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  Newsletter Issue 2, 12 August 2015

 

 

 

Supporters

STEM CELL SOCIETY SYMPOSIUM 2015

"Opportunities & Challenges in Stem Cell Based Medicine"

17 -18 November 2015

Matrix Building
30 Biopolis Street, Singapore 138671

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Dear Members, Friends, Supporters, and Colleagues,

In this issue of the newsletter we present the profiles of Paula Salmikangas from the Finnish Medicines Agency, Finland and Udi Sarig from Nanyang Technological University, Singapore.

Please note that the Early-bird Registration and the Oral Abstract Submission deadline is on the

11 September 2015.

Don't miss the opportunity that your abstract gets selected as an oral presentation. Oral abstract submission cannot be consider after this deadline.

Enjoy reading about two of our plenary speakers and do register early to save some funds!

To learn more about the symposium, follow this LINK.

To register, click HERE.

In case you have any queries, contact us HERE.

The Organizing Committee "Stem Cell Society Singapore Symposium 2015"

 

 

 

 

 

Featured Speakers  

Paula SALMIKANGAS

Finnish Medicines Agency, Finland

 
Abstract  
Challenges and successes of Advanced Therapy Medicinal Products (ATMPs): the European perspective

 

A new framework for gene and cell therapy medicinal products and tissue engineered products was established in the European Union in 2009, when Regulation 1394/2007 came into force. For all three product classes, called Advanced Therapy Medicinal Products, a centralized marketing authorization became mandatory.  The European Medicines Agency (EMA) together with its´ Committee for Advanced Therapies (CAT), Committee for Human Medicinal Products (CHMP) and the network of national Agencies is responsible for scientific evaluation of the marketing authorization applications (MAA).

For a new application, data and information relating to manufacturing processes and quality control of the active substance and the final product have to be submitted for evaluation together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMPs are defined in the legislation and guidance for different products is available through several EMA/CAT guidelines. Since the regulatory framework for ATMPs was established, five ATMPs have been licensed in EU, namely

ChondroCelect and Maci for cartilage repair, Glybera for treatment of LPL deficiency, Provenge for treatment of metastatic prostate cancer and most recently, Holoclar, for treatment of limbal stem cell deficiency caused by ocular burn.

Despite of only few licensed products, the pipeline of new ATMPs is much bigger, as seen from the significant numbers of different products discussed by the CAT in scientific advice and classification procedures.

Due to the diversity of ATMPs, a tailored approach for regulating these products is considered necessary. Thus, a risk-based approach has been introduced for ATMPs allowing flexibility for the regulatory requirements. Developing novel products may always be challenging and for ATMPs, several obstacles have been already identified. European Commission together with EMA and its´ Committees is looking for possibilities to enhance early access of promising products, including ATMPs, for unmet medical needs.

Biography Office webpage PubMed

 

Dr Salmikangas is a biochemist by original training, with a Ph.D. in muscle cell biology. Her main research work career has been in cell and molecular biology of various inherited diseases. Since 2006, she has been an Adjunct Professor of Biochemistry for the University of Helsinki.

Dr Salmikangas has worked as a senior researcher at Finnish Medicines Agency, Finland since 2003. Her main areas of expertise are biological medicinal products, especially cell-based medicinal products and combination products.

 

Dr Salmikangas has been a member and chair of Cell Products Working Party (CPWP) in the European Medicines Agency (EMA) during 2005 and 2012. She has been the Vice-Chair and member of the Committee for Advanced Therapies (CAT) from 2009 to 2014 and since February 2014, the Chairperson of the CAT.

Interview  

Where do you think stem cell research will be with regards to clinical application in 5-10 years’ time?

I´m sure there will be many successful cell-based therapies commercially available and some disease treatments have totally changed due to the innovative treatments. However, I also see many unsolved constraints for stem cell products (e.g. tumourigenicity) that need to be resolved before they can become clear treatment options.

What in your opinion will potentially be the next major breakthrough in stem cell research?

Most probably MSC-based products for various indications.

What do you believe is the most promising direction in stem cell research?

At the moment, MSC-based therapies and tissue-specific stem cells (progenitors) like limbal stem cells.

From which other scientific fields would you suggest stem cell researchers could benefit the most?

Medical devices, especially combination of novel matrices with cells, 3D printed individual devices for tissue defects etc..

What would you tell a student asking for advice whether to pick up a career in the stem cell field?

I would tell this area is full of potential, but still requires a lot of work for success.

How many medically approved allogeneic stem cell therapy products are currently available in the market (anywhere in the world)?

In Europe none, but I expect this to change within next years to come.

Your company's banner could be here. Contact us.

Udi SARIG

Nanyang Technological University, Singapore

 

 
Abstract  
Extracellular Matrix and Stem Cells – a STARTling bioactive dialogue  

The Singapore Technion Alliance for Research and Technology (START) aims to develop intermediate and long term regenerative-medicine solutions for the failing heart. A highly bioactive porcine cardiac extracellular matrix (pcECM) scaffold is produced in our labs as an ultimate cardiac regenerative medicine scaffold, and an ideal tool to study ECM interactions with various multi- and pluri-potent stem cells.

Lessons from this complex dialogue will be presented shedding light on stem cell plasticity phenomena in an ECM bioactive environment. These phenomena are challenging tissue engineering dogmas, and the value of end product purities for regenerative medicine applications.

Biography PubMed  

Udi Sarig earned his PhD from the faculty of Biotechnology and food engineering, Technion - Israel institute of technology, under the supervision of Prof Marcell Machluf. He is a member of the Tissue Engineering and Regenerative medicine International Society (TERMIS) and the Singapore Stem Cell Society (SSCS) and a co-author of more than 20 publications in international recognized peer reviewed journals and scientific conferences. Nowadays he is working as a postdoctoral research fellow (Nanyang Technological University, NTU) and a group leader in the regenerative medicine initiative in cardiac restoration therapy under the Singapore–Technion Alliance for Research and

Technology (START) at the campus for research excellence and technological enterprise (CREATE) in Singapore.

His research focuses on the development of a functional tissue engineered cardiac patch and employs various tissue engineering approaches to regenerate the infarcted myocardium both in vitro and in vivo. His talk will address the challenges, problems and achievements obtained in this ongoing research endeavor, from an ECM-stem cell dialogue perspective, focusing on human multi- and pluri-potent stem cells as two complementary cell sources.

Interview

 

What was the first phenomenon you can recall that fascinated you to do science?

The complexity of a human hair follicle and blood sample when observing them with a kids light microscope at home at the age of 7.

What is your most memorable career achievement?

Observing the actual sprouting of functional new blood vessels from recreated vascular beds ex vivo, supplying a thick and human applicable sized tissue with a custom bioreactor unit, which we designed.

What attracted you to a career in Science?

The ability to make a contribution to mankind and leave a legacy behind me which can better the biomedical sector and patients alike.

Who are your scientific heroes/role models and why?

My scientific role models change with time along with my perspective I guess. As an undergraduate, Isaac Newton, Charles Darwin and Gregor Mendel were the ones I looked up to for their ability to observe the same phenomena everyone else took for granted, ask the right questions and boldly produce a theory which could explain their findings even if it had far reaching implications with little mechanistic understanding; As a graduate student – my mentor Prof Marcelle Machluf served (and still is) as an inspiration – for the laborious work required on a daily basis in order to get funding, teach and produce valuable insights and results as well as to her ability to manage million issues simultaneously without neglecting anything while getting the maximum out of each person around her.

What publication(s) had the most influence on you and why?

Dogma changing ones like the Yamanaka article on the production of induced pluripotent stem cells – such article don’t provide only a marginal improvement over previous work. Without of course decrying the importance of other works as well (present company included) dogma changing articles can revolutionize the entire field and achieve a leap forward in many related fields as well.

What influenced you to pursue stem cell research?

It really fascinated me – the ability to monitor, control and direct cell fate is the closest bio-medical scientists, like me, can get to playing with god’s building blocks. This way we can hope to one day generate viable solutions that can better the human condition.

Do you believe stem cells will ever be successful commercially?

Yes, probably first with human mesenchymal stem cells and the like. However, cell source – allogeneic vs. autologous – is still an issue of concern to me, particularly from actual medical application perspectives. While allogeneic cells are more easily produced and scaled up, working on autologous cells is much more relevant sometimes however it is also much more tedious and required a different ultrastructure and approach altogether, one which in some aspects actually exists here in Singapore.

© 2015 Stem Cell Society Singapore