Ester Lovsin Barle, DVM, MSc, PhD, MScTox is the global head of product sustainability and stewardship and at Takeda Pharmaceuticals. She lives in Zurich, Switzerland.

Ester is passionate about generating value with product safety and sustainability. She is leading the cross-organizational product sustainability workstream sustainability by design for the planet pillar of purpose-led sustainability in Takeda. Her responsibilities also include product stewardship topics, such as safety data sheet process, maintaining article and material regulatory compliance and scientific development and cross-organisational implementation of health-based exposure limits (HBEL) in support of research and manufacturing in Takeda globally. Previously she has held corporate positions at Lonza and Novartis. She has been working in the pharmaceutical industry for over 15 years. She received her PhD in veterinary sciences from University of Ljubljana, Slovenia, and a second master’s degree in toxicology and risk assessment from Medical University in Vienna. Ester is a certified toxicologist.

Dr. Jan Backmann leads the chemical legislation unit of the multinational healthcare company F.Hoffmann-La Roche Ltd. (Basel, Switzerland). After earning his MSc in chemistry, he worked at Robert-Koch Institute Berlin (German Federal Health Office) and completed his doctorate at Berlin Free University. He conducted postdoctoral research at the University of Brussels and the Flemish Institute of Biotechnology (Belgium). This was followed by a position at the International Soap and Detergent Association A.I.S.E., located in Brussels. Afterwards, Jan worked in the Swiss contract research organisation RCC Ltd. as well as in the chemical companies Ciba and BASF. His special interests are in the field of chemical policy and sustainable chemistry.

Dr. Michael Hell is a chemist (MSc) and cell biologist (PhD) by education with substantial experience in manufacturing and operations of biopharmaceuticals. Before being appointed to head of sustainability at Merck’s Healthcare operations, he was leading environment, health, and safety for Merck KGaA’s global biotech manufacturing and led a packaging, logistics, and visual inspection operation unit.

Michael brings a diverse background in manufacturing, spanning environment, health, and safety, strategy development, continuous improvement/LEAN, operations, and business consulting. He is an active member of ISPE and chaired conference tracks or contributed as speaker. Michael co-authored scientific papers or book chapters.

Fabrice Gallou received his PhD from Ohio State University in the field of natural products total synthesis. He then joined the chemical development at Boehringer Ingelheim, USA, working as a process chemist responsible for route scouting and supply of early phase programs. He subsequently moved to the chemical development group at Novartis, Switzerland, as a process development chemist, and rapidly became responsible for global scientific activities, overseeing development and implementation of practical and economical chemical processes for large scale production of APIs. His research interests rely on the research and development of sustainable synthetic methodologies intended for large-scale implementation. He published more than 250 peer-reviewed papers, book chapters, and patents.

Sebastian Gerner is corporate sustainability manager with Ypsomed Delivery Systems and president of the Alliance to Zero. He is driving the transition of Ypsomed from a linear take-make-waste economy towards a circular economy. He is a mechanical engineer with more than 10 years of medical device experience in various medical and pharmaceutical companies.

Thomas Hauser works for G-CON Manufacturing in a business development assignment in the EMEA region to educate the market for offsite prefabricated and prequalified factory and clean-room solutions in a drive to bring forward the pharmaceutical facility of the future concept.

On the other hand, he supports companies in the life science segment mainly for expansion strategies, strategical facility implementation, startup support, and pharmaceutical packaging supply and technologies.

Before 2020, Thomas worked in various leading global positions in business development, strategic implementation, and sales in the pharmaceutical packaging field, namely in injectables and semi-solid and oral-solid packaging. He has more than 25 years of experience dealing with the global life science industry and its market and manufacturing requirements.

Thomas holds an international MBA from the University of Ottawa, Canada, and a BA for European business from the ESB Reutlingen and the ESC Reims.

Novartis has set ambitious environmental sustainability targets to achieve carbon neutral own operations by 2025, plastic neutrality and water sustainability by 2030, and net-zero by 2040.  Novartis was recently recognized by CDP as the only big pharma company globally with a Double-A leadership rating in the Climate Change and Water Security categories.

Jürgen’s role as Environmental Sustainability lead for Novartis’ global development organization covers the set-up and execution of low carbon clinical trials. On top, Jürgen is in charge of the company-wide target of “all new products meet sustainable design principles by 2030”, which spans from research up to commercial.  Jürgen represents Novartis within two workstreams of the Sustainable Markets Initiative (SMI) Health System Task Force and within the Sustainable Healthcare Coalition’s industry low carbon clinical trial workstream.

Jürgen has been very engaged and passionate about the topic of environmental sustainability for more than three decades. Prior to joining Novartis in 2011, he was the CFO of the NGO Solar Energy Foundation, supporting the roll-out of solar energy in rural East Africa. From 2015-20, he was the finance head of Novartis’ global clinical supply unit, during which he was awarded with the Novartis “Better World Award for Environmental Sustainability” for significant progress in the decarbonisation of clinical trials.

Courtney Soulsby works as a global director for the healthcare and life sciences sector team for British Standards Institution (BSI), focussing on pharmaceutical sustainability. Working to understand market challenges and future needs of the healthcare sector, Courtney works with key clients and industry partners to develop holistic solutions, strategies, and programs. Courtney has worked with the pharmaceutical industry and their supply chain for over 10 years – with a deep understanding of the issues with regulation, environment, security, compliance, quality, and other risk exposures when manufacturing and transporting medicines.

Fred Ohsiek is the senior global technical manager, life science (cleaning validation) for Ecolab in North America. His focus at Ecolab is to assist customers with cleaning validation/cleaning challenges and cleaning process optimisation.

He earned his bachelor’s in chemistry from University of South Florida. His professional work experience includes seven years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 22 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Boehringer Ingelheim, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.

His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring of cleaning processes for equipment used in small molecule (oral dose - solid and liquid - and parenteral), peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional product manufacturing.

The scope of his work involved drug substance and drug product manufacturing startup; remediation and legacy justification; creating/improving routine monitoring programs; and increasing manufacturing capability. He has also introduced and incorporated methods to lean the CV footprint by reducing documentation and execution.

He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.