Translational Expertise for Cell and Gene Therapies
Let LIS BioConsulting accelerate your pathway to the clinic.
Dr Silverman specializes in helping early stage cell and gene therapy companies, and related technology/services providers, achieve their goals by helping to:
Transition exciting new scientific discoveries in the space of cell and gene therapy into tangible products by creating foundational product and process definition documents to drive internal and external alignment, using Quality by Design principals
Establish a strong relationship with FDA and create an aggressive yet achievable regulatory strategy to move into the clinic as efficiently as possible
Identify operational milestones to justify early-stage fundraising and then support successful execution
Gain access to an experienced, trusted leader in the field who can collaborate with a lean, internal team and delay the need for costly FTEs.
Ways that we can work together:
1) Planning Roadmaps and Development Pathway Reports
Define key work streams and timeline to enter the clinic
Identify regulatory touch-points and required data
Integrate with business and fund-raising activities, including staffing
2) Remediation Services
Address deficiencies in regulatory submissions
Overcome manufacturing challenges
Identify path forward with challenging preclinical or clinical studies
3) Serve as Part-Time Employee
Manage external CRO/CDMOs, and guide internal research
Draft Target Product Profile, Manufacturing Process Overview (per Quality By Design) and Clinical Trial Synopsis
Write and execute regulatory filings including INTERACT, pre-IND and IND
Meet LISBC’s Principal Consultant
About Lara Ionescu Silverman, PhD
Lara Ionescu Silverman, PhD, has deep expertise leading translational development activities for cell and gene therapies. She combines nuanced understanding of the scientific, clinical and commercial landscapes to drive a company’s strategic decisions. Her scientific development experience includes process design, analytical methods, raw materials, lab operations, intellectual property, regulatory interactions, and outward-facing communications. She has overseen multi-functional, multi-layered teams and has developed plans and strategies with both short and longterm implications for businesses. Her work has resulted in numerous peer-reviewed manuscripts and presentations at academic and industry conferences, as well as issued patents. She earned a BSE in Chemical Engineering from Princeton and a PhD in Bioengineering from University of Pennsylvania.
Dr. Silverman has been invited to speak at many Universities and conferences. Here is a selection:
Dr. Silverman’s research and insights have been featured in many journals, such as:
