Regulatory

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    Diamond Pharma Services has extensive experience in assisting companies to navigate thr...

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    Sometimes there is sound logic for a pharmaceutical company to outsource a significant ...

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    Meet our experienced team of regulatory and product development specialists. Each member of our team is personally selected to compliment one another and to offer different backgrounds and skill sets.

    Dr. Maureen Graham
    Managing Director, Diamond BioPharm Ltd

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    Dr Graham has over 25 years experience within the industry and previously held roles within Glaxo, MSD, IVAX & Amgen. Maureen most notably held the position of Director of European Regulatory Affairs in her tenure at Amgen and is widely recognised within the industry. Maureen is the founder of Diamond and her aim when setting up the company in 2005 was to provide a complete service for clients whilst allowing highly qualified, committed staff to express themselves on the industry.

    Dr. Maureen Graham<br />Managing Director, Diamond BioPharm Ltd

    Nick Littlebury
    Deputy Managing Director

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    Nicholas Littlebury is the Deputy Managing Director at Diamond BioPharm Ltd, consulting across a variety of European projects from initial concept to post approval, covering full lifecycle management across Centralised, MRP, DCP and National procedures for NCE’s and Generics. International experience includes Asia Specific, Japan and Emerging Markets.

    In previous roles he has built up a breadth of European and International experience from working in small, medium & global pharmaceutical environments in organisations including Teva, GlaxoSmithKline and the Medicines and Healthcare Products Regulatory Agency (MHRA).

    Nicholas is also a member of the Organisation for professionals in Regulatory Affairs (TOPRA).

    Nick Littlebury<br />Deputy Managing Director

    Dr. Antony Appleyard
    Technical Director

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    Dr Antony Appleyard is the Technical Director at Diamond BioPharm Ltd. and has over 15 years experience in pharmaceutical and biotechnology R&D. Antony provides drug development support to clients for CMC, non-clinical and clinical projects for new chemical entities and biologics. Services include technical project management, coordination of CMO/CRO interactions and regulatory dossier planning, preparation and submission. In addition he has provided interim Development Director support for clients.

    Prior to joining Diamond Antony was Associate Director of Natural Products Chemistry at Novacta Biosystems and Cantab Biopharmaceuticals where he also held the development positions of CMC Lead and Head of Analysis for antibacterial programmes. Preceding Novacta, he was a Purification Team Leader at Abbott Laboratories in Dartford where he managed the technology transfer of MAb processes from US to UK sites. He was awarded a degree in Chemistry with honours and a Ph.D. in Biochemistry at the University of Leeds, and carried out post-doctoral research in the Departments of Chemistry and Biochemistry at the University of Cambridge.

    Antony is a Fellow of the Royal Society of Chemistry, a Chartered Chemist and a member of TOPRA.

    Dr. Antony Appleyard<br />Technical Director

    Carl Barker
    Head of Finance & Administration

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    Carl joined Diamond BioPharm in October 2013 as General Establishment Manager and is a qualified accounts technician with over 10 years experience in practice. Carl provides the platform for our team of professionals to concentrate on our client’s needs together with ensuring that the day to day business needs are maintained at the highest standards.

    Carl has developed the required skills to work within different environments having previously worked within the retail/telesales sector where he held a number of positions from accounts to sales and operation positions. Carl is a member of the team ensuring Diamond’s continued growth is managed productively and effectively together the financial and commercial challenges.

    Carl Barker<br />Head of Finance & Administration

    Sean Russell
    Global Regulatory Affairs Director

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    Sean is the Global Regulatory Affairs Director of Diamond BioPharm Ltd, providing EU regulatory advice and operational expertise to clients, through all stages of the development and approval process as well as having responsibility for the growth of the US team and delivery of regulatory expertise for the US. Sean offers a wealth of knowledge in all areas of regulatory affairs across a diverse range of products including small molecules and biologics, but predominantly leads projects involving novel biologics and advanced therapy medicinal products (ATMPs), especially gene and cell therapies.

    In addition to project based activities, Sean has undertaken a number of interim positions for his clients, including Global Regulatory Lead for radiopharmaceutical products and Regulatory Compliance Manager for gene therapy products.

    Sean is also a member of the Diamond BioPharm Senior Management Team, promoting growth and excellence throughout the company. Sean undertakes regular business development activities, connecting clients with experienced professionals to promote commercial success.

    Prior to joining Diamond, Sean worked for Teva Pharmaceuticals Europe and 3M Healthcare, giving him a solid foundation of regulatory operations, regulatory compliance, and product development.

    Sean Russell<br />Global Regulatory Affairs Director

    Lena Demetre
    Senior Business Development Manager

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    Lena Demetre is Senior Business Development Manager at Diamond BioPharm Ltd with a cross department responsibility into Diamond PV Services Ltd. Lena has 13 years experience within the pharmaceutical arena covering a broad client and sector base.

    Lena is the primary contact for new business enquiries and is responsible for developing future business and marketing activities in line with Diamond’s five year growth plan. Lena also hold responsibility for new proposal and contract negotiations on behalf of Diamond and works with both UK based and global organisations.

    Prior to joining Diamond, Lena gained a wealth of industry experience encompassing multiple industry sectors. Lena’s pharmaceutical career started with an eight year stint as a Clinical Trials Project Manager with the AmerisourceBergen Group where she managed the needs and expectations of Clinical Trials clients working with a number of National, International and Multinational Pharmaceutical and Healthcare companies including WHO and Cancer UK Ltd. developing bespoke trial specific packaging ensuring design met the integrity of the trial. Lena then moved into the Generic Development sector and was responsible for out-licensing business activities covering S.E. Asia with support function into Far East and Middle East for Athens based developer and manufacturer Pharmathen. More recently, Lena was Business Development Manager for Panacea Pharma Projects responsible for generating UK and European business.

    Lena Demetre<br />Senior Business Development Manager

    Dr. Nancy Markovitz
    Director, Regulatory Affairs

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    Broadly-trained biomedical scientist with 14 years experience in regulatory affairs across all sectors of the industry: FDA/CBER, a top 5 global biopharmaceutical company, and a global Clinical Research Organization (CRO). Regulatory experience backed by more than 20 years basic and applied research, most recently investigated safety (non-clinical) and molecular characterization of oncolytic and gene therapy vectors for disorders of the CNS. Energized by teamwork focused on solving novel technical regulatory challenges related to innovative biologic product development.

    • As Regulatory Affairs CMC Subject Matter Expert (SME), provided strategic advice on biotechnology product development and lifecycle strategies, focusing on regulatory compliance, safety, comparability and potency assays for ATMPs (cell therapy, gene therapy, and tissue-based products), cancer and oncolytic vaccines, monoclonal antibodies, therapeutic proteins, peptides, siRNAs, Request for Designations (RFDs);
    • Experienced in post licensure changes for BLAs including biologic/ device combination products;
    • Routinely performed gap analysis of Module 3 CTD regulatory dossiers for biologics INDs to identify regulatory risks and remediation strategies;
    • Served as FDA contact for pre-INDs, INDs, BLAs/NDAs, FDA Type II meetings;
    • Represented Regulatory Affairs CMC function on due diligence teams for in-licensing of cutting edge biologics;
    • INN/ USAN – Initiated and prepared company appeal resulting in a more favourable gene therapy non-proprietary name.

    Dr. Nancy Markovitz<br/>Director, Regulatory Affairs

    Mark Abel
    Head of Regulatory Affairs

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    Mark is the Head of Regulatory Affairs at Diamond BioPharm Ltd specialising in providing full life-cycle support and advice on generic product development and EU Marketing Authorisation applications.

    Prior to joining Diamond Mark was employed, in increasingly senior roles, in the regulatory functions of GSK, Mylan and Glenmark Pharmaceuticals. Mark has managed regulatory groups in both Mylan and Glenmark providing advice and support in a range of areas including submission strategy, dossier preparation, due-diligence activities and post-approval maintenance activities on a range of therapeutic products authorised via National, MRP, DCP and centrally approved procedures.

    Mark was awarded a degree in Genetics with honours from the University of Nottingham and a PhD in Genetics and Molecular Biology from the University of Liverpool and is also a member of TOPRA.

    Mark Abel<br/>Head of Regulatory Affairs

    Alison Malcom
    Senior Regulatory Affairs Manager

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    Alison Malcolm is a Senior Regulatory Affairs Manager at Diamond where she provides support to clients through all stages of the development process, in particular, clinical trial applications, MAAs and licence maintenance.

    Alison has over 20 years experience in the pharmaceutical industry, from early phase research through to the licencing of medicinal products. Prior to joining Diamond Alison was employed in the regulatory affairs functions of Amgen and Mylan where she gained broad experience in regulatory affairs and built a solid knowledgebase of regulatory procedures and guidelines. At Amgen Alison managed the clinical trial activities for several oncology development products within the EU and ROW, while compiling regulatory landscape documents to facilitate End of Phase 2 decisions. In her time at Mylan, Alison was involved in full life-cycle activities for generic products authorised by DCP, MRP or national authorisation, including defining submission strategy and preparing for product launch.

    Before moving into regulatory affairs, Alison spent many years within research and development at GSK and legacy companies. In this time she was involved in a wide variety of early phase projects, including the identification of ligands for orphan receptors cloned as part of the Human Genome Project. Alison was Team Leader of a group involved in the development of cell based assays for recombinant protein targets. She was also Project Leader for several multi-disciplinary research teams, defining strategy and resource requirements to enable early targets and molecules to progress through the drug discovery process.

    Alison possesses a joint honours degree in Biochemistry and Pharmacology and is a member of TOPRA.

    Alison Malcom<br />Senior Regulatory Affairs Manager

    Andy Lau
    Regulatory Affairs Manager

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    Andy Lau is a Regulatory Affairs Manager at Diamond BioPharm Ltd. and has over ten years’ experience in Regulatory Affairs. Andy provides strategic and authoring support to clients for CMC and clinical projects, specialising in providing regulatory support for large pharmaceutical companies. His most notable activities involve post-approval maintenance for established products including active pharmaceutical ingredient and finished product manufacturing site transfers, CMC harmonisation activities and variations. He has extensive experience of regulatory submission planning and project co-ordination.

    Andy was awarded a degree in Pharmacy from the School of Pharmacy, University of London and an MSc in Medical Informatics from King’s College, University of London.

    Andy is a qualified pharmacist, registered with the General Pharmaceutical Council, with involvement and knowledge in community, hospital and industrial pharmacy. He is also a Member of the Royal Pharmaceutical Society of Great Britain and a member of TOPRA.

    Andy Lau<br />Regulatory Affairs Manager

    Dr. Stuart Beattie
    Regulatory Product Development Manager

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    Stuart is a Regulatory Product Development Manager at Diamond BioPharm Ltd., providing regulatory support and advice for advanced therapy investigational medicinal products (ATIMPs) especially gene and cell therapies.

    Stuart has 18 years’ experience working within the field of gene therapy in both academia and industry, with extensive experience developing recombinant gene transfer vectors based on adeno-associated virus (AAV).

    Prior to joining Diamond, he developed gene therapies for inherited retinal blinding disorders at The Institute of Ophthalmology, University College London. This involved the optimisation of AAV vector components to translate proof-of-concept studies to clinical trial for congenital Achromatopsia. Stuart was responsible for the assessment of patient immunological responses to AAV2-RPE65 vector, as part of PhI/II trial for gene therapy for Lebers Congenital Amaurosis type II. Stuart directed an AAV vector production laboratory and developed improved methods to purify and characterise AAV.

    From 2008 to 2012, Stuart was a Research Scientist at Amsterdam Molecular Therapeutics (now UniQure) and developed Liver-based AAV therapeutics including those for Acute Intermittent Porphyria and Haemophilias B and A. Stuart led the AAV integration/episomal maintenance (safety) studies as part of application for market authorisation of Alipogene Tiparvovec, Glybera®, to the EMA (approved by the European Commission November 2012).

    He was awarded a degree in Biotechnology with honours at the University of Surrey and a Ph.D. in Biochemistry at Royal Holloway University of London, developing potential gene therapies for dyslipidaemias.

    Stuart was a post-doctoral Research Fellow in the laboratory of Professor Terry Flotte at the University of Florida, developing AAV therapeutics to treat alpha1-antitrypsin deficiency and disorders of fatty acid oxidation. Continuing this research, he was then a Faculty member at at the University of Massachusetts Medical School.

    Dr. Stuart Beattie<br/>Regulatory Product Development Manager

    Roberta Gubbings
    Finance Manager

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    Roberta is employed as Accounts Manager for all companies falling under the Diamond Pharma Services umbrella.

    Roberta spent over 30 years working within the banking sector within a number of different roles before moving into an accounts focused role.

    Her responsibilities range from the day to day accounting responsibilities of maintaining Sales & Purchase Ledgers.

    Roberta Gubbings<br />Finance Manager

    Sharon Campbell
    Regulatory Affairs, Associate Manager

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    Sharon Campbell is a Senior Regulatory Officer at Diamond BioPharm Ltd and has over 14 years experience in pharmaceuticial R&D. Sharon provides Regulatory Support to clients for Post Authorisation activities for National, MRP and Centralised Procedures. Services include project Management, variation preparation and submission, SME applications, and specialises in Linguistic Reviews, Labelling, User Testing and eCTD publishing.

    Prior to joining Diamond Sharon was a Regulatory Associate at Eisai, in the Neurosciences Therapy area and at GSK, previously SmithKline Beecham in Project Management and later in Clinical in the Neurosciences Therapy area. Sharon is a member of TOPRA and has attended CRED TROPRA training for SPC/Labelling/Leaflets, Regulatory Affairs, Medical Devices and eCTD and at the MHRA received training on the MHRA Portal and Bromi submissions.

    Sharon Campbell<br />Regulatory Affairs, Associate Manager

    Petrina Pearce
    Regulatory Affairs, Associate Manager

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    Petrina Pearce is a Regulatory Affairs, Associate Manager at Diamond where she predominantly provides support to clients for licensing and post licensing activities for National, MRP/DCP and Centralised Procedures. Petrina has over 20 years’ experience in the pharmaceutical industry, from analytical testing through to the licencing of Medicinal Products and Medical Devices. Prior to joining Diamond, Petrina was employed in Regulatory Affairs for Forest Laboratories, where she gained broad experience in regulatory strategy, regulatory CMC and regulatory compliance and built a solid knowledge base of regulatory procedures and guidelines. Before moving into Regulatory Affairs, Petrina spent many years in Quality Assurance at GSK. During this time she was responsible for a variety of activities, such as the release of batches of active pharmaceutical ingredients, inspection readiness, GMP compliance and regulatory conformance, implementation/maintenance of the validation lifecycle for nominated processes and also the investigation of problems (including the implementation of corrective and preventative actions). Petrina’s most significant achievement from this time was when she was responsible for all quality considerations for the introduction of a new drug substance from research and development into commercial manufacture and supply; this included contributing to dossiers for regulatory submissions, which resulted in licences being granted for a new multi-million pound product. Petrina possesses a honours degree in Chemistry and is a member of the Organisation for Professionals in Regulatory Affairs (TOPRA).

    Petrina Pearce <br/> Regulatory Affairs, Associate Manager

    Zahra Eastwood
    Senior Regulatory Officer

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    Please contact us for more information about Zahra.

    Zahra Eastwood <br/> Senior Regulatory Officer

    Mark Fitchmun
    Biologics Development Consultant

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    Mark Fitchmun is president and founding partner of Somatek Inc., San Diego CA, a consulting firm specializing in the development of biologics manufacturing processes, assays, and formulations. Since founding Somatek in 2003, Mr. Fitchmun has consulted on over 40 biopharmaceutical and analytical projects including therapeutic antibodies, antibody-drug conjugates, fusion proteins, viruses, and clinical diagnostics. Mr. Fitchmun has also served as Vice President of Accelagen, a provider of enzymes for molecular biology research; Manager of Process Development at GenStar, a gene therapy company; and Group Leader at Desmos, developing new antibodies, and assays, and research methods for the study of extra cellular matrix proteins.

    Mark Fitchmun<br/>Biologics Development Consultant

    Ralph Smalling
    US Regulatory Affairs Consultant

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    Mr Smalling was with Amgen Inc. for over 23 years. He started with their R&D group and was responsible for the cloning a number of therapeutic proteins, as well as construction and characterization of the cell bank used in the commercial production of epoetin alfa. He then joined the Regulatory Affairs Department where he held roles of increasing importance and was ultimately named to Amgen's most senior regulatory affairs position.

    As Vice President of Regulatory Affairs and International Clinical Safety he oversaw the development of more than 40 antibody and recombinant protein therapy projects. Ralph was responsible for US and European regulatory affairs, and for providing regulatory oversight to Canada, Australia and Japan. Under his leadership Amgen obtained marketing authorizations, supplemental approvals, and orphan drug designations in the US, EU, Canada and Australia for numerous products, including Neulasta®, Aranesp®, Kineret®, Infergen® and Neupogen®. Ralph was a member of the industry team that negotiated PDUFA II, and drafted several of the provisions included in the FDAMA legislation passed by Congress in 1997.

    Since 2005, Ralph has been an independent consultant and he continues to perform regulatory work in some of the most innovative areas of therapeutic product development including antibody drug conjugates, stem cell and gene therapies. In addition to his work on regulatory filings Ralph also authors development plans, conducts due diligence work for clients considering product acquisitions, performs product analyses for venture capital firms, and has also been involved in the QC/QA of therapeutic proteins having spent 11 months as the interim Head of Quality at a biotechnology company.

    Ralph graduated from Occidental College with a BA in Biology and attended California State University at Long Beach (UCSB), where he obtained his Masters Degree in Microbiology.

    Ralph Smalling<br/>US Regulatory Affairs Consultant
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