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Criterium, Inc. a full-service contract research organization (CRO) dedicated to providing efficiency and expertise in Clinical Trial Services to pharmaceuticals, biotech, and medical device companies throughout the world, celebrates its 30th anniversary.
Continue readingIn the recent PharmaVoice Feb 2016 
issue highlighting Outsourcing, PV asked Pharma’s KOL’s to answer some key questions regarding the current state of Outsourcing & Strategic Partnerships.
John M. Hudak, President and Founder, Criterium Inc., answered these 2 questions for them:
Sponsors can have unrealistic expectations of CRO partners. Most partnerships work top-down at both Sponsors and CROs, and are evidenced in timelines and budgets. But top-down management may not always translate into trickle-down commitment. There are some discouraging figures out there about the high percentage of studies that don?t meet their timelines. When timelines and budgets are estimated to satisfy board members or project committees, it?s imperative to include all key factors that affect early planning stages, and be grounded in fiscal reality.
Planning needs transparency and communication, in concert. Sponsors can sometimes have impractical expectations regarding timelines and budgets. And CROs can end up having the same unrealistic expectations of study sites. Everyone wants to meet expectations and win the job ? but this sometimes results in unworkable time estimates and budgets. There needs to be more open discussion among stakeholders, Sponsors, CROs and sites regarding the environments in which studies are conducted — and realistic strategies for successful completion.
About John M. Hudak, MBA, President and Founder
John has more than 40 years of experience in the pharmaceutical research and business development arena serving the pharmaceutical and contract clinical services sectors. He has extensive expertise in strategic planning and competitive analysis, market development, promotional planning and tracking, proposal design and custom-services development, international project management and clinical study completion, protocol design and implementation, electronic data capture, and market communications and has worked with drugs, biologics, generics and medical devices.
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Each month, we investigate a different Clinical Trial Case Study that posed us with a challenging question; this time it’s a look at an orphan indication in HEMATOLOGY, and significant cost reductions for the sponsor:
We asked ourselves:
Scenario: A Phase IV study was required by the FDA as a condition of approval of an orphan drug. The sponsor was faced with monitoring, managing, and locking data for a 12-month study conducted at 100 sites.
Criterium offered an integrated technology-enhanced solution that allowed the sites to register 
patients and allowed the patients to record their event data directly into our remote systems.
Criterium’s solution enabled the client to eliminate most of the scheduled monitoring visits. Criterium’s diligence and centralized system meant that monitors only had to visit sites that had problems.
What If: If the client had used traditional methods, the cost would have soared for a product that has modest revenue and it would have taken much longer to provide the data to the FDA and the prescribing community.
Results: Criterium’s centralized real-time data accession utilizing Automated CRFs and Interactive Voice Response (IVR) medical history and patient diary application saved the client $1 million to $1.5 million in clinical monitoring and data management costs. In addition, the data were satisfactory for rapid submission to the FDA for conditional approval, were provided to the medical community to support the indication for which the drug was approved and numerous publications resulted from this fairly large body of data for this orphan indication.
Read more of our successful case studies
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Criterium proudly announces our two newest Oncology Consortia Groups: ATOMIC (The Academic Thoracic Oncology Medical Investigator’s Consortium) focusing on Thoracic and Lung Cancers, and ABRCC (The Academic Breast Cancer Consortium), dedicated to Breast Cancer research. These new consortia consist of a collaboration of outstanding Cancer Research Consortia that deliver innovative research and unparalleled expertise. These two new consortia will join Criterium’s already successful AGICC (the Academic GI Cancer Consortium) directed by Dr. Wells Messersmith, established in 2008, and AMyC (the Academic Myeloma Consortium) established in 2010 with Dr. Brian G. M. Durie directing 3 high profile studies.
All of Criterium’s Oncology Consortia specialize in translational research design to bring novel cancer therapies to market in accelerated time frames. “These new types of therapies allow cancer drugs to more effectively target only the destructive cancer cells, while allowing healthy cells to remain untouched, thereby providing a less toxic treatment, with better patient survival outcomes,” stated Dr. Jack Macdonald, the Senior Medical Consultant for the Oncology Consortia.
Dr. D. Ross Camidge of the University of Colorado?s Cancer Center in Aurora, Colorado has been appointed as ATOMIC’s Director. “ATOMIC brings together a powerful mixture of mature thought leaders and the next generation of experts with the sole goal of designing and completing clinical trials that will change the way we do business in thoracic oncology for the better,” says Camidge.
Also from the University of Colorado is Dr. Peter Kabos, 
the newly named Director for ABRCC. “ABRCC is an academic consortium formed for the new era of clinical trial design and implementation. Our goal is to rapidly translate advances in breast cancer research into targeted therapies that will benefit our patients,” states Kabos. Both bring an exceptional set of credentials in advanced research and organizational skills to the collaboration.
The Consortia Model for research and development in pharmaceuticals utilizes translational science methodologies to streamline cancer research. The Consortia rosters are presently represented by Key Opinion Leaders (KOLs) and Top Investigators at 24 of the most prestigious institutions in the USA. In this way, Criterium brings together these physician-scientists into highly effective and productive new drug development entities. To learn more, please visit: www.CriteriumInc.com/OCC.php
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Get To Know The South African Healthcare System
The South African healthcare system consists of public healthcare, which is financed and managed by the South African government, and private healthcare, which is primarily funded by health insurance and private direct fee for service payments. Private healthcare consumes more than 50% of total healthcare spending in South Africa, but only services about 20% of the population able to afford health insurance or direct funding of their healthcare needs.
The Attraction of South Africa as Clinical Research Destination
South Africa is classified internationally as a developing country and is often viewed by the less-informed as a poorly developed African country. This is far from the truth.? South Africa has a long history of conducting clinical research; this translates to interest of the medical profession in furthering their knowledge and remaining at the cutting edge of medical development. This is a good indication of the pool of experienced clinical research staff available for research, which is growing and developing as the research environment changes over the years. Clinical research experience is of paramount importance in the South African research environment: it is a regulatory requirement that investigators may only participate as principal investigator after having participated in at least two different clinical trials as a sub-investigator.
A Sophisticated Infrastructure and Clinical Trial Support System
South Africa has a sophisticated infrastructure and clinical trial support system available. Laboratory support to process and analyze blood and tissue samples is readily available in all the large metropolitan cities in South Africa. Most, if not all, of the major laboratories have a clinical trial division that specifically caters for the clinical trial environment, and usually have some partnership/working relationship with the large multinational analytical laboratories. All 
the clinical laboratories are audited and accredited by SANAS. These facilities meet all of the international standard requirements.
Product Depots with Strict Control Mechanisms in Place
As South Africa is located quite a distance from the major manufacturing facilities in the USA, Europe and Asia, investigational product depots are often used to import and distribute clinical trial products to site. These facilities adhere to all international packaging and manufacturing (GMP) and clinical trial requirements (GCP). As they generally receive, store, and distribute clinical trial investigational product for a number of different studies and companies, they have very strict control mechanisms in place to ensure confidentiality and safety of clinical trial product. They are able to manage all types of investigational product at all temperature ranges.
Interested in more in-depth information on this topic? Download our complete article from the May 2014 Journal for Clinical Studies:
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Dr. John S. Macdonald
Senior Consultant for The Oncology Consortia of CRITERIUM, INC.
In the past, typical anti-cancer systemic therapies that worked, albeit poorly, did so by killing cancer cells only slightly better than they killed normal cells. There were relatively few of these drugs and they were given to patients with all kinds of cancers. This toxic therapy could be depended upon to make patients sick all the time while rarely making cancers significantly improve.? To effectively develop these new treatments, clinical investigators must not only be excellent physicians but also be first rate molecular and cellular biologists.
CHEMOTHERAPEUTIC AGENTS KILL MORE CELLS THAN THEY SHOULD
The classic chemotherapeutic agents are relatively non specific toxins that function by killing or at least seriously injuring cells. These agents cause significant toxicity to patients because all or most of the cells in the body are injured by these drugs. A successful chemotherapeutic agent kills cancer cells a little better than it kills normal cells.
CHEMOTHERAPY MAKING A CANCER COMPLETELY DISAPPEAR IS RARE
One of the real negative aspects of chemotherapy is that all patients receiving a drug experience toxicity which may be life threatening, but only a minority of patients with cancer will actually have treatment make the tumor regress. Having chemotherapy make a cancer completely disappear with treatment with the therapy producing a CR or complete response, is rare. The final phase III trials required to show that a new treatment is equal to or superior to a standard therapy, require hundreds of patients most of whom will be made sick by the therapy but not get any anti-tumor benefit.
CLASSIC CHEMOTHERAPY PRODUCES UNWANTED ADDITIONAL EFFECTS
Finally since classic chemotherapy agents are toxins they may produce late effects such as second cancers and major organ (bone marrow, kidney, liver, lung, etc.) damage in patients who receive treatment and or cured of their original cancers. So the bottom line with classic chemo is that these are agents that are always toxic, rarely curative, require hundreds of patients on clinical trials to demonstrate efficacy and may result in serious late effects.
Recently this paradigm of toxic relatively ineffective cancer therapies is changing. Because of increased knowledge of molecular biology and molecular genetics, more specific targeted therapies that are less toxic to normal cells are being developed. Some dramatic improvements in survival have been reported with such treatments.
IN TARGETED THERAPIES, ONLY CANCER CELLS ARE DAMAGED
AND NORMAL CELLS ARE SPARED
The key factors that make targeted cancer therapies and immunotherapy different from and in theory superior to chemotherapy are that these treatments dependent upon specific anti-tumor effects. In other words in the ideal situation only? the cancer cells are injured or killed with a targeted approach or an immunotherapy approach. Thus if a target exists only in tumor cells or is over expressed in tumor cells, then a targeted therapy only affects the cancer cell and does minimal if any damage to normal cells. Ideally the result is tumor death and no normal cell toxicity. Likewise with immunotherapy, the only cells damaged would be the cells (tumor cells) carrying the antigen or marker that the immune system recognizes. Again the result is that cancer cells are damaged and normal cells are spared.
TARGETED THERAPIES ARE MORE EFFICIENT AND LESS TOXIC
The factor to keep in mind is that the clinical development of more targeted therapies should clearly be much more efficient than development of chemotherapy. Only patients with the specific target are entered in clinical trials so the likelihood of benefit is increased. Targeted or immunotherapeutic treatments may be active against the tumor at dose levels that are minimally toxic. Thus small targeted relatively non toxic trials may be used in development of newer approaches to cancer treatment.
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Criterium, Inc., a full-service CRO is proud to be the CRO of record as the supplier of services and support for this important trial. Further study details are provided by the pharmaceutical development sponsor, AtoxBio Ltd. on ClinicalTrials.gov
A complete article detailing the trial and its current progress was highlighted in JAMA’s April 2014 issue in print and online (http://archsurg.jamanetwork.com/article.aspx?articleid=1859986). This is a study to evaluate the safety and pharmacokinetics profile of different doses of AB-103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care. The primary study hypothesis is that AB-103 can be administered safely to the patients presenting with Necrotizing Soft Tissue Infections. Secondary endpoints are efficacy by exploratory descriptive analyses of specific efficacy endpoints from three outcome domains to demonstrate treatment benefit of AB-103 in comparison to placebo in patients with Necrotizing Soft Tissue Infections.
The efficacy domains 
are:
Criterium, with extensive experience in dermatology and infectious disease indications, particularly with wound and burn treatments, provided services for data and project management, clinical and medical monitoring, biostatistics, safety, regulatory support, and medical writing.
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