James F. Lynch Email & Phone Number

Columbus, OH, US

Columbus, Ohio Metropolitan Area

DNA Nanobots is a biotechnology company with a proprietary platform that offers major advantages over current gene delivery systems such as larger drug payloads over current ADCs and better cell/tissue targeting over current LNPs.Nanobots are engineered DNA nanostructures ("origami") that enable precision control over the number and spatial locations to.

Troy, New York, United States

• CEO/ BOARD MEMBERDeveloped & implemented short-/long-term strategic goals for the Company/Board to advance its glioblastoma drug into first-in-man Phase I clinical trial, while increasing company’s value by.
• Day-to-day operations, including 2 major initiatives: o Initiation of Phase Ia dose-escalation glioblastoma clinical trial at Yale Brain Tumor Center via our CRO. o Manufacturing and stability testing of cGMP batches.
• Fundraising: o Completed $4.1 M fundraise in first 5-months allowing the initiation of Company’s first cancer clinical trial. o Continuously identified & developed communications with potential new strategic partners.
• Implemented & maintained financial controls & contracts.
• Developed Board governance, quarterly meetings, and communication materials; actively manage current shareholder communications to support & prepare for next fund raise.
• Prepared and managed budgets and contracts (CROs, CDMOs, vendors, consultants) to drive & align Company’s decisions and programs for most efficient value-creation, de-risking and partnering.

• A biopharmaceutical company dedicated to providing innovative drugs for the treatment of iron deficiency and anemia (CKD, nephrology, hematology).
• Drove geographic expansion through strategic partnerships and international alliance management.
• Identified and vetted 24 MENA region pharmas to fulfill OUS expansion strategy to enter this territory; closed deal valued at $86 M.
• Managed 5 international partnerships: China, India, S.Korea, Turkey, Brazil, Peru. Aggregate value of $234 M.
• Represented US interests for territorial expansion strategies in JP, EU, MENA, ASEAN.
• Structured deal negotiations utilizing financial models, deal intelligence, contract language, intellectual property, and commercial insights.

New Jersey

• Acquired all assets in a distressed agency sale, and secured private funding to restructure heavy debt burden, while streamlining processes to increase profitability by 17% within the first 8 months.
• Re-negotiated all vendor contracts for more favorable terms, saving 36% to the bottom line.
• Expanded from temp to higher margin retainer-based searches which produced incremental net sales of 28%.

• Cultivated major pharmas to deploy flexible Contract Commercial Teams for new drug launches; Nurse Educators, Sales Reps, MSLs.
• Identified sales opportunities with annual aggregate proposals over $220 million.
• Maintained high visibility within clients developing deep knowledge of pipelines and strategic initiatives.

Provided interim senior management, business development & licensing advisory to start-ups/ emerging biopharmaceutical clients.Notable projects and deals by therapeutic area:- Launch Team (Respiratory): Hospital/Acute Care (drug-device): led strategic launch plan/team for a neo-natal critical care drug device.- CEO (Oncology): Phytomedical Technologies.

• Engineered M&A plan & deal structure to integrate European oral liquid business into N. America.
• Established all policies, procedures, and budgets; led all opportunity identification and approval processes.
• Partnered (out-license) oncology product from European affiliate.
• Identified multiple strategic alliances (21 drugs) to complement internal pipeline in auto-immune diseases including rheumatology, inflammation, and pain; identified 8 companies for potential take-over, strategic.
• Established all policies, procedures, and budgets for the BD department; led all opportunity identification and approval processes.

Basking Ridge, NJ

Helped to start this Specialty Pharmaceutical (NewCo); grew to 1,080+ employees, then sold to GSK for $1.6B. Established its virtual Supply Chain with 7 direct reports; structured various external partnerships to produce commercial & clinical supplies, and promotional samples from API to production, packaging and distribution.

• Led the first drug acquisition from Novartis ($91M), triggering VC investment ($135M).
• Led co-promotion partnership on second CV drug ($124M).
• Responsible for in-licensing, deal structure, due diligence, negotiations, and alliance management Identified, and evaluated multiple in-licensing/asset acquisition/co-promotion & merger opportunities.

• Within 1-month identified a co-promotional partnership ($305 M) with a major pharma to replace CV drug pulled from the US market.
• Responsible for coordination of CEO's Annual Senior Executive Management Summit.
• Co-led annual 5-year Strategic Plan.

• Promoted quickly to Managing Consultant
• Led global project teams (R&D Acceleration) for major pharma clients (Pfizer, Mallinckrodt).
• Re-engineered the Global Regulatory Process (WW) and Biometrics function (US/EU/Japan).
• Developed CRO vendor model for assessment, selection, and management for pipeline drugs saving approx. 6 weeks in the vetting and onboarding process.

Princeton, NJ

• Devised and conducted a benchmarking study that revealed best practices across 9 top pharmaceutical companies, "Project Management for Drug Development, Processes & Decision Points."
• Built New Product Management Process & Manual with timelines, deliverables, and decision gates for Sr Management.
• Interfaced weekly with all major clients, evaluating project performance.

• ASSOCIATE DIRECTOR, CLINICAL OPERATIONS / PHASE IV (Market Studies)
• Re-engineered post-launch clinical development process with potential time savings of 6-14 weeks.
• Developed an activity-based model to measure clinical study performance identifying 5 areas of improvements.
• Optimized drug replenishment system reducing the time by 62%. PRODUCT MANAGER – MARKET DEVELOPMENT
• Led competitive intelligence efforts in assigned areas; identified a ‘hidden’ osteoporosis drug in a competitor’s portfolio to plug a critical gap in our development pipeline; developed strategic fit analysis which led.
• Created and managed forecasting models that drove portfolio resource allocation decisions for developmental programs for 4 strategic therapeutic areas; dyslipidemia, thrombosis, diabetes, and osteoporosis.

Master Of Business Administration - Mba, Strategy Entrepreneurialism Leadership

Doctor Of Philosophy - Phd, Inorganic/Analytical Chemistry

Activities and Societies: Awarded the prestigious Graduate Research Fellowship from the National Science Foundation to support his research

Bachelor Of Science - Bs, Chemistry

Activities and Societies: Awarded Siena's Student of the Year by American Chemical Society (ACS)