Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere

Luiz Levy has over ten years of medical device industry experience, primarily focused on high-risk devices, including implantable devices, electrical medical equipment, and disposables subject to INMETRO Certification. Luiz’s background includes: implementing and auditing quality systems to B-GMP Regulation RDC 16/2013, ISO 13485:2016, Directive 93/42/EEC, Regulation (EU) 2017/745, FDA 21 CFR 807, FDA QSR 21 CFR 820, MDSAP-Medical device Single audit program; performing multiple local and foreign (US, Europe, Japan) audits to prepare companies for ANVISA inspections; assisting companies during ANVISA inspections; compiling medical device and IVD applications; clinical data review; compiling clinical evaluation reports and compiling and peer-reviewing market access reports. 

As Director, Quality and Regulatory Affairs, Luiz has peer-reviewed more than 300 regulatory filings and reports, conducted multiple onsite audits on local and foreign manufactures, performed internal audits, and performed or reviewed more than 350 classifications/technical files of healthcare products, attended strategic meetings with ANVISA to help Agency on the final draft of new regulations (RDCs). Luiz is the designated Health Manager for Emergo’s Brazil Registration Holder services, and he additionally managers Emergo Brazil’s RDC 16/2013 quality system. Prior to Emergo, Luiz held RA/QA positions at CPL Medicals, Goen3, and Medics. 

Mitchell is the President of H Clinical, the leader in decentralized trial and home health services for clinical trials across Latin America. With a 15-year passion for enabling clinical research, supporting life sciences, and transforming organizations, Mitchell is responsible for H Clinical’s strategy, business activities, and operations. Prior to H Clinical, Mitchell served as Managing Director, Everglade Rx, Executive VP & General Counsel, Advarra, and Associate Attorney, K&L Gates. Mitchell is on the Board of Directors for Life Science Washington, Faculty for RAPS, and a former Steering Committee Member for Harvard MRCT. He is a published author on FDA regulations and a frequent speaker on technology in clinical research. 

Chris Sedgwick is the Americas Trade Specialist at the Illinois Department of Commerce and Economic Opportunity Office of Trade and Investment. He has lived in Chicago for 9 years. Born in Los Angeles, he attended California State University Northridge where he received his Bachelor of Arts in French. As a student, he participated in the Junior Year Abroad program at the University of Aix-en-Provence in France. He later went on to receive his MBA from the Thunderbird Graduate School of Global Management in Glendale, AZ.

After a few years in the freight forwarding and customs brokerage business, Chris went on to a career in international sales for a variety of industrial manufacturing companies in the reinforced plastics, welding, specialty and medical gas, and personal protection equipment industries.

Dr. Uzbelger Feldman's mission is 'Smiles for All'. He is the first Hispanic dentist to adopt Teledentistry and the first dentist implementing it in Ohio, Pennsylvania, Minnesota, and South Dakota since July 2018 as well as in Latin America. Due to his exceptional front-line services during the first month of the pandemic, Daniel received ‘The Teledentist of the Month’ award in March 2020. He received his IBM Blockchain Certificate in February 2018 and is currently innovating in blockchain for healthcare. Daniel has been granted several awards for his patented cinematic radiography and low radiation dose pioneering NeoImaging breakthrough. This research has been presented at the Massachusetts Institute of Technology as well as at prestigious dental meetings. In 2014, his low-dose x-ray imaging concept received the Medical Device & Diagnostic Industry Dare-to-Design Reader's Choice Award at the Medtech Design Challenge. 

Since 2003 Dr. Uzbelger Feldman has been teaching in the Department of Endodontology at Temple University Kornberg School of Dentistry where he earned his DMD certificate in 2006. With 25 years of experience, he practiced dentistry for seven years in Philadelphia, PA, nine years in Cleveland, OH, and was serving patients in Ballantyne/Indian Land, NC/SC suburbs before Covid-19. He is currently introducing and expanding pioneering Teledentistry and dental aligners services.

Kameel is the Principal of KDF Ventures LLC, venture capital and private equity firm. He is a leader in global finance with over 20 years of experience in established and emerging markets within the biopharmaceutical industry.

Prior to KDF Ventures, Kameel was the Senior Vice President of Finance at Ionis Pharmaceuticals, Inc the world leader in developing RNA-based human therapies. He also worked at Amgen, one of the world’s leading biotechnology companies, for 16 years. While at Amgen, Kameel held multiple leadership positions in International operations and regional CFO roles of Latin America/Canada/Australia, the Middle East, and Africa.

Jhonatan Bringas Dimitriades, MD is a Medical Doctor and executive who works with technologists, developers, medical professionals, and patients to deliver the right digital and technical solutions to enhance the diagnosis, treatment, recovery, and quality of life of patients around the globe.

Dr. Bringas believes in the democratization and digitalization of medicine. He Bringas has worked in the implementation of medical technologies in some of the top medical centers worldwide, such as the Mayo Clinic, the Cleveland Clinic, the Panama Clinic, the Hong Kong University Hospital, the AMC UMC Amsterdam, and many others. His work is related to the medical implementation of technologies, digital health, and innovation in the medical devices area. 

Jhonatan is a certified Occupational Physician, with postgraduate education in Public Health, Business Strategy, and Digital Healthcare solutions. Jhonatan holds a Medical Degree, recertified in 3 continents and has held the positions of Medical Director, Chief Medical Officer, and is currently the Chief Communications Officer of Finnish MedTech NUKUTE, a respiratory / sleep medicine wearable company with a deep development in diagnostics and digital health tools.

Alejandro Badia, MD, FACS is a hand and upper extremity surgeon at Badia Hand to Shoulder Center in Doral, Florida. Dr. Badia studied physiology at Cornell University and obtained his medical degree at NYU, where he also trained in orthopedics. A hand fellowship at Alleghany General Hospital in Pittsburgh was followed by an AO trauma fellowship in Freiburg, Germany. He runs an active international hand fellowship, serves on the editorial board of two hand journals, and previously organized a yearly Miami meeting for surgeons /therapists devoted to upper limb arthroscopy and arthroplasty. This international meeting was held at the world-renowned Miami Anatomical Research Center  ( M.A.R.C. ), the world’s 2nd  largest surgical cadaveric training lab which Dr. Badia co-founded in 2005. He is a founding member of the American Hand Institute, a think tank, and medical device start-up company focused on minimally invasive solutions to hand, wrist, and elbow pathology.

In 2008, Dr. Badia completed the Badia Hand to Shoulder Center, a fully integrated clinical facility for the upper limb also encompassing the Surgery Center at Doral, a  rehabilitation center, and an MRI imaging facility. In 2010, Dr. Badia inaugurated OrthoNOW, the first immediate orthopedic care center in South Florida which is staffed by surgeons from the Doral Orthopedic Center (DOC), a group of surgeons from the lower extremity, upper limb, and spine subspecialties who also treat elective orthopedic problems, frequently in international patients. OrthoNOW was officially franchised in early 2013 and is actively engaging healthcare entrepreneurs and surgeons, here and abroad to open orthopedic urgent care facilities nationally and abroad.

Antonino was born and raised in Italy and moved to Mexico in 2016 as Latin America BD and Marketing Director for Ferring Pharmaceuticals. In 2018, he joined Mundipharma also as LATAM BD Director and then assumed the role of General Manager in Argentina. During his tenure in the pharma industry, Antonino has covered all commercial positions, including general management, business development & licensing, alliance management, project and transition leadership, marketing and sales, market access, pricing & reimbursement. 

Antonino is the Founder of Audaces Iuvat, a consultancy BD and commercial firm based in Mexico. Audaces Iuvat is the ideal partner for small to medium pharmaceutical/biotech companies that want to face the vast and complex Latin American market and need local expertise. It provides support from the search, selection, and negotiation of a partnership, to alliance management and follow-up of the commercial activities. AUDACES IUVAT may also advise on market access and pricing & reimbursement dynamics.

Dr. ​M. Samir​ Qamar​ is the CEO of MedWand, a telehealth technology company. Dr. Qamar invented the award-winning MedWand, a medical device that​ allows clinicians to examine patients over the Internet on smartphones and computers. The handheld MedWand​ advances the telemedicine industry by allowing clinicians​ to remotely obtain real-time vitals, auscultate heart and lungs, look into ears and throats, obtain EKGs, and monitor chronic conditions during video visits. Dr. Qamar has been on the company's board since co-founding the company and is also its chairman.

Prior to MedWand, Dr. Qamar was one of the pioneering minds behind the rapidly-rising Direct Primary Care (DPC) industry. He created one of the nation's first DPC companies, MedLion, in 2009 and helped catapult DPC nationwide by focusing on low-cost subscription-based, high-quality primary care. In 2018, MedLion changed its name to MedLion Clinic and converted to a complete Internet-based Virtual Primary Care model. Prior to MedLion, Dr. Qamar began one of the first concierge medical practices in California, where ​​for many years he also served as the official house doctor for the famed Pebble Beach Resorts​.​

​Dr. Qamar completed his medical training at Penn Medicine - Lancaster General Hospital in Pennsylvania, one of the nation’s first and top-ranked primary care residency programs. His visions on the future of primary care have been referenced in many publications, including The Wall Street Journal, Fox Business News, Forbes, and Time. Dr. Qamar is a member of the MIT Technology Review Global Panel, American Medical Association, American Academy of Family Physicians, and several other organizations. He speaks six languages, has studied and practiced in health care systems worldwide, and currently resides in​ Las Vegas,​ Nevada where he also maintains an active medical practice.

Riley is helping new and existing telemedicine programs find the best solutions to fit their program needs. AMD has over 8500 patient end-point installations in more than 96 countries and delivers preeminent telemedicine solution design, turnkey installation, and training for telemedicine programs across the globe, including Latin America.