Archives: Speakers

Emma is the Head of EMEA at Ignition. She has over 15 years’ experience in Commercial, Accounting, Finance and Business Strategy environments across NZ, AU, US and UK. She started her career with a global accounting firm before taking time out to deploy with the British Military. Emma has spent the last decade on senior leadership teams of successful technology businesses including Xero, Tradify and Ignition. She founded Bastion Consulting Services in 2018, delivering consultative services to a range of international clients. She is passionate about seeing firms succeed with a focus on operational excellence, technology, team culture and delivery of strategic priorities.

Mark Wheeldon is the founder and CEO of Formedix. He is an active supporter of the Clinical Data Interchange Standards Consortium (CDISC) which Formedix has been a member of since its inception two decades ago. Mark is a member of the CDISC Industry Advisory Council (CAC), and firmly believes that a more efficient end-to-end clinical trial process lies in the successful implementation of data standards and clinical trial automation technologies

Bonnie is the Business Development Manager at Enthalpy Analytical, LLC. Her background is in regulatory toxicology and has extensive experience managing in vitro toxicology studies for ENDS products, supporting nonclinical sections of FDA PMTA ENDS submissions and conducting toxicological evaluations of ingredients in tobacco, nicotine and cannabis products. Bonnie received her BS in biology from Texas State University, and PhD in pharmacology from Vanderbilt University. She completed a postdoctoral training in tobacco regulatory science at Altria Client Services, and was hired on as a research scientist in 2014 and later as Principal Scientist until 2019. Prior to joining Enthalpy, she was the principal toxicologist and founder of ToxPharm LLC, a regulatory toxicology consulting company created in 2019.

Enthalpy is the largest independent tobacco, smoke and e-vapor testing lab in the U.S. offering regulatory and research services to commercial, governmental, academic and regulatory agencies since 2000. We are an International Organization for Standardization (ISO)-17025 accredited lab offering comprehensive and exhaustive analysis of cigarette smoke, filler, smokeless tobacco, e-liquid, e-vapor, in vitro toxicology and product stability testing.  Enthalpy operates three smoke labs capable of e-vapor sample collection between its Richmond and Durham laboratories, allowing for redundancy and flexibility in our testing processes.  Enthalpy offers analysis and testing of e-vapor and e-liquids for the presence of nicotine, propylene glycol, glycerin, carbonyls (i.e., diacetyl, formaldehyde, etc.), particle sizing, and the FDA list of HPHCs. Enthalpy has analytical methods in place to meet requirements of the 2019 FDA Final Guidance for Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS) Regulations and European Union Tobacco Product Directive (EU-TPD).

Stan is the Practice Lead for Materials Science with Consilium Sciences, LLC. His specialty includes investigating complex material science and addressing regulatory science through a varied background in nanotechnology, chemistry, engineering, and biotechnology.  Stan received his BS in biotechnology from James Madison University, MS in chemistry from Virginia Commonwealth University, and PhD in nanoscience and nanotechnology from Virginia Commonwealth University. He completed a postdoctoral training in chemical and life science engineering at Virginia Commonwealth University. Stan is an author on 12 peer-reviewed publications in leading chemistry and material science journals.

Currently, he leads the tobacco regulatory team at Consilium which supports numerous clients as they prepare for Premarket Tobacco Product Application (PMTA), Substantial Equivalence (SE), and Tobacco Product Masterfile (TPMF) submittals. He often leads projects by guiding clients through every step of the complex tobacco regulatory process including designing regulatory-facing studies or submitting regulatory applications. In addition to his project leadership and management expertise, he often specifically focuses on the chemistry aspects of regulatory submissions including nonclinical study design and data analytics. He is well versed in all areas of tobacco regulatory including chemistry, manufacturing, and control (CMC), nonclinical studies, and clinical studies as well as compiling all information and studies of a PMTA into the electronic tobacco technical document (eTTD) format.

Consilium employs a core group of full-time, senior-level Principal Scientists, combined with the broader Consilium Scientific Network of more than 300 consultants from across the globe.  This unique distributed-consulting approach allows us to build cost-efficient, project-specific teams that solve our clients’ needs quickly and effectively.  Typically, a Consilium project team will have one or more of our full-time consultants leading the project. Our teams are custom-built and project-specific, ranging in size from one individual up to a 40-person team. At Consilium, we present goals, explain requirements, embark on study design, conduct research, develop strategy, and prepare complete regulatory submissions. Consilium also supports clients beyond submission with follow-up correspondence, responses to deficiency letters, post-market surveillance, and design and execution of annual reporting requirements.

Liz is the Regulatory Compliance Manager for Pyxus International, LLC and joined the company in 2019. Ms. Sprowl oversees the regulatory filings for its e-liquid division and supports day-to-day company compliance and regulatory efforts for its multiple e-liquid brand companies and its joint venture Purilum LLC, a manufacturer of flavors and e-liquid products for a number of industry brands. Prior to joining the company, she was the Regulatory Compliance Attorney for Turning Point Brands, previously served as a defense litigator for a number of national and regional law firms, and was the quality control manager for a division of a national food company.

Ms. Sprowl currently serves on the Coalition of Manufacturers of Smoking Alternatives Board of Directors. She holds a J.D. from the Salmon P. Chase Northern Kentucky School of Law, an M.B.A. from Bellarmine University, and a B.A. in Biology from Washington University in St. Louis.