Dealing and Healing: How to Engage with Hospitals & Large Health Systems for Clinical Studies & Beyond
- Bibaswan GhoshalOBIO
- Jason McKeownNeurovalens
- Samantha PulliamAxena Health
- Sandra Powell-ElliottHackensack Meridian Health
Summary
When is a medical innovation ready for testing in a human clinical study, and how should you approach this important milestone? Our last MTI LIVE of 2024 will guide attendees through the critical steps of planning and executing a successful clinical trial. Whether your company is navigating a PMA pathway or simply looking to gather clinical data for marketing and adoption purposes, we will address key considerations for timing, strategy, and execution. During this session, we will explore scenarios where clinical data may be required or be beneficial, even if not mandated, to bolster your device’s market positioning. We will also discuss what level of pre-clinical data is necessary before proceeding to the clinical trial phase, especially for different device risk profile devices. The pros and cons of partnering with a Contract Research Organizations (CROs) for your clinical trial will be discussed, as well as tips for deciding between single-site and multi-site trials. Additionally, panelists will discuss how to approach patient enrollment, trial duration, control groups, and outcome measures to maximize the impact and efficiency of your study. Finally, panelists will share their advice for startups, including creative ways of funding trials. Fill your Halloween season with clinical study “tricks for treat–ments”!
Speaker bios
Bibaswan Ghoshal, OBIO
Bibaswan Ghoshal is a seasoned executive who guides early-stage healthcare companies in getting their products into the market. Bibaswan has ushered 120+ startups to obtain $30M+ in sales and $15M+ in investments. Bibaswan has a background in informatics and digital health and has been involved in developing and commercializing health technologies. He completed his graduate studies in neuroscience, bioinformatics and animal sciences at the University of Alberta. He has worked in the hospital sector on developing informatics tools and later on in technology transfer, intellectual property protection, and commercialization of early-stage technologies. Bibaswan also runs a not-for-profit organization in the arts and culture industry.
He leverages expertise in business strategy, regulatory affairs, technology adoption, and intellectual property to:
1. Develop & execute winning business plans through mentorship and strategic guidance.
2. Secure dilutive and non-dilutive funding with compelling pitch decks and proposals for investors & government grants.
3. Navigate market access in Canada and develop effective go-to-market strategies.
4. Draft & negotiate complex agreements including licenses, NDAs, and collaborations.
5. Creating a comprehensive intellectual property strategy through patents, copyrights and trademarks.
He is skilled in public procurement, stakeholder negotiation, market research, business model development, VC/Angel fundraising, project management, licensing and commercialization. This comprehensive skill set makes him a valuable asset to medical device and digital health start-ups seeking growth and success.
Jason McKeown, Neurovalens
Dr. Jason McKeown is a UK trained Medical Doctor and started his career in the NHS. Through his work in the field of neuroscience and a combined intrigue and passion for technology, Jason believed that there was a better way to treat many of the diseases he had seen affecting the daily lives of his patients. After successfully completing multiple pivotal clinical trials, Jason then achieved FDA Clearance in October 2023 for Modius Sleep, a treatment for Chronic Insomnia. Just a few months later, in March 2024, Neurovalens also received FDA clearance for Modius Stress, a treatment for Generalised Anxiety Disorder.
Samantha Pulliam, Axena Health
Senior executive with 15+ years of diverse and extensive leadership experience across industry and academic medical centers. Valued as a strategic thinker with a proven ability to lead cross-functional teams, develop talent and influence and inspire team members at all levels of the organization. Expert in building team consensus for strategic direction, evaluating and executing challenging decisions in crisis situations, and developing new paradigms for clinical research. Strong healthcare services professional skilled in Pelvic Reconstructive Surgery, Healthcare Management, Healthcare, Clinical Research, and Medical Education.
Sandra Powell-Elliott, Hackensack Meridian Health
Innovator, problem-solver, and all around implementation guru! Responsibilities include the development and implementation of the Life Sciences Research Enterprise at the Center for Discovery and Innovation as well as the development and implementation of a network wide innovation strategy. Our efforts include fostering new ideas and opportunities internally and leveraging external innovation to drive new care processes and improve outcomes.









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