Outsourcing in Clinical Trials West Coast 2020
Hyatt Regency San Francisco Airport
3rd-4th March, 2020
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Outsourcing in Clinical Trials West Coast 2020
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Arena International is thrilled to announce return of the leading clinical outsourcing and operations conference on the West Coast! The 12th OCT West Coast edition will be hosted in San Francisco on 3-4th March 2020.
Last year's event was attended by 700+ clinical trial stakeholders. Following its success, we are pleased to forecast the 2020 edition will be even in larger scale, with a great speaker line up and engaging content.
This edition aims to give attendees practical take-aways which they can apply to their studies.
The 2020 programme has four dedicated streams:
- Clinical Operations & Outsourcing
- Technology & Innovation
- Patient Engagement (NEW for this editions)
- Medical Device Trials
Attendees will hear talks from Dan Trigub, Head of Uber Health - who will give details on how to remove transportation as a barrier to care, as well as a keynote presentation from Microsoft’s Clinical Research Innovation Hub. Minorities in clinical trials and investment checklists for biopharma companies will be discussed during the practical workshops and for the first time a patient engagement stream will give participants the opportunity to debate best practices on how to include patient voices in clinical trials and the best approaches to recruitment. The day 2 of this executive summit will discuss the premise of Synthetic Control Arms during the Technology track and a case study will be given by Abbvie.
Do not miss this opportunity to network with your peers and learn best practices from the industry leaders.
We look forward to seeing you there!
WHAT TO EXPECT FOR 2020
The meeting place for healthcare pioneers and innovators
Join pharmaceutical, medical device and biotechs experts to discuss new trends and opportunities and learn how to optimize their clinical operation knowledge and stay ahead of the game.
Find the right solution providers to partner with to accelerate your trial timelines.
700+
ATTENDEES
95+
EXHIBITORS
40+
SPEAKERS
50%
ATTENDEES AT
DIRECTOR + LEVEL
Why Attend
NETWORK
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This is an exceptional networking opportunity for industry accelerators. Meet industry C-Suite and Director level executives to make valuable connection at this annual thought leadership platform.
LEARN
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Join like-minded peers to learn new perspectives and case studies through presentation, panel discussions, interactive round tables and workshops.
ACTION
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The conference discusses the vital connections between process, tools and techniques to manage change. Update your knowledge to create new strategies enabling you to enact change.
Ben Hwang
CEO,Profusa, Inc
Biography: From his early exposure as an undergraduate research fellow at the lab of Leroy Hood at Caltech where the automated DNA sequencer was developed, to bringing cutting edge life-sciences tools to the market at Life Technologies Corp. (acquired by Thermo Fisher Scientific, Inc.), Ben has both seen and led scientific and technological transformations that have changed our world for the better. Professional experiences: Life Technology, McKinsey and Company, Los Angeles Dodgers Education: Ph.D., The Johns Hopkins University
Session Details: CASE STUDY - Leveraging virtual reality to create patient-centric medical device clinical trials 04-03-2020, 3:15 pm View In Agenda
Hayley Lewis
Senior Vice President of Operations,Zosano
Biography: Hayley Lewis serves as the Senior Vice President of Operations, where she oversees the functional areas of Nonclinical, R&D, Analytical Development and QC, Operations and Engineering, Manufacturing, and Regulatory Affairs, and continues to be responsible for overseeing all regulatory interactions with the FDA and other government agencies. Hayley joined the company as the Vice President of Regulatory Affairs and Quality in October 2015. Prior to joining Zosano, Hayley spent over 11 years in Regulatory Affairs at Depomed, Inc., a specialty pharmaceutical company, where she was involved in the approval of 3 commercial products. Over the course of her career, she has enabled 9 investigational products to be studied in humans, 6 of which have advanced to completion of Phase 3 trials. Hayley’s pharmaceutical development experience, spanning over 20 years, covers solid oral dosage forms, and combination products such as systemic and local inhalation products, a single entity combination injectable, and transdermal systems. Ms. Lewis received a B.S. in Pharmaceutical Sciences from the University of Greenwich in England, and has attained several management diplomas from Kellogg School of Management, as well as Stanford’s Graduate School of Business.
Session Details: Getting FDA approval for your trial 04-03-2020, 9:00 am Speaker Hosted Roundtables 04-03-2020, 3:45 pm Speaker Hosted Roundtables 04-03-2020, 3:45 pm View In Agenda
Lian Cunningham
Senior Vice President,BAROnova
Biography: Dr. Cunningham is a veteran clinical executive in medical device industry. She currently serves as Senior Vice President of Clinical & Regulatory Affairs at BAROnova, a medical device company developing innovative solutions for the treatment of obesity. Over the past decade, she has been in clinical and regulatory leadership positions overseeing various stages of clinical programs, ranging from FIM to pivotal to post-market phases. She has a unique perspective in leading clinical programs in a dynamic startup environment.
Session Details: PANEL DISCUSSION - Do you outsource in the US or outside the US? 04-03-2020, 12:15 pm View In Agenda
Nick Damiano
Co-Founder & CEO,Zenflow
Biography: Nick is a serial entrepreneur with broad experience in medical devices and digital health. He has nearly fifteen years of experience as a healthcare entrepreneur, engineer, and leader. He is currently Co-Founder & CEO of Zenflow, a clinical-stage company developing a novel office-based therapy for urinary obstruction related to benign prostatic hyperplasia (BPH). Zenflow has raised over $35 million in funding and treated over 50 patients successfully to date. Zenflow originated in the Stanford Biodesign fellowship, where Nick and co-founder Shreya Mehta spent one year as fellows. Prior to Biodesign, Nick co-founded Avail MedSystems (f.k.a. Nurep), a company aiming to transform surgical support. Nurep allows medical device representatives to support operating room cases remotely via a mobile device. In this role, Nick led the technical development effort to bring the company's product to market and also played key roles in strategy, sales, and fundraising. Nick also spent four years as a Research Engineer at EBR Systems developing a leadless cardiac pacing system. In this role, he designed and implemented several key algorithms critical to the functionality of the device. Before EBR, he worked in R&D engineering for Kensey Nash Corporation and performed clinical research in Cardiothoracic Surgery at Washington University in St. Louis. Nick grew up on the east coast and earned his M.S. and B.S. with Distinction in Management Science & Engineering from Stanford University.
Session Details: Best practices for working with CROS across different global regions 04-03-2020, 11:45 am View In Agenda
Norm Gitis
Chair of the Board of Directors,Embolx, Inc
Biography: Norm Gitis has earned Ph.D. in Engineering, has authored over 150 scientific papers, three books and over two dozen patents, chaired and organized over three dozen international scientific conferences. Norm founded and ran two profitable test-instrumentation companies, Center for Tribology, Inc. in Mountain View (1994-2000) and CETR in Campbell (2000-2011). He was twice named by the Business Journal the CEO of Top 20 Fastest Growing Private Companies in Northern California. He is a managing partner of Lymo Ventures, Board chair of two medtech startups, Board observer of two other medtech startups. His investment portfolio includes two dozen med-tech and a half-dozen biotech startup companies. Norm serves on screening committees of Life Science Angels and Band of Angels, both in Silicon Valley.
Session Details: FIRESIDE CHAT - Strategies for effective trial design and securing funding 04-03-2020, 1:45 pm View In Agenda
Ritu Verma
Head of Global Clinical Affairs,Natus Medical Incorporated
Biography: Ms. Verma is Director of Global Clinical Affairs with Natus Medical, founder and President of ClinVitals and Advisory member with Wai Technologies bringing extensive expertise in Medical Device clinical research and product development. A recognized health care and life science leader with more than 20 years of mentoring experience, leadership skills, strategic thinking in multi-therapeutic acumen. Ms Verma has served several start-up and public firms encompassing all phases and types of Medical Device clinical research.
Session Details: Overcoming major data management challenges in device trials 04-03-2020, 10:15 am PANEL DISCUSSION - Do you outsource in the US or outside the US? 04-03-2020, 12:15 pm Speaker Hosted Roundtables 04-03-2020, 3:45 pm Speaker Hosted Roundtables 04-03-2020, 3:45 pm View In Agenda
Vinod Mahendroo
CEO,Vitruvian Medical Devices
Biography: Mr. Mahendroo is CEO of Vitruvian Medical Devices, an early stage start-up developing medical devices and therapeutics focused on the wound care market, founded by two UCSF professors and surgeons. He is also an active Lifesciences Angel Investor with 15 investments in companies ranging from advanced medical devices to CAR-T cell therapeutics. He is a founding Board member of Flock Software, Inc., member of the Band of Angels, Sierra Angels & Life Science Angels, and has served on the Board of Investment Groups (Life Science Angels), Private Companies and Non-Profits (The Tech, San Jose, CA). He has been CEO of two VC-backed start- ups & COO of a third one (all achieved liquidity), raised over $50M in VC and strategic funding, and is an active mentor at StartX at Stanford University. He previously worked at Applied Materials, as Chief Marketing Officer and President of the Global Services Business Unit, at Chips and Technologies as Head of Marketing, and at Intel, in Marketing and Operational roles across different product lines. He has extensive experience in marketing technology products in global markets, and in all parts of revenue generation from market exploration and product definition to early sales, scale up, managing the supply chain, manufacturing, distribution and service. Mr. Mahendroo has a Bachelor of Technology degree in Electrical Engineering from the Indian Institute of Technology, Delhi, and an MBA from Harvard Business School. He is a winner of the IIT Delhi Distinguished Alumni award.
Session Details: FIRESIDE CHAT - Strategies for effective trial design and securing funding 04-03-2020, 1:45 pm View In Agenda
Anthony Orosz
Assistant Director, Pharmaceuticals & Chemicals Center for Excellence & Expertise US Borders and Customs,
Paul Slater
Co-Founder, Clinical Research Innovation Hub,Microsoft
Biography:
Session Details: KEYNOTE- Microsoft Case Study: Delving into the future of clinical research and identifying best practices for accelerating innovation 03-03-2020, 9:30 am View In Agenda
Ivan Chan
VP, Global Head Statistical Sciences,Abbvie
Biography:
Session Details: PANEL DISCUSSION - Why are Machine Learning and AI techniques gaining traction in the life science industry? 03-03-2020, 1:45 pm Abbvie Case Study: Introducing the Synthetic Control Arm 04-03-2020, 9:00 am View In Agenda
Jacqueline Mardell
VP Clinical Operations,Ascendis Pharma
Biography: JACQUIE MARDELL has over 35 years of pharmaceutical and biotech industry and education experience. She has a broad background in planning, implementing, monitoring and analyzing clinical development programs, has built clinical operations organizations and led teams in the execution of clinical programs in a wide variety of therapeutic areas in industrialized and emerging countries, and has contributed to several successful product registrations. For 15 years she taught the Good Clinical Practice and elective courses at the UC Santa Cruz certificate program on clinical trial design and management, and she is a regular columnist for ClinicalTrialsArena.com.
Session Details: LIVE DEBATE- Patient recruitment is most successful when taking the grass roots approach compared to investing in social media 03-03-2020, 11:00 am SPOTLIGHT- Evolving clinical trial outsourcing models and considerations - What really matters? 04-03-2020, 9:00 am View In Agenda
April Binder – Lewis
Senior Director R&D Technology,GSK
Biography: April Lewis currently leads the technology strategy for GSK's Trial Operations and Site Engagement portfolio. Prior to joining GSK, April served at the GM for IQVIA's Clinical Trial Optimization Solutions, was a member of the Executive Merger Team for Quintiles/IMS, and led several performance improvement and transformation exercises in clinical operations for Covance, RapidTrials, Merck and Wyeth. April holds an M.S from Saint Joseph's University in Organizational Development and Organizational Psychology.
Session Details: Leading the charge to redefine and modernize GSK's technology approach to enable successful trial planning, operational and site engagement 03-03-2020, 2:45 pm View In Agenda
Yu Ping Yen
VP Clinical Operations,Dance Biopharm
Biography:
More than 25 years of hands-on experience and working knowledge in clinical development and operations in both diagnostics and therapeutics at the Senior Director and Vice President capacity. Track record includes delivering supportive clinical data culminating in multiple NDA/BLA and PMA/510(k) product approvals in the US and EU. Experienced in leading highly motivated in-house clinical and cross-functional teams, vendors and CROs in strategic planning and execution of early to late phase clinical trials in oncology, immunotherapy, CNS, CVD and upper respiratory disorders in a cost-effective and timely manner. Experienced in planning and executing complex, hard to recruit, large global studies across 5 continents. Authored publications, protocols, study documents, training material and mentored direct reports.
Session Details: PANEL DISCUSSION 03-03-2020, 11:00 am THINK TANK - CRO selection and planning ahead for Phase II: With such a crowed CRO landscape how can we differentiate and make a choice? 03-03-2020, 1:45 pm View In Agenda
David Larwood
CEO,Valley Fever Solutions
Biography: David Larwood is a founder, the CEO, and chief chemist for Valley Fever Solutions, running the manufacturing process for a novel antifungal headed for Phase 2a trials in summer 2020. In his role as BD lead, he is responsible for many aspects of the company’s planning and operations. Valley Fever Solutions is a small startup working first on a new and improved treatment for Valley Fever (coccidioidomycosis). Their NikZ will transform the standard of care. Mr. Larwood co-invented his first two commercial molecules before age 30. His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today, where he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. As a bench chemist, he was the first to make Iotrolan, a CT contrast agent, now generic. Moving to law, he advised well known companies on patent matters, later moving to Apple Computer. Later, he took a VP role at startup FormFactor, staying in an IP role, then became the first General Counsel for startup Verisity Design, taking them public in 2001, then ultimately through acquisition in 2005. Mr. Larwood is the third of his family to be involved in Valley Fever. His father was a clinician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. His mother started a foundation in about 1998 and raised some $20M for research into vaccines against Valley Fever.
Session Details: Establishing how best to position your study design to maintain an agile protocol 03-03-2020, 8:30 am PANEL DISCUSSION 03-03-2020, 11:00 am View In Agenda
Paul Slater
Co-Founder,Clinical Research Innovation Hub, Microsoft Corporation
Biography: Co-Founder, Clinical Research Innovation Hub, Microsoft Corporation The Clinical Research Innovation Hub (CRIH) is the first industry focused internal startup in Microsoft. Innovation hubs are engines that allow Microsoft to focus on pressing industry problems by combining the speed, agility and autonomy of a startup with resources available to a large enterprise. CRIH analyzes problems deeply through interviews and experiments, then rapidly builds solutions alongside Microsoft customers and partners. Paul is responsible for the strategy of the innovation hub, for establishing a target technology architecture for clinical research, and for building partnerships within and outside of Microsoft that realize the transformation vision. Microsoft and its partners are building solutions that will allow end-to-end digitization of the study, maximize the value of research data and ensure patient needs are met as research modernizes. Paul has been at Microsoft for 8 years. Prior to his current role he worked as Worldwide Director of Industry Strategy for Life Sciences, and as a Director of Enterprise Architecture, focused on developing incubation solutions in the life sciences industry and multiple other industries, including energy production, discrete manufacturing, financial services and education. Before joining Microsoft, Paul was a Senior Enterprise Architect at Weyerhaeuser – a global forest products company. He was responsible for the overall technology architecture of the organization, developed Weyerhaeuser’s virtualization, cloud and security strategies, and defined a target architecture for shared services across multiple lines of business. He is the author or co-author of multiple papers and books on both health and technology issues. He has delivered keynote addresses at multiple conferences in the United States and Europe, including CDISC Interchange, BME Global Pharma Supply Chain Congress, Parexel Horizons, and the Society for Clinical Data Management. He holds a Bachelor of Science (Hons) in Mathematics from King’s College. London.
Session Details: View In Agenda
Ryan Tubbs
Co-Founder, Clinical Research Innovation Hub,Microsoft Corporation
Biography: Co-Founder, Clinical Research Innovation Hub, Microsoft Corporation The Clinical Research Innovation Hub (CRIH) is the first industry focused internal startup in Microsoft. Innovation hubs are engines that allow Microsoft to focus on pressing industry problems by combining the speed, agility and autonomy of a startup with resources available to a large enterprise. CRIH analyzes problems deeply through interviews and experiments, then rapidly builds solutions alongside Microsoft customers and partners. Ryan is responsible for the operations of the innovation hub, for the management of the portfolio, and for creating the conditions for agile and open innovation. CRIH is enabling Microsoft and its partners to conceptualize, incubate, and ultimately deliver the technology innovations that will drive the adoption of new clinical research paradigms. Ryan has been with Microsoft for 12 years. Prior to his current role he served as a Chief Transformation Officer for the US subsidiary, responsible for designing and executing change management strategies for transforming sales, marketing, and services operations for the $33B business. Before joining Microsoft, Ryan was the CIO for the City of Chicago city council, responsible for implementing IT policies and data security protocols to protect the integrity of sensitive citizen and employee data. He partnered with Microsoft and implementation partners to modernize and transform dozens of legacy systems, enabling greater transparency in government and more citizen-centric applications. Ryan holds a Bachelor of Science in Chemical Engineering from North Carolina State University and a Master of Business Administration from Duke University (The Fuqua School of Business).
Session Details: View In Agenda
Alexandre Schappo
Global Solutions Engineer,Furukawa
Suman Nambiar
Global Head – Strategy, Offerings & Alliances,Mindtree
Donald Kellerman
VP of Clinical Development and Medical Affairs,Zosano Pharma
Biography: Donald Kellerman is the Vice President of Clinical Development and Medical Affairs for Zosano Pharma. Dr. Kellerman has more than 30 years of experience working in several areas of the pharmaceutical industry, primarily clinical development. Dr. Kellerman has led registration trials in a number of therapeutic areas, including respiratory, allergy, ophthalmology, cardiovascular, and neurology. From 2008 to 2013, Dr. Kellerman served as Senior Vice President, Clinical Development and Medical Affairs at MAP Pharmaceuticals, Inc., where he led the development of Semprana for migraine. Prior to joining MAP, Dr. Kellerman held management positions at Inspire Pharmaceuticals, Inc. Glaxo Wellcome, plc, Sepracor, Inc., Ciba-GEIGY Corporation, and E.R. Squibb and Sons, Inc. He has served as project leader on multiple development teams including those working on Flovent,® Advair,® and Xopenex®. Dr. Kellerman received his Bachelor of Science and Doctor of Pharmacy from the College of Pharmacy at the University of Minnesota. He has authored major sections of eight NDAs, created labelling strategy for several pharmaceutical products, and has co-authored over 80 publications related to the results of clinical development activities.
Session Details: Chairman’s Opening Remarks 03-03-2020, 8:20 am PANEL DISCUSSION 03-03-2020, 11:00 am Budget Negotiations: Is the process optimized? 03-03-2020, 2:45 pm View In Agenda
Dr Elise Brownell
Executive Vice President of Operations and Project Management,Amarantus BioScience
Biography: Elise Brownell, PhD. has spent the last 35 years in the bio/pharmaceutical arena where she has played key roles in Discovery, Development and Opportunity Assessment to drive innovation. After completing her doctorate at Yale University, Elise’s career started at SUNY Stony Brook. She continued her interest in comparative molecular biology during her tenure at Frederick Cancer Research Facility and expanded her facility with molecular genetics while in various functions at Bayer Healthcare. Her efforts were widely recognized by promotion to Director, Project Management, where she led global cross-functional teams. Elise also became a member of the founding team of a venture-backed spin out (Aerovance, Inc), where she became head of project management. Dr. Brownell serves in Interim Executive capacities for a number of emergent and highly innovative companies in the Life Science sector, and as a mentor to the entrepreneurs who run them. Elise received her MS, MPhil and PhD from Yale University, and her BS from Allegheny College
Session Details: WORKSHOP: Syncing the investment checklist for both large and small biopharma companies: What are investors looking for? 03-03-2020, 3:30 pm PANEL DISCUSSION - Exploring ways to negotiate and manage study budgets to ensure resources are allocated efficiently 04-03-2020, 2:45 pm View In Agenda
Archana Sah
Therapeutic Area Leader, Oncology, Director,Genentech
Biography:
Session Details: FIRESIDE CHAT - Immuno-oncology and personalized cell therapies have proven to be one of the most promising to advance oncology clinical research: But how can we combat the operational challenges? 04-03-2020, 12:15 pm View In Agenda
Jordan Glenn
VP of Clinical Development,Neurotrack
Biography: Jordan Glenn, Neurotrack, VP of Clinical Development Jordan has a diverse background in the digital health space where he has used his expertise in exercise, nutrition, and the psychology of behavior change to focus on disease states such as diabetes and now Alzheimer’s disease. As Neurotrack’s VP of Clinical Development, he helps lead business development/partnerships while also informing the company's research pipeline.
Session Details: PANEL DISCUSSION 03-03-2020, 11:00 am CASE STUDY - Unlocking the potential of digital therapeutics 04-03-2020, 12:15 pm View In Agenda
Bruce Morimoto
Vice President, Drug Development,Cerecin Inc
Biography: Bruce has over 22 years of experience in leading project teams in the development of innovative medicines, as well as providing strategic guidance, designing preclinical and clinical development programs, and advancing the development of new therapies. Previously, Bruce held leadership roles at Alkahest, Celerion; and Allon Therapeutics. His therapeutic expertise is in CNS indications like Parkinson, Alzheimer and frontotemporal dementias. He started his career on the faculty in the Chemistry Department at Purdue University where his independent research focused on neuronal signal transduction. Bruce earned his doctorate in biochemistry from UCLA and completed a postdoctoral fellowship at the University of California Berkeley.
Session Details: Conducting Phase I studies in renal impaired patients: Exploring points to consider and lessons learned 04-03-2020, 11:15 am View In Agenda
Stephanie Molteni
Associate Director, Site Budgets & Contract Management, Clinical Operations,Ultragenyx Pharmaceutical Inc
Biography: Stephanie Molteni, JD, Associate Director, Site Budgets & Contract Management, Clinical Operations, Ultragenyx Pharmaceutical Inc. Stephanie Molteni is the Associate Director, Site Budgets & Contract Management, Clinical Operations, at Ultragenyx Pharmaceutical Inc. where she oversees a team who manages the global investigator site budgets and contracts. Stephanie is also responsible for the strategic development of the group, focusing on process refinement, key performance indicators and change management. Stephanie has worked with contracts and budgets for more than 20 years, 10 of which at a large medical device company. Prior to entering the biotech industry, Stephanie spent several years in compliance, contracts and operations within the insurance industry.
Session Details: Speaker Hosted Roundtables 04-03-2020, 3:45 pm View In Agenda
Neil Vivian
Senior Director of Business Solutions and Product Manager,OmniComm
Biography: Neil Vivian joined OmniComm in 2009 as Senior Director of Business Solutions and Product Manager. He is responsible for providing technical support to the Business Development group in positioning OmniComm Applications and Services to potential and existing clients. His Product Manager role responsibilities include providing guidance and high level business requirements for new product features based on his industry experience and understanding of new emerging Regulatory Guidance. He has over 40 years’ experience in the software industry, 26 of those focused on Life Sciences built from a solid foundation in the Defense Industry. He has a BSc in Physics and Engineering Science and MSc in Information Technology.
Session Details: Patient Engagement – the future of clinical trials will change 04-03-2020, 11:45 am View In Agenda
Daniel Trigub
Head of Uber Health,Uber
Biography: Dan Trigub leads Uber Health. Before Uber, Dan spent 2.5 years at Lyft as Regional VP of healthcare partnerships. Dan has over ten years of experience in healthcare and founded several companies, including OpenPlacement, a care coordination platform allowing hospital professionals to connect with post-acute care providers for their patients at the moment of discharge. Dan worked in consulting and investment banking in healthcare, and his family owns one of the largest privately-owned homecare business in the Bay Area.
Session Details: UBER CASE STUDY: Removing transportation as a barrier to care 03-03-2020, 12:15 pm View In Agenda
Alia Hawkes
Senior Director , Clinical Compliance, FibroGen,
Biography: Alia is closing in on a 20 year career in the biotech industry where she spent most of her career in Drug Safety. She has worked for large and small biotech companies throughout the Bay Area but has worked at her current company, FibroGen, Inc., since 2010. She took on Drug Safety Compliance in 2013 which brought her over to Clinical Compliance in 2017 where she took on the Trial Master File and other operational compliance functions. Alia is a board certified Family Nurse Practitioner and Registered Nurse and attended UC Berkeley and the University of San Francisco.
Session Details: PANEL DISCUSSION : Considering a small company’s perspective on eTMF management for effective running of your clinical trial 04-03-2020, 10:15 am View In Agenda
Laurin Vincent
Head, Supplier Performance Management,Genentech/Roche
Biography: Laurin Vincent holds the position of Head, Supplier Performance Management at Roche/Genentech, located in South San Francisco. In this role, she is responsible for the supplier oversight, sourcing and the governance ecosystem for vendors used in late phase studies. She has over 18 years of clinical development experience in various roles and companies. She joined Roche in October 2013 managing strategic partnerships across the technology and clinical sectors. Prior to joining Roche/Genentech, she worked at Amgen as well as technical vendors/ CRO’s.
Session Details: SPOTLIGHT- Evolving clinical trial outsourcing models and considerations - What really matters? 04-03-2020, 9:00 am View In Agenda
Mark J. Milberg
Director, Clinical Procurement and Outsourcing,Ultragenyx Pharmaceutical
Biography: Mark Milberg has over 27 years of management and operational experience in the biopharmaceutical, medical device, and healthcare industries. He currently works as Senior Director, Clinical Outsourcing at Ultragenyx Pharmaceutical Inc., supporting all of the clinical programs in this clinical-stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases. He worked at Medtronic previously for 8 years in increasingly responsible positions, including leading the contract function for the entire company. Mark’s career has included work in medical and dental practice management as well. He has both a MSW and a MBA. He was appointed to his local community’s Citizen Finance Oversight/Advisory Committee. Mark has presented at numerous industry conferences and is a well-respected collaborator and influencer in his field.
Session Details: PANEL DISCUSSION - Exploring ways to negotiate and manage study budgets to ensure resources are allocated efficiently 04-03-2020, 2:45 pm Speaker Hosted Roundtables 04-03-2020, 3:45 pm View In Agenda
Christine Von Raesfeld
Independent Patient Advocate,
Biography:
Session Details: LIVE DEBATE- Patient recruitment is most successful when taking the grass roots approach compared to investing in social media 03-03-2020, 11:00 am WORKSHOP: Uncovering specific minorities within patient populations and how to ensure they aren’t being left out of clinical trials 03-03-2020, 2:45 pm View In Agenda
Meghan McKenzie
Clinical Program Director, Clinical Operations,Genentech
Biography:
Meghan McKenzie is a Clinical Program Director in Genentech’s Research and Early Development (gRED). Meghan has worked across all phases of drug development for over 20 years. In Clinical operations, she manages complex programs in Neurology and Infectious Disease and is leading gRED’s Patient Centricity team. The gRED Patient Centricity vision is to empower Early Clinical Development to obtain and amplify the patient voice to improve development planning, trial design, and trial execution. This team also focused on Inclusion Research.
She received her Bachelor’s in Economics at UNC- Chapel Hill and her Master’s in Biology: Human Physiology at San Francisco State University. Before joining Genentech in 2005, Meghan held various positions at a CRO, a research site, at NASA in their Human Research Center as well as at nonprofit think tanks in Washington, D.C.
She and her husband (a veterinarian) have two dogs, and they enjoy music and travel with their 19-year old daughter, when they can get her attention.
Session Details: Gaining patient input to improve your protocols and clinical development plans (Why, How, Impact) and enrolling under-represented patient populations 03-03-2020, 1:45 pm View In Agenda
Pablo Gersberg
Vice President, Information Technology & Digital Health, Blackthorn Therapeutics,
Robert Collyar
Chief Strategist, Patient Advocates In Research (PAIR),
Biography:
Session Details: LIVE DEBATE- Patient recruitment is most successful when taking the grass roots approach compared to investing in social media 03-03-2020, 11:00 am Divulging the latest in Patient Centricity: Does it exist and what does it mean to different people? 03-03-2020, 4:00 pm View In Agenda
Zachary Lee
Associate Director, Clinical Development, Nektar Therapeutics,
Biography:
Session Details: PANEL DISCUSSION 03-03-2020, 11:00 am Bridging the gap between technology and healthcare: Disruption in clinical trials 03-03-2020, 3:30 pm View In Agenda
Jacqueline Lee
Director, Clinical Operations,Cytokinetics
Biography: Jacqueline Lee has been working in the clinical research industry for over 28 years. She brings a unique perspective in that she has worked in several different capacities, including at the site level, the CRO level, and the Sponsor side of this industry. For the past 14 years, Jacqueline has been working at Cytokinetics, a biopharmaceutical company located in South San Francisco, California. She is currently the Director of Clinical Operations and has provided strategic planning, leadership, and oversight for over 35 clinical trials, the majority of which were conducted internationally
Session Details: Solutions-focussed approach: Overcoming hurdles presented with CRO oversight, governance and turnover 04-03-2020, 10:15 am View In Agenda
Shaily Garg
Senior VP Clinical Development and RA, Vaxart,
Biography:
Session Details: FIRESIDE CHAT - Fireside Chat: Navigating the launch of international trials and study start up from a small companies’ perspective to examine next steps 03-03-2020, 4:00 pm View In Agenda
Trisha Devlin
Sr. Director, Patient Value, Dermira,
Biography:
Session Details: Balancing clinical trial perspectives by involving patients in the protocol design phase of your study 03-03-2020, 12:15 pm View In Agenda
Melanie Morrison
Vice President, Clinical Operations and Data Management, Nuvation Bio,
Biography: Melanie Morrison is a leader in Clinical Development and Project Management with 20 years of experience driving corporate transitions from early stage to late stage clinical development organizations. Ms. Morrison is currently Vice President, Clinical Operations, Data & Systems at Nuvation Bio, a biotechnology company focusing on the foremost unmet needs in oncology. Prior to Nuvation, Ms. Morrison was at Aduro Biotech, where she served as interim Project Team Leader for one of its lead oncology assets, Chief of Staff, and Vice-President, Process Optimization. She also served as the Vice President, Oncology Platform Lead at Immune Design (now part of Merck & Co) leading the Clinical Operations and Project Management groups as well as managing the core team for its oncology assets. Ms. Morrison was Vice President, Clinical Operations for Medivation prior to its acquisition by Pfizer. In this role, she oversaw the development and execution of clinical development plans, functional resourcing for a team of approximately 100 employees, and budgeting for 40+ studies. Ms. Morrison was at Genentech from 1999 to 2007 in roles with increasing responsibility within Clinical Operations and Project Management supporting Genentech’s oncology pipeline. She holds a Master of Science in Health Sciences from The George Washington University School of Medicine and Health Sciences and a Bachelor of Science from UC Davis. She holds numerous certifications in regulatory affairs, project management, clinical research management, and public health from such organizations as UC Berkeley, UC Santa Cruz, and UNC Chapel Hill. Ms. Morrison is also an Executive Scholar in Leadership from the Kellogg School of Management
Session Details: PANEL DISCUSSION 03-03-2020, 11:00 am PANEL DISCUSSION : Considering a small company’s perspective on eTMF management for effective running of your clinical trial 04-03-2020, 10:15 am View In Agenda
Stewart Howard
European Brand Ambassador,Æcorn Aperitifs
Biography: Stewart Howard is the European Ambassador for Seedlip, the world’s first distilled non-alcoholic Spirits. With a background managing bars in London for restauranteurs including Mark Hix, Stewart’s expertise in cocktails, menu development and training has enabled Seedlip & Aecorn to be championed by many of Europe’s best cocktail bars and restaurants. A keen cyclist, nature lover and Biomimicry student, Stewart is the embodiment of a modern day drinks industry brand ambassador.
Session Details: View In Agenda
Sue Naim
Sr. Director Clinical Operations, Astex Pharmaceuticals,
Biography:
Session Details: Saama Technologies: Leveraging analytics to improve CRO relationships 03-03-2020, 9:00 am Speaker Hosted Roundtables 04-03-2020, 3:45 pm View In Agenda
Jonathan Riek
Vice President, Musculoskeletal and Metabolic Imaging, BioTel Research,
Biography: Jonathan Riek, PhD serves as the Vice President of Musculoskeletal & Metabolic Imaging for BioTel Research. He has a PhD in Electrical Engineering from the University of Rochester, and his doctoral thesis was on motion and artifact reduction in MRI. He worked on the development of a 3D CT scanner as a postdoctoral researcher, then spent 7 years in the research labs at the Eastman Kodak Company. While at Kodak, Jonathan worked in the areas of motion estimation, frame rate conversion, and video compression. He also served as the liaison between the image science division and the corporate software group. He joined VirtualScopics in 2000 to return to medical imaging and apply his skills interfacing between image science and software. In 2004, he led the development of the system that is still used to run clinical trials and analyze medical images. In his current role, Jonathan has scientific responsibility for all of BioTel Research’s musculoskeletal and metabolic imaging studies, including arthritis, muscle diseases, diabetes, and liver diseases such as NASH and NAFLD. He holds four patents and has published many articles on various topics regarding MRI.
Session Details: PANEL DISCUSSION - Why are Machine Learning and AI techniques gaining traction in the life science industry? 03-03-2020, 1:45 pm View In Agenda
Kumar Gadamasetti
CEO, Certum Bio,
Biography:
Session Details: PANEL DISCUSSION 03-03-2020, 11:00 am PANEL DISCUSSION - Why are Machine Learning and AI techniques gaining traction in the life science industry? 03-03-2020, 1:45 pm View In Agenda
Rhonda Critchlow
Senior Director, PSI CRO,
Biography:
Biography:
Rhonda Critchlow is Senior Director of Operations at PSI CRO and heads up the oncology division. With decades of experience spanning the clinical research industry, Rhonda is passionate about innovations in oncology research and holds unique expertise in Master Protocols.
Company Profile:
PSI is a privately-owned, full-service clinical research organization (CRO) operating globally. PSI’s global reach supports clinical trials across multiple countries and continents, and is known to be highly selective about the work that they pursue. With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its customers and its employees.
Session Details: Focussing on how CROs can adapt to support basket studies 04-03-2020, 9:45 am View In Agenda
Reginald Hooks
Associate Director, Clinical Operations,Oncolytics Biotech, Inc
Biography: Mr. Hooks has been active in clinical research since 2004, having conducted studies in the non-profit, biotechnological, pharmaceutical, academic, medical device and in vitro diagnostic arenas. His research prowess is further derived from years of experience in clinical laboratory, study site and CRO settings. He has managed clinical trials in over 15 countries; specializing in expedited site activation techniques and creative study rescue activities. He enjoys teaching at professional research conferences and volunteering his time as a career development mentor to other research professionals. Mr. Hooks earned a Master of Public Health degree in Epidemiology in 2006, and a Master of Forensic Science degree in 2002. He is a native Oklahoman, and proud alumnus of both the University of Central Oklahoma and the University of Oklahoma Health Sciences Center.
Session Details: Developing best practices for communicating with internal teams to ensure you are working towards a common goal 03-03-2020, 12:15 pm View In Agenda
Romil Rambhia
Director Of Quality Assurance and Regulatory Affairs,Half Moon Medical (The Foundry)
Biography:
Session Details: CASE STUDY: Investigational device exemption 101 04-03-2020, 9:45 am View In Agenda
Angie Maurer
Clinical Research and Emotional Intelligence Consultant,GRAIL
Biography:
Session Details: Navigating a case history focusing on the monitoring paradigm 04-03-2020, 11:15 am Discovering the use of emotional intelligence in vendor management 04-03-2020, 1:45 pm View In Agenda
Brian Nugent
Sr. Director Clinical Operations and Compliance,GRAIL
Biography:
Session Details: Navigating a case history focusing on the monitoring paradigm 04-03-2020, 11:15 am View In Agenda
Tracy MacNeal
CEO,Materna Medical
Biography:
Session Details: Innovation in women’s health and the future of FemTech 04-03-2020, 2:15 pm View In Agenda
Dr. Michael Murphy
Chief Medical and Scientific Officer, Worldwide Clinical Trials,
Sponsors
Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives. www.covance.com.
As a global leader in business services for over 20 years, TransPerfect is a woman-owned, privately held company with over 90 offices globally on six continents. Since its inception, TransPerfect has been supporting life sciences in the conduct of global clinical development, commercialization and life cycle management of products catering to the health care community.
Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences. Visit our website to learn more about how we deliver a Better Clinical Experience.
With over 40 years’ experience, 600 beds and locations in NA, EU and Asia, Celerion conducts First-in-Human, clinical Proof-of-Concept and patient dose response studies, cardiovascular safety and NDA-enabling clinical pharmacology research. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services.
CPi Global, contract research organization, provides full service to our clients in the areas of Hematology/Oncology, Dermatology, Endocrinology, Rare Disease and Medical Device.
Our purpose is to do our part to ensure drugs and treatments that can truly make a difference are given the best chance to do so.
CROMSOURCE is an international contract research organization providing a comprehensive services to the pharmaceutical and biotechnology companies. Specializing in clinical development and staffing solutions, we offer a flexible approach to ensure our clients’ unique needs are supported. CROMSOURCE is unparalleled in offering an end-to-end guarantee covering trial timelines, enrollment, and price. CROMSOURCE operates offices across Europe and North America.
KPS is a global, innovative, Clinical Outsourcing Provider delivering clinical trial monitoring, management and quality oversight services to pharmaceutical, biotechnology, medical device, and related industries. Founded and operated as a more customer centric and nimblealternative to traditional CROs, KPS offers a full range of services leveraging the latest clinical technologies.
MedPoint Digital develops intuitive, ICH-GCP compliant eClinical platforms for virtual investigator meetings, trial portals, interactive modules, and virtual clinical trials. Our digital solutions enable sites to be more productive, with online study training, study eBinders (eISF), digital study alerts and SUSARs, patient visit guides, and a wide range of study tools, available via web portals and mobile apps.
Nucleus Network is Australia’s premier dedicated Phase I clinical trials organization. Nucleus Network has an 80-bed clinical unit that is co-located with a major tertiary teaching hospital in Melbourne. We primarily work with FIH, Healthy Volunteers and have done patient studies with added cohorts.
Oracle Health Sciences
Oracle is a leading strategic software solutions provider to the health sciences industry, helping pharmaceutical, biotechnology, medical device, and healthcare organizations become the most successful in the world by offering the most innovative products and services that deliver the most compelling customer and shareholder value. Oracle's comprehensive industry solutions include clinical trial management and analysis, electronic data capture, adverse event reporting and pharmacovigilance, and healthcare interoperability. Oracle partners with health sciences industry leaders – including 20 of the top 20 life sciences companies and 14 of the top 14 Fortune Global 500 healthcare organizations – to prevent and cure disease, enhance quality of life, and accelerate insights for better health.
Pharm-Olam International delivers cost effective, quality clinical services to pharma and biotech sponsors across all therapeutic areas in more than 40 countries. Since 1994, we have been committed to our objective: to create value for our clients by satisfying their clinical development needs with consistent and dependable solutions and services.
ACT Oncology is now Precision Oncology, part of Precision for Medicine. We are the first Precision Medicine Research Organization dedicated to oncology research. We offer sponsors integrated oncology clinical trial and biomarker services - all under one roof. With our own Oncology Site Network dedicated to 90-day start up, biomarker and analytics services and expert clinical trial execution, we provide sponsors with an accelerated pathway to proof-of- concept and all the way through registration for their oncology innovations.
- Experience in a broad range of therapeutic areas
- Phase I-IV clinical trials
- Highly-skilled project management services
Stiris Research is an elite CRO focused on meeting client needs by providing highly experienced Project Management and Monitoring professionals for Phase I-IV clinical trials. Our strength is seamlessly integrating as an extension of your organization to assemble the perfect team and deliver a highly efficient, cost effective outsourcing solution.
Syneos Health (Nasdaq:SYNH*) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together, we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to lifeTM visit SyneosHealth.com.
WCCT Global is a multi-site, full service CRO of outsourced early drug development and late phase services to the pharmaceutical, biotechnology and medical device industries. WCCT has extensive experience with healthy volunteer studies including First-in-Human, as well as specific therapeutic expertise in Allergy, Asthma, HCV, Ophthalmology, Oncology, Renal, and Vaccines.
We are the quantitative imaging experts working across the entire drug development spectrum to better diagnose, characterize, treat and cure disease. Invicro is leading innovation to elucidate biological processes for our pharmaceutical and biotechnology partners around the world. www.invicro.com
MedTrials, Inc
Industry: Healthcare,Outsourcing Clinical Trials,
SPONSORSHIP ENQUIRIES
To enquire about sponsorship opportunities for the conference, please contact:
Nick McCudden
T: +61 280 978 126
E: NicholasMcCudden@arena-international.com
CONFERENCE ENQUIRIES
We identify and invite individuals we believe to be the best speakers in the market, if you think you can make a difference to the quality of our events please contact the programme director of the event:
Chloe Roberts
T: +44 (0) 207 936 6822
E: chloe.roberts@arena-international.com

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