Making Miracle Happen
Weiyong Li, Ph.D.
Co-Founder, Chief Scientific Officer
Weiyong Li received his B.S. from the East China Institute of Chemical Technologies in Shanghai, China. After graduation, he worked for the SFDA in Beijing where he first learned the drug filling process. He later came to the United States to pursue post-graduation education with Prof. Daniel Armstrong at the University of Missouri-Rolla. His Ph.D. thesis was on enantiomeric separation by capillary gas chromatography using derivatized cyclodextrin stationary phases. His research efforts resulted in the commercialization of several types of chiral capillary gas chromatographic columns, which are still on the market today. Since earning his Ph.D., Dr. Li has worked in the pharmaceutical industry for about 20 years, most recently as a Research Fellow with Johnson & Johnson Pharmaceutical Research & Development, LLC. He participated in the development and commercialization of several important J&J products including Topamax, Ultram, Evra contraceptive patch and Tapentadol PR. He has extensive experience in analytical method development and validation for supporting late phase pharmaceutical product development. His most recent achievements have been in the area of process analytical technologies, using near infrared spectroscopy and multivariate modeling for fast and non-destructive analysis pharmaceutical products. Dr. Li is the author and coauthor of 40 peer-reviewed manuscripts, book chapters, and review articles. He has given numerous presentations at national and international conferences. He has also served as a peer reviewer for many scientific journals.
Mr. Allen Luo has 17 years of accomplishment as a process and medicinal chemist with DuPont-Merck Pharmaceutical and Johnson & Johnson. At DuPont-Merck, he carried out the chemical development of DMP266, later become Sustiva™ (Efavirenz), a highly successful NNRTI used to treat AIDS. During the tenure at Johnson & Johnson he worked on 6 targets in CNS therapeutic area, each with the improvements in potency, selectivity, bioavailability, and BBB penetration. Mr. Luo is co-founder of NiRACLE, LLC, an innovative Contract Research Organization (CRO), providing Near Infrared (NIR) method development, Process Analytical Technology (PAT), Quality by Design (QbD), formulation and process validation support to the pharmaceutical industry. His is also VP of Technology and Business Development at Astatech Inc, a leading chemistry CRO based in Pennsylvania. Furthermore, he is the founder of North Point Energy (2008), an energy saving firm focusing on China coal fire power plants modification. In 1994 he obtained FAA VFR license (private rating) and continuing to fly today. He is also a long time freelancing writer at Chinese World Journal Daily and Sing Tao Daily. Mr. Luo received MS degree in organic chemistry from Auburn University in 1992 and finished 12 MBA ACS Harvard Course © in 2009
Bill Wei, Ph.D.
Chief Technology Officer
Bill Wei received his Ph.D. in Pharmaceutics from University of Minnesota and B.S. in Pharmacy from Beijing University. Dr. Wei is an expert in numerous drug delivery systems, particularly in controlled release formulations, low-solubility drug formulations, combination products, topical formulations, and injectables. In his distinguished 20+ year industrial career with Roche, Johnson & Johnson, Novartis, NexMed, and Revogenex Inc, he has developed more than 20 products including blockbuster drugs over $1 billion in sales. Dr Wei's expertises expand the entire spectrum of pharmaceutical development including formulation development, process development, regulatory filing, process validation and commercial production. He is the author of 8 formulation patents and 8 publications. He was also adjunct Professor at Rutgers University, New Jersey between 2002 and 2011.
Dr. Pat N. Confalone
VP, Global R&D, E.I. Du Pont de Nemours
Chief Advisor, NiRACLE
A graduate of M.I.T. , he obtained a Ph.D. at Harvard  with Nobel Laureate Prof. R.B. Woodward. After a post doctoral stint  with Prof. R.B. Woodward, directed toward the total synthesis of Vitamin B12, he joined the Chemical Research Department of Hoffmann-La Roche . Moving to DuPont , his Bioorganic Chemistry group developed the fluorescent dye-labeled reagents that were used in automated DNA sequencing, eventually employed in the human genome project. With DuPont's Pharmaceutical Division, Dr. Confalone recruited a world class Medicinal Chemistry department that discovered CozaarTM, a major anti-hypertensive based on angiotensin II antagonism. After 22 years in Discovery Research, he moved into pre-clinical development and built a highly successful Chemical Process R&D organization that carried out the chemical development of CozaarTM and SustivaTM, a highly successful NNRTI used to treat AIDS. Currently, he is Vice President, of Global R&D, DuPont Health, Nutrition, and Crop Protection.
Dr. Confalone has presented more than 110 invited or plenary lectures worldwide, published over 140 papers and obtained over 50 U.S. Patents. He has received honors and awards, including the Harvard Graduate Society Prize, the Alpha Chi Sigma Award, and was nominated to the Harvard Society of Fellows. Dr. Confalone was Chairman of the Natural Products Gordon Conference and appointed to Editorial Advisory Boards of Current Drugs, Bioorganic and Medicinal Chemistry, The Journal of Organic Chemistry, Synlett, Progress in Heterocyclic Chemistry, Synthesis, Medicinal Chemistry Research, Medicinal Chemistry Letters, and Drug Design and Discovery. He was elected Chair of the Organic Division of the ACS, Chairman of the ACS Committee on Chemistry and Public Affairs, and was recently elected to the ACS Board of Directors. He is on the governing boards of the Council for Chemical Research, the United States National Committee for IUPAC, and is an elected fellow of the American Association for the Advancement of Science.Dr. Confalone has presented >110 invited or plenary lectures worldwide, published >140 papers and obtained >50 U.S. Patents. He has received honors and awards, including the Harvard Graduate Society Prize, the Alpha Chi Sigma Award, and was nominated to the Harvard Society of Fellows. Dr. Confalone was Chairman of the Natural Products Gordon Conference and appointed to Editorial Advisory Boards of Current Drugs, Bioorganic and Medicinal Chemistry, The Journal of Organic Chemistry, Synlett, Progress in Heterocyclic Chemistry, Synthesis, Medicinal Chemistry Research, Medicinal Chemistry Letters, and Drug Design and Discovery. He was elected chair of the Organic Division of the ACS, chairman of the ACS Committee on Chemistry and Public Affairs, and was recently elected to the ACS Board of Directors. He is on the governing boards of the Council for Chemical Research, the United States National Committee for IUPAC, and is an elected Fellow of the American Association for the Advancement of Science.
|Method Development||Process Validation||Troubleshooting||Material Identification||User Training|
|NiRACLE assists clients in developing NIR-based methods for both GMP and non-GMP applications. Non-GMP NIR methods take advantage of NiRACLE’s proprietary modeling method and designing a comprehensive sampling plan.||NiRACLE is specialized in multivariate data analysis, which plays a critical role in today’s process validation.NiRACLE works with clients in selecting suitable process monitoring methods and designing a comprehensive sampling plan.||Using NIR chemical imaging and multivariate data analysis tools, NiRACLE can assist clients in troubleshooting product and process related problems.||NiRACLE can help clients in developing a NIR-based raw material identification system to replace the conventional wet chemistry methods.||NiRACLE provides training in basic and advanced NIR/NIR chemical imaging related method development, which include proper use of instruments, experiment design and multivation...|
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