claude, Author at PHETAIROS

Dr Stephen Bingham CEng, FIChemE Chemical Engineering

08/05/202108/05/2021 by claudeNo Comments

Stephen studied Chemical Engineering at Bradford University, gaining an MSc and then an at Unilever gained an external PhD for his work on developing new scale-up methods for Agitated Ball Mills. Over the last 35 years Stephen has lead projects that have made step changes to manufactured product quality and manufacturing efficiency; applying science and a fundamental understanding of engineering principles to make products better, faster and cheaper. He was recently voted a Fellow of the Institute of Chemical Engineers. He has worked in the food, FMCG and OTC Healthcare sectors, leading projects ranging from fundamental up-stream technical research through process development to plant design/build and running production departments on 2 factory sites. Unless you have lived as a hermit, you will almost certainly have had your life improved by using a product he has formulated or that has been manufactured on one of the plants he has designed, built or run: be it applying VapoRub to soothe a cold, eating chocolate,...

Dr C Mike Perkins Mb Chb Mrcp Md Frcp(E) Ffpm

15/04/202115/04/2021 by claudeNo Comments

An experienced professional who engages effectively at the highest levels of the Pharmaceutical Industry, Government, the Medical Profession and Academia. A strong and effective leader providing strategic direction and inspiration whilst achieving results through teamwork and empowerment. Has brought more than 20 new commercially successful drugs to the market and has worked with over 250 New Chemical Entities [NCEs]. Extensive experience of working with E.U., U.S. and Japanese regulators and health care professionals. Possesses in-depth knowledge of drug development from research through Phase 1-3, Phase 4 and line extensions/new indications. He has managed clinical and preclinical programmes to proof of mechanism and proof of concept. Established development and medical functions including quality systems, 21CFR11 compliant document management system and GCP compliant outsourcing practices. ...

FMCG, Functional Head R&D

12/02/2021 by claudeNo Comments

Phetairos provided key strategic and operational insights against an initiative focused on bringing together physically disparate global teams to align values and work product, while identifying opportunities for efficiency gains. These services were very helpful for us as they laid a solid foundation for future business growth....

Patricia Barclay, BCL LLB Law

03/02/202103/02/2021 by claudeNo Comments

Patricia studied law at Edinburgh and Oxford Universities and qualified as a solicitor before starting her life science career at Pfizer first in the UK and then in New York. She returned to the UK to take up the position of General Counsel at Vernalis PLC before moving to Denmark as GC of the Ferring Group a position she subsequently held at Solvay Pharmaceuticals in Belgium before returning to the UK to set up her own law firm specialising in the life sciences. She has hands on experience of the pharmaceutical, medical device, animal health and cosmetic industries working with both traditional products and those involving genetics, IT, AI and photonics. Her work has been widely recognised. She is listed as a leading individual in Chambers Legal Directory for Life Sciences and by Legal 500 for Intellectual Property and is one of only a handful of UK lawyers honoured with a Fellowship by the American Bar Association. She is a...

What is the Blue Line?

14/01/202111/04/2023 by claudeNo Comments

The 'Blue Line' is a tool that helps you visualise how well your organisation is positioned to run projects successfully. It's a plot of a generalised level of your project management (PM) capabilities, against your company size, and/or the number of projects ('portfolio size) that you are running right now. At it's most straightforward, where these points intersect, are you on the line? An organisation on this line is in perfect balance - where the capabilities have developed to best facilitate delivery of any project or a portfolio of projects. These capabilities need to change as the size of the organisation changes as well as with evolving context. However, we’ve seen many companies that don’t have this balance right. Small organisations may struggle if they don’t evolve to stay on the line. Equally, others may set over-ambitious goals for sophistication, when ‘good’ is perfectly adequate. What do we mean by project management capabilities? If you have experience working in a large company's project management office (PMO), you may well be able to develop a rounded view of the PM capability level of your...

Target Product Profiles in Drug R&D – Regulatory Profiles

09/01/202117/01/2021 by claudeNo Comments

Regulatory Target Product Profiles (RTPPs) RTPPs describe the aims of a drug development programme in terms of labelling concepts. They can be used by regulatory agencies to quickly see the claims the developer is aiming for with a new drug and therefore the data, experimentation and clinical trials needed to support these claims from the regulatory perspective. An RTPP is a valuable reference document that helps the drug developer and regulatory agency understand the entire drug development process, from pre-investigational new drug application (pre-IND) through post-approval programs to pursue new labeling claims or indications. An RTPP is not a necessarily a fixed description of the aims of drug development but may change as more becomes known about the nature of the drug under development. Possible sections of an RTPP could include: Therapeutic area Indications and usage Patient population Dosage, dosage form and administration Claims and labelling Clinical pharmacology Proposed clinical programme and data to be provided Toxicology programme and data to be provided Contraindications and drug interactions Adverse reactions Warnings and...

Target Product Profiles in Drug R&D – Emerging profiles

09/01/202117/01/2021 by claudeNo Comments

Emerging TPPs As a drug moves through development its properties, activity and effect on disease are revealed. ETPPs are used to summarize these aspects for the drug given the current understanding of the drug’s performance and how they align with the critical elements of the Aspirational TPPs. ETPPs typically describe the value critical aspects of the drug from the developer’s perspective - which may be the potential usage and uptake in patients for a commercial drug developer, or how the drug can enable access to hard to reach neglected diseases from a not-for-profit drug developer, or even how the approach may drive the science in a new area and foster innovation from a more academically focussed developer. ETPPs should cross reference the critical requirements of the ATPPs, unless the drug in question is in a new and unexpected area where no ATPP exists. Some examples of the elements of ETPPs are: Efficacy and toleration profile Number of hospital days saved Sttability data for the formulation...

Target Product Profiles in Drug R&D – Aspirational profiles

09/01/202117/01/2021 by claudeNo Comments

Aspirational Target Product Profiles (ATPPs) ATPPs provide the context for and set targets along a range of key criteria that are required to be met for a new treatment. They are constructed with the needs of patients, physicians, payers and the developing organization in mind and thus require an in-depth understanding of those needs. They are intended to be fixed, and will not change as the properties of any new treatment become known. In this way they set out the aims of a drug development programme and act as a guide to focus efforts and set targets. The key requirements for the treatment may not be expressed through efficacy and safety alone. For example, the treatment may be needed to reduce the number of days of hospitalized per year, it could provide a more stable formulation that permits flexible transport and storage, it could lead to less frequent dosing which provides improved compliance, or it may deliver a reduced potential for abuse. These key criteria will be...

Target Product Profiles in Drug R&D – Introduction

09/01/202125/01/2021 by claudeNo Comments

Target Product Profiles (TPPs) are descriptions of key features needed in a new treatment for a disease and are used to guide and drive drug research and development. They can save time and aid communication with regulatory agencies, they can provide direction for drug development programmes, they can help to stop inappropriate drug development and save resources, they can point the way to the critical experiments, and they can summarize drug profiles to varying stakeholders. As we shall see, TPPs have different meaning and structure dependent on usage. Here we intend to explore and clarify. TPPs can be broadly divided into 3 related forms: Aspirational (ATPP). A fixed description of the essential attributes of a treatment for a disease, derived from a wide ranging understanding of the disease in question, the medical and commercial opportunity, the regulatory hurdles, any real or potential competitors, the access and re-imbursement environment, and the goals of the developing organization. Emerging (ETPP). As the drug undergoes trials its properties are revealed. This...