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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
 
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
 
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
 
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