Day 2 - 23 April 2013

8:00-9:30	Registration
09:30 - 10:10 Plenary Session: Chair: Avi Treves	Adult MSCs: The New Medicine Arnold Caplan Biology, Case Western Reserve University, Cleveland, USA
10:10 - 10:40	Coffee break
	Hall A - Rayman Central	Hall B - Rayman West
10:40-12:20	Session E: Translational Research & Bio Banking Chair: Yehudit Cohen Scientific Director - Institutional Tissue Banks, Sheba Medical Center, Israel	Session F: Supporting Environment Chair: Arik Hasson Executive VP, Research & Development, Kadimastem Ltd., Israel
10:40 - 11:00 Keynote Lectures	Stem Cell Derived Nano-Vesicles, a New Platform Targeting the Tumor Bed Marcelle Machluf Faculty of Biotechnology and Food Engineering, Technion - Institute of Technology, Haifa, Israel	Bringing Cell Therapies into Clinical Routine Dirk Balshuesemann Clinical Business, Miltenyi Biotec GmbH, Bergisch Gladbach, Germany
11:00 - 11:20	Human Umbilical Cord Blood: More than a Source of Hematopoietic Stem Cells: Neurological Potential Arnon Nagler Sheba Medical Center, Ramat Gan, Israel	Building Bridges from Research to Therapy: Enabling the Utilization of Human Induced Pluripotent Stem Cells for Clinical Therapies Thomas Fellner Pluripotent Stem Cell Innovation Center, Lonza, Inc., Walkersville, USA
11:20 - 11:40	The Role of Pluripotent Stem Cells in Modeling Human Disorders and in Drug Screening Nissim Benvenisty Stem Cell Unit, Genetics, Hebrew University, Jerusalem, Israel	Current Regulatory and cGMP Compliance Trends for Cellular Therapeutics and the Challenges in Translation to Late-Stage Commercial-Ready Manufacturing Alan Moore VP Testing and Cell Services, WuXi AppTec Philadelphia, USA
11:40 - 12:00	Building Quality Biological Collections to Maximize Use Katheryn Shea Precision Bioservices, Inc., Frederick, USA	Intellectual Property Issues Related to Cell-Based Inventions Leora Havin Biotech, Ehrlich and Fenster, Ramat Gan, Israel
12:00 - 12:20	IPS Stem Cell Banking Ida Biunno IRGB, IRGB-CNR, Milan, Italy	Stem Cells in Preclinical Studies: Choosing the Optimal Animal Model Judith Ben-Porath Pharmaseed, Israel
12:20 - 12:40	Human Embryonic Stem Cells – From Bench to Bedside Benjamin Reubinoff Sidney and Judy Swartz Embryonic Stem Cell Research Center, Hadassah University Medical Center, Jerusalem, Israel	Supportive Methodologies Utilized in the Development of an Autologous Cell Product (BGC101) Yael Porat BioGenCell Ltd., Sanz Medical Center, Laniado Hospital, Netanya, Israel
12:30 - 14:00	Lunch break
14:00 - 14:40 Plenary Session: Chair: Avi Treves	The T-Body Approach: From the Mouse Cage to The Patient’s Bed Zelig Eshhar Immunology, Weizmann Institute, Rehovot, Israel
14:40 - 15:10	Coffee break
	Hall A - Rayman Central	Hall B - Rayman West
15:10-16:30	Session G: Company-Regulator Interface Chair: Ofra Axelrod Deputy Director, The Institute for Standardization and Control of Pharmaceuticals, Israeli MOH, Israel	Session H: Funding Chair: Anat Naschitz Managing Director, OrbiMed Advisors, LLC
15:10 - 15:30 Keynote Lectures	The Regulatory Challenges for the Approval of Advanced Therapies in Europe Margarida Menezes Ferreira Medicines Evaluation Department, INFARMED, National Authority of Medicines and Health Products, Lisboa, Portugal Member of the Committee for Advanced Therapies and of the Biologics Working Party/CHMP – EMA, Portugal (15 min.) FDA: Is it Really a Black Hole? Joyce Frey-Vasconcells Frey-Vasconcells Consulting, LLC, Sykesville, USA (15 min.) EU Regulators’ Expectations for a Stem Cell Based Product Development - a Focus on CMC and NC Development Anne Dupraz-Poiseau Voisin Consulting Life Sciences, France (15 min.) A Harmonized Approach in Regulation of PLX-PAD Racheli Ofir Intellectual Property & Senior Scientist, Pluristem, Haifa, Israel (15 min.) Special Panel - Meet the Regulator: Audience Questions and Open Discussion (20 min.)	The Office of the Israel Chief Scientist Incentives for R&D in Cell Therapy, Regenerative Medicine and Stem Cells Janette Lazarovits The Office of the Chief Scientist, Israel
15:30 - 15:50		Pontifax, Vision and Investment Strategy Silvia Noiman Pontifax, Israel
15:50 - 16:10		Syndicate Innovation Venturing Alain Vertes Park BioVentures, New York, NY, USA
16:10 - 16:30		The Israeli Cell Therapy Landscape Avi Treves Sheba Cancer Research Center, Israel
16:30-16:40	Short break
16:40 – 17:20 Plenary Session: Chair: Michel Revel Chief Scientific Officer, Kadimastem, Ltd.	Intraspinal Stem Cell Transplantation in ALS: Results of the First Phase 1 FDA Clinical Trial Tamir Ben Hur Department of Neurology, Hadassah University Medical Center, Jerulem, Israel
17:20 – 17:35	Closing Shosh Merchav CEO, Multifacet Biosolutions Ltd., Israel,* Co-Chairman Israstem 2013*

This program is subject to change

<table style="border-color: #5c5d5b; border-width: 1px; border-style: solid;" border="1" cellpadding="5">
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<td bgcolor="#FFCC66" nowrap="nowrap">8:00-9:30</td>
<td colspan="3" bgcolor="#FFCC66" valign="top">Registration</td>
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<td bgcolor="#FFCC66" nowrap="nowrap">09:30 - 10:10 Plenary Session: Chair: Avi Treves</td>
<td colspan="3" bgcolor="#FFF0D2" valign="top"><img style="margin: 10px; float: left;" alt="Caplan 2012" src="/images/Caplan_2012.jpg" height="75" width="61" /><a href="/israstem-abs/out_of_pdf/adultmscsth_Arnold_Caplan.pdf" target="_blank">Adult MSCs: The New Medicine </a> Arnold Caplan Biology, Case Western Reserve University, Cleveland, USA <img src="http://isranalytica.org.il/images/US-flag.gif" alt="USA" height="20" width="35" /> </td>
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<td bgcolor="#FFCC66" nowrap="nowrap">10:10 - 10:40</td>
<td colspan="2" bgcolor="#FFFF99" valign="top">Coffee break</td>
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<td colspan="3" bgcolor="#99CC00" height="3" nowrap="nowrap"></td>
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<td bgcolor="#FFCC66" nowrap="nowrap">10:40-12:20</td>
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<div>
<div><img style="margin-left: 10px; margin-right: 10px; float: left;" alt="Yehudit Cohen Sheba Tissue Banks" src="/images/Israstem13/Yehudit_Cohen_Sheba_Tissue_Banks.jpg" height="78" width="56" />Session E: Translational Research & Bio Banking Chair: Yehudit Cohen Scientific Director - Institutional Tissue Banks, Sheba Medical Center, Israel <img alt="Israel" src="http://isranalytica.org.il/images/israel-flag.gif" height="25" width="35" /></div>
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<td bgcolor="#E4E9D8" valign="top" width="50%"><img style="margin-left: 10px; margin-right: 10px; float: left;" alt="אריק חסון" src="/images/Israstem13/%D7%90%D7%A8%D7%99%D7%A7_%D7%97%D7%A1%D7%95%D7%9F.jpg" height="77" width="55" />Session F: Supporting Environment Chair: Arik Hasson Executive VP, Research & Development, Kadimastem Ltd., Israel <img alt="Israel" src="http://isranalytica.org.il/images/israel-flag.gif" height="25" width="35" /></td>
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<td bgcolor="#FFCC66" nowrap="nowrap">
10:40 - 11:00  
Keynote Lectures </td>
<td bgcolor="#FFF0D2" valign="top"><a href="/israstem-abs/out_of_pdf/stemcellderiv_Marcelle_Machluf.pdf" target="_blank">Stem Cell Derived Nano-Vesicles, a New Platform Targeting the Tumor Bed </a> Marcelle Machluf Faculty of Biotechnology and Food Engineering, Institute of Technology, Haifa, Israel <img alt="Israel" src="http://isranalytica.org.il/images/israel-flag.gif" height="25" width="35" /></td>
<td bgcolor="#FFF0D2" valign="top"><a href="/israstem-abs/out_of_pdf/bringingcellt_Dirk_Balshuesemann.pdf" target="_blank">Bringing Cell Therapies into Clinical Routine</a> Dirk Balshuesemann Clinical Business, Miltenyi Biotec GmbH, Bergisch Gladbach, Germany <img src="http://isranalytica.org.il/images/DE-flag.gif" height="23" width="35" /> </td>
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<td bgcolor="#FFCC66" nowrap="nowrap">11:00 - 11:20</td>
<td valign="top"><a href="/israstem-abs/out_of_pdf/humanumbilical_Arnon_Nagler.pdf" target="_blank">Human Umbilical Cord Blood: More than a Source of Hematopoietic Stem Cells: Neurological Potential</a> Arnon Nagler Chaim Sheba Medical Center, Ramat Gan, Israel <img alt="Israel" src="http://isranalytica.org.il/images/israel-flag.gif" height="25" width="35" /> </td>
<td valign="top"><a href="/israstem-abs/out_of_pdf/buildingbridge_Thomas_Fellner.pdf" target="_blank">Building Bridges from Research to Therapy: Enabling the Utilization of Human Induced Pluripotent Stem Cells for Clinical Therapies</a> Thomas Fellner Pluripotent Stem Cell Innovation Center, Lonza, Inc., Walkersville, USA <img src="http://isranalytica.org.il/images/US-flag.gif" alt="USA" height="20" width="35" /> </td>
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<td bgcolor="#FFCC66" nowrap="nowrap">11:20 - 11:40</td>
<td valign="top"><a href="/israstem-abs/out_of_pdf/theroleofplu_Nissim_Benvenisty.pdf" target="_blank">The Role of Pluripotent Stem Cells in Modeling Human Disorders and in Drug Screening</a> Nissim Benvenisty Stem Cell Unit, Genetics, Hebrew University, Jerusalem, Israel <img alt="Israel" src="http://isranalytica.org.il/images/israel-flag.gif" height="25" width="35" /> </td>
<td valign="top"><a href="/israstem-abs/out_of_pdf/currentregulat_Alan__Moore.pdf" target="_blank">Current Regulatory and cGMP Compliance Trends for Cellular Therapeutics and the Challenges in </a><a href="/israstem-abs/out_of_pdf/currentregulat_Alan__Moore.pdf">Translation to Late-Stage Commercial-Ready Manufacturing</a> Alan Moore VP Testing and Cell Services, WuXi AppTec  Philadelphia, USA <img src="http://isranalytica.org.il/images/US-flag.gif" alt="USA" height="20" width="35" /> </td>
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<td bgcolor="#FFCC66" nowrap="nowrap">11:40 - 12:00</td>
<td valign="top"><a href="/israstem-abs/out_of_pdf/buildingqualit_Katheryn_Shea.pdf" target="_blank">Building Quality Biological Collections to Maximize Use</a> Katheryn Shea Precision Bioservices, Inc., Frederick, USA <img src="http://isranalytica.org.il/images/US-flag.gif" alt="USA" height="20" width="35" /> </td>
<td valign="top"><a href="/israstem-abs/out_of_pdf/intellectualpr_Hadassa_Waterman.pdf" target="_blank">Intellectual Property Issues Related to </a><a href="/israstem-abs/out_of_pdf/intellectualpr_Hadassa_Waterman.pdf">Cell-Based Inventions</a> Hadassa Waterman Biotech, Ehrlich and Fenster, Ramat Gan, Israel <img alt="Israel" src="http://isranalytica.org.il/images/israel-flag.gif" height="25" width="35" /> </td>
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<td bgcolor="#FFCC66" nowrap="nowrap">12:00 - 12:20</td>
<td valign="top"><a href="/israstem-abs/out_of_pdf/ipsstemcellb_Ida_Biunno.pdf" target="_blank">IPS Stem Cell Banking</a> Ida Biunno IRGB, IRGB-CNR, Milan, Italy <img src="http://isranalytica.org.il/images/italy-flag.jpg" alt="italy" height="23" width="35" /> </td>
<td valign="top"><a href="/israstem-abs/out_of_pdf/stemcellsinp_Judith_Ben-Porath.pdf" target="_blank">Stem Cells in Preclinical Studies: Choosing the </a><a href="/israstem-abs/out_of_pdf/stemcellsinp_Judith_Ben-Porath.pdf">Optimal Animal Model</a> Judith Ben-Porath Pharmaseed, Israel <img alt="Israel" src="http://isranalytica.org.il/images/israel-flag.gif" height="25" width="35" /> </td>
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<td bgcolor="#FFCC66" nowrap="nowrap">12:20 - 14:00</td>
<td colspan="3" bgcolor="#FFFF99" valign="top">Lunch break</td>
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<td bgcolor="#FFCC66" nowrap="nowrap">14:00 - 14:40 Plenary Session: Chair: Avi Treves</td>
<td colspan="3" bgcolor="#FFF0D2" valign="top"><img style="margin: 10px; float: left;" alt="ZE photo" src="/images/Israstem13/ZE_photo.jpg" height="84" width="60" /> <a href="/israstem-abs/out_of_pdf/thet-bodyappr_Zelig_Eshhar.pdf" target="_blank">The T-Body Approach: From the Mouse Cage to The Patient’s Bed</a> Zelig Eshhar Immunology, Weizmann Institute, Rehovot, Israel <img alt="Israel" src="http://isranalytica.org.il/images/israel-flag.gif" height="25" width="35" /> </td>
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<td bgcolor="#FFCC66" nowrap="nowrap">14:40 - 15:10</td>
<td colspan="2" bgcolor="#FFFF99" valign="top">Coffee break</td>
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<td colspan="3" height="3" nowrap="nowrap"></td>
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<td bgcolor="#FFCC66" nowrap="nowrap">15:10-16:30</td>
<td bgcolor="#E4E9D8" valign="top"><img alt="Israel" src="http://isranalytica.org.il/images/israel-flag.gif" height="25" width="35" />Session G: 
 Funding 
 Chair: Anat Naschitz 
 Managing Director, OrbiMed Advisors, LLC 
 </td>
<td colspan="2" bgcolor="#E4E9D8" valign="top"><img style="margin: 10px; float: left;" alt="IMG 2381" src="/images/Israstem13/IMG_2381.JPG" height="75" width="58" />Session H: Company-Regulator Interface Chair: Ofra Axelrod Deputy Director, The Institute for Standardization and Control of Pharmaceuticals, Israeli MOH, Israel <img alt="Israel" src="http://isranalytica.org.il/images/israel-flag.gif" height="25" width="35" /></td>
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<td bgcolor="#FFCC66" nowrap="nowrap">15:10 - 15:30 Keynote Lectures</td>
<td bgcolor="#FFF0D2" valign="top">
The Office of the Israel Chief Scientist Incentives for R&D in Cell Therapy, Regenerative Medicine and Stem Cells 
Janette Lazarovits 
The Office of the Chief Scientist</td>
<td colspan="2" rowspan="4" valign="top" bgcolor="#FFFFFF"><a href="/israstem-abs/out_of_pdf/theregulatory_Margarida__Menezes_Ferreira.pdf" target="_blank">The Regulatory Challenges for the Approval of Advanced Therapies in Europe </a> 
 Margarida Menezes Ferreira 
 Medicines Evaluation Department, INFARMED, 
 National Authority of Medicines and Health Products, Lisboa, Portugal 
 Member of the Committee for Advanced Therapies and of the Biologics Working Party/CHMP – EMA, Portugal 
 <img title="7628969_flagbig1.gif" alt="7628969_flagbig1.gif" src="http://dr.doali.co.il/admin/temp/newsletters/1006/7628969_flagbig1.gif" height="23" width="35" /> 
 
 <a href="/israstem-abs/out_of_pdf/fdaisitrea_Joyce_Frey-Vasconcells.pdf" target="_blank">FDA: Is it Really a Black Hole?</a> 
 Joyce Frey-Vasconcells 
 Frey-Vasconcells Consulting, LLC 
 
 
 <a href="/israstem-abs/out_of_pdf/euregulators_Anne__Dupraz-Poiseau.pdf" target="_blank">EU Regulators’ Expectations for a Stem Cell Based Product Development a Focus on CMC and NC Development</a> 
 Anne Dupraz-Poiseau 
 Voisin Consulting Life Sciences, France 
 <img src="/images/frlarge.gif" alt="france" height="23" width="34" />
A Harmonized Approach in Regulation of PLX-PAD 
 Racheli Ofir 
 Pluristem, MATAM  Park, Haifa, Israel (15 min.)
<img alt="Israel" src="http://isranalytica.org.il/images/israel-flag.gif" height="25" width="35" /> 
     
 
 
<img style="float: left;" alt="104714569" src="/images/icons/104714569.jpg" height="76" width="96" />Special Panel-Meet the Regulator: 
 Audience Questions and Open Discussion 
 
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<td bgcolor="#FFCC66" nowrap="nowrap">15:30 - 15:50</td>
<td bgcolor="#FFFFFF" valign="top">Pontifax, Vision and Investment Strategy 
Silvia Noiman 
Pontifax, Israel 
<img alt="Israel" src="http://isranalytica.org.il/images/israel-flag.gif" height="25" width="35" /></td>
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<td bgcolor="#FFCC66" nowrap="nowrap">15:50 - 16:10</td>
<td bgcolor="#FFFFFF" valign="top"><a href="/israstem-abs/out_of_pdf/syndicateinnov_Alain_Vertes.pdf" target="_blank">Syndicate Innovation Venturing</a> 
Alain Vertes 
Park BioVentures, New York, NY, USA 
<img src="http://isranalytica.org.il/images/US-flag.gif" alt="USA" height="20" width="35" /></td>
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<td bgcolor="#FFCC66" nowrap="nowrap">16:10 - 16:30</td>
<td bgcolor="#FFFFFF" valign="top"><a target="_blank" href="/israstem-abs/out_of_pdf/theisraelicel_Avi__Treves_.pdf">The Israeli Cell Therapy Landscape</a> 
Avi Treves 
Sheba Cancer Research Center, Israel 
<img alt="Israel" src="http://isranalytica.org.il/images/israel-flag.gif" height="25" width="35" /></td>
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<td bgcolor="#FFCC66" nowrap="nowrap">16:30 – 17:10 
Plenary session: 
Chair: 
Michel Revel</td>
<td colspan="3" valign="top"><img style="margin: 10px; float: left;" alt="EvaFeldman-BannerPhoto" src="/images/Israstem13/EvaFeldman-BannerPhoto.jpg" height="83" width="61" /><a href="/israstem-abs/out_of_pdf/intraspinalste_Eva_Feldman,_MD,_PhD.pdf">Intraspinal Stem Cell Transplantation in ALS: Results of the First Phase 1 FDA Clinical Trial</a> Eva Feldman  Neurology University of Michigan, Ann Arbor, USA <img src="http://isranalytica.org.il/images/US-flag.gif" alt="USA" height="20" width="35" /> </td>
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<td bgcolor="#FFCC66" nowrap="nowrap">17:10 – 17:25</td>
<td colspan="3" valign="top"><img style="margin: 10px; float: left;" alt="Shosh Merchav" src="/images/Shosh_Merchav.jpg" height="81" width="64" />Closing Shosh Merchav CEO, Multifacet Biosolutions Ltd., Israel, Co- Chairman Israstem 2013 <img alt="Israel" src="http://isranalytica.org.il/images/israel-flag.gif" height="25" width="35" /></td>
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