Name: Hope, Hype, Happening: Our Current Era of Clinical Trials by Applied Clinical Trials Magazine
Duration: 21 min 46 s
Description: Mike Keens, VP of Operations at Anju Software, offers his insights into the current state of decentralized trials, the state of clinical trials technology and the near-future skill sets for clinical trials professionals.

Mike Keens, VP of Operations at Anju Software, offers his insights into the current state of decentralized trials, the state of clinical trials technology and the near-future skill sets for clinical trials professionals.

Hope, Hype, Happening: Our Current Era of Clinical Trials

David Klein, co founder and CEO of Click Therapeutics, discusses the new FDA SaMD guidance, the clear differences between companion apps and  SaMD, and gives insight into what to expect from this combination in the future.

New FDA SaMD Guidance Will Bring Monumental Changes to Industry

Rinol Alaj, senior director, head of clinical outcomes assessment & patient innovation at Regeneron and Jaclyn Patterson, head, clinical trial management & site head, Basking Ridge, also with Regeneron speak to advancements in the clinical trials space, specifically the use of biomarkers and how the benefits of new solutions are transferring to the clinic.

Bringing Innovation To The Clinic

Edward Triebell, Commercial Executive Director for MRN Technologies, discusses the biggest digital trends in clinical research right now, how COVID-19 impacted the use of digital within sponsors and CROs, what the future of DCT services looks like, and much more.

DCT Opportunities in Clinical Research

In this exclusive PC Podcast interview—sponsored by Alltrista—Raphael Chin Fo Sieeuw, DHL’s VP of life sciences and healthcare, Americas, uncovers how his plethora of experience successfully prepared him to perform the required duties in his current position; the latest trends that are helping to reshape and impact the pharma supply chain; what can be done to combat 300 million tons of plastic waste every year that the global healthcare sector generates (according to the World Health Organization); and how the industry can continue to dig itself out of the national drug shortage hole.

Implementing Sustainable Business Practices

Editor Andy Studna shares some sound bytes from KOLs he spoke with during SCOPE EUROPE 2023.

SCOPE EUROPE 2023 Recap

In this PC Podcast episode, Editor Nicholas Saraceno reviews the past year by providing a look at five articles that made a splash.

A Year in Review

In this PC Podcast interview that originally aired for Pharmaceutical Executive, Camille Lee, UCB’s SVP and US head of immunology, dives into the history behind UCB's work in psoriasis;
the significance behind UCB announcing the commercial availability of Bimzelx for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy; how Bimzelx Navigate can be utilized as a resource for patients on this drug; and what listeners should keep an eye out for in terms of UCB's rheumatology pipeline.

Treating Psoriasis While Providing Patient Support

In this exclusive PC Podcast interview, Dave DeJean, Systech’s VP of global strategic accounts, dives into the valuable lessons he’s learned along the way, given his three and half decades of experience at Systech; an overview of the Drug Supply Chain Security Act (DSCSA), including its three main pillars; how he would interpret this “Stabilization Period” that the FDA provided this past summer, and what he pharma industry do now during this period in order to avoid penalties later; and whether or not he anticipates the FDA implementing any other sort of delays in the near future in order to help remedy these issues/challenges surrounding the enactment of DSCSA

Complying With the DSCSA

In this exclusive PC Podcast interview, Rob Besse, Archbow Consulting’s VP of distribution services, shares a general overview of how the 3PL process works, using his 20-plus of pharma supply chain experience as added insight; the factors that manufacturers should consider when selecting a 3PL, along with the array of services that a quality 3PL should provide; valuable lessons he believes 3PLs learned during the COVID-19 pandemic that have helped improve efficiencies; and trends affecting the pharma industry that 3PLs be on the lookout for the rest of the year/

A First-Hand Account of 3PLs

In this exclusive PC Podcast interview, Brandon Newman, Xevant’s CEO and founder, explores the implications of the Inflation Reduction Act’s price negotiation provisions, and how these could result in ripple effects across the healthcare system; the role that pharmacy benefit managers (PBMs) and other intermediaries' play when it comes to determining drug costs, and how spread pricing is involved; how Xevant helps improve drug cost transparency efforts; and strategies for affordability Newman would offer the pharma industry that can be implemented immediately.

Hope, Hype, Happening: Our Current Era of Clinical Trials

Applied Clinical Trials Magazine

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