DAY ONE - Stream A: Cell Therapy & Regenerative Medicine

last modified: 22 May '12

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2.30pm

Chairman’s opening remarks

Prof. Chris Mason

Prof. Chris Mason MBBS, PhD, FSB, FRCSI, FRCS Stem Cell & Regenerative Medicine Bioprocessing Unit Advanced Centre for Biochemical Engineering University College London Mason is internationally recognized to be at the forefront of the emerging...

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› Prof. Chris Mason, Chair of Regenerative Medicine Bioprocessing, UCL

ADVANCES IN THE CLINIC AND THE CRUCIAL LESSONS LEARNED

2.35pm

Taking a neural stem cell therapy to the clinic in stroke

Michael Hunt

Michael Hunt was appointed Chief Executive Officer of ReNeuron in July 2005. Prior to ReNeuron, he spent six years at Biocompatibles International plc (sold to BTG plc) where he held a number of senior financial and general management positions. His ...

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Current progress with the UK clinical trial
Clinical and regulatory issues
Lessons learned

› Michael Hunt, CEO, ReNeuron Group plc

3pm

Updates, developments and lessons learned from FT1050 program

Dan Shoemaker

Dr. Dan Shoemaker is the chief technology officer and is leading the development of quantitative cell state analysis for the Company's therapeutic development and iPS cell technology. Dr. Shoemaker was most recently chief scientific officer of...

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› Dan Shoemaker, Chief Technology Officer, Fate Therapeutics

3.25pm

Progressing into phase III with an orphan indication

Mr. Eduardo Bravo

Mr. Bravo has more than 18 years experience in the pharmaceutical industry. His professional career includes several senior management positions at Sanofi-Aventis, including Vice President for Latin America, where he was in charge of more than 2000...

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Pros and cons for choosing Orphan indications
Regulatory hurdles and clinical development choices
Lessons learnt

› Mr. Eduardo Bravo, Managing Director and CEO, Tigenix

3.50pm

Translating Cellular Therapeutics for Branded Product Commercialization

Dr Donna Skerrett

Donna Skerrett - MD, MS - Chief Medical Officer As Mesoblast’s Chief Medical Officer, Dr Skerrett oversees clinical development of the antibody-based stem cell selection technology and in vitro culture processes, as well as the human clinical trial...

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Identifying unmet needs
Cellular Products- what are the choices
Non-Clinical Evidence- when, how much, and what we look for
Clinical Development Planning –when the goal is licensure and commercialization

› Dr Donna Skerrett, Chief Medical Officer, Mesoblast Ltd

4.15pm

Afternoon refreshments

4.40pm

Phase III development of a cellular therapy product

Timothy Mayleben

Timothy M. Mayleben, Mr. Mayleben joined Aastrom as a member of the Companys Board of Directors in June 2005, and currently serves as Chief Executive Officer, President, Chief Financial Officer and Director. Mr. Mayleben was formerly an advisor to ...

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The benefits of a special protocol assessment
Achieving manufacturing readiness
Understanding clinicians, patients and the indication

› Timothy Mayleben, CEO, President & Director, Aastrom Biosciences

5.05pm

Successes and ongoing advancements of human clinical trials for the treatment of AMD & Stargardt’s disease

Gary Rabin

Gary Rabin's 24-year career in finance and operations has primarily encompassed investing in, managing and raising capital for small-cap and emerging growth companies. From 2007 to 2010, he was Managing Partner at GR Advisors, LLC, a hedge fund...

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· Ongoing ESC-based human clinical trials in US and EU

· Clinical update on ACT's three trials using ESC-derived RPE cells to treat Dry AMD and Stargardt's disease

· Applying lessons learned to next phases and future trials

› Gary Rabin, Chairman & CEO, Advanced Cell Technology

5.30pm

StemEx pivotal trial completed – countdown to results

Yael Margolin

Dr. Margolin is the president and CEO of Gamida Cell. Prior to joining the company, Dr. Margolin served as vice president of Denali Ventures LLC, where she specialized in investments in pharmaceutical and biotechnology companies. Dr. Margolin also...

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It is all in the manufacturing data
The move from fresh to frozen product
From SPA to label

› Yael Margolin, CEO, Gamida Cell Ltd.

5.55pm

World’s first off-the-shelf allogeneic cord-blood stem cell drug CARTISTEM®

Antonio Lee

Dr. Antonio (Tony) Lee - Associate Director, Business Development and R&D Strategy at MEDIPOST Co., Ltd., is involved in product development, clinical trials, licensing and marketing of human Umbilical Cord Blood-derived Mesenchymal Stem Cell...

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What was the journey to the market?
Challenges of product development: product delineation and potency marker systems
What to do and what not to do during clinical trials
Reimbursement and sales: what is the marketing strategy