TRN - Key Persons

Alan Harris graduated from Southampton University and began his career as a graduate medicinal chemist with Allen and Hanburys (now part of GSK) at their site in Ware, Hertfordshire. During this time he completed a part time MPhil degree on the synthesis of bicycle [3,2,1] octylamines as potential agents for the relief of pain. He then moved into process development with Fisons where he initially worked on the development of compounds for the treatment of Asthma, first as a process chemist and later as a team leader. During this time he completed a part time PhD at Coventry University on the use of sodium formaldehyde sulphoxylate as a reagent for synthesis. During this period Fisons diversified its portfolio and Alan became responsible for the development of a potential anti epilepsy compound, Remacemide, which was taken through to the end of Phase 3, acting as project manager as well as the chemistry lead and sitting on the global development team. This project involved making some 25 tonnes of API for phase 3 and commercial launch and involved the management of several different CROs . Fisons R&D was absorbed into the Swedish company Astra in 1995 and Alan moved into a role of Pilot Plant Operations manager where he was responsible for all the chemistry undertaken, as well being responsible for the development of the quality and safety systems, in the newly built plant. Following the Astra and Zeneca merger he became responsible for building the early development outsourcing group within AZ, working with a large range of CROs in Europe, the US and India to deliver materials for Phase 1/2 development studies. He was also involved in the several focus groups aimed at unifying quality systems across the newly merged organisation and was responsible for the introduction of an electronic SOP system for the Global Process R&D organisation. A further responsibility was leading the User Design Teams for laboratory blocks being constructed in Bangalore, India and in Loughborough. As part of his outsourcing responsibilities he was involved in auditing suppliers from technical, QA and HSE perspectives. Since 2010, Alan has been advising small and virtual Pharma companies on their outsourcing requirements and small CROs on their strategy and systems development. Recently he has worked with several Chinese companies and can offer an insight into the risks and advantages of low cost outsourcing in this region. He has published a number of scientific papers as well as contributing to the key API chapter of a book on Technology Transfer, published by the PDA, which is currently being revised and updated. He has also published and presented on outsourcing theory and practice. Alan's offers over 30 years of broad experience in all aspects of process R&D work (Technical, Quality and HSE) and is ideally qualified to set up and manage outsourcing projects for small pharma companies who do not have the required internal expertise. Expertise Regulatory, UK, Process R&D, API drug substance, development, Technology Transfer, Quality, QbD, Audit, Pharmaceutical, R&D, Route, Process, Analytical, Validation, Scale-up, Clinical Supply.

Andrew has more than 25 years experience in the pharmaceutical industry across all phases of drug discovery from early target identification and validation to late PhIIb. During his career in AstraZeneca, Andrew has worked as a bioscientist in several disease areas. For the past 12 years he has focused on type 2 diabetes and obesity, leading multidisciplinary drug discovery project teams that have delivered 3 anti-diabetic compounds into development. He offers a broad perspective of what is required to take a compound through a successful discovery and development programme, and in particular how to address the biological and pharmacological challenges involved in bringing forward novel agents in the field of metabolic disease through effective design and execution of appropriate pre-clinical scientific studies. He provides advice on optimising risk and resources across a balanced portfolio of projects including, as appropriate, the placement of studies to Contract Research Organisations (CROs). Andrew also provides due diligence evaluation of bioscience and translational science dossiers for potential in-licensing opportunities. Andrew has extensive experience of leading and managing other bioscientists in drug discovery. He has worked internationally, most recently leading a section of in vitro and in vivo bioscientists working on aspects of metabolic disease at AstraZeneca in Sweden. Andrew has also led cross functional teams identifying new target opportunities, and has provided bioscience expertise in due diligence evaluations of licensing opportunities for direct entry into early (PhI/II) development. He has been an active member of science review panels advising senior management and has led international teams evaluating and introducing new technologies and capabilities across a global business. Andrew holds a degree in Natural Sciences and a PhD in organometallic chemistry from Cambridge University, which was followed by a post-doctoral fellowship at Harvard University working in the fields of enzymology and molecular biology. Expertise Biology-in-vitro, Biology-in-vivo, Biology-Molecular, Clinical-Development, CVMD, UK

Job Titles:

• CEO

Andy graduated from Churchill College Cambridge in 1980 with a first class degree in Natural Sciences and completed a PhD in synthetic organic chemistry before joining Glaxo as a medicinal chemist in 1983. He spent seven years at the Ware and Greenford sites working on CNS targets and then three years at the Research Triangle Park in North Carolina as the lead chemist on Cardiovascular projects. Andy joined Pfizer in Sandwich in 1993 as a manager in the Medicinal Chemistry department. He became Therapeutic Area Lead for Cardiovascular and Neurodegeneration Research, and later on Tissue Repair managing a portfolio of projects up to First in Human. He had his first taste of process improvement at Glaxo building strong relationships with IT and operational groups and advancing a range of continuous improvement initiatives.

Job Titles:

• Drug Discovery Scientist and Research Project Leader

Blanda is a highly motivated Drug Discovery Scientist and Research Project Leader with 18 years experience in Pharmaceutical R&D with a proven ability to deliver drug candidates and to build, manage & lead matrix teams. She is a co-inventor of maraviroc (Celsentri/Selzentry). Blanda has in-depth Medicinal Chemistry design experience across a number of small molecule projects in various therapeutic areas from early discovery through to Proof-of-Concept. She has always been driven by the passion to make a difference to patients' lives. Blanda is a highly driven Drug Discovery Scientist and Research Project Leader with 18 years experience in Pharmaceutical R&D. As Project Leader she has been accountable for delivery of small molecule projects from early discovery through to Proof-of-Concept and has led matrix team of several discipline leads charged with identification of a once a day oral drug. Blanda is an expert on all safety aspects of the Drug Discovery process. She organised and chaired a Safety and Attrition workshop at Pfizer during 2010 which addressed the design of safer drug candidates and was targeted at all partner lines. The workshop was afterwards rolled-out globally to all Pfizer Research sites. Blanda graduated from the Ruhr University in Bochum, Germany in 1989. She obtained her PhD (Dr. rer. nat.) after only two years of research with Professors P Welzel and W. Roth for which she was awarded a student prize from the Deutsche Forschungsgemeinschaft, the leading science funding body in Germany. After 18 months of post-doctoral research with Prof. W. Oppolzer in Geneva, Switzerland, she joined Pfizer in 1993.

Brendan Leighton, Ph.D., is a Biochemist who has provided professional bioscience services to the pharmaceutical industry since 1998. With more than 14 years of pharmaceutical industry experience, Dr. Leighton provides drug discovery expertise/scientific leadership to global drug discovery and development project teams, formulates biology strategies for small molecule and biological pharmaceutical target proteins. Brendan has a deep knowledge of cardiovascular and metabolic diseases. An expert in Experimental design and devising screening cascades for drug discovery including in vitro and in vivo experimentation, as well, he reviews, interprets, and integrates study data into formal reports for project teams. Dr Leighton was a Project Licence Holder under the Animals (Scientific Procedures) Act 1986. Due diligence services can also be provided. Dr Leighton also has experience in the scientific development of scientists and/or organisations towards enhance performance and delivery (e.g. Bioscience Experimental Design Teams). Brendan is experienced in initiating, maintaining and collaborating with colleagues in the Pharmaceutical Industry, academia and CROs. Dr. Leighton's background is as a Principal Scientist at AstraZeneca (Alderley Park, U.K.). In addition, he was Lead Biologist for 12+ years and reported to senior staff and executive site management for the preclinical drug development of 12 compounds that entered human clinical development phase. During Dr. Leighton's 14+ years at AstraZeneca, he worked in the global Pre-Clinical Drug Research and Development Departments, Project Management, and a leader within s Science Ladder. After graduating in Biochemistry (B.Sc., 1979) from Manchester University (1984), he completed his Ph.D. (Manchester University, 1984). His career began as a Post-Doctoral scientist (1984-87) in the Department of Biochemistry at Oxford University, then later, he was appointed a Departmental Lecturer (1987-1998). He has published over 80 peer-reviewed full research articles and was a college tutor for Biochemistry at University of Oxford. His academic research focussed on biological mechanisms underlying skeletal muscle insulin resistance and impaired glucose metabolism. Dr Leighton demonstrated that the pancreatic hormone, called amylin, had biological activity. A synthetic analogue of amylin, called Symlin, is now a treatment developed by Amylin Pharmaceuticals for insulin requiring diabetics. Expertise Biology-in-vitro, Biology-in-vivo, CVMD, Small Molecule, UK

Charles has extensive experience in medical leadership of face to face meetings with regulators in the US, UK, Canada and Australia. Providing the clinical overview for registration filings of a biologic product, Type II variations on existing products, and CTA/s for new compounds. He also has a track record of success in negotiations with regulators and responding to their questions in a rapid, flexible and credible manner. Expertise Clinical-Development, Regulatory, UK

Dr. Tuffin's area of professional expertise is the biological sciences (biochemistry / pharmacology / physiology) as applied to preclinical research and development in the pharmaceutical industry; primarily in the discovery and development of small molecule therapeutics. Dr. Tuffin provides technical expertise and consultancy advice relevant to preclinical discovery (Lead Identification and Optimisation) and early development phase activities, focussing on the cardio-metabolic (diabetes / obesity / dyslipidaemia) therapy areas. Dr. Tuffin offers expertise and advice on development candidate target profiles and nomination, portfolio risk management, strategic planning, change management, and continuous improvement in the pharma R&D environment. Dr Tuffin can assist with collaboration and inlicensing activities, alliance management, placing of CRO studies, compiling of Investigator brochures, due diligence exercises and report writing. Dr Tuffin can advise on writing complex grant proposals eg for the EU Framework and Innovative Medicines Initiative (IMI) programmes. Finally, Dr Tuffin has held personal and project licenses under the UK ASPA system and, as a former Certificate Holder for 10 years, can offer guidance on the contents and implementation of the new EU2010/63 animal experimentation legislation which replaces the 1986 Act (EU 86/609). Dr. Tuffin holds a Ph.D. in Physiology/Pharmacology from Kings College London in conjunction with the former Wellcome Research Laboratories, and has worked in the UK pharmaceutical industry in preclinical R&D for 35 years. He has held positions of increasing seniority in successive companies (Rhone-Poulenc, G.D. Searle and AstraZeneca plc) as a postdoctoral scientist, project manager, line manager of small teams, sections, and ultimately ten years as Vice President/ Head of Department (a multidisciplinary cardiovascular/metabolic disease department of approximately 200 staff comprising chemistry, bioscience, DMPK, and laboratory animal science functions). Dr. s primary area of professional expertise relates to the discovery and early development of candidate drugs in the cardio-metabolic field. Dr s department ran a portfolio of cardio-metabolic projects which delivered multiple candidate drug nominations against a spectrum of targets and mechanisms. Dr Tuffin was closely associated with the development of the statin Crestor. Dr Tuffin was the first HOD in AstraZeneca UK to introduce the principles and practice of continuous improvement using Lean Sigma analysis and implementation. Expertise Biological, Biology-in-vitro, Biology-in-vivo, CVMD, UK

Dermott O'Callaghan has over 9 years experience in the pharmaceutical industry. His focus has been on early drug discovery in neuroscience with an emphasis on ion channels. He has in-depth experience of numerous drug discovery approaches and technologies ranging from high-throughput screening to pre-clinical candidate selection. He is an experienced manager leading several screening teams with Pfizer and AstraZeneca. These teams worked across multiple projects, against a range of target classes in a cross-functional setting building a reputation for delivering high quality data against exacting deadlines. He has experience of running outsourced projects with both domestic and over-seas contract research organisation. He has worked extensively with data analysis methodologies both to enable discovery projects and implement novel software tools. The consequence of this has been the development of new compound triage approaches to identify novel chemistry. As an external consultant he has engaged with large pharmaceutical clients to manage specific drug discovery projects, to build centralised global screening capacities and provide key technical evaluations for capital purchases. His approach is based on embracing the emerging outward facing drug discovery business models to ensure clients are best placed to capitalise on pre-competition interactions, cloud based open-access data sharing, out-sourced experimental work and new technological advancement. Expertise Biology-in-vitro, CNS, Pain, Small Molecule, UK, Ion channel, Electrophysiology, Cell based assays, High throughput assays, High throughput screening, HTS, Cellular assays, Assays, Primary screen, Primary screening, FLIPR, Fluorescence based assay, Plate based, sodium channel, Nav1.7, Nav1.8, Potassium channel, Calcium channel, transient reception potential channel, Neuroscience, Nav, Cav, Kv, TRP, GABA, GABAA, ENaC, Neuronal calcium signalling, IonWorks, QPatch, IonFlux, Neuron, Neurone, Patch Clamp, hERG, Cardiac safety, Drug discovery, Project management.

Dr William Speed has over 25 years experience within the Pharmaceutical Industry, the majority in the field of Drug Metabolism and Pharmacokinetics (DMPK). He has supported projects through all stages of the R&D continuum ranging from early drug discovery to late stage clinical development, in therapeutic areas including CNS, antibiotics, oncology, gastrointestinal (GI) and pain. During this time he has become familiar with all of the in silico, in vitro and in vivo ADME related methodologies available to generate the data required to discover and develops. Expertise ADME, CNS, Gastrointestinal, Oncology, Pain, UK

Graham is a highly experienced and motivated drug discovery scientist and senior leader with over 20 years of experience gained from working as an inventive and creative medicinal chemist in a number of therapeutic areas including Pain, Internal Medicine, GI, Urology and Sexual Health. He has led discipline and matrix teams of up to 50 scientists and has successfully run drug discovery programmes from idea (hit-generation) to first-in-human (candidate selection and R1). Throughout his career he has made inventive contributions to the discovery of a range of clinical candidates leading to the publication of >25 patent applications and the initiation of >15 FIH studies. Graham has extensive experience of the evaluation of in-licencing opportunities and has initiated and managed a number of external collaborations with organisations such as Icagen and Hydra Biosciences. Graham graduated from the University of Leeds in 1982 with an honours degree in Chemistry and worked for 3 years in the Hoechst Pharmaceutical Laboratories researching novel histamine H2-antagonists prior to beginning his PhD in Total Synthesis with Professor Steven V Ley, FRS at Imperial College, London. After 2 years post-doctoral research in Organo-Cuprate methodology with Professor Robert Boeckman Jr at the University of Rochester, Graham joined Pfizer R&D in Sandwich, Kent. Since joining Pfizer in 1991, Graham has gained extensive experience of medicinal chemistry design and has applied this to the discovery of novel, small-molecule drug candidates against a range of biological targets leading to, for example, enzyme inhibitors, GPCR agonists, GPCR antagonists and ion-channel modulators (voltage and ligand-gated). He has also developed an interest in the design of peripherally restricted molecules as a means of minimising the potential for centrally-mediated adverse events. Graham has considerable scientific leadership experience and has previously held the senior positions of Head of Pain Chemistry, Head of Genitourinary, Allergy and Respiratory Chemistry and Head of Exploratory Chemistry, New Opportunities Unit at Pfizer and was responsible for defining the Medicinal Chemistry strategy for large teams of talented scientists. He also worked within matrix Therapeutic Area Leadership teams and was co-chair of a number of Joint Steering Committees responsible for the successful management of external collaborations. Over recent years Graham has successfully employed CRO resources from Europe, India and China to enhance the productivity of research projects leading to the establishment of integrated drug discovery projects at an Indian CRO. Expertise Chemistry-Medicinal, Gastrointestinal, Pain, Patents, Respiratory, Sexual Health, Small Molecule, UK

Job Titles:

• Pharmacist With a

Janet is a pharmacist with a PhD in medicinal chemistry, alumni Manchester and Strathclyde respectively. She has worked in Regulatory Affairs supporting drug development from scientific advice through early phase development (clinical & technical) to final dossier submission, via a number of significant changes within the regulatory environment Through Janet's professional career she has supported applications in the UK/Europe/ASEAN and USA markets, covering medical devices, pharmaceuticals (OTC & ethical) and food supplements on a number of well-known brands. Janet developed her regulatory skills working in the fast paced environment of generic medicines, working for Thomas Kerfoot & Sons and Medeva. She broaden her knowledge through European and Global requirements through management of 3M's CFC free pressurised metered dose inhalers (Airomir™ & Qvar™). In order to gain insights into consumer understanding Janet supported a number of generic medicines into the Republic of Ireland for Boots and latterly the Strepsils™ brand across a number of markets (>120 territories). She was responsible for the introduction and approval of new flavours, products and maintaining compliance across a complex matrix of products. The opportunity to lead a European, then global team for Vectura plc, as the Director of Regulatory Affairs in inhaled medicines, lead to initiation of a number of scientific advice meetings and a deeper understanding of the clinical requirements within a dossier submission. Janet combined this role, with site operations for the Nottingham site, until its closure in 2010. Since this time Janet has explored a number of innovation opportunities both within Boots and externally. The understanding of a number of regulations permits exploration of opportunities within the overlapping boundaries of different product categories. Janet's key skills are: regulatory strategies to support innovation; ideas and product development); external collaboration; technical reviews and delivering the bigger picture in drug development. Expertise Regulatory, UK

Job Titles:

• Pharmacist

Julia is a qualified pharmacist who joined ICI (later Zeneca and AstraZeneca) in 1988 following a PhD and post Doc in antibody-directed drug delivery at Nottingham University. She spent 8 years providing formulation support to drug discovery teams, trouble shooting issues and delivering novel formulations and biopharmaceutics advice to development project teams with compounds already in man. From 1996, Julia supported global drug discovery and development teams as the DMPK representative supporting both pre-clinical DMPK and clinical pharmacology and working with compounds from candidate selection stage right through to regulatory filing. She spent three years in senior management with responsibility for clinical pharmacology and DMPK project leaders in the UK and US, driving functional strategy and planning. She also delivered functional portfolio and project advice to the Oncology and Infection Therapy Area Team. Following a re-organisation in 2011, Julia moved into the projects area as a Clinical Program Director in early Oncology, remaining in this role until she left AstraZeneca in 2015. She designed, developed, secured and managed multi-million dollar budgets for drug development programs from candidate selection, through First in Man and into Phase I/II, delivering studies through external partners and building productive relationships with key investigators and external companies. Expertise ADME, Clinical-Pharmacology, Oncology, Regulatory, UK

Keith Purdy is a graduate of Leicester School of Pharmacy and registered as a Pharmacist after Pre-Registration training at Addenbrookes Hospital, Cambridge and MSD, Hoddesdon. Following this he completed a PhD in Pharmaceutics at the University of Bath (stability of chlorhexidine). Keith then began his career in the pharmaceutical industry with Boots Pharmaceuticals where he undertook pre-formulation studies on all NCEs and provided formulation research support to Boots development and marketed products. He then moved to Fisons as Team Leader for tablet development projects where he had accountability for the formulation development and manufacture of clinical supplies for remacemide. As this compound progressed to Phase III clinical studies, he also led the technology transfer in to an Operations facility. Following the acquisition of Fisons by Astra, he continued as Team Leader then Section Manager to lead formulation development programmes for a range of product types across multiple therapy areas. Keith's responsibility included both early and late stage projects, the manufacture and packaging of clinical trial supplies and Regulatory Authority submissions and he line managed a group of 15-20 scientists. Following the merger between Astra and Zeneca he then moved into a Project Management role having accountability for the CMC development of early and late stage NCEs. He led cross-functional teams delivering the pharmaceutical development contribution to AZ global projects and sat on numerous global development teams. One of these was the AZ compound ticagrelor (Brilinta/Brilique), where Keith has been Project Manager since the first study in man, through large complex clinical studies and to regulatory submissions and market approval in over 100 territories. As a consequence, he has extensive experience in all aspects of the end-to-end development process including scale-up and technology transfer, clinical trial supplies (including comparators), working with CROs, Regulatory Authority submissions / interactions and life-cycle management. Additionally, as Project Manager, he has expertise in project planning and control, budget forecasting and reporting, stakeholder management / communication and managing complex project across geographical and cultural boundaries. From the many development projects he has led, he also has significant experience in forming and leading new teams, defining objectives and milestones and then closing down or transferring teams / projects. Keith's expertise and skills, acquired over 30 years working with hundreds of development projects, is a valuable resource for any project or technical issue regardless of stage of development or product type. Expertise CMC, Formulation, UK

Job Titles:

• Fellow of the Chartered Management Institute

Paul has over 17 years of experience as a drug hunter working within the Pharmaceutical and Biotechnology industry and has led several Chemistry Departments composed of up to 74 staff members. Paul has gained experience working, most recently, in the anti-infective, bone and joint disease and cardiovascular therapeutic areas and he has successfully run programmes from idea to hit generation to candidate selection. Paul has extensive experience of the evaluation of in-licencing opportunities and he has led a number of external collaborations. To date, Paul has over 60 peer-reviewed publications and patents. Currently, he is a member of the Advisory Board for Spinnovation Analytical NV who are based in Nijmegen, The Netherlands. He was recently Vice President of Chemistry for Boehringer Ingelheim(Canada) Ltd. based in Laval, Quebec. Before taking up this role at Boehringer Ingelheim he held a number of positions, most notably he was Director and Head of Chemistry for the biotechnology company Galapagos, based in Mechelen, Belgium. Prior to this he was Director of Medicinal Chemistry for Santhera Pharmaceuticals (previously Graffinity) based in Heidelberg, Germany. Before this he spent nearly seven year at Pfizer Global Research & Development based in Sandwich, Kent in the United Kingdom. Here he held various positions in the Medicinal Chemistry and Lead Discovery Technologies Departments. His first industrial employment came at Oxford Asymmetry International Ltd., (now Evotec), based in Abingdon, Oxfordshire in the United Kingdom. Prior to taking up tenure in industry, he was firstly a SmithKline Beecham postdoctoral fellow with Regents' Professor Paul G. Gassman at the University of Minnesota, USA, and then a postdoctoral fellow with Professor Steven V. Ley, FRS at the University of Cambridge in the United Kingdom. In 1989 Paul was awarded a BSc honours degree in Chemistry, followed in 1992 by a PhD degree in organic chemistry, both from the University of Leicester in the United Kingdom. In 2005 Paul received an MBA degree from the Open University in the United Kingdom. Paul is a Fellow of the Chartered Management Institute (FCMI) and a Chartered Manager (CMgr), he is a Chartered Chemist and Fellow of the Royal Society of Chemistry (C.Chem, FRSC), and a Chartered Scientist (CSci). Expertise Antiviral, Chemistry-Medicinal, CVMD, Pain, Sexual Health, Small Molecule, UK

Pirthipal joined ICI in Dec 1978 (Natural Products Group) as an Experimental Officer, after graduating in Biochemistry from University of Leeds. He developed a range of radioligand binding assays and subsequently established the concept of high throughput screening, by introducing the 96-well mictrotitre plate-based assays. Overall, he worked at the Alderley Park site for nearly 30 years, during the demerger (ICI + ICI + Zeneca) and re-merger (Astra + Zeneca + AstraZeneca) phases, by providing support in assay development and assay trouble shooting across all therapeutic areas, working with his colleagues in the project teams, covering most research sites, in a global manner. He was actively involved in assay technology evaluation and deployment within the HTS group (SPA; Amersham and HTRF; Packard) and project teams, where appropriate, through effective training of research staff. His training role extended to running workshops with new graduate students, as well working with research staff. Regarding sandwich students, this also involved direct line management of their research projects. He worked extensively with vendors to identify further development of reagents / detection systems, through collaborative projects to evaluate their prototype products in ‘real' assays and a variety of ‘test compounds' to help validation. In some cases, this involved working on projects at the ‘leading edge' of technology development. During the latter part of his career, the focus of his work was in the kinase area, relating to the development of novel assay formats and technologies; working with AZ colleagues and external vendors, in a collaborative manner. During his time at Alderley Park (particularly the first 20 years; working in the HTS group), he was an active member of the SBS, where he ran workshops and on-line tutorials. Subsequently, he was recognised as an expert in the kinase area and related assay technologies. He was regularly invited to present his findings from the assay technology evaluations, at various international conferences. Some of this work was also submitted for publications. Furthermore, Pirthipal was the first Bioscientist to be appointed as an Associated Principal Scientist, at AstraZeneca, Alderley Park. Expertise Biology-in-vitro, Biology-Molecular, Biomarker, Chemistry-Medicinal, UK

Stuart G. Levy, PhD, has provided chemistry consulting services to the pharmaceutical industry as an independent consultant since 2010. Dr. Levy has more than 18 years of experience in the pharmaceutical industry, primarily at start-up and medium size biotech pharmaceutical companies. Stuart's consulting practice is focused on the transition and advancement of small molecule leads from discovery into preclinical and clinical development. Within this focus, Stuart performs evaluation of synthetic routes to discovery hits and leads, troubleshooting of difficult chemistries, conception of operationally simple and scalable syntheses, guidance and leadership in initial scale-up efforts, strategy, planning and execution for production and manufacture of API and dosage form for preclinical and clinical studies, guidance and leadership for API salt screening and selection and drafting and finalization of the necessary CMC regulatory documents to support IND filing. Stuart has overseen and led the overall effort for the development of small molecules for numerous preclinical and clinical drug candidates. Given that all of Stuart's employers were at least partially virtual in chemistry capabilities, part of his professional role has been management of outsourced chemistry R&D, production and manufacturing for the last 15 years. Stuart also has significant experience in due diligence evaluations of therapeutic assets offered for consideration for in-licensing for employers and client companies, from the point of view of chemistry and CMC viability. Previously, Stuart held two positions at the director level, at PPD Dermatology (formerly Magen Biosciences) as Director of Chemistry, and as Director, Pharmaceutics and Manufacturing at Elixir Pharmaceuticals. He had full responsibility for all CMC activities at both positions, as well as roles in supporting discovery and medicinal chemistry activities at both employers. Stuart's career as a bench chemist includes positions as Senior Staff Scientist in chemistry R&D at EPIX Pharmaceuticals, project leader at the CDMO/CRO Ricerca, process chemist at the biotech SUGEN, and Scientist at the CDMO SERES Laboratories. . Stuart's employment at two vendors providing chemistry services has afforded him a full perspective on the process and dynamic between vendors and their customers, and the ability to create and maintain optimally productive, respectful relationships between vendors and his employers/clients. Expertise Chemistry-GMP, Chemistry-Medicinal, Chemistry-Synthetic, CMC, CNS, CVMD, Dermatology, Formulation, Oncology, Regulatory, Small Molecule, USA, Stereochemistry, Route scouting, Route selection, API manufacturing, GMP, IND, NDA, Preformulation, Solid state chemistry, Salt screen, Polymorphism, Characterization, Troubleshooting, Metabolic disease, Injectable dosage, Oral dosage, Due diligence, Process development, Process discovery, Chemical mechanism, Enabling synthetic route, Asymmetric synthesis, Classical resolution - HPLC and SMB, Chiral separation, Starting material and raw material sourcing, Radiosynthesis, Stable isotopic label synthesis.