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.

Gabriella is the Global Head of Organisational Effectiveness at Roche, pRED. She is a highly successful Continuous Improvement professional, with significant experience in scientific research & business process developments. She has 20 years’ experience in the pharmaceutical industry, because after her Ph.D. in Pharmaceutical Sciences, she started her career in GlaxoSmithKline in 1997, as Project leader in Medicinal Chemistry. In 2010 after the strategic acquisition from Aptuit, a worldwide CRO, she got certified as Lean six Sigma Black Belt and she became Operational Excellence Manager; subsequently she completed her Executive MBA, at Politecnico in Milan.

She joined Roche, pRED, with the current role in 2015. She has strong business knowledge of process excellence and she is an expert in process re-engineering, business analysis, operating models′ design and implementation.

She has a proven record in setting organizational change management strategy and in delivering plans and measurements for large scale technology improvements, process improvements or other large scale/site organizational transformations.

Chris is currently working as a Sourcing Project Manager at AstraZeneca, Macclesfield supporting clinical trials by project managing outsourced drug substance and drug product manufactures. 

He did a chemistry degree at Nottingham University and then spent a year working for Oddbins Wine Merchants followed by a year with Zeneca Process Chemistry before doing a chemistry PhD at Imperial College, London. After an industrial post doc at Avecia he started working at AstraZeneca in 2000 as a Senior Research Scientist. After 13 years at the bench he left the lab for a secondment in Research Outsourcing and then 3 years ago moved to his current role. 

He enjoys eating, swimming and skiing and has recently stood down as Chairman of the AZ Wine Tasting Group after 14 years of service.

Dr. Husbyn holds the position as CMC Manager in Lytix Biopharma, a virtual Norwegian Biotech company within therapeutic cancer immunology. She is responsible for the CMC and Clinical Supply strategy and operations for clinical stage and discovery API’s and drug products. She obtained her PhD from University of Oslo in peptide chemistry and executed on the synthesis and in vitro, ex vivo testing of complex cyclic peptide domains as anticoagulants. She has previously had various scientific and leadership roles at GE Healthcare in analytical method and chemical process development.

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 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.

Yogeshwar Bachhav is associated with AiCuris Anti-infective Cures GmbH Wuppertal (Germany) for more than 3 years. AiCuris (name derived from 'anti-infective cures') is focused exclusively on the discovery, research and development of novel antiviral and antibacterial drugs. 

Yogesh has more than 11 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/stable APIs for oral parenteral and topical route. 

Dr Fu has over 25 years' experience in small molecule API Development and Manufacturing.  Before joining STA, Dr. Fu was a Senior Fellow of Process Chemistry at Merck Research Lab/Schering-Plough Research Institute.
 
Dr Fu received his Ph.D. in Synthetic Organic Chemistry from University of Wisconsin-Milwaukee.

Dr. Alison Foster joined Quay Pharmaceuticals Ltd in 2013 she is the Pharmaceutical Technical Manager. Before joining Quay pharma she was, the Pharmaceutical Programme Director and co-founder of IOTA NanoSolutions Ltd., Alison has over 7 years’ experience in the formulation of nanoparticles of poorly soluble drugs using a proprietary technology. She worked closely with Business Development during this time to promote the technology across Europe and the US. Prior to IOTA NanoSolutions, Alison gained post doctoral experience at the School of Pharmacy at the University of Manchester under Dr. Sally Freeman before joining Unilever R&D as a scientist, working on numerous projects ranging from Oral Care through to laundry detergents gaining experience in polymer chemistry, sensory molecules and delivery of active ingredients.

Education:  BSc Biochemistry, MSc Biotechnology

Brian joined Almac Pharma Services, part of Almac Group, in May 2010. Brian leads the Business Development and Business Support functions for the company’s Pharmaceutical Development, Clinical & Commercial Manufacturing and Product Launch services.

Prior to joining Almac, Brian worked as Corporate Business Manager for a local Healthcare company for four years after gaining almost ten years’ experience working within the R&D department at Norbrook Laboratories Ltd. Brian holds a Bachelor of Science (Hons) degree in Biochemistry from the Queens University, Belfast and a Master’s of Science degree in Biotechnology from University of Ulster, Coleraine.

Michel has been Business Development Manager at Piramal since 2012 working with biotech and large pharma companies on various development and commercial small molecule projects. Prior to Piramal, he was independent business consultant and, before that, sales manager at Synkem (now part of Corden Pharma). Michel started his carrier in the pharmaceutical industry at Sipsy (now Zach) as process R&D manager with a focus on new asymmetric catalytic technologies and then API process development manager for 10 years. He is familiar with both technical and economic aspects of pharma development and manufacturing. Michel has a PhD in Organic Chemistry from Lyon University, France, and holds a MBA from ESSEC Management Education, France.

Andrea Cusack has more than 20 years of experience working in pharmaceutical, drug delivery and biotech companies. She joined Catalent  Pharmaceutical Solutions in 2012 as Senior Business Development and Licensing Director, based in Europe. She is  focused  primarily on the company’s proprietary platform technologies and works closely with companies in both a Business Development and Alliance Management capacity. Prior to relocating to France and joining Catalent  Pharmaceutical Solutions she ran her own consulting business in the UK. Andrea has previously worked for both small drug delivery companies (backed by either private equity or venture capital) as well as large pharma and drug delivery device companies. Andrea holds an MBA and a Degree in Polymer Engineering and Applied Chemistry from the University of Cardiff, Wales.

Anthony Toto is the Director of Process Engineering, Pharmaceutical Sciences, at TESARO, an oncology-focused biopharmaceutical company in the Boston area. Mr. Toto has over 20 years of experience and broad knowledge in pharmaceutical R&D covering small molecule synthesis scale-up from laboratory to pilot scale to commercial scale manufacturing. Additionally, Mr. Toto possesses early and late stage process development, process transfer, validation and product launch at major pharmaceutical companies as well as biopharma.

Mr. Toto received his Bachelor's and Master’s Degrees in 1994 and 1996 from New Jersey Institute of Technology, Newark NJ, USA. He joined the Process R&D department at Schering-Plough, where he performed development and scale-up activities and subsequently managed pilot and commercial manufacturing plant facilities while taking increased responsibilities. After merging with Merck, Mr. Toto continued working for company for an additional 3 years. After almost 20 years with major pharma, Mr. Toto moved to TESARO in 2015 as Director of Process Engineering supporting both drug substance and drug product activities from late stage development to commercialization.

Michael graduated in Pharmacy from Sunderland School of Pharmacy and was awarded his PhD from The University of Nottingham. In 1994, he joined SmithKline Beecham Pharmaceuticals working in Pharmaceutical Development on solid oral dosage formulations across all phases of development from the discovery interface to technology transfer of large scale processes to the commercial production network. He developed formulations, authored regulatory submissions, manufactured clinical trials supplies and project managed and delivered on development projects with a team of formulation and analytical scientists.

In 2002 Michael moved to Laboratoires Fournier as the Head of Pharmaceutical Sciences, working on nano-particulate formulations and combination products. He had responsibility for the pharmaceutical development department and successfully commercialised a nano-particulate tablet dosage form for EU and US markets before the company was acquired by Solvay.

In 2006 Michael returned to GlaxoSmithKline as Technical Director working on the transfer of development projects in to commercial manufacture, with a particular focus on QbD applications and interactions with US, European and International regulatory agencies.

In 2010 he joined Almac Pharma Services and is currently the Head of Formulation & Process Development. He is responsible for all drug product development activities from Phase 1 through to Phase 3 and technical transfer to commercial production. His department covers development and GMP manufacture of solid oral dosage forms.

After a short period in academic biopharmaceutical research at the Royal School of Pharmacy, Annette Römmelmayer Lundegaard started working in the pharmaceutical industry for more than 20 years.  The first few years were with formulation development of Solid Dosage Forms within the generic area - Dumex Alpharma. She joined ALK in 2000 as a chemist and worked within different CMC areas, mainly responsible for development of different Drug Products primarily for sublingual immune therapy (SLIT). She has had technical and financial responsibility for developing several SLIT tablets in collaboration with different contract organisation. She has also been highly involved in different aspect of partnership with Big Pharma companies.

Annette is currently Director of department of Product Supply SLIT Tablet, Drug Product with responsibility for global commercial supply and late stage development of SLIT-tablets.

She holds a master Degree of Science in Pharmacy from the Royal School of Pharmacy in Denmark.

Graham supports client projects providing expert interpretation of data including prediction, modelling and simulation of PK and PK-PD. He joined XenoGesis in 2015, bringing over 14 years industrial drug discovery experience, as well as a track record of delivering pre-clinical drug candidates in oncology and inflammation through integration of DMPK properties into compound design to increase the probability of success.

Prior to joining XenoGesis, Graham worked at UCB for 8 years before joining Almac Discovery in 2009. As Director of Medicinal Chemistry, he was responsible for medicinal chemistry strategy across all projects including integration of DMPK properties into design and progression of compounds. Whilst at Almac Discovery, Graham directed an allosteric Akt inhibitor project from hit-ID to candidate nomination.

Graham graduated from the University of Nottingham with a PhD in Synthetic Organic Chemistry and went on to complete his Postdoctoral Research at the University of Geneva.

Dr Rob Harris has over 30 years experience in the pharmaceutical industry. He started his career in production support roles with Warner Lambert and GSK before spending time in academia as a Research Fellow at the University of Manchester, developing novel drug delivery systems. For the last 15 years Rob has worked in the contract pharmaceutical development sector, holding senior technical roles with Quay Pharma, Capsugel and Penn Pharma.

Rob is currently Chief Technical Officer at Juniper Pharma Services.

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 [email protected].

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.

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.

Johannes studied Economics at the University of Hohenheim, Stuttgart in Germany, specializing in healthcare systems. He began his career as an entrepreneur and consultant, co-founding the company SMATOS (Subject Management and Treatment Organisation System), which supplies healthcare software for managing clinical trials in clinics, medical practices, and scientific institutions. Johannes joined Vetter in 2011, and was 6 years responsible for supporting biotech companies of all sizes in bringing their drug product to market. Johannes was named Director Business Development, Europe in June 2016. In this role, he is responsible for new customer acquisitions of existing products and services, generating business for new innovations, products and services, client intelligence, and the establishment of partnerships. Johannes has extensive experience in clinical and commercial fill & finish manufacturing at global level.

Jorgen has over 30 years of experience in the pharmaceutical industry covering development of biologics, peptides and small molecules from lead candidate selection, through scale up to technical transfer before commercialization. He has direct responsibility at a senior management level as both line as well as global project manager.  Jorgen is involved in document preparation, regulatory agency interactions and regulatory submissions to FDA, EMA and PMDA. His work experience includes different drug substances, drug products and medical devices with focus on parenteral sterile products such as liquids and lyophilisates. Jorgen has significant involvement in outsourcing activities covering technology transfer, process development including scale-up and Quality by Design.

Aiala Lorente-Trigos is CMC Project Coordinator at NovImmune, a biopharmaceutical company based in Geneva (Switzerland) and dedicated to the discovery and development of therapeutic monoclonal antibodies against immune related diseases and cancer. She joined the company in 2012, after 8 years of experience as research scientist in the cancer research field, where she acquired expertise in cellular and molecular biology, immmunochemistry, cell based assays and in vivo disease models. As Project Coordinator in the Bioprocess R&D department, she is now responsible for the coordination of the internal and outsourced activities of different projects in the pipeline. These include cell line, process and assay development, drug substance and drug product manufacture, quality control and release of monoclonal antibodies to support preclinical and clinical studies.

Fabrice has over 15 years of commercial and business experience in the pharmaceuticals market.  He is currently the Enterprise Solutions Modality Leader for GE Healthcare Life Sciences, and has held previous commercial leadership roles within Solvay Pharma, Lonza and others.

John is Business Development Manager at Intertek Pharmaceutical Services in Manchester UK.

John graduated from University of Manchester with a BSc (Hons) Degree in Chemistry, following which he spent 5 years with a UK based Contract Testing Laboratory as a Technical Sales Consultant and was involved in building partnerships with global organisations through the provision of complex analytical and consultancy solutions.

John joined Intertek Pharmaceutical Services in 2015 as part of the UK Business Development Team, with a view to continue Intertek’s strategy in establishing a one source solution for protein analysis (relating to ICH Q6B), as well as growing the bioanalytical business and furthering Intertek’s profile and reputation within the biopharmaceutical industry. John currently works with biopharmaceutical companies in order to support their analytical and bioanalytical needs, throughout the development pipeline.

Intertek Manchester is home to their GMP compliant centre of excellence for biologics characterisation, which in additional to refurbished facilities opened in 2015 has seen a high level of investment in cutting edge capability and highly skilled staff. Outside of the specific capabilities of Intertek’s Manchester facility, they also provide a global network of GLP/ GCP and cGMP laboratories and specialists to deliver high quality support including GMP analysis, GLP/GCP bioanalysis for preclinical and clinical support, formulation development, GMP biologics characterization, specialist inhalation development expertise, regulatory consultancy, risk assessment,  auditing and supply chain management solutions. John is part of a close network whose aim is to provide flexible Total Quality Assurance contract services to the global pharmaceutical industry.

Karl Abele obtained a M.Sc. and Ph.D. in chemistry at the Ruhr University in Bochum, Germany. He is an expert in the fields of mass spectrometry and separation technology for small molecules and worked several years as application specialist for three MS manufacturers. In 2010 he joined Solvias, where is currently leading the Extractables and Leachables team within the elemental and trace analysis unit.

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.

Dr. Richard Dennett is responsible for the management of projects involving the Regulatory and Technical Strategy for Chemistry Manufacturing and Control (CMC) and Quality, at Voisin Consulting Life Sciences.  Current focus includes:
- EU/US regulatory submissions and strategy plus strategic support for EMA/FDA Scientific Advice
- CMC development and commercialization strategy, quality by design, cGMP compliance, technology trans-fer/outsource manufacture, product comparability/ process validation

Richard brings over 20 years applied industrial and commercial biopharmaceutical experience, acquiring in depth knowledge across a broad range of biopharmaceutical technologies and product types including recombinant vaccines, gene therapies, (stem) cell-based therapies, monoclonal antibodies and biosimilars.

Previous key role responsibilities include:
- Eden Biodesign (company co-founder):  project manager for the design input, construction phase, cGMP compliance and facility validation though to successful MHRA approval of the UK’s former National Biomanufacturing Centre. Subsequent commercial operation as a successful CMO though to company acquisition by Allergan.
- Celltech Medeva (Novartis):  lead of process development from early concept through to successful pan European market approval of a complex 3rd generation vaccine for hepatitis B.
- AstraZeneca:  commercial expression system develop-ment and cell biology research
-  White Rose Centre for Enterprise:  establishment of high-technology start-up companies

With a PhD research grounding in applied biochemistry matched with his varied industrial technical background, Richard is able to bridge technical  and  regulatory  expertise;  being  able  to  readily  understand  and quickly overcome complex development scenarios and in being able to translate this into successful project delivery.

Niko is Head of ESO Pharma Technology within Global Pharma Operations/Global manufacturing and supply. In this role, Niko and his ESO Pharma Technology group are providing knowledge and leadership in science and technology to guarantee robust external global production, quality and supply. There is focus on technical product lifecycle, continuous improvement and CMC knowledge.

During the last 15 years, Niko had various positions in global manufacturing and supply, managing CMO selection, tech transfer, product submission as CMC leader, implementation and launch - driving CMO business and reviews covering Quality, Regulatory, Supply and Production, KPIs and workflows with focus on Quality and costs in both areas, NCE/small molecules and NBE/biotech.

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.

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.

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.

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.

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.

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 Laura Millichamp is a UK registered Pharmacist with a PhD in Pharmaceutical Sciences from the University of Manchester, UK in the field of hydrogels for topical drug delivery.
She has over 7 years’ experience in the regulation of medicines at the European level gained as a Pharmaceutical Assessor at the Medicines and Healthcare Regulatory Agency (MHRA). In this role Laura gained extensive experience of all licensing procedure types (Centralised, Decentralised, National, Mutual Recognition, variations, CMDh referrals, recalls) and provided regulatory and scientific advice on a European level, presenting challenging applications at UK Expert committees and CHMP discussion meetings. Laura has experience of assessing MAAs including Quality by Design (QbD), Real Time Release Testing (RTRT) and Rapid Microbial Methods (RMM).

In her current role as a Director of CMC and Quality, she applies her in depth regulatory expertise to deliver highly successful pre and post approval regulatory strategies, aligned with client business needs. Her scientific, technical and regulatory expertise includes provision of solution focused advice at all stages of product development, and reviewing and preparing regulatory pharmaceutical documentation.

Laura has experience of collaborating with companies of all sizes, from start up to global, and at all stages of the drug development process.

Dr. Richard Dennett is responsible for the management of projects involving the Regulatory and Technical Strategy for Chemistry Manufacturing and Control (CMC) and Quality, at Voisin Consulting Life Sciences.  Current focus includes:

• EU/US regulatory submissions and strategy plus strategic support for EMA/FDA Scientific Advice
• CMC development and commercialization strategy, quality by design, cGMP compliance, technology transfer/outsource manufacture, product comparability/process validation

Richard brings over 20 years applied industrial and commercial biopharmaceutical experience, acquiring in depth knowledge across a broad range of biopharmaceutical technologies and product types including recombinant vaccines, gene therapies, (stem) cell-based therapies, monoclonal antibodies and biosimilars.

 Previous key role responsibilities include:

• Eden Biodesign (company co-founder):  project manager for the design input, construction phase, cGMP compliance and facility validation though to successful MHRA approval of the UK’s former National Biomanufacturing Centre. Subsequent commercial operation as a successful CMO though to company acquisition by Allergan.
• Celltech Medeva (Novartis):  lead of process development from early concept through to successful pan European market approval of a complex 3rd generation vaccine for hepatitis B.
• AstraZeneca:  commercial expression system development and cell biology research
• White Rose Centre for Enterprise:  establishment of high-technology start-up companies

With a Ph.D. research grounding in applied biochemistry matched with his varied industrial technical background, Richard is able to bridge technical  and  regulatory  expertise;  being  able  to  readily  understand  and quickly overcome complex development scenarios and in being able to translate this into successful project delivery.

Dr. Alain Bernard is former Vice-President, Biopharmaceutical Process Sciences at UCB, overseeing process developments for new chemical and new biological entities as well as for life-cycle management of marketed products. He joined UCB in 2006, from Serono where he was Director of Process Development.  He had joined Serono in 1998 and was formerly responsible for the biotechnology department in the R&D function. Prior to that move, he had been working at the Glaxo-Wellcome Institute of Molecular Biology. He holds a PhD in biochemical engineering and worked both in the US and Europe on process/product development and reactor design for a variety of biotechnological processes. He has authored or co-authored many publications in biotechnology.

Roxana is working as Associate Director Global Procurement Biologics External Manufacturing, supporting clinical and commercial supply of outsourced drug substance and drug product manufacturing, leading BMS Global Biologics Category Drug Product. With over 14 years’ experience in the (bio)pharmaceutical and chemical industry, has started in 2000 in Capgemini in junior marketing roles and subsequent to engineering studies has joined several Contract Manufacturing Organizations (Patheon, Dr. Reddy’s) in different roles, from Project Lead to Business Development and Procurement. Roxana has extensive experience in identifying growing technologies and optimizing asset portfolio, Business Development and sales strategies, corporate Outsourcing, Acquisitions, Licensing, and Change Management areas. She received a Master of Chemical Engineering in 2001 from National Polytechnic Institute of Toulouse (INPT) and a Ph.D. in controlled delivery and Nanotechnology from the University of Basel and ETHZ. She is licensed PMI and IPMA Project Management Professional.

Signe Maria Christensen, Ph.D. has more than 17 years of experience with API development activities and outsourcing hereof for the pharmaceutical industry and biotech companies. Signe joined LEO Pharma in April 2011, and in her current position as Strategic Alliance Manager she is responsible for managing several R&D collaborations. 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.

I joined MMV in 2009 when I saw a unique opportunity to apply novel and exciting science to solve some real problems which will not only stop people from dying or becoming sick but can also turn their lives around and enable them to escape from poverty. I have almost nineteen years of experience in drug discovery and development gained in the  biotechnology and contract research sectors and  including six years at MMV.    Prior to joining MMV, I held positions in business development with  Paragon Biomedical, Synarc Inc., and PPD in Cambridge, UK and before that I  worked as a research and senior scientist at Cambridge Antibody Technology.   I have a Ph.D. in Immunology from the University of London and a B.Sc. in Biochemistry from the University of Glasgow. In 2014, I enrolled for a master’s degree in biomedical ethics and healthcare with the University of Leeds.

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.

TBC

Unmesh has 10 years of healthcare industry expertise, comprising of strategy consulting, primarily with global pharmaceutical companies. His particular expertise lies in market opportunity assessment, portfolio, brand, growth and go-to-market strategy.

His industry expertise lies among life sciences engagements across various therapeutic areas, leveraging relationships with key opinion leaders in sectors such as Global Pharmaceutical & Biologics Contract Outsourcing, API manufacturing in India & China, European Oncology & Diabetes market prognosis & Pharma sales force effectiveness.
He has authored thought leadership on Data Driven Solutions Transforming the Bio-pharmaceuticals Manufacturing Market,  Biologics & Biologics Contract Manufacturing, Growth Opportunities in the EU Biosimilar Market, CRO & Bio-analytical Market, Pharmaceutical Extractables and Leachables,  Cell Banking, Pharmaceutical Stability Testing and Analysis of the Global Contract Manufacturing Organization Market. In addition, he has hosted briefings with leading market participants on 'Biologics Manufacturing – Is Your Company Ready?' and 'Growth Opportunities and Disruptive Business Models Emerge in the Contract Manufacturing Organisation Market'. Unmesh holds a MSE (Biomedical Engineering) University of Michigan- Ann Arbor, MI, USA.

Karen Van de Wal is working for 4 years at Galapagos as a Senior Lead, CMC Development focusing on Drug Product development. In this role, she is responsible for the formulation development for pre-clinical and clinical studies and next to that she represents the CMC team in the cross-functional project teams for several projects, where she is responsible for determining the overall CMC development strategy.

She is a bio-engineer in cell and gene biotechnology by training (MSc) and has 12 years of experience in the pharmaceutical industry. Previously she worked for 6 years at Movetis (Shire-Movetis) as Associate Director Product Development and started her career at Janssen Pharmaceutica (J&J) where she worked for 2 years in a CMC regulatory role.   

Joslyn received her Ph.D. from Northwestern University and conducted postdoctoral research at the Dana Farber Cancer Institute.  She came to the FDA in 2009 through the Commissioner’s Fellowship Program and moved into a Product Quality review position in the Office of Biotechnology Products in 2011.  Since 2014, Joslyn has been a Product Quality Team Leader in the Office of Biotechnology Products.

Dr Ian Barker has worked at Juniper Pharma Services since 2014. Currently working as a Principal Scientist, Dr Barker leads the enabling technologies/drug delivery team at Juniper Pharma Services – a team dedicated to developing formulations that enhance bioavailability in poorly soluble compounds. Dr Barker holds a PhD in materials and synthetic organic polymer chemistry from the University of Nottingham.

Dr. Abbas Razvi is currently with Lonza as Principal Group Leader at their Drug Product Services division in Basel. Previously Dr. Razvi has worked for Novartis Pharma also in Basel. He holds a Ph.D. in Protein Biochemistry.