OCT_New-England_2014_Agenda

http://www.arena-international.com/octnewengland

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6th

Annual Outsourcing in Clinical Trials New England, October 7-8 2014

The leading clinical outsourcing roadshow for the biotech, pharma and medical device industries

Over 50 industry leaders will be presenting at the conference, including:

Larry Blankstein Senior Director, Clinical Research Genzyme

Efi Kozorovitsky Roe WW Leader – Franchise Clinical Operations DePuy Synthes

Kenneth Olovich Director of Finance and Procurement Eli Lilly

Tia DeFeo-Fraulini Director, Clinical Operations CivitasTherapeutics

Hemant Patel Director Clinical Operations ImmunoGen

Katharine Stohlman VP Regulatory and Clinical Affairs Thermedical

Andy Soman Director Regulatory Strategy ETEX Corp

Zach Hallinan Director of Patient Communication and Engagement Programs, CISCRP

Sri Srivastava Director, Pre-Clinical & Early-Clinical Development, Aestus Therapeutics

Adrian Orr Clinical Research Director Haemonetics

Karin Daun Director of Clinical/Biomentrics Sourcing Eli Lilly

Dennis Goldberg President and CEO LipimetiX

Christopher LaFarge CEO & Chairman MedicaMetrix

Lynnett Voshage Stahl, Director, Global Clinical Project Management, Boston Scientific

Carol Lewis-Cullinan Senior Director Clinical Operations Forum Pharmaceuticals

Michael Dioguardi Clinical Project Manager Haemonetics

Lisa Virzi Clinical Trial Operations Manager Sanofi Aventis

Gordon Jamieson CEO Translational Therapeutics

Robert Arbeit Vice President, Clinical Development Idera Pharmaceuticals

Susan Stewart, Senior Vice President Regulatory, Quality and Compliance, Tokai Pharmaceuticals

Susan Flint Executive Director and Head of Clinical Operations, Oxyrane

Kevin Anderson Associate Director, Global Clinical Operations Alexion

Kathleen Findlen Head of Clinical Operations and Project Management, Piramal Imaging

Albine Martin COO Precision Biologics

Kathryn Stiede Senior Director Clincal Operations Lantheus Medical Imaging

Simona Cipra VP Clinical Operations Tesaro

James Weston VP Head of Global Regulatory Affairs Oxyrane

Colleen Graham Clinical Operations Lead, Global Clinical Operations, Biogen Idec

Steven Kates Adjunct Professor Northeastern University

Simona Cipra VP Clinical Operations Tesaro

Mike Sullivan Director Business Operations Pfizer

Linda Tedder Director US Clinical Project Management DePuy Synthes

Bernice Kuca Head of Clinical Operations CoLucid Pharmaceuticals

Sondra Smyrnios Senior Director Clinical Operations Alkermes

Keynote Presentation: ‘Anticipating How Patient Centric Clinical Trials will Profoundly Impact Sponsor-CRO

Relationships’

Ken Getz, Director and Associate Professor, Tufts Center for the Study of Drug


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Arena International’s 6

th Annual Outsourcing in Clinical Trials New England Conference, Boston

Program Day One – October 7

th 2014

07:45 Registration and refreshments

08:20 Chair’s opening remarks

08:30

Assessing public and patient perceptions and experiences with clinical research Reviewing recent results characterizing public and patient awareness and knowledge of

clinical research

Identifying perceived benefits and expectations from patients to assist sponsor companies in improving their recruitment and retention effectiveness

Targeting opportunity areas where recruitment and retention are most falling short

Exploring volunteer participation experiences and needs to help shape patient-centric clinical trial solutions

Zach Hallinan, Director of Patient Communication and Engagement Programs, CISCRP

09:00

Session reserved for Event Sponsor

09:30

Evaluating real applications of Risk Based Monitoring and how successful it has been

Determining how to implement RBM as an overall monitoring standard and guarantee quality

Highlighting results that indicate savings and other benefits from a RBM model

Providing updates on different regulations around monitoring

Analyzing how CROs can assist sponsors within RBM; the benefit of integrating monitoring processes

Looking at trends and successes in different companies and countries for RBM

Reviewing piloted RBM plans that have now reached FDA approval to uncover if there were any issues

Kathleen Findlen, Head of Clinical Operations and Project, Piramal Imaging

10:00

Session reserved for Event Sponsor

10:30

Morning refreshment break and networking


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11:00

Reflecting on post approval requirements and the need to conduct pediatric trials

Assessing changing expectations from FDA around conducting pediatric trials for all drugs

Highlighting particular challenges for conducting this branch of trials

Advising on how to overcome heightened caution and reluctance from patients

Exploring patient recruitment strategies that are suited to pediatric trials

Sourcing and convincing investigators to take on your pediatric trial

James Weston, VP Head of Global Regulatory Affairs, Oxyrane

Bringing business strategies about outsourcing models under the spotlight to see how these decisions are made [from a small company perspective]

Marrying up your trial needs with your existing resources and finances to determine what outsourcing model is both possible and appropriate

Sharing methods of assessing company/trial priorities which will point you towards the right model for you

Reflecting on various case studies that demonstrate success within different outsourcing models

Comparing risk-sharing approaches in different outsourcing models to determine how they differ

Reflecting on industry-wide trends with respect to preferred partnerships vs FSP models

Evaluating number of trials needed before undertaking in-house activities is cost-effective

Dennis Goldberg, President and CEO, LipimetiX

11:30

Session reserved for Event Sponsor Session reserved for Event Sponsor

12:00

Panel: Revolutionizing approaches to quality management structures, internally and with trial partners

Exploring how clinical compliance interact with corporate quality across different companies: what models exist and which are working

Investigating the growing trend for Clinical Operations departments to take on Quality Control to uncover why this is happening

Aligning your concept of QA with your partner so you are working towards the same standards

Working with your service providers to provide transparent and honest self assessments of quality and compliance

Installing an appropriate trigger system that flags areas on non-compliance or substandard quality – both with CROs and at site

Assessing how large multinational

Panel: Virtual Companies: creating and managing a CRO network

Details to follow

Albine Martin, COO, Precision Biologics Kathryn Stiede, Senior Director Clincal

Operations, Lantheus Medical Imaging Simona Cipra, VP Clinical Operations,

Tesaro


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clinical trials instill QA requirements in all their partners

Michel van Rossem, Director Clinical Research/Trial Operations Team Leader, Genzyme

Kate Didio, Clinical Operations, Ariam Pharmaceuticals & CereSpir

James Weston, VP Head of Global Regulatory Affairs, Oxyrane

12:30 Lunch break and Networking

2:00

Personalized medicine and the IVD process: getting going, not just getting started

Details to follow

Robert Arbeit, Vice President, Clinical Development, Idera Pharmaceuticals

Aligning different sites when conducting global clinical trials for greater continuity

Outlining roles and responsibilities of people in-country with respect to the overall Clinical Director

Putting in place data management systems that translate across countries, companies and sites so everyone can input easily into the same system

Juggling logistical and operation issues across multiple countries and sites to tie in your results together

Working with multiple different CROs on the same project

Streamlining multiple sites to allow for comparison between your results

Colleen Graham, Clinical Operations Lead, Global Clinical Operations, Biogen Idec

2:30


3:00

Panel: Overcoming specific challenges encountered within Orphan Drug clinical trials

Highlighting differences between Orphan Drug and other clinical trials

Juggling different time frames involved and adjusting project plans accordingly

Exposing details of Breakthrough Designation (and other regulatory issues) and how this can be used to your benefit

Reviewing examples of project finance for orphan drug trials that can help or

Panel: Tying together financial and operational perspectives when planning and running a clinical trial

Delving into how to fundraise for a clinical trial: considering the route of Big Pharma or Venture Capitalists

Translating company interests from contractual arrangements into trial delivery smoothly by involving different teams at all stages of the process

Exploring how different CROs charge for their time and the degree to which flexibility is possible


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hinder you

Tackling additional problems in patient recruitment that are unique to Orphan Drug trials

Larry Blankstein, Senior Director Clinical Research, Genzyme (a Sanofi company)

Susan Stewart, Senior Vice President Regulatory, Quality and Compliance, Tokai Pharmaceuticals

Robert Arbeit, Vice President, Clinical Development, Idera Pharmaceuticals

Susan Flint, Executive Director and Head of Clinical Operations, Oxyrane

Reviewing how Clinical Operations can budget better and share more information with their finance teams for mutual benefit

Kenneth G. Olovich, Director of Finance and Procurement, Eli Lilly

Kathleen Findlen, Head of Clinical Operations and Project Management, Piramal Imaging

Mike Sullivan, Director Business Operations, Pfizer

3:45 Afternoon refreshment break and networking

4:15


4:45

Analyzing case studies of conducting trials outside the USA: the MENA region and the specific challenges involved

Undertaking vendor sourcing without your usual tools and contacts to assist you

Identifying key differences regarding patient recruitment and interaction that are culture-specific to the region

Modifying your trial design to adapt to regional specifications with respect to business styles and language barriers

Highlighting regulatory differences that can help or hinder your trial progression

Adapting communication styles to ensure you get realistic estimate of approval times

Managing trial progress remotely by having adequate representation in-country and/or having appropriate metrics in place to keep you in-the-loop

Steven Kates, Adjunct Professor, Northeastern University

Enhancing project planning and contract negotiation from both sides in order to avoid change orders as much as possible

Accurately forecasting of timelines by sponsors and service providers to result in realistic plans

Addressing mis-matched expectations at the point of contract negotiation, before it is too late, enabling both parties to meet goals and prevent change orders from occurring

Establishing a system for open and transparent discussions around potential scope changes

Developing a process around change-orders ahead of time, so you are aware of your own flexibility and restraints

Noting lessons learnt from previous clinical trials so as to anticipate likely change orders and determine your flexibility around them should they arise

Hemant Patel, Director Clinical Operations, ImmunoGen

5:30 Chair’s summation and close of day one


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Arena International’s 6th

Annual Outsourcing in Clinical Trials New England Conference, Boston Program Day Two – October 8

th 2014

08:00

Registration and refreshments

08:20 Chair’s opening remarks Chair’s opening remarks

Finding the right partner Medical Devices

08:30

Determining whether bigger is better: sourcing the right size vendor for your trial

Finding vendors that offer skills, strengths and styles that match your priorities

Assessing the preferred provider model for evidence of improved efficiency and reduced costs

Evaluating if repeat partnerships result in higher quality trials

Ascertaining how and to what extent niche providers can potentially serve your interests better

Aiding you in comparing new vendor selection vs preferred providers to determine the best overall option for your next trial

Karin Daun, Director of Clinical/Biometrics Sourcing, Eli Lilly

Understanding the different sourcing models – pros and cons in a clinical operations environment

Exploring nuances of the different models (in sourcing, outsourcing, functionally sourcing)

Analyzing different cons and pros of each model by considering some practical examples

Evaluating the impact of each sourcing model on clinical programs

Determining which sourcing model is right for me?

Efi Roe Kozorovitsky, Director – World Wide Leader – Franchise Clinical Operations, DePuy Synthes

09:00


09:30

Panel: Facilitating continuity throughout your trial when your service provider is sub-outsourcing

Investigating the need for vendors to inform sponsors if they are sub-outsourcing and with whom

Navigating the issue of sub-outsourcing at the contract stage to elucidate on plans, capabilities and responsibilities and avoiding incorrect assumptions being made later on

Clarifying the role of sponsors in oversight/communications with 3rd party; what should they be doing and what produces better outcomes

Inspecting the grey area of liability when 3rd parties are used

Panel: Looking into selection processes to build best-practice in finding the right service provider for you

Outlining your trial needs and prioritizing these ahead of contract negotiations so you are aware of your own flexibilities

Researching your potential partners and short listing them in a fast and effective manner

Constructing a RFP that ensures you find out as much as possible ahead of bid defense meetings

Highlighting methods of understanding vendors’ true capabilities during the bid defense process

Building clear designations of


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Utilizing metric insight into performance of 3rd parties to check up on quality and the potential for a sponsor to request an alternative party should they be dissatisfied

Exploring the role of consultants and their ability to provide greater support and project management skills for more inexperienced companies

Tia DeFeo-Fraulini, Director, Clinical Operations, CivitasTherapeutics

Hemant Patel, Director Clinical Operations, ImmunoGen

Carol Lewis-Cullinan, Senior Director Clinical Operations, Forum Pharmaceuticals

responsibility into your contract to avoid confusion later on

Balancing the pros and cons of opting for a preferred provider or sourcing a new company

Considering the position of first-time trial managers: what to look for and how to protect your assets and interests

Christopher LaFarge, CEO & Chairman, MedicaMetrix

Lynnett Voshage-Stahl, Director, Global Clinical Project Management, Boston Scientific

Linda Tedder, Director US Clinical Project Management, DePuy Synthes

10:00

Morning refreshment break and networking

Project Management Medical Devices

10:30

Session Reserved, Detail TBA. Bernice Kuca, Head of Clinical Operations, CoLucid Pharmaceuticals

Delving into a case study of an IVD trial to uncover specifications around quality

Updating you on how the FDA is now distinguishing trials between quantitative and qualitative results

Evaluating the need to self-examine processes to ensure you are conducting your trial in the manner that is expected of you

Michael Dioguardi, Clinical Project Manager, Haemonetics

11:00 Session reserved for Event Sponsor Session reserved for Event Sponsor

11:30

Improving communications between partners for better trial oversight

Working more effectively together for mutual benefit

Increasing openness and sharing of needs, wants and deliverables

Combating miscommunications of expectations

Clarifying responsibilities for every part of the trial

Fully understanding the scope of each

Overcoming additional obstacles faced when conducting a clinical trial outside the USA

Working through contractual negotiations of a non-US trial and the extra concerns to be considered

Adapting your team, business style and trial management to local cultures and practices

Acquainting yourself with local understandings of role and


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others’ work for greater respect

Scrutinizing the extent to which optimizing protocols can have a knock-on impact on your entire trial

Training internal and partner team members to ensure everyone is on the same page

Sri Srivastava, Director Clinical Development, Aestus Therapeutics

responsibilities so there are no miscommunications or unfounded assumptions

Sourcing excellent local knowledge with which to navigate specific regulations, risks and liability issues that are different from the US

Positioning yourself appropriately in-country and/or remotely so you have adequate oversight

Katherine Stohlman, VP Regulatory and Clinical Affairs, Thermedical

12:00

Lunch break and networking

1:00

Exposing the true meaning of strategic partnerships through case study analysis

Outlining different concepts of a strategic partnership to see how much it varies across the sector and how common they are

Pinpointing features of partnerships which involve high level commercial and regulatory discussions

Determining when and where service providers should have a say in planning and protocol design

Assessing the potential for innovative pricing models that reflect more strategic high-level models

Asking what financial accountability the service provider takes on when following insight and input at of the trial construction

Evaluating advantages to having high-level insight from your service provider from end-to-end

Ensuring due diligence of both parties when involved in a more balanced relationship

Kevin Anderson, Associate Director, Global Clinical Operations, Alexion

Examining varying approaches to modeling clinical trials through case study analysis

Deconstructing stages within trial development to determine where there is scope for optimizing your model

Revealing potential behind online data systems for storing and sharing data across different trials and partners

Exposing the benefit of partnering with centers in terms of time, resources and cost

Combating issues of confidentiality and exclusivity when accessing large amounts of data

Adrian Orr, Clinical Research Director, Haemonetics

1:30 Session reserved for Event Sponsor Session reserved for Event Sponsor


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2:00

Keynote Presentation (for both Pharma/Biotech and Medical Devices streams):

Anticipating How Patient Centric Clinical Trials will Profoundly Impact Sponsor-CRO Relationships

Characterizing the patient centric clinical trials movement

Highlighting areas where patient centric strategies and practices are/will take hold

Describing areas where CROs are pioneering patient centric innovations

Forecasting ways that patient centric clinical trials will transform the drug development process and redefine sponsor-CRO collaborations

Ken Getz, Director and Associate Professor, Tufts Center for the Study of Drug Development

2:45 Session reserved for Event Sponsor

3:15 Afternoon refreshment break and networking

3:45

Speaker Hosted Roundtables Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. All roundtable session run twice, for 30 minutes, allowing delegates to attend up to 2 roundtables

Round-table 1

Exploring suitability of different outsourcing models Host: Robert Arbeit, Vice President, Clinical Development, Idera Pharmaceuticals

Round-table 2

Generating best-practice for [Medical Device] start-up companies Host: Andy Soman, Director Regulatory Strategy, ETEX Corp

Round-table 3

Reflecting on experiences of conducting trials outside the USA

Host: Katherine Stohlman, VP Regulatory and Clinical Affairs, Thermedical

Round-table 4

CMOs: Outsourcing From a Virtual Company Perspective: Maximizing Partnership Value Host: Gordon Jamieson, CEO, Translational Therapeutics

Round-table 5

Sharing strategies for optimal bid defense meetings Host: Lisa Virzi, Clinical Trial Operations Manager (CTOM), Sanofi Oncology

4:45 Chair’s summation and close of conference

OCT_New-England_2014_Agenda

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