L2 Consulting works with an international client base of life science industries in finance, business planning, M+A, program design, executional oversight and interim management. Scientifically, L2 has contributed to many hundreds of new drug clinical trial applications (preclinical), has raised over U$200m in new funding and has been pivotal in closing 6 mid-sized M&A’s in the industry (including execution of full due diligence) with deal values of up to US$50m. L2’s team encompasses senior level expertise in clinical, preclinical, bioanalytical, immunological, regulatory affairs, finance and business/corporate development.
As an Associate Partner in L2 Consulting, Ruben Sanchez has held various senior management roles most recently Vice President of Regulatory Affairs providing strategic regulatory leadership to companies in North America with global regulatory activities. With over 20 years of regulatory experience, he has managed all facets of drug development from IND through marketing application. He has been part of cross functional teams providing guidance for all drug development disciplines, including CMC and Labeling development. He has filed multiple investigational applications including ex-US CTAs for global Phase 3 programs and several marketing applications in the US, including ANDAs, and 505 b(2) NDAs. Recent activities include Global Regulatory Leadership role for a global multiple myeloma development program leading to submission of a successful NDA and MAA.
Through his global regulatory filing experience, Ruben has supported programs in various disease indications including Alzheimer’s, Multiple Sclerosis, Parkinson’s Disease, and numerous oncology indications (including multiple oncolytic vaccines). His ability to translate strategic objectives into operational execution plans has made him a strong leader focused on building interdisciplinary team relationships.