<p>Biotech Outsourcing Strategies <em>cmc</em>, Copenhagen, 2014</p>

Attending Biotech and Pharma

Attending Biotech and Pharma logo and links

Speaker Profiles - Small Molecule Stream

Dr Rene Holm, Divisional Director, Biologics and Pharmaceutical Science,
Lundbeck A/S
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René Holm received his pharmaceutical training at the Royal Danish Schoolof Pharmacy, now the school of pharmacy at the University of Copenhagen, Denmark, in 1998 and his PhD in biopharmaceutics from the same institution in 2002.  Dr Holm joined Lundbeck in 2001, and worked within pharmaceutical development, formulations for non-clinical testing in drug discovery, physical chemistry and material science and is now divisional director for the functional unit responsible the CMC development of biological development, pharmaceutical research and preformulation, ie in practice tasks from drug discovery, over-development and troubleshooting in production.

Dr Holm is (co-)author of more than 70 original articles in peer-reviewed journals and patents in the field of biopharmaceutics and preformulation.  Furthernmore, Dr Holm is an Adjunct Associate Professor in Drug Delivery at the Faculty of Health and Medical Sciences, Copenhagen University.

Read Abstract...

Formulation Strategies for Low Soluble Drugs - an overview

René Holm, Biologics and Pharmaceutical Science, H.Lundbeck A/S, Ottiliavej 9, DK-2500 Valby, Denmark

A large proportion of new chemical entities (NCE) entering drug development possess insufficient aqueous solubility to allow sufficient and consistent absorption from conventional pharmaceutical formulation systems. This have lead to the development of a number of different pharmaceutical enabling technologies including salt formation, size reduction of NCE, stabilization of nanoparticles, complexation with cyclodextrins, solid solutions, liquid filled capsules etc.. These drug delivery systems either increase the dissolution rate or present the compound in a solubilised form, thereby circumventing the dissolution step. The different technologies will be discussion based upon the industrial considerations related to the individual method.

Dr Christoph Rosenbohm, Senior Director - Research Operations,
Santaris Pharma A/S
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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.

He is author and co-author of than 30 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 supervisor. In addition he is an MBA graduate of the Copenhagen Business School.

Alex Robertson, Director, Sourcing,
AstraZeneca
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Alex trained as a Chemist and has 26 years experience in the Pharmaceutical industry in a wide variety of roles.

Alex spent the initial part of his career as a process development chemist working on wide range of projects from early development through to technology transfer and commercial establishment. During this period he also worked in pilot plant chemical manufacturing.

He has experience in project management and setting up and managing global commercial stability programmes.

For a significant period Alex worked in a number of quality roles in both commercial and R&D environments.  His experience in quality ranges from managing QC laboratories, Quality Management of commercial API manufacture, QA support of investigational medicinal products and Quality Management of API supply to development.

Currently Alex is managing the Pharmaceutical Development Sourcing group in AstraZeneca which has responsibility for managing all development ‘CMC’ external activities from API raw material through to packaging and distribution of investigational products as well as external scientific and technology work.

Dr Martin Schubert, Director & Head of Chemical Pharmaceutical Development,
UCB Pharma SA
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Martin Schubert is Director and Head of Chemical Pharmaceutical Development at UCB Pharma SA based in Braine L’Alleud, Belgium. After his PhD in Pharmaceutical Technology, Martin started to work in pharmaceutical companies in 2004, specifically in pharmaceutical manufacturing and development, focusing on drug product development activities throughout the entire compound life cycle from candidate selection to early/late clinical phases, up to market launch and line extensions. He is accountable for the pharmaceutical development of finished dosage forms with the required quality and productivity, coordination of DP development and supply activities, and responsible for ensuring state-of-the-art results in small molecule formulation and process design and development from laboratory up to commercial manufacturing.

Dr Kaspar van den Dries, R&D Director,
Patheon
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Kaspar van den Dries, Ph.D., is R&D Director at Patheon.  Kaspar has master degree in Pharmaceutical Sciences (University of Utrecht, the Netherlands), and a PhD degree on high shear granulation.  Kaspar has spent a significant part of his career solving formulation and process challenges in solid dosage forms for, amongst others, poorly soluble compounds at Organon, Schering-Plough and Merck. In addition, he was the global CMC project lead for the development, registration and commercialization of one of the late stage projects. This project was also selected as a pilot for quality-by-design, which included the implementation of quality risks management on in-line NIR blend control in commercial production.

Read Abstract...

•    General overview of gelatin based delivery technologies in softgels and associated benefits
•    What if your molecule is brick dust?; showcase of improving bioavailability with softgels
•    What if you want to improve consumer satisfaction?; showcase for chewable softgel formulation

Dr Marcel Hogerheide, Head of Business Development, Europe & Asia Pacific,
Hovione
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Marcel Hogerheide earned his Ph.D. in the area of organometallic chemistry. After initially working in the area of hybrid coatings, he has held various Sales and Business Development positions with service providers to the Pharmaceutical industry for the last 14 years. He joined Hovione in 2011 as Sr. Business Development Manager, with a focus on new business development in Europe and Japan. He is currently Head of Business Development, Europe & Asia Pacific.

Mr Maarten van Geffen, Vice President CMC, Operations & Quality,
Amakem Therapeutics NV
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Maarten van Geffen’s career in the industry spans nearly 25 years, with substantial experience in pharmaceutical product development and regulatory affairs. Maarten was previously Director of Product Development at Shire-Movetis NV, where he was responsible for the pharmaceutical development of the GI early and late phase products and was the CMC lead for due diligence of early phase and late phase small and large molecule products. While at the Company, Maarten also played a pivotal role in the strategic development of commercial and pipeline products as well as carrying out quality control on dossiers and interacting with regulatory authorities. 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 partpharmaceutical dossiers for the Dutch Health and Environmental agency. Mr. van Geffen received an MSc in Biology from the University of Utrecht, the Netherlands.  

Dr Jérôme Detreille, Senior Director New Business Development,
Penn Pharma
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Jerome is the Senior Director of New Business Development at Penn Pharma. Appointed in April 2012. Jerome has over 15 years’ experience in selling services for both conventional and highly potent drugs covering all dosage forms from oral solid dose and drug delivery platforms to sterile injectables. Jerome has held a number of senior positions and prior to joining the Executive Team at Penn Pharma, he worked at Catalent Pharma Solutions as Head of European Sales and Business Development.

Dr Alexander Straetz, Sales Manager,
CARBOGEN AMCIS AG
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Dr Alexander Strätz is Sales Manager at Switzerland-based CARBOGEN AMCIS, a Dishman Group Company.  He holds a Ph.D. in metallorganic chemistry from the University of Cologne, where he focused on developing new platinum complexes as precursor for chemical vapor deposition (CVD) processes.

Alexander’s strong functional expertise on GMP production and validation of APIs and intermediates is further built on more than 10 years working within the pharmaceutical and chemical industry. Prior to joining CARBOGEN AMCIS, Alexander worked as a Business Development Manager for the Group Novasep SAS where he gained hands-on experience on custom development and manufacturing of APIs and Highly Potent APIs (HPAPIs) and chromatography. Previous assignments also include several positions in the sales Organization of Acros Organics (Thermo Fisher Scientific).

In his role as Sales Manager at CARBOGEN AMCIS, Alexander is responsible for business development in Scandinavia, The Netherlands and Eastern Europe and focuses on the coordination of CMC activities related to API and HPAPIs development and manufacturing on customers’ behalf.

Read Abstract...

CARBOGEN AMCIS is a leading chemistry service provider offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries at all stages of drug development and commercial manufacture. Core competencies are centered around drug substance and drug product supply for preclinical, clinical and commercial applications.

Providing a project based approach on purification, CARBOGEN AMCIS runs large scale preparative chromatography units as well as a dedicated laboratory for the development of crystallization processes.

Regarding chromatography, CARBOGEN AMCIS offers preparative chromatography from 1 to 45cm ID allowing for quantities of purified material of up to 30 Kg/day. For binary systems like separation of racemates, CARBOGEN AMCIS has two SMB units operating in continuous mode and at low solvent consumption.

In addition, CARBOGEN AMCIS offers crystallization services in its dedicated laboratory led by Kurt Vögtli, featuring salt and polymorphism screening as well as crystallization development as part of CARBOGEN AMCIS’ services offering.

If you want to learn more about our capabilities and services, attend our show case during the small molecule track entitled: “Chromatography vs. Crystallization – Purifying your API” held by Dr. Alexander Strätz, as well as Kurt Vögtli’s presentation “What Physico-Chemical Data is Needed to Develop an API into a Drug Product?” on the pre-event Workshop or visit us at our booth # 6 !

Sören Olsson, Director, New Products,
Cambrex Karlskoga
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Mr Sören Olsson has been with Cambrex for 34 years. Over this period, he has held the position as Manager R&D Analysis for 15 years and Project Leader Strategic Projects for two years. Since 2003, Sören has been the Director R&D New Products with primary responsibility for project management. Prior work experience includes time with Billerud as a Chemical Engineer.

Read Abstract...

Globally, Cambrex offers a variety of technology-driven products and services that accelerate the development of small molecule therapeutics from custom development to commercial manufacturing, including high potency and controlled substance APIs, and drug intermediates. Our commitment to quality, safety and regulatory compliance allows Cambrex to seamlessly support our clients’ API needs from clinical trials through commercial launch. Cambrex Charles City and Cambrex Karlskoga have recently expanded their facilities to provide additional cGMP API manufacturing capabilities for both existing and new products.

Dr Ian Walker, Head of Project Leadership,
Acacia Pharma Ltd
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Ian is currently Head of Project Leadership at Acacia Pharma Ltd, a virtual company focussed upon cancer supportive care. Ian joined Acacia from Sosei R&D where he was Development Group Head and was responsible for leading several programmes through to commercialisation, including AD237 for COPD and AD923 for cancer breakthrough pain.  He gained B. Pharm and PhD degrees from the University of Nottingham, and has significant global development experience gained with a range of pharmaceutical companies, including Reckitt and Colman, Ethical Pharmaceuticals, Quadrant Healthcare, Arakis and Sosei. 

Andrew Maitland, Business Development Manager, Drug Development Services,
LGC
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Andrew is a Business Development Manager within Drug Development Services at LGC. He has over 10 years of business development experience selling contract analytical and manufacturing services. His particular area of expertise lies in pharmaceutical drug development and pre-clinical and clinical development, along with experience of regulatory requirements of cGMP, GLP and GCP. As well as his role in business development, Andrew is an analytical chemistry graduate with laboratory expertise.

Speaker Profiles - Biologics Stream

Dr Ulrich Rumenapp, Contract Manufacturing Biotech, Head Biotech Projects,
Bayer Pharma AG
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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 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]

Jesper Valbjorn, Vice President, CMC Operations,
Genmab A/S
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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 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 Mary Reilly, VP Pharma Development & Operations,
Opsona Therapeutics
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Mary Reilly joined the Opsona management team in March 2005 to head up the pharmaceutical development of its pre-clinical candidates.

Her role is to direct the development of lead compounds from discovery through pharmaceutical development including chemistry, manufacturing and controls (CMC) and their progression into the clinic.

She has extensive experience in drug development from late-stage discovery to registration and approval of products at all stages of the development cycle within Europe and the USA.

Before joining Opsona she worked for 15 years with Elan Pharmaceuticals where she was Associate Director and Project Leader for development projects. She also has experience in parenteral sterile drug development, manufacture and registration.

Mary Reilly currently oversees programme management, pharmaceutical and clinical development and operational activities. She has QP qualifications in line with EU clinical directive 2001/20/EC.

 

Dr Rikke Morkeberg, Director, Drug Development,
Alk Abello
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Rikke Mørkeberg is Director of Drug 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.

Dr Amer Alghabban, Dr Amer Alghabban, Global Director Research & Development and Good Vigilance Practice Quality Assurance,
Abbott Pharmaceuticals Operations
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Amer completed his M.Sc in Pharmacology at Bradford University, Postgraduate studies in Medical Sciences at University College Hospital, Diploma in Biological Sciences from Salford University & Postgraduate Certificate in Clinical Research from Surrey University.  

Amer is a frequently invited speaker at international congresses and has presented and chaired at over 47 international congresses. He has over 23 years track record in the pharmaceutical industry (Clinical Development, Quality Assurance, Pharmacovigilance, Medical Information, & Medical Communications). For some time, he was the Assistant Editor for 11 Medical & Pharmaceutical journals. He contributed further to these disciplines by writing “The Pharmaceutical Medicine Dictionary” in April 2001 and “The Dictionary of Pharmacovigilance” in May 2004. He is currently writing his 3rd book, Dictionary of Clinical & Pharmaceutical Development.

Amer is currently the Global Head of GCP & GVP Quality Assurance at Acino Pharma AG. Prior to his current role, he was Director, Global Head of Quality Assurance & Audit Management at Merck Serono, Geneva, Switzerland. His previous positions include: Global Head of GxP (GCP, GMP, GLP and GPP) Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Auditor at Novartis Pharma Headquarters in Switzerland and he was the first Pharmacovigilance Compliance Coordinator of the Medicines and Healthcare products Regulatory Agency (MHRA).

In these roles, Amer conducted a vast number of audits including a spectrum of GCP, Pharmacovigilance, Clinical Laboratories, GLP, GCLP, GMP, Vendor, Protocol, Clinical Study Reports, Due Diligence, Fraud investigation and Databases audits. He is certified as a Lead Auditor by the International Register of Certified Auditors.

He served as an Executive Committee Member of International Society of Pharmacovigilance (ISoP) and the Good Pharmacovigilance Practice Committee of the British Association of Research Quality Assurance (BARQA), and is a member of the Society of Pharmaceutical Medicine, Associate of the Institute of Quality Assurance (IQA), DIA, Member of the Association of Clinical Research Professional (ACRP), and the Organization for Professions in the Regulatory Affairs (OPRA).


Read Abstract...

Ensuring the right match between your company and your Partner - strategies to ensure a productive partnership (due diligence/selection strategies/vendor collaboration management)

•        Identifying the “best mix” of the right partners: selection criteria
•        Partnership governance
•        Challenges/frequently identified issues
•        Vendor oversight (from macro management to collaboration)
•        Auditing your suppliers - working in partnership for more effective results: a win-win situation

As the pharma industry continues to become increasingly competitive, it has never been more important for companies to focus on what they do well, and outsource where provides a perfect business opportunity to focus on their own strengths. As the ultimate legal responsibility for the product quality lies on the sponsor/contractor, it’s critical to conduct outsourcing very carefully.

Prof Rolf G Werner, Professorship for Industrial Biotechnology,
Eberhard Karls University of Tübingen
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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.

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India has a regulatory environment enabling a fast track to market development for biopharmaceuticals. Large graduate pool from academia and technical schools enables growing skilled labor. Competitive investment and labor cost as well as high quality standards provides access also to markets outside India. Preclinical and clinical development can be achieved in less than 30 month. A number of countries accept Indian data for registration. Options for international companies are to build own subsidiaries or use qualified CROs and CMOs with international quality standards and take full advantage of economic drug development and manufacturing in India. But CROs and CMOs in India are confronted with concerns on protection of IP and confidential information of their customers, on robustness of the Indian legal regime and on enforcement practices. However India’s Intellectual Property laws and statutes cover every significant aspect of the protection of IP in accordance with the international standards as required by the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Intellectual property is enforced in India by bringing actions in the civil courts or through criminal prosecution. Patent law in India is governed by the Indian Patents Act, 1970. Protection of data such as confidential information and trade secrets is governed by Information Technology Act, 2000 (IT Act), Indian Penal Code, 1860 (IPC) and The Indian Contract Act, 1870 (ICA).

The CROs and CMOs supplement the protection afforded by the Indian legal framework with several internal measures, precautions and safeguards of its own interest at preventing any unauthorized leakage of valuable information and data by CROs and CMO’s employees as well as third party vendors. As selection criteria for contract service organizations several performance criteria have to be considered. Thorough background checks conducted on all employees with past employers before hiring of employees. All employees, vendors and service providers sign Confidentiality and Assignment Agreements upon the formalization of their employment with CROs or CMOs. Secured Access Control for all buildings with restricted access to employees based on need and designation of employee. Employee access to data and internet restricted by role and responsibility. Access to emails restricted and ability to send emails to an external email address is given to authorized users only. Upon termination of engagement, employee is obliged to immediately surrender to the Company any and all items that constitute or contain confidential information or relate to intellectual property. The CROs or CMOs have to treat every breach with the utmost seriousness and where a breach comes to the attention of the management, measures have to be undertaken. In conclusion the current Indian legal framework is sufficiently robust, substantively and procedurally prepared to effectively protect CROs and CMOs Clients’ data. The internal security measures undertaken by CROs and CMOs supplement the legal framework and provide an additional, difficult to penetrate layer of protection to CROs and CMOs Clients’ data.

Cory Pigeon, Business Development Director,
Gallus BioPharmaceuticals LLC
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Cory Pigeon joined Gallus in 2012 as Director of Business Development with responsibility for establishing and maintaining client relationships with early to late phase pharma and biotech companies in the US and Europe.  
 
Cory has 15 years of experience within the biopharma industry with positions in sales, marketing, business development, and commercial leadership at ProMetic BioSciences, Catalent Pharma Solutions, and Wave Biotech/GE.  He is experienced with the development and use of single-use bioreactors and bioprocessing systems in the biopharma industry.
 
Cory holds a B.S. in Biology and an MBA with the University of Phoenix. 

Dr Gittan Gelius, Principal Scientist,
Cobra Biologics
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Gittan Gelius works as a Scientific Lead and Team Leader at Cobra Biologics’ mammalian protein production facility in Sweden. She has  previously worked with cell line development using Cobra’s MaxXpress system and in her current role leads the Bioassay Analytical team tasked with the set up and qualification of cell based potency assays. Gittan has a background in Cell and Molecular Biology and a PhD. from the Karolinska Institute in Stockholm.

Read Abstract...

Title  Monoclonal antibody process development and manufacture 

Abstract

Accelerated time lines are crucial in drug development programs, from cell line development to production of material for clinical trials.

During cell line and fermentation development, evaluation of cell culture media, additives and feeds, as well as optimization of process parameters and their combined effect on product quality must be measured and understood. These studies are multi-factorial, extensive and can be both time consuming and expensive. 

This presentation shows how a microbioreactor system can be used in cell line and upstream development to define product quality attributes early in the program and to address the challenge to produce product of the correct quality and potency faster.

 

Dr Daniel Ozanne, Senior Commercial Development Manager,
Fujifilm Diosynth Biotechnologies
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Dr Ozanne, MBA joined FUJIFILM Diosynth Biotechnologies in August 2011 as Senior Commercial Development Manager.  His territory covers UK & Ireland, Scandinavia and Israel. Prior to that he was with Catalent.

Dr Annika Shirley, New Business Development Director,
Patheon
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After gaining a degree in Biomedical Sciences and specializing in Neuropharmacology, Annika has held a number of technical and commercial roles in the pharmaceutical cluster of DSM, first in the generics division of DSM and later in DSM Biologics.

During the 13 years at DSM (now Patheon), Annika has gained a deep understanding managing large pharma accounts and business development activities in both small and large molecule drug substance. In addition, Annika held a central role in the forward integration of DSM into licensing of finished dosage dossiers, both centrally active in the dossier development/ acquisition and subsequently in licensing activities in both the US and EU markets.

Annika has also numerous years of experience in technology licensing in various fields. Through the various roles held by Annika, she has had the opportunity to be conduct business deals in Europe, Asia, the US and Latin America.

Annika currently holds the position of New Business Development Director Europe at Patheon Biologics in which her primary role is to engage and secure new business contracts with new and existing clients for both CMO activities and technology licensing.

Speaker Profiles - Session Chair

Eva Iden, Owner,
Better and Beyond AB
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Eva Idén has 22 years’ experience in the Pharma industry covering all aspects of Operations from internal manufacturing, external sourcing, strategic supply chain design and management, launch of new products as well as Operations leadership. She has been with AstraZeneca (e.g Global Supply Director, Head of UK Operations, Head of external supply API) and Orexo (Chief Operating Officer). Today she is running her own consultancy business focusing on helping companies improve their performance, strategic alignment and leadership capabilities.

Kim Hejnaes, CEO,
Hejnaes Consult
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Kim Ry Hejnaes (M. Sc. in Biochemistry from University of Copenhagen) has worked in the biopharmaceutical industry for more than 35 years as a protein chemistry principal scientist, project director, chief operating officer and chief executive officer hereof 20 years with Novo Nordisk and 5 years with CMC Biologics. Kim Hejnaes is the co- founder of L&K Biosciences, SMC Biotech, Hejnaes Consult, help4biotech and invest4biotech and serves as an adjunct professor in Biotechnology at University of Aalborg, Denmark.

Since 1998, Kim Hejnaes has focused on outsourcing aspects of Chemistry, Manufacturing and Control (CMC) operations with involvement in a substantial number of international biotech projects over the years.

Stephan Christgau, Investment Director,
Novo Seeds
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Stephan joined Novo A/S in September 2007 as Investment Director of Novo Seeds.

Stephan obtained his MSc degree from the Technical University of Denmark in 1988 and his PhD degree in 1992 from the Technical University of Denmark, for a project in diabetes immunology, conducted at Hagedorn Research Institute and University of California, San Francisco.

Prior to joining Novo Seeds, Stephan was Executive Vice President and Chief Operating Officer at Osteologix where he played a leading role in the development of the company, taking the lead candidate drug through all stages from lead identification to Phase II testing for osteoporosis treatment. He also played an active role in the company’s financing including a public listing in the USA on the OTC exchange through a reverse merger with a public shell company. Previously Stephan has worked in the metabolic bone disease and arthritis areas in Nordic Bioscience and Osteometer Biotech and as a protein chemist in Novo Nordisk A/S.

Stephan serves on the Board of Directors of Adenium Biotech ApS, Aros Pharma ApS, Forendo Pharma OY, Galecto Biotech AB and Inagen ApS. He also serves as chairman for VentureCup, a non-profit entrepreneurship organization.

 

 

 

Dr Stephan Christgau, Investment Director,
Novo Seeds
Dr Signe Maria Christensen, R&D Outsourcing Manager,
Leo Pharma A/S
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Signe Maria Christensen, Ph.D. has more than 13 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 R&D Outsourcing Manager she is responsible for outsourcing of CMC activities up until phase III. 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.

Dr Hasse Kromann, Head of Partnership Management, Research & Innovation,
Leo Pharma A/S
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Hasse Kromann is currently Head of R&D Partnership Management, Research and Innovation at LEO Pharma A/S in Ballerup, Denmark. In his current role he is leading a team of outsourcing and alliance managers supporting LEO’s chemical and biological research, pre-clinical as well as CMC/API departments. Hasse has over 10 years industry experience in outsourcing and partnering and he holds an MBA from Copenhagen Business School and a PhD in Medicinal Chemistry from the Royal School of Pharmacy in Copenhagen.

Speaker Profiles - Plenary

Dr Paul Little, Senior VP CMC,
InsuSense ApS
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Paul Little is Director of CMC and Preclinical Development at Orphazyme ApS. Orphazyme develops innovative new therapies for the treatment of a family of serious genetic disorders called lysosomal storage diseases. The company was founded in June 2009. Orphazyme is based on discoveries emerging from the academic laboratory of its scientific founders: Professor Marja Jäättela and Thomas Kirkegaard Jensen. Their pioneering work on the cytoprotective properties of human heat shock proteins provides a novel and paradigm-changing approach to developing medicines for the treatment lysosomal storage diseases. Previously Little has over ten years of experience progressing a number of small molecule and peptide projects from discovery to phase II clinical development. From 2008 to 2011 Director of Chemistry, Manufacturing & Controls, at 7TM Pharma A/S. Little holds a PhD, in Benzyne Chemistry from Cardiff University, and was postdoctoral fellow in natural product total synthesis at Nottingham University.

Dr Signe Maria Christensen, R&D Outsourcing Manager,
Leo Pharma A/S
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Signe Maria Christensen, Ph.D. has more than 13 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 R&D Outsourcing Manager she is responsible for outsourcing of CMC activities up until phase III. 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.

Dr Juergen Stichler, Director, Group Leader Drug Substance Operations,
Actelion Pharmaceuticals
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Starting his industrial career in 1999, Jürgen - who holds a PhD from ETH-Zurich - has worked for Lonza, Roche and DSM before joining Actelion's Drug Substance Operations group end 2006. Since January 2013 he is heading the group, responsible for the technical development, manufacturing and outsourcing of all clinical development and marketed compounds. Jürgen has expertise in synthetic organic chemistry, chemical process development, GMP manufacturing, project management, CMC management, tech-transfer and outsourcing.

Speaker Profiles - Workshop

Dr Gerry Steele, Managing Director, ,
PharmaCryst Consulting Ltd
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Gerry Steele BSc, MSc, PhD, CChem FRSC, CEng MIChemE, MAPS

 

Gerry holds a BSc (Hons) degree in Chemistry, an MSc in Applied Colloid and Interface Science and was awarded a PhD for research into colloidal drug delivery agents from the Pharmacy Dept. of the University of Strathclyde, Glasgow.  After a further year as a research associate investigating the physical chemistry of drug-membrane interactions, he joined the pharmaceutical industry and worked for 25 years at the Loughborough site of Fisons, Astra Charnwood and latterly, AstraZeneca. During this time he worked in the Preformulation area of Pharmaceutical and Analytical R&D (1985-2002) and the Process Engineering section of Process R&D (2002-2011).  The preformulation studies involved the physicochemical characterisation of candidate drug molecules and their salts.  As one of AZs Principal Scientists in Process Engineering, he led a team that concentrated on the development, scale up and trouble-shooting of crystallisation processes. After taking early retirement due to the Loughborough site closure, he set up PharmaCryst Consulting Ltd and now consults regularly with a number of innovator and generic companies in his areas of expertise. Gerry is a Fellow of the Royal Society of Chemistry, a Member of the Institution of Chemical Engineers and a Member of the Academy of Pharmaceutical Sciences. He is also a Visiting Professor to the Pharmacy Dept. of the University of Strathclyde and the Dept. of Chemical Engineering, Loughborough University. 

Kurt Vögtli, Scientific Specialist,
CARBOGEN AMCIS AG
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Kurt Vögtli works as a scientific specialist for CARBOGEN AMCIS.

He studied chemistry at the University of Applied Sciences (FHBB) in Muttenz and finished his master thesis on Combinatorial Chemistry before starting at CARBOGEN AMCIS in 2001 as a project chemist working hands on the projects from bench to > 50 kg scale.

In 2007 Kurt was entrusted to set up a crystallisation laboratory at the CARBOGEN AMCIS Aarau site implementing processes tailored for crystallisation, which he is heading today.

The services provided are: crystallisation screening and development, polymorphism and salt screenings but also consulting of customers and fellow workers.

Over the past seven years, Kurt and his group have acquired a profound experience in a broad range of crystallisation technologies leading to the successful development of several straightforward crystallisation processes.

Kurt Vögtli is of Swiss nationality and lives near CARBOGEN AMCIS’ Hunzenschwil (Neuland) facility.

 

Dr Noel Hamill, Investigator, Physical Sciences Group,
Almac Sciences
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Following a PhD in chemistry from Queens University Belfast, Noel has spent twelve years in various roles in the pharmaceutical industry encompassing technology transfer, process development, crystallisation science, physical organic chemistry and reaction engineering. Currently, Noel leads the Almac Physical Sciences Group (offering services in crystallisation development, solid form screening and characterisation, method development and validation) and advises clients on solid state issues (e.g. form selection and control, scale-up and interpretation of experimental data) in the manufacture of drug substance and drug product.

 

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