About Preclinical Development Operations Summit

Transcription

1 Prioritizing the sourcing and management of preclinical vendors for faster and more successful candidate development About Preclinical Development Operations Summit The Preclinical Development Operations Summit launched in 2016 in the East Coast, where a hub of preclinical development companies has flourished. Now, for the 3 rd year in a row, this platform brings recognized professionals in the preclinical development space annually to discuss, collaborate and network with a variety of key service providers and industry stakeholders to create innovative and collaborative ideas in order to understand and overcome preclinical development operations challenges presented in their own trials. As a new Conference, steadily growing larger and larger, this conference is steadily finding its feet in the preclinical scene in the East Coast to meet the lives of the scientists in the process of early drug development. Through constant collaboration and support with members of the local industry, this conference is ensured to have the latest trends in preclinical development and to inspire discussion on how to overcome preclinical challenges felt by our attendees 2018 Speakers Include: Conference Chairperson: Michael G. Palfreyman, Chief Scientific Officer, Amorsa Therapeutics Szczepan Baran, Global Head of Animal Welfare and Compliance Training, Novartis Eyal S. Ron, Chief Technology Officer, Gelesis James L. Sherley, CEO and Founder, Asymmetrex Harry Barnett, Executive Chairman, Lubris BioPharma Karin Zeh, Head of Program Management and Regulatory Operations, Zafgen Alexandros Makriyannis, Founder and Director, Center for Drug Discovery Lawrence J. Thomas, Director of Preclinical Research and Development, Celldex Therapeutics Diane Joseph-Mc Carthy, Vice President, Translational Science, Enbiotix Shiva Kazerounian, Principal Scientist, BERG Healthcare David Peters, Director of Toxicology, Summit Plc Frank Reynolds, CEO, CFO and CSO, PixarBio Corporation Barbara Hibner, President and CSO, PercepTx Christopher Kruczynski, Preclinical Safety Assessment, Vertex Pharmaceuticals Harold Smith, CEO, Oyagen Weng-Lang Yang, Chief Scientific Officer, TheraSource Sachindra Raj Joshi, Scientist, Preclinical Pharmacology, Acceleron Pharma, Inc. Theo Hatzipetros, Senior Scientist, ALS Therapy Development Institute Thomas Fitzgerald, Chief Operating Officer, Oyagen Anne Christensen, Associate Director, Stoke Therapeutics

2 Conference Name: Preclinical Development Operations Summit 2018 Conference Date: 14 th 15 th November 2018 Programme Day One 08:15 Registration and refreshments 08:50 Chair s opening remarks Managing Outsourced Vendors Effectively to Enhance Outcomes and Promote Efficiency 09:00 Determining the best communications structure for managing vendor relationships Deciding what and when to delegate to various members of the vendor s team Understanding the difference between managing large vendors and small vendors Recognizing the pros and cons of single point of contact How to deal with surprises and unexpected outcomes Harry Barnett, Executive Chairman, Lubris BioPharma 09:30 SPONSORED SESSION Generating ideas on how to manage a high volume of outsourced work to get the optimal effort from your CROs 10:00 Deconstructing challenges faced with working with CROs and effective processes to overcome them Managing the process of relationship development with the right CRO to reduce unnecessary consumption of time Unveiling mistakes and understanding the best way to work with CROs to strengthen relationships with your current and new vendors Emphasizing the importance of coordination and communication and how that benefits your work load and organisation of preclinical trials Eyal S. Ron, Chief Technology Officer, Gelesis Managing timelines to effectively stay one step ahead of your preclinical development 10:30 Managing preclinical toxicology studies to support the end goal of clinical plan Exploring Method development for bioanalytical (verify exposure) and dose analysis (verify dose level) Scheduling studies with the CRO and finding subcontractors for successful prioritization of workload Developing test article formulation to achieve sufficient bioavailability and exposure Applying translational biomarkers to preclinical studies David Peters, Director of Toxicology, Summit Therapeutics 11:00 Morning refreshments and networking Fuelling the Preclinical Program in Smaller Biotech Companies: Uncovering availability in funding. 11:30 Sharing priority in accessing funding and investment from groups with appropriate tolerance for risk and longer time to return on investment from drug discovery biotech companies Balancing basic research with the focus needed for preclinical development Biotech-lite: Defining capital needs based on core competency, outsourcing

3 Consultants and developing and patent estates as part of the costs of doing business Managing business relationship with fee-for-service CROs and government/foundation grants Harold Smith, CEO, OyaGen Inc 12:00 SESSION AVAILABLE TO SPONSOR SESSION RESERVED FOR STOKE THERAPEUTICS 12:30 SESSION RESEVED: Anne Christensen, Associate Director, Stoke Therapeutics 13:00 Lunch and networking Determining the right questions to assess which potential solution provider is engaged in your studies 14:00 Understanding more efficient method to find CROs - benefits, implications and drawbacks of word of mouth to find the best CROs most suitable for your area of expertize to find a partner that will take your vision to the best area possible Comparing the strengths and weaknesses in a multitude of vendors to determine the ideal skillset you will need to compliment your trial Discussing the best process to pick a vendor; Conducting preclinical laboratory research thoroughly in order to determine the best service providers for your research Strategically finding the best partners to create investment who understand the goals for your trials Defining what you need in a partner to evaluate how you can find the right skillset to successfully support your project Diane Joseph-Mc Carthy, Vice President, Translational Science, Enbiotix Standardizing tissue stem cells for improved preclinical applications for drug development and regenerative medicine clinical trials 14:30 Understanding concerns about shortcomings in the current standardization procedures used for preclinical analyses with cells in general Discovering the need for preclinical standardization of therapeutic tissue stem cells' number and function Focusing how stem cell standardization would increase preclinical applications for pharmaceutical drug development Observing how the lack of standardizing procedures for stem cells limits the quality of regenerative medicine clinical trials Discovering the large potential markets that would be created by effective standardization methods for tissue stem cells James L. Sherley, CEO and Founder, Asymmetrex 15:00 SESSION AVAILABLE TO SPONSOR Study Monitoring and the Benefits of Maintaining CRO/Sponsor Relationships 15:30 SESSION RESERVED : Christopher Kruczynski, Preclinical Safety Assessment, Vertex Pharmaceuticals 16:00 Afternoon refreshments and networking Investigating the standardization of laboratory procedures and literature to encourage the ease of data reproducibility across the industry 16:30 Uncovering why standardization of laboratory procedures is needed to create ease when pinpointing

4 the accuracy of preclinical data Sharing laboratory techniques within the preclinical development community in the East Coast to develop a comprehensive method of standardization for the ease of recreation across different laboratories Working closely with laboratories across the region to develop a method of standardization for laboratory literature and rid the unnecessary complication that could delay your preclinical trials Defining the difference between standardization of preclinical and clinical results and how to apply methods from the clinical side Generating literature to compare laboratory techniques to collect data and results as efficiently and effectively as possible Theo Hatzipetros, Senior Scientist, ALS Therapy Development Institute Discovering new methods of data organisation to accurately generate and interpret a higher percentage of results 17:00 Understanding the challenges faced in preclinical biopharmaceuticals in screening to prevent loss of results which could unnecessarily hinder your preclinical trials Organizing effectively data collection and screening for the collection of important results critical to developing into the next step of the preclinical trials Defining the advantages of organising data progressively to work smarter against your timeline Eliminating old styles of data collection techniques in favor of new, quicker and competent processes with a better clarification and coverage of your preclinical data Barbara Hibner, President and CSO, PercepTx 17:30 Chair s summary and close of conference Conference Name: Preclinical Development Operations Summit 2018 Conference Date: 14 th 15 th November 2018 Programme Day Two 08:15 Registration and refreshments 08:50 Chair s opening remarks PANEL DISCUSSION: Evaluating as whether preclinical drug candidates are ideal for clinical development to measure which trial will be the best use of your time Analyzing what preclinical drugs can progress towards the clinical phase and how you can prioritize your time, focusing upon the data that provides you the best return on investment Reviewing the optional steps for shortening timelines and focusing upon the drug candidate that brings the highest return on investment in terms of early drug development Determining the safety of preclinical drug candidates in a variety of different animal models to generate the most beneficial result that will promote your drug into the clinical phase productively Progressing efficiently towards clinical trials to help ensure preclinical drug candidates move forwards in the next step in development Understanding how to overcome challenges involved in preclinical development and how to manage them effectively from preclinical to clinical development Managing the process efficiently towards follow up studies once a criteria has been created for preclinical development Michael G. Palfreyman, Chief Scientific Officer, Amorsa Therapeutics

5 Alexandros Makriyannis, Founder and Director, Center for Drug Discovery Shiva Kazerounian, Principal Scientist, BERG Healthcare 09:45 SESSION AVAILABLE FOR SPONSORSHIP From Nonclinical Study to Regulatory Submission for efficient process of management 10:15 Understanding the different sources of data in order to correctly identify information needed within the regulatory reports Reviewing options for ensuring that all studies are captured centrally Understanding the importance of timely report preparation to effectively manage the process towards regulation Preparing use of reports for the long run Karin Zeh, Head of Program Management and Regulatory Operations, Zafgen Morning refreshments and networking Maximizing the translational switch between preclinical and clinical development to get the upmost information from your data from your techniques within the laboratory 11:15 Defining the worth of a project moving towards clinical trials, in order to establish investment in the best project that will return a higher financial return in investment in the long run Validating the trial results to gather if you have all the information needed to go forward into clinical phase in order to effectively use your time Analyzing the methodical approach of preclinical trials and the information needed to make informed decisions to progress your clinical development Focusing upon the timeline of your project to pinpoint stages and create a level of apprehensive control upon the data provided once advancing into clinical development Maximizing results to cover all possible angles of the preclinical development phase to ensure you have everything you need and to gather the best possible understanding from your data SESSION RESERVED: Frank Reynolds, CEO, CFO and CSO, PixarBio Corporation How Brexit will affect certain regulations in the upcoming years what you should be aware of and how to prepare when working with the UK 11:45 Understanding the potential pitfalls and benefits Brexit might develop in the UK, the USA and in Europe and ways to mitigate this Assessing whether regulations will differ from the UK to Europe and what does this mean for the US preclinical market Analyzing if the pharmaceutical international relationships between the US and UK needs more attention in the future Defining the changes in the relationship with international and British-based CROs and how to prepare Deconstructing whether Brexit could be beneficial to the US economy and possible insights to strengthen relationships with the British pharmaceutical industry SESSION RESERVED: Thomas Fitzgerald, Chief Operating Officer, Oyagen Inc

6 Animal models: Developing standardized animal models to help establish accurate results in preclinical development 12:15 Overcoming difficulties found in animal model creation with vendors and how to oversee effectively the creation of a standardized model of animal cell line Increasing reproducibility of animal models through implementation of digital assessment tools and how this affects the outcome in your development within a human cell line Increasing clinical relevance of animal models through alignment of clinical and preclinical digital endpoints Increasing efficiencies through refinement of data access and sharing processes in drug development Overcoming challenges in adaptation of novel preclinical models, emerging technologies and disruptive processes Szczepan Baran, Head of Emerging Technologies, Novartis 12:45 Lunch and networking 13:45 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. RT 1 RT 2 RT 3 RT 4 All roundtable session run twice, for 45 minutes, allowing delegates to attend up to 2 roundtables Collaborating effectively with vendors: What is the best method to recruit a vendor that will be able to work with you effectively to get the most understanding and critical results when outsourcing Lawrence Thomas, Director of Preclinical Research and Development, Celldex Therapeutics Understanding what you believe are the best methods to manage a multitude of CROs. Shiva Kazerounian, Principal Scientist, BERG Healthcare Unveiling challenges faced with the collection of data and discussing methods to help improve the obtaining of results Sachindra Raj Joshi, Scientist, Preclinical Pharmacology, Acceleron Pharma, Inc. Developing methods of timeline management when interacting with CROs and vendors in multiple countries Weng-Lang Yang, Chief Scientific Officer, TheraSource 17:00 Chair s summary and close of conference