• An emblematic pharmaceutical product development leader with strong skills in communication, engaging and developing staff, CDMO collaborations, innovation and technical problem-solving. • Proven track record of directing, executing and delivering various aspects of pharmaceutical product development and drug delivery technologies in a myriad of dosage forms (including oral solid and liquid modified-release, lipid-based vesicles (oral, topical) for NDA (505(b)(2), OTC) and ANDA products throughout project inception (product design), early-phase development (pre-formulation, prototype formulation & process development), clinical supplies, late-phase development (optimization, scale-up and full-scale, technology transfer, validation, c-GMP manufacturing), and preparation and review of regulatory documentation at start-up, midsize and big pharma companies.• A holder of 23 US and 10 European granted patents (principal-/co-inventor), of which 5+ were successfully implemented in marketed NDA/505(b)(2) and Paragraph IV oral MR products for various disease states - ADHD, diabetes and anti-hypertension.• Considerable hands-on experience in formulating new molecular entities (NMEs) and active pharmaceutical ingredients (APIs) including small and large molecules, addressing and resolving various technical challenges in drug delivery (clinical unmet needs), formulation (taste masking, solubility enhancement, stability improvement) and pharmacokinetics (bioavailability enhancement).• Experience in due diligence (DD), licensing and acquisition (L&A), venture capital (VC) fund raising, product life cycle management (PLM) and product development in conjunction with internal cross-functional teams and external CRO/CDMO collaborators and business partners.• FDA CMC reviewer on modified-release (MR) and other dosage forms.• Published scientific author as well as invited domestic and international speakers for 10+ drug delivery conferences and workshops.• Completed PMI’s Project Management and Agile Project Management coursework. • Conducted enzyme purifications (NAD-dependent Prostaglandin Dehydrogenase) from human placenta and E-Coli (DNA ligase), and monoclonal antibody studies in rabbits. Completed PMI’s Project Management and Agile Project Management coursework.
Arcana Pharma Llc.
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FounderArcana Pharma Llc. Jul 2021 - PresentFlemington, Nj• Provide advice to pharmaceutical companies (domestic and international), participate in weekly project meetings, identify and rectify various technical issues related to CMC, drug delivery technologies, formulation, process and complex dosage form design and strategy, solubility and bioavailability enhancement, scale-up, tech transfer and manufacturing process.• Identify and assess new product opportunities and new business growth areas for licensing (in/out), internal and external co-development of 505(b)(2), Paragraph IV and ANDA products.
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Chief Scientific Officer, Head Of InnovationHq Pharma Tech Ltd (New Jersey Based) May 2020 - Jun 2021Shanghai/Shanghai, China• Worked closely with senior management members, board members and cross-functional key stakeholders in identifying and assessing new product opportunities and new business growth areas for internal and co-development of 505(b)(2) and Paragraph IV products, licensing (in/out) and acquisitions (L&A), VC fund raising (~ $16M USD raised from a renowned VC in China), as well as formulating and executing a 5-year business strategy and product pipeline. • Participated in project review meetings, provided scientific solutions to rectify various technical issues pertaining to CMC, formulation, process, solubility, scale-up, tech transfer, and bioavailability.• Represented the company in external technology forums and drug delivery conferences as a scientific leader and speaker to promote the company’s capabilities and competencies.
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Co-FounderArcana Pharma Llc. Sep 2019 - May 2020Skillman, New Jersey, United States• The company was set up to become the US subsidiary of an oversea company and obtained signed Mutual Confidentiality and Non-Disclosure Agreement. Due to the impact of Covid and the international economy uncertainties, the acquisition was not completed.o A detailed Arcana business plan, outlining the management team, business model, novel platform technologies, product pipelines (including 505(b)(2) and Paragraph IV), stage-wise product timelines, funding strategy, market forecast and projected revenue, was provided.
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Senior DirectorTulex Pharmaceuticals Jan 2017 - Aug 2019Cranbury, New Jersey• Led and directed formulation and process development operations for company portfolio, including scale-up and commercial manufacturing of complex ANDA, Paragraph IV and NDA/ 505(b)(2) products.• Developed innovative platform technologies and products to enhance the Company’s business growth opportunities. o Resolved technical challenges and completed all the technology transfer deliverables to overseas business partner achieving successful scale-up, pilot and pivotal batches. Delivered successful pilot and pivotal bioequivalence (BE) results for high-barrier generic MR products. The ANDA review was completed and is pending for approval by Regulatory authorities. -
Cmc ReviewerFda Apr 2016 - Dec 2016Silver Spring, Maryland• Reviewed and evaluated chemistry, manufacturing and control (CMC) CTD information on applications of MR and other dosage form products.• Assessed the adequacy of:o Pharmaceutical development and manufacturing processes, testing and control strategy of drug substances, excipients, container closures and drug products, and product usability and acceptability to patients.o Analytical methods and associated validation reports of drug substances and drug products. -
Research Director, Inaugural Johnson & Johnson Fellow, Global Technology, R&DJohnson & Johnson Jan 2002 - Apr 2016Fort Washington, Pa• Identified and implemented novel technology initiatives to spur business growth of Rx and OTC portfolio. o Served as R&D CMC representative to collaborate with cross-functional teams (Medical, Business Development, Regulatory, Marketing and Global Innovation) on L&A due diligence and PLM of Rx and OTC products.o Evaluated and identified potential compounds (including new molecular entity (NME)), products and novel technologies to support L&A and PLM on various indications, dosage forms and delivery systems with clinical unmet needs, enhanced efficacy and bioavailability. • Served as a subject matter expert (SME) to provide technical and scientific solutions for various challenging projects in other J&J subsidiaries.• Developed a lipid-based self-nanoemulsifying drug delivery system (SNEDDS) to overcome and enhance the solubility (~10,000x), stability (~97-99 % potency remaining up to 10 months at 40°C vs. 3-4 hours at 25°C in aqueous medium) and bio-availability (AUC: 2x-3.3x; Cmax: 2.1x-4.4x) challenges of a prodrug to support the Global Digestive Health Franchise (5 US patents granted, 2 US patents pending).• Led internal and external (CRO/CMO) Formulation and Analytical teams in developing various novel drug delivery technologies and products (sNDA and NDA), achieving various release profiles and configurations for various MR oral solid and liquid pediatric products, and biphasic pulsatile release of a NSAID with enhanced clinical efficacy (12 US patents and 7 European patents granted).o Managed preclinical studies at CRO leveraging MatTek’s human buccal cell line tissues and human cadaver intestinal segments to assess alternative drug delivery systems (e.g., buccal and colonic) for existing marketed oral drug products. -
Manager Project Outsourcing, Formulation R&DPfizer Mar 1999 - Jan 2002Morris Plains, Nj• Identified and assessed CDMO key external complementary product technologies and competencies, as well as managed external project outsourcing and technology transfer initiatives.o Successfully resolved the tablet defect issue of a new molecular entity (NME), NDA project by leveraging a polymer’s thermoplastic characteristics and high degree of plastic flow to allow the seamless tech transfer from the CDMO to the in-house project team for the commercial-sized batches manufacturing.• Implemented and executed pivotal formulation and process optimization to save a NME NDA project timeline culminating in successful exhibit batches manufacturing at Pfizer’s France facility.• Appointed as the point person pertaining to MR projects in Pfizer Global R&D in Morris Plains, NJ. -
Pharmaceutical Group Leader, R&DAdare Pharma Solutions Oct 1996 - Mar 1999Vandalia, Oh• Provided technical support and developed project proposals and timelines for business partners (Marketing and BD). • Managed and directed the Formulation Team to develop various novel solid and liquid MR 505(b)(2) projects and to identify and rectify process and stability challenges. o Delivered two novel 505(b)(2) products with pulsatile release characteristics for chronotherapeutic medication (2 US patents granted).o Delivered an oral reconstituted taste-masked antibiotic suspension with 21-day shelf-life. -
Group Leader, Product Development, R&DAllergan Mar 1994 - Sep 1996Fort Lauderdale, Fl• Developed three (3) complex Paragraph IV generic MR projects.o Principal inventor/co-inventor of 4 US and 2 European granted patents on osmotic-controlled proprietary technologies and pulsatile delivery system. The patented technologies were successfully leveraged in ANDA and NDA marketed products. o Said patents were crucial to the successful IPO of Andrx in 1996. -
Senior Scientist, Parenteral/Liquid Department, R&DPfizer May 1992 - Feb 1994Rouses Point, Ny• Authored 10+ assessment reports for the American Home Product (AHP) Scientific Steering Committee of new drug delivery technologies for PLM of marketed products.• Responsible for the development of NDA projects: o Liquid dosage forms of a NME lipid regulator with high drug concentration.o Liquid dosage forms of a NME peptide with enhanced solubility, stability and taste-masking.o Oral reconstituted MR suspension of a NME antibiotic in Montreal, Canada facilities.
Der-Yang Lee, Ph.D. Education Details
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Pharmaceutics; Ocular Pharmacokinetic -
Bs In Pharmacy -
Nabp (National Association Of Boards Of Pharmacy), Chicago, IlPassed The Foreign Pharmacy Graduates Equivalency Examination With A Fpgec Certificate -
Avtech Institute Of Technology, South Plainfield, Nj.Completed Pmi’S Project Management And Agile Project Management Coursework.
Frequently Asked Questions about Der-Yang Lee, Ph.D.
What company does Der-Yang Lee, Ph.D. work for?
Der-Yang Lee, Ph.D. works for Arcana Pharma Llc.
What is Der-Yang Lee, Ph.D.'s role at the current company?
Der-Yang Lee, Ph.D.'s current role is Proven Senior Pharmaceutical Product Development Leader, Communicator, Innovator and Technical Solutions Provider..
What schools did Der-Yang Lee, Ph.D. attend?
Der-Yang Lee, Ph.D. attended University Of Iowa College Of Pharmacy, Taipei Medical University, Nabp (National Association Of Boards Of Pharmacy), Chicago, Il, Avtech Institute Of Technology, South Plainfield, Nj..
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