DAY TWO – Plenary - Tuesday 22nd May 2012

last modified: 22 May '12

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9am

Chairman’s opening remarks

Dr Christopher Bravery

Christopher Bravery founded CAB Ltd at the end of 2009 in order to focus his activities within the Regenerative Medicine sector. CAB Ltd provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory...

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› Dr Christopher Bravery, Director, Consulting on Advance Biologicals

9.10am

Case Study: Taking an approved product and reinventing the commercialisation process

Dean Tozer

Dean Tozer is Senior Vice President at Advanced BioHealing, Inc. (ABH). In this role he oversees marketing, corporate development, reimbursement, government affairs, product development, various regulatory functions and international...

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Looking for assets: the good, the bad, the ugly
Our commercialisation approach and the key functional players
What was the end result?
Where we are today and what have we learned?

› Dean Tozer, Senior Vice President, Corporate Development, Advanced BioHealing

DETERMINING A SUCCESSFUL REGULATORY PATH

9.35am

Recognising regulatory hurdles for stem cell therapies and how to negotiate them

Dr Maria Cristina Galli

Degree in Biological Sciences, PhD in Molecular Medicine; currently senior researcher, Cell Biology and Neurosciences Department, Istituto Superiore di Sanità, Roma, Italy. Dr. Galli was active for more than 20 yrs as researcher in experimental...

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What are the regulatory challenges for gaining approval in different global markets?
What are the toxicity concerns of potential therapies and are they being overlooked?
How can you overcome requirements for submitting immunological data?
How should the regulatory understanding evolve with the industry advancements?
With a critical mass of stem cell companies, what is the uniform regulatory pathway?

› Dr Maria Cristina Galli, Senior Researcher, EMA/CAT

10am

Inspecting and guaranteeing the quality of the manufacturing process: a regulators perspective

Paula Salmikangas

Dr. Salmikangas is a biochemist by original training, but her main research work career has been in cell and molecular biology of various inherited diseases. Since 2006, she has been an Associate Professor of Biochemistry for the University of...

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What are regulators principle manufacturing issues of cell therapies?
What is the role of regulators to ensure manufacturing, distribution, cell line shelf life and preparation techniques are of an acceptable quality?
Challenges for unlicensed and licensed route to market

› Paula Salmikangas, Vice Chair/Co-ordinating Senior Research,, CAT/Finnish Medicines Research

10.25am

Panel discussion:

Dr Gopalan Narayanan

Current Appointment: 2001 to date Expert Medical Assessor Biologicals unit Licensing Division, Medicines and Healthcare products Regulatory Agency Previous Appointments: Associate Director, Clinical Development Chiron...

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Paula Salmikangas

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Maria Galli

Maria Cristina Galli, PhD - EMA Committee for Advanced Therapies (CAT) member, GTWP Chair, Istituto Superiore di Sanità, Roma, Italy Degree in Biological Sciences, PhD in Molecular Medicine; currently senior researcher, Cell Biology and...

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10.55am

Morning Refreshments

REIMBURSEMENT FOR CELL THERAPIES

11.30am

Ensuring the benefit provided by the therapy significantly outweighs he risk

Dr John Fraser

Dr Fraser is Principal Scientist at Cytori Therapeutics Inc, a San Diego-based company engaged in commercialization of adult stem and regenerative cells from human adipose tissue. He has more than 25 years of experience working with adult stem...

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Proving safety of product and demonstrating efficacy to warrant market approval
What impact will existing treatments have on gaining market approval?
Linking benefit to the ultimate price of a therapy
How can sponsors show long term benefit and acquire relevant data whilst ensuring short term return on investment?

› Dr John Fraser, Principal Scientist, Cytori Therapeutics

12pm

The validity of a cell therapy: what is truly an unmet medical need?

Paul Kemp

Paul Kemp has been involved in commercial regenerative medicine for over 20 years. During that time he has developed a successful track record in virtually all aspects of the private and public Biotech business in both the U.S. and U.K. from...

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Avoiding budget busting prices and ensuring the market exists in reality
Reimbursement protocol for stem cell based therapies need to be more innovative?
Proving the real value of a therapy and presenting the clinical added value
How to ensure the therapy is affordable and is of significant benefit?

› Paul Kemp, CEO & CSO, Intercytex

12.30pm

Stem cell applications for neurodegenerative disorders

Richard Garr

Richard Garr, JD, has been a director and our Chief Executive Officer since 1996. Mr. Garr was previously an attorney with Beli, Weil & Jacobs, the B&G Companies, and Circle Management Companies. Mr. Garr is a graduate of Drew University (1976) and...

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