Daniel F. Orfe & Betsy A. Fallen

Daniel F. Orfe & Betsy A. Fallen

Daniel F. Orfe

President & CEO, Regulatory eSubmissions LLC

Dan Orfe is an industry leader with 20+ years experience in Regulatory electronic submission production. He is a subject matter expert for electronic Common Technical Document (eCTD) solutions and associated tools that impact the upstream and downstream activities associated with eCTD sequence publishing and management. He is a business process analyst for efficient eCTD submission publishing, dossier management and outsourcing oversight.

Dan has held eCTD responsibilities for a large Pharma (Merck), an eCTD software/service provider (Datafarm), an emerging Pharma (Radius) and a major generic Pharma (Teva). He has managed global eCTD production groups and has been accountable for the delivery of dozens of original New Drug Applications (NDAs)/Biologic Licensing Applications (BLAs)/Investigational New Drug submissions (INDs) to the FDA as well as corresponding filings to Health Canada, EMA and other regulatory agencies. In addition to the original eCTDs, Dan has been responsible for the delivery of thousands of eCTD sequences. Dan has also been responsible for vendor and outsourcing evaluation, selection and oversight.

Dan has been a key member of several industry/agency initiatives to establish electronic submission standardization and efficiencies. He has presented and chaired sessions at DIA Annual Meetings and DIA Electronic Document Management (EDM)/Regulatory Submission, Information & Document Management (RSIDM) Conferences. He has served as Conference co-chair and Program committee member for DIA EDM/RSIDM Conferences. He was a technical representative to the Pharmaceutical Research and Manufacturer Association (PhRMA) Electronic Regulatory Submissions (ERS) task force for 10 years.

Betsy A. Fallen

Principal Consultant, BAFallen Consulting LLC

Betsy Fallen is an authority on the business processes and associated use of information technology in drug development. A passionate advocate for moving life sciences business on-line, Betsy is an expert on IT in regulatory and clinical operations, data management, and ancillary supply chain, among other areas.

Betsy left Merck after two decades of outstanding contributions. She has participated in many industry initiatives including DIA Communities (including TMF Reference Model) and eRegulatory & Intelligence and Annual Meeting Planning Teams; IRISS Global Submissions Operations Group and FDA-PhUSE Site Selection Working Group.
Currently, Betsy is an Independent Consultant providing expertise to industry. She is an active member of DIA and frequently participates in conferences and meetings as Program Chair, speaker, or session chair. She has also presented globally on diverse topics in clinical and regulatory areas for many conferences.