Patient Engagement Center; Liam Paschall, Senior Consultant, Management Development; Amy McKee, M.D., Chief Medical Officer & Global Head, Oncology Center of Excellence – discuss the barriers faced by the transgender and nonbinary communities and provide recommendations for more gender-inclusive clinical trials.   To view the Discussions on Diversity report, click here.      

Cancer is not one disease, which means it cannot be addressed by one type of treatment or research. In this episode, Chris Learn, Vice President of Cell and Gene Therapy at Parexel, talks about oncology research, cell and gene therapies, and the patients' journey navigating this space. Chris discusses next-generation therapies and the challenges common sites may face in adopting them. Tune in to learn more about cancer research and treatment developments from Chris! Click this link to the show notes, transcript, and resources: outcomesrocket.health

Rare disease is an often overlooked field of medicine, but one which is rapidly gaining ground, which is certainly a good thing as rare diseases affect around 300 million people globally. By their nature, rare diseases are incredibly difficult to research and develop medicines for, but this just makes it all the more urgent to fulfil this unmet need for rare disease patients.In this podcast I am joined by Rachel Smith; Rachel is the Executive Director, Global Head of Rare Diseases at Parexel. Rachel brings more than a decade of experience in every development phase of rare disease and cell and gene therapy clinical trials to her work with Parexel's rare disease clients. Previously, she served as Vice President of Clinical Operations, Portfolio Director of Rare Disease, and Global Head of the Cell & Gene Center of Excellence at Veristat LLC. She led programs in ADA-SCID, Canavan disease, congenital adrenal hyperplasia, Fabry disease, Gaucher disease, metachromatic leukodystrophy, and Wiskott-Aldrich Syndrome. Rachel has expertise in clinical development strategy, novel and adaptive trial design, decentralized trials, and other creative solutions for rare disease products with a non-classical route to market.

On this special podcast episode, we are joined by Kelly Cheung, Immunology Medical Affairs Fellow at UCB. Kelly has been a highly involved member of IPhO serving as the ACPHS Local Chapter President, and later becoming a Regional Student Officer and joining the IPhO National Fellows Council. Kelly's engagement with the pharmacy community doesn't stop with IPhO. While at ACPHS, Kelly also served as a student ambassador, a peer tutor, a student researcher, and the President of the Multicultural Club which won club of the year award 2 years in a row under her leadership.  Tune in this week to hear more on how Kelly was able to leverage her experiences through IPhO and ACPHS to successfully break into industry pharmacy without having direct industry experience. All this and more on episode 32 of the IPhO Podcast! A special thank you to our episode sponsors, Parexel and the University of the Pacific: Parexel:  https://jobs.parexel.com/IPhO-Webinar-Path-to-Project-Leader-Program#:~:text=Parexel%27s%20Path%20to%20Project%20Leader%20Program%20provides%20the%20opportunity%20for,to%20an%20Associate%20Project%20Leader University of the Pacific:  https://pharmacy.pacific.edu/pharmacy/fellowship/

Data governance isn't easy. It demands a vision, strategy, and clear-cut plan that ultimately supports the business. Many have tried, and failed, to lead governance initiatives. What can we learn from the rare few who have led these tricky projects to success?Learn top tips in this supercut episode, which compiles the best data governance advice from season 1. Featuring Bob Seiner of KIK Consulting, Jennifer Belissent, Principal Data Strategist at Snowflake, Francesco Marzoni, CDO of Inkga Group, Michelle Hoiseth, former CDO of Parexel, and more!--------“We were, very much, very careful about using language around data enablement, not data governance. Yes, there's a certain amount of this, of course, that's about control. But it's control and service to the aims of the business. It's not a gate control for the sake of pure defensive posture. As a business, we needed to be able to do more with our data. It's been an educational journey and it had to be timed with the advanced analytics initiatives.” - Michelle Hoiseth, former CDO of Parexel--------Time Stamps* (1:12) What is Data Governance?* (4:38) How to get stakeholders excited about governance* (7:10) Making your implementation a success--------SponsorThis podcast is presented by Alation.Learn more:* Data Radicals: https://www.alation.com/podcast/* Alation's LinkedIn Profile: https://www.linkedin.com/company/alation/* Satyen's LinkedIn Profile: https://www.linkedin.com/in/ssangani/--------Links* Connect with guest Bob Seiner on LinkedIn* Connect with guest Paola Saibene on LinkedIn* Follow guest Francesco Marzoni on LinkedIn* Follow guest Jennifer Belissent on LinkedIn* Follow guest Wendy Turner-Williams on LinkedIn

In this episode on n-Lorem Foundation's podcast series, Patient Empowerment Program, our CEO Jamie Macdonald interviews with Dr. Stanley T. Crooke, Founder, CEO and Chairman of n-Lorem Foundation. During their conversation, Jamie shares the moment he realized his desire to make a difference, Parexel's role in clinical trials and our partnership with n-Lorem aimed to serve patients.

When developing and bringing a therapeutic for a rare disease to market, sponsors should think with the end in mind and plan for payer requirements early in protocol design. The economic and clinical value evidence required by payers for market access differs from the clinical efficacy and safety evidence demanded by regulators. Securing approval but lacking market access results in unrealized revenue and, most importantly, patients left untreated. But how do we price and how do we gain access on the promise of long-term value when we don't have the long-term data? In this podcast by Blog Talk Radio, Sangeeta Budhia, VP and Global Head, Pricing and Market Access, and Wyatt Gotbetter, Worldwide Head, Access Consulting, of Parexel discuss early market access planning, including inclusive data collection, payer models and the impact of new regulations and innovative trial design on data collection and ongoing evidence provision.

As CEO of YPrime, Shawn Blackburn provides strategic leadership and direction. Since co-founding YPrime in 2006, Shawn has led the company growth from a two-person consulting firm to a global organization that focuses on evolving technologies to help accelerate development timelines, simplify process complexity, and improve data quality across the clinical development continuum. With a background in systems architecture and information management, Shawn has built a reputation for helping companies discover insights about future opportunities by bringing together siloed information in meaningful context to support strategic decision making. Prior to YPrime, Shawn had a long career as a technology consultant for Cephalon and Parexel. While at Cephalon, he was instrumental in the company's development of applications to improve clinical trial workflow and provide deeper visibility into clinical trial performance. This week we discuss clinical trial technology, the lack of flexibility of many tech vendors, and decentralized clinical trials.

In this session recorded at DPHARM 2022, moderated by Pfizer's Amy Cramer, the panelists discuss patient data. Often the elephant in the room that hinders the advancement of innovation in clinical trials for the benefit of patients in the lack of structured, clean patient data. R&D executives know the ability to garner greater data value from all data sources [clinical trials, EHRs, claims data, etc] is critical to supporting the future of drug development. The continued conundrum is that data is too often unstructured, incompatible, incomplete and unreliable and leads to an output of a research-intensive, operational bottlenecks. We have a unique group of panelists who will prioritize the critical issues first, provide potential solutions and address what to do about pending issues to be resolved. Speakers: Amy Cramer, Global Product Development Strategic Partnerships, PfizerXiaoying Wu, MD, MS, VP, Data Science Data Platform & Privacy, The Janssen Pharmaceutical Companies of Johnson & JohnsonPaul Bleicher, MD, PhD, Executive Partner, Arden EquityLekan Wang, Head, Machine Learning Services, Parexel

About The Episode When developing and bringing a therapeutic for a rare disease to market, sponsors should think with the end in mind and plan for payer requirements early in protocol design. The economic and clinical value evidence required by payers for market access differs from the clinical efficacy and safety evidence demanded by regulators. Securing approval but lacking market access results in unrealized revenue and, most importantly, patients left untreated. But how do we price and how do we gain access on the promise of long-term value when we don't have the long-term data? Join Sangeeta Budhia, VP and Global Head, Pricing and Market Access, and Wyatt Gotbetter, Worldwide Head, Access Consulting, of Parexel, to discuss early market access planning, including inclusive data collection, payer models and the impact of new regulations and innovative trial design on data collection and ongoing evidence provision. About the Speakers:  Sangeeta Budhia is VP and Global Head, Pricing and Market Access, at Parexel. Her role is to ensure that global strategies including pivotal clinical trials, long-term data collection studies, real world evidence generation plans and HEOR strategies are prepared for the reimbursement challenges that each product will face.  Wyatt Gotbetter is SVP & WW Head of Access Consulting, leading all facets of Parexel's Access Consulting business with a focus on helping customers position products for market success.  With more than 25 years of industry experience, he brings unique insights to guide Parexel's strategy as we invest in this segment of the business to further our patients-first focus. Sangeeta and Wyatt can be contacted at Sangeeta.Budhia@parexel.com & Wyatt.Gotbetter@parexel.com.

This episode is sponsored by our partner, Parexel, one of the world's largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services. Parexel provides clinical operations, real-world data solutions, medical and regulatory expertise and innovative clinical research tools that significantly enhance and streamline n-Lorem's therapeutic development efforts. Their depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare's most complex areas, like rare disease. Jamie Macdonald, CEO of Parexel, joins Stan to discuss the moment he realized his desire to make a difference, Parexel's role in clinical trials and their partnership with n-Lorem aimed to serve patients.

At Parexel, we are committed to improving patients' lives through clinical research. Within Parexel FSP — a division of Parexel — we fulfill key clinical development roles through functional service outsourcing models across a variety of disciplines for leading pharmaceutical sponsors. To explore a Parexel FSP employee advancement journey, Host Mrs. Jan Back, Recruitment Marketing Manager, Parexel FSP, is joined by Kerri McCaul Claus, Vice President, FSP Solutions Biometrics. Kerri has held various roles during her 25-year career. Today we delve into her career development and subsequent advancement to become a Vice President within the organization. Key Takeaways: [1:11] Kerri shares her career pathway at Parexel FSP including the multiple opportunities that led to her role as VP of FSP Solutions Biometrics. [4:30] Leading the dedicated client support teams offers insights into the key differences in how FSP supports clients and the full-service model. [5:32] Kerri attributes the ongoing learning opportunities in her various roles as the lens that allows her to see the full scope of FSP's bigger picture. [6:59] In Kerri's pursuit to grow the business, a key factor of the FSP team's success is taking every step forward from a client's perspective. [8:05] Kerri expresses how Parexel's guiding principles of patience, quality, respect, empowerment, and accountability assist dedicated FSP team members in contributing to positive client outcomes. [9:44] Kerri shares the long-term growth and development opportunities that exist at Parexel FSP for career seekers and the flexible environment in which they can expect to work. [12:06] With 25 years of experience, Kerri still appreciates the dynamic career opportunities and the support she receives from the leadership team at Parexel. [13:37] With regard to career development, Parexel believes individuals have the opportunity to craft the type of career they want for themselves. How to find out more: Explore: Parexel's Functional Service Provider Career Website

Non-profits can influence the community in a way that sponsors and site organizations cannot. In this session, Javara and Greater Gift present a partnership case study and show how they were able to achieve community access as a team. Speakers: Amanda Wright, Co-Founder & Chief Development Officer, JavaraJennifer Byrne, Founder, Greater Gift / CEO, JavaraKushal Gohil, MBA, SVP, Corporate Strategy & Innovation, Parexel

At Parexel, we are committed to improving patient's lives through clinical research. Within Parexel FSP — a division of Parexel — we fulfill key clinical development roles through functional service outsourcing models across a variety of disciplines for leading pharmaceutical sponsors. This includes finding the best candidates for vitally important CRA positions. To explore how Parexel FSP meets sponsor needs while creating rewarding career opportunities for talented clinical research professionals, Host Mrs. Jan Back, Recruitment Marketing Manager, Parexel FSP, speaks with Nannette Penny, Director, FSP Operations, and Alex Raines, Senior Executive Clinical Recruiter. The trio discuss how working for an FSP client differs from supporting a full-service client engagement, how the recruitment process works at Parexel FSP, the current career opportunities available for CRAs, and resources available to candidates interested in building an impactful career with a better quality of life. Key Takeaways: [:51] In her role as Director, Nannette oversees all recruitment and sourcing activities for a key client. [2:34] In his role as a Senior Executive Recruiter, Alex is responsible for finding, interviewing, and extending offers to candidates. [3:44] Nannette explains how the FSP model differs from full-service client engagement from a candidate's perspective. [5:50] Roles and responsibilities of a CRA in FSP on a typical day. [7:33] In the clinical research global landscape, a mismatch exists in available talent and the current increased demand for CRAs. [9:18] Alex shares the characteristics he looks for when seeking out CRA candidates. [10:38] The benefits and opportunities available when working with Parexel in an FSP. [11:59] Current CRA positions available and common contract terms. [13:40] How candidates can contact a Clinical Recruiter at Parexel FSP. [14:23] Nannette and Alex share their first-hand employee feedback about working at Parexel FSP. How to find out more: Visit: Parexel's Functional Service Provider Career Website Connect with: Alex Raines on LinkedIn Explore: Current CRA positions available at Parexel

Chris Learn, Head of Cell and Gene Center of Excellent at Parexel, discusses his participation at the recent Clinical Research Virtual Summit hosted by the Society for Immunotherapy of Cancer, and the implications for clinical research.

In this third episode of the Decentrally Speaking series, we explore the topic of Integrating the Patient Voice into Decentralized Trials. Join our guests from AstraZeneca, who partnered with Parexel to deploy a fully virtual clinical trial. We'll learn how the team incorporated the patient voice within trial planning and execution, some of the innovative approaches used in the trial, and lessons learned to take forward into future trial design. Rosamund Round, Vice President, Patient Innovation Center, Parexel, one of the world's leading global clinical research organizations (CRO). Evelina Björnsson, Senior Director, Study Management, AstraZeneca, is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines. Karin Enarsson Ringqvist, Global Study Director, AstraZeneca, is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines.  

During the Covid lock down, many people were inspired to use their free time to try new things. Steve Neat, the GM of Alation in EMEA was no exception; he took up cycling. Though of course he was intimately familiar with the strong benefits that the Alation data catalog offers, he had never really experienced these benefits for himself in such a clear-cut way. Listen is as he shares his unique story.   ABOUT STEVE NEAT: A software industry executive and sales leader with over 30 years of experience helping leading global enterprises to maximize the business value of their IT investments and data assets. Successfully assisted high-growth companies like Oracle and Siebel to establish their UK sales operations, transformed the commercial sales organisations at SAP and SAS, and successfully scaled early-stage, VC-backed start-ups like Roambi and Collibra in the EMEA market. Experienced in building and managing direct (enterprise and inside) and indirect sales teams by attracting, motivating and leading some of the best talent in the industry. Operating internationally across all vertical industry sectors, and accomplished in SaaS, Cloud, ERP, CRM, BI, analytics, mobile and data intelligence propositions.   ABOUT ALATION: Alation is the leader in enterprise data intelligence solutions including data search & discovery, data governance, data stewardship, analytics, and digital transformation. Alation's initial offering dominates the data catalog market. Thanks to its powerful Behavioral Analysis Engine, inbuilt collaboration capabilities, and open interfaces, Alation combines machine learning with human insight to successfully tackle even the most demanding challenges in data and metadata management. More than 330 enterprises drive data culture, improve decision making, and realize business outcomes with Alation including AbbVie, American Family Insurance, Cisco, Exelon, Fifth Third Bank, Finnair, Munich Re, NASDAQ, New Balance, Parexel, Pfizer, US Foods, and Vistaprint. Headquartered in Silicon Valley, Alation was named to Inc. Magazine's Best Workplaces list and is backed by leading venture capitalists including Blackstone, Costanoa, Data Collective, Dell Technologies, Icon, ISAI Cap, Riverwood, Salesforce, Sanabil, Sapphire, and Snowflake Ventures. For more information, visit alation.com.

In this second episode in the Decentrally Speaking series, we will be discussing how pharmaceutical depots are evolving their services and operations to support both sites and patients as a critical part of decentralized trials (DCTs). Expanding geographies, ancillary procurement, and storage of investigational drugs and supplies to be shipped either direct to patient or direct to site create a complex supply chain that must be carefully managed and controlled. Join our Parexel clinical trial supplies and logistics experts who share their collective experience to ensure the right mix of solutions for conducting decentralized trials to benefit sponsors, sites, and patients within a complicated and evolving regulatory environment. Sanjay Vyas, Executive Vice President And Global Strategic Business Unit, Head For Clinical Trial Supplies And Logistics Laurie McRae, Senior Director, Solutions for Clinical Trial Supplies and Logistics Daniel Meyer, Project Manager Leader, Supply and Logistics Our Decentrally Speaking series engages with subject matter experts and thought leaders on expanding clinical access for patients through the use of decentralized trials. Join us as we also explore opportunities to operationalize DCTs across our industry.   

Let AI, Embedded in the Alation Product do the Cumbersome Data Discovery Alation is the leader in enterprise data intelligence solutions including data search & discovery, data governance, data stewardship, analytics, and digital transformation. Alation's initial offering dominates the data catalog market. Thanks to its powerful Behavioral Analysis Engine, inbuilt collaboration capabilities, and open interfaces, Alation combines machine learning with human insight to successfully tackle even the most demanding challenges in data and metadata management. More than 330 enterprises drive data culture, improve decision making, and realize business outcomes with Alation including AbbVie, American Family Insurance, Cisco, Exelon, Fifth Third Bank, Finnair, Munich Re, NASDAQ, New Balance, Parexel, Pfizer, US Foods, and Vistaprint. Headquartered in Silicon Valley, Alation was named to Inc. Magazine's Best Workplaces list and is backed by leading venture capitalists including Blackstone, Costanoa, Data Collective, Dell Technologies, Icon, ISAI Cap, Riverwood, Salesforce, Sanabil, Sapphire, and Snowflake Ventures. For more information, visit alation.com. 

Our Decentrally Speaking series engages with subject matter experts and thought leaders on expanding clinical access for patients through the use of decentralized trials (DCTs). Join us as we also explore opportunities to operationalize DCTs across our industry.   In this first series episode, we will be discussing operational experiences and best practices in optimizing inclusivity for patients from Under-Represented Communities (UCs). We'll share ideas for trial recruiting, protocol review, patient and community outreach, and on-site implementation for inclusive practices from experts: Rosamund Round, Vice President, Patient Innovation Center, Parexel, one of the world's leading global clinical research organizations (CRO). Carlos Orantes, CEO, Alcanza Clinical Research, whose purpose and mission is to defend wellness for all people through the science of clinical research with efforts that are inclusive, impactful, and outstanding.

Researchers have identified more than seven thousand rare diseases, but effective treatments are available for fewer than ten percent. Drug development for rare diseases is complex given the challenges of the limited, geographically dispersed patient populations, many of which are children. In this Parexel podcast episode we explore those challenges with rare disease experts: Dr. Lucas Kempf, Vice President, Regulatory Affairs at Parexel, who has former rare disease regulatory experience at the FDA Sarah Glass, Chief Development Officer at n-Lorem Foundation, a non-profit organization dedicated to charitably provide medicines to treat nano-rare patients diagnosed with diseases that are the result of a single genetic defect unique to only one or very few individuals Stacy Hurt, whose youngest son, Emmet suffers from a genetic chromosome abnormality so rare that his syndrome doesn't have a name.  

The world of data is often elusive and nebulous. And as time goes on, different myths circulate the zeitgeist. Today's guest walks us through some common myths, and serves as our own personal mythbuster. Michelle Hoiseth, Chief Data Officer of Parexel, uncovers the biggest data challenges facing the pharmaceutical industry, and shares how you too can be a data mythbuster, how you can lead a data journey at your organization, and much more. --------“I use a cartoon still where the top frame is ‘who wants clean data' and everybody in the crowd has their hand up. Then the next frame is ‘who wants to clean their data' and everyone's hand is down and they're looking at their shoes—and that was Parexel." - Michelle Hoiseth--------Time Stamps* (0:00) Being a data mythbuster * (2:45) The data problems facing the pharmaceutical industry* (10:42) Embarking on a data journey* (24:10) Lessons learned from a data overhaul* (25:23) A data cultural evolution--------SponsorThis podcast is presented by Alation.Hear more radical perspectives on leading data culture at Alation.com/podcast--------LinksConnect with Michelle on LinkedInCheck out Parexel

Originally Published as The Niche PodcastMuddy waters of data privacy and genetic databases, antibody-drug conjugate approvals, unabetted wild enthusiasm for CROs, and mobile MRIs go public.Story Referenceshttps://tinyurl.com/Niche-058-1https://tinyurl.com/Niche-058-2https://tinyurl.com/Niche-058-3https://tinyurl.com/Niche-058-4https://tinyurl.com/Niche-058-5Music by Luke Goodsonhttps://www.soundcloud.com/lukegoodsonAbout The Niche PodcastLife Science Today is your source for stories, insights, and trends across the life science industry. Expect weekly highlights about new technologies, pharmaceutical mergers and acquisitions, news about the moves of venture capital and private equity, and how the stock market responds to biotech IPOs. Life Science Today also explores trends around clinical research, including the evolving patterns that determine how drugs and therapies are developed and approved. It's news, with a dash of perspective, focused on the life science industry.

Dr. Clare Grace, Chief Patient Officer at Parexel, a leading Clinical Research Organization (CRO) discusses a report titled "Discussions on Diversity" that includes key takeaways regarding candid discussions on the topic of racial and ethnic diversity in clinical trials. As Chief Patient Officer for Parexel, Dr. Grace leads Parexel's global patient advocacy and site efforts, including patient engagement strategies and efforts to enhance clinical trial diversity as well as new, innovative approaches to help teams and customers work more effectively with investigative sites. Most recently she served as Vice President, Site & Patient Access at Syneos Health, formerly INC Research, where she oversaw all departments responsible for patient engagement, feasibility, site identification, strategic site relations and investigator payments. Her experience also includes senior-level patient and site-focused leadership roles with PPD, Astra Zeneca and Antisoma. With more than 20 years of experience in the CRO and biopharmaceutical industries, Dr. Grace was recognized in 2018 by PharmaVoice as one of the top 100 most inspirational leaders in the pharmaceutical industry. She earned a doctorate in Molecular Oncology from the University of Manchester Institute of Science and Technology and a bachelor's degree in applied biochemistry from Liverpool John Moores University, both in England. Dr. Grace is active in several global and national-level advisory groups, including the Society for Clinical Research Sites (SCRS) and the SCRS Leadership Council. #Parexel