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Trk 09: Med Devices-InVitro-CombProd [clear filter]
Monday, June 27
 

8:30am

#113: Clinical Developments in Immuno-Oncology, Part 1 of 2: Science, Current Methodologies, and Achievements
Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-554-L01-P; CME 1.25; IACET 1.25; RN 1.25

In this session, representatives from large pharmaceutical companies will present and discuss the science, current methodologies and achievements in their advanced clinical programs in the area of immuno-oncology. They will address what makes the difference to standard and targeted therapies, what has been learned by studying the interaction of the tumor and the immune system, and the predictors for patient response.

Part 2 is scheduled for Monday, June 27, 10:45AM-12:00PM.

Learning Objectives

Describe the most recent advances in cancer immunotherapy; Discuss the interaction of the tumor and the immune system; Identify predictors for patient response.

Chair

Holger G. Adelmann

Speaker

Overview of Immuno-Oncology
Ashok K. Gupta

Molecular Predictors of Response to Immuno-Oncology Therapeutics
Brandon Higgs, PhD

Opportunities and Challenges for the Use of Biomarkers in Anti-PD1/PD-L1 Immunotherapy
Ti Cai, PhD



Chair
avatar for Holger Adelmann

Holger Adelmann

Senior Vice President and Managing Director, DIA EMEA
Dr. Holger G. Adelmann, MD PhD. Board certified Clinical Pharmacologist. Clinical training in internal medicine. Several leading positions in pharma since 1989 with Bayer & Tropon (Germany), AstraZeneca (UK and Sweden), and Merck Serono (Germany). He is member of the American Association... Read More →

Speakers
TC

Ti Cai

Director, Global Clinical Biomarkers and Companion Diagnostics, EMD Serono
Ti Cai joined EMD Serono in March 2015 as Director, Clinical Biomarkers and Companion Diagnostics. He is currently leading clinical biomarker development for avelumab (anti-PD-L1 antibody) program. Prior to EMD Serno, Ti worked at Celgene, Sanofi and Amgen where he led biomarker research... Read More →
AG

Ashok Gupta

Vice President, Head of Clinical Immuno-Oncology, Medimmune
avatar for Brandon Higgs

Brandon Higgs

Director, MedImmune
Dr. Higgs leads the Bioinformatics function within Translational Medicine at MedImmune. He has 15+ years of industry experience in biomarker development within indications of oncology, autoimmunity, inflammation, CNS, and transplantation. He has a PhD in Computational Biology and... Read More →


Monday June 27, 2016 8:30am - 9:45am
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#135: Clinical Developments in Immuno-Oncology, Part 2 of 2: Clinical Implementation of Biomarkers
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-562-L01-P; CME 1.25; IACET 1.25; RN 1.25

In this forum, the panelists will give a state-of-the-art overview of the exciting new area of cancer immunotherapies, the current learnings and methodologies, the benefits and challenges, as well as an outlook into the future.

Part 1 is scheduled for Monday, June 27, 2016, 8:30-9:45 AM.

Learning Objectives

Discuss examples of clinical implementation of biomarkers in the development of cancer immunotherapies; Describe what the future looks like for cancer immunotherapies; Explain the role of new technologies for companion diagnostics.

Chair

Holger G. Adelmann

Speaker

Panelist
Arnold B. Gelb

Panelist
Brandon Higgs, PhD

Panelist
Marc Theoret, MD



Chair
avatar for Holger Adelmann

Holger Adelmann

Senior Vice President and Managing Director, DIA EMEA
Dr. Holger G. Adelmann, MD PhD. Board certified Clinical Pharmacologist. Clinical training in internal medicine. Several leading positions in pharma since 1989 with Bayer & Tropon (Germany), AstraZeneca (UK and Sweden), and Merck Serono (Germany). He is member of the American Association... Read More →

Speakers
avatar for Arnold Gelb

Arnold Gelb

Senior Director, Clinical Biomarkers and Companion Diagnostics, EMD Serono Research & Development Institute, Inc.
avatar for Brandon Higgs

Brandon Higgs

Director, MedImmune
Dr. Higgs leads the Bioinformatics function within Translational Medicine at MedImmune. He has 15+ years of industry experience in biomarker development within indications of oncology, autoimmunity, inflammation, CNS, and transplantation. He has a PhD in Computational Biology and... Read More →
MT

Marc Theoret

Associate Director of Immunotherapeutics, OHOP, OND, CDER, FDA
Dr. Theoret is a medical oncologist and the Associate Director of Immunotherapeutics in the Office of Hematology and Oncology Products, CDER, FDA. In his role as Associate Director, Dr. Theoret is leading initiatives in immuno-oncology product development—regulatory, scientific... Read More →


Monday June 27, 2016 10:45am - 12:00pm
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

10:30am

#221: Envision the Future: How Big Data and Artificial Intelligence Change Our Regulatory Environment
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-555-L04-P; CME 1.25; IACET 1.25; RN 1.25

The complexity of the regulatory environment is growing rapidly in light of new technologies for disease surveillance, diagnostics, and medication. This session will focus on future knowledge and predictions in intelligence with an impact on the regulatory world.

Learning Objectives

Recognize the complexity of the future regulatory environment in light of new technologies; Identify challenges and opportunities in the field of digital data for disease surveillance, personalized medicines and individual stakeholder engagement through innovative tools; Evaluate future knowledge against new technologies.

Chair

Joseph C. Scheeren, PharmD

Speaker

Current Status of Big Data Use in the Health Care Sector: View from the Market
Luke D. Dunlap, MSc

Big Data Being Part of FDA eHealth Policy: Viewpoint of the Regulator
Robert M. Califf, MD

Challenges of Big Data in the Regulatory Environment from the Legal Point of View
Denise Esposito, JD



Chair
avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors... Read More →

Speakers
avatar for Robert Califf

Robert Califf

Commissioner, FDA
Robert M. Califf, MD, MACC, is the Food and Drug Administration's commissioner of food and drugs. As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public healt... Read More →
LD

Luke Dunlap

Senior Principal, Real World Evidence Solutions, IMS Health
avatar for Denise Esposito

Denise Esposito

Partner, Covington & Burling LLP


Tuesday June 28, 2016 10:30am - 11:45am
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#267: FDA Institutes/Centers of Excellence: A Step Toward Patient Focused Drug Development?
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

The historic structure of FDA is oriented around the products it regulates. Today, the treatment of many diseases involves numerous different technologies and interventions centered on providing optimal care for the patient, and a patient-centered orientation to reflect the current multimodal approach to patient care is being proposed. Cross-center Institutes of Excellence could help FDA to further advance the promotion of human health. These institutes could foster increased intellectual collaboration and a consistent FDA approach by forming teams of Agency staff with cutting-edge expertise in the treatment and prevention of specific types of diseases. Consolidating disease-oriented activities at FDA may help reduce redundancies within the current FDA Centers and better consolidate core competencies to focus on scientific advancement within the Agency and streamline processes for the review of products to treat high impact disease areas. The benefits of such a restructuring will be explored and discussed by a panel of experts.

Learning Objectives

Describe how the proposed reorganization could affect drug development and review by FDA; Discuss whether the proposed reorganization could benefit patients; Explain path forward and potential challenges associated with the proposed reorganization.

Chair

Margaret A. Anderson, MA

Speaker

Panelist
Wade Ackerman, JD

Panelist
Steven K. Galson

Panelist
Eric H. Rubin, MD

Panelist
Ellen Sigal, PhD



Chair
avatar for Margaret Anderson

Margaret Anderson

Executive Director, FasterCures, A Center of the Milken Institute
Margaret Anderson is the executive director of FasterCures, a Washington, DC-based center of the Milken Institute, which is driven by a singular goal – to save lives by speeding up and improving the medical research system. FasterCures focuses on spurring cross-sector collaboration... Read More →

Speakers
avatar for Wade Ackerman

Wade Ackerman

Former Senior FDA Counsel for the Senate HELP Committee, NA
Wade Ackerman recently served as Senior FDA Counsel for Ranking Member Patty Murray on the US Senate Committee on Health, Education, Labor and Pensions (HELP) where he handled issues related to pharmaceuticals, medical devices, animal products, cosmetics, and other FDA-related areas... Read More →
avatar for Steven Galson

Steven Galson

Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc.
Dr. Steven Galson is Senior Vice President - Global Regulatory Affairs & Safety at Amgen. Prior to Amgen, Galson spent more than 20 years in government service, including two years as acting Surgeon General of the United States. He also served as director of FDA’s Center for Drug... Read More →
avatar for Steven Galson

Steven Galson

Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc.
Dr. Steven Galson is Senior Vice President - Global Regulatory Affairs & Safety at Amgen. Prior to Amgen, Galson spent more than 20 years in government service, including two years as acting Surgeon General of the United States. He also served as director of FDA’s Center for Drug... Read More →
ER

Eric Rubin

Vice President and Therapeutic Area Head, Merck Research Laboratories
ES

Ellen Sigal

Chairperson and Founder, Friends of Cancer Research
Dr. Ellen Sigal has been a devoted patient advocate and stanch supporter of cancer research. She founded Friends of Cancer Research in 1996 to mark the anniversary of the National Cancer Act. Friends is a cancer research think tank and advocacy organization based in the Washington... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

10:30am

#317: Global Medical Device Development: Regulatory Concordance or Discordance?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-558-L04-P; CME 1.25; IACET 1.25; RN 1.25

Developing medical devices for a global environment is difficult, with regulatory authorities working to regulatory convergence not harmonization. Participants will explore the latest developments from the International Medical Device Regulators Forum and Asian Harmonization Working Party to guide global device development decision-making.

Learning Objectives

Describe the growing regulatory landscape for medical devices; Discuss how to apply the advancements toward a converged regulatory environment for necessary global regulatory support to create more streamlined global development plans.

Chair

Mary Ann Smith, MS, RPh

Speaker

Industry Perspective
Anthony D. Watson, MBA, MS

Health Canada Perspective
Nancy Shadeed



Chair
MA

Mary Ann Smith

DRA Policy Head of Medical Device and Combination Products, Novartis Pharmaceuticals Corporation
Mary Ann Smith is Regulatory Policy Director, Digital Medicine & Devices, with Novartis since 2009 focused on software as a medical device, technology applications and enabled clinical trials, combination products and regulatory strategy. Ms. Smith has regulatory experience at Nektar... Read More →

Speakers
NS

Nancy Shadeed

Special Advisor, International Programs Division, Health Canada
DIA
avatar for Anthony Watson

Anthony Watson

Associate Vice President, Regulatory Affairs - Devices, Sanofi US
Anthony Watson is the Head of Regulatory Affairs - Devices, for Sanofi, in Cambridge, Massachusetts. Before Sanofi, he was the Director of Regulatory Affairs, CMC, Combination Products at Biogen. Prior to Biogen, he was a Division Director responsible for drug delivery devices in... Read More →


Wednesday June 29, 2016 10:30am - 11:45am
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#344: Companion Diagnostics: Driving New Business Models for Successful Outcomes
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This forum will identify critical issues and success factors in the evolving field of companion diagnostics, with a focus on addressing operational challenges and delivering benefits to patients through successful business partnerships.

Learning Objectives

Describe the evolving field of companion diagnostics; Identify best practices for successful collaborations between pharmaceutical and diagnostics companies.

Chair

Patrick Phillips

Speaker

Panelist
Robert Bilkovski

Panelist
Kelly R. Pitts, PhD



Chair
avatar for Patrick Phillips

Patrick Phillips

Chief Executive Officer, Health Decisions, Inc.
Dr. Phillips is an experienced and respected clinical development executive and industry leader. He is responsible for executive oversight and strategic leadership of Health Decisions. Before his appointment as CEO, Dr. Phillips served for over two years as Health Decisions’ Vice... Read More →

Speakers
avatar for Robert Bilkovski

Robert Bilkovski

Head, Medical and Clinical Affairs, Abbott Molecular
Following medical school (Rosalind Franklin Univ/Chicago Medical School), Dr. Bilkovski focused on research in sepsis and noninvasive hemodynamic management. After 5 years, he identified his zeal for entrepreneurship and pursued his MBA (Notre Dame). His primary focus has been in... Read More →
avatar for Kelly Pitts

Kelly Pitts

Vice President, Research & Development, Site Manager - Colorado Operations, Corgenix, Inc.
Kelly R. Pitts, PhD is Vice President of R&D at Corgenix, Inc., an IVD company specializing in cardiovascular, autoimmune, and companion diagnostics. He previously held leadership positions at Myogen, Gilead Sciences, and Amgen, focused on drug discovery, development, and commercialization... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#365: Cross-Labeling of Drugs and Devices: How Can It Be Done?
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-559-L04-P; CME 1.25; IACET 1.25; RN 1.25

Cross-labeling poses regulatory challenges. Device and drug labeling may mention another product, but the reference is not mirrored. This session will present the challenges faced by both FDA and regulated industry to properly align labels of drugs and devices intended to be used together.

Learning Objectives

Discuss the regulatory challenges of aligning the labels of drugs and devices approved for combined use under separate applications; Explore the possible regulatory solutions to better aligning labels for drugs and devices intended to be used together; Identify the challenges misaligned labeling presents for industry, patients, health care practitioners, and regulators.

Chair

Heidi F. Gertner

Speaker

Panelist
Lene Garde Sommer

Panelist
Diane Macculloch Johnson, MS

Panelist
John Barlow Weiner, JD



Chair
avatar for Heidi Gertner

Heidi Gertner

Partner, Hogan Lovells US LLP
Heidi Gertner is a partner at Hogan Lovells in their drug regulatory group. Heidi began her professional career with a focus on bioethics and law, completing two post-doctoral bioethics fellowships-at the Cleveland Clinic and at NIH. Heidi then worked at the FDA's Office of Chief... Read More →

Speakers
avatar for Diane Johnson

Diane Johnson

Senior Director, North American Regulatory Affairs Policy and Intelligence, Johnson & Johnson
Diane is responsible for providing key strategic direction and regulatory intelligence across the North America device sector. Supports shaping of growth plans by translating the impact of regulatory environmental changes/trends on Strategic Business Plans. 20yrs of experience in... Read More →
avatar for Lene Sommer

Lene Sommer

Vice President, RA Devices, Novo Nordisk A/S
VP of Regulatory Affairs Devices at Novo Nordisk A/S. Responsible for regulatory strategies for development of devices as well as maintenance of devices on the market. She has more than 18 years of experience in the world of pharmaceuticals (medical devices). She has wide experience... Read More →
avatar for John Weiner

John Weiner

Associate Director for Policy, FDA
John Barlow Weiner is the Associate Director for Policy in the Office of Combination Products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA's Office of Chief Counsel and in private practice. He received a BA from Princeton University and a JD with honors... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Thursday, June 30
 

10:45am

#409: Current Status of Genetic Testing in Medical Therapies: What Regulations We May Need in a Convergent Regulatory Environment
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-560-L04-P; CME 1.25; IACET 1.25; RN 1.25

In the current status of new treatment, prevention and diagnostic modalities, genetic testing in medical therapies offers promising potential, and public interest is extremely high. What regulations do we need in a convergent regulatory environment?

Learning Objectives

Recognize the huge impact of genetic testing in health care; Identify challenges and opportunities that exist in the current regulatory environment; Realize that many questions about patient rights and privacy still need to be resolved; Conceive the legal framework and the impact it has in today's health care environment.

Chair

Joseph C. Scheeren, PharmD

Speaker

Patient Perspective
Sue Friedman, DVM

Industry Perspective
Morten Sogaard, PhD

Regulator Perspective
Robert Schuck, PharmD, PhD



Chair
avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors... Read More →

Speakers
SF

Sue Friedman

Executive Director and Founder, Facing Our Risk of Cancer Empowered (FORCE)
Dr. Friedman was a practicing veterinarian in 1996 when she was diagnosed at age 33 with breast cancer and later learned she carried a BRCA2 mutation. She founded the nonprofit organization Facing Our Risk of Cancer Empowered (FORCE) in 1999 to improve the lives of people affected... Read More →
avatar for Robert Schuck

Robert Schuck

Clinical Pharmacologist, Genomics and Targeted Therapy, OTS, CDER, FDA
Robert Schuck, Pharm.D., Ph.D. is a Clinical Pharmacologist in the Genomics and Targeted Therapy Group at the FDA. In his current position, Dr. Schuck contributes to regulatory review of investigational new drug (IND), new drug (NDA), and biologic licensing (BLA) applications to effectively... Read More →
MS

Morten Sogaard

Vice President and Head, Enterprise Scientific Technology Operations, Pfizer Inc
Morten has been with Pfizer since 2009 and is VP, Enterprise-wide Scientific Technology Operations and a member of Pfizer’s R&D leadership team . He oversees technology investment and Pfizer’s human genetics, computational biomedicine, diagnostics and bio-banking organizations... Read More →


Thursday June 30, 2016 10:45am - 12:00pm
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA