4th EUFEMED Conference
25-26 May 2023 - Berlin (Germany)
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Mastering the New Time Pressure on Human Pharmacology
Focused strategies based on lessons learned in the pandemic
25-26 May 2023 - Berlin (Germany)
Mastering the New Time Pressure on Human Pharmacology
Focused strategies based on lessons learned in the pandemic
Charité Research Organisation GmbH
PD Dr. med. Badakhshi is the Medical Director of Charité Research Organisation. He is …
PD Dr. med. Badakhshi is the Medical Director of Charité Research Organisation. He is a board certified clinical oncologist and a faculty member of Charité – Universitätsmedizin Berlin, clinical researcher and author of more than 100 publications and two medical books. Dr. Badakhshi served as the leading physician in clinical oncology departments. With Charité Research Organisation he is keen to provide a platform for innovative and experimental translational research and pioneering clinical developments embedded in Charité – Universitätsmedizin Berlin
CRS Clinical Research Services Berlin GmbH
Dr. Sybille Baumann is medical doctor by training and is board certified as …
Dr. Sybille Baumann is medical doctor by training and is board certified as anaesthesiologist and clinical pharmacologist. Her working experience includes about ten years in anaesthesiology in several institutions including the University Hospital at Homburg/ Saar. After her clinical career Dr. Baumann gained experience in clinical trials first as Investigator at the former IKP Bobenheim GmbH and later as Deputy Medical Director at CRS Mannheim GmbH where she performed and supervised phase I/IIa trials in healthy subjects and patients from planning until reporting. In January 2016 she joined her present position as Medical Director at CRS Berlin GmbH, a unit with special focus on First in Human Trials and clinical trials in the field of women´s health. Sybille is President of the German Association of Applied Human Pharmacology (AGAH e.V./ Hamburg) since 2022.
Viedoc
Dr. Kerstin Breithaupt-Grögler (MD) studied medicine at J.W. Goethe-University Frankfurt, Germany (1976‑1983). After state approval…
Dr. Kerstin Breithaupt-Grögler (MD) studied medicine at J.W. Goethe-University Frankfurt, Germany (1976‑1983). After state approval as physician and medical thesis (doctor of medicine, summa cum laude) worked as Junior Research Fellow at Center of Physiology, University Frankfurt (1983-1985).
From 1986 to 1995 Research Physician / Clinical Investigator at Center of Cardiovascular Pharmacology, Mainz-Wiesbaden, Germany and Board Certification in Clinical Pharmacology. Since 1995 working as independent consultant in clinical pharmacology and medical writer. More than 20 years experience in planning, conduct, evaluation and reporting of clinical trials, writing of expert reports including safety dossiers, clinical summaries / overviews, scientific presentation and publication (30 original papers, more than 80 abstracts and oral presentations).
Founding member of the German Association of Applied Human Pharmacology (AGAH e.V., Hamburg), Board Member since 1997; President 2012-2014, Past President 2014-2018, since 2018 AGAH Regent / Consultant to the AGAH Board. AGAH Delegate to EUFEMED (European Federation for Exploratory Medicines Development, Brussels). Member of scientific programme committees, conduct of workshops and conferences, training courses in exploratory medicines development, qualification of study teams.
-kbr- clinical pharmacology services
Dr. Kerstin Breithaupt-Grögler (MD) studied medicine at J.W. Goethe-University Frankfurt, Germany (1976‑1983). After state approval…
Dr. Kerstin Breithaupt-Grögler (MD) studied medicine at J.W. Goethe-University Frankfurt, Germany (1976‑1983). After state approval as physician and medical thesis (doctor of medicine, summa cum laude) worked as Junior Research Fellow at Center of Physiology, University Frankfurt (1983-1985).
From 1986 to 1995 Research Physician / Clinical Investigator at Center of Cardiovascular Pharmacology, Mainz-Wiesbaden, Germany and Board Certification in Clinical Pharmacology. Since 1995 working as independent consultant in clinical pharmacology and medical writer. More than 20 years experience in planning, conduct, evaluation and reporting of clinical trials, writing of expert reports including safety dossiers, clinical summaries / overviews, scientific presentation and publication (30 original papers, more than 80 abstracts and oral presentations).
Founding member of the German Association of Applied Human Pharmacology (AGAH e.V., Hamburg), Board Member since 1997; President 2012-2014, Past President 2014-2018, since 2018 AGAH Regent / Consultant to the AGAH Board. AGAH Delegate to EUFEMED (European Federation for Exploratory Medicines Development, Brussels). Member of scientific programme committees, conduct of workshops and conferences, training courses in exploratory medicines development, qualification of study teams.
Independent Senior Consultant
Dr. Henri Caplain, MD, MSc is a physician, senior adviser in early clinical development strategy and drug risk management. He is the…
Dr. Henri Caplain, MD, MSc is a physician, senior adviser in early clinical development strategy and drug risk management. He is the past President of the ‘Association Française de Pharmacologie Translationnelle (AFPT) - Le Club Phase 1’ founding member of EUFEMED. After 15 years as primary investigator for early phase clinical trials and medical scientific director within an International CRO ‘Aster-Cephac Group’, he joined Sanofi-Synthelabo Research as head of clinical pharmacology and Exploratory, member of the R&D board. He became associate VP, deputy-head of worldwide clinical pharmacology for Sanofi-Aventis R&D, then head of the risk management center of excellence within Sanofi, member of the Benefit-Risk Assessment Committee chaired by the Sanofi Chief Medical Officer (CMO).
Novartis Insitutes for BioMedical Research (NIBR)
Dr. Jelena Curcic is a Senior Data Scientist at Novartis Institutes for …
Dr. Jelena Curcic is a Senior Data Scientist at Novartis Institutes for Biomedical Research in Basel, Switzerland with the expertise in development, deployment and advanced analytics of digital endpoints and biomarkers in Neuroscience disease area. Her topics of interest are cognition and neuropsychiatric symptoms in neurodegenerative and mood disorders.
BIOTRAL / DANJOU consulting
I trained a s clinical Pharmacologist at the Pitié Salpêtrière Hospital , Pierre & Marie Curie University where I mostly …
I trained a s clinical Pharmacologist at the Pitié Salpêtrière Hospital , Pierre & Marie Curie University where I mostly worked on CNS compounds and Translational Medicine, not labeled as so in this time. I did my PhD in Humans and my MD dissertation on rodents behavioural modeling. I then was research fellow at the New York Psychiatric Institute.
In the Pharmaceutical industry I worked at Synthelabo (on zolpidem, alpidem, and a few other non-registered compounds) then at Wyeth Ayerst Research (venlafaxine, zaleplon, rapamycine) the Sanofi as Head of ClinPharm worldwide and then Merck Sharpe and Dohme in the UK at Terlings Parks. This later was a superb experience in translational neuroscience.
Last in 2007 and came back to France and was hired by Forenap and then Biotrial. Technologies and know-how from Forenap which disappeared in 2012 have been revalidated and expanded at Biotrial Core Lab.
My Centers of interests are Psychiatry, Neurology and Pain for which I was Board certified in 2012. In particular I have been much involved in a precompetitive consortium for the use of EEG as a translational tool and in some ongoing European Project (e.g. PRISM,NEUROFgL etc).
HRA, Specialist Research Ethics Committee
After post graduate training in respiratory paediatric medicine, completing an …
After post graduate training in respiratory paediatric medicine, completing an MD in the application of radionuclide lung scanning in childhood pulmonary disease, and on appointment as a consultant, I developed an interest in research ethics and took a place on the local research ethics committee. From 1994 to 1997 I was chairman of the Brent research ethics committee up until appointment to the chair of the North Thames multi centre research ethics committee. I held this until 2002 when I was seconded to the Central Office of Research Ethics Committees as ethics and training advisor. I was the research ethics advisor at the National Research Ethics Service providing support and training to RECs in the United Kingdom and took up a similar role with the Health Research Authority up to April 2015. From then until 2020 I was training advisor at the HRA. From 2015 I have been chair of Oxford A REC. I have also worked in Europe within the EU to provide similar training through the European Forum for Good Clinical Practice.
UZ Leuven, Center for Clinical Pharmacology
After obtaining a Master’s degree in Chemical Sciences Jan de Hoon was trained as a Medical Doctor and …
After obtaining a Master’s degree in Chemical Sciences Jan de Hoon was trained as a
Medical Doctor and specialised in General Internal Medicine at the University of Leuven.
Subsequently, he became a certified Clinical Pharmacologist and obtained a PhD in Medical
Sciences at the University Medical Centre of Maastricht in The Netherlands.
Jan has over 25 years of experience in clinical pharmacology, partly in industry, partly in
academia. He has a special interest in early clinical drug development including exploratory
clinical trials, first-in-human, imaging and biomarker studies.
He is a founding board member – previous president – of EUFEMED: the European
Federation for Exploratory Medicines Development (founded in 2015). He was founder of the
Belgian Association of Phase I Units (BAPU) which became part of Healixia. He is board
member of Healixia, a fellow of the British Pharmacological Society, Council member for
Belgium within the European Association for Clinical Pharmacology and Therapeutics
(EACPT) and a former board member of the Dutch Society for Clinical Pharmacology and
Biopharmacy.
At present, he is appointed as Full Professor in (Clinical) Pharmacology at the Faculty of
Medicine of the University of Leuven (KU Leuven). Since 2000 he is heading the Center for
Clinical Pharmacology, an Academic Research Organisation located in the University
Hospitals of Leuven near Brussels, with a focus on early clinical drug development.
Jan is married to Ann Van Hoof and the proud father of 3 lovely children: Pieter, Fien and
Emma.
Galápagos Biopharma Netherlands B.V.
Dick de Vries is a physician and clinical …
Dick de Vries is a physician and clinical pharmacologist by training. After residencies in internal medicine and cardiology he has been a Principle Investigator on over 100 phase 1-3 clinical trials at a CRO before joining industry. Initially as a Medical Safety Advisor in PharmacoVigilance, he is now a senior Medical Director in Clinical Research and Translational Medicine covering indications like RA, lupus, systemic sclerosis, fibrosis, IBD, and collaborates on patient engagement in clinical research.
QPS Netherlands
Dr Izaak den Daas is a Clinical Pharmacologist and Director Patient Studies…
Dr Izaak den Daas is a Clinical Pharmacologist and Director Patient Studies at QPS Netherlands, an early phase CRO in Groningen, The Netherlands. He has been working for QPS for more than 17 years in various senior functions. He is a board member of EUFEMED and member of ACRON. Before his time at QPS he worked in R&D at GSK, Merck KGaA and Bavarian Nordic.
eurofins OPTIMED
Dr Yves Donazzolo is a medical doctor and a clinical pharmacologist. In 1990, he co-founded Eurofins Optimed, a company…
Dr Yves Donazzolo is a medical doctor and a clinical pharmacologist. In 1990, he co-founded Eurofins Optimed, a company dedicated to the early clinical development of drugs and health products in Europe with particular expertise in early development studies, from First-into-Human to Proof-of-Concept trials. He has served as Principal Investigator in several hundreds of trials.
He has been a lecturer in several teaching programs in clinical pharmacology and drug development and is responsible for a Master Module at Grenoble Alps University.
He is an active member of the French Society of Translational Pharmacology (AFPT – Le Club Phase I), where he has served as President for two terms. He has been a founding member of EUFEMED, the European Federation for Exploratory Medicines Development. In addition, he is a member of the French Society of Pharmacology (SFP), the British Pharmacological Society (BPS) and the American College of Clinical Pharmacology (ACCP).
Eli Lilly
Paul Goldsmith is an Associate VP in Clinical Pharmacology Eli Lilly with…
Paul Goldsmith is an Associate VP in Clinical Pharmacology Eli Lilly with 24 years’ experience in the pharmaceutical industry within Neurology, Psychiatry, Respiratory and Diabetes therapeutic areas.
Novartis Institutes for BioMedical Research (NIBR)
Kristin is a translational medicine and clinical endpoint expert at Novartis. She holds …
Kristin is a translational medicine and clinical endpoint expert at Novartis. She holds a PhD in Neuropsychology and more than 20 years of experience in neuroscience (14 thereof in industry). Kristin has specialized in Alzheimer’s disease and other neurodegenerative disorders and greatly appreciates the need for strong clinical endpoint strategies in drug development.
Niche Science & Technology Ltd.
Dr Tim Hardman is a post-doctoral scientist with knowledge of a broad range of scientific disciplines and a thorough…
Dr Hardman is a post-doctoral scientist with knowledge of a broad range of scientific disciplines and a thorough understanding of the process of drug development. He started Niche Science and Technology Ltd in 1998 and now manages a multi-disciplinary team performing specialist CRO services for pharmaceutical and academic organisations. Dr Hardman is currently the Chairman of the Association for Human Pharmacology in the Pharmaceutical Industry.
Bayer AG
Dr. med. vet. Joachim Höchel has over 20 years of experience in …
Dr. med. vet. Joachim Höchel has over 20 years of experience in pharmaceutical industry and held diverse positions in Preclinical Pharmacokinetics and Clinical Pharmacology. Since 2010, Joachim has worked in Clinical Pharmacology at Bayer covering a broad spectrum of indications. Joachim serves as AGAH's Regent and is a co-organizer of the annual PK/PD-Expert Meeting in Germany.
SGSBelgium
Dr Jelle Klein is Medical Director at SGS…
Dr Jelle Klein graduated as Medical Doctor in 2016 from the University of Antwerp with a Master of Science in Medicine. Prior to this, he received a Bachelor of Health from the Hanzehogeschool in Groningen in 2009. Between 2016 and 2018, he specialized in Obstetrics and Gynecology in several hospitals in Belgium. In October 2018, Dr Klein joined the SGS Phase I unit as Principal Investigator, gaining experience in the coordination and set-up of phase 0-IV clinical trials (in different area’s as immunology, dermatology, cardiology, etc.) while being responsible of the safety and wellbeing of the subjects on site as well as the collection and review of the medical clinical data. Since mid 2022, Dr Klein is CPU Medical Director, and overall responsible for medical and scientific aspects of the CPU early phase projects.
Pharmaplex bvba
Physician, specialized in General Medicine, Clinical Pharmacology and Pharmaceutical Medicine with over 30 years of…
Physician, specialized in General Medicine, Clinical Pharmacology and Pharmaceutical Medicine with over 30 years of experience in different senior medical, operational and managerial functions in pharmaceutical industry, CROs and clinical trial sites with focus on clinical trial design and management, ethical and regulatory aspects.
Since January 2003 she has her own pharmaceutical development and site management support consulting company.
Dr Klingmann is Chairman of the Board of the European Forum for Good Clinical Practice (EFGCP). On behalf of EFGCP she was and is involved in different FP7- and IMI-funded projects (ICREL, PatientPartner, PharmaTrain, EUPATI, Combacte-NET, PARADIGM, ConCEPTION, PharmaLedger) and with her company in the FP7-funded paediatric LENA project. Her broad professional background as physician with experience in patient care, clinical development, site management, regulatory affairs, clinical research ethics, and patient engagement enables Dr Klingmann to bridge the gaps between the interests and skills of all different stakeholders in medicines development with the aim to develop new patient-relevant treatments more efficiently.
Dr Klingmann is also President of PharmaTrain Federation, the not-for-profit organisation focussing on global standardisation and improvement of post-graduate training in medicines development sciences. She also teaches on different clinical research and regulatory affairs topics in diploma and master courses at the University of Bonn, Germany, University of Basel, Switzerland, and the Université Libre de Bruxelles, Belgium.
Sanofi-Aventis Deutschland GmbH
Andreas Kovar, Ph.D., F.C.P., is currently head of Translational Medicine and Early Development Germany at Sanofi-Aventis…
Andreas Kovar, Ph.D., F.C.P., is currently head of Translational Medicine and Early Development Germany at Sanofi-Aventis.
Andreas was an elected member of AGAH's Board of Regents from 2001-2018 and serves as the president of AGAH since 2020. Further, he is a co-organizer of the annual PK/PD-Expert Meeting in Germany.
Biokinetica S.A.
Agnieszka Kulesza is Chief Operating Officer at Biokinetica…
Janssen Pharmaceutica N.V. – CPU
Erik is Deputy Head of the Janssen Clinical Pharmacology Unit since 2017. He has a tenure of 25 years with Janssen…
Erik is Deputy Head of the Janssen Clinical Pharmacology Unit since 2017. He has a tenure of 25 years with Janssen R&D, during which he had different scientific and managerial positions in the area of clinical pharmacology. Most of his experience is related to the clinical pharmacology development of compounds in internal medicine, CNS and oncology, both in early and late stages of clinical development. Erik graduated as a PharmD, PhD, with expertise in analytical toxicology, from the K.U.Leuven.
Centre for Human Drug Research
Matthijs Moerland obtained his PhD in cell biology at Erasmus University …
Matthijs Moerland obtained his PhD in cell biology at Erasmus University Rotterdam. He is research director at the Centre for Human Drug Research in Leiden, heading the experimental immunology research group. His key focus is the development and application of in vivo immune challenge models in clinical pharmacology studies.
ICON
Emma is an experienced clinical research management …
Emma is an experienced clinical research management professional with over 15 years of experience in the management of regulatory submissions for clinical research. She oversees the project management of regulatory submissions under EU-CTR at ICON supporting sponsors to make the process as smooth and efficient as possible.
PreClinical Safety (PCS) Consultants Ltd
Dr. med. vet. Stephanie Plassmann is a board certified specialist in veterinary pharmacology and toxicology and acts as an independent consultant…
Dr. med. vet. Stephanie Plassmann is a board certified specialist in veterinary pharmacology and toxicology and acts as an independent consultant for international companies and institutions since 2004. Her expertise focuses on pharmacology, non-clinical safety and drug development, both from a strategic as well as a hands-on operational perspective comprising a broad spectrum of indications from early to late stage development. She has over 29 years’ experience in pharmaceutical industry and held positions including in senior management at F.Hoffmann-La Roche AG (Basel, Switzerland), Switch Biotech AG (Munich, Germany) and Morphochem AG (Munich, Germany). In 2011, she has taken over PreClinical Safety (PCS) Consultants Ltd (Basel, Switzerland), an international consultancy in all aspects of non-clinical drug development from early compound selection through to marketing approval. The company was founded in 1989.
Sanofi-Aventis Deutschland GmbH
Imperial College London
Emma Smith has managed a UK-government funded Network called “HIC-Vac” since…
Emma Smith has managed a UK-government funded Network called “HIC-Vac” since 2017. Their focus has been growing and supporting the human challenge field globally via funding opportunities, human challenge-focussed conferences, encouraging new collaborations and expertise sharing, and driving ethical and regulatory frameworks.
Richmond Pharmacology
Dr Jörg Täubel is medical practitioner and CEO of Richmond Pharmacology, a centre of excellence for phase I, II and I…
Dr Jörg Täubel is a medical practitioner and CEO of Richmond Pharmacology, a centre of excellence for experimental medicine studies, which he co-founded in 2001. A specialist in clinical pharmacology, Dr Täubel has extensive experience in cardiology, neurology, gastroenterology, and ethnic bridging studies. He was Principal Investigator in over 500 clinical trials in Phases 1 – 3. He is an MHRA recognised investigator for First in Human trials involving healthy and/or patient participants.
Most recently Dr Täubel has dosed the first patient in the pioneering global FIH study of NTLA-2001, the first CRISPR-Cas9 in vivo gene editing for transthyretin (TTR) amyloidosis. Working in close collaboration with Professor Julian Gillmore at Royal Free Hospital, Dr Täubel has enrolled the largest cohort of ATTR heart failure patients in five clinical studies.
Dr Täubel also established the Richmond Research Institute; a not-for-profit organisation dedicated to academic research to improve and save lives.
University of Leiden
Prof. Joop van Gerven (1958) studied Medicine at Utrecht University. He obtained his MSc (cum laude) in 1982 and MD in 1984. He subsequently worked in…
Prof. Joop van Gerven (1958) studied Medicine at Utrecht University. He obtained his MSc (cum laude) in 1982 and MD in 1984. He subsequently worked in the Department of Internal Medicine at Leiden University Medical Center (LUMC). In 1990 he completed a PhD-thesis on aldose reductase inhibitor treatment in diabetes mellitus. He was trained as a neurologist in Erasmus Medical Center Rotterdam (EMCR Dijkzigt Hospital) from 1988 to 1994. He subsequently completed his training as a clinical pharmacologist. Since 1994 he is Director CNS Research at the Centre for Human Drug Research (CHDR) in Leiden, where he is responsible for consultancy, research and training on central nervous system drugs and methods. He is also Professor of Clinical Neuropsychopharmacology at Leiden University and Staff Neurologist at LUMC. His primary scientific interest is in demonstration of ‘proof of pharmacology’ for central nervous system-active agents during early phases of drug development. He has published over 200 peer reviewed scientific articles and book chapters, and is a regular invited speaker and board member of scientific organisations and conferences on various aspects of this subject. Since 2011, prof. van Gerven has been the clinical pharmacologist, vice-chairman and acting chair of the Central Committee on Research Involving Human Subjects (CCMO), the Dutch clinical trial authority and central ethics committee. In 2017 he was appointed Chairman of the Committee.
Paul-Ehrlich-Insitut
Bettina Ziegele is Liaison Officer at the PEI. She set up the innovation office and has many years of experience in…
Bettina Ziegele is Liaison Officer at the PEI. She set up the innovation office and has many years of experience in pharmaceutical regulation and ATMP. Bettina is a member of the EU Innovation Network and Chair of the Working Group of the Simultaneous National Scientific Advice. She holds a master's degree in economics and linguistics from the University of Heidelberg.
SocraMetrics GmbH
Rob Zuiker studied medicine at the University of Amsterdam. From 2007 …
Rob Zuiker studied medicine at the University of Amsterdam. From 2007 onwards, Rob joined CHDR as a clinical research physician and has since been working on a wide range of projects. He is registered as a clinical pharmacologist since 2012, and obtained a doctoral degree for his thesis entitled “Development and use of biomarkers in clinical development of new therapies for chronic airway disease” in 2016. His current position is associate director with a special focus on project management. Next to his work at CHDR, Rob is vice president and treasurer at the Association for Contract Research Organisations in the Netherlands (ACRON).
SocraMetrics GmbH
Barbara Schug studied pharmacy at Rheinische Friedrich-Wilhelm-Universität, Bonn, she received a scholarship from the…
Barbara Schug studied pharmacy at Rheinische Friedrich-Wilhelm-Universität, Bonn, she received a scholarship from the "Studienstiftung des Deutschen Volkes" and was awarded a doctor’s degree for experimental pharmacological work.
She started her professional career at Zentrallaboratorium Deutscher Apotheker, Eschborn. In 1998 she founded, together with Prof Dr Henning Blume, an independent research institute, SocraTec R&D. In 2007 she founded SocraMetrics, an independent biometrical institute. She is currently managing shareholder in both companies.
Her area of work covers the planning and realisation of early phase (I and II) trials in healthy subjects and patients and she is also responsible for phase-III and phase-IV studies realised by her companies.
Dr Schug is a member of numerous national and international scientific societies, including Deutsche Pharmazeutische Gesellschaft (DPhG)[1], Arbeitsgemeinschaft für angewandte Humanpharmakologie (AGAH)[2], Deutsche Gesellschaft für Pharmazeutische Medizin (DGPharMed)[3], European Federation of Pharmaceutical Sciences (EUFEPS) and Gesellschaft für Dermopharmazie[4].
She was president of AGAH in the past and has been an active member of the organisational committee of the German Pharmacokinetic / Pharmacodynamic Experts Conference for many years. Furthermore, she is active member of the EUFEPS Network on Bioavailability and Biopharmaceutics and in this function she is chair of the Global Bioequivalence Harmonisation Conference (next: Dec 2021 in Amsterdam, USA). Furthermore, she is co-founder and active member of the EUFEPS Network on Dermatopharmacy.
[1] German Pharmaceutical Society
[2] Association for Applied Human Pharmacology
[3] German Society for Pharmaceutical Medicine
[4] Society for Dermopharmacy
Biopharma Excellence GmbH
Dr Diane Seimetz is a leading drug development and regulatory expert with proven track record bringing…
Dr Diane Seimetz is a leading drug development and regulatory expert with proven track record bringing first in class products from idea to approval.
Dr Diane Seimetz has over 22 years of global drug development, regulatory affairs and management experience in the biopharmaceutical industry. She is co-founder and CEO of Biopharma Excellence, THE consulting company for biopharmaceutical drug development and regulatory strategies.
Since the inception of Biopharma Excellence in 2013 she supported more than 150 clients in bringing their biopharmaceutical products to the clinical trial stage or to approval. Of note, she supported the development and regulatory strategy for the first genome edited product of a commercial sponsor using the Crispr/Cas technology.
Since 2017 she is member of the Decision Board of the Helmholtz Validation Fund, a fund that has been implemented to bridge gaps between scientific findings and their commercial applications. Furthermore, she is advisory board member of the Aglaia Oncology Fund.
Before founding Biopharma Excellence, she was Executive Vice President and Chief Scientific Officer of the Fresenius Healthcare group (Biotech division). Together with her team she developed on an international level first in class biopharmaceutical products, such as the first bispecific, trifunctional antibody. Besides the novelty of the drug format this development program involved the implementation of a new clinical trial endpoint as well as a tumor-histology independent indication. After approval in the EU, this program was awarded the “Prix Galien” which honors outstanding research and innovative drug development. In addition, during her industry career she was closely involved in the successful launch of a first in human study for one of the first genetically engineered cell therapy products in Germany.
Dr Diane Seimetz received her degree in pharmaceutical science from the University of the Saarland and completed her PhD at the University of Heidelberg. Her research work was conducted at the German Cancer Research Center and the Johns Hopkins University in Baltimore (USA).
Federal Institute for Drugs and Medical Devices BfArM
Photo and CV n/a
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Consultant
Prof. Dr. med. Hildegard Sourgens is a board-certified Clinical Pharmacologist and board-certified Pharmacologist and…
Prof. Dr. med. Hildegard Sourgens is a board-certified Clinical Pharmacologist and board-certified Pharmacologist and Toxicologist. She was head of an industry-owned Research Institute for Clinical Pharmacology and head of Clinical Pharmacology of a German CRO. Hildegard Sourgens is a consultant for the pharmaceutical industry since 1996 and is involved in early drug development projects as well as international and national scientific advice and approval procedures.
From 2014-2016 she served as president of the AGAH; from 2017-2019 she served as the president of EUFEMED.
For publications please see: www.sourgens.de
Richmond Pharmacology Ltd.
Dr Jörg Täubel is medical practitioner and CEO of Richmond Pharmacology, a centre of excellence for phase I, II and I…
Dr Jörg Täubel is a medical practitioner and CEO of Richmond Pharmacology, a centre of excellence for experimental medicine studies, which he co-founded in 2001. A specialist in clinical pharmacology, Dr Täubel has extensive experience in cardiology, neurology, gastroenterology, and ethnic bridging studies. He was Principal Investigator in over 500 clinical trials in Phases 1 – 3. He is an MHRA recognised investigator for First in Human trials involving healthy and/or patient participants.
Most recently Dr Täubel has dosed the first patient in the pioneering global FIH study of NTLA-2001, the first CRISPR-Cas9 in vivo gene editing for transthyretin (TTR) amyloidosis. Working in close collaboration with Professor Julian Gillmore at Royal Free Hospital, Dr Täubel has enrolled the largest cohort of ATTR heart failure patients in five clinical studies.
Dr Täubel also established the Richmond Research Institute; a not-for-profit organisation dedicated to academic research to improve and save lives.
Widler & Schiemann AG
Dr. Widler, a Ph.D. graduate from the Swiss Federal Institute of Technology (ETHZ) in Zurich, and…
Dr. Widler, a Ph.D. graduate from the Swiss Federal Institute of Technology (ETHZ) in Zurich, and
holds the Swiss Diploma of Pharmaceutical Medicine.
He operates as an independent CQA, Quality Risk Management, GCP & Pharmacovigilance Auditing
Expert and is Managing Partner at Widler & Schiemann AG (www.wsqms.com) in Zug Switzerland.
Over his 35 years long career in the pharma industry he built his extensive knowledge in the field of
clinical development. From 1986 till 2012 Dr. Widler worked for Hoffmann-La Roche first as an
International Drug Regulatory Affairs officer, then as a Senior Clinical Research Scientist. In 1993 he
then joined the International Clinical Quality Assurance department. From 1997 to 2011 he was the
Global Head of the Department for Quality, Ethics and Systems’ in Roche Pharma. In 2012 he
founded together with Dr. Peter Schiemann Widler & Schiemann Ltd.
Medicines and Healthcare Products Regulatory Agency MHRA
Dr Kirsty Wydenbach is an Expert Medical Assessor and the Deputy Unit Manager in the Clinical Trials Unit at MHRA…
Dr Kirsty Wydenbach is an Expert Medical Assessor and the Deputy Unit Manager in the Clinical Trials Unit at MHRA, having joined in 2009. She has been involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including ATMPs and numerous First-in-Human studies. She has also been involved in European discussions aiming to establish an EU harmonised approach to clinical trials, particularly for Developmental Safety Update Reports (DSURs) and Reference Safety Information (RSI). She was also an EMA expert for the update of the First-in-Human guideline. Other recent work has included collaboration with external industry groups and regulators regarding adaptive and novel trial designs: she is leading on this for the MHRA CTU in order to implement that aspect of the UK Life Sciences Industrial Strategy, and was a co-author for a peer-reviewed publication for complex innovative design trials. More recently Kirsty has overseen the clinical trial work for COVID-19 and provided regulatory expertise on vaccines.
Paul-Ehrlich-Institut
Bettina Ziegele is Liaison Officer for national and international affairs at the Paul-Ehrlich-Institut (PEI) – the Federal Institut…
Bettina Ziegele is Liaison Officer for national and international affairs at the Paul-Ehrlich-Institut (PEI) - the Federal Institute for Vaccines and Biomedicines in Germany. She started working at the President’s Office of the PEI, before implementing and managing the institute’s technology transfer and Intellectual Property issues. Afterwards she established the Innovation Office of the PEI and introduced an early “tailor-made” stepwise advice concept to support pharmaceutical development especially in the area of personalized medicine and ATMP. Being Head of the Innovation Office for several years, she was delegated to the Federal Ministry of Health, where she worked as an expert in the “Pharma Dialogue” and, subsequently, the division “Biotechnological Innovation, Nanotechnology, Genetic Engineering”. During a following delegation to the German Joint Committee, G-BA, she became acquainted with HTA aspects of pharmaceutical development at national and European level. Bettina Ziegele is a long-standing member of the EU Innovation Office Network at EMA and Head of the Drafting Group of the “Simultaneous National Scientific Advice” project. She holds a Master’s degree in economics and philology from the University of Heidelberg.
CSi Hamburg GmbH
Goernestraße 30
20249 Hamburg (Germany)