Precision Medicine Strategies: Designing Individual

Chicago
Chapter
Precision Medicine
Strategies: Designing
Individual-Specific Care
May 29, 2014 @ 1871, Chicago IL
Event Sponsors
Chicago
Chapter
In the past decade, the emergence of personalized/precision
medicine has ushered in a groundbreaking era in healthcare,
challenging current delivery models and practices. Precision
medicine has the ability to provide dramatically improved
diagnosis, prognosis, and patient treatment processes. This
new model of medicine and healthcare has been nurtured by
emerging cost-effective and cutting-edge science in genome
sequencing, incorporating molecular information into patient
records with the aim to deliver:
"The right treatment …
…for the right person…
…at the right time."
AGENDA
PANELISTS
May 29, 2014 @ 1871, Chicago IL
5:15 - 6:10 pm
Registration / Networking Reception
Bahija Jallal, Ph.D.
6:10 - 7:40 pm
Introduction – Ikbel Achour, Ph.D.
Seema Kumbhat, M.D.
Director of Precision Health University of Arizona
EL Chicago Council on Global Affairs
WIB-Chicago Funding Chair
Welcome Remarks – Christina Fleming, Ph.D.
President and CSO, Pharma Start
Panel Discussion & Q/A
Executive Vice President of AstraZeneca,
Head of MedImmune
Global Medical Director-Biologics, Hospira
Olufunmilayo Olopade, M.D., FACP, OON
Professor of Medicine and Human Genetics,
Associate Dean of Global Health, and
Director of the Center for Clinical Cancer Genetics,
University of Chicago
Concluding Remarks – Jamie Dananberg, M.D.
Pia Gargiulo, Ph.D.
Executive Vice President,
Head, Therapeutic Area Group,
Takeda Pharmaceuticals International, Inc.
Moderator Chris Meda, M.S.
Managing Director, PGx Consulting
Chief Business Officer, incellDx
7:40 - 8:15 pm
Dessert / Networking Reception
Event
Sponsors
Bahija Jallal,Ph.D.
Executive Vice President of
AstraZeneca, Head of MedImmune
a global biologics research and development
organization with locations in Gaithersburg,
California and Cambridge, UK. Dr. Jallal has
guided, since 2006, the MedImmune R&D
organization through unprecedented growth and expansion
of its biologics pipeline from 40 drugs to more than 120 today.
She inspires creativity, out-of-the-box thinking and a dedication to
scientific excellence to the more than 2,500 employees at
MedImmune. Dr Jallal serves as a member of the Board of Directors
for the Association of Women in Science and an advisory member
of the Healthcare Business Women’s Association. Dr. Jallal has
authored over 70 peer-reviewed publications and has over 15 patents."
Olufunmilayo Olopade, M.D., FACP, OON
Professor of Medicine and Human Genetics,
Associate Dean of Global Health, and
Director, Center for Clinical Cancer Genetics,
University of Chicago. A global leader in cancer
genetics, Dr. Olopade seeks to identify those at risk
for hereditary breast and ovarian cancer earlier in life,
intervene aggressively to reduce risk and preempt disease development
to effectively control cancer. She studies familial forms of cancers,
molecular mechanisms of tumor progression in high-risk individuals
as well as genetic and non-genetic factors contributing to tumor
progression in diverse populations. Her current laboratory research is
focused on using whole genome technologies and bioinformatics to
develop innovative approaches to accelerate progress in cancer research
and reduce disparities in health outcomes.
Seema Kumbhat, M.D.
Pia Gargiulo, Ph.D.
Global Medical Director-Biologics, Hospira
Managing Director, PGx Consulting
Dr. Kumbhat has more than 18 years
of experience in healthcare. At Merck,
she launched several new drugs for osteoporosis,
hypertension, and hypercholesterolemia in South
Florida, growing this market to #1 in the nation.
Currently at Hospira, she has developed new tools and
programs for early detection of complex clinical conditions,
drug-device combination solutions, and currently serves as Global
Medical Director, Biologics, where she is responsible for bringing
Hospira’s biosimilar pipeline to approval, globally. Dr. Kumbhat’s
honors include several clinical publications and speaking
engagements. Recently, she was elected to the Emerging Leaders
Program, Chicago Council on Global Affairs, class of 2013.
Dr. Gargiulo has lead teams in the development and
delivery of companion programs focusing on the utility
and uptake of commercialization models for both the
pharmaceutical and diagnostic sectors. Dr Gargiulo has
worked on 8 PMA Submissions resulting in three pivotal Companion
Drug-Diagnostic Offerings to Breast, Colorectal, and Lung Cancer
Patients. She joined Precision Health Holdings in 2012 as Managing
Director of Companion Diagnostic Solutions. Prior to this, she was Vice
President at Qiagen, overseeing the Companion Diagnostic Partnership
Team, which was responsible for the delivery over 12 companion
diagnostic programs. She is a regional member of the American Cancer
Society, I-Bio and World Business Chicago and was recently appointed
to the Governor’s Commission on Women’s Health.
Chris Meda, M.S.
Christina Fleming, Ph.D.
Chief Business Officer, IncellDx
Meda has 30 years of leadership in the
global diagnostic and pharmaceutical
Industries. Her management responsibilities
have included the creation of worldwide
strategic business direction and plans,
operations and commercialization of more than 30 products
for various disease areas at Hoffman-LaRoche, Schering AG
pharmaceuticals, Bio-Rad Laboratories, Diagnostics Products
Corporation (now Siemens), Meridian Diagnostics. Currently,
Meda is CBO at IncellDx; Chair, of Women in BIO-San Francisco
Chapter; and, a Board Director for Claremont BioSolutions, a
company providing laboratories with diagnostics and devices for
molecular diagnostics and bioscience research.
Jamie Dananberg, M.D.
Executive Vice President,
Head, Therapeutic Area Group,
Takeda Pharmaceuticals International, Inc.
Dr. Dananberg has served in a wide range of
leadership positions in healthcare. Until July 2012, he
was Vice President, Translational Medicine and
Tailored Therapeutics leading global clinical pharmacology,
Pharmacogenomics, Diagnostic and Experimental Medicine (Clinical
Pathology), Laboratory for Experimental Medicine, and Translational
Imaging. Most recently, he serves as Head of Therapeutic Areas at
Takeda. He remains active in the Indiana Clinical and Translational
Science Institute. He participates on a number of external groups
focused on personalized medicine and he has also been involved in
a number of innovation-centered efforts within the biomedical
research community.
President and CSO, Pharma Start
As the founder of Pharma Start, Dr. Fleming
provides the company’s strategic direction by
leveraging her 20+ years of biopharmaceutical and
CRO industry experience. Dr. Fleming’s experience
includes building, managing and leading Clinical
Development, Medical Writing, and Pharmacovigilance Divisions at
Searle, TAP, Neopharm Inc., and Baxter Healthcare as well as
developing the outsourcing/CRO consulting services at several CROs.
This experience led her to create and develop Pharma Start into a
highly successful and unique outsourcing organization. Dr. Fleming
earned her Bachelor of Science (BS) in Biology at Saint Mary's College
and her Doctor of Philosophy (PhD) in Pharmacology from the
University of Illinois at Chicago.
"
"
Medicine & Healthcare moving forward
‘’One drug fit all’’
Stratified – Personalized – Precision Medicine
Towards smaller population to one individual/patient design
The use of molecular data such as genomics, epigenomics, exposure,
and other data define individual disease profile with the potential to
provide individualized and precise treatment
The use of a companion diagnostic to predict in advance which
patients are most likely to benefit from a particular therapy
Considering current and emerging examples in which therapies are
matched with specific patient population characteristics using
clinical biomarkers or genomics profiling
APPROACHES
Drug Development "Rx"
Value of Precision Medicine
DISCOVERY"
DEVELOPMENT"
Iden9fica9on"of"
Mechanisms""
Linked"to"Human"
Disease"
Improved"Therapeu9c"
Index"in"Selected"
Pa9ent""
Subpopula9on"
REGULATORY"
Superior"Safety"&"Efficacy"
Profile"in"PreTdetermined"
Pa9ents"
CLINICAL"PRACTICE"
Op9miza9on"
Of"Pa9ent"Care"
Applica9on"of"Knowledge"From"Extensive"Pa9ent"Experience"–""
to"every"stage,"within"a"dynamic"R&D"environment""
Companion Diagnostics vs. Complementary Diagnostics
Both are molecular assays that measure levels of proteins, gene expression, or presence
of specific mutations to assess a patient's risk factor for a number of conditions to provide
a specific therapy at the one individual/patient level.
COMPLEMENTARY Diagnostics
Tests that are being developed in
parallel with the drug that is currently
in development (FDA term)
COMPANION Diagnostics
Tests that have been developed
independently / after a drug has
come to market
Outcomes
Increased
Improved
likelihood of patient
response to therapy
patient
management
More efficient
clinical trial design
Reduced
societal costs
Identification
of other patients
likely to respond
owing to genetic
alterations in target
pathway
APPROACHES
Companion Diagnostic Development "CDx"
Prototype"Assay"
Phase"I"
Locked"Assay"
Phase"II"A"
Feasibility Phase
Assess
Biomarker
POC"
Final"Assay"
Phase"II"B"
Phase"III"
Development Phase
Establish
Performance
IVD"PreTSubmission"
Mee9ng"
Design"
"Lock"
Validation Phase
Verify
Performance
IDE""
Submission"
NDA"
Validate
Design
PMA""
PMA""
Design"
Transfer" PreTSubmission" Submission"
Mee9ng"
Source:(2014,(FDA(Companion(Diagnos9cs(Website(
Major Trends in Personalized / Precision Medicine
POLITICAL – Effectiveness to Cost-effectiveness
Worldwide acceptance that healthcare $$ are finite
Increased emphasis on economic efficiency; comparative effectiveness
Increasing CDx from BioPharma"
SCIENTIFIC – Targeted Therapies
Advances in understanding of disease processes leading targeted drugs –
precision on specific molecular targets
Increasing demand for CDx tools to classify disease sub-types
and predict those likely to respond to therapy
REGULATORY – Passive to Active
Regulatory authorities realized benefits of CDx to patients.
FDA and EMA encouraging Rx companies to explore the use
of CDx during drug development
CDx-Rx combination will become a mandatory path
of NDA/BLA submission and product labeling
Benefits of Personalized Healthcare
PATIENTS
PHYSICIANS
Increased
effectiveness
of therapies
Increased
safety in
treatment
decisions
PAYERS
Better
outcomes
for lower
costs
Rx COMPANIES
Regulatory
approval and
competitive
advantage
CDx COMPANIES
New market
opportunities
Seven Critical Issues for Commercial Readiness
CLINICAL
Sufficient data to demonstrate the clinical utility
TECHNICAL
Assays need to be reliable, robust and compatible with lab operations
REGULATORY
Approval needed for the drug, the diagnostic and (in US) the instrument
AVAILABILITY
Needs to match the global distribution of the drug if there is a pharma partner
REIMBURSEMENT
Early strategy for value-based $ for CDx
IP
Technology and genetic licenses in place
COMMERCIAL
Different models needed depending on level of drug company involvement
is delighted in your interest and
participation in events and initiatives supporting
Chicago’s and Illinois’ life sciences community.
Our local footprint provides a home to individuals
from world-class research institutions, multinational
life sciences companies, non-profit organizations
and entrepreneurial companies, as well as a
growing number of investors and professional
service providers committed to the life science
industry. The State of Illinois is a leader in biotech
and pharma, ranking as one of the top ten states in
terms of both number of businesses and R&D
expenditures. This foundation provides fertile
ground upon which to build our WIB chapter, and
we invite new members to join us in this venture.
Thank&you.&&
Become a
MEMBER
Become a
SPONSOR
Chicago Chapter - Our Team
! Katherine Neville – Chapter Chair
Larisa Lacis – Chapter Vice Chair
! Dimitra Georganopolou – President Elect
Funding Committee
! Ikbel Achour – Chair
! Carolyn Hollands – Vice Chair
Jessica Hilliard
! Bich Duong
Emily Miao
Shyama Majumdar
Programming Committee
! Michelle Kouba – Chair
Carolyn Brougham – Vice Chair
! Alis Gjeci
Elese Hanson
! Heather Kissling
Sherri Oslick
Emily Miao
Alyssa Master
Membership Committee
! Lynn Janulis – Chair
Communication Committee
! Heather Kissling – Chair
! Lynn Janulis – Vice Chair
Julie Langdon – Vice Chair
! Tina Rogers
Erica Watson
Tanya Yankelvich
Young Women In Bio Committee
! Sharon Sintich – Chair
May 29th event ! Organizers ! Volunteers
JOIN&US&@&&
WIB at 2014 BIO Convention, San Diego
WIB Chicago Summer Events
VISIT"US"at"the"Exhibit"Hall"Booth"#2403.""
June 23, 2014 – Welcome Celebration
June 18, 2014 – Symphony in the Park
4:00 p.m. at Hilton San Diego Bayfront,
Sapphire Terrace. Honored guest
Annalisa Jenkins M.D., a leading figure
in the biopharmaceutical industry.
4:45 p.m. at Millennium Park
July 17, 2014 – Book Club
6 p.m. at Katten, Muchin and Rosenman
Book: “The Confidence Code” by
June 24 and 25, 2014 – Meet up
2:00 p.m. and 3:00 p.m. at Booth #255.
WIB-Southern California
Area Professionals and Executives
in the Life Science Industry (June 24)
Speed Networking for Existing and
Prospective WIB Members (June 25)
[email protected]"
h]p://www.womeninbio.org/wibTchapters/chicago"
Katty Kay & Claire Shipman
August 14, 2014 – Metro Mix and Mingle
Networking Event
5:30 p.m. at two locations:
Northshore – Cooper's Hawk Winery
Downtown – The Kerryman
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!& “The"science"has"never"been"be]er’’"
"
!& Companion"vs."Complementary"Diagnos9cs"
"
Diagnos9cs"Key"Benefits:"Pa9ents/Individuals,""
!& Physicians,"Healthcare"System,"Pharmaceu9cal""
and"Diagnos9c"Companies"""
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!& “Clashing"Interests”"–"What"Are"They?"
!& How"Do"We"Accelerate"To"Market?"
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!& Economics:"Reimbursement,"Affordable,""
Emerging"Markets"
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#precisionmed"
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