Diaceutics Experts Insights. | Diaceutics

Expert Insights

Experts in the space provide a wide range of insights on the world of diagnostics and precision medicine
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April 19th, 2018
The CMS National Coverage Decision on NGS
Jeff Schreier
Robert Feeney
I. Introduction On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination (NCD) that covers diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced can...
January 19th, 2018
What does the EU IVD Regulation mean for companion diagnostics and LDTs?
Dave Smart
Dave Smart, PhD, Director at Diaceutics, discusses the introduction of the EU IVD Regulation. While it is considered a necessary step, the Regulation raises issues not only for labs and those manufacturing companion diagnostic and laboratory devel...
September 1st, 2017
Liquid biopsy: clearing the barriers to support pharma, labs and patients
Marianna Sciortino
There was considerable discussion around liquid biopsy at ASCO 2017 at a time when questions about its clinical utility are still to be addressed. Marianna Sciortino, Associate Director, Diaceutics, assesses the current landscape and looks at the ...
June 5th, 2017
Leave no patient behind: how the FDA approval of Keytruda for specific biomarkers will put laboratory testing in the front line
Marcos Tadeu dos Santos
Merdol Ibrahim
Dawn Wilkinson
The FDA approval of Merck’s Keytruda (pembrolizumab) “for a specific genetic feature (biomarker)” is leading us into a new era in which the integration of diagnostics and biomarker detection on the treatment pathway is not an option, but man...
May 25th, 2017
Test availability at launch can be underestimated, under-budgeted and under-resourced: an example using real-time, real world analysis of PD-L1
Jordan Clark
Diaceutics gave a presentation at TriCON 2017 discussing how biomarkers and diagnostics are still falling short at launch, even though the industry is no longer in its infancy. Here, Jordan Clark, Managing Director, reports on how we can track the...
May 8th, 2017
FDA has approved Philips’ digital pathology solution as a primary diagnosis tool – it’s about time
Merdol Ibrahim
Following the FDA’s decision to approve Philips’ digital pathology solution, Merdol Ibrahim, Managing Director, Diaceutics, assesses the implications for laboratories and suggests this move heralds not the end of the pathologist’s microscope...
March 2nd, 2017
White paper: Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
Jordan Clark
Amit Kumar Jain
FDA draft guidance on the Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product, published on July 14, 2016, can be viewed as a testament to the Agency’s commitment to incorporate scientific advances ...
January 23rd, 2017
Pharma Finance and the Trump Effect
Philip White
In the month that Donald Trump becomes the 45th President of the United States, Diaceutics assesses the possible impact of the new administration on the world of pharma, diagnostics and precision medicine as rising drug prices come under fire. Few...
September 19th, 2016
How to Introduce Laboratories to a Diagnostic Scenario on Tropical Diseases that will Lead to a Better Diagnostic Pathway
Luiz Corrêa
Rapid Diagnostic Testing (RDT) has the potential to identify many millions of people infected with tropical diseases, but even more is possible when diagnostic identification of patients is combined with the infrastructure and expertise offered by...
September 15th, 2016
Feedback on IASLC Molecular Testing Guideline for Selection of Lung Cancer Patients – Revision 2016 Draft Recommendations
Patrick Considine
Maria Fe Paz
Neil Atkey
In August 2016, a team of experts from Diaceutics submitted a response to the IASLC Molecular Testing Guideline for Selection of Lung Cancer Patients, during the public open comment period1. Here they share a summary of their thoughts and concerns...
August 17th, 2016
Pharma’s Increasing Need for Competitive Intelligence
Steve Vitale
Competitive intelligence can offer huge benefits to pharma companies, especially in personalized medicine where market trends are continually shifting. In a world where available data grows by the second, Steve Vitale of Diaceutics examines how it...
August 15th, 2016
Optimizing the 2017 Budget Allocation for Personalized Medicine
Jordan Clark
Ryan Keeling
Jordan Clark and Ryan Keeling of Diaceutics appreciate the difficulties in determining the unknown costs of a diagnostic program, but are on hand with advice and solutions to successfully guide you through the budgeting process. As a project leade...
July 26th, 2016
IVD Market Access and Reimbursement Issues in 2016
Eirini Vavatsikou
Eirini Vavatsikou, Consultant with Diaceutics, provides an informative overview of the current system of IVD and LDT submission to the FDA and suggests how the problems that arise from diagnostic access and reimbursement could be eased. Market acc...
July 7th, 2016
Diagnostics Ignored in Targeted Therapy Pricing, Access and Value
Peter Keeling
Peter Keeling of Diaceutics provides insight on the role personalized medicine can play, specifically the diagnostic, in adding value to a therapy and why pricing models need to be reviewed to reflect the value that complementary and companion ...
June 21st, 2016
Great Expectations for Personalized Medicine Outside Oncology
Peter Keeling
Steve Vitale
We are all familiar with personalized medicine in oncology but future developments involving new technologies are likely to flourish in other disease areas. Peter Keeling and Steve Vitale of Diaceutics look at challenges and opportunities in the n...
June 20th, 2016
Physicians’ Lag in Understanding of Personalized Medicine is Pharma’s Opportunity
Andrew Van Aken
Andrew Van Aken, of CAHG, discusses the findings of a survey by CAHG and the Adelphi Group which focused on the perceptions of personalized medicine among various medical professionals of the implications for pharma when launching a targeted ...
June 6th, 2016
Complementary Testing in PD-L1 – A Groundbreaking Concept?
Ewelina Golebiewska
The FDA’s decision to approve what it terms a complementary diagnostic may not have been a groundbreaking event after all. In fact, it might make the testing landscape even more complex to navigate. Ewelina Golebiewska, Associate Director, Diace...
June 5th, 2016
Big Data: Harnessing Its Personalized Medicine Power
Peter Keeling
Everyone is talking about the possibilities and promises offered by big data and attempts are being made from many directions to harness the power it contains. Peter Keeling, CEO of Diaceutics, assesses where big data currently stands in relation ...
May 24th, 2016
What Minerva Knows That Pharma Does Not Yet
Peter Keeling
Peter Keeling of Diaceutics discusses the Minerva supercomputer built by Mount Sinai Medical Center. It has the potential to be a disruptive force in the personalized medicine space as it bypasses the old guidelines-driven treatment paradigm mar...
May 13th, 2016
Pharma Leaders Who Are PM-Ready See Their Efforts Reflected In Share Prices
Philip White
Philip White, Chief Financial Officer at Diaceutics, is not surprised to see that pharmaceutical companies we regard as personalized medicine leaders are being rewarded for their innovation with higher share prices, but while they benefit from the...
April 29th, 2016
Deal With GSK Brings New Personalized Rx Opportunities to Novartis
Peter Keeling
In garnering rights to GlaxoSmithKline’s portfolio of oncology drugs, Novartis has access to several newly-launched personalized cancer drugs that the company hopes to drive towards blockbuster status, in the company of its own star names Gleevec ...
April 4th, 2016
The Return On Investment of Better CDx Planning Based on Early PD-L1 Observations in NSCLC
Sanna Jousi
Sanna Jousi of Diaceutics assesses the financial benefits of integrating the planning, analytical and action steps for successful development and commercialization of testing into targeted therapies. The anti PD-1 therapy market promises to be the...
February 28th, 2016
Will the CMS Proposal to Adjust Laboratory Reimbursement Through Data Collection Disproportionately Hurt Small Labs?
Eloise Aita
Eloise Aita, PhD, of Diaceutics, writes that on the surface CMS proposals for laboratory reimbursement could simplify a complex process but is concerned that smaller labs, particularly those offering fast test turnaround for critically ill patient...
February 22nd, 2016
Should We Bring a Test In-House?
Yan Victoria Zhang
Tom Jackson, PhD
Yan Victoria Zhang and Tom Jackson, University of Rochester Medical Center, New York, discuss whether laboratories should conduct tests in-house or send their tests out. Bringing tests in-house is a major undertaking and factors related to benefit...
February 5th, 2016
The Knight’s Move in PD-L1 Chess
Peter Keeling
What does the future hold for PD-L1? Who will advance or move into the space? Peter Keeling of Diaceutics provides his insights on this hot topic. And so it begins, the rolling regulatory approvals of anti PD-1 therapy, an oncology drug class like...
December 21st, 2015
2016 Personalized Medicine Long Range Weather Forecast
Peter Keeling
In this end of year review, Peter Keeling predicts that trade winds will favor the most seaworthy of pharma companies. The outlook in brief High and Low Pressure Points Likely To Impact Pharma’s 2016 Personalized Medicine Plans – 50%+ more targe...
November 9th, 2015
Budget Allocation for Diagnostic Development and Commercialization (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In the final part of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg discusses the importance of allocating a large enough budget for diagnostic development and commercialization to support the goal of becom...
November 9th, 2015
Ensure Diverse Internal Capabilities in a Personalized Medicine Pharma Company (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 8 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses how the internal capabilities of a pharmaceutical company, like that of a successful soccer team, are essential to a wel...
October 27th, 2015
Funding a Diagnostic Test at Launch to Ensure Test Adoption (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 6 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses why pharma should consider funding a diagnostic test at launch to ensure adoption. Uber is a young company that, as yo...
October 27th, 2015
Engaging with Laboratories (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 7 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses the importance of pharmaceutical companies engaging with laboratories, which are often the forgotten stakeholder. Have...
October 21st, 2015
Pharma Communication and Education for Stakeholders (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 5 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses how pharmaceutical companies should communicate with and educate stakeholders to ensure test adoption. Do your grandpa...
October 21st, 2015
The Shift Towards Patient Centricity (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 4 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses how the pharmaceutical industry is putting the patient first by making a shift towards patient centricity. Sometimes y...
September 30th, 2015
Partnering and Managing Partnerships (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 3 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses the ways to establish and manage partnerships between pharma and diagnostic companies and how to keep the relationship hea...
September 14th, 2015
Drug/Diagnostics Partnering Deals Flow: A Changing Landscape
Tessa Sandberg
Ewelina Golebiewska
Are in-house diagnostic companies a must-have or a nice-to-have when trying to achieve personalized medicine leadership? And are pharmaceutical companies moving away from companion diagnostics? These questions are examined by Tessa Sandberg and E...
September 14th, 2015
Drug Pricing Models
Jeffrey Waldron
In the wake of numerous articles on the high cost of new drugs, several organizations have developed drug pricing models. With a number of these scorecards arriving at the same time to raise the profile of cost versus value, could they pose a majo...
September 6th, 2015
Integrating and Aligning the Diagnostic Strategy with the Drug Strategy (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 2 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses integrating and aligning the diagnostic strategy with the drug strategy. Do you know Bob, the guy who holds the budget...
August 24th, 2015
Personalized Medicine: What Pharma Should Do To Get Ready
Tessa Sandberg
The first class of an entrepreneurial program teaches students that change goes hand-in-hand with opportunity. At the moment, the clinical world is experiencing a revolutionary shift towards personalized medicine (PM) and so a huge opportunity is ...
August 24th, 2015
Establishing a Robust Diagnostic Development and Commercialization Strategy on Time (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 1 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses the importance of establishing a robust diagnostic development and commercialization strategy on time. Christmas alway...
May 19th, 2015
How Big can Merck’s Keytruda be in Lung Cancer? It’s Too Early to Call in the PD-L1 Arms Race!
Peter Keeling
Maria Fe Paz
Maria Fe Paz and Peter Keeling of Diaceutics discuss the competitiveness of the PD-L1 market and highlight that the key to success, for those in pharma, will be ensuring they leverage all the test adoption drivers to support uptake of the therapy...
March 16th, 2015
The PD-L1 Case – Immune Checkpoint Inhibitors and the Lack of Robust Biomarkers
Maria Fe Paz
Patrick Considine
Many experts say that out of all the therapies developed to harness the power of the immune system to fight cancer over the past several decades, PD-1/PD-L1 inhibitors look to be the most promising, even though it is still relatively early days in...
February 11th, 2015
Obama’s Precision Medicine Brouhaha: What’s the Point?
Peter Keeling
Peter Keeling, CEO of Diaceutics, gives his reaction to the recent announcement by President Obama that $215 million is to be invested in a new precision medicine initiative in the United States.  Few events over the past decade will have trigger...
November 3rd, 2014
Pharma’s Personalized Medicine Dilemma with Google et al and Treatment Guidelines
Maria Fe Paz
Patrick Considine
Maria Fe Paz and Patrick Considine of Diaceutics provide a further update on Google’s immersion into the health care realm and highlight an opportunity for pharma to collaborate. We continue to follow Google’s inexorable march into health care a...
July 7th, 2014
The Disruptive Rivalry of Immature CDx Markets
Peter Keeling
Peter Keeling of Diaceutics discusses competition in companion diagnostic markets and suggests that diagnostic adoption rules learned only recently will not be so dependable. We all knew it was coming, we just didn’t know when. Specifically, th...
April 16th, 2014
In a Novel Rx/Dx Deal, Biodesix Stands to Share in Risks and Profits of Personalized Medicine
Dr Christof Kölsch
Peter Keeling
As part of an article for Genomeweb, Christof Koelsch and Peter Keeling of Diaceutics comment on the AVEO Oncology and Biodesix partnership for ficlatuzumab and VeriStrat. ‘Drugmaker Aveo Oncology and test developer Biodesix entered into a partn...
April 3rd, 2014
Pharma CEOs Get Ready! Arrival of Personalized Medicine Litigation is as Much About Culture as Science
Peter Keeling
Peter Keeling, CEO of Diaceutics, comments on the Plavix lawsuits and the impact on personalized medicine. As recently reported in the US financial press [i] [2014], the first real personalized medicine influenced litigation has arrived. Specific...
March 12th, 2014
Pharma is Slowly Adapting to the Complexities and Challenges of Developing Personalized Medicine
Genomeweb
In the first of a two-part piece, Turna Ray reflects on the Personalized Medicine World Conference, 2014 and the discussions held there around the state of drug development, recent advances in the field, scientific challenges facing the industry a...
February 24th, 2014
French ALK Study Helps Illuminate the High Negative Dollar Impact of Single Test Strategies With Companion Diagnostics
Peter Keeling
Jordan Clark
Jordan Clark and Peter Keeling of Diaceutics critique a journal article exploring the effectiveness of parallel FISH and IHC methods for the detection of ALK. They go on to discuss the financial implications for pharma companies if they do not en...
February 22nd, 2014
Economics of Genomic Testing for Women with Breast Cancer
Jordan Clark
Jordan Clark of Diaceutics comments on the American Journal of Managed Care article ‘Economics of Genomic Testing for Women With Breast Cancer’ and highlights that personalized medicine is being held back by the unwillingness of payers to reimb...
January 28th, 2014
“More misleading and unhelpful hyperbole, but we wouldn’t want to be anywhere else.”
Peter Keeling
Peter Keeling of Diaceutics discusses how recent headlines in the personalized medicine space can be confusing for the reader by inferring that medicine has moved forward dramatically. He highlights that whilst new technology or solutions are now ...
October 25th, 2013
Oncology Shaping the Future of Personalized Healthcare: How Cancer Drug Development Holds the Key to Success for Precision Therapeutic Approaches
Pharmaphorum media
Early in 2013, pharmaphorum filmed a round table debate exploring how developments in personalized healthcare cancer treatments are defining the future for this area beyond oncology. In this white paper, which accompanies the broader video and wri...
October 8th, 2013
Diagnostics Are a Driver, Not a Cost: Head of Merck Serono Pharma Links Erbitux Peak Sales With KRAS Diffusion Investment
Peter Keeling
Peter Keeling of Diaceutics highlights the financial return on investment possible when pharma invests in companion diagnostic testing, with a focus on Merck Serono’s Erbitux. Belén Garijo, head of the Merck Serono’s pharma unit [2013], hits ...
October 7th, 2013
Why PM1.0 Will Not Create Radical Health Care Change Prompting the Need for PM2.0
Peter Keeling
Peter Keeling of Diaceutics explores the concept of PM2.0 in this article for the pharmaphorum website. The five forces behind 2.0 anything… The nomenclature ‘2.0’ has become synonymous with second generation trajectories. We have all experience...
September 23rd, 2013
New Device and Diagnostics Legislation Could Shake Up the Drug Industry
Patrick Considine
Patrick Considine of Diaceutics comments on the 2013 proposals by the European Parliament’s Health Committee to introduce new legislation for devices and in vitro diagnostics.  This month [September 2013], the European Parliament’s Health Com...
September 23rd, 2013
Google’s Entry Shifts the Personalized Medicine Tipping Point to The Edge
Peter Keeling
Peter Keeling of Diaceutics comments on Google’s announcement that it will create Calico, a new type of company focused on disease management, and highlights how it is a game changer in the personalized medicine space. At an offsite meeting of D...
September 17th, 2013
Personalized Medicine Needs a Statistical Makeover
Aiden Flynn
Aiden Flynn, Exploristics, highlights how early engagement with statisticians in personalized medicine planning would enable the identification of many more biomarkers with clinical utility and reveal the revenue opportunity for a particular the...
August 21st, 2013
Response to Andrew Jack’s article “Back to the Lab”
Peter Keeling
Andrew Jack’s article “Back to the Lab” in the Financial Times (FT) on the 16th August 2013 (http://www.ft.com/cms/s/0/e5679dae-e565-11e2-ad1a-00144feabdc0.html ) captured some of the step change underway within Pharma R&D as it embraces personali...
August 5th, 2013
Data-Powered Decision-Making in Personalized Medicine: High Return On Investment of Proactively Managing the Quality of Companion Diagnostic Testing
Maria Fe Paz
An overview of the Labceutics External Quality Assurance (EQA) modelled study [2013] looking at the impact of inter-laboratory variability of BCR-ABL1 testing. An abstract was submitted to ESH iCMLf International Conference on CML, Biology and Th...
July 29th, 2013
Data-Powered Decision-Making in Personalized Medicine: Cost-Effective Integration of Expert PM IT System into Lifecycle Therapy Planning Process
Ryan Keeling
Personalized medicine business planning is complex, with over 400 decisions to be made in order to integrate diagnostics into the patient pathway.  Knowledge of how to do this can vary across the therapy team and result in a lag in therapy lau...
July 22nd, 2013
Data-Powered Decision-Making in Personalized Medicine: Increasing the Frequency of Patient Engagement
Sanna Jousi
In this Expert Insight, Sanna Jousi of Diaceutics discusses patients’ perceptions of the pharmaceutical industry and diagnostic testing and the opportunity this presents for the pharma and the diagnostic industries to connect with patients. A rece...
July 16th, 2013
Potential New Trend-Setting Lifecycle Management Enabled by Personalized Medicine
Patrick Considine
Patrick Considine of Diaceutics comments on the recent approvals of Tarceva® and Gilotrif™, highlighting that the approval of Tarceva® for Roche is an interesting and potentially trend-setting new lifecycle management  approach.  In ...
July 15th, 2013
From Niche to Norm
Tiffany Olson, BSc MBA
Tiffany Olson discusses PM2.0 and provides insight on how it will change the industry as whole. As one of the personalized medicine industry veterans, it was in 2000 that I gave my first presentation on this ‘new concept’, about using in vitro d...
July 10th, 2013
The Future of Health Care is Personalized Medicine
Peter Keeling
Peter Keeling comments on the Bill Frist article which discussed how personalized medicine will be the future of health care. Bill Frist’s excellent article first published in the perhaps obscure G8 magazine and republished here (http://billfris...
June 26th, 2013
BRCA Testing: Will the US Supreme Court Judgement Make A Difference?
Peter Keeling
It’s not often that a gene mutation becomes a topic for general discussion but the actress Angelina Jolie’s disclosure that she carries the ‘faulty gene’ that can lead to breast and ovarian cancer has raised the profile of BRCA testing. A ...
June 9th, 2013
Overcoming the Commercial Challenges of Promoting Drugs and Their Companion Diagnostic
Peter Thornton
Managing the commercialization of companion diagnostic and drug combinations requires a different approach to sales and marketing than that employed for conventional treatments. The pharmaceutical industry is well aware of the need to target physi...
May 14th, 2013
PM & IT: R U Ready?
Ryan Keeling
IT will play a key role in internally embedding personalized medicine, enabling pharma executives to be fully equipped with the knowledge to develop and launch a commercialization strategy for the targeted therapy. Ryan Keeling of Diaceutics hig...
April 12th, 2013
Still Waiting For Pharma’s Personalized Medicine Share Price Bounce!
Philip White
This industry’s share price landscape has lost a little of its shine, but Philip White of Diaceutics looks at the financial road ahead and how, from a broader enabling perspective, personalized medicine can address the value challenge for pharm...
April 4th, 2013
The ‘One Companion Diagnostic – One Drug’ Paradigm is Not Fit For Purpose
Joanna Przewrocka
The cancer therapy market is evolving dynamically. We understand more and more about cancer biology and we are now able to develop drugs that selectively target the molecular drivers of tumorgenesis. Joanna Przewrocka examines a development in the...
February 22nd, 2013
Personalized Medicine Partnering: The Pharma Retort
Dr Bob Holland
In a follow-up to the recent pharma partnering article, ‘Beauty and the Beast – CDx Partnership Disparity’, Bob Holland provides the pharma viewpoint. It’s a very seductive myth that the co-creation of a novel medicine with a companion diag...
February 22nd, 2013
Collaboration, Collaboration, Collaboration: The European Solution
Tom Zietlow, PhD, MBA
Tom Zeitlow provides analysis on the recent report by Frost & Sullivan,’European Genetic Testing and Screening Services Market’. Two things struck me about a recent report from Frost & Sullivan entitled European Genetic Testing and Screening Servi...
February 8th, 2013
Beauty and the Beast – CDx Partnership Disparity
Jane Papadaki Markley
Jane Papadaki Markley of Asuragen explains why she believes the current Rx/Dx partnering model is at best no longer fit for purpose and, at worst, broken. The CDx partnership heralds a new era in bringing drugs to market with matching diagnostics,...
January 24th, 2013
Bringing Patient Voices to Personalized Medicine
Gwen Darien
Gwen Darien, Director of The Pathways Project, makes the compelling case for ‘patient-centric’ rather than ‘industry-centric’ thinking in personalized medicine. Of all the frequently employed models for cancer research and care, and the theme of ...
January 24th, 2013
“Whatever Anything Is it Ought to Begin by Being Personal”
Sanna Jousi
Research shows that patients are interested in talking about testing. In this Expert Insight, Sanna Jousi discusses how personalized medicine offers the chance for pharma and physicians to reconnect with their patients and put the person back into...
January 15th, 2013
Mystery Solved! What is the Cost to Develop and Launch a Diagnostic?
Dr. Doug Dolginow
Dr. Katherine Tynan
Noel Doheny
Peter Keeling
Diaceutics asked four senior executives in the pharma and diagnostic industry to come up with a value on how much it would cost to launch and commercialize a novel diagnostic test. Here’s what they came up with.  Every other year Diaceutics h...
January 10th, 2013
Laboratories are the Forgotten Stakeholder in Personalized Medicine
Mark Reis
Mark Reis highlights the importance of the laboratory in the delivery of personalized medicine and explains how the Diaceutics network adds value by creating a halo effect for both the laboratory and the therapy. [Note, July 2017: Labceutics i...
January 9th, 2013
Personalized Medicine Can Help Reshape the Pharma Financial Business Model
Dr Christof Kölsch
When long-awaited Zelboraf was finally launched in Europe it was met not only with excitement and hope but with fear arising from its likely price tag. Christof Koelsch asks if personalized medicine is doomed because it is simply too expensive, o...
November 18th, 2012
Regulated and Disseminated: A Way Forward For LDTs
Ron Mazumder PhD
Ron Mazumder of Janssen Diagnostics discusses how laboratory developed tests offer pharma an opportunity and comments on how risk can be minimized and how they could be used alongside in vitro diagnostics. Laboratory developed tests (LDTs) hav...
November 1st, 2012
Dx Reimbursement: Not Broken, Just Fragmented
Margery Rothenberg
The murky world of companion diagnostic reimbursement and access around the world is not easy to navigate and for pharma and companion diagnostic partners, these complexities will not go away anytime soon. However, as a starting point, reimburseme...
October 30th, 2012
Rheumatoid Arthritis – First Mover Advantages and Tea Leaves
Peter Keeling
Peter Keeling of Diaceutics considers the reasons why treatments for rheumatoid arthritis will likely transform to a predominantly personalized medicine market faster than we think.  Rheumatoid arthritis (RA) will likely transform to a predomina...
October 19th, 2012
Rx/Dx Partnerships – Four Basic Rules
Tom Zietlow, PhD, MBA
After working on over 20 Rx/Dx partnerships, Tom Zietlow, President of Diaceutics, believes there are four main issues you need to focus on when establishing an Rx/Dx partnership in order to make it a successful one. A big part of the Diaceutic...
October 12th, 2012
No Single Pharma Model For Commercialization of Biomarkers (View from a Companion Diagnostics Company)
Richard Kennedy
Richard Kennedy of Almac Diagnostics and Queen’s University Belfast, writes that in his experience there is no one route to market for biomarkers in the personalized medicine space. Each pharmaceutical and diagnostic company has its own preferre...
October 5th, 2012
Laboratory Developed Tests Versus IVD Kits Versus Quality
Iain D. Miller, Ph.D.
One of the critical success factors of personalized health care is access to high quality testing. But what is high quality testing? There are lots of definitions of quality but they tend to converge around the perception of whether the product or...
September 6th, 2012
Personalized Medicine Has Arrived … But The Tough Times Are Still To Come
Dr Christof Kölsch
Christof Koelsch discusses the companion diagnostic evolution and the key issues Diaceutics foresees if pharma doesn’t invest in the critical drivers of test adoption. For those of us focusing our daily efforts on the subject of personalized medic...
August 2nd, 2012
A Dose of Reality: Laboratories Need to be a Key Priority in Companion Diagnostics
Mark Reis
Mark Reis highlights the Labceutics’ survey on the attitudes and behavior of labs in the EU5 which finds that pharma-lab communication is poor. He calls for pharma to give labs further discussion and analysis as new companion diagnostics and dia...
July 18th, 2012
Recognizing Their Value? Diagnostic Acquisitions
Tiffany Olson, BSc MBA
In an assessment of the acquisitions taking place in molecular diagnostics during 2012, Tiffany Olson confirms that diagnostics will continue to play an important role in the future of health care. One of the common threads is that each of the acq...
July 12th, 2012
Prometheus… UnChained?
David Resnick
Nicole Kling
The recent Prometheus decision issued by the U.S. Supreme Court has become the talk of the personalized medicine field, generating a swarm of comments from legal and industrial pundits and influencing strategic legal and economic decisions in this...
July 10th, 2012
Our New Personalized Medicine Catchphrase: Like It, Learn It, Leverage It
Mollie Roth, J.D.
Mollie Roth discusses how the Diaceutics’ catchphrase can sum up not only a positive commercialization approach for pharmaceutical companies and their relationship with personalized medicine, but also the history of the industry itself. Diaceuti...
July 6th, 2012
Laboratories are the New Entrants in Personalized Medicine But Will Become a Dominant Force
Maria Fe Paz
Maria Fe Paz of Diaceutics considers that laboratories will become key influencers, ultimately emerging as one of the most dominant stakeholder groups in the future personalized medicine space. From the melting pot of opportunity that personalize...
July 6th, 2012
Xalkori/Zelboraf Approvals: Watching and Waiting
Sanna Jousi
Diaceutics has been monitoring Xalkori/Zelboraf stories as they evolve, tracking the responses and reactions of a number of key stakeholders, such as labs, physicians and payers, to ensure the key lessons to be taken from these two cutting edge a...

Latest Blogs

Blogs

Webinars & Podcasts

August 9th, 2018
Podcast: Oncology Patient Research
Why do we need to talk biomarkers with patients? Senior Director of Market Research at Diaceutics, Marianne Fillion, recently spearheaded an effort to gather insights directly from oncology patients to get an understanding of what they know about ...
April 20th, 2018
Podcast: PM Readiness Report 2018
Peter Keeling discusses the landscape and challenges for precision medicine, companion diagnostics, CDx or biomarker and conduit diagnostics are discussed including global laboratory test data analysis and forecasts for budget impact and value.

Publications

September 11th, 2018
BRAF mutation testing in melanoma – Poster presented at European Congress of Pathology 2018
BRAF mutation testing in melanoma: a study including Austria, Germany and UK, highlighting concordance for current technologies, and potential requirement of more sensitive technologies in future applications.
August 3rd, 2018
A Way Forward: Leveraging Advanced Diagnostic Testing to Unlock the Value of Precision Medicine
Read about how advanced diagnostic testing, ensuring that right patient gets the right therapy, at the right time, particularly with respect to therapies where the test result determines whether or not the therapy should be used (precision medicin...

Competitive Benchmarking Reports

March 16th, 2018
PM Readiness Report 2018 Summary
March 14th, 2017
Pharma Readiness for Diagnostic Integration 2017
All
Biomarkers
Commercialization
Diagnostics
Financial
General
Laboratories
Market Access
Marketing
Non-Oncology
Partnering
Patients
pdl1
Pharma
PM Development
Regulation
Reimbursement
Test
Testing
Therapy
• Commercialization
April 19th, 2018
The CMS National Coverage Decision on NGS
Jeff Schreier
Robert Feeney
I. Introduction On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination (NCD) that covers diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced can...
January 19th, 2018
What does the EU IVD Regulation mean for companion diagnostics and LDTs?
Dave Smart
Dave Smart, PhD, Director at Diaceutics, discusses the introduction of the EU IVD Regulation. While it is considered a necessary step, the Regulation raises issues not only for labs and those manufacturing companion diagnostic and laboratory devel...
September 1st, 2017
Liquid biopsy: clearing the barriers to support pharma, labs and patients
Marianna Sciortino
There was considerable discussion around liquid biopsy at ASCO 2017 at a time when questions about its clinical utility are still to be addressed. Marianna Sciortino, Associate Director, Diaceutics, assesses the current landscape and looks at the ...
June 5th, 2017
Leave no patient behind: how the FDA approval of Keytruda for specific biomarkers will put laboratory testing in the front line
Marcos Tadeu dos Santos
Merdol Ibrahim
Dawn Wilkinson
The FDA approval of Merck’s Keytruda (pembrolizumab) “for a specific genetic feature (biomarker)” is leading us into a new era in which the integration of diagnostics and biomarker detection on the treatment pathway is not an option, but man...
May 25th, 2017
Test availability at launch can be underestimated, under-budgeted and under-resourced: an example using real-time, real world analysis of PD-L1
Jordan Clark
Diaceutics gave a presentation at TriCON 2017 discussing how biomarkers and diagnostics are still falling short at launch, even though the industry is no longer in its infancy. Here, Jordan Clark, Managing Director, reports on how we can track the...
May 8th, 2017
FDA has approved Philips’ digital pathology solution as a primary diagnosis tool – it’s about time
Merdol Ibrahim
Following the FDA’s decision to approve Philips’ digital pathology solution, Merdol Ibrahim, Managing Director, Diaceutics, assesses the implications for laboratories and suggests this move heralds not the end of the pathologist’s microscope...
March 2nd, 2017
White paper: Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
Jordan Clark
Amit Kumar Jain
FDA draft guidance on the Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product, published on July 14, 2016, can be viewed as a testament to the Agency’s commitment to incorporate scientific advances ...
January 23rd, 2017
Pharma Finance and the Trump Effect
Philip White
In the month that Donald Trump becomes the 45th President of the United States, Diaceutics assesses the possible impact of the new administration on the world of pharma, diagnostics and precision medicine as rising drug prices come under fire. Few...
September 19th, 2016
How to Introduce Laboratories to a Diagnostic Scenario on Tropical Diseases that will Lead to a Better Diagnostic Pathway
Luiz Corrêa
Rapid Diagnostic Testing (RDT) has the potential to identify many millions of people infected with tropical diseases, but even more is possible when diagnostic identification of patients is combined with the infrastructure and expertise offered by...
September 15th, 2016
Feedback on IASLC Molecular Testing Guideline for Selection of Lung Cancer Patients – Revision 2016 Draft Recommendations
Patrick Considine
Maria Fe Paz
Neil Atkey
In August 2016, a team of experts from Diaceutics submitted a response to the IASLC Molecular Testing Guideline for Selection of Lung Cancer Patients, during the public open comment period1. Here they share a summary of their thoughts and concerns...
August 17th, 2016
Pharma’s Increasing Need for Competitive Intelligence
Steve Vitale
Competitive intelligence can offer huge benefits to pharma companies, especially in personalized medicine where market trends are continually shifting. In a world where available data grows by the second, Steve Vitale of Diaceutics examines how it...
August 15th, 2016
Optimizing the 2017 Budget Allocation for Personalized Medicine
Jordan Clark
Ryan Keeling
Jordan Clark and Ryan Keeling of Diaceutics appreciate the difficulties in determining the unknown costs of a diagnostic program, but are on hand with advice and solutions to successfully guide you through the budgeting process. As a project leade...
July 26th, 2016
IVD Market Access and Reimbursement Issues in 2016
Eirini Vavatsikou
Eirini Vavatsikou, Consultant with Diaceutics, provides an informative overview of the current system of IVD and LDT submission to the FDA and suggests how the problems that arise from diagnostic access and reimbursement could be eased. Market acc...
July 7th, 2016
Diagnostics Ignored in Targeted Therapy Pricing, Access and Value
Peter Keeling
Peter Keeling of Diaceutics provides insight on the role personalized medicine can play, specifically the diagnostic, in adding value to a therapy and why pricing models need to be reviewed to reflect the value that complementary and companion ...
June 21st, 2016
Great Expectations for Personalized Medicine Outside Oncology
Peter Keeling
Steve Vitale
We are all familiar with personalized medicine in oncology but future developments involving new technologies are likely to flourish in other disease areas. Peter Keeling and Steve Vitale of Diaceutics look at challenges and opportunities in the n...
June 20th, 2016
Physicians’ Lag in Understanding of Personalized Medicine is Pharma’s Opportunity
Andrew Van Aken
Andrew Van Aken, of CAHG, discusses the findings of a survey by CAHG and the Adelphi Group which focused on the perceptions of personalized medicine among various medical professionals of the implications for pharma when launching a targeted ...
June 6th, 2016
Complementary Testing in PD-L1 – A Groundbreaking Concept?
Ewelina Golebiewska
The FDA’s decision to approve what it terms a complementary diagnostic may not have been a groundbreaking event after all. In fact, it might make the testing landscape even more complex to navigate. Ewelina Golebiewska, Associate Director, Diace...
June 5th, 2016
Big Data: Harnessing Its Personalized Medicine Power
Peter Keeling
Everyone is talking about the possibilities and promises offered by big data and attempts are being made from many directions to harness the power it contains. Peter Keeling, CEO of Diaceutics, assesses where big data currently stands in relation ...
May 24th, 2016
What Minerva Knows That Pharma Does Not Yet
Peter Keeling
Peter Keeling of Diaceutics discusses the Minerva supercomputer built by Mount Sinai Medical Center. It has the potential to be a disruptive force in the personalized medicine space as it bypasses the old guidelines-driven treatment paradigm mar...
May 13th, 2016
Pharma Leaders Who Are PM-Ready See Their Efforts Reflected In Share Prices
Philip White
Philip White, Chief Financial Officer at Diaceutics, is not surprised to see that pharmaceutical companies we regard as personalized medicine leaders are being rewarded for their innovation with higher share prices, but while they benefit from the...
April 29th, 2016
Deal With GSK Brings New Personalized Rx Opportunities to Novartis
Peter Keeling
In garnering rights to GlaxoSmithKline’s portfolio of oncology drugs, Novartis has access to several newly-launched personalized cancer drugs that the company hopes to drive towards blockbuster status, in the company of its own star names Gleevec ...
April 4th, 2016
The Return On Investment of Better CDx Planning Based on Early PD-L1 Observations in NSCLC
Sanna Jousi
Sanna Jousi of Diaceutics assesses the financial benefits of integrating the planning, analytical and action steps for successful development and commercialization of testing into targeted therapies. The anti PD-1 therapy market promises to be the...
February 28th, 2016
Will the CMS Proposal to Adjust Laboratory Reimbursement Through Data Collection Disproportionately Hurt Small Labs?
Eloise Aita
Eloise Aita, PhD, of Diaceutics, writes that on the surface CMS proposals for laboratory reimbursement could simplify a complex process but is concerned that smaller labs, particularly those offering fast test turnaround for critically ill patient...
February 22nd, 2016
Should We Bring a Test In-House?
Yan Victoria Zhang
Tom Jackson, PhD
Yan Victoria Zhang and Tom Jackson, University of Rochester Medical Center, New York, discuss whether laboratories should conduct tests in-house or send their tests out. Bringing tests in-house is a major undertaking and factors related to benefit...
February 5th, 2016
The Knight’s Move in PD-L1 Chess
Peter Keeling
What does the future hold for PD-L1? Who will advance or move into the space? Peter Keeling of Diaceutics provides his insights on this hot topic. And so it begins, the rolling regulatory approvals of anti PD-1 therapy, an oncology drug class like...
December 21st, 2015
2016 Personalized Medicine Long Range Weather Forecast
Peter Keeling
In this end of year review, Peter Keeling predicts that trade winds will favor the most seaworthy of pharma companies. The outlook in brief High and Low Pressure Points Likely To Impact Pharma’s 2016 Personalized Medicine Plans – 50%+ more targe...
November 9th, 2015
Budget Allocation for Diagnostic Development and Commercialization (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In the final part of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg discusses the importance of allocating a large enough budget for diagnostic development and commercialization to support the goal of becom...
November 9th, 2015
Ensure Diverse Internal Capabilities in a Personalized Medicine Pharma Company (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 8 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses how the internal capabilities of a pharmaceutical company, like that of a successful soccer team, are essential to a wel...
October 27th, 2015
Funding a Diagnostic Test at Launch to Ensure Test Adoption (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 6 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses why pharma should consider funding a diagnostic test at launch to ensure adoption. Uber is a young company that, as yo...
October 27th, 2015
Engaging with Laboratories (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 7 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses the importance of pharmaceutical companies engaging with laboratories, which are often the forgotten stakeholder. Have...
October 21st, 2015
Pharma Communication and Education for Stakeholders (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 5 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses how pharmaceutical companies should communicate with and educate stakeholders to ensure test adoption. Do your grandpa...
October 21st, 2015
The Shift Towards Patient Centricity (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 4 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses how the pharmaceutical industry is putting the patient first by making a shift towards patient centricity. Sometimes y...
September 30th, 2015
Partnering and Managing Partnerships (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 3 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses the ways to establish and manage partnerships between pharma and diagnostic companies and how to keep the relationship hea...
September 14th, 2015
Drug/Diagnostics Partnering Deals Flow: A Changing Landscape
Tessa Sandberg
Ewelina Golebiewska
Are in-house diagnostic companies a must-have or a nice-to-have when trying to achieve personalized medicine leadership? And are pharmaceutical companies moving away from companion diagnostics? These questions are examined by Tessa Sandberg and E...
September 14th, 2015
Drug Pricing Models
Jeffrey Waldron
In the wake of numerous articles on the high cost of new drugs, several organizations have developed drug pricing models. With a number of these scorecards arriving at the same time to raise the profile of cost versus value, could they pose a majo...
September 6th, 2015
Integrating and Aligning the Diagnostic Strategy with the Drug Strategy (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 2 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses integrating and aligning the diagnostic strategy with the drug strategy. Do you know Bob, the guy who holds the budget...
August 24th, 2015
Personalized Medicine: What Pharma Should Do To Get Ready
Tessa Sandberg
The first class of an entrepreneurial program teaches students that change goes hand-in-hand with opportunity. At the moment, the clinical world is experiencing a revolutionary shift towards personalized medicine (PM) and so a huge opportunity is ...
August 24th, 2015
Establishing a Robust Diagnostic Development and Commercialization Strategy on Time (Personalized Medicine: What Pharma Should Do to Get Ready)
Tessa Sandberg
In Part 1 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses the importance of establishing a robust diagnostic development and commercialization strategy on time. Christmas alway...
May 19th, 2015
How Big can Merck’s Keytruda be in Lung Cancer? It’s Too Early to Call in the PD-L1 Arms Race!
Peter Keeling
Maria Fe Paz
Maria Fe Paz and Peter Keeling of Diaceutics discuss the competitiveness of the PD-L1 market and highlight that the key to success, for those in pharma, will be ensuring they leverage all the test adoption drivers to support uptake of the therapy...
March 16th, 2015
The PD-L1 Case – Immune Checkpoint Inhibitors and the Lack of Robust Biomarkers
Maria Fe Paz
Patrick Considine
Many experts say that out of all the therapies developed to harness the power of the immune system to fight cancer over the past several decades, PD-1/PD-L1 inhibitors look to be the most promising, even though it is still relatively early days in...
February 11th, 2015
Obama’s Precision Medicine Brouhaha: What’s the Point?
Peter Keeling
Peter Keeling, CEO of Diaceutics, gives his reaction to the recent announcement by President Obama that $215 million is to be invested in a new precision medicine initiative in the United States.  Few events over the past decade will have trigger...
November 3rd, 2014
Pharma’s Personalized Medicine Dilemma with Google et al and Treatment Guidelines
Maria Fe Paz
Patrick Considine
Maria Fe Paz and Patrick Considine of Diaceutics provide a further update on Google’s immersion into the health care realm and highlight an opportunity for pharma to collaborate. We continue to follow Google’s inexorable march into health care a...
July 7th, 2014
The Disruptive Rivalry of Immature CDx Markets
Peter Keeling
Peter Keeling of Diaceutics discusses competition in companion diagnostic markets and suggests that diagnostic adoption rules learned only recently will not be so dependable. We all knew it was coming, we just didn’t know when. Specifically, th...
April 16th, 2014
In a Novel Rx/Dx Deal, Biodesix Stands to Share in Risks and Profits of Personalized Medicine
Dr Christof Kölsch
Peter Keeling
As part of an article for Genomeweb, Christof Koelsch and Peter Keeling of Diaceutics comment on the AVEO Oncology and Biodesix partnership for ficlatuzumab and VeriStrat. ‘Drugmaker Aveo Oncology and test developer Biodesix entered into a partn...
April 3rd, 2014
Pharma CEOs Get Ready! Arrival of Personalized Medicine Litigation is as Much About Culture as Science
Peter Keeling
Peter Keeling, CEO of Diaceutics, comments on the Plavix lawsuits and the impact on personalized medicine. As recently reported in the US financial press [i] [2014], the first real personalized medicine influenced litigation has arrived. Specific...
March 12th, 2014
Pharma is Slowly Adapting to the Complexities and Challenges of Developing Personalized Medicine
Genomeweb
In the first of a two-part piece, Turna Ray reflects on the Personalized Medicine World Conference, 2014 and the discussions held there around the state of drug development, recent advances in the field, scientific challenges facing the industry a...
February 24th, 2014
French ALK Study Helps Illuminate the High Negative Dollar Impact of Single Test Strategies With Companion Diagnostics
Peter Keeling
Jordan Clark
Jordan Clark and Peter Keeling of Diaceutics critique a journal article exploring the effectiveness of parallel FISH and IHC methods for the detection of ALK. They go on to discuss the financial implications for pharma companies if they do not en...
February 22nd, 2014
Economics of Genomic Testing for Women with Breast Cancer
Jordan Clark
Jordan Clark of Diaceutics comments on the American Journal of Managed Care article ‘Economics of Genomic Testing for Women With Breast Cancer’ and highlights that personalized medicine is being held back by the unwillingness of payers to reimb...
January 28th, 2014
“More misleading and unhelpful hyperbole, but we wouldn’t want to be anywhere else.”
Peter Keeling
Peter Keeling of Diaceutics discusses how recent headlines in the personalized medicine space can be confusing for the reader by inferring that medicine has moved forward dramatically. He highlights that whilst new technology or solutions are now ...
October 25th, 2013
Oncology Shaping the Future of Personalized Healthcare: How Cancer Drug Development Holds the Key to Success for Precision Therapeutic Approaches
Pharmaphorum media
Early in 2013, pharmaphorum filmed a round table debate exploring how developments in personalized healthcare cancer treatments are defining the future for this area beyond oncology. In this white paper, which accompanies the broader video and wri...
October 8th, 2013
Diagnostics Are a Driver, Not a Cost: Head of Merck Serono Pharma Links Erbitux Peak Sales With KRAS Diffusion Investment
Peter Keeling
Peter Keeling of Diaceutics highlights the financial return on investment possible when pharma invests in companion diagnostic testing, with a focus on Merck Serono’s Erbitux. Belén Garijo, head of the Merck Serono’s pharma unit [2013], hits ...
October 7th, 2013
Why PM1.0 Will Not Create Radical Health Care Change Prompting the Need for PM2.0
Peter Keeling
Peter Keeling of Diaceutics explores the concept of PM2.0 in this article for the pharmaphorum website. The five forces behind 2.0 anything… The nomenclature ‘2.0’ has become synonymous with second generation trajectories. We have all experience...
September 23rd, 2013
New Device and Diagnostics Legislation Could Shake Up the Drug Industry
Patrick Considine
Patrick Considine of Diaceutics comments on the 2013 proposals by the European Parliament’s Health Committee to introduce new legislation for devices and in vitro diagnostics.  This month [September 2013], the European Parliament’s Health Com...
September 23rd, 2013
Google’s Entry Shifts the Personalized Medicine Tipping Point to The Edge
Peter Keeling
Peter Keeling of Diaceutics comments on Google’s announcement that it will create Calico, a new type of company focused on disease management, and highlights how it is a game changer in the personalized medicine space. At an offsite meeting of D...
September 17th, 2013
Personalized Medicine Needs a Statistical Makeover
Aiden Flynn
Aiden Flynn, Exploristics, highlights how early engagement with statisticians in personalized medicine planning would enable the identification of many more biomarkers with clinical utility and reveal the revenue opportunity for a particular the...
August 21st, 2013
Response to Andrew Jack’s article “Back to the Lab”
Peter Keeling
Andrew Jack’s article “Back to the Lab” in the Financial Times (FT) on the 16th August 2013 (http://www.ft.com/cms/s/0/e5679dae-e565-11e2-ad1a-00144feabdc0.html ) captured some of the step change underway within Pharma R&D as it embraces personali...
August 5th, 2013
Data-Powered Decision-Making in Personalized Medicine: High Return On Investment of Proactively Managing the Quality of Companion Diagnostic Testing
Maria Fe Paz
An overview of the Labceutics External Quality Assurance (EQA) modelled study [2013] looking at the impact of inter-laboratory variability of BCR-ABL1 testing. An abstract was submitted to ESH iCMLf International Conference on CML, Biology and Th...
July 29th, 2013
Data-Powered Decision-Making in Personalized Medicine: Cost-Effective Integration of Expert PM IT System into Lifecycle Therapy Planning Process
Ryan Keeling
Personalized medicine business planning is complex, with over 400 decisions to be made in order to integrate diagnostics into the patient pathway.  Knowledge of how to do this can vary across the therapy team and result in a lag in therapy lau...
July 22nd, 2013
Data-Powered Decision-Making in Personalized Medicine: Increasing the Frequency of Patient Engagement
Sanna Jousi
In this Expert Insight, Sanna Jousi of Diaceutics discusses patients’ perceptions of the pharmaceutical industry and diagnostic testing and the opportunity this presents for the pharma and the diagnostic industries to connect with patients. A rece...
July 16th, 2013
Potential New Trend-Setting Lifecycle Management Enabled by Personalized Medicine
Patrick Considine
Patrick Considine of Diaceutics comments on the recent approvals of Tarceva® and Gilotrif™, highlighting that the approval of Tarceva® for Roche is an interesting and potentially trend-setting new lifecycle management  approach.  In ...
July 15th, 2013
From Niche to Norm
Tiffany Olson, BSc MBA
Tiffany Olson discusses PM2.0 and provides insight on how it will change the industry as whole. As one of the personalized medicine industry veterans, it was in 2000 that I gave my first presentation on this ‘new concept’, about using in vitro d...
July 10th, 2013
The Future of Health Care is Personalized Medicine
Peter Keeling
Peter Keeling comments on the Bill Frist article which discussed how personalized medicine will be the future of health care. Bill Frist’s excellent article first published in the perhaps obscure G8 magazine and republished here (http://billfris...
June 26th, 2013
BRCA Testing: Will the US Supreme Court Judgement Make A Difference?
Peter Keeling
It’s not often that a gene mutation becomes a topic for general discussion but the actress Angelina Jolie’s disclosure that she carries the ‘faulty gene’ that can lead to breast and ovarian cancer has raised the profile of BRCA testing. A ...
June 9th, 2013
Overcoming the Commercial Challenges of Promoting Drugs and Their Companion Diagnostic
Peter Thornton
Managing the commercialization of companion diagnostic and drug combinations requires a different approach to sales and marketing than that employed for conventional treatments. The pharmaceutical industry is well aware of the need to target physi...
May 14th, 2013
PM & IT: R U Ready?
Ryan Keeling
IT will play a key role in internally embedding personalized medicine, enabling pharma executives to be fully equipped with the knowledge to develop and launch a commercialization strategy for the targeted therapy. Ryan Keeling of Diaceutics hig...
April 12th, 2013
Still Waiting For Pharma’s Personalized Medicine Share Price Bounce!
Philip White
This industry’s share price landscape has lost a little of its shine, but Philip White of Diaceutics looks at the financial road ahead and how, from a broader enabling perspective, personalized medicine can address the value challenge for pharm...
April 4th, 2013
The ‘One Companion Diagnostic – One Drug’ Paradigm is Not Fit For Purpose
Joanna Przewrocka
The cancer therapy market is evolving dynamically. We understand more and more about cancer biology and we are now able to develop drugs that selectively target the molecular drivers of tumorgenesis. Joanna Przewrocka examines a development in the...
February 22nd, 2013
Personalized Medicine Partnering: The Pharma Retort
Dr Bob Holland
In a follow-up to the recent pharma partnering article, ‘Beauty and the Beast – CDx Partnership Disparity’, Bob Holland provides the pharma viewpoint. It’s a very seductive myth that the co-creation of a novel medicine with a companion diag...
February 22nd, 2013
Collaboration, Collaboration, Collaboration: The European Solution
Tom Zietlow, PhD, MBA
Tom Zeitlow provides analysis on the recent report by Frost & Sullivan,’European Genetic Testing and Screening Services Market’. Two things struck me about a recent report from Frost & Sullivan entitled European Genetic Testing and Screening Servi...
February 8th, 2013
Beauty and the Beast – CDx Partnership Disparity
Jane Papadaki Markley
Jane Papadaki Markley of Asuragen explains why she believes the current Rx/Dx partnering model is at best no longer fit for purpose and, at worst, broken. The CDx partnership heralds a new era in bringing drugs to market with matching diagnostics,...
January 24th, 2013
Bringing Patient Voices to Personalized Medicine
Gwen Darien
Gwen Darien, Director of The Pathways Project, makes the compelling case for ‘patient-centric’ rather than ‘industry-centric’ thinking in personalized medicine. Of all the frequently employed models for cancer research and care, and the theme of ...
January 24th, 2013
“Whatever Anything Is it Ought to Begin by Being Personal”
Sanna Jousi
Research shows that patients are interested in talking about testing. In this Expert Insight, Sanna Jousi discusses how personalized medicine offers the chance for pharma and physicians to reconnect with their patients and put the person back into...
January 15th, 2013
Mystery Solved! What is the Cost to Develop and Launch a Diagnostic?
Dr. Doug Dolginow
Dr. Katherine Tynan
Noel Doheny
Peter Keeling
Diaceutics asked four senior executives in the pharma and diagnostic industry to come up with a value on how much it would cost to launch and commercialize a novel diagnostic test. Here’s what they came up with.  Every other year Diaceutics h...
January 10th, 2013
Laboratories are the Forgotten Stakeholder in Personalized Medicine
Mark Reis
Mark Reis highlights the importance of the laboratory in the delivery of personalized medicine and explains how the Diaceutics network adds value by creating a halo effect for both the laboratory and the therapy. [Note, July 2017: Labceutics i...
January 9th, 2013
Personalized Medicine Can Help Reshape the Pharma Financial Business Model
Dr Christof Kölsch
When long-awaited Zelboraf was finally launched in Europe it was met not only with excitement and hope but with fear arising from its likely price tag. Christof Koelsch asks if personalized medicine is doomed because it is simply too expensive, o...
November 18th, 2012
Regulated and Disseminated: A Way Forward For LDTs
Ron Mazumder PhD
Ron Mazumder of Janssen Diagnostics discusses how laboratory developed tests offer pharma an opportunity and comments on how risk can be minimized and how they could be used alongside in vitro diagnostics. Laboratory developed tests (LDTs) hav...
November 1st, 2012
Dx Reimbursement: Not Broken, Just Fragmented
Margery Rothenberg
The murky world of companion diagnostic reimbursement and access around the world is not easy to navigate and for pharma and companion diagnostic partners, these complexities will not go away anytime soon. However, as a starting point, reimburseme...
October 30th, 2012
Rheumatoid Arthritis – First Mover Advantages and Tea Leaves
Peter Keeling
Peter Keeling of Diaceutics considers the reasons why treatments for rheumatoid arthritis will likely transform to a predominantly personalized medicine market faster than we think.  Rheumatoid arthritis (RA) will likely transform to a predomina...
October 19th, 2012
Rx/Dx Partnerships – Four Basic Rules
Tom Zietlow, PhD, MBA
After working on over 20 Rx/Dx partnerships, Tom Zietlow, President of Diaceutics, believes there are four main issues you need to focus on when establishing an Rx/Dx partnership in order to make it a successful one. A big part of the Diaceutic...
October 12th, 2012
No Single Pharma Model For Commercialization of Biomarkers (View from a Companion Diagnostics Company)
Richard Kennedy
Richard Kennedy of Almac Diagnostics and Queen’s University Belfast, writes that in his experience there is no one route to market for biomarkers in the personalized medicine space. Each pharmaceutical and diagnostic company has its own preferre...
October 5th, 2012
Laboratory Developed Tests Versus IVD Kits Versus Quality
Iain D. Miller, Ph.D.
One of the critical success factors of personalized health care is access to high quality testing. But what is high quality testing? There are lots of definitions of quality but they tend to converge around the perception of whether the product or...
September 6th, 2012
Personalized Medicine Has Arrived … But The Tough Times Are Still To Come
Dr Christof Kölsch
Christof Koelsch discusses the companion diagnostic evolution and the key issues Diaceutics foresees if pharma doesn’t invest in the critical drivers of test adoption. For those of us focusing our daily efforts on the subject of personalized medic...
August 2nd, 2012
A Dose of Reality: Laboratories Need to be a Key Priority in Companion Diagnostics
Mark Reis
Mark Reis highlights the Labceutics’ survey on the attitudes and behavior of labs in the EU5 which finds that pharma-lab communication is poor. He calls for pharma to give labs further discussion and analysis as new companion diagnostics and dia...
July 18th, 2012
Recognizing Their Value? Diagnostic Acquisitions
Tiffany Olson, BSc MBA
In an assessment of the acquisitions taking place in molecular diagnostics during 2012, Tiffany Olson confirms that diagnostics will continue to play an important role in the future of health care. One of the common threads is that each of the acq...
July 12th, 2012
Prometheus… UnChained?
David Resnick
Nicole Kling
The recent Prometheus decision issued by the U.S. Supreme Court has become the talk of the personalized medicine field, generating a swarm of comments from legal and industrial pundits and influencing strategic legal and economic decisions in this...
July 10th, 2012
Our New Personalized Medicine Catchphrase: Like It, Learn It, Leverage It
Mollie Roth, J.D.
Mollie Roth discusses how the Diaceutics’ catchphrase can sum up not only a positive commercialization approach for pharmaceutical companies and their relationship with personalized medicine, but also the history of the industry itself. Diaceuti...
July 6th, 2012
Laboratories are the New Entrants in Personalized Medicine But Will Become a Dominant Force
Maria Fe Paz
Maria Fe Paz of Diaceutics considers that laboratories will become key influencers, ultimately emerging as one of the most dominant stakeholder groups in the future personalized medicine space. From the melting pot of opportunity that personalize...
July 6th, 2012
Xalkori/Zelboraf Approvals: Watching and Waiting
Sanna Jousi
Diaceutics has been monitoring Xalkori/Zelboraf stories as they evolve, tracking the responses and reactions of a number of key stakeholders, such as labs, physicians and payers, to ensure the key lessons to be taken from these two cutting edge a...

Blogs

Webinars & Podcasts

August 9th, 2018
Podcast: Oncology Patient Research
Why do we need to talk biomarkers with patients? Senior Director of Market Research at Diaceutics, Marianne Fillion, recently spearheaded an effort to gather insights directly from oncology patients to get an understanding of what they know about ...
April 20th, 2018
Podcast: PM Readiness Report 2018
Peter Keeling discusses the landscape and challenges for precision medicine, companion diagnostics, CDx or biomarker and conduit diagnostics are discussed including global laboratory test data analysis and forecasts for budget impact and value.

Publications

September 11th, 2018
BRAF mutation testing in melanoma – Poster presented at European Congress of Pathology 2018
BRAF mutation testing in melanoma: a study including Austria, Germany and UK, highlighting concordance for current technologies, and potential requirement of more sensitive technologies in future applications.
August 3rd, 2018
A Way Forward: Leveraging Advanced Diagnostic Testing to Unlock the Value of Precision Medicine
Read about how advanced diagnostic testing, ensuring that right patient gets the right therapy, at the right time, particularly with respect to therapies where the test result determines whether or not the therapy should be used (precision medicin...

Competitive Benchmarking Reports

March 16th, 2018
PM Readiness Report 2018 Summary
March 14th, 2017
Pharma Readiness for Diagnostic Integration 2017
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