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home > epc > Spring 2015
PUBLICATIONS

European Pharmaceutical Contractor

epc
Spring 2015

   
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introduction
Editor’s Letter

With compliance deadlines looming, Graham Hughes reflects on the various regulatory updates featured in this issue.
 
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Marketplace & Business
CRO Market

Property Protection


Coller IP’s Robert Gleave highlights CROs’ struggle to maintain their position in such a competitive market. He suggests prioritising an intellectual property protection plan in order to strengthen long-term value.
 
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Outsourcing Models

The Perfect Match


Organisations often rush the preparatory stage when engaging with new suppliers, argues Tim Wright from Pillsbury Winthrop Shaw Pittman LLP. There is much to consider in selecting the right outsourcing model, as each comes with its own risks and benefits.
 
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Collaborative Business Models

Dream Team


In order to accelerate drug timelines, companies should address their current business model. Tom Johnson at Exostar advocates stronger communication with partners, through seamless and secure collaboration.


 

 
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Legal & Regulatory
Identification of Medicinal Products

Hidden Benefits


In mid-2016, the requirements of the Identification of Medicinal Products guidance will come into full effect. Due to their complexity, adhering to these new standards will be no mean feat – Wim Cypers at ArisGlobal tells us how to get the most our of compliance.

 
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Falsified Medicines Directive

Against the Clock


Christoph Krähenbühl of 3C Integrity warns pharma of the need to begin implementation strategies now for the EU's Falsified Medicines Directive. Despite the 2018 deadline and uncertainty surrounding the safety features provisions, some firms risk falling behind and having to withdraw their products from the European market.

 
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Pharmacovigilance

Constant Change


Graeme Ladds
from PharSafer guides companies through the ever-evolving world of pharmacovigilance and considers what is to come in 2015. With key pieces of legislation to be resolved by July this year, there is plenty to keep businesses busy.
 
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Regulatory Management

Informed Decisions


When getting to grips with the increasingly demanding regulatory environment, a holistic decision-making framework can help professionals make sense of the vast volumes of relevant data and lessen the risk of product delay. MakroCare’s Ravi Varahalu and Dr Raju K Dorisetty explain.

 
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Electronic Solutions
Medical Management

Search Engine


Europital’s Mohamed El Malt, Vijayanand Rajendran and Christopher Smith outline the complexity of medical-related issues management in clinical studies – which is often exacerbated by information being transferred remotely and electronically – and propose the use of a global, harmonised platform.
 
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Biomarkers & Drug Development
Precision Medicine

Hitting Targets


Patients are not the only beneficiaries of targeted therapy, as the approach can also reduce timelines and costs. PPD's Holly Hilton and Kenneth Butz recommend the use of biomarkers as a means of improving disease understanding and more specific trial design, as well as taking precision medicine to the next level.


       

 
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Therapeutic Innovation
Immunotherapy

Therapeutic Thought


Although the method has become a focal point of many oncology pipelines, there is a prevailing resistance to utilising immunotherapy. Cedric Francois and Pascal Deschatelets of Apellis Pharmaceuticals state its case for transforming autoimmunity management.


        

 
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Genomic Medicine

Precision Prospects


Genomic medicine is long due its recognition as a potential pharma game-changer, contends IBM’s Heather Fraser. But despite strong market demand, a lack of reported success brings into question whether this approach to targeted therapy will develop further.
 
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Manufacturing Environment
Quality by Design

Making a Difference


Detlev Haack at Hermes Pharma endorses the Quality by Design concept for enhancing pharmaceutical manufacturing. This process encourages the use of novel technology, and can result in reduced cost and project duration.


       

 
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Interview
Q&A: Clinical Processes

Problem Solving


Industry pressures can be turned into an advantage – Andrew Newbigging at Medidata talks data, mHealth technologies and transforming trial processes.
 
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Industry Insight: Outsourcing Trends

Commercial Imperative


Michael Griffith from inVentiv Health tells EPC how businesses can capitalise on recent outsourcing developments, as well as forecasting future trends.


       


 
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Supply Chain Management
Supply Chain Security

Cyber Threat


Extended enterprises have become progressively common within the industry, but with collaboration comes greater systemic risk. Investing in cyber security is crucial to sustaining a resilient and protected supply chain, advises Phil Huggins at Stroz Friedberg.

 
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In Conclusion
In Conclusion

Simply Complex


Graham Hughes contemplates the irrepressible complexity and risk brought on by expanding clinical trials.

 
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Published quarterly in
February, May,
August, and November

News and Press Releases

PCI Pharma Services Announces Agreement to Acquire Sherpa Clinical Packaging

Philadelphia, USA – September 10, 2018 Leading global biopharmaceutical outsourcing services provider PCI Pharma Services (PCI) is pleased to announce the acquisition of San Diego-based Sherpa Clinical Packaging (Sherpa), which expands PCI’s U.S. operations to the West Coast. The acquisition of Sherpa, a provider of clinical trial supply services, further strengthens PCI’s position as a leader in outsourced clinical trial support services. The addition of Sherpa’s capabilities also enables PCI to better support customers from early phases of clinical development through to commercial launch.
More info >>

White Papers

Modifying MDI Canister Surfaces to Improve Drug Stability & Drug Delivery

Presspart Manufacturing Ltd

Hydrofluoroalkane (HFA)-based propellants are widely used in modern metered-dose inhalers (MDIs), due to their lack hazardous and environmentally-damaging effects. However, an HFA's active pharmaceutical ingredient can interact with the canister substrate, causing deposition of the drug to the canister walls, or interact with the solution, causing degradation and resulting in increased impurity levels. Over the past few years, a number of surface coatings have been developed that can be applied to MDI canisters and valve components, to protect the contents from deposition and degradation. More recently, plasma processes have been developed to modify and improve the surface energy performance of a MDI canister. This approach has a number of advantages to alternative coatings but requires careful optimisation to ensure the highest quality finish and MDI performance. Richard Turner, Business Development Director, Presspart Manufacturing Ltd, explains.
More info >>

Industry Events

Clinical Trial Supply East coast 2018

16-17 October 2018, King of Prussia, PA

This unique event brings together leading pharma, device and biotech professionals from across the East Coast region, to collaboratively enhance the clinical supply chain. Over the two days, delegates and speakers will discuss how to select forecasting and planning technology, how to reduce waste in clinical trials supplies, how to choose your packaging strategy, but we will also discover all the new technologies that will disrupt your clinical trials supplies.
More info >>

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