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Register 3
for the price of 2 with the coupon code rcdvb! |
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Day 1 - Monday, February
25, 2013 |
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| 7:00 |
Registration & Continental Breakfast |
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| 7:55 |
Welcome & Opening Remarks |
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KEYNOTE PRESENTATION
Moderator: Elizabeth Bachert, Senior Director, Pfizer
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| 8:00 |
Partnering with AstraZeneca and MedImmune in Oncology |
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Timothy Herpin
Vice President
Strategic Partnering & Business Development Oncology
Science & Technology Licensing
AstraZeneca
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Oncology is a key disease area for AstraZeneca
and MedImmune and we are working with many partners to discover and develop
novel therapeutics. The presentation will explore how partnerships have been
used to access innovation and will address the following questions:
• What is the approach to oncology that AstraZeneca and MedImmune are pursuing?
• How have recent partnerships been structured?
• How does AstraZeneca work with academic institutions to create innovation? |
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Panel Discussion: Innovative Partnering & Licensing
Moderator:
Timothy Herpin, Vice President, AstraZeneca |
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| 8:45 |
Panelist: Anne Altmeyer, Vice President, Business Development & Licensing,
Oncology, Novartis |
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Panelist: Klaus Damm, Licensing Director, Amgen |
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Panelist: Elizabeth Bachert, Senior Director, Worldwide Business Development,
Pfizer |
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Panelist: David Snitman, Chief Operating Officer & Vice President, Business
Development, Array BioPharma |
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Panelist: Matthew Call, Vice President, Business Development, Endocyte |
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Panelist: Philippe Lopes-Fernandes, Corporate Vice President, Head of Licensing,
Business Development & Alliance
Management, Merck KGaA |
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Topics to be Discussed:
- Oncology drug partnering 101
- Rationale driving key deals of 2012 and
continued trends into 2013
- Aligning deal structures with corporate
strategic goals
- How the heightened risk environment is
affecting deals
- Pros and cons of regional deal-making
- At what stage or what type of data makes
the asset most attractive to a buyer?
- How do you find and decide who a good
partner is?
- What determines the value of the deal?
- What preparation should you do before the
deal?
- What kind of terms besides financials
should you think about?
- What are the criteria to attract
investors?
- Creative partnering appears to be
stemming from shrinking R&D budgets at large Pharma and large Pharma
interest in sharing risk, how do biotechs feel about sharing funding for
projects and sharing risk? How is this balance best achieved?
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| 10:00 |
Morning
Networking & Refreshment Break |
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Investment, Partnerships and Acquisitions: Trends & Recent
Deals
Moderator:
Anne Altmeyer, Vice President, Novartis |
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| 10:30 |
Partnering - the View from Biotech |
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Martin Buckland, Chief Business Officer,
Astex Pharmaceuticals |
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Partnerships are in the lifeblood of the biotech
industry. Biotech companies depend on partnerships both to validate their
technologies and products, and to help provide financing and a route to market.
This presentation will outline some of the trials and tribulations of
partnering, as well as some of the advantages and benefits of partnering, using
examples from Astex’s experience.
• How to survive as a private biotech company
• The importance of partnering to help drive financing strategy
• Accessing not-for-profit funding
• Lessons for biotech, and for pharma partners |
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10:55 |
Novel Partnering Structures to Advance Pipeline Development |
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Tracey Vetterick, Director, Business Development, MedImmune |
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In a budget constrained environment, it is
becoming more challenging to develop the breadth and depth of clinical assets
needed to better treat patients. This presentation will discuss novel partnering
structures to increase development capacity while also bringing beneficial
therapeutic combinations to light earlier in the development process.
Benefits of this talk:
1. Importance of partnering to increase therapeutic options available to
patients
2. Considerations for how to progress a broad pipeline and gather important data
to enable future development decisions
3. Discussion around novel deal structures which have been implemented |
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| 11:20 |
Case Studies in Structuring Partnerships to Build Long Term Value |
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David Snitman, Chief Operating Officer & Vice
President, Business Development, Array BioPharma |
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Array BioPharma is a 14 year old biotech company
focused on the development and commercialization of oncology therapeutics. Array
has built a portfolio of 15 clinical programs, 11 in Phase 2, through selective
deal making and partnerships. This talk will review key partnership deals that
have been strategic in allowing Array to advance its own internal programs while
bring in ~$600M in non-dilutive financing. The structure of several of these
deals and their strategic role in Array’s development will be discussed. |
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11:45 |
Is It Time to Get Hitched? |
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Elan Ezickson, EVP and Chief Operating Officer, Aveo Pharmaceuticals |
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Biotech companies who are developing late-stage
oncology drugs are often faced with the dilemma of becoming a commercial
organization or seeking a large partner to launch and market the compound. As
this is a critical strategic decision for any biotech company in this situation,
it is imperative that all options and potential ramifications are carefully
weighed.
This presentation will explore the issues, and potential pros and cons, of
striking a commercial partnership vs. “going alone”. How do you balance asset
dilution vs. equity dilution? Long-term upside vs. near-term capital risk? Lead
asset vs. pipeline? Building an infrastructure for the future vs. leveraging an
established infrastructure for the present? Just as the decision to partner is
typically neither black nor white, nor is the structure of an alliance. In order
to make the “right” decision, both companies must understand the pros and cons
of a prospective relationship as well as the individual needs of each company.
Benefits of Talk
• Understand the pros and cons of commercializing vs. partnering with larger
companies
• Gain an appreciation for the wide variety of potential deal structures
(co-promotes, geographic splits, profit splits, etc.)
• Gain insight into some of the operational challenges of alliances (budgets,
pricing, etc.)
• Learn from real world examples of the decision making process |
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| 12:10 |
Lunch on Your Own |
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| 1:30 |
Biotech Partnering: Trends & Recent Deals for Sustaining Biotech Innovation |
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Eric Risser, Vice President, Business
Development, MacroGenics |
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This presentation will highlight recent trends in
biotech partnering models. It will cite some specific examples of recent
industry deals, and reference the impact on the various stakeholders in the
biotech innovation ecosystem, including venture capitalists, biotech
entrepreneurs, and major pharmaceutical companies. |
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| 1:55 |
Business Development: Opportunities to Synchronize with and/or Catalyze
Corporate Evolution |
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Natasha Hernday, Vice President, Corporate Development, Seattle Genetics |
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Business development goals and objectives change
significantly over the course of a company’s evolution. I will provide an
overview of Seattle Genetics’ deal making from inception through the launch of
ADCETRIS® (brentuximab vedotin), the company’s first commercial product.
• Internal and external factors that influenced deal making
• Lessons learned from various deal structures
• The shift from out-licensing to current partnering and in-licensing efforts
• Observations from incremental vs. transformational deal making (industry
examples) |
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| 1:20 |
Rita (Glykeria) Theodotou, Director, Global
Marketing, Oncology, Bayer |
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2:45 |
Addressing the Dilemma of Small Biotech: How To Build A Substantial Pipeline
with Limited Resources |
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Chris Varma, President and Chief Executive Officer, Blueprint Medicines |
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Small biotech companies with productive product
engines, often venture-backed, are challenged to develop robust pipelines
because of limited capital. Blueprint Medicines is addressing this issue through
the use of creative deal structures called risk-sharing models that leverage
non-capital resources of at least two parties. In this context, risk-sharing
models enable one party to advance an early program to a later phase with the
engagement of a second party. Both parties contribute to the program with their
own resources and therefore both parties obtain an ownership interest in the
program. If the program successfully reaches a point of higher value creation,
then the outcome is a win-win for both parties. |
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| 3:10 |
Afternoon
Networking & Refreshment Break |
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3:40 |
Teaching an Old Dog New Tricks: Twist on an Anti-viral for Thyroid and Other
Solid Tumors |
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John Tagliamonte, Chief Business Advisor, Translational Therapeutics, Inc. (TransRx) |
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The need for targeted treatments of high-grade
metastatic cancers has never been greater. TransRx is developing small molecules
that will be the first-in-class to target the master switch: ieF4E (4E) While
many solid tumors express this control switch at high levels, the company plans
to enter the clinic to address Thyroid Cancer. Related clinical evidence
supporting safety of the company’s lead molecule and the ability to test, treat
and monitor target activity provide hope for a monotherapy. A capital-efficient
structure stretches R&D funds to drive a fast and flexible development plan.
Benefits of the talk are:
1. Learn about a new target and new molecule to treat a highly unmet medical
need.
2. Hear about developing drugs without traditional venture investment
3. Discuss the companion diagnostic model
4. Find non-dilutive sources of funding |
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Oral Presentations from Exemplary Submitted Abstracts |
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RX-5902 is An Orally Administered Highly Potent Anti-cancer, First-in-class,
Small Molecule |
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Vikas Sharma, Director, Business Development, Rexahn Pharmaceuticals |
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RX-5902 is an orally administered highly potent anti-cancer, first-in-class,
small molecule that eliminates cancer cells through Inhibition of phosphorylated
p68 found only in cancer cells. Studies to date have shown it be effective in
solid tumors including melanoma, cancers of ovary, kidney and pancreas. Besides,
effects on primary tumors, RX-5902 is also exhibits potent anti-proliferating
effects on drug-insensitive or drug-resistant human cancer cells at low nano-molar
concentrations and has Synergistic effects with leading anticancer drugs. IND
has been submitted and Phase I trials are planned to start early next year. |
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Oral Presentations from Exemplary Submitted Abstracts |
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4:30 |
Safely Enhancing Brain Drug Delivery in the Treatment of Brain Cancer |
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Frederik Lonnqvist, Chief Medical Officer, to-BBB |
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to-BBB is focused on the treatment of CNS
diseases. Since 98% of all drugs have a poor blood-brain barrier penetration and
many medical needs in CNS diseases are still unmet we have developed a
technology that safely and selectively enhances the delivery of various types of
small molecule drugs across the blood-brain barrier. Our lead product
(2B3-101) builds on the success of Doxil. Thus, 2B3-101 is a targeted liposomal
formulation of doxorubicin that utilizes our G-Technology® platform to enhance
the delivery of doxorubicin to the brain. The G-Technology® concept is built
upon the conjugation of glutathione onto the tips of the pegylated liposomes,
which then actively transports the encapsulated compound across the blood-brain
barrier by use of endothelial glutathione transporters. 2B3-101 can be
used to treat the same indications as Doxil. The important difference vs. Doxil
is that treatment with 2B3-101 results in 5 times higher concentrations of
doxorubicin in the brain as compared to Doxil (based on preclinical data).
Thereby, 2B3-101 also provides an opportunity to treat primary and secondary
brain tumors, in contrast to Doxil. As of mid-January 2013, our phase I/IIa
trial with 2B3-101 is at the end of the MTD phase (60 mg/m2 every 3 weeks) and
the data look very promising, without any DLTs so far. The side effect profile
is in line with Doxil and we are starting to see early signs of preliminary
efficacy on brain tumors in the 40, 50 and 60 mg/m2 cohorts in patients with
solid tumor brain metastases as well as in patients with recurrent gliomas. We
also see signs of preliminary efficacy on the systemic, extra-cranial disease.
We will shortly initiate the expansion phase and should be able to provide a
more consolidated picture of the safety and efficacy when expansion phase has
been completed around August 2013. We have started to actively look for
licensing partners for 2B3-101. |
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| 4:55 |
Networking Reception and Poster Session |
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Day 2 - Tuesday, February 26,
2013 |
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| 7:30 |
Continental Breakfast |
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Novel Advances & Technologies in Oncology (Joint
Session)
Moderator:
Charles Theuer, President & Chief Executive
Officer, Tracon Pharma |
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| 8:00 |
Development of Next Generation Angiogenesis Inhibitors Targeting Pathways Other
than VEGF |
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Charles Theuer,
President and Chief Executive Officer, Tracon Pharma |
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Monoclonal antibodies have revolutionized cancer
care and four antibodies now have annual commercial revenues of greater than $1B
annually. One of these antibodies, bevacizumab, targets the VEGF pathway, which
is essential for angiogenesis. Bevacizumab has been approved in two of the most
prevalent tumor types and its success has prompted the development of a host of
biologics therapies targeting this pathway. Most recently aflibercept, another
protein that binds VEGF was approved in colorectal cancer.
While of proven clinical benefit, VEGF inhibitors do not “cure” cancer and
efforts have now focused on targets that complement the VEGF pathway to further
inhibit angiogenesis and positively impact cancer care. Examples of a second
generation angiogenesis targets are endoglin (CD105) and angiopoietin.
The antibody TRC105 binds to endoglin, a target that (like VEGF) is required for
angiogenesis, prognostically relevant and expressed within the vasculature of
multiple solid tumors. CD105 is up-regulated following the treatment of human
cancer xenografts with VEGF inhibitors, indicating that targeting the endoglin
pathway may be a useful strategy to combine with VEGF inhibition. TRC105 has
been studied with bevacizumab and radiographic regressions have been noted in
bevacizumab refractory patients.
The antibody AMG386 binds to angiopoietins and is being studied in several
studies of ovarian cancer patients in combination with chemotherapy. Additional
studies in combination with VEGF inhibitors are underway.
The goal of the talk will be to review the current state of angiogenesis
inhibition in oncology and emphasize antibody therapies directed to targets that
complement the VEGF pathway. |
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| 8:25 |
Using FDHT-PET and Preclinical Projections to Optimize Dose Selection of ARN=509
in mCRPC |
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Isan Chen, Chief Medical Officer, Aragon Pharmaceuticals |
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Phase I dose selection is a crucial step in the
early clinical development. The traditional paradigm of dose escalation until
‘maximum tolerated dose’ (MTD) with cytotoxic chemotherapeutic agents is
suboptimal since in most instances, the dose and schedule selection are based on
relatively small number of patients and it may or may not be applicable in the
clinical development of hormonal or biological agents and TKIs.
The concern about ‘leaving efficacy on the table’ by proceeding to late stage
clinical trial with doses below that of MTD may be real; however, there are also
examples of agents that required further dose de-escalation studies due to
excessive toxicity of the recommended phase 2 dose.
An integrated and careful assessment of preclinical models of maximal antitumor
activity with clinical safety, PK and PD can be helpful in optimizing the
recommended phase 2 dose with hormonal agents.
An example of the recommended phase 2 dose selection of ARN-509, a
second-generation anti-androgen, combining preclinical projections, clinical
safety, PK, and maximal PD effect based on FDHT-PET will be presented.
“Benefits’ of the talk:
1. Importance of dose selection in Phase I,
2. Examples of study failures potentially due to wrong selection of
dose/schedule,
3. Integration of preclinical and clinical information in the decision process
4. Use of PET scan to support recommended phase 2 dose with ARN-509 |
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| 8:50 |
CCR5 Antagonists Block Basal Breast Cancer and Prostate Cancer Metastasis in Vivo |
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Richard Pestell, Director, Kimmel Cancer Center & Associate Dean, Cancer Programs, Jefferson Medical College Vice President, Oncology Services, Thomas Jefferson University Hospital, Kimmel Cancer Center, Thomas Jefferson University |
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The roles of the chemokine CCL5 and its receptor CCR5 in breast and prostate cancer progression are controversial. Herein, interrogation of microarray analysis of 2,254 human breast cancers demonstrated increased expression of CCL5 and its receptor CCR5, but not CCR3, in the basal and HER-2 genetic subtypes of breast cancer. Human breast cancer cell lines expressed CCR5 by flow cytometry and displayed a functional response to CCL5 by calcium mobilization assays and invasion assays. Using isogenic
oncogene transformed breast and prostate cancer cell lines we show oncogene
transformation induces CCR5 expression and that the subpopulation of cells that express functional CCR5 display increased invasiveness. The CCR5 antagonists Maraviroc or Vicriviroc, developed to block CCR5 HIV co-receptor function, reduced in vitro invasion of basal breast cancer and prostate cancer cell lines without affecting cell proliferation or viability. In a series of preclinical mouse models, Maraviroc decreased breast pulmonary metastasis. The isogenic
prostate cancer cell lines metastasized to bones in immune-competent mice representing an ideal model for testing anti-metastasis therapies. Maraviroc or
Vicriviroc, reduced prostate cancer metastasis to brain bones and lungs. Our findings provide evidence for the key role of CCL5/CCR5 in the metastasis of basal breast cancer and prostate cancer cell lines and suggest that CCR5 antagonists may be used as an adjuvant therapy to reduce the risk of metastasis in patients with the basal breast cancer subtype and prostate cancer. |
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| 9:15 |
Development of the First
Selective Oral HDAC6 Inhibitor to Treat Multiple Myeloma |
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Simon S. Jones, Vice President, Biology & Preclinical Development, Acetylon Pharmaceuticals |
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Histone deacetylase (HDAC)
inhibitors are efficacious in hematologic malignancies either as single agents
or in combination with other antineoplastic agents, for example bortezomib a
proteasome inhibitor (PI), in patients with relapsed and refractory multiple
myeloma (MM); a plasma B-cell malignancy. Significant progress has been achieved
in the last ten years in treating MM with novel therapies such as the PIs
bortezomib (Velcade®) and carfilzomib (Kyprolis®) and the IMiD class of drugs
lenalidomide (Revlimid®). However the rate of relapse in MM and the need for
novel drug combinations remains high.
• HDACs are a family of enzymes which regulate critical cellular functions of a
broad spectrum of proteins
• HDAC inhibitors Zolinza® and Istodax® have been approved targeting T-cell
lymphoma
• Use of first generation, non-selective HDAC inhibitors has been limited due to
the substantial side effect profile of severe fatigue, nausea, vomiting,
diarrhea and myelosuppression associated with Class I HDAC inhibition
• Development of potent, isoform-selective, second generation HDAC inhibitors is
expected to lead to a breakthrough both in basic biology and broadened utility
for oncology
ACY-1215 is the first selective HDAC6 inhibitor in Phase 1 clinical trials for
the treatment of MM in combination with either bortezomib or lenalidomide. HDAC6
regulates an alternative pathway to the proteasome to remove unfolded, misfolded
and excessive amounts of proteins characteristic of MM. The preclinical and
clinical development as well as the superior safety profile of ACY-1215 in MM in
combination with either bortezomib or lenalidomide will be discussed. |
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| 9:40 |
Targeting the Pathways Critical to Cancer Stem Cells |
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Sunil Patel, Senior Vice President, Corporate Development, Oncomed Pharmaceuticals |
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OncoMed is a clinical
development-stage biopharmaceutical company focused on discovering and
developing first-in-class monoclonal antibody therapeutics targeting cancer stem
cells, or CSCs. Our approach has been to target CSCs, which are the
subpopulation of cells in a tumor responsible for driving growth and metastasis
of the tumor. CSCs, also known as tumor-initiating cells, exhibit certain
properties which include the capacity to divide and give rise to new CSCs via a
process called self-renewal and the capacity to differentiate or change into the
other cells that form the bulk of the tumor. Common cancer drugs target bulk
tumor cells but have limited impact on CSCs, thereby providing a path for
recurrence of the tumor. Our product candidates target CSCs by blocking
self-renewal and driving differentiation of CSCs toward a non-tumorigenic state,
and also impact bulk tumor cells.
We utilize our proprietary technologies to (1) identify, isolate and evaluate
CSCs, (2) identify and/or validate multiple potential targets and pathways
critical to CSC self-renewal and differentiation, and (3) develop targeted
antibody and other protein-based therapeutics that are designed to modulate
these CSC targets and inhibit the growth of CSCs. These targets are in pathways
implicated in cancer biology and stem cell biology, including the Notch, Wnt and
other fundamental CSC pathways.
We have five anti-CSC product candidates in clinical development. We are also
continuing to pursue discovery of additional novel anti-CSC product candidates.
We have forged broad strategic pathway collaborations with GlaxoSmithKline and
Bayer HealthCare Pharmaceuticals. |
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| 10:05 |
Morning Networking & Refreshment Break |
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How Big Pharma Values Your Innovation
Moderator:
Charles Theuer, President & Chief Executive
Officer, Tracon Pharma |
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| 10:30 |
How AstraZeneca Values Innovation |
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John Gustofson, Director, Business Development,
Strategic Partnering & Business Development, Oncology, AstraZeneca |
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AstraZeneca is a global pharmaceutical company
working in the areas of Oncology, Infection, Cardiovascular, Gastrointestinal,
Respiratory, Inflammation and CNS. AstraZeneca is continuously looking for and
evaluating both clinical and preclinical oncology opportunities for in-license.
Sources of opportunities include academics, biotechnology companies and peer
pharma from all over the world. AstraZeneca uses traditional financial
evaluations of discounted cash flows and internal rates of return but also
utilizes a strategic evaluation called the 5R’s. This 5R assessment includes
preclinical data, clinical data and commercial assessment such as payor
analysis. This presentation will review AstraZeneca’s methodology of evaluation
and details of the 5R analysis. This talk will also compare and contrast how
AstraZeneca evaluates early stage opportunities that are in emerging areas of
science along with established areas. Finally, this talk will outline how a
company with an asset to license should approach AstraZeneca including 1) with
what type of data and 2) how to present the data to facilitate rapid evaluation.
Benefits of this talk
• Understanding how AstraZeneca evaluates both preclinical and clinical
opportunities
• Knowledge how to pitch an opportunity to AstraZeneca
• Overview of what key oncology opportunities AstraZeneca is looking for |
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| 10:55 |
How to Think About Valuation When You are Seeking a Pharma Partner - A Business
Development Consultant's Advice |
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Linda Pullan, Business Development Consultant,
Pullan Consulting |
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When contemplating partnerships (collaborations,
JVs, Licensing deals, etc) to advance an early drug candidate, a company
naturally asks “how much is this drug candidate worth to a partner?”. Linda
Pullan will talk about different techniques, key variables and how to use
approximations and short cuts for the hugely uncertain variables. And the
partner’s perspective of what adds value will be discussed. |
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Panel Discussion: Regulatory Guidance & Updates
Moderator:
Linda Pullan, Pullan Consulting |
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| 11:20 |
Panelist: Laurie Strawn, Senior Director, Worldwide Regulatory Strategy,
Pfizer |
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Panelist: Isan Chen, Chief Medical Officer, Aragon Pharmaceuticals |
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Panelist: Graham Robinson, Partner, Skadden Arps |
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Topics to be Discussed:
- Accelerated approval opportunities and break
through therapies
- Endpoints for registrational oncology studies
- Single-arm vs. randomized studies
- Orphan drug designation
- Pediatric studies
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| 12:00 |
Lunch Provided by GTC |
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| 1:30 |
Conference Concludes |
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