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Monday, June 27
 

8:30am EDT

#104: Impact of Biologics, Vaccines, Oncology, and Breakthrough Therapy Designation on Traditional Global Drug Development Strategy
Limited Capacity seats available
Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-523-L01-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000186; RN 1.25

This forum will provide an overview of traditional small molecule drug development, and highlight special considerations, opportunities, requirements, and risks for specialized programs, such as oncology, vaccines, biologics, or breakthrough therapies.

Learning Objectives

Explain how oncology, vaccine, and biologic drug development are similar to, or different from, a traditional small molecule program; Compare and contrast oncology, vaccine, and biologic drug development with respect to project leadership and project management strategies, approaches, and resource investment decisions; Discuss the impact of breakthrough therapy designation on each of these.

Chair

Eva M. Finney, PhD, PMP

Speaker

Panelist
Susan Uptain, PhD

Panelist
David Robinson, PhD


Chair
avatar for Eva Finney

Eva Finney

Director, Global Project & Alliance Management, Merck & Co., Inc.
Eva M. Finney, Ph.D., PMP, is Director, Global Project and Alliance Management at Merck, where she has been a Project Manager for 15 years. She has managed multiple development programs from early to late stage, including several NDA submissions leading to successful product approvals... Read More →

Speakers
DR

David Robinson

Principal Consultant, Robinson Vaccines and Biologics LLC
Independent consultant with 25 years experience in global vaccine and biologics product commercialization, process development and CMC regulatory strategy/execution (IND, BLA, PAS). Over 20 years at Merck, chaired the CMC development team that achieved approval of RotaTeq, an oral... Read More →
avatar for Susan Uptain

Susan Uptain

Head of Regulatory Affairs Operations, Baxalta
Dr. Susan Uptain is currently Head of Global Regulatory Operations at Baxalta, where she is responsible for operational excellence in execution of global regulatory strategy and tactics. Previously, she was Director of Project Management and Alliance Management at Merck & Co., Inc... Read More →
avatar for Susan Uptain

Susan Uptain

Head of Regulatory Affairs Operations, Shire
Dr. Susan Uptain is currently Head of Global Regulatory Operations at Baxalta, where she is responsible for operational excellence in execution of global regulatory strategy and tactics. Previously, she was Director of Project Management and Alliance Management at Merck & Co., Inc... Read More →

Monday June 27, 2016 8:30am - 9:45am EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj-Port Mgt-Strat Planning, Forum

8:30am EDT

#110: Updates and Pending Issues in the US Biosimilar Environment
Limited Capacity seats available
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-544-L01-P; CME 1.25; IACET 1.25; RN 1.25

The US biosimilars market is maturing rapidly. In the past year, we’ve seen the first biosimilar launch in the US market, multiple draft guidances on biosimilars and biologics emerge from the FDA, and several biosimilar applications that focus on diverse range of complex reference products. The debate and discussion in the US around biosimilars highlights the importance of the biosimilars market to the US drug industry, and the continued impact of the 2010 Biologics Price Competition and Innovation Act. This panel will discuss recent developments in US biosimilars regulation from a manufacturer’s perspective, lessons learned, and areas that would benefit from further global policy discussion.

Learning Objectives

Discuss recent developments in US biosimilar regulation: Identify areas that would benefit from further global policy discussion.

Chair

Andrew S. Robertson, JD, PhD

Speaker

Panelist
Karen M Hauda

Panelist
Mark McCamish

Panelist
Kimberly Greco


Chair
AR

Andrew Robertson

Director, Global Regulatory Policy, Merck & Co., Inc.
Andrew S. Robertson works in Global Regulatory Affairs at Merck & Co., focusing on regulatory policies concerning vaccines, biologics, biosimilars, in vitro diagnostics, mobile medical apps and software medical devices. He has over 13 years of experience spanning academia, industry... Read More →

Speakers
avatar for Kimberly Greco

Kimberly Greco

Director, Research and Development Policy, Amgen Inc.
avatar for Karen Hauda

Karen Hauda

Senior Director, Regulatory Policy, Novo Nordisk A/S
Karen Hauda is the Senior Director for Regulatory Policy in the Clinical Development, Medical and Regulatory Affairs Division at Novo Nordisk. In this role, she supervises regulatory advocacy and develops filing strategies to positively influence the regulatory environment in the... Read More →
avatar for Mark McCamish

Mark McCamish

Global Head Biopharm and Oncology Injectables Development, Sandoz, Inc
Dr. McCamish is a physician scientist with a long history of drug, biologic, and biosimilar development in large and small organizations. He is currently Global Head of Biopharmaceutical Development for Novartis biosimilar development housed in Sandoz International.

Monday June 27, 2016 8:30am - 9:45am EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Forum
 
Tuesday, June 28
 

10:30am EDT

#219: Regulatory Science Considerations Applying to Novel Combinations of Biologics and Bifunctional Biologics Development
Limited Capacity seats available
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-552-L01-P; CME 1.25; IACET 1.25; RN 1.25

This session will focus on specific aspects of the regulatory development of novel combination biologics, as well as bifunctionals. Specific considerations for each of these modalities for different clinical stages and therapy areas will also be addressed, and a comparison/contrast of development requirements for each will be provided.

Learning Objectives

Describe the regulatory requirements for development of combinations of novel biologicals and bifunctional biologics.

Chair

Owen Fields, PhD

Speaker

Unique Challenges in the Regulation of Bispecific Antibodies
Raj G Nair, MD

Unique Preclinical and Clinical Aspects of Bifunctional Development
Rakesh Dixit, PhD

Q and A Panel
Badrul Chowdhury, MD, PhD


Chair
avatar for Owen Fields

Owen Fields

Vice President, Inflammatory and Immunology, WW Safety and Regulatory, Pfizer Inc
I received my Ph.D. in molecular and cellular biology from Berkeley. Following this I worked in food biotechnology regulation at the US FDA. I then moved to regulatory strategy at Wyeth where I worked in autoimmune disease, tissue repair, and other areas. After the merger with Pfizer... Read More →

Speakers
avatar for Badrul Chowdhury

Badrul Chowdhury

Director, Division of Pulmonary, Allergy, and Rheumatology Products, OND, CDER, FDA
Dr. Badrul A. Chowdhury is the Director of the Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research, US Food and Drug Administration. Dr. Chowdhury is trained and board certified in Internal Medicine, and in Allergy and Immunology, and... Read More →
avatar for Rakesh Dixit

Rakesh Dixit

Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune
RN

Raj Nair

Medical Officer, DPARP, OND, CDER, FDA
I am a medical officer within the Division of Pulmonary Allergy, and Rheumatology since 2013. I was previously an assistant professor in Rheumatology at Georgetown University with an interest in use of musculoskeletal ultrasound in diagnosis and management of patients with rheumatic... Read More →

Tuesday June 28, 2016 10:30am - 11:45am EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session

4:00pm EDT

#268: Emerging Biopharma Therapeutic Modalities: Scientific and Policy Implications
Limited Capacity seats available
Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will examine three emerging scientific platforms with potential to drive the next wave of therapeutic innovation. Participants will be presented with how to evaluate new platforms, recognize the hurdles and consider what regulatory pathways and policies are needed to bring these new therapies to patients.

Learning Objectives

Discuss three emerging therapeutic modalities and what aspects make them particularly useful as new therapies; Define the characteristics of each modality that present the most significant near-term challenges and inflection points for greater therapeutic utilization; Recognize what policies are needed to ensure development and delivery of these innovations as new therapeutics.

Chair

Adam Hacker, PhD

Speaker

Microbiome: What Is It and Why Do We Need to Prepare for It?
Adam Hacker, PhD

Regenerative Medicine: How Adaptive Biomedical Innovation Can Support Development of Cell and GeneTherapy Products
Anne-Virginie L. Eggimann, MS

Responding to Global Health Emergencies: A Regulatory Perspective
Luciana Borio, MD


Chair
avatar for Adam Hacker

Adam Hacker

Vice President, Head of Vaccines & Microbiome, Global Regulatory Affairs, Janssen Pharmaceuticals (johnson & Johnson)
Adam Hacker was appointed VP Head of Vaccines & microbiome for Global Regulatory Affairs at Janssen Pharmaceuticals (Johnson & Johnson company) in June 2015. As Head of Vaccines he is responsible for driving regulatory strategy with a focus on the accelerated development of Janssen’s... Read More →

Speakers
avatar for Luciana Borio

Luciana Borio

Acting Chief Scientist, Office of the Chief Scientist, OC, FDA
Dr. Luciana Borio is FDA’s acting chief scientist. In this capacity, she is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. The Office of the Chief Scientist works closely with FDA’s product centers, providing strategic leadership... Read More →
avatar for Anne-Virginie Eggimann

Anne-Virginie Eggimann

Senior Vice President, Regulatory Science, bluebird bio, Inc.
Anne-Virginie joined bluebird bio in 2011 to lead global regulatory strategy and create innovative pathways to accelerate the development of bluebird bio’s gene therapy products. Previously, AV was an Executive Director at Voisin Consulting, leading rare diseases, oncology, and... Read More →

Tuesday June 28, 2016 4:00pm - 5:15pm EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 10: Pub Pol-HealthCare Compl-Law, Session
 
Wednesday, June 29
 

10:30am EDT

#312: Human Tissue Models: A Look into the Future of Safety Pharmacology Studies
Limited Capacity seats available
Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

The session will address the nonclinical regulatory development of robust human tissue (HT) technologies/models, validation, applications and the possible future switch from in vivo animal models to HT technologies.

Learning Objectives

Discuss the acceptability of human tissue (HT) technologies data in support of clinical trials and MAA submissions; Identify nonclinical requirements for the use of data generated with HT technologies; Describe validation of models; Identify GLP requirements.

Chair

Michelle Cathian Beharry, MS

Speaker

Overcoming Barriers to Human Tissue Use for Safety Assessment
Anthony Holmes, PhD

The Use of Human Tissue Technologies in Support of Clinical Trials and Marketing Authorization Regulatory Submissions
Michelle Cathian Beharry, MS


Chair
avatar for Michelle Beharry

Michelle Beharry

Senior Non-Clinical Assessor, Medicines and Healthcare products Regulatory Agency (MHRA)
Michelle spent 4 years in the pharmaceutical Industry as a regulatory/investigative toxicologist, then joined the MHRA and is now a Senior Pharmaco-Toxicologist. Principally, this involves the assessment of nonclinical data for Clinical Trials and Marketing Authorisation applications... Read More →

Speakers
AH

Anthony Holmes

Head, Technology Development, NC3Rs
Anthony Holmes is Head of Technology Development at the NC3Rs. He oversees a programme of work focusing on the interface between academia and industry and the acceleration of technologies out of the science base and in to application to reduce animal use and address scientific and... Read More →

Wednesday June 29, 2016 10:30am - 11:30am EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Session

4:00pm EDT

#360: Biomarkers and Sample Stability: Bottlenecks in Study Planning, Ensuring Sample Stability as the Key for Reliable Lab Results
Limited Capacity seats available
Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

The need for biomarkers means that expertise in handling frozen samples is required. This session will present strategies and solutions to ensure both that frozen specimens are correctly collected and shipped and that they arrive in stable conditions at the lab where biomarkers can be reliably tested.

Learning Objectives

Discuss how handling of critical biological samples is essential to be able to rely on the lab results obtained after testing; Describe how to collect, handle, store and ship samples appropriately.

Chair

Hermann Schulz, DrMed

Speaker

Piecing Together a Successful Biomarker Strategy: A Catalyst for Precision Medicine
Paul Travis, MSc

Ensuring Sample Stability When Handling Biomarkers
Hermann Schulz, DrMed


Chair
HS

Hermann Schulz

Executive Vice President, Synlab Pharma Institute
Before founding INTERLAB in 1994, Hermann Schulz held senior R&D positions in Pharma for 12 years. He was a Board member of the German Society of Pharmaceutical Medicine for 6 years, is visiting professor for applied clinical pharmacology and has written more than 35 scientific publications... Read More →

Speakers
avatar for Paul Travis

Paul Travis

Exec. Director, Medpace Global Labs, Medpace
Paul Travis MSc, Executive Director of Global Business Strategy at Medpace Laboratories. +25 years of Experience in R&D within the pharma and contract research industries. Attained MSc in Biomedical Science & began career with Ciba Geigy UK, working in early research and development... Read More →

Wednesday June 29, 2016 4:00pm - 5:00pm EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Session

4:00pm EDT

#364: Cell and Gene Therapies: Current Global Landscape
Limited Capacity seats available
Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session aims to cover the current global regulatory landscape for products belonging to gene therapy, cell therapy, and regenerative medicine, a rapidly emerging class of medicinal products with huge potential for managing many unmet medical needs and contribute substantially to patient care. The complexity of the products and the regulatory development and expectations across different regions, both established and emerging, will be covered.

Learning Objectives

Identify and understand the challenges unique to the regulatory review of global clinical trials with gene therapies; Discuss the development of regenerative medicine after new pharmaceuticals and medical devices law was implemented in Japan; Describe the regulatory development of cell therapy in Taiwan, including comparison of regulatory development of cell therapy among selected Asia countries and future prospects.

Chair

Linda F. Bowen

Speaker

Examining the Global Regulatory Environment and Scientific Landscape for Gene Therapy Clinical Trials
Victoria Rocchi

Regulation of Cell Therapy Products in Asia
Chao-Yi Joyce WANG, MSc

New Approach to Development of Regenerative Medicines in Japan
Noriaki Murao, MS


Chair
avatar for Gopalan Narayanan

Gopalan Narayanan

Biologics and Advanced Therapies Expert, NDA Group
Trained in Internal Medicine. Currently providing strategic support and advice to Biotech/Pharma companies on regulatory science primarily in Biotechnology, Cell and Gene Therapy. Previously Head of Biotechnology Unit, MHRA, UK and Expert Medical Assessor; Member of Committee for... Read More →

Speakers
avatar for Linda Bowen

Linda Bowen

Senior Director, Global Regulatory Science and Policy, Sanofi
Linda is Senior Director, Global Regulatory Science and Policy at Sanofi, and has held senior positions at Bayer and Block Drug/GSK, with global regulatory responsibilities for submissions, LCM and due diligence. She is an adjunct professor in the Temple University RA/QA Program... Read More →
avatar for Noriaki Murao

Noriaki Murao

Representative, NM Consulting
Noriaki received BS and MS degrees in pharmacy from Fukuoka University and Kyushu University. He spent his professional career for new drug development in pharmaceutical industries for four decades. He is currently running an independent regulatory consultancy business. He contributed... Read More →
avatar for Victoria Rocchi

Victoria Rocchi

Senior Regulatory Affairs Specialist, AnGes, Inc.
Victoria Rocchi is a Senior Specialist in Global Regulatory Affairs at AnGes, Inc. Ms. Rocchi has extensive experience in communications, project management and is a certified teacher. She began her career in the pharmaceutical industry at Merck Sharp and Dohme in Regulatory Operations... Read More →
avatar for Chao-Yi Wang

Chao-Yi Wang

Director, Division of Medicinal Products, Ministry of Health and Welfare, TFDA, Chinese Taipei
Ms. Chao-Yi (Joyce) Wang was appointed as the Director of Division of Medicinal Products, TFDA, Chinese Taipei, Ministry of Health and Welfare on January 7, 2016. She is responsible for management of pharmaceutical policies and regulations, including premarket approval of medicinal... Read More →

Wednesday June 29, 2016 4:00pm - 5:15pm EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session