aCGT Vector

aCGT Vector are a cell and gene therapy company that are increasing patient access to precision medicines by co-locating its standardised state of the art therapies-as-a-service PODs - with closed system digitised automated pharma operation platform, in hospitals with cancer and rare disease expertise.

Chief Executive Officer and Co-Founder

Gmacpharma

CMC Expertise - early engagement towards success with an our team on your in-house or CDMO partnering commercialisation and digitalisation strategy.  We work closely with you to accelerate your Pharma Biotech drug product business from Start up to Ramp Up. Specifically in the following key areas, from late stage product development P2/3 to commercial manufacturing, packaging, serialisation and funding: 

• Attainment/maintenance of HPRA/EU/FDA manufacturing license
• Robust NDA submission and tech transfer package assurance first time right
• CDMO's scorecard selection and management
• Site capacity planning for incoming NDA’s including cleanroom plant design and build and  organizational right-sizing for growth/consolidation
• Organisational PAI site preparation
• Validation and launch strategy & execution 
• 1to1 executive team coaching 

We also work with Pharma Biotech clients to accelerate their business growth, target strategic Lifescience business opportunities and implement measures to realise them, whilst maintaining a compliance focused organisation.  Specifically in the following key areas:

• Development and execution of company growth strategy and organisational visioning
• Assessment, valuation and structuring of your drug product pipeline, towards a commercialisation timeline to facilitate total alignment of the organisation's resources and assets
• Execution of risk based drug product pipeline candidate selection process
• Acquisition targeting for sustainable growth
• Pharma Biotech ERP (SAP) organisational implementation in a GMP controlled manner
• Development and execution of facility and technology asset CAPEX program to drive growth
• Acting COO to strengthen your leadership
team for growth and/or due diligence 

Our aim is to help accelerate safe and efficacious medicines in to the hands of patients more quickly, helping clients to identify and commercialise drug candidates more effectively through a strategic stage-gate innovation process.

Managing Director and Principal Consultant

Trinity College Dublin

Working in an advisory capacity to further connect the M Pharm with the Pharma Biotech Industry

Professor (Adjunct) School of Pharmacy

AmerisourceBergen

We offer quality, compliance and training services & products across the full product lifecycle covering development (GMP & GCP), tech transfer, production (GMP), supply chain (GDP), post marketing (pharmacovigilance and marketing compliance) and Marketing Authorisation Holder (MAH) compliance. We can help you to design or upgrade your Quality System; we can perform Quality Risk Assessments and mock regulatory audits of your operations against best practice standards and regulatory compliance requirements; we can train you & your colleagues in current GxP standards.

Principal Consultant (Development & Commercialisation)

Merlin Consultancy

Management Consultancy for Lifesciences sector in Scotland and Ireland

Associate

Lonza

As Site Operations Director, held responsibility for ensuring GMP compliance whilst undergoing commercialisation of a strong R&D pipeline of hard gelatine pharma biotech products for a wide range of illnesses, working to MHRA and FDA standards.

Director Site Operations

GMAC Pharma Ltd.

We work closely with you to accelerate your Pharma Biotech drug product business from Start up to Ramp Up. Specifically in the following key areas, from late stage product development to commercial manufacturing, packaging and serialisation:

• Attainment and maintenance of HPRA/EU/FDA manufacturing license
• Formulation of robust NDA submission and tech transfer package to ensure first time commercialisation success of your drug product pipeline - using a formal tried and tested roadmap approach 
• Management of CDMO's
• Site capacity planning for NDA commercialisations, including cleanroom / plant design and build 
• Organisational PAI site preparation
• Validation and launch strategy execution 
• Scaling your operation to transition smoothly from development 
• Preparing for increased complexity from heightened volumes or multiple drug product delivery platforms

We also work with Pharma Biotech clients to accelerate their business growth, target strategic Lifescience business opportunities and implement measures to realise them, whilst maintaining a compliance focused organisation.  
Specifically in the following key areas:

• Development and execution of company growth strategy and organisational visioning
• Assessment, valuation and structuring of your drug product pipeline, towards a commercialisation timeline to facilitate total alignment of the organisation's resources and assets
• Execution of risk based drug product pipeline candidate selection process
• Acquisition targeting for sustainable growth
• Pharma Biotech ERP (e.g. SAP) organisational implementation in a GMP controlled manner
• Development, execution and leveraging of capital facility and technology asset investment program 

Our aim is simply to put safe and efficacious medicines in to the hands of patients more quickly, helping our client to identify and commercialise drug candidates more effectively through a strategic stage-gate innovation process.

Managing Consultant (Lifescience Business Acceleration, Drug Development & Commercialisation)

Microsoft

Company project exploring new product innovation; developing a roadmap for new product development, applicable to multiple industries. This was based on the principles of R G Coopers Open Innovation model, adapted to incorporate best innovation practice in multiple global industries that demonstrate effective sustainable fail fast fail early success in identifying product viability earlier.

Management Consultant (MBA)

Commercially applied learning across organisation function general management principles within a practical application high performance team setting through real world company based assignments. 

Term 1 (Sept. – Dec. 2013) deliverables; in addition to practical study of our first eight examined general management modules, team developed comprehensive business plan for a start-up venture; GMAC Pharma.                                                                                                                                                                  Term 2 (Jan.- April 2014) deliverables; in addition to our phase I industry analysis of our elected multinational company project to provide solutions to the leadership to overcome an agreed strategic challenge and the practical study of a further eight examined general management modules, our team developed a comprehensive marketing strategy plan for start-up venture; GMAC Pharma including website www.gmacpharma.com as part of our digital marketing strategy.                                                                      Term 3 (May – August 2014) deliverables; having immersed and been examined in sixteen different general management principles, the final term focused on application of these principles to the start-up company (gmacpharma), an elected scale-up company, an elected social entrepreneurship company and the overall elected multinational company, the culmination of the MBA program.                                          
Course outline of general leadership skills enhanced; negotiations, developing international high performing teams including professionals and other smart people, strategic management, accounting principles, international finance & financial analysis, quantitative statistical analysis & reporting, organisational behaviour, management organisation, global economics, international business, strategic marketing, strategic human resource management, managing information systems.

Allergan

Leader of Irish Division of the Global Tech Services Group, our Dublin Team Manages Tech Transfer and Commercialization of the in-licensed R&D Pipeline Product Portfolio, Technical Support & ongoing Enhancement of the Manufacturing Site's Marketed Products, Qualification of 2nd Source CMO's for all key products and Tech Transfer of Mature Products to 3rd party CMO's.

Global Technical Services Director

Responsible for all Manufacturing across two plants in Dublin employing approximately 230 people.
In-licensed FDA Pharmaceutical branded Oral Solid Dose and Dry Powder Inhaler products for the treatment of IBS, COPD, Depression, MRSA, Asthma,  Cardiovascular, Alzheimer; all developed and manufactured at two FDA and IMB approved facilities in Ireland and at third party CMO's around the world, marketed and sold in the US and Europe.

Operations Director

I built up and developed a 120 strong manufacturing and technical services group that supported the production of over 2 billion tablets, capsules and dry powder inhalers on an up to three cycle shift operation across two plants with over 50 production suites.

Manufacturing Manager

Development and Tech Transfer of in-licensed pharmaceutical solid dose form products, processes and technology from the US to Ireland.

R&D Manager

Passionate about pharma biotech CMC commercialisation and growing the evolving area of ATMP precision medicines where CMC expertise is helping to overcome the challenge of the manufacturing bottleneck restricting patient access to Cell and Gene Therapies and Vaccines. Digitalisation enablement being a key component of our services offering.

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