Outsourcing-Pharma Podcast: Recent Episodes
William Reed Business Media
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.
Bend Research is “actively” hunting new partnerships similar to its recent alliance with Dow.
Capsugel has expanded its Licaps liquid fill capsule line with a new facility in the US.
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.
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.
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.
Continuous manufacturing offers significant advantages for drug production in terms of quality and efficiency, but more research and regulatory input is needed to help the pharmaceutical sector reap the benefits according to ISP.
LB Bohle says healthy level of demand for processing technology demos at its recently opened service centre is an indication of processing tech market recovery.
ATMI LifeSciences has introduced a new method of integrity testing for its range of single-use bioprocess vessels that, it claims, will take QA in the biomanufacturing sector to a new level.
Next month the United Nations Conference on Trade and Development (UNCTAD) will organise a meeting to discuss ways of encouraging the production of pharmaceutical in Africa.
CRO and Pharma patient recruitment efforts can benefit from social networks and online patient groups, but clarification from the US FDA is still needed.
The mix of materials in confidential biopharm waste is a recycling challenge but also an opportunity to cut “ever increasing” landfill costs.
Contract packagers will lose deals if they fail to adapt to biopharm outsourcing “more and more” serialisation work, according to CEO of Covectra.
Clariant International has set up a unit to help the pharma sector overcome regulatory hurdles involved with developing colour packaging
Big pharma has taken a less heavy handed approach to relationships as cutbacks have made outsourcing key, according to Stephen Munk, CEO of Ash Stevens.
Solvent selection and solid loading are critical to optimising the spray drying process and unlocking its solubility-enhancing properties for drug production according to a new report by ISP Pharmaceuticals.
Kerri Weingard, research director for Accumed, says the growing numbers of patients enrolling in multiple clinical trials are threatening the integrity of the clinical development process.
Almac invests $4m in biocatalysis R&D, describing such technologies as the way forward for the cost efficient production of highly chiral APIs and intermediates.
Recipharm says changes to Big Pharma and drug industry globalisation make having a worldwide manufacturing reach a virtual necessity for CDMOs.
Mark Weinstein, CEO of Bioclinica, has hit back at a public letter from Nicusa Capital CEO, Paul Johnson, claiming that the company's corporate strategy is 'flawed' and demanding the resignation of three top executives.
Adoption of electronic submission by regulators around the world is good news for drugmakers’ efforts to access emerging markets says industry expert Kate Wilber.
The US FDA’s risk evaluation mitigation strategy (REMS) can be a challenge for pharmaceutical companies unfamiliar with the process according to PPD’s executive director of risk management Frank Gallo.
Addressing the drug industry's need to demonstrate value to stakeholders presents a significant opportunity for service providers, according to Jim Featherstone, VP of Quintiles' commercial arm.
Clinical data management is, and will continue to be a key concern for the pharmaceutical industry, according to Susan Bornstein, executive vice president of eClinical solutions, who discussed the issue with Outsourcing-pharma earlier this week.
Scientists say counterfeit drug and ingredient detection using NQR could benefit both manufacturers and pharmacies.
Patient recruiters and national regulators must learn from each other to better understand outreach tactics and how they fit with a country’s ethics and laws.
Tracking “non-content” metadata is an important part of any pharmaceutical submission, yet many drugmakers fail to take an integrated approach to the task according to regulatory expert Kate Wilber.
Biomarkers are critical to discovery and can help pharmaceutical firms make development a more efficient and cost effective process accord to bioanalysis services provider KCAS.
Almac says an effective biomarker strategy boosts a drug candidates’ chance of success and can ultimately add value to a developer’s business by opening door to diagnostics.
The Asia Pacific trial sector grew during the global economic downturn as sponsors sought to improve access to patients, cut costs and improve data quality according to Novotech CEO Alek Safarian.
Proposed changes to USP chapters 232 and 233 on trace impurities would increase drug industry use of automated analysis, creating “huge number” of potential new customers says Thermo Fisher Scientific.
In the first of a series of special in-pharmatechnologist podcasts Kate Wilber, Image Solutions’ (ISI) director of regulatory Services, Europe discusses the emerging trends in BPO and talks about how it can benefit drugmakers.
eResearchTechnology (ERT) says self-rated IVR technology can help clinical trial sponsors meet “suicidality monitoring” requirements.
Demand for drug discovery services is growing again according to Domainex, who predicted that we will see greater pharmaceutical industry reliance on specialist CROs going forward.
CRO Quintiles says biomarkers give insight into cancer drug candidates’ efficacy earlier in the development process, reducing trial costs and duration.
Quintiles’ Jay Norman tells Outsourcing-pharma that data sharing and patient and payer concerns will drive drug industry competition and clinical development decisions accord to new research.
The role of the pharma industry in supporting the COE anti-counterfeiting treaty, which aims to criminalise activities, “cannot be underestimated”, according to a directorate member.
Increased focus on post-market safety and value has resulted in CROs handling more Phase IV work, according to a PharmaNet EVP, and this trend may continue as regulators seek real world evidence.
Russia, the Ukraine and Belarus have emerged as destinations for clinical studies and now offer “enormous” potential according to US-based CRO ClinStar.
Recipharm CEO Thomas Eldered reflects on RecipharmCobra Biologics (RCB) launch, telling Outsourcing-pharma that US is key market.
Liquent and Take Solutions say their new partnership provides pharmaceutical firms with an efficient, cost effective outsourced solution for regulatory publication and submissions.
CEO Steffen Mittwich updates in-PharmaTechnologist on Atacama Labs' pneumatic dry granulation (PDG) API processing tech, its deal with German CMO Excella and future development plans.
INC Research is partnering with invivodata to add ePRO to its offering, selecting the eClinical firm over its competitors in part because it understands the “aggressive” approach the CRO takes.
E Research Technology (ERT) launches Centralised Cardiac Safety 2.0 (CCS 2.0) service for ECG data and says approach improves efficiency, cuts costs and helps sponsors reach database lock quicker than distributed model.
Contract services giant Quintiles has continued its expansion in Africa with a new clinical research services office in Nairobi, Kenya.
An adaptive approach to both the design and operation of a clinical trial can boost efficiency, reduce timelines and cut costs says Health Decisions' CEO Michael Rosenberg.
Payne Security has acquired BP Secure Solutions, adding the UK firm's roster of adhesive security labelling technologies to its drug industry offering.
SAFC Pharma is preparing for the shift towards cell culture-based vaccines, while still supplying and growing in the traditional sector, to ensure it can grow in coming years, according to a company director.
There are signs that 2010 will be a better year for the fine and custom chemistry industry but companies at Informex remained cautious and are planning accordingly.
The impact of the economic downturn is still being felt but SAFC remains "cautiously optimistic" about 2010, believing its close relationships with clients and investment in key emerging markets will generate business.
The capabilities of the MDS Pharma Services' sites Ricerca is set to acquire "perfectly dovetail" with its existing capacity, according to a company vice president.
Clinical trials are often biased against the recruitment of older people says the European Union's PREDICT group, which has launched a charter designed to protect such patients' right to take part.
Improving healthcare infrastructure across the region and a large treatment-naïve patient population makes the Middle East and North Africa (MENA) an increasingly attractive destination for drug trials says ClinTec CEO Rabinder Buttar.
Conducting trials in smaller patient populations when developing personalised medicines poses challenges, such as how to recruit patients fast enough, but these can be overcome using adaptive methods, according to a CEO.
UK contract services firm Quotient Bioresearch says its "Synthesis-to-clinic" service for 14 C labelled compounds can simplify early drug development.
AAPS 2009 has drawn to a close but over the three days numerous trends and debates emerged, including the strategies CROs are using in the downturn, and we take a look at these in our conference round up.
Following the first full day of AAPS 2009 in Los Angeles, California, US we take a look at the major developments and talking points.
As CPhI 2009 draws to a close we take a look back on the show, which, despite some negatives, appears to have been an overall success.
We look ahead to CPhI 2009 which takes place in Madrid, Spain next week and will showcase the world’s leading ingredients, contract services, machinery and biotech companies.
Transcrip Partners’ “augmentation” solution for contract R&D “differs from the normal consultancy alternative by fielding ‘doers’ who can think strategically and ‘thinkers’ who are happy to get their hands dirty” according to senior partner Paul Branthwaite.
US group Thermo Fisher Scientific and industrial engineering giant Siemens have teamed up to offer the pharmaceutical industry a new way of assessing processes used during early drug development, manufacturing scale up and commercial production.
At BIO 2009 Symyx was promoting its new CDMO offering, which it believes meets a “real need in the industry” and can save clients time and materials by leveraging its prior knowledge.
UK CRO Quotient Bioresearch has bought a clinical research facility in Edinburgh, Scotland, which in conjunction with an existing unit in Nottingham, England will serve as a base for its new Quotient Clinical unit.
UK software group Cisiv has unveiled a web-based EDC platform, Baseline Plus, which is specifically tailored to meet the demands of post market trials.
Two recombinant human albumins made by Novozymes' biopharma division have become the first to comply with the USP-NF's recently revised excipient monograph.
Tom Beil, SAFC’s VP of Quality and Regulatory affairs, whose talk on fine chemicals supply was a highlight of last month's DCAT week, spoke with in-PharmaTechnologist about the benefits and risks of working with global suppliers.
Michael Schmitt, president of Alcan Global Pharmaceutical Packaging, believes a recovery in the global economy, the increasing demand for quality and the emergence of markets like India and Brazil will be key drivers for the packaging sector over the next few years.
With M&A activity dominating Big Pharma's agenda at the moment, the contract research market is having to evolve and adapt to the turbulent environmnet. Outsourcing-pharma asked Frost & Sullivan analyst Barath Shankar to offer his opinion on the state of the sector and to predict how it will develop.
This week in-PharmaTechnologist's Pharma Phacts podcast focuses on a nanotechnology method that could produce more effective barrier packaging using less material.
New research suggests that deuteration, the replacement of hydrogen atoms with heavier forms, can alter an API's crystallisation properties and help drugmakers make better more effective drugs.
Late last week the US Department of Health and Human Services (HHS) awarded Novartis a $490m contract to continue work on its cell-culture influenza vaccine plant in Holly Springs, North Carolina, US. in-PharmaTechnologist spoke with Novartis spokesman Matt Stober about the new plant.
Since its inauguration last year, IPEC China has been working to improve the quality of excipient manufacturing in the country. in-PharmaTechnologist spoke with organisation president Nevin Cheng about the steps the body has taken so far and what it will be doing in 2009, including its plans for a new SFDA approved Drug Master File (DMF) scheme.
The timely identification of contaminants in pharmaceutical manufacture can be critical to avoiding costly delays. While it is relatively straightforward to establish the composition of a contaminating particle, determining its origin in the manufacturing process can be much more problematic. in-PharmaTechnologist spoke with McCrone Associates' Heidi Ullberg at this year's AAPS in Atlanta about a light microscopy that can help drugmakers address this problem.
Icon's recent $43.2m acquisition of New York-based Prevalere Life Sciences is the latest part of the firm's expansion in the US CRO market. Outsourcing-Pharma spoke with Icon's VP of bioanalytical development, Brian O'Dwyer, and Prevalere CEO Mario Rocci from a busy AAPS conference in Atlanta.
American Association of Pharmaceutical Scientist's (AAPS) president Dr Karen Habucky sets out the programme for the group's forthcoming annual meeting and exposition, which is being held in Atlanta, US between November 16- 20.