Daniel F. Orfe is a Leadership professional with 20+ years’ experience in Regulatory eSubmission production and 30+ years experience in support of the Life Science industry. Presently managing Regulatory eSubmissions LLC, providing subject matter expertise focused on “cloud-based” eCTD and EDMS solutions. Dan is recognized within the industry as an executive level change agent and business process analyst for efficient submission assembly, dossier management and eCTD/eCTD life-cycle production. He has been a key member of several industry/agency initiatives to foster electronic submission standardization and efficiency. Valued for his experience on the topic of eSubmissions, Dan has presented or chaired sessions at 11 of the past 14 DIA Annual Meetings and was conference co-chair for the DIA Electronic Document Management (EDM) Conference in 2009, 2010 and 2011. Dan presently serves as a program committee member for the DIA Regulatory Submissions, Information, and Document Management Conference (RSIDM).
Dan was responsible for the establishment and management of eSubmission production groups at Merck & Co., Inc. and Datafarm Inc. Areas of expertise include regulatory submissions strategy and business / technology process improvements; uniquely adept at identifying innovations which facilitate the automation of activities for efficiency and error reduction. Dan established and managed the Electronic Submissions group at Merck. This group of 10 people located in the US, Canada, EU, and Japan produce over 300 eCTD/eSubmission deliverables per month. Merck’s achievements within this field established the team as an industry direction setter and submission delivery record setter. Dan oversaw Datafarm’s Regulatory Services Group; directing the company’s electronic submission publishing and management activities; and providing strategic support for the further expansion of Datafarm’s Submission Services. At Teva, Dan oversaw the harmonization of worldwide electronic submission publishing and document management. At Radius Inc., Dan was responsible for eCTD and EDMS activities, processes and tools.
Kathleen Warner, Ph.D., VP of Consulting Services for RCM Technologies, Life Sciences, is an executive consultant with 25+ years of experience in information technology (IT) and the life sciences.
John Giantsidis is the President of CyberActa and brings a deep understanding of the rapid development and constantly changing landscape of our industry.
Kevin takes a practical approach which allows scientists to assess risk with limited data sets. He is effective in facilitating team discussions to document current state product and process understanding.
Dalfoni Banerjee is an award-winning, solution-focused entrepreneur. Beginning her career over 25 years ago in academic, pharmaceutical, and biotechnology research laboratories, she went on to lead inspection-readiness efforts, drive clinical research and clinical operations, manage relationships between pharma and key opinion leaders, develop marketing strategies/tactics, and launch new drug products – across 12+ therapeutic categories
Brooke L. Casselberry
Brooke Casselberry is the founder of Cyan Life Sciences, providing consulting services across the regulatory product lifecycle. Brooke’s experienced in developing regulatory domains, expanding business, and supporting clients in knowledge exchange, technology procurement and support, project management, and methodology development.
Natalee received her Nursing Degree from Union University and has practiced in the areas of Intensive Care and Surgery. She has a background in Sales and Sales Management in Home Infusion, Capital Equipment, Surgical devices and Biologicals.
Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years.
Lisa Olson has over 30 years of experience in FDA-regulated industry, with a major pharmaceutical company, three CROs, and in consulting roles. With a background in system development and support of clinical research systems, she developed her career into regulatory compliance of computer systems and a specialization in 21 CFR Part 11.
Luisa Monica’s experience includes oversight of electronic TMF (eTMF) implementation, quality control, coordination of migration projects, facilitated training programs, enhancement and development of TMF processes, and extensive inspection readiness preparation for FDA and MHRA inspections.
Jackie Morrill’s experience includes oversight of electronic TMF (eTMF) implementation, coordination of a large migration and integration projects, development of robust metrics and training programs, enhancement and development of TMF processes, and extensive inspection readiness preparation for FDA, MHRA, and PDMA inspections.
With 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification.
Terry is an implementation consultant for rfxcel whose mission is to provide a reliable track and trace solution for Manufactures, Re-packagers, Wholesale Distributors, and Dispensers.
Penelope Przekop, MSQA, RQAP-GCP
Penelope Przekop, RQAP-GCP, is a Quality Management Systems, Assurance & Compliance Consultant with 25 plus years of experience in Pharmaceutical GxP Global Quality Systems with key focus in clinical development, data management and pharmacovigilance.
Jack Tarkoff is Chief Strategy Officer and co-founder of rfxcel with the vision of building a product that would meet the track and trace needs of pharmaceutical industry.
Dr. Ben Locwin has been an executive for Top 10 pharma companies, as well as advising startups and biotech organizations to boost their market launches and profitability. He has consult for the major regulatory bodies across the world on topics such as inspection practices, drug safety, and data analysis.
Peter T. Vishton, P.E.
Peter is an Independent Pharmaceutical Water Systems Consultant working with several companies. He has 25 years of experience in the Pharmaceutical area which includes 10 years with Pharmaceutical Water Systems.
Michael Esposito has over 30 years’ experience in the pharmaceutical industry and 14 years’ experience in GMP training and document management.
Dr. Good has spent his years in industry in Manufacturing, Project Management, and for the last 12 years, Quality. Throughout his career, he has helped remediate Consent Decrees, Warning Letters and many FDA Observations. He has worked with Fortune 500 Pharmaceutical and Biotechnology companies and solved complex, multi-operational compliance issues. Dr. Good has spoken professionally at ISPE and PDA regional and national meetings on the subject of Compliance risk and solutions.
Erich Bozenhardt has 11 years of experience in the biotechnology and aseptic processing business and has led several biological manufacturing projects, including cell therapies, mammalian cell culture, and novel delivery systems.
David Kane, with over 20 years in the field of technology, is the CEO of Ethical Intruder, a Pittsburgh based Cyber Security firm and focuses on Cyber Security related to software products.
Expertise includes trial management, protocol writing, clinical development plans, vendor management, vendor assessment and issue resolution, gap analysis, program management, regulatory submissions and SOP writing.
Experience in global operations, technical management, strategic planning, implementation of environmental health and safety programs, regulatory compliance and engineering support in a Fortune 200 setting.
Managing Partner at Widler & Schiemann Ltd, focusing on all aspects of clinical development from Protocol Quality by Design to Study set-up, Project Management and Risk-based oversight of Clinical Trials.
Specializes in the risk-based monitoring of pediatric and adult pharmaceutical, biologic and medical device clinical trials, in compliance and data management auditing and in training and education.
Expertise includes country and site selection principles, acceleration of site initiation, technology implementation and supplemental recruitment support.
Experience spans large and small molecule development and has played pivotal roles in designing novel ways to screen compounds for safety, resulting in several marketed products.
30+ years of GMP, GLP, and GCP quality assurance and compliance experience with Active Pharmaceutical Ingredients (APIs), clinical research materials, and finished product.
Specialties include emerging company clinical research management and training, curriculum development, change management, CGP, and project management oversight.
Mark Allen Durivage
Lead on-site quality inspections at facilities throughout the North America, Europe, and Asia for a $4.5B manufacturer of orthopedic products and instruments.
Christina Meyer Dell Cioppia
Has assisted biopharma, vaccine, pharma, and aseptic processing firms worldwide in commissioning, qualification, validation, design reviews, cGMP audits, and worldwide regulatory compliance.
Focused on regulatory strategy for novel products and applications, products intended to meet unmet healthcare needs, and projects involving vulnerable populations.
Specializes in providing regulatory and organizational strategy support, process improvement, inspection readiness support, and integration and harmonization of SOPs for medical device and pharma companies.
Diverse therapeutic experience background includes cardiology, neuromodulation, asthma/allergy, Duchenne muscular dystrophy, hereditary hemophilia and diabetes.
Experience with large scale initiatives such as assessments and implementation of organizational data integrity and compliance frameworks and responses to FDA warning letters and consent decrees.
Extensive knowledge and experience in the application of FDA law, regulations, and policy, particularly as it relates to compliance and enforcement programs and strategy.
Helped over 300 companies and organizations from Fortune 100 to entrepreneurial companies develop leadership, corporate turnarounds, team building and managing change.
Experienced in manufacturing technologies producing aseptic and terminally-sterilized parenteral API and finished drug products, solid and liquid oral products, inhalation drugs, and radiopharmaceuticals.
Herman Bozenhardt has 41 years of experience in pharmaceutical, biotechnology, and medical device manufacturing, engineering, and compliance.
Michael Pierro, a highly experienced facilitator and subject matter expert, provides clinical operations and GCP/SOP training to the biotechnology, CRO and pharmaceutical industry.
Focuses on operations management for small manufacturing companies, including quality assurance, quality management, production planning, inventory management, and health/safety.
Expertise in clinical development, medical affairs, business operations, project management, process optimization, metrics, and data-driven strategic planning.
Danielle is a subject matter expert specializing in quality assurance and quality systems. She assists companies facing warning letters and consent decrees as well as those wishing to improve GxP practices and establish more robust quality systems.