Dan Solis is a recognized expert in FDA’s import operations and is the Assistant Commissioner for OII’s Office of Import Operations. Prior to this position he was the Division Director for the Division of West Coast Imports since February 9, 2018. He started his career with FDA in 1998. Prior to working in FDA, Mr. Solis worked in the Bioresearch field focusing on Medical Device and Drug Application Products after graduating from the University California of Irvine and the University of La Verne. Mr. Solis has held many positions within FDA, including work at the FDA lab in Irvine, Ca. as a Microbiologist, headquarter position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer, and working in the FDA Los Angeles District Office as a Director of Import Operations Branch. Mr. Solis brought leadership to the Office of Import Operations in March 2020, during the Covid-19 pandemic and became permanent Assistant Commissioner for Import Operations in November 2020.
Mark Milberg has over 27 years of management and operational experience in the biopharmaceutical, medical device, and healthcare industries. He currently works as Senior Director, Clinical Outsourcing at Ultragenyx Pharmaceutical Inc., supporting all of the clinical programs in this clinical-stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases. He worked at Medtronic previously for 8 years in increasingly responsible positions, including leading the contract function for the entire company. Mark’s career has included work in medical and dental practice management as well. He has both a MSW and a MBA. He was appointed to his local community’s Citizen Finance Oversight/Advisory Committee. Mark has presented at numerous industry conferences and is a well-respected collaborator and influencer in his field.
Michael’s background spans contract and proposal development; contract negotiations in multiple languages; set up and management of vendor oversight and governance programs; and related change management. He has worked for CROs as well as small and large biotechnology companies. Over the course of his career, he has worked on clinical development of 23 compounds currently marketed in 1 or more therapeutic indications.
Davey’s railway career began in 1978 as a Traction Trainee, qualifying as a train driver by 1981 and becoming a trainer from the late 80’s. By the early-90’s he progressed into management where he has held various roles covering safety, standards, audit and assurance along with senior traincrew line management. Notably, Davey kept his train driving competence for many years after becoming a manager, helping him keep touch with the job at the “sharp end” whilst now being involved with decisions being made that had impact on that part of the operation. GC is an “Open Access” train operator that commenced operating in 2007, providing direct high-speed passenger trains connecting parts of Northeast England and the West Riding of Yorkshire not directly served by other (franchise) operators, with London Kings Cross. Davey joined GC in 2009 and has held several senior leadership posts. More recently he has worked part-time and from early 2020 took on the role as GC’s Business Change Manager for the East Coast Digital Programme (ECDP). This will bring about the introduction (in stages) of ETCS over the East Coast Mainline south by the mid-2020’s and whilst Network Rail led, requires involvement and collaboration with all parties that provide trains over this route (train operators, designers, maintainers, etc). Aside from all the above, Davey is a tutor for the Chartered Institution of Railway Operators (CIRO) education programme, tutoring diploma and degree students on modules dealing with Safety Law and Management and Whole System Thinking in Rail. He has been tutoring for almost 15 years. With more time away from work these days and his family now grown up, Davey often spends his spare hours out and about cycling the coast and countryside of North-East England. He is also a long-suffering season ticket holder at Newcastle United Football Club.
I was born in Edinburgh 1962 and have always lived in Scotland. I was educated at the local Grammar School and left in 1978 when I was 16 with seven “O” levels, average qualifications at the time. I started work on the railways as a mechanical apprentice at the Craigentinny Maintenance Depot in Edinburgh in 1978. This four year apprenticeship was intensive, broad based and included college studies in Mechanical and Production Engineering to HNC level. I have worked on all aspects of Rolling Stock maintenance on the depot as a fitter, was further trained to carry out electrical work. I progressed through the supervisory grades to Senior Shift Supervisor. Through this I developed an in depth knowledge of safety critical systems. I have also had specialist training in Non-Destructive testing, and have gained an in-depth knowledge of wheels bogies and running gear. I have had 14 years experience as a Rolling Stock Inspector carrying out in-service inspection, fault diagnosis and repairs on high speed diesel and electric trains. I have an extensive knowledge of the environment that Rolling Stock has to operate and how it performs in reality at speeds in service up to 125 mph. This included understanding what makes them reliable and what can be done to still operate when parts of systems are defective or have been badly damaged or isolated. Due to time limitations, rapid decision making was necessary and it was also necessary to work within what limited resources were available in isolated locations such as tools, and materials. I have undertaken further academic education in addition to normal work through the Open University and gained a BSc (Hons) degree and Diplomas in Systems Practice, Pollution Control and Professional Management. I am also an Incorporated Engineer IEng, a member of the IET and Associate Member of the IMechE. I was the project engineer for life extension work and reliability improvements to the East Coast Inter-City 125 High Speed Train fleet. This included ; Re-painting in, complete new vehicle interiors, laminated glass, MTU engines, new cooling systems, upgraded electronic control, reliability modifications, production of enhanced component overhaul specifications for rotating machines and bogies. I am currently responsible for Assurance and Engineering Standards including the production and control of Maintenance, Quality and Policy documentation relating to the London North Eastern 225 Electric fleet and Assurance of the new Hitachi Class 800 fleet. I am an IRCA registered Lead auditor for both ISO9001 and ISO14001. I represent London North Eastern Railway on various Rail Industry forums through both the Rail Safety and Standards Board (RSSB) and Rail Delivery Group (RDG). These include; fire, vehicle maintenance, pantographs, energy, wheelsets, axle bearings and standards. I am chair of the BSI RAE3/-/2 committee for Roller Bearings and Lubricants. I am passionate about the Assurance, safe design, reliability, cost effective maintenance, effective management of Engineering change, vehicle configuration and operation of trains.
