Wei Li, Ph.D Email and Phone Number
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As a Biotech/Pharma Executive, my passion is to translate scientific vision and breakthrough technologies into new drug therapies through strategic, comprehensive development. With a strong science background, drug R&D expertise, business wisdom and operational excellence, I help biopharmas successfully advance drug development and business/corporate development objectives.As a founding member of 2 biotech companies, I helped lead the entire journey of building/scaling a startup from scratch to growing it into a mid-size company with multiple phase 3 clinical trials. Through this extraordinary opportunity, I accumulated extensive and comprehensive hands-on expertise in all aspects of drug research & development, including preclinical development & pharmacology, clinical development and operations, regulatory, biomarker development, and CMC, as well as business development, and biotech operations. I played a key role in the following outcomes: • Developing a first-in-class drug selected as one of the world’s top ten cancer drugs in late stage clinical development by Fierce Biotech• Out-licensing products and eventual sale of a start-up biotech company to a big pharma for a total deal size of $2.63B • Forming a biotech company ranked as the most capital efficient company of the year (2012) and deemed one of the most capital efficient biotech companies in history by Venture Capital Journal I enjoy leading and inspiring cross-functional and multidisciplinary teams to explore the future of biotech/biopharma and achieve corporate initiatives. I love each step of the process of building high-performing functional teams, while coaching and mentoring team members to help develop their own careers. I believe in open communication, accountability, collaboration and positive reinforcement to build strong relationships and positively impact the success of projects and programs.Cross-functional & Multidisciplinary Leadership, Overall drug R&D, Strategic Portfolio & Program Management, Preclinical & Pharmacology, Clinical Development & Operations, Regulatory, Translational & Biomarker Development, CMC, Start-ups, Business Development, Licensing, Acquisition, Business & Contract Negotiation, Alliance Management, Vendor Management, Biopharmaceuticals, IP Strategies, Team Building, Budgets, P&L, Coaching & Mentoring, Problem Solving, Strategic & Analytical Thinking, Cell Therapy, Gene Editing, Biologics, Small Molecules, Oligonucleotides
Cytovia Therapeutics
View- Website:
- cytoviatx.com
- Employees:
- 11
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Chief Scientific OfficerCytovia TherapeuticsBoston, Ma, Us
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Board MemberNaya Biosciences Oct 2023 - PresentAventura, Florida, Us -
Chief Scientific OfficerCytovia Therapeutics 2020 - PresentAventura, Florida, Us
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Board MemberCytolynx Therapeutics 2021 - Present
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Scientific Advisory BoardArtus Therapeutics 2019 - 2021 -
Chief Development OfficerOlix Pharmaceuticals, Inc. 2018 - 2020Suwon-Si, Gyeonggi-Do, KrRecruited to establish and run the US Corp, leading product development and business development activities as well as alliance management. -
Board MemberOlix Us, Inc. 2018 - 2020
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Executive Vice PresidentBoston Biomedical 2012 - 2018Selected 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.
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Vice PresidentBoston Biomedical 2007 - 2012Initially 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)
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Manager/Senior Investigator, In Vivo CenterArqule 2005 - 2007Set up multiple Genetically Engineering Mouse models, designed in vivo studies, and managed the in vivo facility.
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InstructorHarvard Medical School 2004 - 2005Boston, Ma, Us -
Research FellowHarvard Medical School 2001 - 2004Boston, Ma, Us
Wei Li, Ph.D Skills
Wei Li, Ph.D Education Details
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Harvard Medical SchoolBrigham & Women'S Hospital -
Georgia State UniversityMolecular Virology
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Sun Yat-Sen UniversityBiochemistry
Frequently Asked Questions about Wei Li, Ph.D
What company does Wei Li, Ph.D work for?
Wei Li, Ph.D works for Cytovia Therapeutics
What is Wei Li, Ph.D's role at the current company?
Wei Li, Ph.D's current role is Chief Scientific Officer.
What is Wei Li, Ph.D's email address?
Wei Li, Ph.D's email address is wl****@****cal.com
What is Wei Li, Ph.D's direct phone number?
Wei Li, Ph.D's direct phone number is (781)-278*****
What schools did Wei Li, Ph.D attend?
Wei Li, Ph.D attended Harvard Medical School, Georgia State University, Sun Yat-Sen University.
What skills is Wei Li, Ph.D known for?
Wei Li, Ph.D has skills like Pharmaceutical Industry, Technology Transfer, Negotiation, Drug Discovery, Cmc Development, Drug Development, Clinical Development, Business Development, Biotechnology, Lifesciences.
Who are Wei Li, Ph.D's colleagues?
Wei Li, Ph.D's colleagues are Ubat Gugurkan Kandungan Misoprostol Cytotec, José E. Virella Cortés, Guilan Liu.
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