Attending Biotech and Pharma
Speaker Profiles
Dr Søren Bregenholt, Senior VP, Projects and Portfolio Management, ,
Symphogen
Søren Bregenholt is the Chief Operating Officer at Symphogen. Since joining the company in 2002 Søren Bregenholt has held various management positions including SVP of Project Management. He joined Symphogen from a position as Investment and Project Manager at Novo Nordisk A/S. He received his Ph.D. in immunology from University of Copenhagen and worked as a post doctoral fellow at the Pasteur Institute in Paris, France. He has solid Project Managing experience from both drug discovery and development projects.
He has published more than 45 papers in international scientific journals.
Dr Nick Lowther, Director Technical Development,
Fulcrum Pharma
Dr Lowther is Leading Technical Consultant in Fulcrum’s CMC Team. Prior to joining Fulcrum in November 2003, Dr Lowther spent over 17 years in technical R&D within big Pharma. He has particular expertise in developability assessment, active ingredient characterisation, physical form selection, pre formulation, early drug substance route/process development and manufacture, and early formulation development.
At Fulcrum, Dr Lowther has managed several ‘candidate selection to Proof of Concept’ projects for clients both in the EU and in Japan. Dr Lowther has directed technical development activities via appropriate selection and management of external suppliers of both drug substance and drug product services. He has many years experience of working at the Discovery/Development interface as well as performing technical due diligence. Dr Lowther has also worked with several clients as a technical consultant.
Dr Karsten Lindhardt, Portfolio Manager,
Egalet a/s
As a Portfolio Manager 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 CRO’s 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 Marianne Svärd, Consultant,
Skogsmollan AB
Dr. Svärd has more than 18 years of experience from the pharmaceutical industry before establishing the consultancy firm Skogsmöllan AB 5 years ago. Skogsmöllan AB is focusing on early stage pharmaceutical development and Dr Svärd has assisted several clients to bring projects from the pre-CD stage through pre-clinical development into clinical program.
Dr Svärd holds a MSc in Chemical Engineering and a PhD in Physical Chemistry /Surface and Colloid Chemistry from the Lund University, Sweden. Industrial experience includes for instance Astra Zeneca, Pharmacia and Ferring. Dr Svärd has experience from pharmaceutical and analytical development work for a number of different formulations e.g. parenteral, topical, oral and nasal formulations. Dr Svärd has special know-how in formulations for drug substances of low water solubility and poor stability.
Contact:
Dr. Marianne Svärd
Skogsmöllan AB
P.O. Box 56
SE-247 26 Veberöd, Sweden
Mobile: +46 70 528 59 87
E-mail: marianne@skogsmollan.se
Nusret Asanovski, Owner,
GXP PharmAid
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.
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 & 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.
Pauline Jäger, VP Business Development,
Avantium Technologies BV
Pauline Jäger is Vice President Business Development for Europe at Avantium. After studying Chemistry at the VU University Amsterdam, she joined the pharmaceutical industry where she has been active in various marketing and business development positions.
During her 20 years in the industry, she gained experience with several stages of drug development. She started her career at Glaxo/Glaxo Welcome, where she was involved in the marketing, sales and clinical trials of marketed drugs. Subsequently, at the Dutch research organization TNO, she was responsible for the development of contract research in preclinical pharmacology. Three years ago she joined Avantium where she is currently responsible for the business development of Solid State Research.
Dr Marcel Hogerheide, European Sales Manager,
Carbogen-Amcis AG
Born in Zeist, the Netherlands, in 1966, Marcel earned his Ph.D. in Organometallic Chemistry from Utrecht University in 1995. He then went on to work with the Netherlands Organization of Applied Scientific Research, where he set up a group in new materials development. In 2000 he joined Avantium Technologies, soon after which he took the position of VP Business Development for the Pharmaceutical Services side of the business. Since 2003 Marcel is at CARBOGEN AMCIS AG, initially as Sales Manager Northern Europe & Regional Manager Asia and currently as European Sales Manager with responsibility for the sales team that covers Europe and Asia Pacific.
Rob Maddox, President,
PharmaCore
As president of PharmaCore®, Rob Maddox strives to build strategic partnerships with pharmaceutical and chemical companies around the world in addition to overseeing general operations of the company. His focus, however, remains on the customer.
A veteran of the biotechnology industry, Maddox previously served as vice president of sales and marketing at PharmaCore® before accepting his current role in 2004. He also worked as vice president of sales and marketing at Genevac and as the western region sales manager for Advanced ChemTech.
A native Kentuckian, Maddox graduated from Centre College in Danville, KY with a Bachelor of Science in Biology.
Dr Kieron Hall, Senior Director Business Development,
Quotient Clinical
Kieron gained a degree in Biological Sciences and has over 15 years’ experience in clinical CROs and pre-clinical service providers, primarily in the field of preclinical-to-clinical ADME and early clinical drug development. He leads Quotient Clinical’s business development team across Europe.
Kieron has been Senior Director Business Development at Quotient Clinical (formerly Pharmaceutical Profiles) for two years and has overseen the uptake of an expanding portfolio of niche services within early clinical development including the ivMicrotracerTM approach and RapidFACTTM, Quotient Clinical’s accelerated make/test capability.
Mike Smallwood, Business Development Director,
Shasun Pharma Solutions
A qualified chemist attracted out of the laboratory to the dark-side of business development and management but retaining the passion for manufacturing, especially the manufacturing of speciality and pharmaceutical chemicals in Great Britain.
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.
Dr Christoph Schaffrath, Business Manager,
Saltigo GmbH
Dr Christoph Schaffrath joined Saltigo, a globally operating Custom Manufacturing Organization based in Langenfeld, Germany, in January 2007.
In his current role as Business Manager, he is responsible for developing and managing business with Emerging and Medium Size Pharma companies throughout Europe.
He gained an Engineering degree in Biotechnology and Applied Chemistry (Germany) in 1998, which was followed by a short industrial position at Analyticon AG. Christoph then undertook postgraduate studies at the Universities of Durham (England) and St. Andrews (Scotland) and completed his PhD in 2002. Between 2002 and 2007 he held positions with Stylacats Ltd (UK) and Onyx Scientific Ltd (UK); initially in a scientific role, later as Commercial Manager.
Dr Bo-Ragnar Tolf, Vice President Chemistry Managing Director,
ACADIA Pharmaceuticals AB
Bo-Ragnar Tolf, Ph.D. has served as our Vice President, Chemistry and Managing Director of ACADIA Pharmaceuticals AB since January 2001. From 1991 until joining us, Dr. Tolf held various positions at Astra, including deputy head of preclinical research in the areas of central nervous system and pain disorders at Astra Zeneca, Vice President of Preclinical Research and Development at Astra Arcus, head of Central Nervous System Preclinical R&D at Astra Arcus, and Director of the Department of Medicinal Chemistry at Astra Arcus. From 1989 to 1991, Dr. Tolf was head of the Department of Medicinal Chemistry at Kabi. From 1985 to 1989, Dr. Tolf served as Manager of Pharmaceutical R&D at Pharmacia Ophthalmics AB. Dr. Tolf completed his postdoctoral work at Stanford Research Institute and at Stanford University. Dr. Tolf received a Master of Pharmacy degree and a Ph.D. in Organic Pharmaceutical Chemistry from Uppsala University in Sweden.
Peter G Nielsen, Executive Vice President of Pharmaceutical Development and CMC ,
LifeCycle Pharma A/S
In his position as Executive Vice President of Pharmaceutical Development and CMC at LifeCycle Pharma, Peter G. Nielsen is responsible for pharmaceutical development and manufacturing activities.
Earlier in his career, Mr. Nielsen served as Corporate Vice President at Novo Nordisk A/S, where he was responsible for formulation development and clinical supplies (logistics, packaging and shipment). He also served at Novo Nordisk A/S as Vice President responsible for other CMC Development activities, including analytical and drug substance development within both biotechnology products and NCEs.
Mr. Nielsen began his career as a chemist for the Danish Ministry of the Environment and later became Manager of Analytical Development at Ferrosan.
His M.Sc. degree in Biochemistry is from the University of Copenhagen.
Dr Peter Tiffin, Director of Technical Development (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.
Jorgen Wittendorff, Vice President Pharmaceutical Drug Development,
Ferring Pharmaceuticals A/S
Jørgen Wittendorff MSc Pharm.
Vice President Pharmaceutical Drug Development, Ferring Pharmaceuticals A/S
Jørgen has more than 25 years of experience from the Pharmaceutical Industry in development of pharmaceutical drug products from selection of lead candidates to world-wide regulatory filing. He has held positions in API production, Pharmaceutical Development, Regulatory and Project Management. For the last 14 years he has been working in Ferring Pharmaceuticals.
Practically he has a wide experience in chemical synthesis, pharmaceutical formulation, scale-up and project management for NCE’s, line extensions and technical transfers.
Strategically he has been working with and introducing Life Cycle Management principles, Project and Portfolio management. Jørgen is currently working with optimisation of CMC and lean activities in Pharmaceutical R&D.
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