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.
Nearinfrared has a long tradition as analytical technology in pharmaceutical industry. In this article/webinar new applications, technology and improvements in regulatory guidances will be presented which will support further growth of nearinfrared in the pharmaceutical and biopharmaceutical industry.Read more >
Following a decade (or more) of concerted effort by industry, regulator, and academic groups, recent technology investments are now beginning to shape how medicines are being developed and manufactured for the global marketplace. While significant focus has highlighted the emergence of continuous manufacturing processes, three additional trends have also influenced and served as underlying drivers for these technology investments. First, the emergence of scientific advances in targeted biology has created high-value personalized medicines with smaller manufacturing volumes (doses/annum). Second, new regulatory pathways, such as the FDA’s Breakthrough Therapy designation, have accelerated the development and commercialization timelines for these new medicines. Finally, manufacturing localization has extended supply chain networks to serve globally-distributed patient populations throughout the world. Together, these drivers have served to shape the future of pharmaceutical development, manufacturing, and distribution of a variety of different dosage forms. The increasing need for product development speed and commercial supply flexibility through small-footprint, modular equipment trains will be highlighted within this paper, using an immediate-release solid oral dosage form example.Read more >
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.Read more >
Learn how to incorporate consumer-grade design principles to radically simplify datacenter operations and management—saving IT administrators time, reducing overall TCO and increasing end-to-end infrastructure efficiency.
- Tarak Parekh, Principal Product Manager, Nutanix
- Melina McLarty, Staff Designer, Nutanix,
- Sree Pentela, Director, IT Architecture & Engineering, Valeant/Bausch and Lomb Pharmaceuticals
- Christian Pedersen, CEO, Zentura
Questions this briefing will address:
· What are the key challenges the CMOs are likely to face in the near- and long-term future? How can CMOs strategize to overcome these hurdles?
· What growth opportunities exist in the pharmaceutical contract manufacturing industry?
· In what ways is the pharmaceutical contract manufacturing industry likely to change to meet industry trends and dynamics?
· Who are the game-changing companies, and what are the disruptive technologies and business models?
· How should CMOs strategically position their assets with pharma companies?
While innovation intelligence provides a wealth of data regarding future drug possibilities and their attachment to therapeutic areas, this information can be difficult to extract and integrate into workflows and processes. As such, it is hard for organizations to formulate a targeted strategy based on all the information available.
In this webinar, we will be investigating the ever increasing pressure to improve collaborative efficiency between R&D, IP and other divisions within pharmaceutical organizations in order to drive successful drug discovery and commercialization.
We will also be discussing:
- Approaches that can be taken to overcome these difficulties
- Steps that can be taken to align all teams during the entire phase of discovery & commercialization
- How to use innovation data systematically to drive further success and explore new opportunities
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.Read more >
Join Erich Sachse, VP Professional Services at Optymyze. and Brad Hardy, VP of Sales at Kowa Pharmaceuticals - the winner of the 2015 Ventana Research Leadership Award for Sales Excellence as they discuss:
- How to maximize sales operations
- How to adapt more rapidly to change
- How to achieve business goals and sell more
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?
70% of organizations say that efforts to transform the business are undermined by internal complexity, including legacy technologies and a lack of collaboration between the business and IT. Business functions can’t wait months for solutions, but IT leaders must to retain oversight to prevent digital projects from spiralling out of control.
Join this interactive webinar to hear how Takeda Pharmaceuticals has used a Digital Business Platform to rapidly build agile applications approved by IT, but owned and customized by the business teams that use them – unlocking benefits that would be attractive to any organization.
Sign up to get practical insights from how Takeda:
•Enabled the operational agility needed to digitally transform
•Rapidly digitized core processes including procurement
•Unlocked the potential for enterprise-wide cost savings
Importantly, you will have the chance to ask your questions about all of the above.
Alexza Pharmaceuticals, Inc. AwardRead more >
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.
Together Chemir Analytical Services and Nature's Fingerprint can provide highly-precise assessment of potential counterfeit pharmaceutical products and, more significantly, protect the highly-valuable process-patent intellectual property of pharmaceutical and biotechnology firms, potentially extending the drug patent life by a number of years.
This webinar will introduce cutting edge technology used for pharmaceutical process and product authentication. Learn how this technique:
-- "Rounds off the patent cliff" to extend effective patent life
-- Defends against counterfeit drugs by "fingerprinting" chemical processes
Standard compute platforms are indispensable in the industry, however deploying and monitoring these platforms can be time consuming and cumbersome. Please join Peter Lutz from Dimension Data for a discussion on how to rapidly deploy these platforms while still meeting compliance requirements.Read more >
The CRO+Consultant+Sponsor Relationship: Collaborating to Ensure Sponsor and Client Success.Collaboration is the key to a successful consulting partnership. This webinar will focus on the responsibilities and perspectives of key stakeholders (Sponsor, consultant and CRO), how to make the most out of the Sponsor/consultant relationship, and key considerations when partnering with a contract research organization. Explore ways to optimize your consultant relationships to ensure success!Read more >
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.Read more >
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.
The global pharmaceutical industry is witnessing an unprecedented era. Several new demand spaces such as innovative therapeutics (immuno-oncology), clinical diagnostics (liquid biopsy), and research tools (next-generation sequencing) have emerged, driving companies to sharpen their long-term positions. Fundamental behavioral shifts in these spaces are redefining the market. Companies are adopting a “beyond-the-pill” approach and increasing investments in innovations related to drug discovery, clinical trials, supply-chain solutions, and patient engagement. This briefing reviews recent industry transformations, changes in business models, growth opportunities, and key predictions for the life sciences industry.Read more >
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.
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.Read more >
Making the Impressional Personal: Best Practices for Customizing Non-personal Promotion. Interview with Darshan Kulkarni, Leif Goranson, Tom Jones. December 4, 2015 Philadelphia. By Pharmaguy John Mack.Read more >
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.
Networks of influence are shifting the decision-making process for life sciences companies. It is no longer enough to simply view the profile of a HCP or HCO to understand their value to your organization.
For life sciences organizations, there is currently a gap in information, understanding, and digital access to these critical customer networks and relationships.
Relying solely on internal knowledge, field experience or purchased data provides an analog, one-dimensional view of these networks. This limits companies from fully understanding key influencers, referral pathways, speaker and authorship networks and more, which once uncovered can significantly influence customer outreach, messaging and engagement.
In this webinar, we’ll discuss how companies who embrace a holistic data and network analytics approach to strategic planning and execution can achieve significant competitive advantage, improved customer engagement and faster market penetration.