March 31, 2020 | March was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Veeva, Celsion, WCG, and more.

Veeva Systems announced Veeva Data Cloud to help support the industry by bringing greater innovation and choice to the data market. Veeva Data Cloud will include longitudinal patient and prescriber data offerings that will cover retail and specialty distribution channels, initially tailored for commercial use cases such as launch planning, patient segmentation, commercial analytics, AI, territory design, targeting, and incentive compensation. Asaf Evenhaim, CEO of Crossix, is leading the development of Veeva Data Cloud. Veeva Data Cloud is powered by the Crossix Data Platform, a technology platform built for the development and delivery of large-scale patient data and analytics. The Crossix Data Platform combines technology, privacy-safe processes, and continually expanding health data sets. Veeva Data Cloud will have the same open and customer-friendly usage agreements that exist today with other Veeva data solutions like Veeva OpenData. “The life sciences industry needs a new, modern approach to patient and prescriber data,” Peter Gassner, founder and CEO of Veeva, said in a press release. “We aim to bring innovation and choice to the market and an open approach centered on customer success.” Veeva Data Cloud’s longitudinal patient and prescriber data solution for the U.S. market is expected to be available by December 2020 and will focus primarily on specialty distribution channels. Offerings for additional countries will follow in the coming years, enabled by a combination of Veeva product development, industry partnerships, and acquisitions. Press release

Celsion announced with Medidata that examining matched patient data provided by Medidata in a synthetic control arm (SCA) with results from the Celsion’s completed Phase Ib dose-escalating OVATION I Study with GEN-1 in Stage III/IV ovarian cancer patients showed positive results in progression-free survival (PFS). The hazard ratio (HR) was 0.53 in the intent-to-treat (ITT) group, showing strong signals of efficacy. GEN-1, designed using Celsion's proprietary TheraPlas platform technology, is an interleukin-12 (IL-12) DNA plasmid vector encased in a non-viral nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. Celsion believes these data may warrant consideration of strategies to accelerate the clinical development program for GEN-1 in newly diagnosed, advanced ovarian cancer patients by the U.S. Food and Drug Administration (FDA). In its March 2019 discussion with Celsion, the FDA noted that preliminary findings from the Phase Ib OVATION I Study were exciting but lacked a control group to evaluate GEN-1’s independent impact on impressive tumor response, surgical results and PFS. The Agency encouraged the Company to continue its GEN-1 development program and consult with FDA with new findings that may have a bearing on designations such as Fast Track and Breakthrough Therapy. GEN-1’s strong and encouraging treatment effect, evidenced by the synthetic control arm, suggests a potentially remarkable improvement in PFS, an FDA recognized surrogate for Overall Survival, and appears to confirm the science behind IL-12’s ability to recruit the innate and adaptive elements of the immune system to fight malignancies. The strong PFS trend is supported with previously published translational data that clearly demonstrates the pro-immune changes in the tumor micro-environment associated with loco-regional GEN-1 therapy. Celsion’s current randomized Phase II OVATION 2 Study in advanced ovarian cancer patients will commence in the 2^nd half of 2020 and is designed to demonstrate a 33% improvement in PFS over current standard of care. PFS is the primary endpoint for this study. Synthetic Control Arms have the potential to revolutionize clinical trials in certain oncology indications and some other diseases where a randomized control is not ethical or practical. SCAs are formed by carefully selecting control patients from historical clinical trials to match the demographic and disease characteristics of the patients treated with the new investigational product. Press release

MMS Holdings (MMS) announced the launch of their Datacise Integrated Safety Explorer, a cloud-based, end-to-end technology platform for data science and real-world evidence (RWE) analytics that includes functionality to identify safety signals, among other use-cases. The platform is built on the Microsoft Azure cloud and analyzes both traditional and emerging data sources, including social media and genomics data channels. While some analytics platforms find it difficult to ascertain why a safety signal is emerging or changing, the Datacise Integrated Safety Explorer is designed to find and contextualize these signals in real time for use in health data mining and analytics, including pharmaceutical, biotech, and medical device development and safety surveillance. Press release

WCG announced that The Michael J. Fox Foundation for Parkinson's Research (MJFF) is introducing a redesigned version of its Fox Trial Finder clinical study matching tool powered by WCG CenterWatch iConnect. Use of the iConnect platform will make it easier for people with Parkinson's disease (PD) and healthy volunteers to both find and participate in clinical trials. "We are proud to be accelerating research and moving our mission forward to get safer, more effective treatments into the hands of patients living with Parkinson's disease as efficiently as possible while maintaining the highest quality and ethical research standards. MJFF's decision to redesign its new Fox Trial Finder on our iConnect platform will make clinical research much more accessible and easier to navigate for patients and their families," Donald A. Deieso, Executive Chairman and CEO of WCG, said in a press release. Press release

Factory-CRO Group announced its rebranding as Avania. Avania brings knowledgeable experts together to form a unique CRO that advances the research of medical devices, novel technology, and combination products. The Avania team’s regional experience and global expertise starts with early strategic consulting that then guides your product from feasibility all the way through post-marketing. “Avania has the unique advantage of having a global perspective in managing complex challenges, built on 30 years of experience,” said Sapna Hornyak, president and chief executive officer of Avania, in a press release. “We have created a better kind of medtech CRO, one that is specialized and worldwide. Our motivated team is known for navigating medical technology to market effectively and efficiently, with expertise and integrity.” The newly branded Avania will continue as one united global CRO, bringing together regional teams of experts across a wide range of therapeutic specialties. Press release