Our community of experts aims to improve the understanding of controlled substances and cross-border shipping legislation worldwide.
Why is this important?
This Community brings together experts to discuss and work on current controlled substance and shipping issues. In the past, the group has facilitated the creation of systems that are used today by governments and top pharma companies to look up the controlled status of a chemical structure across multiple countries and for alerts on new legislation.
Controlled Substance Compliance:
High levels of compliance are vital to the credibility of and public trust in life science R&D. Enhancing community members’ knowledge supports the goal of our industry – improving the health outcomes of all.
Controlled substance legislation has changed rapidly in recent years as legislators respond to the issues and concerns in society. For example, enhanced suspicious order monitoring requirements in response to the opioid epidemic, and ‘super generic’ definitions in response to the rapid increase in synthetic cannabinoid analogs in the mid-2010s. Remaining compliant in this environment is an ever-growing challenge, and consequences for breaches are severe.
Shipping:
Cross-Border Shipping legislation is also a very dynamic environment and ties in very closely with aspects of Controlled Substance logistics. Since the start of the pandemic there have been many additional challenges in moving Pharmaceutical R&D materials. Our members must ensure shipments are fully compliant with all national and international requirements. There is no leeway in making mistakes as delayed or rejected shipments could have a tremendous negative impact on pharmaceutical development timelines.
Meet some of the team
Jack DeCicco
EHS Manager Hazardous Substances and Shipping Lead
GlaxoSmithKline
Akos Papp
Product Manager of Compliance Checker and cHemTS
Chemaxon
Matthew Benkert
Director, Global Controlled Substance Operations
Pfizer
Ania Hajdukiewicz
Global Head, Trade Compliance at Novartis BioMedical Research(NBR)
About Jack:
Jack joined GSK in 2006. In his current position he is leading a global team of Shipping Compliance Managers. Jack holds a BA in Economics from Ohio University.
Why are you part of the CSCS expert community?
This community is wonderful way to keep current with relevant Research and Development controlled substance legislation around the world.
What is the biggest challenge for you in CS compliance?
Interpretation of vague regulations.
Akos joined Chemaxon in 2007, and was the Product Owner of several chemical software solutions. In his current position, he is the Product Manager of Compliance Checker and cHemTS. Prior to ChemAxon he has always worked in the chemoinformatics area, both in the software development and in the drug design field. He holds an MSc in Chemical Engineering from the Technical University of Budapest, Hungary.
Why are you part of the CSCS expert community?
The CSCS community provides an opportunity to meet experts working on this field and act together. We can discuss the challenges posed by the latest regulation updates, and as a community we can contact the regulatory bodies to get clarifications or we can even suggest modifications.
What is the biggest challenge for you in CS compliance?
The proper translation of the wording of regulations to the appropriate (sub)structural queries, which is the key in the accurate detection of controlled substances.
Matthew joined Pfizer’s Global Supply Chain Team in 2019 as a part of the newly formed Controlled Substance Center Function. He and his team are responsible for maintaining compliance with Controlled Substance Regulations across all company business units around the world. Matthew has over fifteen years of experience designing, implementing, and operating effective controlled substance compliance programs across all areas of the pharmaceutical supply chain from R&D through distribution to patient.
Why are you part of the CSCS Expert Community?
Regulations and requirements for controlled substances are always evolving and securing the pharmaceutical supply chain is everyone’s responsibility. There is no university class or industry certification in controlled substance. We all must learn as we go from each other. The CSCS Community provides all its members the opportunity to learn through sharing common challenges, best practices, and digital capabilities available in the market. There is no challenge out there in controlled substances that someone else in the community is not currently facing or has faced in the past that we cannot learn from.
What is the biggest challenge for you in CS compliance?
We can all read controlled substance regulations as they are written but understanding how these regulations are interpreted and enforced by each county authority is why having a solid international community, like the CSCS, comprised of experts with real word experience is so valuable.
Jessie Bin Song
Director, Controlled Substance Compliance
Merck
Joe Bradley
Chief Executive Officer
Scitegrity Limited
Karl Cable
Manager, Radiation and Controlled Substances UK
GlaxoSmithKline
Nicolas Fur
Novartis Institute for Biomedical Research
Jessie joined Merck in 1996. In her current position she is leading company’s controlled substance compliance program worldwide supporting all business divisions. Jessie holds a BA in Chemical Engineering.
Why are you part of the CSCS expert community?
This community provides an open and safe environment for the members to benchmark and share experience in various areas of focus related to controlled substance legislation and regulations around the world. The community works as a team to tackle the challenges and strive to stay current with the changing environment.
What is the biggest challenge for you in CS compliance?
Stay current with the changing requirements and define an effective and efficient approach to maintain compliance.
I co-founded Scitegrity, the developers of Controlled Substances Squared and ExpediChem in 2011. Prior to this, after completing my degree in Biochemistry from the University of Warwick, I worked for over a decade in drug discovery, screening and compound logistics at companies such as Pfizer and AstraZeneca, covering both lab and informatics based roles.
Why are you part of the CSCS expert community?
The CSCS expert community has provided and driven improvements and solutions to long standing challenges relating to controlled substance compliance. Prior to its existence, those tasked with the practical aspects of implementation had very little support, information and tools to help them. Now, through its efforts and those of its members, increasingly legislators are understanding how modern drug discovery works and are discussing how changes to the laws relating to chemical regulation and controlled substances can help with this.
What is the biggest challenge for you in CS compliance?
Where there is ambiguity in legislation, trying to get meaningful and timely engagement from regulators to understand exactly what they mean and how this applies to scientific research.
Karl joined GSK in 1988 (at Glaxo Group Research, Greenford, London). He worked as a radiochemist for many years and was involved in the preparation of drug candidates labeled with radioactive and stable isotopes. In his current position, he leads controlled drug compliance and all aspects of radiation protection (ionising and non-ionising) for GSK R&D in the UK. Prior to joining GSK he studied at the University of Leeds. He holds a Ph.D. in chemistry from the University of Leeds, UK.
Why are you part of the CSCS expert community?
CSCS has proved to be a valuable forum for gathering and sharing intelligence on controlled substances. It has enabled the research sector to develop shared solutions to emerging issues in CS compliance. This is particularly important when new legislation contains ambiguities that are open to interpretation.
What is the biggest challenge for you in CS compliance?
Keeping up with developments and obtaining advanced knowledge of new CS legislation worldwide. Gaining an understanding of how regulators operate and devise new approaches to CS compliance.
Nicolas joined the Novartis Institute for Biomedical Research (NIBR) in 2008 and worked for a decade in medicinal chemistry on multiple projects and technologies. I joined the NIBR controlled substances compliance team in 2019.
Why are you part of the CSCS expert community?
CSCS is a great opportunity to be exposed to various legislations and share best practices with peers. It has benefited the pharmaceutical industry by acting as a common voice and interlocutor with regulation agencies enabling major achievements.
What is the biggest challenge for you in CS compliance?
Keeping up with constantly changing regulations and engage with regulators to understand how they operate and what is the future.
Steering Committee
Project Members
Community Resources
Who Should Get Involved?
- Controlled substance compliance experts
- Shipping and Dangerous Goods experts
- Customs and import/export experts
How does a person from a member company sign up to join and participate in project development?
Please contact Project Manager Birthe Nielsen ( birthe.nielsen@pistoiaalliance.org )
How frequently does the project team or community meet?
We hold quarterly meetings with invited speakers.
Subgroups meet more frequently on an ‘as needed’ basis.