Changes are Coming to Prefilled Injectable Drug Delivery Systems

Jon Ellenthal, President, ApiJect

Jon Ellenthal has devoted over 30 years to starting, building and leading early-stage companies that seek to change how an established industry does business. Mr. Ellenthal has applied his leadership to high-tech and innovative companies, including technology, health, medical and pharmaceutical industries.

Currently, Jon is President of ApiJect Systems, a public benefit corporation dedicated to making injectable medicines safe and available for everyone, using Blow-Fill-Seal prefilled syringes and specialized needle hubs. At ApiJect, he establishes short- and long-term goals, assesses the direction of ApiJect and ensures compliance with the company mission. While managing the overall workforce, Mr. Ellenthal leads through the belief that a company is a community by valuing the importance of attracting and retaining highly technical, well-trained people who think outside the box and work as a team.

Molly Weaver, PhD, Chief Technology Officer, ApiJect

As Chief Technology Officer, Dr. Molly Weaver is responsible for ApiJect’s development of Blow-Fill-Seal injection devices and production of its initial device, a single-dose prefilled drug delivery system. She leads a dynamic team that aims for innovation in new design and continuous improvement on existing ones.

Dr. Weaver is a seasoned industry leader whose leadership and expertise spans strategy, product development and execution across a broad range of drug delivery systems. This relevant experience has been applied in developing injectable technologies comprising self-injection devices and other injectable platforms, as well as to manage and launch products and commercialization of devices globally, including European and Asian markets.

Tim Kram, Managing Director, Rommelag

Tim Kram is an Engineer and pharmaceutical business development professional and is presently the Managing Director for Rommelag Engineering’s US office. For more than 20 years he worked with companies to develop aseptic product fill/finish solutions using Blow/Fill/Seal technology. This work includes container development, clinical trials, regulatory filings, combination device development, primary drug packaging, machine sizing, validation/qualification, and commercial/contract manufacturing. For ten years he has worked to introduce temperature sensitive biotech and vaccine products to BFS technology and has received two foundation grants for the testing of injectable vaccines with BFS technology and CPAD device development. Mr. Kram regularly consults and gives presentations to BFS operators, industry groups and regulatory organizations: PDA, ISPE, DCVMN, FDA, Gates Foundation and PATH. He received a B.S. in Electrical Engineering from the Missouri University of Science and Technology.