Pernille Hemmingsen

Chief Technology Officer
Adcendo

Moderator

Pernille Hemmingsen has more than a decade of experience within development of pharmaceutical products within both solid and liquid dosage forms. With a background in biophysical chemistry and chemical engineering, development of stabile products and robust manufacturing methods has had her particular interest. This interest had led to development of products within cancer targeting liposomes and antibody drug conjugates, tamper resistant tablets and enhanced diabetes formulations. Currently, Pernille Hemmingsen holds responsibility for manufacturing and quality in the role of CTO at Adcendo. Pernille holds a Ph.D. from Department of Chemistry at the Technical University of Denmark and a Master of business administration from Copenhagen Business School.

Helena Lüning

Chairman
Ascro

Collaboration makes you stronger: The value of working together, sponsors and providers

Developing, manufacturing, and going to market within the life science industry is extremely complex. It is very few, if any, companies who can successfully do this on their own.
Life science industry is one of the most complex industries globally. To be efficient, scale and go to market with the right product, having the best possible claims, and global reach; sponsors rely on life science service vendors providing the best and timely services.
This presentation is on how succeed, to bring your product to the market as quickly and efficient as possible by working together, sponsors and the life science service vendors.

Helena Lüning has over 25 years of experience from the Life Science Industry. She has a broad experience from various positions within clinical research and sales&marketing, both from Pharma and CRO companies. She was one of the founders of the Swedish association of CRO:s, ASCRO in 2011, and is the chairman of the organization. She is currently employed by ICON one of the largest global CRO, responsible for study start-up in the Nordic and Baltic countries.

Sverre Bengtsson

Member of the Board
Ascro

Collaboration makes you stronger: The value of working together, sponsors and providers

Developing, manufacturing, and going to market within the life science industry is extremely complex. It is very few, if any, companies who can successfully do this on their own.
Life science industry is one of the most complex industries globally. To be efficient, scale and go to market with the right product, having the best possible claims, and global reach; sponsors rely on life science service vendors providing the best and timely services.
This presentation is on how succeed, to bring your product to the market as quickly and efficient as possible by working together, sponsors and the life science service vendors.

Sverre Bengtsson is a life science veteran with more than 30 years of experience in the life science industry. Sverre co-founded the software company Viedoc Technologies, the company behind the groundbreaking, smart, and feature-rich eClinical system Viedoc. He also successfully co-founded and divested Pharma Consulting Group/PCG Clinical Services, a mid-size CRO based in the Nordics. Sverre sits on the board or is a general advisor of several life science companies and a number of industry organizations, i.e. ASCRO, ACDM and EUCROF. He is also an active angel investor, having invested in roughly 30 life science companies.

Johanna Fälting

Chief Research Officer, Head of Research
BioArctic

How partnership should work to bring innovative medicines to patients

Scientists increasingly find themselves working in bilateral drug development alliances. Alliances are conceptually simple but operationally challenging, resulting in value-eroding misalignment and delays that alliances often experience. In this presentation, I will outline practices identified as contributing to successful partnership in pharma.
Collaboration is a business buzzword that everyone thinks they know what it means and how to do it, but few truly do; yet, it has never been more important than it is today. In a business setting, it is a risk-sharing and resource-leveraging strategic behavior that necessitates coordinating activities and exchanging information for mutual benefit. It requires an environment of trust, transparency, and respect.

Johanna Fälting is Chief Research Officer and Head of Research at BioArctic AB.
She has a Ph.D. in Animal Physiology from Stockholm University, Sweden.

Johanna has more than 20 years of experience from the pharmaceutical industry, both from global pharma and biotech. She has worked in various leading roles within neuroscience/ pharmacology, drug research, translational science and development. She is data driven and has a passion for developing drugs, organizations and people.

Peter Asplund

Project manager, SweTrial
Swedish Medical Products Agency (Läkemedelsverket)

Improving the conditions for clinical trials in Sweden – SweTrial

This session will cover the fundamentals of the national effort on measures for improving the conditions for clinical trials in Sweden through a cross sector national partnership commissioned by the Swedish government through the Swedish Medical Products Agency. The partnership and collaboration should be designed to address the needs of health care, industry, academia, and patients leveraging the strengths of the Swedish eco system in life science. The effort is targeting an efficient, accessible, and open forum and administration supporting innovation and broad engagement.

Peter Asplund is a life science graduate and professional with more than 20-year experience in international clinical development across pharma, medical device and the CRO-industry. In his current position, Peter is the project manager within the Swedish Medical Products Agency on the assignment on improving the conditions for conducting clinical trials in Sweden. Through senior roles across pharma, med-tech, CRO and public health care one of Peters interest has been in cross-sector collaborations particularly in clinical research and clinical trials. Prior to his current role Peter served as inquiry chair in the governmental inquiry on clinical trials commissioned by the Ministry of Climate and Enterprise on how to improve conditions for clinical trials in Sweden in favour of a stronger life science sector and increasing welfare. Peter will be providing an overview of the current assignment to the Swedish Medical Products Agency.

Thomas Eldered

Executive Chairman
Flerie

An investor’s view on outsourcing and virtual organisations

Outsourcing and virtual organizations offer significant advantages for pharmaceutical companies, particularly those in the early stages of development. By partnering with the right service providers, companies can accelerate their development timelines, reduce costs, and access the expertise needed to bring innovative therapies to market. As investors, we recognize the value of these strategic partnerships and encourage companies to consider outsourcing as a key component of their growth strategy.

Thomas Eldered holds a Master's degree in Industrial and Management Engineering and has amassed 40 years of experience in the pharmaceutical industry. As the co-founder of Recipharm AB, he served as CEO from 2008 to 2021, significantly contributing to the company's growth and success. In 2011, he founded Flerie invest AB, further demonstrating his commitment to innovation in the pharmaceutical sector. Currently, Thomas is the chairman of the board for Amarna Therapeutics BV, NorthX Biologics AB, and Prokarium Ltd. He also serves on the boards of Chromafora AB, Kahr Medical Ltd, Nanologica AB, Toleranzia AB, and Xintela AB, among others, where his extensive expertise continues to influence the industry.

Photo: Kristian Pohl

Morten Munk

Director, Alliance Management
FUJIFILM Diosynth Biotechnologies

Tips and tricks for how to establish a successful CDMO partnership collaboration

This presentation will cover several key elements essential for successful CDMO collaborations, including crafting effective quality agreements, comprehensive documentation, aligned expectations, project governance and fostering a transparent relationship.

Morten Munk's focus and success in making pharmaceutical products available for patients, is founded on more than 30 years of industry experience in biopharmaceutical development and manufacturing, which has made him a globally recognized technical expert in the field.
One common denominator for his work has been to use his business and quality mindset in combination with a broad perspective on biomanufacturing, to support all stages of development and the full supply chain of high-quality pharmaceuticals. This includes experience in addressing the areas critical for commercial manufacturing during the process development and subsequent scale-up stages, as well as handling drug product operations and distribution aspects.
Morten holds a position as Director, Global Alliance Management at FUJIFILM Diosynth Biotechnologies (FDB), supporting the strategic partnership collaboration with several FDB’s key partners.
Before joining FDB in 2020, Morten worked at NNE as Global Technology Partner since 2015. In 2001 he co-founded CMC Biologics (now AGC Biologics), after working 14 years at Novo Nordisk.
Morten is active in the biopharmaceutical community as member of scientific committees for various international conferences and as volunteer in international industry organizations such as PDA, ISPE and BPOG. Moreover, Morten has served as Chair of PDA Biotechnology Advisory Board, and is member of the Advisory Board for Master studies at Copenhagen University.

Sofia Mayans

Director of Business Development
Diamyd Medical

How to cope when losing your favourite CDMO

The success of the life sciences sector relies heavily on collaboration between pharmaceutical companies and contract research organizations (CROs) or contract development and manufacturing organizations (CDMOs) that provide essential expertise. In the event that a trusted CDMO, with whom you have a longstanding partnership, is unexpectedly acquired by another company, how can your drug development organization navigate this challenge? There are various strategies to address this situation, and I would like to share how we approached it at Diamyd Medical.

Sofia Mayans is an experienced life science leader with a PhD in Human Genetics from Umeå University, where her dissertation focused on Type 1 and Type 2 diabetes. After her thesis defence, she undertook a postdoctoral fellowship split between Umeå University and the University of Copenhagen, followed by another at the La Jolla Institute for Immunology in San Diego. In 2015, she left academia and co-founded InfiCure Bio, a life science company specializing in drug efficacy testing. She has served as a Senior Innovation and Business Developer at SLU Holding and as interim CEO of Vakona AB. Currently, Sofia serves as Director of Business Development at Diamyd Medicals production site in Umeå.

Annette Roos

Business Unit Director Drug Substance
Ardena

Phase-Appropriate API Development Strategies - The right effort at the right time

Bringing a lead candidate from the lab through the clinical trials and onto the market requires thorough investigations of the various quality aspects of both the lead molecule and its process of manufacture. These investigations rarely come without high costs. In this presentation we will highlight the importance of phase-appropriate development, prioritizing the costs of development onto the critical aspects of your program, while ensuring patient safety throughout the whole process.

Annette Roos, MSc in Organic Chemistry, has over 20 years of experience in the CDMO industry, with a focus on API development. For the past 4 years, she has been the Business Unit Director Drug Substance at Ardena Södertälje, Sweden. Ardena Södertälje develops and manufactures APIs for clinical trials and the commercial market.

Pontus Forsell

Co-founder & Head of Discovery and Research
AlzeCure Pharma

Collaboration and outsourcing strategy, from HTS to clinical phase 2 study

AlzeCure Pharma is a Swedish biotech company specializing in the development of innovative treatments for pain, Alzheimer's disease (AD) and other neurodegenerative diseases. AlzeCure Pharma has a diverse and well-balanced research pipeline that targets both symptomatic and disease-modifying therapies. By using a collaborative approach, we have added value to our projects by focusing on academic collaborations in areas that we want to strengthen. These collaborations have included shared Ph.D. students and collaborations between researchers and have often resulted in scientific publications. Our outsourcing strategy has been based on strengthening the projects in areas where we have lacked certain skills or opportunities to carry out the work ourselves. We have successfully worked with different service providers in phases ranging from HTS to clinical phase 2 studies. We will showcase how we have worked with outsourcing from discovery phase into clinical development.

Pontus Forsell has a PhD in Medical Biochemistry & Biophysics from Karolinska Institutet and more than 25 years of experience from several biotechnology and pharmaceutical companies, such as Biolipox, Orexo, Merck and AstraZeneca in project and management positions. He is an expert in early drug development in the disease areas of neurology, pain and inflammation.

Jens Lindberg

CEO
Medivir

Fostrox – Taking a first-in-class medicine to market through extensive external collaboration

Moving from early, smaller scale clinical development to a global, potentially registrational program increases complexity while adding areas requiring focus and effort. How can a small biotech company with 10 team members run an early-stage program for a first-in-class medicine and at the same time prepare for and execute a global phase 2b program, aiming for accelerated approval? Collaboration, collaboration, collaboration paired with an internal culture of helping.

Jens Lindberg has 25 years of experience from the pharmaceutical industry, spanning global and local responsibilities. He has led product strategy development for late stage compounds, preparing for regulatory approval and commercialization as well as execution of launch for multiple compounds in specialty care, with a primary focus on Oncology. Jens’s experience includes an interim CEO role for Sedana Medical AB and Director Investor Relations at AstraZeneca. Furthermore, Jens is Board Member at Braincool AB.

Sofia Wallström

CEO
Lif (the Trade Association for the Research-based Pharmaceutical Industry

Focus on implementation - collaboration is key for success in a strong life sciences ecosystem

Europe has for long been losing out to the US and increasingly China in terms of investment in life science research and development. This is also emphasised in the Draghi report to the EU Commission, and it is now essential that the EU member countries acknowledge this when designing the future regulatory framework for pharmaceuticals in the EU. Sweden has the potential to grow further as a life science nation. But we must address the missing link. We must have a healthcare system that invests in innovation and in the early use of new effective medicines. This will lead to a healthier population, increased investment in life sciences, and a stronger economy.

Sofia Wallström is CEO of Lif – the research-based pharmaceutical industry in Sweden. She has over 30 years of experience from leading positions in the Government Offices and as Head of Agency in Sweden, in the fields of healthcare, life science and finance. Sofia was during six years Director General of TLV, The Dental and Pharmaceutical Benefits Agency, and five years Director General of IVO, The Health and Social Care Inspectorate. As Director in the Ministry of Health and Social Affairs, she was responsible for the re-regulation of the pharmacy market. As a special Government Investigator, Sofia has submitted several reports on pharmaceutical prices, knowledge management, hospital investments, New Karolinska University Hospital, national pharmaceutical list, etc. As Deputy Director, Ministry of Finance, she was for several years Coordinator for budget negotiations, higher education and research, government grants to municipalities and regions.