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Monday, June 27
 

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

10:45am EDT

#128: Alliance Management Forum
Limited Capacity seats available

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

This forum will provide an overview of the value that can be gained from alliances built between a large global CRO and small or emerging biopharmaceutical companies. Attendees will learn what both the CRO and the biopharmaceutical company must do to build a successful alliance and how to diagnose early on what is needed for a collaborative alliance culture.

Learning Objectives

Identify what large CROs and small biopharmaceutical companies must do to successfully build an alliance with each other; Explain how to build a collaborative alliance culture and what the key questions that must be asked to determine if two companies will have good “chemistry”; Discuss meaningful and effective risk-sharing strategies.

Chair

Solomon Babani, MBA

Speaker

Applying Alliance Management Principles to Help CROs Build Successful Relationships with Small and Emerging BioPharma Companies
Solomon Babani, MBA

New and Emerging Skillsets Needed to Manage Strategic Partnerships
Andrew Townshend

Panelist
Deirdre F BeVard



Chair
SB

Solomon Babani

Vice President, BioPharma Solutions, Covance Inc.
Sol Babani joined Covance in 2013 as Global Vice President, Alliance Management with enterprise-wide responsibilities for several strategic clients. In addition, Solomon is overseeing a corporate-wide initiative aimed at expanding Covance’s relationships with emerging Biopharma... Read More →

Speakers
avatar for Deirdre BeVard

Deirdre BeVard

Vice President, Development Operations, Nektar Therapeutics
Deirdre BeVard is Vice President, Development Operations at Nektar Therapeutics. She is responsible for the operational execution of Nektar’s clinical development programs and works with a creative team for clinical trial leadership, data management and contracting & outsourcing... Read More →
avatar for Andrew Townshend

Andrew Townshend

Senior Vice President, Alliance Development, INC Research
Vice President of Business Development at INC Research. Mr. Townshend has responsibility for developing strategic accounts within the Pharma and biotech industries focused on novel and innovative engagement and alliance models. Prior to this, Mr. Townshend was Vice President Outsourcing... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

4:00pm EDT

#259: Innovative Regulatory Solutions: Utilizing Flexible Outsourcing Strategies
Limited Capacity seats available

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

The session provides an overview of outsourcing models for regulatory activities to achieve a scalable, flexible model, while decreasing the complexity of internal regulatory affairs activities and assuring full regulatory compliance. Both industry and consultant company perspectives will be shared.

Learning Objectives

Describe the benefits of outsourcing of regulatory activities to allow focus on core strategic aspects of the company; Recognize different models of outsourcing of regulatory activities and how to best apply them to your own business; Identify the key success factors to ensure cost efficient and compliant outsourcing.

Chair

Andrew S. Verderame

Speaker

Regulatory Outsourcing: Consultant Perspective
Andrew S. Verderame

Regulatory Outsourcing: Industry Perspective
Dietmar Boecker, PhD

Outsourcing Life Cycle Management: A Model of Efficiency
Alistair Davidson



Chair
avatar for Andrew Verderame

Andrew Verderame

President, Pharmalex US Regulatory
Andrew S. Verderame, MBA, RAC leads the PharmaLex US staff in providing FDA-specific regulatory guidance and consulting services. PharmaLex clients benefit from his wealth of experience, including leading well over one hundred meetings with FDA, managing multi-site regulatory teams... Read More →

Speakers
avatar for Dietmar Boecker

Dietmar Boecker

Vice President, Head Regulatory Affairs, Established Products and Intl Dev, Bayer Pharma AG
since 01.01.2016: VP, Head RA Established Products and Int. Development, Bayer Pharma AG 01.12.2012 - 31.12.2015 Director, RA Marketed Products, Bayer Pharma AG 01.09.2007 - 30.11.2012 Deputy Director Global Submission Management & Archiving, Bayer AG 01.08.2001 - 31.08.2007 Associate... Read More →
avatar for Alistair Davidson

Alistair Davidson

Senior Director, Delivery Solutions, Regulatory Affairs, PPD
Alistair is Senior Director, Regulatory Delivery Solutions at PPD, where he is responsible for country regulatory management and strategic development of PPD’s regulatory services globally. He has held senior leadership roles in regulatory affairs in GSK and Quintiles, with a track... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 03: Innov Part Model/Outsourcing, Session

4:00pm EDT

#272: How Can We Build Reliability and Quality When Outsourcing Pharmacovigilance?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-577-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss the concept that there is no agreed upon or standardized approach to outsourcing pharmacovigilance. Other industries use the safety case model so vendors present a common model for sponsors to examine and the latest thinking will be applied to pharmacovigilance outsourcing.

Learning Objectives

Discuss a more standardized approach to outsourcing pharmacovigilance; Identify a common model for pharmacovigilance outsourcing.

Chair

Brian David Edwards

Speaker

Pharmacovigilance Sourcing, Emerging Business Models
Kelly Traverso

Pragmatic Approach to Pharmacovigilance Outsourcing
Lillian M. Kirk, DrSc



Chair
avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group, United Kingdom
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →

Speakers
avatar for Lillian Kirk

Lillian Kirk

Director, Global Pharmacovigilance Case Management, Alexion
Lillian is a Doctor of Chiropractic with over 19 years’ healthcare experience, including clinical practice, teaching, drug safety/pharmacovigilance & medical affairs. The last 3 years, she provided safety expertise companywide & for external partners. She has worked to develop valuable... Read More →
avatar for Kelly Traverso

Kelly Traverso

Consulting Specialist Leader, Deloitte
Kelly has over 17 years of industry and consulting experience in Life Sciences. She has significant consulting experience in the areas of Quality, Pharmacovigilance, R&D and Regulatory Affairs. Projects she has led and provided extensive subject matter expertise on include, Process... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety/PV, Session
 
Wednesday, June 29
 

10:30am EDT

#311: Outsourcing: Assessing CRO Performance and Challenges
Limited Capacity seats available

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

Outsourcing has been a major topic in the pharmaceutical industry over the last decade. As drug development costs increase, trial complexity grows, and work in emerging markets becomes more important, the industry has looked toward outsourcing to help combat these challenges. But what impact has the rising proportion of outsourcing had on operational performance? How is the effect being measured or tracked? This panel will explore the dynamic between CROs and sponsors and their expectations, the operational benefits of outsourcing, as well as the challenges from outsourcing. It will examine performance and the crucial factors that influence internally-conducted trials versus outsourced trials, how these differences are being managed, and what changes have occurred over time.

Learning Objectives

Recognize the operational benefits and challenges of outsourcing clinical trials; Classify the different approaches to outsourcing and the strategic trade-offs.

Chair

Scott R Martin, JD

Speaker

Creating an External Alliances Structure
John F. Kurtz

How Real World Research Challenges Outsourcing Strategies
Michael George Minor

Controlling Study Level Budgets with CROs
Michael Williamson, MSc



Chair
avatar for Scott Martin

Scott Martin

Principal, KMR Group Inc.
Scott Martin is a Principal of KMR Group a firm specializing on biopharmaceutical R&D performance, information and analytics. Among Scott’s areas of expertise are: clinical development performance, resource management, assessing efficiency and productivity in R&D, and implementing... Read More →

Speakers
avatar for John Kurtz

John Kurtz

Senior Director, External Alliances, Janssen R & D, LLC
John is Senior Director, External Alliances for Janssen Pharmaceutical Companies of Johnson & Johnson. His primary focus is to drive value creation and R&D effectiveness by optimizing collaborations with Key R&D Strategic Suppliers. John has over 25 years’ experience building and... Read More →
avatar for Michael Minor

Michael Minor

Senior Vice President, Global Head Operations and Strategic Planning, ICON Peri-Approval and Observational Research
Michael Minor is SVP, Global Head, Peri-Approval & Observational Research at ICON. Mike has >30 years’ experience leading Phase I-IV and non-interventional research, and as outsourcing professional in pharma companies and CROs giving him a balanced perspective of sponsor/provider... Read More →
avatar for Michael Williamson

Michael Williamson

Associate Director Outsourcing and Contracts Management, UCB Biosciences, Inc.
Mike has been with UCB for over seven years serving as a sourcing and procurement professional implementing innovative sourcing models, vendor strategic partnering arrangements, and spending improvement analysis focused on clinical research. Mike is currently Associate Director and... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 03: Innov Part Model-Outsourcing, Session

2:00pm EDT

#337: Overcoming Deficiencies in the Oversight of Outsourced Clinical Programs: Collaboration and Utilization of Industry Leading Guidelines and Tools
Limited Capacity seats available

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

This forum will present data on industry challenges/opportunities for improvement in sponsor oversight of CROs and service providers. Collaborative efforts for developing and implementing industry leading practice guidelines and tools will be shared.

Learning Objectives

Discuss the oversight requirements and expectations from regulators, sponsors and providers; Explain the collaborative effort to develop and utilize industry leading practices for the oversight of outsourced clinical programs; Demonstrate examples of vital guidelines and tools for achieving top-tier success through appropriate oversight practices.

Chair

Mike Collins, PhD

Speaker

Panelist
Grace M Crawford, MS

Panelist
Joseph Anthony Fortunato

Panelist
Steven B. Whittaker



Chair
avatar for Mike Collins

Mike Collins

Head of R&D Global Vendor Management, Alexion
Mike graduated from the University of Sheffield in the UK with a degree in Genetics. After an MSc in Applied Genetics; he completed his doctorate at the University of Birmingham. Mike has worked in clinical development for over 25 years at Hoechst and Pfizer. He is currently Head... Read More →

Speakers
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality and Compliance, AstraZeneca
Grace joined MedImmune in April 2015 to lead the Clinical Quality & Compliance function. Prior to joining MedImmune, Grace spent over 21 years at ICON where her main focus was leading the Clinical QA Department. She is active in industry participating in forums such as the Society... Read More →
avatar for Joseph Fortunato

Joseph Fortunato

Senior Vice President, Corporate Quality Assurance and Compliance, inVentiv Health Clinical
Joseph Fortunato has over 37 years of experience in the healthcare industry with leadership roles in large pharma and large CROs. _x000D_ _x000D_ Joe joined inVentiv Health Clinical in 2014 as the Sr. VP of Corporate QA and is responsible for leading a group of Quality Assurance professionals... Read More →
avatar for Steven Whittaker

Steven Whittaker

Executive Director, Quality Consortium, The Avoca Group
Steven Whittaker, Executive Director, Avoca Quality Consortium (retired from Eli Lilly and Co.) , consults for the pharmaceutical, biotech, and CRO industries, providing expertise in project management, pharmaceutical development, clinical development, outsourcing strategies and execution... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 03: Innov Part Model-Outsourcing, Forum

4:00pm EDT

#359: Addressing Dysfunction in Provider Prequalification: A New Model to Streamline Processes, Improve Quality, and Reduce Risk
Limited Capacity seats available

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

This forum will present data on industry challenges related to prequalification of technical service providers. Industry leading initiatives to standardize requirements and processes, and regulatory, sponsor and provider perspectives will be shared.

Learning Objectives

Identify risks, challenges, issues and industry dysfunction related to prequalifying technical service providers; Describe new industry standards/processes/approaches for prequalification of technical providers; Explain sponsor/provider/regulator perspectives regarding implications for standardizing and centralizing prequalification to ensure high quality, efficiency and confidence in processes and results.

Chair

Dawn M Niccum, BSN, MS, RN, PMP

Speaker

Panelist
Marta Haley Fields, MBA

Panelist
Mitchell A. Katz, PhD

Panelist
Dennis Salotti, MBA, MS

Panelist
Sean Y. Kassim, PhD



Chair
avatar for Dawn Niccum

Dawn Niccum

Associate Director, Quality, Endocyte
Dawn Niccum is the associate director of quality at Endocyte, where she is responsible for GCP compliance, SOP development, computer system validation oversight, and training. With over 20 years of pharmaceutical experience, Ms. Niccum holds a Master’s Degree in Regulatory Affairs... Read More →

Speakers
avatar for Marta Fields

Marta Fields

Senior Director, Research & Development Quality, Seattle Genetics, Inc.
Marta joined Seattle Genetics in 2008 as Sr Director of Compliance and Quality Systems after 21 years at Amgen where she served as Director of Clinical Compliance. Ms Fields has a BS in Speech from Northwestern University and an MBA in Healthcare Management from California Lutheran... Read More →
avatar for Sean Kassim

Sean Kassim

Director, Office of Study Integrity and Surveillance, OTS, CDER, FDA
Sean serves as the Director of the Office of Study Integrity and Surveillance, CDER/FDA. He oversees the bioavailability/bioequivalence (BA/BE) and GLP inspection programs that inspect and review conduct of regulated pharmaceutical premarket bioanalytical and non-clinical researc... Read More →
avatar for Mitchell Katz

Mitchell Katz

Head of Clinical Research and Drug Safety Operations, Purdue Pharma L.P.
Dr. Mitchell Katz is Head of Clinical Research and Drug Safety Operations at Purdue Pharma L.P. In this position, he is responsible for leading all operational activities across Purdue’s multinational clinical programs. Dr. Katz has 28 years’ experience in the pharmaceutical and... Read More →
avatar for Dennis Salotti

Dennis Salotti

Chief Operating Officer, The Avoca Group
With 20 years in the pharmaceutical industry as a sponsor, provider, and consultant, Dennis Salotti's experience spans preclinical research, clinical operations, data management, quality assurance, eClinical, business operations, and strategic management. Prior to Avoca, he was Director... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Thursday, June 30
 

10:45am EDT

#404: Bringing CRO Collaboration into the 21st Century
Limited Capacity seats available

Component Type: Symposium
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

With ever increasing rates of outsourcing and new outsourcing models being created, pharmaceutical companies are seeking new ways to collaborate with CROs. Whether its data, documents, team collaboration, etc., sponsors and CROs need easier ways to communicate. We will discuss how to solve these challenges.

Learning Objectives

Discuss how to efficiently collaborate with CROs; Explain how to easily understand study metrics and status for a fully outsourced portfolio; Describe how to utilize a CTMS to collaborate between sponsors and CROs.

Chair

Matthew J. Kiernan, MBA

Speaker

Optimizing Collaboration Between Sponsors and CROs Using CTMS in Today's eClinical Landscape
Lynn Fraser, MS

Outsourcing and the Clinical Data Mess, and Why It Isn’t Acceptable
Matthew J. Kiernan, MBA

Building an Integration Platform for Collaborating with CROs
Jennifer Bush, MS



Chair
MK

Matthew Kiernan

Partner, Pharmica
Matt Kiernan is a Partner at PHARMICA Consulting, a firm which focuses on operational excellence in the life sciences industry. Mr. Kiernan has over fifteen years of industry expertise in operational excellence, project management, portfolio management, resource management, and m... Read More →

Speakers
JB

Jennifer Bush

Director, LIfe Sciences Product Strategy, Oracle Health Sciences
Jennifer Bush is a life sciences professional with over 19 years of industry experience in both business and IT environments. She has worked in large pharma & CRO, working in both business and IT departments managing data transformation, eClinical implementations including implementation... Read More →
avatar for Lynn Fraser

Lynn Fraser

Senior Product Manager, BioClinica, Inc.
Lynn Fraser is a Product Manager at Bioclinica where she manages multiple enterprise clinical trial management technology solutions used by thousands of users and within a global environment. She has 7+ years of experience in Clinical Research technology, and 15+ years in web applications... Read More →


Thursday June 30, 2016 10:45am - 12:00pm EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am EDT

#405: Hot Button Protocol and Operational Issues Between Sponsors and Sites in Clinical Pharmacology Studies
Limited Capacity seats available

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

A moderated panel of phase 1 clinical research experts, representing sponsor, CRO and site perspectives, will identify and discuss several hot button issues that can provoke conflict between sponsors and sites or diminish conduct efficiency. Attendees will be invited to join in.

Learning Objectives

Recognize issues that can provoke sponsor/site conflict or diminish conduct efficiency when they arise in the course of preparing to conduct or conducting phase 1 studies; Discuss how to handle such issues with counterparts when they arise; Describe ways to formulate/negotiate when issues resolution.

Chair

Gary L. Steinman, MS

Speaker

Tales from the Front Lines: An Introduction
Gary L. Steinman, MS

Panelist
William B Smith

Panelist
Mary L. Westrick, PhD



Chair
avatar for Gary Steinman

Gary Steinman

President, Medexetech
Gary Steinman has degrees in Electrical & Systems Engineering from RPI where he also served on the faculty and as Director of the Center for Biomedical Engineering. He then joined the Stanford Cardiology Division, launched Pharmiya Medical Technologies in the People’s Republic of... Read More →

Speakers
avatar for William Smith

William Smith

CEO, Alliance for Multispecialty Research/NOCCR
William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical... Read More →
avatar for Mary Westrick

Mary Westrick

Adjunct Professor, University of Wisconsin
Dr. Mary Westrick holds a BS in Chem, and MS & PhD degrees in pharmacology from Purdue University. She has held leadership positions in Global Clinical Pharmacology at Covance, Astellas and Quintiles and currently teaches Project Management and Leadership in the MS Program in Biotechnology... Read More →


Thursday June 30, 2016 10:45am - 12:00pm EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Forum