Therapeutic Areas: Oncology, Neuromuscular Diseases, Chronic Kidney Disease (CKD), Cardiovascular, Diabetes, Rheumatology, Pain, Pediatric Hypoxia (drug-device) and Sepsis / SepticemiaExperienced Pharma Executive and start-up entrepreneur with a successful track record of infusing focus and pace into the entire process, from planning to execution. Strong leadership in building organizations through business development, portfolio & alliance management, drug development, project management, talent acquisition, and management consulting.
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Chief Executive OfficerDna NanobotsColumbus, Oh, Us -
President & Chief Executive OfficerDna Nanobots Jul 2024 - PresentColumbus, Ohio Metropolitan AreaDNA 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 deliver to the right cellular targets including drugs, antigens, siRNAs, mRNAs, peptides, antibodies, biologics, small molecules, as well as, genes and gene editing machinery (e.g. CRISPR-Cas9).We are in partnership with serveral companies to help improve the delivery of various assets to specific cellular targets. -
Chief Executive Officer, Board MemberNanopharmaceuticals Inc. - Glioblastoma Nov 2021 - Nov 2023Troy, New York, United StatesCEO/ 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 transitioning from a pre-clinical to a clinical-stage pharmaceutical company:• 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 of glioblastoma drug via our CDMO.• 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 and investors. o Amassed an investor database of 600+ contacts from diverse investment categories throughout US, Europe, Japan, and Canada including Family Offices, HNW, Angels, Endowments, VCs, and PharmaVCs.• 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.
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Vice President, Corporate & Business DevelopmentRockwell Medical, Inc. Apr 2020 - Oct 2021A 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. -
Ceo, PresidentRegional Personnel Services, Inc. Sep 2014 - Apr 2020New 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%.
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Director, Global Business DevelopmentQuintiles Mar 2012 - Sep 2014• 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. -
CeoStrategic Access Inc. May 1999 - Feb 2012Provided 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, Inc.: developed Phase I clinical plan, clinical supplies, and stability studies for CRC drug licensed from Dartmouth. - CBO (Oncology): Drais and Diatos Ink $46.9M Deal for Early-Stage Anticancer Agent; https://bit.ly/2SBYx8q- CBO (Oncology): Unibioscreen and Drais Deal Up to $31M in Cancer Drug Deal; https://bit.ly/3w6ZiUS- BD Advisor (Derm): closed deal w/$109M aggregate value for a Canadian client to enter US. - BD Advisor (Alzheimer's): start-up company seeking capital, drafted 5-yr Business Plan, Pro-forma P&L/forecasts & investor, grant proposals
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Vice President, Business DevelopmentSavient Pharmaceuticals, Inc. Mar 2005 - Sep 2006• 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 partnerships, merger, or acquisition. • Established all policies, procedures, and budgets for the BD department; led all opportunity identification and approval processes. -
Vice President, Commercial OperationsReliant Pharmaceuticals (Acquired By Gsk; $1.6 Billion) Apr 2002 - Mar 2005Basking Ridge, NjHelped 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.
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Executive Director, Business DevelopmentReliant Pharmaceuticals Apr 2000 - Apr 2002• 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. -
Associate Director, Business Development & Strategic PlanningRoche Apr 1998 - Apr 1999• 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. -
Managing ConsultantPa Consulting Group Jan 1997 - Apr 1998• 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. -
Principle ConsultantPa Consulting Sep 1995 - Dec 1996Princeton, 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. -
Various: R&D, New Products/Strategic Marketing, Clinical Operations, Medical Affairs (Sandoz)Novartis Oct 1986 - Sep 1995ASSOCIATE 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 the discussions between company CEOs. • Created and managed forecasting models that drove portfolio resource allocation decisions for developmental programs for 4 strategic therapeutic areas; dyslipidemia, thrombosis, diabetes, and osteoporosis.• By uncovering and extrapolating future unfavorable market conditions, helped drive Senior Management's decision to kill a CV program saving over $32 M annually, PROJECT MANAGER – NEW PRODUCTS • Developed drug development strategies based on competitive, market intelligence, and regulatory conditions and hurdles for the PhI-PhIII pipeline. • Project Lead on the company’s flagship cardiovascular drug development portfolio.• Streamlined development of hypertensive drug resulting in 6-month acceleration. • Developed an interactive database to centralize Competitive Intelligence for Physician KOL Programs.ASSISTANT FELLOW:• Analytical R&D / Pre-Formulation at Sandoz Research Institute (SRI) • Analytical Methods Development / Manufacturing
James F. Lynch Education Details
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Strategy Entrepreneurialism Leadership -
Inorganic/Analytical Chemistry -
Chemistry
Frequently Asked Questions about James F. Lynch
What company does James F. Lynch work for?
James F. Lynch works for Dna Nanobots
What is James F. Lynch's role at the current company?
James F. Lynch's current role is Chief Executive Officer.
What schools did James F. Lynch attend?
James F. Lynch attended Columbia University - Columbia Business School, Seton Hall University, Siena College.
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