Expert Details
Medical/Pharmaceutical R&D and Manufacturing - New Product Approval and Launch Including FDA, EMA, and Asia
ID: 739165
Georgia, USA
His executive leadership roles have focused on guiding product approval and launch strategies, as well as navigating the intricacies of sales and marketing for both prescription and over-the-counter products. Notably, during the pandemic, he led transformative initiatives at Employer, enhancing supply chain resilience and expanding retail distribution amidst supply challenges, which positioned the company as a leading specialty contract manufacturer in the hair care industry.
Beyond his professional achievements, he is characterized by a profound curiosity for exploring unconventional ideas and an unwavering commitment to continuous learning, demonstrated through his engagement with diverse publications and industry-specific newsletters. His leadership style emphasizes compassion and empathy, recognizing their pivotal role in motivating today's workforce.
Among his notable projects, he successfully directed FDA compliance efforts for Anteis Medical's dermal fillers, facilitated the development and regulatory approval of critical products for high-risk pregnancies at Glenveigh Medical, and resolved FDA issues at Staar Surgical's facilities, enabling the market launch of new products. His accomplishments include managing complex international projects such as CibaVision’s refractive surgery innovations, integrating global vendors and achieving rapid regulatory approvals.
Throughout his career, he has consistently demonstrated a blend of strategic vision, technical expertise, and leadership acumen, contributing significantly to advancements in medical technology and pharmaceutical innovations globally.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1996 | Degree: MS | Subject: International Manufacturing (Joint technology MBA) | Institution: UCSD |
| Year: 1994 | Degree: BS | Subject: Engineering | Institution: Harvey Mudd College |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2019 to Present | Employer: Undisclosed | Title: CEO | Department: |
Responsibilities:Family business in the natural hair and skin care segment. Establish policies, financial controls, hire key senis to run marketing and sales and manufacturing. Develop forecasts for financial planning. Key focus was on supply chain costs and vendor selection to reduce costs and eliminate delays. Drove improvements in manufacturing through selective investment. |
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| Years | Employer | Title | Department |
| Years: 2002 to Present | Employer: Undisclosed | Title: Founder & Chief Strategy Officer | Department: |
Responsibilities:Founded and grew a medical device & drug delivery consultancy focused on the management and execution of new product development, project rescue, and compliance emergency response. Core focus is Class II and Class III products and combination products, with clients in USA, EU, and China. Areas of practice include obstetrics, oncology, neo-natal, peripheral vascular, cardiology, drug delivery, general surgical, cosmeceuticals - ranging in scale from pre-incorporation concept exploration to full commercialization.Clients have included Intarcia, ElectroMedical Systems, Anteis, CIBA Vision, STAAR Surgical, Schwind Eye-Tech, Novartis, Clinton Health Initiative, Exsurco, Bill and Melinda Gates Foundation, Ophtha International, Solo Health, Glenveigh Medical, Duckworth & Kent, Helsinn Pharma, Myelotec, Norwood Eye-Care, and many other firms. |
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| Years | Employer | Title | Department |
| Years: 1991 to 2001 | Employer: Ophthalmic Innovations International | Title: Director of Global Surgical R&D | Department: Surgical R&D |
Responsibilities:Created the R&D department, built staff to five over 18 months, and moved the company from a contract manufacturer to a developer of unique products. Managed design of three generations of refractive anterior chamber IOLs, many posterior chamber IOLs, small incision ocular implants, presbyopic scleral implants, and numerous line extensions. Developed manufacturing processes for new products and materials (Class 3 implants and Class 2 consumables), TQM, SPC, and updated QC methods. Directed many process development projects. Created ISO 13485 complaint systems for product development. Presented protocols and results to FDA, handled audits, created submission packages. Introduced use of advanced software for CAD/CAM, project management, and an intranet distribution system for SOPs, policies, and technical specifications. |
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| Years | Employer | Title | Department |
| Years: 1989 to 1997 | Employer: Self Employed | Title: Consulting | Department: |
Responsibilities:Various projects: Project manager for Maxtor’s first intranet implementation team. Developed IOL instruments and protocols, optical implants for treatment of cataract, new fabrication methods for complex geometry for the first adjustable implantable telescope for Macular Degeneration. Business practice benchmarking for a customer fulfillment group at Caterpillar. Design for manufacturing (DFMAT), process development, complex geometry programming, and CAE for a number of small manufacturing companies in Southern California. Established in-process metrology for Iolab, validated same, and presented to FDA for approval. |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2001 to Present | Country / Region: Germany | Summary: Clients in multiple cities over twenty years. |
| Years: 2001 to Present | Country / Region: Switzerland | Summary: Multiple clients. |
| Years: 2001 to Present | Country / Region: Ireland | Summary: Multiple outsourcing and manufacturing deals. |
| Years: 2011 to Present | Country / Region: China | Summary: Multiple outsourcing and advisory gigs. |
| Years: to Present | Country / Region: United Kingdom | Summary: Multiple clients, outsourcing, advisory, and audit gigs. |
Career Accomplishments
| Professional Appointments |
|---|
| Executive in Residence, Moffitt Cancer Center's Technology Development Office (4 years) Business School Guest Coach, University of South Florida (2 years) Advisory roles & Guest Lecturer, University of Southern California, University of California San Diego, Emory University, Johns Hopkins, Georgia State University, Florida State University, and others. |
Additional Experience
| Vendor Selection |
|---|
| Extensive experience with both regulated and non-regulated vendor selection, verification, validation, and negotiation of supply and quality contracts - global and domestic supply chain optimization. |