What Is The Difference Between Research And Commercial IND Categories?

October 1, 2017

IND Categories There are two categories for INDs: commercial and research. The main difference is who submits the application to FDA and the intended purpose of their clinical research. The FDA publi...

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What are the Types Of INDs?

September 15, 2017

Types of IND Applications A potential new drugs needs IND approval to enter the clinical investigation part of development. IND approval must be completed before the new drug application can be submi...

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What are the Phases of an IND Investigation?

September 1, 2017

Phases of IND Investigations As part of an IND application, clinical protocols are submitted for review. A clinical trial protocol should be written for each phase of the clinical investigation accor...

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Who Must Apply for an IND?

August 15, 2017

Who Must Apply for an IND? An Investigational New Drug (IND) is issued by the FDA to facilitate moving forward with more advanced testing on that drug. At this stage, the potential new drug is still ...

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What is a Clinical Investigation?

August 1, 2017

What Is a Clinical Investigation? Clinical investigation is one phase of the FDA new drug approval process that is used to bring a new drug to market, making it available for treatment in any patient...

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What is the Purpose of an IND?

July 15, 2017

What Is an IND? An investigational new drug (IND) is one that has shown promise in laboratory testing and is ready for clinical trials. Drug development takes a very precise course that is overseen a...

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Who Can Participate In A Clinical Trial?

July 1, 2017

Participating in Clinical Trials The purpose of clinical drug trials is to see how a new drug will work in a real-life situation. Laboratory testing is good, but it cannot simulate every possible det...

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What Are the Phases of a Cancer Clinical Trial?

June 23, 2017

Clinical trials for cancer test various treatment types, such as new drugs, radiation therapy, surgery, immunotherapy and treatment combinations or methods. A cancer clinical trial is the first step i...

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How Can Patients Find Out About a Specific Investigational Drug

June 15, 2017

Investigational Drug Trials Drugs undergo a specific process before they are approved by the FDA for use to treat disease in humans. For people waiting for a cure, this can seem like a long process, ...

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TD2 and Deep 6 AI Announce Partnership to Accelerate Oncology Clinical Trial Recruitment

May 31, 2017

Artificial intelligence used to identify potential clinical trial participants in minutes SCOTTSDALE, Ariz. and PASADENA, Calif. (May 31, 2017) – Translational Drug Development (TD2) and Deep 6...

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What Are Some of the Potential Drawbacks to Receiving an Investigational Drug?

May 13, 2017

Although investigational drugs can provide hope for cancer patients who may not be responding well to standard therapies, there are certainly drawbacks and risks associated with the opportunity. The p...

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TD2 is Attending ASCO Annual Meeting | Chicago, Illinois | June 2-6, 2017

May 8, 2017

Click here to schedule a meeting with us!...

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What Are the Costs Involved in Receiving an Investigational Drug?

April 29, 2017

If they are selected to receive an investigational drug, patients can expect to receive that drug free of charge. In some cases, other costs associated with the treatment itself may pop up, and patien...

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Are There Specific Criteria Used to Determine Whether Patients Can Receive an Investigational Drug Outside the Clinical Trial Setting?

April 15, 2017

To be considered a candidate for receiving an investigational drug outside of a clinical trial drug investigation setting, patients usually must: Have already tried the standard treatments availabl...

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Who Can Provide Access to Investigational Drugs Being Developed by Pharmaceutical Companies?

April 1, 2017

The FDA, in conjunction with the sponsor drug company, is tasked with providing access to pharmaceutical investigational drugs. Physicians must request access to the investigational drug form both the...

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Merrimack and TD2 Work Together on the Phase 1 Study of MM-310

March 24, 2017

Merrimack Initiates Phase 1 Study of MM-310 in Solid Tumors CAMBRIDGE, Mass., March 23, 2017 /PRNewswire/ -- Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) today announced the enr...

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NCI and Investigational Drugs: What Is the Role?

March 18, 2017

The role of the National Cancer Institute (NCI) with respect to investigational drugs is that of a sponsor. NCI acts as a sponsor to many, but not all, investigational drugs moving through the FDA app...

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Are All Investigational Drugs Available Through an Expanded Access or Special Exemption Mechanism?

March 4, 2017

When it comes to oncology drugs, not all investigational drugs are available through an expanded access or special exemption mechanism. The main factors affecting an investigational drug’s avail...

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Are There Other Ways to Get Investigational Drugs?

February 18, 2017

Although the most common way for patients to get access to an investigational new drug is through a clinical trial, there are other avenues that physicians and patients can pursue. Expanded Access C...

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How Do Patients Get Access to Investigational Drugs?

February 4, 2017

Investigational drugs can provide an avenue for patients to try new oncology drugs prior to the treatments completing the FDA approval process. FDA approval is the last step in the drug development pr...

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Are Cancer Clinical Trials Just for Advanced Cancer?

January 27, 2017

Most people wanting to participate in cancer clinical trials are people suffering advanced cancer. Having depleted treatment options that failed to stop the progression of their cancer, these patients...

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If I Enter a Cancer Clinical Trial, Is There a Chance I will Receive a Placebo Instead of Cancer Therapy?

January 13, 2017

Only when a cancer clinical trial involves people with treatment-resistant or progressive cancer would a placebo be given.  Participants are always informed they may receive a placebo prior to th...

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What is a Placebo?

December 31, 2016

Cancer clinical trials rarely employ the use of placebos, or “sugar pills,” since participants typically suffer from a form of cancer that has resisted standard treatments and are searchin...

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What Is the Difference Between Standard Therapy and Experimental Therapy in a Cancer Clinical Trial?

December 16, 2016

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research is responsible for ensuring all drugs marketed in the U.S. are effective and safe for human use. However, the CDER...

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What Is Standard Therapy in Cancer Treatment?

December 2, 2016

Standard therapies for treating cancer include surgery, radiation therapy and chemotherapy, depending on the part of the body affected and stage at which the cancer is diagnosed. Solid tumors respond ...

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TD2 Works Closely with ZIOPHARM Oncology to Conduct a Preclinical Study Presented at the Annual Society for Neuro-Oncology Meeting in Houston, TX

November 21, 2016

November 21, 2016 Ziopharm presents preclinical data generated by TD2; Local Regulated IL-12 Expression as an Immunotherapy for the Treatment of Pontine Glioma.  See attached poster....

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What Is a Randomized Cancer Clinical Trial?

November 18, 2016

All clinical trials progress through levels—Phase I, Phase II and Phase III. Phase I of a clinical trial involves studying the new drug or treatment to discover a safe dose amount. Evaluation of...

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Why Are Randomized Cancer Clinical Trials Important in Developing New Treatments for Cancer?

November 4, 2016

Used extensively in biological experiments and human clinical trials, randomization prevents both accidental and selection bias by eliminating sources of bias and producing comparable groups. Randomiz...

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Where Do Cancer Clinical Trials Take Place?

October 21, 2016

Conducted in hospitals, veterans’ medical centers, university hospitals, medical clinics, cancer centers or physicians’ offices, cancer clinical trials test drugs, blood products, medical ...

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What Is an Investigational Drug?

September 15, 2016

The development of a new drug is a long and involved process that requires months, if not years, of lab work and testing. However, if results are promising, the drug company or a sponsor can send a re...

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TD2 to Present at the Upcoming 4th Annual Tumor Models in Boston

July 15, 2016

TD2's VP of Nonclinical Operations, Paul Gonzales, will be presenting at the upcoming 4th Annual Tumor Models - Boston (www.tumor-models.com) on Wednesday, July 20th.  The topic of the p...

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TD2 Works Closely with ZIOPHARM Oncology to Conduct a Preclinical Study Being Presented at the Upcoming ASGCT Meeting in Washington, DC

April 28, 2016

April 28, 2016 Below is the abstract seelcted for presentation at the upcoming American Society of Gene & Cell Therapy 19th Annual Meeting:   Regulated Expression of IL-12 as Gene Therapy ...

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TD2 and Navigating Cancer Partner to Bring Patient-Reported Outcomes to Clinical Trials Through a Cutting-Edge Mobile Application

April 20, 2015

Leading patient engagement and mobile care management solution and precision oncology CRO partner to revolutionize patient engagement in clinical trials Scottsdale, AZ and Seattle, WA – April 2...

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Paradigm and TD2 Announce Strategic Partnership For Tumor Profiling Service

April 20, 2015

Collaboration to provide expanded use of Paradigm Cancer Diagnostic (PCDx™) service by oncologists across large oncology network SCOTTSDALE, AZ and ANN ARBOR, MI Monday, April 20, 2015 -- Parad...

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Responsibility for Pancreatic Cancer Research Team Moves to Seattle Non-Profit Institution

September 10, 2014

Responsibility for Pancreatic Cancer Research Team Moves to Seattle Non-Profit Institution Seattle, WA. September 8, 2014   Seattle’s own Cancer Research And Biostatics (CRAB), a...

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Inform Genomics and Translational Drug Development (TD2) Announce Strategic Collaboration

June 23, 2014

TD2 and Inform Genomics Announce Strategic Partnership BOSTON, June 23, 2014 (GLOBE NEWSWIRE) -- Inform Genomics, Inc., a privately held company that utilizes a proprietary technology platform to dis...

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MPI and TD2 Join in Strategic Collaboration to Provide Drug Developers a Unique Multi Biomarker Direct Path to Drug Approval

April 3, 2014

MPI and TD2 Join in Strategic Collaboration to Provide Drug Developers a Unique Multi Biomarker Direct Path to Drug Approval Medical Prognosis Institute A/S (MPI) - a Danish company and Translational...

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Nuvilex Selects Translational Drug Development (TD2) to Advance Treatment for Pancreatic Cancer

April 1, 2014

Nuvilex Retains TD2 to Conduct Preclinical and Clinical Studies SILVER SPRING, Apr 01, 2014 (GLOBE NEWSWIRE via COMTEX) -- Nuvilex, Inc. (otcqb:NVLX), a clinical-stage international biotechnolog...

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Forma Therapeutics makes deal with Celgene potentially worth $600M

April 1, 2014

Forma Therapeutics makes deal with Celgene worth $600M Watertown biotech firm Forma Therapeutics has announced a collaboration with drug giant Celgene Corp. potentially worth $600 million over t...

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Dr. Daniel D. Von Hoff named one of ASCO’s 50 Oncology Luminaries

March 10, 2014

Dr. Von Hoff's research led to development of numerous therapeutic agents, and improved patient care. In association with its 50th anniversary, the American Society of Clinical Oncology (ASC...

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Translational Drug Development (TD2) attracts Dallas partner

December 18, 2013

ORIX USA brings investment dollars that will enable TD2 to expand; help grow Arizona’s biomedical economy SCOTTSDALE, Ariz., and DALLAS, Texas — Dec.18th, 2013 — ORIX USA Health and...

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FORMA THERAPEUTICS ANNOUNCES ADVANCEMENT OF TUMOR METABOLISM COLLABORATION WITH JANSSEN

September 16, 2013

Ongoing Collaboration Advances as FORMA Therapeutics Receives Licensing Payment and Additional Research Funding WATERTOWN, Mass., July 9, 2013 – FORMA Therapeutics announced today the advanceme...

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First-in-Human Thunder God Vine Trial-Minnelide

September 12, 2013

TGen and Scottsdale Healthcare launch Phase I 'Thunder God vine' trial for cancer First patient receives treatment at Virginia G. Piper Cancer Center Clinical Trials SCOTTSDALE, Ariz.&n...

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FDA approves drug tested by Scottsdale Healthcare and TGen

September 6, 2013

Abraxane now part of standard-of-care for patients with advanced pancreatic cancer, following studies at the Virginia G. Piper Cancer Center at Scottsdale Healthcare SCOTTSDALE, Ariz., Sept.&nbs...

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TGen-TD2-Scottsdale Healthcare breast cancer pilot study

July 17, 2013

TGen-TD2-Scottsdale Healthcare breast cancer pilot study shows value of molecular profiling and proteomic mapping Patients benefit from treatments tailored specifically for their tumor types; stage se...

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Translational Drug Development (TD2) and 21Century Oncology Partner to Advance Radiation/Cancer Drug Combined Therapy

June 21, 2013

SCOTTSDALE, Ariz. – (June 19, 2013) – Cancer pharmaceutical development company, Translational Drug Development (TD2), and the Translational Research Consortium (TRC) t...

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TD2 helps SideOut Foundation with the conduct of their trial

June 14, 2013

TD2 helps SideOut Foundation with the conduct of their trial Article written by: Michele McDonald at George Mason University Funded by volleyball teams nationwide, a new study released this week show...

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Pancreatic Cancer Research Team (PCRT) celebrates its 10-year anniversary of delivering new treatments for patients with pancreatic cancer

May 30, 2013

Ten Years after its founding, the Pancreatic Cancer Research Team (PCRT) is announcing the positive results of a large Phase III clinical trial involving more than 800 patients. PCRT is celebrati...

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TD2 is the development partner for the FORMA/Celgene partnership

April 29, 2013

TD2 is the development partner for the FORMA/Celgene partnership WATERTOWN, Mass. – April 29, 2013 – FORMA Therapeutics Holdings, LLC (FORMA) today announced a strategic collaboratio...

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Forma Therapeutics teams with TD2

June 18, 2012

Organizational synergies will create transformative cancer therapies June 18, 2012 - FORMA Therapeutics and TGen Drug Development (TD2) today announced an agreement to jointly develop transformative ...

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Flagship Biosciences finds Arizona a great home for serving pathology digitally

June 5, 2012

While most of Flagship’s customers are at biotech and pharma locations around the world, there has been some strong collaborations formed with Arizona biotech firms. “The collaboratio...

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CytRx Initiates Phase 2 Clinical Trial with INNO-206 in Pancreatic Cancer

May 31, 2012

Daniel Von Hoff, M.D., Physician-in-Chief and Distinguished Professor at the Translational Genomics Research Institute (TGEN) in Phoenix will serve as the clinical trial’s principal investigator...

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TGen Drug Development (TD2) partnership with Imaging Endpoints provides comprehensive clinical trial services for drug developers

August 25, 2011

TGen Drug Development (TD2) and Imaging Endpoints have teamed up to enable the rapid development of anti-cancer drugs and deliver them faster to patients in need, the companies announced today.  ...

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Avantra Biosciences

August 11, 2011

Avantra Biosciences teams with TGen Drug Development to assist pharma...

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