May 12, 2016

Integrating Pediatric Studies into Adult Oncology Drug Development

Tufts CSDD Executive Forum Roundtable: May 12, 2016
Integrating Pediatric Studies into Adult Oncology Drug Development: Maximizing Efficiency and Economics While Meeting FDA and EMA Requirements

AGENDA

9:30 - 9:45am: Welcome and Introductions
Christopher-Paul Milne
Director of Research, Research Associate Professor
Tufts Center for the Study of Drug Development, Tufts University

9:45 - 10:30: Improving Drug Development for Pediatric Oncology
Steven Hirschfeld (Invited)
Associate Director for Clinical Research
GRiP Coordinator, NICHD, NIH

10:30 - 11:15: Pediatric Oncology Trials at Sanofi: Practical Considerations
Jeffrey Barrett
Vice President and Global Head of Pediatric Clinical Pharmacology
Sanofi Pharmaceuticals 

11:15 - 12:00pm: Matching Children with Cancer to the Right Drug
Hubert Caron

Global Clinical Leader, iPODD team, Pediatrics
Roche-Genentech

12:00 - 12:30: Discussion

12:30 - 1:15: Lunch

1:15 - 2:00: Pediatric Oncology Drug Development at Celgene: Perspectives and Challenges
Bouchra Benettaib
Executive Medical Director, Clinical R&D
Celgene Corporation

2:00 - 2:45: Disease-Centric Approach and Collaboration of Stakeholders at BMS
M. Brigid Bradley-Garelik

Director, Global Clinical Research in Oncology
Bristol-Myers Squibb, Pharmaceutical Company

2:45 - 3:30: EU Oncology PIPs Overview: The Way Forward
Klaus Rose
Pediatric Drug Development Specialist
Klausrose Consulting

3:30 - 4:00: Discussion and Wrap-up
Christopher-Paul Milne

 

May 14, 2015 Executive Forum Roundtable | Tufts Center for the Study of Drug Development

May 14, 2015

Diagnostic-Therapeutic Co-development Strategies and Best Practice

The R&D portfolio of many pharmaceutical companies currently includes personalized and targeted medicines. However, having an effective strategy for the co-development of a complementary or companion diagnostic often represents a significant bottleneck in the R&D process. In this roundtable, we will explore different diagnostic-therapeutic co-development strategies and discuss insights and best practices. 

FEATURED SPEAKERS:

Michael A. Pacanowski, PharmD, MPH
Associate Director for Genomics and Targeted Therapy, Office of Clinical Pharmacology, Office of Translational Research
CDER; FDA

Debra Rasmussen, MBA, RAC
Diagnostic Regulatory Lead
Janssen

Richard Watts
Vice President
Global Business Development, Companion Diagnostics, Americas
Quigen

Dan Rhodes, PhD
VP Oncology
Thermo Fisher Scientific

Joshua P. Cohen, PhD
Research Associate Professor
Tufts Center for the Study of Drug Development, Tufts University

 

For more information on this roundtable, please e-mail .(JavaScript must be enabled to view this email address).

Tufts CSDD Special Events | Tufts Center for the Study of Drug Development

October 29, 2015

Manufacturing Strategy for Diverse Biologic Pipelines of the Future

Manufacturing Strategy for Diverse Biologic Pipelines of the Future
A Strategy Workshop and Panel Discussion at Tufts CSDD

Thursday, October 29th, 2015, 10:00 AM - 2:00 PM
Tufts University School of Dental Medicine
1 Kneeland Street, Boston, MA, 02111, Floor 14, Room 1415

Tufts CSDD, in conjunction with Boston Oncology, is holding a special workshop entitled "Manufacturing Strategy for Diverse Biologic Pipelines of the Future." Industry experts will address critical issues and challenges in biologics manufacturing.


Workshop Objectives: 

  • Manufacturing strategies in light of increasingly diversified pipelines and markets
  • Benchmarks for successful strategies
  • Best practices for efficient manufacturing of biologics

Workshop Chairs:

  • Abdullah Baaj, Chief Executive Officer, Boston Oncology
  • Kenneth I Kaitin, Professor and Director, Tufts Center for the Study of Drug Development

Confirmed Participants:

  • Paul Beninger, Genzyme & Tufts University School of Medicine
  • Jen Campbell, Merck Millipore
  • Jack Campion, The Hart Companies
  • Carl Carlson, M+W Group
  • Bo Crouse, M+W Group
  • David Dunn, Thomson Reuters
  • Christopher Earnhart, Naval Surface Warfare Center, Dahlgren Lab
  • Gabriel Ellis-Ferrara, Talk with Pictures
  • Philip Ferro, Department of Health & Human Services
  • Bert Frohlich, Shire HGT
  • Parrish Galliher, General Electric Healthcare Life Sciences
  • Kimball Hall, Amgen Inc.
  • Kevin Hanley, Pfizer
  • Marty Joyce, Boston Oncology
  • David Pollard, Merck
  • Thomas Ransohoff, BioProcess Technology Consultants
  • Mari Serebrov, Thomson Reuters
  • Will Waterfield, Pfizer
  • Dave Williams, US Army, DOD, JPEO-CBD

AGENDA:

10:00 - 10:10am: Welcome & Introductions
Abdullah Baaj & Ken Kaitin

10:10 - 10:25am: Industry Trends
Tom Ransohoff

10:25 - 10:55am: Innovation strategies for Diversified Pipelines
Parrish Galliher

10:55 - 11:00am: Break

11:00 - 11:15am: SUT Risk Assessment and Facilities of the Future
Carl Carlson

11:15 - 11:30am: COGS Predictor of Efficiency
Jen Campbell

11:35 - 12:00pm: Best Practices
David Pollard

12:00 - 12:25pm: Emerging Market Strategies
Abdullah Baaj

12:25-12:30pm: Break

12:30 -  1:30pm: Group Discussion

1:30  -  1:35pm: Closing Remarks 

 

REGISTRATION IS CLOSED

November 12, 2015 Executive Forum Roundtable | Tufts Center for the Study of Drug Development

November 12, 2015

Patient Recruitment and Retention 2.0

The convergence of clinical care data, clinical research data, and engaged patient communities has introduced promising new approaches to identifying, attracting and retaining study volunteers for pre- and post-approval clinical trials. This roundtable will begin with a CSDD assessment of a variety of novel approaches and their impact to date. We will then discuss specific case examples in detail to shed light on strategic insights and opportunities. 

 

AGENDA

10:00am - 10:15am - Welcome and Opening Remarks
Ken Getz, Director, Sponsored Research Programs and Associate Professor
Tufts CSDD

10:15am - 11:15am - The Global Community of Patients & Health Care Providers: Review of 2015 Study Results
Mary Jo Lamberti, Senior Research Fellow & Ranjana Chakravarthy, Research Analyst
Tufts CSDD

11:15am - 11:45am - DISCUSSION

11:45am - 12:30pm - LUNCH

12:30pm - 1:30 pm - Patient Engagement in a Brave New World of R&D
Bonnie Brescia, Founding Principal
BBK Worldwide

1:30pm - 2:30pm - Anticipating the Impact of Apple ResearchKit
Shyam Deval, President
Boston Technology Corporation

2:30pm - 3:30pm - Navigating the Evolving Patient Recruitment Landscape
David Coman, Independent Consultant
Coman Consulting

3:30pm - 4:00 pm - Closing Remarks
Ken Getz, Director, Sponsored Research Programs and Associate Professor
Tufts CSDD

 

For more information on this roundtable, please e-mail .(JavaScript must be enabled to view this email address)

September 17, 2015 Executive Forum Roundtable | Tufts Center for the Study of Drug Development

September 17, 2015

Novel Approaches to Overhauling the Clinical Development Process

The time, cost and risk of drug development remain formidable obstacles for drug sponsors and contract research organizations (CROs). This roundtable will explore novel approaches that are being piloted and widely adopted by leading pharma companies to speed development time, lower cost, improve efficiency and increase the probability of success for clinical candidates. As we review these novel and innovative approaches, the goal will be to assess what works and what doesn’t work.

AGENDA

10:00-10:15am -Welcome and Opening Remarks

10:15-11:00am - Changing Organizational Structure, Technology Solutions, Operating Processes and Practices to Transform Protocol Design

11:00-11:45am - Patient Centric Initiatives Impacting Clinical Development Processes and Performance

11:45-12:30pm - Mobile and Wearable Technologies and Solutions in Clinical Trials

12:30-1:30pm - Lunch

1:30 -2:15pm - Transforming Development with Big Data Analytics

2:15-3:00pm - Social Media Use in Pharmaco-vigilance and Study Conduct Activity

3:00-3:45pm - Improved Decision Inputs to Better Predict Program Success Rates

3:45-4:15pm - Open Discussion and Wrap Up

For more information on this roundtable, please e-mail .(JavaScript must be enabled to view this email address).

February 26, 2015 Executive Forum Roundtable | Tufts Center for the Study of Drug Development

February 26, 2015

FDA’s Breakthrough Therapy Designation – A Three-Year Assessment

Breakthrough Therapy Designation (BTD), part of the reauthorization of the Prescription Drug User Fee Act in 2012, allows the FDA to expedite the development and review of drugs intended to treat a serious condition where preliminary clinical evidence suggests substantial improvement over available therapy on a clinically significant endpoint or on symptoms that represent serious consequences of the disease. The roundtable will open with a review of recent CSDD data on the BTD program in its first three years. This will be followed by individual company experiences and lessons learned with the program.

AGENDA

10:00-10:45am - Welcome and Introductions
Review of Trends with FDA's Breakthrough Therapy Designation

Christopher-Paul Milne, DVM, MPH, JD
Associate Professor and Director of Research
Tufts Center for the Study of Drug Development, Tufts University

10:45am-12:00pm - FDA's Breakthrough Therapy Designation - The FDA's Perspective
Sarah Pope Miksinski, PhD
Acting Division Director for the Division of New Drug Quality Assessment 2 in the 
FDA's Office of New Drug Quality Assessment (ONDQA)
CDER; FDA

12:00-12:30pm - Open Discussion

12:30-1:30pm - Lunch

1:30-2:15pm - Strategies Behind Developing a Drug with a Breakthrough Therapy Designation
Rick Lilley 
Senior Vice President of Global Regulatory
Vertex Pharmaceuticals

2:15-3:00pm - Strategies Behind Developing a Drug with a Breakthrough Therapy Designation - the CRO's Perspective
Jenny Vestsal
Senior Directory, Regulatory Affairs
ICON

3:00-3:30pm - Open Discussion and Wrap-Up
Christopher-Paul Milne, DVM, MPH, JD
Associate Professor and Director of Research
Tufts Center for the Study of Drug Development, Tufts University

For more information on this roundtable, please e-mail .(JavaScript must be enabled to view this email address).

February 21, 2013 Exec Forum roundtable | Tufts Center for the Study of Drug Development

February 21, 2013

TUFTS CSDD EXECUTIVE FORUM

Protocol design strategies, such as decreasing the prevalence of unused protocol data, reducing protocol complexity, and limiting the number of protocol amendments, can decrease costs and streamline timelines. This roundtable will open with a presentation of recent Tufts CSDD findings on the incidence and cost of protocol amendments and unused protocol data, and will follow with a discussion on specific strategies to reduce protocol complexity and improve clinical study performance and cost. 

November 1, 2012 Exec Forum roundtable | Tufts Center for the Study of Drug Development

November 1, 2012

TUFTS CSDD EXECUTIVE FORUM

September 13, 2012 Exec Forum roundtable | Tufts Center for the Study of Drug Development

September 13, 2012

TUFTS CSDD EXECUTIVE FORUM

May 17, 2012 Exec Forum roundtable | Tufts Center for the Study of Drug Development

May 17, 2012

Academic-Industry Partnerships: Opportunities and Pitfalls

February 23 Exec Forum roundtable | Tufts Center for the Study of Drug Development

February 23, 2012

Managing the Transition from Nonclinical to Early Clinical Development

November 3 Exec Forum roundtable | Tufts Center for the Study of Drug Development

November 3, 2011

Resource Management and Other Strategies to Optimize Performance and Manage Pipeline Risk

September 15 Exec Forum roundtable | Tufts Center for the Study of Drug Development

September 15, 2011

Designing and Maintaining Successful Innovation Partnerships

May 19 Exec Forum roundtable | Tufts Center for the Study of Drug Development

May 19, 2011

Management Implications of the Global Regulatory Environment

Postgraduate Course | Tufts Center for the Study of Drug Development

February 1-5, 2016

Tufts CSDD Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation

PGC 2016 brochure coverTufts CSDD’s highly acclaimed, five-day Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation provides advanced instruction in practical and technical problem-solving in the areas of clinical pharmacology, drug development & clinical trial strategies, biopharmaceutical development, drug safety, and new drug regulation.

WHO SHOULD ATTEND THE COURSE

  • Physicians, pharmacists, marketing executives, clinical researchers, nurses, analysts, investors and any professional working with or in the research-based drug industry.  
  • Professionals looking to begin work in the pharma or biotech sectors, and are seeking comprehensive and foundational industry knowledge and training.
  • Individuals employed by regulatory agencies, academic institutions, outsourcing providers, consultancy firms, niche service providers, and other organizations involved in the research, development, and regulation of pharmaceutical products. 

COURSE GOALS
The goal of the CSDD Postgraduate course is to provide a broad and basic overview of topics related to pharmaceutical development and regulation for professionals involved in pharmaceutical and biopharmaceutical innovation.  Educational Objectives for CME - at the conclusion of the activity, participants will be able to:

  • Clinical Pharmacology: Integrate the relevant pharmacology, pharmacokinetics, and statistics related to drug development and the nature of evidence required for proof of efficacy and safety.  
  • Drug Development and Clinical Trials: Using a case-study approach identify and solve practical, theoretical, and technical problems in human drug studies, and analyze an experimental design for a new drug candidate. 
  • Regulation: Evaluate the science, laws, and regulations pertaining to the development and review of new drug products in the USA, Europe, Japan and other pharmaceutical markets.

 

PRICING

*Registration for the 2016 course has closed

 

February 24 Exec Forum roundtable | Tufts Center for the Study of Drug Development

February 24, 2011

Managing Global Investigative Sites for Peak Operational Efficiency

November 4 Exec Forum roundtable | Tufts Center for the Study of Drug Development

November 4, 2010

Strategies for Optimizing the Drug Development Process: Translational Science, New Technologies, and Clinical Design Improvement

September 16 Exec Forum roundtable | Tufts Center for the Study of Drug Development

September 16, 2010

Outsourcing Strategies Across the Value Chain

Tufts CSDD Executive Forum | Tufts Center for the Study of Drug Development

Tufts CSDD Executive Forum

The Tufts CSDD Executive Forum is the only roundtable of its kind focusing on pharmaceutical and biopharmaceutical development strategies and practices. Because the emphasis is on small group dynamics and discussion, space for each quarterly Tufts CSDD Executive Forum roundtable is limited. Don't miss out on your chance to be part of this exceptional, innovative, and unique program.

Tufts CSDD Executive Forum members receive the following benefits:

  • Opportunity for two attendees to participate in each quarterly Tufts CSDD Executive Forum roundtable.
  • Subscription to the Tufts CSDD R&D Management Report, summarizing the presentations and main discussion points of each roundtable.
  • Presentations by Tufts CSDD senior research staff on cutting-edge research on critical industry topics.
  • Opportunity to network with industry colleagues.

Tufts CSDD Executive Forum Dates and Topics:

May 12, 2016
Integrating Pediatric Studies into Adult Oncology Drug Development: Maximizing Efficiency and Economics While Meeting FDA and EMA Requirements

Time & Location:

Tufts Center for the Study of Drug Development
75 Kneeland St., Suite 1100
Boston, MA 02111
10:00AM - 4:00PM

May 13 Exec Forum roundtable | Tufts Center for the Study of Drug Development

May 13, 2010

Strategies for Managing Drug Development Risk: Maintaining Portfolio Diversity

February 25 Exec Forum roundtable | Tufts Center for the Study of Drug Development

February 25, 2010

Improving ROI and Late Stage Clinical Success Rates

Leadership Course | Tufts Center for the Study of Drug Development

July 12-13, 2016

Leadership for Drug Development Teams

This fast-paced two-day course brings together team leaders, program managers, functional directors and scientists from across the industry to build leadership skills for cross-functional R&D efforts. Created specifically for pharmaceutical professionals, this highly interactive, case-based program teaches you how to lead multi-disciplinary teams to collaborate effectively in face of the increasingly complex challenges of life science innovation.

Our curriculum has evolved in close collaboration with front-line professionals from across the spectrum of R&D - from drug discovery, pre-clinical research and clinical development to regulatory affairs, CMC, and marketing.

 

FEATURING
Merle Kummer, MBA
Learning Program Lead
Kummer Consulting LLC
Robert Putnam, EdD
Co-Founder
Action Design
Kenneth I Kaitin, PhD
Professor and Director
Tufts CSDD

LEADERSHIP SKILL MODULES INCLUDE:

  • Team dynamics – diagnosing barriers to progress.
  • Alignment – moving from unilateral to mutual action.
  • Cross-functionality – managing clashing perspectives.
  • Facilitation – creating productive conversations.
  • Knowledge creation – expanding your team's ability to learn.
  • Collaboration – bridging organizational boundaries

ACTION LEARNING COACHING COMPANION
This unique post-Course program won’t take time away from work: rather, you will prepare for real meetings, presentations, and decisions in up to seven confidential, individual learning sessions with lead instructor Merle Kummer. All sessions will be scheduled within three months after the course.

PRICING

  • Registration: $3,495
  • Registration w/ Coaching Add-on: $4,470
     
  • Tufts CSDD Sponsor Rate: $3,175
  • Tufts CSDD Sponsor Rate w/ Coaching Add-on: $4,150
     
  • Academic/Gov't/Non-profit rate: $3,075 (.EDU, .GOV, or .ORG)
  • Academic/Gov't/Non-profit rate w/ Coaching Add-on: $4,050 (.EDU, .GOV, or .ORG)
     
  • Special rates are available for groups of 3 or more, .(JavaScript must be enabled to view this email address) or call Jonathan at 617-636-0840 for all inquiries regarding registration.

ACCOMODATIONS

The course will be held at the DoubleTree by Hilton Hotel, 821 Washington Street, Boston, MA 02111. A block of rooms at the DoubleTree Hotel has been reserved for our Leadership course participants at a preferred rate of $279 a night. These rooms will be available at this rate until June 11, 2016. To book, contact the Double Tree Hotel at 1-800-222-8733 and be sure to mention the “Tufts CSDD Leadership Course” to obtain the preferred room rate.