Outsourcing-Pharma Podcast

Changing pills to a more user-friendly formulation can increase patient compliance, brand loyalty, and extend IP exclusivity, says CMO Hermes in an exclusive podcast.

Kemwell CEO Agneta Bergvall says drugmakers' efforts to make pharmaceutical manufacturing green are worth the cost.

Catalent has announced two new softgel solutions as it adds greater versatility to its Advanced Technologies Business Unit.

In the war against counterfeits, regulators have concentrated on serialisation and ePedigree and missed an opportunity on product authentication, according to AlpVision.

Excipient firms that skip lot testing or use alternative analysis methods should justify their decisions according to a new COA guide issued by IPEC Americas.

Risk-based monitoring for clinical trials was a hot topic at this year’s PCT Europe thanks to recent draft guidances from the FDA and the EMA.

The positive impact drug industry demand for quality is having on the fine chemicals sector was evident at industry trade show CPhI last month according to expert Jan Ramakers.

CMO Cobra Biologics says North America is an obvious place to look at for a facility acquisition.

Catalent says making its technology available to industry will not affect its competitive edge.

Capsugel has expanded its Licaps liquid fill capsule line with a new facility in the US.

Bend Research is “actively” hunting new partnerships similar to its recent alliance with Dow.

The proposed changes to European clinical trial regulations accepted by the European Commission (EC) in July will put Europe on an equal playing field, according to Clinipace’s Andrea Schiefer.

Sartorius Stedim says its new range of sterilising-grade filters can allow steam cleaning in dry conditions and minimises protein binding.

Submitting a REMS (Risk Evaluation and Mitigation Strategies) proposal for risky drug developments could earn companies brownie points, according to Quintiles’ Ed Tabor.

Negotiating funding for drugs with local health authorities prior to commercialisation is the key to success for biopharmas working in the changing European market, says Quintiles.

A bigger initial pay-out for REMS means long-term profitability for drugsmakers, says Quintiles Ed Tabor.

The use of home visits in clinical trials could raise the chances of regulatory approval, according to ResearchNurses.co.

Including home visits in clinical trial designs could be the key to patient retention, according to ResearchNurses.co.

‘CROs: look at the entire portfolio, not just the individual project, when planning clinical studies,’ says DIA’s adaptive design scientific working group.

Reduce changeover time on oral solid dose machinery by cleaning equipment offline, Fette Compacting urged drugsmakers at this year’s Interphex.

Advancements in single-use equipment are crucial to the development of the biotechnology industry, according to experts at this year’s Interphex.

SGS has added formulation development to its service offering through the expansion of its laboratory in Illinois.

The European CMO industry could be blocked by over complex layers of regulation, says Frost & Sullivan analyst Aiswariya Chidambaram.

Designing trials around patients’ habits is the key to success in patient compliance, according to online recruitment specialist Rebar Interactive.

Those seeking leadership positions in the pharmaceutical world should take to social networking sites to get noticed, recruitment specialists say.

Regulatory reform was the name of the game at this year’s DIA Euromeeting in Denmark.

Catalent wants to build on its European expansions by replicating the end-to-end drug development services model in emerging markets.

Planning supply chains early is an important part of maintaining margins but is often overlooked by Pharmas too focused on developing the next product in an era of patent expiry says industry consultant.

Aptar Pharma says its new eDevices can help companies gain quicker regulatory approval for their nasal drug products without having to re-do clinical trials.

Detailed market knowledge and an experienced CMO are still critical to successfully developing a biopharmaceutical or biosimilar according to Cobra Biologics.

Excipient makers could save up to 200 man hours with a new industry-driven, third-party audit certification scheme set to launch next week.

Sponsor and CRO perceptions of the quality of outsourced service provision differ markedly according to a study by consulting and survey research organisation, the Avoca Group.

Taste masking plays a vital role in treatment compliance according to Cargill, which has launched a new flavour technology that it claims can make drugs more pleasant to take and help manufacturers save money.

High potency APIs are becoming a key focus of the pharmaceutical business, with drug makers from all areas racing to establish a foothold in the market.

Contract services providers which embed service personnel in pharma companies are becoming more prominent in the industry.

Endeavour Specialty Chemicals has launched a novel range of pyridinyl thioureas designed to cater for growing pharmaceutical industry interest in the development of prion disease treatments.

Almac says growing demand for non-GMP manufacturing work rather than competition was the key driver for expansion of its product development services business.

Asking the right questions is key to giving pharmaceutical industry contract managers the information they need to select the best CRO partners according to the team behind a new performance assessment project.

BASF says solubility and bioavailability will be key focus for its pharmaceutical excipient product development efforts in the next few years.

The human tissue supply industry is under pressure from CROs demanding more complex samples, according to equity analyst Vadim Alexandre.

Pharma industry sponsors want more effective ways of measuring CRO performance according to the team behind a new project aiming to develop a validated set of analysis tools.

Companies outsourcing patient recruitment in emerging markets should have more people on the ground, according to Cutting Edge Information's Shaylyn Pike.

Companies looking to outsource patient recruitment need to think outside the box, says Cutting Edge Information’s director of research Eric Bolesh.

Outsourcing should play a vital role in any patient recruitment strategy, says Cutting Edge Information’s director of research Eric Bolesh.

An evidence-based approach to planning during protocol development is key to successful patient recruitment according to Joseph Kim, director of clinical operations at Shire Pharmaceuticals.

INC Research CEO James Ogle tells Outsourcing-pharma.com that the acquisition of fellow CRO Kendle was about building a presence in emerging trial hotspots and pharmaceutical markets.

Firecrest Clinical has launched a mobile version of its site management and training platform, citing investigator demand for ‘trial in your hand solutions’ and sponsor demand for increased research efficiency.

April saw the publication of the second draft of Excipact, a set of certification standards for third-party auditors of excipient manufacturers.

Parexel CEO Josef von Rickenbach predicts more Big Pharma strategic partnerships.

Pharma needs to learn from other sectors and abandon the multistage development paradigm in favour of a two-stage design and manufacturing model to cut attrition rates.