Andrew Kennedy

AmbioPharm, a global peptide CDMO, was founded in 2005 and is headquartered in North Augusta, South Carolina, USA specializing in developing highly efficient peptide manufacturing processes for peptide-based Active Pharmaceutical Ingredients (APIs) at small to very large scales. In our manufacturing facilities in South Carolina, USA and Shanghai, China, we manufacture New Chemical Entities (NCEs) and peptide APIs under cGMP for clients worldwide. Both facilities have been inspected multiple times by the FDA with excellent outcomes.

Founder of an independent peptide synthesis consultancy company. PeptEd provides peptide synthesis consultancy services and solutions to the pharmaceutical and biotech industries, helping those looking to grow their peptide services and capabilities. We offer guidance and advice in areas such as: - Solid phase peptide synthesis process development - CMC guidance for large-scale GMP manufacture - Instrument selection and procurement - Laboratory design and process workflows - Regulatory compliance - Business strategy

CPC Scientific Inc. is a CRDMO specializing in synthetic peptide production and therapeutic development. Responsible for enhancing, extending and maintaining CPC’s NCE Peptide and Oligo GMP pipeline. Focus on building and maintaining long term business relationships with existing customers and actively seeking new clients. Responsible for delivering CMC documentation for projects entering preclinical, phase I/II/III clinical trials and commercial manufacture.

Achilles Therapeutics is a biopharmaceutical company developing novel cancer immunotherapies targeting clonal neoantigens: protein markers unique to each individual that are expressed on the surface of every cancer cell. Achilles uses DNA sequencing data from each patient, together with a proprietary bioinformatics platform, to identify clonal neoantigens specific to that patient and enable the development of personalised cell therapies. Targeting multiple clonal neoantigens that are present on all cancer cells, but not on healthy cells, allows individualised treatments to target and destroy tumours without harming healthy tissues. Responsible for leading, coordinating and executing process development and manufacturing programs for a newly formed peptides team within Achilles, aiming to manufacture personalised cancer therapeutics. Responsibilities included: - Managing the detailed design phase of a new peptide manufacturing site based in Hayes, London. Detailed planning of 5,000 sq ft of lab space and personnel & material flows. - Managing the peptide manufacturing process, analytical protocols and QA activities. - Establishing production strategy, processes and documentation for the synthesis of peptides and their QA release. - Submission of IMPD documentation relating to neoantigen peptides.

Formed by the merger of Gyros AB (founded in 2000) and Protein Technologies, Inc. (founded in 1985), Gyros Protein Technologies AB is a leading provider of solutions for peptide synthesis and bioanalysis. Now part of Mesa labs Inc., our focus is on helping scientists in academia and industry to increase biomolecule performance and productivity in research, drug discovery, pre-clinical and clinical development, and bioprocess applications. Sole Product Manager for the peptides business of GPT covering all international territories and distributors. Responsible for managing the peptide synthesizer, consumables, reagents and service product portfolio from concept to launch. Responsibilities included: - Managing the verification and validation roadmap for synthesizer design, development and manufacture (ISO13485, 21CFR 820, 21CFR Part 11) - Applying strategic initiatives to the business unit to achieve double digit growth. - Manage the launch of new products and product lines.

Senior position within the product management team of a market-leading manufacturer of peptide synthesizer instruments and consumables. Responsible for developing novel applications and methods for peptide synthesis as a means to market and for promoting the use of GPT instruments in the industry.

Calcivis is an innovative medical devices company focused on revolutionising the management of dental caries or ‘tooth decay’ and enabling preventive dentistry. The Calcivis® Caries Activity and Demineralisation Imaging System will, for the first time, allow dentists to ‘see’ active demineralisation, key to caries and other conditions such as acid erosion. Lead scientist managing the development, verification, and validation program for a novel intraoral camera, including regulatory submission for US and EMEA commercial launch. Responsibilities included: - Managing the V&V roadmap and tasks to ensure successful regulatory submission. - Managing multiple projects and external contractors to develop the prototype device, improved second-generation product and associated accessories.

- Process development of cGMP peptide manufacture (mg to kg scale). - Incorporation of novel methodologies and techniques for both upstream and downstream processing. - Control and monitoring of process technical transfer to the GMP manufacturing facility. - Creation, completion and review of SOPs, process descriptions and batch records for manufacture carried out within facilities regulated by the FDA and MHRA.

Cambridge Research Biochemicals is a global manufacturer, based in the North East of England, and a supplier of high quality contract peptides and antibodies for medical research. Responsibilities included - Maintaining existing key international accounts in both the UK and Europe, whilst creating new key accounts in the Pharmaceutical R&D, and Biotech sector including Research Institutes and Academia. -Growth of the CRB business by establishing new customers and delivering targets of custom peptide and antibody sales within strategic locations across the UK and Europe.

- Development of novel blood glucose monitoring systems within the Blood Glucose Monitoring Group. - Process improvements to existing product manufacture - Development of novel BGM technologies and commercialisation through product characterisation and verification/validation testing for FDA and DEKRA regulatory submission. - Application of process excellence/Six Sigma development tools and training.

- Process development and scale-up manufacture of peptides and synthetic APIs under cGMP conditions. - Management of multiple projects and participation in multidisciplinary teams across the company to achieve successful product release for Phase I/II/III clinical trials. - Creation of manufacturing directions, SOPs, process descriptions and technical reports, as well as review of batch records during manufacturing campaigns. - Supervision of junior chemists and production staff within the GMP manufacturing facility.

- Contract research and manufacture of synthetic peptides, chemokines and biomolecules in a high-throughput production setting under both GMP and non-GMP conditions. - Participation in cross-functional teams between chemistry, biology, production and QA. - Management of catalogue stock peptides including the introduction and marketing of new products. - Management of continuous improvement initiatives as well as the setup of a new GMP laboratory.

Thesis: "Biomimetic Models for Redox Enzyme Systems". Three-year PhD research project investigating non-covalent interactions within model enzymatic systems, specifically those involved in redox processes. A combination of synthetic organic, physical and computational chemistry techniques were used to study these interactions taking place within various synthetic models of naturally occurring biological enzymes. Publications: S. S. Agasti, S. T. Caldwell, G. Cooke, B. J. Jordan, A. Kennedy, N. Kryvokhyzha, G. Rabani, S. Rana, A. Sanyal and V. M. Rotello, Chem. Commun., 2008, 35, 4123. B. J. Jordan, Y. Ofir, D. Patra, S. T. Caldwell, A. Kennedy, S. Joubanian,G. Rabani, G, Cooke, and V. M. Rotello, Small, 2008, 4, 2074. B.J. Jordan, M. A. Pollier, Y. Ofir, S. Joubanian, J. G. Mehtala, C. Sinkel, S. T. Caldwell, A. Kennedy, G. Rabani, G. Cooke and V. M. Rotello, Chem. Commun., 2008, 14, 1653.

MChem in Chemistry with Computer Science. Computational Chemistry Masters Project: "A Theoretical Study of the Selectivity in the Activation of Inert Chemical Bonds". Final year research project using theoretical quantum calculations, specifically Density Functional Theory (BP86) to investigate inert bond activation in model N-Heterocyclic Carbene (NHC) containing ruthenium complexes. Publications: R. A. Diggle, A. A. Kennedy, S. A. Macgregor and M. K. Whittlesey, Organometallics, 2008, 27, 938.