Phacilitate Cell & Gene Therapy Forum 2006
Presentations
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Day 1 | Monday, January 30th, 2006
Morning Plenary Session
Dr Chris Holloway
Keynote regulatory perspectives
Celia Witten, MD, PhD
Stephanie L. Simek, PhD
European regulatory aspects of advanced therapy products
Professor Klaus Cichutek
Negotiating the evolving European regulatory approval system for cell and gene Therapies
Duncan MacKay
Case study
Tackling the key issues involved in pursuing a global cell therapy development strategy
Dr Yaron Daniely – NOT AVAILABLE
Panel discussion
How can public and private sector stakeholders work together to expedite the approval process for cell and gene therapies?
Celia Witten – NO SLIDES PRESENTED
Stephanie L. Simek – NO SLIDES PRESENTED
Professor Klaus Cichutek – NO SLIDES PRESENTED
Dr Sonia Skarlatos
Dr Gary C. du Moulin
Dr Beverly L. Davidson – NO SLIDES PRESENTED
Gil Beyen – NO SLIDES PRESENTED
Workshop 1
Update on the European regulation of cell therapy and gene therapy medicinal products
Dr Chris Holloway Presentation 1 | Presentation 2 | Presentation 3
Dr Lincoln Tsang
Workshop 2
Bridging the gap between bench and bedside - efficiently driving quality cell therapy candidates through to Proof of Concept in man
Dr Shelly Heimfeld
Case study
Delivering a genuinely predictive animal model for a cell therapy in preclinical development
Dr David W. Scharp
Case study
Overcoming the technical and regulatory hurdles in the preclinical to clinical transition for cellular therapeutics
Dr Madhusudan V. Peshwa
What are the strategic keys to building a GMP environment and scaling-up
economically in early development?
Dr Brian Salmons
Case study
Challenges in the development of skeletal myoblasts for cardiac repair
Dr Bruce M. Wentworth
Case study
Developing an allogeneic cell mediated gene therapy for cartilage repair
Dr Kwan H. Lee
Workshop 3
Bridging the gap between bench and bedside - efficiently driving quality gene therapy candidates through to Proof of Concept in man
Dr Karen Kozarsky – NO SLIDES PRESENTED
Regulatory perspective
The use of animal models to facilitate initiation of gene therapy trials
Mercedes Serabian, MS, DABT
Case study
Successfully developing and utilizing an animal model to improve the clinical prospects of a gene therapy
Dr Dan Maneval
RNAi for neurogenetic diseases
Dr Beverly L. Davidson – NOT AVAILABLE
Seizing opportunities in Phase I: streamlining exploratory trials
Dr Daniel Rosenblum
Case study
Addressing the major challenges in the characterization and manufacture of vectored therapies in early development
Dr Bryan T. Butman
Panel discussion
What is the ideal translational research model for cell and gene therapies?
Dr Scott R. Burger – NO SLIDES PRESENTED
Stephen L. Eck, MD, PhD – NO SLIDES PRESENTED
Dr Shelly Heimfeld – NO SLIDES PRESENTED
Day 2 | Tuesday, January 31st, 2006
Morning Plenary Session
How are the US FDA and NIH evolving to boost R&D productivity in the life sciences sector?
Dr Barrie Carter – NO SLIDES PRESENTED
FDA Keynote Address
Facilitating development of new vaccines and cell and gene therapies
Dr Karen Midthun
NIH Keynote Address
How will NIH funding reforms and a new focus on product development and translational research benefit industry?
Dr Barbara M. Alving
Delivering solutions to the key funding challenges facing cell and gene companies
Raymond T. Bartus, PhD
Robert Ward - NOT AVAILABLE
Nessan Bermingham, PhD – NO SLIDES PRESENTED
Mark Kessel – NO SLIDES PRESENTED
Matt Kaplan
Douglas A. Eayrs
Main Afternoon Session
Delivering solutions to your key cell therapy and tissue processing product development/manufacture challenges
Dr Scott R. Burger – NO SLIDES PRESENTED
Addressing key regulatory issues in cellular therapy product manufacture
Kimberly Benton. PhD
Case study
Planning and implementing a compliance strategy to meet Good Tissue Practice requirements
Dr Gary C. du Moulin
Which manufacturing solution, or blend of solutions, is right for your product?
Defining the pros and cons of the major options available to cell therapy companies
Dr Scott R. Burger
Case study
Exploring the logistical challenges in allogeneic cell therapy manufacture and distribution
Michael W. Ramsay
Panel discussion
What are the major issues in the process development of combination products involving cell therapies and devices, and how can they be addressed?
Dr Jim Barry
Breakout session 1
Overcoming the key barriers to regulatory approval and commercialization facing gene therapies in the later stages of clinical development
Dr Alan Boyd – NO SLIDES PRESENTED
Case study
Clinical development of p53 tumor suppressor therapy
Dr Robert E. Sobol
Case study
Clinical development of AAV vectors
Dr Barrie Carter
Case study
Late-stage development of a cancer immunotherapeutic: Allovectin-7®
Alain Rolland, PharmD, PhD
Case study
Preparing a gene therapy for the marketplace - how do you handle manufacturing and quality issues, and put the necessary processes in place for phase III and beyond?
Dr Alan Boyd
2.16 Panel discussion
How will industry meet the most significant remaining challenges to the approval of gene therapies?
Dr Maritza McIntyre – NO SLIDES PRESENTED
Breakout session 2
Delivering alternative funding models for cell and gene therapy companies
Public equity markets: Fickle, be they friend or foe
Mark Kessel
Designing and implementing a successful private investment financing campaign
Dr Riku H. Rautsola
Small business funding opportu"NIH"ties at the National Institutes of Health
Jo Anne Goodnight
Panel discussion
How can cell and gene therapy companies make themselves more attractive to investors?
NO SLIDES PRESENTED
Afternoon Plenary session
How will your company capitalize on clinical development and product commercialization opportunities in the Far East?
Chair's Keynote Address
How are cell and gene therapy R&D activities and the business model evolving in the Far East?
Dr Akihiro Shimosaka
Panel discussion
What are the pros and cons in conducting clinical development and eventually commercializing cell and gene therapies in the Far East?
Professor Chunming Rao
Kye Yung-Su
Dr Lincoln Tsang – NO SLIDES PRESENTED
Day 3 | Wednesday, February 1st, 2006
Morning Plenary Session
Analyzing the key areas of opportunity for the cell and gene therapy sector
Chair's introduction
Dr John Shiver – NO SLIDES PRESENTED
To invest or not invest: the cell and gene therapy value proposition
Nessan Bermingham, PhD
What does it really take to commercialize a cell or gene therapy?
Dr Samuel C. Wadsworth
Short presentations & panel discussion
What are the latest clinical data and commercial expectations for cell and gene therapy candidates in key therapeutic areas?
Dr Robert E. Sobol
Donna R. Rill
Dr Samuel C. Wadsworth
Bruce Cohen
Raymond T. Bartus, PhD
Ted Danse
Panel discussion
The coupling of device and cell as the therapeutic unit and commercial product: the rule not the exception
Dr Beverly H. Lorell – NO SLIDES PRESENTED
Dr Ira S. Cohen – NO SLIDES PRESENTED
Dr Bruce M. Wentworth – NO SLIDES PRESENTED
Dr Scott R. Burger – NO SLIDES PRESENTED
David L Amrani, PhD, FAHA, – NO SLIDES PRESENTED
Main Afternoon Session
How will you prepare your therapeutic cancer vaccine for late-phase clinical trials and the marketplace?
Moderator's introduction
Case study
Onyvax's approach to the development of cancer vaccines
Dr Robert Johnson
Case study
Progress in the treatment of prostate cancer with Provenge
Dr David L. Urdal
3.09 Case study
Late stage development of the GVAX prostate cancer vaccine
Dr Flavia Borellini
Case study
OncoVEX-GMCSF: Product and clinical development
Dr Tony Mills
Panel discussion
What are the remaining technical, regulatory and clinical challenges facing cancer vaccines in development and how might they be addressed?
NO SLIDES PRESENTED
Breakout session 1
Stem cells update - defining the potential value to your business
Moderator's introduction
NIH and human embryonic stem cell research
Dr James F. Battey
Investment opportunities in stem cells
Douglas A. Eayrs
Case study
Piloting a new model for commercializing university and hospital-based stem cell research
Dr Annemarie Moseley
Stem cell applications and opportunities in drug discovery
Dr John D. McNeish
Case study
Transitioning from R&D to the development of the business model and vision in both autologous and allogeneic stem cell therapy
David L Amrani, PhD, FAHA
Case study
Challenges in cell based therapies in skeletal applications
Professor Frank P. Luyten
Panel discussion
What are the next steps for stem cell therapies in development?
NO SLIDES PRESENTED
Breakout session 2
What are the keys to finding a partner for your cell or gene therapy product candidate?
What exactly do the larger, more established companies look for in a prospective partner?
Moderator's introduction
Keys to finding a partner
Richard Murphy
Keys to finding a partner
Big biotech perspective
Dr Samuel C. Wadsworth
Case study
Keys to partnering your gene therapy product.
Richard E. Otto
Dr Jim Barry
Case study
RheoGene/TissueGene – A collaborative strategic alliance between emerging technology companies
J. Kelly Ganjei
Thomas Tillett
Case study
Licensing and collaboration in cell therapy: Rationale, structure and lessons learned
Angelene Simonello
Panel discussion
What are the next steps for cell and gene therapies in development? Take-home messages from the event
Dr Alan Boyd – NO SLIDES PRESENTED
Alain Rolland, PharmD, PhD – NO SLIDES PRESENTED
Dr Flavia Borellini – NO SLIDES PRESENTED
Dr David L. Urdal – NO SLIDES PRESENTED
