How to Select & Execute a Biomarker-Driven Clinical Trial Designs

At the 2016 Duke Industry Statistics Symposium, Dr. Robin Bliss, in collaboration with Dr. Jing Wang of Gilead Sciences, lead a discussion on “Biomarker-Driven Clinical Trial Designs for Precision Medicine.”  Dr. Bliss highlighted two Adaptive Enrichment Clinical Trials performed by Veristat as case studies for how to select and execute an enrichment clinical trial design.

In a world of precision medicine, biomarker-driven clinical trial designs are gaining attention in drug and biological agent research and development.  A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (NIH).  The use of a biomarker-design can improve study efficiency by targeting specific populations and can allow for the focus of research and treatment on each individual patient rather than on an average population.

One subclass of biomarker-driven clinical trials are Enrichment Study Designs.  Enrichment is the prospective use of any patient characteristic (e.g., demographic, physiologic, historic, genetic, etc.) to obtain a study population in which the detection of a drug effect is more likely than it would be in an unselected population (FDA Guidance).  Enrichment designs can be combined with many other adaptive design techniques such as early stopping for futility and efficacy, sample size re-estimation, and focused studies on particular sub-populations of interest.

Many study designs are available for biomarker-driven research, each having different strengths.  The choice of the best study design depends, among other things, on the certainty of the biomarker as a predictive or prognostic factor, the expected difference in mechanism of action and overall effect of the test product among biomarker positive and the overall population, and the prevalence of the disease.  For example, in one case study of a rare oncology trial presented by Robin Bliss at the 2016 Duke – Industry Statistics Symposium, there was some preliminary evidence of a biomarker subpopulation that may impact the effectiveness of the novel treatment; however because the disease was so rare, recruitment in the targeted subpopulation would be difficult.  The study sponsor selected an adaptive enrichment study design which included a planned interim analysis to evaluate the treatment effect in the biomarker positive subjects and the overall population midway through the study.  At that interim analysis, predetermined decision rules were applied to select whether to continue the study with the overall population or with the biomarker positive subjects only.   In a second case study presented by Dr. Bliss, the study sponsor had strong confidence of a prognostic biomarker but was unsure of the treatment performance in the complementary population.   Here, a stratified enrichment study design was selected to allow comparisons between control and novel treatment in both subpopulations of the rare cancer.

These examples illustrate the complexities of selecting the optimal biomarker study design in order to determine a benefit to a biomarker positive or other subpopulation.

 

Robin Bliss, PhD is a Manager of Biostatistics at Veristat who helps clients design and manage their clinical trials, both traditional and adaptive designs.   She is experienced working with regulatory agencies, particularly in helping them understand the advantages of applying adaptive designs for biomarker trials.

Veristat Acknowledged for its Rapid Growth on the Inc. 5000 List of America’s Fastest-Growing Private Companies

Veristat Continues To Be Recognized for Its Positive Impact & Company Growth

Today we announced that we have been recognized once again by Inc. Magazine as one of America’s fastest-growing private companies. Veristat debuted on the list in 2015.  

“Veristat is proud to have secured its ranking on the Inc. 5000 list for another year.” stated Patrick Flanagan, Chief Executive Officer of Veristat, “It’s an honor to receive this acknowledgement and is proof that Veristat’s passion for helping clients accelerate their life-enhancing and life-saving therapies through the clinical development process is working.  I am proud of the entire Veristat team for working so hard to assist clients every day and exhibiting an unwavering commitment to improving people’s lives.”

Veristat was founded over 20 years ago with a core focus in providing pharmaceutical and biotechnology companies with biometrics, medical writing and strategic regulatory consulting services. Over the past decade and particularly over the past 5 years, the company has expanded into a full-service CRO to help clients design, conduct, analyze and submit the results of their clinical studies for regulatory approval. Last year, Veristat doubled the size of its corporate headquarters and opened its first west coast office to serve our long time clients in the San Francisco Bay area.  

In 2016, Veristat expanded into Europe and now offers the ability to run clinical trials in North America, Europe, and Australia. Additionally, we continued the expansion of our United States footprint with the opening of a Raleigh-Durham office scheduled for the fourth quarter of 2016. We will continue to grow organically and through acquisition to meet the growing needs and demands of our clients.  

Earlier this year, Veristat was recognized as one of the “Top 50 Fastest-Growing Private Companies in Massachusetts” by the Boston Business Journal.   Today’s Inc. 5000 ranking is yet another accolade of Veristat from a prestigious organization that measures and endorses the growth of US companies.

Since 1982, Inc. has ranked the fastest-growing private companies in the United States and published the results on its annual 5000 list. The 2016 Inc. 5000 is ranked according to percentage revenue growth when comparing 2012 to 2015.  To qualify, companies must have been founded and generating revenue by the first week of the starting calendar year, and therefore able to show four full calendar years of sales. Additionally, they had to be U.S.-based, privately held, and independent—not subsidiaries or divisions of other companies—as of December 31 of the last year measured. To learn more and to view the 2016 Inc. 5000 list visit: http://www.inc.com/inc5000/list/2016/.

 

About Veristat

Veristat, LLC is an innovative full-service, science-focused clinical research organization (CRO) with over 20 years of experience in supporting clinical trials and regulatory submissions for pharmaceutical, biotechnology, and medical device companies. Veristat offers comprehensive clinical development services, including biostatistics, statistical programming, medical writing, clinical monitoring and data management, for a single study or an entire clinical program, as well as preparation of integrated summary documents and submission-ready CDISC data for regulatory filings. Due to Veristat’s unwavering commitment to scientific integrity, client focus and exceptional performance, long-lasting client relationships are our hallmark. For more information, please visit www.veristat.com.

 

Veristat Contact:
Gillian Dellacioppa, Marketing Director
Gillian.dellacioppa@veristat.com or 508-306-6336

WHAT ARE THE MAJOR/COMMON TYPES OF ADAPTIVE DESIGNS USED IN CLINICAL TRIALS TODAY?

An adaptive design is a clinical trial design that allows adaptations or modifications to aspects of the trial after its initiation without undermining the validity and integrity of the trial. An adaptive design consists of multiple stages. At each stage, data analyses are conducted and adaptations take place based on updated information to maximize the probability of success of a trial. In a recent investigation on the use of adaptive trial designs, it was reported that among all adaptive design types that were reviewed:   29% of studies used Group Sequential Design, 16% of studies used Sample Size Re-Estimation, 21% were Phase-I/II or Phase-II/III seamless designs, and 41% were dose-escalation, dose-selection and a mix of others. However, in order to fully understand the advantages of adaptive designs, you have to consider the different types of adaptive designs, their applicable situations, and the so-called operating characteristics, such as average and maximum sample-sizes, early stopping probabilities, and the power.

Let’s quickly explore the common types of trial adaptations which include:

GROUP SEQUENTIAL DESIGN

A group sequential design (GSD) is the simplest type of adaptive design that allows for premature termination of a trial due to efficacy or futility based on the results of the interim analyses (IA).  There are three sub-types of GSDs which are described by their names: early efficacy stopping design, early futility stopping design, and early efficacy/futility stopping design. Statistically, a GSD requires control type-I error, that is the probability of falsely rejecting null hypothesis must be kept below a nominal level.  A GSD may save cost and time due to early efficacy claim at the IA when the treatment effect larger than expected or early futility claim when the treatment effect is much smaller than expected.

ERROR-SPENDING APPROACH

A GSD has to pre-specify at the design stage the total numbers of analyses to be conducted and the timing of interim analyses. This might not be practical due to e.g., the availabilities of DMC (data monitor committee) members.  The Error-Spending Trial design (ESTD) is essentially a GSD, but with the added extra aforementioned flexibilities to allow changes in the total number and timing of the analyses. To control type-I error, an ESTD requires pre-specified error-spending function such that when the timing of the analysis changes, the error-spent at the interim analysis, thus the efficacy stopping boundary will change accordingly. People sometime call ESTD a group sequential design with certain error-spending (e.g., O’Brien-Fleming-like error-spending function). The concept of error-spending can be used in other adaptive designs as well.

SAMPLE-SIZE RE-ESTIMATION DESIGN

A GSD requires the maximum sample size to be pre-specified at the design stage. However, if the treatment effect is under estimated or the interim data show unfortunately low effect, which may cause a trial continuing to the final stage but marginally failed (i.e, p-value just a little over the threshold), we may want to increase the maximum sample size for the final analysis to protect power or conditional power. Such a GSD, featuring sample-size re-estimation at the interim analyses, is called sample size re-estimation (SSR) design.

PICK THE WINNER DESIGN

(also known as drop-the-loser, drop-arm, adaptive dose-finding design,  or Phase II/III seamless design)

Traditionally, Phase-IIB dose-finding and Phase-III confirmatory study are two independent studies. However, a more efficient design is to combine the two studies into one trial, called Pick-the-Winner design (PWD). Such a design if used properly, can reduce the number of patients required and can shorten the duration of the overall development program for the compound.  A PWD is typically a multiple-arm design with two stages: a selection stage and a confirmation stage. For the selection stage, a randomized parallel design with several doses and a placebo group is employed.  After the best dose (the winner) is chosen the patients of the selected dose group and placebo group continue to enter the confirmation stage. New patients are recruited and randomized to receive the selected dose (winner) or placebo. The final analysis is performed with the cumulative data of patients from both stages.

ADAPTIVE RANDOMIZATION DESIGNS

Response-adaptive randomization Design (RAR) is a trial design in which the allocation of patients to treatment groups is based on the responses (outcomes) of the previous patients. The main purpose is to provide a better chance of randomizing the patients to a superior treatment group based on the knowledge about the treatment effect at the time of randomization. A RAR is typically not required to control type-I error. Instead, the determination of design parameters are so optimized to, e.g., minimize the number of failures in the trial.

ADAPTIVE DOSE-ESCALATION DESIGNS

An adaptive dose-escalation design (ADED) is a design in which the dose level used to treat the next-entered patient is dependent on the toxicity of the previous patients, based on some traditional escalation rules. Many early dose-escalation rules are adaptive, but the adaptation algorithm is somewhat ad hoc. Recently more advanced dose-escalation rules have been developed using modeling approaches (frequentist or Bayesian framework) such as the continual reassessment method (CRM) and other accelerated escalation algorithms. These algorithms can reduce the sample-size and overall toxicity in a trial and improve the accuracy and precision of the estimation of the maximum tolerated dose (MTD).

In an ADED, we need to define the toxicity rate of MTD for your disease indication because different designs target different toxicity rate. The typical evaluation matrix for ADED are the sample size, the number of patients with toxicities, and the accurate of predicted MTDs. No type-I error control is enforced.

BIOMARKER-ADAPTIVE DESIGNS

A biomarker-adaptive design is a design that allows for adaptations using information obtained from biomarkers. A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic or pathogenic processes or pharmacologic response to a therapeutic intervention.  A biomarker can be a classifier, prognostic, or predictive marker each of which have differing effects on the types of adaptations one might plan in the study.  Overall, biomarkers are used at the interim analysis to assist in decision-making, while the final decision will still be based on a primary or gold-standard endpoint, such as survival.

EVALUATION MATRIX OF ADAPTIVE DESIGNS

All adaptive trial designers face a choice among different types of adaptive designs, and the choice of design parameters after determination of a certain type of adaptive design. To make an intelligent choice, the design team has to construct an evaluation matrix and ideally a utility function that combine all aspects in the evaluation matrix into a numerical value. The design corresponding to the maximum utility is the optimal design.

 

READ FULL ARTICLE TO LEARN MORE:

This list of adaptive designs is not exhaustive but will provide a quick foundation of understanding of the types of adaptive designs commonly used in clinical trials today.

To read more in depth about these types of adaptive designs, when to use them and to explore the opportunities and challenges of each design, read the full article “Adaptive Designs- Recent Advancement in Clinical Trials” by Mark Chang, PhD, Senior Vice President of Strategic Statistical Consulting at Veristat and John Balser, PhD, President and Chief Biostatistician at Veristat.

Biostatisticians: 3 Tips to Knowing When Adaptive Design Is Right for Your Clinical Trial

If you’re reading this as a biostatistician or clinical trial professional, you know that the pharmaceutical industry is shifting from classical to adaptive clinical trial design in an effort to reduce NDA failure rate, lower the cost of research and development, and expedite the precision medicine movement. As a member of the Talent & Culture team at Veristat (a CRO), I spend a great deal of time speaking with people like yourself, many of whom are potential candidates excited about the opportunity to work at a company where they may get exposure to an adaptive design trial. Realizing the consistency across these conversations, I have begun wondering if their interest in adaptive designs is a result of it being a current trends, or if it is because adaptive design truly offers increased efficiencies. As a result, I have spent some time research when adaptive design might not be right for a clinical trial and have found two articles that discuss when it is appropriate to use them.

The first article, titled “Adaptive Design – Recent Advancement in Clinical Trials” was written by Mark Chang and John Balser (in full disclosure, I should tell you that Dr. Chang and Dr. Balser are both members of Veristat’s statistical consulting group), and published last month in the Journal of Bioanalysis & Biostatistics. It focuses on how adaptive design can be a more cost efficient clinical trial approach than the traditional design because it optimizes and streamlines the drug development process. This article also provides a high level overview of the different types of adaptive designs and how to select the appropriate one based on the type of clinical trial. Chang and Balser also review many of the controversies surrounding adaptive trials.

 

 

The second article, a discussion between Wade Wirta and Steven Schwager of Medidata Solutions, is titled “When is Adaptive Design Right for your Clinical Trial?” This piece covers similar topics as that of the first article, but leaves out statistical formulations that clarify common confusions among statisticians who have not had a lot of exposure to adaptive trials. Wirta mentions that adaptive trials are not just a change in methodology, but a change in the entire process, including the technology used to run the trial. Additional complexities can be found in operational challenges such as needing a more agile supply chain.

Drawing on these two articles and my conversations with members of the Biostatistics & Statistical Programming Department at Veristat, I have listed three actions that I recommend you take to determine if you should avoid an adaptive design trial:

• Consider the practicality – Everything from “will the recruitment speed jeopardize the adaptive design?” to “can the interactive voice response system (IVRS) support the adaptive design?”

• Recognize the complexity – The statistical methodologies for complicated adaptive designs are still being developed, while methods are readily available for more commonplace adaptive designs like futility analysis.

• Examine the work environment – Adaptive designs only succeed in truly collaborative environments because they require rapid integration of abilities and knowledge from various disciplines into the decision-making process.

Now that you know the challenges posed by adaptive designs, you can go about assessing if an adaptive design in right for your trial. Remember that it doesn’t have to be a complicated adaptation. Perhaps it is as simple adaption such as assessing futility, which is a simple and cost effective adaptation that has the ethical advantage of stopping patient exposure to ineffective drugs.

 

Robin Brodrick is a Talent Acquisition Consultant at Veristat and an aspiring minimalist. Follow Robin on Twitter or LinkedIn for a unique mix of minimalism, job search, and recruiting advice. To learn more about Veristat and its open positions, click here!

What You Missed at the Event of the Year | #DIA2016

Veristat joined over 6500+ life sciences professionals at the Drug Information Associations (DIA) Annual Meeting  that recently took place in Philadelphia, PA. The conference featured over 175 topics in 25 tracks covering the latest innovations, trends, challenges, and solutions faced by drug developers today. The hottest topics of the meeting were related directly to recent industry trends and events, including increased patient safety, the Zika outbreak, harnessing data to find cures, and many more.

In the exhibit hall, Veristat joined 470 other exhibiting firms who support and offer innovative solutions to improve and accelerate drug development. Veristat was excited to promote its recent expansion into Europe, and to announce its plans to open a new office in Raleigh-Durham, North Carolina. We were also delighted to see many familiar faces along with meeting new ones.

WATCH THE VIDEO

See what you missed at DIA, in our time lapse video of the booth on the last morning of DIA.

LEARN MORE ABOUT VERISTAT

Veristat can help you manage your entire clinical trial, starting with program design, regulatory agency engagement and study start-up activities. We will identify and qualify the top sites for patient recruitment success. Our oversight continues with clinical operations and biometrics services through to regulatory submissions support and agency representation.

We have teams on the ground throughout North America, Europe, and Australia to support your programs.

If you missed the chance to speak with us at DIA or want to learn more, visit us online at www.veristat.com or email us today.

 

Fueled by Growth, Veristat Continues Geographic Expansion

Veristat announced today that it is continuing its accelerated growth and geographic expansion with the opening of an office in Raleigh-Durham, North Carolina. In addition to this newly planned North Carolina office, Veristat has additional North American-based offices in Southborough, MA, Cambridge, MA, San Bruno, CA, Montreal, Canada, and its European office in Glasgow, UK. The new office, scheduled to open in the fall of 2016, will support the company’s accelerated growth by engaging an experienced talent pool and providing local support to Veristat’s clients in the area.

“Veristat has hired many talented clinical research professionals in North Carolina,” stated Patrick Flanagan, Chief Executive Officer of Veristat. “The Raleigh-Durham area has a population that includes a very experienced and professional CRO community. We have hired and will continue to hire very talented individuals to grow our team of biometrics and clinical operations professionals. Having a local office will facilitate the expansion of our team and allow us to better serve the clinical development needs of our clients.”

Veristat currently has Clinical Operations, Biostatistics, SAS Programming, Data Management and Business Development/Account Management team members based in North Carolina. The Company is currently hiring professionals for all of its business units, including Clinical Operations, Biometrics, Medical & Regulatory and SG&A. Veristat will rapidly accelerate hiring as the office opens later this year. To learn more about open roles, or to apply, visit Veristat’s Careers page at http://www.veristat.com/careers/.

About Veristat:

Veristat is an innovative full-service, science-focused clinical research organization (CRO) with over 20 years of experience in supporting clinical trials and regulatory submissions for pharmaceutical, biotechnology, and medical device companies. Veristat offers comprehensive clinical development services, including biostatistics, statistical programming, medical writing, clinical monitoring, project management and data management, for a single study or an entire clinical program, as well as preparation of integrated summary documents and submission-ready CDISC data for regulatory filings. Due to Veristat’s unwavering commitment to scientific integrity, client focus and exceptional performance, long-lasting client relationships are our hallmark.

 

Veristat Strengthens Statistical Consulting and Adaptive Design Trial Expertise

Appoints Mark Chang as Senior Vice President of Strategic Statistical Consulting

 

We are proud to announce that we have strengthened our statistical consulting and adaptive design expertise with the appointment of Mark Chang, PhD to the newly created position of Senior Vice President of Strategic Statistical Consulting.   Dr. Chang will help clients evaluate and implement strategic, operational and technical efficiencies to advance products through the clinical trial and regulatory submission process.

“Veristat is thrilled to welcome such an esteemed clinical research and statistical expert to Veristat,” stated John Balser, PhD, President of Veristat. “Mark will provide Veristat’s clients with the intellectual leadership to optimize their clinical development plans, trial designs and regulatory submission strategies.  His experience with designing and implementing both simple and complex adaptive design trials is unmatched in the industry.”

Dr. Chang joins Veristat with more than 20 years of experience as a statistician at both biopharmaceutical firms and CROs, including AMAG Pharmaceuticals, Millenium/Takeda Pharmaceuticals, PAREXEL and MTRA.  He is experienced with NDA submissions and working collaboratively with the regulatory agencies throughout the clinical trial and submission process.  Dr. Chang is also an adaptive design expert, having authored and co-authored dozens of books and peer- reviewed journal publications on adaptive design methodologies and implementation in clinical trials.

In addition, Dr. Chang is a fellow of the American Statistical Association and an adjunct professor of Biostatistics at Boston University.  He is a co-founder of the International Society for Biopharmaceutical Statistics, co-chair of the Biotechnology Industry Organization (BIO) Adaptive Design Working Group, and a member of the Multiregional Clinical Trial (MRCT) Expert Group.  Throughout his career, he has frequently held advisory posts for numerous industry committees and served as an associate editor for many peer-reviewed publications.  He has given over 50 lectures, short courses, and invited speeches at national and international conferences and has been invited twice to present at the US Food and Drug Administration.

Dr. Chang received his Ph.D. in Civil Engineering and his Masters of Science in Biostatistics at the University of Massachusetts in Amherst, MA.   He also received his Masters of Science and Bachelors of Science degrees at Hohai University in Nanjing, China.

 

About Veristat:

Veristat is an innovative full-service, science-focused clinical research organization (CRO) with over 20 years of experience in supporting clinical trials and regulatory submissions for pharmaceutical, biotechnology, and medical device companies. Veristat offers comprehensive clinical development services, including biostatistics, statistical programming, medical writing, clinical monitoring, project management and data management, for a single study or an entire clinical program, as well as preparation of integrated summary documents and submission-ready CDISC data for regulatory filings. Due to Veristat’s unwavering commitment to scientific integrity, client focus and exceptional performance, long-lasting client relationships are our hallmark.  For more information, please visit www.veristat.com.

 

Veristat Contact:
Gillian Dellacioppa, Marketing Director
gillian.dellacioppa@veristat.com or 508-306-6336

The Top 20 Biotech & Pharma Influencers on Twitter

Scientists. Doctors. Academics. Investors. Analysts. Patient advocates. There are a wide variety of social thought leaders in the biotech and pharma Twitterscape (you know, it’s like ‘landscape’, but for Twitter).

There are plenty of articles addressing the regulatory and compliance concerns that are preventing the industry from embracing social media, but very few that talk about bringing the community together to engage in meaningful social conversations. Can you imagine how much activity there could be if more than 10 of the top 50 pharmaceutical companies in the world used all 3 of the top social media channels?

This post is intended to provide you with a list (in no particular order) of the top 20 industry influencers on Twitter as of 26 May 2016 so that you will know who to follow. But it is also a dare to engage with these influencers to get real-time industry news and information and to gain insights into some of the hottest industry topics. (Note: This list does not include corporate accounts, such as @FierceBiotech.)

Amy Harmon (@Amy_Harmon): Amy is a National Correspondent and Pulitzer Prize winner at The New York Times, who digs into topics such as social ethics in science, biotechnology, and genomics.

Eric Topol (@EricTopol): Eric is a prominent Cardiologist at Scripps Health in San Diego, and a Professor of Genomics at The Scripps Research Institute. He was an early advocate of health IT and continues to be a thought leader in this area.

Paul Sonnier (@Paul_Sonnier): Paul runs a 37,000+ member digital health LinkedIn group. He is the founder and principal at Digital Health Consulting and is on the Strategic Advisory Board at Pathway Genomics Corporation.

Ryan Bethencourt (@RyanBethencourt): Ryan is a Program Director & Venture Partner at IndieBio, Cofounder and former CEO of Berkeley Biolabs, Cofounder of Counter Culture Labs. You can count on him for live tweets from industry events and up to date information on industry activists and activities.

Adam Feuerstein (@adamfeuerstein): Adam is a Senior Columnist for TheStreet.com. You can follow him for information on publicly traded biotech stocks. His wit is sharp and he doesn’t hold back any punches if he thinks something is fishy at a company.

Paul Tunnah (@pharmaphorum): Paul is the CEO & Founder of pharmaphorum media, a digital podium for communicating thought leadership and innovation within pharma.

Daniel MacArthur (@dgmacarthur): Daniel is the Co-Director of Medical and Population Genetics at the Broad Institute, and an Assistant Professor at Harvard Medical School. He leads an academic research team devoted to developing methods for interpreting the functional impact of genetic variation.

Jason Moore (@moorejh): Jason is a Director and Professor at the Institute for Biomedical Informatics, Perelman School of Medicine at the University of Pennsylvania. He tweets about science, precision medicine, and how technology is impacting the industry’s future.

Jonathan Eisen (@phylogenomics): Jonathan is a Professor at the Department of Medical Microbiology and Immunology and Section on Evolution and Ecology, U.C. Davis Genome Center, at the University of California. As his handle implies, he tweets a lot about genomics. He also will keep you up to date on what he’s reading and provide some humor about recent political topics.

Craig Lipset (@CraigLipset): Craig is the Head of Clinical Innovation within Worldwide Research and Development at Pfizer and on the Board of Directors for several non-profits. Has been in the field of drug development for over 15 years.

Mike Thompson (@mtmdphd): Mike is a Clinical Adjunct Assistant Professor for the Department of Medicine at University of Wisconsin School of Medicine. He is also a Medical Director, Early Phase Cancer Research Program, Patient-Centered Research at Aura Health Care. Mike runs some interesting Twitter polls and provides frequent ASCO updates.

Rahlyn Gossen (@RebarInter): Rahlyn is a patient experience enthusiast, health tech geek, and proud New Orleanian. She tweets for Rebar Interactive.

Luke Timmerman (@ldtimmerman): Luke is a biotech journalist and founder of @TimmermanReport. He is a contributor at Forbes and co-host of Signal, a podcast at STAT News. He covers all areas of the industry from sexism in the workforce to new PD-L1 breakthroughs.

Bruce Booth (@LifeSciVC): Bruce describes himself as an early stage biotech VC and recovering scientist. He tweets about investing topics, such as the behaviors of first time biotech CEOs and where biotech VC funding is heading in the future. He can also be relied upon for inspiration quotes in the form of Metallica quotes.

Dan Sfera (@TheRealDanSfera): Dan runs a website called The Clinical Trials Guru, where he discusses clinical trials in plain English. His company is called DSCS Sweat Equity & Investments, LLC. He is an entrepreneur who partners with, invests in, and advises clinical research companies. He uses his Twitter account to promote a lot of his YouTube vlogs, which covering everything from dealing with a confrontational CRA to professional development opportunities for PIs. Anyone who follows his Twitter account knows that he is also a frustrated sports fan, as every team he starts to root for instantly looses.

Luke Scicluna (@Biotech_Updates): Luke is an immunologist and neuroscientist who moved to the Biotechnology sector, and is interested in Life Science developments. His tweets will keep you up to date on the latest industry changes, approvals, failures.

Michael Fisch (@fischmd): Michael is the Director of Medical Oncology at AIM Speciality Health and a clinical specialist in the Department of General Oncology at MD Anderson Cancer Center. He tweets about patient advocacy, cost of care, and challenges with getting cancer patients enrolled in clinical trials.

Wendy Blackburn (@WendyBlackburn): Wendy is a marketer who is focused on pharma. She covers topics you won’t see elsewhere, like how to create compliant medidata for branded organic search results.

Mark Schoenebaum (@MarkSchoenebaum): Mark has been a biotech and pharma analyst since 2000. If his profile photo looks familiar, it is because you have probably seen him on CNBC. He also loves sharing data visually, with cool charts and word clouds.

Matthew Herper (@matthewherper): Matthew writes about genomics and other biomedical science topics for Forbes. He also talks about many of the struggles that the industry sees when trying to develop new drugs.

And there you have it. Enjoy your new connections. Get to know them, engage in meaningful conversations with them and with others, and help advance the biotech and pharma industry down a new path!

 

Robin Brodrick is a Talent Acquisition Consultant at Veristat and an aspiring minimalist. Follow Robin on Twitter or LinkedIn for a unique mix of minimalism, job search, and recruiting advice. To learn more about Veristat and its open positions, click here!

Veristat to Share Its Partnership Insights at GoBalto Webinar

The Role of Transparency in CRO-Sponsor Partnerships: Enabling Better Collaboration Models

About the Webinar

Join GoBalto for an exciting webinar that examines both the Sponsors and CROs point of view on how to retain successful Sponsor-CRO partnership that ensures study success.

Tuesday, May 24, 2016

 1:00 – 2:00 PM EDT (10 AM  PDT)

Successful collaborations between sponsors and CROs require skills in communication and relationship management to create a shared vision of partnering and trust. One of the critical components of a successful partnership is transparency, from both a data and business process perspective. This mindset may be lacking in sponsor/CRO relationships, which can limit the potential to complete projects better, faster and more efficiently. The challenge increases significantly when a sponsor works with several CROs. Against this backdrop, many sponsors seek to achieve strategic and transformational change, while many such initiatives currently achieve only small, incremental improvements.

This webinar will address common collaboration obstacles from both the CRO perspective and the sponsor perspective with a focus on increasing the value of strategic partnerships. Panelists will share their views on how transparency in data and business process can be leveraged to increase the quality of the relationship—and ultimately, the success of the study.

Webinar Panelists Include

CINDY HENDERSON
Executive Vice President, Strategic Development
Veristat

BARRY MILTON
Director of Client Engagement
goBalto

VERONICA LUDENSKY
Senior Manager, Clinical Outsourcing Management
Takeda Pharmaceuticals

Register To Attend Webinar

Please visit the GoBalto website to register for this complimentary webinar.

Learn ‘How to Manage Your Outsourcing Strategies’ From Veristat CEO Patrick Flanagan At the Chief Medical Officer East Summit

Join Veristat, as well as Chief Medical Officers and R&D Executives from small to mid-sized life science companies at the Chief Medical Officer Summit East 2016 to share ideas, solutions and support for bringing new products through the clinical development process.

The conference will address the unique challenges of accomplishing this while directing and managing all R&D functions with limited resources, while raising capital and planning for the appropriate exit strategies.

Attend the Panel Discussion

Hear Veristat’s CEO Patrick Flanagan speak on the panel titled:

Whatever the Outsourcing Model, What’s the Best Way to Manage it?

Date:  Wednesday, May 11, 2016

Time:  1:55 – 2:35 pm

 

The reality with clinical outsourcing is that it’s extremely people dependent. Once relationships are sourced and emerging biotech settles on governing and economics, the relationship moves down to different levels into the project teams. Everyone is under huge financial pressure and this tension can drive negative behavior, causing flare-ups.

In this session, we address best practices to meet the long term development needs, specifically non- traditional agreements and approaches to minimize cost, prevent change orders and ensure on time deliverability on a fixed budget. We will hear from both CROs and CMOs on what they really want from their external teams and discuss what can be different for 2016 and 2017.

Panel Moderators:

• ShiYin Foo, MD, PhD Former CMO, Cardioxyl
• Catherine Wheeler, MD CMO, SVP, Clinical Development, Acetylon Pharmaceuticals

Panelists:

• Patrick Flanagan Chief Executive Officer,Veristat
• Lynn Sutton VP, Clinical Operations, InSeption Group, LLC
• Graham Wood, PhD EVP, Phase I Clinical Development, Altasciences Clinical Research: Vince & Associates

Schedule a Meeting

Meet with Veristat at the conference. Even if you are not attending, reach out today to schedule a meeting.

 

Veristat Expands Its Clinical Operations into Europe

Veristat Expands Its Clinical Operations into Europe

Acquires UK-based CRO, Spero Oncology

Veristat announced today that it is expanding its clinical research offerings into Europe through the acquisition of UK-based CRO, Spero Oncology. Spero Oncology is a UK-based CRO specializing in providing clinical operations support for oncology clinical trials primarily throughout Europe, but also in Australia and New Zealand.  With the acquisition of Spero Oncology, Veristat now offers its clients full clinical operations support in Europe including feasibility studies, legal representation in the European Union, Clinical Monitoring, Project Management, Protocol Writing and Regulatory Strategy.

“Veristat’s expansion into Europe marks an important milestone in our history,” stated Patrick Flanagan, Chief Executive Officer of Veristat. “Adding the Spero Oncology team to Veristat will strengthen our ability to deliver value to our clients’ multi-national trials throughout North America and Europe. The Spero team has an impressive reputation for delivering valuable guidance and insight to their clients’ clinical trials. We feel that this team is a great fit culturally and professionally and will enhance our ability to make a difference in the trials we perform on behalf of sponsors.”

Spero Oncology will immediately be integrated and operate under the Veristat brand and name.

Veristat has appointed Spero’s founder and Managing Director, Theresa Bruce, to the newly created position of Vice President of Clinical Operations at Veristat.   In her new role, Theresa will provide leadership and strategic oversight to Veristat’s global clinical operations team.   She joins Veristat with more than 23 years of clinical research experience in both the pharmaceutical and CRO industry.  She is passionate about drug development having spent the last 16 years providing leadership and project management support for numerous oncology trials.  Prior to founding Spero Oncology, she was the COO of Nexus Oncology. And, following the acquisition of Nexus by Ockham Oncology, she remained as Vice-President, Global Operations. Originally trained as a nurse, she worked as a Research Sister in a large teaching hospital in Glasgow and subsequently completed her MBA in the city.

“We are thrilled to be joining the Veristat family,” stated Theresa Bruce, Vice President, Clinical Operations at Veristat. “Being part of an international CRO allows us to provide clients with an expanded service offering and the ability to run clinical trials in North America and Europe. Veristat is a great fit for my team because we share the same passion for helping clients bring new therapies to market.”

About Veristat:

Veristat is an innovative full-service, science-focused clinical research organization (CRO) with over 20 years of experience in supporting clinical trials and regulatory submissions for pharmaceutical, biotechnology, and medical device companies. Veristat offers comprehensive clinical development services, including biostatistics, statistical programming, medical writing, clinical monitoring, project management and data management, for a single study or an entire clinical program, as well as preparation of integrated summary documents and submission-ready CDISC data for regulatory filings. Due to Veristat’s unwavering commitment to scientific integrity, client focus and exceptional performance, long-lasting client relationships are our hallmark.  For more information, please visit www.veristat.com.

 

Veristat Contact:
Gillian Dellacioppa, Marketing Director
gillian.dellacioppa@veristat.com or 508-306-6336

Veristat Recognized as One of the Top 50 Fastest-Growing Private Companies in Massachusetts

Veristat announced today that it has been recognized as one of the top 50 fastest-growing private companies in Massachusetts, taking the #35 slot.   According to Privco[i], there are over 4,000 private firms operating in Massachusetts today.

“Veristat is honored to be recognized as one of the top 50 fastest growing private firms in Massachusetts,” stated Patrick Flanagan, Chief Executive Officer of Veristat. “Over the past four years, Veristat has nearly tripled its size in both revenues and talent.   We continue to grow in order to provide our clients with the strategic and scientific expertise needed to manage their clinical trials and navigate the regulatory process.   In the coming months, we will be expanding our geographic reach and service offerings.”

The Boston Business Journal “Fast 50” list includes the top 50 privately held businesses in Massachusetts that recorded the fastest revenue growth from 2012 through 2015.   This year’s rankings were published in the April 22 weekly edition of the Business Journal.

To learn more and view the BBJ’s list of the Fastest Growing Private Companies in Massachusetts, click on the link below:  (you must be a BBJ subscriber to view the full list):

http://www.bizjournals.com/boston/news/2016/04/21/bbj-honors-the-50fastest-growing-private-companies.html

See Veristat Speak at Regulatory Writing for Approvals Conference

Don’t miss Paula Wun’s panel discussion on “Editing Considerations for Submission Documents” at the 5^th Annual Regulatory Writing for Product Apporvals Conference.

Join Veristat and industry leaders in regulatory writing and submissions management at the upcoming 5^th Annual Regulatory Writing for Product Approvals Conference to share and discuss the challenges of writing regulatory submissions in a continually changing regulatory environment.

Panel Discussion

On Thursday, April 28 at 10:40 AM, we invite you to join Paula Wun and an esteemed panel of industry experts will discuss the following:

EDITING CONSIDERATIONS
FOR SUBMISSION DOCUMENTS
Paula Wun, Senior Director, Medical Writing
Veristat

 

LEARNING OBJECTIVES

• Avoiding edits to verbatim data from source materials
• Designating a final authority decision maker
• Editorial comment specificity
  • Clear text changes
  • Data edits vs. writing style comments
• Develop editorial timelines for success
• Reducing reviewer fatigue
• Editorial checklist development
• Integration of edits into final submission

PANEL EXPERTS INCLUDE:

• Laura Sheppard, MBA, MA, Manager, Medical Writing, MALLINCKRODT PHARMACEUTICALS
• Becky Nuttall, Medical Writing Lead, EMD SERONO
• René Alvarez, Associate Director, Medical Writing, FIBROGEN
• Gretchen Griffin, MS, Director, Regulatory Writing Strategic Solutions and Operations, ABBVIE
• Leslie Lescale-Matys, Medical Writing Group Lead, SHIRE

We hope to see you at this exciting panel discussion.

Schedule a Meeting with Veristat

Veristat can offer you strategic guidance in planning for your regulatory submission, we provide representation at the agency meetings, and we provide the statistical as well as medical writing support to prepare the submission documents. We have over 20 years of experience helping clients prepare INDs, CTAs, NDAs, BLAs, and MAAs.

Schedule a time to speak with Paula or any of Veristat’s experts at the show about the challenges you are trying to overcome with your current or upcoming submission project.

What Does the Future of Quality Assurance and Regulatory Compliance Look Like?

Written by Susan Yadlon, BS. Edited by Robin Brodrick.

What Role does Quality Assurance Play at a CRO?

A contract research organization (CRO) has the unique ability to expose QA Specialists to a broad range of therapeutic areas. QA professionals in a CRO must be flexible to a continually changing environment because the role is exciting, never boring, and very fast paced.

QA Specialists provide guidance and mentor colleagues on Quality Management Systems (QMS) and Good Clinical Practice (GCP) regulations. They may be the administrator of the Document Control program, provide training in the QMS, assist in investigating a departure from standard practice, assess compliance to internal procedures, assist in the selection of vendors, conduct internal or supplier audits, provide input into investigations, create quality metrics, and provide vision to management on the company’s compliance status.

Which Personality Traits do Exceptional QA Specialists Tend to Have?

Successful QA Specialists are self-driven to continually improve the quality and compliance of the organization. They have strong project management skills, with a high-level attention to detail and accuracy, and drive projects to completion.  Their excellent written and communication skills provide guidance and influence over people whom they have no authority. They are flexible, dependable and diligent.  Most companies also look for candidates who have GCP knowledge, a bachelor’s degree in a relevant field, and experience in an FDA regulated environment.

What Does the Future of QA Look Like in Pharma & Biotech?

Quality has a strong influence on the regulatory compliance within an organization.  However, it does not always guarantee a quality product. According to the FDA, everyone owns quality within an organization. Quality needs to be built into the product from concept to final release. Looking at quality from a systems approach will help prevent a reactive mode from occurring after a problem has been discovered, and will change it to a proactive approach where compliance is thought about before a project begins and the system is looked at as a whole. A true clinical quality professional will have a thorough understanding of the overall quality management system (QMS) and will mentor the business to take ownership and build in quality from the start of each project.

Are you a Quality Assurance Specialist in the Greater Boston area? If so, Veristat may be interested in hiring someone like you! Click here to apply for a QA role.

 

Susan Yadlon is passionate about fostering cats that are unlikely to be adopted, civilizing them, and then introducing them to a loving family. She spent several years as an industry consultant before leaving the consulting world and grounding herself back into industry so she could foster cats. Susan is the Associate Director of Corporate Compliance at Veristat, LLC in Southborough, MA. To learn more about Veristat’s open positions, click here.

 

 

Veristat to Attend the MassBio Annual Meeting 2016

Join Veristat and other Massachusetts life sciences companies at the MassBio Annual meeting, as they discuss the most critical challenges in bringing new products to market.

 

Annual Meeting Highlights Include:

Keynotes speeches:

Opening Keynote by Kate Marshall, high school honors student, athlete and CF advocate

Closing Keynote by Dr. Tony Coles, Chairman & CEO, Yumanity Therapeutics

Remarks from special guests: 

• Charlie Baker, Governor, Commonwealth of Massachusetts
• Congressman Richard Neal, Dean of the Mass. Delegation
• Rachel Kaprielian, HHS Regional Director

Discussion topics to include:

• Price & Value
• The 2016 National Landscape
• Advanced Manufacturing
• Innovative Pricing Models: The Future is Now
• The Future of Finance & Capital Markets
• An Evolving Paradigm of Drug Discovery – Externalization, Virtualization, De-virtualization, Contract Research & Strategic Partnerships
• Digital Healthcare
• Technology in Clinical Trials
• The Microbiome
• Immunotherapy in Combination
• Biosimilars
• Science in SpaceThe MassBio Annual Meeting focuses on the most critical challenges facing the Massachusetts life sciences industry. The meeting program is designed by a steering committee of industry leaders and the agenda encompasses keynote presentations, panel discussions, interactive working sessions and extensive networking opportunities.

The MassBio Annual Meeting also includes the Innovative Leadership Award Luncheon, which honors an industry leader for his or her contribution to moving the life sciences industry forward.

Annual Meeting Highlights:

Opening Keynote by Kate Marshall, high school honors student, athlete and CF advocate

Closing Keynote by Dr. Tony Coles, Chairman & CEO, Yumanity Therapeutics

Featuring remarks from special guests: 

• Charlie Baker, Governor, Commonwealth of Massachusetts
• Congressman Richard Neal, Dean of the Mass. Delegation
• Rachel Kaprielian, HHS Regional Director

Discussions include:

• Price & Value
• The 2016 National Landscape
• Advanced Manufacturing
• Innovative Pricing Models: The Future is Now
• The Future of Finance & Capital Markets
• An Evolving Paradigm of Drug Discovery – Externalization, Virtualization, De-virtualization, Contract Research & Strategic Partnerships
• Digital Healthcare
• Technology in Clinical Trials
• The Microbiome
• Immunotherapy in Combination
• Biosimilars
• Science in Space

The MassBio Annual Meeting focuses on the most critical challenges facing the Massachusetts life sciences industry. The meeting program is designed by a steering committee of industry leaders and the agenda encompasses keynote presentations, panel discussions, interactive working sessions and extensive networking opportunities.

The MassBio Annual Meeting also includes the Innovative Leadership Award Luncheon, which honors an industry leader for his or her contribution to moving the life sciences industry forward.

Annual Meeting Highlights:

Opening Keynote by Kate Marshall, high school honors student, athlete and CF advocate

Closing Keynote by Dr. Tony Coles, Chairman & CEO, Yumanity Therapeutics

Featuring remarks from special guests: 

• Charlie Baker, Governor, Commonwealth of Massachusetts
• Congressman Richard Neal, Dean of the Mass. Delegation
• Rachel Kaprielian, HHS Regional Director

Discussions include:

• Price & Value
• The 2016 National Landscape
• Advanced Manufacturing
• Innovative Pricing Models: The Future is Now
• The Future of Finance & Capital Markets
• An Evolving Paradigm of Drug Discovery – Externalization, Virtualization, De-virtualization, Contract Research & Strategic Partnerships
• Digital Healthcare
• Technology in Clinical Trials
• The Microbiome
• Immunotherapy in Combination
• Biosimilars
• Science in Space

 

Schedule a Meeting with Veristat

Take advantage of the time at the event and schedule a time to meet with Veristat.   We are a full-service CRO that can help guide you through the entire clinical development and regulatory process.   Whether you need help writing your protocol, preparing for your regulatory submissions or need a partner to help bring your product from IND to NDA, look to Veristat for a truly collaborative partnership.

How to Beat Your Competition in a Video Interview

 

Video Interviews – Because, What Could Go Wrong?

There is only one thing you need to do to beat your competition in a video interview: Be distraction free.

Skype and GoToMeeting interviews leave an incredible amount of room for error, so having a distraction-free run will automatically put you in a good light. What could possibly go wrong during a video interview that would be distracting? Here are just a few ridiculous things that have actually happened to your fellow job seekers:

• A cat ran across the keyboard and turned the computer off.

• A giant teddy bear was photo-bombing the interview over a candidate’s shoulder.

• The cell phone rang during the interview and the candidate’s ring tone was ‘Blame Canada’ from the South Park Movie. The interviewer was Canadian.

• The candidate wasn’t wearing pants and didn’t realize there was a mirror behind him, revealing that he was wearing only his button front shirt and boxers.

Distractions are a pet peeve of most interviewers, so take whatever actions necessary to eliminate as many as possible. Lock your cat in a different room, put your cell phone on silent, bribe your noisy neighbors to be quiet for an hour with a plate of freshly baked cookies, and for goodness sake, put on some pants!

If a distraction occurs despite having taken these precautions, know that the interviewer will be judging your reaction to it. A potential CEO was on a Skype interview when his maid appeared behind him as she was cleaning. He turned around and politely asked her to come back later. The interviewer would have had a much different opinion of the candidate had he turned around and crossly told her to leave.

5 Tips for a Distraction Free Video Interview

Sheryl Sandberg and Nell Scovell may want you to lean in, but the web camera does not. Skype or video chat with a few friends before your interview so that you become familiar with how the camera perceives your body language. When you lean towards the camera during a video interview it can make you come across as aggressive or eccentric. Instead, sit slightly off-center of the camera frame with one hand on the desk and the other in your lap. According to Forbes, this will create asymmetrical posturing and make you seem relaxed and confident.

Don’t get crazy eyes! Don’t stare directly into the camera, it can come across as really creepy. Another pitfall occurs when you try to make eye contact by looking at the person’s eyes on the computer screen. This makes it appear as though you are looking at your lap or are drowsy. The best option to create the illusion of eye contact is to look over the interviewer’s shoulder.

Consider changing your username if you are currently listed as crzygrl72, spidermanisthebomb, or something similarly unprofessional.

Test your lighting. Bad lighting can be distracting for interviewers if you appear red, blue, or if they can hardly see you. This can make it hard for them to focus on your answers and harder for you to leave a strong impression.

Think about the background. Having a well-organized home office in the background will make a great impression on the interviewer. But, if your house or home office is a mess and you don’t have time to tidy up, consider purchasing a backdrop background and support system. Just set it up and within minutes you’ll have a pristine background for your video interview that is distraction free.

Now you have all the tools you need to beat out the competition in your next video interview. Good luck in your job search!

 

Robin Brodrick is a Talent Acquisition Consultant at Veristat and an aspiring minimalist. Follow Robin on Twitter or LinkedIn for a unique mix of minimalism, job search, and recruiting advice. To learn more about Veristat and its open positions, click here!

 

 

Veristat Strengthens Senior Management Team

Appoints Faith Haines Kolb as Vice President, Biometrics

Veristat, a full service Clinical Research Organization (CRO), announced today the appointment of Faith Haines Kolb to the newly created position Vice President of Biometrics.   Faith joins Veristat with over 20 years of experience leading operational teams and large-scale projects during periods of rapid growth and international expansion for both large and small CROs.  As Vice President of Biometrics, Faith will lead and continue to grow the Biostatistics and Programming teams, as well as the Data Management and Data Standards groups at Veristat.

“The addition of Faith expands and strengthens the Senior Management Team at Veristat,” stated Patrick Flanagan, Chief Executive Officer of Veristat, “Her technical capabilities along with her experiences growing and leading operational international teams will benefit Veristat as we expand our services and geographic reach in 2016.   Faith’s intellect and experience will be an asset to Veristat as we guide our clients through the design and implementation of their clinical trials. Her leadership will be a great contributor to our clients as they advance their products to market efficiently and cost-effectively.”

Faith most recently was the Worldwide Head of Data Management and Biostatistics for PAREXEL’s Early Phase Group.   Prior to that, Faith was the Senior Director of Clinical Operations and Data Management for Cambridge-based CRO, Prometrika.  She spent several years at Averion International as Chief Technical Officer during a period of multiple acquisitions and rapid international growth.  She began her career at PAREXEL where she held various positions leading up to Director of Clinical IT for Data Management Services.   Ms. Kolb received her bachelor’s degree in Mathematics and Education from Clark University in Worcester, MA.    She is an active member of numerous clinical and data management associations, and speaker at industry conferences.

About Veristat:

Veristat is an innovative full-service, science-focused clinical research organization (CRO) with over 20 years of experience in supporting clinical trials and regulatory submissions for pharmaceutical, biotechnology, and medical device companies. Veristat offers comprehensive clinical development services, including biostatistics, statistical programming, medical writing, clinical monitoring, project management and data management, for a single study or an entire clinical program, as well as preparation of integrated summary documents and submission-ready CDISC data for regulatory filings. Due to Veristat’s unwavering commitment to scientific integrity, client focus and exceptional performance, long-lasting client relationships are our hallmark.  For more information, please visit www.veristat.com.

Veristat Contact:
Gillian Dellacioppa, Marketing Director
gillian.dellacioppa@veristat.com or 508-306-6336

Veristat Participates in Cycle for Survival 2016 and Raises over $20,000 to Fund Rare Cancer Research

Veristat Raises $20,355 to Support Rare Cancer Research

On Saturday, February 27th, Team Veristat JOINED THE BATTLE with Cycle for Survival 2016!   Team Veristat had riders at both the Boston, MA and Palo Alto, CA events.

In Boston, over 900 riders participated in this amazing, fun and inspiring event!  Across the country in 2016 alone, over twenty million dollars has been raised to fund rare cancer research.

“Like many of my colleagues, I know the reality that cancer will touch us all, one way or another, and that fearing it is useless – fighting back is the way to beat it,” said Lindsey Lukis, Director of Talent and Culture at Veristat, “I joined Veristat’s Cycle for Survival team to fight back.  As a clinical research company, Veristat often works in oncology research.  Cycle for Survival was an amazing extension of the work we do every day and feel so passionately about; it was also an incredible opportunity to fulfill our personal missions, to #jointhebattle against cancer, and to stand united in giving Rare Cancers no option but to back down.”

Veristat would like to thank all of its supporters who donated to Team Veristat and helped us surpass our goal!  We thank all of our riders, family members, employees and corporate partners for making this possible!

To see how these efforts and donations make an impact in rare cancer research, visit https://www.cycleforsurvival.org/impact.

Veristat hopes that you will be inspired to JOIN THE BATTLE in the fight against rare cancers.

More about Cycle for Survival

Cycle for Survival is the national movement to beat rare cancers. About half of all cancer patients are fighting a rare cancer — Leukemia, lymphoma, pancreatic cancer, bladder cancer, ovarian cancer, and all pediatric cancers are just some of the many rare forms of the disease. These patients often face limited or no treatment options. Since 2007, Cycle for Survival has raised over $50 million through its signature high-energy, indoor, team cycling events; funding pioneering rare cancer research led by Memorial Sloan Kettering Cancer Center. Together with the movement’s founding partner, Equinox, Cycle for Survival has supported over 100 innovative clinical trials, research studies, and major research initiatives.

100% of every donation funds rare cancer research.

Did you know that Monday, February 29 is Rare Disease Day 2016?

Support and Honor Rare Disease Day 2016 with Veristat

Rare Disease Day calls attention to the public health issues associated with rare diseases, which affect nearly 30 million Americans and countless others around the world.

The Commonwealth of Massachusetts joins a coalition of organizations recognizing the day, being coordinated by the National Organization for Rare Disorders (NORD), which includes patient organizations, professional societies, government agencies, medical researchers, pharmaceutical and biotechnology companies, and patients.

Locally, MassBio, The MGH Center for Rare Neurologic Diseases, The MGH Frontotemporal Disorders Unit, member companies, patient groups, patients and legislators have joined together and coordinated an event to recognize Rare Disease Day.

Please join us to recognize Rare Disease Day and the research being done in Massachusetts to treat and cure rare disease. Together, we can raise awareness of rare disease. 

Rare Disease Day 2016 Event: The Patient Voice

Monday, February 29, 2016 from 11:00 AM – 12:00 PM 

State House, Great Hall, 24 Beacon Street, MA US 01233

Entry into the event is free, though it requires a pre-registration.  Please click below to register:

Connect with Veristat at Boston’s Rare Disease Day Event

Veristat is MassBio member and supporter of Rare Disease Day and will be attending the event.   We are looking forward to helping raise awareness of rare diseases.    We hope that you too will attend this event.    If you would like to meet up with Veristat at the event, click on the Let’s Connect button below.  

Consider Attending the SCOPE Summit for Clinical Operations Executives

 

Join Veristat and other Clinical Operations Executives from pharmaceutical, biotech and other healthcare firms at The 7th Annual SCOPE Summit, taking place February 23-25, 2016 in Miami, FL.   This event features three days of in-depth discussions focused on the challenges related to each aspect of clinical trial planning and management including:

• Data Integration
• Site Feasibility, Selection & Management
• Patient Engagement, Recruitment and Retention
• Mobile Technologies
• Project Management
• Outsourcing
• Forecasting, Budgeting and Contracting
• Quality (QbD) in Trial Conduct
• Risk-Based Monitoring
• Post-Marketing Studies
• Observational Research
• Statistics
• Biomarker-Driven Trials

 

Attending the Event?  Meet up With Veristat.

Veristat will be sending a few members of its Clinical Operations team to the event who will be available to speak with you to discuss your goals for 2016.  It is our goal to help you advance your clinical trials and regulatory submissions so that your therapy can help the patients who need them, faster.

Brenda Baxter, RN
Director, Clinical Monitoring

Martha Plaza
Director, Project Management

 

In addition, our Director of Development Eric Monroe will be at the event.   Reach out today to schedule a meeting with us at the event or anytime that works for you!

Learn More About Veristat

Click to learn more about Veristat’s Monitoring and Project Management services.