PharmaLex is a global leading provider of specialized services for the pharmaceutical, biotech and medical device industries with an international office network and a solid track record of excellence of over 20 years. We provide strategic guidance and comprehensive practical support to commercialize medical technologies in major international markets. Our integrated approach to regulatory affairs, quality, post market surveillance, health economics and reimbursement means we can navigate the entire pathway to the full commercialization of your technology. Our deep expertise with a flexible, strategic approach and a commercial focus never loses sight of your objective - market access.

Digital Medical Arts LLC introduces MAX, an innovative software platform that delivers an interactive multimedia education experience to patients. Created by urologists for urologists, MAX allows physicians to print and email drawings, pictures, documents, and their own writing on the spot. This revolutionary software platform helps doctors accelerate patient interactions, maximize their time and patient satisfaction, and improve productivity.

Hemadvnce is developing next generation bio-therapeutic molecules to diagnose, manage and treat the onset and progression of coagulation disorders. By fusing different proteins via synthetic linkers, we create molecules with super activity and new biological functions. They can then be used to identify genetic alterations in plasma, such as Protein C deficiency and Factor V Leiden (aPC-resistance). Coagulation disorders are the leading cause of death worldwide - Chimeras offer an innovative new solution.

Led company from academic research project to a clinical stage enterprise focused on the development of collagen scaffolds for regenerative medical applications, embarked in pre-clinical and clinical program seeking European approval of an injectable class III Medical Device.Management:• Established and managed a team of 15 including executives, directors and scientists• Directed and executed all financial plans, including securing and deploying over $5M in investments• Managed all negotiations and investor communications• Executed fund-raising campaigns and presentations and coordinated due diligence process for investment and strategic partnerships Product Development/Operations:• Established and managed supply chain including raw material suppliers and contract manufacturers• Performed scale-up analysis and developed protocols for bench-top manufacturing• Coordinated product development with commercialization efforts in pre-launch activities• Oversaw implementation of quality systems for compliance to GMP/GLP & ISO 13485 standardsLegal and Intellectual Property:• Secured and managed portfolio of intellectual property patents, trademarks and domains• Responsible for management of all legal aspects of firm including employee agreements

EternoGen is a medical device start-up company founded by researchers at the University of Missouri and is a spin-out startup from the Biodesign & Innovation Fellowship. The mission of EternoGen is to unlock the potential of Collagen in regenerative medicine through applied nanotechnology. The purpose of the company is to design, manufacture and commercialize novel collagen replenishment therapies for soft tissue therapeutic application. Bringing advanced nanotechnology into the field of protein engineering has allowed EternoGen to create biological implants that are uniquely shielded from enzymatic degradation and work in harmony with the natural physiological processes of the body to deliver lasting natural results.

Top US pharmaceutical benefit management company, division of IT Data Warehousing and Corp Systems • Program administrator for the bid response to a RFP for a multi-billion annual revenue client and designed status metrics over 6 IT departments managing the project budget • Project manager for a $7 million department cost reduction initiative to eliminate 30% of data entry• Provided business analyst support and high-level application design for strategic initiatives• Developed enterprise-wide program management service

Provided consulting on strategic business development and analysis for high-growth potential innovations specialized on:• Pharmaceutical products development plans and regulatory approval analysis• Alternative fuels and market penetration strategies• Business incubation alternatives for business start-ups

Privately owned dietary supplement company focused on powder encapsulated specialty formulations• Engineered and oversaw the implementation of Master Production Records and Material Specifications for over 100 products and raw materials in compliance to nutraceuticals manufacturing, 21 CFR 111• Responsible for the design and implementation of the company’s production scheduling and supply chain system using VBA, substantially reducing transportation costs and product backorders. • Created and oversaw the implementation of Master Production Records and Material Specifications to maintain compliance with new FDA GMP regulations associated with manufacturing of nutraceuticals • Assured and improved Quality control in all operations through the development of quality protocols• Validated raw material analytical chemistry instrumentation and developed homogeneity assays

• Participated in cross functional teams to execute priority projects in a cGMP controlled environment. • Executed implementation plans and presented weekly status reports in departmental meetings of Corrective and Preventive Actions. Helped maintain a 100% success rate for implementation deadlines. • Executed and directed batch record re-engineering and managed changes through change control. • Managed the validation of production equipment for technology transfer of a new product line.

• Designed, rated and sized shell and tube heat exchangers related to quoting procedures.• Trained on quality control inspection of heat transfer equipment as per TEMA and ASME requirements.• Executed Research & Development projects and implemented data analysis algorithms.