Outsourcing in Clinical Trials West Coast 2020

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, 2:15 pm View In Agenda

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 your QMS defined for your Combination Product 04-03-2020, 9:00 am Speaker Hosted Roundtables 04-03-2020, 3:30 pm Speaker Hosted Roundtables 04-03-2020, 3:30 pm View In Agenda

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, 11:15 am View In Agenda

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

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

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, 10:00 am PANEL DISCUSSION - Do you outsource in the US or outside the US? 04-03-2020, 11:15 am Speaker Hosted Roundtables 04-03-2020, 3:30 pm Speaker Hosted Roundtables 04-03-2020, 3:30 pm View In Agenda

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

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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

Biography: Dr Ivan S.F. Chan has 20+ years of experience in pharmaceutical industry. He is Vice President and Head of Statistical Sciences, Data & Statistical Sciences, at AbbVie Inc. In this capacity, he leads the statistics organization supporting discovery, biomarker development, clinical development and global medical affairs for all therapeutic areas. Prior to joining AbbVie, Ivan was Executive Director of Biostatistics at Merck Research Laboratories.   Ivan is a Fellow of the American Statistical Association (ASA) and a Fellow of the Society for Clinical Trials (SCT). Ivan serves as Executive Director of the International Society for Biopharmaceutical Statistics (ISBS). He has 80+ publications in statistical and clinical journals.

Session Details: PANEL DISCUSSION - Why are Machine Learning and AI techniques gaining traction in the life science industry? 03-03-2020, 2:00 pm Abbvie Case Study: Introducing the Synthetic Control Arm 04-03-2020, 9:00 am View In Agenda

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, 11:15 am SPOTLIGHT- Evolving clinical trial outsourcing models and considerations - What really matters? 04-03-2020, 9:00 am View In Agenda

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.

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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 - 'Working with niche CROs allows our study to be a priority because it’s a bigger piece of their pie…' is it this simple? 03-03-2020, 11:15 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, 2:00 pm View In Agenda

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, 11:15 am View In Agenda

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.

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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).

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Biography: Dr. Jhee is a clinical pharmacologist with expertise in a wide range of early drug development studies from First-in-Human through Proof-of-concept. His work involves drugs in a variety of therapeutic areas. However, a significant portion of the programs are in Neurology and Psychiatry. Dr. Jhee works closely as an expert partner with his pharmaceutical industry colleagues in the strategic planning, protocol development, clinical conduct, data analysis and reporting of clinical studies. In recent years, Dr. Jhee has also serves as an expert on ethnic sensitivity studies (Ethnobridging) to help pharmaceutical companies gather Asian data in the US and UK in support of Asian drug development.

Session Details: Significantly increase Asset value and global reach by including Asians in your First in Man study 04-03-2020, 11:45 am View In Agenda

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 - 'Working with niche CROs allows our study to be a priority because it’s a bigger piece of their pie…' is it this simple? 03-03-2020, 11:15 am Budget Negotiations: Is the process optimized? 03-03-2020, 3:00 pm PANEL DISCUSSION - Exploring ways to negotiate and manage study budgets to ensure resources are allocated efficiently 04-03-2020, 2:15 pm View In Agenda

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, 4:15 pm PANEL DISCUSSION - Exploring ways to negotiate and manage study budgets to ensure resources are allocated efficiently 04-03-2020, 2:15 pm View In Agenda

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Session Details: SCENARIO SESSION - 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

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Session Details: PANEL DISCUSSION 03-03-2020, 11:15 am CASE STUDY: Unlocking the potential of digital therapeutics 04-03-2020, 11:15 am View In Agenda

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

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, 3:30 pm Speaker Hosted Roundtables 04-03-2020, 3:30 pm View In Agenda

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

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

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, 10:00 am View In Agenda

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

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, 2:15 pm Speaker Hosted Roundtables 04-03-2020, 3:30 pm Speaker Hosted Roundtables 04-03-2020, 3:30 pm View In Agenda

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Session Details: LIVE DEBATE- 'Patient recruitment is most successful when taking the grass roots approach compared to investing in social media' 03-03-2020, 11:15 am WORKSHOP: Uncovering specific minorities within patient populations and how to ensure they aren’t being left out of clinical trials 03-03-2020, 3:00 pm View In Agenda

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, 2:00 pm View In Agenda

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Session Details: LIVE DEBATE- 'Patient recruitment is most successful when taking the grass roots approach compared to investing in social media' 03-03-2020, 11:15 am Divulging the latest in Patient Centricity: Does it exist and what does it mean to different people? 03-03-2020, 4:45 pm View In Agenda

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Session Details: PANEL DISCUSSION 03-03-2020, 11:15 am Bridging the gap between technology and healthcare: Disruption in clinical trials 03-03-2020, 4:15 pm View In Agenda

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, 10:00 am View In Agenda

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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, 4:45 pm View In Agenda

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Session Details: LIVE DEBATE- 'Patient recruitment is most successful when taking the grass roots approach compared to investing in social media' 03-03-2020, 11:15 am Balancing clinical trial perspectives by involving patients in the protocol design phase of your study 03-03-2020, 12:15 pm View In Agenda

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 - 'Working with niche CROs allows our study to be a priority because it’s a bigger piece of their pie…' is it this simple? 03-03-2020, 11:15 am PANEL DISCUSSION : Considering a small company’s perspective on eTMF management for effective running of your clinical trial 04-03-2020, 10:00 am View In Agenda

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Session Details: Saama Technologies: Leveraging analytics to improve CRO relationships 03-03-2020, 9:00 am Speaker Hosted Roundtables 04-03-2020, 3:30 pm Speaker Hosted Roundtables 04-03-2020, 3:30 pm View In Agenda

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, 2:00 pm View In Agenda

Biography: Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. Currently he is the CEO of Certum Bio in San Francisco Bay area. Over the past 30 years his focus has been in the areas of drug substance as well as drug product R&D, manufacturing and outsourcing the small molecules as well as biologics. The therapeutic areas include: Cancer, CV, CNS and infectious diseases. He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. CA; X-Mine, CA; Delphian Pharma, CA and Certum LLC, CA). He has been actively involved on both sides of the business in managing CDMOs and CROs. Of the several programs he worked at Pharma and Biotech companies, three culminated in making to the market [PaclitaxelTM – Bristol-Myers Squibb; SensiparTM – Amgen and DuexisTM - Horizon Therapeutics). As the Founder and Chairman, he spearheaded the ACS ProSpectives international conferences on, ‘Process Chemistry in the Pharmaceutical Industry’, and as the chair, speaker and the moderator at numerous national and international conferences on API Process Chemistry and Drug Discovery & Development. He has been a visiting professor at Catholic U., Louvain, Belgium and U. Pittsburgh, Pittsburgh, PA and visiting speaker at Humboldt U. in Berlin, Germany. In addition to several peer reviewed publications and patents he published two volumes on, ‘Process Chemistry in the Pharmaceutical Industry’ and currently is working on the third volume entitled, ‘Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry’ jointly with the bio-process leaders at Pfizer. Kumar earned his Ph.D. from the University of Vermont and was a post-doctoral fellow at the University of Virginia.

Session Details: PANEL DISCUSSION - 'Working with niche CROs allows our study to be a priority because it’s a bigger piece of their pie…' is it this simple? 03-03-2020, 11:15 am PANEL DISCUSSION - Why are Machine Learning and AI techniques gaining traction in the life science industry? 03-03-2020, 2:00 pm View In Agenda

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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.

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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

Biography: Romil has 12 years of regulatory experience in Class III combination products (Transcatheter Mitral/Aortic Valve Replacement Systems and Drug Eluting Stents) and Class II medical devices (Alpha-1 antitrypsin test, Software validation, Endoscope defogging device, Holter recorder, etc) Romil has an in-depth understanding of regulatory, quality and clinical requirements, and he has a history of successfully managing regulatory submissions such as Premarket approval (PMA), Investigational Device Exemption (IDE), Early Feasibility Study (EFS-IDE), Premarket Notification [510(k)], Design Dossier (CE Mark), European Directorate for the Quality of Medicines & HealthCare (EDQM) Certification, Shonin Submission (Japan), Clinical Trial Applications (Europe & Japan), Global Regulatory Submissions, Amendments, Supplements and Annual Reports.

Session Details: CASE STUDY: Investigational device exemption 101 04-03-2020, 9:30 am View In Agenda

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Biography: Tracy MacNeal is an engineer, healthcare entrepreneur, and MedTech investor.  She is CEO of Materna Medical, a Series B startup focused on transforming the standard of care in women’s pelvic health.  As an investor in Portfolia’s FirstStep fund, she supports the commercialization of high-growth segments typically undervalued and overlooked by traditional investing approaches.  Tracy serves as the national Chair of Advamed’s Women’s Executive Network, connecting and amplifying the top women leaders in the MedTech industry. She previously served as President of Diagnostics and Digital Health for Ximedica, held by SV Life Sciences, a private equity healthcare firm, after serving in Chief Strategy Officer and Chief Financial Officer roles at two successful medical devices companies.  Tracy received a Bachelor of Chemical Engineering with full scholarship at the Cooper Union in New York City and an MBA from Duke’s Fuqua School of Business, graduating summa cum laude as a Fuqua Scholar.

Session Details: Innovation in women's health & the future of FemTech 04-03-2020, 12:15 pm View In Agenda

Biography: Dr. Murphy’s professional career has spanned 25 years and his positions within the pharmaceutical industry emphasize the integration of medical and scientific acumen with operational excellence. He is board-certified in psychiatry and has a doctorate in pharmacology, with training at Tulane University, Stanford University and the Mt. Sinai School of Medicine. Dr. Murphy worked with Dr. Cutler in articulating this vision for Worldwide when the company was established as a global CRO in 1995 and was responsible for consulting services for protocol and program design, and executive oversight for the execution, analysis and interpretation of clinical trials across multiple therapeutic areas. His supervisory responsibilities as Chief Medical & Scientific Officer at Worldwide are international in scope and include the design and implementation of protocol feasibility assessments, protocol development for phases I–IV including non-interventional research, the provision of medical monitoring and drug safety services, medical writing, and coordination of rater certification and surveillance activities for clinical trial assessments. Prior to joining Worldwide, Dr. Murphy was Chief Medical Officer and Senior Vice President of Discovery and Development at TorreyPines Therapeutics, Inc., with contributions emphasizing translational research in neurodegenerative conditions and analgesia. Dr. Murphy also served as President of the clinical research organization then Chief Medical and Scientific Officer for a large CRO. As President, this CRO was rated “number one” in the United States by CenterWatch. He has been a consultant for the Duke Clinical Research Institute and is Research and Development Editor for American Health and Drug Benefits™, a publication that focuses upon cost, quality and access in the transition of novel diagnostics and therapeutics from discovery to commercialization. As a faculty member within the Center for Experimental Pharmacology and Therapeutics at Harvard-MIT Division of Health Sciences and Technology, he has been a lecturer for 15 years within a competitive and credentialed clinical investigator training program.

Session Details: When Novelty Is Not Enough: Strategic outsourcing in an era of innovative R&D 04-03-2020, 1:45 pm View In Agenda

Biography: Patricia Mosher, UBC’s Vice President, Global Late Stage Operations & Strategic Engagement is responsible for global day-to-day operations.  Patti has a broad therapeutic and operations background with more than 30 years of industry experience managing operations in Phase l - lV across all functions of delivery in drug products and devices with an emphasis in cardiovascular/metabolic disease, neuroscience/pain, and vaccines/rare disease.

Session Details: Strategic partnership and outsourcing approaches for emerging biotech 03-03-2020, 2:30 pm View In Agenda

Biography: Larry Vong is a Senior Clinical Data Specialist at Nevro, Corp. with over 8 years of experience in the medical device industry. During his time at Nevro, he has aided the company at achieving FDA approval, while supporting clinical trials in different phases, regions, and therapeutic areas. His responsibilities in Data Management have included data entry, transitioning from paper to electronic data capture, managing database builds, and preparing reports for scientific analysis.

Session Details: PANEL DISCUSSION - Do you outsource in the US or outside the US? 04-03-2020, 11:15 am Speaker Hosted Roundtables 04-03-2020, 3:30 pm Speaker Hosted Roundtables 04-03-2020, 3:30 pm View In Agenda

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Session Details: PANEL DISCUSSION 03-03-2020, 11:15 am PANEL DISCUSSION - Why are Machine Learning and AI techniques gaining traction in the life science industry? 03-03-2020, 2:00 pm View In Agenda

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Session Details: Optimizing Early Oncology Studies Through Adaptive Trial Designs 03-03-2020, 11:45 am View In Agenda

Biography: With over 13 years in the pharmaceutical services industry and over 20 years of software development experience, Shad has a strong foundation for delivering real value to clients and partners. In his current role as Director, Vault Clinical at Veeva, Shad drives the development of product and market strategy for Veeva Vault eTMF, CTMS, and Study Startup. Shad aspires to help bring the next generation of clinical development applications and capabilities to the life sciences industry. With a degree in Business Administration and an MBA, Shad’s expertise in software development and project management in the pharmaceutical industry provides him with the ability to analyze the most demanding business needs in life sciences.

Session Details: Technology is Transforming Information Sharing and Collaboration 03-03-2020, 11:45 am View In Agenda

Biography: As Vice President of Biometrics at Synteract, Ms Hall oversees global operations for Biometrics services, including Clinical Data Management, Biostatistics and Programming, Medical Writing, Pharmacometrics, and Biometrics Project Management. She has over twenty years’ experience in the clinical research industry, all in Biometrics. Ms Hall provides strategic leadership to ensure corporate operational and financial goals are met, and clinical trials are executed successfully in accordance with regulatory, GCP, SOP and protocol requirements. She has extensive experience in identification and implementation of clinical technology solutions to meet the needs of clinical trials. In addition, Ms Hall has proven leadership in organizational change, staff development, process creation and harmonization, and strategic client management.

Session Details: Early planning & implementation of your submission strategy: Ready, Set, Submit! 03-03-2020, 11:45 am View In Agenda

Biography: Matt is responsible for defining and leading the product strategy for ERT’s digital patient product line, with a focus on direct to patient enablement in both post approval research and patient support. Matt has spent the last 12 years leading teams and innovating products in both the clinical research and commercial healthcare settings to reduce patient burden of participation and to support patients in their healthcare journey.  Most recently, Matt was Global Head of Patient Engagement for ICON’s Commercialization & Outcomes division and, prior to that, Head of Direct to Patient Research (Virtual Trials) at IQVIA.

Session Details: The role of emerging technology in improving the patient experience and generating PROs 03-03-2020, 2:30 pm View In Agenda