NCKU signed a MOU with ScinoPharm Taiwan on Nov. 24th
Tainan, TAIWAN, Nov. 24th
National Cheng Kung University (NCKU), Taiwan signed a MOU with ScinoPharm Taiwan Ltd. on Nov. 24th. The NCKU President, Academician Michael M.C. Lai (賴明詔), attended together with Prof. Chyi-Her Lin (林其和), the Dean of the College of Medicine, Prof. Pin-Wen Lin (林炳文), the Superintendent of the NCKU Hospital, Prof. Ih-Jen Su (蘇益仁), the Deputy Superintendents of the NCKU Hospital, Prof. Ming-Jer Tang (湯銘哲), the Vice President of Academic Affairs, Prof. Jung-Chun Huang (黃榮俊), the Associate Vice President for R&D, Prof. Yung-Nane Yang (楊永年), the Associate Vice President for R&D and the Division Head of University Development, and Distinguished Professor Shu-Hui Chen (陳淑慧) from Institute of Bioinformatics.
Dr. Jo Shen (馬海怡), the President and CEO of ScinoPharm Taiwan, also attended together with Dr. Hardy W. Chan (詹維康), the Executive Vice President & Chief Scientific Officer of ScinoPharm Taiwan and the President of ScinoPharm Biotech and ScinoPharm Kunshan, China, Dr. Kuo-Hsi Cheng (鄭國喜), the Vice President for Operations, Ms. Jessie Wang (汪小鶯), the Director of Human Resource and Public Relationship, Ms. Min-Ling Cheng (鄭敏苓), Corporate Development Project manger, and Ms. Sabrina Wu (吳英英), the Corporate Communications Manager.
According to the MOU, NCKU and ScinoPharm, Taiwan, both agree to encourage and promote cooperation in developing novel therapeutic agents and enabling technologies, as well as building competitive advantage in the knowledge-based industries in the greater China region and other territories. Moreover, they will also facilitate the relevant training of team members which are needed for the projects through exchanges of personnel on a mutually beneficial basis, and will explore opportunities for cooperation in any other areas of mutual interests.
“This is a good start between NCKU and ScinoPharm Taiwan Ltd. I hope to establish the university-industry cooperation and make a big breakthrough on the development of biotechnology industry in the future, which is one of the key industries for the future as declared by the Executive Yuan,” said President Lai.
Biotechnology and pharmaceutical industry has been developed for 20 years, and has especially made a big progress in the past 10 years. It is also one of the six emerging industries specially selected by the Executive Yuan for intensive development. Universities and higher education in Taiwan have produced many graduates with related majors every year. However, the unemployment rate is relatively the highest in biotechnology industry, compared to the other industries. Obviously, students’ trainings in universities could not fit into the demand of this industry. On the other hand, Taiwan has relatively succeeded in the upstream R&D of the biotechnology and pharmaceutical industries. However, the fruitful R&D outcomes from the upstream could not be smoothly transferred to the downstream production in the biotechnology and pharmaceutical industries. Almost all scientists in the upstream R&D were trained from universities and did not learn corporate management in colleges, which led to miscommunication between the upstream R&D and the downstream production, and eventually the misfortune of the biotechnology and pharmaceutical industries. There is a common saying that the successful industries are almost those without any scientists’ involvement. Scientist did not know how to organize and operate the industry. This has posted quite a difficult task in Taiwan, especially in biotechnology area. Therefore, President Lai appreciated and praised that NCKU had the opportunity to collaborate with ScinoPharm Taiwan Ltd, which is considered as the top of Taiwan’s biotechnology and pharmaceutical industries.
“To be honest, without the cultivation and assistance of NCKU, there would be no ScinoPharm Taiwan Ltd today,” said Dr. Jo Shen. She appreciated the contribution and kind help of NCKU. There are so many employees from NCKU. Even more, the first two laboratories of ScinoPharm Taiwan were in the Chemical Engineering Buildings of NCKU. That is, the first-day-at-work of ScinoPharm’s senior employees in the company was indeed at NCKU. “NCKU has the opportunity to become the most competitive biosimilar clinical center over the world. Both of us hope to establish the collaborative relationship in the exchange of students, education, and R&D. We also sincerely hope to have closer relationship with NCKU, especially in biotechnology development,” said Dr. Jo Shen.
ScinoPharm has expanded its chemistry-based API business into the biopharmaceutical area. In addition to the development of biopharmaceutical products and their production technologies, ScinoPharm would leverage NCKU’s recourses by building the standard operating procedure (SOP) of biosimilar clinical trials. “We hope that NCKU will lead the biotechnology industry over the top one around the world through the collaboration,” said Dr. Jo Shen.
About Biosimilar
(Full text available or see the Library of Congress website and search with H.R. 1548.)
Biosimilar or Follow-on biologics are terms used to describe officially approved new versions of innovator biopharmaceutical products, following patent expiry. Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to manufacturing process changes. The follow-on manufacturer does not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process. Finally, nearly undetectable differences in impurities and/or breakdown products are known to have serious health implications. This has created a concern that copies of biologics might perform differently than the original branded version of the drug.
However, similar concerns also apply to any production changes by the maker of the original branded version. So new versions of biologics are not authorized in the US or the European Union through the simplified procedures allowed for small molecule generics. In the EU a specially-adapted approval procedure has been authorized for certain protein drugs, termed "similar biological medicinal products".
This procedure is based on a thorough demonstration of "comparability" of the "similar" product to an existing approved product. In the US the Food and Drug Administration (FDA) has taken the position that new legislation will be required to address these concerns. Additional Congressional hearings have been held, but no legislation had been approved as of December 2007. On March 17, 2009, the Pathway for Biosimilar Act was introduced in the House.
About generic drugs
A generic drug (generic drugs, short: generics) is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active pharmaceutical ingredient (API).
A generic must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use. The FDA's use of the word identical is very much a legal interpretation, and is not literal. In most cases, generic products are available once the patent protections afforded to the original developer have expired.
National Cheng Kung University (NCKU), Taiwan signed a MOU with ScinoPharm Taiwan Ltd. on Nov. 24th. The NCKU President, Academician Michael M.C. Lai (賴明詔), attended together with Prof. Chyi-Her Lin (林其和), the Dean of the College of Medicine, Prof. Pin-Wen Lin (林炳文), the Superintendent of the NCKU Hospital, Prof. Ih-Jen Su (蘇益仁), the Deputy Superintendents of the NCKU Hospital, Prof. Ming-Jer Tang (湯銘哲), the Vice President of Academic Affairs, Prof. Jung-Chun Huang (黃榮俊), the Associate Vice President for R&D, Prof. Yung-Nane Yang (楊永年), the Associate Vice President for R&D and the Division Head of University Development, and Distinguished Professor Shu-Hui Chen (陳淑慧) from Institute of Bioinformatics.
Dr. Jo Shen (馬海怡), the President and CEO of ScinoPharm Taiwan, also attended together with Dr. Hardy W. Chan (詹維康), the Executive Vice President & Chief Scientific Officer of ScinoPharm Taiwan and the President of ScinoPharm Biotech and ScinoPharm Kunshan, China, Dr. Kuo-Hsi Cheng (鄭國喜), the Vice President for Operations, Ms. Jessie Wang (汪小鶯), the Director of Human Resource and Public Relationship, Ms. Min-Ling Cheng (鄭敏苓), Corporate Development Project manger, and Ms. Sabrina Wu (吳英英), the Corporate Communications Manager.
According to the MOU, NCKU and ScinoPharm, Taiwan, both agree to encourage and promote cooperation in developing novel therapeutic agents and enabling technologies, as well as building competitive advantage in the knowledge-based industries in the greater China region and other territories. Moreover, they will also facilitate the relevant training of team members which are needed for the projects through exchanges of personnel on a mutually beneficial basis, and will explore opportunities for cooperation in any other areas of mutual interests.
“This is a good start between NCKU and ScinoPharm Taiwan Ltd. I hope to establish the university-industry cooperation and make a big breakthrough on the development of biotechnology industry in the future, which is one of the key industries for the future as declared by the Executive Yuan,” said President Lai.
Biotechnology and pharmaceutical industry has been developed for 20 years, and has especially made a big progress in the past 10 years. It is also one of the six emerging industries specially selected by the Executive Yuan for intensive development. Universities and higher education in Taiwan have produced many graduates with related majors every year. However, the unemployment rate is relatively the highest in biotechnology industry, compared to the other industries. Obviously, students’ trainings in universities could not fit into the demand of this industry. On the other hand, Taiwan has relatively succeeded in the upstream R&D of the biotechnology and pharmaceutical industries. However, the fruitful R&D outcomes from the upstream could not be smoothly transferred to the downstream production in the biotechnology and pharmaceutical industries. Almost all scientists in the upstream R&D were trained from universities and did not learn corporate management in colleges, which led to miscommunication between the upstream R&D and the downstream production, and eventually the misfortune of the biotechnology and pharmaceutical industries. There is a common saying that the successful industries are almost those without any scientists’ involvement. Scientist did not know how to organize and operate the industry. This has posted quite a difficult task in Taiwan, especially in biotechnology area. Therefore, President Lai appreciated and praised that NCKU had the opportunity to collaborate with ScinoPharm Taiwan Ltd, which is considered as the top of Taiwan’s biotechnology and pharmaceutical industries.
“To be honest, without the cultivation and assistance of NCKU, there would be no ScinoPharm Taiwan Ltd today,” said Dr. Jo Shen. She appreciated the contribution and kind help of NCKU. There are so many employees from NCKU. Even more, the first two laboratories of ScinoPharm Taiwan were in the Chemical Engineering Buildings of NCKU. That is, the first-day-at-work of ScinoPharm’s senior employees in the company was indeed at NCKU. “NCKU has the opportunity to become the most competitive biosimilar clinical center over the world. Both of us hope to establish the collaborative relationship in the exchange of students, education, and R&D. We also sincerely hope to have closer relationship with NCKU, especially in biotechnology development,” said Dr. Jo Shen.
ScinoPharm has expanded its chemistry-based API business into the biopharmaceutical area. In addition to the development of biopharmaceutical products and their production technologies, ScinoPharm would leverage NCKU’s recourses by building the standard operating procedure (SOP) of biosimilar clinical trials. “We hope that NCKU will lead the biotechnology industry over the top one around the world through the collaboration,” said Dr. Jo Shen.
About Biosimilar
(Full text available or see the Library of Congress website and search with H.R. 1548.)
Biosimilar or Follow-on biologics are terms used to describe officially approved new versions of innovator biopharmaceutical products, following patent expiry. Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to manufacturing process changes. The follow-on manufacturer does not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process. Finally, nearly undetectable differences in impurities and/or breakdown products are known to have serious health implications. This has created a concern that copies of biologics might perform differently than the original branded version of the drug.
However, similar concerns also apply to any production changes by the maker of the original branded version. So new versions of biologics are not authorized in the US or the European Union through the simplified procedures allowed for small molecule generics. In the EU a specially-adapted approval procedure has been authorized for certain protein drugs, termed "similar biological medicinal products".
This procedure is based on a thorough demonstration of "comparability" of the "similar" product to an existing approved product. In the US the Food and Drug Administration (FDA) has taken the position that new legislation will be required to address these concerns. Additional Congressional hearings have been held, but no legislation had been approved as of December 2007. On March 17, 2009, the Pathway for Biosimilar Act was introduced in the House.
About generic drugs
A generic drug (generic drugs, short: generics) is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active pharmaceutical ingredient (API).
A generic must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use. The FDA's use of the word identical is very much a legal interpretation, and is not literal. In most cases, generic products are available once the patent protections afforded to the original developer have expired.
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