David Cutler is the Director of Project Management at WCG for the EAC service line. David provides leadership to the WCG EAC organization and serves as a subject matter expert for management of endpoint adjudication committees. In his current role, David leads WCG’s EAC Project Management group with a focus on developing and managing expert committees in alignment with industry and regulatory best practices.
David has over 15 years industry experience and prior to joining WCG David worked in a variety of leadership roles in healthcare, academic, and nonprofit organizations building healthcare delivery programs and managing research teams. David spent the early part of his career developing and managing operations for NEURO-NET, a program aimed at improving long term outcomes for patients with catastrophic injuries. Prior to his focus on EACs, David’s work in clinical research was at a large public hospital building clinical research infrastructure enabling underserved patient populations to gain access to industry sponsored clinical trials and public/private grant funded research initiatives.
David holds a Bachelor of Arts in Psychology from the University of California Santa Cruz and a Master of Arts in Counseling, Health Psychology from Santa Clara University.
Maria is the Head of Formulation Development at Recipharm. Maria has a master’s degree in chemical engineering towards pharma and a PhD in Physical Chemistry from Stockholm Royal Institute of Technology.
Maria has 15 years of experience in formulation development from academia, research institutes, and industry such as KTH, RISE, and Nanologica. She has worked with pre-clinical development and early clinical phase development (CTM) with a broad range of dosage forms including sterile products. She has a particular interest in encapsulation and controlled release of APIs in formulations as well as coating technologies and experience in formulations with peptides and proteins.
Dr. Uwe Hanenberg, Head of Product Development, Oral Solid Dose (OSD) at Recipharm. Uwe is responsible for implementing and executing the OSD product development strategy that assures science driven, timely development of new products or services.
Uwe has 25 years of experience in the pharmaceutical industry with Bayer, Altana, Grünenthal and Catalent. He has held several leading positions in quality, manufacturing and packaging, product development, project management within the science & technology sphere. His areas of expertise are oral formulation development, oral manufacturing technologies, stick pack technologies and pharmaceutical contract services and project management.
Balasubramaniam Jagdish, PhD, Assistant Vice President, Formulation Development at Recipharm. Bala is leading the formulation development at Recipharm’s Bengaluru facility in India. He holds a PhD degree in Pharmaceutics (Indian Institute of Technology, Banaras Hindu University) and a Diploma in Intellectual Property Management and Clinical Studies Management. He has worked in the Pharmaceutical Industry since 2003, mostly in the area of Product Development, for both generics and NCEs, specialising in Oral Solid Dose forms.
Peggy Smith is the Global Head of ESG Solutions at HSBC Global Private Banking based in London. She is responsible for the Bank’s Sustainable Investment proposition and strategy for Wealth and Private Banking clients globally, covering more than 20 markets. This includes product development, client engagement capabilities across advisory and digital channels, employee upskilling and communication. Peggy joined HSBC in 2006 and has 15 years of wealth management experience. Peggy holds a Master degree of Business Administration from The Hong Kong University of Science and Technology and she has completed CFA certificates in ESG Investing as well as Climate and Investing.
Andrey Maramzine was appointed Chief Sustainability Officer at BNP Paribas Leasing Solutions in May 2022, a position that marked a pivotal moment in the organisation’s commitment to sustainability. His presence on the global executive committee underscores his influential role in shaping the company’s direction.
In his capacity as Chief Sustainability Officer, Andrey has been instrumental in orchestrating a comprehensive Sustainability Strategy that encompasses every facet of the organisation. Previously, Andrey devoted over 16 years to BNP Paribas Corporate and Investment Bank, where he held a diverse array of positions. His tenure as a macro, sector, and thematic equity strategist afforded him a multifaceted perspective on the financial world, which he now leverages to drive sustainability initiatives.
Andrey’s credentials reflect his dedication to sustainability and responsible finance. He proudly holds both the CFA ESG and “Certified ESG Analyst” certifications from the prestigious European Federation of Financial Analysts Societies, further affirming his expertise in the field. Andrey studied at Sciences-Po Paris and HEC Paris.
Kay heads up our digital and sourcing practice across our regional offices. Kay leads and guides clients through their digital procurements and business process outsourcings, be they major change or transformation programmes, levelling up agendas or business as usual procurements. Kay’s clients include central Government departments, NHS trusts, ICSs and blue chip FSI clients.
Kay has nearly 20 years’ experience helping clients deliver their digital and business processing procurement and sourcing strategies having advised on some of the most novel, large scale and complex transactions, protecting her clients interests and identifying and mitigating risk through legal contractual mechanisms.
Kay specialises within the public sector, the health and social care sector and the financial services sector, offering deep industry knowledge and experience. This has been gained through working closely with clients in those sectors for many years including through secondments and long-term projects, spending time with clients on site.
Kay advises on the implementation and running of a myriad of novel and tried and tested solutions including blockchain and cloud integrations through various contractual approaches and structures such as framework arrangements, special purpose vehicles, tower model structures including SIAM and collaboration arrangements and SaaS license contracting models. Kay advises on cross-border transactions and provides guidance and support on successfully managing distressed projects.
Kay’s expertise is recognised by her long-standing clients for whom she acts as a trusted adviser.
Joe Im is currently the head of digital health technology operations at Regeneron. He has 15 years of experience within the clinical trial space, where he’s been able to exercise his interest in cutting–edge technologies and his passion to improve the lives of patients. He has held positions on the supplier and sponsor sides within the COA project management function, as well as in imaging category management. In his current role, he leads a team responsible for deploying and operating digital health technologies such as eCOA, sensor devices, digital apps, medical devices, and eClinical solutions in clinical trials. Joe has successfully led initiatives at Regeneron including the COA operations team development, adoption of eCOA BYOD as a standard modality, and development of a decentralized trial operating strategy.
Donna’s diverse career began in healthcare as a registered nurse and evolved to focus on technologies that support patients in clinical research. Donna has published articles in trade journals and presented at pharmaceutical industry conferences on topics including patient centricity, improving enrollment success, eCOA, BYOD, and more. With over 18 years in the clinical trials space, Donna currently serves as Senior Vice President, Strategic Solutions at YPrime, where she is responsible for developing and growing strategic partnerships. Donna earned her Bachelor of Science degree in nursing from Thomas Jefferson University.