RegeneRative mediCine - ALM Events
RegeneRative mediCine - ALM Events
RegeneRative mediCine - ALM Events
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Group Discount Offer<br />
See Inside for Details!<br />
6th Annual<br />
Stem Cells&<br />
Regenerative Medicine<br />
The Annual Standard in Industry-Focused Applications of Stem Cell Research<br />
Opening Keynote:<br />
Shelly Heimfeld, Ph.D., Director of Cellular Therapy<br />
and Cell Processsing Facilities Associate Member<br />
Fred Hutchinson Cancer Research Center<br />
President<br />
the International Society of Cellular Therapy<br />
Featured Sections Include:<br />
4 Discovery Cells<br />
4 Discovery-Enabling Materials<br />
4 Pre-Clinical Development<br />
4 Clinical Development<br />
4 New Technologies<br />
4 Commercialization and Investment Opportunities<br />
4 Regulatory Issues<br />
Platinum Sponsor:<br />
Presentations By:<br />
4 Advanced Cell Technology<br />
4 Aggregate Therapeutics<br />
4 Arteriocyte<br />
4 Avlar BioVentures Ltd<br />
4 Celgene<br />
4 Cellerant Therapeutics<br />
4 Center for Biologics Evaluation and<br />
Research/US-FDA<br />
4 Eli Lilly<br />
4 Fred Hutchinson Cancer Research Center<br />
4 Geron<br />
4 Intercytex<br />
4 Novocell, Inc.<br />
4 Pfizer<br />
4 Pittsburgh Lifesciences Greenhouse<br />
4 Plasticell<br />
4 Proteus Venture Partners<br />
4 Q Therapeutics, Inc.<br />
4 Reeve-Irvine Research Center<br />
4 Repair Technologies<br />
4 Rodman & Renshaw<br />
4 Stem Cell Therapeutics Corp.<br />
4 The Biologics Consulting Group, Inc<br />
4 McGowan Institute for Regenerate<br />
Medicine (MIRM) and The Pittsburgh Tissue<br />
Engineering Initiative (PTEI)<br />
4 University of Wisconsin - Madison<br />
©2006 Strategic Research Institute. All rights reserved.<br />
October 16-17, 2006 • Renaissance Pittsburgh Hotel • Pittsburgh, PA<br />
To Register Call 800-599-4950 / 212-967-0095 or Visit www.srinstitute.com/stemcells
Welcome<br />
Dear Colleague:<br />
The promise of stem cells & regenerative medicine discoveries and their potential<br />
to transform the treatment of disease, continues to drive biological research and<br />
technology development in the life sciences. The fact that analysts predict that a<br />
market based on stem cell therapies could grow anywhere from $10-30 billion by<br />
2010 makes it crucial for us to gather and discuss the research and commercialization<br />
activities currently being conducted by academia and industry. The field of<br />
regenerative medicine is surrounded by hype, but successful commercialization<br />
will depend on careful analysis of business strategies that can deliver hope to<br />
patients.<br />
Please join us in Pittsburgh, Pennsylvania, October 16-17, 2006 for the 6th Annual<br />
Stem Cells & Regenerative Medicine meeting.<br />
This forum is the perfect setting for thought leaders in regenerative medicine to<br />
convene and share critical perspectives on the current status and future of stem<br />
cell research and regenerative medicine. This meeting is designed to promote<br />
interactions that will ultimately result in the acceleration of scientific discovery and<br />
the development of new technologies, in the end benefiting patients worldwide.<br />
We look forward to being your hosts in Pittsburgh for the second consecutive<br />
year. Pittsburgh’s strengths in the areas of transplantation, tissue engineering and<br />
stem cell research continue to make it a great location for us to come together for<br />
the advancement of regenerative medicine.<br />
Regards,<br />
Dr. Doros Platika, Conference<br />
Co-Chair, President & CEO<br />
The Pittsburgh Life Sciences<br />
Greenhouse<br />
5<br />
CALL:<br />
(800) 599.4950<br />
(212) 967.0095<br />
8:30 - 5:30 Eastern Time<br />
Monday – Friday<br />
FAX:<br />
(212) 967.8021<br />
MAIL:<br />
Return Registration Form to:<br />
Strategic Research Institute<br />
333 Seventh Avenue, 9th Floor<br />
New York, NY 10001<br />
E-MAIL:<br />
info@srinstitute.com<br />
WEB:<br />
www.srinstitute.com/stemcells<br />
Dr. Alan Russell, Conference<br />
Co-Chair, Director, McGowan<br />
Institute for Regenerative<br />
Medicine (MIRM) and<br />
Executive Director, The Pittsburgh<br />
Tissue Engineering Initiative<br />
(PTEI)<br />
P.S. Register by September 1, 2006 and Save $300<br />
Easy Ways To Register<br />
Group Discount:<br />
Group Discounts Available: If you send two delegates<br />
to this conference at the full registration fee, the third and<br />
subsequent delegates receive a $200 discount off the<br />
conference registration fee.<br />
PAYMENTS: $695 Academic/Government/Nonprofit; $1195<br />
Early bird: until Friday September 1, 2006; $1495 After<br />
September 1st and before October 6th; $1595 after October<br />
6th<br />
This includes all breakfasts, lunches, refreshments, receptions<br />
and the conference documentation workbook. Payments<br />
may be made by company check, American Express, Visa,<br />
MasterCard or Diners Club. Please make checks payable<br />
to: Strategic Research Institute L.P. and make sure to write<br />
the registrant’s name on the face of the check along with the<br />
conference code CS369. Payments are required fifteen (15)<br />
business days prior to attendance at the seminar. If payment<br />
has not been received prior to registration, a credit card hold<br />
will be required and will be processed 2 weeks following the<br />
seminar.<br />
LIMITED NUMBERS: The number of participants is limited to<br />
maximize the amount of personal involvement and feedback<br />
you receive. During this seminar, you will have the opportunity<br />
to try out techniques and take risks in a small group of your<br />
colleagues, benefiting from expert guidance throughout the<br />
day.<br />
CANCELLATIONS: All cancellations will be subject to a<br />
$227 administration fee. In order to receive a refund, your<br />
notice of cancellation must be received in writing (by letter or<br />
fax) no later than August 18, 2006. We regret that refunds<br />
Scientific Advisory Board:<br />
Gabriela Cezar, Ph.D., Associate<br />
Professor<br />
UNIVERSITY OF WISCONSIN -<br />
MADISON<br />
Karen Chandross, Ph.D., Head, Multiple<br />
Sclerosis-Regeneration/Repair Group,<br />
CNS Division<br />
AVENTIS PHARMACEUTICALS<br />
Annemarie Moseley, Ph.D.,<br />
M.D. , Acting CEO, Aggregate<br />
Therapeutics<br />
Chairman, REPAIR TECHNOLOGIES<br />
Doros Platika, M.D., Ph.D, President &<br />
CEO<br />
PITTSBURGH LIFE SCIENCES<br />
GREENHOUSE<br />
Dr. Alan Russell, Conference<br />
Co-Chair, Director, McGowan Institute<br />
for Regenerative Medicine (MIRM)<br />
and Executive Director, The Pittsburgh<br />
Tissue Engineering Initiative (PTEI)<br />
Darin Weber, Ph.D., Senior Consultant<br />
BIOLOGICS CONSULTING GROUP<br />
Frequency Program: If you personally attend three Strategic<br />
Research Institute conferences in 2006 as a fee-paying<br />
delegate, you will be credited 50% off the full registration<br />
fee of third event. Please be sure to indicate that it is your<br />
third event when registering so that your invoice may be<br />
adjusted accordingly. Discounts cannot be combined.<br />
will not be issued after this date. The registration fee may be<br />
transferred to you or another member of your organization for<br />
any Strategic Research Institute conference during the next<br />
12 months. If you plan on sending a substitution in your place,<br />
you must please notify us as soon as possible so that material<br />
and preparations can be made. In the event of a conference<br />
cancellation, Strategic Research Institute assumes no liability<br />
for non-refundable transportation costs, hotel accommodations<br />
or additional costs incurred by the registrants.<br />
SUGGESTED DRESS: Business Casual<br />
Hotel Accommodations:We have reserved a limited<br />
block of rooms with the hotel at a special discounted rate<br />
for our attendees. To secure your accommodations, please<br />
contact the hotel BY September 18th, 2006 and be sure to<br />
mention that you are a Strategic Research Institute delegate.<br />
VENUE: Renaissance Pittsburgh Hotel<br />
107 6th Street , Pittsburgh, PA 15222<br />
Tel: 412-562-1200 - Fax: 412-992-2010<br />
Web: marriott.com/property/propertypage/PITBR<br />
To Register: Visit www.srinstitute.com/stemcells or Call 800-599-4950 / 212-967-0095
Monday October 16, 2006<br />
7:15 - 8:00<br />
Registration and Continental breakfast<br />
8:00 - 8:15<br />
Chair’s opening remarks<br />
Doros Platika, M.D., Ph.D., President & CEO<br />
PITTSBURGH LIFE SCIENCES GREENHOUSE<br />
Dr. Alan Russell, Conference, Co-Chair, Director<br />
McGowan Institute for Regenerative Medicine<br />
(MIRM) and Executive Director, The Pittsburgh Tissue<br />
Engineering Initiative (PTEI)<br />
Stem Cells update<br />
8:15-9:00<br />
Keynote<br />
Application of cellular therapy to the field of regenerative<br />
medicine is one of the most promising and exciting areas of<br />
biomedical research. Identification of new sources and types of<br />
stem cells, discovery of “additional/unexpected” differentiation<br />
pathways, along with advances in purification, culture, and tissue<br />
engineering technologies are all contributing to an explosion of<br />
research publications, initiation of clinical trials, and tremendous<br />
public interest. The talks to be presented in this meeting reflect<br />
the broad scope, the remarkable potential, and the challenges<br />
that need to be overcome before cell-based regenerative<br />
medicine can become the standard of care.<br />
Shelly Heimfeld, Ph.D., Director<br />
Cellular Therapy and Cell Processsing<br />
Facilities<br />
Associate Member, Fred Hutchinson Cancer<br />
Research Center<br />
President, the International Society of Cellular<br />
Therapy<br />
Discovery Cells<br />
9:00 - 9:30<br />
hESC-derived beta-islets for therapeutic<br />
intervention in diabetes<br />
Cell Therapy for the widespread treatment of diabetes is currently<br />
limited by the lack of an unlimited safe supply of islet cells and a<br />
means of delivering these cells without chronic immunosuppresion.<br />
Novocell is committed to the development of a transformational<br />
cell replacement product for the treatment of diabetes by<br />
combining a clinically relevant cell encapsulation technology with<br />
an unlimited supply of functional insulin secreting cells derived<br />
from hESCs. Current progress towards these goals will be<br />
discussed.<br />
Alan Lewis, Ph.D., President & Chief Executive Officer<br />
Novocell<br />
9:30-10:00<br />
Human ESC-derived cells for rescue of visual<br />
function and repair of vascular damage<br />
Embryonic stem cells promise to provide a well-characterized<br />
and reproducible source of replacement tissue for human clinical<br />
studies. Two early potential applications of this technology<br />
are the use of human embryonic stem cell (hESC)-derived<br />
retinal pigment epithelium (RPE) for the treatment of retinal<br />
degenerative diseases such as macular degeneration and retinitis<br />
pigmentosa, and the use of hESC-derived hemangioblasts for<br />
vascular restoration of organs and limbs. Recent progress using<br />
these cells to affect substantial functional and morphological<br />
rescue in animals will be discussed.<br />
Robert Lanza, M.D., Vice-President of Research and<br />
Scientific Development<br />
Advanced Cell Technology<br />
10:00 -10:30<br />
Bioreactor-actuated ovarian follicle maturation<br />
Chemotherapy for girls with cancer can lead to infertility later<br />
in life. Embryonic stem cell generation is dependent on a not<br />
entirely safe process for collection of oocytes from adult women.<br />
Both of these problems could be solved if it were possible, in<br />
vitro, to convert immature ovarian follicles into functional oocytes.<br />
Unfortunately, immature ovarian follicle culture results in follicle<br />
death within days let alone oocyte generation. This presentation<br />
will describe the first bioreactor that has been developed<br />
specifically for maturation of immature follicles and will discuss<br />
the results that have been obtained. The implication of the results<br />
on safe stem cell derivation will be summarized.<br />
Dr. Alan Russell, Conference, Co-Chair, Director<br />
McGowan Institute for Regenerative Medicine<br />
(MIRM) and Executive Director, The Pittsburgh Tissue<br />
Engineering Initiative (PTEI)<br />
10:30 -11:00<br />
Networking break & Exhibitions<br />
Discovery-Enabling materials<br />
11:00 - 11:30<br />
Driving Stem Cell Differentiation with a Novel<br />
High Throughput System<br />
Plasticell has developed a high throughput method for the<br />
determination of complex protocols that can direct the differentiation<br />
of embryonic stem cells. Pluripotent stem cells grown on<br />
microscopic beads (microcarriers) are shuffled through many<br />
thousands of different culture conditions, followed by phenotypic<br />
screening to identify microcarriers bearing differentiated cells.<br />
Using fluorescent labels added during the culture steps it is<br />
possible to deduce the protocols that resulted in directed<br />
differentiation. Since these are compatible with microcarriers,<br />
the process is straightforwardly scaled up for manufacturing.<br />
Yen Choo, Ph.D., Founder & CEO<br />
Plasticell<br />
11:30 - 12:00<br />
Chemical and Functional Genomic Approaches<br />
toward Regenerative Medicine<br />
Under conditions of trauma or disease, the adult animal is able<br />
to selectively re-activate the same developmental pathways used<br />
during embryonic development to heal and regenerate tissue.<br />
To Register: Visit www.srinstitute.com/stemcells or Call 800-599-4950 / 212-967-0095
Monday October 16, 2006<br />
Since stem cells play an important role in regenerative medicine,<br />
understanding their developmental pathways could open the<br />
door for the treatment of a multitude of current diseases for<br />
which few or no treatments currently exist. It is conceivable that<br />
modern pharmacological approaches could drive the renewal of<br />
parts of the human body—including the growth of neurons in the<br />
brain and spinal cord, repopulation of diseased blood cells, and<br />
eventually, perhaps, the re-growth of lost limbs. Recent advances<br />
in stem cell technologies, such as stem cell-based phenotypic<br />
and pathway-specific screens of synthetic compounds and RNAi,<br />
have made it possible to identify both candidate drug targets and<br />
small molecules that can be used to selectively control stem cell<br />
fate. Such molecules will likely provide new insights into stem<br />
cell biology, and may ultimately contribute to effective medicines<br />
for tissue repair and regeneration.<br />
John Hambor, Ph.D., Associate Research Fellow,<br />
Genetically Modified Models Center of Emphasis<br />
Pfizer Global Research and Development<br />
12:00 - 1:30 Lunch<br />
Pre-Clinical Development<br />
1:30 - 2:00<br />
Glial Progenitor Cells for Neurological Diseases<br />
Human glial progenitor cells are being developed as therapeutics<br />
for the treatment of demyelinating diseases. The process of<br />
antibody based cGMP cell manufacture will be presented<br />
along with product characterization methodologies for cells<br />
sourced from fetal cadaveric tissue. In vivo studies in the<br />
twitcher mouse, a lysosomal storage disorder model, and the<br />
shiverer mouse, a general model for demyelinating diseases,<br />
demonstrate that these glial progenitors engraft robustly, migrate<br />
extensively and differentiate into astrocytes and myelin producing<br />
oligodendrocytes. Additional studies in animal models will be<br />
discussed.<br />
James Campanelli, Ph.D., Director of Research<br />
Q Therapeutics<br />
2:00 - 2:30<br />
Human Embryonic Stem Cell Derived<br />
Oligodendroglial Progenitors for the Treatment of<br />
Spinal Cord Injury<br />
Demyelination contributes to loss of function following<br />
spinal cord injury, and so a potential therapeutic strategy<br />
involves replacing myelin forming cells. Here, we show that<br />
transplantation of human embryonic stem cell (hESC) -derived<br />
oligodendrocyte progenitors (OPCs) into adult rat spinal cord<br />
injuries enhances remyelination and promotes recovery of motor<br />
function. We hypothesize that hESC OPCs promote neural<br />
repair and behavioral recovery through multiple mechanisms,<br />
including transplant-mediated remyelination and transplantmediated<br />
effects on endogenous cells. We present both efficacy<br />
and safety data concerning the use of this cell population in<br />
transplant regimes, and regulatory concerns regarding the<br />
translation of stem cell technologies into human treatments.<br />
Hans Keirstead, Ph.D., Associate Professor of Anatomy<br />
and Neurobiology, Co-Director of the Stem Cell Research<br />
Center<br />
Reeve-Irvine Research Center<br />
2:30 - 3:00<br />
Novel Therapeutic Application of Universal Adult<br />
Stem Cell Derived Myeloid Progenitor Cells<br />
Neutropenia induced by chemotherapy, ablative conditioning<br />
for hematopoietic transplantation or exposure to high doses of<br />
radiation is frequently accompanied by significant morbidity and<br />
mortality due to high susceptibility to infection. Cellerant’s CLT-<br />
008 is a universal off-the-shelf cellular product that consists of<br />
myeloid progenitors capable of producing mature myeloid cells<br />
such as granulocytes, macrophages, platelets and erythrocytes<br />
in vivo. Pre-clinical studies using mouse models have shown<br />
that the myeloid progenitor cells prevent fungal and bacterial<br />
infection in neutropenic mice and increase survival in allogeneic<br />
transplantation. The results from these studies and the<br />
development path for clinical evaluation will be discussed.<br />
Ram Mandalam, Ph.D., Vice President, Pharmaceutical<br />
Operations<br />
Cellerant Therapeutics<br />
3:00 - 3:30 Networking break & Exhibitions<br />
Clinical Development<br />
3:30 - 4:00<br />
Cellular Therapies for the Treatment of Coronary<br />
Ischemia<br />
Arteriocyte is a clinical stage research and development company<br />
focused on developing cellular therapies to treat ischemic<br />
disease. The company will capitalize on the bench to bedside<br />
expertise of its scientific founders to develop stem cell-based<br />
therapies for ischemic diseases with an initial focus on coronary<br />
applications. The clinical objective is “therapeutic angiogenesis”<br />
or the generation of new blood vessels to replace those blood<br />
vessels which no longer adequately supply a tissue. These cellular<br />
therapies will eventually help patients suffering from a number of<br />
ischemic conditions including coronary artery disease.<br />
Don Brown, Chief Executive Officer<br />
Arteriocyte<br />
4:00 - 4:30<br />
Clinical Development of Regenerative Medicinal<br />
products in North America and Europe<br />
Intercytex is a UK based Regenerative Medicine Company and<br />
became operational in early 2000. It recently floated on the<br />
London Stock Market’s AIM market and has facilities in the UK<br />
and US. It currently has 4 products in clinical development in the<br />
US and Europe and plans to launch its first product in 2007. The<br />
company has its own licensed GMP manufacturing facility and<br />
is beginning to set up a sales and marketing infrastructure. The<br />
talk will discuss the clinical strategy adopted by the company,<br />
how the changing regulatory environment on both continents<br />
has influenced the company’s development and the results it has<br />
obtained to date in Europe, Canada and the US.<br />
Paul Kemp, Ph.D., Chief Scientific Officer<br />
Intercytex<br />
To Register: Visit www.srinstitute.com/stemcells or Call 800-599-4950 / 212-967-0095
4:30-5:00<br />
Capitalizing on Endogenous Stem Cell<br />
Populations<br />
Stem Cell Therapeutics Corp. (SCT) is a Canadian company<br />
focused on bringing to market therapeutics that utilize<br />
endogenous stem cell populations to replace damaged, lost,<br />
or diseased tissue. SCT’s first clinical program, termed NTx-<br />
265, is based on a neuroregeneration strategy for treating the<br />
functional and cognitive deficits that are inevitable following a<br />
stroke. This program is currently in a Phase IIa clinical trial in the<br />
United States. The NTx-265 therapeutic regimen utilizes two,<br />
on-market pharmaceuticals that have been found to promote<br />
endogenous neural stem cell proliferation and differentiation<br />
into neurons. By repurposing these products, SCT has rapidly<br />
advanced its stroke recovery program into the clinic. Additional<br />
indications are being identified utilizing a similar approach.<br />
Allen Davidoff, Ph.D., Vice President, Product<br />
Development<br />
Stem Cell Therapeutics Corp<br />
5:00 - 5:30<br />
Preclinical, Product, and Clinical Development of<br />
Human Embryonic Stem Cell Based Therapies<br />
Human embryonic stem cells (hESCs) can be differentiated<br />
into any cell type and serve as a limitless source of cells for<br />
the treatment of degenerative diseases. As one example of<br />
the therapeutic potential of these cells, hESCs have been<br />
differentiated into oligodendroglial progenitor cells which<br />
can induce lesional repair and locomotor improvements upon<br />
transplantation in animals with spinal cord injuries. To enable<br />
translation to clinical development, extensive preclinical<br />
safety studies and scaled cGMP manufacturing operations<br />
are underway. Updates on our progress towards clinical<br />
development will be discussed.<br />
Jane Lebkowski, Ph.D., Senior Vice President Regenerative<br />
Medicine<br />
Geron Corporation<br />
5:30-7:00 Cocktail reception<br />
Call for Posters<br />
Why should you present your research poster at the 6th Annual<br />
Stem Cells & Regenerative Medicine Conference?<br />
4 Your poster will be exposed to senior-level decision-makers,<br />
research scientists, and clinicians involved in Stem Cells &<br />
Regenerative Medicine from major pharmaceutical, biotech,<br />
academic and government institutions.<br />
4 Your poster abstract will be published in our conference<br />
documentation book and the title of your poster will be published<br />
on the conference website.<br />
To be considered for a poster presentation, please contact Seth<br />
Fritts at: 212-967-0095 x 256 or sfritts@srinstitute.com before<br />
Friday September 22nd.<br />
How to submit your poster presentation:<br />
1. Please email your titled abstract to Seth Fritts at sfritts@<br />
srinstitute.com<br />
2. The abstract should include a title and be up to 1 page in<br />
length. Include your name, title, company and full contact<br />
information.<br />
Tuesday October 17, 2006<br />
7:15 - 8:00<br />
Registration and Continental breakfast<br />
New Technologies<br />
8:00 - 8:30<br />
Adult Multipotential Cells: Novel Sources, Novel<br />
Uses<br />
Aggregate Therapeutics Inc, was formed to commercialize<br />
technologies from the labs of stem cell scientists within the<br />
Stem Cell Network of Canada, a National Center of Excellence.<br />
Aggregate Therapeutics will initially focus its efforts on<br />
commercialization of cellular therapies for the large regenerative<br />
medicine markets. Aggregate has identified novel technologies<br />
based on multipotential cells derived from skin, pancreas and<br />
retina, as well as genetically-modified cells from bone marrow.<br />
The basic science and early preclinical data from the initial<br />
multipotential cell development program will be presented.<br />
Annemarie Moseley, Ph.D., M.D., Acting CEO<br />
Aggregate Therapeutics<br />
Chairman, REPAIR TECHNOLOGIES<br />
8:30 - 9:00<br />
Opportunities for adult stem cell technology<br />
in high throughput content screening (HTS) of<br />
pharmaceutical compounds<br />
(Please see website for abstract)<br />
Sitta Sittampalam, Head, Lead Optimization Biology<br />
Eli Lilly<br />
9:00 - 9:30<br />
Therapeutic Utility of Small Molecule Stem Cell<br />
Modulators<br />
(Please see website for abstract)<br />
Kyle Chan, Senior Director, Discovery Research<br />
Celgene<br />
9:30 - 10:00<br />
Human embryonic stem cells and predictive<br />
toxicology: a novel systems biology approach<br />
The predictive toxicity of chemicals to humans is determined<br />
largely in animal models. These models have limitations to<br />
emulate human response Our laboratory examines the ability<br />
of human embryonic stem cells to predict toxic outcomes of<br />
chemicals during early human development. We seek biomarkers<br />
of toxic response using a systems biology approach that<br />
integrates molecular and functional cellular responses. We<br />
have preliminary evidence that toxicity in this human in vitro<br />
model is consistent with in vivo animal studies at the molecular<br />
level. These initial studies provide proof of concept for future<br />
application of hES cell technology in predictive toxicity of<br />
chemicals.<br />
Gabriela Cezar, DVM, Ph.D., Assistant Professor,<br />
Developmental Biology<br />
UW-Madison, Wisconsin Stem Cell Research<br />
Program<br />
10:00 - 10:40<br />
Networking break & Exhibitions<br />
To Register: Visit www.srinstitute.com/stemcells or Call 800-599-4950 / 212-967-0095
Tuesday October 17, 2006<br />
Commercialization and Investment Opportunities<br />
10:40-11:00<br />
New Model for successful commercialization<br />
in life sciences - The Pittsburgh Life Sciences<br />
Greenhouse Model<br />
The Pittsburgh Life Sciences Greenhouse (PLSG) was created<br />
as part of a larger plan to ensure continued growth in the life<br />
sciences in Pennsylvania. Since its inception, the PA Greenhouse<br />
Initiative has established a national and international reputation.<br />
The PA Greenhouse Initiative has been cited as one of only two<br />
university/industry funding programs focused solely on the life<br />
sciences in the U.S., and it has become a national model for<br />
state funding of early stage risk capital in the life sciences. The<br />
PLSG has taken the initiative one step further and is working on<br />
programs to address later stage commercialization opportunities<br />
for the region. This presentation will outline the PLSG’s programs,<br />
successful initiatives, and collaborative efforts that are in place to<br />
commercialize technology in Pittsburgh in order to create a selfsustaining<br />
life sciences industry.<br />
Doros Platika, M.D., Ph.D., President & CEO<br />
PITTSBURGH LIFE SCIENCES GREENHOUSE<br />
11:00 - 11:20<br />
Outlook on the Stem Cell Sector: A Perspective<br />
from Wall Street<br />
The stem cell space has rapidly advanced from relative<br />
obscurity to the forefront of innovative therapeutic development<br />
addressing areas of large unmet need. The “driving force” for the<br />
advancement of the future of stem cells remains biotechnology<br />
companies willing to take large risks. In our view, the “fuel” to<br />
drive the development of innovative products remains scientific<br />
knowledge and investor dollars. This presentation will address<br />
several crucial aspects of the stem cell universe from the point of<br />
view of Wall Street including understanding the investor mindset,<br />
the relative valuation metrics and factors that drive market value of<br />
stem cell companies, as well as the potential to “time” the market<br />
for funding opportunities.<br />
Reni Benjamin, Ph.D., Senior Biotechnology Analyst<br />
Rodman & Renshaw<br />
11:20 - 11:40<br />
A UK VC perspective investing in stem cell<br />
therapeutics<br />
The presentation aims to highlight the current status and<br />
impact of the EU regulatory framework, funding sources (public<br />
(including government), private and pharma), IP, business models<br />
and infrastructure logistics.<br />
Cathy Prescott, DPhil, Science Director<br />
Avlar BioVentures<br />
11:40-12:00<br />
Venture Capital perspective<br />
Mr. Bonfiglio is the Managing Director of Proteus Venture Partners,<br />
a newly formed venture fund that will be investing solely in<br />
regenerative medicine companies. Mr. Bonfiglio will review the<br />
current funding environment for regenerative medicine companies<br />
– where we are, how we got here, and what the future holds<br />
from funding sources. Mr. Bonfiglio also will discuss where<br />
regenerative medicine companies can find funding and the typical<br />
deal structures for companies that are successful in securing<br />
funding.<br />
Gregory Bonfiglio, Managing Director<br />
Proteus Venture Partners<br />
12:00 - 1:15 Lunch<br />
1:15 - 2:00<br />
Commercialization and Investment Opportunities-<br />
Panel discussion<br />
Moderator:<br />
Doros Platika, M.D., Ph.D., President & CEO<br />
PITTSBURGH LIFE SCIENCES GREENHOUSE<br />
Panelists:<br />
Reni Benjamin, Ph.D., Senior Biotechnology Analyst<br />
Rodman & Renshaw<br />
Gregory Bonfiglio, Partner<br />
Proteus Venture Partners<br />
Cathy Prescott, DPhil, Science Director<br />
Avlar BioVentures<br />
Regulatory<br />
2:00 - 3:30<br />
Regulatory issues in Stem Cells & Regenerative<br />
Medicine<br />
What are some of the regulatory challenges in taking your stem<br />
cell-based/regenerative medicine product to clinic? The answer<br />
largely depends on:<br />
1. The complexity of your product (for example, does it consists<br />
of cells only, or include a biomaterial?)<br />
2. The source of the tissue used ( for example, embryonic, fetal,<br />
adult, xenogeneic)<br />
3. The development of analytical tools for testing and<br />
characterization of stem cell component (for example, cellspecific<br />
biomarkers, unique genomic or proteomic profiles).<br />
The planned clinical indication, severity of disease and route<br />
of administration.<br />
4. The availability of relevant preclinical animal models of<br />
disease (for example, is a small animal model sufficient to<br />
assess safety or will larger animals be needed?)<br />
This panel will consist of members who have ‘real world’<br />
experience with one or more of these issues along with<br />
regulatory experts who can share their experiences. Active<br />
participation from the audience is expected and encouraged and<br />
intended to answer your questions and foster an exchange of<br />
ideas.<br />
Donald Fink, Jr., Ph.D., Cell Therapy Branch<br />
Office of Cellular, Tissue and Gene Therapies<br />
Center for Biologics Evaluation and Research/US-FDA<br />
Darin Weber, Ph.D., Senior Consultant<br />
The Biologics Consulting Group<br />
3:30 End of conference<br />
To Register: Visit www.srinstitute.com/stemcells or Call 800-599-4950 / 212-967-0095
Special Thanks to our Sponsors<br />
PLATINUM LEAD SPONSOR<br />
The Pittsburgh Life Sciences<br />
Greenhouse (PLSG) is a strategic<br />
economic development initiative.<br />
Our goal is to grow southwestern<br />
Pennsylvania’s region to become a<br />
premier national and international<br />
center for the Life Sciences. It is a collaborative effort<br />
including key government, university, industry and economic<br />
development organizations that will result in a critical mass<br />
of bioscience companies, jobs and research infrastructure.<br />
The PLSG initiative is being built on a powerful base of<br />
advanced research and healthcare capabilities led by the<br />
University of Pittsburgh, Carnegie Mellon University and the<br />
UPMC Health System. www.pittsburghlifesciences.com<br />
Progenitor Cell Therapy (PCT)<br />
is a client-based cell therapy<br />
services company that supports the<br />
development and commercialization<br />
of cellular therapies. PCT provides<br />
cGMP-compliant cell manufacturing and consulting services<br />
that address regulatory, financial, technical, process, and<br />
quality system strategies. Services include a full spectrum<br />
of support including process and product development,<br />
consulting, validation, due diligence evaluations, tissue<br />
collection, processing, and storage, product manufacturing,<br />
distribution and transportation.<br />
BioSpherix Ltd. specializes in<br />
productive biological atmospheres.<br />
Featured on exhibit will be a unique<br />
new STEM CELL CLOSED-SYSTEM<br />
INCUBATOR which offers (1) better expansion of stem<br />
cell cultures, (2) unprecedented new ability to manipulate<br />
stem cell phenotype, and (3) the first clear critical path to<br />
cGMP-compliant production of stem cells for clinical trials<br />
and therapeutic use. Not only can it accelerate stem cell<br />
research and development by large factor, but as a practical<br />
and economical new alternative to bricks-and-mortar cleanrooms,<br />
it should save huge amounts of money and time<br />
getting new stem cell therapies into the clinic. No other<br />
system offers so much for so little. Please stop by and pick<br />
up a brochure!<br />
Epiontis GmbH Berlin, Germany<br />
Epiontis GmbH is an innovative<br />
biotechnology company that exploits<br />
the biological phenomenon of DNA<br />
methylation as an analytical tool in Regenerative Medicine.<br />
Epiontis provides QC tests that determine identity, purity<br />
and potential contaminations of cell products (EpiTest kits) and<br />
HTS screens to identify new growth factors (EpiScreen).<br />
Epiontis proprietary DNA-methylation analysis is more<br />
universal, sensitive and robust than conventional analysis<br />
methods such as cDNA arrays, enzyme assays and<br />
immunological test. www.epiontis.com<br />
Thank you to our Media Partners<br />
Sponsor / Exhibitor Opportunities<br />
An Outstanding Business Development Opportunity:<br />
By becoming a Sponsor and/or Exhibitor at this executive<br />
conference, your company or firm will join some of this industry’s<br />
leading decision-makers. Since 1993 the Strategic Research<br />
Institute has specialized in organizing executive conferences (not<br />
trade shows). Consequently, our clients who attend include only the<br />
most senior decision-makers in this business space.<br />
Pre-Event Exposure:<br />
Before each conference, the event brochure and other marketing<br />
efforts reach a very targeted group of senior decision-makers;<br />
and by partnering with SRI in presenting this conference, your<br />
company brand and a brief description of your products or services<br />
may be included in a pre-event marketing campaign that reaches<br />
approximately 25,000 to 35,000 targeted executives.<br />
Face-to-face Business Development Opportunities:<br />
At the conference itself, there are only a limited number of<br />
sponsorship and exhibit opportunities. For example, you may<br />
choose to sponsor one of several informal networking functions<br />
such as the morning breakfast buffet, mid-morning or mid-afternoon<br />
refreshment break, or a luncheon or evening networking reception.<br />
All sponsorships may include an approximately 8’ x 10’ exhibit<br />
space. If your sponsorship is confirmed early in the development of<br />
the conference agenda, a speaking role on one of the conference<br />
sessions or panels may be included if appropriate.<br />
For more information about how your company can take advantage<br />
of this exclusive gathering of your potential customers, contact<br />
Hank Woji at hwoji@srinstitute.com or 719-290-8836.<br />
To Register: Visit www.srinstitute.com/stemcells or Call 800-599-4950 / 212-967-0095
Present A Poster<br />
See Inside for Details<br />
6th Annual<br />
Stem Cells&<br />
Regenerative Medicine<br />
The Annual Standard in Industry-Focused Applications of Stem Cell Research<br />
October 16-17, 2006 • Renaissance Pittsburgh Hotel • Pittsburgh, PA<br />
6th Annual Stem Cells & Regenerative Medicine<br />
REGISTRATION FORM<br />
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October 6th<br />
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