<p>Biotech Outsourcing Strategies <em>cmc</em> 2015 &nbsp; &nbsp; &nbsp;&nbsp;</p>

Pepijn Bink is part of Roche’s pharma technical development organization and is managing the external development and manufacturing of its small molecule clinical pipeline.

He has 18 years of experience in the pharmaceutical development and supply, leading process development, transfer and scale-up activities in all phases between phase 1 and commercial product launch. He worked for MSD, Xendo, Actelion and in between as a consultant for biotech start-ups and bigger innovator companies, gaining ample experience in working with technical partners, like CMO’s and medical device companies, before moving to Roche.

He received his MSc in pharmaceutical technology from the University of Groningen (NL) and has an MBA from Melbourne business school (AUS) & UCLA Anderson (USA).

Antonio Giordani received his degree in Organic Chemistry from University of Pavia and his PhD from Polytechnic of Milan in 1989, where he specialized in stereospecific synthesis. After working as medicinal chemist in major pharmaceutical companies such as Beecham and FarmitaliaCarloErba, he joined the API group of Pharmacia Co in ‘97, formerly as Director of Process Development Labs and later as Project Leader within API Global Supply & Technology Management Group, where he coordinated the development of several drugs. In 2003 he joined Rottapharm, a privately-owned Italian company. Recently the R&D group became Rottapharm Biotech, where he coordinates the Drug Development activities, including Process and Analytical Development and Solid State Studies.

Dr. Richard Dennett is responsible for the management of projects involving the development of Chemistry Manufacturing and Control (CMC).

He provides scientific, technical and regulatory expertise for the following activities:

• Quality by Design (QbD), Technology Transfer/Comparability, cGMP compliance/validation, Technical due diligence and gap analysis, identification and project management of outsource cGMP contract manufacture
• Preparation and review of regulatory documentation (CMC sections of IND and IMPD for clinical trials applications and MAA, BLA/IND Module 3 and 2.3 submissions).

Richard brings over 20 years applied industrial and commercial biopharmaceutical experience to his role, with a previous 8 years in cGMP Biopharmaceutical Contract Development and Manufacture; 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. 

Richard has worked on a number international projects involving successful ‘start to finish’ recombinant drug product development, cGMP manufacture and market approval. Richard has significant experience with cGMP facility design and realization; including interfacing project management for the construction and validation of a €30M, UK Government funded ‘National Biomanufacturing Centre’, Liverpool, UK (now a biologics subsidiary of Actavis Plc.).  He has additional expertise in technology transfer of intellectual property and the commercialization of new start-up companies and therefore readily understands the challenges for emerging biotech and early stage biopharmaceutical development.

Richard has held key role positions at companies which include Eden Biodesign, Celltech Medeva, Automation Partnership, Sheffield University, AstraZeneca.

With a Ph.D. research grounding in applied biochemistry, obtained at Liverpool John Moores University (UK), matched with his industrial technical background, Richard is able to provide cross matched technical and regulatory expertise; being able to readily understand and translate the needs of the client to deliver focused and successful projects.

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.

Dr. Frederik Beck has more than 20 years of experience from pharmaceutical and biotech companies. He is the CMC outsourcing manager at Zealand Pharma and has held this position for the past four years and has successfully completed 2 IMPD’s for two new chemical entities. As CMC outsourcing manager Dr. Beck is responsible for the outsourcing of all activities relating to clinical trials, both DS and DP. Prior to joining Zealand Pharma Dr. Beck worked for CMC Biologics as Project Director and as scientist/ project manager at Hexal. Dr. Beck received a Master of Chemical Engineering in 1992 from the Technical University of Denmark and an industrial Ph.D. from the University of Copenhagen in collaboration with DAKO A/S in 1999.

An experienced pharmaceutical external manufacturing leader who believes that perceptive partnering is a critical skill and has developed partnering methodologies to aid success of virtual and CMO organizations. With over 20+ years of proven success at Eli Lilly & Co in the manufacturing, supply and distribution of medicines and drug devices, Miriam has used her knowledge and experience to improve the overall business of partnering. Miriam recently led the External manufacturing drug product business at Lilly, responsible for identifying and implementing the manufacturing of new and existing products at more than 20 CMOs in Europe, Africa and Asia.

Rob Harris has over 30 years of experience in the pharmaceutical industry, having held senior technical positions with Warner Lambert, GSK and with CDMO’s such as Quay Pharma and Penn Pharma. He has also worked in academia, having spent 5 years as a Research Fellow at the University of Manchester. Rob is currently Chief Technical Officer with Juniper Pharma Services, where he is responsible for directing the pharmaceutical development strategy within the company.

Simon Hamilton has worked in Business Development at Almac for 7yrs years; with responsibility for chemical and analytical development services (Almac Sciences) during this time.  He has worked in various regions including the UK, Scandinavia and the East/West Coast of the US – and is now responsible for European sales team. Before entering a career in Business Development, Simon spent two years as a Regulatory Affairs executive at Almac and conducted his degree/PhD in Biochemistry at Queen’s University Belfast.

I represent LGC's rapidly expanding Drug Development Services.  I work closely with our customers to enhance their research and development, manufacturing and quality assurance activities through the provision of regulatory compliant analytical services.

Utilising LGC’s capabilities and expertise we support clinical trials and Pharmaceutical product development, to help our customers develop new drugs and ensure the safety of drugs on the market.

I have worked within worked within the pharmaceutical industry at contract manufacturing organisations and contract research organisations for 15 years in a range of technical and commercial roles since completing my degree in Analytical Chemistry.

Alexandra Pichard Nielsen has more than 15 years of experience with sales and business development in the pharmaceutical industry. Alexandra joined Cambrex in August 2003 and in her position as Sales & Business Development Director, she is responsible for business development in the northern part of Europe. Prior to Cambrex, Alexandra held a position as Key Account Manager at Atofina.

A short abstract of the presentation (Title: Quality, Speed, Flexibility and Customer Focus - An Introduction to Cambrex).  Partnership and communication are key to success in the outsourcing environment.

Cambrex is presenting a case study illustrating the dynamics in the partnership between the client and Cambrex, with the overall objective to secure tight deadlines and to obtain a successful project execution.

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]

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

Andrew is the Group Leader for the Analytical Sciences group at Ipsen Bioinnovation (formly Syntaxin), within the Pharmaceutical Sciences department.  The team is responsible for development of analytical methods and non-GxP testing of biological APIs and in-process samples, during early drug discovery through to early development.  

Andrew joined Syntaxin in 2012 as a Senior Scientist, with the primary role of managing outsourced analytical validation and testing, and became Group Leader in 2013.  Prior to Syntaxin Andrew worked in the CRO and CMO industry as an analyst and study director at Covance, and as a team leader at Patheon.  In these roles he has developed, performed and validated a wide variety of methods for biological drug substances and drug products at all stages of drug development.  Andrew studied Biological Chemistry and received his Ph.D. in Biochemistry at the University of Sheffield (J. Waltho).

Aiala Lorente-Trigos is Bioprocess R&D 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.

Colas Swalus was born in Belgium in 1986. After a Bachelor’s degree in Bioengineering and Chemistry, he received his Master's degree in Nanobiotechnology and Materials Science from the Université Catholique de Louvain (UCL) in Louvain-la-Neuve (Belgium) in 2009.

He then joined Prof. Gaigneaux's heterogeneous catalysis group at the Institute of Condensed Matter and Nanosciences (IMCN) where his initial work focused on CO2 methanation for environmental applications. His Ph.D. in Nanotechnology was oriented towards the development of new polymers and hybrid organic/ inorganic nanomaterials for liquid heterogeneous alkene epoxidation.

Finally, after a training in management at the ICHEC Brussels Management School, he started working as a Business Development Manager at Quality Assistance in October 2014.

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

Andrew Carver is the Senior Commercial Manger at FUJIFILM Diosynth, a full service CDMO that manufactures recombinant biologics and has GMP manufacturing facilities in Billingham UK, Research Triangle Park, USA and a Vaccine Manufacturing facility in College Station, Texas.

Andrew is based in the UK and works with small biotech companies as well as midsize companies and large Pharma organisations to align and develop client programmes that are suitable for early phase clinical manufacture and robust enough for scale-up, late phase manufacture and commercial launch.

Andrew has 25 years of experience working in the Biotechnology, Medical Devices and Life Science sectors developing, commercialising and licensing product and product opportunities. Andrew’s commercial experience began at PPL Therapeutics developing the company’s transgenic animal programmes and from there in-licensing, OEM manufacture and acquisitions in the medical device sector before moving to Angel Biotechnology, a CMO in the regenerative medicine space and now FUJIFILM Diosynth a recombinant biologics manufacturer.

For the past three years I have worked within LGC's rapidly expanding Drug Development Services division initially as a Principal Scientist and now as the Head of CMC in the UK.  As a leading independent provider of analytical testing services and reference materials to the pharmaceutical and healthcare industries, LGC work strategically with our customers to support their research and development, quality assurance and regulatory activities.

Prior to LGC, I worked as a Senior Scientist for Pfizer Global R&D (13 years) providing significant contribution to drug development teams as analytical team leader for projects at varying stages of development.  These projects were delivered through extensive knowledge of own subject area (Analytical Chemistry/Physical Properties) and wide understanding of the pharmaceutical R&D process.  By  maintaining effective partnerships with colleagues in Pharmaceutical Sciences, Clinical Sciences, Regulatory CMC, Legal and Manufacturing ensured key milestones for clinical studies, regulatory submissions and commercial milestones were met.

My education has been completed in parallel with my career through day release or distance learning; BSc in Chemistry, MSc in Pharmaceutical Sciences concluding with an MBA.

Since January 2015, Nico has been working for Patheon as Account Executive, responsible for Southern Germany and Austria regions. He has more than 17 years of sales, business development and marketing experience within the pharmaceutical & chemical industry.

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. Petra Wicklandt, Vice President, Global Head of Chemical & Pharmaceutical Development, Merck, Darmstadt 

Dr. Petra Wicklandt currently acts as Vice President, Global Head of Chemical & Pharmaceutical Development. She is responsible for chemical process development, formulation and analytical development, clinical trial supply and regulatory CMC documents. Her responsibility includes early discovery phases, development and life cycle management activities and transfer to production. Between May 1994 and now Petra has held various roles within Merck both in R&D and in pharmaceutical production. Before Merck, Petra also acted as a scientist in the Medical/Scientific Information Department at DuPont Pharma. Petra´s educational background includes a Degree in Pharmacy and a PhD from the Johannes Gutenberg University, Mainz.

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.

Ian is a biochemist who after initially working in a variety of roles for SmithKline Beecham moved into project management. Ian has more than 20 years of project and programme management experience spanning all phases of product development. This has been gained within varied organisational structures spanning large pharmaceutical company, pharmaceutical service companies, contract research organisations and the virtual pharmaceutical biotech environment. He now splits his time between working for Destiny Pharma Ltd., a clinical phase UK based biotech company and providing consultancy services, IPHarmaConsult Limited.

Paul Madeley, Ph.D., is an organic chemist with over thirty years’ experience of chemical synthesis. He has worked for three large companies (Boots, Courtaulds and Abbott Laboratories) and two biotech companies (British Biotech and OSI Pharmaceuticals) before setting up his consultancy company, Synth-Isis Ltd. Dr. Madeley has worked on over one hundred projects, comprising more than six hundred individual reaction steps; at scales ranging from a few grams to several metric tonnes.

In 1995, having worked as a pilot plant manager for five years with Abbott Laboratories, Dr. Madeley moved to virtual pharma and has been responsible for outsourcing more than two hundred manufacturing contracts. This involved development of template agreements and site visits for technical appraisal of potential manufacturers. He has visited more than fifty manufacturing sites in Europe and the US. He has acted as the CMC technical lead for a number of due diligence meetings on behalf of clients on more than twenty occasions; in which he presented the technical package for the API to potential investors. He has also undertaken due diligence examinations of potential in-licensing opportunities. Since setting up Synth-Isis Ltd in 2004, Dr. Madeley has worked with over twenty small biotech and emerging pharma companies, together with a number of service companies, and has prepared the chemistry sections of seventeen IMPDs and three INDs. This has included technical oversight of manufacture of the APIs.

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.

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.

Jacques-Alexis Funel is Technical Project Leader within Technical Operations at Actelion (Allschwil, Switzerland) reporting to the head of Drug Substance Operations.
For each project in his portfolio, he is responsible for the development of the API manufacturing process coordinating technical and business relations with external partners (CMO/CRO).  For each assigned project, as leader of the CMC  team (Chemistry Manufacturing Control), he acts as supply chain responsible, accountable for quality and regulatory aspects dealing with small molecules candidates for clinical phase I onwards to and including commercialization.

Trained as an Engineer (ENSTA, Paris, France), he holds a PhD in organic chemistry (from Ecole Polytechnique, Paris) with post-doctoral training in Germany. He started his professional carrier at Actelion in 2006 as laboratory head within the Process Research Chemistry group. Appointed Associate Director, Senior Lab Head in 2012, he moved to his current position within Technical Operations in 2014.

Since December 2013, Emmanuel has been leading Novartis global Supplier Performance & Innovation strategy for Warehousing & Distribution, across all Novartis divisions.

Prior to his current position, he held progressive strategic sourcing roles in a wide array of companies (from medium businesses to niche consulting firms and large multi-entity corporations), across various industry verticals (telecommunications, consumer products, healthcare & life sciences, automotive and management consulting) and through a broad scope of direct and indirect sourcing categories (logistics, professional services, IT, marketing and media...).

In 2007, after completing two Masters degrees in Global Sourcing and Supply Management, Emmanuel relocated to Montreal, Canada, where he joined Novartis 3 years later. In 2013, he successfully led the deployment of the first-ever Vested Outsourcing partnership in the pharmaceutical industry worldwide. As he currently pursues his career in global procurement in Europe, Emmanuel keeps challenging the way Business Value is perceived, triggered and recognized in today’s organizations through solution-focused category management, cross-functional partnering, sophisticated outsourcing models, breakthrough innovation and highly collaborative supplier relationships.

Certified Purchasing Professional by the “Compagnie des Dirigeants et Acheteurs de France” in 2005, Emmanuel has also been certified as Vested Deal Architect by the University of Tennessee in 2014, as well as FORTH Innovation facilitator the same year.

Dr Dawn Toronto, PhD, has 18 years of international Pharmaceutical Development experience gained from leadership and technical positions at both contract manufacturing organizations and in pharmaceutical industry.  She is the founder of CMCPlus, a consulting firm that specializes in the area of CMC, regulatory affairs and supplier compliance for small pharmaceutical companies entering into clinical development.  She has been involved in the development of over 40 clinical candidates, covering a variety of indications, including oncology therapies and theranostics. Dr Toronto received her PhD in Chemistry in 1994 from University of California Davis.

Organic chemist by education (Milan & Montreal), he accumulates more 25 years of industrial experience in large (Pharmacia; BMS), medium size (Sigma-tau & Antibioticos) and small (Dipharma, Indena) companies. During his career he covered several positions in drug discovery (medicinal chemistry and combichem), preclinical development, DS & DP Process R&D,  and Quality & Compliance. He published >150 patents & publications and a book “From Bench to Market” byOUP. The actual position is VP of API R&D at Fresenius-kabi.

David Bryde is a Professor in Project Management at Liverpool John Moores University, UK. He has a PhD in project management, is a Member of the Project Management Institute (PMI) in the US and of the Association of Project Management (APM) in the UK.  David is interested in aspects of project management from both management sciences, social sciences and psychological perspectives.  He has published widely in journals, books and monographs and has presented his research at numerous international conferences.  With his co-researcher Roger Joby, a widely experienced practitioner in clinical research, David has undertaken extensive study of the management of clinical trials.  For example, in 2014/15 David and Roger were recipients of funding from the APM for a study of different levels of project success of outsourced clinical trial projects in comparison to outsourced construction projects, using agency theory as a theoretical lens for the investigation.  The results of this research project form part of the presentation given at the conference by Professor Bryde – on behalf of himself and Roger.  David and Roger are also co-authors, with Jake Holloway, of the forthcoming book “A Practical Guide to Dealing with Difficult Stakeholders”, which is scheduled for publication by Gower in August 2015.

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

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

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

Nicolaas Schipper has a more than 20 years of experience from the pharmaceutical industry. He started his career at Pharmacia & Upjohn in 1995. He then joined AstraZeneca in 1998 where he worked until 2012. At AstraZeneca he has had different positions from team leader for the early pharmaceutical characterization and formulation of new drug candidate to project leader for the process development of API and finally he became project leader for pharmaceutical development for new drug candidate up to launch phase project. Since 2013 Nicolaas is a section manager at SP Process Development and he is in charge of GMP manufacture.

Noel has a PhD in Chemistry from Queen’s University Belfast and twelve years’ experience in the pharmaceutical industry, acting as a solid state consultant on for the manufacture of drug substance and drug product. He is currently leading the Physical Sciences group within Almac, delivering crystallisation development, polymorph/salt & cocrystal screening and analytical projects to clients for the last six years. Previous roles in Almac, Avecia and NPIL encompass process development and technology transfer of pharmaceutical processes to third parties in UK, Europe and India.

James is a graduate Chemist with over eighteen years’ experience in the pharmaceutical industry. His expertise relates to the development and commercialisation of drug products, specifically solid oral dose and inhalation products. He is currently a member of the senior management team within the Product Development Services department of Almac managing a department of scientists and supporting client partners in the development of drug products, production of IMPs and commercialisation of new and generic medicines. Having held previous roles within both large Pharma and contract development he has experienced both perspectives in the partnership between client company and contract organisation.