Can you share with us a little about your background in this industry?
I currently lead the Advanced Structural Characterization, Trace Analysis, Extractables/Leachables and Elemental Impurities team at Eli Lilly in Indianapolis. I have over 37 years' experience with application of advanced mass spectrometry in characterization of diverse chemical entities, 25 years of which are in the Pharmaceutical Industry. Prior working in Pharma, my experience was working with EPA, DoD and some private and government research laboratories. I also serve on the USP Packaging and Distribution Expert Committee, the USP Expert Panels on Biocompatibility and Elastomeric Closure for Injections, Board of Directors for the ELSIE (Extractables/Leachables Safety Information Exchange) Consortium, and am a PhRMA representative on the WG for the upcoming ICH Q3E effort. I’m also involved with assembling multidisciplinary alliances (industry/academia/government) to advance ultrarapid threat detection and development, manufacture and deployment of pharmaceutical countermeasures for unanticipated medical needs and point-of-use patient therapies.
Why have you decided to participate in the conference this year?
I have participated in some prior years with the Smithers E&L conferences as a speaker, and find the conference programs to offer an exceptional opportunity to share current knowledge regarding the state of E&L industry practice and regulatory expectations, innovative approaches to solving problems, and outstanding networking opportunities.
You will be a panelist during the “Future Direction E&L” panel, what do you hope delegates take away from the panel discussion?
One of my favorite authors is Michael Crichton, who once stated “I’m not interested in the future; I’m interested in the future of the future.” I think this exemplifies my own team’s philosophy with regard to not only E&L but applied technology and approaches to broader problem solving across pharmaceutical development and commercialization. Particularly, addressing challenges commensurate with rapid manufacture and delivery of point-of-use patient therapies including those developed with so-called “new modalities” such as siRNA, ADC and cell/gene therapies, this being highly reliant on single-use/disposable technologies and rapidly reconfigurable digital biomanufacturing suites. Achieving this in practicality requires attention to inclusion of AI, automation and new tools to facilitate rapid, comprehensive dataset interpretation.
What industry barriers/challenges exist, technical or otherwise, that prevent progress? How does this event help to address those challenges?
The current technical and regulatory landscape are positioned for more traditional drug development and commercialization, but are rapidly evolving to not only advance to embrace newer technologies but also a risk-appropriate framework for unique therapies. Benefiting from multidisciplinary collaboration is one attractive approach and is being explored to much greater extent.
Can you offer your thoughts in the proposed ICH guidelines and what impact they may have on this industry?
Global harmonization of E&L practice and regulatory expectations is an attractive prospect. However, in any effort of this magnitude and scope it is important, in my opinion, to be sure to recognize and include the benefits from extensive and pioneering work completed by other groups that have established the foundation of current E&L practice and understanding, such as USP, PQRI, etc.
What changes or innovations do you hope to see in the future direction of E&L as it pertains to regulations or other aspects of the industry?
Greater partnership and shared learning between suppliers of materials, components, analytical technologies and pharmaceutical/biotechnology drug manufacturers to cooperatively speed development and delivery of much-needed therapies to patients. This includes collaborative efforts with regulatory agencies to develop a risk-based framework that reflects the current state of the industry.
How are you working toward achieving them?
Establishing collaborative multi-disciplinary alliances not only with pharmaceutical/biotech companies and their suppliers but also with govt and academia partners enables the exploration and incorporation of the broader innovative landscape.
What are some of the most interesting and/or innovative solutions that are impacting your work at this time
Developing tools for the rapid interpretation of highly complex mixtures of structurally and compositionally diverse extractable chemical entities to establish comprehensive profiles and enable meaningful decision making regarding E&L impact on a drug product or process. Inclusion of AI, machine learning, and automation also, and shared learning regarding rapidly configurable digital biomanufacturing as well as exploding propagation of disposable systems in manufacturing and commercial process development.
What are you most looking forward to at the conference?
Inspiring presentations, discussion with foremost industry and regulatory experts, and understanding the current and future state of industry practice and regulatory landscape.
