Product Development Expertise and Leadership Development Services for Health and Science Organizations
Sajjadi Consulting supports organizations working to foster a society in which all people can achieve their full potential for health and well-being across the lifespan. We focus on health and science organizations that provide quality products and services designed to improve quality of life for the patients they serve. These organizations also desire high quality outcomes for their internal systems and people.
For your product development
- Assay design, development, and validation
- Data review and documentation for IND filings
- Basic biostatistics training
For your team
- Healthy culture of quality
- Leadership development
- Executive coaching
Fostering healthy team dynamics and effective product development processes
Nancy Sajjadi has devoted her career to the success of organizations involved in biopharmaceutical product development. She leverages her education and experience to foster healthy team dynamics and effective product development processes. An expert with a transparent, energetic and effective approach that gets results, Nancy’s goal is to grow competencies and create cohesion across workplace teams. She applies big picture thinking to help clients focus on what matters most for strategic and technical success.
Chemistry, Manufacturing and Control Support
Sajjadi Consulting has the expertise to facilitate development of cutting-edge biologics. Nancy brings real-word experience to support cell and gene therapy programs and development of emerging modalities.
A Synergy Oriented, Systems Approach to Achieving a Culture of Quality
Nancy guides technical, scientific, and healthcare organizations toward a culture of quality by ensuring complementarity across functions is fueled by caring behaviors. Healthy organizations are well-positioned to achieve success at all levels. She takes a systematic and proven approach to help teams increase cohesion across the organization, to cope with challenging times, and to succeed.
Meet Nancy Sajjadi
Founder and Principal Consultant
Nancy Sajjadi obtained her M.Sc. and first applied the genetic engineering skills she learned to research programs involving biofuels and malaria vaccines. In 1989, she joined Viagene, Inc. a start-up venture in San Diego and one of the world’s first cell and gene therapy companies.
At Viagene, she built retroviral vectors and then learned from hands-on-experience, the types of data needed to bring a complex biologic from proof-of-concept through to a successful regulatory filing. She was promoted to Director, Quality Control and managed a 20+ person department responsible for lot release, assay development and product specific patient monitoring functions for multiple programs.
In 2000, Nancy launched a consulting business and has provided support to biopharmaceutical companies, academic institutions and other organizations involved in developing complex biologics. She continues to be influential in setting standards and evolving best practices in the application of US FDA regulations and guidance to cutting edge therapies.
With over 20 years of consulting experience in the era which brought cell and gene therapy its first product approvals, Nancy leverages her understanding of science, regulation and how a culture of quality is achieved in an organization to support the development and delivery of safe and effective products.
- Founder and Principal Consultant: Sajjadi Consulting has worked with over 40 organizations:
- Contract laboratories
- Academic institutions
- Federal and state government agencies
- Standard setting organizations
- Community hospitals
- Adjunct Professor, Biology, Northern Virginia Community College
- Professional Course Development and Instructor
- Introduction to Assay Design, Development and Validation/Biostatistics
- Creating a Culture of Quality
- Viagene/Chiron Technologies Center for Cell and Gene Therapy (1989-2000)
- Directed efforts in research, development and QC leading to successful IND and DMF filings including the first ever clinical trial involving direct injection of a genetically engineered virus into humans
- Author and co-author multiple peer reviewed journal articles totaling over 500 citations
- Cited in current FDA guidance on replication competent retrovirus testing
- Summarizing Phase I study in hemophilia patients with over 200 citations
- Leading to industry paradigm shift in evaluation of parallelism in bioassays
- USP Ad hoc advisory panel member involved in drafting 5 general chapters
- Mental Health First Aid USA (2019-2022)
- Certified Corporate Wellness Specialist (2017-2019)
- Zenger Miller Frontline Leadership Certified Trainer