Kenneth Lee

Biopharmaceutical advisory and deal execution focused on M&A, Licensing, CDMO, and CRO.

InSol Co., Ltd. is a platform company focused on diagnostics, ENT medical devices, consumer healthcare, and biopharma innovation, headquartered in Korea with a US office in Boston, MA. Led corporate strategy, new business development, operational scale-up, and R&D planning. As an equity partner, drove long-term value creation and growth across InSol’s diversified portfolio.

- Execute M&A, J/V, investment, and partnerships - Identify and launch new biologic growth engine - Materialize new business ideas into tangible assets - Oversee and operate new businesses/ assets created

- Built, oversaw, and mentored US/ Canada/ LATAM GenScript ProBio commercial organization consisting of Sales, BD, MKT, KAM, and Commercial Operations - Grew sales by 81% YOY from 2018 to 2021 - Established customer base, brand, and trust of quality and commitment of GenScript ProBio businesses in the US, Canada, and LATAM - Strategically collaborated with US research institutions and hospitals in developing treatments for COVID-19 - Established and managed GMP plasmid and virus manufacturing partnerships in the US - Signed and developed global strategy for in/out-licensing of biologic NMEs and biosimilars, and cell and gene therapy assets - Contracted over 200 biologics discovery, development and manufacturing deals

Commercial Strategy - Managed sales in North America, EU, APAC, and MENA, leading 270%+ sales growth from 2016 to 2019 Alliance Management - Established Alliance Management function and processes within the company, effectively operating and managing global commercialization partnerships Business Development - Valuated, assessed opportunities and risks, and led corporate decision to enter new markets - Successfully negotiated sold assets at above target deal size

- Initiated, led and signed mAb biosimilar licensing deals with #1 companies in two major "pharmerging" countries - Directed licensing, J/V, investment, contract manufacturing, and export projects in over 25 countries - Delivered keynote speeches at bio-conferences (including annual Bio International conventions, Bio Europe and CPHI among others) - Conducted IR (Investor Relations) activities to create investment partnerships and to raise overseas fund

See above: "Senior Manager, Business Development"

- Conducted study-specific, process-based, CRO and internal BioMarin facility inspections to assess compliance with applicable FDA regulations and Good Laboratory Practices (GLP) - Reviewed study protocols, raw data, reports and submission documents associated with nonclinical and clinical studies conducted by BioMarin to evaluate regulatory compliance - Identified compliance risks and assisted in development and guidance of administration programs to promote and monitor the quality and performance of operations - Provided timely audit reports to Management and client groups. Evaluated corrective action plans and collaborated with clients to ensure completion of corrective actions - Wrote, revised, and filed change requests for SOPs

- Directly assisted CBO in localizing Crystal Genomics, a Korean biotech company, in Emeryville, CA, USA, managing internal programs/ projects development - Interfaced with research/investment partners and participated in IR meetings to raise investments and business partnerships - Maximized corporate profit through negotiations, and restructuring and streamlining expenses - Researched and self-taught HTML, then developed and published the company website utilizing CMS

- Screened over 20,000 target compounds researched and synthesized at Gilead using HTS - Created archive and master plate library for all the compounds, and designed and created an electronic tracking system - Micro-weighed and prepared compound solutions for various target testing and formulations

- Managed chemo-genomically designed compound libraries (UniStore); Performed processing, analysis, formatting, and plating of small organic molecule samples for NIH - Tested solubility and purity of hundreds of thousands of compounds using HTS and state-of-the-art machinery such as Bohdan, HVAC, and FlexiWeigh, under strict GMP guidelines

Jan. 2015 - Dec. 2015

Fall Exchange (Aug. 2015 - Oct. 2015)