Terry Katz is Senior Director of Biostatistics and Data Management Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA International, and a Statistician at Schering-Plough. He holds Accreditation as a Professional Statistician and Certifications as a Quality Engineer and a Six Sigma Green Belt. He is Chair of DIA's GCP-QA Community; formerly he was a Core Committee member for NJ CDISC User Group and Chair of the Statistical Taskforce for the Animal Health Institute. Terry also completed a 3-month Fellowship in Kenya to improve capacity and capability for the local hospitals to run oncology clinical trials.

Satish Dachepally is an Executive Director at Incyte Corporation focusing on Clinical Data Management areas. Satish has over 20 years of success in overseeing the collection, analysis, and reporting of clinical trial data.  He is adept at implementing industry standards and best practices, including CDISC SDTM and CDASH to ensure data integrity, compliance, and streamlined processes.  He is dedicated leader passionate about advancing clinical research through robust data management practices.  He made significant contributions to successful approval of multiple marketed drugs across diverse indications.  Satish earned a Master of Science degree from United Kingdom.

• Strategic and analytical senior IS executive and trusted advisor qualified by 20+ years of accomplishments in Insurance, Manufacturing, life sciences and healthcare industries with an expertise in clinical research, data warehousing, business intelligence, and big data applications.
• Offer a rich career encompassing senior IS/IT project/program management, IS/IT leadership, management consulting, IS strategies and roadmaps, business process optimization, vendor negotiations and management, business analytics, enterprise information architecture, and systems architecture, development, and integration.
• Successful in solving challenging business problems with innovative information systems to improve and revitalize business operations.
• Applications focused on data warehousing, Master Data Management, Business Intelligence, clinical data management, clinical operations, manufacturing, clinical safety data management, document management, QA/QC and more, used by 2,000+ global users.
• Led implementation of 10+ major enterprise data warehouse, enterprise architecture, solution architecture, and systems projects, including offshore models used to develop and introduce new pharmaceutical products. Managed $3M+ project and departmental budgets.
• Consistently improved business value by leveraging data as an asset, implementing cutting-edge systems needed for life sciences and healthcare, creating complex software products, and persuading business leaders, scientists, and physicians on the value of new software systems.
• Combine success in IS leadership, IS project/program management, and IS compliance with deep knowledge of healthcare data, drug safety, clinical, regulatory, quality, and new drug development processes.
• Constantly deliver systems 30-40% below the average industry cost. Motivate and empower staff who give much more than 100% of efforts to all projects.

Experienced Data Manager having worked in the following therapeutic areas:
* Oncology
* CNS
* Diabetes
* Infectious Diseases
* Respiratory

Also, experience in Phase I, II, III and IIIb studies in both the EDC environment (primarily in OC RDC and Medidata) and the paper CRF environment.

Provides process development and evaluation.
Develops training for data manager in areas from GCP and the CDM role to query writing and CRF development.
Provides mentoring and general consulting to the DM group.

Specialties: Vendor Management
Risk Analysis & Management
Problem Solving
Team Building and Communication
Training
Mentoring
GCDMP
SQL and SAS Programming
Tableau

Experienced Clinical Trial Manager with a demonstrated history of working in the pharmaceuticals industry. Skilled in Strategic Planning, Customer Relationship Management (CRM), Pharmaceutical Industry, Team Building, Change Management and Data Management processes. Strong operations professional with a Master's focused in Experimental Methodology/ Psychology from Towson University.

Lead project management, monitoring and data management initiatives for 500 projects, using expertise in leadership, analysis, evaluation, resource requirements, and technical tools to increase productivity, and to proactively create contingency plans that resolve significant issues. Extensive global leadership for 80 Biometric professions in the processing of large multi-central trials that achieved NDA/MAA submissions/approvals and post approval requirements, while managing Biometrics department P&L.

Dedicated security professional with a diverse history of working in healthcare, education, nonprofit and SaaS environments. Skilled in Microsoft 365 architecture, IAM/IGA and business process automation. Current MSc candidate in Computing Security at Rochester Institute of Technology.

How to simplify the data management process and activities. Highly motivated, astute, and results-driven self-starter with exceptional organizational, analytical, and clinical data management skills. B.S. and 15 + years of award-winning and progressive experience delivering the highest standards of clinical data management at Bayer and Bristol Myers Squibb (BMS). Bayer Gold Award 2017, Bronze Award 2016, and Pinnacle Award 2015; BMS Performance Award. In-depth knowledge of all aspects of clinical data management, Oncology expertise, reporting, reconciliation, study reviews, and standards development that drive pharmaceutical businesses forward. Diligent, detail-centric, and trustworthy. A strategic and critical-thinking collaborator and avid problem solver. Known for taking on the most challenging tasks and the ability to fast break into uncharted areas.
Currently leading data management Inspirna(formerly known as Rgenix) and supporting CMO and the rest of the team.

Data Delivery Head, for the Outsourced Projects in Early Development Clinical Operations at Sanofi. Strategic partnerships for the fully outsourced projects, functional services, and resourcing. Partnership management with engagement and collaborations across different functions to align data management deliverables. Define and set deliverables based on Key Performance and Quality Performance Indicators across multiple therapeutic areas.

Worked in the Pharmaceutical/Biotech/CRO industry since last 23 years with more than 20 years of experience in the Clinical Data Management area on both Sponsor & CRO Side. Successfully led multi-faceted data management project teams to globalize clinical data management processes, systems & organizations and currently working at Regeneron Pharmaceuticals as the Data Management Site Head (Basking Ridge, NJ)/ Associate Director, CDM. Handled and supported several Clinical Studies (Phase 1 to Phase 4) across various therapeutic areas like Immunology, Oncology, CV, CNS, & Rare diseases. Completely familiar with technology and its role in the Clinical Data Management space and performed/supported several technology related initiatives.

Accomplished formulating product strategy and roadmap, leading and delivering complex cross-functional projects driving operational excellence and organizational change focusing on business growth and improving efficiency with specialization in Pharmaceuticals, Retail, Sales and Clinical initiatives

Solution Oriented Business Analyst/Project Manager - Certified by NYU-SCPS, with extensive experience as an IT Business Analyst/IT Lead /Service Delivery and Business Partner

Managed and mentored global teams to drive multiple complex IT digital projects.

An experienced digital strategist in clinical R&D space with end-to-end knowledge on dataflow, business processes, systems and technologies. He currently plays a role of IT Business Partner in Otsuka for multiple business functions: Clinical Data Management, Pharmacovigilance, Statistical Programming, Biostatistics and Clinical Operations. He speaks the language of both business and IT and is responsible for large platform transformations, ideations, digital vision and roadmap. He manages strategic R&D partnerships with product vendors in the areas of clinical data review, SCE, clinical analytics and submission platforms. He also works with the leadership of Otsuka affiliate pharma companies: Taiho Oncology, Otsuka Japan etc. Previous to Otsuka, he has provided his consulting services as clinical R&D solution architect to big pharma companies: GSK Consumer Health, BMS, Amgen and Novartis.

Diligent, results-focused professional with 10+ years’ experience in clinical data management, providing essential leadership to guide the efficient validation, entry, and programming to ensure data integrity and completeness. To ensure ICH GCP regulations and SOPs are adhered for all the CDM activities. Adapt at allocating tasks, aligning efforts, and supervising performance to support achievement of company goals while driving adherence to operating procedures and corporate guidelines. Articulate and engaging with excellent interpersonal skills; readily establish collaborative partnerships with colleagues, vendors, and managers. Capable of efficiently managing offshore data management teams. Therapeutical experience in Oncology, CNS, Hemophilia, Gastroenterology, Anti-Infectives.