Medical or Pharmaceutical R&D and Manufacturing - New Product Approval and Launch Including FDA, EMA, and Asia
ID: 739165 Georgia, USA
Executive Management and Coaching with a focus on Medical or Pharmaceutical R&D and Manufacturing. Extensive experience with new product approval and launch, as well as the associated sales and marketing requirements for prescription and OTC products.
Relevant Experience & Capabilities à Led brand licensing for Employer, with terms satisfactory to the owners. This was enabled in the three years of pandemic by:
- Starting in January 2020, well before most business leaders were thinking about risks, solidifying and rebuilding supply chains, establishing direct imports, and rationalizing manufacturing.
- Increased retail distribution by a factor of four, enabled by being able to reliably ship product when others could not due to pandemic supply issues.
- Expanded the business to include contract manufacturing and white-label. Competing formulators were focused on hand sanitizers and high-volume, which left many mid-size and small hair care companies stranded, creating a market opportunity as a specialty contract house.
- Hired great people so that a smaller team could be more deliverable.
- Directed and led projects leading to over thirty 510(k), PMA, and NDA approvals in drug delivery, ophthomalogy, dental, cosmetics, emergency medicine, obstetrics, oncology, and diabetes.
- 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 ranging from concept-phase startups through multinationals.
- Curiosity in a constantly changing world; investigating the odd corners and edge effects allows for preparation and creates opportunities that are otherwise invisible, or the avoidance of risks otherwise unrecognized.
- Constant Learning requires a commitment to daily investigation of the latest political, environmental, economic and scientific news. Current subscriptions include The Atlantic, Harpers, New Yorker, New Scientist, The Guardian, Al Jazeera, Der Spiegel, and a host of industry specific newsletters.
- Compassionate Leadership is vital with the generations that now make up the bulk of our workforce. In order to motivate this new talent a different approach is required: empathy and coaching are critical.
|Year: 1996||Degree: MS||Subject: International Manufacturing (Joint technology MBA)||Institution: UCSD|
|Year: 1994||Degree: BS||Subject: Engineering||Institution: Harvey Mudd College|
|Years: 2019 to Present||Employer: Undisclosed||Title: CEO||Department:|
Responsibilities:Turnaround a 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.
In February of 2020 pivoted to ensuring that the company would grow through the pandemic, resulting in factor of four (4x) increase in Mass Market retail penetration. Led brand exits to satisfaction of owners, currently pivoting subsidiary to contract manufacturing.
|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.
- Drive product development, product validations, and manufacturing transfers, specializing in ‘at-risk’ situations such as FDA warnings or short time to market. 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.
- The emphasis on support for international companies entering the USA market is also noteworthy. At any given time there may be two to four FDA submissions in process.
- Directed FDA compliance, cleanroom and process validation, and quality system development for a new factory build project outside Geneva. Sterile fill and controls implementation were a key focus for the dermal fillers (Anteis Medical). The first pre-PMA approval audit had a small number of observations which were resolved quickly, supporting approval of the first dual-crosslinked dermal filler in the USA market.
- Created project teams and directed development of multiple products for high-risk pregnancies for Glenveigh Medical (USA), from concept through to volume launch. All projects were successful, including FDA and international approvals. Of particular note is the EBB product which had significant technical and regulatory challenges.
- Created and managed a crash validation project for Staar Surgical’s facility in Nidau (Switzerland) to resolve FDA issues which had resulted in a series of warning letters and a hold on key PMAs. This facility passed the FDA audit four months later. Performed the same task for their facility in Aliso Viejo (including radioneucleotides), same timelines, and the same result. All issues in warning letters were resolved to the satisfaction of the FDA and they received permission to market their new products.
- Program manager for CibaVision’s Centurion Epikeratome and microkeratome projects, integrating vendors on four continents to develop a fully outsourced solution for refractive surgery invented by the father of LASIK. CE and 510(k) approvals less than 18 months after project start. The product was successfully outlicensed.
|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.
|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.
|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.|
|Associations / Societies|
|1988 to 1994 membership in GHTF task groups, 1994 to 2002 on ANSI/ISO working groups to ISO 13485 and various specific product standards, such as ANSI Z80.|
|Executive in Residence for Moffitt Cancer Center's Technology Development Office (4 years)
University of South Florida, Business School Guest Coach 2013 and 2014
Have served in advisory roles or as a guest lecturer for regulatory and business school programs at the University of Southern California, University of California San Diego, Emory University, Johns Hopkins, Georgia State University, Florida State University, and others.
|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.|
|Other Relevant Experience|
|Prior Experience Aerospace tool and die maker. CAD/CAM programmer (wrote the code for CAM software). Robotics programmer.|