Medpace’s Post

Tempus xT CDx is a differentiator because we rely on RWD to identify unmet needs, and through regulatory expertise to support the complex submission process. Come see how Tempus is building a CDx ecosystem in a unique and effective manner. #ngs #nextgenerationsequencing #worldcdx #companiondiagnostics #cdx

Thrilled to have attended the SCOPE conference alongside my Daiichi Sankyo, Inc. colleagues Starr Vang, Laura Naranjo, Kristine Koontz, PhD, MBA, Susie Campos, Mohammad F., Jehan Poco, and Kevin Douglass - a fantastic experience of collaboration and shared knowledge! Explored groundbreaking discussions on patient-centric trial design, highlighting the pivotal role of prioritizing the patient experience in shaping future trials. Discussed effective approaches to streamline site activation and start-up processes, fostering efficiency in the clinical trial journey. Delved into strategies for enhancing clinical trial diversity, emphasizing inclusivity for more robust and representative outcomes. Exciting times ahead in revolutionizing the future of clinical trials! #SCOPE2024 #ClinicalTrials #PatientCentricity #DiversityInResearch #Innovation

🌟 Join Advarra at DPHARM 2023! 🌟 #DPHARM2023 is just around the corner, and we couldn't be more excited! Join our thought leaders in Boston from September 20-22 as we delve deep into the future of clinical research. Feel free to swing by booth 24 to say hello to the team! 🔍 Day 1: Investor Views on Technology Investment in Clinical Trials - Navigate the complex landscape of technology investments in clinical trials with insights from industry experts. Engage in thought-provoking discussions on fostering innovation and alignment between investors and end-users, spearheaded by Bryan C. Spielman. 🚀 Day 2: How to Future-Proof Your Technology Ecosystem with Sites in Mind - Stuart Cotter takes you on a journey to streamline research operations effectively. Gain actionable insights from Advarra's extensive research site community and stay ahead in the evolving landscape of research technology. 🎤 Day 3: Today Show at DPHARM - Don't miss Elisa Cascade in the Today Show at DPHARM, where transformative themes in clinical research take center stage. Engage in impactful discussions that promise to reshape the industry. Visit us at booth 24 to learn more about how we foster collaboration, empower stakeholders, and pave the way for a brighter, more efficient future in clinical research. 🔗 https://lnkd.in/dGGZqcD

What does the future of DTx clinical trials look like? We are excited to discuss this topic during the panel discussion, moderated by Dani Bradley from Big Health, at the DTx Conference Series this week. Joining as a panelist, our Director of Solutions Consulting, Kristen Harnack, will share how technology vendors can provide customized solutions that fit the unique needs of digital therapeutic trials. ________ Timothy Callahan Josh Rose Dr. Elena Heber Philips Pharma Solutions, formerly BioTel Research CVS Health HelloBetter Austin Reid Steve Simpson Ted Mehalic Marshall Wallut #decentralizedclinicaltrials #clinicalresearch #digitalhealth #digitaltherapeutics #CastorEvents

Thank you, Needham & Company, for the opportunity to share our story with the executives, leaders, and investors who attended the 23rd Annual Needham Virtual Healthcare Conference.    Our CEO, Dave Marver, gave a presentation on progress towards our 2024 strategic objectives. Our highlights so far this year include:   ⭐️ Our recent De Novo medical device application to the US Food & Drug Administration (FDA) for our first-of-its-kind investigational ARC-EX® System designed to restore upper limb function after spinal cord injury (SCI).   ⭐️ Acceptance into the US FDA’s new Total Product Lifecycle Advisory Program (TAP), which provides us with streamlined US regulatory review for our investigational ARC-BCI™ System. We are the second brain-computer interface (BCI) company to be accepted into this prestigious program.   ⭐️ We received our tenth Breakthrough Device Designation (BDD) from the US FDA for our ARC-BCI System based on clinical data from two human feasibility studies. This makes us the FIRST company in the world to receive breakthrough designation for a BCI paired with therapeutic stimulation. ⭐️ Our successful EUR 20M capital raise, led by EQT Life Sciences, Inkef, our CEO Dave Marver, and several members of our Board of Directors and Management Team.    We appreciate the opportunity to collaborate with digital health leaders and investors dedicated to supporting innovative solutions for the SCI Community.   *All ONWARD Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.   #EmpoweringMovement #SCI #Innovation

Join us at the upcoming DPHARM Summit in Boston from September 20-22!  Connect with our experts Denisa McKnight and Francesca Properzi, and dive deep into the world of clinical innovation.  We'll explore cutting-edge trends like digital maturity, participant experiences, and the invaluable voice of customers – all fuelling transformative clinical trial strategies. Don't miss out!  Meet you there and let's elevate your clinical game together!  #DecentralizedClinicalTrials #DPHARMSummit  

The Swiss HLG 2024 conference starts in beautiful Montreux on Sunday evening. We are thrilled to have Ed Saltzman, Senior Strategic Advisor at Lumanity as Key Note speaker. I caught up with Ed on his Key Note last night and his analysis and insights blew my mind - conference attendees are in for a real treat. Ed's topic is: Biopharma dealmaking: Time for a Rethink?   Biotechs have to accomplish two overarching goals to achieve a lucrative licensing deal with large pharma: 1) move their products through multiple stages of clinical and regulatory de-risking and; 2) demonstrate that these products have substantial revenue potential (now $1bn or more). Most pre-commerical biotechs continue to prioritize the first goal, but in today’s dynamic and volatile commercial environment, especially in the US, most fail to secure deals because they cannot make a compelling case that their asset can deliver on the second one. In 2009 when capital to fund development though PoC de-risking was scarce, Ed proposed a new value-driving concept for sellers: Proof of Relevance (PoR). PoR is a less capital intensive and faster route to de-risking assets prior to traditional PoC, by making a compelling case for an asset’s therapeutic and thus commercial value. By focusing only on clinical and regulatory de-risking, sellers were missing this opportunity.   Despite recent very challenging capital markets, a record number of companies have raised sufficient capital to move past PoC. Unfortunately, this has led to the value of establishing PoR being overlooked. The result is a surplus of clinically de-risked assets weighed down by unattractive commercial risk profiles.   Pharma perceives only a minority of assets to have the inherent, compelling commercial prospects needed to pass minimum revenue thresholds. These “corner property” assets are the basis of today’s mega-deals. However, the reality is that the vast majority of biotechs with post-POC assets are unlikely to achieve any large pharma deal unless PoR is as compelling as PoC.   In his Key Note talk, Ed will share his thoughts on how biotechs can best address this critical challenge, followed by discussion and Q&A led by Nigel Sheail of Versant Ventures. It's not too late to register and hear Ed's insights, please register here ➡ https://lnkd.in/daxgmUHa You can now find Ed's presentation here: https://lnkd.in/gH5wAUQ6 #swisshlg #biopharma #dealmaking #innovation #networking

My key takeaways from the DTx East conference in Boston this week: ** The question is no longer "whether" to integrate #digitaltherapeutics into patient care, but "which" DTx intervention to use. Omar Manejwala, M.D. ** Lack of obvious reimbursement pathways remains a real issue. Wins in #valuebasedcare are what will set the stage for success with digital therapeutics. Michael Hasselberg ** Acceptance and adoption of DTx will increase as the younger generation of providers and patients grows. DTx integration with clinical workflow and EHRs is critical. Liesl Oldstone, PhD, MBA, RPh ** Clinicians don't just want data from DTx and #digitalhealth interventions; they want actionable insights. Peter Clardy Amy McDonough ** Opinions are mixed as to whether Direct-to-Consumer/Over-the-Counter models are sustainable. Patricia Bradley ** Collaborative relationships between FDA, CMS, and state Medicaid programs are needed to get #DTx innovations into the market. ** While there are definite challenges facing digital therapeutics innovators, there are also opportunities to think creatively and find solutions. Risa Weisberg, Ph.D. My co-panelists (minus our star moderator SMIT PATEL💊📲) on "Managing the Regulatory Obstacles for #SaMD" below. Jyotsna Mehta Sonja Fulmer Andy Molnar Bunty Kundnani

Today, CUREator deployed $5.84 million to five clinical-stage companies and $1.37 million to three pre-clinical stage companies through a ‘top-up’ round. 🧬Funding was made available from the Federal Government’s Medical Research Future Fund’s Early-Stage Translation and Commercialisation Support (ESTAC) grant. 🧬To date, CUREator-backed companies have secured $45.7m in private sector cash and in-kind support, from the $37.4m deployed by the program. 🧬CUREator delivers funding like an investor, in tranches based on milestone attainment. 🧬A novel program feature allows for the redistribution of funds from unmet milestones to supplement top-up funding rounds. 👇🏾Press release with awardees can be found here: https://rb.gy/h5ln44

inClinico is the ultimate tool to predict clinical trial outcomes, and you're invited to explore its incredible capabilities! Visit our website to dive into the future of clinical trial prediction, and discover how InClinico can help you achieve remarkable outcomes here 👉 : https://lnkd.in/dvgdJhAj #InClinico #ClinicalTrials #PredictiveAnalytics #MedicalInnovation