Attending Biotech and Pharma
Speaker Profiles
Dr Karsten Lindhardt, Senior Director for Portfolio and Alliance Management,
Egalet A/S
As Senior Director for Portfolio and Alliance Management in Egalet A/S, Denmark, I am responsible for the Project Management function in the company. I am highly interested in optimising project management and have in my work in various sizes and types of companies got an in depth understanding of the interaction between Project Manager/Project culture/ Matrix Organisation/Risk Management. I came from a position as Senior Clinical Project Manager at Curalogic A/S, Denmark and before that I was Project Director in Prosidion, UK. Here I was responsible of driving projects from Discovery into early development ensuring API upscaling (mg scale to multiple kg scale), Characterisation, Purification, Formulation, Pre-clinical and Early clinical trials using CROs and experts guidance to get two development programs into man, whereafter the programs were outlicensed to a large pharmaceutical company. Prior to that I held Clinical Pharmacogologist positions at Ferring Pharmaceuticals and Novo Nordisk A/S.
Dr Christoph Rosenbohm, Director, Chemistry & CMC,
Santaris Pharma A/S
Christoph Rosenbohm is responsible for managing the company's chemistry activities including in-house synthesis of both novel analogues and oligonucleotides, synthesis of non GMP and GMP material at CMO, analytical chemistry and project management. Is author and co-author of more than 25 scientific publications and patents. M. Sc. and Ph.D. in chemistry were obtained from the University of Southern Denmark with Prof. Jesper Wengel - one of the inventors of LNA - as a supervisor. In addition he is and MBA graduate of the Copenhagen Business School.
Markas Marriott, Associate Director, Regulatory Affairs,
Fulcrum Pharma (Europe) Ltd
Markas Marriott is Associate Director, Regulatory Affairs at Fulcrum Pharma (Europe) Limited and is responsible for pre-approval and post-approval regulatory activities and due diligence. He joined Fulcrum in February 2010 and has 17 years experience in the pharmaceutical industry. Prior to joining Fulcrum Markas worked in various positions with PwC, Shire, Baxter, Boots/Knoll, Merck Generics and SmithKline Beecham.
Markas’ expertise spans across all phases of R&D from basic research, novel paradigms to late stage clinical development and regulatory submissions. He has been involved in the development of small and large molecules as well as devices. His core areas of expertise are due diligence activities in regulatory affairs and operational management.
Prof Per-Goran Gillberg, VP Development,
Albireo Pharma AB
Per-Göran Gillberg, PhD, Professor at Neuroscience department, Uppsala University, has proven expertise and a track record of success in the Swedish pharmaceutical industry with 18 years’ experience at Pharmacia, Kabi, as well as AstraZeneca. He has industry experience covering drug discovery and development through to marketed products. He has played an instrumental role in the pre-clinical and clinical development of tolterodine, a successful product available in many markets for the treatment of urinary incontinence.
He has since February 2008 worked as Vice Precedent of Development within Albireo, which is an independent Swedish biotechnology company spun-out of AstraZeneca. Albireos is developing products for Gastrointestinal therapies.
Dr Anna Maria Tivert, CMC Consultant,
Albireo Pharma AB
Anna-Maria Tivert, Pharmacist, PhD in Analytical Pharmaceutical Chemistry from Uppsala University, have more than 25 years of experience of analytical and pharmaceutical research and development in AstraZeneca. She has industry experience covering drug discovery and development through to registration, marketing and post approval support. She now works as CMC consultant for small biotech companies like Albireo.
Dr Lena Morath, VP Pharmaceutical Innovation and Development,
Orexo AB
Lena Pereswetoff-Morath, PhD in Pharmaceutics from Uppsala University, has 15 years of experience from pharmaceutical industry. She worked several years at Astra/AstraZeneca as pharmaceutical project manager for projects in CNS and pain control therapeutic areas and represented Pharmaceutical & Analytical R&D on Global Project Teams. In 2001 Lena joined, as one of the first, the start-up company Biolipox as VP Pharmaceutical Development. She was responsible for all activity in the area of pharmaceutical and analytical development, e.g. supply of API, support to preclinical investigations, out-sourcing of analytical and pharmaceutical development and supplies of products for clinical trials and documentation for regulatory filings. Biolipox was acquired by Orexo AB in 2007. Orexo is a pharmaceutical company focused on developing new, patented drugs by combining well-documented substances with innovative technologies. When the organisations merged, Lena was set to lead the combined organisation Pharmaceutical Innovation and Development.
Dr Simon Hamilton, Business Development Manager,
Almac
Simon Hamilton has been working on business development for Almac’s chemical and analytical development services for over 2 years now; covering Northern Europe and more recently Massachusetts in the US. Prior to this Simon gained experience in drug development at Almac within a regulatory affairs position.
Simon has dealt with a range of companies from virtual biotech to mid and large sized Pharma, managing the sales process for small molecule and peptide API synthesis, biocatalysis, solid state analysis, carbon-14 radiolabelling and stand-alone analytical services.
Simon received his degree and Ph.D. in Biochemistry from Queens University Belfast; his main work involved the use of classical biochemistry techniques to monitor the modulation of cancer cell signalling pathways using cell permeable peptides.
Dr Paul Quigley, Head of Technical Solutions,
Shasun Pharma Systems
Dr. Paul Quigley is head of technical services for Shasun Pharma Solutions Ltd. Paul has over 20 years experience in the Fine Chemical and Pharmaceutical industries in a variety of senior management roles, covering Technical Management of UK Sites, and Senior Project and Operational roles within a number of international organizations including ICI, Schering Plough, Clariant and Rhodia. Paul graduated with a PhD in Natural Product Chemistry from University College Dublin in 1988 and with an MBA from Warwick Business School in 2000. He has co-authored a number of papers in the areas of Biocatalysis, Organic Synthesis, Polymer Chemistry and Natural Product Chemistry, and has generated several Patents in this area. Paul is a Member of the Royal Society of Chemistry and the Association of MBA’s.
Mrs Sonal Naik, UK and Scandinavia Sales Manager,
Carbogen Amcis AG
Sonal Naik has been working on business development for CARBOGEN AMCIS' chemical and analytical development services for over 2 years now; covering UK and more recently Scandinavia. Prior to this Sonal gained experience in pharmaceutical sales.
Sonal has dealt with a range of companies from virtual biotech to mid sized Pharma, managing the sales process for small molecules including Highly Potent APIs and peptide API synthesis, biocatalysis, solid state analysis, and stand-alone analytical services.
Sonal received her degree in Medical Biochemistry and MSc in Marketing from The University of Birmingham, UK.
Dr Jean-Paul Hermet, Business Development Manager,
Sochinaz SA
Jean-Paul Hermet joined Sochinaz in 2008 where he is in charge of promoting the custom synthesis activity of Sochinaz and of supervising projects.
Jean-Paul deals with a wide range of companies from virtual biotechs to large multinational Pharma groups, managing the sales of small molecules and Highly Potent APIs.
Jean-Paul received a Master of Chemical Engineering form the chemistry Engineering School of Marseille (France) and a Ph.D. in Organic Chemistry from the University of York in the UK.
Mr John McDermott, Director, Drug Product Optimisation,
Quotient Bioresearch
John McDermott is the Service Area Director for Drug Product Optimisation at Quotient Clinical, a strategic business unit of Quotient Bioresearch specialising in early drug development with particular focus on First-in-Human/proof of concept, 14C-enabled drug development and drug product optimisation.
After receiving his BSc in Analytical Chemistry from the University of Hull in 2000, John worked in the Pharmaceutical Analysis department at Covance, before joining Quotient Clinical, then Pharmaceutical Profiles, in 2001. After fulfilling roles in the development and validation of radiolabelling methods for solid oral dosage forms, and their subsequent manufacture for administration in clinical trials, John was appointed to his current position and now has overall responsibility for the development of the Drug Product Optimisation service, ensuring that the service develops in line with the requirements of the pharmaceutical industry.
Dr Elisabeth Vang Carstensen, Director Pharmaceutical Operations,
TopoTarget A/S
Elisabeth joined TopoTarget A/S in 2000 and was among the first employees of the company. Her first position was as Head of Synthetic Chemistry and until recently, she held the position as Head of Quality Assurance. Since 2005, Elisabeth has been responsible for CMC at TopoTarget, latest as Director, Pharmaceutical Operations. She was part of the successful registration of the products Savene in Europe and Totect in the US and is currently working on preparing the CMC of TopoTarget's future product, Belinostat, for an NDA filing. Elisabeth Vang Carstensen received a Master of Chemical Engineering and a Ph.D. in Organic Chemistry from the Technical University of Denmark.
Dr Signe Maria Christensen, CMC Coordinator,
NeuroSearch A/S
Signe Maria Christensen, Ph.D. has ten years of experience with chemical synthesis, scale-up and outsourcing for pharmaceutical industry and biotech companies. Signe joined NeuroSearch A/S in April 2007, and in her position as CMC Coordinator she is responsible for coordination and outsourcing of CMC activities related to development and manufacturing of drug substance and drug product. Before joining NeuroSearch, Signe has held a position as Development Chemist at Novo Nordisk and as Research Scientist with Santaris Pharma. Signe received a Master of Chemical Engineering and a Ph.D. in Organic Chemistry from the Technical University of Denmark.
Prof Graham Buckton, CEO,
Pharmaterials Ltd
Professor of Pharmaceutics, School of Pharmacy, University of London
Graham Buckton graduated with a BPharm degree from Chelsea College London in 1981. He obtained his PhD from King’s College London in 1985 and was awarded the degree of Doctor of Science by the University of London in 1997, for “Materials characterisation of importance to drug delivery”.
Professor Buckton is a fellow of the Royal Pharmaceutical Society, Royal Society of Chemistry, AAPS and APSGB. He joined the staff of King’s College London as lecturer in pharmacy in 1984. In 1989 he moved to the School of Pharmacy, University of London where he progressed through the positions of Lecturer, Senior Lecturer, Reader and Professor and was the Head of Department and Professor of Pharmaceutics. He is Chief Executive Officer of Pharmaterials Ltd which is the contract research company that he founded in 2001.
He retains a research group at the School of Pharmacy, University of London. The research relates to the amorphous state, powder processing, surface science, solid oral dosage forms, inhalation drug delivery and modified release dosage forms. He has published a book and over 175 papers on these themes. He has received the Pfizer Award, the British Pharmaceutical Conference Science Medal and the Stig Sunner Award (for “outstanding work in Thermochemistry and Thermal Analysis” from the US Calorimetry Conference). He
• Has just ended a 10 year term as Editor of the International Journal of Pharmaceutics and has recently served, on the editorial boards of Pharmaceutical Research, The AAPS Journal and the steering committee for the Excipients Handbook.
• Was the first Chairman of the Academy of Pharmaceutical Sciences of GB and a past Chairman of the Pharmaceutical Sciences Group of the Royal Pharmaceutical Society of Great Britain,
• Was past Chairman of the Chemistry, Pharmacy and Standards sub-committee of the Committee on Safety of Medicines and a member of the CSM, is a member of the CPS TAG of the Commission on Human Medicines.
• Was Science Chairman of the British Pharmaceutical Conference 2003.
• Is a British Pharmacopoeia Commissioner
Dr Paul Brian Little, Director Chemistry, Manufacturing and Controls,
7TM Pharma A/S
Paul Little has been working in Medicon Valley at 7TM Pharma for almost a decade, firstly in drug discovery and then taking our first preclinical candidate into development. We have since progressed a trio of projects into clinical development up to phase IIa. At 7TM Pharma we focus on developing our pipeline of clinical assets forward with a primary therapeutic focus in obesity, related metabolic diseases and gastrointestinal diseases. Our pipeline contains peptides and small molecules.
Dr Peter Tiffin, Director Technical Operations (CMC),
Fulcrum Pharma
Dr Tiffin is Director of Technical Development and responsible for chemistry, manufacturing and controls (CMC). He joined Fulcrum in June 2008 and has 15 years experience in the pharmaceutical industry. Prior to joining Fulcrum Dr. Tiffin worked in various positions with Chiroscience, Roche, Phytopharm and Sosei.
During this time Dr Tiffin has led the chemical development of processes for the manufacture of active ingredients both by chemical synthesis and extraction form natural products. He has extensive experience in the field of solid-state properties and early formulation development.
Dr Tiffin has extensive experience in CMC project management and the preparation of dossiers for regulatory submissions. He is the inventor of 9 patents.
Dr Hans Lindner, Head Global Pharmaceutical Development,
Bayer Schering Pharma AG
Dr. Hans Lindner is Head of Global Pharmaceutical Development in Bayer Schering Pharma. It is the central function for formulation, analytical and process development located in Berlin, Germany.
Hans is a pharmacist by training with a doctorate degree in pharmaceutical technology from university of Kiel. He started his industrial career as formulation scientist at Arzneimittelwerk Dresden GmbH, Germany, and became later group leader of the process transfer team. In 1996 he joined Ferring Pharmaceuticals, heading a formulation team in Germany. Later, he became head of formulation teams in Sweden, Denmark and Germany. In 2001 he took over responsibility for the consolidated pharmaceutical development function, joining it in the Ferring Development Center in Copenhagen. In 2004 Hans moved to Schwarz Pharma, Germany, leading the pharmaceutical development organisation. After the merger with UCB S.A. in 2007 he headed Drug Product Development & Industrialisation in Belgium until he joined BSP in 2008. Hans is member of the editorial board of the European Journal of Pharmaceutics and Biopharmaceutics, member of various professional associations and past vice president of the European Association Pharma Biotechnology (EAPB).
Dr Martin Roland Jensen, CEO,
CytoVac A/S
Martin Roland Jensen is the CEO of CytoVac A/S and executive Chairman of ExpreS2ion Biotechnologies. CytoVac develops live cell based cancer vaccines and is clinically testing a novel T-cell receptor based prostate cancer therapy.Expres2ion Bio. provides a novel S2 insect cell based technology for manufacturing complex recombinant proteins for therapeutic ad diagnostic purposes. MRJ's background and education is in molecular and celluar biology and he has almost 20 years experience in commercial Biotech and Pharmaceutical companies. MRJ has worked in various positions both as project manager and development head, as well as the founder and developer of new biotechnology companies. As such he has a wide experience with coordination and outsourcing CMC activities both as customer and as the service provider.
Dr Anne Bondgaard Tolstrup, Director Antibody Expresssion,
Symphogen
Anne B. Tolstrup holds the position as Director for Symphogens Antibody Expression department. Here, her focus is cell line development and manufacturing of recombinant antibodies, including recombinant polyclonal antibodies, a new class of therapeutics that Symphogen has brought into clinical development.
Anne has 20 years experience with mammalian cell cultivation and has worked on multiple drug discovery and development projects. She has extensive experience in collaborating with CMOs and CROs.
Anne holds a Ph.D. in Molecular and Cell Biology from the University of Aarhus, where she worked as associate professor with HIV-research before shifting to the biotech industry.
Prior to joining Symphogen, Anne worked with drug discovery in the Danish biotech companies Inoxell and Pharmexa, holding positions as Director and Project Manager 1997-2003.
Dr Andreas Castan, Director Upstream Development,
Biovitrum AB
Andreas Castan is Director Upstream Development at Biovitrum AB. After studying chemical engineering at the Technische Universität Hamburg-Harburg (TUHH), he received a Ph.D. in Biochemical Engineering at the Royal Institute of Technology (KTH), Stockholm. His research was focused on the characterization and scale-up of processes for the production of recombinant therapeutic proteins in high cell density cultures. At Biovitrum, his group is focused on expression system development, process development of microbial and mammalian cell based processes and scale-up to c-GMP manufacturing scale. During the last 15 years, Andreas has been working in various positions in the company including project and line management as well as manufacturing.
Dr Torben Lund Hansen, Owner,
Lund Hansen Consulting ApS
Master of Science in Biochemistry and PhD in human genetics. Worked at Novo Nordisk for 16 years with NovoSeven™ in Development, Manufacturing ,Process Development and international project management. Joined Maxygen, a Danish American biotech company in 2000 as Director for CMC. From 2002 VP for manufacturing at Genmab responsible for outsourcing all CMC activities. Later appointed SVP and responsible for the manufacturing facility in Minnesota US and global quality. In 2009 founded Lund-Hansen Consulting ApS, an international CMC consulting company.
Mr Philip Hansen, Owner,
CMC Consult Aps
Philip Hansen, MSc (pharm.) has a long and broad industrial product development background from biotech (Pharmexa) and from the pharmaceutical industry (Leo Pharma and Novo Nordisk). Since CMC Consult Aps was founded in 2007, he has as consultant delivered his services to a large number of early phase development projects; the tasks have involved small molecules, peptides, proteins and nucleotides; formulated for parenteral, topical and oral use - and the customer list includes biotech, medical device, health care, food ingredient and pharmaceutical companies.
Dr Michael Becker, Head of Marketing & Communication, Product Manager Solid-State Development,
Solvias AG
Michael received his PhD at the Max-Planck-Institute for Solid-State Development in Stuttgart, Germany and joined Solvias AG in January 2001. He started as Key Account Manager in the Marketing and Sales Department, responsible for selling the whole of the Solvias product portfolio. After developing the Scandinavian market he was appointed Head of Business Development. Since November 2007 he has been Product Manager for Solid-State Development activities and Head of Marketing & Communication.
In addition to his scientific expertise in Solid-State Development of drug substances, Michael has a broad range of experience in the marketing and business development of the full range of Solvias’ services for drug development.
Eva Balslev Jorgensen, BioPharma Account Manager,
Novozymes
As BioPharma Account Manager at Novozymes A/S, Eva is responsible for the sales of products and technologies to companies across the biopharmaceutical value chain, from drug discovery & development through biomanufacturing to drug formulation and delivery.
Eva holds a Master of Science degree within biochemical engineering and have worked at Universitàt Autònoma de Barcelona within the field of optimizing monoclonal antibody production with mammalian cell cultures.
For 15 years, Eva has worked in a variety of operational functions within life sciences such as R&D, production, QC/QA, sales & marketing, and representing the companies Novozymes A/S, Foss A/S, Medi-Cult A/S and Life Technologies A/S she has participated in a range of international professional organizations.
Dr Roman Hlodan, Biopharmaceutical Specliast,
Patheon Inc
Roman Hlodan, PhD. joined Patheon in July 2004 as Biopharmaceutical Section Manager and was appointed to his current position of Biopharmaceutical Specialist in November 2009. Prior to Patheon, Roman worked for 6 years, as a Senior Scientist, at Cambridge Antibody Technology. His career also includes positions within Cobra Therapeutics and various academic research positions in both the UK and US. Roman holds a PhD. in Biochemistry from University of Newcastle upon Tyne and is both the author and co-author of numerous scientific papers in the field of Biopharmaceuticals and protein chemistry.
Dr John Fox, Chief Development Officer,
Merrion Pharmaceuticals Ltd.
Dr Fox has over 20 years experience in the pharmaceutical industry. He joined Merrion from Hunter Fleming where he served as Chief Operating Officer and was responsible for pharmaceutical development of new medicines, regulatory compliance, valuations, portfolio planning and IP maintenance. He was also responsible for representing their development portfolio to potential investors and licensees.
Prior to the formation of Hunter Fleming, Dr Fox held a variety of senior positions for Shire Pharmaceuticals. As Group Planning Director he covered planning and new project evaluation for constituent companies within Shire and was responsible for project implementation in the United States, Europe and Japan.
Dr Fox holds a PhD and BSc in Biochemistry from Queens University Belfast as well as an MBA in Information Flows in Pharmaceutical Drug Research from Henley Management College. He has published several clinical pharmacology papers and abstracts and is a member of the Royal Society of Medicine and the Drug Information Society.
Niels Johansen, Senior Director, Vaccine Research and Discovery,
ALK
Since 2007 Niels Johansen is heading the Vaccine Research & Discovery function at ALK-Abelló. It is the function in R&D working with basic research and early discoveries within the allergic disease covering: New treatment concepts, translational research and vaccine mode-of-action, protein chemistry, drug delivery, analytical chemistry, and experimental immunology and biomarker discovery.
Niels holds a M.Sc. degree in Chemical Engineering and has more than twenty years of international experience from pharmaceutical industry and medical device industry from previous positions as R&D Specialist, Director of Product Development and Director of Diagnostic Business Unit in ALK.
He is member of the Board of Directors in Medical Prognosis Institute A/S.
Dr Jesper Valbjoern, Director, CMC Operations,
Genmab A/S
Jesper Valbjørn 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 15 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 Per Edebrink, Principal Scientist,
RecipharmCobra Biologics
Dr Per Edebrink is Principal Scientist at RecipharmCobra Biologics, a Contract Development and Manufacturing Organisation (CDMO) in the Recipharm group. In 1995, he finished a PhD in Organic Chemistry focused on studies on complex carbohydrate structures by mass spectrometry and NMR spectroscopy. Afterwards he joined AstraZeneca where he held positions as team manager and Associate Principal Scientist within pharmaceutical and analytical research and development working with characterisation of small molecule pharmaceuticals and protein biopharmaceuticals. In 2006, he joined the BioProcess R&D organisation of AstraZeneca where he continued working with the characterisation of protein biopharmaceuticals from in-house and external sources. Since 2009, he is responsible for characterisation and comparability studies of proteins biopharmaceuticals at RecipharmCobra Biologics, Södertälje, Sweden.
Dr Nusret Asanowski, Owner,
GxP PharmAid ApS
Nusret Asanovski is a M.Sc. in Pharmacy and has experience from the pharmaceutical industry where he has worked with sterile and non-sterile production and quality assurance of different dosage forms.
He has furthermore years of experience from a position as Medicines Inspector with the Danish Medicines Agency (DMA). His responsibility was to inspected Danish as well as international pharmaceutical companies.
In 2003 Nusret Asanovski started his own GMP consultancy company, GXP PharmAid that today supports the pharmaceutical industry with quality establishment, improvement and maintenance of:
- Quality Systems
- Qualifications & Validations
- Qualified Person
- Training
- Audits
GXP PharmAid has helped several companies to achieve a manufacturing authorization from DMA.
Mr Jesper Sonne Johansen, Senior CMC Project Manager,
Novo Nordisk A/S
Professional experience record at Novo Nordisk A/S
Senior CMC Project Manager: Head Chemistry, Manufacturing and Control development core team. Change management project of technology development in R&D, Development and Production. Development of a new device for Growth hormone and development of a new matrice for NovoSeven production.
Production Coordinator: Coordination of production of all new products in Biopharmaceuticals, including establishment of strategies and manufacturing, overview of product capacity and economy related to new products. Member of CMC core teams in related development projects. Project Manager for production of a MAb, and establishment of a new analytical department.
Department Manager: Manager of two support departments employing a total of 45 FTE´s, responsible for setting directions, budgets, support activities and development documentation. Member of Glucagon Product Committee (LCM), Human Growth Hormone Product Committee (LCM) and NovoSeven Product Committee (LCM).
Chemist: Support to the API production. Registration of a new API. Member of CMC coregroups on NovoSeven, Human Growth Hormone and Glucagon.
Product specialist: Marketing biotechnology products, incl. Protein- and molecular biology technologies.
Education: University of Copenhagen, Denmark; 1993 MSc. Biology
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