CORPORATE COUNCIL MEETING
Royal Palms Resort
Phoenix, AZ
October 2-3, 2011
Table of Contents
Page
Agenda
3
List of Participants
5
ASBMT Research Priorities
8
Anti-Trust Guidelines
11
2
ASBMT Corporate Council Agenda
Royal Palms Resort
Phoenix, Arizona
Sunday, October 2
6:00 pm
Welcome Reception
Palmera Garden
7:00 pm
Dinner
Palmera South
"How to Commercialize Cellular Therapy Successfully"
Raymond J. Wood
Managing Director
Cell Therapies
9:00 pm
Adjourn
Monday, October 3
7:00 am
Breakfast
Palmera Lounge
7:30 am
Welcome and Introductions
Palmera North
Armand Keating, MD
University of Toronto
7:40 am
Scientific Session

"Immunotherapy to Address Stem Cell Transplant
Donor Issues"
Denis-Claude Roy, MD
Maisonneuve-Rosemont
Hospital Research Centre
(CRHMR)

“It’s not Over by Day 100: How to Study Long-Term
Effects of Transplant”
Daniel Weisdorf, MD
University of Minnesota

“Accrual is Always too Slow: How can We Make
it Better?”
Daniel Weisdorf, MD
University of Minnesota
10:00 am
Break
10:15 am
Changing CME Environment
11:15 am
Linda Caples, MBA
Medical College of Wisconsin

“New CME Guidelines”

“Impact on Corporate Sponsored Symposia and
programs”

“Strategies for Meeting Corporate and Physician Needs”
Training
Market Expansion
“Shortage of BMT physicians: What can be done to
Recruit more BMT fellows”
3
Richard Champlin, MD
M.D. Anderson Cancer Center
ASBMT Corporate Council Agenda (cont’d)
Monday, October 3
12:00 Noon
Lunch
Palmera Lounge
12:45 pm
Promoting ASBMT Research Priorities
Helen Heslop, MD
Baylor College of Medicine
1:45 pm
Economic Modeling of BMT Processes
John Kersey, MD
University of Minnesota


Current Cost of Care
Cost Reduction Strategies
2:45 pm
Other Business
Armand Keating, MD
University of Toronto
3:00 pm
Adjourn
Departure for Phoenix Sky Harbor International Airport
4
Council Participants
Corporate Leaders
Amgen, Inc.
Dave Mc Fadden, Director of Medical Affairs, One Amgen Center Drive, Thousand Oaks, CA 91320.
Phone: (805) 447- 3564
e-mail: davem@amgen.com
Celgene Corporation
Scott Miller, Regional Medical Liaison, 86 Morris Avenue Summit, NJ 07901.
Phone: (972) 333-0548
e-mail: smiller@celgene.com
Fresenius Biotech
J. Frank Glavin, Vice President, Head of North America, 920 Winter Street, Waltham, MA 02451.
Phone: (781) 699-4614
e-mail: Frank.Glavin@fresenius-biotech.com
Genzyme Corporation
Richard Kadota, MD, Medical Director, Oncology Transplant, Global Medical Affairs, 55 Cambridge
Parkway, Cambridge, MA 02142.
Phone: (617) 761-8509
e-mail: richard.kadota@genzyme.com
Hospira Inc.
David Peritt, PhD, Scientific Director, Hematology/Oncology, 275 North Field Drive, Building H2-2E,
Department 087W, Lake Forest, IL 60045.
Phone: (224) 212-2546
e-mail: david.peritt@hospira.com
Otsuka America Pharmaceutical
Raul Perez-Olle, MD, PhD, Medical Director, 100 Overlook Drive, Princeton, NJ 08540.
Phone: (609) 853-2064.
e-mail: Raul.Perez-Olle@otsuka-us.com
Sharon Roell, Associate Director, Global Clinical Development, 100 Overlook Drive, Princeton, NJ 08540.
Phone: (612) 710-4888
e-mail: sharon.roell@otsuka.com
Guest Speakers
Linda D. Caples, MBA, Director, Office of Continuing and Professional Education, Medical College of
Wisconsin, 10000 Innovation Drive, Milwaukee, WI 53226.
Phone: (414) 955-4900
e-mail: lcaples@mcw.edu
Denis-Claude Roy, MD, Director of the Research unit of Cellular Therapy, Maisonneuve-Rosemont
Hospital Research Centre (CRHMR), 5415, boulevard de l'Assomption, Montréal (Québec) H1T 2M4
Montreal, Canada.
Phone: (514) 252-3400
e-mail: denis-claude.roy@umontreal.ca
Raymond J. Wood, FIE Aust, FAICD, Managing Director, Cell Therapies Pty Ltd, Ground Floor,
10 St Andrews Place, East Melbourne, Victoria, 3002.
Phone: +61 (0)419 344 530
e-mail: raywood@celltherapies.com.au
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ASBMT Leaders
Richard Champlin, MD, Past-President of ASBMT, Chairman and Professor, Stem Cell Transplantation &
Cellular Therapy, M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030.
Phone: (713) 792-3619
e-mail: rchampli@mdanderson.org
Nelson Chao, MD, ASBMT Past-President, Chief Medicine/Cellular Therapy, Duke University Medical
Center, 2400 Pratt Street, Durham, NC 27710.
Phone: (713) 792-3619
e-mail: chao0002@mc.duke.edu
Helen Heslop, MD, ASBMT Past-President, Professor of Medicine and Pediatrics and Director of the
Adult Stem Cell Transplant Program in the Center for Cell and Gene Therapy at Baylor College of
Medicine; 6621 Fannin Street, Houston TX 77030
Phone: (832) 824-4662
e-mail: heheslop@txccc.org
Armand Keating, MD, ASBMT Past-President, Director, Division of Hematology, University of Toronto,
Director, Cell Therapy Program, Princess Margaret Hospital, 610 University Avenue, Toronto, Ontario
M5G 2M9, Canada.
Phone: (416) 946-4595
e-mail: armand.keating@uhn.on.ca
John Kersey, MD, ASBMT Past-President, Founding Director Emeritus, Masonic Cancer Center,
Professor and Land Grant Fund Chair in Pediatric Oncology, University of Minnesota, 420 Delaware
Street, Minneapolis, MN 55455.
Phone: (416) 946-4595
e-mail: kerse001@umn.edu
Robert Korngold, PhD, Editor-in-Chief, Biology of Blood and Marrow Transplantation, Chief of the
Division of Research, Cancer Center Hackensack University Medical Center, 30 Prospect Avenue,
Hackensack, NJ 07601.
Phone: (201) 336-8662
e-mail: rkorngold@humed.com
C. Fred LeMaistre, MD, ASBMT Vice President and President of the Foundation for Accreditation of
Cellular Therapy (FACT), Director and Founder of Bone Marrow Transplant Program Texas Transplant
Institute, 7711 Louis Pasteur, San Antonio, TX 78229.
Phone: (210) 575-8500
e-mail: charles.lemaistre@mhshealth.com
Elizabeth J. Shpall, MD, ASBMT President-Elect, Professor, Department of Stem Cell Transplantation,
Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd,
Unit 423, Room FC5 3050, Houston, TX 77030.
Phone: (713) 745-2161
e-mail: eshpall@mdanderson.org
Keith Sullivan, MD, ASBMT Past-President, James B. Wyngaarden Professor of Medicine, Duke
University Medical Center, 2400 Pratt Street, Durham, NC 27710.
Phone: (919) 668-1011
e-mail: sulli025@mc.duke.edu
Daniel Weisdorf, MD, ASBMT President, Director of the Adult Blood and Marrow Transplant Program,
University of Minnesota, 420 Delaware Street SE, Minneapolis, MN 55455.
Phone: (612) 624-0123
e-mail: weisd001@umn.edu
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Staff
Thomas Joseph, Executive Director, American Society for Blood and Marrow Transplantation, 85 West
Algonquin Road, Suite 550, Arlington Heights, IL 60005.
Phone: (847) 427-0224
e-mail: thomasjoseph@asbmt.org
Robert Krawisz, Associate Executive Director, American Society for Blood and Marrow Transplantation,
85 West Algonquin Road, Suite 550, Arlington Heights, IL 60005.
Phone: (847) 427-0224
e-mail: robertkrawisz@asbmt.org
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2009 ASBMT Research Priorities
The American Society for Blood and Marrow Transplantation has reviewed recent advances and problems in
hematopoietic cell transplantation (HCT), and has identified priorities in several areas of basic and clinical
research:

Stem Cell Biology (cell manipulation, sources of stem cells, inducible pluripotent stem cells, cancer stem
cells)

Tumor Relapse (prevention and therapy for post-transplant relapse, immunotherapy with T cells and
dendritic cells)

Graft-versus-Host Disease (separation of GVHD and graft-versus-tumor effects, immune reconstitution and
GVHD, markers predicting GVHD, role of regulatory T cells)

Applying New Technology to HCT (genomics, proteomics, imaging, markers of immunologic recovery,
pharmacogenomics)

Expanded Indications for HCT (solid tumors, regenerative medicine, autoimmune diseases, response to
bioterrorism and radiation accidents)

Survivorship (long-term complications, longevity, quality of life)

Transplants in Older Patients (biology of aging, indications, outcomes and quality of life)

Improving Current Use of HCT (graft sources, conditioning intensity, cost-effectiveness)
These research areas are closely interrelated and of growing importance as a greater number and higher risk
patients are being transplanted. Each area has an interface between basic science and clinical practice.
Research in each of these areas can have direct and immediate clinical benefits.
Stem Cell Biology
Multiple sources of stem cells are now available for transplantation, including bone marrow, mobilized
peripheral blood stem cells and umbilical cord blood, as well as cells induced to provide particular biological
functions. The development of these multiple sources was initially for the purpose of expanding the donor pool
and facilitating access, but it now is clear that these cell populations have considerable differences that can be
therapeutically exploited. A better understanding of stem cell biology is needed to optimize the therapeutic
potential of these several cell sources. That understanding is essential to successful action against cancer
stem cells, with differing repopulation kinetics, repair capacities and treatment resistance. More investigations
are needed to better define the potential of inducible pluripotent stem cells and problems that may be
associated with their use.
Tumor Relapse
Relapse remains of paramount concern after autologous HCT to treat hematologic malignancies. We need to
understand the mechanisms by which cancer cells can resist cytotoxic therapies in autologous HSCT. Use of
immune therapies, monoclonal antibodies, molecular targeted agents and chemotherapeutics – alone or in
combination – should be explored in the context of HCT. This may also help in applying autologous HCT to a
wider spectrum of malignancies.
Disease recurrence remains a major problem after allogeneic HCT in which cytotoxic therapy is combined with
immunotherapy provided by donor cells. A better understanding of the mechanisms by which cancer cells
resist cytotoxic therapy might lead to more effective immunotherapies, be they cellular, humoral or vaccination,
or a combination of these. These efforts also should include strategies for patients with minimal residual
disease after transplantation who are at a high risk of relapse but who may also be more responsive to
immunotherapy.
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Studies have shown the effective use of adoptive T cell transfer after reduced-intensity conditioning in patients
with melanoma. However, adoptive therapy with allogeneic cells also is associated with the risk of GVHD.
Therefore, techniques that modify autologous cells so they can be used for tumor antigen-specific
immunotherapy might improve efficacy and decrease toxicity. Studies on cell trafficking of immune effector cells
may also provide important information on the role of “homing” receptors and how those could be used to
design more effective therapy.
Graft-versus-Host Disease
GVHD is still the most frequent complication after HCT. While the use of reduced-intensity conditioning
regimens appears to lower the incidence – and possibly severity – of acute GVHD, there has been little impact
on chronic GVHD. We need a better understanding of the pathobiology of chronic GVHD and must find new
ways to target it clinically. The identification of early biomarkers and prognostic indicators could be helpful in
distinguishing patient populations who might benefit from different preemptive or therapeutic strategies. Rather
than broad immunosuppression, targeted approaches and possibly selective immunostimulation should be
explored. It is likely that this will lead to more individualized management that considers the underlying
disease, conditioning used for transplantation, prior therapy and patient age, among other factors.
The role of regulatory T cells, shown to be of central importance for tolerance in animal models, deserves
clinical exploration. Natural killer (NK) cells are another effector arm in need of better characterization, both as
anti-tumor effectors and as immunodulators. Similarly, NK/T cells and suppressive dendritic cell subsets
require investigation of their immunomodulatory effects. Understanding pathways that can distinguish GVHD
from the graft -versus -tumor effect and the roles of the various immune cell populations in these processes
continue to be of central importance for applying HCT in cancer therapies.
Applying New Technology to HCT
The advent of proteomic and genomics has increased the need to validate potential clinical markers. Such
markers have important implications for patient selection, prognosis and treatment. Application of new imaging
techniques will not only allow assessment of clinical efficacy and cellular therapy trafficking, but also advance
our basic understanding of disease processes. Using proteomics to determine correlative markers for GVHD
progression and to identify high-risk patients is of considerable importance. Enzyme polymorphisms are likely
relevant for drug metabolism and tissue repair, and a better understanding of these relationships could help
tailor conditioning regimens and GVHD prophylaxis. Another critical area is development of immune monitoring
parameters that reflect immune competence and recovery, particularly with the increasing use of HCT in older
patients.
Expanded Indications for HCT
HCT may have applications in solid organ transplantation by inducing immune tolerance. Studies of the
application of HCT to solid tumors are a priority.
HCT also may be useful in other therapies including, but not limited to, regenerative medicine (heart disease
and others), autoimmunity and restoration of hematopoiesis and immunity in the advent of bioterrorism attack or
mass radiological accident. Preclinical and clinical studies of immune reconstitution, tolerance, efficacy and
long-term effects will aid in understanding the applicability of HCT in these conditions and situations.
Survivorship
Some former patients have now been followed for three and four decades after transplantation – cured of their
disease, but not necessarily without long-term complications. Patients are dealing with problems such as
chronic GVHD, immune deficiency, endocrinologic failure, bone loss and secondary malignancies. Recent data
suggest that life expectancy in patients after HCT is shortened by about 30 percent, compared with age matched controls. Thus, there is a high priority for investigations of risk factors for late complications,
development of relevant preclinical models, design of interventional strategies to prevent complications and
development of better means of assessing quality of life in long-term survivors.
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Transplants in Older Patients
Older patients, who are an increasingly dominant population with respect to cancer and other diseases,
represent unique challenges in biologic understanding and extrapolation of preclinical findings and clinical
studies. Toxicities of cytoreductive therapies are heightened in the older patient. Poor immune function in the
aged leads to increased susceptibility to opportunistic infections and relapse from the cancer. The science of
aging needs to be applied to HCT. There are basic questions about the effects of age on hematopoiesis,
immune function and response to insult and stress. These need to be coupled with clinical studies on the
effects of age on recovery, outcomes and quality of life and general questions about “gain” versus “loss” that
may be associated with HCT.
Improving Current Use of HCT
We need to define the optimal stem cell sources (cord blood, peripheral blood stem cells, bone marrow, and ex
vivo expanded stem cell populations) and conditioning intensity as they relate to the treatment of specific
diseases.
Finally, it must be acknowledged that HCT can be resource intensive and expensive. There is a need for
studies of the cost-effectiveness of HCT compared to other therapies for achieving desired outcomes.
– Adopted by the ASBMT Executive Committee
September 17, 2009
___________________________________________________________________________
The ASBMT Board of Directors and Executive Committee wish to thank the members of the Task Force on
Research Priorities that helped with the development of this policy statement: H. Joachim Deeg, MD (chair),
John F. DiPersio, MD, PhD, James W. Young, MD, Richard T. Maziarz, MD, Claude Perreault, MD, and David
A. Margolis, MD, Robert H. Collins MD. The Board of Directors also wishes to acknowledge the
recommendation and encouragement of the ASBMT Corporate Council to develop these research priorities.
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ANTITRUST GUIDELINES
FOR MEETINGS AND ACTIVITIES
Active participation in the ASBMT is an important aspect of membership in the ASBMT. Participation
not only adds to the vitality and energy of the organization, but it also furthers the ASBMT’s mission of
advancing the field of blood and bone marrow transplantation.
While the positive contributions of professional societies and associations are well recognized and
encouraged by government, association activities also are subject to close scrutiny under both federal and
state antitrust laws. The single most significant law affecting associations is the Sherman Antitrust Act,
which makes unlawful every contract, combination or conspiracy in restraint of trade. Because an
association is, by nature, a group of competitors joined together for a common business purpose, an
association satisfies what would ordinarily be a difficult element in proving an antitrust violation. As such,
any association activity that arguably could be perceived as a restraint of trade exposes ASBMT and its
members to antitrust risk.
Historically, the most significant area of antitrust concern for associations has been price fixing. Price
fixing is a very broad term which includes any concerted effort or action that has an effect on prices, terms
or conditions of trade, or on competitors. Accordingly, meeting participants should refrain from any
discussion which may provide the basis for an inference that they agreed to take any action
relating
to prices, services, production, allocation of markets or any other matter having a market effect. These
discussions should be avoided both at formal meetings and informal gatherings and activities.
In
addition, meeting participants should be sensitive to other matters that may raise particular antitrust
concern for associations: membership restrictions, codes of ethics or other forms of self-regulation,
product standardization or certification. The following are guidelines that should be followed at all ASBMT
meetings, informal gatherings and activities:

DON’T discuss your own or others’ prices or fees for service, or anything that might affect
prices or fees, such as costs, discounts, terms of sale, or profit margins.

DON’T stay at a meeting where any such price talk occurs.

DON’T make public announcements or statements about your own prices or fees, or those of
competitors, at any ASBMT meeting or activity.

DON’T talk about what other entities or their members or employees plan to do in particular
geographic or product markets or with particular customers.

DON’T speak or act on behalf of the ASBMT or any of its committees unless specifically authorized
to do so.

DO alert ASBMT staff or legal counsel about any concerns regarding proposed statements to
be made by the association on behalf of a committee.

DO consult with your own legal counsel or the ASBMT before raising any matter or making any
statement that you think may involve competitively sensitive information.

DO be alert to improper activities, and don’t participate if you think something is improper.
Adherence to these guidelines involves not only avoidance of antitrust violations, but avoidance of
behavior which might be so construed. Bear in mind that the antitrust laws are stated in general terms,
and that these guidelines only provide an overview of prohibited actions. If you have specific questions,
seek guidance from your own legal counsel or from the ASBMT’s Executive Director or legal counsel.
11