In Life Sciences 4.0: securing value through platform-based businesses, EY’s latest edition of our Progressions series, we explore how health is being reimagined as a result of scientific and technological change and rising customer expectations. We also examine the ramifications for life sciences companies’ market offerings, business models and the new capabilities needed as the disciplines of health care and technology merge to become “health technology.”
Articles & Features
Download this Special Report, written by Mike Ward, Head of Content for Informa Pharma Intelligence Insights Portfolio, to learn how attrition rates in oncology drug discovery and development can be improved and why a multidisciplinary approach to R&D is needed. This report includes key coverage of the Bionow’s Accelerating Cancer Drug Development - From target to patients conference, which was hosted at Alderley Park in Cheshire where its Mereside life science campus is home to some 65 SMEs and 150 start-ups, many of which work in oncology.
As coverage and reimbursement landscapes change, drug developers must assess how healthcare systems will handle the incoming wave of treatments for rare diseases that often carry a high list price, and they should prepare for restrictive practices that pass more of the costs along to patients. Developers can speed orphan medicines to patients through better communication of value to payers and other stakeholders.
Big data, real-world evidence and breakthrough technologies are expected to underpin a revolution in health care provision. The agents of this disruption, as is usually the case, are stakeholders not traditionally associated with health care but who are now converging with existing players. Participants at the IMPACTIV BIO CEO Summit Thought Leader Discussion panel, highlighting marquee deals such as the Amazon, Berkshire Hathaway and JPM three-way, considered how such convergences will be crucial to health care’s evolution.
In the increasingly complex world of biopharmaceutical commercialization, executives at emerging companies are often faced with the need to understand what levels of spend are appropriate for successfully launching a product. Many clinical-stage companies find themselves either underfunding launches and underperforming in the market, or overfunding launches and incurring costs that do not add incremental value to commercial success. And while every company is different, and every launch is different, all face the same question: What is the threshold of commercial spend needed to increase the probability of a successful product launch?
Pharma is at a most critical point in its evolution. It is being held back by a lack of flexibility, speed and mastery of analytical power. The R&D process that has been its foundation now underpins an inefficient clinical trial process that is costly, often unprofitable and which makes it harder to successfully meet the changing and challenging demands of disease in the 21st century. The model of three fixed study phases is no longer viable to produce the therapeutic solutions that are required to meet increasingly complex healthcare demands dominated by an aging population with multiple health needs. ICON has undertaken research, assisted by ISR Research, and conducted an industry survey with Informa’s Pharma Intelligence, to examine the challenges facing pharma and find solutions.
Iron4u, a pharmaceutical company founded in 2012 by investors from five European countries and based just outside Copenhagen, Denmark, have developed an innovative high-dose IV iron product for the treatment of iron deficiency or iron-deficiency anemia. They believe Polyglucoferron could set a new benchmark in the field of intravenous iron therapy. Developed in partnership with the German company Serumwerk Bernburg, the product is now in Phase III clinical trials for human use as an injection or infusion.
Three decades ago when biotech was in its infancy many of the pioneers had ambitions to create fully integrated pharmaceutical companies (FIPCOs). Picking low hanging fruit – recombinant versions of therapeutically relevant human proteins, such as insulin, human growth hormone, erythropoietin and tissue plasminogen activator – a number of the first movers prospered but many withered on the vine. The FIPCO model fell out of fashion and subsequent start-ups pursued strategies that took assets to proof of concept before licensing to established commercial organizations. The advent of personalized medicines and initiatives to incentivize development of therapeutics to treat orphan diseases has underpinned a renaissance of the FIPCO model. However, challenges still exist.
Developing products that are clinically meaningful requires more than a novel approach to an unmet medical need. A panel of biotech executives and venture investors discuss how to meet the challenges of building a sustainable business from day one.
Alderley Park, one of the UK's leading bio and life science campuses, has just hosted a new conference, Accelerating Cancer Drug Development - From Target to Patients. At the event Mike Ward spoke to two of SMEs based at the site in Cheshire about the challenges of growing a business in the oncology supply chain.
Downloads & Multimedia
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| Research Reports
|Addressing the Data Challenges of Pharmacovigilance||Download PDF|
|Clinical Trial Randomization and Supply Management Systems of Tomorrow||View Video|
|Addressing the Data Challenges of Pharmacovigilance||View Video|
|Simplifying Regulatory Processes For Post-approval Changes With Unified RIM||Register|
|More Patients, Faster. The Next Evolution Of Oncology Drug Development||Register|
|Disrupting The Status Quo Of eClinical Identity Management: Removing The Burden At Clinical Trial Sites||Register|
|Does the UK’s Life Sciences Industrial Strategy And Sector Deal Make Brexit Easier to Swallow?||Register|
|Addressing Key Challenges In The Clinical Development Of Combination Immuno-oncology Therapies||Register|
|eConsent: Better For The Patient, Better For The Site||Register|
|What's Next In eCOA? - New Insights Into Equivalence Testing Methodology And Implications For BYOD||Register|
|Using Innovative Materials To Drive Medical Device Design||Register|
|Using Innovative Materials To Drive Medical Device Design - Part 2||Register|
|Body Fluids Analysis With Linearity Down to Zero||Register|
| Whitepapers & Special Reports
|Accelerating Cancer Drug Development||Download PDF|
|Improving Pharma R&D Efficiency: The Case for a Holistic Approach to Transforming Clinical Trials||Download PDF|
|Meeting Growth Challenges Roundtable||Download PDF|
|Innovation UK: Pushing life science frontiers in the North of England||Download PDF|
|Medical Devices Aren’t Luxury Goods, So Why Does Medtech Try to Sell Them That Way?||Download PDF|
|Translating Innovation Medtech Made Local||Download PDF|
|Positioning Key Accounts at the Center of Medtech’s Commercial Model||Download PDF|
|Assessing Patient Availability||Download PDF|
|Adaptive Design Years Later; What have we learned?||Download PDF|
|Applying Disruptive Innovation in CNS Clinical Trials to Reduce Variability||Download PDF|
|Cell And Gene Therapy Rapid Approvals Can Pose Commercialization Challenges||Download PDF|
|Successful Linguistic Validation of Clinical Outcomes Assessments||Download PDF|
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