Edgar Nicolas Email & Phone Number

Exton, Pa

Alfa-Bits is a small company with big ideas. Our goal is to design, develop, and make available innovative games and puzzles that will benefit society through entertainment, family bonding, education, and cognitive maintenance and rehabilitation. Wabbits, our initial and flagship product, takes word games to a higher level. Skill (fast thinking, sharp eyes, and quick hands) and some luck are needed to win. Kids and adults can compete on even terms so anyone can win. The game is fast and interactive with as many as 8-12 players simultaneously trying to form words. Loud fun is mixed with focus and alertness. A game lasts just 10-15 minutes, but it is never over until the last carrot has been won. We are growing our product line by working with educators to refine AYBE, our educational game set. Many games can be played with the set, each targeted towards the learning needs of each student. AYBE will be commercialized soon at an affordable price, so as to help disadvantaged children. All Alfa-Bits games and puzzles are based on word bits (fixed letter sets that can be paired with each other to form a word). The difficulty can be dialed up or down to match the skills of each player. Designed to be played as solitary, cooperative, or competitive activities, they are suitable for schools and clinical settings. Children in special ed and gifted child programs as well as ESL students can learn the alphabet, spelling, and/or reading while playing. Key products have been tested in senior living facilities and doctors' offices. Results indicate that aging adults can maintain their cognitive and motor skills by playing; and patients recovering from stroke or other brain trauma can also benefit. Hence, we will keep working with doctors, scientists, and other health care professionals to identify how these puzzles and games can be used as tools for maintaining, improving, or recovering certain brain functions critical to a good quality of life.

Serve as global head of the analytical function supporting toxicology and safety phamacology in seven sites. Coordinate the creation and improvement of harmonized systems and procedures used for activities such as method validation and transfer, GLP-complaint sampling and analysis of formulations, and documentation and CTD-compliant report writing. Member of Global GLP Compliance Committee. Member of global advisory committee on genotoxic impurities (GTI's); leader and organizer of GTI training in multiple sites; co-chair of special multi-site project meetings to discuss GTI's; and creator and administrator of a GTI eRoom used for project management of GTI's across departments. Other responsibilities include global coordination of Safety and global coordination of Training for the Global Analytical Sciences Department.

Headed the Analytical Sciences Department in the US, collaborating with Pharmaceutical Sciences, Chemical and Process Development, Industrial Affairs, Toxicology, and similar analytical departments in other sites (in Europe). Supervised directors of in charge of Analytical Development, Quality Control, Chemical Development Support, Molecular and Physical Characterization, Industrial Technical Services, and CMC Dossier Preparation. Created and coordinated a global team that linked the Molecular and Physical Characterization functions in all the company sites.

Restructured and led the analytical function supporting the development and scale up of the synthetic process for new chemical entities. Directed several groups responsible for testing raw materials, intermediates and drug substance for developmental projects from pre-clinical to phase III stage. Introduced and routinely utilized new technologies such as supercritical fluid chromatography, LC-MS-MS, and chiral chromatography. Strengthened GMP compliance.

Managed quality control department composed of groups in two sites for Ganes, a Swiss-owned toll API manufacturer in New Jersey. Introduced and implemented GMP concepts and requirements to the company. Tested and released raw materials, intermediates and drug substance according to USP and EP specifications.

Worked for Mead Johnson, a Bristol Myers company. Led a group of analysts performing quality control testing of infant formula and multi-vitamin products. Developed HPLC methods that simultaneously determined multiple analytes, some at trace levels and many unstable, in very complex matrices. Introduced numerous improvements that resulted in significant efficiency gains in terms of samples analyzed per day.