Life Science Companies Research Articles

Pengaruh Organizational Justice terhadap Organizational Commitment pada Karyawan PT X

PT X aims its vision to become a World Class Life Science Company with Global Competitiveness. In order to support that vision, PT X needs its employees to be committed to contribute in achieving said vision. This research aims to investigate the effect of Organizational Justice to Organizational Commitment among the employees of PT X using linear regression statistical analysis. The research was done to 550 employees on the level of Heads of Department all the way to the Operators using supervised self-report questionnaires. Data collection was done by deploying Organizational Justice questionnaire, developed from the Justice Questionnaire by Colquitt et al., and Organizational Commitment questionnaire based on the questionnaire by Allen & Meyer. Research result indicates significant effect of Organizational Justice towards Affective (R=0,436, p<0,001), Continuance (R=0,087, p<0,001), and Normative (R=0,411, p<0,001) Commitment.

“The Good, the Bad, the Ugly”: Leadership Lessons From two Companies – Amgen and Theranos

We review two books that provide perspective on leadership challenges and best practices for building successful companies. Lessons and frameworks are extracted from our reviews of recent books focused on two high-profile life science companies, Amgen and Theranos. Amgen, a pioneer in commercializing biotechnology was very successful, and along with Genentech set the standard for how to build and scale successful companies in the industry based on transformative life science technologies. Theranos, a more recent undertaking, illustrates a very high-profile company that pursued commercialization of a revolutionary diagnostic technology for blood testing with the promise of multi-purpose diagnostics obtained “from a single prick of blood”. Theranos has turned out to be anything but a success and as reported by Molly Brown at Geekwire (loc. cit.) is actually a “what not to do guide for startups”. We reprise and summarize materials previously published by one of us as a book review on Amgen (“Science Lessons: What I Learned about Management from Biotechnology”, by Gordon Binder and Phillip Bashe). Amgen serves as a role model for “the good” in building successful life science companies. Then, we provide a short review of the recent best seller on the Theranos story, titled “Bad Blood: Secrets and Lies in a Silicon Valley Startup” by John Carreyrou. In Theranos, the “bad and the ugly” are self-evident. Carreyrou’s excellent investigative reporting is highlighted in our review of that book, but as of this writing the story continues to unfold in the press and in the court system as a result of the alleged fraud from misrepresentation to investors, partners, and regulators by Theranos leadership. We use these two book reviews to highlight the 3Ps that comprise the ingredients for a successful company – the Problem (or opportunity), the People (leadership, ethics, culture) and the Processes (which are employed to validate the product/market fit incrementally prior to being able to exploit the full potential of the technology that underlies the platform and business model). The People dimension (team, leadership and culture, e. g. execution) is indeed critical to success, and we focus on that here.

First person – Marcel Nowak and Benjamin Suenkel

ABSTRACT First Person is a series of interviews with the first authors of a selection of papers published in Journal of Cell Science, helping early-career researchers promote themselves alongside their papers. Marcel Nowak and Benjamin Suenkel are co-first authors on ‘DCAF8, a novel MuRF1 interaction partner, promotes muscle atrophy’, published in JCS. Marcel subsequently worked as a Product Manager for a life science company. Benjamin is a postdoc in the lab of Thomas Sommer at Max-Delbrück-Center for Molecular Medicine (MDC), Berlin-Buch, Germany, investigating protein biochemistry and quality control.

Applications of Internet of Things in Pharmaceutical Industry

The pharmaceuticals and life sciences industries are generally required quite advanced technology to compete with the worldwide market share. Pharmaceutical and life science companies invest more time, effort and money into digitalization of their business. It is estimated that by 2020, there will be 50 billion connected devices, and in five years, 80% of companies are expected to utilize IoT in their digitized firms. IoT revolutionizes the pharmaceutical sector by providing and automating pharmaceutical manufacturing, the discovery of drugs and remote monitoring of patients and more. Digitization holds tremendous potential to help pharma companies address various challenges. This chapter intends to provide an insight into the Internet of Things in Pharmaceutical sectors.

PNS133 POLICIES TO IMPROVE AMR PRACTICES: AN INDUSTRY AND HCP PERSPECTIVE

Antimicrobial resistance (AMR) is a major threat to global public health. In the last five years, governments across the world have been developing initiatives alongside the pharmaceutical industry to tackle AMR through ‘responsible use’ policy interventions. We reviewed the current initiatives targeted towards the pharmaceutical industry and healthcare professionals (HCPs) to evaluate the impact they have had in tackling AMR. A structured literature search of online sources was conducted to find publications relating to educational campaigns implemented by governments and industry to tackle AMR. Searches were limited from 2013–present. Several HCP-targeted initiatives have been introduced by government bodies in recent years, including the ‘Antibiotic Guardian’ behavioural change campaign. The campaign was launched in 2014 and aims to increase commitment from HCPs and the public to reduce AMR through online pledges. After initial success in the UK, the programme has been expanded across many other European countries. The campaign has been qualitatively evaluated in several studies and found to be effective in increasing commitment of HCPs and the public to reduce AMR. The pharmaceutical industry is also developing initiatives and investing in reducing AMR on a larger scale. The AMR Industry Alliance comprises of over 100 life sciences companies, across 20 countries worldwide. These companies have partnered to reduce the development of AMR, invest in R&D to meet global public health needs and improve access to high-quality antibiotics. In the last five years, governments, industry and HCPs have operated at different levels of the healthcare system to develop education programmes like ‘Antibiotic Guardians’ to have a positive impact on reducing AMR. Although the long-term impacts of these educational campaigns have yet to be evaluated, short term outcomes demonstrate that campaign engagement results in positive behavioural changes towards antibiotic use.

AMCP Partnership Forum: Building the Foundation for Patient-Reported Outcomes-Infrastructure and Methodologies.

Section 3002 of the 21st Century Cures Act, which was signed into law in December 2016, requires the FDA to develop one or more sets of new guidances regarding the collection of patient experience data. To explore how patient-reported outcomes (PROs) can support value-based care and discuss challenges to using PROs more widely, the Academy of Managed Care Pharmacy (AMCP) convened a stakeholder forum in 2017 on PROs and the role they can play in defining the value of health care interventions. This forum achieved consensus on the importance of PROs in improving patient care through implementing value-based payment models and the need for strong organizational systems to fully adopt and use PROs in health care decision making. To explore strategies to build on these findings and implement them in practice, AMCP convened a second forum on October 25, 2018, in Orlando, FL, to focus on identifying specific methods and infrastructure to support the ideal use of PROs in practice. In light of the FDA's plans to propose new guidance for incorporating PROs in the regulatory process, this forum focused on the following: (a) describing the current state of using PROs for FDA regulatory and value-based coverage decisions; (b) defining a process for collecting and sharing PROs with the FDA and managed care organizations for value-based decisions; (c) identifying the necessary infrastructure needed to support the ideal use of PROs; and (d) identifying the health information technology strategies needed to support PRO use across managed care stakeholders. Strategies for the development and implementation of PROs were discussed throughout the forum, including a focus on appropriate activities to address the needs of patients, health care providers, managed care organizations, and life science companies and researchers. Health care leaders representing health plans, integrated delivery systems, pharmacy benefit managers, employers, national associations of health care professionals, patient advocacy organizations, health infrastructure technology companies and biopharmaceutical companies participated in the forum. The AMCP forum was supported in collaboration with Allergan, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Novo Nordisk, PhRMA, Sanofi, Takeda, and Xcenda. DISCLOSURES: The AMCP Partnership Forum and the development of the proceedings document were supported by Allergan, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Novo Nordisk, PhRMA, Sanofi, Takeda, and Xcenda.

Stem cells derived from burned skin - The future of burn care.

BackgroundThermal injuries affect millions of adults and children worldwide and are associated with high morbidity and mortality. The key determinant for the survival of burns is rapid wound healing. Large wounds exceed intrinsic wound-healing capacities, and the currently available coverage materials are insufficient due to lack of cellularity, availability or immunological rejection.MethodsUsing the surgically debrided tissue, we isolated viable cells from burned skin. The isolated cells cultured in tissue culture dishes and characterized.FindingsWe report here that debrided burned skin, which is routinely excised from patients and otherwise considered medical waste and unconsciously discarded, contains viable, undamaged cells which show characteristics of mesenchymal skin stem cells. Those cells can be extracted, characterized, expanded, and incorporated into created epidermal-dermal substitutes to promote wound healing in immune-compromised mice and Yorkshire pigs without adverse side effects.InterpretationThese findings are of paramount importance and provide an ideal cell source for autologous skin regeneration. Furthermore, this study highlights that skin contains progenitor cells resistant to thermal stress.FundCanadian Institutes of Health Research # 123336. CFI Leader's Opportunity Fund: Project # 25407 National Institutes of Health 2R01GM087285-05A1. EMHSeed: Fund: 500463, A generous donation from Toronto Hydro. Integra© Life Science Company provided the meshed bilayer Integra© for porcine experiments.

Entrepreneurial Strategies to Seek Venture Capital Funding.

Innovation is vital for progress in any industry. Evolving technology, paired with human ingenuity, brings ideas for prototypes and business models. Many physicians conceptualize platforms to serve their patients; however, many struggle and ultimately fail to bring their product or service to market. Financing is often the limiting factor. Studies have proven venture capital (VC) funding to be a pivotal source for helping a business survive in its early stages. Plastic surgeons can benefit from learning how to seek out VC funding. In this presentation, common terminology and key players will be defined, from seed capital to angel investors. Doing recommended "homework" will help the plastic surgeon identify a financier tailored to their specific needs-ideally one with a focus in the medical space. A clear-cut approach to assembling a "pitch deck" presentation will be outlined to prepare the plastic surgeon for their first meeting. Insider pearls will be presented from the VC perspective. The plastic surgeon should be prepared to answer fundamental questions expected at different stages of the process. Nevertheless, each meeting also serves as an opportunity for the plastic surgeon to probe the VC firm and their intentions. The role of background checks, social media, and electronic profiles will be discussed. Transparency from both parties at all times can help establish a successful relationship, even if it ends in a referral to a better suited VC firm. Between January and September of 2017, $12.1 billion of seed and VC was invested into life science companies in the United States. Growth is exponential. The surgeon is at the frontier of developing ideas and cutting-edge products that help us serve our patients with enhanced care and improved outcomes. In seeking out the proper financier, your product or service can become a reality in the market, contributing to the betterment of medicine and plastic surgery.

Work Load Analysis on State-Owned Companies in The Health Sector in Bandung-Indonesia

Objective - This study conducts a workload analysis on state-owned companies in the health sector in Bandung-Indonesia. The study focuses on a company established on 6 August 1890, which is a manufacturer of vaccines and antisera, and is now developing into a life science company. The objective of Polio eradication by 2020 demands competitiveness and a change in organizational culture in order to increase organizational profits. There are two possible solutions to this phenomenon. From a technical perspective, the company has decided to undertake market expansion. From a psychological perspective, the company needs to change the attitude of its employees to effectively meet the competition. This situation raises problems for the human resources division of the company. First, it increases employee health problems such as high cholesterol, high blood pressure and lower back pain, which increases health costs. Methodology/Technique - Based on the phenomena of excessive workload and the problems posed, this study aims to examine empirical data regarding the workload of the company. The workload analysis in this study is conducted in October 2016 using several methods such as discussions, interviews, questionnaires, and observation. The validation of the data is achieved using a triangulation methodology. Findings – The result show that, when comparing the fair amount workload index with the total number of employees in the company, there is a difference of 11.61%. The six directorates have 75-85% for effectiveness and 79-87% for efficiency. This shows that work load is not a contributing factor to the phenomena's described above in this company. Novelty - The research sheds light on the increasing need for counselling in companies. One of the leading reasons for this is employee work loads and the increase in some employees working overtime. These factors may lead to other problems such as family issues, low job satisfaction, discipline, and absenteeism. Type of Paper - Empirical. Keywords: Bandung; Health Sector; Indonesia; State-Owned Company; Workload Analysis. JEL Classification: J80, J81, J89.

Digital Transformation and Disruption of the Health Care Sector: Internet-Based Observational Study.

BackgroundDigital innovation, introduced across many industries, is a strong force of transformation. Some industries have seen faster transformation, whereas the health care sector only recently came into focus. A context where digital corporations move into health care, payers strive to keep rising costs at bay, and longer-living patients desire continuously improved quality of care points to a digital and value-based transformation with drastic implications for the health care sector.ObjectiveWe tried to operationalize the discussion within the health care sector around digital and disruptive innovation to identify what type of technological enablers, business models, and value networks seem to be emerging from different groups of innovators with respect to their digital transformational efforts.MethodsFrom the Forbes 2000 and CBinsights databases, we identified 100 leading technology, life science, and start-up companies active in the health care sector. Further analysis identified projects from these companies within a digital context that were subsequently evaluated using the following criteria: delivery of patient value, presence of a comprehensive and distinctive underlying business model, solutions provided, and customer needs addressed.ResultsOur methodological approach recorded more than 400 projects and collaborations. We identified patterns that show established corporations rely more on incremental innovation that supports their current business models, while start-ups engage their flexibility to explore new market segments with notable transformations of established business models. Thereby, start-ups offer higher promises of disruptive innovation. Additionally, start-ups offer more diversified value propositions addressing broader areas of the health care sector.ConclusionsDigital transformation is an opportunity to accelerate health care performance by lowering cost and improving quality of care. At an economic scale, business models can be strengthened and disruptive innovation models enabled. Corporations should look for collaborations with start-up companies to keep investment costs at bay and off the balance sheet. At the same time, the regulatory knowledge of established corporations might help start-ups to kick off digital disruption in the health care sector.

Commentary: how will interventional oncology navigate the "valleys of death" for new medical devices?

Whereas clinical trials of cancer drugs have methodological standards and conventional primary endpoints, these are not necessarily applicable to the clinical development of loco-regional treatments and new medical devices. The current challenge is to generate high-level clinical evidence for loco-regional treatments to define the benefits for patients. In this article, we argue that, to generate convincing evidence of clinical efficacy and safety, the collective coherence of the entire data package is often more important than the primary endpoint of one clinical trial. We also propose that, when a comprehensive clinical data package is not feasible, limited clinical data can be supplemented with other types of evidence. Emerging life science companies often define the “valley of death” after securing initial investment to translate an early medical device concept to a development stage that is attractive to funders. Unfortunately for this industry, there is a second “valley of death” if the focus and goal is only regulatory approval, to the neglect of clinical acceptance and reimbursement. For the emerging specialism of interventional oncology, it is critical to plan a clear line of sight for each new medical device to avoid the valleys of death and to demonstrate the clinical benefit. Increased international guidance to establish realistic yet convincing standards in this area may avoid attrition of potentially beneficial devices and therapeutic procedures in the valleys of death.

Lost opportunities.

Life science companies are missing out on the benefits of open innovation. Life science companies are missing out on the benefits of open innovation.

Value Tools in Managed Care Decision Making: Current Hurdles and Future Opportunities.

Organizations such as the National Comprehensive Cancer Network, American Society of Clinical Oncology, Institute for Clinical and Economic Review, and Memorial Sloan Kettering have created distinct tools to help different stakeholders assess the value of oncology treatments. However, the oncology value tools were not necessarily created for payers, and it is unclear whether payers are using these tools as part of their drug management process. To understand what value tools payers are using in oncology management and what benefits and shortcomings the tools may have from the payer perspective. A survey targeting drug coverage decision makers at health plans was conducted in August 2016. Respondents attesting to using 2 or more value tools in drug management were eligible for an additional in-depth interview to understand the respondents' perceived benefits and shortcomings of current value tools. Respondents also were asked to describe desired attributes of a hypothetical payer-centric value tool. A total of 28 respondents representing approximately 160 million commercially insured medical lives completed the survey. Twenty respondents (71%) reported using at least 1 value tool in their drug management process. Twelve respondents (43%) used at least 2 tools, and 4 respondents (14%) used at least 3 tools. A total of 6 respondents were selected for in-depth interviews. Interviewees praised value tools for advancing the discussion on drug value and incorporating clinical evidence. However, interviewees felt available value tools varied on providing firm recommendations and relevant price benchmarks. Respondents most commonly recommended the following attributes of a proposed payer-centric value framework: taking a firm position on product value; product comparisons in lieu of comparative clinical trials; web-based tool access; and tool updates at least quarterly. Interview respondents also expressed some support for allowing manipulation of inputs and inclusion of quality-of-life and patient-reported outcome data. Although nearly half of payers surveyed use 2 or more value tools in the drug management process, payers identified a number of areas where the tools could be revised to increase their utility to payers. No outside funding or assistance of any kind was used for this research or in manuscript preparation. Schafer and Galante are employed by Precision for Value, a payer ad marketing agency that works exclusively with life science companies. Shafrin is employed by Precision Health Economics, a consulting company to insurance and life science industries. Shafer, along with Galante and Shafrin, contributed to study design, data collection, and manuscript preparation. The authors contributed equally to data analysis and interpretation and manuscript revision.

The IMAGINE IF! Accelerator: Leveraging the U.K ecosystem to attract and accelerate early stage life-science companies

The IMAGINE IF! Accelerator: Leveraging the U.K ecosystem to attract and accelerate early stage life-science companies

Belgium ∙ 'Sunshine' in Belgium: New Statutory Transparency Requirements for Life Sciences Companies

Belgium ∙ 'Sunshine' in Belgium: New Statutory Transparency Requirements for Life Sciences Companies

Compensation inflation remains consistent at private life science companies.

Non-founder total target cash compensation increased 3.3% at private life science companies in 2015.

Incubator Labs Open In Alderley Park

The U.K. bioscience incubator firm BioCity has introduced open access analytical labs in Alderley Park, a British science park that was formerly the R&D headquarters for AstraZeneca. The labs feature liquid chromatography, mass spectrometry, and informatics equipment produced by Waters Corp. Alderley Park is home to about 115 life sciences companies. Waters says it is keen to engage with companies in the park to gain deeper insight into their needs and challenges.

Connecting life science entrepreneurs with resources and expertise: the role of iungens brokerage in life science innovation

ABSTRACTLife science innovation demands detailed expertise at each stage of the development of a commercial product. Besides a perceived shortage of venture capital, venturing life science companies face the challenge of limited access to qualified expertise in regulatory affairs and commercialisation. Examining a bio hub initiative at a major pharmaceutical company, a form of in-house incubator wherein life science companies can both take advantage of laboratory facilities and the stock of expertise of the hosting company, it is argued that such initiatives support the life science innovation field. Taking on an iungens brokerage role, the hosting company effectively connects previously separated actors, thus lowering the transaction costs incurred when accessing qualified scientific, regulatory, and commercial know-how, which are all of great value to life science companies during the venturing phase. The iungens brokerage role thus represents a highly valuable position in the field of life science innovation.

Highlights from the Dechert Survey of Securities Fraud Class Actions Brought Against U.S. Life Sciences Companies

Highlights from the <i>Dechert Survey</i> of Securities Fraud Class Actions Brought Against U.S. Life Sciences Companies

Total target cash compensation shows a healthy increase at private life-science companies.

Nonfounder total target cash compensation increased by 4.2% at private life-science companies in 2014.