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Monday, June 27
 

8:30am EDT

#115: Clinically Relevant Specifications: Translating Voice of the Patient Into Quality Attributes of the Product
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-605-L04-P; CME 1.25; IACET 1.25; RN 1.25

Clinical relevance has re-emerged within recent discussions in both the quality and regulatory arenas, with specific focus on patient expectations, clinically relevant specifications, residual uncertainty, and benefit-risk based decision making. Translating highly technical information into the pertinent patient-centric frame requires an intricate balance. This session highlights multiple opportunities for collaboration and communication, with the end goal of improving medicines, ensuring their availability, and assuring their use in accordance with patient needs.

Learning Objectives

Share common experiences regarding the establishment of clinically relevant specifications; Identify areas for future discussion with regard to clinical relevance in the quality arena; Discuss specific cases that illustrate establishment and/or challenges establishing clinically relevant specifications.

Chair

Richard T. Lostritto

Speaker

Paving the Road Toward Setting Clinically Relevant Drug Product Specifications: The Relevance of Biopredictive Dissolution Testing
Sandra Suarez Sharp, PhD

Industry Perspective
Ganapathy Mohan, PhD

FDA Perspective
Laurie Graham



Chair
RL

Richard Lostritto

Acting Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
Richard (Rik) Lostritto currently serves as a Division Director In FDA's ONDQA. Prior to this, he served in the FDA as a Team Leader, and Chemsitry Reviewer.

Speakers
LG

Laurie Graham

Acting Director, DIPAP, OPPQ, OPQ, CDER, FDA
Ms. Graham is the Acting Directorof the Division of Internal Policies and Programs (DIPAP), which leads the development and evaluation of OPQ internal policy documents.
avatar for Ganapathy Mohan

Ganapathy Mohan

Head of External Affairs (Quality), Merck & Co., Inc., United States
Ganapathy Mohan leads the Global External Advocacy and strategies for Global Quality and Compliance. Prior to this until April 2017, he was the head of Small Molecule Development Quality. Mohan was the head of Global CMC regulatory Affairs at Merck until April 2015. Prior to joining... Read More →
SS

Sandra Suarez Sharp

Biopharmaceutics Lead (Acting), DB Branch III, ODNP, OPQ, CDER, FDA
Dr. Sandra Suarez-Sharp joined the Office of Clinical Pharmacology (OCP) at the FDA, in September 1999. Currently, she works at the Office of New Drug Products/Division of Biopharmaceutics (FDA/OPQ/ONDP) as a Master Biopharmaceutics Reviewer/Biopharmaceutics Lead (acting) supporting... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 12: Pharm Quality, Session

10:45am EDT

#138: Risk Communication and Management: The Art of Communicating Risk - Challenges and Best Practices
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-599-L04-P; CME 1.25; IACET 1.25; RN 1.25

The adoption of quality by design principles and subsequent incorporation of enhanced approaches in regulatory submissions introduced several challenges for industry as well as regulators. This session will discuss how the principles described in ICH Q9 are applied, specifically how quality risks are assessed, managed, and communicated by industry and evaluated by regulators and how results from risk assessments are used to determine quality criteria for demonstrating control and developing and maintaining a robust control strategy for a product.

Learning Objectives

Describe how quality risks are assessed, managed, and communicated by industry; Discuss how quality risks are evaluated by regulators.

Chair

Kristin Murray, MS

Speaker

Benefit-Risk Considerations and Strategies for Investigation and Control of Impurities
David White

Risk Management: A Team Sport
Wendy Wilson-Lee, BSN, PhD

Applications of Risk Management Tools to Quality by Design and Control Strategy Creation in Rare Disease
Joseph Kauten



Chair
KM

Kristin Murray

Director, Global CMC Regulatory Affairs, Shire Pharmaceuticals
Kristin Murray, MS, BS - Ms. Murray is a director in the Global Regulatory Affairs CMC department and oversees a team who manage global regulatory CMC submissions for both investigational and commercial products at Shire Pharmaceuticals, Lexington, MA. Before her tenure in regulatory... Read More →

Speakers
JK

Joseph Kauten

Biologics CMC Control Strategy Leader, Shire Pharmaceuticals
Dynamic Technical Leader with a proven track record of value driven innovation, robust process development, and cross-functional influence. Extensive experience in facility and process design from greenfield/brownfield through to successful technology/process transfer, process performance... Read More →
avatar for David White

David White

Principal Scientist, AstraZeneca
I joined pharmaceutical development in 2003 as line manager in analytical science working primarily in late phase projects. After secondments to formulated product development and then post approval regulatory, I returned to drug substance in 2014 as a principle scientist responsible... Read More →
avatar for Wendy Wilson-Lee

Wendy Wilson-Lee

Acting Branch Chief, Office of New Drug Products, OPQ, CDER, FDA
Wendy is an acting Branch Chief in the Office of New Drug Products, bringing 10 years of review experience to the position. She has a B.S. in Chemical Engineering as well as a B.S. in Chemistry from North Carolina A&T State University. She earned her Ph.D. in Pharmaceutical Science... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 12: Pharm Quality, Session
 
Tuesday, June 28
 

2:00pm EDT

#245: Risk-Based Inspections
Limited Capacity seats available

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

Inspections are a critical component for assuring product quality. The adoption of a risk-based approach to inspections has enabled the integration of product review with traditional inspection criteria and focuses efforts on inspection issues rather than simply on assurance of compliance. This session will highlight ongoing efforts and initiatives geared towards the continuing implementation of risk-based inspections.

Learning Objectives

Discuss related procedural and/or policy challenges and present specific case studies related to risk-based inspections; Identify best practices and ideas for future discussion with regard to risk-based inspections; Identify potential areas for further collaboration on risk-based inspections.

Chair

Mahesh R. Ramanadham, PharmD, MBA

Speaker

Quality Agreements: Defining the Business of Pharmaceutical Quality
Karen Bossert

Integrated Quality Assessment of the Manufacturing Process and Facilities
Robert Iser, MS



Chair
avatar for Mahesh Ramanadham

Mahesh Ramanadham

Division Director (Acting), Div. of Inspectional Assessment, OPF, OPQ, CDER, FDA
Acting Director for the Division of Inspection Assessment within OPQ/OPF. His division is primarily responsible for the center level discipline review of facilities and inspections in support of drug applications. He joined the Agency in November 2009 after graduating with his PharmD... Read More →

Speakers
KB

Karen Bossert

Vice President, Scientific Affairs, Lyophilization Technology, Inc.
Karen Bossert is the Vice-President, Scientific Affairs at Lyophilization Technology, Inc. She has over 25 years of experience in pharmaceutical manufacturing and development. She received her Bachelor of Science degree in Pharmacy and her Doctorate in Pharmaceutics. Karen has authored... Read More →
avatar for Robert Iser

Robert Iser

Acting Director, Office of Process and Facilities, OPQ, CDER, FDA
Bob joined the FDA in 2003. He is currently the acting Director of the Office of Process & Facilities. Prior to the formation of OPQ, Bob was acting Associate Director for Policy Development in OPS. He was also a Division Director and CMC Team Leader in OGD. Prior to joining the FDA... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 12: Pharm Quality, Session
 
Wednesday, June 29
 

10:30am EDT

#314: Transforming Clinical Protocols into a Digital Platform: Driving Quality and Efficiency End-to-End
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-539-L04-P; CME 1.00; IACET 1.00; RN 1.00

A panel of experts will discuss novel approaches to developing and implementing a machine-readable protocol. Representatives from the clinical development, data standards, and regulatory affairs disciplines will review the impact of traceability.

Learning Objectives

Discuss the evolution of a protocol from a document to a digital platform; Describe an end-to-end traceability model from protocol to analysis; Describe the approach to automate reuse of protocol level information.

Chair

Robert A. DiCicco, PharmD

Speaker

Panelist
Eileen E. Navarro Almario

Panelist
Rebecca D. Kush, PhD

Panelist
Christine Pierre, RN



Chair
avatar for Robert DiCicco

Robert DiCicco

Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline
Rob DiCicco is the Vice President of Clinical Innovation and Digital Platforms at GSK. He is the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate and one of the Team Leads on CTTI’s Mobile Clinical Trials Novel Endpoints Project. He has over... Read More →

Speakers
avatar for Eileen Navarro Almario

Eileen Navarro Almario

Lead Medical Officer, OCS, OTS, CDER, FDA
Eileen Navarro is Associate Director for Clinical Affairs in the Office of Computational Science, OTS, CDER, where she leads a team of analysts in providing regulatory review and training support to medical officers, statisticians, and safety evaluators. She is a Fellow of the American... Read More →
avatar for Rebecca Kush

Rebecca Kush

President and Chief Executive Officer, CDISC
Rebecca Daniels Kush, Ph.D. is a Founder and the President and CEO of the Clinical Data Interchange Standards Consortium (CDISC). Dr. Kush has worked for the NIH, academia, a global CRO and pharmaceutical companies in the U.S. and Japan. Dr. Kush earned a Ph.D. in Physiology and Pharmacology... Read More →
avatar for Christine Pierre

Christine Pierre

President, Society for Clinical Research Sites
Christine is the President of the Society for Clinical Research Sites, a global trade organization representing over 9,000 sites in 47 countries committed to providing sites a community and voice for site sustainability. Christine is an internationally recognized expert on the global... Read More →


Wednesday June 29, 2016 10:30am - 11:30am EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Forum

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

#367: Quality at the Edge(s): Design It Right and Keep It Going in Non-Interventional Studies
Limited Capacity seats available

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

Quality must be assured at all stages of clinical development. Quality planning and risk management begins well before the first protocol for a clinical program is drafted and continues through the life cycle of the product, including postmarking studies. Approaches, including protocols assessment by cross-functional teams and development of control strategies, can identify and address risks before the study starts. At the other end of the clinical development cycle, interest in postmarketing, noninterventional studies is increasing from both the regulatory perspective and their potential support new indications. This session will discuss how these studies have their own set of challenges, yet proper oversight can be achieved through innovative approaches.

Learning Objectives

Describe a framework to reduce risk in early-phase trials; Identify how to drive value from the protocol review stage; Discuss the necessity and challenges of cross-functional risk assessment; Describe the current landscape and expectations for sponsors of non-interventional research; Recognize oversight activities with respect to challenges of postmarketing observational trials; Discuss innovative solutions for overcoming the challenges through risk adapted surveillance activities.

Chair

David William Fryrear, MSc

Speaker

A Proactive QRM Framework that Breaks Down Functional Silos and Drives Higher Quality into Clinical Trials
Tim Strauss, MS

Sponsor Oversight of Non-Interventional Research
Christine R. Sahagian, MS



Chair
avatar for David Fryrear

David Fryrear

Senior Director, R&D Quality Assurance, AbbVie, Inc.
David Fryrear is a Senior Director in R&D Quality Assurance at AbbVie.  In this role, he is the global head of clinical and pharmacovigilance quality assurance and has responsibility for R&D documentation standards and Quality Knowledge Management.  Prior to joining AbbVie in January... Read More →

Speakers
CS

Christine Sahagian

Head, Clinical and Medical QA and Compliance, Shire US Inc
Christine is Head of Clinical and Medical QA and Compliance at Shire. She began her career with clinical trial operations responsibilities at Parexel and CareStat/Battelle CRO. Christine has also had roles in Outsourcing and Clinical QA and Compliance at Vertex, Biogen, and Cubist... Read More →
avatar for Tim Strauss

Tim Strauss

President, Quality Solutions, QI Path


Wednesday June 29, 2016 4:00pm - 5:00pm EDT
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm EDT

#362: Risk-Based Monitoring: Best Practices in Implementation for the Data Manager and Key Stakeholders
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-534-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will explore how companies are implementing successful risk-based monitoring (RBM), with particular emphasis on the realignment of processes and roles, and applying central monitoring and data quality oversight to support the RBM strategy.

Learning Objectives

Define key challenges in risk-based monitoring (RBM) implementation; Identify how processes and roles need to change in the organization to support the RBM; Discuss real-time analytics as a key enabler to achieve adaptive, centralized monitoring; Demonstrate how results from analytics can be turned into actionable items to mitigate risks.

Chair

Teresa Ancukiewicz, MA

Speaker

Lessons Learned in Implementing Risk-Based Monitoring and eSource: The Data Manager’s Expanded Role
Vadim Tantsyura

Risk-Based Monitoring Best Practices for the Data Manager: Lessons Learned from Sponsors and Sites
Amita Malik, MS

Using Powerful and Pragmatic Central Statistical Analytics to Drive Quality into Clinical Trials
Erik Doffagne, MSc



Chair
avatar for Teresa Ancukiewicz

Teresa Ancukiewicz

Senior Manager, Clinical Data Management, Boston Scientific Corporation
Senior Manager in Clinical Operations at Boston Scientific, CCDM. Responsible for providing leadership on outsourcing initiatives and Risk Based Monitoring. Over 20 years of experience in data management, process development and improvement, and vendor management. Active in the DIA... Read More →

Speakers
avatar for Erik Doffagne

Erik Doffagne

Product Manager, CluePoints
Erik holds a bachelor degree in Computer Science and a master degree in Biostatistics. He has more than 10 years of experience in the life science industry. Erik has spent the last 5 years at developing methodology and technology for central statistical monitoring. Erik has co-authored... Read More →
avatar for Amita Malik

Amita Malik

Senior Manager, Product Management, Oracle Health Sciences
Senior Manager in Oracle Health Sciences Product Management organization, responsible for providing product leadership on current market leading Clinical Data Acquisition and Management products. Prior to Oracle, worked at Phase Forward and led delivery of large scale technology adoption... Read More →
avatar for Vadim Tantsyura

Vadim Tantsyura

Director, Data Management, Target Health Inc.
Dr. Tansyura has 15+ years of pharmaceutical experience, including a Head of DM role at Regeneron, Infinity and Cincinnati Children's Hospital. Dr. Tantsyura is a co-founder and member of the Advisory Board for OpenCDISC (2008-2010) and SCDM board member (2014-2016). Dr. Tantsyura... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Session

4:00pm EDT

#369: Innovative and Emerging Technologies
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-607-L04-P; CME 1.25; IACET 1.25; RN 1.25

Recent technological advances in manufacturing, product delivery, and control provide opportunities and challenges to improve quality assurance. Improved regulatory understanding of continuous manufacturing, product delivery, and control should enable and encourage adoption of novel technologies. This session will focus on emerging innovative technology and approaches to developing quality products.

Learning Objectives

Discuss emerging innovative technology and how quality assurance can be improved.

Chair

Daniel Blackwood

Speaker

Process Validation for Lyophilized Drug Products: Developing a Program for Continued Process Verification
Karen Bossert

Portable, Continuous, Miniature, and Modular: An Integrated Development and Manufacturing System for Solid Oral Dossage Forms
Daniel Blackwood

API Particle Engineering: Bridging Primary and Secondary Processes for Continuous Oral Solid Dose Manufacturing
Sonja A. Sharpe, PhD



Chair
avatar for Daniel Blackwood

Daniel Blackwood

Director, Pharm Science Technology and Innovation, Pfizer Inc
Daniel O. Blackwood is a Director, Technology & Innovation, within PharmaTherapeutics Pharmaceutical Sciences at Pfizer. He received his BS in Mechanical Engineering from Cornell University in Ithaca NY, and his MS in Industrial Engineering from Columbia University in New York City... Read More →

Speakers
KB

Karen Bossert

Vice President, Scientific Affairs, Lyophilization Technology, Inc.
Karen Bossert is the Vice-President, Scientific Affairs at Lyophilization Technology, Inc. She has over 25 years of experience in pharmaceutical manufacturing and development. She received her Bachelor of Science degree in Pharmacy and her Doctorate in Pharmaceutics. Karen has authored... Read More →
avatar for Sonja Sharpe

Sonja Sharpe

Director, Technology Development, Advanced Manufacturing Technologies, GlaxoSmithKline
Sonja leads a global team responsible for developing novel secondary (drug product) manufacturing technologies with the goal of streamlining and simplifying drug product process development and manufacturing. She has over 11 years of experience in the area of process engineering and... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 12: Pharm Quality, Session