|
|
- Optimizing patient recruitment, data capture and trial design to ensure faster regulatory approval
- Keynote address: From design to decision-making from a clinical development perspective: effective project management techniques for ensuring your study runs smoothly
- Ensuring overall project management of trials in order to contribute to R&D excellence
- Managing the team: what makes a good compound leader and how to coordinate the internal teams and external stakeholders
- Establishing effective approaches to solve strategic problems and address challenges effectively
- Implementing trial design into practice: making the right decisions to boost strategic effectiveness of your trials within drug development
- Panteli Theocharous, Senior Clinical Project Scientist (Associate Director), J & J Global Clinical Development, JOHNSON & JOHNSON
- De-risking oncology clinical development: mitigating risk from phase I to III
- Phase I trial design: single agent or combination studies? Solid or haematological tumours? All tumour types or disease specific patient populations?
- Cost effective phase I studies: maximizing the information collected to inform decisions about phase II design and working with the right phase I sites
- Phase II study designs: the pros and cons of randomized phase II studies: indications and dilemmas
- Enriching patient populations in phase II development using biomarkers and genetics
- Feasibility assessments: how to ensure that recruitment rates quoted during feasibility are accurate
- Mitigating the risk to patient recruitment in phase II studies
- The decision to move into phase III
- Going for gold: moving straight to phase III from an expanded phase I program
- Clare Wareing, CEO, NEXUS ONCOLOGY
- Panel discussion: Improving the communication and cooperation between trial sponsors, academic research networks and study sites to maximize patient enrolment
- Complying with the study sites’ requirements from a sponsor’s perspective to ensure a smooth enrolment process
- Identifying key obstacles with sites and sponsors to cooperate with each other in terms of patient recruitment and how to overcome them
- Specifying actions to be taken by sponsors to help the site recruit
- Assessing how networks can work more closely with sponsors and physicians on-site to enroll patients effectively
- Handling competition between oncology trials at one site: how to build a strong sponsor-site-relationship o tackle this issue successfully
- Identifying crucial action points to prevent delays with patient enrolment in order to guarantee the study starts on time
- Chair: Clare Wareing, CEO, NEXUS ONCOLOGY
- Panellist: Prof. Christian Ohmann, Member of the Board, Network of Coordinating Centers for Clinical Trials, KKS NETWORK Elmar Stridde, Head of Clinical Study Centre, Clinical Centre of the Ludwig Maximillians University Munich Denis Mir, Senior Manager, Clinical Operations - Oncology, EISA, Global Clinical Development
- Assessing the feasibility of oncology clinical trials to ensure trials stay on track at any development stage
- Establishing the need for a feasibility assessment and the crucial points to consider to ensure an accurate measure
- Evaluating the benefits of feasibility surveys and how to measure them
- Outlining the sources of data that can be used to help plan oncology studies whilst ensuring the data quality is maintained
- Providing access to the data needed: presenting a PPD case study
- Martin Lee, Executive Director, Feasibility Services, Board Certified, Internal Medicine and Medical Oncology, PPD
- Understanding new regulatory considerations surrounding cancer clinical trials
- Explaining amendments to clinical trials guidelines in terms of continuous safety monitoring and reporting requirements
- Clarifying Eudralex Volume 10:
- New additions: Q&A document on safety reporting
- Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use
- Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in clinical trials
- International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): exploring the revision of the Development Safety Update Report guideline
- Janet Schriever, Unit Clinical Trials, BFARM
- Establishing innovative trial marketing approaches involving academic research networks and study sites to maximize patient enrolment
- Realistically forecasting the number of patients to be recruited to enable efficient trial execution
- Assessing the means to proactively communicate with sites in order to accelerate the process of finding appropriate patients
- Defining the role and responsibilities of CRAs in the recruitment process: how they manage to motivate and effectively communicate with sites in order to get them actively involved
- Working with CROs to optimize the recruitment process
- Facilitating cooperation between academic research organizations and the industry to inform the maximum number of experts and patients
- Outlining options to inform patients directly about a trial to encourage them to contact a clinician
- Ensuring compliance with ethics committee guidelines
- Leveraging eHealth affinity of cancer patients
- Finding new ways of cancer clinical trial marketing
- Jody Spooner, Business Development Associate, CMED
- Case study: Addressing the challenge of historical efficacy data in the design of a phase III study for a placebo-controlled chemotherapy trial
- Ensuring effective product development and understanding the resulting clinical efficacy data for adjuvant instillation therapy of gemcitabine in patients with non-muscle-invasive bladder cancer (NMIBC): An analysis following the outcome of a phase III trial: single postoperative instillation of gemcitabine in patients with NMIBC, reviewing the results of a randomized, double-blind, placebo-controlled phase III multicentre study
- Creating an effective study design based on an in vitro cell line, animal data, phase II data of the experimental drug and understanding of the phase III data for the control arm
- Presenting an overview of an unplanned interim analysis: follow-up during the study was terminated after only approximately 50% of recurrences occurred at the initially planned follow-up-period
- Understanding why final results showed not different but unexpected high rates for (recurrence-free survival RFS) in both arms
- Clarifying contributing factors to results: exploring the “experimental” setting of the placebo arm (instillation of saline)
- Clemens Stoffregen, Internist, Regional Tumour Team Leader, European Platform, Oncology, Medical Advisor, Lilly
- Moving towards personalized cancer therapies to increase the potential value of a medicine with respect to reimbursement
- Case study: Overcoming the operational challenges of implementing a personalized healthcare strategy in early phase oncology studies
- Developing medicines with improved and more predictable outcomes, thereby allowing the clinician to optimize the therapy
- Selecting biomarkers of interest in the context of novel molecules and identifying appropriate analytical laboratories and assay validation
- Burden on both the patient and investigational sites in the collection, processing and management of multiple samples which can be particularly challenging in the context of serial tumour biopsies
- Integrating laboratory based biomarker assessments with radiological assessments such as CT/PET or DCE-MRI within the same protocol
- Ensuring a high level of compliance consistency in sample collection both within and across clinical centers
- Obtaining the necessary ethical and regulatory approvals
- Receiving patient informed consent
- Thomas Pepper, Clinical Research and Exploratory Development(CRED), Operations Leader - Oncology (COL), Clinical Program Management - Study Management Group (PDEC-S), ROCHE PRODUCTS
- Identifying diagnostic testing methods to evaluate the results of your oncology trial effectively through the use of the right endpoints
- Keynote address: Exploring the amended guidelines of RECIST 1.1 (Response Evaluation Criteria in Solid Tumours) and learning how to adapt them accurately
- Understanding its use and benefits in clinical trials with a primary endpoint of objective response
- Evaluating the tumour response: assessing tumour shrinkage and disease progression based on the sum of diameters without anatomical-based imaging
- Outlining the relevant changes: Number of lesions to be assessed, measurement of pathological lymph nodes, confirmation of response, disease progression and imaging guidance
- Exploring remaining issues to be defined
- Identifying how to adapt RECIST 1.1 and leverage benefits
- Robert A. Morgan, Senior vice President, Regulatory Affairs, Quality, and Clinical Development, ZIOPHARM ONCOLOGY
- Uncovering independent central review (ICR) for oncology clinical trials: challenges and lesson learned
- Assessing endpoints in oncology trials and ensuring verification for regulatory approval
- Identifying the process of an ICR as well as resources involved
- Why ICR: outlining potential purposes and how to produce greater consistency in image interpretation
- Clarifying operational considerations
- Explaining discordance between local and central interpretations and how to handle this
- Overcoming challenges regarding protocol requirements
- Karoline Meurer, Managing Director, RADPHAR004D
- Case study: Moving beyond simple procedures like computed tomography (CT) to positron emission tomography (PET): highlighting advances of tumour development analysis
- Molecular imaging: making it real
- Imaging the hallmark of cancer with PET
- Angiogenesis, apoptosis, proliferation
- Enhanced amino acid transport
- Quality control in imaging clinical trials
- The importance of sophisticated analysis tools
- Jonathan Allis, Head Global Imaging Network, GE HEALTHCARE
- Explaining Primary Systemic Therapy (PST) or Neo adjuvant (Chemo) Therapy (NA(C)T) in invasive breast cancer: state-of-the-art, current issues, and future perspectives for drug development
- Explaining Primary Systemic Therapy (PST) or Neo adjuvant (Chemo) Therapy (NA(C)T) in invasive breast cancer: state-of-the-art, current issues, and future perspectives for drug development
- Broadening the indication for PST or NA(C)T from downsizing locally advanced, inoperable breast cancers to smaller breast cancers in order to allow breast conserving therapy (BCT) and to yield better cosmetic results
- Outlining the results of the large, randomized, pivotal phase III neo adjuvant trials NSABP B-18 and NSABP B-27 and explaining the advantages and disadvantages of neo adjuvant chemotherapy
- Using NA(C)T for in-vivo chemo sensitivity testing and as innovative platform for the in-vivo testing of new drugs, e.g. cytotoxic and molecularly targeted agents and their combinations
- Accomplishing a pathologic complete response (pCR), i.e. the absence of invasive tumour in the breast specimen and/or in the axillary lymph nodes, which shows PST to be a surrogate end point for recurrence and survival
- Testing in-vivo chemo sensitivity of new drugs and drug combinations in the neo adjuvant setting using the PCR-rate as a surrogate end point (i.e. substituting recurrence-free (RFS) and overall survival (OS) in the adjuvant setting) in order to speed up drug development in early breast cancer
- Presenting large, ongoing, neo adjuvant clinical trials applying this new paradigm in drug development in primary breast cancers according to their molecularly defined subtypes
- Wolfgang Hamm, MD, PhD, Senior Clinical Research Physician, HARRISON CLINICAL RESEARCH
- ADAPTIVE AND SEAMLESS DESIGNS FOR LATE STAGE ONCOLOGY STUDIES: examining actual interim analysis trial case studies and their impact on our industry and your own development efforts
- Assessing why adaptive approaches are increasingly common in early clinical studies, but only beginning to be utilized at the all important confirmatory stage
- Designing and implementing seamless phase 2 / 3 trials - defining the opportunities and challenges
- Re-estimating sample size and events for survival endpoints
- Determining efficacy and futility stopping rules in cancer trials
- Clarifying what to expect from regulators: best practices from recent experiences
- Yannis Jemiai, Ph.D., Associate Director of Biostatistics, CYTEL INC.
- Learning from case studies on novel therapeutic approaches: highlighting targeted, antibody and supportive care therapies
- Case study: A phase I-directed, non-clinical development strategy for a CDK-/kinase inhibitor: establishing nonclinical data to give guidance on phase I trial design in terms of the determination of safety/efficacy relevant endpoints and early warning signs for adverse effects
- A non-clinical testing strategy: an overview (PD, PK and toxicology)
- Specific aspects of individual non-clinical safety studies
- Dealing with drug-specific, non-clinical study findings
- Non-clinical study results and their impact on phase I clinical trial designs
- Regulatory feedback and overcoming related issues
- Thorsten Meyer, Associate Director, GPC BIOTECH
- Case study: IPH 2101, a novel anti-Natural Killer Immunoglobulin like Receptor (KIR) monoclonal antibody that enhances NK cells cytotoxicity: preclinical and phase I studies results in various hematological malignancies
- NK cell activation as a novel immunotherapy approach for the treatment of hematological cancers
- Pre-clinical development: pharmacodynamic and pharmacokinetic aspects and relevance of preclinical models
- Modelisation for dose ranging to be tested in phase I
- Designing the first in man study: selecting safe starting dose and escalation scheme
- Selection of indications to be tested in phase II and impact of potential surrogate endpoints
- Patrick Squiban, Chief Medical Officer, EVP Medical and Regulatory Affairs, INNATE PHARMA
- Overcoming operational challenges in large phase III oncology studies
- Choosing and managing CROs by proactively building a strong relationship with them
- Gaining access to laboratory and imaging data in a timely manner
- Considering the use of pharmacogenomics when running global clinical trials in order to evaluate scientific differences accurately
- Describing new testing systems and trial strategies based on the genetic differences of patients
- Monitoring the trial processes and increasing investigator site performance and productivity
- Understanding regulatory issues: how to get the right information and guarantee compliance with data guidelines
- Exploring approaches to speed up clinical operations processes to optimise the trial outcome
- Denis Mir, Senior Manager, Clinical Operations - Oncology, EISAI GLOBAL CLINICAL DEVELOPMENT
- Case study: Phase II trial designs in oncology: what really matters to ensure an optimum outcome using common and innovative methods and prevent failure of the trial at a later stage
- Establishing the purpose of phase II trials
- Assessing the success rate of phase III trials
- Outlining factors to reduce the number of failures
- Benefitting from using innovative ways to assess tumour burden
- Setting up statistical trial designs for phase II
- Validating biomarkers effectively
- Christiane Langer, Group Director Early Oncology, BRISTOL-MYERS SQUIBB EUROPE
- Supportive care in oncology: challenges and opportunities in drug development to improve outcomes for patients
- Emerging areas of toxicity with new therapies
- Meaningful endpoints in supportive care
- Specific challenges in running supportive care studies
- Patient reported outcomes and the regulatory perspective
- Old drugs for new problems
- Julian D. Howell, Head of Clinical Development, PROSTRAKAN
- Case study: Outlining skin toxicity of targeted therapies: epidemiology and management
- Understanding cancer epidemiology and clinical presentation
- Managing skin toxicity from a scientific c perspective
- Clarifying international guidelines
- Skin toxicities in clinical trials: presenter’s experience
- Establishing a guide for patients
- Investigator education
- Thomas Bogenrieder, Clinical Director Oncology, Oncology Centre of Excellence, Europe, Asia-Pacific, Japan & Emerging Markets, GLAXOSMITHKLINE
- Combining targeted cancer therapies successfully: what are the possibilities, crucial factors to be considered and solutions to benefit from?
- Deciding whether to combine targeted therapies or run sequential therapies: outlining the benefits of combination
- Explaining how to handle toxicity issues when complying with safety guidelines
- Leveraging synergetic effects of combined targeted therapies: how to make your targeted therapies more effective
- Exploring how to maximise the effectiveness of a targeted therapy choosing the right complementary therapy
- Outlining the combination opportunities between targeted therapy and radiotherapy: decisive parameters for an optimal combination
- Combining targeted therapy and chemotherapy: how to merge schedules effectively
- Creating strategies for reaching a balance between efficacy
- and safety to optimise the overall outcome of the combined targeted therapy
- Murray Yule, vice President Clinical Development, ASTEX THERAPEUTICS
More Oncology/Hematology reports by Arena International
Clinical Trials Oncology by Arena International
See all reports like this >>Synopsis
The proceedings of the Clinical Trials Oncology conference, including audio recordings of all presentations and Q&A sessions, as well as presentation slides
...
Research assistance
We can help you find what you need. Call us or write us: Need help in your search?
US: 800.298.5699
Int'l: +1.240.747.3093
Related Markets
Oncology/Hematology Reports
- Triple Analysis: Cancer Vaccines, Protein Kinase Inhibitors and Peptides
- Triple Analysis: Angiogenesis, Antibodies and Peptides
- Triple Analysis: Angiogenesis, Protein Kinase Inhibitors and Peptides
- Triple Analysis: Apoptosis, Antibodies and Peptides
- Triple Analysis: Apoptosis, Protein Kinase Inhibitors and Peptides
