Quality Alchemist (品質煉金術師): HKSTP 2nd Hong Kong & Guangzhou International Conference on Stem Cell and Regenerative Medicine

2016年12月16日星期五

HKSTP 2nd Hong Kong & Guangzhou International Conference on Stem Cell and Regenerative Medicine

Hong Kong Science and Technology Parks Corporation (HKSTP) and Guangzhou Institutes of Biomedicine and Health (GIBH) co-organized the 2nd Hong Kong & Guangzhou International Conference on Stem Cell and Regenerative Medicine that was held on 16 December 2016. A half-day session on 15 Dec engaged regulatory agency representatives and academics to discuss some polices for regulating stem cell research and cell therapies. Today, stem cell regulation system among different countries would be shared and discussed. Minda and I also took a photo in front of HeathBaby booth.

In the beginning, Mrs Fanny Law Fan Chiu-fun, GBS, JP (Chairperson, HKSTP) gave welcome speech. She said stem cell brought innovation of bioscience and made Hong Kong to be Cell Therapy Centre. Hong Kong, Guangzhou and Shenzhen should be more collaboration. Based on demand increasing, HKSTP would build more laboratory site for bioscience.

The Honourable C.Y. Leung (Chief Executive, Hong Kong Special Administrative Region) gave an opening remark. He said this is his three visits to Science Park in these two months. Stem cell research and regenerative medicine were the major goals of “Innovation 2020” plan of the Chinese Academy of Sciences. Moreover, we had siet over US$2.3 billion on promoting Innovation and Technology (I&T) included US$250 million to finance mid-stream research in universities. He hoped that the Government, the academia, the industry and the community worked together for stem cell and regenerative medicine for the betterment of life. (Full CE speech at http://www.info.gov.hk/gia/general/201612/16/P2016121600334.htm )

Prof. Bai Chunli (President, Chinese Academy of Sciences) was our Guest of Honour and gave a guest speech. Prof. Bai said stem cell was one of most growing areas in bioscience. They had cooperated with HKU and CUHK for some projects. He expected to enhance Hong Kong and Guangzhou collaboration in bioscience.

Then Prof. Bai presented the plate “Guangzhou Institutes of Biomedicine and Health – Hong Kong Center, Chinese Academy of Sciences” to Prof. Pei Duanquing for celebrating the establishment of center in Hong Kong.

Prof. Pei Duanqing (Professor and Director General, Guangzhou Institutes of Biomedicine and Health (GIBH), Chinese Academy of Science) gave a speech. He said medical revolution had happened in the past decade. There were many exchange opportunity in Guangzhou through different conference.

Then Mr. Michael T. Murphy (Chief Development Officer, The National Academies of Sciences, Engineering and Medicine) gave a speech. He said they started DNA research and stem cell since 2005. They would focus to genetic engineering, medical device, and clinic trial and therapy.

The first speaker was Prof. Marc Turner (Medical Director, Scottish National Blood Transfusion Service, Scotland) and his presentation topic entitled “Current Regulatory Landscape – Similarities and Differences”. Firstly, he introduced the working group on Premises Processing Health Products for Advanced Therapies in Nov 2012. It was discussed the regulatory framework to ensure public health and safety for medical treatments and clinical trials. They aimed to identify gaps in the current principles and processes for cell therapy regulations.

Then all guests and speakers were took a group photo.

Then Prof. Marc Turner (Medical Director, Scottish National Blood Transfusion Service, Scotland) presented his 2nd topic was “Operational Challenges in the Manufacture of Cellular Therapies”. Firstly, he introduced the Scottish National Blood Transfusion Service.

The Scottish Centre for Regenerative Medicine was briefed which occupation was in Aug 2011, MHRA/HTA licensure in Apr 2013 and the first product release was in Dec 2013. The floor plan of SCRM Translational Unit was demonstrated.

After that Prof. Marc Turner explained the Supply / Value Chain for Substances of Human Origin from Donor, to Procurement, to Processing or Manufacture, to Distribution and then to Recipient.

At the end, Prof. Turner mentioned their product development. I like this statement “Start with the end in mind”.

The second speaker was Dr. Jacqueline Barry (Director of Regulatory Affairs, Cell and Gene Therapy Catapult, UK) and her presentation topic named “The Regulatory Landscape for Cell and Gene Medicinal Products in the EU”. In the beginning, Dr. Barry briefed cell therapy clinical trials by year from 2013 to 2015 in UK that Phase I, I/II, II, II/III and III were increasing trend.

Then she briefed EU (28 member states), European Commission (Legislation) and European Medicines Agency (EMA). Advanced Therapy Medicinal products (ATMP) related legislations included Medicinal product (2001/83/EC) and ATMP (Reg 2007/1394 and 2009/120/EC amending 2001/83/EC). The related legislation summary was demonstrated in the following diagram.

The legislation flow chart was showed as follows.

Finally, Dr. Barry briefed the requirement of Good Manufacturing Practice GMP Directive 2003/94/EC. There had three part and part I included 9 chapters.

The third speaker was Prof. Martin Pera (Professor of Stem Cell, University of Melbourne) and his topic was “The Ethics and Science of Stem Cell Research and Therapy”. Prof. Pera recommended the “Guidelines for Stem Cell Research and Clinical Translation” issued by ISSCR on 12 May 2016.

Assessment of Cellular Therapeutics for Approval in Australia had four levels. Level 1 was the lowest possible risk and Level 4 required the highest level of assessment. The operational procedure was demonstrated as following diagram.

Laboratory stem cell research had current questions in ethics and regulatory policy showed as follows:

- The 14 day rule for embryo research in vitro

- Embryo like structures from pluripotent stem cells

- Artificial gametes

- Advances in gene editing in the light of the above

- Mitochondrial replacement therapy

Prof. Pera frequently mentioned the maximum penalty for 14 Offence was imprisonment for 15 years!

He also briefed the mitochondrial replacement therapy for mitochondrial disease. I remembered I had met Dr. Han-Chung Cheng (鄭漢中) who was Chairman of Taiwan Mitochondrion Applied Technology Co., Ltd. and employed this technique during CSQ Annual Dinner 2016. (https://qualityalchemist.blogspot.hk/2016/11/hksq-study-mission-for-industry-40-day_18.html )

Prof. Philip Newsome (Director of Centre for Liver Research / Professor of Hepatology, University of Birmingham) was the fourth speaker and his topic named “Stem Cell Therapy for Liver Fibrosis”. Prof. Newsome introduced that Hepatic stellate cells (HSC) are pericytes found in the perisinusoidal space of the liver. The stellate cell is the major cell type involved in liver fibrosis, which is the formation of scar tissue in response to liver damage.

His research about how MSC anti fibrotic mechanism was descripted as following diagram. Finally he concluded haematopoietic stem cells could be compelling pre-clinical efficacy but NOT clinically. However, role of mesenchymal stromal cells (MSC) was still unproven.

Dr. John J. Casey (Director of the Scottish National Islet Transplant Programme and Chair UK Pancreas Transplant Advisory Group, University of Edinburgh / Royal Infirmary of Edinburgh) was the fifth speaker and his topic entitled “Cell Therapy for Diabetes – Clinical and Translational Advances”.

Firstly, Dr. Casey introduced the Centre for Regenerative Medicine in the University of Edinburgh and the whole process flow of cell therapy for diabetes. He briefed the diabetes mellitus (DM) that would raise blood glucose concentration. Type I – autoimmune destruction of beta cells (15%) and Type II – insulin resistance or beta cell dysfunction. Where life expectancy in Type I DM reduced by 20%!

Dr. Casey said simultaneous Pancreas and Kidney transplant could have >85% insulin independence, >90% 1 year kidney graft survival and reduction in complications of DM. The yellow color was Pancreas. 1-2% of mass of pancreas contained Beta cells (65-80%), Alpha cells (15-20%), Delta cells (3-10%) and PP cells (1%)

The following diagram was the Isolation lab floor plan design. There had some regulation and quality assurance requirement below:

- EU Tissue and Cells Directive – Sept 10 – HTA to regulate islet cells,

- Human Tissue (Scotland) Act 2006,

- Virology testing,

- Bacteriology testing, etc.

Finally, Dr. Casey concluded a proof of principal that cell therapy for diabetes worked and regenerative strategies could produce functional cells for transplantation.

Prof. Li-Huei Tsai (Professor and Director, Massachusetts Institute of Technology,) was the last speaker and her topic named “Illuminating Alzheimer’s Disease through Epigenetic Fingerprinting and Tissue Engineering using IPSCs”. She said Alzheimer’s disease is a global epidemic.

Then Prof. Tsai showed the normal and Alzheimer’s diagram to explain the different that Amyloid plagues appeared in Alzheimer’s disease brain.

Most of drug trails for Alzheimer’s disease (AD) were not success in Phase 3.

The flow of therapeutic intervention of AD was discussed from Prevention to Treatment and to Symptom Management. Finally, she summarized that AD phenotypes in organoids from fAD patient-derived iPSCs (induced pluripotent stem cells). These observations indicated that AD patient derived 3D cultures could serve as a powerful tool for screening small molecules for the purpose of therapeutic intervention.

At the end of conference, Prof. Lap-Chee Tsui, GBM, GBS, JP (President of The Academy of Science of Hong Kong; President of Victor and William Fung Foundation) gave closing remarks.