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    • Information Risk and Cyber Security - Pharmaceutical Industry in India
      Information Risk and Cyber Security - Pharmaceutical Industry in India Chandra Prakash Suryawanshi, SVP , Deepak Simon, Solution Advisor, IAM, and Anand Mohan Nair, Lead Consultant, Risk Advisory. Recorded: Jan 2 2017 12:10 pm UTC 59 mins
    • The Pharmaceutical sector is one of the top targets for data threats. According to a 2015 survey by Crown Records Management, a global consulting company, 2/3rd of pharma companies have suffered serious data breaches while 1/4th have been hacked!

      The primary reason for the threat is Intellectual Property (IP). The pharmaceutical sector is rich in intellectual property (IP) and research & development (R&D) of new drugs and medicines, the loss of which can significantly impact a company’s future. IPs targeted could be multiple across drug discovery programs, clinical development programs, drug registration applications, molecular formulae, patient records, production processes, manufacturing records, quality assurance and compliance data.

      Also compromises in trial information or quality of product can seriously dent credibility of the company's brand and products. It can also lead to serious penalization by regulatory authorities.

      Today, given that Indian pharma companies are an integral part of the global pharmaceutical ecosystem, they are not insulated from what is happening globally as can be seen from the recent happenings.

      As per ASSOCHAM study, India's domestic drug formulations market is likely to cross $20 billion by 2018-2019 from a level of about $11 billion in 2013-2014.

      A 2015 survey by KPMG related to India's Cyber-crime said that 44% of respondents believed that the pharma sector was a target for cyber-criminals. The primary reason being financial (65% respondents), but the close next was corporate espionage (46% respondents).

      As obvious, there are outside threats, but also insider and business partner threats, because this industry has some of its most sensitive data often scattered across locations, sometimes with multiple partners.

      In this webinar, learn about information risks in the pharma industry, and how to mitigate them by focusing on very specific areas.

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    • Single-Use Stainless Steel BioReactors: Quality Factors for Consideration When S
      Single-Use Stainless Steel BioReactors: Quality Factors for Consideration When S Dr Trevor Deeks, Principal and Consultant of Deeks Pharmaceutical Consulting Services, LLC Upcoming: Nov 8 2017 3:00 pm UTC 75 mins
    • Single-use (SU) systems are now in common use in pharmaceutical bioprocessing, as well as in other related technologies such as the manufacture of diagnostics and other biological products, and their popularity is increasing. Some types of SU systems have been in use for many decades now. The earliest SU systems being disposable filter cartridges that do not require a stainless steel (SS) filter housing. This present article seeks to focus in particular on SU bioreactors for cell culture and bacterial fermentation for the purpose of producing therapeutic proteins, monoclonal antibodies and vaccines. SU bioreactors are of particular value in early phase (Clinical Phases 1 and 2) GMP manufacturing. In some cases their use has now stretched through into commercial processing, albeit that the scale of operation is currently limited and in general the largest commercially available SU bioreactors are around 2000L working volume (WV). However, the small footprint that they require, and the reduction in investment needed for support services and utilities, means that the scale limitations can be overcome to a significant degree by having multiple SU bioreactors operating in parallel within a facility. The harvest from multiple bioreactors can be pooled for downstream processing, or each harvest can be processed as a separate batch, based upon considerations of the risks versus the economies of pooling.

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    • Pharmaceutical  Manufacturing in the 21st Century-From Batch to Continuous Manuf
      Pharmaceutical Manufacturing in the 21st Century-From Batch to Continuous Manuf Dr Sau (Larry) Lee & Dirk Leister Recorded: Jun 15 2016 1:00 pm UTC 76 mins
    • The FDA’s Office of Pharmaceutical Quality (OPQ) is working to encourage the development and adoption of emerging technologies in the pharmaceutical industry that have potential to enhance drug product quality. To achieve this goal, OPQ established the emerging technology team (ETT) program and focuses on advancing regulatory science for emerging technologies. OPQ has identified Continuous Manufacturing as one such emerging technology which has the potential to increase the efficiency, flexibility, agility, and robustness of pharmaceutical manufacturing. The ETT provides industry early engagement opportunities with FDA to receive feedback on potential technical and regulatory issues and FDA’s recommendations for regulatory submission content related to continuous manufacturing and other emerging technologies. In addition, OPQ has started a regulatory science and research program on continuous manufacturing to address remaining gaps in our knowledge and experience. Our research program is currently focused on the following areas in (1) integrated process modeling, (2) understanding of the impact of material properties, and (3) implementation of advanced process control strategies and real time release testing. The results and knowledge developed in this program can be utilized to support the implementation of continuous manufacturing and to ensure that FDA regulatory policies reflect state-of-the-art manufacturing science.

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    • Overcome Hurdles to Effective Pharmaceutical Marketing
      Overcome Hurdles to Effective Pharmaceutical Marketing By PharmaGuy, aka John Mack Author, Pundit, Blogger, Editor of Pharma Marketing News Recorded: Feb 18 2016 3:00 pm UTC 45 mins
    • Topics and discussion points include:

       Regulations: What are the most often cited violations? Are pharma marketers getting better at compliance? Cautionary tales – beware of agencies with limited regulatory experience.

       Ethics: Why are ethics in marketing important? What ethical principles should pharmaceutical marketers obey, especially in the digital realm? A bit of history: The eHealth Code of Ethics

       Transparency: Do you have a transparency policy? Is transparency good in theory, but not in practice?

       Patient Power: How are patients affecting pharmaceutical marketing? Mining the views of patients via social media to guide you marketing efforts.

       Digital: How digital media and mobile are disrupting pharma marketing and what to do about it. What digital marketing channels are preferred by physicians?

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    • Pharmaceuticals Market Briefing
      Pharmaceuticals Market Briefing Rathanesh Ramasundram Recorded: Jun 26 2015 1:30 am UTC 62 mins
    • The Asia Pacific is the third largest pharmaceutical market in the world after North America and Europe, with generics being the major driver for the pharmaceutical industry in this region, aided by factors such as the aging population and impending expiry of patented drugs. It is a necessity for pharmaceutical companies to be aware of the key trends in the APAC generics market and maximise the market opportunities in order to remain relevant.

      In today’s rapidly evolving business landscape, pharmaceutical companies are also starting to realise the importance of the customer experience as a key differentiator. With a gradual shift from product to the customer, the pharmaceutical industry needs to keep up with other industries in terms of providing the perfect digital customer experience. A well-executed digital strategy is essential for today’s pharmaceutical companies to better connect with their clients.

      Join us as we discuss these and other key topics.

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    • Making continuous processing a reality in the pharmaceutical industry
      Making continuous processing a reality in the pharmaceutical industry Mark Gibson and Marcel de Matas Recorded: Aug 21 2013 2:35 pm UTC 31 mins
    • The principal benefits of continuous processing are considered to be reduced cost, increased speed, agility and quality. Use of such technology for pharmaceutical products is in its relative infancy despite the existence of appropriate processing platforms. Notable perceived barriers to the use of continuous manufacturing are with the initial capital spend, regulatory uncertainties and low technical competence limiting its uptake. This presentation provides details of early experiences with continuous drug product manufacture in the pharmaceutical industry and identifies areas of focus which is believed will drive adoption of this technology for the benefit of future pharmaceutical production.

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    • SDL Multilingual Pharma Labeling Solution
      SDL Multilingual Pharma Labeling Solution SDL Recorded: May 2 2017 1:15 pm UTC 4 mins
    • Getting global approval for a new drug is extremely complex. One of the most challenging steps is gaining regulatory sign off for all the language versions of drug label information. And, things are getting worse: pharmaceutical companies need to produce an increasing number of labels with ever more detailed content.
      The SDL Multilingual Pharma Labeling solution streamlines the
      many steps of the multilingual labeling process, ensuring timely
      and accurate global drug releases.

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    • Sales reps in the digital age
      Sales reps in the digital age Dominic Tyer Recorded: Jul 9 2015 12:00 pm UTC 76 mins
    • As the number of doctors willing to see pharmaceutical sales representatives in person declines how can digital tools help with access, reach and rep effectiveness?

      One of the factors blamed for the reduction in access was digital preferences – particularly among younger doctors.

      However, digital interactions – though clearly on the rise – can will never entirely supersede face-to-face contact, so how can the industry best get the digital/face-to-face mix right?

      This PMGroup webinar, in association with M3 Europe and Veeva Systems, will look at the place of sales reps in the digital age and how best to support them with digital tools and channels.

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    • Common Technical Challenges with Outsourcing Nonclinical Studies
      Common Technical Challenges with Outsourcing Nonclinical Studies Scott Boley, PhD, DABT, Greg Ruppert, BA Recorded: Sep 29 2016 5:00 pm UTC 61 mins
    • A primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity before entering into human clinical trials. Nonclinical testing is required to evaluate the potential efficacy of a new therapeutic and establish a safe starting dose for initial human clinical trials. Knowing when and where to invest your time and effort in preparing for these nonclinical studies is a critical component of a company’s drug development strategy. Many companies outsource their nonclinical testing to contract research organizations (CROs) and have little to no prior experience in working with a CRO. There are a number of technical challenges involved in the process of outsourcing, which if not taken under consideration, can cause delays and unexpected expenses in developing a compound. These challenges range from determining which species is appropriate for your project to basic formulation and dosing aspects. Being aware of and mitigating as many of these challenges early in the process as possible reduces the potential for delays and allows a company to proceed with increased confidence. This webinar will describe some common technical challenges that we have encountered while working with our Sponsors.

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    • Next-generation KOL Intelligence: Better insight, better outcomes
      Next-generation KOL Intelligence: Better insight, better outcomes Dominic Tyer Recorded: May 13 2015 1:00 pm UTC 61 mins
    • Advances in KOL Intelligence are delivering richer insights into clinical landscapes than ever before. The pharmaceutical organisations which harness these insights to inform strategic planning will be better able to meet the challenges of an increasingly competitive and complex environment for KOL Engagement. There’s a wealth of information out there, but it’s not all about Big Data – it’s about smart data and insight that you can easily act on.
      Is your KOL Intelligence a mass of data, or is it a tool that broadens your understanding of influence and helps you make smarter decisions? Can you confidently identify who’s suitable for ad boards? Are your network maps simply impressive graphics, or a tool for better engagement? Or are you new to KOL intelligence and looking for guidance on where to begin?
      As the pioneers of KOL mapping and the UK's leading KOL intelligence agency, we believe the strength of our work doesn't simply lie in the quality of our research, but in how we help our clients understand it. If you’re new to KOL intelligence we’d like to show you what you can learn. And if you already know how valuable it is, you’ll understand how important it is to stay on top of the latest trends in KOL analysis.
      On May 13th, at 12pm (GMT), in association with PMLiVE, Kendle Healthcare will host a free webinar, “Next-generation KOL Intelligence: Better insight, better outcomes”, which will help you understand how to use KOL intelligence to make better-informed decisions. Our webinar will be interactive and we welcome any questions you may have.

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    • A Practical 2D-LC System Developed for Complex Pharmaceuticals
      A Practical 2D-LC System Developed for Complex Pharmaceuticals Lianjia Ma, Ph.D.* and Anthony Alexander, Ph.D. Recorded: Mar 23 2011 3:00 pm UTC 31 mins
    • A comprehensive two-dimensional liquid chromatograph (LC × LC) was constructed from commercially available conventional HPLC equipments. This system utilizes two independently configurable 2nd dimension binary pumping systems to deliver independent flow rates, gradient profiles and mobile phase compositions to dual Fused-Core secondary columns. Very fast gradient separations (30 seconds total cycle time) were achieved at ambient temperature without excessive backpressure and without compromising optimal 1st dimension sampling rates by using superficially porous stationary phases. A practical approach to optimize the various inter-related instrumental parameters will also be presented.

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    • Designing unique patient solutions in rare disease
      Designing unique patient solutions in rare disease Clare Bates Recorded: Jul 15 2014 1:00 pm UTC 51 mins
    • Living with any chronic health condition can be demanding, but rare diseases bring a unique set of challenges for patients.

      These can range from diagnosis difficulties to limited information and support, a lack of knowledge - even within medical services - and social stigma. Such challenges negatively impact patients and carers - preventing the best possible health outcomes from being achieved.

      This webinar will help pharmaceutical companies understand how they can better address the unmet needs of such patients.

      On Tuesday 15 July at 2pm this free event will feature a health psychology specialist and a patient research expert, who will discuss how a ‘belief-based’ support approach can be delivered.

      The webinar will also investigate how a long-term strategy that accommodates the changing support needs of individual patients from childhood to adulthood can be delivered at a global level – while still resonating at an individual level for patients.

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