Archives: Speakers

Global Regulatory Affairs executive with 20+ years of drug development and management experience with expertise in all stages of drug development and successful filing and registration experience.
Therapeutic areas include oncology (hematology and solid tumors) gastroenterology, ophthalmology, HIV as well as combination products and medical devices.

Driven by a passion for transformative innovation, I leverage my deep expertise in data science, informatics, and data management to pioneer solutions in the biotechnology and pharmaceutical sectors. With a robust background in system and data analytics, I excel in orchestrating change to address complex scientific and clinical challenges.

Holding a Ph.D. in neuroscience complemented by extensive training in clinical research, epidemiology, and data science, I am at the forefront of integrating cutting-edge technologies into practical applications. My journey has led me to spearhead projects harnessing the power of Large Language Models and AI agents, specifically tailored to enhance clinical outcomes and drug safety.

As a seasoned data technologist and research scientist, my proficiency encompasses the full software development lifecycle, project management, and the creation of dynamic databases and informatics systems. I thrive on cultivating internal and external partnerships, leading multidisciplinary teams distributed across geographies.

My current endeavors focus on deploying AI-driven platforms that refine clinical systems and data management projects. I am committed to advancing the capabilities of AI to improve decision-making processes, reduce risks, and ultimately elevate patient care and safety in the medical field.

Clinical development executive with 29 years of experience of increasing responsibility.
Key achievements include:

1. Drove development and successful launch of NCE product for the treatment of MDR-TB
   2. Procured over 35 million in non-dilutive funding for development of a suite of products to treat multiple infectious disease indications.
   3. Served as Steering Committee Member and clinical representative for PAN-TB consortium (including Evotec, Janssen, GSK, Otsuka, GMRI, and BMGF)
   4. Drove strategic planning for IND-enabling and clinical-stage programs for small biotech clients and for the development of internal assets.
   5. Expanded company revenue streams to include a clinical services solution and achieved profitability within 12 months.
   6. Collaborated with the C-suite team in developing short-term and long-term goals and strategies to increase clinical revenue.
   7. Drove development of multiple cross-functional strategic development plans and built pathways to licensure.
   8. Increased monthly enrollment rate by 85% from H1 2023 to H2 2023 in a pivotal phase 3 trial for first-line treatment of pancreatic cancer.
   Strengths include communication, analytical thinking, leadership, negotiation, and problem solving.

Jenelle Lin is the Associate Director, Clinical Operations at Aditum Bio. Jenelle has extensive experience in operations oversight and program management, having previously led the first pivotal program in rare disease Transthyretin Cardiomyopathy at Eidos Therapeutics, a BridgeBio company, from early stage to NDA filing. Jenelle contributed to global programs in hematology and oncology at FibroGen and supervised multiple trials at the University of California San Francisco. Jenelle has academic research experience in oncology, ophthalmology, morbidity and human papillomavirus (HPV). Additionally, Jenelle currently advises biotechnology startups through California Life Sciences. Jenelle holds a MSc in Epidemiology and Public Health from the University of Miami School of Medicine and is currently pursuing an executive program at Stanford University Graduate School of Business.

Hands on experience in early, mid, and late stage product development and regulatory strategy in small and large pharma.

Rigorous scientific background with 10+ years of experience driving academic and industry research programs from product ideation to commercialization. Passionate about the intersection between health research and new technologies. Subject-matter expert for novel health applications, excelling in cross-functional partnerships with engineering, regulatory, legal and privacy, and product development teams. Specialized in research strategy and technical operations, including large-scale data collection and curation to drive AI model development.

As the leader of Medidata’s Global Compliance & Strategy function,  Ari applies a risk based approach to navigating and interpreting the global regulatory landscape of the clinical trial ecosystem.  With nearly 25 years of experience working with regulated industries, Ari integrates cross functionally to bring a balanced application of compliance, governance, risk, and controls within Medidata’s products and services.  Leveraging the experience of an international team, Ari actively promotes increased trust and transparency regarding the areas that matter most in maximizing the potential of the Medidata Platform.

Rohan Simon is the Associate Director for Business Development at the Insights Research Organization & Solutions (IROS) – the first homegrown Contract Research Organisation in the UAE. At IROS, Rohan is responsible for promoting the clinical research operations landscape in the UAE and the region.

With over two decades of experience in the pharmaceutical industry, Rohan has held senior roles across leading entities in the sector. Prior to IROS, Rohan was the Head of Clinical Trial Services at Alliance Healthcare (part of AmerisourceBergen), where he expanded the clinical trial supply from a UK-only business to a global scale and working closely with IQVIA to build its Clinical Trials Supply Chain services.

With a strong track record of building a business ground-up and implementing new services within a GxP environment such as manufacturing, clinical trials, and supply chain, Rohan was earlier associated with GSK Global Manufacturing & Supply in various roles and with Barts NHS Trust, specialising in oncology, clinical trials, and pharmacy manufacturing unit.

He is qualified as a pharmacist in the UK and has completed his Master’s in Pharmacy from the Aston University, Clinical Pharmacy Diploma at the Queens University, Belfast, and was named as production manager on a MHRA IMP & GMP License.

Experienced professional in the financial sector Luca held senior roles in Banks and Equipment Finance local and multinational companies such as Hewlett-Packard, GE Capital, IFIS Banca and Banca illimity in providing financial solutions in Technology, Industrial, Healthcare and Renewable spaces through vendor finance and captive business models.
He is Country Manager of GreenFlex Italy, the fully owned subsidiary of TotalEnergies dedicated to the energetic, environmental and societal transformation of organizations.

Renee’s long professional journey in the pharmaceutical/biotechnology industry enabled her to work or support across multiple GxP areas. She has experiences in production quality control, clinical operations, operational quality management, pharmacovigilance, and clinical research quality assurance –  where majority of her exposure is and where she finds her drive.

Currently at CSL Ltd, Renee provides quality and qualification oversight of third parties involved in their clinical trials globally, manages audit program for specific clinical studies, performs audits, and supports regulatory authority inspections. She was previously with GSK, Quintiles, Eli Lilly, Pfizer, and Ciba-Geigy.

Renee obtained her Bachelor of Science in Pharmacy degree from the University of the Philippines Manila and resides in Melbourne, Australia.