Bio-Tech AS

FAIRFIELD, Conn.--( BUSINESS WIRE )-- Gold Rabbit Sports , a boutique sports advisory group, and Prothegen , a biotech company developing new treatments for ferroptosis, a specific type of cell death, have announced a strategic partnership designed to aggressively address concussions and other traumatic injuries in sports. “We want to leverage our collective networks to inspire the sports world to think differently about athlete safety,” said André Schunk , Gold Rabbit CEO and founder. “By investing in transformational medical innovations that measurably improve human health, sports leagues, governing bodies, and teams can position themselves as visionary incubators for a compelling alternative to ‘thoughts and prayers.’” According to the National Institute of Health , there are 1.7 million documented and 3.8 million estimated Traumatic Brain Injuries (TBIs) in the U.S. annually. About 173,000 are sports-and-recreation-related TBIs among children and adolescents, and roughly 5.3 million men, women, and children are living with a permanent TBI-related disability in the United States. Prothegen co-founders Davide Zanchi (PhD & MBA, Stanford University), Prof. Scott Dixon (PhD, Stanford University) and Prof. Derek Pratt (PhD, Ottawa University) believe tackling the situation is more attainable than ever. “When a traumatic injury – like a concussion – occurs, a type of cell death called ferroptosis, takes place. Our scientifically proven, peer-reviewed treatment arrests ferroptosis, keeps cells functioning, and significantly diminishes the damage created by the trauma. Essentially, we’ve developed a potentially transformational treatment for concussions, strokes, Parkinson’s, and even Alzheimer’s disease,” said Zanchi. Michael Chad Hoeppner , Gold Rabbit’s Head of Strategy added, “The reality is that concussions and other traumatic injuries pose a genuine threat to the viability, watchability, and long-term commercial legitimacy of our favorite games.” Hoeppner concluded, “We believe the major purveyors of the sports world are inherently incentivized to seek out and support medical innovations like this and to catalyze the research and development of treatments that could literally prove game-changing for sports and society at large.” About Gold Rabbit Sports and Entertainment Founded in 2020 by sports industry veteran André Schunk, Gold Rabbit Sports specializes in imagining and developing unique and unexpected collaborations within the sports ecosystem. About Prothegen Prothegen is an early-stage biotech company delivering revolutionary therapies to regulate cell death with exquisite precision. Founded by academics in world leading institutions and pharma veterans, Prothegen develops new therapeutics in the realm of neuroscience and oncology.

DUBLIN, July 11, 2022 /PRNewswire/ -- The 'Global Clinical Trials Connect 2022' conference has been added to ResearchAndMarkets.com's offering. The Global Clinical Trials Connect 2022 will provide a platform to discuss on the futuristic advancements in clinical trials and clinical research. This multidisciplinary program involves broad participation of people from clinical trials community from around the globe who are focused on learning more about clinical research, clinical trials planning and management. The Pharma and Bio-Tech companies are consistently evolving and new clinical studies, technologies and advancements in care and treatments have augmented the efficiency and at the same time, the complexity of clinical trials has increased, with tests being carried out in a highly structured and closely coordinated manner. It is high time that we look into innovative strategies, new technologies, effective and quality collaborations to address these issues, which can cater to the needs of the patient and the industry. This conference intends to focus on the global health and clinical trials around the world. Bioethics, regulations, patient recruitment, site selection, real-world data, data integration & Strategy, outsourcing, vendor management, quality (QbD) in Trial Conduct, risk-based monitoring, clinical auditing & financial planning and other significant topics that play a key role in clinical trials will be addressed along with innovative sessions on new technologies, effective and quality collaborations. This program will certainly educate health care scientists on trial design, operations, organizing trials, research computing, regulatory aspects, report on clinical trials and gain a better knowledge of the implications of clinical trials in prevention, diagnosis, clinical trial-related ethics and disease treatments. The summit will facilitate an invaluable networking opportunities with decision makers and focus on real case studies, insightful presentations and round tables. Agenda: Day 1 - Wednesday - 21st September 2022 (Time Zone - BST) 09:30 - Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking 09:40 - Chairperson's opening remarks Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer eMQT 09:50 - Transforming the Way We Do Clinical Trials: Pragmatic Trials Combined with EHR Enabled Services Mats Sundgren Mats Sundgren Director Health Informatics AstraZeneca 10:15 - Novel approaches in Clinical Trial Design to Improve Efficiency of Research Strategies & Methods for flexible design trials The Adoption and Impact of Adaptive Trial Designs Preclinical environment and trial designs Opportunities and Limitations 10:40 - Learnings from a Fully Decentralized Trial in Oncology and a Hybrid Decentralized in Autism Connecting the developed and the developing nations Dealing with differences owing to culture and ethnicity Role of CROs and third party stakeholders Thomas Wiese Thomas Wiese Principal Medical Director, Clinical Expert Team Leader Roche 11:05 - How the World Health Organization's International Clinical Trials Registry Platform (ICTRP) is improving research transparency globally. Ghassan Karam Ghassan Karam Project Manager World Health Organization Patient Recruitment & Site Selection 11:30 - How Digital recruitment is changing the face of clinical trials Livia Dixon Livia Dixon Director Digital Recruitment Strategist Novartis 11:55 - Innovative technologies for data-driven predictive modelling, forecasting and optimizing patient recruitment in clinical trials Advanced technologies to maximize patient recruitment predictability at different stages Forecasting recruitment under different restrictions Optimal time-cost efficient recruitment design, sites / countries selection Centralized statistical monitoring and detecting unusual data patterns Forecasting future recruitment performance Vladimir Anisimov Vladimir Anisimov Principal Data Scientist, Data Science, Center for Design & Analysis Amgen 12:20 - Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats) 13:00 - Monitoring and Quality Assurance in site selection and patient recruitment to optimize clinical trials Site pre-assessment and selection Ensure patient protection and to deliver high quality data Quality assurance can at times be difficult as regulatory requirements, standards and access to care differ globally - How are we going to handle this? 13:25 - Feasibility in clinical trials Importance of conducting feasibility The stages of clinical trial feasibility Feasibility challenges Dex Bilkic Dex Bilkic Manager, Study Start-up, Patient Recruitment and Outsourced Studies Bayer 13:50 - How can clinical research be truly patient centric? The Journey of Bringing the Voice of Patients and Sites into End-to-End Clinical Development Bert Santy Bert Santy Patient and Site Engagement Lead Boehringer Ingelheim 14:15 - Panel discussion: Effective patient recruitment and retention in clinical trials to boost trial success What will persuade and impact the patient? Is there anything pharma can provide for a trial member that will increase the value of participation? The aim of patient-driven clinical trials is to diminish the burden of participation by making the participant journey as convenient and pleasant as possible Utilize fitting procedures and techniques to limit dropouts without, in any capacity, constraining a patient to remain in the study Dex Bilkic Dex Bilkic Manager, Study Start-up, Patient Recruitment and Outsourced Studies Bayer Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer eMQT 14:40 - Harnessing the power of Deep Site Data and AI to advance clinical trials - Gain insights that would not be possible with traditional approaches Patient Centricity & Patient Engagement 15:05 - Bringing the patient voice in the design of clinical trials and how patient engagement/inclusiveness must be planned and implemented throughout the lifecycle of clinical development Lea-Isabelle Proulx Lea-Isabelle Proulx Patient Voice Partner Roche 15:30 - Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees) 15:50 - Patient partnering strategies in clinical research Patient partnership models to assist researchers assess which method of engagement could work best Active role in setting research priorities Patient associations leading research projects 16:15 - Multistakeholder approach from the patient perspective A session on the multistakeholder contributor network that is the basis behind 'Patient Focused Medicines Development' initiatives Carole Scrafton Carole Scrafton Patient & Health Advocate FibroFlutters 16:40 - Global Clinical Development - Complex Generics Siddharth Chachad Siddharth Chachad Executive Vice President & Head - Global Clinical Management Dr. Reddy's Laboratories 17:05 - The patient's perspective: why their voice is so important in clinical research Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer eMQT Mary Lynne Van Poelgeest-Pomfret Mary Lynne Van Poelgeest-Pomfret International patient advocate World Federation for Incontinent Patients - WFIP 17:30 - Interactive Breakout Discussions: All the participants will have a great opportunity to discuss and explore a selection of most interesting topics discussed during the conference in small groups with their industry colleagues in an informal setting. Round Table 1: Innovation in Clinical Trials - Digital Approaches Round Table 2: Patient Centricity Round Table 3: Globalization and Country Specifics Round Table 4: Recruitment Challenges - Patients and Sites Round Table 5: Changing Clinical Trials - What needs to be addressed Round Table 6: Patient Retention 18:00 - Chairperson's closing remarks Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer eMQT 18:10 - Networking Drinks Session Day 2 - Thursday - 22nd September 2022 (Time Zone - BST) 09:30 - Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking 09:40 - Chairperson's opening remarks Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer eMQT 09:50 - Topic TBC Rebecca Jackson Rebecca Jackson Sr. Mgr. Clinical R&D Innovation & Novel Modalities IT Janssen Pharmaceutical 10:15 - Enrolment and retention in clinical studies before and during Covid-19 pandemic: clinical challenges and new opportunities. A case report from a phase 3 clinical program in fibromyalgia Domenico Merante Domenico Merante Global Clinical Development TA Lead Nephrology and Orphan Disease Area Vifor Pharma Decentralized Clinical Trials 10:40 - Exploring Decentralised and Virtual trials, with pilot studies and challenges encountered Michael Zaiac Michael Zaiac Head of Medical Affairs Oncology Region Europe Novartis 11:05 - Optimizing your Decentralized Clinical Trials with Real-World Data 11:30 - Setting up Your Decentralised Trial for Success New business model based on the Technological advances and research activities integrated seamlessly into clinical trials Developing custom made contracts by third-party vendors, CROs and sponsors for modern clinical trials Angel Soubhie Angel Soubhie Head clinical trial scientists - Medical Director Bayer Outsourcing & Clinical Trials 11:55 - A key factor in vendor Selection - The role of the CRO in advancing patientcentric clinical trial approaches Jan Schmejkal Jan Schmejkal Associate Director, Clinical Project Lead Alexion Pharmaceuticals, Inc 12:20 - Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats) 13:00 - Panel Discussion - A collaborative clinical ecosystem: How to effectively manage partnerships with all Stakeholders including Patients, Sites, CROs, Sponsors and Regulators. Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer eMQT Sonia Houston Pichardo Sonia Houston Pichardo Business Lead of MyStudyWindow Boehringer Ingelheim Quality, Compliance & Risk Management 13:30 - The effectiveness of new generation analytics models in RBM Centralized monitoring can characterize key risk classifications and pointers from all clinical and operational source data available. To evaluate risks to site performance, subject safety and data quality using Data and Analytics Differentiating the relative risks between sites and subjects using the new age analytics models. Shawntel Swannack Shawntel Swannack Director, Central Monitoring and Data Analytics GSK 13:55 - Implementing risk based approaches within clinical trial Laura Galuchie Laura Galuchie Senior Director & TransCelerate Program Lead Merck 14:20 - Are we obsessed with Quality Tolerance Limits? Choosing QTL Parameters wisely Are you asking the right questions when considering the application of Quality Tolerance Limits (QTL)? Controlling risk within diagnostic clinical studies Mireille (Zerola) Lovejoy Mireille (Zerola) Lovejoy Director of Clinical Risk Management GE Healthcare Clinical Data & Tech Driven Clinical Trials 14:55 - FDA draft guidance on 'Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Benoit Marchal Benoit Marchal Senior IT Project Manager (PMP) F. Hoffmann-La Roche AG 15:20 - Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees) 15:40 - Interpretation and Impact of Real-World Clinical Data Strategies for better decision-making High-level models and simulations compelled by data will allow elimination of risky trials The potential of real world data in clinical research goes past patient identification and patient recruitment Mohamed Sharaf Mohamed Sharaf EMEA Medical Program Lead (Immunology) Janssen Europe, Middle East & Africa (EMEA) 16:05 - Clinical trials in the era of digitization - the impact of smart innovations in clinical research Rethinking the R&D Clinical Process Patient-Centred Innovation in Clinical Trials New trial designs and analysis methods Discovering and validating sequential, personalized decision-making strategies An Integrated Business Model - Using technology to streamline processes Maria Palombini Maria Palombini Leader, Healthcare Life Sciences Practice IEEE Standards Association 16:30 - Leverage AI to create value in Clinical Trials 16:55 - Panel Discussion: The Future of Clinical Trials - The Role of Advanced Analytics and Artificial Intelligence Mohamed Sharaf Mohamed Sharaf EMEA Medical Program Lead (Immunology) Janssen Europe, Middle East & Africa (EMEA) Bhupathy Alagiriswamy Bhupathy Alagiriswamy Director Credence Clinical Solutions Ltd Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer eMQT 17:25 - Novel techniques- Tech-driven clinical trials Effectively using Technology is enabling patient centricity How to implement mobile technology and make it work in clinical trials Does consumer technology devices used in clinical trials? IoT in digital transformation of clinical trials 17:50 - Integrating Blockchain into clinical research Uses & challenges for Blockchain in Clinical Trials Storing all types of data safely and securely Better Clinical Trials Quality 18:15 - Chairperson's closing remarks Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer eMQT For more information about this conference visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 SOURCE Research and Markets