Amy Bohn has 20 years of experience focused on innovative solutions in Clinical Operations.  Most recently, as a Director in Bayer’s DCT Strategy and Implementation team, Ms Bohn has worked closely with study teams to implement both hybrid and fully remote decentralized clinical trials. With Bayer’s fit-for-purpose model, Ms. Bohn is driven to implement tailored solutions that facilitate remote participation and are user friendly for both trial participants and investigative site partners.

Prior to joining Bayer, Ms Bohn worked for a start-up organization that pioneered remote centralized ratings to address the high failure rate of clinical trials in CNS disorders. Over the course of a decade, she held leadership roles scaling operations from small start-up to global CRO provider. Her specialized experience implementing central ratings, telemedicine, eCOA, and digital platforms is a natural transition to the modern-day decentralized clinical trial.

Ms Bohn is a graduate of Christopher Newport University and resides outside of Philadelphia in Bucks County.

Brett Kleger is a nationally recognized executive leader with deep strengths in sales, marketing, corporate development and product management. He has extensive experience building healthcare technology and services companies and divisions, and bringing new offerings and capabilities to market. He is particularly interested in data-driven digital solutions. Prior to Inspire, Brett was CEO of Datacubed Health, where he transitioned the company during the pandemic from early stage concepts to a major contender in the eCOA and decentralized clinical trial platform categories. Prior to Datacubed, Kleger was Chief Commercial Officer and Chief Operating Officer at DrugDev, where he led the company’s market success to become the leading provider of site facing technologies, resulting in an acquisition by IQVIA. He remained at IQVIA for several years post acquisition to consolidate and lead the commercialization for all of IQVIA’s clinical trial technologies. Brett holds a business degree from the University of Maryland and a juris doctorate from the Villanova School of Law. In 2018, he was named to the PharmaVoice 100 in recognition of his considerable career achievements.

Mohammed Irfan Syed is an Associate Director at Formulation Application Services Lab of Evonik at Piscataway, NJ, USA. He currently heads the formulation group, focused on developing novel oral drug delivery systems of immediate, delayed and sustained release products using Eudragit and Eudraguard line of Polymers. During his career, he has held several positions in CRO’s, CMO’s, Generic and OTC organizations and has developed several complex solid and liquid oral modified release dosage forms. Some of his work on oral transmucosal and self-emulsifying drug delivery systems for specific diseases, which has been patented.

He holds bachelor’s in pharmaceutical sciences, master’s in chemistry and PhD in pharmaceutical sciences. During his academic journey he has presented his work on gastro retentive drug delivery systems, nanoparticles/solid dispersion formulations in several scientific organizations. His recent research is on improving solubility of weakly ionic drugs by using the concept of Acid-Base Supersolubilization and its application in development of personalized medication as Immediate release 3D Printed tablets by fused deposition modeling technique. He believes lygometry is the way to grow oneself and as a team.

With nearly two decades of medical device design experience, Matthew Keiser has driven innovative medical device development in the arenas of orthopedic spine implants and self-administration injection devices. Most recently, he led a large technical team in the development and launch of EMD Serono’s new connected electromechanical autoinjectors. These devices are connected to EMD Serono’s healthcare provider and patient facing software applications and transmitting device related information in markets world-wide. He leads all technical aspects as well as the coordination of regulatory, data privacy, patient training and internal business franchise stakeholder management related to these connected devices. Matt also leads the Industrialization Organization for medical devices within EMD Serono which ensures supply continuity, capacity management and close supplier management of EMD’s medical device manufacturing partners and its internal assembly plants. Matt is part of the leadership team of EMD’s device group and provides strategic directional support and general mentorship to the broader organization. Matt holds a B.S. and M.S. in Mechanical Engineering from Bucknell University and Stevens Institute of Technology respectively.

Mr Fox is passionate about developing partnerships that improve healthcare through the integration of innovative polymer technologies. His background as an orthopedic product development engineer highlighted the pivotal role that materials advancement plays in enhancing patient outcomes. Most of his career has been dedicated to supporting the adoption of novel polymer technologies in medical device and drug delivery applications, forming collaborations across industry and academia to create and commercialize the next generation of medical therapies.

Erin Reynolds is an Associate Director on the Data Science and Analytics team at AbbVie. Throughout her 10 years at AbbVie, Erin has been working with study teams and functional area leaders to find ways to use clinical, operational, and real-world data to transform drug development while improving clinical trial operations and access for both patients and sites. Her recent work has focused primarily on AbbVie’s diversity and patient inclusion efforts to ensure that AbbVie’s strategy has the data and insights needed to inform decisions. Erin earned her Bachelor’s in Biology from Loyola University Chicago and her Master's in Applied Probability & Statistics from Northern Illinois University.

Rob Schulz has over 18 years of multifunctional FDA regulatory experience with 16 years of Management experience and 12 years of Global Quality and Regulatory Affairs experience. Mr Schulz, has hands on experience in Quality and Regulatory compliance for Class I, II, and III, devices including combination, IVD/companion Diagnostics, sterile, software, and implantable products for both design and manufacturing. As a thought leader, Mr Schulz, has leveraged his vast project management, leadership and combination product experience to build effective teams, drive and deliver projects on time and troubleshoot challenges to execute projects.

Academic & Professional Qualifications:

• BS, Biology, California State University, Chico
• Graduate Coursework in Regulatory Science / Quality Systems / Device Regulations, University of Southern California

Training, Quality Systems, & Specialties:

• Regulatory Affairs/Submissions/Strategy
• Quality System Management
• ISO 13485, including completion of audit training
• ISO 14971
• IEC 60601
• ISO 10993
• IEC 62366
• IEC 62304

Eben Scanlon is Chief Commercial Officer at OneStudyTeam. His 20-year career has spanned from research in computational protein folding to clinical data management. Currently, as leader of OneStudyTeam’s recruitment strategy and customer operations, he is focused on partnering with sponsors and CROs to optimize patient recruitment outcomes.

Jennifer Hillner, Vice President of Strategic Accounts at OneStudyTeam, leads a seasoned sales team and is responsible for the success of the StudyTeam platform across top sponsor partners. Jenn collaborates with all OneStudyTeam departments including product, marketing and customer success to help create the best solution possible to help accelerate clinical research. She strives to take an all encompassing view of the organization and its solutions in order to provide the best possible experience to sponsors and sites. Jenn has been with OneStudyTeam for more than five years and has been instrumental in company growth.

Rakhshita Dhar is Senior Director of Venture Investments at Leaps by Bayer, where she is responsible for investing and managing portfolio companies. She currently serves on the boards of Deka Biosciences, NextPoint Therapeutics, Gro Bioscienes, ReCode Therapeutics, Vesigen Therapeutics, AffiniT Therapeutics, Bloom Biosciences and Sudo Therapeutics. Prior to Leaps, Ms Dhar was Director of Business Development at Roche Pharmaceuticals where she led multiple transactions. Previously, she served in Innovation Sciences at MassBio developing an accelerator program for life science startups.

Ms Dhar received her MS in molecular biology from Georgetown University, and holds a BS in biochemistry from Mumbai University. 

Sandeep Bhat is a Senior Leader, Digital Health Partnerships and Digital Engagement, Global Clinical Operations for GSK. Mr Bhat champions transformation in global clinical research through initiatives in innovation, information exploitation (Data Science, AI/ML), emerging technology, and paradigm shifts (Decentralized Clinical Trials / DCT). As a scientist, consultant, ops professional, and technologist, he has seen industry advancement and provided advisory and mentorship in Life Sciences for 27 years. His undergraduate and graduate degrees are from the University of Pennsylvania, both in Bioengineering.

Mackenzie McKinney brings over 10 years of experience in Health Care, Project Management, and Clinical Research. In her current role as Senior Manager of Patient Centricity, she leads the delivery of innovative clinical trial solutions, focusing on enhancing the participant and site experience. Her expertise spans various areas, including Mobile Health, eConsent, eCOA, and Innovative Care Options.