SEDA PHARMACEUTICAL DEVELOPMENT SERVICES - Key Persons
Job Titles:
- Pharmacist
- Senior Scientist
Alan is an overseas Pharmacist with 9 years' experience in the pharmacy environment. He has an MSc degree with distinction in Drug Design and Discovery from the University of Salford, and another MSc in Pharmaceutical Analysis from the University of Strathclyde. Alan has experience working as a QC analyst for almost 2 years in a GMP environment, and has worked for 2 years as an assistant lecturer in the School of Pharmacy at University of Sulaimani. He has special interests in characterisation of pharmaceutical materials, nanomedicines, analytical method development and utilising spectroscopy and chromatography in chemical and bioanalysis.
Job Titles:
- Associate
- Principal Scientist
Alex has a background in chemistry and holds a PhD in pharmaceutics from University College London, during which he gained extensive experience in the solid-state characterisation of pharmaceutical materials, including polymorphism and co-crystallisation, combining both thermal and structural analyses to develop a full picture of the changes occurring when materials undergo phase transitions. More recently he has worked on projects in formulation development with a particular focus on the microfluidic manufacture of nanomaterials for administration of sustained release parenterals. He also has valuable experience in the development and manufacture of oral solid dosage forms.
Job Titles:
- Scientist
- Senior Principal
- Senior Principal Scientist in Clinical Pharmacology and DMPK
Alison is a Senior Principal Scientist in Clinical Pharmacology and DMPK at Seda with a PhD in Drug Metabolism from the University of Manchester and an MSc in Toxicology from the University of Birmingham. She is an experienced multidisciplinary scientist having spent over 10 years in DMPK Discovery with AstraZeneca and, for the last 10 years, specialised in PBPK modelling using GastroPlus with Quotient Sciences. At Seda she provides scientific input into Clinical Pharmacology and DMPK study design and provides interpretation and analysis of client data.
Andy's background started in Community Pharmacy in Finance and Commercial roles. Since then, Andy has operated as Finance Director/CFO in a number of high-growth, privately owned and private equity backed businesses. Andy's experience ranges from education, healthcare, childcare, IT Services & property.
Job Titles:
- Associate
- Principal Scientist
- Associate Principal Scientist in Analytical Sciences
Arun Kamath is an Associate Principal Scientist in Analytical Sciences at Seda. He has a Master of Chemistry (MChem) from the University of Leeds, with over 14 years' experience in the global pharmaceutical industry. His area of expertise is in analytical sciences for drug product development, which has involved working with a wide range of analytical techniques and developing a comprehensive understanding of drug project analytical strategy requirements and critical product quality attributes.
Ashleigh has a background in both in-silico modelling and chemistry, understanding both compound analysis and the modelling approaches harnessed in drug development. During her MSc, she spent her final months developing a Mechanistic Kidney Model to predict creatinine Drug-Biomarker Interactions (DBIs) aiming to reduce false-positive predictions of Acute Kidney Injury (AKI.)
In her spare-time, she worked within community pharmacy where she gained a strong understanding of patient welfare and pharmaceutical demand.
Expertise:
Oral Drug Delivery
Asimo has a Bachelor's in Biological Sciences and a Master's in Biotechnology with 12 years of experience working in Molecular Diagnostics and in Pharma Biotech. She specialises in assay product development (Oncology and Infectious Diseases portfolios), analytical design transfer and laboratory management. She has previously worked as a Laboratory Manager for a couple of organisations where she was involved in setting up laboratories and making sure that the labs are audit ready at all times.
Job Titles:
- Associate - Complex Medicines
Bethany has a first-class degree in medicinal and biological chemistry and 5+ years of pharmaceutical analytical method development experience in a CDMO environment. Bethany's focus is on U/HPLC and dissolution analysis, with experience in leading analytical projects from initial method establishment through to GMP validation and supporting formulation development. At Seda, Bethany will be developing fit-for-purpose analytical methods for a variety of drug products.
Expertise:
Oral Drug Delivery
Dr Bill Moss has over 25 years' experience as a scientist and leader working in the following areas:
Chemical Development and manufacture of clinical and commercial drug substance
Expertise in the Discovery interface, Preclinical and Phase1/Phase II development, supporting the progression of new candidate drugs from discovery into development
Drug substance project strategy development and integration with drug product, safety and clinical planning
Extensive experience of outsourcing drug substance development and manufacture
Authoring and reviewing regulatory submissions from Phase I to marketing submissions
Job Titles:
- Chief Executive Officer
- Chief Scientific Officer
- Co - Founder
Job Titles:
- Associate
- Director
- Principal Scientist
- Senior Scientist
- Associate - Chem. Dev
Job Titles:
- Associate
- Principal Scientist
Chris is an Associate Principal Scientist working in DMPK at Seda. He has over 10 years experience in DMPK during which time he has worked in CRO's as well at small biopharma. As a DMPK team leader in a small biopharma his main focus has been on small molecule projects taking candidates from the discovery phase all the way through to IND submission.
Claire Patterson is Director, Complex Medicines at Seda with a Master of Pharmacy (MPharm) and a Ph.D. in Pharmaceutics from the Universities of Nottingham and University College London. Claire is an experienced Biopharmaceutics scientist having spent 12 years with former employer AstraZeneca with roles in Early and Late Stage Product Development, linking in vitro to in vivo product performance. Current focus areas include subcutaneous and complex parenteral biopharmaceutics (including nanomedicines) and other non-oral routes of administration.
Prior to joining Seda, I have worked for in the pharmaceutical industry for 26 Years. During this time, I have been involved in R&D Projects across a wide range of Therapeutic areas and in Sterile Manufacturing, Solid Oral Dosage Forms and in Active Pharmaceutical Ingredients (API). I have managed the Facilities team for many years upgrading a number of existing facilities, introducing new equipment, new technologies and services (eg purified water systems, HVAC Systems) as well as System owner for a number of GMP IT systems. In addition, the team I managed ensured the routine cleaning, maintenance and calibration of the Drug Product and API manufacturing plants along with the large High bay warehouse. In the last 2 years before joining Seda I worked within the Development Quality function responsible for the Quality Management System (QMS) and GMP Training.
David Handbury is a Chartered Quality Professional and UK/EU Qualified Person ( eligibility under Permanent Provisions since 1991). He has over 28 years' experience in Quality leadership roles in pharmaceutical development and clinical and commercial manufacturing at Astra Zeneca. He has been a consultant to biotech companies since 2021.
Dominic is a Senior Scientist at Seda. He completed an MChem at the University of Bradford and has over 8 years GMP experience having spent most of his career working in pharmaceutical testing environments.
Dr Talbir (Tal) Austin is a consultant providing expertise in solid state, material design and characterisation, and development with particular focus on the early development phase. Dr Austin is a structural organic chemist who has worked within the pharmaceutical industry for nearly three decades. Her previous positions involved complex problem solving and troubleshooting of projects - overseeing material design, selection and development, from the Preclinical phase through to Early Development at AstraZeneca. She also led the design and implementation of AstraZeneca's material selection strategy at the discovery and development interface. Dr Austin has extensive experience in optimising material properties for different therapy areas (Respiratory, Inflammation, CNS, CV, GI and Oncology) and modes of administration; oral, inhalation, parenteral, topical.
Job Titles:
- Director, Quality Control
Effi is a dedicated QC Director at Seda, she is a Principal Scientist and Leader within the pharmaceutical industry. Joining Seda with Line Management responsibilities, she immersed herself in Pharmaceutical Development, gaining valuable insights into the nuanced needs of our clients. In her prior role at a distinguished GxP-accredited CRO, Effi emerged as a leader in analytical testing, specializing in Oligonucleotides and RNA for both commercial and developmental Drug Substance and Product. Drawing on her background as a studied organic chemist, she possesses a wealth of knowledge in small molecules and their comprehensive analysis, cultivated over years of focused expertise. Effi's multifaceted experience uniquely positions her to understand and address the diverse needs of Seda. As she journeyed from an R&D environment during her studies and PhD to a GxP environment, the understanding and implementation of good quality control processes increased throughout her career and brought her to this exciting opportunity
First class Medical Science graduate with 1.5 years experience working in the pharmaceutical industry. Areas of focus include formulation development for both preclinical and clinical studies across a range of administrative routes and indications, including the use of amorphous solid dispersions to enhance the solubility of poorly soluble compounds.
Elizabeth studied chemistry at the University of Sheffield and has been working as an analytical scientist for past 7 years. She has a broad range of experience in using different analytical techniques, such as HPLC, GC-MS, ICP-OES, Karl Fisher, XRF. She also has experience of testing clinical samples for toxicology and is keen to focus on method development.
Expertise:
Oral Drug Delivery
First from the University of Birmingham studying Mechanical Engineering with a final year focus in biomedical engineering. Using my academic background with my interest in this area, I will be working with the modelling team within Seda.
Emily Stables has a first-class BSc in Chemistry and MSc with Distinction in Drug Discovery, Development and Delivery with a project on Immunomodulating Brain Targeting Peptide-Based Nanoparticles. She also has experience working with analytical techniques such as PXRD, HPLC, IR, NMR, DSC, TGA and flow cytometry. Emily's areas of focus at Seda will be formulation development for preclinical and clinical studies alongside analytical development.
Emily has a degree in economics from University of Leeds and has 4 years of experience working in accountancy and audit in practice before moving into an industry role. She is an ICAEW Chartered Accountant after completing her ACA qualification. Emily provides support in the finance management of the business.
Essy has a pharmaceutical science background with a PhD from Queen's University Belfast. During her PhD she worked on 3D printed systems for transdermal drug delivery and the use of microfluidics for nanoparticle fabrication along with extensive experience in a range of analytical characterisation techniques. At Seda she will use her experience in pharmaceutics within the formulation development team, focusing on oral dosage forms and complex medicines. Essyrose Mathew - Google Scholar
Fanny has a bachelor's degree in chemistry, an engineer diploma in Materials Science and a PhD in Polymer Chemistry. Following her studies, she worked as a Research Associate for 6+ years in both Academia and large Pharma focussing on polymers for healthcare and precision nanomedicine applications. She joined Seda as Senior Scientist to facilitate the development of complex parenterals using her knowledge of nanotechnology.
Expertise:
Oral Drug Delivery
After a 20 year career in HR working primarily in the Pharmaceutical Industry, Faye Briffa set up Ashfield HR, an HR Consultancy supporting North West based small and medium sized companies who have no in-house HR capability. Faye is CIPD qualified having achieved a Post Graduate Diploma in HR Management from Manchester Metropolitan University in 2002. Since then, she has held a variety of HR roles, including in Recruitment, Employment, Business Change and HR Business Partnering.
Harri is able to apply commercially available software PK-Sim, in order to form translational PB-PK modelling for different species or populations and help with dose selection in the early clinical stage settings. As a Mathematics graduate his background enables him to bring systems thinking to PK modelling to identify sources of uncertainty and risk.
Job Titles:
- Associate Principal Modeller
A physics graduate, with over 3 years' experience in the pharmaceutical industry. Jake has applied analytical, mathematical, and problem-solving skills to the assessment of the likelihood of drug candidate success and to identify the likely risks involved in the formulation of a drug. Areas of expertise include PK / PK-PD-TGI modelling in preclinical species and translation to man to aid in dose prediction. Jake has developed models and applications including Nora Max, an in silico absorption model, that aids decision making in late preclinical and early clinical drug development phases of drug development and enables the identification of the formulation technologies required for FiH.
BSc in Pharmaceutical Science, MSc in Model-based Drug Development from the University of Manchester. At Seda, Jingrao's role is to create translational PB-PK modelling for various species or populations and assist with dose selection in early clinical stage settings.
Kati is a first-class maths graduate from Keele University and has 1.5 years' experience working for a marketing and advertising agency. With a mathematical background, she has a particular interest in finance management and accounting. Kati provides support within all areas of the business, to enhance efficiency and productivity, including procurement, finance management and marketing.
Expertise:
Pharmacokinetic Modelling
Kieran completed an MPharm at the University of Manchester and is a registered Pharmacist. He has 4 years of experience as a formulation scientist responsible for formulation design and manufacturing process optimisation for a range of OSD projects. He will support the GMP Operations team to establish a robust, GMP manufacturing capability.
Expertise:
Oral Drug Delivery
Libby Stott joined Seda following her A level studies. She works to ensure the efficient running of the laboratory including material receipt and coordination, Health and Safety aspects and lab organisation. She also acts as a primary contact for all aspects of Facility Management.
Expertise:
DMPK Consultancy and Dose Selection
Pharmacokinetic Modelling
Job Titles:
- Director
- Scientist
- Senior Principal
Linette is a Senior Principal Scientist at Seda with a BSc (Hons) and PhD in Chemistry from Universities of Glasgow and Edinburgh, respectively. She is an experienced Biopharmaceutics and DMPK scientist having spent 17+ years with AstraZeneca where she held roles in Discovery and Early Pharmaceutical Development, providing expert physicochemical, ADME and Biopharmaceutics input into compound design and selection, and applied knowledge of in vitro, in silico and in vivo models to enable material choice and project progression from discovery to early clinical development. Her current focus is on translation of DMPK/PD and biopharmaceutics understanding into meaningful product and clinical study design within Seda.
Lorraine has over 20 years' high quality laboratory experience at a leading global pharmaceutical company and one of the world's leading toxicology laboratories. She is experienced in most aspects of drug development and toxicology, ranging from pre-clinical toxicology through to human clinical trials.
Expertise:
Complex Medicines
Marcel has a track record in a range of management and senior scientific positions in industry and academia. Most recently he was a Principal Scientist in Product Design and Innovation at AstraZeneca, where he was responsible for introducing the latest science, new technologies (advanced drug delivery and manufacturing) and product design thinking into the Product Development group.
Marcel has led technical activities, provided project leadership and has managed product development teams responsible for the delivery of drug projects from initial concept design through late stage development, regulatory submission and launch (including advanced drug delivery systems). He has led teams at the drug discovery-development interface, assessing the level of chemistry manufacturing and controls (CMC) technical risk and defining product design strategies in early development. Project experience has covered projects across a range of disease and therapy areas with substantial experience in the oncology field.
Job Titles:
- Analytical and Formulation Laboratory Technician Apprentice
I intend to follow my aspirations and learn everything I can and become a contributing member of the scientific community. My apprenticeship is 18 months and in that time I will try my best to learn everything I can and offer a different outlook while shadowing my peers. Once I complete my apprenticeship, I plan on going on to the next level as soon as is possible to further develop my skills and experiences.
Expertise:
Analytical Sciences
Mike has over 15 years' experience in respiratory drug delivery and diagnostic manufacturing. Prior to working with Seda, Mike was based in Boston, MA as VP Device Manufacturing Operations at Sense Biodetection with responsibility for contract manufacture, and distribution of all North American and European diagnostic products. Before joining Sense, Mike held the role of Director of NPI and GMP Manufacture with Vectura Ltd, with responsibility for the manufacture and supply of pilot and clinical scale dry powder inhaler and nebuliser drug delivery systems.
Nicola holds a MSc in Pharmaceutical Chemistry from the University of Messina and a PhD in Pharmaceutics from UCL School of Pharmacy. He is an accomplished Formulation Scientist with 9+ years' experience in the field and roles at AstraZeneca and GlaxoSmithKline. He additionally holds a qualification from the Association for Project Management (PFQ). He is expert in planning, leading and managing clinical drug product development projects and has a deep understanding of change control, risk and stakeholder management processes.
Pankaj has held several senior product development & technology transfer leadership roles in Large & Mid-size Pharma introducing new manufacturing technologies, product innovation & design to expedite the overall drug development pathway.
Pankaj has managed product development and technical teams responsible for delivering products to the patients from FTiH through late-stage development, linking regulatory and launch activities in multiple international markets. Passionate about the technical capability build with the application of robust Quality by Design & Quality Risk Management principles, Pankaj will enhance the technical product robustness and business development function at Seda.
Job Titles:
- Chief Scientific Officer
- Co - Founder
Paul has held several senior science leadership roles in Academia and Large Pharma. These roles focused on applying the best science in projects to ensure optimal product performance in the patient, thus bridging pharmaceutical and clinical disciplines.
Immediately prior to founding Seda Pharmaceutical Development Services Paul was Senior Clinical Pharmacology Scientist at AstraZeneca and led the clinical pharmacology program to NDA/MAA for AZD9291/osimertinib, which had been awarded ‘breakthrough therapy' status by the FDA. Formerly Paul was a Principal Scientist within Pharmaceutical Development (AZ) leading both the global biopharmaceutics network and the Medicines Evaluation science community (USA, SE, UK).
Paul has been at the forefront of recent advances in the understanding of in vitro performance criteria that assure product performance in the patient including clinically relevant dissolution specifications (CRDS). Paul has co-authored papers with FDA staff focussed on efforts to combine biopharmaceutics with ICH Q8 (BioRAM) and is past Chair of the AAPS ‘QbD and product performance' focus group.
Job Titles:
- Associate - Complex Medicines
Paul has 33+ years' experience in Drug Discovery and Development at AstraZeneca, specialising in novel formulation, drug delivery and product design. He has led many projects and teams in identifying, evaluating and designing novel viable drug delivery-based products and new drug delivery technologies across a broad range of routes of administration and drug modalities including many complex medicines.
From 2017 to 2021, in additional to his role as Senior Principal Scientist in Drug Delivery, Paul was the Science & Innovation Director for Drug Delivery and Product Design, accountable for driving and championing science and innovation in drug delivery and product design to create new implementable business opportunities. Paul started and led AstraZeneca's Global Novel Drug Delivery Network for many years and is widely recognised outside AstraZeneca as an expert on drug delivery technologies and the external drug delivery environment, including patent and intellectual property aspects.
Paul has collaborated extensively with academic groups and drug delivery companies and is the co-author and co-inventor of a number of publications and patent applications. He has been a member of a range of external groups including Editorial advisory board member for the Nanomedicine journal, Scientific Advisory Board member and Programme Chair for the Controlled Release Society Conference, Scientific Consultant to the Wellcome Trust and EPSRC programme External Advisory Board member.
Expertise:
Quality Assurance
Paul is an established pharma executive with extensive global experience. Prior to joining Seda he was Vice President, Global Product Development at AstraZeneca, leading a group of over 350 scientists and engineers in the development of all products, manufacturing processes and analytical methods for the AstraZeneca small molecule portfolio.
AstraZeneca Global Product Development has centres in the UK, Sweden, US and China and a network of partnerships with colleagues all over the world and under Paul's stewardship registered 10 global products.
At AstraZeneca Paul was accountable for the Drug Product CMC component of all Due Diligence assessments and was CMC lead on several multibillion dollar acquisitions. In addition, Paul is a visiting Professor of Pharmaceutics at the University of Manchester, UK and founder of the North West Centre for Drug Delivery (NoWCADD) at the University.
He is a proven senior manager and strategic leader in Pharmaceutical Development with experience across geographical boundaries. Passionate about the development of individual and group capabilities and the application of innovation and scientific rigour to bring new medicinal products to market.
He is recognised within the Industry and with Regulatory Agencies as a driving force in the establishment and realisation of best practice in CMC Quality by Design.
Job Titles:
- Head of Sales & Marketing
Paula brings with her to Seda PDS 25 years of commercial sales, business development and marketing experience, gained largely from blue chip, branded FMCG organisations including Diageo and Sara Lee Corporation where she had demonstrable success in identifying and converting brand building opportunities, leading first to market launches and delivering significant profitable growth to both Client and Brand.
In recent years she has been working with some of the world's biggest technology brands to deliver pan European technical projects where her focus was solely on delivering high quality, accurate data on time and in budget, in line with Client expectations.
Paula is looking forward to working alongside the team in building, implementing and delivering a strategic sales and marketing plan that will further cement Seda's growing importance and contribution to the pharma sector.
Job Titles:
- Associate - Analytical Sci
Peter has worked in the pharmaceutical and healthcare sector for over 25 years with leadership and scientific positions at J&J, AstraZeneca and Glaxo. He has extensive experience in the management of outsourced projects with a focus on analytical development activities. Peter has authored many regulatory submissions from FiH to NDA / MAA and has an expert understanding of the regulatory requirements at each stage of development. He has been a consultant to the biotech sector since 2017.
Expertise:
Complex Medicines
Oral Drug Delivery
Roy is an experienced Pharma Industry & Regulatory CMC professional having spent time as a quality assessor at MHRA and with over 25 years in large pharma organisations leading numerous small molecule projects from FTiH through Marketing Authorisation and launch. As an Independent Consultant he has worked with many small companies as well as collaborating with consultancy firms and is currently supporting the South African Agency (SAHPRA) as a Quality/CMC reviewer supporting their generic backlog programme.
Roy has successfully led 4 major global submissions through Phase 3 to marketing authorisation approval. His key area of regulatory scientific expertise and interest centres on biopharmaceutics aspects of solid oral dosage forms of small molecules and the bridge between quality performance and the pharmacokinetic profile linked to safety and efficacy.
Expertise:
Chemical Development
Job Titles:
- Director
- Development Scientist
Shanoo is an experienced pharmaceutical development scientist with many years' experience in large pharma and the biotech sector. She has a particular interest in biopharmaceutics, development of clinically relevant in vitro tests and the development of products for paediatrics.
Tahera Begum has 2 years' analytical experience working in the Cannabis Industry. She has previously worked on formulation of cannabinoid-based products including food and cosmetics, where her main responsibilities included analysis of cannabinoid content in final formulations using HPLC. At SEDA Tahera hopes to continue building on her analytical expertise and move towards pharmaceutical drug development.
Expertise:
Complex Medicines
Oral Drug Delivery
Toby is an MChem graduate from the University of Sheffield, focused on the development and characterisation of novel metal-organic nanosheets within the Foster research group. Areas of experience include analytical science and chemical development. Toby formally joined SEDA as an analytical scientist in 2021.
Expertise:
Pharmacokinetic Modelling
Clinical Pharmacology
Valerie brings over 25 years of experience in both the pharmaceutical and chemical industries. She has designed and built quality systems for both QC and other departments. Valerie has managed analytical multistage early phase projects and is proficient in writing protocols and reporting validations. With extensive skills in method development and troubleshooting, Valerie will play a vital role in setting up our laboratory for QC testing.
Expertise:
Quality Assurance
Van is a pharmacist by training. Before joining Seda she did an industrial PhD with AstraZeneca and University of Leeds in applied mathematics where she developed complex models of heterogenous cancer cell population, tumour immune interactions and optimised combination therapy using ODEs, PDEs, agent-based modelling and reinforcement learning (an artificial intelligence method).
Job Titles:
- Director, Quality Assurance
Vijay is an experienced Quality Professional with a distinguished career marked by several senior quality roles within various pharmaceutical organisations primarily in the CDMO/CMO space.
His comprehensive understanding of the pharmaceutical landscape, coupled with his strategic thinking, has enabled him to navigate the complexities of the evolving industry standards.
Vijay has a proven track record spanning over 9 years in the pharmaceutical industry as well as training to be a Qualified Person (QP), which will bring valuable experience to the Seda GMP team and ensuring a commitment to upholding regulatory standards.
Graduated with BSc in Biomaterial and tissue engineering and MRes in regenerative medicine from University of Manchester. Working as a pharmaceutical scientist in Seda since 2020. Focus on analytical and formulation development for both preclinical and clinical studies.
Job Titles:
- Registered Pharmacist With a
Wang Wang Lee is a GPhC registered pharmacist with a PhD in Pharmaceutical Sciences and MBA from the University of Strathclyde. She has deep industry and academic experience particularly in the areas of biopharmaceutics and product development. Her expertise in early and late-stage development, risk assessing and mitigating the development challenges has helped clients transition compounds into the clinic from discovery.
Wendy is a pharmaceutical microbiologist with 30+ years experience with former employer Astrazeneca, where she worked in product development and was responsible for the microbial control strategy for all formulation types including complex parenterals. Prior to Astrazeneca, Wendy worked as a medical microbiologist in the NHS. She also has experience of CMC documentation, quality assurance and microbial small scale fermentation.
Expertise:
Analytical Sciences
CMC Regulatory
Zhixin got her BSc in Clinical Pharmacy, MSc in Model-based Drug development from University of Manchester. She specialises in project background understanding, population PK modelling and also has experience with preclinical PK-PD-TGI modelling and support to build model for human translation, which helps to the first in human dose selection. Zhi-Xin Jiang - Google Scholar