Combining Business and Clinical Development Strategies ......2016/02/02  · Combining Business and...

13
Combining Business and Clinical Development Strategies with Scientific Updates to Prepare the Market for Accelerating Clinical Trials REGISTER AT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580 IMMUNO- ONCOLOGY 360° FEBRUARY 2 - 3, 2016 THE NEW YORK ACADEMY OF MEDICINE, NEW YORK, NY Organized by Executive Sponsors Supporting Partners Lead Advisor Axel Hoos, MD, PhD GlaxoSmithKline Lead Advisor James Gulley, MD, PhD National Cancer Institute Hematologic Malignancies Carl June, MD University of Pennsylvania Combinations Jedd Wolchok, MD, PhD Memorial Sloan Kettering Cancer Center Methodological Advances Roy Baynes, MD, PhD Merck Research Labs Business Aspects Anne Altmeyer, PhD, MBA, MPH Baxalta Clinical Advances David Reese, MD Amgen CAR-T Mark Frohlich, MD Juno Therapeutics IO360 Biomarkers Priti Hegde, PhD Genentech FDA Perspective Peter Bross, MD FDA

Transcript of Combining Business and Clinical Development Strategies ......2016/02/02  · Combining Business and...

Page 1: Combining Business and Clinical Development Strategies ......2016/02/02  · Combining Business and Clinical Development Strategies with Scientific Updates to Prepare the Market for

Combining Business and Clinical Development Strategies with Scientific Updates to Prepare the Market for Accelerating Clinical Trials

REGISTER AT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

IMMUNO- ONCOLOGY 360° FEBRUARY 2 - 3, 2016 THE NEW YORK ACADEMY OF MEDICINE, NEW YORK, NY

Organized by

Executive Sponsors

Supporting Partners

Lead AdvisorAxel Hoos, MD, PhD

GlaxoSmithKline 

Lead AdvisorJames Gulley,

MD, PhDNational Cancer

Institute

Hematologic MalignanciesCarl June, MD University of Pennsylvania

CombinationsJedd Wolchok, MD, PhD

Memorial Sloan Kettering Cancer

Center

Methodological Advances

Roy Baynes, MD, PhDMerck Research Labs

Business AspectsAnne Altmeyer, PhD, MBA, MPH

Baxalta

Clinical AdvancesDavid Reese, MD

Amgen

CAR-TMark Frohlich, MD Juno Therapeutics

IO36

0

BiomarkersPriti Hegde, PhD

Genentech

FDA PerspectivePeter Bross, MD

FDA

Page 2: Combining Business and Clinical Development Strategies ......2016/02/02  · Combining Business and Clinical Development Strategies with Scientific Updates to Prepare the Market for

WWW.THECONFERENCEFORUM.ORG

OVERVIEW The Conference Forum is delighted to present the 2nd Annual Immuno-Oncology 360°, the only conference that combines business and clinical development strategies with scientific updates to prepare the market for accelerating immuno-oncology (IO) clinical trials.With rapid development of cancer immunotherapy drug development, breakthrough FDA approval status, and fast-tracking clinical trials, competition is fierce. The science behind immune-based therapies is driving rapid change. Both small and large companies are racing to bring game-changing therapies to the market and in many cases, partnering to maximize on combination therapies. As a result, innovative approaches and developments are also creating increased momentum for investment/business development opportunities.

“The activity we are seeing with immunotherapy is offering hope to many

cancer patients. I think it is the first essential step to unlocking the true potential of the

immune system to be able to reliably eradicate tumors in a high proportion of patients.”

James Gulley, MD, PhD National Cancer Institute

Designed by lead advisors Dr. Axel Hoos (GSK) and Dr. James Gulley (NCI) along with support from Cancer Research Institute (CRI), Association for Cancer Immunotherapy (CIMT) and Society for Immunotherapy of Cancer (SITC), the 2nd Annual Immuno-Oncology 360° event will enable you to obtain the most up-to-date information regarding business aspects, clinical advancements and scientific data that will help transform the way cancer is treated.The 2nd Annual Immuno-Oncology 360° event will delve into key areas of business, clinical and scientific advancements including:

•Business Aspects for IO

•Differences of Modalities in Immunotherapy

•Methodological Advances – Investigating Immunotherapies in the Clinic

• Immunotherapy Practice Altering Clinical Advances

•Hematologic Malignancies

• Emerging Biomarkers

•Randomized Phase II Combination Therapy Trials

We want to thank our IO supporting partners and sponsors for their insights and support on content and agenda development. In particular, we would like to thank our lead advisors, Dr. Axel Hoos and Dr. James Gulley, for their

unwavering guidance, expertise and enthusiasm to present a unique 360-degree program for cancer immunotherapy.

Who Should Attend The program is designed for large pharma, mid-sized biopharma, biotechs and investors seeking to accelerate clinical trials in the emerging immuno-oncology space.

We look forward to seeing you!

Sincerely,

Kate WodaConference DirectorThe Conference Forum

Valerie BowlingExecutive DirectorThe Conference Forum

Jessica RothenbergMarketing DirectorThe Conference Forum

Meredith SandsExecutive Director, Business DevelopmentThe Conference Forum

Elizabeth BardBusiness Development ManagerThe Conference Forum

Geeta Bachani Business Development ManagerThe Conference Forum

Bridget Murphy Conference CoordinatorThe Conference Forum

IMMUNO-ONCOLOGY 360° OVERVIEW

2

Page 3: Combining Business and Clinical Development Strategies ......2016/02/02  · Combining Business and Clinical Development Strategies with Scientific Updates to Prepare the Market for

WWW.THECONFERENCEFORUM.ORG 3

SPEAKING FACULTY IMMUNO-ONCOLOGY 360°

SPEAKING FACULTY

Anne Altmeyer, PhD, MBA, MPHVP, Business Development & Licensing, Head Negotiations, OncologyBaxalta

Steven Anderson, PhDChief Scientific OfficerCovance

Robert Ang, MD, MBAChief Business OfficerNeon Therapeutics

Philippe Armand, MD, PhD Senior Physician, Dana-Farber Cancer Institute Associate Professor of Medicine, Harvard Medical School

Edward Ashton, PhD Chief Scientific OfficerVirtualScopics

Roy Baynes, MD, PhD SVP, Global Clinical DevelopmentMerck Research Labs

Kenneth Bloom, MD, FACPCMOGE Healthcare

Gideon Blumenthal, MDClinical Team Leader, Thoracic and Head/Neck OncologyFDA

Jeffrey Bockman, PhDVice PresidentDefined Health

Cedrik Britten, MDHead of Cell Therapy GlaxoSmithKline

Peter Bross, MDMedical Review Officer, Office of Cellular, Tissue, and Gene Therapy, Center for Biologics Evaluation and ResearchFDA

Edward Cha, MD, PhDAssociate Medical DirectorGenentech

Philippe Lopes-FernandesSVP and Head of Global Licensing & Business DevelopmentMerck KGaA

Mark Frohlich, MDEVP, Development and Portfolio ManagementJuno Therapeutics

Winald Gerritsen, MD, PhDProfessor and Medical OncologistRadboud Medical Center

John Graham, MB, ChB, FRCR, FRCPManager, National Institute of Clinical Excellence (NICE) Director, National Collaborating Centre for Cancer

James Gulley, MD, PhDHead, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute (Co-CHAIR)

Omid Hamid, MDChief, Translational Research and Immunotherapy/Director, Melanoma TherapeuticsThe Angeles Clinic and Research Institute

Priti Hegde, PhD Anti-angiogenesis and Cancer Immunotherapy Franchises Biomarker Lead, Oncology BiomarkersGenentech

Axel Hoos, MD, PhD SVP, Oncology R&DGlaxoSmithKline (Co-CHAIR)

Carl June, MDDirector, Translational Research Program, Professor of Pathology and Laboratory Medicine, Abramson Cancer Center, Perelman School of MedicineUniversity of Pennsylvania

Shyam Kalavar, MPH, CT (ASCP) Scientific Reviewer, Division of Molecular Genetics and Pathology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health FDA

Michael Kalos, PhD CSO, Cancer ImmunobiologyEli Lilly

Howard Kaufman, MD, FACSChief Surgical Officer, Associate Director,Rutgers Cancer Institute of New JerseyPresident, Society for Immunotherapy of Cancer (SITC)

Herbert Kim Lyerly, MD Professor of Surgery, Assistant Professor in Immunology, Associate Professor of PathologyDuke Cancer Institute

Page 4: Combining Business and Clinical Development Strategies ......2016/02/02  · Combining Business and Clinical Development Strategies with Scientific Updates to Prepare the Market for

WWW.THECONFERENCEFORUM.ORG

IMMUNO-ONCOLOGY 360° SPEAKING FACULTY

4

Michael King Jr Managing Director and Senior Biotech AnalystJMP Securities

Ron Korn, MD, PhD Founder, Chairman and CMOImaging Endpoints

Kamala Maddali, DVM, PhD VP, Biopharma Collaborations & Companion DiagnosticsCancer Genetics

Patricia Marinello, PharmD Clinical Director, Oncology Clinical ResearchMerck Research Labs

Ian McCaffery, PhDVP, Translational SciencesCorvus Pharmaceuticals

Abigail McElhinny, PhD VP, Assay and Reagent Development Ventana Medical Systems

David Minor, MD Associate DirectorCalifornia Pacific Medical Center Research Institute

Shannon Morris, MD, PhD Senior Director, Immuno-Oncology Clinical Development MedImmune

RJ Motzer, MDMedical OncologistMemorial Sloan Kettering Cancer Center

Eustache Paramithiotis, PhD VP, Biomarker Discovery & DiagnosticsCaprion Proteome

Andrea Perrone, MDHead of Clinical Imaging, Translational MedicineMerck Research Labs

Lisa Johnson-Pratt, MD Head, Pipeline Commercial StrategyGlaxoSmithKline

David Reese, MDSVP, Translational SciencesAmgen

Jonathan Reuter Associate Director of R&D Global Procurement Bristol-Myers Squibb

Naiyer Rizvi, MDDirector, Thoracic Oncology & Immunotherapeutics in Medical OncologyNY Presbyterian / Columbia University Medical Center

Patrick Roche, PhDSVP, Research & DevelopmentHTG Molecular

Eric Rubin, MD VP, Global Clinical OncologyMerck Research Labs

Rita Shaknovich, MD, PhD Medical Director and VP, HematopathologyCancer Genetics

Mark Simon, MBAPartnerTorreya Partners

Elena Spanjaard, PhDDirector, Worldwide Research & Development, Regulatory AffairsPfizer

Robert Stein, MD, PhDPresident, Research & DevelopmentAgenus

Marc Theoret, MDLead Medical Officer, Office of Oncology Drug Products, CDERFDA

Peter Thompson, MD, FACPPrivate Equity PartnerOrbiMed Advisors

Jeffrey Weber, MD, PhDDeputy Director, Laura and Isaac Perlmutter Cancer Center, Co-Director, Melanoma Program & Head of Experimental Therapeutics NYU Langone Medical Center

Kari Whitehead, MS, RDCo-FounderEmily Whitehead Foundation

Tom WhiteheadCo-FounderEmily Whitehead Foundation

Jedd Wolchok, MD, PhDChief, Melanoma and Immunotherapeutics ServiceMemorial Sloan Kettering Cancer Center

Cissy Young, PhD, MBA Executive DirectorRussell Reynolds Associates

Page 5: Combining Business and Clinical Development Strategies ......2016/02/02  · Combining Business and Clinical Development Strategies with Scientific Updates to Prepare the Market for

WWW.THECONFERENCEFORUM.ORG

DAY ONE - TUESDAY, FEBRUARY 2, 2016 7:00 am Registration & Breakfast

8:00 am IO360º Co-Chairs’ Opening Remarks James Gulley, MD, PhD Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute

Axel Hoos, MD, PhD SVP, Oncology R&D, GlaxoSmithKline

10:10 amNetworking Break

10:40 amDirect Identification of Neo-epitopes for Cancer Vaccines and Adoptive T-Cell Therapies In this talk, Dr Paramithiotis of Caprion Proteome will demonstrate how the direct detection of peptides presented by MHC is the most physiologically relevant way to identify both modified and non-modified neo-epitopes associated with cancer. Dr Paramithiotis will show specific examples of how naturally presented peptides were characterized in a pilot study of surgically resected renal cell carcinoma as well as characteristics of overall peptide presentation and cancer associated peptides.

Eustache Paramithiotis, PhD VP, Biomarker Discovery & Diagnostics, Caprion Proteome

10:55 amImmune-related RECIST (irRECIST) for Immunotherapy This talk will share Merck’s approach to irRECIST in collaboration with several key opinion leaders that was developed based on data from prior trials. This strategy has been shared extensively with multiple pharma and biotech partners in support of collaborative trials. Additionally, four imaging CROs have developed imaging charters and read systems to support this design along with new lesion measurements that are also captured centrally for retrospective analysis.

Andrea Perrone, MDHead of Clinical Imaging, Translational Medicine, Merck Research Labs

5

AGENDA IMMUNO-ONCOLOGY 360°

8:15 am - 10:10 am Plenary Session 1: Business Aspects for IO This opening session addresses key components of business that are creating increased momentum for development opportunities in the immuno-oncology space.

Session Chairperson: Peter Thompson, MD, FACP Private Equity Partner, OrbiMed Advisors

8:15 am - 8:30 amCurrent Business Landscape: Updates on Partnerships and Deals

Peter Thompson, MD, FACP Private Equity Partner, OrbiMed Advisors

8:30 am - 9:10 amReimbursement: Perspectives on Criteria and Decision Making Processes to Better Navigate Regulatory Hurdles

John Graham, MB, ChB, FRCR, FRCPManager, National Institute of Clinical Excellence (NICE)Director, National Collaborating Centre for Cancer

Lisa Johnson-Pratt, MDHead, Pipeline Commercial Strategy, GlaxoSmithKline

9:10 am - 10:10 amPanel Discussion: Impact of IO on Business

Moderator:Mark Simon, MBAPartner, Torreya Partners

Panelists:Anne Altmeyer, PhD, MBA, MPHVP, Business Development & Licensing, Head Negotiations, Oncology, Baxalta

Robert Ang, MD, MBAChief Business Officer, Neon Therapeutics

Jeffrey Bockman, PhDVice President, Defined Health

Philippe Lopes-FernandesSVP and Head of Global Licensing & Business Development, Merck KGaA

Michael King JrManaging Director and Senior Biotech Analyst, JMP Securities

Robert Stein, MD, PhDChief Science Officer, Agenus

Cissy Young, PhD, MBA Executive Director, Russell Reynolds Associates

Page 6: Combining Business and Clinical Development Strategies ......2016/02/02  · Combining Business and Clinical Development Strategies with Scientific Updates to Prepare the Market for

WWW.THECONFERENCEFORUM.ORG

11:30 am Imaging for Clinical Trials in Immuno-Oncology This talk will discuss the challenges that immune-modulating therapies present to accurate and reproducible response assessment in a clinical trial setting, focusing on the problem of pseudo-progression. It will also provide a survey of imaging techniques that can be used to make an early distinction between pseudo-progression and true progression.

Edward Ashton, PhD CSO, VirtualScopics

11:45 am Imaging the Immune System in Solid Tumors This talk will cover the spectrum of immunotherapy from an imaging perspective along with current trends including novel imaging methodologies and enhanced techniques beyond conventional imaging.

Ron Korn, MD, PhD Founder, Chairman and CMO, Imaging Endpoints

12:00 pmGrab and Go Lunch

12:30 pmLunch Session: Panel Discussion - Driving Guidance for Clinical Endpoints in Immunotherapy This session will provide an update on what regulatory activities are taking place for immunotherapy and a discussion including other guidelines that are in the works and may be coming out in the near future.

Moderator:Axel Hoos, MD, PhD SVP, Oncology R&D, GlaxoSmithKline

Panelists:Peter Bross, MDMedical Review Officer, Office of Cellular, Tissue, and Gene Therapy, Center for Biologics Evaluation and Research, FDA

Elena Spanjaard, PhDDirector, Worldwide Research & Development, Regulatory Affairs, Pfizer

Marc Theoret, MD Lead Medical Officer, Office of Oncology Drug Products, CDER, FDA

1:15 pm Concurrent Session Transitions

IMMUNO-ONCOLOGY 360° AGENDA

6

1:25 pm - 3:25 pm Concurrent Session 1: Differences of Modalities in Immunotherapy This session addresses talks that highlight the unique features of drugs and how they behave within each modality and identify their differences from one another.

Session Chairperson: Herbert Kim Lyerly, MD Professor of Surgery, Assistant Professor in Immunology, Associate Professor of Pathology, Duke Cancer Institute

1:25 pm - 1:55 pmCheckpoint Modulators Omid Hamid, MDChief, Translational Research and Immunotherapy Director, Melanoma Therapeutics, The Angeles Clinic and Research Institute

1:55 pm - 2:25 pmOncolytic Viruses Howard Kaufman, MD, FACSChief Surgical Officer, Associate Director, Rutgers Cancer Institute of New Jersey and President, Society for Immunotherapy of Cancer (SITC)

2:25 pm - 2:55 pmTCR/CAR-T Cedrik Britten, MDHead of Cell Therapy, GlaxoSmithKline

2:55 pm - 3:25 pmCancer Vaccines Herbert Kim Lyerly, MD Professor of Surgery, Assistant Professor in Immunology, Associate Professor of Pathology, Duke Cancer Institute

3:25 pm Networking Break

1:25 pm - 3:25 pm Concurrent Session 2: Methodological Advances – Investigating Immunotherapies in the Clinic This session addresses talks that show how immunotherapy methods have advanced from late 2000s to the present.

Session Chairperson: Abigail McElhinny, PhD VP, Assay and Reagent Development, Ventana Medical Systems

Page 7: Combining Business and Clinical Development Strategies ......2016/02/02  · Combining Business and Clinical Development Strategies with Scientific Updates to Prepare the Market for

WWW.THECONFERENCEFORUM.ORG

3:55 pm Systematic Approach to Combination Therapy This talk addresses how to approach combination therapy from designing preclinical programs that lead to clinical investigation that enables you to have a rationalized and systematic approach to combinations.

James Gulley, MD, PhD Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute

6:25 pmDay One Concludes & Networking Reception

7

AGENDA IMMUNO-ONCOLOGY 360°

4:25 pm - 5:55 pm Plenary Session 2: Randomized Phase II Combination Therapy Trials This session presents the most recent data regarding combinations involving targeted combinations, immuno-immuno combinations, single arm combination studies, along with toxicity management for combinations.

Session Chairperson: Jeffrey Weber, MD, PhDDeputy Director, Laura and Isaac Perlmutter Cancer Center, Co-Director, Melanoma Program & Head of Experimental Therapeutics,NYU Langone Medical Center

4:25 pm - 4:55 pmImmuno-immuno Combination on Ipilimumab plus Nivolumab in Melanoma: Update

Jedd Wolchok, MD, PhDChief, Melanoma and Immunotherapeutics Service,Memorial Sloan Kettering Cancer Center

4:55 pm - 5:25 pmTargeted-immuno Combination on Dabrafenib and Trametinib plus Ipilimumab

David Minor, MDAssociate Director, California Pacific Medical Center Research Institute

5:25 pm - 5:55 pm Single Arm Combination Study on Trametinib (MEK) plus Dabrafenib (BRAF) with PDL1

Shannon Morris, MD, PhDSenior Director, Immuno-Oncology Clinical Development, MedImmune

5:55 pm - 6:25 pmToxicity Management with IO Combination Therapies

Jeffrey Weber, MD, PhDDeputy Director, Laura and Isaac Perlmutter Cancer Center, Co-Director, Melanoma Program & Head of Experimental Therapeutics,NYU Langone Medical Center

1:25 pm - 1:55 pmAdvancements in Personalized Approaches to Combinations

Edward Cha, MD, PhD Associate Medical Director, Genentech

1:55 pm - 2:25 pmFDA Perspective: Utilization of Biomarkers in the Clinic

Gideon Blumenthal, MDClinical Team Leader, Thoracic and Head/Neck Oncology, FDA

Shyam Kalavar, MPH, CT(ASCP)Scientific Reviewer, Division of Molecular Genetics and Pathology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health, FDA

2:25 pm - 2:55 pmImmune Gene Expression Profiling from Challenging Clinical Specimens

Patrick Roche, PhDSVP, Research & Development, HTG Molecular

2:55 pm - 3:25 pmAccelerated Development Enabled by Adaptive Phase 1 Studies and Targeted Indication Identification

Roy Baynes, MD, PhD SVP, Global Clinical Development, Merck Research Labs

3:25 pm Networking Break

Page 8: Combining Business and Clinical Development Strategies ......2016/02/02  · Combining Business and Clinical Development Strategies with Scientific Updates to Prepare the Market for

WWW.THECONFERENCEFORUM.ORG

DAY TWO - WEDNESDAY, FEBRUARY 3, 2016 7:30 amContinental Breakfast

8:00 amIO360º Co-Chairs’ Welcome

James Gulley, MD, PhD Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute

Axel Hoos, MD, PhD SVP, Oncology R&D, GlaxoSmithKline

8:10 amThe First Pediatric IO Cancer Survivor Story: Emily Whitehead’s Journey Nine year old Emily Whitehead was diagnosed in May 2010, a few weeks after her 5th birthday with standard risk pre-b acute lymphoblastic leukemia. Emily was told she had an 85 to 90 percent chance of being cured, however, after two relapses, her chances were diminishing significantly. Emily’s parents Kari and Tom Whitehead were willing to try something different to help cure the cancer. April 2012, Emily enrolled in a phase I clinical trial at Children’s Hospital of Philadelphia, the first pediatric patient to receive genetically modified T-cells led by Dr. Carl June and his team.

Emily's parents, Kari and Tom Whitehead, join us at IO360º to share Emily’s remarkable story.

You can learn more about Emily’s story at https://www.youtube.com/watch?v=Sz11e0r2L_s

Kari Whitehead, MS, RDCo-Founder, Emily Whitehead Foundation Tom WhiteheadCo-Founder, Emily Whitehead Foundation

10:45 amNetworking Break

IMMUNO-ONCOLOGY 360° AGENDA

8

8:30 am - 9:00 amCAR-T Data for Hematologic Malignancies

Carl June, MDDirector, Translational Research Program, Professor of Pathology and Laboratory Medicine, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania

9:00 am - 9:30 amJuno Therapeutics on CAR-T

Mark Frohlich, MDEVP, Development and Portfolio Management, Juno Therapeutics

9:30 am - 10:00 amPembrolizumab in Multiple Myeloma

Patricia Marinello, PharmDClinical Director, Oncology Clinical Research,Merck Research Labs

10:00 am - 10:30 amPD-1 Data in Hodgkin’s Lymphoma

Philippe Armand, MD, PhDSenior Physician, Associate Professor of Medicine, Harvard Medical School, Dana-Farber Cancer Institute

10:30 am - 10:45 amDiagnostic Assays for Immuno-Oncology: Considerations for Assay Development and Commercialization Precision medicine, biomarkers and companion diagnostics have played a significant role in the development of a variety of targeted therapies in oncology. Understanding the role that biomarkers, such as the expression of PD-L1, have in the development of immuno-oncology therapies is an important and rapidly evolving scientific area. Currently there are examples of both companion and complementary diagnostics for immuno-oncology drugs, used to treat patients with non-small-cell lung cancer (NSCLC). This talk will focus on the importance of biomarker based assays both during the drug development process and post-approval of the therapy. Discussion will focus on the clinical utility and performance of these companion and complementary diagnostics, post-approval of the therapy and the companion diagnostic test.

Steven Anderson, PhD Chief Scientific Officer, Covance

8:30 am - 10:30 am Plenary Session 3: Hematologic Malignancies This session presents development advances and data updates on hematologic malignancies that will help foster new ideas on how to treat cancer.

Session Chairperson: Carl June, MDDirector, Translational Research Program, Professor of Pathology and Laboratory Medicine, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania

Page 9: Combining Business and Clinical Development Strategies ......2016/02/02  · Combining Business and Clinical Development Strategies with Scientific Updates to Prepare the Market for

WWW.THECONFERENCEFORUM.ORG

4:45 pmConference Concludes

9

AGENDA IMMUNO-ONCOLOGY 360°

11:15 am - 2:00 pm Plenary Session 4: Emerging Biomarkers This session will provide an overall perspective on emerging biomarkers, addressing what we have learned from clinical trials, how we leverage clinical studies to get new insights, how industry is utilizing biomarkers and technologies that support biomarker development.

Session Chairperson: Ian McCaffery, PhDVP, Translational Sciences, Corvus Pharmaceuticals

11:15 am - 11:45 amProgress of Emerging Biomarkers Michael Kalos, PhD CSO, Cancer Immunobiology, Eli Lilly

11:45 am - 12:15 pmMechanisms of Immune Response to Checkpoint Inhibition

Priti Hegde, PhD Anti-angiogenesis and Cancer Immunotherapy Franchises Biomarker Lead, Oncology BiomarkersGenentech

12:15 pm - 12:45 pmPDL2: Understanding the Tumor Microenvironment and What the Drivers Are Eric Rubin, MD VP, Global Clinical Oncology, Merck Research Labs

12:45 pm - 1:00 pmSpecialized vs. Central Lab Outsourcing for Biomarker-Centric Immuno-Oncology Clinical Trials: Which Strategy is More Effective? Kamala Maddali, DVM, PhD VP, Biopharma Collaborations & Companion Diagnostics, Cancer Genetics

Jonathan Reuter Associate Director of R&D Global Procurement,Bristol-Myers Squibb Rita Shaknovich, MD, PhD Medical Director and VP, Hematopathology, Cancer Genetics

1:00 pm - 1:30 pmGrab & Go Lunch

1:30 pm - 2:00 pmMulticolor IHC for Co-expression of Different Markers in Different Types of Cells Kenneth Bloom, MD, FACPChief Medical Officer, GE Healthcare

2:00 pm - 4:45pm Plenary Session 5: Immunotherapy Practice Altering Clinical Advances There are new indications for immunotherapy being studied and approved. This session features talks on clinical programs that are changing the standard of care in Lung Cancer, Prostate Cancer, Acute Lymphoblastic Leukemia, Renal Cell Carcinoma and Melanoma.Session Chairperson: Axel Hoos, MD, PhD SVP, Oncology R&D, GlaxoSmithKline

2:00 pm - 2:30 pm Ipilimumab in Adjuvant Melanoma

Axel Hoos, MD, PhD SVP, Oncology R&D, GlaxoSmithKline

2:30 pm - 3:00 pm Nivolumab and Pembrolizumab as a Contrast in Non Small Cell Lung Cancer Naiyer Rizvi, MDDirector, Thoracic Oncology & Immunotherapeutics in Medical Oncology, NY Presbyterian / Columbia University Medical Center

3:00 pm - 3:15 pmAfternoon Networking Break

3:15 pm - 3:45 pm Renal Cell Carcinoma Phase III Data for Nivolumab RJ Motzer, MDMedical Oncologist,Memorial Sloan Kettering Cancer Center

3:45 pm - 4:15 pm Ipilimumab in Prostate Cancer

Winald Gerritsen, MD, PhDProfessor and Medical Oncologist, Radboud Medical Center

4:15 pm - 4:45 pm Blinatumomab Targeting CD19 for Acute Lymphoblastic Leukemia

David Reese, MDSVP, Translational Sciences, Amgen

Page 10: Combining Business and Clinical Development Strategies ......2016/02/02  · Combining Business and Clinical Development Strategies with Scientific Updates to Prepare the Market for

WWW.THECONFERENCEFORUM.ORG

VENUE The New York Academy of Medicine 1216 Fifth Avenue New York, NY 10029 212-822-7200 www.nyam.org

The New York Academy of Medicine is located at 1216 Fifth Avenue, at the corner of Fifth Avenue and 103rd Street. The entrance is on 103rd Street.

Suggested New York City accommodations located nearby The New York Academy of Medicine:

Upper East Side Hotel Wales 1295 Madison AvenueNew York, NY 10128(between 92nd and 93rd)(917) 639-4820www.hotelwalesnyc.com

The Marmara 301 E 94th StreetNew York, NY 10128(Just in from 2nd Avenue)(212) 427-3100manhattan.marmaranyc.com

East Side Mid-Town Doubletree by Hilton 569 Lexington AvenueNew York, NY 10022(between 50th and 51st)(212) 752-7000metropolitanhotelnyc.com

New York Marriott East Side 525 Lexington AvenueNew York, NY 10017(between 48th and 49th)(212) 755-4000www.marriott.com/hotels/travel/nycea-new-york-marriott-east-side

If staying at one of the above hotels, attendees will have the option to take complimentary bus transportation to the conference venue in the morning and after the program on February 2 and again to the conference venue on February 3.

REGISTRATION & PRICING Early Bird - through December 18, 2015 $1,695 Standard - through January 15, 2016 $1,795 Standard - after January 15, 2015 $1,895 Academic / Govt. Early Bird 3 $897.50 Academic / Govt. Standard Ticket $947.50

The conference fee includes the program, morning coffee/tea, luncheon, reception and conference documentation.

Discount Programs Group Registration – Receive a 10% discount off each registration when two or more colleagues from the same company register online.

Large group discounts available.For groups of 4 or more, please contact [email protected] or call 646-350-2580 for any questions on discount rates.

Payment Policy Payment must be received in full by the event date. All discounts will be applied to the Conference-Only fee (excluding add-ons)‚ cannot be combined with any other offer‚ and must be paid in full at the time of conference.

Substitution and Cancellation Policy If you are unable to attend and would like to register a substitute, please email [email protected]. Please ask your substitute to provide identification on-site.

If you need to cancel your registration, please note the following policies based on the start date of the event:

Ten or more business days prior: A full refund less the administration fee of $295, or a pass to another event valid for two years from the date of issue.

Less than ten business days prior: A pass to a future event for either yourself or a colleague from the same company valid for two years from the date of issue.

To cancel and receive a refund or pass, please email [email protected] or call 646-350-2580 ext. 1.

IMMUNO-ONCOLOGY 360° VENUE / REGISTRATION & PRICING

10

Page 11: Combining Business and Clinical Development Strategies ......2016/02/02  · Combining Business and Clinical Development Strategies with Scientific Updates to Prepare the Market for

WWW.THECONFERENCEFORUM.ORG

EXECUTIVE SPONSORS Caprion is a specialty CRO providing laboratory services to pharmaceutical/biotechnology companies with GCP/GLP/GCLP capabilities. Caprion’s ImmuneCarta® Division, offers

multi-parametric flow cytometry, cytokine testing, and ELISpot for analyses of innate and adaptive immune responses. Caprion’s ProteoCarta™ Division leverages its expertise in mass spectrometry for protein analysis in support of biomarkers development. www.caprion.com

Covance Inc., the drug development business of Laboratory Corporation of America Holdings (LabCorp)

headquartered in Princeton, New Jersey, USA, is the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real®. Information on Covance’s solutions can be obtained through its website at www.covance.com.

Imaging Endpoints is an Imaging Research and Core Laboratory (iCRO) based in Scottsdale, Arizona, with a new East Coast office being added in Waltham Massachusetts. We specialize in providing the

industry’s leading imaging experts, most advanced technology, exquisite service, and experience that extends from translational to phase 3 trials and every step in-between. Our organization is unique in that it is owned by a team of over 40 in-house radiologists and nuclear medicine physicians that specialize in advanced imaging technologies. Our comprehensive services span all aspects of trial planning and conduct, including protocol development, site qualification and standardization, real-time image receipt/QC and reads, data management, regulatory compliance and preparation for meetings/submissions to regulatory authorities. Our Rapid Detection and Assessment of Response program (RaDAR) is designed to accelerate product development by integrating the most advanced imaging technologies into clinical trials. Our world-renowned experts evaluate your unique agent and harness the power of imaging to improve and/or accelerate drug development. At Imaging Endpoints, our capabilities go above and beyond the typical imaging core lab offering. For more information visit www.imagingendpoints.com.

VirtualScopics, Inc. (NASDAQ:VSCP) is a leading imaging CRO/Central reader,

providing clinical trial imaging solutions to accelerate drug development. Medical and scientific expertise, operational flexibility and responsiveness are hallmarks of our daily work and collaborative approach. We understand the risks and time constraints that clinical trial study teams, medical directors, Radiologists, and imaging scientists face. We focus on addressing these challenges by consistently delivering quality imaging data and imaging services on time and within budget. It’s these exceptional performance advantages that truly set our clinical trial imaging services apart. For more information about VirtualScopics, Inc., please visit www.virtualscopics.com.

ASSOCIATE SPONSORS Cancer Genetics Inc. is an emerging leader in DNA-based cancer diagnostics. Our tests target difficult to

diagnose hematological, urogenital and HPV-associated cancers. They are designed to guide the prognosis and treatment of these cancers with the goal of improving outcomes for patients. We have established strong clinical research collaborations with major cancer centers such as Memorial Sloan Kettering, The Cleveland Clinic, Mayo Clinic and the National Cancer Institute. Visit www.cancergenetics.com.

Headquartered in Tucson, Arizona, HTG’s mission is to empower precision medicine at the local level. In 2013 the

company commercialized its HTG Edge instrument platform and a portfolio of RNA assays that leverage HTG’s proprietary nuclease protection chemistry. HTG’s product offerings have since expanded to include its HTG EdgeSeq product line, which automates sample and targeted library preparation for next-generation sequencing. Additional information is available at www.htgmolecular.com.

IntelliCyt enables rapid and cost effective screening and profiling of physiologically-relevant model systems using

cell and/or bead-based assays. Our easy-to-use hardware, software, and reagent systems are optimized to work together to conserve precious samples, use less reagent, and to minimize time-to-answer to enhance productivity and preserve the biology of interest. For more information, please visit www.intellicyt.com.

11

SPONSORS & PARTNERS IMMUNO-ONCOLOGY 360°

Page 12: Combining Business and Clinical Development Strategies ......2016/02/02  · Combining Business and Clinical Development Strategies with Scientific Updates to Prepare the Market for

Neon was founded by Third Rock Ventures, recently raised a Series A of $55M, and is focused on developing next-generation vaccine and T cell therapies leveraging neoantigen biology. Neon’s lead program is a Phase 1 personalized neoantigen vaccine that builds upon R&D from the Broad Institute and Dana-Farber Cancer Institute. For more information visit http://neontherapeutics.com.

Ventana Medical Systems, Inc. a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. VENTANA products are used in clinical histology and drug development research laboratories worldwide. The company’s intuitive, and integrated staining, support diagnosis and enable informed treatment decisions by anatomic pathology professionals. Visit www.ventana.com.

SUPPORTING SPONSOR

Defined Health is a leading biopharmaceutical asset development strategy consultancy with 25+ years of experience. Our consultants hold advanced degrees in science, medicine and business, and have industry experience in business development, commercial evaluation, finance, licensing, drug discovery and R&D. Our clients include top global pharma, large cap biotech, specialty pharma and hundreds of pre-commercial biotech and platform technology companies. Our work encompasses asset evaluation, early commercial strategy, indication prioritization and sequencing, life-cycle management and search and evaluation. Learn more at www.definedhealth.com.

EXHIBITORS

As an innovator in reagents and tools, Abcam’s purpose is to serve life science researchers globally to achieve their mission, faster. Providing the research and clinical communities with tools and scientific support, the Company offers highly validated biological binders and

assays to address important targets in critical biological pathways. Visit http://www.abcam.com.

Biomedical Systems is a leading clinical trial provider to pharmaceutical, medical device, biotech and CRO’s. Our solutions include Cardiac Safety, Pulmonary, Imaging, Echocardiography, eCOA/ePRO, and Scientific Affairs. The longest privately held clinical trial service provider, we deliver quality data on time to support successful study execution. Visit www.biomedsys.com.

Malaysian Biotechnology Corporation (BiotechCorp) is the lead development agency for bio-based industries in Malaysia. BiotechCorp is under the purview of the Malaysian Ministry of Science, Technology and Innovation (MOSTI) and is owned by the Ministry of Finance Incorporated. We act as a central contact point, providing support, facilitation and advisory services to both foreign and local bio-based companies. For more information, visit: www.biotechcorp.com.

Loncar Investments LLC was founded by noted independent biotech investor and analyst Brad Loncar. Mr. Loncar regularly provides his unique insight and analysis on this market segment to the investment community via a variety of publishing platforms. Through Loncar Investments LLC, Mr. Loncar incorporates his extensive research into biotech companies and technology to develop indexes focused on precise investment opportunities. www.loncarinvestments.com.

Personalis, Inc. provides clinical trials researchers with neoantigen identification for immuno-oncology with ACE ImmunoID™. Our ACE (Accuracy and ContentEnhanced) Exome and ACE Transcriptome  supplement coverage of over 8,000 biomedically important genes, including over 1,600 cancer-related genes, enabling identification of variants more accurately and reliably in difficult-to-sequence regions. Visit www.personalis.com.

WWW.THECONFERENCEFORUM.ORG12

SPONSORS & PARTNERS IMMUNO-ONCOLOGY 360°

Page 13: Combining Business and Clinical Development Strategies ......2016/02/02  · Combining Business and Clinical Development Strategies with Scientific Updates to Prepare the Market for

PAGE �13WWW.THECONFERENCEFORUM.ORG

Provecs is a biopharmaceutical developer of novel combinatorial immunotherapeutics addressing the cancer microenvironment. Derived from the adenoviral ENVIRO platform, Immunalon® expresses three immunemodulating proteins. Comprehensive and rapid microenvironment reprogramming was documented by transcriptome and TIL-profiling employing Provecs’ EXVIRO human cancer tissue platform. Provecs seeks further partnering in distinct cancer indications. For more information, please visit www.provecs.com.

World Courier is a global specialty logistics company that designs world-class logistics and supply chain programs in complete alignment with our customers’ business goals. At World Courier we help our clients optimize pharmaceutical transport costs by ensuring that their investigational drugs, clinical trial supplies, biological samples and commercial products consistently arrive on time and in within desired temperature range. With 2,000+ associates in more than 140 offices across the globe, we offer solutions that instill confidence in the on-time, on-temperature delivery of critical products. To learn more, visit: www.worldcourier.com.

SUPPORTING PARTNERS

Cancer Research Institute is a nonprofit organization dedicated exclusively to the advancement of immunotherapy for cancer. It raises funds and provides research grants to laboratory and clinical scientists who are progressing this field. It also connects patients with cancer immunotherapy clinical trials and with other patients and caregivers considering treatment with immunotherapy. Learn more at http://www.cancerresearch.org.

The Association for Cancer Immunotherapy (CIMT) is a members-based information and education platform that facilitates the knowledge exchange between academic and

industry scientists, physicians and regulatory authorities who research and develop cancer immunotherapies. CIMT was founded in 2002 by physicians and researchers from different fields of clinical and theoretical medicine as an independent non-profit organization. CIMT has its offices in Mainz, Germany, and is financed by donations, congress fees, industry sponsorship and by public and foundation grants. For more information, visit www.cimt.eu.

Established in 1984, the Society for Immunotherapy of Cancer (SITC) is a not-for-profit organization of medical professionals dedicated to improving patient outcomes by advancing the development, science and application of cancer immunotherapy. As the world’s leading member-driven organization dedicated to cancer immunotherapy and tumor immunology, SITC is comprised of nearly 1,000 influential basic and translational scientists, clinicians, health care professionals, government leaders and industry professionals from around the globe. For more information about SITC, please visit www.sitcancer.org.

MEDIA PARTNERS

IMMUNO-ONCOLOGY 360° SPONSORS & PARTNERS

13