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 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".
Dr Vicky Steadman, General Manager,
Vicky carried out a PhD and post-doc in total synthesis of macrocyclic natural products at Cambridge University with Prof Ian Paterson and at U Penn with Prof Amos B. Smith, III. Her industrial career initiated at Merck (Terling’s Park) working on neuroscience targets. She then moved to GlaxoSmithKline (Harlow) focussing on anti-infectives and anti-inflammatories. Upon joining Selcia in 2008, she rose from Senior Scientist to Director of Discovery. Upon Selcia’s acquisition by Eurofins in 2017, she has become general manager of Eurofins Selcia Drug Discovery and additionally taken on a global role as Business Line Leader of Integrated Drug Discovery Services at Eurofins Pharma Discovery Services. Vicky has a strong track record in innovative medicinal chemistry, and has delivered multiple pre-clinical candidates for customers. She is named on around 30 papers and patents and is a Fellow of the Royal Society of Chemistry.
Confirmed Presentation: "Drug Discovery: Collaborations between CROs and the Pharmaceutical Industry"
Dr Brice Campo, Director, Discovery Department,
Medicines for Malaria Venture
Brice is a Director Drug Discovery at Medicines for Malaria Venture (MMV). He leads drug discovery activities in the context of individual projects and pharmacology platforms. As Director Drug Discovery, Brice provides scientific advices and leadership to portfolio of drug discovery activities projects and pharmacology platforms. He works with partners from both academia and industry in order to deliver pertinent and optimal biological test cascades as well as safe and efficacious pre-clinical candidate which will be part of the next generation of anti-malarials. Brice has a particular interest in molecules and biological assays that tackle the liver stage of the parasite and more precisely the hypnozoites reservoir in order to find the new drugs that will help eradicate Malaria. He joined MMV in November 2011, bringing with him more than 14 years of experience in drug discovery, gained primarily with the Genomic Institute of the Novartis Foundation (GNF) and Addex Pharmaceuticals S.A. He has broad experience in molecular pharmacology and drug discovery in several disease areas such as Neuroscience, Metabolic Disease and Inflammation, and has successfully led and contributed to teams at all stages of drug discovery. Brice holds a PhD in Neuroscience and Immunology from the University of Sheffield (UK) and has published a significant number of scientific papers and patent applications.
Confirmed Presentation Title: Pushing the boundaries of Biology: Utilising an external research network to develop new assays for Malaria Drug Discovery
Dr Silvia Fonquerna, Head of Research Alliances,
PhD from University of Barcelona and Post-doc at University of Sheffield with Prof V. Aggarwal.
Joined Almirall in 1998 as a member of the starting Combinatorial Chemistry Group. From 2000 to 2008 worked as chemistry program leader working on a variety of targets including GPCRs, enzymes, chemokines and ion channels in the Respiratory therapeutic area. Since 2009 promoted to Medicinal Chemistry Head of Section and Inhalation Team Leader of a multidisciplinary group devoted to the design of inhaled drugs. Since 2015 involved in Idea Generation Groups for developing incremental innovation and repositioning projects.
Worked in several strategic collaborative programs and in 2018 promoted to Head of Research Alliances of a group responsible for running collaborations with other Biotechs, CROs and academic groups, obtain public funding and coordinate open innovation initiatives.
Confirmed Presentation Title: Developing and Implementing Collaborative Strategies in Discovery to Harness Innovation
Dr Nicolas Lantz, Senior Regional Category Manager Discovery Services,
F. Hoffmann-La Roche Ltd
Speaker Profiles - Small Molecule Stream
Dr Charlie Hitscherich, Head of Clinical Supply & External Manufacturing,
Dr Hitscherich has been working in industry for close to 20 years. He is currently the Head of Clinical Supply Chain & External Manufacturing at Alnylam Pharmaceuticals. Prior to joining Alnylam he had positions at Biogen, Bristol Myers and Wyeth. He has participated in the development and commercialization of numerous parenteral products. Dr Hitscherich received his BS in Chemical Engineering from Penn State University, MBA from Northeastern University, and his PhD in Biochemical Engineering from the University of Iowa.
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".
Dr Stefan Hildbrand, Head of Process Chemistry & Catalysis,
F. Hoffmann-La Roche Ltd
Stefan Hildbrand studied organic chemistry at the University of Bern and gained his PhD under the supervision of Prof. Christian Leumann in 1996. After completing post-doctoral studies in the Trost group at Stanford University he moved as R&D scientist and Project Leader to the New Business Development Department of Lonza in Visp, Switzerland. In 2001 he joined the Chemical Development Department of F. Hoffmann-La Roche in Basel, where he started as a plant chemist. After a job rotation in a process research lab in 2003 he moved as lab head in the Process Development group. In 2010 he made a short-term job rotation as Manager of Chemical Development to Florence (SC). From 2013 to 2016 he was a section head in Process Development and since October 2016 Stefan is the head of the Process Chemistry & Catalysis Department with 75 employees. In this role he is responsible for end-to-end Drug Substance process design and development using state of the art synthetic methodologies (e.g.; metal- or biocatalysis) and the external workbench to deliver the company’s portfolio of small molecules from entry into human through transfer to commercial manufacturing, including optimal support for regulatory submissions.
Stefan has more than 50 publications (more than 30 patent applications). He is a member of the Swiss Chemical Society, a member of the Scientific Advisory Board for the ACS publication “Organic Process Research & Development” and a member the API Leadership Group of the “International Consortium for Innovation & Quality (IQ) in Pharmaceutical Development”.
Stefan enjoys sport (squash, skiing and hiking), reading historical books and bibliographies, and spends as much time as possible in his holiday home in the Alps.
Confirmed Presentation: "Utilizing biocatalysis and the external workbench to deliver the Roche Small Molecules pipeline"
Dr Alexandre Gil, Head of External Development - Small Molecules / Oral Delivery Platform,
Dr. Alexandre GIL, Ph.D. Head of External Development - Small Molecules / Oral Delivery Platform
Expert in Pharmaceutical development with more than 15 years of experience in pharmaceutical sciences in a broad business area covering generic, OTC, veterinary and Rx with missions all along the value chain (from preclinical to launch). From 1999 to 2007 progressing from pharmaceutical research at Pierre Fabre (Consumer Health Care and prescription medicines), Ethypharm (Drug Delivery company) and Virbac (Animal Health).
Joined Sanofi in 2007 and since then have had increasing responsibilities within the pharmaceutical sciences department and recently moved in the Business Excellence organization of CMC in charge of the External Development department for Small Molecules / Oral Delivery Platform.
Confirmed Presentation: Dosage Form pathways for poorly soluble small molecules and opportunities for CMO innovation.
Dr Craig Harris, Senior Expert Scientist API Synthesis,
As the lead for both discovery and development synthesis, Craig is responsible for driving the synthesis from lead generation all the way through to cGMP manufacture for Galderma S.A., Entre-Deux-Villes, Switzerland. After receiving his B.Sc. and Ph.D. from the University of Manchester in 1997, Craig was taken on by AstraZeneca as Senior Process Chemist at Macclesfield, U.K. In 2000, after a short secondment at Alderley Park working in the Oncology iMed, Craig transferred to the Reims site in France and continued to support the Oncology iMed contributing to many programs including the clinical candidates AZD1845, AZD4769 and AZD8835. In 2012, AstraZeneca closed the research facility in Reims and, after a short spell at Adocia (Lyon, France), Craig was recruited to lead the research synthesis for Galderma, a dermatology-focused pharma company in Sophia-Antipolis, France. In 2014, he was promoted to Senior Expert Scientist and became responsible for the synthesis support strategy to both the discovery medicinal chemistry and aesthetic and corrective project portfolio. During his time at Galderma, Craig drove both internal and external synthesis (CRO) teams to deliver 10 development candidates on a variety of targets linked to skin diseases such as psoriasis, acne, skin cancer, atopic dermatitis and in the aesthetic and corrective field on the Sophia site. In 2017, after Nestlé’s decision to stop active research and development activities on the Sophia-Antipolis site in France, Craig was chosen to lead the synthesis going forwards for Galderma S.A., now adopting a virtual R&D model in Switzerland.
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
This presentation will include the following:
• 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 Andreas Aspoeck, Head of External Manufacturing,
Hookipa Biotech AG
Andreas Aspöck is Head of External Manufacturing at Hookipa Biotech in Vienna, Austria. Hookipa Biotech is a clinical stage biopharmaceutical company developing prophylactic and therapeutic treatments based on viral vector platforms. These arenavirus-based treatments are novel treatments (ATMP) and there are some challenges around the manufacturing process, as every biotechnology company experiences.
As Head of External Manufacturing Andreas is responsible for the aligning all aspects of the manufacturing strategy with the company pipeline. This includes the supplier selection, scheduling and supervising the manufacturing campaigns.
Andreas started at Hookipa Biotech in 2012 as a Scientist in the Up-Stream Department (UPS), and later became Head of UPS to drive the development of the upstream processes.
From 2008 to 2012 Andreas worked at AVIR Green Hills Biotech, a biopharmaceutical company focusing in developing an attenuated Influenza vaccine. At AVIR Green Hills Biotech he assisted the Head of Manufacturing and PD in the manufacturing campaign and led later the Up-Stream Development.
Andreas finished his studies in life science with a master degree at the University of Applied Life Sciences in Vienna.
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
Dr Thomas Wegge has been working in biotech and pharmaceutical industry for close to 20 years and is currently Senior Director of Analytical Sciences at Ascendis Pharma where his department is developing bioanalytical and CMC methods. Prior to Ascendis Pharma he hold positions at Roche and Complex Biosystems. He was part of the team that created the TransCon technology and has participitated in the development of several TransCon products. Thomas has a diploma degree in chemistry from the University of Dortmund and a PhD from the Philipps University of Marburg.
Confirmed Presentation Title: "Creating a robust analytical development strategy powered by external partnerships".
Dr Karlheinz Landauer, Managing Director,
Dr Karlheinz Landauer is an expert in Biotechnology with a PhD and an MSc title in Applied Microbiology with 15+ years of work experience. He has specialized on cell line engineering, up-stream process development, scale-up and tech transfer strategies, GMP operations and was a program manager of an NBE (=new biological entity).
After his PhD in the field of animal cell culture medium development, he took several jobs in the above-mentioned fields with increasing responsibilities, when in 2011 he eventually was Head Manufacturing and COO at Celonic AG in Basel.
In 2016, he has founded his own company QBDC, with its core focus on consultancy for biotech companies in CMC matters, process development, tech transfer & scale-up, facility layout & design, project management, and QM & QA.
At QBDC, he is driving the company towards high quality standards and problem-solving communication strategies. For QBDC’s customers, he is an easily accessible, goal-oriented technical solution provider.
- 05/2017 to date: Managing Director, Quality Operations Saudi Biotechnology Manufacturing Company, Riyadh, Kingdom of Saudi Arabia
- 01/2016 to date: Managing Director at QBDC GmbH, Nusshof, Switzerland.
- 12/2007 to 12/2015: Director R&D, in 01/2011 promoted to COO and Head Manufacturing at Celonic AG, Basel, Switzerland.
- 11/2006 to 10/2007: Assistant Senior Manager at Celltrion Inc, Incheon, South Korea.
- 12/2002 to 06/2006: Post-Doc, later Deputy Head of Manufacturing, eventually promoted to Head Manufacturing at Igeneon, Krebs-Immunotherapie Research and Development GmbH, Vienna, Austria.
Confirmed Presentation: "Creating a framework for effective CMO selection for late phase biopharmaceutical drug substance production".
Dr Arjan Roozen, Chief Technology Officer,
Arjan Roozen, Chief Technical Officer, Zelluna Immunotherapy
Arjan Roozen joined Zelluna Immunotherapy in April 2018 and is responsible Zelluna’s Manufacturing and Development strategy. Arjan has extensive experience in GMP manufacturing in the EU and US. The supply chain management from raw materials, GMP cell manufacturing for clinical and commercial supplies. Prior to joining Zelluna, Arjan served as VP GMP Solutions & Manufacturing at Cellectis, where he headed up the team responsible for the sourcing of the critical raw materials as well as the manufacturing of the gene modified cell therapy products. Additionally, he has previous valuable experience from the CDMO Pharmacell, recently acquired by Lonza, responsible for its operational activities. Arjan has a degree in microbiology with specialization in molecular microbiology.
Sebastian Pungel, Programme Manager,
Sebastian joined Univercells (Belgium, Germany) in 2017 as a Program Manager for recombinant proteins and was leading multidisciplinary project teams to ensure successful delivery of the project’s objectives. Today, Sebastian is responsible of science and innovation. He is in charge of evaluating technologies across all Univercells businesses covering all aspects of manufacturing technologies for producing drug substance, drug product of therapeutic proteins and vaccines as well as analytical and equipment development.
Sebastian Püngel graduated with a Bachelor degree from University of Applied Sciences Emden (Emden, Germany) followed by a Master degree from Beuth University of Applied Sciences Berlin (Berlin, Germany) with a focus on cell culture technology and recombinant protein production.
Confirmed Presentation: Strategies towards optimised and flexible facilities for vaccine and biotherapeutic manufacturing.
Speaker Profiles - Session Chair
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 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.
Brian Cox, Professor of Pharmaceutical Chemistry. Co-Director and Co-Founder ,
Sussex University & Photodiversity Ltd
Brian has had a highly successful career in drug discovery in industry with GSK and Novartis. Brian has a BSc in Pharmacy and PhD from the University of Manchester where he worked on novel antifungal agents. This was followed by Post Doctoral study at the University looking at novel opioid-like analgesics, then a two-year industrial Post Doctoral position at Schering Plough in New Jersey focussed on the total synthesis of the marine natural products Pseudopterosins.
Brian then spent 12 years at Glaxo/GlaxoWellcome/GSK working in many different disease areas (CNS, respiratory, cardiovascular, GI and antibacterials). Moving to Novartis (Horsham) in 2002 he became Head of Chemistry with the site specialising in respiratory and GI research, as well as acting as an expertise hub for automated synthesis for the Novartis chemistry organisation (Global Discovery Chemistry). He developed a keen interest in the modulation of ion channels as a target class and the design of inhaled medicines, which he is now a recognised expert in.
Brian moved to the University of Sussex (November 2014), where he is now Professor of Pharmaceutical Chemistry growing a medicinal chemistry platform underpinned by extensive automated synthesis capability. His group’s focus is the application of high throughput automated synthesis in hit and lead optimisation and the synthesis of novel archive diversity enhancement libraries. Along with Professor Kevin Booker-Milburn, he is co-founder and co-director of Photodiversity Ltd, a start-up company from the Universities of Sussex and Bristol which specialises in the use of Photochemistry to produce novel sp3 rich fragment and diversity libraries for screening against Pharmaceutical and agrochemical biological targets.
He is a Fellow of the Royal Pharmaceutical Society of Great Britain and registered pharmacist, Fellow of the Royal Society of Chemistry, chartered Chemist and chartered scientist. He is a member of the Royal Society of Chemistry’s Chemistry organic and Medicinal Chemistry Sector committee. He is associated with a number of marketed compounds and multiple late stage clinical candidates and is a champion of diversity and inclusion (D&I).
Dr Anna Matranga, Business Consultant,
AMC Alliances & Consulting SASU
Anna M.C. Matranga, PhD, MBA, CA-AM
AMC Alliances & Consulting SASU
AMC is a British/Italian national based in France. She has worked in international leadership roles for the pharmaceutical industry over the last 25+ years working for Eli Lilly (Erl Wood, UK), Allergan (Sophia Antipolis, France), Galderma (Sophia Antipolis, France) & at Ipsen Innovation (Paris, France). She has also worked in Baden-Baden, Germany.
She started her consultancy practice in 2016. She provides business strategy to operations support to pharma/biotech/CROs/academia in alliance management, B2B matchmaking, outsourcing/ procurement, contract management and operational excellence. She also provides group and/or 1:1 training/coaching in effective communication, leadership, management of cultural diversity, effective negotiations, how to manage the risk in your service contracts, vendor quality management and how to optimize the Sponsor/Partner/Supplier relationship. These are conducted in English and French (and some Italian when needed!). She is a part-time lecturer at several business schools.
She holds a PhD in microbiology (from Bristol University) and an MBA in general management/finance (from Henley Management College) and has obtained certification in alliance management (from ASAP). She has strong experience in alliance/relationship management, leadership, project management, procurement/negotiation, training, and performance management. AMC is an alumni member at the universities of Trent, Bristol and Henley management college as well as a member of SIETAR. She is a regular industry speaker at pharma conferences.
Yogeshwar Bachhav, Associate Director Pharmaceutical Development,
Dr. Yogeshwar Bachhav is associated with AiCuris Anti-infective Cures GmbH Wuppertal (Germany) for around 4 years. AiCuris (name derived from 'anti-infective cures') is focused exclusively on the discovery, research and development of novel antiviral and antibacterial drugs.
Yogeshwar has around 12 years of experience in Pharmaceutical development (CMC) of poorly soluble/stable drugs for oral, parenteral and topical route from the start-up and mid-size Pharmaceutical companies in Europe. In his current role at AiCuris, he is responsible for the outsourcing of drug product for preclinical and clinical trials up to phase II. His experience involves both in house and external Pharmaceutical development of poorly soluble/labile APIs for oral parenteral and topical route.
Speaker Profiles - Plenary
Dr 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.
Dr Helge Tippmann, Senior Category Manager,
Novo Nordisk A/S
Helge Tippmann joined Novo Nordisk in 2013 and currently works as Senior Category Manager in Strategic Sourcing, responsible for outsourcing of API, intermediates and complex materials. Helge has been responsible for different direct spend categories, has a strong negotiation background and has extensive experience with implementing ethical sourcing standards in the supply chain. Helge has over a decade experience with outsourcing for global pharmaceutical companies and has been working within the Biotech field for 17 years in different positions in Specialist and Manager Roles.
Presentation Title: Evaluating Sourcing Models; Cost, Benefits, Risks and Rewards.
Gabriele Sassi, Non Clinical Outsourcing Manager (CMC),
CHIESI FARMACEUTICI SPA
Gabriele Sassi joined Chiesi Farmaceutici in 2010 and currently works as Non Clinical Outsourcing Manager in R&D Outsourcing Management, responsible for outsourcing R&D core activities for CMC such as Analytical Development, Clinical Trial Supplies and Drug Product / Drug Substance Manufacturing activities. Gabriele is mostly involved in establishing and managing the relationship with CROs and CMOs and the consequential contract management: this implies an intense knowledge of Procurement and Outsourcing processes that mainly refer to Supplier Selection and Qualification, Contract Awarding & Contract Management and Supplier Relationship Management. Gabriele has 9 years’ experience with procurement / outsourcing areas, starting his career in Procurement Department for Indirect Spend Categories (IT software, Laboratory Chemicals & Equipment).
Confirmed Presentation Title: Building a robust, risk based, supplier qualification process.