Outsourcing in Clinical Trials New England 2022
The Westin Boston Seaport District
12th-13th October, 2022
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Outsourcing in Clinical Trials New England 2022
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Arena International are delighted to announce Outsourcing in Clinical Trials New England will be returning to Boston on October 12th-13th 2022!
For this years show we are thrilled to welcome Craig Lipset (Advisor and Founder, Clinical Innovation Partners), who will be giving a Keynote presentation on Day 2, discussing Democratizing Decentralized Trials, including how innovative solutions can be accessible for all. Join us at 2pm for Craig's insights!
Our event will open with Shaheen Lakhan and Laura Taraboanta from Click Therapeutics presenting on Enabling Innovation in Spite of Barriers. Audience members can get involved with numerous interactive sessions, such as a panel discussion on 'What the clinical trial industry really wants from its service providers- reversing the conversation'.
Our Boston event boast 4 tracks, meaning there truly is something for everyone;
- Clinical Operations & Outsourcing
- Decentralized & Hybrid Trials
- Rare Disease Trials
- Technology, Innovation & Devices
The programme will, through a variety of interactive session formats, offer insight on promoting successful collaboration between the clinical trials community and once again offer attendees practical take-aways that they can apply to their own studies.
Don’t miss out; join us in Boston on October 12th & 13th! We can't wait to see you there!
Your chance to meet and catch up with colleagues from across the industry
As this event returns to an in-person format, you can look forward to a networking focused event with industry leading presentations, interactive formats and the most innovative solution providers attending. Hear from industry leading speakers, Learn what is round the corner in terms of future trends and get the latest knowledge on new and upcoming disruptors.
▶️ Keynote presentations on the topics affecting you: from COVID to shipping to disruptive technologies
▶️ Join in with audience discussions, panel debates and add your voice to the conversation

Craig Lipset
Co-Chair,Decentralised Trials and Research Alliance
Biography:
Session Details: KEYNOTE Democratizing Decentralised Trials: How Innovative Solutions Can be Accessible for All 13-10-2022, 2:00 pm View In Agenda

Shaheen Lakhan
CMO,Click Therapeutics
Biography:
Session Details: OPENING KEYNOTE: Enabling Innovation in Spite of Barriers 12-10-2022, 8:30 am View In Agenda

Marissa Fayer
President of DeepLook Medical, Executive Director of Women’s Health,
Biography: Marissa Fayer is a 22-year medtech executive, innovator, entrepreneur, investor, and philanthropist. She is the CEO and founder of social enterprise / non-profit HERhealthEQ, President of DeepLook Medical, VP of Operations at Ultrasound AI, and US Partner at Goddess Gaia Ventures. Her mission is to move innovation and the health of women forward throughout the world. Marissa has previously served as an executive at Hologic, Olympus (formerly ACMI), Maquet-Getting (formerly Atrium Medical), Providien Medical, and Accumed Innovative Technologies. Her consulting clients include many of the Top 500 healthcare companies and innovative start-ups including Pfizer, Boehringer Ingelheim, Nuvasive, the National Institute of Health (NIH), Oerlikon Medical, Lonza Precision Medical, Emit Imaging, and others. Marissa sits on the board of medtech companies Welwaze Medical and DeepLook both focused on improving the diagnosis of breast cancer; Ultrasound AI focused on predicting Preterm birth, and PMD Medical focused on urinary incontinence; Marissa graduated from Boston University with a BS in Manufacturing Engineering and from University of Connecticut with an MBA. Marissa is a TEDx Speaker (2019 at TEDxLugano), a UCSC Miller Center Social Entrepreneur Fellow, and has been listed as one of the Top 100 Women in Medtech in 2018, a Top Woman Activist to Watch, awarded the 2018/9 Africa Development Award, a Wonder Women in Medtech, and has delivered keynote discussions at the World Alliance Forum, MedExec Women, Lithuanian Biotechnology Association, Leading Entrepreneurs of the World, Women’s Health Innovation Summit, DeviceTalks, HER.Talks, and others. Marissa has appeared in several online and print publications such as Medical Design & Outsourcing, BloombergLaw, FemTech Analytics, the Maven Collective, Med Device Online, and TheStreet.com. Marissa leads the #wealththroughhealth and #healthequityforwomen movements and is dedicated to innovative solutions for global operations and improving women’s health throughout the world. Marissa lives in New York City and can be found at www.marissafayer.com
Session Details: PANEL DISCUSSION Overcoming the Barriers to Trial Innovation and Technology Access from a Small Company’s Point of View 12-10-2022, 2:45 pm The Diversity Conversation 13-10-2022, 10:00 am View In Agenda

John Seman
CEO ,REVITALE Pharma
Biography: John Seman is a Pharmaceutical Executive with a consistent track record of building teams, solving problems, adapting to changing markets, and establishing long term growth strategies. Mr. Seman began his career in global life science corporations working for E. R. Squibb & Sons and multiple divisions of Johnson & Johnson, holding various management positions in sales, marketing and business development. During his tenure at Squibb, he was a team member responsible for the introduction a new cardiovascular drug that achieved highest first year sales in company history. At Johnson & Johnson, he managed a portfolio of eight biotech products in various stages of pre-clinical and clinical development, and actively participated in the licensing and acquisition of anti-infective pharmaceutical products. He served as Vice President of Marketing at the central laboratory division of Corning Pharmaceutical Services where he was responsible for expansion of services into the European market, and for developing an innovative marketing strategy to increase profitability with a growing base of top tier pharma customers. For the past 20 years, Mr. Seman has been a serial entrepreneur involved in multiple startups including: A Founder of AVANTEC, an innovative technology based company focused on accelerating the receipt of clinical trial data from investigator sites, where he secured over $10M from multiple rounds of financing; CEO at HealthBridge, a reimbursement services company, where he tripled revenue and successfully positioned the company for a sale; CEO at PhysioGenix, a preclinical research company, where he secured seed funding from angel investors; and most recently licensed technology from universities for commercialization with ZOETIC Pharmaceuticals and REVITALE Pharma focused on expanded use of anti-virals. Mr. Seman’s non-profit experience includes executive leadership of the Alosa Foundation, an independent medical education organization, where he secured multi-year contracts from the Commonwealth of Pennsylvania, the Commonwealth of Massachusetts and the District of Columbia public health departments for the dissemination of evidence based treatment strategies to primary care physicians. He also served as the Founding CEO of Launch NY, an economic development organization serving the 27 counties of upstate New York, raising $7 million from the federal government and regional foundations. Mr. Seman holds a Bachelor of Science degree in Pharmacy, and received a Master of Science degree with honors in Pharmaceutical Economics and Business Administration, from the Massachusetts College of Pharmacy. He is an active participant in industry associations, and continues to be sought after to present at national and regional life science conferences. Mr. Seman also volunteers as a coach and mentor to aspiring life science entrepreneurs from the University at Buffalo, McMaster University, and Syracuse University to support their efforts to build companies, win business plan competitions, and secure financing.
Session Details: PANEL DISCUSSION Exploring Repurposing Off-Patent Drugs as an Effective Clinical Trial Strategy 13-10-2022, 11:00 am View In Agenda

James L. Sherley, M.D., Ph.D
President & Chief Executive Officer,Asymmetrex
Biography: James L. Sherley, M.D., Ph.D. is the founder, President, and CEO of Massachusetts stem cell biotechnology company Asymmetrex, LLC. Asymmetrex develops and markets technologies for advancing stem cell medicine, including the first method achieving specific and accurate certification of the dosage of therapeutic tissue stem cells, called kinetic stem cell (KSC) counting. Asymmetrex’s kinetic stem cell counting platforms are also used to optimize manufacturing of therapeutic stem cells and for evaluations of drug effects on tissue stem cells. Dr. Sherley is a graduate of Harvard College, with a B.A. degree in biology, and the Johns Hopkins University School of Medicine, earning joint M.D. and Ph.D. degrees. Prior to founding Asymmetrex, he held academic research appointments at the Fox Chase Cancer Center, Massachusetts Institute of Technology, and Boston Biomedical Research Institute. Dr. Sherley’s professional awards include Pew Biomedical Research Scholar, Ellison Medical Foundation Senior Scholar in Aging Research, and NIH Director’s Pioneer Award.
Session Details: Impact of Dosage Standardization Innovation on Stem Cell Clinical Trials Operations and Support Needs 12-10-2022, 12:15 pm View In Agenda

Bonnie Bain, PhD
Global Head and Executive Vice President of Healthcare Operations and Strategy,GlobalData Healthcare
Biography: Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.
Session Details: Chair’s opening remarks 12-10-2022, 8:25 am Outsourcing & Clinical Operations 12-10-2022, State of the Biopharmaceutical Industry – 2022 13-10-2022, 12:15 pm View In Agenda

Oliver Steinbach
Vice President Clinical and Regulatory Affairs,Imagion Biosystems
Biography: Oliver has more than 20 years of experience in pharmaceutical, diagnostics and medical technology solution. He joined in 2022 Roche to lead a regulatory team focusing on especially oncology companion diagnostics. Till end 2011 he was the Vice president Clinical and regulatory affairs in Imagion Biosystems, a FDA-Breakthrough status clinical stage medical device company combining transformative, high-sensitivity imaging and nanomedicine for better, safer diagnosis and therapy delivery in cancer and other diseases. Previously, Oliver served as Vice President R&D at TransCode Therapeutics, dedicated to microRNA-targeted, image-guided, personalized cancer detection and treatment solutions. Before, he held at PHILIPS the positions of Senior Director Clinical Research Board, governing the North America clincial innovation program, moving several products through human trials and approval, further as Senior Director Biomolecular Engineering leading diagnostic/interventional imaging and drug-device combination developments. Oliver started in various R&D positions at ALTANA Pharma AG building the Functional Genomics Group and entrepreneurial ALTANA Research Institute. He received his Ph. D. degree in biochemistry from the University of Tuebingen, Germany
Session Details: OPENING KEYNOTE Doing your first Proof of Concept Study in “Down Under”: Lessons learned from Clinical Trials Outside of the United States 13-10-2022, 9:00 am View In Agenda

Amanda Murphy
Director of Product Management,GlobalData
Biography: Amanda Murphy is the Director of Product Management at GlobalData, a company that focuses on research, data analytics and consulting that provide actionable insight into the pharmaceutical and medical device sectors. She has 10+ years of experience working in pharmaceutical data science and web platform development (including BioPharm Insight, Lead Sheet, and the Pharma Intelligence Center). She has developed models and solutions to support Clinical Operations & Feasibility teams plan and optimize trials, including an e-feasibility questionnaire tool resulting in 4x faster response rates from sites. Amanda also has many years of experience supporting business development at CROs through data-driven lead delivery and CRM integration solutions.
Session Details: Clinical Trial Technology & Innovation 12-10-2022, PANEL DISCUSSION Overcoming the Barriers to Trial Innovation and Technology Access from a Small Company’s Point of View 12-10-2022, 2:45 pm Decentralized, Remote and Virtual Trials 13-10-2022, View In Agenda

Arkady Gusev
Director, Laboratory Excellence and Operations,Novartis Pharmaceuticals
Biography:
Session Details: Patient Centric SMART Blood Sampling 12-10-2022, 1:45 pm View In Agenda

Adrian Orr
Director of Clinical Affairs,Anika Therapeutics
Biography: Adrian Orr is the Executive Director of Clinical Affairs at Anika Therapeutics, Inc in Bedford, MA. Adrian has previously worked in a range of small to medium-sized medical device and biologics companies including Gyrus Medical, Serica Technologies, and Haemonetics. He has focused on re-structuring and developing clinical teams to tackle technically challenging surgical and biologics trials. Adrian’s current focus is on joint preservation and tissue regeneration in orthopedics. His talk today will center on the use of eDiaries in clinical research.
Session Details: TOPIC TBC - CASE STUDY: Diving into the Sponsor Experience of eDiary Use in Clinical Trials 13-10-2022, 11:00 am View In Agenda

Christopher Missling
CEO,Anavex Life Sciences
Biography: Dr. Missling, President and CEO of Anavex, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex®, he served as the Chief Financial Officer of Curis and ImmunoGen. In addition, at Aventis (now Sanofi), Dr. Missling worked as head of financial planning on all aspects of financial strategy and M&A. His career experience also includes working as an investment banker in the healthcare practice at Deutsche Bank, serving pharmaceutical, biotech, and diagnostic companies, as well as serving as the head of healthcare investment banking at Brimberg & Co. in New York. Dr. Missling has an MS and PhD from the University of Munich in Chemistry and an MBA from Northwestern University Kellogg School of Management.
Session Details: Top Tips for Starting up Trials in the Rare Disease Space: Best Practices and Considerations 12-10-2022, 11:15 am View In Agenda

Peter Henstock
Harvard Extension School & Machine Learning & AI Technical Lead,Pfizer
Biography: Strategic & technical leader applying machine learning, data mining, visualization and analytics skills to solve key data science problems. Data science is a hybrid field integrating computer science, visualization, statistics, and business knowledge. The standard skill set emphasizes breadth over depth yet both are critical: ● Advise and guide the technical direction of Pfizer's machine learning, deep learning and AI entries into natural language processing, image processing, and predictive modeling ● Harvard University lecturer teaching the Master's software engineering capstone and the graduate level, machine learning and data mining courses ● Analytics researcher: developed ~30 novel visualization and analytical tools in use at Pfizer ● Ph.D. in computer science emphasizing artificial intelligence and machine learning ● Master's degrees: software engineering, applied statistics, applied linguistics, image processing and biology ● Statistician: primary site statistician for 10 years supporting up to 200 scientific researchers ● Broad industry experience including pharmaceuticals, defense, text mining, and education
Session Details: Harnessing the Benefits of clinicaltrials.gov to Improve your Access to Clinical Trial Data and Movement Towards DCTs 13-10-2022, 10:00 am View In Agenda

Kimberlyn Ford Festi
Associate Director, Site Contracts & Budgets,Deciphera Pharmaceuticals, LLC
Biography:
Session Details: Facing up to Increased Trial Costs: Top Tips for Staying in Budget 12-10-2022, 12:15 pm View In Agenda

Oscar Gonzalez
Sr. Project Manager, Research and Development,Lifemine
Biography:
Session Details: FIRESIDE CHAT Navigating the New Technology Landscape: Are we able to Deliver on the Technological Promise? 12-10-2022, 3:45 pm View In Agenda

Daniel Klamer
Vice President, Business Development & Scientific Strategy,Anavex Life Sciences
Biography: Dr Daniel Klamer, Vice President of Business Development and Scientific Strategy of Anavex, has more than 15 years of experience in neuroscience and the orphan disease space, with acquisition, partnering and R&D experience in Europe and the USA. Prior to Anavex he worked at Retrophin and Neurosearch Sweden. At Neurosearch Sweden, Dr Klamer led and evaluated multiple discovery-phase neuropharmacological research products with an emphasis on strategic evaluation of preclinical and clinical development. Dr. Klamer earned his PhD in Pharmacology at The Sahlgrenska Academy at University of Gothenburg, Sweden, his MBA at Fordham Gabelli School of Business, and his Post-Doctoral training at the Department of Psychiatry, Yale University School of Medicine. In addition, Dr. Klamer holds a position as an Associate Professor at the Department of Pharmacology at The Sahlgrenska Academy at the University of Gothenburg.
Session Details: View In Agenda

Andrea Bottkova
Director, Vendor and Contracts Managemen,Karyopharm Therapeutics
Biography:
Session Details: Facing up to Increased Trial Costs: Top Tips for Staying in Budget 12-10-2022, 12:15 pm View In Agenda

Michael Patel
Senior Scientist in Biomarker Development ,Novartis Pharmaceuticals
Biography: Michael Patel is a Senior Scientist II at Novartis Institutes of BioMedical Research in Cambridge, MA. There, he is involved in biomarker planning and implementation on early phase clinical programs and studies across a wide range of therapeutic areas. Specifically, he has been heavily involved in identifying and evaluating near patient sample collection and analysis technologies. This includes engaging and collaborating with internal and external partners on progressing to the ultimate goal of applying these to future decentralized and patient-centric clinical studies. Michael received a bachelor’s degree from Rutgers University and a doctorate in pharmacy from the University of North Carolina.
Session Details: View In Agenda

Michael Breen
Associate Director, Infectious Disease,GlobalData Healthcare
Biography: Michael Breen, PhD, is the Senior Director of Infectious Diseases and Oncology at GlobalData in Boston. He has over eight years of experience in market analysis, business intelligence, and providing strategic insight for the pharmaceutical industry. Prior to his current role, he was a Senior Analyst for Decision Resources Group, where he gained extensive experience writing in-depth reports and developing forecasts for a variety of indications, including rare and infectious diseases and vaccines. Michael has a BA in biology and biochemistry from Hunter College, and a PhD in biochemistry from Boston University School of Medicine.
Session Details: Rare Diseases 12-10-2022, Technology, Innovation & Devices 13-10-2022, OPENING KEYNOTE Movement Towards Decentralized Clinical Trials 13-10-2022, 9:00 am View In Agenda

Dana Lee
Senior Scientist II, Laboratory Excellence & Operations, Biomarker Dev / Translational Medicine,Novartis
Biography: Dana Lee PharmD, RPh is currently a Senior Scientist within the Biomarker Development group at Novartis Institutes for BioMedical Research (NIBR) in Cambridge, MA. She provides biomarker sample management and support in early phase clinical trials, working in close collaboration with Biomarker Experts and the clinical trial team. Along with her primary role, she is also a member of the Central Lab SME Team along with the Smart Sampling/Testing Task Force within NIBR-TM. Within the Central Lab SME Team, she contributes to leading efforts around process improvement / strategy in Central Lab partnership to enable Novartis clinical trials. Dana received her PharmD degree from Temple University School of Pharmacy in 2020 and Bachelor's degree in Biology from Clark University.
Session Details: Partnering with central lab vendors on continuous improvements 12-10-2022, 1:45 pm View In Agenda

Hollie Schmidt
VP of Scientific Operations,Accelerated Cure Project for Multiple Sclerosis
Biography: Hollie Schmidt is the VP of Scientific Operations at Accelerated Cure Project for Multiple Sclerosis. She co-chairs the Research Committee of iConquerMS™, a research cohort established to perform and support patient-centered research in MS. She also founded and leads the MS Minority Research Engagement Partnership Network, a multi-stakeholder initiative aimed at increasing racial and ethnic diversity in MS research studies.
Session Details: Mind the Gap: Improving the Diversity and Inclusion of Under-Represented Groups in Clinical Research 12-10-2022, 11:15 am View In Agenda

Kathryn Duschean, Pharm D
Post-Doctoral Fellow- Biomarker Development,Novartis Pharmaceuticals
Biography: Dr. Kathryn Duschean is a post-Doctoral fellow in Biomarker Development at Novartis Institutes for Biomedical Research in Cambridge, MA. She is currently involved in biomarker operational planning, implementation, and validation of novel patient-centric sampling techniques, in early phase clinical programs across a variety of therapeutic areas. Her deep personal passions and former research in autoimmune and related conditions heavily influence and progress her interests and projects in this area. She believes that engaging with internal and external partners is critical to advancing toward the ultimate goal of fully decentralized clinical trials in these spaces. Kathryn received both bachelors in English, and in Health Sciences from the University of Iowa, and her Pharm.D from the University of Colorado. She is also currently an adjunct faculty member at the Massachusetts College of Pharmacy and Health Sciences, focusing on teaching various elements associated with the innovation and operational consideration in clinical trials.
Session Details: Patient Centric SMART Blood Sampling 12-10-2022, 1:45 pm View In Agenda

Amanda McEwen
Vice President, Clinical Development,Elevian, Inc.
Biography:
Session Details: The Future of Rare Disease Trials: How can we Encourage Innovation Whilst Protecting Affordability? 12-10-2022, 12:15 pm View In Agenda

Behtash Bahador MS
Director, Health Literacy,CISCRP
Biography: Behtash Bahador is an Associate Director at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.
Session Details: TOPIC TBC - This is Not a Trend: Exploring Why Patient-Centered Clinical Research Will Continue to Change the Research Paradigms of the Past and the Impact it Can Have 13-10-2022, 12:15 pm View In Agenda

David Sherris
Chief Executive Officer,Penrose TherapeuTx
Biography: Dr. Sherris has over 30 years’ experience in translational medicine involving basic research, pharmaceutics and diagnostics. Dr. Sherris has been a successful serial entrepreneur developing biotechnology companies from the ground up, devising corporate strategy, enacting programs and carrying companies through funding and acquisition. Dr. Sherris prides himself as a “roll up your sleeves” CEO, entrepreneur, business development officer, drug developer and scientist, not simply a delegator. Dr. Sherris has worked with venture capital companies, investment banks and angel investors where he has advised and raised well over $100 million for biotech companies. Dr. Sherris has been employed by pharmaceutical and biotechnology companies to manage external (academic groups and contract research organizations) and internal (directly manage, augment and expand internal scientific programs) research and development. Dr. Sherris has been a frequently invited guest speaker at biopharmaceutical business and scientific conferences, a published author and holder of patents in a wide range of therapeutic areas including oncology, ophthalmology, dermatology, neurology, gene therapy and infectious disease. Dr. Sherris has held positions of increasing responsibility in public and private companies. Dr. Sherris has developed drugs from the bench to the clinic, partnered technologies to pharmaceutical companies and raised capital for companies at the triple digit million dollar levels.
Session Details: PANEL DISCUSSION Overcoming the Barriers to Trial Innovation and Technology Access from a Small Company’s Point of View 12-10-2022, 2:45 pm View In Agenda

Laura LaRosa
Director of Clinical Quality Assurance,Syros Pharmaceuticals
Biography:
Session Details: Who is Quality and what do they do? How can we invite Quality into the Clinical Operations conversation and into the partnership? 12-10-2022, 2:45 pm View In Agenda

Francis Kendall
Head of Oncology Programming, Biometrics, Oncology R&D ,AstraZeneca
Biography: A strong proactive leader of groups within the Data Analysis and IT disciplines in the Healthcare industry sector. A managerial style based upon vast global experience, which incorporates a pragmatic approach to issue management together with a progressive attitude to create and successfully implement business driven strategic change initiatives within multicultural environments. Recent key achievements (1) Led a team that developed and implemented a Strategic systems approach to capitalise on the Clinical Data assets own by the Roche Product Development Group (2) Optimising the global sourcing solutions within the group by taking advantage of CRO, Contractors and Offshoring solutions. (3) Transitioned the programming group from being heads down programmers to Analysts who proactively provide and develop solutions for partners and customers
Session Details: A Deep Dive into Decentralised Trials: Managing the Moving Parts to Result in a Successful Trial 12-10-2022, 11:15 am View In Agenda

Joshua Freeman
VP of Clinical and Regulatory Affairs,Solace Therapeutics
Biography: Josh has over 20 years of experience working in the as a clinical operations and regulatory affairs professional. Working both as an consultant and leading teams in-house, his career has focused on getting novel medical technology to the market through the design and execution of robust clinical trials, and the preparation of quality regulatory submissions to regulatory authorities in the US and abroad. Through creativity and collaboration, he has helped several medical device start-ups progress towards commercialization across a variety of therapeutic areas, including cardiovascular, diagnostics, orthopedics, and women’s health.
Session Details: PANEL DISCUSSION Overcoming the Barriers to Trial Innovation and Technology Access from a Small Company’s Point of View 12-10-2022, 2:45 pm OPENING KEYNOTE Preparedness for FDA Audit for Devices: What Should you be Focusing on Right Now? 13-10-2022, 9:00 am View In Agenda

Chris Adams
Chief Executive Officer,Andarix
Biography:
Session Details: Targeted Personalized Cancer Therapy: The Holy Grail of Cancer Treatment 12-10-2022, 2:45 pm View In Agenda

Jodi Coughlin
Director, Vendor Relationship Management,Deciphera Pharmaceuticals

Rinaldo Dorman, MBA, CPSM
Associate Director, R&D Global Procurement & Strategic Sourcing,Sarepta Therapeutics
Biography:
Session Details: PANEL DISCUSSION Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers 12-10-2022, 4:45 pm View In Agenda

Leonella Seeley
Associate Director of Vendor Management and Operations,Karyopharm Therapeutics Gordon Jamieson, CEO, Translational Therapeutics
Biography:
Session Details: Facing up to Increased Trial Costs: Top Tips for Staying in Budget 12-10-2022, 12:15 pm View In Agenda

Judyth Zahora
Sr. Director, Global Quality Systems & Process Improvement,Agenus
Biography: Ms. Zahora is Sr. Director, Global Quality Systems & Process Improvement with Agenus and is responsible for the Quality Management System (QMS) including document control, vendor management, training, process improvement initiatives, risk/quality issue management, and establishing quality systems analytics. She has a MBA from St. Joseph’s University, a Six Sigma Black Belt, and is PMP certified. Ms. Zahora has developed and implemented an organizational QMS, compliance metrics to assess performance of global quality standards, and has created and implemented: (1) enterprise wide Root Cause Analysis training supporting CAPA effectiveness, (2 ) process review methodology with a Process Scorecard enabling a consistent method for corporate wide process review, (3) Data Trending including visibility of audit findings/quality issues by Key Core Process, SOP, and Corrective/Preventive Actions, and (4) Regulated documentation standards to ensure clear, concise, and compliant process documentation fit for purpose. Ms. Zahora is an instructor for Society of Quality Assurance (SQA) Quality College, Past President of NERCSQA, Past Chair of the Beyond Compliance Specialty Section (BCSS) and is on Nahant’s Advisory & Finance Committee.
Session Details: FIRESIDE CHAT Navigating the New Technology Landscape: Are we able to Deliver on the Technological Promise? 12-10-2022, 3:45 pm Outsourcing & Clinical Operations 13-10-2022, View In Agenda

Laura Taraboanta
Sr. Manager, Head of Clinical Innovations,Click Therapeutics
Biography:
Session Details: OPENING KEYNOTE: Enabling Innovation in Spite of Barriers 12-10-2022, 8:30 am View In Agenda

Hyun Kim
Head, Clinical Operations,AOBiome
Biography: Hyun has been a part of AOBiome’s clinical pipeline leadership since 2016. Hyun brings over 24 years of drug development experience in the pharma and biotech industry. Prior to this, Hyun has led Clinical and R&D programs and departments at Pfizer, Anika Therapeutics, Transport Pharmaceuticals, and Olympus Biotech. He started his career at Genetics Institute and Wyeth, where he developed biologics for tissue repair. He attended Brown University where he studied Biomedical Engineering and completed a PhD in Medical Science.
Session Details: A Beginner’s Guide to Decentralizing your Trials from a Small Company’s Point of View 13-10-2022, 11:00 am View In Agenda

Cathleen Platt
VP, Clinical Operations,Click Therapeutics
Biography:
- Former Associate Vice President, Global Clinical Trial Management at Allergan
- Former Executive Director, Global Clinical Trial Management at Actavis plc
- Former Executive Director, Clinical Operations at Warner Chilcott
- Former Senior Director, Technical Services at Consumer Product Testing Company
- Former Section Head, Toxicology at Leberco Testing
- A., Biology, Rutgers University
Session Details: PANEL DISCUSSION Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers 12-10-2022, 4:45 pm View In Agenda

Robin Sutherland
Vice President, Human Resources and Clinical Operations,Renovia
Biography:
Session Details: Accelerating Digital Trials to Improve Outcome Success While Keeping Patient Experience at Heart 13-10-2022, 12:15 pm View In Agenda

Sloane Allebes Phillips
VP Clinical Operations, Iterative Scopes

Harry Barnett
Executive Chairman and Founder,Lubris BioPharma
Biography: Harry Barnett Harry is the co-founder and Executive Chairman of Lubris BioPharma, a clinical-stage biotech company developing a proprietary version of the novel, ubiquitous human protein, PRG4, for use in multiple indications. Novartis owns rights to Lubris’ technology for ophthalmology. Harry’s two-decade life science career includes: (i) co-founding and executive management roles at three life science companies and two CROs; (ii) incubating, partnering and licensing successfully a wide array of pharmaceutical products and technologies including Pepcid Complete®, the OTC hearburn remedy sold by J&J, and; (iii) innovating multi-center, clinical trial processes using techniques that have been adopted as industry standard. Prior to his transition to life science and biotech, Harry was a transactional business lawyer in private practice at DLA Piper in San Diego, and later at Faneuil Advisors, Inc., an investment advisory firm based in Boston where he served as General Counsel and Executive Vice President.
Session Details: PANEL DISCUSSION Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers 12-10-2022, 4:45 pm Speaker Hosted Roundtables 13-10-2022, 4:00 pm View In Agenda

Leigh Dallow
Advocate for Rare Disease Research and Development, Treatment Access and Patient Support Educator,Rythm Pharmaceuticals
Biography:
Session Details: Sharing Experiences of Being on Both Sides of a Rare Disease Trial; Focussing on the Move Towards Decentralization and the Patient Journey 12-10-2022, 1:45 pm View In Agenda







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Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem. Our Precision Matching software mines millions of patient records, including “unstructured” physician notes, to pin-point eligible study patients in real-time. Deep 6 eliminates months of manual data validation, to de-risk and accelerate clinical trials, because clinical trials should be a gatekeeper (accelerator), not a bottleneck to innovation.



















Philips BioTel Research is an industry leader in medical imaging and cardiovascular safety testing for clinical trials.
Philips BioTel Research offers global operational support for cardiovascular monitoring in all therapeutic areas, and advances imaging services in oncology, cardiovascular, metabolic, musculoskeletal, neurologic, and medical device studies. Their experienced research team comprises key opinion leaders, board-certified cardiologists and radiologists, sub-specialty scientists, and highly trained technicians – who acquire, evaluate, and report high-quality data through an efficient, cloud-based infrastructure. Many biopharmaceutical trial sponsors rely on or scientific leaders to help design and optimize their protocols and statistical analysis plans. We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date.










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.








1nHealth Delivers Patient-Centric Online Recruitment.
We believe patient recruitment is about starting conversations. The most important elements: Who you talk to and What you say.
The future is almost certainly a personalized one, and that’s how we approach recruitment today. We exist to reach the right people, and present the study’s messaging that meets them where they are.
We deploy our patient-centric, inclusive targeting using engaging study assets that deliver high volumes of pre-qualified study participants, and it works…for Sponsors, and for Patients.
1nHealth. We Fill Studies.




The medical device and diagnostic industry is currently valued at over $350 billion. Technological advances in medical device and diagnostics design are driven by an increasingly demanding market and legislative requirements. A growing patient population and a worldwide governmental drive towards preventive therapies are also fuelling the development of innovative devices.
Medical Device Developments is published in response to the increasing information needs of the major global medical device manufacturers/OEMs. The publication, which is published biannually, will incorporate authoritative reviews of current trends and emerging technologies, and provide the industry's decision-makers with clear, concise and unbiased technical articles and case histories on cutting edge developments, products and applications, drawing on the expertise of leading engineers and designers from around the globe.
L: www.linkedin.com/groups/2098440
T: Medical Device (@MedDeviceDevpt) / Twitter

Today’s healthcare providers are faced with the almost impossible task of increasing the standard of care afforded to each patient, while reducing the operational costs associated with providing this improved level of care. The care delivered throughout a healthcare facility is crucial to patient outcomes; from the emergency department through to outpatient operations, encompassing wound care, critical care and clinical care at the bedside..
e-Care, which spans the entire spectrum of patient care, is also a rapidly growing area, and one that healthcare professionals are embracing not only to improve the standard of care in areas including medication administration and patient education, but also to reduce spending. Throughout a patient’s stay in a medical facility, clinicians are faced with inevitable challenges including staff management and education, infection control and equipment failure.
Practical Patient Care is published specifically to provide medical practitioners and senior managers with the information they need in order to deliver successful care management strategies that will allow them to achieve their objective of improving patient care at a reduced cost..
L: www.linkedin.com/company/practical-patient-care
T: twitter.com/P_PatientCare


Pharmaceutical Technology
SPONSORSHIP OPPORTUNITIES
To enquire about sponsorship opportunities for the Outsourcing in Clinical Trials conference, please contact:
Nicholas McCudden
Healthcare Manager
E: NicholasMcCudden@arena-international.com
SPEAKING OPPORTUNITIES
Please get in touch with our production team if you would like to be part of the program:
Chloe Roberts
T: +44 (0) 207 936 6822
E: chloe.roberts@arena-international.com