<p>Biotech Outsourcing Strategies <em>cmc</em> 2016, Basel</p>

Stefan Abele studied chemistry in Germany, France, and Switzerland. He did his diploma work with Prof. Dr. R. R. Schmidt on C–ketosides in Konstanz and obtained his PhD under the guidance of Prof. Dr. D. Seebach at the ETH Zurich in 1999.

For 7 years, he was working at Carbogen-Amcis, where he had the pleasure to perform or supervise the production of more than 80 Active Pharmaceutical Ingredients (API), in the roles of Project chemist, Group Leader R&D, and Head GMP production. In addition, he was deputy Head ESH releasing production protocols at the Neuland site.

In 2006, Stefan Abele set up a fully integrated Process R&D group at Actelion Pharmaceuticals Ltd with responsibility for all scientific, technical, organizational, and budgetary aspects. His teams’ tasks encompass route finding and production of multi-kilogram amounts of API’s, and the development of 2^nd generation routes, thereby combining scientific understanding and flexibility with commercial perspectives. Outsourcing parts of the work is driven by tactical or technological considerations and is deemed crucial for a lean and efficient drug development.

He has authored more than 55 scientific papers and patent applications, and he is frequently giving invited lectures in industry, international conferences, and at universities.

Dr Paul Deutsch currently heads the Chemical Process Research & Development (CPR&D) department within BioPharmaceutical Process Development group (CMC development function) at UCB Pharma. Major activities within CPR&D include chemical route selection, process development and scaleup for material supplies for all NCEs in UCB’s portfolio, technology transfer and validation of processes, as well as major process lifecycle management initiatives. 

Paul received his BS in Chemistry from Lehigh University (Bethlehem PA, USA) and a PhD in Chemistry from University of Rochester (Rochester NY, USA).  He subsequently spent 13 years performing, coordinating and managing process development and scale-up activities for active pharmaceutical ingredients at several CMOs – Lonza, Aerojet Fine Chemicals, and Cambrex. This included efforts working with many big and medium pharma companies as well as startups, and ranging from tox supplies to clinical supplies to launch, for both innovator and generic molecules. 

Dr. Deutsch then added 8 years experience within pharma companies, initially working as Director API development and Manufacturing at DOV Pharmaceutical, where he was involved with all GMP API activities, before moving to UCB.

Dr Elder studied chemistry at Newcastle upon Tyne (BSc, MSc), before moving to Edinburgh to study for a PhD in Crystallography. He is a visiting professor (King’s College, London). Dr Elder has 38-years experience at a variety of different pharmaceutical companies (Sterling, Syntex and GSK).  He is currently a director within the product development group in GSK R&D.  

Dr Elder is a member of the British Pharmacapoeia (Expert Advisory Group PCY: Pharmacy), a council member of the Analytical Division, Royal Society of Chemistry (RSC), UK and the chairman of the Joint Pharmaceutical Analysis Group, UK.  He is a fellow of the RSC (FRSC).

He has presented regularly on drug development and drug delivery. He has nearly 90 publications and given 110 external presentations at scientific symposia. He has co-edited one book on the Analytical Characterisation and Separation of Oligonucleotides and their Impurities and is compiling a second on the ICH Quality Guidelines.

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.

Jozsef Repasi is the managing director of Soneas Research Ltd and Soneas Chemicals Ltd (formerly known as Ubichem Research), leading CRO and CMO service provider in Central Europe.

He is responsible for business development and R&D activities of the company.

Jozsef received his MS in pharmaceutical chemistry from Eötvös Lorand University (Budapest, Hungary). After graduating he spent five years in various academic research positions doing plant protection research. Before founding Ubichem Research Ltd in 1996 he was working in Hungary, Austria and UK doing process R&D, scale-up and lead manufacturing operations. He also worked for UNIDO in international team in planning pharmaceutical industrial complex.

Since the foundation of Ubichem (currently known as Soneas) he was working in various management positions, including general management, marketing operation, research, development and manufacturing of generic and innovative drugs. Parelel to the management functions in Hungary he was also director at Ubichem Plc in UK for three years.

With an in-depth experience in API Process Research & Manufacturing,  Giordani Antonio spent more than 20 years in managing Drug Development projects in the Pharmaceutical Industry, both in multinational (Beecham, FarmitaliaCarloErba, Pharmacia Co.) and in privately owned companies (Rottapharm-Madaus). He graduated in organic chemistry (1982, University of Pavia) and he specialized in stereospecific synthesis (1989, Polytechnic of Milan). After working as medicinal chemist in major pharmaceutical companies he joined the API group of Pharmacia Co. as Project Leader within API Global Supply & Technology Management Group, where he coordinated the development of several drugs, mainly in CNS and Oncology areas. In 2003 he joined Rottapharm, a privately-owned Italian company, as Director of R&D Chemistry. His current activity in Rottapharm Biotech is in coordination of the Drug Development activities, including Process and Analytical Development and Solid State Studies.

Dr. Jochen Bergmann has more than 10 years’ experience in the pharmaceutical industry. He works at Solvias as a Development Manager, mainly serving the European market. In this role, he is responsible for building strong relationships with partners, especially in projects involving multiple partners. Previously, Jochen has worked as analytical chemist at a service provider in an ISO 17025/GMP/GLP environment. He is a trained food chemist and holds a Ph. D. from the Technical University of Munich.

Pascale Clement has recently joined Catalent as the Director of Science & Technology ensuring scientific leadership for the Optiform Solution Suite bioavailability enhancement platform and Softgel Development for the European market. Pascale has extensive experience in pharmaceutical development of multiple dosage forms for NCEs and Generics.

Over the last 16 years, she has taken progressive leadership roles working at Skyepharma and Pharmascience in Canada and at HWI Analytik (Germany) where she led a Project Management and Pharmaceutical Development team.   Pascale graduated with a Ph.D. in Pharmaceutical Sciences from Paris XI University. 

Stefan Mix was born in Berlin / East Germany, where he also completed his secondary education.  After graduation with a Diploma in chemistry, he received his doctorate in 2004 from the Technical University of Berlin after working in the group of Prof. Siegfried Blechert on stereoselective synthetic methodology and olefin metathesis.  He is the author of several publications, and has been working with Almac Group since 2005.  He has gained broad industrial experience including applications of biocatalysis, crystallisation development, process development for chiral building blocks and APIs, and technology transfer to manufacturing network partners.  

His hobbies include sailplane gliding, kayaking and gardening.

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.

Shahid Uddin is Head of Formulation sciences at MedImmune Cambridge (MedImmune is the biologics arm of AstraZeneca). He joined the company in 1998 previously Cambridge Antibody Technology after holding research posts in several start up biotech companies specialising in polyclonal antibody therapeutics.  In his current role he is responsible for development for both antibody and peptide therapeutics, encompassing new novel formats.  His experience involves both early stage formulation development as well as late stage development as both liquid and lyophilized presentations. His group also have experience of several types of drug delivery technologies. Currently his team is set up to support up to phase II clinical studies then projects are transferred to the US group for commercialization.

Jesper Valbjorn joined Genmab A/S in 2006. He is heading CMC Operations with responsibility for the CMC activities in Genmabs projects from early phase to late phase validated commercial scale. Additionally the unit is responsible for the clinical drug supply logistics and preparation of CMC sections for regulatory filings.

Jesper Valbjørn has 20 years of experience within CMC development in the biopharma industry with positions as project manager, line manager and scientist at H. Lundbeck, Statens Serum Institut and Novo Nordisk.

Jesper Valbjørn holds a MSc in Plant Biochemistry and is inventor of patents in the field of analytical science and process science.

Dr. Rümenapp is based in Berlin, Germany and working within the Product Supply Biotech division of Bayer Pharma AG, where he is responsible for external manufacturing cooperations in the field of biotechnological APIs and finished products.

In his current position as Head of Biotech Projects in Contract Manufacturing, he provides expertise in team leadership, manufacturing processes, and project management to both current and planned external cooperations, with the goal to ensure reliability in supply, quality, and economy of costs.

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 for small molecules 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's area of expertise is the management of external relationships for the manufacture and supply of bio-pharmaceutical products and outsourcing CMC activities. He has more than 10 years of experience in the bio-pharmaceutical industry.

To correspond with Dr. Rümenapp, please contact him at: [email protected]

Since 2010, Dr. Müller has been leading a technical development group in the Late-Stage Pharmaceutical and Processing Development at F. Hoffmann-La Roche Ltd (Basel, Switzerland) with the main focus based on commercial protein formulation and process development.

2008, Dr. Müller took over a formulation research lab in the group of Formulation R&D Biologics at F. Hoffmann-La Roche Ltd (Basel, Switzerland) working on early-stage biotech R&D projects.

From 2005-2008, he was working as formulation scientist in the group of Formulation R&D Biologics at F. Hoffmann-La Roche Ltd (Basel, Switzerland), with the main focus based on high concentration protein formulation development.

From 2001-2005, he was working as process and formulation scientist at Merck KGaA (Darmstadt, Germany) in the group of Formulation Development Sterile Dosage Forms.
He has technical experience in formulation development of sterile dosage forms including biologics, combination products and application of quality by design principles, production of clinical trial and non-clinical study material, up-scaling and process validation.

Dr. Müller holds a PhD in pharmaceutical technology from the Martin-Luther University Halle/Saale, Germany and an engineering degree in Biotechnology obtained at the University of Applied Sciences Bingen/ Rhein, Germany.

Ashleigh Wake is the Biotechnology Program Manager at Intertek Pharmaceutical Services, Manchester, UK Ashleigh graduated from Huddersfield University (West Yorkshire, England) with a B,Sc. in Analytical Chemistry and joined Zeneca as Biotransformation Chemist followed by technical and operational management roles with AstraZeneca and Syngenta before joining Intertek. With a background in MS and a career of almost two decades as an operational/technical team leader and study director for projects spanning the drug development process (including metabolism, PK studies and API/product characterization, CMC support analytics and ICH stability studies), Ashleigh has specialized in the design and delivery of regulatory (GXP) studies relating to the physiochemical and biological activity of biomolecules. Ashleigh is responsible for the strategic growth and technical direction of Intertek’s GMP compliant centre of excellence for biologics characterization in Manchester, UK. Intertek’s strategy has been to establish a one source solution for protein analysis relating to the requirements of ICH Q6B and biosimilar development.

Vikki has worked in the pharmaceutical industry for 15 years. With a career starting in academic research using Lab-on-a-Chip principals, Vikki was subsequently involved in a spin out venture centred on the resultant IP. Vikki’s awareness and capabilities in commercial services resulted in a shift to business development revolving around pharma services, engaging in consultative selling and customer satisfaction. Vikki has driven the implementation of the internal growth and development of Tepnel Pharma Services through culture, coaching and mentoring and continuous improvement initiatives. As the General Manager, responsible for Tepnel’s cGMP analytical services, Vikki is focused on the management and delivery of multi-disciplinary projects. Vikki is committed to the delivery of systems and processes that maximise the customer experience whilst delivering high quality satisfaction to all stakeholders. Vikki is the company advocate for adopting lean principles and pro-actively supporting the Pharmaceutical Quality System. Vikki is involved with Skills Development Scotland and a member of Scottish Life Science Association. - See more at: http://tepnelpharmaservices.com/about/management-team/#sthash.JpRZ8Rax.dpuf.

Lance Wong is managing director of Strand Bio, a CMC consultancy based in San Francisco (U.S.A.). Lance has over 18 years of experience in technical operations and advancing various biologics through the pipeline, encompassing proof-of-concept through registration and commercial launch. He has expertise in devising and executing technical development and manufacturing using both internal & external partners.

Lance has contributed substantially to four biologic product registrations in the US, Europe and Canada; to the partnering success of an immunotherapeutic in phase 3 with a major pharma, as well as numerous early-stage molecules.

Lance is advising clients working on antibody, cell & viral vector therapy. Recent projects include therapeutic molecule engineering, process transfer & comparability, and CMO identification. Lance was most recently with Bavarian Nordic and MedImmune/AstraZeneca. He received his Ph.D. in Chemical Engineering from the University of California, Los Angeles.

Allan holds a BSc in Chemistry from Edinburgh University and is a Member of the Royal Society of Chemistry (MRSC)

Allan has been working in analytical chemistry since 1996. Prior to joining Piramal, Allan had 7 years experience in analytical development and characterisation of small molecules and a further 10 years in large molecule technology transfer and Quality Control.

Allan joined Piramal as Analytical Development Manager in January 2014. He has extensive experience in a wide range of analytical techniques and has managed multiple customer programmes in both development and Quality Control.

Allan has 20 years’ experience in analytical chemistry, extensive experience in technology transfer, method development and quality control, and has strong experience in project management and quality improvement.  He is responsible for Management of analytical development, technology transfer and validation projects for the Piramal Grangemouth site.

Jesper Valbjorn joined Genmab A/S in 2006. He is heading CMC Operations with responsibility for the CMC activities in Genmabs projects from early phase to late phase validated commercial scale. Additionally the unit is responsible for the clinical drug supply logistics and preparation of CMC sections for regulatory filings.

Jesper Valbjørn has 20 years of experience within CMC development in the biopharma industry with positions as project manager, line manager and scientist at H. Lundbeck, Statens Serum Institut and Novo Nordisk.

Jesper Valbjørn holds a MSc in Plant Biochemistry and is inventor of patents in the field of analytical science and process science.

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.

Dr. Raffael J. Koller received his MSc in Chemistry from the ETH Zurich after a research exchange at the Imperial College in London. He obtained his PhD in organic chemistry under the guidance of Prof. Dr. A. Togni at the ETH Zurich working on electrophilic trifluoromethylation. After his postdoctoral work with Prof. Dr. B. M. Trost at the Stanford University he started his industrial career at BASF SE in the agrochemical field.

In 2014, he then moved to F. Hoffmann-La Roche Ltd as process research team leader. He has experience in rapid troubleshooting of discovery chemistry syntheses, the design of scalable routes to support API preclinical and clinical supplies, and the elaboration of manufacturing routes. He has co-authored more than 15 scientific publications and patent applications.

Prof. Dr. Rolf G. Werner is one of the worldwide leading experts in the area of research, development and production of safe and efficient antibiotics, biopharmaceuticals and vaccines with more than 3 years in academia at Max Planck Institute for Molecular Genetics, Berlin, Germany and Massachusetts Institute for Technology, Cambridge, USA and more than 35 years experience in industry at Boehringer Ingelheim in top leading positions. He identified new antibiotics and optimized lead compounds to improve the patient benefit. He was responsible for the development and registration of the first, genetically engineered, protein therapeutic from mammalian cell culture: tissue plasminogen activator for myocardial infarction and stroke. More than 20 therapeutic proteins and monoclonal antibodies have been developed, manufactured and regulatory approved under his responsibility. Under his supervision, processes for vaccines have been developed. He is Honorary Senator of University of Tuebingen and teaching Industrial Biotechnology. He is member of the Scientific Advisory Board of DZIF, German Center for Infection Research and is consulting biopharmaceutical and vaccine companies in US, Europe and Asia in all aspects of research and production technologies. His achievements have been recognized with the honorary PhD of University Chiang Mai, Thailand, the Prize of the City of Vienna, Austria, for outstanding scientific work as well as from the Hangzhou Government, China, as Hangzhou Qian Jiang Distinguished Expert in Biotechnology and consultant of Wuhan National Bioindustry Base, China.

Expert in quality and regulatory compliance with over 20 years of experience in the pharma industry, APIC certified auditor, carried out numerous GMP audits, preparations for PAI inspections of API facilities worldwide, provided GMP training to manufacturers of human and veterinary drugs, participated in numerous FDA audits and due diligence activities in-house and for external clients.  

Violeta also held various CMC positions and established herself as a leader with significant achievements in the global contract manufacture of innovative new chemical entities (NCEs). Skilled in life-cycle management of major projects through CMC development to commercialisation, delivering strategic direction, high technical excellence and cost effectiveness.

Dr. Frederik Beck has more than 20 years of experience from pharmaceutical and biotech companies. He is the CMC 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.

Kim K. Burson, Ph.D. is the Global Head of External Quality, Small Molecule Development Products at F. Hoffmann La-Rochelocated in Basel, Switzerland.  Her organization is managing the Roche quality oversight of over 50 CMOs in 10+ countries.   Kim has over 20 years of quality experience in pharmaceuticals, biotechnology and medical device industries.  She also has extensive experience in health authority inspections and helping sites to identify gaps and establish defense and/or mitigation plans.  Kim received her Ph.D. in Chemistry from Stanford University.

Signe Maria Christensen, Ph.D. has more than 15 years of experience with outsourcing of R&D work for the pharmaceutical industry and biotech companies. Signe joined LEO Pharma in April 2011, and in her position as Head of Research and Innovation, Partnership Managment, she is responsible for outsourcing of R&D services supporting LEOs discovery function and CMC development. Before joining LEO Pharma, Signe has held a position as CMC Coordinator at NeuroSearch and as Development Chemist at Novo Nordisk. Signe received a Master of Chemical Engineering and a Ph.D. in Organic Chemistry from the Technical University of Denmark.

Emma Williams is currently Sourcing Team Manager (Development & Manufacture) for Supply Chain, Pharmaceutical Technology & Development (PT&D), AstraZeneca UK and is based at Macclesfield, Cheshire. Her large team of Sourcing Project Managers based across AZ Gothenburg and AZ Macclesfield are responsible for outsourcing the development and manufacture of Drug Substance and Drug Product including Analytical Services for Early Phase clinical trials (except Biologics).

Emma has 22 years of experience in the Pharmaceutical Industry. After gaining a first class honours degree in Chemistry (BSc) from the University of Nottingham she started her career in Drug Discovery at Zeneca Pharmaceuticals at Alderley Park, Cheshire as a Research Scientist. She has held positions across AZ’s core therapy areas and been team manager for synthetic chemistry teams accountable for large scale synthesis, new technology and outsourcing. She has authored several publications and been a named inventor on patents. In 2014 she was nominated in the first cohort of twenty participants to attend the AZ’s Women as Leaders programme in London. This AZ Diversity initiative is aimed at supporting the career development of women in Science and increasing the percentage of women in Science holding senior level roles.

Maarten van Geffen’s career in the industry spans more than 25 years, with substantial experience in pharmaceutical product development and regulatory affairs. Currently Maarten Works for Janssen IDV as senior scientist within the Drug Product Development group. Maarten was previously Vice President Quality & CMC with Amakem NV developing an ophthalmic lead. He joined Amakem following the completion of the integration of Movetis NV with Shire PLC. At  Shire-Movetis he was responsible for the pharmaceutical development of the GI early and late phase products. Prior to working at Shire-Movetis NV, Mr. van Geffen held several positions as Director of CMC Regulatory Affairs at Barrier Therapeutic NV, Centocor BV, and Janssen Research Foundation, where he was involved in managing and executing product development and regulatory approval. Before initiating his career in the industry Mr. Van Geffen was assessor of quality part pharmaceutical dossiers for the Dutch Health and Environmental agency. Mr. van Geffen received an MSc in Biology from the University of Utrecht, the Netherlands.   

Amer Alghabban joined Karyopharm in August 2015 as Vice President, GxP Quality Assurance, Compliance and Training, bringing with him over 25 years of experience in the pharmaceutical industry. Prior to joining Karyopharm, he was the Managing Director of GxP Compliance and Training Partners (GCTP) helping pharmaceutical companies and academic institutions to achieve compliance with GCP, GVP and GLP. Prior to that, he was Director, Global Head of Quality Assurance & Audit Management at Merck Serono.​ Earlier in his career, Mr. Alghabban was the Global Head of GxP Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Audit Manager at Novartis and he was the first Pharmacovigilance Compliance Officer of the MHRA in the UK. He has an innovative methodology is​ ​recognized internationally as evidenced by the fact that he is an invited speaker at over 74​ ​ international conferences and academic institutions world-wide.

Dr. Scott Coffey is currently the Senior Director of CMC for Chorus, a small, operationally independent clinical development organization within Eli Lilly and Company that specializes in drug development from candidate selection to clinical proof of concept. He has over 15 years of early and late-phase pharmaceutical research and development and regulatory experience.

Scott joined Eli Lilly and Company in 1999 as a Senior Organic Chemist in Chemical Process R&D. He held several roles in Lilly's CMC organization, including Director in Chemical Process R&D. Prior to his current position in Lilly-Chorus, Scott was Director, Global Regulatory Affairs — CMC at Lilly, where he was responsible for the CMC regulatory sciences deliverables for the small molecule development portfolio and commercial products.

Scott received his B.S. degree from Western Kentucky University and his Ph.D. from Indiana University. Prior to joining Lilly, he was an NIH post-doctoral fellow at the University of California, Irvine.

Rikke Mørkeberg is Senior Director of Formulation and Process Development at ALK, Hørsholm. After her Master in Chemical Engineering at the Danish Technical University and a Master in Biotechnology at Reading University she started working for ALK in 1994 developing novel allergy vaccine for immunotherapy. The first 10 years she worked with analytical method development and then shifted to heading the drug substance and drug product development departments including supply of IMP for clinical studies. CMC development at ALK covers both the tasks of acting as a CMO for Partners in the US and Japan and managing a CMO for our sublingual tablet drug product development and manufacturing. Thus, Rikke has over the last 10 years achieved experience with managing both roles in CMC outsourcing leading to the recent two FDA approvals of ALKs sublingual immunotherapy tablet for grass and for ragweed pollen allergies and approval of a sublingual immunotherapy tablet for house dust mites in Japan and Europe.

Vikki has worked in the pharmaceutical industry for 15 years. With a career starting in academic research using Lab-on-a-Chip principals, Vikki was subsequently involved in a spin out venture centred on the resultant IP. Vikki’s awareness and capabilities in commercial services resulted in a shift to business development revolving around pharma services, engaging in consultative selling and customer satisfaction. Vikki has driven the implementation of the internal growth and development of Tepnel Pharma Services through culture, coaching and mentoring and continuous improvement initiatives. As the General Manager, responsible for Tepnel’s cGMP analytical services, Vikki is focused on the management and delivery of multi-disciplinary projects. Vikki is committed to the delivery of systems and processes that maximise the customer experience whilst delivering high quality satisfaction to all stakeholders. Vikki is the company advocate for adopting lean principles and pro-actively supporting the Pharmaceutical Quality System. Vikki is involved with Skills Development Scotland and a member of Scottish Life Science Association. See more at: http://tepnelpharmaservices.com/about/management-team/#sthash.JpRZ8Rax.dpuf.

Lauded by World Trade Magazine as one of the “Fabulous 50+1” most influential people impacting global commerce, author, educator and business consultant Kate Vitasek is an international authority for her award-winning research and Vested® business model for highly-collaborative relationships, Her practical and research-based advice for driving transformation and innovation through highly-collaborative and strategic partnerships launched a book series that includes: Vested Outsourcing: Five Rules That Will Transform Outsourcing, Vested: How P&G, McDonald’s and Microsoft Are Redefining Winning in Business Relationships and Getting to We: Negotiating Agreements for Highly Collaborative Relationships

Vitasek has been featured on Bloomberg radio multiple times, NPR, and on Fox Business News. She also has been featured in over 300 articles in publications like Forbes, Chief Executive Magazine, CIO Magazine, The Wall Street Journal, Journal of Commerce, World Trade Magazine and Outsource Magazine.

Passionate in her quest to help companies transform their business relationships, Vitasek inspires and motivates business leaders with five proven “rules” for achieving transformational results.  Following the Vested mindset and methodology shifts a relationships from a “What’s in it for Me” to a “What’s in it for We” foundation and outcome based business model.  Skeptics walk away believers when Vitasek shares powerful, real-world examples of companies (big and small) that have achieved transformational results by adopting a Vested mindset and business model for highly-collaborate, win-win relationships.

Sachin Dubey is presently working with Glenmark Pharmaceuticals, Switzerland, where he is heading formulation and analytical development. He is responsible for drug product manufacturing and clinical trial preparations. Sachin earned his PhD from the University of Geneva, Switzerland and has worked with Novozymes Biopharma, Denmark. His principal research interests are protein/mAb formulation, stabilization, downstream processing and QbD. He also has a keen interest in practicing lean principles and optimizing timelines for multiple projects. He has received multiple research awards and has several publications and presentations to his credit.

Emma Williams is currently Sourcing Team Manager (Development & Manufacture) for Supply Chain, Pharmaceutical Technology & Development (PT&D), AstraZeneca UK and is based at Macclesfield, Cheshire. Her large team of Sourcing Project Managers based across AZ Gothenburg and AZ Macclesfield are responsible for outsourcing the development and manufacture of Drug Substance and Drug Product including Analytical Services for Early Phase clinical trials (except Biologics).

Emma has 22 years of experience in the Pharmaceutical Industry. After gaining a first class honours degree in Chemistry (BSc) from the University of Nottingham she started her career in Drug Discovery at Zeneca Pharmaceuticals at Alderley Park, Cheshire as a Research Scientist. She has held positions across AZ’s core therapy areas and been team manager for synthetic chemistry teams accountable for large scale synthesis, new technology and outsourcing. She has authored several publications and been a named inventor on patents. In 2014 she was nominated in the first cohort of twenty participants to attend the AZ’s Women as Leaders programme in London. This AZ Diversity initiative is aimed at supporting the career development of women in Science and increasing the percentage of women in Science holding senior level roles.

Peter Van Brusselt is currently head of facilities management EMEA for Janssen Pharmaceutical companies of Johnson and Johnson.

His team is responsible for providing facilities services to and manages infrastructure for Commercial, R&D and Supply Chain. Given the highly outsourced nature of the facility business Peter is currently engaging in next generation partnerships with facilities providers.

Peter has 20 years of experience in Pharmaceutical Industry. His main focus has been in supply chain where he has been leading operations/ manufacturing before turning his focus to end to end supply chain management. In this capacity he has led the global supply chain network strategy for J&J and the focused effort to improve end commercial Line Item Fill Rate through improvements from product development up to distribution.

Andrea Calenne Biography

Employed as Sr. 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.

In August 2014 I founded and lead Strekin as CEO. Strekin is a Biotech company developing drugs in the area of stress related pathways after a scientific cross disease area assessment in new indications.

Since January 2013 I am working as independent consultant supporting Venture Capital Funds in investment decisions as well as small biotech companies in strategic drug development/business plan questions. I can build on more 20 years experience in pharmaceutical research, development, and strategic marketing with more than 10 years as cross functional project leader. In this time I successfully led projects from phase 00 to phase 3 in several indications.

Prior to this role I gained 10 years experience in technical research and technical project leadership finally as head of solid dosage Form development at Hoffmann La Roche in Basel. I have expertise in formulation research, aerosol development, as well as powder technology.

Dr University of Bologna, Italy; MRSC CChem, UK Stefano is a chemist with experience in both major pharma and biotech companies. For 12 years in GSK, he covered several positions, as Antibacterials Laboratory Head, he contributed to the discovery of sanfetrinem and other tricyclic carbapenems, invented and developed a number of novel ketolides. Previous roles include Director of Chemistry at Neuro 3D S.A. Director Research Laboratories, NicOx.

Contributed to the identification and development of numerous drugs and drug candidates Inventor on over 40 patents dealing with antibiotics (macrolides, β-lactams), CNS, cardiovascular, ophthalmic, and anti-inflammatory drugs.