Archives: Speakers

A data driven, high performing and results orientated Team Leader, with 20+ years of experience in Strategic Planning and Programs Execution and with 15+ years of experience in direct management and development of teams and individuals, with a proven track record for delivering and optimizing clinical studies, leading high-performing teams in global, matrix-based environment across multiple therapeutic areas and compounds.

Expert in data analysis and interpretation, proficient in tools and technologies associated to project execution and recruitment strategies, and confident to work across different stakeholder groups to develop tactical/operational plans aligned with regulatory and commercial objectives.

Passionate about science, project management and people mentoring and improvement, with also a solid expertise in the regulation of clinical studies and data protection, risk assessment and root cause analysis, audits and implementation of CAPAs.

As a physician scientist, Eugenie Suter, MD, PhD, is dedicated to improving life for people with neurologic disorders. Her commitment
to drug development is founded on experience in research (Ph.D. in Neuroscience at Northwestern University; Immunology at Harvard’s Boston Children’s Hospital) as well as clinical medicine (Northwestern University; UCLA). Dr. Suter enjoys fostering innovation by drawing on her own experience and training in business, clinical trials, public policy and linguistics,. Driven by the need she witnesses clinically, she aims to bring new treatment options to individuals living with neurologic and other life-altering disorders through her work in Neuroscience & Rare Diseases as well as the Cardiovascular & Metabolic group at Roche.

Accomplished Clinical Operations and Development Executive with an impressive track record, boasting hands-on experience in Clinical Development, (25 years in consultancy) Across all phases (I to IV), from translational medicine to lifecycle management.

Held pivotal roles including Program Management, Clinical Operations, Site Selection and Patient Recruitment, Regulatory Affairs, Safety Oversight, Medical Writing, and Clinical Quality Assurance.

Spearheaded and successfully navigated asset licensure initiatives.

Worked with a diverse client base ranging from medium-sized pharma companies to venture capital-backed startups.

Managed a workforce of up to 32 individuals, overseeing operations both domestically and internationally.

Possesses a global perspective, having lived and worked in diverse regions including the UK, Germany, Japan, and Australia. Proven ability to excel in culturally complex and logistically challenging geographies, as well as managing single protocol global studies.

Led strategic transformation initiatives by identifying opportunities for efficiency improvement, enhancing business performance, driving innovation through strategic thinking, cross-company leadership, change management expertise, and a profound knowledge of industry trends and best practices.

Actively served as a Corporate and Departmental Diversity, Equity, and Inclusion (DE&I) representative, emphasizing the importance of diversity and inclusion within the workplace.

Held the role of a guest lecturer at King’s College London, contributing to the Masters in Clinical Research program.

Joined to the project of biotechnologies in 2012, at the beginning of the Advanced Therapies. The labour as Oncologist in Big Pharma from September of 2016 until today has been taking part of international research organizations in which participated actively; Working as a Cross-functional role for Spain and Portugal, clinical development of Lilly portfolio, deep dive of clinical trials and preclinical studies of new drugs, from First Human dose to Phase III/IV. Expert in Regulatory terms and access negotiation, in Pre-launching and Clinical Launching of drugs developing the brand plan and operational plans supporting all implicated areas, from I+D, clinical operations, to marketing and sales.

Other Qualities are management and leadership, strategy and innovation, technology, operations, and value chain management, Emotional intelligence and empathy. The road map to achieve all theses capabilities has been intense working in 10 Hospitals, in basic science, preclinical research in Advanced Therapy Medicinal Product, developing drugs from human origen from Wharthon´s jelly MSCs, fat and dental pulp to recover damaged soft tissue, chronic stroke and chemotherapy damage and been author of books papers, communications in international meetings and participating in many advanced projects nationwide health demonstrating great capacity for teamwork to solve complex situations.

Debarshi is currently Global Head of Biostatistics and Data Management consisting of approximately 30 Biostatisticians, Statistical Programmers and Data Managers across two global sites in Munich, Germany and Boston, USA for a Bio-Pharmaceutical company engaged in bringing novel drugs in Oncology and Auto-immune disease to patients.

With more than 11 years of experience in drug development in the pharmaceutical industry, Debarshi has extensive and proven track-record of impactful data-driven leadership in all phases of drug development and successful regulatory interactions regarding New Drug Application (NDA) and Biologics License Application (BLA) with USFDA, EMA, and PMDA.

Debarshi was the Lead Statistician of a pivotal oncology study with a real-world component, which resulted in a successful FDA approval in July 2020. In the course of the path to approval, Debarshi provided strategic leadership, led multiple interactions with FDA and provided strong statistical input in regulatory aspects of the submission. Debarshi has designed Phase I-III clinical trials, with complex adaptive features, calculating optimal sample size taking advantage of advanced simulation methods.

In his current role, Debarshi has been instrumental in setting up a fully functional Statistics and Data Management Department from scratch , including a CFR 21 Part 11 validated SAS programming environment for performing in-house programming.

Digital innovation business leader experienced in setting and scaling up digital solutions in the
pharmaceutical space. My mission is to foster innovation in digital health, with the aim to advance healthcare and help patients.

I am a results-driven and visionary leader with over 20 years of experience in the pharma and biotech industries. I have successfully led and grown companies, both as a CEO and a Managing Director, by leveraging my expertise in business development, licensing, financial modeling, negotiation, and market analysis.

Currently, I am the Managing Director of an undisclosed company, where I oversee the strategic direction, operations, and partnerships of the organization. I am passionate about finding innovative solutions for difficult challenges and creating value for stakeholders. I am also a team player who builds strong relationships and alliances across functions and geographies. My goal is to make a positive impact on the health and well-being of people around the world.

Co-founder of DX Compliance, a lawyer who previously worked as Head of AML & Compliance for Germany’s first challenger bank, on a mission to help financial services companies with more unique needs achieve regulatory compliance by having deeper insights into their customers’ and employee’s behaviour.