Expert Details
Rapid Development of Controlled Release Drug and Drug-Device Combination Products
ID: 728254
California, USA
"Chemistry, Manufacturing and Controls", CMC in short, is a key module in a regulatory submission that includes all key development information demonstrating proper identity, strength, quality, and purity of the medical product seeking regulatory approval. One of my consulting services is to advise clients to achieve "CMC Right the First Time". It is of utmost importance to adopt this philosophy from concept to launch to minimize unnecessary reloops and maximize probability of technical/regulatory success for any projects. Especially with the tighter timelines of developing drug-eluting devices, flawless CMC executions, together with excellent communications with diverse cross-functional experts, including device engineers, are crucial to successful product advancement and launch.
Expert is a passionate leader with strong diverse interdisciplinary knowledge with a number of key skill sets:
1. Broad Product R&D Experience on Complex Products — over 12 years experience (16+ years in life science) in early and late stage development of drug delivery and drug-device combination products (proteins to small molecules); overcome numerous complex drug-device interface issues; served as technical counsel to executive management in assessment of technology licensing and IP base; drove team to full compliance with ICH, USP/EP/JP, cGMP, ISO, AAMI and Design Control guidelines
2. Rapid Innovation from Concept Definition through Tech Transfer — drive concepts from feasibility to commercialization rapidly by incorporating sound scientific/regulatory approaches to minimize unnecessary re-loops and cost creep (Conor); led multiple successful troubleshooting teams to resolve product issues during development and post launch, leading to substantial monetary savings
3. Strong Drug Delivery Expertise — extensive development experience with drug-device implantable products for systemic and local drug delivery; acted as Technology Leader to emerging technology platforms; led team to develop novel, stable, and highly concentrated self-injectable mAb formulations for non-IV use (ALZA/J&J); excelled in unbiased technology assessment with focus on user/patient needs
4. Expand Versatility of Drug Delivery Platforms — advanced drug-eluting stent platform to new vascular indications with input from key opinion leaders (Conor); expanded intellectual property base for emerging technology platforms (ALZA/Conor); identified candidate drugs to explore new product concepts with platform technologies; acted as major liaison to strategize delivery needs for mAb (ALZA/Centocor)
5. Proven Track Record in Team Leadership and Project Management — Led multiple product and platform development teams to meet timelines and budget; acted as point liaison and led collaborations with external companies; supervised focused R&D teams and provided strong mentoring for direct reports to enhance staff engagement, innovativeness and organizational success
assisted an international company engaging in drug-eluting stent development to understand regulatory requirements as well as technical development issuesassisted a company developing an emerging drug-device combination products for ENT applications in mapping certain technical tasks to enhance regulatory submissions, including a comprehensive technical gap analysisassisted a company developing a novel drug-eluting device in conducting a technical gap analysis on their entire CMC operation
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1996 | Degree: PhD | Subject: Chemical Engineering, Biosurfactants | Institution: University of Delaware |
| Year: 1989 | Degree: BS | Subject: Chemical Engineering | Institution: New Jersey Institute of Technology |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2010 to 2015 | Employer: CooperVision | Title: Senior Director | Department: New Technologies/Program Management |
Responsibilities:Expert is responsible for advancing multiple novel ophthalmic device platforms from feasibility to proof of concept stage. |
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| Years | Employer | Title | Department |
| Years: 2006 to 2009 | Employer: Cordis/Johnson and Johnson | Title: Senior Director R&D | Department: Convergent Product Development |
Responsibilities:Expert is responsible for leading an R&D team to advance drug-eluting stent concepts and products from feasibility to commercialization, with special emphasis on all aspects of controlled drug release including raw material proceurement, formulation design, analytical testing, process development, and packaging development. |
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| Years | Employer | Title | Department |
| Years: 2000 to 2006 | Employer: ALZA | Title: Product Development Manager/Engineering Fellow | Department: |
Responsibilities:Expert is responsible for leading an R&D team (as well as acting as program manager) to advance 2 novel injectable/implantable drug-eluting platforms/products from feasibility to commercialization, with special emphasis on all aspects of formulation design and process development. |
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| Years | Employer | Title | Department |
| Years: 1996 to 2000 | Employer: Astra Zeneca | Title: Team Leader/Senior Research Chemist | Department: Agrochemical |
Responsibilities:Expert is responsible for leading an R&D team to advance multiple new herbicide (immediate and controlled release) formulations all the way to commercialization. Work includes technical support and troubleshooting for marketed products in the field. |
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| Years | Employer | Title | Department |
| Years: 1994 to 1996 | Employer: Insite Vision | Title: Research Scientist | Department: |
Responsibilities:Expert is responsible for advancing multiple sustained release ophthalmic formulations and associated processes from clinical testing to commercialization. |
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Career Accomplishments
| Associations / Societies |
|---|
| ACS, AAPS, CRS, B2DG, CABS |
| Awards / Recognition |
|---|
| multiple Encore Platinum Awards at Cordis (2006-08) ALZA Special Award Recipient (10/2001) -- highest level Zeneca Performance Award 06/99 Recognition by Castro Valley Unified School District in 2006 for Science-based community services |
| Publications and Patents Summary |
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| Expert has over 10 patent applications and over 20 external publications/ presentations |
Additional Experience
| Training / Seminars |
|---|
| He has served as an invited speaker at the Third Annual Drug Delivery Summit Focusing on Ground-breaking Innovations in Biologic, Targeted, and Nanotech Drug Delivery, as well as at the 4th IIR Conference on Protein/Peptide Formulation Strategies. |
| Vendor Selection |
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| He has identified high-quality API, excipient, and novel excipients for drug product development. |
| Marketing Experience |
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| CMC/Regulatory Expert in the area of sustained release drug-device combination implantable/injecatble technologies for the delivery of protein, peptide, and small molecule drugs. Expert published an expert opinion paper in the Newsletter, 'Surfaces in Biomaterials.' |
| Other Relevant Experience |
|---|
| A. Product and Process Development (from concept evaluation to commercialization) -- Select optimal formulation or drug delivery technology for initial concept evaluation given a set of Design Input requirements (product requirement) and drug properties -- Design and author preclinical pharmacokinetics (PK) study protocols -- Assist in API and Excipient sourcing, review, and specification setting -- Prepare Engineering Study Protocols and Reports following QbD philosophy for Design Verification and Tech Transfer -- Develop product specifications for pharmaceutical attributes -- Rapid troubleshooting of CMC Issues related to Product Development (formulation, analytical, process, packaging). For instance, issues such as 1.drug content uniformity 2.drug degradation and excipient content change 3.in vitro release rate measurement 4.stability-related questions 5.in vitro and preclinical data reproducibility -- Provide CMC-Regulatory support 1.Draft and/or review of CMC documents and responses for OUS clinical trial approval or regulatory submission (US and OUS) 2.Conduct comprehensive gap analysis prior to submission -- Conduct Design Control activities for Drug-Device combination products 1.act as independent reviewer 2.conduct risk analysis B. CMC Program Management -- Develop CMC/pre-clinical strategy and project plan to advance product concepts from feasibility through clinical testing to tech transfer -- Act as CMC subteam leader to lead and coordinate development activities, with client's staff and external CRO/CMO, to meet timelines and regulatory requirement -- Develop line extension strategies for drug delivery technologies and drug-device combination products C. Technology Assessment -- Due diligence assessment on 1.drug delivery technologies for systemic and local drug delivery of proteins, peptides and small molecules 2.novel biomaterials in the areas of sustained release technologies and biodegradable polymers 3.process technologies for drug carrier fabrication such as coating technologies -- Full technical analysis of related competitors' technologies -- Review IP Strategy |
Language Skills
| Language | Proficiency |
|---|---|
| Chinese | High, Cantonese dialect |
Fields of Expertise
biodegradable system, biosurfactant technology, Chemistry, Manufacturing and Controls, controlled-release drug delivery, controlled-release drug delivery technology, drug formulation, drug implant, medical device product development, parenteral drug delivery, pharmaceutical product development, pharmaceutical product formulation, pharmaceutical research and development, polymer drug-delivery method, protein drug delivery, drug-eluting stent, protein drug, active pharmaceutical ingredient, investigational drug procedures, pharmaceutical technology, polymer implantable device, drug release polymer, medical device coating material, medical coating material, Current Good Manufacturing Practice, coating technology, drug degradation, injectable pharmaceutical product, pharmaceutical research, drug stability, drug development, stent, parenteral product, drug dosage form development, Food and Drug Administration regulation, pharmaceutical drug, implantable device, dosage form