Here is an overview of the conference programme. You can browse by category to see full details of the sessions you are most interested in or click on the tabs on the interactive calendar to see what's on each day. Clicking on any of the speakers or sponsors will show you more information about them and why they are supporting this event.
Jodie Morrison COO, Vice President of Clinical Affairs Tokai Pharmaceutical
• Analyzing performance measures and profit and loss margins to reach a common denominator in business motivations
• Customizing risk-sharing approaches to empower relationship building • Keeping the end in mind – designing today’s practices to achieve long-term goals • Defining key relationship milestones to assist conflict resolution • Establishing transparency in costs and profitability to excel at communication and expectation management throughout the organization • Learning efficient strategies that will help you solve the puzzle of continuous process improvement and efficiencies • Discovering how to effectively delegate authority to strengthen decision-making in alliance management • Managing the unmanageable – what can we do about change orders? • Where do investigator site relationships fit in the big picture? • Creating an appropriate issue escalation methodology• Promoting joint efforts in identifying sources of financial flexibility in the budget to cover unexpected change orders
• Demanding reasonable justification of a proposed change order to avoid increasing the budget beyond your means while adhering to natural trial deviations • Conveying the detrimental cost implications of change orders to clinical teams to foster real understanding and motivate the teams to find alternative ways to complete the study within the prescribed perimeters • Planning what actions you will take and who you will talk to if a certain scenario happens to make situations predictable and eliminate surprises • Leveraging the negative impact of a change order on your budget with the positive impact on the result of your study to make informed decisions about crucial out of scope changes • Learning how to critically query your CRO’s expert decisions to prevent sudden increases in costs• Investigating why oncology and rare diseases are different from other therapeutic areas when it comes to enrolling clinical trials to shed light on a new paradigm
• Exploring challenges of enrolling oncology and rare diseases and distinguishing them from other therapeutic areas • Uncovering the challenges of accruing patients in oncology and rare disease clinical trials • Shifting focus to the team providing healthcare to provide information and critical support to the treatment team and lower historic barriers to enrollment • Understanding what implications to approach for improving or changing process of clinical trials• Outlining the unique late stage development challenges for this rare disease treatment
• Exploring the effect the FDA comment and the SPA process played in honing the phase 3 strategy • Discussing which aspects of the program Raptor outsourced, and what was handled in-house and why • Explaining how the partner qualifications criteria were determined and analyzing whether this experience can serve as a model for future outsourced collaborations• Determining if your company should outsource the entire trial or rely on certain in-house expertise to maximize resources
• Challenging the concept of preferred providers to maintain competitive pricing and intelligent bids for best service at lowest price • Uncovering the perils of strategic alliances to adjust your outsourcing model well in advance and accommodate the appropriate level of flexibility for a functioning and well-oiled partnership • Scrutinizing various outsourcing models and learning from real experiences of small, medium and large pharma and biotech to discover your personal path for success• Exploring outsourcing strategies to maximize your resources when managing a CRO
• Understanding CRO initiatives to curtail the frequency of staff changes • Checking CRO for red flags for high turn over Exploring key actions sponsors can take to lower turnover rates at CROs • Advanced identification of your CRO’s approach to overall staff changes and plans for bridging the resulting gap to minimize quality damage • Identifying corrective action strategies in advance for seamless transition of key CRO staffStream A
Developing optimized outsourcing measures for fully integrated pharma organizations
Jodie Morrison COO, Vice President of Clinical Affairs Tokai Pharmaceutical
• Analyzing performance measures and profit and loss margins to reach a common denominator in business motivations
• Customizing risk-sharing approaches to empower relationship building • Keeping the end in mind – designing today’s practices to achieve long-term goals • Defining key relationship milestones to assist conflict resolution • Establishing transparency in costs and profitability to excel at communication and expectation management throughout the organization • Learning efficient strategies that will help you solve the puzzle of continuous process improvement and efficiencies • Discovering how to effectively delegate authority to strengthen decision-making in alliance management • Managing the unmanageable – what can we do about change orders? • Where do investigator site relationships fit in the big picture? • Creating an appropriate issue escalation methodology• Promoting joint efforts in identifying sources of financial flexibility in the budget to cover unexpected change orders
• Demanding reasonable justification of a proposed change order to avoid increasing the budget beyond your means while adhering to natural trial deviations • Conveying the detrimental cost implications of change orders to clinical teams to foster real understanding and motivate the teams to find alternative ways to complete the study within the prescribed perimeters • Planning what actions you will take and who you will talk to if a certain scenario happens to make situations predictable and eliminate surprises • Leveraging the negative impact of a change order on your budget with the positive impact on the result of your study to make informed decisions about crucial out of scope changes • Learning how to critically query your CRO’s expert decisions to prevent sudden increases in costs• Investigating why oncology and rare diseases are different from other therapeutic areas when it comes to enrolling clinical trials to shed light on a new paradigm
• Exploring challenges of enrolling oncology and rare diseases and distinguishing them from other therapeutic areas • Uncovering the challenges of accruing patients in oncology and rare disease clinical trials • Shifting focus to the team providing healthcare to provide information and critical support to the treatment team and lower historic barriers to enrollment • Understanding what implications to approach for improving or changing process of clinical trials• Outlining the unique late stage development challenges for this rare disease treatment
• Exploring the effect the FDA comment and the SPA process played in honing the phase 3 strategy • Discussing which aspects of the program Raptor outsourced, and what was handled in-house and why • Explaining how the partner qualifications criteria were determined and analyzing whether this experience can serve as a model for future outsourced collaborations• Determining if your company should outsource the entire trial or rely on certain in-house expertise to maximize resources
• Challenging the concept of preferred providers to maintain competitive pricing and intelligent bids for best service at lowest price • Uncovering the perils of strategic alliances to adjust your outsourcing model well in advance and accommodate the appropriate level of flexibility for a functioning and well-oiled partnership • Scrutinizing various outsourcing models and learning from real experiences of small, medium and large pharma and biotech to discover your personal path for success• Exploring outsourcing strategies to maximize your resources when managing a CRO
• Understanding CRO initiatives to curtail the frequency of staff changes • Checking CRO for red flags for high turn over Exploring key actions sponsors can take to lower turnover rates at CROs • Advanced identification of your CRO’s approach to overall staff changes and plans for bridging the resulting gap to minimize quality damage • Identifying corrective action strategies in advance for seamless transition of key CRO staff• Striving for streamlined convergence of expectations to boost positive team dynamics for the successful completion of your trial
• Generating common goals and milestones prior to study start-up to mitigate unfulfilled promises and promote timely execution of services • Assessing your ability to manage your CRO to avert the danger of the CRO managing and manipulating you to their advantage • Uncovering efficient strategies for exemplary CRO oversight to secure appropriate attention and maintain the highest quality of your project • Engaging the entire team in decision making on a constant basis to exploit fresh perspectives and unbiased opinions and eliminate counterproductive hierarchies • Generating efficient team-building exercises to inspire productive enthusiasm and find common ground in trial execution strategies• Training your CRO in strategic quality management to ensure that CRFs are completed in time as well as to the highest quality standard
• Exploring efficient methods for the logistical management of data for superior quality in the through-put of data • Establishing fast and easy access to pristine data for rigorous oversight to guarantee data integrity • Highlighting the importance of quality to site staff to extinguish the root cause for poor quality• Identifying keys to success when navigating Russia and Eastern Europe
• Uncovering crucial tactics for effective time and budget management • Exploring effective patient recruitment strategies to accelerate the successful completion of your study• Analyzing social media’s potential to determine patient eligibility and eliminate the need for time consuming and costly chart reviews
• Examining statistical proof of how the benefits of social media to unlock sites blocked by the company’s IT system • Exploring social media as a time- and cost-efficient tool for communication with potential patients to gain a competitive edge over stale and outdated devices • Scrutinizing social media from a legal perspective and analyzing its potential as a marketing and patient recruitment/retention tool to spearhead the electronic revolution • Assessing best practices to overcome the dangers of social media • Web listening • Control over negative feedback • Dos and Don’ts of promoting your trial online • Gaining insight into the FDA’s guidance document on the application of social media in clinical research to simplify the decision-making process in vendor selection• Identifying reliable biomarkers for diagnosing and treating Neuroendocrine Carcinoid tumors to reduce prevalence of these cancers
• Understanding what Pancreastatin (PST) is and how it is used to treat Neuroendocrine Carcinoid tumors • Developing and validating a Radioimmunoassay (RIA) for measurement of Pancreastatin levels in patients with Neuroendocrine cancers • Reliably measuring Pancreastatin levels using the Cambridge Biomedical RIA to detect of tumor progression more efficiently than currently used markers Chromogranin-A and Serotonin • Unveiling the stability of RIA measurements of PST levels and discovering a more dependable biomarker for assessing tumor progressionStream B
Achieving Operational Superiority for small companies, start-ups and virtuals
Jodie Morrison COO, Vice President of Clinical Affairs Tokai Pharmaceutical
• Analyzing performance measures and profit and loss margins to reach a common denominator in business motivations
• Customizing risk-sharing approaches to empower relationship building • Keeping the end in mind – designing today’s practices to achieve long-term goals • Defining key relationship milestones to assist conflict resolution • Establishing transparency in costs and profitability to excel at communication and expectation management throughout the organization • Learning efficient strategies that will help you solve the puzzle of continuous process improvement and efficiencies • Discovering how to effectively delegate authority to strengthen decision-making in alliance management • Managing the unmanageable – what can we do about change orders? • Where do investigator site relationships fit in the big picture? • Creating an appropriate issue escalation methodology• Promoting joint efforts in identifying sources of financial flexibility in the budget to cover unexpected change orders
• Demanding reasonable justification of a proposed change order to avoid increasing the budget beyond your means while adhering to natural trial deviations • Conveying the detrimental cost implications of change orders to clinical teams to foster real understanding and motivate the teams to find alternative ways to complete the study within the prescribed perimeters • Planning what actions you will take and who you will talk to if a certain scenario happens to make situations predictable and eliminate surprises • Leveraging the negative impact of a change order on your budget with the positive impact on the result of your study to make informed decisions about crucial out of scope changes • Learning how to critically query your CRO’s expert decisions to prevent sudden increases in costs• Investigating why oncology and rare diseases are different from other therapeutic areas when it comes to enrolling clinical trials to shed light on a new paradigm
• Exploring challenges of enrolling oncology and rare diseases and distinguishing them from other therapeutic areas • Uncovering the challenges of accruing patients in oncology and rare disease clinical trials • Shifting focus to the team providing healthcare to provide information and critical support to the treatment team and lower historic barriers to enrollment • Understanding what implications to approach for improving or changing process of clinical trials• Outlining the unique late stage development challenges for this rare disease treatment
• Exploring the effect the FDA comment and the SPA process played in honing the phase 3 strategy • Discussing which aspects of the program Raptor outsourced, and what was handled in-house and why • Explaining how the partner qualifications criteria were determined and analyzing whether this experience can serve as a model for future outsourced collaborations• Determining if your company should outsource the entire trial or rely on certain in-house expertise to maximize resources
• Challenging the concept of preferred providers to maintain competitive pricing and intelligent bids for best service at lowest price • Uncovering the perils of strategic alliances to adjust your outsourcing model well in advance and accommodate the appropriate level of flexibility for a functioning and well-oiled partnership • Scrutinizing various outsourcing models and learning from real experiences of small, medium and large pharma and biotech to discover your personal path for success• Exploring outsourcing strategies to maximize your resources when managing a CRO
• Understanding CRO initiatives to curtail the frequency of staff changes • Checking CRO for red flags for high turn over Exploring key actions sponsors can take to lower turnover rates at CROs • Advanced identification of your CRO’s approach to overall staff changes and plans for bridging the resulting gap to minimize quality damage • Identifying corrective action strategies in advance for seamless transition of key CRO staff• Collaborating with your vendor on a strategy for clear communication of issues and define stages of notification to optimize issue escalation
• Unveiling efficient techniques to create common objectives on a tactical level • Leading critical conversations about the team’s emotional perception of the partnership for faster conflict resolution • Outlining clear definitions of critical, noteworthy and futile issues to clarify which issues must be communicated immediately to avoid costly and time consuming issue escalation • Spelling out all levels of severity and updating plans and SOPs along the process for optimal trial oversight and readiness to tackle unexpected challenges • Designing an excruciatingly detailed scope of work to heighten the degree of accountability on both sides of the equation for a genuinely joint effort in the study’s success• Scrutinizing each vendor’s annual report to minimize the amount of overhead you will have to carry when committing to a long-term relationship
• Compiling objective decision criteria to determine the right fit • Acquiring at least three competitive bids from small, medium and large CROs for comparative reasons • Conducting a thorough financial analysis as a precaution to bankruptcy protecting yourself from unanticipated and costly rescue missions • Collecting references and actively contacting them for a current and accurate account of the CRO’s services • Generating detailed questionnaires to precisely measure the vendor’s level of engagement and amount of preparation during the bid defense meeting for effective vendor selection • Identifying connecting points you can drill down on during bid defense in order to examine the CRO’s ability to correctly cost services and assess if they match your expectations• Streamlining the collection process to PK labs to reduce the time it takes to complete your data lock allowing you to meet targets and lower costs
• Consolidating specimen collection and shipping and creating a single point of contact to accelerate the data cleaning process • Exploring best practices for a robust strategic relationship to secure a consistent exchange with your central lab • Creating strong ties to your central lab to efficiently facilitate the work order through a common understanding of data formats throughout the lifecycle of your study • Deploying periodic shipments to sub-vendors to eliminate duplicate shipments to sites to elevate user-friendliness and save money in reduced shipping • Introducing esoteric assays which stay volume-driven by protocols across the study program to allow you to meet study-specific deadlines• Discovering intelligent concepts that will help you reconcile the differences in SOPs when working with a multitude of CROs
• Generating a fail-safe work instruction for cross-vendor documentation for impeccable information overview and to keep a record of vital information in preparation of an FDA inspection • Defining the rules of play between all participants to harmonize trial procedures and work towards a common goal • Developing a sound communication plan to reach out to all vendors simultaneously and receive timely responses to vital queries • Identifying each person's exact role in the trial to eliminate duplication or work and set up clear lines of responsibility to minimize misunderstandings • Defining the flow of communication in small and big partnerships to harmonize your service providers' performance level and maximize your available resources• Juxtaposing business with clinical arguments to devise best practices in fund raising
• Uncovering effective strategies to close the gap in funding of Phase I and early Phase II studies to quickly get proof of concept • Developing an efficient exit strategy for Venture Capital firms and taking a virtual approach to outsourcing to wet investors’ appetites for efficient risk reduction • Assessing the outsourcing feasibility of some phase I units that are all-inclusive from a clinical operations perspective to enhance your timelines • Regularly evaluating the quality of your study and publishing milestone-based press releases to support your business case for further funding • Exploring innovative funding possibilities: learning how to incentivize charitable foundations and “philanthropic angels” to fund your early trials • Tapping into the financial resources of academic institutions and developing a mutually beneficial relationship to optimize the development of your compound
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