Archives: Speakers

Carsten worked as a technical analyst for an aquaculture investment fund where he oversaw equity investments in various aquaculture feed, health, IT and production start-ups before founding Alimentos Ventures in 2016 and co-founding HATCH in 2017. Carsten holds a PhD in aquaculture nutrition from the Institute of Aquaculture, University of Stirling, has been a lecturer at Yale University and has a number of published works focusing on alternative feed.

Ben is the CEO and Secretary General of PEFC International, the world’s largest forest certification system, covering over 300 million hectares of certified forests in 46 member countries.

Ben has spent most of his working life in forestry, starting as a forestry worker. After completing his studies at Aberdeen University, Ben joined the University of Wales, Bangor as a researcher in Forest Economics. This was followed by various positions in the Timber Growers Association in the UK where he dealt with technical and policy aspects of forestry. Ben then became involved in forest certification when he took on the position of Technical Director.

In 1999, he became Secretary General of PEFC International. As a chartered forester, Ben has been further developing his skills with a Master’s in Business Administration from the Open University, and more recently a Diploma in Company Direction from the Institute of Directors.

With a career spanning more than two decades, Mrs. Jackson brings a wealth and breadth of knowledge and experience which is highly valued; providing key Regulatory Operations and TMF Management consulting guidance to Regulatory and Clinical Operations departments.  Working with large and small pharmaceutical and biotechnology companies has allowed Tamika to develop proven methodologies in any organization required to prepare, submit, manage, track and produce “real-time” inspection ready TMFs and regulatory submissions to ensure agency approval.  Tamika, along with her SWAT team of professionals, now work to efficiently and effectively evaluate companies’ resources, processes, documentation, systems, and TMF Management activities to methodically streamline the operation from end-to-end.

As Founder and Chief Executive Officer of Axiom Real-Time Metrics, Andrew Schachter delivers the visionary leadership integral to the company’s 20 years of eClinical technology and Managed services success.

Under his leadership, Axiom has grown into a well-established and recognized innovator and leader in the small-to-medium life science Clinical solutions landscape. His expertise and profound understanding of complex clinical studies have transformed the Axiom global team into a devoted and virtuous leader in the industry.

Over the past 20 years, Schachter’s passion for innovating technology solutions continues to drive Axiom to empower smarter and faster clinical studies and yield better study results for helping patients worldwide.

Today, Axiom’s state-of-the-art unified eClinical Suite Fusion has over 15 powerful and highly configurable modules. In addition, Axiom also offers global clients intelligent Data Management, Data Analytics, Pharmacovigilance & BioStats services.

Ensures that processes related to clinical documentation and training, meet
quality/regulatory standards. Develops proactive strategies to implement GCPcompliant processes. Monitors and assesses clinical trial disclosure requirements,
to ensure that the department is covered by adequate procedures and systems for
training and that training is delivered in accordance with Department needs,
Company’s policies and SOPs; support during Inspection/Audit; to support the
Study Team to ensure a complete and accurate TMF through documentation
quality and consistency; to develop TMF culture through all the clinical process and
ensure the implementation of the eTMF.

his position participates in tactical & strategic planning to develop a state-of-the-art labeling design organization. Lead initiatives related to development and implementation of design systems in preparation for upcoming product launches and ongoing commercial operations. Work with functional groups including Regulatory Affairs, Quality Assurance, Commercial, Legal, Packaging Engineering, and Manufacturing to further refine the process for design & development of clinical and commercial labeling. Work with Commercial and Regulatory to develop and finalize graphic elements and product branding elements of labeling for EU, US and ROW. Develop estimates for labeling component printing quantity and cost requirements to support needed clinical and commercial activities. Review and approve packaging artwork for accuracy, regulatory requirements and production requirements. Lead drafting, review, update (as needed) and approval of function SOPs. Identify, develop and lead opportunities for continuous improvement for deliverables and processes. Lead sub-groups and teams as required to assist in product launches. Evaluate capabilities and capacities of current or proposed suppliers. Work with bluebird bio’s Supplier Relationship Management & Quality teams to qualify and on-board labeling/packaging suppliers. Participate in technical supplier audits. Be single point of contact for suppliers and coordinate with cross functional team to review and resolve supplier service performance expectations to ensure bluebird bio requirements are being met. Work with Finance team to create/maintain label design budget, PO creation and invoice payments. Lead design activities for creating labeling/packaging artwork, preparing associated specifications, managing related electronic labeling systems and quality systems and coordinating printing for both clinical and commercial labeling.

Responsible for developing EU MDR localization strategies across Medtronic businesses and functions. Engaged in development of industry guidance related to interpretation of EU MDR requirements. Focused on implementing efficient localization strategies that result in high quality, consistent localized content that meets the requirements of notified bodies and provides clear information to all end users including healthcare providers and patients.