DAY TWO - Stream A: Cell Therapy & Regenerative Medicine

last modified: 22 May '12

Please enable javascript to see more information on speakers

2.05pm

Chairman’s opening remarks

Michael Siani-Rose

Mr. Siani-Rose at Kiverdi is helping design next generation biofuels and specialty chemicals using microbes to perform waste gas conversion. Michael has 15+ years of regenerative medicine and biotechnology experience. As President and Founder of...

more..

› Michael Siani-Rose, BioInformatics Executive, Kiverdi, Inc

THE REALITY OF CELL THERAPIES FOR THE END USER

2.10pm

The human element - consideration for clinicians in the future

Dr Rahul Aras

Dr. Aras is the founding President and CEO for Juventas Therapeutics, a regenerative medicine company developing novel biopharmaceuticals for treatment of ischemic disease. In his role, he has led the company from concept through its recent...

more..

How will clinicians order, receive, administer and pay for future cell therapies?
How can industry assist clinicians in getting reimbursed quickly?
How can the financial risk be appropriately shared and agreed between industry, clinicians and payers?
What are the major challenges to cell therapies becoming common practice in healthcare?

› Dr Rahul Aras, Chief Executive Officer, Juventas Therapeutics

2.35pm

Translating research into viable clinical treatments - building on the past to deliver the future

Mr Simon Ellison

Simon Ellison is developing strategies that are enabling the National Blood Service to utilise its technical skills, GMP facilities, and clinical contacts to provide contract manufacturing services to the growing cellular therapy field, under the...

more..

The criticality of managing the process from consent to patient.
Utilising open innovation partnerships can deliver treatments and revenue.
How to generate patient focused manufacturing and scale up.
Accessing validated national cold supply chains

› Mr Simon Ellison, Specialist Services Commercial Manager, NHS Blood and Transplant

MANUFACTURING TOWARDS A GLOBAL SCALE

3pm

Panel discussion: the need for foresight – automated processing is essential to commercial success but when is the right time to invest?

David James

David James is the Senior Director of Life Sciences and Pharmaceutical at Invetech, a world leading contract development company that assists Clients around the world to commercialise their products. David has nearly 25 years experience providing ...

more..

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 ...

more..

Greg Bonfiglio

Mr. Bonfiglio is the Founder & Managing Partner of Proteus, LLC – an investment and advisory firm focused solely on regenerative medicine. Proteus provides fund management, consulting, and investment banking services to the regenerative medicine...

more..

What is “Process Integrity” and why is it so important?
Do you really understand your current cost of goods and what is needed to achieve your commercial target?
If a change to a process technology is required, when should it be introduced into the clinical trials program?
What are the pros & cons of customised systems versus off-the shelf instruments?
Is your process truly “scalable” and do you have the equipment, people and systems to succeed?
Clinical trials are expensive and the outcome is uncertain so when is the right time to invest in automation?

3.35pm

Afternoon refreshments

4.05pm

Enabling process scale-up through effective cell characterisation

David Smith

Mr. Smith joined Cambrex Bioproducts in January 2002 as the Business Unit Director of the emerging Cell Therapy business. In 2004, he was promoted to Vice President, Business Development, and in December 2005 to Vice President, Cellular...

more..

Process changes are required for scale-up and cost reduction
In-depth knowledge of a cell therapeutic is necessary to verify process improvements
A panel of cell characterization assays is essential for selection and justification of a potency assay

› David Smith, Head, LBS Commercial Services, Lonza

SUCCESSFUL COMMERCIALISATION FOLLOWING MARKET APPROVAL

4.30pm

Pushing for commercialisation of your lead stem cell-based therapy: an SME perspective

Todd McAllister

Dr. McAllister has a Ph.D. in BioMedical Engineering from the University of California, San Diego. He is the co-founder and CEO of Cytograft Tissue Engineering, Inc. Dr. McAllister has been an early proponent of tissue engineered self-assembly...

more..

How are current owners going to launch their products?
Is there a need for a partner to drive commercialisation?
What is needed to be seen in a potential partner?
How can all partners extract value?

› Todd McAllister, CEO, Cytograft

4.55pm

The path to a CBER FDA allogeneic cell therapy approval

Geoff MacKay

Geoff MacKay has served in his current leadership role since Dec. 2003. Mr. MacKay provides Organogenesis Inc. with significant global, commercial experience spanning the pharmaceutical and biotechnology sectors. Mr MacKay has held numerous...

more..

· What have been the learnings along the regulatory/quality pathway?

· Facing the challenges ahead following market approval