On-Site Conference

1-3 November Messe Frankfurt, Frankfurt, Germany Europa 2, Hall 4.0

Track Sponsored by:

TRACK I: Ingredients & Formulation

November 1st (Morning)

Time	Session Details
10.45-11.15 AM	Keynote Introduction of Psychedelic Therapies into Mental Health - Current Status and Future Perspective David Erritzøe is an Honorary Clinical Research Fellow at Imperial College London and researches using psychedelics for clinical psychiatric purposes. Due to the history of psychedelics, the subject of David and his team seems a bit controversial. But the research area is blossoming, and the interest in the field is higher than it has been in many years. In this session, David and Henry Fisher to introduce us to psychedelics and his research on how they might be a key to solving mental illness problems. David Erritzoe, Clinical Director and Deputy Head, Centre for Psychedelic Research Henry Fisher, Chief Scientic Officer, Clerkenwell Health
11.20-11.45 AM	The Benefits of the Next Generation Enteric Capsugel® Capsule for your Future Product Development The next-generation enteric capsule enables pharmaceutical companies to develop a targeted delivery solution while simplifying their manufacturing processes. The solution offers: An acid-protective dosage form with enteric drug release through a patient-centric delivery solution; A simple encapsulation process that allows for fast and stable preparation. This solution is supported by scientific studies, both in-vitro and in-vivo, showing that enteric protection and targeted delivery to the distal intestine are achieved compared to marketed references. Backed up by performance studies, this capsule showcases excellent machinability and mechanical properties, in line with standard immediate release HPMC capsules. It is available commercially in large quantities. Join Dr Vincent Jannin to learn more about the newly launched enteric solution. Vincent Jannin, Head of Applications Lab, Lonza Capsules & Health Ingredients
11.50-12.15 PM	Using the Genomic Medicine Toolkit to Develop and Optimize Innovative LNP Formulations This session will provide: An overview of LNP as an innovative approach to genomic medicine and vaccine development Insights on core technologies for developing RNA-LNP genomic medicines and vaccines: The Genomic Medicine Toolkit Best practices of LNP formulation, optimization and manufacturing Case study snapshots: Using the Genomic Medicine Toolkit for the development of cell therapies, gene therapies, and vaccines Serra GÜRCAN Field Application Scientist - EMEA, Precision NanoSystems ULC
12.20-12.45 PM	Latest Developments, the Application of EXCiPACT GMPs to Pharmaceutical Auxiliary Materials EXCiPACT is extending its certification scheme to PAMs and is developing a guide for manufacturers and auditors. As these materials may be in intimate contact with a material which will be administered to patients, they should be manufactured in accordance with GMP principles. Typically, PAMs are removed before use in the manufacture of a drug product or function as processing aids in the manufacture of the excipient. Although the manufacturing processes used for PAMs may not be traditional chemical manufacturing processes, applying the risk-based approach in EXCiPACT GMP means this standard can be applied to PAMs. The guide will help manufacturers apply EXCiPACT GMP to the preparation and distribution of PAMs and auditors to assess their compliance for certification purposes. Iain Moore, President, EXCiPACT
12.50-13.40 PM	Lessons from the Future: Cannabis and Psychedelic Industries - Panel Discussion With North America’s recent embrace of the emerging cannabis and psychedelic industries, there are countless lessons to be learned about how to operate in such an exciting and challenging field. This international and scientifically diverse panel will discuss their cannabis and psychedelic experience in North America to help bolster and harmonize European advancements. These speakers will share a transatlantic perspective in these emerging medical markets with examples that encompass all aspects of the product development pipeline. Regional specific development challenges, including differences in market preferences, will be highlighted. Monica Vialpando, Founder and CEO, Via Innovations Amber Wise, Scientific Director, Medicine Creek Analytics Markus Roggen, President and Chief Scientific Officer, Delic Labs George McBride, Chief Commercial Officer, Clerkenwell Health

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TRACK II- Future Therapies

November 1st (Afternoon)

Time	Session Details
14.00-14.30 PM	Keynote: Delivering on the Promise of Cell and Gene Therapies: A Patient Centric Approach In this session, attendees will gain insights into the complexities of the CGT ecosystem and the challenges that must be overcome to successfully move these therapeutics from the laboratory to the patient. The presentation will outline best practices, tools, and integrated solutions for streamlining CGT development and discuss key areas of focus for improving the journey of patients enrolled in CGT clinical trials and beyond. Panteli Theocharous, Global Vice President, Cell and Gene Therapy Strategy Lead, Thermo Fisher Scientific
14.40-15.30 PM	Transactional Strategies to Access Future Therapeutics and Technologies - Panel Discussion What is the best strategy to access novel therapeutic approaches and technologies? Licensing vs M&A? How to build a stake in competitive future therapies and innovations How to beat competitors to your desired goals Exploiting innovation arising in non-medical fields and other industries Fintan Walton, CEO and Founder, PharmaVentures Adrian Dawkes, Managing Director, PharmaVentures Anil Kane, Sr Director, Global Head of Technical and Scientific Affairs, Thermo Fisher Scientific Kevin Johnson, Co-Founder and Venture Partner, Medicxi Niels Emmerich, VP, Global Head Search & Evaluation, Abbvie
15.35-16.00 PM	The State of Advanced Genetic Therapies in 2022 The pipeline for advanced genetic therapies has grown exponentially since 2014, and now totals over 3,500 different developmental candidates. This session provides a comprehensive global snapshot of this R&D landscape, spanning gene, cell, and RNA-based drug modalities. This includes analysis of drug pipelines and active clinical trials for prominent classes such as gene transfer, gene editing, genetically modified cell therapies, messenger RNA, and non-coding RNA. The common diseases targeted and sponsors leading these advances will also be reviewed, as well as important investment trends. The presentation will help professionals involved in any aspect of developing and commercializing advanced therapeutics stay abreast of the latest developments. Daniel Chancellor, Thought Leadership and Consulting Director, Citeline
16.05-16.30 PM	mRNA based Therapies & Regulatory Pathways mRNA has been called the software of life. It can help treat everything from cancer to cardiovascular diseases and be used on high-scale and for niche indications. Covid-19 has put mRNA technology in the spotlight. The technology is therefore appealing to investors. However, how are these medicinal products regulated - are the vaccines differently regulated or are we talking about gene therapy altogether. After this presentation: You’ll understand why this topic is relevant in the development of mRNA-based therapies You’ll feel empowered as to where to place vaccines, ‘ordinary’ medicinal products and ATMPs (gene therapy, somatic cell therapy) in the legal space Hanneke Later Nyland, Attorney-at-law / Partner, Genome Lawyers
16.35-17.00 PM	The Microbiome Therapeutics Market and its Potential for New Therapies The human microbiome enlists all the microorganisms and their related metabolites/products identified in and on the human body. Technological advancement has enabled the assessment of the pleiotropic effects of the human gut microbiome in health and diseases. With the extensive role of microbes in human health, they have an enormous potential to be used as therapeutics for disease management and acts as the potential source to achieve the objective of personalized therapy by overcoming key issues like interpersonal variability and stability in every type of environment. This presentation aims to address the current knowledge and landscape of microbiome therapeutics, provides examples of existing health-and-disease applications and discusses the potential future directions of microbiome modulations. Christian Roghi, Director of Microbiome Solutions, Eagle Genomics

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TRACK III- Digital

November 2nd (Morning)

Time	Session Details
10.45-11.15 PM	Keynote: Johannes Galatsanos, Head of Data - Lean Digital Core ERP Transformation, Novartis
11.20-11.45 AM	Enabling a Digital Culture Through Integrated Business Processes The acceleration of digital transformation across industries has been a prominent theme in the wake of COVID-19. In the pharmaceutical industry, the pandemic highlighted the need for agility and resiliency within the supply chain, fueling an increased urgency for the adoption of Pharma 4.0 technologies that bring together the workforce, customer, equipment, supplier, and environment to help businesses gain greater organizational clarity and process reliability. Digitally enabled systems that improve performance through integrated business process, manufacturing automation, and supply chain integration are essential for responding to industry and environmental challenges and ensuring that safe, high-quality products get to patients when and where they need them. This presentation will share our perspective for achieving digital transformation and digital culture enablement, focusing on: Innovative solutions for meeting market demands and managing increasing complexity through integrated business process Opportunities for attaining new levels of operational excellence through proven technologies to drive digital transformation and Pharma 4.0 journey Key considerations for transforming the traditional supply chain model into a digitally integrated value chain network Sara Sheriff, VP of Integration/ Engineering Operations Services Optimization Leader, Thermo Fisher Scientific
11.50-12.15 PM	Movement Towards Decentralized Trials A review of how big pharma has reacted to the trend: who is going virtual with their trials? The usage data of virtual trial elements pre and post pandemic Predictions for the future Scotty Chung-Siu, Senior Analyst, GlobalData
12.20-12.45 PM	Digital Health Value Pools and Digital Health Reimbursement Have you wondered what value digital health brings to health systems? This session will cover the ~25 main digital health value pools on health system level and show what value digital health solutions provide. In addition, digital health reimbursement is addressed, with a particular focus on the new digital therapeutics' reimbursement process in Germany (the so-called “DiGA process”). Tobias Silberzahn, Partner and host of the global Health Tech Network, McKinsey & Company
12.50-13.40 PM	Data of this World United – What it Takes to Enable Health Data Collaboration Across Organisations and Industries Cross-organizational and multi-sectoral collaborations are becoming the future state of healthcare. The health challenges our world faces are increasingly multi-faceted and complex, thus requiring a diverse set of actors and data to be addressed. However, collaboration over data is still very limited: Data privacy regulations, complexity of data interoperability, and fear of losing a competitive asset are key drivers for data silos across organizations. Data collaboratives are an emerging form of collaboration enabling leveraging the collective power of data across organizations and industries. Bringing together various healthcare actors, this panel discussion aims to discover where the biggest potential for data collaboration lies as well as how hurdles of data collaboration can be overcome to truly unlock the value of data to improve outcomes and lower costs. Fabian Gautschi, Consulting Manager-Digital Health, Accenture Sudha Kodati, Senior Manager - Digital health interoperability lead, Accenture Mohamed Noor, Digitalization Manager, National Institute for Bioprocessing Research and Training (NIBRT) Tamas Rujan, Head of Genedata Profiler Business, Genedata

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Track Sponsored by:

TRACK IV- Manufacturing Excellence

November 2nd (Afternoon)

Time	Session Details
14.00-14.30 PM	Manufacturing Excellence Keynote Pfizer’s manufacturing excellence story can be likened to the sport of crew rowing. Eight people, literally rowing in the same direction in unison. Multiple efforts, focus and strengths are combined in the pursuit of a common goal. It takes precise choreography, teamwork and a common understanding of the manner in which results can and should be achieved. “The power of the team is unlocked as each rower works in harmony, adding their power to the whole. When everyone buys in and commits to the system, great things can be achieved.” IMEx (Integrated Manufacturing Excellence) is Pfizer’s production system that mandates a common way of working, applies that at all levels, globally and rewards individuals, teams and facilities on their outcomes. The advantages and success of IMEx are shown clearly in increased speed to patients. That’s the focal point of what Pfizer does and a tool like IMEx is important because it supports that global goal. But how do we apply it to our CDMO business? How do we leverage such a powerful tool to create the same value for our clients? How does the coxswain and team, working together, create harmony with a supply chain that isn’t entirely our own? Answering these questions are the crux of this presentation. Paul Duffy, Senior Vice President, Small Molecule Operations, Pfizer Global Supply
14.40-15.30 PM	Manufacturing Excellence - Panel Discussion This leadership-powered panel discussion will touch upon some of the actions, challenges and the way ahead for producers of fine chemicals to achieve manufacturing excellence through sustainable competitiveness, growth and the promotion of responsible global environmental performance. Elisabeth Stampa, CEO, Medichem & Director, Medicines for Europe Roberta Pizzocaro, President, Olon Vincent Touraille, President of SICOS- Chief Strategy Officer EuropAPI Pierre Luzeau, CEO, Seqens Aurelio Arias, Engagement Manager Thought Leadership, IQVIA Session hosted by European Fine Chemicals Group (EFCG)
15.35-16.00 PM	Accelerating Innovation and Development of Future Biomanufacturing Processes BioPhorum has brought together biomanufacturers, supply partners, engineering partners, and regional innovation hubs to build a consensus strategy roadmap, encompassing considerations for all aspects of development from raw material to product, for the future of the industry. The roadmap will be presented alongside recent developments in priority areas agreed by the industry. These developments facilitate progress for the industry through identifying technology targets and modeling solutions. Current work includes proof of concept demonstrators and business case modeling, plug-and-play hardware, smaller buffer preparation footprints, and driving the move for more standard facility design to accelerate capacity builds. Andrea Johnston, Phorum Director, Technology Roadmapping, BioPhorum
16.05-16.30 PM	Broader Adoption of Continuous Manufacturing - Tackling the Difficult Problems Significant scientific and technological advancements have been made in the past two decades that have enabled continuous manufacturing (CM) of pharmaceuticals. These include discovery of new routes for chemical synthesis, development of process monitoring and modeling techniques, and modern equipment to handle and transform materials sequentially in a continuous manufacturing line. Despite these advances, there are only a handful of products that have been approved using CM. Many manufacturers are looking to adopt such advanced manufacturing technologies but face barriers in the form of expert knowledge, economic uncertainty, and regulatory risk. To address these barriers, it is essential to provide a platform where industry, academia, and regulators can convene to discuss, comment on, and collaborate on the best, most relevant research, develop consensus best practices, and solve collective problems. Gabriela Grasa Mannino, Pharmaceutical Continuous Manufacturing (PCM) Programs Director, Advanced Manufacturing Technologies, USP Lawrence De Belder, Pharmaceutical Continuous Manufacturing (PCM) Practice Lead, Pharmatech Associates, a USP company
16.35-17.00 PM	Is Local Manufacturing and Tech Transfer still a Challenge in the MEA Region? The demand for localization of pharma products in the countries of the MEA region is booming! Are the know how and the local infrastructures ready? Is there a clear understanding of the processes? What is the best business model and partnership when it comes to tech transfer? Case Study: Reshaping of KSA pharma business & industry from Importation to Localization Dr Manel Chikh, CEO, Zaphyr Pharmaceuticals Dr.Mahmoud Omar Ashri, CEO, Alshaeir Pharmaceutical Factory

Track Sponsored by:

TRACK V- Patient Centricity

November 3rd (Morning)

Time	Session Details
10.45-11.15 AM	Keynote: A CDMO’s Journey to Patient Centricity Stuart Needleman, CCO & Chief Patient Centricity Officer, Piramal Pharma Solutions
11.20-12.10 PM	Latest Trends in Consumer Health Worldwide, people are increasingly health-conscious and aware of the impact of individual lifestyle choices on their health and the health of others. In the latest year, consumers seek more and more transparency from companies through their brand, product manufacturing, and actions that promote well-being for the world around them. While also looking for more affordable, accessible, and personalized product experiences. This session will explore the latest news and insight on consumer health, including how pharma engages patients in education and decision-making. David Ridley, Senior Editor – Europe-HBW Insight, Citeline Paul Smaltz, Vice President of Pharmaceutical Solutions, Roquette Raquel Mirabent Pages, Business Director - Consumer Health & Veterinary Health, Croda Rajiv Khatau, Founder & Managing Director, LODAAT LLC
12.15-12.40 PM	Innovation – Addressing Patient Compliance and Enhancing Consumer Experience It’s a hard pill to swallow, but medication adherence is a crucial issue today. For oral formulations in pharma and nutraceuticals, taste, appearance, and aroma directly impact patient compliance and consumer experience. Choosing the right excipients to provide optimum performance while continuing to appeal to patients and consumers alike is critical in bringing finished formulations to market. Arnaud Verhaeghe, Head of Oral Dosage Market, Roquette
12.45-13.10 PM	On-Demand Manufacturing for Medicine Supply Chain Resiliency & Patient-Ready Medicine Delivery On Demand Pharmaceuticals is creating technology platforms that enable point-of-care medicine manufacturing whether on the battlefield or hospital. By building modular automated systems that can produce raw materials to finished drug product, we are strengthening medicine supply chain resiliency and transforming how patients access medicines. This vertically integrated approach offers agility, flexibility, and a rapid response capability that will mitigate drug shortages while providing quality medicines when patients need them. Eugene Choi, Chief Technology Officer, On Demand Pharmaceuticals, Inc.
13.15-13.40 PM	Advanced Digital Customer Segmentation–Elevating Customer Understanding by Leveraging AI For the past few years, the traditional one-size-fits-all go-to-market strategy, predominantly based on physical channels, has failed to support drug launches and meet business objectives. Inadequate or incomplete understanding of customer needs has been identified as one of the top-3 root causes. To optimise patient outcome, biopharma companies need to target and engage effectively with key stakeholders, differentiating the approach based on distinct behaviours and preferences. Our advanced segmentation approach enables to define data-driven HCP segments by leveraging AI and machine learning algorithms. In particular, we display a detailed use case that describes how we have helped biopharma companies leverage data and AI to build differentiated and actionable HCP segments. Our recommendations detail next best actions to optimize customer engagement and assess the implications on company’s overall level of push marketing actions. Essentially, it will enable to reach the right customers, through the right channel with the right frequency. Federico Careddu, Manager Life Sciences and Healthcare, Monitor Deloitte Switzerland

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