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In this session recorded at CMO Summit 2022, the panel discusses: How to onboard hires who don’t have industry experienceRetaining talent and managing expectationsThe role of flexible working models, title inflation, non-monetary incentives, etc. in this process Speakers: Debora Barton, MD, CMO, Carisma Therapeutics, IncPatrick Burnett, MD, PhD, FAAD, CMO, Arcutis BiotherapeuticsDonna Higgins, CEO, The Higgins GroupBarbara Day, Principal, Pharmaceutical Practice, Penfield Search PartnersJames Lewis, Executive Director, Barrington James

In this podcast, you will hear a panel discussion moderated by Dr Mahesh Chaubal, Baxter International, from the 2022 PODD Conference regarding opportunities to lower costs of development and manufacturing of drug delivery technologies through working with regulatory bodies, reformulating drugs to be more cost effective and analyzing the role of lifecycle management to reduce cost of goods. Panelists include: Ryan Doxey, KymanoxWenlei Jiang, FDA CDER/OGD/ORSRaymond Knox, Lyndra Therapeutics To learn more about the PODD Conference, please visit PODDConference.com.  

In this session recorded at CMO Summit 2022, Dr Paul Burton shares his experience leading Moderna as CMO since June 2021: Transitioning from pharma to biotechLeveraging data science and digital technologies to reimagine medical engagementThoughts on the future of clinical trial innovationLessons LearnedQ&A Speaker: Paul Burton, MD, PhD, FACC, MRCS, CMO, Moderna

This session recorded at CMO Summit 2022 gives CMOs an update on current views on patient-centric medicine development, what it really means and the benefits for both the patient and trial. More specifically: Achieving timely recruitment by better selecting sites and writing good protocolsWorking with patient advocacy groups to integrate patient voice in trial design and drive better enrollmentAchieving enrollment when there is so much competition for patients Speakers: Jodie Gillon, MPH, SVP Corporate Affairs & Patient Advocacy, PeptilogicsBarry Ticho, MD, PhD, CMO, Stoke TherapeuticsRolf Benirschke, Patient Advocate & Former NFL Player, Legacy Health StrategiesRoger Waltzman, MD, MBA, CMO, Molecular Templates

Boehringer Ingelheim shares their initiatives on systematically operationalizing patient engagement within their drug development lifecycle. Case examples will be shared that demonstrate: • How they are building patient insights into their development and commercial programs • How patient perspective differs based on region culture, and how they incorporate those considerations Hilary Wilson, Director, Patient Engagement, Boehringer Ingelheim Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

About The Episode As technology advances in clinical research manage operational workflows, others arise as research sites juggle non-integrated technology systems deployed by sponsors and CROs, slowing operations and duplicating work. In this podcast, Stuart Cotter, VP of Product Strategy and Innovation at Advarra, will explain the work being done to allow sites to bring their own tech to research studies when they are working with sponsors and CROs.  This episode addresses: sponsor concerns around site technology being fit-for-purpose; the pain points sites currently face on a daily basis; and Advarra’s Site-Sponsor Consortium that brings together stakeholders to brainstorm and problem-solve this issue.   About the Speaker:  Stuart Cotter, VP, Product Strategy and Innovation, Advarra Stuart Cotter is the Vice President of Product Strategy and Innovation at Advarra. In this role, he collaborates with current customers and the research community to understand their challenges and translates those challe

About The Episode As patient-centricity influences every part of the clinical trial process, sponsors may be surprised at how they impact eCOA strategy.  On this episode, THREAD Research's Chris Watson and Rebecca Tomalty share their expertise and experience, strategizing and developing patient-centric eCOAs to avoid surprise costs and delays. Listeners will learn: when to start thinking about eCOA implementation, the unexpected hurdles that can pop up, the ways that patient-centricity has impacted future eCOA planning, and the questions to be asking of your eCOA partners.  About the Speakers:  Chris Watson, Director, Consulting, THREAD Chris has over 27 years of experience in product and service development within regulated industries across multiple markets. The last 13+ years have focused on Clinical technologies, including tools and platforms to engage, educate and retain participants (and their families) in clinical studies. Chris is a recognised subject matter expert in eCOA and patient engagement

About This Episode:  DataArt's engineering capabilities with xCures' oncology expertise created a Natural Language Processing tool. This collaboration tackles the difficult task of ingesting a patient's health records, parsing free-text cancer notes, in order to help patients navigate their options for oncology treatments.    This Conversation Specifically Addresses: The unique challenges facing xCuresHow DataArt and xCures began their collaborationThe ongoing conversations required to create something novel and get the finished product to the end user: the patient Plus how this technology could positively impact clinical trial matching  About the Speakers:  Jamie McCulloch is Vice President of Client Solutions at DataArt. DataArt is a global software engineering firm with over 25 years of experience, teams of highly-trained engineers around the world, deep industry sector knowledge, and ongoing technology research, to help clients create custom software that improves their operations and opens new marke

About This Episode:  What is in the future for biosimilars?  In this episode, Pierre Bourdage, Chief Operating Officer at Sandoz, lays out the promise and potential of biosimilars, and the important role they play in healthcare system sustainability. We also hear about the new initiative Act4Biosimilars which addresses the challenges of biosimilar approvability, accessibility, acceptability and affordability, with the goal of increasing the global adoption of biosimilars by at least 30% in 30+ countries by 2030.   Key Takeaways: How biosimilars can fuel competition, innovation and generate savingsThe lasting impact on access for patientsHow Act4Biosimilars works to support biosimilar adoption and access   About the Speaker:  Pierre Bourdage is the Chief Operating Officer of Sandoz, a division of Novartis, driving high quality off-patent medicine accessibility and affordability for millions of patients. He is a member of the Sandoz Executive Committee. His previous roles at Sandoz include Global Head, Biop

DPHARM Directors, Valerie Bowling and Tracey Kimball, provide a brief overview of what to expect at the 12th annual DPHARM: Disruptive Innovations to Modernize Clinical Research conference. Get 10% off with code TEML.

In this 9 minute webinar, CRAACO® Conference Producer, Andrew Goldstein is joined by Executive Director, Valerie Bowling where they give a summary on what you can expect at the CRAACO: Clinical Research as a Care Option conference. Embedding clinical research in the care setting can lead to higher rates of clinical trial participation inside of a health system, better health outcomes, lower cost of care and more satisfied patients. CRAACO is a unique opportunity for pharma, healthcare and patients to come together and address how we can build a more integrated research ready platform to improve patient access to clinical trials. The conference takes place September 12, 2022 at the Westin Copley Place in Boston, MA. For more information please visit www.craacoevent.com

Directors Valerie Bowling and Kate Woda provide a quick overview on what to expect at the 9th annual Mobile Tech in Clinical Trials in under 9 minutes. Get 10% off with code TEML.

In this podcast, Valerie Bowling, Director of the PODD: Partnership Opportunities in Drug Delivery conference gives a 5 minute overview on what you can expect at the 12th annual PODD taking place October 24-25 at the Westin Copley Place in Boston. Learn more about the upcoming conference at poddconference.com

Summary: Join us for an important discussion about the necessity to adjust and adopt media and research strategies to ensure clinical trial recruitment of diverse populations. PharmaTalkRadio’s Valerie Bowling speaks with BBK Worldwide industry experts Justin Jones and Gaby Grekin who will share specific strategies and approaches to apply at the research and media planning stage to achieve more balanced clinical trial representation. More specifically, our guests discuss: FDA expectationsStrategic media approaches to create a more diverse and inclusive clinical trial environmentWhat to do before initiating an enrollment or engagement campaignKey considerations for planning and executing an effective outreach campaign that engages and motivates diverse audiencesWhat to prioritize? This podcast will especially benefit study sponsors, site staff, PIs, CROs/CRAs, designers and planners of clinical studies, as well industry professionals who support these groups to aid in study recruitment and strategy. Guests:

About the Episode: The number of biotech companies out there makes the struggle to find good talent and good outsourcing partners more difficult and more expensive. As a biotech CMO, working with a CRO more worried about delivering their margins than delivering on what you need leads to an insourcing problem of being inappropriately staffed and an outsourcing problem of not being serviced. In this podcast, Joe Arcangelo, Co-founder & Managing Partner, InSeption Group, and Dr Steven Zelenkofske, CMO, SwanBio Therapeutics discuss how the biotech and CRO industries have evolved and how you can identify the best partner for your needs. Key Takeaways: How to assess and select outsourcing partnersFocusing on the individuals assigned to your company as opposed to the entire CRODetermining when to outsource and what model to useIntegrating CROs while remaining nimble and flexible as a biotech

About This Episode:  Dr Derk Arts, Founder and CEO of Castor, lays out what he views as the next phase of data presentation to regulatory agencies, moving away from the standard SDTM (study data tabulation model) into something that more accurately represents the diverse streams of data that are being generated. Potential impacts include: drug approvals based on quality of life, a step forward into precision medicine, and overall increase in patient centricity. Key Takeaways: How companies can prepare for a more data-friendly futureWorking groups at the FDA and their involvement in data submission What this direction means for precision medicine, remote monitoring and other innovations in clinical research      About the Speaker:  Derk Arts, MD, PhD, has over fifteen years of experience in medicine, research and technology. He founded Castor to solve the biggest issues in clinical research: a lack of inclusivity, patient focus and impact of data. Castor enables sponsors worldwide to run patient-centric t

COVID-19 changed the clinical research landscape by proving the use and efficacy of DCTs, patient-centricity and adaptive designs. Dr Ubavka DeNoble, Executive Vice President of Biotech Operations and Senior Medical Officer of Parexel Biotech shares advice on how CMOs can think about leadership, change management and investing in new technologies such as artificial intelligence, improved data collection and system interoperability to improve patient recruitment and retention and drug development efficacy. Key Takeaways: How to lead with an eye on industry changes and flexibilityThe importance of rewarding innovation rather than standardizing a single approachObservations of successful change management throughout the COVID-19 pandemic

About This Episode:  What is the future of drug delivery for patients, and how do we get there?  In this episode, Dr Shawn Davis, who leads the Drug Delivery team of the Biopharmaceuticals Development organization at AstraZeneca, lays out a bold vision discussing how the future of drug delivery is patients interacting less with their disease, and what steps we can take to make that future a reality.    Key Takeaways: How companies can de-risk drug delivery innovationsHow the current moment in drug delivery is shaping our long-term visionBalancing the competitive landscape, portfolio and patient needs    About the Speaker:  Shawn Davis, PhD is an Executive Director at AstraZeneca and leads the Drug Delivery team of the Biopharmaceuticals Development organization. The team improves patients’ lives by ensuring AZ’s therapies are as safe, effective, and convenient as possible using technologies that target the delivery of medicines to the site of action and optimizing their effective half-life.   This requ

About This Episode:  Current efforts to source and disseminate patient insights in clinical trial planning are expensive and time-consuming.  In this episode, Fabio Gratton, CEO and Co-Founder of InVibe, which was recently acquired by THREAD Research, discusses how patient voice listening technology is enhancing and disrupting clinical research by making it easier to collect and use patient responses. The result could be more patient-centric trials informed by the actual patient voice.    Key Takeaways: How current listening technology can accurately capture and convey patient responses, emotion and perspectiveThe difference from current methods of sourcing patient feedbackNext steps in the journey of making trials more patient-centric   About the Speaker:  Fabio Gratton, Co-Founder and CEO of inVibe, part of THREAD Research, is a digital health entrepreneur. For over two decades he has adapted his early experience as a Hollywood scriptwriter with innate acumen in science and data to redefine how health

About the Episode:  Creating options for patients with decentralized clinical trials can provide tremendous benefits for certain patients and indications. In this podcast, Labcorp’s Linda Ross, Associate Director of Commercial Strategy, Decentralized Clinical Trials, brings an on-the-ground perspective to the benefit of incorporating decentralized strategies into your clinical trial approach. Having worked on multiple sides of clinical research, Ms Ross is using her experience running clinical trials via flexible approaches to discuss how, after COVID, the industry can and should continue broader applications of flexible, decentralized clinical trials.    Key Takeaways: How to convey the value of consistent DCT planning to sponsorsUnderstanding current attitudes and burdens around decentralizationThe next steps in wider adoption of flexible approaches   About the Speaker:  Linda Ross has over 20 years’ experience in the pharmaceutical industry and commenced work with Labcorp in Nov 2008 where she is cur