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Sunday, June 26
 

8:30am EDT

#25: Signal Detection: Identifying and Managing Safety Signals
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-501-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Signal detection is an essential element of the overall risk management process. This intermediate to advanced tutorial provides a concise review of current methods of drug safety signal detection for marketed products and the role of signal detection within the larger signal and risk management process. Emphasis is on practical pragmatic approaches. Outputs from quantitative signal detection will be the basis for a hands-on exercise and discussion. The tutorial also provides participants with the context to evaluate new research in the field.

Who should attend?

This tutorial is designed for members of clinical safety and pharmacovigilance organizations who oversee, manage, or perform signal detection activities. The tutorial will also benefit participants who make risk management decisions based on signal detection results.

Learning Objectives

• Identify strengths and limitations of methods for signal detection;
• Interpret outputs from automated quantitative signal detection methods (data mining results);
• Discuss how to integrate signal detection methods into the larger signal and risk management process;
• Describe emerging methods for signal detection.


Speakers
avatar for James Buchanan

James Buchanan

President, Covilance LLC, United States
Dr. James Buchanan is presently an independent drug safety consultant. After leaving Gilead Sciences, Dr. Buchanan started the drug safety department at Tularik Inc where he acted as Chief Safety Officer until the company was acquired 5 years later by Amgen. Following the merger with... Read More →


Sunday June 26, 2016 8:30am - 12:00pm EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Preconference Tutorial, Tutorial |   Trk 14: Clin Safety-PV, Tutorial
 
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

#105: Maximize the Value of Your Product by Beginning with the End in Mind
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000189; RN 1.25

Less than 1% of compounds make it to market. It is critical for biopharmaceutical developers to evaluate their probability of success. In this interactive forum, experts will share their insights to help you maximize the value of your asset.

Learning Objectives

Describe the elements of a regulatory strategy and why it is needed; Discuss the value of your product as part of your development strategy; Explain why and how to develop a target product profile; Discuss how the TPP guides the drug development process and sets expectations; Describe how to avoid typical reasons for delays and denials of a product marketing application.

Chair

Jayanthi Reddy, MBA, MS, PMP

Speaker

Panelist
Bill Hanlon, PhD

Panelist
Carrie Furin



Chair
JR

Jayanthi Reddy

Director, Global Project Management, Merck & Co., Inc.
Jay has over 20 years of pharmaceutical industry experience and over 14 years of project Management experience. She is currently the cardiovascular franchise leader within the Project Management group at Merck.

Speakers
avatar for Carrie Furin

Carrie Furin

Manager, Clinical Trial Management, Eli Lilly and Company
Carrie is a Manager with Eli Lilly and Company overseeing Clinical Trial Managers on Oncology trials. She has over 10 years of drug development experience in clinical operations and project management. Carrie has led teams across multiple therapeutic areas and phases, which has provided... Read More →
avatar for Bill Hanlon

Bill Hanlon

Chief Development Officer and Head of Global Regulatory Affairs, Covance Inc.
Dr. William Hanlon, PhD, is the chief development officer and head of global regulatory affairs for Covance. He has been with Covance for four and a half years, after spending 25 years in pharma in the discovery and the development side of developing drugs for global commercialization... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am EDT

#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 EDT
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Session |   Trk 09: Med Devices-InVitro-CombProd, Session

10:45am EDT

#123: Global Clinical Trials: Innovative Approaches to Clinical Trials in Japan, India, and Latin America
Limited Capacity seats available

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

In this symposium, the presenters are examining various innovative approaches to and requirements for conducting clinical trials in Japan, India, and Latin America, as well as how their respective regulatory environments have contributed to fostering innovation, product development, and clinical research.

Learning Objectives

Discuss the requirements for conducting clinical trials in Japan, India and Latin America; Share insights into innovative regulatory approaches that could impact clinical studies in these regions; Describe factors one needs to consider when conducting ethno-bridging studies outside the United States.

Chair

Larry A. Blankstein, PhD

Speaker

Issues and Solutions When Conducting Complex Caucasian Clinical Studies in Japan
Andrew Melli

Clinical Trials in India: An Update on Current Status
Charu Gautam, MD

Clinical Research in Latin America: Trends, Challenges and New Opportunities
Maria João Queiroz, MD



Chair
avatar for Larry Blankstein

Larry Blankstein

Consultant, Clinical Development, Blankstein Consulting Group
Dr. Larry Blankstein is an independent Senior Consultant to the Pharmaceutical and Biotechnology industry. He has over twenty-two years experience in drug development strategy, clinical operations and mergers and acquisitions. He received his Ph.D. degree in Biology from Wesleyan... Read More →

Speakers
avatar for Charu Gautam

Charu Gautam

Senior Medical Director, IQVIA
Charu Gautam is a Physician with over 20 years experience in research and academics. Been associated with leading companies in India to lead the clinical operations and medical teams. Qualified as MBBS, MD and a board certification in Clinical Pharmacology . She is also a lead faculty... Read More →
avatar for Andrew Melli

Andrew Melli

Senior Manager, SOUSEIKAI Global Clinical Research Center
Andrew Melli is the Senior Manager of Global Clinical Development at SOUSEIKAI Global Clinical Research Center, serving as both liaison for international business development and investment, as well as an active member of the clinical trial team. It is his hope to help bridge the... Read More →
avatar for Maria João Queiroz

Maria João Queiroz

Global CEO, Eurotrials Scientific Consultants
More than two decades at executive leadership positions in the pharmaceutical industry, Founding Member & CEO at Eurotrials, a CRO in Europe and Latin America. With a Degree in Medicine, specialization in Immunohematology and a post-graduation in Pharmaceutical Medicine. Has active... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Symposium

10:45am EDT

#126: Hope Is Not a Strategy: Quantifying Knowledge for Better Decision Making in Clinical Development
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-596-L04-P; CME 1.25; IACET 1.25; RN 1.25

If studies have 90% power, why don’t 90% of studies have a successful outcome? This workshop will demonstrate how eliciting knowledge from experts and calculating the probability of success of a study or development program can leverage strategic decision-making.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Explain the statistical concept of Assurance (a.k.a. Probability of Success or PoS) with respect to drug development strategy; Describe the benefits of quantifying current knowledge (prior elicitation) among product and disease experts; Quantify the probability of success of a future clinical trial by participating in a mock exercise to elicit a prior.

Chair

Colleen Russell, MS

Speaker

Facilitator
Sharon Cornell Murray, PhD

Facilitator
David A. Burt



Chair
avatar for Colleen Russell

Colleen Russell

Associate Director, Biostatistics, PAREXEL
Colleen is an experienced pharmaceutical R&D statistician who has oversight of drug development and execution, insuring that work processes and client expectations are satisfied. She is focused on applying published statistical methods for comparing like devices to understand the... Read More →

Speakers
DB

David Burt

Director, Biostatistics, Trevena Inc
David received his PhD in Statistics from Virginia Tech in 2000 and has since been working in the pharmaceutical industry for a number of different companies. Currently he is serving as the Director of Biostatistics at Trevena Inc a biotech company based out of King of Prussia, P... Read More →
avatar for Sharon Murray

Sharon Murray

Associate Director, Biostatistics, PAREXEL
Sharon Murray is Associate Director, Statistics at PAREXEL Ltd. She provides statistical support for the design, analysis and operational aspects of Oncology clinical trials as well as for drug development strategy. Sharon holds an MS and PhD in Biostatistics from the University of... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj-Port Mgt-Strat Planning, Workshop

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

10:45am EDT

#133: Take Advantage of Global Expedited Pathways: Breakthrough, Sakigake, PRIME!
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-543-L04-P; CME 1.25; IACET 1.25; RN 1.25

The Breakthrough Designation (US), PRIME (Europe), and Sakigake (Japan) aim to reduce overall drug development times for certain products. This session shows you how to take advantage of these and other global expedited development programs.

Learning Objectives

Compare and contrast global expedited development pathways; Discuss ways to adapt global development programs to take advantage of all expedited pathways.

Chair

Khyati Roberts, RPh

Speaker

The New Japanese “Sakigake” Strategy for Accelerated Development and Approval: Status, Procedure, and Prospects for Industry
Alberto Grignolo, PhD

Strategies for Using the New European PRIME Pathway
Sharon N. Olmstead



Chair
avatar for Khyati Roberts

Khyati Roberts

Head US/Canada, Regulatory Policy and Intelligence, AbbVie, Inc.
Khyati leads regulatory policy advocacy efforts for the U.S. and Canada and coordiantes international harmonization efforts. She joined AbbVie in 2012 and has nearly 30 years of regulatory experience. Khyati has also provided regulatory advice to the biopharmaceutical industry on... Read More →

Speakers
avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, Parexel, United States
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National... Read More →
avatar for Sharon Olmstead

Sharon Olmstead

Global Head, Development and Regulatory Policy, Novartis Pharmaceuticals Corporation
Sharon Olmstead is the Global Head of Development & Regulatory Policy at Novartis. She first joined Novartis in 1997, in their FDA Liaison Office. From 2002 until returning to Novartis in 2011, she held leadership positions at Merck, Schering-Plough, and Pharmacia. She built a foundation... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am EDT

#135: Clinical Developments in Immuno-Oncology, Part 2 of 2: Clinical Implementation of Biomarkers
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-562-L01-P; CME 1.25; IACET 1.25; RN 1.25

In this forum, the panelists will give a state-of-the-art overview of the exciting new area of cancer immunotherapies, the current learnings and methodologies, the benefits and challenges, as well as an outlook into the future.

Part 1 is scheduled for Monday, June 27, 2016, 8:30-9:45 AM.

Learning Objectives

Discuss examples of clinical implementation of biomarkers in the development of cancer immunotherapies; Describe what the future looks like for cancer immunotherapies; Explain the role of new technologies for companion diagnostics.

Chair

Holger G. Adelmann

Speaker

Panelist
Arnold B. Gelb

Panelist
Brandon Higgs, PhD

Panelist
Marc Theoret, MD



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
avatar for Arnold Gelb

Arnold Gelb

Senior Director, Clinical Biomarkers and Companion Diagnostics, EMD Serono Research & Development Institute, Inc.
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 →
MT

Marc Theoret

Associate Director of Immunotherapeutics, OHOP, OND, CDER, FDA
Dr. Theoret is a medical oncologist and the Associate Director of Immunotherapeutics in the Office of Hematology and Oncology Products, CDER, FDA. In his role as Associate Director, Dr. Theoret is leading initiatives in immuno-oncology product development—regulatory, scientific... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, Forum |   Trk 04: Preclin Transl-Early Clin Dev, Forum
 
Tuesday, June 28
 

8:00am EDT

#203: Next Generation Collaborations: Transforming the Industry
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-609-L04-P; CME 1.50; IACET 1.50; RN 1.50

“Alone we can do so little; together we can do so much.” Harnessing the power of collaboration truly has the ability to alter the healthcare landscape as we know it today. What is the next generation of collaborations and what will be unique about them? What will change in our organizations in the future, and how will they be different from today? Is collaborative R&D going to become a reality for our industry? What roles will FDA and other stakeholders play? This forum will bring together a diverse panel representing some of the industry’s most influential and powerful organizations for a candid and innovative conversation about what is needed to shake up the current ecosystem and truly transform patient health. Submit your questions in advance for the panelists to annualmeetingprogram@diaglobal.org; subject line: Next Gen Collaborations.

Learning Objectives

Review the role of collaborations to date in better aligning biopharmaceutical R&D with needs and constraints of an evolving health ecosystem; Discuss the impact of coming landscape changes on the industry of tomorrow and needs that new collaborations must address; Describe the stakeholders and innovative elements of the new and transformational collaborations that are emerging.

Chair

Dalvir Gill, PhD

Speaker

Panelist
Margaret A. Anderson, MA

Panelist
Christopher P. Austin, MD

Panelist
Jonathan P. Jarow, PhD

Panelist
C. David Nicholson, PhD

Panelist
Drew Schiller



Chair
avatar for Dalvir Gill

Dalvir Gill

Chief Executive Officer, TransCelerate BioPharma Inc.
Dalvir Gill has more than 25 years of drug development & leadership experience. Prior to his appointment as CEO of TransCelerate, he was the President of a major international CRO. Dr. Gill earned his BSc from the University of Hertfordshire and his PhD from the Royal Free Hospital... Read More →

Speakers
avatar for Margaret Anderson

Margaret Anderson

Executive Director, FasterCures, A Center of the Milken Institute
Margaret Anderson is the executive director of FasterCures, a Washington, DC-based center of the Milken Institute, which is driven by a singular goal – to save lives by speeding up and improving the medical research system. FasterCures focuses on spurring cross-sector collaboration... Read More →
avatar for Christopher Austin

Christopher Austin

Director, National Center for Advancing Translational Sciences, National Institutes of Health (NIH)
Christopher P. Austin has served as director of the NCATS since 2012. Prior to this role, he was NCATS’ scientific director, focusing on translating basic science discoveries into new treatments and technologies to improve the efficiency of therapeutic/diagnostic development. He... Read More →
avatar for Jonathan Jarow

Jonathan Jarow

Senior Medical Advisor, FDA
Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology... Read More →
avatar for C. David Nicholson

C. David Nicholson

Executive Vice President, Brand R&D, Allergan
Dr. Nicholson joined Actavis as SVP, Global Brands R&D in August 2014. Previously, he served as Chief Technology Officer and EVP, R&D for Bayer CropScience from March 2012 to August 2014; VP of Licensing and Knowledge Management at Merck from 2009 to December 2011; and SVP, responsible... Read More →
avatar for Drew Schiller

Drew Schiller

Co-Founder and Chief Technology Officer, Validic
Drew Schiller co-founded Validic and serves as the CTO. At Validic, Drew leads the product and technology strategy, drives key initiatives, and works closely with senior executives at partner organizations to stay ahead of the technology curve. Drew sits on the Consumer Electronics... Read More →


Tuesday June 28, 2016 8:00am - 9:30am EDT
Ballroom A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 19: DIAmond, Forum

10:30am EDT

#218: Lessons Learned from Eight Years of Drug Development Tool/Novel Methodology Qualification
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-548-L04-P; CME 1.00; IACET 1.00; RN 1.00

Innovative tools/methods acceptable to drug developers and regulators require focused development strategies for necessary evidence. This session presents case studies illustrating what has been learned to achieve success based on real examples.

Learning Objectives

Discuss the importance of consortia in advancing biomarkers, modeling, and simulation tools that inform drug development; Describe through a lessons learned approach on reaching consensus on the science (e.g. data sharing, governance procedures); Identify and help scientists understand the competencies and expectations involved in development of novel tools and methodologies.

Chair

Martha Ann Brumfield, PhD

Speaker

FDA Perspective
ShaAvhree Y. Buckman-Garner, MD, PhD



Chair
avatar for Martha Brumfield

Martha Brumfield

President and Chief Executive Officer, Critical Path Institute
Martha A. Brumfield, PhD, heads the Arizona-based non-profit in its mission to catalyze the development of new tools to advance medical product innovation and regulatory science. She has 20 years’ experience at Pfizer most recently as senior vice president of worldwide regulatory... Read More →

Speakers
avatar for ShaAvhree Buckman-Garner

ShaAvhree Buckman-Garner

Director, Office of Translational Sciences, CDER, FDA
ShaAvhrée Buckman-Garner, MD, PhD, FAAP is the Director of the Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), at the FDA. Prior to serving as Director of OTS, Dr. Buckman-Garner served as Deputy Director for OTS and as medical team leader in the... Read More →
avatar for Emer Cooke

Emer Cooke

Chair, ICMRA; Executive Director, European Medicines Agency (EMA), Netherlands
Es Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. "I take up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” said... Read More →


Tuesday June 28, 2016 10:30am - 11:30am EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Forum

10:30am EDT

#210: Effective Strategies to Leverage PMO Best Practices for Program and Portfolio Management
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000190; RN 1.25

This session will familiarize the audience with the Project Management Office (PMO), with a focus on the value added opportunities that a PMO can provide to your organization. Utilizing best practices and real-world examples, we will identify those PMO processes and tools that assist companies with achieving their project goals along with their overall portfolio strategies. This session will dovetail information regarding value added portfolio management, the effective utilization of processes and tools within a PMO, and the challenges of building a culture of innovation in project portfolio life cycle.

Learning Objectives

Define the role of a Project Management Office (PMO) and how it can bring value to an organization; Describe what a structured PMO can do in partnership with their functions; Discuss how to introduce incremental and radical innovation to drive the project portfolio and gain a competitive edge and accelerate growth.


Chair

Karen M. Marks

Speaker

What Value Can a Project Management Office Bring to Your Organization?
Kristin Fitzgerald, MBA, PMP

Best Practices for a PMO: Developing a PMO with Effective Processes
Karen M. Marks

Driving Innovation by Expanding the Role of Integrated Project Portfolio: Challenges and Best Practices
Dinesh Singh, MBA



Chair
avatar for Karen Marks

Karen Marks

Vice President, Global Program Management Office, Baxter International, Inc.
Karen Marks is the Vice President of the Global PMO for Baxter. Prior to joining Baxter, she has held positions in ConvaTec and Merck & Co and AT&T. Karen’s educational background includes a BS from Muhlenberg College in Human Resources Management, Master's Certification in Project... Read More →

Speakers
avatar for Kristin Fitzgerald

Kristin Fitzgerald

Director, Global Project Management, Project Management Office, Merck & Co., Inc.
Kristin Fitzgerald has been in the pharmaceutical industry for over 16 years and has worked in many different areas including, IT, Data Management, and Operations. In her current role, she manages support and leadership to Project Managers, Finance, and IT with respect to project... Read More →
avatar for Dinesh Singh

Dinesh Singh

Client Partner, Life Sciences, Cognizant
He is a seasoned advisor with 13 years of experience in business strategy, complex program management and large transformation/integration initiatives in life sciences industry. He has worked with leading pharmaceuticals clients to help them address key business problems and align... Read More →


Tuesday June 28, 2016 10:30am - 11:45am EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am EDT

#211: Collaboration with a Purpose
Limited Capacity seats available

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

While there is much to do in addressing many areas in need of attention within our industry, TransCelerate BioPharma, Inc., the Association of Contract Research Organizations, and the Society for Clinical Trials have been actively working towards a collaboration with a purpose. With ample opportunities to focus their attention, these three collaborators have chosen areas that will yield a significant impact on site sustainability and thereby bring efficiencies and increased quality to the overall industry. Topics to be discussed will include site best practices, Common Language Evaluation and Reconciliation (CLEAR), site score card, and Site Advocacy Groups (SAGs).

Learning Objectives

Discuss how collaboration with a purpose can impact site sustainability and increase quality; Identify initiatives to support a collaboration with a purpose.

Chair

Christine Pierre, RN

Speaker

Panelist
Rehbar H. Tayyabkhan

Panelist
Douglas J. Peddicord, PhD



Chair
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 →

Speakers
avatar for Doug Peddicord

Doug Peddicord

Executive Director, Association of Clinical Research Organizations (ACRO)
Following a career as a clinical psychologist, Doug Peddicord came to Capitol Hill as an American Association for the Advancement of Science (AAAS) Congressional Fellow in 1994. With policy expertise in the conduct and regulatory oversight of clinical trials, Dr. Peddicord serves... Read More →
avatar for Rehbar Tayyabkhan

Rehbar Tayyabkhan

Executive Director, Global Clinical Operations, Bristol-Myers Squibb Company
Reb Tayyabkhan is the Head of Central Clinical Services at Bristol Myers Squibb. He is responsible for Vendor and Outsourcing Management, R&D Contracts and Transparency across as phases of development. He is a member of TransCelerate as the sponsor for the risk based monitoring... Read More →


Tuesday June 28, 2016 10:30am - 11:45am EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 03: Innov Part Model-Outsourcing, Forum

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

2:00pm EDT

#235: Global Clinical Supply Logistics Study
Limited Capacity seats available

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

The Tufts Center for the Study of Drug Development has recently conducted a study gathering metrics on the impact of clinical supply logistics on global studies among 14 biopharmaceutical, CRO, and provider companies. A comprehensive survey was conducted and study data on logistics were gathered.

Learning Objectives

Describe the top strategies that companies use to optimize distribution networks; List some insights gained into shipping practices and approaches to investigational drugs and supplies; Identify performance indicators for successful distribution strategies.

Chair

Mary Jo Lamberti

Speaker

Distribution Networks and Strategies
Eric A. Valentine, MBA

Cycle Time Metrics and Impact on Study Conduct
Cheryl D. Mahon, PharmD



Chair
avatar for Mary Jo Lamberti

Mary Jo Lamberti

Associate Director of Sponsored Research, Research Assistant Professor, Tufts Center for the Study of Drug Development, United States
Mary Jo Lamberti is on the faculty at Tufts University and is Associate Director of Sponsored Research at Tufts Center for the Study of Drug Development (CSDD). She leads multi-company sponsored research studies and has extensive experience conducting research on biopharmaceutical... Read More →

Speakers
avatar for Cheryl Mahon

Cheryl Mahon

Director, Clinical Pharmacy, Astellas Pharma US, Inc.
Cheryl Mahon is a Director at Astellas Pharma US, Inc, responsible for the North American Clinical Supply Coordination team since 2007. This group is part of a global function responsible for forecasting, planning, packaging/labeling, distribution and return of clinical materials... Read More →
avatar for Eric Valentine

Eric Valentine

Global Director, Clinical Distribution Services, Catalent Pharma Solutions
Eric Valentine is the Global Director of Distribution Services for Catalent Pharma Solutions, responsible for developing the facilities network and logistics strategies in support of Catalent's Clinical Supply Services business. He has a background of 20 years' experience serving... Read More →


Tuesday June 28, 2016 2:00pm - 3:00pm EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Session

2:00pm EDT

#241: Disease Interception: Shifting the Paradigm from Treatment to Prevention of Disease
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-547-L01-P; CME 1.25; IACET 1.25; RN 1.25

Disease interception focuses on the development of medicines that stop or delay disease progression for patients at risk or asymptomatic within the disease continuum. Learn as regulators and payers share perspectives in this new drug development space.

Learning Objectives

Discuss the regulatory and implementation challenges to innovation in disease interception; Propose solutions to regulatory challenges to innovation for disease interception therapies; Assess the benefit and risk framework and value of disease interception therapies.

Chair

Karin Van Baelen, PharmD

Speaker

FDA Perspective
Ellis Unger, MD

EU Perspective
Hans-Georg Eichler

Payer Perspective
Sean R. Tunis, MD, MSc



Chair
avatar for Karin Van Baelen

Karin Van Baelen

Head, Global Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson
Karin is leading the Global Regulatory Affairs organization at Janssen. She facilitates the relationship between the Janssen pharmaceutical companies and global health authorities, influencing and interpreting global regulatory requirements and enabling our companies to meet those... Read More →

Speakers
avatar for Hans-Georg Eichler

Hans-Georg Eichler

Senior Medical Officer, European Medicines Agency, European Union
Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at... Read More →
avatar for Sean Tunis

Sean Tunis

Senior Strategic Advisor, Center For Medical Technology Policy (CMTP)
Sean Tunis, MD, MSc, is Founder and Senior Strategic Advisor of the Center for Medical Technology Policy, an independent, non-profit organization that provides a neutral platform for multi-stakeholder collaborations that promote high value innovation by improving the quality, relevance... Read More →
avatar for Ellis Unger

Ellis Unger

Director, Office of Drug Evaluation I, OND, CDER, FDA
Ellis F. Unger is the Director, Office of Drug Evaluation-I, Office of New Drugs, Center for Drug Evaluation and Research, FDA. His Office oversees the regulation of drugs for cardiovascular, renal, neurological, and psychiatric disorders. Dr. Unger is a board-certified internist... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Forum

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
 
Wednesday, June 29
 

8:00am EDT

#303: Value-Based Health Care Decision Making: The Quest for Smarter Spending
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.50; IACET 1.50; RN 1.50

As demand increases for better management of health care costs while still providing the highest levels of care, the landscape is evolving into one assessed on value. All stakeholders – providers, payers, manufacturers, and ultimately patients – are interested in the impact this movement toward value has, including who is making or influencing access decisions and what information and evidence is being used to define value. In this session, you will hear perspectives from multiple stakeholders to better understand the challenges and implications brought by this new focus towards value, and uncover ideas of collaboration to realize smarter health care spending.

Learning Objectives

Review the global landscape of value-based health care decision making; Discuss the challenges facing health care stakeholders as they work to understand this new “value” assessment and what that means for future decisions and patient access; Identify evidence considerations for pharmaceutical research and development plans; Share ideas on stakeholder collaboration for optimal results.

Chair

Jennifer Snow, MPH

Speaker

Panelist
Ben Heywood, MBA

Panelist
Sarah Garner

Panelist
Richard J. Willke, PhD

Panelist
Newell McElwee



Chair
avatar for Jennifer Snow

Jennifer Snow

Director, Health Policy, Xcenda
Jennifer Snow, MPH, is a Director of Health Policy and keeps clients and stakeholders informed on the latest legislative and regulatory updates and their commercial impact. Her team analyzes the healthcare environment and provides strategic guidance on how to best navigate challenges... Read More →

Speakers
avatar for Sarah Garner

Sarah Garner

Associate Director – Science Policy and Research, National Institute for Health and Care Excellence (NICE)
Professor Sarah Garner is a pharmacist specialising in the interface between Health Technology Assessment (HTA) and regulation. Sarah is the Associate Director for Scientific Policy and Research at NICE and an honorary professor at UCL and Manchester University. She leads Work Packages... Read More →
avatar for Ben Heywood

Ben Heywood

President and Co-Founder, PatientsLikeMe
As President and Director of PatientsLikeMe, Benjamin Heywood is responsible for setting the company vision to improve healthcare and accelerate research, while directing its business growth strategy. Inspired by his brother Stephen’s battle with ALS, Heywood co-founded the company... Read More →
avatar for Newell McElwee

Newell McElwee

Assistant Vice President, Center for Observational and Real-world Evidence, Merck & Co., Inc.
Newell McElwee, PharmD, MSPH, is Executive Director of U.S. Outcomes Research, Merck & Co., Inc. Dr. McElwee serves an active role on many committees including the Steering Committee for the AHRQ Centers for Education, Research, & Training, the Advisory Board for the Institute for... Read More →
avatar for Richard Willke

Richard Willke

Chief Science Officer, International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Dick became ISPOR’s first Chief Science Officer in 2016, where he develops, leads, and supports strategic initiatives related to research, scientific, and content priorities. Prior to ISPOR he worked for 25 years at Pfizer and its legacy companies, where he retired as a vice president... Read More →


Wednesday June 29, 2016 8:00am - 9:30am EDT
Ballroom A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 19: DIAmond, Forum

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

10:30am EDT

#310: Bridging CMC and Project Management to Achieve High Quality Product Submissions and Launch
Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000191; RN 1.25

This session will review case studies of differing delivery modality, to demonstrate diversified perspectives on product development, highlighting the project management-CMC interface.

Learning Objectives

Describe how to integrate the key/critical elements for successful pharmaceutical product project management into a receptive organization; Recognize the key/critical elements (critical path and common decision points) for successful CMC development, submission, and launch of pharmaceutical products.

Chair

Russell Maus, PhD

Speaker

CMC Case Study 2: Combination Device/Biologic Product
Maria Paola Schick, PMP

Case Study 3: Bioequivalency of Inhaled Products
Bela Elkin, PhD



Chair
avatar for Russell Maus

Russell Maus

Director, Merck & Co., Inc.
Russell joined Merck in 2002 in Merck Manufacturing in a role supporting analytical methods for in-line products. In 2006 he moved to Merck Research Labs to provide analytical support for PhI and PhII pharmaceutical development. In 2012 he took on a 2.5 yr stint as Scientific Project... Read More →

Speakers
avatar for Bela Elkin

Bela Elkin

Laboratory Manager, PPD
Dr. Bela Elkin has +30 years of experience in numerous chemistry-related fields, including research, drug development, the pharmaceutical industry, teaching, management and administration. She has +15 years of analytical chemistry laboratory experience in the FDA regulated pharmaceutical... Read More →
MS

Maria Schick

CMC Integration Sr. Project Manager, Amgen Inc.
Biotechnology professional with 13+ years of industry experience with a focus on project management to enable commercialization of biologics and combination products by partnering with scientific leads and Global Operations Leads to co-lead and manage cross-functional project teams... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am EDT

#309: Global Stakeholder Management: Across the Ocean Between East and West
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000188; RN 1.25

In this forum, participants will learn and discuss practical techniques and tips for global stakeholder management, such as identification of key stakeholders. The focus will be on West-East hybrid R&D organizations.

Learning Objectives

Discuss practical advantages/limitations of stakeholder management implementation; Identify key success factors in global stakeholder management in pharmaceutical R&D; Describe ideas for effective implementation of global stakeholder management.

Chair

Atsushi Tsukamoto

Speaker

Panelist
Robert A. Hilke, MA

Panelist
Gareth Julian Monteath



Chair
avatar for Atsushi Tsukamoto

Atsushi Tsukamoto

Vice President, New Drug Regulatory Affairs, Daiichi Sankyo Co., Ltd.
Atsushi is VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He is also Head of Specialty Medicine RA in R&D division, to lead gobal specialty medicine regulatory strategies. As Head of Japan New Drug RA, he is responsible for leading new drug RA activities for all projects... Read More →

Speakers
avatar for Robert Hilke

Robert Hilke

Chief Executive Officer, Hilke Communications Corporation
Robert Hilke is the CEO of Hilke Communications Corporation, a firm specializing in providing intercultural communications and TOEIC training for global businesspeople, many of whom work in the pharmaceutical industry. Mr. Hilke's primary research interest is the management of diverse... Read More →
avatar for Gaz Monteath

Gaz Monteath

Executive Director, Link Global Solution Inc.
Dr. Gareth ("Gaz") Monteath is Executive Director at Link Global Solution Inc., an HR and OD consulting firm based in Tokyo. In his position, Gaz is responsible for the overall content and quality of programmes. LGS has long experience of working with pharmaceutical and medical instruments... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj/Port Mgt/Strat Planning, Forum

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

10:30am EDT

#313: The Future of Clinical Research Data: 2020 and Beyond
Limited Capacity seats available

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

This forum will engage a panel of experts who will discuss current and emerging opportunities and trends in the representation and use of research data and describe a future vision for capitalizing on these to improve the future research process.

Learning Objectives

Describe current state, trends and opportunities such as data transparency, electronic health records, interoperability, wearable technologies, regulatory science, data standards and analytics; Describe a vision for future clinical research data systems and processes that can logically evolve from the current state to meet these requirements including opportunities to improve the research process.

Chair

Wayne R. Kubick, MBA

Speaker

Panelist
Dave Evans, MS

Panelist
Armando Oliva, MD

Panelist
Kenneth A. Getz, MBA



Chair
avatar for Wayne Kubick

Wayne Kubick

Chief Technology Officer, HL7
Mr. Kubick is CTO for Health Level Seven International, intent on improving clinical research through technology and data standards. He was formerly CTO and a Board member for CDISC, and has 2+ decades in a variety of leadership roles in clinical R&D with BBN, Parexel International... Read More →

Speakers
avatar for Dave Evans

Dave Evans

Managing Director, Accenture
Dave Evans is a senior technology and clinical research executive with over 35 years of experience in the clinical research, regulatory and healthcare industries. He is recognized industry-wide as a leading technology visionary for developing and implementing complex process and... Read More →
avatar for Kenneth Getz

Kenneth Getz

Director, Research Professor, Tufts Center For the Study of Drug Development
Kenneth A. Getz, MBA, is the Deputy Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the Founding Chair of the Center... Read More →
avatar for Armando Oliva

Armando Oliva

President and Chief Medical Officer, Semantica LLC
His expertise includes clinical data standards, regulated study data submissions, and regulatory submission and review policy. A former Associate Director for Informatics in OCS, he focused on developing, adopting, and implementing clinical data standards to support premarketing assessment... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am EDT

#315: Enhancing Pediatric Product Development in a Global Regulatory Environment: Extrapolation and Modeling and Simulation, Oh My!
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-549-L01-P; CME 1.25; IACET 1.25; RN 1.25

This forum will examine how the international regulatory community is responding to the challenge of pediatric product development (limited access to patients) with alternative strategies to generate meaningful data and enhance program efficiency.

Learning Objectives

Discuss the unique challenges and opportunities associated with development of therapies for pediatric populations; Describe how stakeholders can work together to improve the development of, evaluation of, and application of innovative strategies that will advance pediatric product development; Identify opportunities to translate policy into advances for the field of pediatric drug development.

Chair

Christina Bucci-Rechtweg, MD

Speaker

FDA Perspective
Lynne P. Yao, MD

FDA Perspective
Mary Dianne Murphy, MD

Health Canada Perspective
Ariel E. Arias

Panelist
Jordi Llinares Garcia



Chair
avatar for Christina Bucci-Rechtweg

Christina Bucci-Rechtweg

Global Head, Pediatric and Maternal Health Policy, Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation
Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 16 yrs of experience in Clinical Development and Regulatory Policy... Read More →

Speakers
avatar for Ariel Arias

Ariel Arias

Senior Advisor, Centre for Biologics Evaluation, BGTD, Health Canada
Dr Arias has many years of experience in the assessment of drug products. He has provided expert advice for a number of drug safety regulatory initiatives and represented Health Canada in various international drug regulatory technical committees (e.g., ICH, PAHO). He is an adjunct... Read More →
avatar for Jordi Llinares Garcia

Jordi Llinares Garcia

Head of Product Development Scientific Support Department, European Medicines Agency, European Union
Jordi Llinares is a medical doctor specialised in clinical pharmacology. He worked as clinical pharmacologist at Hospital de Sant Pau and has experience as member of an ethics committee. Jordi has academic experience as lecturer in clinical pharmacology. He has a Masters degree in... Read More →
MM

Mary Murphy

Director, Office of Pediatric Therapeutics, Office of Special Medical Programs, FDA
Dianne Murphy, MD, FAAP, is Director of the Office of Pediatric Therapeutics (OPT) Office of the Commissioner at FDA. Dr. Murphy was a medical officer at Bethesda Naval; Dir. of the virology laboratory at the U. of Tenn., Knoxville & tenured Professor at the U. of Florida, Jacksonville... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, MD, is the Director, Office of New Drugs, Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, US Food and Drug Administration. The Division of Pediatric and Maternal Health oversees quality initiatives within the Office of New Drugs... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Forum

1:20pm EDT

#332B: SAP Innovation Theater: Too Much R&D Data to Develop New Drugs and Medical Devices?
Limited Capacity seats available

Component Type: Session
Level: Intermediate

Making sense of Big Data in R&D is challenging. Relevant information comes from many sources and in varying formats. Collecting, consolidating and analyzing this data can take long – too long.

This presentation will show how to manage Big Data in R&D efficiently. Find out how to analyze scientific texts, genomics, clinical data and postmarket studies. Hear how to consolidate and analyze structured and unstructured data in real-time. See how visualization can help gain relevant insights.

Chair

SAP America Inc.


Chair
Wednesday June 29, 2016 1:20pm - 1:50pm EDT
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm EDT

#353: The Utility of Natural History Studies in Drug Development and Approval
Limited Capacity seats available

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

A well-designed natural history study can help in designing an efficient drug development program and support marketing approval. This session will discuss the utility of natural history studies and strategies for designing them.

Learning Objectives

Recognize the ways in which a natural history study can guide each stage of drug development; Identify features of natural history registries that will support drug development activities; Summarize the use of natural history controls to support important FDA drug approvals.

Chair

James E. Valentine, JD

Speaker

FDA Draft Guidance and the Utility of Natural History Studies in the Development of Drugs for Rare Diseases
Jonathan C. Goldsmith, MD, FACP

Considerations in the Use of National History Studies: Development and Registration Perspective
Camilla V. Simpson, MS

Use of Historical Controls to Support Drug Approvals
James E. Valentine, JD



Chair
avatar for James Valentine

James Valentine

Attorney, Hyman, Phelps & McNamara, PC
James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →

Speakers
avatar for Jonathan Goldsmith

Jonathan Goldsmith

Associate Director for Rare Diseases, Office of New Drugs, CDER, FDA
Dr. Goldsmith is Associate Director for Rare Diseases in the Office of New Drugs/CDER/FDA. Prior to federal service, he was a tenured professor in academia and focused on clinical drug development in regulated industry, at NHLBI/NIH and at orphan disease foundations. He earned his... Read More →
avatar for Camilla Simpson

Camilla Simpson

Group Vice President Regulatory Affairs, BioMarin Pharmaceutical Inc.
Camilla Simpson is a Global Regulatory Affairs executive with 20+ years in the Biopharmaceutical Industry. She is currently working for BioMarin, where she leads a team of 150 professionals. Prior to this she was with Shire Pharmaceuticals, and Abbott Laboratories. She is experienced... Read More →


Wednesday June 29, 2016 2:00pm - 3:00pm EDT
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 17: Rare-Orphan Diseases, 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

2:00pm EDT

#338: Evolving Methods in Pain Trials: Evaluating Abuse Deterrence, Drug Interactions, and Appropriate Patient Selection
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-525-L01-P; CME 1.25; IACET 1.25; RN 1.25

Analgesics are useful drugs but have limitations of effectiveness, safety, and tolerability in some patients. In this symposium, we will discuss why evaluating abuse deterrent opioids, drug interactions and targeting specific pain phenotypes are critical areas of analgesic research.

Learning Objectives

Discuss the benchtop/clinical evaluations required to assess abuse deterrent opioid formulations; Explain the challenges in evaluating drug-drug interactions between pain medications or withdrawal maintenance drugs and other drugs; Describe European Medicine Agency views on how particular biomarker methods can be used in the stratification of patient populations in neuropathic pain trials.

Chair

Beatrice Setnik, PhD

Speaker

Abuse Deterrent Opioids: Benchtop and Clinical Approaches to Testing Real World Drug Abuse
Beatrice Setnik, PhD

A Quantitative Approach to Understanding the Dynamic Interplay Between Pain and Concomitant Medications, and Genetics
Galina Bernstein, PhD

Proposal for the Use of Biomarker Methods to Enable Stratification of Patient Populations in Clinical Trials for Neuropathic Pain
Andrew Whiles, LLM, MBA



Chair
avatar for Beatrice Setnik

Beatrice Setnik

Vice President, Clinical Pharmacology, Early Phase, INC Research
Dr. Setnik has been working in the area of CNS research and clinical drug development for over 16 years and is an expert in the area of abuse and dependence potential evaluation of drugs. Dr. Setnik is currently the Vice President of Clinical Pharmacology at INC Early Phase and oversees... Read More →

Speakers
avatar for Galina Bernstein

Galina Bernstein

Director of Pharmacometrics, Early Phase, INC Research
Dr Galina Bernstein received PhD in Biochemistry from Moscow State University, postdoctoral training from College of Pharmacy, U of Michigan, and pharmacokinetics training at Pfizer GRD PDM department. She has 15+ years’ experience in analytics, PK and PK/PD modeling for IVD, small... Read More →
AW

Andrew Whiles

Director, Regulatory Affairs, Pfizer Ltd
Andrew Whiles has 29 years’ regulatory experience in researching , registering and maintaining pharmaceuticals and devices on the market. Over the last four years he has focused on early development regulatory strategies from Phase 1 through to Proof of concept studies within the... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Symposium

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

#361: Protocol Endpoints: A Clear Map to Navigate the Yellow Brick Road and the End of Endpoint-Creep
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-533-L04-P; CME 1.00; IACET 1.00; RN 1.00

Investigators and regulatory agencies find it commonplace to receive protocols with a wide variety of primary and secondary endpoints to demonstrate efficacy for a given disease area. It is also commonplace for a medical writer or clinician to need to reinvent the wheel of endpoints for every new compound. The resulting product is that investigators and regulators receive inconsistent endpoints for similar indications, requiring the interpretive skills of a wizard. We have all gone down the ‘Yellow Brick Road’ of developing protocols and improving our endpoints for a disease area many times. Despite a plethora of research publications with clear descriptions of endpoints, it is common place to begin protocol development with no clear standards of endpoints. Clinical teams involved in protocol development often find that the long circuitous path down the ‘Yellow Brick Road’ is filled with a multitude of choices, missing bricks, potholes and wrong directions. Some of the key inefficiencies in protocol development stem from delays to endpoint finalization and resultant cascade of delays to additional protocol content such as assessments and statistical analyses. Protocol authors, whether medical directors or writers, struggle to achieve clear, consistent endpoints and all wish for ‘Dorothy shoes’ to click together for the right path. Additionally, the common occurrence of endpoint creep translates into significant increases in development costs. This session will provide insights to optimal endpoint and protocol content development required for registration protocols.

Learning Objectives

Describe the approach used to develop primary and secondary endpoints in a therapeutic area.

Chair

Anne B. Cropp, PharmD

Speaker

The ABCs of Writing Effective Clinical Study Protocols
Julia Forjanic Klapproth, PhD



Chair
avatar for Anne Cropp

Anne Cropp

Vice President, Pfizer Inc
Anne Cropp has led the strategic planning and clinical development of several compounds in Cardiovascular and Metabolic diseases, Phases 2-4. Anne has led many business process improvements and has led several initiatives across the spectrum of clinical trial planning, design and... Read More →

Speakers
avatar for Julia Forjanic-Klapproth

Julia Forjanic-Klapproth

Senior Partner, Trilogy Writing & Consulting, Germany
PhD in Developmental Neurobiology, Julia started her career as a medical writer in the pharma industry. In 2002, Julia co-founded Trilogy Writing & Consulting, a company specialized in providing medical writing of clinical regulatory documentation. In addition to company management... Read More →


Wednesday June 29, 2016 4:00pm - 5:00pm EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 06: Med Comm-Wrtg-MSL, Session

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

4:00pm EDT

#363: Expedited Reviews and Other Pathways to Speed Up Access to Medicines
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-550-L01-P; CME 1.25; IACET 1.25; RN 1.25

Patients with unmet medical needs want early access to medicines. Regulators need to feel confident that the the benefit-risk balance of a medicine they are licensing is positive. Regulators from the EU, Japan, and the US will discuss how access to medicines can be speeded up and the use of postmarketing data to reduce the uncertainties.

Learning Objectives

Recognize the concepts and current progress with speeding up access to medicines in different regions.

Chair

Stella C.F. Blackburn

Speaker

Sooner or Later? Cost and Benefit of Utilizing Rolling Reviews in US and Japan
Toshiyoshi Tominaga

EU Adaptive Pathways Process
Hans-Georg Eichler

Expedited Reviews and Using Postmarketing Data to Supplement Clinical Trials
Gerald J. Dal Pan, MD



Chair
avatar for Stella Blackburn

Stella Blackburn

Vice President, Global Head of Early Access & Risk Management, RWI, QuintilesIMS
Dr Stella Blackburn is currently VP, Global Head of Early Access & Risk Management at QuintilesIMS. She joined QI in April 2014 after more than 25 years working in PhV and pharmacoepi in industry and the European Medicines Agency. Stella is a Fellow of the International Society of... Read More →

Speakers
avatar for Hans-Georg Eichler

Hans-Georg Eichler

Senior Medical Officer, European Medicines Agency, European Union
Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... Read More →
avatar for Toshiyoshi Tominaga

Toshiyoshi Tominaga

Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session
 
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