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 of Product Strategy and 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

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

Press play to hear what your colleagues had to say…

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<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