Confirmed speakers. Sponsors

Transcription

1 Confirmed speakers Karen Paese, Director, Clinical Supply Chain Management, Gilead Sciences Richard Horn, Director, Clinical Supplies, Nektar Therapeutics Robert Bottome, Executive Director, Global Supply Chain, BioMarin Pharmaceuticals William Goure, Chief Operating Officer, Acumen Louie Burks, Clinical Supply Manager, Exelixis John Simons, Director of Clinical Quality Assurance, Gilead Sciences Justin Bourret, Engineer II, Genentech David Larwood, Chief Operating Officer, Valley Fever Solutions Ryan Landers, Supervisory Import Specialist/Trade Enforcement Coordinator, Pharmaceuticals & Chemicals Center for Excellence & Expertise Lilian Kee, Associate Director of Clinical Supply Chain, Achaogen Robert Bronstein, Director, Clinical Supplies Management, Dynavax Technologies Kavita Vermani, Senior Manager, Pharmaceutical Development, Adamas Pharmaceuticals Denise Steckel, Cancer Immunotherapy, Alliance Manager, Genentech Patrick Pillsbury, Senior Manager, Logistics and Trade Compliance, Portola Pharmaceuticals Heidi Hoffmann, Senior Director, Supply Chain and CMC Lead, Sutro Biopharma Johnny Zhang, Senior Manager Clinical Supply Chain, Biogen Scott Sabalvaro, Senior Supply Chain Analyst, BioMarin Sponsors

2 8:15am 8:50am 9 am Conference Name: Clinical Trial Supply West Coast 2018 Conference Date: May 23 rd 2018 Programme Day One Registration and refreshments Chair s opening remarks Reflecting change implementation into forecasting to increase the likelihood of adequately achieving new goals Adapting to change in operations such as an increase in distributing countries and/or patient members to meet growth goals Ensuring timeframes, labeling and supply is aligned with new distributing country regulations to avoid regulation breaches and consequent penalties Ensuring planning is flexible enough to deal with change to avoid resource wastage Maintaining supply without gaps in order to cater to demands and remain one step ahead in clinical trials Connecting new technologies that facilitate effective planning according to past patterns and future goals Robert Bottome, Executive Director, Global Supply Chain, BioMarin Pharmaceuticals 9:30 am Session Reserved for PCI Maintaining the temperature of increasing large molecule and protein-based therapies market in the Bay area to avoid product loss and the consequent costs incurred 10 am Connecting the increased large molecule and protein-based therapies market in the Bay area to suppliers with capabilities matching their the 2 to 8 degree temperature range requirements Matching the temperature-focused tests run by logistics providers to product range to ensure the integrity of products is maintained during distribution Outlining best practice in international shipping to ensure the quality and efficiency of products in transit in order to move closer to a common industry framework Distinguishing the best packaging materials to maintain the integrity of trial materials during transit and in trials Justin Bourret, Senior Engineer II, Genentech Interactive panel: Debating the efficiencies of comparator and placebo controlled trials 10:30am Highlighting the pros and cons of a comparators versus placebo trials to distinguish which is most conducive to a fair and accurate outcome Considering blinding options such as de-inking, over printing, over-encapsulating and over-coating as a means of getting a fair evaluation during trails to ensure data is not skewed by patient biases Identifying challenges in regards to the use of 222 forms in blinded tests and its negative impact on clinical site supply Closing the information gap between the clinical sites and contract packagers to facilitate the flow of materials to best compliment the clinical study Richard Horn, Director, Clinical Supplies, Nektar Therapeutics

3 Lesson Learning: Comparing the overlapping and contrasting landscapes of small pharma and big pharma companies 11:15 am Morning refreshments and networking Focus on Temperature control of protein substances in order to maintain product integrity throughout the clinical supply chain 11:45 am Comparison of available forms of shipping containers such as active versus passive, reusable versus single use and cartridge versus dry ice/gel packs Group review of available shipping services for temperature sensitive protein substances Discussion of experiences with different vendors Debate of pros and cons of local depots versus centralized warehousing for protein substances Heidi Hoffmann, Senior Director, Supply Chain and CMC Lead, Sutro Biopharma 12:15 pm Session Reserved for World Courier Exposé: Revealing the forecasted challenges for small biotechs in the pre-trial phase opposed big pharma challenges to initiate overcoming measures 12:45 pm 1:15am Predicting the difficulty of patient retention in studies requiring a change of lifestyle to strategise the best way of ensuring the study is able to progress with the ultimate aim of commercial release Highlighting emotional attachment as a means of securing the required patient pool for clinical trials Considering how high expenses, cultural differences, ambiguous consent procedures, personnel capabilities and site conditions can lead to difficulties in global clinical trials within emerging markets Assessing how the increased granting of responsibilities to the patient lead to high dropout and skewed data affecting the quality of clinical supply throughout the study? Understanding the impact of having minimal access to regulatory information due to the associated costs with the alternative of developing in-house regulatory knowledge William Goure, Chief Operating Officer, Acumen Pharmaceuticals Lunch and networking Focusing on technology as a solution to streamlining the clinical supply chain 2:15pm Technology Demo Showcase The showcase will include a shortlist of leading technology providers revealing their disruptive and targeted technologies. The selected providers offer solutions to current challenges being faced by both small pharma and big pharma companies within the clinical supply space. Particular focus will be placed on illustrating how these technologies can be implemented within existing processes that are both rigid and flexible. To include technologies such as: 222 documentation tracking VIP shippers as a form of reusable packaging Temperature controlled packaging Forecasting tools E-labels

4 IVRS system Data Integrity: Are you complacent about your compliance? 3:15pm 4:45pm 5:15pm Is your data storage process compliant? How do you become more cost effective by streamlining and automating your Event Log processes Are you audit ready? 21 CFR Part 11 Implement controls to maintain the integrity of your electronic records Nicole Nepomuceno, Program Manager, Sensitech Afternoon refreshments and networking Exploring transportation management software (TMS) and customized solutions for supply, kits and samples Flexibility to customize end-user experience & requirements by study, sample, kit & more Making data self-serve to all supply chain stakeholders Data centralization to monitor, manage & measure global supply chain activity Centralized shipment data for real-time visibility and tracking across all carriers Patrick Pillsbury, Senior Manager, Logistics and Trade Compliance, Portola Pharmaceuticals Using and advancing the use of machine learning as a tool facilitating clinical trial operations and improve efficiency in clinical supply 5:45pm 6:15pm Exploring the use of AI to identify the right pool of patients for the most accurate and relevant clinical trial results Showcasing AI as a means of organizing information through data pattern recognition whilst considering its influence on planning and forecasting Incorporating AI as a lesson-learning tool to expose issues in trial design thus initiating the re-design of more targeted and productive trials Revealing early signals of scientific breakthrough in clinical trials through AI as an indication of the overall success of the study Louie Burks, Clinical Supply Manager, Exelixis Chair s summary and close of conference

5 Conference Name: Clinical Trial Supply West Coast 2018 Conference Date: May 24 th 2018 Programme Day Two 8:15 am Registration and refreshments 8:50 am Chair s opening remarks Reviewing changes attributed to QP release and the potential impact of Brexit on distributing product to Europe Uncovering border control requirements to ensure your trial drug reaches their destination without delays 9 am Examining permit complexities with importing trial drugs into the US to prevent delays in your clinical trials Exploring import-export processes when shipping your drugs from central depots to trial sites to ensure your supplies are compliant with country specific regulations Establishing mechanisms through which clinical supply managers can be regularly informed about regulatory changes which impact drug supplies Considering advantages and disadvantages of manufacturing in one or multiple sites from an import/export perspective to overcome border controls Maximizing vendor knowledge to smooth the delivery of your trials Ryan Landers, Supervisory Import Specialist/Trade Enforcement Coordinator, Pharmaceuticals & Chemicals Center for Excellence & Expertise Planning for global clinical trials in light of potential changes to QP release requirements and a hard-brexit outcome 9:30 am Debating whether changes to Annex 16 have made requirements more or less stringent when distributing and running trials in Europe to adapt accordingly Exploring how changes in requirements may result in the difficulty of finding compliant CMOs Considering the ever-approaching impact of Brexit on UK-based partnerships whilst considering the use of alternative pathways to run global trials Highlighting the pros and cons of running trials in non-eu countries such as Georgia due to lack of regulatory resistance and increased pool of therapy naïve patients Robert Bronstein, Director, Clinical Supplies Management, Dynavax Technologies 10 am Session Reserved for Durbin Case Study: Utilizing a Global Network of CMOs for Phase 1 Trials 10:30am Understanding import challenges and transportation routes from DS, to FG and final delivery to patients. Ensuring shelf-life management is prioritized for minimal impact to clinical sites. Re-examining the roles of internal functional groups to maximize efficiencies and team effectiveness. Highlighting key factors that may contribute to significant delays in IP availability prior to first patient dosing. Lilian Kee, Associate Director of Clinical Supply Chain, Achaogen am Morning refreshments and networking Broadening the distribution network whilst overcoming local challenges

6 Distributing to emerging markets: Investigating the clinical trials landscape in Asia and Africa 11 am Stepping over the hurdles and showcasing the opportunities of running trials in Asia and Africa Contemplating whether some hurdles such as contrasting lifestyles, motivations and contextual factors can skew data leading to the impracticality of distributing to emerging regions Exploring how developments in countries such as Singapore have made import and customs obstacles almost obsolete Contingency planning for customs related delays in emerging markets to facilitate project continuity and limited additional workflow costs Finding compatible service providers in emerging markets to run and manage trials TBC What to do when CRO relationships go wrong to ensure clinical supply goals remain on track 11:30 am 12:15 pm Managing deliverables that do not match expectations in order to move forwards in the most productive way for the clinical study Ensuring CROs are adequately resourced to carry out tasks in line with clinical requirements Prioritizing the quality of customer service from your CRO team to secure open communication and effective results for clinical studies Comparing the quality of deliverables from CROs to big pharma opposed to small pharma companies. Dealing with high turnover within CROs and easing the impact it may have on the clinical study Highlighting the best practice when auditing CROs prior to agreement to ensure the best fit in terms of culture and capabilities for the project goal Switching CROs and the exploring the potential impact it will have on releasing drugs to the market Johnny Zhang, Senior Manager Clinical Supply Chain, Biogen Session Reserved Scott Sabalvaro, Senior Supply Chain Analyst, BioMarin 12:45 pm Session Reserved for RxSolutions 1:45 pm Lunch and networking Tracing the CMO relationship from start to finish to assure long-term and harmonious working relationships Selecting CMOs in Asia: What considerations should be made when selecting big player CMOs? 2.45pm Comparing and contrasting the benefits and shortfalls or using CMOs in Europe versus Asia Exploring where other potential big player CMOs are located as well as the possibility of partnering with them Navigating around informal regulations in emerging markets to avoid potential breaches as a result of miscommunication Establishing best practice for the interpretation of foreign regulation to ensure compliance in global trials Theorizing ways in which small pharmas can catch up to big pharma companies in establishing relations with regulators in emerging markets Looking at Samsung/Boehringer Ingleheim as a leading CMO John Simons, Director of Clinical Quality Assurance, Gilead Sciences

7 Selecting the right CMO for your specific manufacturing needs whilst ensuring continued productivity in light of emerging needs 3:15 pm Identifying the challenges in the CMO selection procedure such as overpromised capabilities to account for these prior to agreements Accounting for the differences in CMO-small pharma relationships and CMO-big pharma relationships to identify the best way to achieve collaborative success Highlighting potential hiccups between the CMO and sponsor to adequately have a pre-emptive solution Conducting an audit conducive to the alignment of CMO capabilities and the task in question to ensure the best outcome Karen Paese, Director, Clinical Supply Chain Management, Gilead Sciences GMP requirements for Different Phases of Manufacturing 3:45pm Kavita Vermani, Senior Manager, Pharmaceutical Development, Adamas Pharmaceuticals Case Study: Working with Partners in Caner Immunotherapy Combination Studies 4.15pm pm Looking what CIT means in cancer immunotherapy combination studies Working with CIT partners in order to optimize performance Highlighting the key factors in making CIT partnerships successful in order to ensure studies run smoothly Analyzing what happens after the first materials are moved and the study has started Denise Steckel, Cancer Immunotherapy, Alliance Manager, Genentech 4.45pm Afternoon refreshments and networking 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. Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables Roundtable 1 Roundtable 2 Detangling GMP requirements attributed to non-licensed products to accelerate trial products arrival to the clinic site Assessing the practicality of re-usable packaging in relation to quality, long term and short term cost and environmental impact Roundtable 3 5:45pm Finding the best approach to navigating importation tax to ensure accurate claim value and reduced product delays Chair s summary and close of conference