Loading…
This event has ended. Visit the official site or create your own event on Sched.

Sign up or log in to bookmark your favorites and sync them to your phone or calendar.

Advanced [clear filter]
Monday, June 27
 

8:30am EDT

#104: Impact of Biologics, Vaccines, Oncology, and Breakthrough Therapy Designation on Traditional Global Drug Development Strategy
Limited Capacity seats available

Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-523-L01-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000186; RN 1.25

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

Learning Objectives

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

Chair

Eva M. Finney, PhD, PMP

Speaker

Panelist
Susan Uptain, PhD

Panelist
David Robinson, PhD



Chair
avatar for Eva Finney

Eva Finney

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

Speakers
DR

David Robinson

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

Susan Uptain

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

Susan Uptain

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


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

8:30am EDT

#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
 
Tuesday, June 28
 

10:30am EDT

#219: Regulatory Science Considerations Applying to Novel Combinations of Biologics and Bifunctional Biologics Development
Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-552-L01-P; CME 1.25; IACET 1.25; RN 1.25

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

Learning Objectives

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

Chair

Owen Fields, PhD

Speaker

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

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

Q and A Panel
Badrul Chowdhury, MD, PhD



Chair
avatar for Owen Fields

Owen Fields

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

Speakers
avatar for Badrul Chowdhury

Badrul Chowdhury

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

Rakesh Dixit

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

Raj Nair

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


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

2:00pm EDT

#251: Embracing Virtual Training Solutions in 2016: Focus on Performance!
Component Type: Workshop
Level: Advanced
CE: CME 1.25; IACET 1.25; RN 1.25

In today’s global clinical research framework, delivering face-to-face training, is not always an option. This workshop explores the solutions that webinars and virtual classrooms provide for the stated learning objectives as well as the desired stakeholder performance outcomes after the training.

**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

Differentiate between webinar and virtual classroom training delivery methods for investigator meetings, employee training and development; Discuss best practices, challenges and successes with webinar and virtual classroom instructional design, methods, and tools; Identify three attributes of webinars and virtual classrooms that promote employee engagement and learning, as well as the associated activities that support organizational performance goals.

Chair

Liz Wool, BSN

Speaker

Facilitator
Jim Bohlen



Chair
avatar for Liz Wool

Liz Wool

Global Head of Training, Barnett International
Liz Wool CCRA, CID, CMT, is Global Head of Training at Barnett International, an education, training and consulting company. Liz possesses 26 years in the product development industry and 37 years in the healthcare industry. Liz's expertise is in clinical research, operations strategy... Read More →

Speakers
avatar for Jim Bohlen

Jim Bohlen

Vice President, Business Development, Blue Sky Broadcast
Jim is responsible for business development and strategic partnerships for Blue Sky’s Life Sciences division. With over 15 years of experience in providing virtual meeting and eLearning solutions for investigator training programs, Jim has become a respected thought leader in the... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 16: Prof Development, Workshop

4:00pm EDT

#275: Creating a Competency-Based Onboarding and Learning Program on a Budget
Component Type: Workshop
Level: Advanced
CE: CME 1.25; IACET 1.25; RN 1.25

The competitive talent landscape demands effective investment in onboarding and employee development. Workshop participants will design a departmental-level onboarding program and individual learning plan using an industry competency model.

**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

Examine the life sciences industry competency model for organizational adoption and implementation; Identify approaches for development of a department-employee level onboarding program that is a right fit for the organization; Evaluate industry lessons learned in implementing individual employee learning plans-competency models.

Chair

Patterson Shafer

Speaker

Create an Onboarding Curriculum That Fits Your Budget
Liz Wool, BSN



Chair
PS

Patterson Shafer

Specialist Leader, Deloitte Consulting LLP
Pat is a specialist leader in Deloitte Consulting’s Life Sciences group with more than 30 years of consulting experience. During his career, he has led dozens of learning and development initiatives, including curriculum design, competency model development, running train the trainer... Read More →

Speakers
avatar for Liz Wool

Liz Wool

Global Head of Training, Barnett International
Liz Wool CCRA, CID, CMT, is Global Head of Training at Barnett International, an education, training and consulting company. Liz possesses 26 years in the product development industry and 37 years in the healthcare industry. Liz's expertise is in clinical research, operations strategy... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 16: Prof Development, Workshop
 
Wednesday, June 29
 

10:30am EDT

#318: Changes to Common Rule Likely Affecting FDA-Governed Research
Limited Capacity seats available

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

Although the Common Rule for research does not govern FDA governed clinical investigations, the proposed changes likely will eek over into FDA governed research. This session explores those proposed changes and their expected effects.

Learning Objectives

List key proposed changes to the Common Rule for Research; Contrast changes to FDA's requirements; Hypothesize how changes will affect FDA governed research.

Chair

David Vulcano

Speaker

Industry Perspective
David Vulcano

Industry Perspective
Neil McCullough



Chair
avatar for David Vulcano

David Vulcano

Vice President, Clinical Research Compliance and Integrity, HCA Healthcare, United States
David is a well-known leader in the clinical research industry through numerous associations, boards and initiatives. Among other things he is currently employed by HCA Healthcare, the largest private healthcare provider in the United States, as the Responsible Executive for Clinical... Read More →

Speakers
NM

Neil McCullough

Executive Vice President, Clinical Quality Compliance, ICON Clinical Research
Dr. McCullough has vast experience leading global quality and compliance teams within the industry. His expertise in quality assurance, regulatory affairs, risk-based auditing, continuous improvement, and project management are relied upon by PPD and its clients to achieve high quality... Read More →


Wednesday June 29, 2016 10:30am - 11:30am EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 10: Pub Pol/HealthCare Compl/Law, Session |   Trk 01: Clinical Operations, Session

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

#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

4:00pm EDT

#357: The Internet of Things and Clinical Research: Privacy, Security, and Ethical Aspects
Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-515-L04-P; CME 1.25; IACET 1.25; RN 1.25

The Internet of Things (IoT) refers to objects simultaneously producing data in an automated way. It is revolutionary to clinical research and pushes the limits of current policy, requiring us to examine regulation that could limit its potential.

Learning Objectives

Describe potential advantages and benefits of the Internet of Things (IoT) in clinical research, and the complexities and barriers to adoption; Summarize the impacts and issues involved in leveraging the IoT within health care and clinical research in particular.

Chair

Ellen Kelso

Speaker

Does “Big Data” for Enhanced Recruiting Invade Patient Confidentiality?
Lea Studer



Chair
avatar for Ellen Kelso

Ellen Kelso

Executive Director, Chesapeake IRB
Founder, managing member & CEO of Goodwyn IRB, Ellen Kelso is recognized for her experience & expertise in clin. trial mgt & reg. affairs. Has provided educ., consultation & services to the pharma industry supporting clinical research & regulatory strategies, submissions & compliance... Read More →

Speakers
avatar for Lea Studer

Lea Studer

Senior Vice President of Marketing Communications, SCORR Marketing
Studer is an accomplished marketing and communications professional with more than 20 years of experience developing and implementing compelling, award-winning marketing and communication strategies and tactics in the global life sciences industry.


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Session
 
Thursday, June 30
 

10:45am EDT

#406: Navigating Partnerships and Submissions: Best Practices for Successful Medical Writing Deliverables Involving Multiple Stakeholders
Limited Capacity seats available

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

The current trend in the industry involves multiple stakeholders working toward a similar goal, whether that be creation of a clinical study report (CSR), an entire marketing application, or any other medical writing deliverable. Such work could include collaborations between pharma companies, CROs, independent contractors, or any combination thereof. The speakers will present successful case studies involving codevelopment of products between two pharmaceutical companies as well as a specialized strategic medical writing partnership between pharma and a CRO, focused on writing and primary publishing of the sponsor’s CSRs. You will leave this session with a strategy for creating high-quality deliverables on time and within budget across a product’s life cycle, regardless of the type of partnership utilized in your organization. Come with questions!

Learning Objectives

Assess challenges associated with different types of partnerships and proactively implement solutions; Evaluate and establish an outsourced strategic medical writing partnership; Identify and incorporate best practices for successful partnerships and submissions in your organization.

Chair

Tammy Franklin, MSc

Speaker

Sponsor Companies as Partners: Tips for Creating a Successful Partnership for Medical Writing
Tammy Franklin, MSc

A Specialized Strategic Medical Writing Partnership: A Case Study
Timothy D. Garver, PhD

Partnerships in Action: Learning from Real-Life Submissions Involving Multiple Stakeholders
Angela Campbell, PhD



Chair
avatar for Tammy Franklin

Tammy Franklin

Head of Global Medical Writing, UCB
Tammy Franklin is the Senior Director of Global Medical Writing at UCB and is responsible for the leadership and management of a medical writing organization. She has over 15 years of experience in regulatory writing, including extensive knowledge of submission planning and content... Read More →

Speakers
avatar for Angela Campbell

Angela Campbell

Principal Medical Writer/AD, Shire Pharmaceuticals
I have been a medical writer for over 14 years, with experience at all phases of drug development, from pre-clinical to post-marketing. I have prepared a variety of regulatory documents in support across many therapeutic areas. I have also worked on suport documents such as manuscripts... Read More →
TG

Timothy Garver

Chief Operating Officer and Executive Vice President, Impact Pharmaceutical Services
Tim Garver, PhD, is the Executive VP and COO of Impact Pharmaceutical Services, Inc., a consulting and contract research organization. Tim has over 20 years of medical writing experience for both drugs and biologics, during which time he has played a key role in over 25 marketing... Read More →


Thursday June 30, 2016 10:45am - 12:00pm EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA