PROGRAMME & SPEAKERS

PHARM Connect Congress each year brings you an overview of the Central Eastern European trends and impacts on the pharmaceutical manufacturing & biotechnology world.

We are currently working on the 2019 agenda which will be published in October 2018.


TOPICS & PRESENTERS IN 2018:

POST EVENT INFORMATION
CHAIRPERSON

 

Biotech and R&D

Dr. András Ballagi
Dr. András Ballagi

Chief Technology Officer


Dr. András Ballagi

Dr. András Ballagi

Chief Technology Officer, Diagon

Dr. Ballagi moved to Sweden shortly after completing his degree in Bioengineering. There he worked in the field of the diagnosis and molecular evolution of veterinary viruses at the Swedish Veterinary Institute. He received his PhD for his research on application of PCR for virus detection and analysis of viral outbreaks. Later he moved on to fermentation technology of recombinant microorganisms at the University of Uppsala. After almost 20 years in Sweden he returned to Hungary in 2006 and joined Gedeon Richter Plc. to lead the technology development for biosimilar medicine production using bacteria (E.coli) as well as mammalian (CHO) cells.

In 2014 he formed the Biotechnology unit in the newly established Pharmatech Model Laboratory (PML) at the Budapest University of Technology and Economics, where he also holds an Honorary Professorship. Since November 2016 he has been responsible for the recombinant protein development and production of human diagnostic at the Diagon Ltd, Budapest.

CHAIRPERSON

 

Industrial

Prof. Dr. Romána Zelkó
Prof. Dr. Romána Zelkó

Dean Faculty of Pharmacy


Prof. Dr. Romána Zelkó

Dr. Romána Zelkó

Dean Faculty of Pharmacy, Semmelweis University

Romána Zelkó Ph.D., D.Sc. has her expertise in formulation and stability tracking of polymer-based drug delivery systems including various micro- and nanofibrous systems. Her research work focuses on different synthetic and natural polymeric delivery systems, physical ageing of polymers, microstructural characterization of dosage forms associated with their functionality-related characteristics. She is the author of 190 journal full papers and 5 patents and expert works. From 1991 she is employed by the Faculty of Pharmacy of the Semmelweis University.

She advanced her studies in the pharmaceutical technology at the Ghent University, Belgium. She has been successfully passing the achievements of her scientific research work on to her students at various Ph.D. studies. She has held a variety of functions. She has served as a Vice-Dean (2003-2009) and from 2013 as the Dean of the Faculty of Pharmacy of the Semmelweis University.

CHAIRPERSON

 

Technological

Prof. Dr. Stane Srčič
Prof. Dr. Stane Srčič

Head of Pharmaceutical Technology Department


Prof. Dr. Stane Srčič

Prof. Dr. Stane Srčič

Head of Pharmaceutical Technology Department, Faculty of Pharmacy, University of Ljubljana

Dr. Stane Srčič is a Professor for Pharmaceutical Technology at the Faculty of Pharmacy, University of Ljubljana, Slovenia. His expertise is focused on solid oral dosage forms development and manufacturing and includes pre-formulation and formulation, new manufacturing methods and customized equipment. After PhD he spent as post doc at the University of Regensburg, and was/is acting as a visiting Professor at the University of Liverpool, Szeged and Sarajevo.

He served for more than 10 years as an expert from Slovenia on EMA (London) in the Committee for drugs in veterinary medicines and was responsible for quality parts of the dossiers.

He published more than 150 papers and is holder of numerous patents and patents applications in EU, US, Russian Federation and India. He is strongly connected with domestic and foreign pharmaceutical industry and was leading a lot of different academia-industry projects.

His international collaboration on the education and research areas has been recognized and awarded with the honorary doctorate from the University of Szeged (Hungary).

CHAIRPERSON

 

Regulatory

Assoc. Prof. Dr. Ildikó Csóka
Assoc. Prof. Dr. Ildikó Csóka

Director of the Institute of Pharmaceutical Technology and Regulatory Affairs


Assoc. Prof. Dr. Ildikó Csóka

Prof. Dr. Ildikó Csóka

Director of the Institute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged 

Ildikó works at University of Szeged since 1990, after graduating as a pharmacist at University of Szeged.

Between 1990 – 2003 she worked as an assistant lecturer and later as an Assistant Professor at the Department of Pharmaceutical Technology. Experiences and competencies: dermal and transdermal dosage form design, the teaching of drug manufacturing processes, process development. Based on her research on colloidal drug delivery systems, she got the PhD title in the year 1997. Between 2004 – 2016, she worked at the Institute of Drug Regulatory Affairs; since 2008 as the Head of the Institute. She got the Dr. habil. degree and became Assoc. Professor in the year 2007.

Paralelly with these activities she worked as Educational Vice-Dean of the Faculty of Pharmacy between 2009-2012; was the Head of the „Office for Postgraduate Studies” at Faculty of Pharmacy (2010-2012), and also for two years (2010-2011) she was the Head of Department of Clinical Pharmacy.

Prof. Ildikó Csóka has been working for the University Management since 2012; presently as the General-Director for Strategy. Based on the close cooperation between the Department of Pharmaceutical Technology and Institute of Drug Regulatory Affairs, in 2016 she founded a new Institute dealing with a „Quality by Design” based dosage form development and manufacturing process optimisation together with 50 colleagues in teaching and research, and presently she is the Head of this Institute. She has postgraduate specialisations in Pharmaceutical Technology, Health Care and Pharmacy Management and Quality Assurance.

Her research field covers: regulatory pharmacy based dosage form design in the field of nano and biotechnology, developments in alternative drug delivery routes; co-creation and knowledge transfer in healthcare and pharmaceutical R & D; patient expectations, satisfaction and adherence evaluations in connection with the quality of life measurements.

KEYNOTE PRESENTATION

Biosimilars: Opportunities and Challenges for Pharmaceutical Industry. Pegfilgrastim Case Study

András Illés
András Illés

Deputy Head of Clinical Development of Biologics


András Illés

Biosimilars: Opportunities and Challenges for Pharmaceutical Industry. Pegfilgrastim Case Study


• Biologics, biosimilars, generics – facts and definitions

• Biosimilar market trends

• Pegfilgrastim case study: focus on clinical development and Phase III study considerations


Andras Illés is a senior clinical scientist at Clinical Development of Biologics, Gedeon Richter Pl. headquartered in Budapest, Hungary, since 2008 and he is the deputy head of Clinical Development of Biologics since 2015. In his roles, his responsibility includes development of clinical programs for biosimilars and sponsor side project management. He is medical doctor with a PhD in molecular biology from the Semmelweis University, Budapest, Hungary. He worked as researcher from 2001 to 2008 in Hungary (Semmelweis University).

 

PRESENTATION

Enabling smooth product life cycling – process characterization on sound data science and QbD tools  

Prof. Dr. Christoph Herwig
Prof. Dr. Christoph Herwig

Head of Research Division Biochemical Engineering, Institute of Chemical, Environmental and Bioscience Engineering


Prof. Dr. Christoph Herwig

Enabling smooth product life cycling – process characterization on sound data science and QbD tools  


Process characterization is a central tool in process validation from step 1 to 3 in the product life cycle. We need:

• Advanced statistics to be deployed to define NORS and PARs

• Models for experimental design, scale down models qualification and real-time predictive control


Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to enter his interdisciplinary PhD studies at EPFL, Switzerland in bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and facility design of biopharmaceutical facilities. Since 2008, he is full professor for biochemical engineering at the Vienna University of Technology.

The research area focuses on the development of methods for integrated, science-based and efficient bioprocess development along PAT and QbD principles. The product fields are circular economy and biopharmaceuticals within industry driven projects.

CASE STUDY

Making it fit: The challenges of transferring new products into a running facility

Judit Sallai
Judit Sallai

Technology Transfer Project Leader


Judit Sallai

Making it fit: The challenges of transferring new products into a running facility


Process characterization is a central tool in process validation from step 1 to 3 in the product life cycle. We need:

• Advanced statistics to be deployed to define NORS and PARs

• Models for experimental design, scale down models qualification and real-time predictive control


Judit Sallai is the E2E Project Leader of Technology Transfer at GSK Biologicals Hungary. She majored in microbiology at the University of Science Budapest (ELTE). She started her career at the Researching Institute of Small Animals as microbiologist in 1995. She has gained tremendous experience in several fields of vaccine manufacturing as a manager of manufacturing units, laboratory head of microbiology and biochemistry labs, QA manager of sterility assurance department, (GSK Hungary) leader of QC development department (GSK Germany, Dresden).

She has obtained several certificates during her career for example on validation of analytical test procedures, measurement uncertainty, and validation of microbiological test procedures. She is a member of EBSA as former Biosafety Officer and certified on this field having deep experience on biosafety/biosecurity. Her professional background among others includes vaccine manufacturing by fermentation technologies, aseptic manufacturing and sterility assurance, environmental and utility system monitoring, as well project management/leading on different pharmaceutical projects.

CASE STUDY

Making it fit: The challenges of transferring new products into a running facility

Christopher Hunley
Christopher Hunley

Site Head and Managing Director


Christopher Hunley

Making it fit: The challenges of transferring new products into a running facility


Process characterization is a central tool in process validation from step 1 to 3 in the product life cycle. We need:

• Advanced statistics to be deployed to define NORS and PARs

• Models for experimental design, scale down models qualification and real-time predictive control


Chris is the Site Director at the GSK Biologicals Kft. Vaccine manufacturing facility in Gödöllő.  He joined the site in 2015, after 5 years working in Italy and Germany with Novartis Vaccines. Before moving into the vaccines business, he spent several years working for Amgen in the United States on the manufacturing of various bulk biologics.  Chris is a chemical engineer, who has spent his career working in manufacturing facilities with roles in Manufacturing, Validation, Project Management, and Manufacturing Sciences & Technology.

CASE STUDY

Implementing Single-use Continuous Bioprocessing: A case study on large-scale continuous mAb purification

Britta Badertscher
Britta Badertscher

MSc, Technical Specialist SLS


Britta Badertscher

Implementing Single-use Continuous Bioprocessing: A case study on large-scale continuous mAb purification


• Process intensification through continuous bioprocessing

• Case study on large-scale continuous mAb purification

• Regulatory aspects of continuous bioprocessing


Britta Badertscher obtained a master’s degree in pharmaceutical biotechnology from the Zurich University of Applied Sciences. She worked at the Zurich University of Applied Sciences as research assistant in the Institute of Tissue Engineering and Cell Culture Technologies before moving to Pall International in 2016. In her role as continuous bioprocessing scientist, she is focussing on the development, implementation and integration of continuous bioprocessing solutions.

PRESENTATION

Three Dimensional Printing (3DP) technology in Pharmaceutical Manufacturing

Marek Cichocki
Marek Cichocki

Head of Operational R&D


Marek Cichocki

Three Dimensional Printing (3DP) technology in Pharmaceutical Manufacturing


• Technology description

• 3DP techniques & examples

• Spritam – first 3D printed drug product

• Advantages and challenges


Marek Cichocki has been working in pharmaceutical industry for 13 years. He is an R&D expert with special focus on solid oral dosage forms development and manufacturing. Marek’s professional specialization includes: formulation design, scale-up and technology transfer activities, process validation, and new manufacturing methods.

Marek started his career in 2005 in Pliva Kraków (Poland) where he was a Formulation Scientist. From the beginning of 2010 Marek spent almost 4 years at Synthon BV (The Netherlands) being responsible for the implementation of newly developed products at Contract Manufacturing Organisations.  In February 2014 Marek joined Polpharma (Poland) and became Head of Formulation Development team. Currently he is holding a position of Head of Operational R&D and his main responsibilities are: post-approval product maintenance, technology transfers, R&D support for industrial operations and new technologies implementation.

CASE STUDY

Quality by Design (QbD) Approach in Formulation Development

Dr. Devendra Ridhurkar
Dr. Devendra Ridhurkar

Senior Scientist (Special Formulations)


Dr. Devendra Ridhurkar

Quality by Design (QbD) Approach in Formulation Development


• FDA’s Initiative on Quality by Design (QbD)

• Introduction of QbD and its role in improvement of Quality

• The current Vs QbD approach of formulation development

• Five-step QbD methodology, key aspects and tools of QbD and Formulation by Design (FbD)


Dr. Devendra Ridhurkar works as a Senior Scientist (special formulations) at Egis Pharmaceuticals Plc., Budapest, Hungary. In his capacity he is responsible for development of a value added, complex generic formulations and solid oral generic formulations for highly potent drugs (oncology). He was associated with various reputed pharmaceutical companies like Dr. Reddys, IPCA, Alkem laboratories and Macleods Pharmaceuticals. He has over 11 years of experience in formulation and development of complex and various generics (ANDA), 505(b)(2) products for the global market using different NDDS approaches and various platform technologies which includes hot melt extrusion (HME), gastroretentive drug delivery systems, nanotechnology and cyclodextrin complexation to name a few.

He is an expert in materializing the design of experiments (DOE); quality by design (QbD). He obtained his M. Pharm and Ph.D. degree in Pharmaceutics from Indian Institute of Technology, Banaras Hindu University, Varanasi, India. He has published over 8 peer-reviewed papers in reputed international and national journals and 5 patents to his credit. He has been associated with various pharmaceutical bodies in India and abroad namely Indian Pharmaceutical Graduate Association (IPGA) and American Association of Pharmaceutical Scientists (AAPS). He has attended and delivered seminars and presentations at various national and international conferences.

CASE STUDY

Orally Disintegrating Tablets and Films: A Modern Innovative Drug Delivery System

Prof. Vladimír Král
Prof. Vladimír Král

Group Leader & Professor of Medicinal Chemistry


Prof. Vladimír Král

Orally Disintegrating Tablets and Films: A Modern Innovative Drug Delivery System


Professor Král holds a degree in organic chemistry and received his PhD degree in organic chemistry and biochemistry. Between 1995 and 2005 he held the position of Professor of Analytical Chemistry at the Technical University of Prague, Czech Republic, conducting research on sensor analysis, supramolecular chemistry, bioanalytical chemistry, and biosensors. Between 2000 and 2004 Professor Král was a visiting professor in the department of chemistry and biochemistry at the University of Texas in Austin, USA, where he focused on anion sensors, drug development, texaphyrins, and pharmacylic.
Between 2000 and 2005 he also spent two months each year as a visiting professor at the medical school of the University of Texas in San Antonio, USA, focusing on selective NOS inhibitors.

CASE STUDY

Optimization of lyophilization process for the parenteral product

Dr. Aljoša Maglica
Dr. Aljoša Maglica

Product Steward Senior


Dr. Aljoša Maglica

Optimization of lyophilization process for the parenteral product


• Using PAT tools at the production scale

• Production scale up of the parenteral product

• Development of new lyo cycle in order to reduce total production cost (TPC) and increase production capacity


Aljoša Maglica received his B. S. degree in Chemical Engineering from the University of Ljubljana and earned his Ph.D. in Nanoscience and Nanotechnology from Jožef Stefan International Postgraduate School in Ljubljana.  Aljoša has more than 5 years of experience in the Nanoscience and Nanotechnology according to research projects and scientific improvements to the production scale. At the beginning of 2011 he started his work in the sterile production - Lek Pharmaceuticals. As a Product Steward Senior he is responsible for regular production support, transfer of new product to the production and quality of parenteral drug products. In addition, his is also covering the lyophilization process.

CASE STUDY

Continuous manufacturing into the context of product development

Massimo Bresciani
Massimo Bresciani

Executive Director Scientific Operations & Board Member


Massimo Bresciani

Continuous manufacturing into the context of product development


• Critical factors to be considered and assessed upfront

• Early vs. late phase, in continuous product development

• Building the team and the technical confidence


Massimo Bresciani has been working in the Pharmaceutical field for 25 years.

In his current position he is responsible for Business Development and Scientific Operations and for the whole RCPE projects and business opportunities.

He started his career in a drug delivery startup which was followed by positions at Recordati, Eurand, Glaxo Smith Kline and CRO Aptuit. Before joining RCPE he was Director of Chemistry Manufacturing & Control at Aptuit (former GSK R&D Neuroscience Centre). In that role he was heading a 100+H/Cs CMC business unit, being responsible for P&L management (25MIO) and scientific operations (API development and manufacturing, product development, clinical supply operations, respiratory technology and MS).

He has a consolidated multidisciplinary expertise in pharmaceutical development of New Chemical Enti- ties (NCEs) from lead optimisation/candidate selection throughout all the preclinical and clinical phases (regulatory submissions included in UK, US/Canada and RoW) to PoC and beyond; and he is used to work at the interfaces with all other chemical, pharmacological, biological, toxicological and clinical components in a strongly integrated R&D context.

He is also Board Member of Geriatric Medicine Society and Committee Member of several other international scientific teams active in life science and innovations and author and Co-author of scientific publication and IPs.

CASE STUDY

Xellia Central Laboratory Services Case Study

Eva Farkas
Eva Farkas

Quality Director, Head of Centralized Laboratory Services


Eva Farkas

Xellia Central Laboratory Services case study


• Xellia history, present and future in a nutshell

• Central Laboratory Services concept and what is behind

• How to select, attract and integrate new colleagues considering the current challenging labor market


Eva Farkas is the Quality Director of Xellia Pharmaceuticals Budapest manufacturing site. She has graduated as a chemist and as a computer scientist. She was working for several global pharmaceutical companies, like Egis, Sanofi and Mylan, and took different positions in API and finished dosage forms R&D, industrial development and manufacturing QC and QA organizations.
She was working in the information management area where she leaded GxP IT validation activities as well as managed to build competitive information flows by using RSS, semantic web and text-mining technologies.
Before joining Xellia she was responsible to build a European Central Laboratory and to establish a European Stability Center as a brown field investment in Mylan Komarom.

CASE STUDY

How to manage process deviations and showcase your data

A Laboratory case study

Eugenio Filippi
Eugenio Filippi

Associate Director Plasma Logistics & Analytics Europe


Eugenio Filippi

How to manage process deviations and showcase your data

A Laboratory case study


• Increase employees awareness around the concept „total cost of deviations“, as human errors are very often the main culprit

• Reduce process deviations from a daily to a monthly event, so that you can invest your time working on effective preventive actions rather than fire-fighting

• Present your data in the right way after all the hard work done: how to use the concepts of “Defect-free“ & 6-Sigma analysis


Prior to joining Baxter as Molecular Biology Manager in 2010, Eugenio has worked in a number of roles at IBM, among which as Operations Manager in the Bratislava International Services Center and as IT & Transformation Manager for IBM Austria & Switzerland.

In April 2013 Eugenio was appointed Senior Manager Plasma Logistics, and since April 2016 he is leading all European Plasma Operations, which include Logistics, Testing (Serological and NAT) and Plasma dispositioning. 

Eugenio, who is originally from Italy, holds a Master of Science in Biotechnology from Wagningen University (The Netherlands) as well as a Master in Business Administration from Henley Management College (England).

Aside from his interests in Cold Chain Logistics and process optimization, Eugenio has been focusing on 6 Sigma and LEAN methodologies which are becoming strong elements of his company culture.

PRESENTATION

WINNING PROJECT OF THE MANUFACTURER & SOLUTION PROVIDER CATEGORY

Apply for the 5th Central Eastern European Pharmaceutical Manufacturing Excellence Award!


MORE ABOUT THE AWARD

 

The winners will have the unique chance to put their most outstanding products, services or best practices in the spotlight, by presenting their projects to the top pharmaceutical and biotechnology management professionals of the region aiming to raise their visibility on the professional horizon.

The organiser - TEG The Events Group - is supporting the winning projects with additional PR activities via more than 40 local and international media partners as well as associations highlighting the best innovations in each category.

PANEL DISCUSSION

HOW TO HANDLE IMPURITIES IN GENERAL?

• The improving analytical methods are able to show even the trace of impurities

• Where is the limit of the increasing purity requirements?

• How to satisfy regulatory requirements?

• New guidelines for Elemental Impurities - Implementation best practice examples

Bogdan Gavaneci
Bogdan Gavaneci

Senior Scientist (special formulations)


Bogdan Gavaneci
Lenka Francišković
Lenka Francišković

Head of Processes and Products Quality


Lenka Francišković
Dr. Katalin Ganzler
Dr. Katalin Ganzler

Head of the Analytical Division, Formulation R&D Delivery


Dr. Katalin Ganzler

PLANT EXCURSIONS

Explore the enchanting world of factories as a PHARM Connect VIP visitor! Each year, participants of PHARM Connect are given a unique chance to visit and experience various pharmacutical manufacturing sites of Research Centers of market-leading organisations.

12th MARCH 2018 | 15:00

Site visit to Meditop Pharmaceutical

Site visit to Meditop Pharmaceutical - The Winner of the 3rd CEE Pharmaceutical Manufacturing Excellence Award in 2017


Participants of PHARM Connect 2018 can learn more about the award winning innovation and visit the Meditop Pharmaceutical plant near Budapest. It is limited for 30 delegates only and available on a complimentary, first-come, first-served basis.

Meditop Pharmaceutical Ltd. as a middle size company develops and manufactures its own products and offers services as a Contract Manufacturing Organisation to produce solid dosage forms in flexible manner and to provide support in development and manufacturing of pharmaceutical and nutraceutical products suffering with special sensitivity.

Meditop Pharmaceutical developed an innovative approach to improve film coating efficiency with developing and applying of a continuous film coater for which they received the 3rd CEE Pharmaceutical Manufacturing Excellence Award in 2017. With the innovation they:

• Successfully developed a method to coat soft tablets with high quality,

• Managed to coat heat sensitive actives without degradation,

• Saved considerable time and energy, and

• Obtained flexible and fast change-over and batch size change. 


TRANSFER: The bus will leave in front of the CORINTHIA Hotel at 14:00 on 12th March and will return after the visit at approximately 18:00.

14th March 2018 | 16:00

Site visit to the Research Centre for Natural Sciences

Site visit to the Research Centre for Natural Sciences at the Hungarian Academy of Science


The congress provides the opportunity to visit the Research Centre for Natural Sciences at the Hungarian Academy of Science (MTA TTK) in Budapest; this is limited for 60 delegates only and available on a complimentary, first-come, first-served basis. The MTA Research Centre for Natural Sciences carries out multidisciplinary research in natural sciences. 

Priorities are given to the following disciplines:

Materials- and environmental chemistry

Research of discovery and experimental development in some key areas of materials- and environmental science, with special emphasis on chemical aspects thereof. Exploratory research in the field of nanoscale functional materials and application of the results in integrated nano/micro systems.

Cognitive neuroscience and psychology

Research of discovery and applications in experimental psychology, human-, developmental and comparative psychophysiology, social development psychology, social psychology and cultural psychology.


TRANSFER: The bus will leave in front of the CORINTHIA Hotel at 16:00 on 14th March and will return after the visit at approximately 20:00.