Vision

To become the de facto standard for paperless or digitized validation life cycle management systems for operational processes across the life science sector.

Mission

To provide our clients with state-of-the-art, enterprise-wide software applications that manage and automate their validation processes to ensure compliance, improve efficiency, enhance data integrity, and significantly reduce validation cycle time to create significant savings in both time and cost.

Before founding ValGenesis, Dr. Siva Samy held several technical and management positions at various biotech, pharmaceutical, and medical device companies in the fields of validation and Information technology. He has been credited with over fifteen research articles and holds a patent on ‘Validating and Maintaining Respective Validation Status of Software Applications, Manufacturing Systems and Business Processes’  by USPTO, and received a master’s degree in Analytical Chemistry, a Ph.D. in Medical Devices, and a post-doctoral from the University of Madras and University of Toronto.

Narayan Raj is responsible for managing ValGenesis’s worldwide sales, partnerships, and lead generation. Raj drives our company sales strategies, including new customer acquisition and expansion with existing customers. He has extensive sales experience in software solutions for regulated life science companies. He has held several sales management positions, including Sr. Director of Industry Solutions at Pilgrim Quality Solutions and Director of Pre-Sales at Infor.

As Vice President of Professional Services of ValGenesis, Robert Van Der Laan is responsible for managing ValGenesis’s Implementation and Professional Services group. Robert has over 15 years of experience identifying and solving customer information system needs, with the last eight years in leadership positions in enterprise system software companies. He drives customer satisfaction with the successful implementation of on-premise and cloud-based systems that provide tangible benefits in terms of lower costs, improved usability, and enhanced business intelligence. Robert has held several management positions including VP of Professional Services at Pilgrim Quality Solutions and Client Business Executive at Click Software.

Pradeep has worked in diverse areas of product development, quality systems, computer system validation, process engineering, tool automation, and support functions in both the IT and manufacturing industries. He has a deep understanding of the life science domain and has supported pharma clients in optimizing and validating disparate systems through process design and computerization. His extensive knowledge of implementation in complex business processes, models with controls at the enterprise level, results in continual improvement, and effective risk governance. He has led and supported many global life science clients to optimize processes and build stronger solutions using LEAN & Six Sigma methods to reduce costs and improve compliance. Prior to ValGenesis, Pradeep was associated with Navitas Life Sciences Ltd. and Cognizant Technologies, providing solutions/support for top pharma organizations such as AstraZeneca, Abbott Laboratories, Pfizer, GSK, and Cipla in the areas of safety, quality, security, CSV, operations, customer support, and regulatory compliance.

Anil has international work experience spanning 30+ years in software services with business focus on outsourced product development and application development and maintenance areas, while working with enterprise, ISV and start-up customers in domains including Healthcare, Retail, Manufacturing, Banking and Education. Anil has worked in entrepreneurial mode and has built, ramped up and managed several businesses and practices that are sustainable and profitable from the ground up. He has experience in delivery and customer engagement management, building and managing ODCs, providing solutions using multiple technologies, generating new practices, designing project processes, setting up KRAs/KPAs for employees, process audits, personnel appraisals, and recruitment. His experience in Sales & Marketing spans generating new services, taking new services to the market, developing reliable web marketing channels, managing sales targets, managing customer accounts, and drafting proposals. Anil has a Master’s Degree from the Indian Institute of Technology, Kharagpur.

Kevin is a marketing leader with 20 years of experience in B2B software. Focusing on the intersection of demand generation, sales enablement, creative excellence and user experience, Kevin advocates for a “complete brand” approach to marketing. Prior to joining ValGenesis, Kevin was Chief Marketing Officer of DocuWare, based in Munich, Germany, where he lead the launch of a new corporate brand, built a demand generation engine, and supported new efforts in channel enablement, events, product marketing and more. Kevin was also Brand Director at Oracle, overseeing corporate messaging and managing acquisition integrations, and Director of Brand Strategy at Lexmark, where he led design, content and web development teams.

Kevin is a solution-oriented problem solver with experience in both private and public companies. His key strength is delivering business and financial counsel to operational managers that allows a company to proceed confidently towards objectives. Kevin has experience with both VC and PE-backed companies, with a broad range of merger, acquisition, and capital raise transaction experience. Before joining ValGenesis, Kevin was SVP of Finance and Accounting at SugarCRM, and Chief Financial Officer at Virtual Instruments, PanTerra Networks, and Cassatt Corporation.

Cesar is passionate about partnering with people and organizations to achieve results. He is both a strategic and hands-on leader with 15+ years’ global experience. As an adept communicator focused on change management, Cesar collaborates with leadership and people at all organizational levels by aligning business goals with departmental goals which yield positive outcomes. Cesar’s areas of expertise include: People & Culture (HR), Talent Acquisition, Building community for sustainable growth, Organizational Development, Wellness, Diversity & Inclusion, Change Management, Leadership Development, Engagement, Coaching, and Employee Relations. Prior to joining ValGenesis, Cesar was Vice President of Human Resources at SS White Dental and Vice President of Human Resources, NTENT. Cesar has a Master’s in HR Management & Organizational Psychology from Columbia University.

Before founding ValGenesis, Dr. Siva Samy held several technical and management positions at various biotech, pharmaceutical, and medical device companies in the fields of validation and Information technology. He has been credited with over fifteen research articles and holds a patent on ‘Validating and Maintaining Respective Validation Status of Software Applications, Manufacturing Systems and Business Processes’  by USPTO, and received a master’s degree in Analytical Chemistry, a Ph.D. in Medical Devices, and a post-doctoral from the University of Madras and University of Toronto.

Melissa is a Managing Director of Morgan Stanley Expansion Capital. Previously, she served as Co-Head and Managing Member of Morgan Stanley Venture Partners. She has been an active growth equity investor and board member in numerous software, healthcare service, healthcare IT and medical device companies. Her investment experience includes Arcadian Management Services, Autism Behavior Strategies (ABS), Clinipace Worldwide, Discoverx, EKOS, IDeaS, Medsphere, Nanostring, National Healing, PeopleClick, RocketLawyer, Sanuwave, SouthernCare, Spinal Kinetics, and Vbrick Systems. Prior to joining Morgan Stanley, Ms. Daniels held operational and management roles in private companies, and also served as staff on a subcommittee of the US House of Representatives. She earned a BA in Economics from the University of North Carolina at Chapel Hill and earned her MBA from the University of California at Berkeley.

Dr. Ajaz Hussain is a distinguished contributor and acknowledged leader in the advancement of pharmaceuticals, regulatory science, and drug development. During Dr. Hussain’s tenure at the FDA, as Deputy Director, Office of Pharmaceutical Science, he led the FDA efforts on Process Analytical Technology (PAT) Initiative and CGMPs for the 21st Century. He was the FDA’s lead for Quality ICH negotiations and the establishment of ICH initiative on Pharmaceutical Quality for the 21st Century (ICH Q8, Q9, and Q10). He has served as the President of the National Institute for Pharmaceutical Technology & Education (a not-for-profit collaboration among leading American universities), as the principal of his consulting company Insight, Advice & Solutions. He has also held several senior management positions including CSO & President of Biotechnology at Wockhardt, Chief Scientific Officer at Philip Morris International, VP & Global Head of Biopharmaceutical Development at Sandoz, and Associate Professor of Pharmaceutics at the University of Cincinnati’s College of Pharmacy.

Dr. Johnson has a distinguished pharmaceutical leadership career of over 30 years in new product and process development, technical services, innovation and technology, and advanced manufacturing solutions with Pfizer Inc. As Vice President, Technology and Business Solutions at Pfizer, he led the development and implementation of digital transformation, advanced process control, process analytical technologies, continuous processing, knowledge management, technology transfer, and systems design for rapid development paradigms for accelerated new products. After retiring from Pfizer, he continues to learn and contribute as a consultant. Dr. Johnson served as Chair of the Steering Committee for an Engineering Research Center focused on continuous manufacturing and was a Board Member of the Smart Manufacturing Leadership Coalition. Dr. Johnson earned his Ph.D. degree from Purdue University with research in controlled release, and holds a BS degree in Pharmacy from the University of North Carolina, Chapel Hill.

Dr. Vidal serves as SVP, Quality Assurance and Process Sciences at Atara Biotherapeutics. He is responsible for leading and advancing the Chemistry, Manufacturing and Control (CMC) components of allogeneic T-cell therapy, including Quality and Quality Control Operations; functionality and compliance; scientific product, process, and analytical development; successful global regulatory approval; and preparation for commercial launch. Dr. Vidal also manages the product and process development pipeline from preclinical stage through commercialization, as well as the industrialization of the cell therapy manufacturing process. Prior to Atara, he served as Vice President of Global Drug Product Process Development, and Vice President of Drug Substance Operations at Amgen. Dr. Vidal has held several senior roles at Wyeth and Pfizer. With over 20 years of experience, he has been involved in the development of more than 100 products, as well as technology transfers, regulatory filing, and product launches in jurisdictions around the globe. He received his bachelor’s degree in molecular biology, master’s degree in molecular endocrinology and biochemistry, and doctorate in cellular molecular biology, all from the University of Puerto Rico, Rio Piedras.

Dr. Chapman is a founder, investor and active independent board member of public and private companies. She works with entrepreneurs to create and scale meaningful new ventures. She is an Executive Leader for startups to Fortune 50 companies and has significant experience in building successful teams, developing and executing business plans, equity investing, licensing, and business development. Dr. Chapman has been an advisor in several initiatives, including solving global challenges to drive sustainable impact in health, and improve health outcomes through clinically and economically beneficial digital health solutions and new approaches to predictive analytics. Dr. Chapman previously held senior roles at J&J, GE, Mohr Davidow Ventures, and several startups. In these roles she partnered with entrepreneurs to launch, invest and build companies such as Evidation Health, Adamas (IPO: ADMS), RainDance (acquired: BioRad), Pacific Biosciences (IPO: PACB), ParAllele (acquired: AFFX), Sequenta (acquired: ADPT), and Verinata (acquired: ILMN). She holds BA and Ph.D. degrees from the University of Cambridge, UK.

Rob Miotke has over 30 years of experience in the Biopharma industry holding positions as Commercial Director, Angus Fine Chemicals; VP, General Manager, Hickson International; VP, President, Aerojet Fine Chemicals LLC and President, NextPharma, NA. Rob was involved in the design, construction and start-up of manufacturing facilities in Ireland and the U.S. After his stint at NextPharma, Rob founded Advantage Pharma Solutions LLC (APS), a consultancy business to assist pharmaceutical and biotechnology companies, CROs/CMOs, private equity/venture capital firms and nutraceutical companies in Strategic Planning, Technology Development/Positioning, Global Supply Chain Outsourcing Strategies, Introduction of New Technologies, M&A and Business Development/Intelligence projects. APS is globally recognized today, leveraging Rob’s extensive professional network that supports clients in the U.S., Europe and Asia. Rob has a technical degree (BS Chemistry) from the University of Wisconsin-LaCrosse