Speaker Profiles - Discovery/Early Development Track
Dr Christoph Rosenbohm, Head of Discovery Ops,
Roche Innovation Center Copenhagen
Dr. Christoph Rosenbohm
Head of Discovery Operations, RNA Molecule Research (RMR)
Pharma Research and Early Discovery (pRED)
Roche Innovation Center Copenhagen (RICC)
As Head of Discovery Operations, RMR Christoph is responsible for leading the Oligonucleotides synthesis, Pharmacology, and Screening Operations teams and as a member of the RMR-LT he participates in defining and setting the strategy for RMR.
Christoph holds a Master of Science and a Ph.D. in Organic Chemistry from the University of Southern Denmark (the lab of Prof. Jesper Wengel - one of the inventors of LNA). After his PhD, Christoph worked as a post-doctoral fellow at the Danish Technical Univerisity. In addition Christoph holds an executive MBA in Technology, Market and Organisation from Copenhagen Business School.
Christoph started his biotech career in Cureon as chemist with the task of synthesizing the LNA monomers. The company was later merged with Pantheco A/S to create Santaris Pharma A/S in 2003, where he become group leader for the chemistry team. Later the group was joined with CMC, Bioinformatics, PK and Pharmacolgy to form the Research Operation Department for which he became the director. A position he held until the acquisition by Roche in 2014.
Presentation Title: On-boarding New Technologies into existing Discovery Outsourcing Partnerships.
Dr Werngard Czechtizky, Senior Director, Head Medicinal Chemistry, IMED RIA,
Werngard Czechtizky obtained her PhD at ETH Zürich. After a postdoctoral stay at Harvard University, she worked on GPCR lead generation in a global Chemical Biology platform at Aventis. At Sanofi, from 2005, she moved into a parallel synthesis team working in the fields of CNS and CV diseases. In 2010, she became leader of a Medicinal Chemistry section working on Diabetes programs. In 2014, she was appointed Head of Chemistry at Sanofi R&D Germany, with therapeutic focus on Diabetes, pain and inflammatory indications. Since 2017, she is Head of Medicinal Chemistry, Respiratory, Inflammation and Autoimmunity, at AstraZeneca in Sweden.
Dr Garry Pairaudeau, Head of Hit Discovery,
Garry Pairaudeau is currently Head of Hit Discovery at AstraZeneca; the group comprising HTS, Comp Chem, Virtual screening and DEL is responsible for generating high quality starting points for AstraZeneca. In addition, the group works extensively with academic centres of excellence through open innovation and strategic collaborations with groups such as MRC, CRUK, Life Arc and many others to help support academic drug discovery.
Garry also chairs the Global Chemistry Leadership team in AstraZeneca responsible for chemistry strategy and has been particularly active in building Automation and Machine learning capabilities in addition to continuing to lead AZ Discovery chemistry outsourcing.
Garry obtained his PhD in chemistry from the University of Southampton in 1991, followed by post-doctoral work at UC Irvine California. He joined AstraZeneca in 1994 as a medicinal chemist and was part of the chemistry team that discovered Brilinta. He has experience leading projects through all phases of Drug Discovery contributing to multiple clinical candidates in the respiratory, inflammation and CV areas. He has a long standing interest in lead generation, hit identification and diversity screening. Prior to taking up his current position in 2012 he was Director of Chemistry for the cardiovascular group at Alderley Park.
Confirmed Presentation Title: Innovation in Hit Identification
Dr Hartmut Strobel (provisional Confirmation), Global Integrated Drug Discovery Outsourcing,
Sanofi-Aventis Deutschland GmbH
Dr Paul Beswick, Director of UK Chemistry & IP,
PhD from Imperial College. Joined Glaxo in 1984 and stayed until 2009 worked on a variety of targets including ion channels, GPCRs, nuclear receptors and enzymes. During the GSK era worked in the Neurology area as a department head in Medicinal Chemistry largely focussed on pain programmes.
Left GSK in 2008 and joined Almirall in Barcelona as Head of Chemistry where the focus was on respiratory projects and inhaled delivery and in 2013 returned to the UK to join the Drug Discovery Group at the University of Sussex with the responsibility of developing collaborations with both academic groups and industry and raised 12.5M in funding to support the group’s activities.
Started working with Bicycle in 2016 as a consultant while still at Sussex and joined as Director of Chemistry in October 2018
Confirmed Presentation Title: "Discovery & Development of Bicycles, a brand new class of chemically synthesised medicines and the role played by CROs".
Speaker Profiles - Small Molecule Stream
Dr Charlie Hitscherich, Head of Clinical Supply & External Manufacturing,
Confirmed Presentations: "ONPATTRO story - meeting the development challenges presented by pioneering technologies".
Dr Rudolf Hausmann, VP Technical Development & Operations,
Rudolf Hausmann, originally from Kiel Germany, studied Pharmacy before his Ph.D. in Immunology. He has also a degree in Pharmaceutical Medicine from Basel University.
His career in the Pharmaceutical Industry started at Hoffmann La-Roche in Basel/Switzerland and he held different positions in Galenical Production, Formulation Development and Project Leadership. He worked on numerous development projects from pre-Phase-I up to launch.
2005 he started at Santhera Pharmaceuticals, a Biotech company near Basel, Switzerland, which is focussed on Development and Commercialization of new medicines against Neuromuscular Diseases. In his position as Head Technical Development & Operations he is responsible for Technical Development from Phase-I to Phase-III and commercial manufacturing & supply. He is also involved BD&L activities and has additional responsibilities as Project Leader.
Confirmed Presentation: "Flexibility and Agility in the transfer and scale-up of development and launch products".
Speaker Profiles - Biologics Stream
Dr Ulrich Rümenapp, Head of Launch Preparation and Co-ordination, Biological Development ,
Dr. Rümenapp is based in Wuppertal, Germany and working within the Biological Development organization of Bayer AG, where he is responsible for the transfer of Bayer’s pipeline candidates (antibodies and antibody-drug-conjugates) to external manufacturing partners and regulatory submission and launch preparations.
Prior to working in Development, Dr. Rümenapp was Head of Biotech Projects in Product Supply Biotech at Bayer, where he was responsible for contract manufacturing partnerships in the field of biotechnological drug substances and drug products and interdisciplinary project management with the goal to ensure market supply.
Before it was acquired by Bayer, Dr. Rümenapp hold a similar position at Schering AG, and before that, he worked in the Production & Logistics department of Schering, where he was responsible for production aspects of in- and out-licensing deals, due diligences, and product acquisitions of small molecule products and biologics.
Dr. Rümenapp studied chemistry and holds a Ph.D. in biosciences. He worked several years in academic research in the field of signal transduction and as an assistant teacher in the field of general pharmacology.
Today, Dr. Rümenapp area of expertise is the set-up and management of external relationships for the development and supply of bio-pharmaceutical products. He has more than 15 years of experience in the bio-pharmaceutical industry.
To correspond with Dr. Rümenapp, please contact him at firstname.lastname@example.org.
Biologics Outsourcing: Preparing for Launch Readiness with your CMO Partner
• The benefits and risks of outsourcing
• Special challenges with the outsourcing of biologics and new therapeutic modalities
• Best practices for selecting and managing your supplier
• The journey from contracting through partnering, tech transfer and GMP manufacture to launch readiness, incl. sufficient quality oversight
Dr Firelli Alonso, Senior Director, External Supply,
Dr. Firelli Alonso is Senior Director, External Supply at Pfizer, Inc. She heads the BioTherapeutics and Vaccines Outsourcing group in Worldwide Research and Development. Fi has more than 31 years of combined experience in research, development, and cGMP production of biological products and vaccines, and more than 11 years of experience in outsourcing, project / contract management, and technology transfer to qualified third parties. Her areas of expertise include viral vectors and vaccine development, biotherapeutics and vaccine process development and cGMP production, project management, technology transfer, outsourcing, and budgets and operations.
She obtained her Ph.D. in Microbiology from the University of Alabama in Birmingham, followed by postdoctoral research at the U.S. Army Medical Research Institute for Infectious Diseases, Sloan-Kettering Institute for Cancer Research, and Rutgers University Center for Advanced Biotechnology and Medicine. Prior to working for Wyeth / Pfizer in 1996, Fi was at The Salk Institute (Government Services Division), a vaccine contract manufacturer for the U.S. Army.
Dr Andreas Aspoeck, Head of External Manufacturing,
Hookipa Biotech AG
Confirmed Presenation: "Hookipa's Supercharged Immunotherapeutics: Sourcing & Project Managing a complex network of external CROs and CMOs".
Dr Christian Cimander, Director, CMC,
Confirmed Presentation: "Optimised CMO partnerships to expedite early stage development of bispecific antibodies ".
Dr Thomas Wegge, Senior Director of Analytical Sciences,
Ascendis Pharma GmbH
Speaker Profiles - Session Chair
Dr Frederik Barfoed Beck, Senior Outsourcing Manager,
Dr. Frederik Beck has more than 20 years of experience from pharmaceutical and biotech companies. He is the CMC Senior Outsourcing Manager at Zealand Pharma and has held this position for the past four years and has successfully completed 2 IMPD’s for two new chemical entities. As CMC outsourcing manager Dr. Beck is responsible for the outsourcing of all activities relating to clinical trials, both DS and DP. Prior to joining Zealand Pharma Dr. Beck worked for CMC Biologics as Project Director and as scientist/ project manager at Hexal. Dr. Beck received a Master of Chemical Engineering in 1992 from the Technical University of Denmark and an industrial Ph.D. from the University of Copenhagen in collaboration with DAKO A/S in 1999.
Speaker Profiles - Plenary
Andrea Calenne, Senior Manager External Manufacturing,
Employed as Senior Manager External Manufacturing at Biogen International, Andrea is supplier relationship manager for the outsourced manufacture of injectable products (Biologicals and Oligonucleotides).
Over the past 15 years Andrea worked in multiple QA and External Manufacturing roles for CSL Behring, Bayer Healthcare and Biogen, managing a relevant number of manufacturing sites and a product portfolio including plasma derivatives, biologicals, as well as non-sterile pharmaceuticals distributed globally.
Starting his career in Corporate Quality Management within a Japanese automotive company (Bridgestone), Andrea developed his professional identity in an environment where outsourcing is key to product compliance as well as to the performance of the supply process.
Andrea holds a M.Sc. in Organic Chemistry from University La Sapienza in Rome, after graduation he completed a Master in Intellectual Property at the Italian Patent and Trade Mark Office. Andrea speaks Italian, English, French, Spanish and German.
Born 1972 in Rome (Italy) Andrea lives in Switzerland with his family since 2005. Andrea is Italian and Swiss national.
Confirmed Presentation: "Developing a supplier governance model as part of an integrated supplier relationship strategy".
Lidia Cappellina, Head of R&D Outsourcing Management,
CHIESI FARMACEUTICI SPA
Lidia is the Head of Outsourcing Management for Chiesi Corporate R&D. She has 23 years’ experience in the pharmaceutical industry, started in 1992 in GSK Italy where she covered the role of Head of Licensing and License Management Department and subsequently she become the Head of Procurement. She moved in Astra Zeneca Italy in 2003 with the role of Strategic Business Development & Planning Director, and joined Chiesi with the current role in 2009. Lidia has an extensive business development, commercial and procurement / outsourcing areas experience, with in-depth knowledge of large and medium pharma commercial and R&D processes and needs, and consolidated skills in outsourcing and business development strategies, asset evaluation & prioritisation, deal making, alliance management, P&L optimisation processes, at affiliate and corporate level.