CANCER IMMUNOTHERAPY: A NEW HOPE

By Reshma Jagasia, Ph.D, Scientist at Cato Research

The current standard of care for cancer treatment is surgery, chemotherapy, and radiation therapy – a standard that has persisted for decades. These treatments are invasive and not specific, killing healthy cells and tissues along with tumors. In the past decade, more targeted therapies have emerged, including the monoclonal antibodies (mAbs) rituximab (Rituxan® or MabThera®) and trastuzumab (Herceptin®), and the chemotherapy drug imatinib (Gleevec®). These treatments target cancer cells by taking advantage of the inherent molecular differences between cancer and healthy cells. Now a new class of treatment is emerging, one that purports to harnesses the patient’s own immune system to combat the patient’s disease. Called immunotherapy, this class of treatment is being described by researchers as the “fifth pillar” of cancer treatment. There are currently five types of FDA-approved immunotherapy for the treatment of cancer: (1) monoclonal antibodies, (2) immune checkpoint inhibitors, (3) cancer vaccines, (4) oncolytic viruses, and (5) other, non-specific immunotherapies. This article reviews these commercially available immunotherapies for cancer.

Monoclonal Antibodies

Monoclonal antibodies (mAbs) have been used to treat cancer and a number of other diseases. A therapeutic mAb functions by binding to a specific (targeted) antigen to elicit an immune response in the body against that target. In some cases, a toxin or radioisotope can be attached to the mAb, essentially turning the mAb into a drug-delivery system to an individual cancer cell. The key to this therapeutic strategy lies in identifying an antigen that is specific to the cancer cell over healthy cells. For some cancers, the identification of such an antigen has been difficult, hindering mAb drug development for these cancers.

There are currently over two dozen FDA-approved mAbs for the treatment of various types of cancer (see Table 1). Still more mAbs are in clinical trials. As suitable antigens for cancer treatment are identified, new mAbs are being developed for cancer treatment. New developments also include modifying mAbs to reduce potential adverse events, and combining the binding regions of two different mAbs (known as a bispecific antibody) to enhance cell targeting.

Table 1: Current* FDA-Approved Monoclonal Antibodies for Cancer Treatment

Monoclonal Antibody Brand Name Target FDA Approval Date Indication
alemtuzumab Campath® CD52 2001 Chronic lymphocytic leukemia
atezolizumab Tecentriq® PD-L1 2016 Bladder cancer
Non-small cell lung cancer
bevacizumab Avastin® VEGF 2004 Colorectal cancer
2006 Non-small cell lung cancer
2009 Glioblastoma
Renal cell cancer
2014 Cervical cancer
Ovarian epithelial, fallopian tube, or primary peritoneal cancer
blinatumomab Blincyto® CD19 and CD3
(bispecific)
2014 Acute lymphoblastic leukemia
brentuximab vedotin Adcetris® CD30 2011 Anaplastic large cell lymphoma
Hodgkin lymphoma
cetuximab Erbitux® EGFR 2004 Colorectal cancer
2006 Head and neck cancer
daratumumab Darzalex® CD38 2015 Multiple myeloma
denosumab Prolia®
Xgeva®
RANKL 2013 Giant cell tumor of the bone
dinutuximab Unituxin® GD2 2015 Neuroblastoma
elotuzumab Empliciti® CS1 2015 Multiple myeloma
gemtuzumab ozogamicin
(discontinued in 2010)
Mylotarg® CD33 2000 Acute myeloid leukemia
ibritumomab tiuxetan Zevalin® CD20 2002 Non-Hodgkin lymphoma
ipilimumab Yervoy® CTLA-4 2011 Melanoma
necitumumab Portrazza® EGFR 2015 Non-small-cell lung cancer
nivolumab Opdivo® PD-1 2014 Melanoma
2015 Non-small-cell lung cancer
Kidney cancer
2016 Classical Hodgkin lymphoma
Head and neck cancer
obinutuzumab Gazyva® CD20 2013 Chronic lymphocytic leukemia
2016 Follicular lymphoma
ofatumumab Arzerra® CD20 2009 Chronic lymphocytic leukemia
olaratumab Lartruvo® PDGFR alpha 2016 Soft tissue sarcoma
panitumumab Vectibix® EGFR 2006 Colorectal cancer
pembrolizumab Keytruda® PD-1 receptor 2014 Melanoma,
2015 Non-small-cell lung cancer
2016 Head and neck cancer
pertuzumab Perjeta® HER-2 2013 Breast cancer
ramucirumab Cyramza® VEGFR-2 2014 Adenocarcinoma of the stomach or gastroesophageal junction
Non-small cell lung cancer
2015 Colorectal cancer
rituximab Rituxan®,
Mabthera®
CD20 2006 Non-Hodgkin lymphoma
2010 Chronic lymphocytic leukemia
siltuximab Sylvant®   2014 Multicentric Castleman disease
tositumomab
(discontinued in  2014)
Bexxar® CD20 2003 Non-Hodgkin lymphoma
trastuzumab Herceptin® HER-2 2006 Breast cancer
2010 Adenocarcinoma of the stomach or gastroesophageal junction

*As of the authorship of this article. Information was acquired from the American Cancer Society website, www.cancer.org.

 

Immune Checkpoint Therapies

The immune system functions by recognizing foreign or sick cells from healthy ones using “checkpoints”, stimulatory or inhibitory mechanisms that prevent autoimmunity. Some cancers are able to adopt checkpoint mechanisms, thereby evading detection by the immune system. By inhibiting such checkpoint mechanisms, a cancer cell could become unmasked and potentially be killed.

Two checkpoint receptors have emerged as accessible targets for cancer treatment: PD1 and CTLA-4, two cell-surface proteins expressed by T cells. When PD1 on a T cell binds its native ligand, PD-L1, on a healthy cell, the T cell is prevented from attacking. Some cancer cells display large quantities PD-L1, mimicking healthy cells. Pembrolizumab (Keytruda®) and Nivolumab (Opdivo®) are both FDA-approved monoclonal antibodies that target PD1 for the treatment of several types of cancer, including melanoma, non-small cell lung cancer, kidney cancer, head and neck cancers, and Hodgkin lymphoma. Atezolizumab (Tecentriq®), also a mAb, targets PD-L1 for bladder and metastatic non-small cell lung cancer (NSCLC). Ipilimumab (Yervoy®), is an FDA-approved mAb that targets CTLA-4, a checkpoint receptor that functions similarly to PD1.

A concern for checkpoint inhibitors is that they can target normal cell functions, affecting healthy cells as well as tumors. Many new checkpoint inhibitor drugs are currently being studied. Also being considered is the use of combination treatment, such as nivolumab, which targets PD-1, and ipilimumab, which targets CTLA-4, to improve efficacy. Use of this combination has been shown to work well in melanoma patients but comes with an increased risk of serious side effects.

Cancer Vaccines

Traditional vaccines against viruses are intended to prime the body’s immune system to mount a response should a viral infection occur. Some cancers appear to be linked to viral infections. Various strains of the human papilloma virus (HPV) have been linked to cervical, anal, and throat cancers. People with chronic hepatitis B virus (HBV) are at a higher risk for liver cancer. Traditional vaccines targeting these viruses potentially could reduce the risk of an infected but otherwise healthy person developing one of these associated cancers.

Cancer vaccines, on the other hand, are intended to treat patients already diagnosed with cancer. These vaccines attempt to boost the patient’s own immune system to attack cancer cells in the body.

Tumor cell vaccines: These vaccines are made from cancer cells that have been removed from the patient during surgery or biopsy. These cells are altered (and killed) in the lab to improve immunogenicity, then injected back into the patient with the intent to elicit a strong immune response. Most tumor cell vaccines are autologous, but allogeneic vaccines are much easier to make. It is not yet clear if one type works better than the other.

Antigen vaccines: These vaccines boost the immune system by using only one (or a few) antigens rather than whole tumor cells. These antigens are often proteins or peptide-segments of proteins. Often, these antigens are specific to certain types of cancer mutations and may not be effective for all patients with similar cancer.

Dendritic cell vaccines: Dendritic cells are antigen-presenting cells that can be recognized by T cells. The resulting activated T cells then initiate an immune response against any cells in the body that present these antigens. The manufacturing process of dendritic cell vaccines is complex and expensive, involving the removal of white blood cells (primarily dendritic cells) from the patient, modification of the dendritic cell to present the patient’s cancer antigen on its surface, and reinfusion of these cells into the patient to enhance the immune response. Because the starting material for the manufacturing of this “live drug” is the patient’s own white blood cells, each batch of drug is precisely intended only for that patient. It is hoped that the vaccine might continue to work long after being administered, as well as become incorporated into the immune system’s memory.

Sipuleucel-T (Provenge®) is a dendritic cell vaccine and the only cancer vaccine currently approved to treat cancer in the United States. This therapy is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic prostate cancer. While this therapy has not been shown to cure the patient, it has been shown to extend patients’ lives on average of several months.

Dendritic cell vaccines have shown the most success among vaccines in treating cancer, and have accordingly garnered much excitement in the research community. The concept of adoptive cell therapy (ACT) – the removal, modification, and reinfusion of a patient’s own T cells – is being researched heavily with many new therapies entering early-phase clinical trials.

Vector-based vaccines: These vaccines use vectors to deliver a vaccine drug to the tumor site, potentially improving treatment efficacy. Vectors can be viruses, bacteria, yeast cells, or other structures. While these vaccines differ from other vaccine categories only by their delivery system (e.g., there are vector-based antigen vaccines), they do offer some benefits over their counterparts. Vectors allow for the delivery of multiple antigens at a time, increasing the likelihood of an immune response by the body. In fact, the vector itself is a potential immunogen. Vector-based vaccines may also be less expensive to manufacture compared with some other vaccines.

Oncolytic Viruses

Talimogene laherparepvec (Imlygic®) is an injectable oncolytic virus approved by the FDA in 2015 for the treatment of melanoma lesions that cannot be surgically removed in the skin and lymph nodes. This novel product uses a herpes virus to infect cells at the injection site. While the virus can infect both healthy and cancerous cells, it has been engineered to not replication inside healthy cells. When inside a cancer cell, the replicating virus synthesizes and secretes GM-CSF, a protein that boosts the immune response. The proliferation of the virus and the increased concentration of GM-CSF afford a heightened immune response targeted at the sight of virus delivery, i.e., the tumor. This treatment has been shown to shrink treated tumors but not to affect tumors in other parts of the body.

Non-Specific Immunotherapies

Instead of targeting cancer cells specifically, non-specific immunotherapies stimulate the immune system globally with the intent to improve the response to a patient’s cancer cells. These therapies can be administered alone as cancer treatments or used as adjuvants with other treatments. Cytokines are the most common non-specific immunotherapeutic. One cytokine, interleukin-2 (IL-2), is approved to treat advanced kidney cancer and metastatic melanoma. Other interleukins, such as IL-7, IL-12, and IL-21, are currently being studied for cancer therapy. Another cytokine, interferon-alpha (IFN-α), is known to enhance the overall immune response but may also directly inhibit cancer cell proliferation and angiogenesis. IFN-α has been used to treat a variety of cancers, including hairy cell leukemia, chronic myelogenous leukemia (CML), follicular non-Hodgkin lymphoma, cutaneous (skin) T-cell lymphoma, kidney cancer, melanoma, and kaposi sarcoma.

Other non-specific immunomodulating drugs include thalidomide (Thalomid®), lenalidomide (Revlimid®), and pomalidomide (Pomalyst®). These drugs are used to treat multiple myeloma and some other cancers. Imiquimod (Zyclara®) is a topical cream that stimulates a local immune response against skin cancer, especially early-stage cancers located in sensitive areas on the body. Bacille Calmette-Guérin (BCG) is an attenuated version of a Mycobacterium bovis, a bacterium closely related to Mycobacterium tuberculosis, the agent responsible for tuberculosis. BCG does not cause serious disease in humans but can activate the immune system. BCG was one of the earliest immunotherapies used against cancer and is still being used today to treat early stage bladder cancer.

Immunotherapies are quickly gaining momentum to become an important option for cancer treatment. Immunotherapy development has proven to be more difficult than originally anticipated by researchers due to the complex nature of the immune system and the adaptability of cancer to evade immune attack. However, over the past three decades, new knowledge about cancer and immunity has abounded, and researchers are hopeful that, alongside chemotherapy, radiation therapy, and surgery, immunotherapy will play a key role in the future of cancer treatment and prevention.

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New FDA Guidances for February 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research

FDA draft and final guidances, released from CDER, CBER, and CDRH in February 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

Special Interest Guidances/Information Date Posted
Q11 Development and Manufacture of Drug Substances—Questions and Answers (regarding the selection and justification of starting materials – Draft Guidance 17 Feb 2017
Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act— Compliance Policy – Final Guidance 16 Feb 2017
Guidance Agenda: Guidances CDER is Planning… – Draft Guidance 15 Feb 2017
Dear Health Care Provider Letters: Improving Communication of Important Safety Information – Final Guidance 08 Feb 2017
Upcoming Meetings (* = New)
Pediatric Advisory Committee Meeting; 06 March 2017; Silver Spring, MD
Pediatric Advisory Committee Meeting; 07 March 2017; Silver Spring, MD
Vaccines and Related Biological Products Committee Meeting; 09 March 2017; Rockville, MD
Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; 13-14 March 2017; Silver Spring, MD
Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting; 15 March 2017; Washington, DC
Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee; 17 March 2017; Gaithersburg, MD
* Blood Products Advisory Committee Meeting; 4-5 April 2017; Silver Spring, MD
2017 Advisory Committee Tentative Meetings
* new entry
Last updated: 01 March 2017
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What’s New Health Canada? February 2017

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy, and Christine Straccini, B.Sc., Regulatory Associate; Cato Research Canada

 

What’s New in:

Therapeutic Products Directorate:

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/update-miseajour/index-eng.php

Biologics and Genetic Therapies Directorate:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php

Medical Devices: http://www.hc-sc.gc.ca/dhp-mps/md-im/update-miseajour/index-eng.php

Natural and Non-prescription Health Products Directorate: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/new-neuf-eng.php

 

Health Canada New Guidance Documents (Drugs and Biologics):

January-February 2017

Health Canada Guidance Type Date Posted
Use of Certificates of Suitability as supporting information in Drug Submissions Consultation Document

 

Draft Guidance 31 Jan 2017

 

Updates from Health Canada (Drugs and Biologics):

January-February 2017

Type of Update and Link Date Posted
Updated Notice: eCTD Pilot for Clinical Trial Regulatory Activities 18 Jan 2017
Updated ICH Q3D Notice: Health Canada recommendations for implementation of the ICH Harmonised Guideline for Elemental Impurities (Q3D) for new and marketed products 19 Jan 2017
Record of Proceedings for Scientific Advisory Panel on Anti-Infective Therapies (SAP-AIT) for 2016-10-06 Meeting 23 Jan 2017
Consultation on the Health Canada Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions 31 Jan 2017
Notice – Submission Filing Requirements – Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL) 02 Feb 2017
Consultation: Release of International Council on Harmonisation (ICH) Document: Good Clinical Practice (GCP) “Renovation” Reflection Paper 02 Feb 2017

Santé Canada: Quoi de neuf?

Par Amélie Rodrigue-Way, Ph.D., RAC (CAN), Directrice associée, Stratégie réglementaire, et Christine Straccini, B.Sc., Associée réglementaire ; Cato Recherche Canada

Quoi de neuf :

Direction des produits thérapeutiques

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/update-miseajour/index-fra.php

Direction des produits biologiques et thérapies génétiques:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-fra.php

Instruments médicaux: http://www.hc-sc.gc.ca/dhp-mps/md-im/update-miseajour/index-fra.php

Direction des produits de santé naturels et sans ordonnance:

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/new-neuf-fra.php

 

 

Nouvelles lignes directrices de Santé Canada (Médicaments et Produits biologiques):

Janvier-Février 2017

Ligne directrice de Santé Canada Genre Date
Utilisation de certificats de conformité à titre d’information à l’appui des présentations de drogue Document de consultation Ébauche de la ligne directrice 31 Jan 2017

 

Mises à jour de Santé Canada (Médicaments et Produits biologiques):

Janvier-Février 2017

Genre de mise à jour et lien Date
Avis mis à jour: Projet pilote sur le format eCTD pour les activités de réglementation liées aux études cliniques 18 Jan 2017
Q3D Avis mis à jour : Recommandations de Santé Canada sur la mise en œuvre de la directive harmonisée de l’ICH concernant les impuretés élémentaires (Q3D) pour les nouveaux produits et les produits commercialisés 19 Jan 2017
Compte rendu des délibérations du groupe consultatif scientifique sur les traitements anti-infectieux (GCS-TAI) pour la rencontre du 06-10-2016 23 Jan 2017
Consultation sur l’ébauche de la ligne directrice de Santé Canada – Utilisation de certificats de conformité à titre d’information à l’appui des présentations de drogue 31 Jan 2017
Avis : Exigences relatives au dépôt de présentations – Bonnes pratiques de fabrication (BPF) et licences d’établissement de produits pharmaceutiques (LEPP) 02 Fév 2017
Consultation: Publication de document l’International Council for Harmonisation (l’ICH) : Good Clinical Practice (GCP) « Renovation » Reflection paper 02 Fév 2017

 

 

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A New Expedited Review Designation: Regenerative Advanced Therapy

By Michelle Villasmil, Ph.D., RAC (U.S.), Regulatory Scientist at Cato Research

One of the many changes brought by the 21st Century Cures Act is the new expedited review designation entitled Regenerative Advanced Therapy (with the unfortunate acronym of RAT).

FDA provides brief guidance for a RAT designation on their website (provided below). A drug is eligible for RAT designation if:

  • “the drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations;
  • the drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
  • preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition.”1,2

While the benefits of RAT designation are less clearly defined than its more established expedited review designation counterparts (i.e., breakthrough therapy, fast track, accelerated approval, priority review), FDA does outline the following benefits of RAT designation:

  • early interactions to discuss potential surrogate or intermediate endpoints to support accelerated approval of an application;
  • eligibility for priority review; and
  • eligibility for accelerated approval.1

Primary data is not required to apply for RAT designation, but the RAT designation request should at least describe preliminary clinical evidence. The RAT designation request can be submitted with an Investigational New Drug application (IND) or as an amendment to an existing, cleared IND.

The submission process for RAT designation requests is detailed on the FDA website.2

Guidance on RAT designation:

  1. 21st Century Cures Act, Section 3033
  2. http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm

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New FDA Guidances for January 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research

FDA draft and final guidances, released from CDER, CBER, and CDRH in January 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

Special Interest Guidances/Information Date Posted
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers – Draft Guidance 18 Jan 2017
Considerations in Demonstrating Interchangeability With a Reference Product – Draft Guidance 17 Jan 2017
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers – Draft Guidance 17 Jan 2017
Assessment of Abuse Potential of Drugs – Final Guidance 17 Jan 2017
2016 Medical Gas Container-Closure Rule Questions and Answers – Final Guidance 17 Jan 2017
Emergency Use Authorization of Medical Products and Related Authorities – Final Guidance 13 Jan 2017
How to Prepare a Pre-Request for Designation (Pre-RFD) – Draft Guidance 13 Jan 2017
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act – Final Guidance 13 Jan 2017
Referencing Approved Drug Products in ANDA Submissions – Draft Guidance 13 Jan 2017
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA – Draft Guidance 13 Jan 2017
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions – Final Guidance 13 Jan 2017
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act – Final Guidance 13 Jan 2017
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities – Final Guidance 12 Jan 2017
Guidance for Industry 180-Day Exclusivity: Questions and Answers – Draft Guidance 12 Jan 2017
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application – Draft Guidance 12 Jan 2017
Multiple Endpoints in Clinical Trials – Draft Guidance 12 Jan 2017
Nonproprietary Naming of Biological Products – Final Guidance 12 Jan 2017
Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions – Final Guidance 11 Jan 2017
Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery – Draft Guidance 11 Jan 2017
Guidance Agenda: Guidances CDER is Planning… 11 Jan 2017
Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus – Final Guidance 10 Jan 2017
Current Good Manufacturing Practice Requirements for Combination Products – Final Guidance 10 Jan 2017
Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers – Draft Guidance 09 Jan 2017
Labeling of Red Blood Cell Units with Historical Antigen Typing Results – Draft Guidance 03 Jan 2017
Premarket Notification (510(k)) Submissions for Bone Anchors – Draft Guidance 03 Jan 2017
Upcoming Meetings (* = New)
* Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting; 23 February 2017; Gaithersburg, MD
* Pediatric Advisory Committee Meeting; 06 March 2017; Silver Spring, MD
* Pediatric Advisory Committee Meeting; 07 March 2017; Silver Spring, MD
* Vaccines and Related Biological Products Committee Meeting; 09 March 2017; Rockville, MD
* Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; 13-14 March 2017; Hyattsville, MD
Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting; 15 March 2017; Washington, DC
* Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee; 17 March 2017; Gaithersburg, MD
2017 Advisory Committee Tentative Meetings
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