Archives: Speakers

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.

In the world of global hospitality, few people show innovation and leadership like Mr. Elias Saad. With a career spanning over 25 years, Mr. Saad has made a significant impact on the hospitality industry. His continuous pursuit for new ideas and his commitment to exceeding industry standards have made him a model of excellence and creativity. 

Mr. Saad’s career is a prime example of both operational and strategic brilliance. He has led many successful pre-opening projects and developed business strategies that often exceeded operational goals. His strategic skills and operational success have earned him many awards, including the Gold Winner F&B Director/Leader of the Year 2024 and a spot among the Best 30 F&B Leaders in the Middle East 2023. These awards highlight his outstanding leadership and dedication to improving the hospitality experience. 

Mr. Saad holds a Master of Business Administration from Cardiff Metropolitan University, which strengthens his professional achievements. His deep understanding of business, management, marketing, and related services supports his strategic and operational decisions, driving the success of the establishments he leads. 

Mr. Saad’s career demonstrates his versatility and impact in various high-profile roles. His journey from an assistant manager at Hilton Abu Dhabi to an executive leader at some of the Middle East’s most prestigious hotels is inspiring. At Bab Al Qasr Hotel in Abu Dhabi, he has served as Executive Assistant Manager I/C Food & Beverage , where his leadership has been key in achieving high levels of culinary excellence and customer satisfaction. His previous roles at Fairmont Bab Al Bahr, Le Meridien Hotel Abu Dhabi, and Emirates Palace also show a consistent record of improving operational efficiency and customer loyalty. His commitment to challenging norms and driving excellence continues to shape the future of the hospitality industry. His story is not just one of professional success, but also one of transformative leadership and visionary ambition that encourages others to strive for greatness in their careers. 

One of his notable achievements is the implementation of the first ISO 22000 standards in the Middle East and Africa, highlighting his dedication to excellence and safety in hospitality operations. His recognition for Total Hotel Revenue Management by HSMAI Middle East in May 2023 shows his innovative approach to maximizing profitability and efficiency. 

Beyond his professional work, Mr. Saad has become an influential presence, leveraging social media to extend his impact and inspire others in the hospitality industry. His adept use of digital platforms demonstrates a modern and dynamic approach to leadership, setting an example for the next generation of hoteliers. 

In the world of hospitality, Mr. Saad is a significant figure whose legacy of excellence, innovation, and leadership will continue to influence the industry for years to come.