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Biologics-Biosimilars [clear filter]
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

10:45am EDT

#127: Innovative Partnerships: gOVERN - A Research and Early Development’s Outsourcing Vision to Enable Resourcing INovation
Limited Capacity seats available

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

Genentech Research and Early Development (gRED), in partnership with two CROs, has created a novel outsourcing model. This forum will detail the gOVERN model in the areas of partnership, operations, contracting and governance.

Learning Objectives

Discuss the partnership build and structure for the gOVERN model in Genentech Research and Early Development (gRED); Share key structure, learnings and innovation for this novel partnership which promotes transparency, cross-company commitments, and therapeutic-area program-level allocation.

Chair

Hilary Nelson

Speaker

Panelist
Margaret Taylor

Panelist
Jami Norris, MS

Panelist
Kerryn Cress



Chair
avatar for Hilary Nelson

Hilary Nelson

Senior Clinical Program Leader, Genentech, A Member of the Roche Group
Hilary Nelson is Sr. Clinical Program Leader who joined Genentech in 2004. She has held positions on increasing responsibility in Clinical Operations having worked at both the trial and program levels in oncology early clinical development. In addition to her work with CRO alliance... Read More →

Speakers
avatar for Kerryn Cress

Kerryn Cress

Senior Director, Technology, Innovation & Performance, PPD
Kerryn has over 12 years of clinical research experience. During her career she has held positions of increasing responsibility in driving transformational change, implementing strategic partnerships, leading cross-functional teams, and developing proposals. Kerryn is a certified... Read More →
avatar for Jami Norris

Jami Norris

Vice President, Clinical Development Strategic Partnerships, Quintiles
Jami has more than 22 years of clinical research experience, including 14 years with Quintiles. In her current role, Jami leads the development of Strategic Partnerships. Previously, Jami has worked extensively in overseeing the delivery of key customer portfolios resulting in 5 approved... Read More →
avatar for Margaret Taylor

Margaret Taylor

Associate Director, Oncology Program Group Leader, Clinical Operations, Genentech, A Member of the Roche Group
Peg Taylor is an Associate Director/Program Group Lead at Genentech early development (gRED ) Oncology Clinical Operations. Peg served as the gRED Lead on the gOVERN CRO Strategic Alliance.. Peg has over 25 years of pharma/biotech industry with a deep expertise in early clinical study... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 03: Innov Part Model-Outsourcing, 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

4:00pm EDT

#260: A Risk-Benefit Approach to Planning Early Clinical Development
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-598-L04-P; CME 1.25; IACET 1.25; RN 1.25

Presentations will examine different but overlapping aspects of assuring safety and evaluating activity in early clinical development activities to enable rational clinical development, followed by an interactive discussion of potential future directions.

Learning Objectives

Discuss different aspects of including safety in early phase drug development processes; Identify aspects to be considered for risk assessments during a first-in-human study; Describe a dose selection process for cell and gene therapies to increase likelihood of efficacy; Explain recommended standards for operating an early phase CPU with staff training programs.

Chair

Howard Greenberg, MD

Speaker

Structured Risk Assessment and Risk Mitigation in First-in-Human Studies
Thijs Van Iersel, MD

Dose Finding for Cell and Gene Therapies: Is Safety the Main Driver?
Gopalan Narayanan, MD, FFPM, FRCP

Site Training as a Critical Key to Safety
Donna W. Dorozinsky



Chair
avatar for Howard Greenberg

Howard Greenberg

Medical Safety Officer, Janssen Research and Development, LLC
Dr. Greenberg is a Medical Safety Officer for Janssen Pharmaceuticals R&D, and Adjunct Associate Professor in the Department of Pharmacology & Experimental Therapeutics of Thomas Jefferson University. He is a Clinical Pharmacologist with education and experience in chemical engineering... Read More →

Speakers
avatar for Donna Dorozinsky

Donna Dorozinsky

President, Just In Time GCP
Donna is a business consultant who has over 25 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. She encourages strategic thinking and implementation of solutions not only... Read More →
avatar for Mattheus Van Iersel

Mattheus Van Iersel

Senior Director, Scientific Affairs - Clinical Pharmacology, PRA Health Sciences
Dr van Iersel is an MD with 25 years of experience in clinical development. He is trained in Clinical Pharmacology in the UK and the Netherlands. Currently he is a Senior Director of Science at PRA. Previously he worked as Researcher at Urology and as Principal Investigator, Medical... Read More →
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 →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Symposium

4:00pm EDT

#274: Statistical Issues in the Evaluation of Biosimilars
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-588-L04-P; CME 1.25; IACET 1.25; RN 1.25

The 2010 Affordable Care Act amended the Public Health Service Act to create a new abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-licensed biological product. A biosimilar should be shown to be highly similar to and to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. In this session, we will discuss important regulatory and statistical issues in the evaluation of biosimilars. A regulatory perspective will be provided on key concepts, and and industry representatives will describe approaches to critical aspects of biosimilar development such as the evaluation of immunogenicity and inference based on the totality of the clinical evidence.

Learning Objectives

Discuss key regulatory and statistical issues in the development and evaluation of biosimilars; Describe approaches to critical aspects of biosimilar development.

Chair

Gregory Levin, PhD

Speaker

A Novel Statistical Model of the Relationship Between Exposure to a Biopharmaceutical and Immunogenic Reactions
Marek Ancukiewicz, PhD

Statistical Methodology to Assess Biosimilarity Based on Totality of the Evidence
Zhiying "Jean" Pan, PhD



Chair
GL

Gregory Levin

Deputy Director, DBIII, OB, OTS, CDER, FDA
Greg Levin is a supervisory mathematical statistician at the Center for Drug Evaluation and Research within FDA. He joined FDA after receiving a PhD in biostatistics from the University of Washington in 2012. At FDA, Greg has helped regulate products across a wide range of therapeutic... Read More →

Speakers
avatar for Marek Ancukiewicz

Marek Ancukiewicz

Principal Biostatistician, PAREXEL International
Biostatistician with 25+ years of experience in clinical research. Currently (3 years) at PAREXEL (Principal Biostatistician) Previously (16 years) at Harvard Medical School (Assistant Professor) and at Duke University (post-doc fellow) and also a private consultant for industry... Read More →
ZQ

Zhiying "Jean" Pan

Senior Manager, Biostatistics, Amgen Inc.
Dr. Pan is a Biostatistics Senior Manager in Biosimilars Global Development at Amgen. As the global statistical lead, she provides strategic input to and is responsible for all statistical aspects of clinical development for multiple biosimilar products in oncology and inflammation... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, 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

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