Welcome message

European Federation for Medicinal Chemistry and Chemical Biology

Welcome to the Summer School on Pharmaceutical Analysis!

Over the last two decades, groundbreaking therapeutic approaches and drug modalities have transformed the healthcare landscape. However, advanced therapies still grapple with significant analytical challenges.

As new drug products come to life, their accompanying analytical methods must advance in tandem to guarantee that these products meet stringent quality standards. If these standards are not upheld, the effectiveness of the therapy may be compromised, potentially leading to toxic and adverse reactions that jeopardize patient safety and squander valuable financial resources.

The 2025 edition of the Summer School on Pharmaceutical Analysis is poised to tackle these pressing analytical challenges linked to cutting-edge therapies. Specifically, this year's edition, titled "New therapeutic approaches, new analytical challenges: nucleic acid- and cell-based therapies" focuses on the analytics to ensure safe, consistent, and high-quality therapeutic DNA- and cell-based products are achieved.

SSPA2025 allows you to learn from recognized experts from academia and industry who will share invaluable insights throughout the program.

Plus, our planned social activities are tailored to foster networking and interactions between participants and lecturers, making this event even more enriching.

Due to these interactive elements, attendance is capped at just 80 participants.

We are dedicated to making this event a remarkable opportunity for you to boost your scientific competitiveness while enjoying a warm and dynamic experience.

Join us in Rimini to broaden your understanding of advanced pharmaceutical analysis and its application to innovative therapeutic avenues!

Manuela Bartolini
Chair of SSPA
Department of Pharmacy and Biotechnology, Alma Mater Studiorum University of Bologna

 
Main SSPA2025 Topics

ATMPs a challenge for the future
ATMP and regulatory aspects
Critical attributes for gene and cell-based therapies
Characterization of oligonucleotides by high-performance liquid chromatography-mass spectrometry
Nucleic acid therapeutics: Impurity profile assessment
Aggregates and higher order structure of the API in the product
Analytical challenges for vector-based or promotor-driven oligonucleotides
Analytical method for the quantitation of oligonucleotides in biological matrices
Analytical methods for the assessment of pre-existing and drug-induced humoral anti-drug antibody (ADA) in preclinical studies
Cell therapies characterization and analysis
Flow cytometry validation to assess the number of circulating cells in preclinical studies
qPCR validation and application to biodistribution studies
Analytical methods for clinical monitoring
Analytical methods for dose concentration analysis of ATMP compounds
Case Studies on nucleic acid-based therapeutics (antisense oligonucleotides or PNAs)
Case Studies on Cell Therapies

The Summer School on Pharmaceutical Analysis (SSPA) is organized by the Divisione di Chimica Farmaceutica, Società Chimica Italiana (Division of Medicinal Chemistry, Italian Chemical Society) and sponsored by the European Federation for Medicinal Chemistry and Chemical Biology (EFMC).

Divisione di Chimica Farmaceutica, Società Chimica Italiana (Division of Medicinal Chemistry, Italian Chemical Society)
European Federation for Medicinal Chemistry and Chemical Biology

Location

Rimini (IT)

Date

22nd-24th Sept 2025

Speakers

14 Drug Discovery Professionals

Tickets

80 Students

Program

The tentative scientific program can be downloaded here (Printer friendly version).

Developing cell and gene therapies: a journey from concepts to patients.

Università degli Studi di Modena e Reggio Emilia, Italy

Abstract
ATMPs: regulatory aspects

Aptuit (Verona) Srl, an Evotec Company, Italy

Abstract
Navigating the analytical lifecycle: strategic management for streamlined product development

San Raffaele Telethon Institute for Gene Therapy (SR-Tiget), Milan, Italy

Abstract
Characterization of synthetic oligonucleotides by high-performance liquid chromatography-mass spectrometry

Chromatographic approaches for the analysis of Oligonucleotide Therapeutics and Vectors for AAV Gene Therapy

Tosoh Bioscience GmbH, Germany

Abstract

10.30-11.00   Coffee break

Analytical challenges in mRNA and pDNA production - Enhancing mRNA-based therapeutics safety and efficiency

Sartorius BIA Separations, Slovenia

Abstract
Mass Spectrometry toolbox for the analysis of adeno-associated virus capsids used in gene therapy treatments.

National Institute of Bioprocessing Research and Training, Dublin, Ireland

Abstract

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LC-MS bioanalysis of oligonucleotide drugs: technology considerations and analytical challenges

F. Hoffmann-La Roche Ltd, Basel, Switzerland

Abstract
Separation and identification of therapeutic oligonucleotides impurities - Nusinersen case study for the treatment of spinal muscular atrophy

Nicolaus Copernicus University, Torun, Poland

Abstract

15.45-16.15   Coffee break

Challenges in cell therapy characterization and analysis

ACG Biologics, Milan, Italy

Abstract

10.40-11.10   Coffee break

Immunogenicity of ATMs: evaluation of the presence of anti-drug antibodies using ligand binding assays

Frontage Europe S.r.l., Nerviano, Italy

Abstract
The experience of mRNA and AdV vaccines: humoral and cellular biomarkers for the evaluation of the immune response to SARS-CoV-2 vaccination and breakthrough infections

IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy

Abstract

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Flow cytometry validation to assess the number of circulating cells in preclinical studies

Aptuit (Verona) Srl, an Evotec Company, Italy

Abstract
qPCR validation and application to biodistribution studies qPCR validation and application to biodistribution studies

Aptuit (Verona) Srl, an Evotec Company, Italy

Abstract

Location

The SSPA is housed in Rimini. The school venue is conveniently located at a walking distance from the rail station and in Rimini city center.

By car

From North: A1 Motorway Milan – Bologna, then A14 Motorway Bologna – Rimini
From South: A14 Motorway Bari – Rimini
Exit: Rimini Sud (for Rimini centre)

By train

Rimini is well connected by train to all the main cities in central and northern Italy. High speed trains connect Rimini to Bologna (1 h), Milan (2.5 h), Florence (2 h), Ancona (1 h) and Rome (4 h) several times a day.
Main railway station: Piazzale Cesare Battisti
Tickets can be bought on-line through the Italian railway website.

By plane

The city airport (‘Federico Fellini’ International Airport) is located in Miramare di Rimini.
Federico Fellini International airport in Rimini Federico Fellini International www.riminiairport.com
Closest Internationl airport is the Bologna International airport www.bologna-airport.it

Meet Our Speakers

Alessandro Armandi

Alessandro Armandi
 

Sciex, Milan, Italy
 
Abstract  |  
Sara Carillo

Sara Carillo
 

National Institute of Bioprocessing Research and Training, Dublin, Ireland
Abstract  |  


Dr. Sara Carillo completed her PhD in Chemical Sciences in 2013 at the University of Naples Federico II focusing on the structural characterization of polysaccharides and glycoconjugates from Gram-negative bacteria via NMR and mass spectrometry techniques. In 2015 she joined CCL group in NIBRT working on the understanding of the effects of extractables and leachables from single-use bioreactors on CHO cells N-glycome and produced monoclonal antibodies. She is now working in NIBRT as Bioanalytical Research Lead and is mainly interested in the development on new mass spectrometry based analytical approaches to ensure deeper and easier understanding of biomanufacturing process and biopharmaceuticals structural complexity.

Chiara Cazzin

Chiara Cazzin
 

Aptuit (Verona) Srl, an Evotec Company, Italy
Abstract  |  


I am currently Senior Supervisor of Regulated Bioanalysis & Biomarkers Immunoassay Team 2 in Aptuit Verona where Im responsible of management of immunoanalytical support to preclinical and clinical studies. In particular, ELISA, Flow Cytometry and qPCR techniques to support bioanalysis of preclinical and clinical studies, according to appropriate regulatory standards (GLP and GCP). My previous job experience was as Associate Scientist in GlaxoSmithKline Verona. I have a Degree in Pharmaceutical Biotechnology (University of Bologna) and PhD in Biotechnologies Applied in Biomedical Science at University of Verona.

Werner Conze

Werner Conze
 

Tosoh Bioscience GmbH
 
Abstract  |  


At Tosoh Bioscience GmbH, I work as an application scientist in the research and development department. My main tasks include testing LC product prototypes, developing customer applications, presenting results internally and externally (conferences), conducting LC customer workshops and supervising bachelor's and master's students. A few words about my scientific background: I began my scientific training as a biology technician, then completed my degree in biology at the Max Planck Institute for Biogeochemistry and received my PhD in biophysics from the Institute for Molecular Biophysics in Mainz (Germany) in 2005.

Massimo Dominici

Massimo Dominici
 

Università degli Studi di Modena e Reggio Emilia, Italy
Abstract  |  


Full Professor of Medical Oncology, Director of the Oncology Division at the University Hospital of Modena and Reggio Emilia (UniMoRe, Modena, Italy). Since November 2024 is the Director of Dpt. of Surgical and Medical Science @UNIMORE. Since 2005 he is also heading the Laboratory of Cellular Therapies with 310 papers, >52000 citations, H-index of 67 and 14 patents. More than 300 invited lectures. Founder of Rigenerand and of EIR Biotherapies, gene therapy start-ups. Former board member of JACIE, WBMT and scientific advisor for the Italian Minister of Health. He has been President of ISCT 2014-2016, Since October 2019 expert advisory Panel member of the INN, acting as chair for cell and gene therapy of the World Health Organization in Genève.

Luca Ferrari

Luca Ferrari
 

F. Hoffmann-La Roche Ltd, Basel, Switzerland
Abstract  |  


Dr. Luca Ferrari is Strategy Area Leader for Small Molecule Bioanalytics and Biomarkers at F. Hoffmann-La Roche, which he joined in 2013. Previously, he spent seventeen years at Glaxosmithkline where he became Head of Bioanalysis at the Italian R&D Site in 2001. In 2010 he joined Aptuit Verona S.r.l. as Head of Regulatory Bioanalysis. He possesses an excellent understanding of LC-MS, bioanalytical method development and validation, GxPs and current global bioanalytical guidance. He has been member of the board of Directors of the Italian Society of Chemists. He is author of several scientific papers and speaker at numerous conferences

Michela Gabaldo

Michela Gabaldo
 

Aptuit (Verona) Srl, an Evotec Company, Italy
Abstract  |  


Michela is Vice President ATMP Global Regulatory Affairs at EVOTEC International where she is responsible to support the teams working on new innovative allogeneic/autologous cells and gene therapies programs to enter the clinical validation.
Michela brings almost 25 years of experience in drug development spanning from NCE (new chemical entities) up to advance therapies. While working at the SR-TIGET Institute, shes been actively involved in the development and patient access of the 1st ex-vivo gene therapy registered worldwide, Strimvelis in 2016 and Libmeldy in 2020.
Shes currently an active member of the IRDIRC (International Rare Disease Reasearch Consortium) Regulatory Scientific Committee and of the ISSCR (International Society for Stem Cell Research) Regulatory Working Group

Silvia Lorenzi

Silvia Lorenzi
 

Aptuit (Verona) Srl, an Evotec Company, Italy
Abstract  |  


Silvia Is a Senior Supervisor of Regulated Bioanalysis and Biomarker Immunoassay at Aptuit Verona. She has over 10 years in pharmaceutical development. She started as Associate Scientist in Merck R.B.M (Ivrea) in the Flow cytometry lab of the Clinical Biomarker unit, then she moved to Aptuit Verona where she worked for several years in the immunoassay lab conducting assays and ultrasensitive assays validation for Biomarkers quantification, PK, Immunophenotyping to support preclinical and clinical study. She is Study Director of validation studies and Responsible Scientist to support clinical phase studies. Silvia graduated with honors in Medical, Molecular and Cellular Biotechnology and holds a PhD in Immunology.

Elena Piccoli

Elena Piccoli
 

Frontage Europe S.r.l., Nerviano, Italy
 
Abstract  |  


I'm responsible of the Biologics Bioassay Unit in Frontage Europe since January 2024. Before, I was Head of Analytical Biology group in Accelera srl..I have more than 8-years' experience in development and validation of Ligand Binding assays (LBA) for the analysis of biological therapeutics as support to preclinical and clinical studies. I graduated in Biotechnology (MSc) in 2007. Between 2007 and 2015 I worked as Research Fellow at IRCCS Istituto Neurologico Carlo Besta in Milan, mainly involved in biochemical and biological research on neurodegenerative dementias.

Chiara Piubelli

Chiara Piubelli
 

IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy
Abstract  |  


Dr. Chiara Piubelli is a molecular biologist with a PhD in biotechnology. Currently she is the head of the Biomedical Research Unit at the Department of Infectious, Tropical Diseases and Microbiology of IRCCS Sacro Cuore Don Calabria Hospital (Negrar di Valpolicella, VR, Italy). She is also the Director of Tropica Biobank (bbmri-eric:ID:IT_1605519998080235) at IRCCS Sacro Cuore Don Calabria. Her main scientific interest is focused on translational studies for the characterization and monitoring of emerging pathogens. She is author of 95 scientific publications with a Scopus h-index = 27.

Jasmina Puc

Jasmina Puc
 

Sartorius BIA Separations, Slovenia
 
Abstract  |  


Dr. Jasmina Puc earned her PhD in Biosciences from the University of Ljubljana in 2016, specializing in gene identification related to leanness in mice. She joined Sartorius BIA Separations in 2018 as a project manager, focusing on nucleic acids and developing scalable processes for DNA and RNA therapeutics using CIM technology. In March 2025, she transitioned to the business development unit as a product manager, where she continues to enhance production processes for plasmid DNA, messenger RNA, and other nucleic acid-based therapeutics, including saRNA, tRNA, ssDNA, and cRNA.

Francesca Rossetti

Francesca Rossetti
 

AGC Biologics
 
Abstract  |  


Francesca is the Analytical Methods Development Director and Qualified Person at AGC Biologics, Milan site. Joining the company in 2004, she became Head of Analytical Development in 2017, focusing on designing analytical methods for the characterization and release of retroviral, lentiviral, adeno-associated vectors, primary and stem cells, exosomes under GMP rules and ICH guidelines. With 20 years of experience, Francesca has played a pivotal role in advancing products from pre-clinical to market, contributing to regulatory submissions (IMPD, IND, CTD, BLA), defining CMC strategies, and ensuring ATMP quality through robust analytical method development and validation.

Sylwia Studzinska

Sylwia Studzinska
 

Nicolaus Copernicus University, Torun, Poland
Abstract  |  


Sylwia Studzinska is an associate professor at the Faculty of Chemistry NCU. She has co-authored more than 85 scientific papers, as well as book chapters and patents. She led five scientific projects and expanded her knowledge during several internships. Her main research interests are separation techniques, especially liquid chromatography and mass spectrometry. She uses various modes of liquid chromatography coupled with mass spectrometry to analyze nucleic acid-based therapeutics extracted from biological samples. For years, she has been conducting advanced research on developing methods for sample preparation, separation, and determination of therapeutic oligonucleotides - active ingredients of drugs for genetic diseases.

Ilaria Visigalli

Ilaria Visigalli
 

San Raffaele Telethon Institute for Gene Therapy (SR-Tiget), Milan, Italy
Abstract  |  


Ilaria Visigalli, born on July 30, graduated in 2013 in Medical Biotechnology at the University of Milan, obtained a PhD in Cellular and Molecular Biology and Gene Therapy in 2009 at San Raffaele University. Since 2003 she has been working at the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget), in the field of research on gene therapy. In 2011 she began a GLP training course with the aim of creating a GLP-certified testing center to carry out toxicology and biodistribution studies for the development of innovative gene therapy drugs. In 2014 the GLP certification was obtained, the only one in an academic reality. She has led over 30 GLP studies in the development of innovative gene therapy drugs, including safety and validation studies.

Registration

Please fill in the on-line registration form HERE and send a copy of the bank transfer by email to the SSPA2025 Secretariat at secretariat@sspaweb.com. Your registration will be confirmed only upon reception of the Proof of Payment.

Participants to the SSPA2025 can choose between three registration packages: an All Inclusive Registration (attendance in presence), a Basic Registration (attendance in presence) and a Virtual ticket (virtual meeting).

ALL INCLUSIVE

  • Conference Tickets
  • Coffee breaks and meals
  • Abstract book
  • Social dinner
  • 3 nights accommodation§

€ 440

SCI/EFMC members
Before July 6, 2025 (*Prices inclusive VAT)
€ 470 After July 6, 2025 (last acceptance: September 7, 2025) (*Prices inclusive VAT)

€ 470

Not SCI/EFMC members
Before July 6, 2025 (*Prices inclusive VAT)
€ 510 After July 6, 2025 (last acceptance: September 7, 2025) (*Prices inclusive VAT)
§in a double/twin room at a three-star hotel located at a walking distance from the SSPA2025 venue (Single room supplement for 3 nights € 90, Extra night single room € 78, Extra night double room/person € 48)

BASIC

  • Conference Tickets
  • Coffee breaks and meals
  • Abstract book
  • Social dinner
  •  

€ 315

SCI/EFMC members
Before July 6, 2025 (*Prices inclusive VAT)
€ 365 After July 6, 2025 (last acceptance: September 7, 2025) (*Prices inclusive VAT)

€ 350

Not SCI/EFMC members
Before July 6, 2025 (*Prices inclusive VAT)
€ 390 After July 6, 2025 (last acceptance: September 7, 2025) (*Prices inclusive VAT)

VIRTUAL TICKET

  • Conference Tickets
  • Three-day access to lectures
  • Abstract book
  •  
     

€ 125

SCI/EFMC members
Before July 6, 2025 (*Prices inclusive VAT)
€ 150 After July 6, 2025 (last acceptance: September 7, 2025) (*Prices inclusive VAT)

€ 150

Not SCI/EFMC members
Before July 6, 2025 (*Prices inclusive VAT)
€ 170 After July 6, 2025 (last acceptance: September 7, 2025) (*Prices inclusive VAT)

Registration policy and fees All registrations will be accepted until September 6, 2025. After this date, only basic and virtual will be accepted. Registration will close on September 15, 2025.

Payment All payments should be made in Euro by bank transfer to:
Account holder: Società Chimica Italiana-SSPA
Bank address: DEUTSCHE BANK MILANO C 463, VIALE GIUSTINIANO 1
Iban Code: IT50N0310401603000000821734
Swift Code: DEUT IT M1463
Remittance have to be free of any bank charges to the organizers.

Proof of Payment must be submitted by e-mail (secretariat@sspaweb.com) at the time of registration. Please ensure that the name and company/University of each delegate is printed clearly to ensure that the payment will be correctly registered. Participants having limitations with payment by bank transfer can contact the SSPA2025 secretariat at secretariat@sspaweb.com to evaluate a suitable alternative option.

GDPR The personal information we receive from participants will also be required after the School for statistical purposes and for the dispatch of information on relevant symposia/school in the future. If you do not wish your personal data to be published or distributed, please inform us when you register for the summer school.

Confirmation An e-mail confirming your registration will be sent to you upon reception of a pdf proof of bank trasnfer.

Cancellation must be submitted in writing to the SSPA Secretariat (secretariat@sspaweb.com). The policy regarding refund of the registration fee is as follows: For all inclusive registrations, cancellations received before September 4, 2025 will not be charged by any fee but bank fee will be deducted. After September 4, 2025 no refund will be made.
For basic and virtual registrations, for cancellations received before September 12, 2025 there will not be a cancellation charge (bank fee shall be deducted). After September 12, 2025 no refund will be made.

Insurance The Organizing Committee cannot accept any liability. Participants should make their own arrangements with respect to health and travel insurance.

Fellowships

Congratulations!

We are delighted to announce the recipients of the travel grants awarded by the Division of Medicinal Chemistry of the Italian Chemical Society (SCI) and the European Federation for Medicinal Chemistry and Chemical Biology (EFMC).

These competitive grants aim to support and promote the active participation of young researchers, offering them the opportunity to present their work, exchange ideas, and build new collaborations across borders.

The fellowships granted by the Division of Medicinal Chemistry have been awarded to:
Faloci Federico, Università di Padova, IT
Khalid Ayesha, Università degli Studi di Pavia, IT
Medri Francesca, Alma Mater Studiorum Università di Bologna, IT

The EFMC fellowship has been awarded to:
Athanasios Tsalmpouris, University of Geneva, CH

 
Committees

Scientific committee

  • Manuela Bartolini, Chair, Alma Mater Studiorum University of Bologna, IT
  • Giancarlo Aldini, Università degli Studi di Milano, IT
  • Zeynep Ates-Alagoz, Ankara University, TR
  • Massimo Breda, Aptuit (Verona) S.r.l, an Evotec Company, IT
  • Francesco Epifano, "G. d'Annunzio" University of Chieti-Pescara, IT
  • Alberto Massarotti, Università del Piemonte Orientale, IT
  • Federica Pellati, University of Modena and Reggio Emilia, IT
  • Edoardo Maria Sommella, University of Salerno, IT
  • Caterina Temporini, University of Pavia, IT
  •  

Local Organizing committee

  • Manuela Bartolini, Alma Mater Studiorum University of Bologna, IT
  • Wendy Appiagyei Mensah, Alma Mater Studiorum University of Bologna, IT
  • Serena Montanari, Alma Mater Studiorum University of Bologna, IT
  • Marina Naldi, Secretariat, Alma Mater Studiorum University of Bologna, IT
  • Rosaria Spagnuolo, Secretariat, Alma Mater Studiorum University of Bologna, IT
  •  
UNIBO QuVi
UNIBO FABIT
DCF
European Federation for Medicinal Chemistry and Chemical Biology

Golden Sponsor

Evotec

Previous editions

Drug development: bioanalytical aspects

Sept 21-23, 2022 (Rimini, IT)

Summer Course on Pharmaceutical Analysis

Sept 26-27, 2007 (Island of Elba, IT)

Summer Course on Pharmaceutical Analysis

June 29-30, 2006 (Cogne, IT)

Summer Course on Pharmaceutical Analysis

Sept 29-30, 2005 (Rimini, IT)

Summer Course on Pharmaceutical Analysis

May 2, 2004 (Florence, IT)

Summer Course on Pharmaceutical Analysis

July 1-3, 2003 (Cogne, IT)

Summer Course on Pharmaceutical Analysis

June 10-13, 2002 (Island of Elba, IT)

Summer Course on Pharmaceutical Analysis

June 3-5, 2001 (Lipari, IT)

Summer Course on Pharmaceutical Analysis

Sept 30-Oct 3, 2000 (Island of Elba, IT)

Summer Course on Pharmaceutical Analysis

June 28-29, 1999 (Rome, IT)

Summer Course on Pharmaceutical Analysis

June 10-12, 1998 (Island of Elba, IT)

Summer Course on Pharmaceutical Analysis

Sept 15-16, 1997 (Island of Elba, IT)

Summer Course on Pharmaceutical Analysis

June 12-14, 1996 (Island of Elba, IT)