Shows
What's New In DataFrom Compliance to Catalyst: How Parexel’s CIO Builds for ImpactJonathan Shough, CIO of Parexel, joins us to talk about leading data modernization in one of the world’s most regulated industries. He shares how compliance can be reframed as an enabler, not a blocker—and why it’s critical to deliver value to patients, not just platforms. We get into Parexel’s pragmatic approach to AI adoption, the role of human interaction in digital transformation, and what it really means to modernize data infrastructure without breaking what works.If you’re balancing transformation with trust—or just trying to give your teams back their Fridays—this one’s for you...2025-06-2643 min
The Verisian Community PodcastThe Birth of the CRO Industry: How Parexel Transformed Drug Development | Episode 16Description
Josef von Rickenbach is a true pioneer in the pharmaceutical industry. In 1982, he co-founded Parexel, a company that would go on to define the CRO industry as we know it today. Over the next 36 years as CEO, he led over 40 acquisitions, scaled the company to 19,000 employees, and helped set industry standards that still shape biopharma today.
But Josef’s story isn’t just about business. It’s a story of relentless execution, risk-taking, and building an entirely new industry from scratch. Convincing pharma companies to outsource clinical research - an idea that was unheard of at...2025-03-071h 26
The Parexel PodcastEnabling Successful Sites, Episode 5: Strategies for improving communication between sites, sponsors and CROsInvestigative 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.
2025-02-2422 minThe Parexel PodcastIs there room for new COAs in neuroscience?As we strive to improve health outcomes for patients with neurological conditions, the development of new clinical outcomes assessments (COAs) is crucial. Advancements in COAs are at a tipping point, significantly impacting the future of clinical trials and patient care.
Our clinical development and regulatory experts discuss the importance of developing new COAs to better capture the full spectrum of patient experiences, particularly in conditions like multiple sclerosis (MS). With MS as a focal point, our experts highlight the gaps in current assessments and
In this episode, Andreas Lysandropoulos, Naomi Suminski, and Simona Stankeviciute share...2025-02-2428 minThe Parexel PodcastEnabling Successful Sites: Episode 4, Part Two: Leveraging AI to improve patient recruitment and retentionAI 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.
2025-01-0608 minThe Parexel PodcastEnabling Successful Sites: Episode 4, Part One: Partnering with sites to improve patient recruitment and retentionPatient 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 wi...2025-01-0626 minThe Parexel PodcastLeveraging people, processes and technology to deliver for biotechSmall and emerging biotech companies have varied challenges compared to mid-large size pharma companies, with paths that aren’t always as straightforward as taking a compound through clinical development to launch. Our biotech clients drive towards these key inflection points from proof of concept to compound development, to capital raises based on data, to acquisition, and sometimes even launching a compound themselves. And they need a partner that brings deep clinical, scientific, therapeutic, and regulatory expertise, and still being agile and nimble to help them develop and execute their plans with confidence.
In this podcast, Jennifer Warneke, Se...2024-12-0721 min
CEO Tech LiveCyber Leadership Unlocked - Parexel Chief Information Security Officer, Nelly NaumanEver wonder how cybersecurity leaders protect what matters most in healthcare? Nelly Nauman, Chief Information Security Officer at Parexel, joins Ben Fanning to share her journey from finance to biopharma and the critical role storytelling plays in safeguarding patient data. Discover how Nelly bridges the gap between technical teams and decision-makers, empowering her team with the skills to face today's toughest cyber threats. Her passion and insights promise to change the way you think about cybersecurity.You'll also Discover:How Nelly uses storytelling to make cybersecurity strategies clear to...2024-11-0522 minThe Parexel PodcastNavigating market access in neuroscience: Challenges and strategiesDr. 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 obstac...2024-10-1626 minThe Parexel PodcastThe challenges and opportunities in market access strategies in neurology and psychiatryWe are at a major tipping point of scientific breakthroughs. There are accelerating the frontiers in neuroscience; there is a greater sense of hope, but delivering on that hope for patients and caregivers requires a new approach to market access. In this podcast episode, we will delve into the unique challenges of access strategies in neurology and psychiatry,
the implications and the need for new approaches, and how to develop successful strategies.
2024-10-0926 min
CEO Tech LiveThe Forward-Thinking Leader, Parexel Chief Information Officer, Jonathan ShoughThe Forward-Thinking LeaderJoin Jonathan Shough, CIO of Parexel, as he unveils his groundbreaking leadership strategy designed to empower his team to think proactively and act decisively. Discover how this transformative approach reshapes communication styles, enhances email effectiveness, and drives remarkable results. Jonathan’s practical strategies not only elevate team dynamics but also foster a culture of innovation and responsiveness. Get ready to explore how forward-thinking leadership can revolutionize your organization from the ground up!Connect with Jonathan here: https://www.linkedin.com/in/jonathanshough/Learn more ab...2024-10-0321 minThe Parexel PodcastLeveraging people, processes and technology to deliver for biotechSmall and emerging biotech companies have varied challenges compared to mid-large size pharma companies, with paths that aren’t always as straightforward as taking a compound through clinical development to launch. Our biotech clients drive towards these key inflection points from proof of concept to compound development, to capital raises based on data, to acquisition, and sometimes even launching a compound themselves. And they need a partner that brings deep clinical, scientific, therapeutic, and regulatory expertise, and still being agile and nimble to help them develop and execute their plans with confidence.
In this podcast, Jennifer Warneke, Se...2024-10-0122 min
BioCentury This WeekEp. 257 - Schizophrenia, Sickle Cell Drugs, D.C. UpdateApproval of BMS’s first-in-class schizophrenia drug is good news for patients and the company’s thinning pipeline alike, but maximizing Cobenfy’s commercial potential depends on readouts in additional indications. On the latest BioCentury This Week podcast, BioCentury’s editors assess the significance of the new therapy and what the pharma needs to do to make its launch a success.They also discuss the impact of the withdrawal of Pfizer's sickle cell therapy; the work left unfinished on biotech-related legislation in Congress; BioAge's NASDAQ IPO; and the importance of FDA’s Oncologic Drugs Advisory Committee meeting on the use of...2024-10-0132 min
BioCentury This WeekEp. 256 - ESMO Recap: Keeping TIGIT Alive, Rybrevant & Immunotherapy AnniversaryThe 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...2024-09-2626 minThe Parexel PodcastDe-risking Drug Development | Episode 5: Expand the use and value of your product over timeDe-risking Drug Development is a five-part podcast series that explores the business-critical decisions that take place at each stage of the drug development process. We know that novel therapies often don’t meet their revenue expectations, but through informed decision-making, you can minimize risk and maximize the probability of commercial success.
Episode five is the last in our series, and we focus on post-launch market development and how to expand the use and value of your product over time. Exploring lifecycle optimization for biotech companies, our experts discuss the importance of planning as early as Phase 1-2 cl...2024-09-2534 minThe Parexel PodcastDe-risking Drug Development | Episode 4: Implement market launch strategy, pre-approvalDe-risking Drug Development is a five-part podcast series that explores the business-critical decisions that take place at each stage of the drug development process. We know that novel therapies often don’t meet their revenue expectations, but through informed decision-making, you can minimize risk and maximize the probability of commercial success.
In episode 4, we focus on the pre-approval phase of drug development, where commercial launch planning should be started 2 - 3 years before marketing authorization. We discuss why it’s critical to start early, and highlight approaches that biotechs should implement, specifically those with a first-time launch. Our expe...2024-09-2533 min
BioCentury This WeekEp. 255 - Pediatric PRVs, Biosecure & Novo's Obesity MissRep. Frank Pallone’s misunderstanding of how the pediatric priority review voucher program works has been one factor undermining support for an incentive that brings new drugs to kids, argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin explains how the voucher process works and why it’s valuable to the country’s youngest patients, as well as to small biotechs and larger biopharma alike.Usdin also discusses the latest twists and turns for the Biosecure Act, and BioCentury’s Stephen Hansen assesses the obesity data from Novo Nordisk that destroyed more than $30 billion in value...2024-09-2421 min
BioCentury This WeekEp. 253 - IPOs, GLP-1 & Obesity, AI & BiotechOn the latest BioCentury This Week podcast, BioCentury’s editors assess the shifting market for biotech IPOs, including the profiles of the three companies that went public on NASDAQ last week, the aftermarket performance of the year's IPO class, and the prospects for more companies to make their own debut in the coming months. BioCentury’s editors also discuss whether the rush to GLP-1s for obesity will mirror the development of PD-1s for cancer and the impact on biopharma of the recent mainstream expansion of AI. This episode of BioCentury This Week was sponsored by Parexel Biotech. ...2024-09-1732 min
BioCentury This WeekEp. 252 - Akeso's Bispecific, Vaxcyte & Woodcock's Quality MindsetWill bispecifics be the drugs to dethrone cancer’s biggest blockbusters? Akeso is the latest company with a bispecific to impress in a head-to-head study, this one for non-small cell lung cancer. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the latest data from Akeso’s ivonescimab, a VEGFxPD-1 bispecific antibody that went up against Keytruda pembrolizumab in one of its largest indications, first-line non-small cell lung cancer.The editors also discuss data from Vaxcyte that the infectious disease company parlayed into the year’s largest follow-on financing and a new initiative by FDA veteran Janet Woo...2024-09-1018 min
藥企哪裡學Ep.05【CreareCmu百大藥業職人系列】百瑞精鼎 Parexel Business Analyst (下) | Work-Life balance：對現代年輕人來說工作只是生活的一部份，這一小部分不一定會讓人快樂，所以會去追求讓自己比較快樂的工作 | ft. Tiffany#2024 藥企哪裡學 Podcast # 核心單元【CreareCmu百大藥業職人系列】
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🌟節目單元目的：
邀請各個在業界大放異采的優秀藥業職人來到本節目，
分享他們過去一路走到業界的人生經歷，
每個位置都有它獨特的任務和工作型態，
究竟這些業界精英們是如何在他們各自的領域混的風生水起?
一起來聽聽他們是如何去譜寫自己的故事吧！
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Ep.05【CreareCmu百大藥業職人系列】
今天我們邀請到的來賓 Tiffany 是中國醫藥大學的學姊，
同時，她現在是 百瑞精鼎 Parexel 的 商業分析師，
而她曾經遠赴美國康乃爾大學攻讀碩士，
而後更是先後去過 賽諾菲 Sanofi、愛爾康 ICON 等知名外商工作，
身經百戰的她，年紀輕輕便斬獲許多一般人難以企及的人生經歷。
她到底是怎麼去規劃自己的人生呢？
話不多說，馬上來聽聽她的分享！
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🌟本集精彩內容重點大綱：
01 (00:42) 淺談CRO的意義
02 (04:38) 她分享In-house CRA的相關職稱及工作內容
03 (09:20) 她覺得研究所經歷對於CRA這份工作的幫助
04 (11:09) 她講述ICON及Parexel兩間CRO的工作模式差異
05 (15:22) 她在Parexel做BA時的工作內容
06 (17:55) 她分享在換工作時的考量點
07 (20:55) 她覺得成為一個專業的BA需要的技能和特質
08 (22:55) 對她來說日常工作中的壓力來源
09 (26:44) 她的Work-Life balance的生活哲學
10 (30:13) 她對未來想進入業界學弟妹的建議
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🌟本集核心思維摘要：
01
「CRA (Clinical Research Associate) 主外，工作包括到醫院做Site monitor In-house CRA=CTA (Clinical Trial Associate)=SSU (Study Startup)=CTAA (Clinical Trial Application Associate) 主內，工作包括協助CRA文書送審及歸檔」
02
「學歷通膨：大學學歷已經沒有像以前一樣那麼值錢，對藥業來講，在招募兩個 Entry Level 的新鮮人時，在起跑點一致時，學歷便會是關鍵的決勝點」
03
「Work-Life balance：過去的人下班後的生活也是工作的一部份，對現代年輕人來說工作只是生活的一部份，這一小部分不一定會讓人快樂，所以會去追求讓自己比較快樂的工作」
04
「壓力來源在藥業來講，來自於工作中的不確定性比較高一些些，常需要自我的學習，在有空的時候，去跟上這個步伐，所以在這個壓力下，我常反思：我這個階段的學習是否對於我現在是足夠的」
05
「多嘗試趁大家還年輕， 現在嘗試的話比較沒有什麼機會成本，然後大家也比較願意給我們一些機會去做嘗試」
06
「多開開自己的視野，念藥學系一般在課堂上真的都是非常藥學相關的，外面還有許多有趣的工作不一定是那麼的藥學相關，但或許是你內心有興趣還沒被開發的，所以我覺得多嘗試多看看，我覺得會有意想不到的收穫，甚至你會找到比當藥師更適合你的工作」
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👉歡迎追蹤我們的Instagram**：**@crearecmu | 中國醫 職涯發展研究社
也歡迎用IG聯繫我們，與我們分享你的心得與回饋哦！
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Hosting provided by SoundOn 2024-08-1332 minThe Parexel PodcastPodcast: Accelerated approvals – what’s next, confirmatory trials, access, and pricingFocusing on cell and gene therapies, this podcast discusses the use of accelerated approvals for fast tracking promising novel medicines through clinical development to registration.
2024-08-0512 minThe Parexel PodcastDe-risking Drug Development | Episode 3: Plan how to get to market quickly, post proof-of-conceptDe-risking Drug Development is a five-part podcast series that explores the business-critical decisions that take place at each stage of the drug development process. We know that novel therapies often don’t meet their revenue expectations, but through informed decision-making, you can minimize risk and maximize the probability of commercial success.
This is episode three, where we discuss how to accelerate development and opportunities to differentiate your product through innovative and adaptive trial design. We focus on the importance of creating evidence packages that meet both regulatory and payer requirements, and the critical role of early value st...2024-07-1639 min
藥企哪裡學Ep.04【CreareCmu百大藥業職人系列】百瑞精鼎 Parexel Business Analyst (上) | 就數字來講，對我們就不單只是數字，他們其實是讓我們找到一個故事背後的原因 | ft. Tiffany#2024 藥企哪裡學 Podcast # 核心單元【CreareCmu百大藥業職人系列】
🌟節目單元目的：
邀請各個在業界大放異采的優秀藥業職人來到本節目，
分享他們過去一路走到業界的人生經歷，
每個位置都有它獨特的任務和工作型態，
究竟這些業界精英們是如何在他們各自的領域混的風生水起?
一起來聽聽他們是如何去譜寫自己的故事吧！
------------------------------------------------------------
Ep.04【CreareCmu百大藥業職人系列】
今天我們邀請到的來賓 Tiffany 是中國醫藥大學的學姊，
同時，她現在是 百瑞精鼎 Parexel 的 商業分析師，
而她曾經遠赴美國康乃爾大學攻讀碩士，
而後更是先後去過 賽諾菲 Sanofi、愛爾康 ICON 等知名外商工作，
身經百戰的她，年紀輕輕便斬獲許多一般人難以企及的人生經歷。
她到底是怎麼去規劃自己的人生呢？
話不多說，馬上來聽聽她的分享！
------------------------------------------------------------
🌟本集精彩內容重點大綱：
01 (02:40) 她最初進入藥業的契機
02 (03:25) 她畢業後先選擇當Pharmacist Intern的理由
03 (03:59) 她從Pharmacist Intern的工作中體悟到的事情
04 (05:40) 她選擇研究所的理由和初心
05 (08:39) 國外研究需要準備哪些事情
06 (14:32) 她念研究所最大的收穫
07 (21:12) 她到Sanofi做Intern的經歷
08 (23:30) 淺談OCE的意義
09 (28:46) 她做OCE Intern學習到的思維方式
10 (33:28) 她對未來想進入業界學弟妹的建議
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🌟本集核心思維摘要：
01
「藥師的工作要學會與他人相處，放下身段」
02
「就數字來講，對我們就不單只是數字，他們其實是讓我們找到一個故事背後的原因」
03
「OCE的目標其實就是在業務拜訪之外，我們還會有其他渠道，增強HCP與藥廠之間的互動，然後再從數據層面去檢視說HCP是不是喜歡」
04
「其實面試官心裡常想的問題是：我為什麼要用你?
而你最好的方式就是去回答為什麼他需要你以及為什麼你適合這個職位或公司
你可以透過網路知道這家公司，但唯有透過實習才能了解這個工作分為是不是你喜歡的」
05
「專業知識的培養也很重要，我們常常會覺得自己是學生，就是來學的，不會有太大的貢獻，但我覺得你可以調整一下自己的心態，因為可能一兩個月後，從這個實習結束了，你就脫離學生了，所以也可以調整一下自己還是學生的心態，變成一個”準社會人”。另外你也可以檢視一下你平常的表現，你對自己的工作是不是很負責，以及你工作的完成度，這些是不是你未來的主管他看待員工會在意的點。」
06
「我非常推薦實習的原因是因為，你可以把自己丟在那個當下，我覺得你把自己放在那個環境下，就是可以最快最直接的方式，可以了解說，你是不是喜歡這個職位，是不是喜歡這個工作，是不是喜歡這個公司。」
------------------------------------------------------------
👉歡迎追蹤我們的Instagram**：**@crearecmu | 中國醫 職涯發展研究社
也歡迎用IG聯繫我們，與我們分享你的心得與回饋哦！
--
Hosting provided by SoundOn 2024-07-1537 minThe Parexel PodcastEnabling Successful Sites Ep. 2: Empowering Sites to be More Inclusive Through Cultural Sensitivity TrainingThe second episode of our ‘Enabling Successful Sites’ series features a discussion between Karen McIntyre (VP, Global Site Alliances), Xoli Belgrave (Sr. Director, Head of Clinical Trial Diversity and Inclusion), Jamie Langley (Executive Director, Parexel Academy) and Dr. Lovie Negrin, CEO and Founder of Randomize now on how we can empower and leverage sites with the tools and training they need to more successfully recruit diverse patient populations for their studies. They talk about the impact of not including diverse patient populations in studies is discussed, the need for sponsors and CROs to share their diversity, equity, and inclusion strategies...2024-06-2827 minThe Parexel PodcastEnabling Successful Sites Ep. 3: Taking the complexity out of oncology trialsOncology clinical trials present unique challenges for investigative sites, including complex trial designs, challenging eligibility criteria, and invasive procedures. In addition, the oversaturation of trials leads to competition for patients and experienced sites.
The third episode of Enabling Successful Sites features a discussion between Karen McIntyre (VP, Global Site Alliances), Mitch Carter (Assoc. Director, Global Site Alliances), and Angela Galindo, Vice President, Client Engagement at START Network as they talk about the competition for patients and experienced sites for oncology trials, why a site would pass on a study opportunity and how we can make oncolo...2024-06-2826 minThe Parexel PodcastDe-risking Drug Development | Episode 2: Focus on safety and efficacy and prove quickly that your product worksDe-risking Drug Development is a five-part podcast series that explores the business-critical decisions that take place at each stage of the drug development process. We know that novel therapies often don’t meet their revenue expectations, but through informed decision-making, you can minimize risk and maximize the probability of commercial success.
In episode two we discuss the critical decision points in early phase development (phase I to IIa) that can ultimately determine the success of your product. Specifically, we discuss why drugs fail at this early stage, focusing on safety, tolerability and efficacy. We focus on the im...2024-06-1938 minThe Parexel PodcastDe-risking Drug Development | Episode 1: How to drive value in pre-clinical development2024-05-2323 min
Spotnana's Travel Is a Human Emotion PodcastDiscussing distribution and sustainability with Parexel’s Ben ParkBen Park, Executive Director of Travel & Sustainability at Parexel and Chair of GBTA Europe’s Advisory Board, joins Johnny Thorsen, VP of Business Development for Content Distribution at Spotnana, to discuss the evolution of travel programs in 2024, the growing importance of sustainability in corporate travel, and the impact of innovative technology on the business travel experience.2024-05-2325 minThe Parexel PodcastEnabling Successful Sites, Episode 1: Solving Site Feasibility and Start-Up ChallengesThe 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.
2024-05-1016 minThe Parexel PodcastRare Endpoints: Delivering on Unmet Patient NeedsThe 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.
2024-05-0711 minThe Parexel PodcastAdvancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 3 In this third episode on advancing precision oncology, we continue discussing the role of expanding patient access to biomarkers and evolving testing capabilities. Our precision oncology experts delve into the challenges and opportunities that lie ahead in the rapidly changing landscape. They explore advancements in data, machine learning, and testing capabilities on the horizon. They also discuss the roles of payers and healthcare providers in ensuring patient access to these advancements.
2024-04-2513 minThe Parexel PodcastAdvancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 2In this second episode on advancing precision oncology through patient access to biomarkers and testing, the discussion focuses on the benefits of integrating multi-omic data in precision oncology and how it can enhance treatment selection. Our experts discuss the importance of looking beyond genomics and considering other omics, such as immunomics and metabolomics, to gain a better understanding of the tumor and the patient's immune system and physiology.
2024-04-2513 minThe Parexel PodcastAdvancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 1In this first episode, join our clinical development and market access experts who discuss the role of biomarker research, discovery, and patient access in advancing precision oncology to date. Biomarkers have been central to improving patient outcomes and guiding treatment guidelines in lung, breast, and blood cancers. With that backdrop, our experts discuss the role of large-scale data sets and real-world evidence in furthering precision oncology research and improving patient outcomes in more types of cancer.
Dr. Gwyn Bebb, Senior Vice President and Global Therapeutic Head of Oncology
Wyatt Gotbetter, Senior Vice President Worldwide, Access Consulting
2024-04-2520 min
SCRS TalksBuilding Strong Partnerships: Parexel's Commitment to Research SitesKaren 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. 2024-03-2511 minThe Parexel PodcastCAR-T boxed warnings: What comes next?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 c...2024-03-0633 min
The Top LineCAR-T boxed warnings: What comes next?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...2024-03-0133 min
The Endpoint Podcast: A Clinical Trial PodcastThe Endpoint Podcast. Episode 20: With Stacy Hurt. Chief Patient Officer at ParexelStacy Hurt joins Liam on this week’s podcast episode. Stacy is the Chef Patient Officer (CPO) at Parexel. It’s one of the largest clinical research organizations (CROs) and provides the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. In this session we explore a range of topics including, Stacy’s inspiring journey from caring for her son and battling cancer to becoming a patient advocate, along with other topics such as how in her new role as CPO she is leading the charge on helps Sponsors be more patien...2024-02-1239 minThe Parexel PodcastPreparing for a Cell and Gene Future | Episode 1: Looking Back at 2023 AchievementsThis episode is the first of our new 2024 series – Preparing for a Cell and Gene Future. In this episode, we take a look back at a banner year for cell and gene therapies and what to expect in 2024 in terms of next-generation therapies and gene editing progress with Chris Learn, Senior Vice President and Head of the Cell and Gene Center of Excellence.
2024-01-1017 minThe Parexel PodcastThree trends impacting market access in the EURare disease drug developers face three major market access challenges in the EU market today. Parexel Pricing and Market Access expert, Sangeeta Budhia, shares what they need to know to succeed.
2024-01-0413 minThe Parexel PodcastHow can we advance fair and ethical reimbursement for patients?In this podcast, Parexel Vice President of Patient Engagement Rosamund Round leads a discussion on practical challenges and regulatory considerations for patient reimbursement programs in clinical trials. Elizabeth Barksdale, Director of Regulatory Affairs and Scientific Policy for LUNGevity Foundation, a non-profit lung cancer advocacy group, and Luke Gelinas, Senior IRB Chair Director for the global clinical research compliance organization Advarra, advocate for a new framework that fully reimburses patients for travel and compensates them for an additional tier of “soft” costs that will positively impact many patients’ ability to join or remain in a clinical trial, and improve health equity2023-11-2111 min
Molecule to Market: Inside the outsourcing spaceFrom MBO to global, family-run CROIn 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 ho...2023-07-2851 minThe Parexel PodcastBeyond the Binary: Navigating Gender Diversity in Clinical ResearchThere 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...2023-06-0827 min
Outcomes RocketRC: New Possibilities in Oncology Research with Chris Learn, Vice President of Cell and Gene Therapy at ParexelCancer 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.health2023-03-2836 min
Prescription for Better AccessBreaking Down Barriers: An Interview with Peyton HowellThis episode features an interview with Peyton Howell discussing the evolution of patient access over the past three decades, the creation of the hub industry, and the continuing challenges faced by pharma companies and service providers in supporting patient access to medications.
Peyton Howell, Chief Operating and Growth Officer, Parexel
Parexel
Lash Group
Genentech
Biologics
How Automation Is Transforming Healthcare Jobs
Do you have a prescription for better access? Share your ideas and show topics with us at comments@prescriptionforbetteraccess.com
...2023-03-0739 min
CPhI Podcast SeriesRare Diseases Day – Pharma fulfilling an unmet needRare 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...2023-02-2833 min
Microsoft Teams Insider20,000 users, 50 countries, 4 weeks to Microsoft Teams with Chul-Young, Collaboration Product Manager at ParexelI really enjoyed this conversation. Chul-Young, Product Manager, Collaboration Platforms & Services at Parexel, takes us through his and their Microsoft Teams journey.- Rolling Microsoft Teams out to 20,000 users in 50 countries in 4 weeks- Keeping things as standard as possible- How is Team creation and lifecycle managed?- With great power comes great responsibility- Experience rolling out Teams Phone and reducing the number of Phone users- Looking at this year and Microsoft Viva2023-02-0626 min
The IPhO PodcastEpisode 32: A Roadmap to Success with Kelly CheungOn 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 i...2023-01-2325 min
Data RadicalsData Governance 101: All You Need to Know (But Were Afraid to Ask)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 abou...2023-01-1815 minThe Parexel PodcastWhy Rare Disease Therapeutics Need Early Market Access PlanningWhen 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 Bl...2023-01-0330 minThe Parexel PodcastCROs and Their Role for Nano-rareIn 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.
2023-01-0327 min
PharmaTalkRadioWhy Rare Disease Therapeutics Need Early Market Access PlanningAbout 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 an...2022-12-2130 min
Why Rare Disease Therapeutics Need Early Market Access PlanningAbout 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 an...2022-12-2131 min
Patient Empowerment Program: A Rare Disease PodcastCROs and Their Role for Nano-rareThis 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 mo...2022-12-1427 minThe Parexel PodcastRBQM Podcast Series | Episode 4: Three ways to de-risk your DCT implementationMuch like RBQM, decentralized clinical trials (DCTs) are an approach to conducting clinical trials, interacting with patients and sites, and implementing fit for purpose technologies for the collection and capture of critical data and monitoring patient safety. The overall objective of DCTs is the facilitation is to lessen the patient burden of patients and sites, therefore increasing patient participation, while ensuring the collection and capture of critical data, such as efficacy endpoints and safety data.
In the fourth episode of the RBQM podcast series, Amy Adams, Senior Director, Clinical Operations and Cris McDavid, Director, Clinical Ope...2022-12-0509 minThe Parexel PodcastCareers at Parexel — FSP Podcast Series | Episode 2: Celebrating a 25-Year Career with Kerri McCaul-ClausAt 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.
Ke...2022-12-0516 minThe Parexel PodcastCareers at Parexel — FSP Podcast Series | Episode 1: Get Recruited to Be a Clinical Research Associate: The Benefits of Parexel’s FSP ProgramAt 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...2022-10-2618 minThe Parexel PodcastThe Parexel Podcast | Episode 20: Driving change in Cell & Gene Therapies: Key learnings from the SITC Virtual SummitChris 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.
2022-09-1908 minThe Parexel PodcastDecentrally Speaking | Episode 3: Integrating the Patient Voice into Decentralized TrialsIn 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...2022-07-2814 minThe Parexel PodcastRBQM Podcast Series | Episode 3: Staying within the Guardrails: How to Push the Boundaries in a Highly Regulated IndustryBy designing quality into trials, we focus on the most critical data and create a framework for efficiently identifying and addressing any risks to patients, the integrity of data, or regulatory compliance. While part of regulatory guidance, consistent interpretation of RBQM approaches by regulatory inspectors is an area of concern. In such a highly regulated industry that is notably slow to adopt change, biopharmaceutical companies and CROs are still debating how to go with evidence-backed documentation to satisfy regulatory requirements when using risk-based approaches.
In the third episode of our RBQM podcast series, Amy Kissam-Sands, Senior Vice...2022-06-2014 minThe Parexel PodcastDecentrally Speaking | Episode 2: The Shifting Roles of Pharmaceutical Depots within a Decentralized Trial EnvironmentIn 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...2022-05-0921 min
Plug And Pay - A Global Payroll Talk ShowCan the right payroll data foundation take the organization further? - With Thomas Emmrich (Parexel)On this occasion, we had a chat with Thomas Emmrich, International Payroll Manager at Parexel, who has been working for years on developing a seamless data flow between his global payroll department and the rest of the organization to help the business make more informed decisions.During our conversation, we touched upon his experience on🔹Are organizations recognizing more the value of payroll data than they used to?🔹The crucial requirements for any organization wanting to use payroll data to make better business decisions -processes, tools, and mindset.🔹Why customer focus is essential to manage...2022-04-1241 minThe Parexel PodcastRBQM Podcast Series | Episode 2: Cultivating Risk-based BehaviorsAs risk-based quality management (RBQM) practices become a requirement of global regulators, industry adoption will require end-to-end organizational change.
In this second episode of our RBQM series, Amy Kissam-Sands, Senior Vice President of Clinical Operations, Dr. Kristin Murphy, Senior Director and Global of the Change in Adoption Center of Excellence, and Amy Adams, Senior Director of Clinical Operations, discuss the key questions and practices that form a robust change management strategy that impacts behavior from the organizational level down to the individual.
2022-03-2309 minThe Parexel PodcastDecentrally Speaking, a Parexel Podcast | Episode 1: Optimizing Trial Inclusivity For Patients From Under-Represented CommunitiesOur 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 clinic...2022-03-2115 minThe Parexel PodcastEpisode 19: Improving Rare Disease Drug DevelopmentResearchers 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...2022-02-2839 minThe Parexel PodcastRBQM Podcast Series | Episode 1: Getting it Right Upfront - Managing Study Risk from End-to-EndRisk-based quality management (RBQM) is fast becoming a critical success factor for clinical development programs. Global regulatory agencies are putting more focus on RBQM components to ensure patient safety, data quality and the validity of study results. However, companies don’t always approach risk management in a holistic, collaborative approach increasing their chances of missing risk signals.
In this Parexel podcast episode, the first of our RBQM five-part series, RBQM experts Amy Adams, Senior Director of Clinical Operations Liz Gough, Associate Director Business Process Excellence, and Kirsty Botes, Associate Director Clinical Operations, discuss strategies and bes...2022-02-2512 minData RadicalsMaking Big Data an Asset in Medicine with Michelle Hoiseth, CDO, ParexelThe 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 han...2022-02-1629 minThe Parexel PodcastEpisode 17: Funding Biotech Innovation: How to Attract InvestorsThe biotech industry posted record financing, deals, and M&A numbers in 2020 and 2021, spurred in part by the swift and successful development of COVID-19 vaccines. Despite this favorable funding environment, the industry faces ongoing challenges. The cost of developing new therapies continues to climb and fewer than 8% of product candidates make it from Phase I to market.
In this episode, biotech experts – Jim Anthony, Executive Vice President and Global Head of Parexel Biotech, and Mike Davitian, Vice President, Health Advances – share findings from a proprietary research report on the biotech investment landscape. Find out what investors are look...2022-01-1823 minThe Parexel PodcastEpisode 16: COVID-19 Vaccines and Kids: The Research and Vaccine ExplainedIn the United States, the FDA and CDC recently granted emergency use authorization (EUA) for Pfizer’s COVID-19 vaccine for 5–11-year-olds, making it the first COVID-19 vaccine available for younger children and arriving nearly one year after Pfizer’s COVID-19 vaccine received EUA for adults. If the adult vaccine was authorized for this long, why did it take so long to make one available for younger children?
In today’s episode, Nathalie Sohier, Global Head of Infectious Disease and Vaccines, and Shipra Patel, Global Head of Pediatrics explain the clinical trial process for vaccines, the nuances in this pro...2021-11-1814 min
PharmaTalkRadioBuilding a Successful Relationship with your Development PartnerWhile the idea that trust between sponsors and development partners is integral to success is well known, actually building that relationship requires real effort and empathy from both groups. Today, Dr Skip Sands, Senior Vice President and Senior Medical Officer of Parexel Biotech, discusses practical examples of how to build and maintain that relationship of trust and navigate challenges that arise based on his experience on both sides of the sponsor and CRO partnership. Key takeaways: How to choose the right development partnerBuilding the relationship infrastructure from the bid process through clinical developmentCommunicating and managing expectations between sponsors and CROs Gu...2021-10-0515 min
Health Professional Radio - PodcastParexel - Healthcare Industry Report On Lack Of Diversity & Inclusion In Clinical TrialsDr. 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 He...2021-05-2711 minThe Parexel PodcastEpisode 15: Pandemic Preparedness: Investing in the future of infectious disease vaccine developmentViral infections continue to emerge and represent a serious threat to global public health, from SARS to H1N1 influenza to MERS. Yet none has caused the level of global devastation levied by the coronavirus. In fact, the long-term complications of COVID-19 on our healthcare system are just beginning to come into focus. Managing these complications will increase the demand for healthcare resources in the years to come and will elevate the need for novel therapies to manage them. This episode features Sy Pretorius, Parexel’s President, Clinical Development & Chief Medical Officer; Paul Bridges, Senior Vice President, Regulatory and Ac...2021-02-0835 min
PharmaTalkRadioThe Practical Implementation of Sensors in the Changing Drug Development WorldIn this conversation, you'll learn lessons of how to implement sensors for the most impact in your clinical trials. Join three sensor experts as they discuss: What phases of clinical trials are more suited for sensor useHow to select and integrate the deviceHow to ensure compliance Speaking: Keith Wenzel, Senior Director, Parexel’s Scientific Data Organization: Keith's areas of subject matter expertise include electronic clinical outcomes assessment, patient sensors and a broad range of eClinical technology used within clinical drug trials.Julia Lakeland, Solutions Architect and Program Director, Parexel: Julia is responsible for selection and implementation of real-world scientific data source...2021-01-2222 min
The Practical Implementation of Sensors in the Changing Drug Development WorldIn this conversation, you'll learn lessons of how to implement sensors for the most impact in your clinical trials. Join three sensor experts as they discuss:
What phases of clinical trials are more suited for sensor useHow to select and integrate the deviceHow to ensure compliance
Speaking:
Keith Wenzel, Senior Director, Parexel’s Scientific Data Organization: Keith's areas of subject matter expertise include electronic clinical outcomes assessment, patient sensors and a broad range of eClinical technology used within clinical drug trials.Julia Lakeland, Solutions Architect and Program Director, Parexel: Julia is responsible for selection and implementation of real-world scientific data source...2021-01-2223 minThe Parexel PodcastEpisode 14: Why Parents and Children Join Research Studies: CISCRP’s 2020 Pediatric Perceptions & Insights Survey Reveals Critical InsightsPediatric participation in clinical trials is essential to understanding how drugs perform in children, whose side effects and responses to medications are often very different from adults. Yet the vast majority of medications are only evaluated in adults, and pediatric participation in clinical trials remains exceedingly low worldwide. In this podcast, experts discuss critical insights gleaned from a survey of 500 parents and children about their perceptions and experiences of clinical research. Hear from Sarah Glass, Global Head of Rare Diseases at Parexel; Shipra Patel, Senior Medical Director at Parexel and a pediatric endocrinologist at UNC-Chapel Hill; Annick de Bruin...2020-12-0839 min
PharmaTalkRadioUsing Sensor Technology to Deploy Decentralized Trials and Improve Patient CareIn this PharmaTalk episode, get guidance from patient innovation and technology experts about the proper ways of harnessing technology in order to deploy Decentralized Clinical Trials and improve patient care. Specifically, in this episode Rosamund Round and Julia Lakeland, both of Parexel, discuss: How sensors can be utilizedThe patient impact of COVID-19 and clinical trialsEfforts to support patient safety and trial continuityProtocol around assessments for data collection with sensors Interview Guests: Julia Lakeland, Solutions Architect and Program Director at Parexel, is responsible for selection and implementation of real-world scientific data sources and wearables for clinical trial use. Her background is in...2020-10-2922 min
Using Sensor Technology to Deploy Decentralized Trials and Improve Patient CareIn this PharmaTalk episode, get guidance from patient innovation and technology experts about the proper ways of harnessing technology in order to deploy Decentralized Clinical Trials and improve patient care.
Specifically, in this episode Rosamund Round and Julia Lakeland, both of Parexel, discuss:
How sensors can be utilizedThe patient impact of COVID-19 and clinical trialsEfforts to support patient safety and trial continuityProtocol around assessments for data collection with sensors
Interview Guests:
Julia Lakeland, Solutions Architect and Program Director at Parexel, is responsible for selection and implementation of real-world scientific data sources and wearables for clinical trial use. Her background is in...2020-10-2923 min
Real World Talk with COTAAn Exciting Time for Real World Data with Michelle Hoiseth of ParexelEpisode Summary During this episode of Real World Talk, host Zoe Li has a chat with Michelle Hoiseth, the Chief Data Officer of Parexel. Michelle talks about an exciting time for real world data and the opportunity that exists for the life sciences industry. She pinpoints some of the challenges involved with further adoption of RWD in clinical development and regulated uses and discusses how the industry can work together for the benefit of patients and their loved ones. Episode Highlights Michelle Hoiseth opens up the conversation by stating how she feels like, with real world data in...2020-08-1128 minThe Parexel PodcastEpisode 13: The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19Once the COVID-19 pandemic passes or is contained, the world will look and work very differently. The biopharmaceutical industry is no exception. In this podcast, Peyton Howell, Parexel’s Chief Commercial and Strategy Officer, talks with Paul Bridges, Worldwide Head of Regulatory and Access, and Sheela Hegde, a Partner with Parexel’s Health Advances subsidiary, about the regulatory, investing and clinical development changes that are most likely here to stay – The New Pragmatism. After listening, you can read more about Paul and Sheela’s perspective in this article: https://regulatory-access.parexel.com/parexels-covid-19-expert-content/covid-19-and-the-new-pragmatism
2020-07-3025 minThe Parexel PodcastEpisode 12: ASCO20 Debrief: The latest in cell and gene therapyIn 2020, ASCO went virtual for the first time. While the format was different, one thing was clear: despite all that is happening in the world, there are still many patients in need. Todd Shuster, MD, Head of Parexel’s Oncology Center of Excellence; Matthew Cooney, MD, co-lead of Parexel’s Cell and Gene Therapy initiative; and Keith Donovan, an expert in Early Phase Development with a focus on oncology, join Alberto Grignolo, Corporate Vice President, Regulatory and Access, to discuss the progress made in cell and gene therapy as presented at ASCO and how the industry can continue to move...2020-06-0542 min
The Parexel PodcastEpisode 11: Maintaining Clinical Trial Continuity During COVID-19: The Patient PerspectiveNow more than ever it's important to recognize and show our appreciation for clinical trials and the critical role that they play in advancing public health. Since the outbreak of the COVID-19 pandemic we've seen many changes that have been made to clinical trials to maintain continuity. In this podcast, we explore how clinical trials have changed and adapted, and how those changes may impact clinical trials in the future for patients. Ken Getz, professor at Tufts University School of Medicine and the Founder and Chairman of the Center for Information and Study on Clinical Research Participation (CISCRP) moderates...2020-05-1942 minThe Parexel PodcastEpisode 10: The emerging role of wearables in clinical trialsThe COVID-19 pandemic has forced us to rethink just about every aspect of clinical trials. An area of significant potential is the use of wearables as part of Decentralized Clinical Trials (DCTs). Today, wearables are enabling at-home care and providing long-term monitoring of COVID-19 patients. How can wearables change the game in this most critical time for our industry? What considerations need to be kept in mind when involving wearables in a clinical trial? Julia Lakeland, solutions architect, program director, and wearables expert for Parexel joins Sheng Feng, Parexel’s head of real-world data in Asia-Pacific, in this episode ho...2020-05-1516 minThe Parexel PodcastEpisode 9: Making the Most of Functional Service Provider (FSP) RelationshipsIn this episode, we discuss how Functional Service Provider or FSP partnerships have been gaining traction and increasing in relevance in today’s environment because of their potential to offer flexibility, access to expertise, and reduce costs in outsourcing without compromising quality. Parexel’s Head of Global FSP Chris Baker discusses with FSP leaders Joanne Sullivan, Alisdair Falconer and Beth Shaleesh several “tips and tricks” for making the most of FSP relationships, how Parexel has built a successful FSP culture in areas including India, and what factors contribute to a successful FSP relationship - right from the outset.
2020-05-0723 minThe Parexel PodcastEpisode 8: Performing clinical trials in a shifting development landscapeThe COVID-19 pandemic is having lasting and far-reaching impact on the drug development industry. Fundamental aspects of drug development are undergoing changes that were unimaginable just weeks ago. However, the pursuit of new medicines cannot stop. Learn from Parexel regulatory experts Amy McKee, an oncologist and former FDA CDER regulator; Bridget Heelan, a former senior clinical assessor in the biological unit at the MHRA; and Jenny Gidley, global head of Parexel’s Clinical Operations Leaders about the implications of this pandemic for the important work of drug developers, researchers, and regulators. How are we to cope with the new re...2020-04-0823 min
The Parexel PodcastEpisode 7: International Women’s Day: Insights from Ascending DavosIn this episode, Parexel Executive Vice President and Chief Commercial & Strategy Officer Peyton Howell interviews Meghan FitzGerald, Parexel Board Advisor and author of the new book Ascending Davos: A Career Journey from the Emergency Room to the Boardroom. The two healthcare leaders discuss topics including Meghan’s career pivots from nursing to the healthcare industry to private equity, why you should take your CFO to lunch, and their unexpected friendship.
2020-03-0627 min
The Parexel PodcastEpisode 6: The opportunity for biotechs in precision medicine: driving value and bringing important new therapies to patientsWithin the past 20 years, the field of precision medicine has been transformed. For biotech companies, this new landscape holds tremendous promise for innovation. So, why aren’t more companies leveraging this approach? In this episode, Parexel precision medicine experts Angela Qu and Arlene Hughes join host Alberto Grignolo to discuss this conundrum, and what biotechs should be thinking about right from the start, to open up the opportunity for this approach to help bring innovation and new therapies to more patients.
2020-03-0431 minThe Parexel PodcastEpisode 5: CAR-T: How far have we come and where are we going?In this episode, Doug Olson, one of the first CAR-T patients treated on a clinical trial for CLL almost 10 years ago, details his experiences with this therapy in its earliest days. Parexel’s experts Mo Heidaran, Alexander Gee and host Alberto Grignolo, all part of our newly-integrated Regulatory & Access consulting unit, also weigh in on the current regulatory and reimbursement landscape for CAR-T and what we might look forward to in the future for this and other cell and gene therapies.
2020-02-2734 min
Clinical Research PodcastInterview With A CRA About Differences Working for Sponsor and CROInterview With A CRA About Differences Working for Sponsor and CRO In this episode I interview a CRA and friend of mine about the differences of working for a Contract Research Organization (CRO) and a Sponsor. We dive into the differences between working for a company like Johnson and Johnson or Roche versus a company like Parexel or IQVIA. What are the challenges that a CRA might face. Find out in this jam packed interview!
Don't forget to Subscribe for new content! Subscribe: https://youtube.com/eliteclinicalrese...Call or Text: 910-502-3732 Email: eliteclinicalgroup@gmail.com Podcast: htt...2020-02-1924 min