09
November

08:00 AM EST

Clinical Operations

Strategy Meeting East Coast USA 2022

New Discoveries in Technology to Enhance Remote & Virtual Approaches, Utilisation of Telemedicine To Optimise Your Clinical Operation Success

Le Meridien Cambridge Boston

A MEETING EXPERIENCE UNLIKE ANY OTHER

Fresh Clinical Operations Insights

Tired of the same conference experience? Real discussions and genuine networking are often promised, but not always delivered. Proventa International’s Clinical Strategy Meetings are designed to avoid the pitfalls of a typical conference, by providing the right environment to make those important connections through interactive roundtable discussions, exclusive networking and keynote panel debates. Join Clinical Operations professionals from across the East Coast, in Boston MA, to discover new insights and take your company’s mission to the next level.

What makes our strategy meetings unique?

Roundtable Discussions

Intimate discussions led by renowned industry experts. Have your voice heard and debate alongside like-minded life science executives.

Unrivalled Networking

With senior delegation from big pharma and innovative biotech from across the East Coast, you can network with peers from different locations, all in one place.

Personalised Agenda

Choose the topics that matter to you. Reserve your place at the roundtable discussions and ensure your whole day delivers the insights you need to hear.

Solutions to your Problems

We’ve partnered with the best solution providers to solve your biggest challenges. Engage in pre-arranged, private meetings to address your specific needs and find a tangible solution.

Industry Researched Topics

We guarantee our agenda is up-to-date and mission critical because its designed by you. We speak to our extended network of senior decision makers to ensure the most important topics are discussed.

Senior Decision Makers

The entire strategy meeting is specifically tailored to the needs and challenges of senior life science professionals. Discover how your peers are dealing with the same challenges as you.

Meet Our 2022 Facilitators

Our panel of facilitators play a key role in shaping the agenda for the day. See who will be bringing their expertise to the table at our Clinical Operations strategy meeting.

Aruna Adhikari Thapa

Senior Director, Product Management IQVIA Technologies

Gayle Hamilton

Director, RBQM, Digital Trial Management Suite IQVIA Technologies

John Cassidy

Global Head of Product & Commercial, eClinical Labcorp

Stan Letovsky

VP of AI and Bioinformatics Labcorp

Lindsey Morales

Associate Director, Site Centric Solutions Labcorp

Reginald Swift

Head of Study Management and Monitoring Successful Strategies for Life Sciences

Claudia Hesselmann, PhD

Co-founder & CEO ARENSIA

Ash Rishi

CEO and Co-founder, Founder COUCH Health, Demand Diversity and COUCH Academy

Scott Chetham

Co-Founder, CEO Faro Health

Debashish Niyogi, PhD

Vice President, Product Management Anju Software

Adrian Otte

MB BCh, Executive Strategic Advisor & Board Member KPS Life

Jeff Repper

EVP Strategic Site Initiatives Transformative Pharmaceutical Solutions

Dina Berdieva

VP of Clinical Operations Arcturus Therapeutics

William Blumentals

Head of Pharmacoepidemiology Sanofi Genzyme

William Blumentals is the Head of Pharmacoepidemiology at Sanofi Genzyme in the Epidemiology and Benefit-Risk Team and based in Cambridge, MA. While leading Sanofi Genzyme, Willy was also the Interim Head of Pharmacoepidemiology for General Medicines and Consumer Healthcare. Willy has over 18 years of experience working in pharma companies on Pharmacoepidemiology to support Drug Safety, Regulatory, Medical Affairs, and Commercial. Previously, he served as an epidemiology director and safety epidemiology lead at Shire. Other recent positions included Shionogi, where Willy established a new global epidemiology department; introducing and developing epidemiology recognition during an 18-month appointment in Osaka, Japan. He also served as Global Head of Epidemiology for Virology and Transplant and Administrative Site Head at Hoffmann-La Roche in Nutley, New Jersey. 
Willy received his doctoral degree in epidemiology from the University of South Florida, and holds an M.S. in statistics from Temple University, and an M.P.H. in epidemiology from the University of Alabama at Birmingham.

Elspeth Carnan

Senior Vice President, Clinical Development Operations Alkermes Inc.

Elspeth Carnan, Ph.D. serves as <a href="https://www.alkermes.com/">Alkermes</a>’ Senior Vice President of Clinical Operations. In this role, Dr. Carnan leads the clinical trial management, clinical supply chain, data management and study start-up functions. She is responsible for the execution of all clinical programs supporting Clinical Development at Alkermes.
Dr. Carnan has more than 30 years of global clinical program and portfolio management experience in preclinical and clinical stage programs across a variety of therapeutic areas. Prior to joining Alkermes, she served as the Vice President, Global Head of Clinical Trial Management and Global Monitoring at Regeneron, ED Strategic Sourcing at EMD Serono , Merck KGa, ED R&D Strategy at Sunovion Pharmaceuticals, ED Global clinical Operations at Amgen and various roles at GlaxoSmithKline.
Dr. Carnan received a bachelor’s degree in Physiology from the University of Glasgow and a Ph.D. in Physiology from the University of Newcastle Medical School in England.

Sashka Dimitrievska

Global Therapeutic Area Head Oncology Clinical Insights AstraZeneca

Jim Marshall

Associate Director, Materials Management Alnylam Pharmaceuticals

Jim Marshall is a performance-driven Supply Chain leader with over 20 years of experience in the BioPharmaceutical industry. Materials Management expert who has led the implementation of an SAP ERP system in a commercial environment utilizing both in-house and external manufacturing. Experienced in supplier auditing and qualification processes, sourcing and management of CMOs, and the use of QRM and OpEx to manage the end to end supply chain. Well-developed leadership skills that include formulation and deployment of strategy, succession planning and talent development, operational budget responsibility and ensuring compliance with Corporate Standards and cGMP/ICH regulations. A compliance-minded individual with strong knowledge of cGMPs, global regulatory requirements, and an understating of how they impact the supply chain. Demonstrated capability in a primary engagement role representing supply chain and functional operations to external regulatory agencies.

Amanda McEwen

Vice President, Clinical Development Salubris Biotherapeutics

Amanda McEwen has over 14 years of experience in clinical research that spans work in academia, contract research organizations, and several Boston-area small-to-mid-size biotechnology companies. Throughout her career, Amanda has held roles of increasing responsibility within the Clinical/Regulatory Development space across a range of therapeutic areas including rare, neurodegenerative, respiratory, infectious, and metabolic diseases. Her experience includes a variety of therapeutic product types, including combination products, most notably a novel dry powder inhalation therapy to treat motor issues in Parkinson’s patients, Inbrija™, approved by the FDA and EMA. Amanda has a particular affinity for early phase work and has played pivotal roles in shepherding several programs from the bench to the clinic, most recently in her previous role as Vice President of Clinical Development of Nocion Therapeutics, where she successfully led the efforts to complete Nocion’s first Phase 1 study amidst the backdrop of the emerging SARS-CoV-2 pandemic. In addition to her work in industry, Amanda serves as an adjunct faculty member for Northeastern University’s Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices, specializing in courses on the strategic and technical considerations for IND and NDA/MAA submissions and Pharmacovigilance regulations and best practices. Amanda holds a BA in Psychology from the College of the Holy Cross and a Master of Research Methods in Psychology degree from the University of York.

Frank Leu

Founder & Managing Member/ Managing Member BioPharMatrix LLC/ Novapeutics LLC

Oscar Segurado

Chief Medical Officer ASC Therapeutics

Oscar Segurado is an executive veteran of the biopharmaceutical industry with extensive global leadership experience in translational science, clinical development and global medical affairs. C-suite executive and industry leader providing in-depth expertise for pre-clinical and clinical study strategy, planning, execution and monitoring, regulatory interactions, investor relations, fundraising, M&A and IPO process and deliverables. Chief Medical Officer for ASC Therapeutics, former CMO for Symvivo, Myriad Genetics and CellMax Life, Vice President for Becton Dickinson and Global Medical Head for Abbott/AbbVie (Humira). Author and co-author of over 100 peer-reviewed publications, including Nature, Lancet and Journal of Experimental Medicine, books and medical articles and member of several scientific and medical societies. Holding a tenured Professorship of Immunology at the University of Leon, Spain. Received PhD from the University of Wuerzburg, Germany and MD from the University of Salamanca, Spain.

Ana Sharma

Vice President, Head of Research & Development Clinical Quality Assurance Takeda

First name	Last name	Job title	Company name	Photo URL	Bio Position
Aruna	Adhikari Thapa	Senior Director, Product Management	IQVIA Technologies	https://proventainternational.com/wp-content/uploads/2022/10/Aruna-Adhikari-Thapa-2.jpg	Aruna Adhikari-Thapa is a seasoned technology strategist with 20+ years’ experience in software product management. She excels in leading cross-functional teams, shaping product strategies, justifying investments, and launching innovative solutions to address complex business challenges. Aruna holds a B.Sc. in Network Modeling & Simulation and Statistics from Saint Cloud State University, along with an MBA in Strategic Technology Management from Augsburg College. Aruna’s career is marked by her commitment to delivering innovative solutions creating maximum value for end users. She was recently named to the PharmaVoice 100 in the Tech and AI Wizard category.
Gayle	Hamilton	Director, RBQM, Digital Trial Management Suite	IQVIA Technologies	https://proventainternational.com/wp-content/uploads/2022/04/Gayle-Hamilton-New-1.jpg	Gayle Hamilton is an experienced Risk-Based Monitoring project advisor and project lead with a strong background in clinical operations and project management. She has supported study trial teams and IT development in RBQM implementation across all phases and therapeutic areas, driving the development of processes, tools, and systems. Gayle is also experienced in assuring high-quality business performance of clinical operations within global projects.
John	Cassidy	Global Head of Product & Commercial, eClinical	Labcorp	https://proventainternational.com/wp-content/uploads/2022/10/John-Cassidy.jpg	John leads the innovation and commercialization of Labcorp Drug Development’s proprietary DCT platform, SnapClinical. With two successful acquisitions by Contract Research Organizations, John displays a passion for the creation of solutions designed to reduce the burden on patients while increasing the proliferation of technology to support bringing life-saving drugs and therapies to market.
Stan	Letovsky	VP of AI and Bioinformatics	Labcorp	https://proventainternational.com/wp-content/uploads/2022/11/Stan-Letovsky.jpg
Lindsey	Morales	Associate Director, Site Centric Solutions	Labcorp	https://proventainternational.com/wp-content/uploads/2022/10/Lindsey-Morales.jpg	Lindsey Morales has over 17 years of industry experience across sponsors, CROs and academic research sites. Her background includes roles in site relationship management, site identification, feasibility, study start-up and site monitoring. She currently serves as an Associate Director in Site Centric Solutions, which is part of the DCT and Patient Centricity team at Labcorp Drug Development. In her current role, she builds strong partnerships with site networks throughout North America and also collaborates in the planning and execution of Labcorp’s health screening events for patients across the US. Lindsey is passionate about finding ways to make research more patient centric and promoting research as a care option in our communities.
Reginald	Swift	Head of Study Management and Monitoring	Successful Strategies for Life Sciences	https://proventainternational.com/wp-content/uploads/2022/09/Reginald-Swift.jpg	Reginald Swift, Ph.D, Clinical Partner for Successful Strategies – using innovation at a greater scale to change how health outcomes can be realized through patient product and service innovation. With a background in mechanical engineering, many of the research pursuits also involve the development of regenerative metals to target specific diseases such as Multiple Sclerosis for Myelin regeneration, ALS, PLS, PKAN and much more (with a rare and infectious disease focus).
Claudia	Hesselmann, PhD	Co-founder & CEO	ARENSIA	https://proventainternational.com/wp-content/uploads/2020/01/Claudia-Hesselmann-Arensia-Headshot-e1584469734743.png	Claudia Hesselmann, PhD, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics.
Ash	Rishi	CEO and Co-founder, Founder	COUCH Health, Demand Diversity and COUCH Academy	https://proventainternational.com/wp-content/uploads/2022/07/Ash-Rishi.jpg	In his own words, Ash is a ‘failed neuroscientist’. Ash is a passionate, supportive leader – one who truly eats, sleeps and lives our mission to make healthcare more human. Ash shares over 15 years of experience in creative communications, patient engagement, and patient recruitment strategies for clinical trials, with a key focus to improving diversity in clinical trials. Ash is driven to make a difference, and is inspired to defy the odds, always standing up for what’s right. It’s why he set out to make COUCH Health what it is today.
Scott	Chetham	Co-Founder, CEO	Faro Health	https://proventainternational.com/wp-content/uploads/2022/03/Scott-Chetham.jpg	Scott Chetham Ph.D. is an experienced healthcare entrepreneur who is currently the CEO and co-founder of Faro Health. Scott leads the strategy for the Faro Health platform, which is designed to power clinical development by connecting data to decision making in a fundamentally new way. Previously, he was the Head of Clinical Research Operations and Data Management at Verily Life Sciences, formerly known as Google Life Sciences. This multifaceted strategic and operational role involved leading the clinical strategy, clinical teams, process development and operations for all clinical projects of the company, including Google and Google[x]. Scott has also served as a Venture Partner at Versant Ventures, CTO and Co-founder of Intersection Medical (sold to ImpediMed), and VP Clinical Affairs (ImpediMed). In these latter two roles he was responsible for clinical research strategy and operations.
Debashish	Niyogi, PhD	Vice President, Product Management	Anju Software	https://proventainternational.com/wp-content/uploads/2022/09/Debashish-Niyogi.jpg	Debashish has over 18 years of experience in the life sciences / clinical trials industry, including various leadership roles in Product Management. He is currently responsible for the vision, strategy, and roadmap of the eTMF and CTMS solutions at Anju Software. His expertise is in the eTMF / regulated content management space, and he is a member of the TMF Reference Model Project Team. Debashish has previously managed successful eTMF products at Veeva and Medidata as well as clinical trial imaging tools at Synarc (now part of Clario). He has also held senior level roles at various biotech and pharmaceutical companies (including Gilead Sciences, Genentech, and Otsuka). He has a PhD in Computer Science.
Adrian	Otte	MB BCh, Executive Strategic Advisor & Board Member	KPS Life	https://proventainternational.com/wp-content/uploads/2022/10/Adrian-Otte.jpg	Dr Otte has over 35 years’ experience leading Global Clinical Operations at companies such as Amgen, Pfizer, Parexel and Zeneca. His most recent experiences include: Amgen Inc., Thousand Oaks, California Vice President, Global Development Operations responsible for overall phase 2-4 clinical trials operations. Pfizer Inc., New London, Connecticut Senior Vice President, Global Development Operations responsible for phase 1-4 clinical trials operations. His additional roles leading development operations at a large CRO and as COO for a major Site Management Organization (Clinical Studies Ltd) add to his unique perspective on clinical research
Jeff	Repper	EVP Strategic Site Initiatives	Transformative Pharmaceutical Solutions	https://proventainternational.com/wp-content/uploads/2022/06/Jeff-Repper.jpg
Dina	Berdieva	VP of Clinical Operations	Arcturus Therapeutics	https://proventainternational.com/wp-content/uploads/2021/04/Dina-Berdieva-1.jpg	Dina is the Vice President of Clinical Operations for Arcturus Therapeutics, a platform-based mRNA company in San Diego, CA. Prior to joining Arcturus, Dina was a founding member of the Gates Medical Research Institute, serving as the Head of Project Management & Clinical Operations. Dina has 20 years of industry experience which spans small biotechnology, global pharmaceutical and contract research organizations. Much of her career has been focused on the development of vaccines and treatments for infectious diseases. Dina holds a Bachelor of Arts degree from Clark University and a Master of Public Health degree from Boston University.
William	Blumentals	Head of Pharmacoepidemiology	Sanofi Genzyme	https://proventainternational.com/wp-content/uploads/2020/10/William-A-Blumentals-1.jpg	William Blumentals is the Head of Pharmacoepidemiology at Sanofi Genzyme in the Epidemiology and Benefit-Risk Team and based in Cambridge, MA. While leading Sanofi Genzyme, Willy was also the Interim Head of Pharmacoepidemiology for General Medicines and Consumer Healthcare. Willy has over 18 years of experience working in pharma companies on Pharmacoepidemiology to support Drug Safety, Regulatory, Medical Affairs, and Commercial. Previously, he served as an epidemiology director and safety epidemiology lead at Shire. Other recent positions included Shionogi, where Willy established a new global epidemiology department; introducing and developing epidemiology recognition during an 18-month appointment in Osaka, Japan. He also served as Global Head of Epidemiology for Virology and Transplant and Administrative Site Head at Hoffmann-La Roche in Nutley, New Jersey. Willy received his doctoral degree in epidemiology from the University of South Florida, and holds an M.S. in statistics from Temple University, and an M.P.H. in epidemiology from the University of Alabama at Birmingham.
Elspeth	Carnan	Senior Vice President, Clinical Development Operations	Alkermes Inc.	https://proventainternational.com/wp-content/uploads/2022/10/Elspeth-Carnan-Alkermes.jpg	Elspeth Carnan, Ph.D. serves as Alkermes’ Senior Vice President of Clinical Operations. In this role, Dr. Carnan leads the clinical trial management, clinical supply chain, data management and study start-up functions. She is responsible for the execution of all clinical programs supporting Clinical Development at Alkermes. Dr. Carnan has more than 30 years of global clinical program and portfolio management experience in preclinical and clinical stage programs across a variety of therapeutic areas. Prior to joining Alkermes, she served as the Vice President, Global Head of Clinical Trial Management and Global Monitoring at Regeneron, ED Strategic Sourcing at EMD Serono , Merck KGa, ED R&D Strategy at Sunovion Pharmaceuticals, ED Global clinical Operations at Amgen and various roles at GlaxoSmithKline. Dr. Carnan received a bachelor’s degree in Physiology from the University of Glasgow and a Ph.D. in Physiology from the University of Newcastle Medical School in England.
Sashka	Dimitrievska	Global Therapeutic Area Head Oncology Clinical Insights	AstraZeneca	https://proventainternational.com/wp-content/uploads/2021/02/Sashka-Dimitrievska.jpeg	Sashka leads the Global AstraZeneca Oncology Information Practice (IP) department focused on generating informed decisions in late stage drug development across the oncology portfolio. Prior to joining AstraZeneca in 2017, Sashka worked in Alexion Pharmaceuticals Strategy & Intelligence, followed by a role in Alexion US Marketing. She holds a PhD in Biomedical Engineering and an MBA training from Yale University.
Jim	Marshall	Associate Director, Materials Management	Alnylam Pharmaceuticals	https://proventainternational.com/wp-content/uploads/2020/01/Jim-Marshall-1-scaled-e1611143651474.jpg	Jim Marshall is a performance-driven Supply Chain leader with over 20 years of experience in the BioPharmaceutical industry. Materials Management expert who has led the implementation of an SAP ERP system in a commercial environment utilizing both in-house and external manufacturing. Experienced in supplier auditing and qualification processes, sourcing and management of CMOs, and the use of QRM and OpEx to manage the end to end supply chain. Well-developed leadership skills that include formulation and deployment of strategy, succession planning and talent development, operational budget responsibility and ensuring compliance with Corporate Standards and cGMP/ICH regulations. A compliance-minded individual with strong knowledge of cGMPs, global regulatory requirements, and an understating of how they impact the supply chain. Demonstrated capability in a primary engagement role representing supply chain and functional operations to external regulatory agencies.
Amanda	McEwen	Vice President, Clinical Development	Salubris Biotherapeutics	https://proventainternational.com/wp-content/uploads/2022/07/Amanda-McEwen.jpg	Amanda McEwen has over 14 years of experience in clinical research that spans work in academia, contract research organizations, and several Boston-area small-to-mid-size biotechnology companies. Throughout her career, Amanda has held roles of increasing responsibility within the Clinical/Regulatory Development space across a range of therapeutic areas including rare, neurodegenerative, respiratory, infectious, and metabolic diseases. Her experience includes a variety of therapeutic product types, including combination products, most notably a novel dry powder inhalation therapy to treat motor issues in Parkinson’s patients, Inbrija™, approved by the FDA and EMA. Amanda has a particular affinity for early phase work and has played pivotal roles in shepherding several programs from the bench to the clinic, most recently in her previous role as Vice President of Clinical Development of Nocion Therapeutics, where she successfully led the efforts to complete Nocion’s first Phase 1 study amidst the backdrop of the emerging SARS-CoV-2 pandemic. In addition to her work in industry, Amanda serves as an adjunct faculty member for Northeastern University’s Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices, specializing in courses on the strategic and technical considerations for IND and NDA/MAA submissions and Pharmacovigilance regulations and best practices. Amanda holds a BA in Psychology from the College of the Holy Cross and a Master of Research Methods in Psychology degree from the University of York.
Frank	Leu	Founder & Managing Member/ Managing Member	BioPharMatrix LLC/ Novapeutics LLC	https://proventainternational.com/wp-content/uploads/2020/08/Frank-Leu-1.jpg	Frank Leu is a Founder & Managing Member/ Managing Member of BioPharMatrix LLC/ Novapeutics LLC located in Philadelphia, developing a first-in-class insulin-producing beta-cell restoration curative for diabetes. Prior, Frank was at a specialty pharma, Verto Institute, developing curatives for a neuroendocrine cancer. Frank received his Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences, postdoc-ed at a HHMI lab at the Rockefeller University, and served as an instructor at the Rutgers Cancer Institute of NJ. Currently, he is an adjunct professor at Thomas Jefferson University, advisor to 1776 for Pennovation Center Labs, founder of BioPharMatrix (life-science ecosystem), and serving on numerous life-sciences advisory boards.
Oscar	Segurado	Chief Medical Officer	ASC Therapeutics	https://proventainternational.com/wp-content/uploads/2021/09/Photo_Oscar-Segurado_F0-e1631533577811.jpeg	Oscar Segurado is an executive veteran of the biopharmaceutical industry with extensive global leadership experience in translational science, clinical development and global medical affairs. C-suite executive and industry leader providing in-depth expertise for pre-clinical and clinical study strategy, planning, execution and monitoring, regulatory interactions, investor relations, fundraising, M&A and IPO process and deliverables. Chief Medical Officer for ASC Therapeutics, former CMO for Symvivo, Myriad Genetics and CellMax Life, Vice President for Becton Dickinson and Global Medical Head for Abbott/AbbVie (Humira). Author and co-author of over 100 peer-reviewed publications, including Nature, Lancet and Journal of Experimental Medicine, books and medical articles and member of several scientific and medical societies. Holding a tenured Professorship of Immunology at the University of Leon, Spain. Received PhD from the University of Wuerzburg, Germany and MD from the University of Salamanca, Spain.
Ana	Sharma	Vice President, Head of Research & Development Clinical Quality Assurance	Takeda	https://proventainternational.com/wp-content/uploads/2020/01/Ana-Sharma.jpg	Ana Sharma serves as the Vice President, Head of Research and Development Clinical Quality Assurance at Takeda. Prior to joining Takeda, Ana held various roles in quality at Novartis, Amgen and the Dana-Farber/Harvard Cancer Center. Ana has a Bachelor of Science degree in Biology and a Master of Public Health degree in Epidemiology and Biostatistics. Her personal interests are achieving health equity and tackling the world’s most pressing health challenges.

Aruna Adhikari Thapa, Gayle Hamilton, John Cassidy, Stan Letovsky, Lindsey Morales, Reginald Swift, Claudia Hesselmann, PhD, Ash Rishi, Scott Chetham, Debashish Niyogi, PhD, Adrian Otte, Jeff Repper, Dina Berdieva, William Blumentals, Elspeth Carnan, Sashka Dimitrievska, Jim Marshall, Amanda McEwen, Frank Leu, Oscar Segurado, Ana Sharma

See the complete agenda and facilitator line-up

Download the strategy meeting brochure for full details

DOWNLOAD BROCHURE

Who Should Attend the Event?

Clinical Operations

Clinical Project/ Program Leads

Clinical Quality Assurance

Clinical Research

Clinical Outsourcing

Data Management

Vendor Management

Medical/Scientific Officers

Biometrics

Medical Affairs

Patient affairs

Global study

Site management/ selection

Digital health

TMF/eTMF

Data monitoring

Patient recruitment

Patient engagement

Clinical investigation

Study optimisation

Patient insights

Clinical systems

See Which Topics Are Discussed at the Strategy Meeting

09:00 – 10:00

Roundtable Tracks

Finding tactical approaches that support risk-based quality management

What are the challenges organizations face in enrolling diverse populations

Design clinical trials that offers “CHOICE” to patients for in-clinic and at home (hybrid models) visits

Leveraging Outsourcing Strategies to Mitigate Rising Costs & Improve Partnerships

Incorporating real-time clinical insights in clinical development process for faster submissions and accelerated approvals

Identify areas where digital technology solutions could be created to improve the experience, value, and results of patients, clinicians, and organisations – TBC

11:10 – 12:10

Roundtable Tracks

Ensuring Regulatory Compliance and Audit Readiness using RBQM Technology IQVIA

Moving Beyond DCTs (Decentralized Clinical Trials): Next Steps in Trial Transformation LABCORP

Less talk, more action: How to achieve diversity, inclusion, and equity in clinical research COUCH HEALTH

How using SiteChoice to invest in your site’s workforce can transform your study outcomes and patient’s experience. TRANSFORMATIVE PHARMACEUTICAL SOLUTIONS

Effective Management of Essential Clinical Trial Documents Using eTMF Solutions ANJU SOFTWARE

How can we use and optimize data in order to improve study start up and site cycle times SUCCESSFUL STRATEGIES

Reasons To Attend the Strategy Meeting

Our unique closed door round-table discussion format is exclusively designed to engage 10-15 CxO, VP and director-level individuals from pharma, biotech and thought leaders from academia, to address and find solutions to industry challenges from a strategic perspective within the Clinical community

Bespoke networking opportunities to help streamline your procurement processes, meaning the impetus for your peers attending is solely based around making business decisions at the highest level

To gain practical insight with Good Clinical Practice and Risk Based Quality Management strategies

Improve diversity through patient-centric approaches, decentralized trials and new digital technologies

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Clinical Operations & Clinical Trial Supply Chain Strategy Meeting East Coast – Boston 2024

Clinical Operations

Strategy Meeting East Coast USA 2022

<img class="lazy" decoding="async" src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%201%201'%3E%3C/svg%3E" data-src="https://proventainternational.com/wp-content/uploads/2020/12/location.png" >Le Meridien Cambridge Boston

Fresh Clinical Operations Insights

What makes our strategy meetings unique?

Roundtable Discussions

Unrivalled Networking

Personalised Agenda

Solutions to your Problems

Industry Researched Topics

Senior Decision Makers

Meet Our 2022 Facilitators

Aruna Adhikari Thapa

Gayle Hamilton

John Cassidy

Stan Letovsky

Lindsey Morales

Reginald Swift

Claudia Hesselmann, PhD

Ash Rishi

Scott Chetham

Debashish Niyogi, PhD

Adrian Otte

Jeff Repper

Dina Berdieva

William Blumentals

Elspeth Carnan

Sashka Dimitrievska

Jim Marshall

Amanda McEwen

Frank Leu

Oscar Segurado

Ana Sharma

See the complete agenda and facilitator line-up

Who Should Attend the Event?

Clinical Operations

Clinical Project/ Program Leads

Clinical Quality Assurance

Clinical Research

Clinical Outsourcing

Data Management

Vendor Management

Medical/Scientific Officers

Biometrics

Medical Affairs

Patient affairs

Global study

Site management/ selection

Digital health

TMF/eTMF

Data monitoring

Patient recruitment

Patient engagement

Clinical investigation

Study optimisation

Patient insights

Clinical systems

See Which Topics Are Discussed at the Strategy Meeting

REGISTRATION AND WELCOME

OPENING KEYNOTE PRESENTATION Exploring The Success and Lessons Learnt From Virtual Approaches & Remote Monitoring

Roundtable

Roundtable Tracks

Finding tactical approaches that support risk-based quality management

What are the challenges organizations face in enrolling diverse populations

Design clinical trials that offers “CHOICE” to patients for in-clinic and at home (hybrid models) visits

Leveraging Outsourcing Strategies to Mitigate Rising Costs & Improve Partnerships

Incorporating real-time clinical insights in clinical development process for faster submissions and accelerated approvals

Identify areas where digital technology solutions could be created to improve the experience, value, and results of patients, clinicians, and organisations – TBC

REFRESHMENT BREAK

NETWORKING / 1-1 MEETINGS

NETWORKING / 1-1 MEETINGS

NETWORKING / 1-1 MEETINGS

Le Meridien Cambridge Boston

OPENING KEYNOTE PRESENTATION
Exploring The Success and Lessons Learnt From Virtual Approaches & Remote Monitoring