Wei Li, Ph.D Email & Phone Number

Boston, Ma, Us

Aventura, Florida, Us

Aventura, Florida, Us

Suwon-Si, Gyeonggi-Do, Kr

Recruited to establish and run the US Corp, leading product development and business development activities as well as alliance management.

Selected to lead company’s overall product development, oversee IP portfolio and operations, while managing ~150 members of cross-functional development teams. Managed up to $250M annual corporate R&D budget to advance multiple programs from pre-clinical development to pre-NDA stage. ➤ Led cross-functional teams to advance multiple programs from preclinical up to P3 clinical trials.• Formulated development strategy, proactively identified key development challenges, & defined go/no-go criteria for decision making.• Selected as strategic lead on materials for FDA, HC, and EMA to meet regulatory requirements, including all aspects of briefing documents for pre-IND, IND, IMPD, pre-phase III, pre-IDE, and pre-NDA. Actively involved in FDA meetings.• Closely worked with preclinical development team to analyze data from MOA studies and pharm/tox studies for smooth transitions from preclinical to clinical development.• Led company’s key multi-discipline projects, such as biomarker development, IND filings for new indication or NCE, pivotal trial and phase 3 trial design & management.• Strategically led statistical team for clinical trial data analysis & design of new trials. ➤ Key contributor for the successful expansion and continuous improvement of the company from approximately 10-member start-up to a 200 people global oncology center with formal departments/systems for each function while maintaining the innovation culture.• Expanded and directly supervised CMC departments and created an environment for a high-performing team, delivered quality products for fast moving development programs. • Established clinical operation department to support 20+ clinical trials including multiple global phase 2/3 studies.➤ Strategically guided cross-functional teams to select and manage key vendors and negotiate ~10 key development contracts (valued at $100-150M total) per year, including clinical supply and commercial supply contracts and phase 3 clinical trial contracts.

Initially responsible for all corporate and business development-related activities and after achieving business development initiatives, promoted to expand functional area to lead product development.➤ Key contributor to company value creation and maximization of the cash runway while advanced its lead program into the clinical stage:• Assisted the CEO on selection of company direction by conducting landscape and competitive edge analysis. • Managed corporate budget.• Managed corporate intellectual property with creativity in designing claims.• Led cross-functional teams to prepare a data package, resulting in obtaining a National Cancer Institute Cancer Stem Cells Initiative Award.➤ Supported CEO on fundraising, out licensing BBI’s lead program, managed partnership with DSP and subsequently having the company acquired by DSP as a whole for $2.63B:• Strategic preparation of business plans, corporate presentations and confidential data packages. • Managed due diligence, designed deal structure options and negotiated potential partnerships, out-licensing deals, and acquisitions. Managed alliance with DSP. ➤ Contributed to lifting the clinical hold from FDA for BBI’s first program and advanced the program into clinical stage, as Director of Business Development.➤ Led cross-functional teams for product development activities, as VP of Product Development & Business Affairs.• Hands-on management of pre-clinical IND-enabling pharm/tox study. • Set up CMC team with hands-on management of CMC activities to support IND & clinical trials.• Filed IND for BBI’s second program and obtained approval from FDA within 30 days after initial filing. ➤ Key contributor to Boston Biomedical ranked as the most capital efficient company of the year (2012) and deemed one of the most capital efficient biotech companies in history. (Venture Capital Journal)

Set up multiple Genetically Engineering Mouse models, designed in vivo studies, and managed the in vivo facility.

Boston, Ma, Us

Boston, Ma, Us

Postdoc, Department Of Rheumatology, Immunology, And Allergy, Brigham & Women'S Hospital

Doctor Of Philosophy - Phd, Molecular Virology

Bachelor'S Degree, Biochemistry