PDA BioManufacturing Conference 2024

Shaping the Future of Biomanufacturing

Gothenburg, Sweden
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Dear Colleagues,

As global health challenges like infectious diseases and cancer evolve, the pharmaceutical biomanufacturing sector continues to innovate and adapt. This industry's advancements attract significant interest from investors, regulators, and other stakeholders, underscoring the importance of staying informed about the latest developments.

Join us in Gothenburg, Sweden, on 24-25 September 2024, for a two-track, face-to-face conference.

The event will explore new technologies including the application of AI, digital twins, development approaches, CMC strategies, and regulatory frameworks, supporting rapid access to vaccines and biotherapeutics from upstream processes to final filling and lyophilization.

The PDA Biomanufacturing Conference 2024, themed "Shaping the Future of Biomanufacturing", is the ideal venue for exploring these innovations. Now in its sixth year, this event offers a comprehensive program focused on emerging trends, regulatory areas, and key technologies.

We are kicking off this year’s conference with a keynote presentation from a patient perspective and we will continue the discussion on addressing patient needs and offer unique networking opportunities with industry professionals, academics, and regulatory representatives from organizations like the U.S. FDA, MHRA, Medical Products Agency Sweden, Paul-Ehrlich-Institut, EDQM, and CEPI.

Session highlights will feature case studies, expert views on biopharmaceutical innovations, advanced modeling, manufacturing capacity, and sustainability as well as special attention will be given to new regulatory strategies for sustainability reporting.

Another reason to join is the two sessions from our PDA Interest Groups, including Lyophilization IG and Advanced Manufacturing, and Applied Process Digitalization IG, showcasing the latest advancements in these areas.

Check out the agenda which is intended to initiate and support discussion and professional exchange through the diversity of scientific presentations. Meet exhibitors, listen to poster sessions, and enjoy the networking opportunities.

We are looking forward to seeing you in Gothenburg.

Sincerely,

The Co-Chairs

Sabine Hauck, Consultant
Elisabeth Vachette, Sartorius 

SCIENTIFIC PROGRAM PLANNING COMMITTEE

  • Sabine Hauck, Consultant
  • Elisabeth Vachette, Sartorius
  • Andrea Arsiccio, Coriolis
  • Adithya Balasubramanian, ten23 health
  • Bianca Bohrer, PSM
  • Cristiana Campa, GSK 
  • Michael De Felippis, Eli Lilly
  • Sebastian Groel, Daiichi-Sankyo
  • Virginie Le Coent, BioMerieux
  • Julian Lenger, Bayer
  • Yves Mayeresse, GSK
  • Mic McGoldrick, MSD 
  • Maria Papathanasiou, Imperial College London
  • Josh Eaton, PDA
  • Falk Klar, PDA Europe
  • Sabine Hartmann, Manager Programs & Events, PDA Europe

Early Registration

Register by 28 July 2024

Member Price

€ 2.050

GovernmentMember Only

€ 980

Health AuthorityMember Only

€ 980

Early Career ProfessionalMember Only

€ 980

StudentMember Only

€ 980

AcademicMember Only

€ 980

Non-Member

€ 2.350

Standard Registration

Register after 28 July 2024

Member Price

€ 2.250

GovernmentMember Only

€ 1.080

Health AuthorityMember Only

€ 1.080

Early Career ProfessionalMember Only

€ 1.080

StudentMember Only

€ 1.080

AcademicMember Only

€ 1.080

Non-Member

€ 2.550

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Tuesday, 24 September CEST

  • Registration Open

  • Welcoming

    • Committee Member: Falk Klar, PhD, Parenteral Drug Association

  • Welcome from the Co-Chairs

    • Co-Chair: Elisabeth Vachette, MA, BPS Sustainability Business Partner, Sartorius Stedim FMT SAS

    • Co-Chair: Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG

  • Opening Plenary Part I: Addressing Patients Needs

    • Moderator: Elisabeth Vachette, MA, BPS Sustainability Business Partner, Sartorius Stedim FMT SAS

    • A Brief Insight Into Life with Multiple Sclerosis

    • Development of Antibody Drug Conjugates as Specific and Potent Medicinal Products - A Regulator´s Perspective

    • ICH Q6 - Quo Vadis

  • Networking Coffee Break, Poster Session & Exhibition

  • Opening Plenary Part II: Addressing Patients Needs

    • Moderator: Elisabeth Vachette, MA, BPS Sustainability Business Partner, Sartorius Stedim FMT SAS

    • Developing Patient Centric Specification for Commercial Biologics: Real World Case Studies

    • Plenary Discussion

      • Moderator: Elisabeth Vachette, MA, BPS Sustainability Business Partner, Sartorius Stedim FMT SAS

      • Regulatory Panelist: Steffen Gross

      • Regulatory Panelist: Mats Welin

      • Panelist: Jason Warfel

      • Panelist: Karen Somers

  • Networking Lunch Break & Exhibition

  • Guided Poster Walk

    • Moderator: Bianca Bohrer, Dipl Ing, Managing Director, PSM GmbH

  • Session 1 Track A: Processes for New Entities in Freeze-Drying

    • Moderator: Julian H. Lenger, PhD, Head of Laboratory Parenteral Drug Development, Bayer AG

    • Developments in In-Line and Off-Line Analytics Applied to Freeze Drying of Biologicals

    • Building Robustness into the Primary Drying Phase of Lyophilization: A Modelling Framework and Use Cases for Biopharmaceuticals

      • Presenter: Andrea Arsiccio, PhD, Senior Scientist, Coriolis Pharma

    • Solving the Deep-Frozen Challenge – Lyophilization of an Oncolytic Virus

    • Q&A

      • Moderator: Julian H. Lenger, PhD, Head of Laboratory Parenteral Drug Development, Bayer AG

      • Panelist: Andrea Arsiccio, PhD, Senior Scientist, Coriolis Pharma

      • Panelist: Thomas Kriehuber

      • Panelist: Paul Matejtschuk

  • Session 1 Track B: CMC Strategies for Vaccines Biomanufacturing

    • Moderator: Cristiana Campa, PhD, Technical R&D Advisor and Senior Fellow, GSK

    • Vaccines Interest Group Session - Our 2024 journey!

      • Presenter: Sabrina Restrepo, PhD, Director, Vaccines - Technical Product Leadership, Merck & Co., Inc.

    • Patient-Centric Development for Vaccines

      • Presenter: Frédéric Mathot, PhD, Associate Director, Scientific Leader, GSK

    • Applying Prior Knowledge and Patient Centric Based Considerations to Specification Setting

    • Q&A

      • Moderator: Cristiana Campa, PhD, Technical R&D Advisor and Senior Fellow, GSK

      • Panelist: Sabrina Restrepo, PhD, Director, Vaccines - Technical Product Leadership, Merck & Co., Inc.

      • Panelist: Frédéric Mathot, PhD, Associate Director, Scientific Leader, GSK

      • Panelist: Pepijn Burgers

  • Networking Coffee Break, Poster Session & Exhibition

  • Session 2 Track A: Opportunities for Vaccine Access

    • Moderator: Mic McGoldrick, Technical Advocacy and Policy - CMC, Merck Sharp & Dohme Corp. LLC

    • Fast Evolving Vaccine Innovation Landscape

    • Building Health Emergency Preparedness by Harnessing the Potential of Vaccine Platforms

      • Presenter: Ramin Sabet-Azad, PhD, CMC Lead, The Coalition for Epidemic Preparedness Innovations (CEPI)

    • Regulatory Global Convergence, Harmonization, and Reliance

      • Presenter: Navdip Ghai, Director - Regulatory Affairs CMC, Merck Sharpe & Dohme

    • Q&A

      • Moderator: Mic McGoldrick, Technical Advocacy and Policy - CMC, Merck Sharp & Dohme Corp. LLC

      • Panelist: Anna Czwarno, Ms.Eng., Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe

      • Panelist: Ramin Sabet-Azad, PhD, CMC Lead, The Coalition for Epidemic Preparedness Innovations (CEPI)

      • Panelist: Navdip Ghai, Director - Regulatory Affairs CMC, Merck Sharpe & Dohme

  • Session 2 Track B: Innovation in Biomanufacturing

    • Moderator: Michael R De Felippis, PhD, Senior Vice President - Research Bioproduct Research and Development, Eli Lilly and Company

    • Cell-Free Manufacturing of Proteins

    • Application and Utilization of Heat Inactivation as a Downstream Purification Tool in Biomanufacturing Processes

    • Polysorbate Control Strategies in Biopharmaceuticals

      • Co-Presenter: Roman Mathaes, PhD, CEO, Clear Solutions Laboratories

      • Co-Presenter: Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG

    • Q&A

      • Moderator: Michael R De Felippis, PhD, Senior Vice President - Research Bioproduct Research and Development, Eli Lilly and Company

      • Panelist: Matthias Steiger

      • Panelist: Colette Carmody Culhane, MSc., Senior Advisor, Manufacturing Science and Technology, Eli Lilly & Company

      • Panelist: Roman Mathaes, PhD, CEO, Clear Solutions Laboratories

      • Panelist: Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG

  • Networking Event

Wednesday, 25 September CEST

  • Interest Group Session: Advanced Manufacturing and Applied Process Digitalization (former Biomanufacturing IG)

    • Moderator: Toni Manzano, Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV

    • Moderator: Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON

  • Interest Group Session: Lyophilization

  • Registration Open

  • Session 3 Track A: Digital Tools Shaping Future Biomanufacturing

    • Moderator: Adithya Balasubramanian, Director, ten23 health AG

    • The Key Role of AI in Biomanufacturing and Good Practices to Implement it

      • Presenter: Toni Manzano, Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV

    • A Regulatory Framework Enabling Digital Innovation in Manufacturing

      • Presenter: Mónica Perea-Vélez, MSc, PhD, CMC Advocacy and Policy Director, GSK

    • Accelerated Process Development using End-to-End Digital Twins

      • Presenter: Thomas Zahel, PhD, Head of Innovation, Körber Pharma

    • Q&A

      • Moderator: Adithya Balasubramanian, Director, ten23 health AG

      • Panelist: Toni Manzano, Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV

      • Panelist: Mónica Perea-Vélez, MSc, PhD, CMC Advocacy and Policy Director, GSK

      • Panelist: Thomas Zahel, PhD, Head of Innovation, Körber Pharma

  • Session 3 Track B: Future Techniques in Freeze-Drying

    • Sustainable Refrigeration Technologies: Overview and Implementation of Innovative Air-Cooling Technology for Freeze-Drying Processes

      • Co-Presenter: Fabian Plaum, M.Eng., Sales Management, HOF Sonderanlagenbau GmbH

      • Co-Presenter: Christian Sonntag, MS, Senior Project Manager, Roche Diagnostics GmbH

    • Continuous and Controlled Lyophilization of mRNA-LNPs Based Formulations

      • Academic Presenter: Thomas De Beer, PhD, Professor, Ghent University

    • Understanding Thermal Interactions in Biopharmaceutical Freezing: Implications for Nucleation Temperature Distribution

    • Q&A

      • Moderator: Sebastian Groel

      • Panelist: Fabian Plaum, M.Eng., Sales Management, HOF Sonderanlagenbau GmbH

      • Panelist: Christian Sonntag, MS, Senior Project Manager, Roche Diagnostics GmbH

      • Academic Panelist: Thomas De Beer, PhD, Professor, Ghent University

      • Academic Panelist: Roberto Pisano

  • Networking Coffee Break, Poster Session & Exhibition

  • Session 4 Track A: Fill & Finish Processing

    • Moderator: Yves Mayeresse, Director, GSK

    • Discovering Equivalence in Extractables & Leachables Assessments of Single-Use Systems: An Advanced Mathematical Methodology

      • Presenter: Ina Pahl, Senior Scientist, Sartorius Stedim Biotech GmbH

    • VHP Uptake of Manufacturing Tubing Used for Aseptic Fill-Finish Processes of Biopharmaceutical Drug Products

      • Presenter: Dilara Ali, MSc, PhD Student , ten23 health

    • Frame-by-Frame - End-to-End: How Advanced Risk Profiling Accelerated the Development of a Robust Manufacturing Setup for a Brand New Kindeva Fill-Finish Site

      • Co-Presenter: Sebastian Scheler, Mr., Managing Director, Innerspace GmbH

      • Co-Presenter: Jeff Gensler

    • Q&A

      • Moderator: Yves Mayeresse, Director, GSK

      • Panelist: Ina Pahl, Senior Scientist, Sartorius Stedim Biotech GmbH

      • Panelist: Dilara Ali, MSc, PhD Student , ten23 health

      • Panelist: Sebastian Scheler, Mr., Managing Director, Innerspace GmbH

      • Panelist: Jeff Gensler

  • Session 4 Track B: Sustainability

    • Sustainability at the EDQM: A Focus on the Ph. Eur. and the 3Rs

      • Regulatory Presenter: Emmanuelle F Charton, Head of Division B, European Pharmacopoeia Department, EDQM

    • Enhancing Sustainability ESG Scores in BioManufacturing

    • Using Sustainable Taxonomy: Recycle, Reuse, Reduce & Re-purpose Water for pharmaceutical Use

    • Q&A

      • Moderator: Virginie Le Coent

      • Regulatory Panelist: Emmanuelle F Charton, Head of Division B, European Pharmacopoeia Department, EDQM

      • Panelist: Philippe Gadal

      • Panelist: Durga Prasad Madhavapeddi

  • Networking Lunch Break, Poster Session & Exhibition

  • Interactive Questionnaire

    • Moderator: Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG

  • Closing Plenary Part I: Innovative Regulatory Strategies for a Globalized World

    • Moderator: Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG

    • Efficiency in Pharmaceutical Life-Cycle Management: Implementing ICH Q12 and Established Conditions

    • Simultaneous Submission to Multiple Health Authorities Using Accumulus Synergy Platform - Using CMC Platform Best Practices for Comparability Assessments and Manufacturing Process Validation as Pilot

  • Networking Coffee Break, Poster Session & Exhibition

  • Passport Raffle

  • Closing Plenary Part II: Innovative Regulatory Strategies for a Globalized World

    • Moderator: Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG

    • Title to be Announced

    • Plenary Discussion

      • Moderator: Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG

      • Panelist: Thomas Stangler

      • Panelist: Olga Rovira

      • Panelist: Anna Czwarno, Ms.Eng., Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe

      • Regulatory Panelist: Mats Welin

      • Regulatory Panelist: Steffen Gross

      • Academic Panelist: Maria Papathanasiou, PhD, Assistant Professor, Department of Chemical Engineering, Imperial College London

      • Regulatory Panelist: Paul Matejtschuk

      • Moderator: Elisabeth Vachette, MA, BPS Sustainability Business Partner, Sartorius Stedim FMT SAS

  • Co-Chair Conference Summary

    • Co-Chair: Elisabeth Vachette, MA, BPS Sustainability Business Partner, Sartorius Stedim FMT SAS

    • Co-Chair: Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG

  • Closing Remarks & Farewell

    • Committee Member: Falk Klar, PhD, Parenteral Drug Association

Agenda is subject to change.

Presenters

  • Dilara Ali, MSc

    PhD Student , ten23 health

    Panelist
    Presenter
    Read Bio
  • Andrea Arsiccio, PhD

    Senior Scientist, Coriolis Pharma

    Panelist
    Presenter
    Read Bio
  • Adithya Balasubramanian

    Director, ten23 health AG

    Moderator
    Read Bio
  • Bianca Bohrer, Dipl Ing

    Managing Director, PSM GmbH

    Moderator
    Read Bio
  • Pepijn Burgers

    Panelist
    Presenter
  • Cristiana Campa, PhD

    Technical R&D Advisor and Senior Fellow, GSK

    Moderator
    Read Bio
  • Anthony Cannon

    Moderator
  • Colette Carmody Culhane, MSc.

    Senior Advisor, Manufacturing Science and Technology, Eli Lilly & Company

    Panelist
    Presenter
  • Emmanuelle F Charton

    Head of Division B, European Pharmacopoeia Department, EDQM

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Anna Czwarno, Ms.Eng.

    Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe

    Panelist
    Presenter
  • Thomas De Beer, PhD

    Professor, Ghent University

    Academic Panelist
    Academic Presenter
    Read Bio
  • Michael R De Felippis, PhD

    Senior Vice President - Research Bioproduct Research and Development, Eli Lilly and Company

    Moderator
    Read Bio
  • Philippe Gadal

    Panelist
    Presenter
  • Jeff Gensler

    Co-Presenter
    Panelist
  • Navdip Ghai

    Director - Regulatory Affairs CMC, Merck Sharpe & Dohme

    Panelist
    Presenter
    Read Bio
  • Sebastian Groel

    Moderator
  • Steffen Gross

    Regulatory Panelist
    Regulatory Presenter
  • Sabine Hauck, Dr

    EVP Corporate Development & QM, Leukocare AG

    Co-Chair
    Moderator
    Read Bio
  • Falk Klar, PhD

    Parenteral Drug Association

    Committee Member
    Read Bio
  • Atanas Koulov, PhD

    Chief Scientific Officer, Clear Solutions Laboratories AG

    Co-Presenter
    Panelist
    Read Bio
  • Thomas Kriehuber

    Panelist
    Presenter
  • Virginie Le Coent

    Moderator
  • Julian H. Lenger, PhD

    Head of Laboratory Parenteral Drug Development, Bayer AG

    Moderator
    Read Bio
  • Peter J. Makowenskyj, MEng

    Director of Design Consulting, G-CON

    Moderator
    Read Bio
  • Toni Manzano

    Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV

    Moderator
    Panelist
    Presenter
    Read Bio
  • Paul Matejtschuk

    Panelist
    Presenter
    Regulatory Panelist
    Regulatory Presenter
  • Roman Mathaes, PhD

    CEO, Clear Solutions Laboratories

    Co-Presenter
    Panelist
    Read Bio
  • Frédéric Mathot, PhD

    Associate Director, Scientific Leader, GSK

    Panelist
    Presenter
    Read Bio
  • Yves Mayeresse

    Director, GSK

    Moderator
    Read Bio
  • Mic McGoldrick

    Technical Advocacy and Policy - CMC, Merck Sharp & Dohme Corp. LLC

    Moderator
    Read Bio
  • Ina Pahl

    Senior Scientist, Sartorius Stedim Biotech GmbH

    Panelist
    Presenter
    Read Bio
  • Maria Papathanasiou, PhD

    Assistant Professor, Department of Chemical Engineering, Imperial College London

    Academic Panelist
    Read Bio
  • Mónica Perea-Vélez, MSc, PhD

    CMC Advocacy and Policy Director, GSK

    Panelist
    Presenter
    Read Bio
  • Roberto Pisano

    Academic Panelist
    Academic Presenter
  • Fabian Plaum, M.Eng.

    Sales Management, HOF Sonderanlagenbau GmbH

    Co-Presenter
    Panelist
    Read Bio
  • Durga Prasad Madhavapeddi

    Panelist
    Presenter
  • Sabrina Restrepo, PhD

    Director, Vaccines - Technical Product Leadership, Merck & Co., Inc.

    Panelist
    Presenter
    Read Bio
  • Olga Rovira

    Panelist
    Presenter
  • Ramin Sabet-Azad, PhD

    CMC Lead, The Coalition for Epidemic Preparedness Innovations (CEPI)

    Panelist
    Presenter
    Read Bio
  • Sebastian Scheler, Mr.

    Managing Director, Innerspace GmbH

    Co-Presenter
    Panelist
    Read Bio
  • Karen Somers

    Panelist
    Presenter
  • Christian Sonntag, MS

    Senior Project Manager, Roche Diagnostics GmbH

    Co-Presenter
    Panelist
    Read Bio
  • Thomas Stangler

    Panelist
    Presenter
  • Matthias Steiger

    Panelist
    Presenter
  • Elisabeth Vachette, MA

    BPS Sustainability Business Partner, Sartorius Stedim FMT SAS

    Co-Chair
    Moderator
    Read Bio
  • Jason Warfel

    Panelist
    Presenter
  • Mats Welin

    Regulatory Panelist
    Regulatory Presenter
  • Thomas Zahel, PhD

    Head of Innovation, Körber Pharma

    Panelist
    Presenter
    Read Bio

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA recommends the reservation at the following hotel

Elite Park Avenue Hotel 
Kungsportsavenyn 36 - 38
411 36 Gothenburg,
Sweden

PDA Europe has reserved a limited number of rooms until 20 July 2024.

Book your room at the PDA Group Rate using the above-mentioned reservation button.

How to Get Here
By Air

Airport buses travel to and from Landvetter Airport (appox. 20 min. journey) stopping at Gothenburg Berzeliigatan. They run directly between these stops.

Travel and Exclusive Discount Information
Special Lufthansa Group Airlines Fares
Special Lufthansa Group Airlines Fares

The Lufthansa Group airlines bring people together – every day, all around the world.The global route network of Austrian Airlines, Lufthansa, SWISS, Brussels Airlines and Eurowings offers optimal connection and combination options, so you will benefit from quick and direct flights to the event.

You will reach the booking platform via this link https://www.lufthansa.com/de/en/meetings-and-events-delegates and with the event code DEAPILQ. The reduced fares are automatically displayed.

Note: Please enable pop-ups permanently in your browser while booking, otherwise the window in the booking platform will not open.

Of course, you can also book through your IATA travel agency. The travel agency can request the ticketing instructions by sending an email to [email protected], stating the event code DEAPILQ.

Book Flight
Special Deutsche Bahn Train Fares
Deutsche Bahn Train logo

Get there relaxed – get there sustainable – travel CO2-free. Your Event Ticket at a fixed price throughout Germany. From any Deutsche Bahn station to our event, with the City-Ticket included.

Event Ticket one-way and specific train (subject to availability):

  • 1st class 89,90€ (seat reservation incl.)
  • 2nd class 55,90€

Event Ticket one-way and fully flexible:

  • 1st class 112,90€ (seat reservation incl.)
  • 2nd class 77,90€

Book online now and get the lowest price for your preferred route – guaranteed. For technical questions, please contact the service number +49 (0) 30 58 60 20 901. Create the perfect start for your sustainable event: Make active use of your journey to work or just relax and enjoy the high-speed travel experience – with 100% renewable power on regional and long-distance services.

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Area Attractions

Elite Park Avenue Hotel is located within walking distance from Liseberg amusement park and the Swedish Exhibition & Congress Centre. Theatres, concerts and the Gothenburg Museum of Art is a short walk from the hotel. Along Avenyn are parks, boutiques, shopping malls, and cozy cafés.

Enjoy the well-equipped gym and relaxation area with saunas and a smaller cooling pool. We can also show you our favourite running routes around Gothenburg.