Life Science Compliance Update

« November 2012 | Main | January 2013 »

22 posts from December 2012

December 31, 2012

Twenty Academic Industry Alliances of 2012

Industry Academic Partnerships
Over the past few years, we have written about the critical partnerships that the pharmaceutical and medical device industries have created with academic medical centers and medical schools.  Most recently, we wrote about a partnership between Novartis and the University of Pennsylvania to bring to market a new approach to fighting cancer that has shown promising results in early trials.

Previously, we wrote about a new drug research collaboration was announced between pharmaceutical giant Pfizer and the University of California San Diego, which could deliver up to $50 million to local scientists over the next five years, speed the delivery of promising therapies to patients and help refill the fast-depleting pipeline of the world’s largest pharmaceutical manufacturer.   

Earlier this year, Merck announced a collaboration to create the California Institute for Biomedical Research (Calibr), an independent, not-for-profit organization--501(c)(3).   We have also written several times about the University of California, San Francisco Chancellor Susan Desmond-Hellmann, who advocates for establishing closer relationships with industry in order to spark new ideas, fund research, access high-tech equipment and speed medical advances to patients.   

 Consequently, FierceBiotech recently ran a story describing 20 Major Pharma-Academic Alliances in 2012.  We located descriptions of most of these alliances and provided background and links.  It is interesting that many of the alliances are with institutions outside of the United States including Australia, Canada, Germany, Hong Kong, Singapore and the UK 

UCSF and Sanofi  

The University of California, San Francisco (UCSF) has signed an alliance with Sanofi to share expertise in diabetes research and identify drug targets that could lead to new therapies for both type 1 and type 2 diabetes.  The $3.1 million collaboration will bring together scientists in three UCSF labs with deep understanding of the biology of beta cells – insulin-producing cells that are destroyed in type 1 diabetes and often produce too little insulin in type 2 – with Sanofi researchers who are experienced in developing potential drug candidates into actual therapies. 

The alliance is the University’s third collaboration with Sanofi, alongside brain trauma and oncology research launched last year, since the two signed a master agreement in January 2011 to work together in translating academic science into potential new therapies. Master agreements lay out the fundamental terms of research collaborations, align with the University's academic mission including broad publication rights, and form part of a core strategy for the UCSF Office of Innovation, Technology and Alliances to expedite that “bench-to-bedside” research. 

The University of Queensland, Australia and Johnson & Johnson  

Johnson & Johnson and the University of Queensland will co-develop drugs using components of spider venom as a treatment for chronic pain.  The maker of Ultram painkillers will work with Queensland’s Institute of Molecular Bioscience drug development program, the university said in a statement. Financial terms of the 12-month project were not disclosed.  Spider venoms have peptides that may “substantially reduce or block the pain,” Richard Lewis, professor at the institute, said in a phone interview. 

The University of Hong Kong, National University of Singapore, Pfizer, Lilly and Merck 

Scientists at the Genome Institute of Singapore (GIS) have unraveled the mechanism that causes liver cancer (hepatocellular carcinoma, HCC), one of the most common solid tumors worldwide. This genome-wide research was done in collaboration with colleagues from the National University of Singapore (NUS), University of Hong Kong, Eli Lilly & Co. USA, Merck Research Laboratories USA, Pfizer Oncology USA and Beijing Genomics Institute China 

Novo Nordisk and the University of Oxford 

Departing from its core competence, diabetes, Danish insulin giant Novo Nordisk (NOV: N) and the Kennedy Institute of Rheumatology at Oxford University have entered into a new partnership to develop promising new drug candidates and identify novel biomarkers and treatment targets for rheumatoid arthritis and other autoimmune inflammatory diseases.  Novo Nordisk will fund 10 Oxford researchers at the Kennedy Institute of Rheumatology to work within the partnership. A Joint steering committee with members from both parties, including Per Falk and Prof Feldmann, will oversee the partnership and assess research proposals from scientists at both organizations. 

University of Oxford and UCB 

The University of Oxford and UCB have signed a partnership worth £3.6M to work together on cutting-edge pharmaceutical research projects. The new collaboration will see scientists from industry and academia working together to develop innovative medicines to treat serious diseases in the areas of immunology and neurology. 

Novo Nordisk and the Juvenile Diabetes Research Foundation (JDRF) 

To address the underlying autoimmune process that is central to type 1 diabetes (T1D), JDRF and Novo Nordisk are partnering to discover and develop novel immunotherapies to prevent, treat, and help cure the disease.  Type 1 diabetes occurs when the body's immune system attacks and destroys the glucose-responsive, insulin-secreting beta cells of the pancreas, resulting in a lifetime requirement of insulin replacement therapy.  The collaboration between JDRF and Novo Nordisk will focus on research originating from academia and biotechnology companies, as well as from internal research projects at Novo Nordisk. 

Bristol-Myers Squibb and Vanderbilt University 

Vanderbilt University and Bristol-Myers Squibb Company announced a collaboration agreement for the discovery, development and commercialization of novel therapies acting on the mGluR4 glutamate receptor, known as positive allosteric modulators or PAMs, for the treatment of Parkinson’s disease.  Under the collaboration, the Vanderbilt Center for Neuroscience Drug Discovery (VCNDD) will identify drug candidates from its existing program, which obtained major support from The Michael J. Fox Foundation for Parkinson’s Research (MJFF). Bristol-Myers Squibb will have the right to develop and commercialize products resulting from the collaborative research program.  

Under the terms of the agreement, Vanderbilt University will receive an upfront payment and multi-year research funding to continue to discover additional compounds. Vanderbilt is eligible to receive milestones and royalties based on developmental success and worldwide sales of the drugs emerging from the collaboration.  “The long-term commitment of and collaboration with the MJFF were critical to advancing this program to the stage where it is now perfectly positioned to work closely with Bristol-Myers Squibb for further development,” said P. Jeffrey Conn, Ph.D., VCNDD director and Lee E. Limbird, Chair in Pharmacology. “Partnering with Bristol-Myers Squibb is a real win for Vanderbilt and for Parkinson’s patients.”  

Novartis and the University of Pennsylvania 

See our story linked above in the introduction. 

Sanofi, Brigham and Women’s Hospital, and Harvard Medical School 

Sanofi SA, the French drug giant that bought Cambridge-based Genzyme Corp. for $20.1 billion last year, announced a new research collaboration with Brigham and Women’s Hospital, a teaching and research affiliate of Harvard Medical School.  The collaboration is focused on the immunology of type 1 diabetes.  Under the terms of the agreement, researchers from both organizations will undertake studies for a novel approach to treat type 1 diabetes. Sanofi has an option to exclusively license intellectual property emerging from this collaboration.  

Merck and California Institute for Biomedical Research 

Merck announced that it is putting $90 million over the next seven years into a new nonprofit biomedical research institute in San Diego called the California Institute for Biomedical Research (Calibr). The new institute will be led by Peter Schultz, the prominent chemist and biotech entrepreneur at The Scripps Research Institute, who previously ran The Genomics Institute of the Novartis Research Foundation.  The driving concept of the institute is different than just being a branch of Merck’s $8.5 billion global R&D enterprise. By remaining at arm’s length, the company can put in some of its own money, and allow researchers to amplify it with other grant support from academic collaborators. Once a project has reached “preclinical proof of concept,” Merck then has the option to swoop in to in-license drug candidates for further development. 

GlaxoSmithKline and Yale University  

GlaxoSmithKline (GSK) and Yale University will partner to design a new class of molecules to target disease-causing proteins.  This is the latest in a string of deals between Yale’s academic researchers and global pharmaceutical companies.  Under the agreement, the company is granted first chance to license promising protein-destroying drug candidates discovered in a research collaboration between GlaxoSmithKline and the laboratory of Craig Crews, the Lewis B. Cullman Professor of Molecular, Cellular, and Developmental Biology, and professor of chemistry and of pharmacology at Yale. 

The deal comes on the heels of other agreements signed by Yale with Gilead Sciences Inc., which is working with Yale to identify novel cancer therapeutics, and with Johnson & Johnson, which is also interested in drug candidates being developed at Yale’s West Campus. 

AstraZeneca and Broad Institute 

AstraZeneca and the Broad Institute in Cambridge, Massachusetts announced a collaboration to identify new chemical compounds targeting bacterial and viral infections that could speed the development of new antibacterial and antiviral drugs.  Under the agreement, screening and hit-to-lead chemistry will take place in the Broad’s Chemical Biology Platform and AstraZeneca will optimize, develop and commercialize potential compounds from identified, high-quality leads. 

Pfizer, AZ, Janssen, J&J, Boehringer Ingelheim, GSK, Merck, and the University of Dundee 

The five pharma’s will provide £14.4 ($23.1) million to fund a research consortium at the university for an additional four years.  The Division of Signal Transduction Therapy (DSTT) consortium, which was founded in 1998, is studying cell signaling and developing inhibitors of kinases and phosphatases to treat diseases such as cancer, arthritis and lupus. Pharmas share access to unpublished results, technology, reagents and first license to IP.  The DSTT includes 15 research teams based at the University of Dundee. Thirteen of the teams are based within the MRC Protein Phosphorylation Unit and Scottish Institute for Cell Signalling (SCILLS) at the College of Life Sciences. Together, consortium scientists will continue early-stage research in multiple areas, including cancer, arthritis, lupus, hypertension and Parkinson’s disease. 

Abbott, AZ, Lilly, Bayer, Sanofi, Merck, Texas A&M University, Cornell Medical School, and Bill & Melinda Gates Foundation 

Seven pharmaceutical companies have opened up compound libraries and agreed to share data with each other and the research institutions under the Gates Foundation's TB Drug Accelerator program. The program shifted last year to implementing assays and tools into a drug discovery effort from building the assays and tools. The foundation hopes to have proof-of-concept for a one-month, three-drug regimen within 10 years. The structures of lead compounds identified will be placed in the public domain. 

AZ, Genentech, Merck, and Washington University in St. Louis, School of Medicine 

Pfizer, Lilly, Roche, Servier, J&J, Janssen, and Kings College, London 

Five-year research project on autism to develop and validate translational research approaches for autism therapies and establish European clinical sites for autism trials. The project hopes to produce validated cellular assays, animal models, functional MRI (fMRI) methods, PET radioligands and biomarkers 

Accuray and Rupercht-Karls, Universitat Heidelberg 

Accuray Incorporated, the premier radiation oncology company, announced the signing of a multi-year master research and collaboration agreement with the University of Heidelberg, a luminary research institution located in Heidelberg, Germany that contributes to the city’s top international position in therapy, research and science. Accuray and the University of Heidelberg will collaborate on cutting-edge research in radiation oncology to advance treatment technology and provide health care professionals with the most advanced tools for treating patients. 

AZ, Washington University in St. Louis, School of Medicine, Cornell Medical School, The Feinstein Institute for Medical Research, and The University of British Columbia 

AstraZeneca and Dr. Steven Paul of Weill Cornell Medical College announced a first of its kind research alliance that brings four leading academic research laboratories together with AstraZeneca to study a major risk factor for Alzheimer’s disease, the apolipoprotein E4 genotype (ApoE). The newly established collaboration with AstraZeneca is called the A5 alliance.  The A5 alliance members represent a team of academic scientists with expertise in ApoE biology who will focus on identification, validation, and risk reduction of drug targets for treatment of Alzheimer’s disease.

December 28, 2012

CMS: 2014 Clinical Quality Measures

QA checklist
The Centers for Medicare & Medicaid Services recently released the final 2014 clinical quality measures (CQMs) for eligible professionals and eligible hospitals, and the specifications for electronic reporting. 

Beginning in 2014, providers will need to report the new CQMs whether they are reporting in Stage 1 or Stage 2 of the Meaningful Use program.  Eligible professionals will report on nine of 64 CQMs; eligible hospitals will report on 16 of 29 hospitals.

When selecting the CQMs to report, providers must select ones that cover at least three of six domains that have been identified as U.S. Department of Health & Human Services National Quality Strategy priorities for healthcare quality improvement, according to CMS’ tip sheet.  The domains are: 

  • Patient and Family Engagement
  • Patient Safety
  • Care Coordination
  • Population and Public Health
  • Efficient Use of Healthcare Resources
  • Clinical Processes/Effectiveness 

CQMs were a core meaningful use objective in Stage 1 of the program.  They no longer are a core Meaningful Use objective, but providers are still required to submit CQMs in order to successfully participate in the program, according to CMS. 

Attestation also will change, going by the wayside. Beginning in 2014, providers beyond their first year of Meaningful Use must report CQM data electronically.  CMS also has posted the specifications for this reporting on its website. 

CMS is providing new resources to help providers with these changes, including a Data Element Catalog, a Value Set Authority Center, and a United States Health Information Knowledgebase, according to the Office of the National Coordinator for Health IT.

The final rule, published in the Federal Register on Sept. 4, contained several errors concerning the CQMs. The agency issued a document in October to correct these and other errors.   


Eligible Professionals (EPs), will continue to report from the 44 measures finalized for Stage 1 in the same schema laid out for Stage 1 3 core/alternate core  3 additional measures for EPs  

  • Eligible hospitals and CAHs will continue to report the 15 measures finalized for Stage 1
  • Beginning in 2012 and continuing in 2013, there are two reporting methods available for reporting the Stage 1 measures: Attestation (
  • eReporting Pilots: Physician Quality Reporting System EHR Incentive Program Pilot for EPs
  • eReporting Pilot for eligible hospitals and CAH  

2014 and Beyond  

EPs must report on 9 of the 64 approved CQMs Recommended core CQMs – encouraged but not required 9 CQMs for the adult population  

  • 9 CQMs for the pediatric population
  • NQF 0018 strongly encouraged since controlling blood pressure is high priority goal in many national health initiatives, including the Million Hearts campaign  

Selected CQMs must cover at least 3 of the National Quality Strategy domains (See “Measure Selection Process” below.)  

Eligible Hospitals and CAHs must report on 16 of the 29 approved CQMs Selected CQMs must cover at least 3 of the National Quality Strategy domains (See “Measure Selection Process” below.)  

Beginning in 2014, all Medicare-eligible providers beyond their first year of demonstrating meaningful use must electronically report their CQM data to CMS. (Medicaid EPs and hospitals that are eligible only for the Medicaid EHR Incentive Program will electronically report their CQM data to their state.)

December 27, 2012

2012-2013 HHS OIG Semiannual Report to Congress

HHS OIG Report
The Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) recently released its Semiannual Report to Congress, as well as its Compendium of Unimplemented Recommendations.  The Semiannual report, covering the 6-month period ending September 30, 2012, describes significant problems, abuses, deficiencies, and investigative outcomes relating to the administration of HHS programs and operations that were disclosed during the reporting period.  The Compendium describes open recommendations from prior periods that when implemented will save tax dollars and improve programs.  

In fiscal year 2012, OIG achieved record-setting monetary and enforcement results and recommended critical actions to improve HHS programs and protect beneficiaries.  OIG also expanded its outreach to health care providers and industry by launching new tools and forums for promoting compliance.  OIG also continued to capitalize on their partnerships with other law enforcement agencies and HHS colleagues through the Health Care Fraud Prevention and Enforcement Action Team (HEAT), to crack down on those who commit fraud and bilk scarce resources from the Medicare and Medicaid programs.  OIG’s HEAT portfolio expanded during this reporting period to include reports on questionable billing trends in community mental health centers, retail pharmacies, and home health agencies. 

For FY 2011, the Department reported improper payments totaling more than $64 billion in the Medicare and Medicaid programs'.  For FY 2012, OIG reported expected recoveries of about $6.9 billion consisting of $923.8 million in audit receivables and $6 billion in investigative receivables (which includes $1.7 billion in non-HHS investigative receivables resulting from our work in areas such as the States’ shares of Medicaid restitution).  OIG also identified about $8.5 billion in savings estimated for FY 2012 as a result of legislative, regulatory, or administrative actions that were supported by our recommendations. 

The U.S. Department of Justice (DOJ) similarly touted the government’s healthcare fraud enforcement efforts, announcing the $4.9 billion in settlements and judgments in civil cases involving fraud against the government in the fiscal year ending Sept. 30, 2012.  This figure constitutes a record recovery for a single year, eclipsing the previous record by more than $1.7 billion, and brings total recoveries under the False Claims Act since January 2009 to $13.3 billion – which is the largest four-year total in the Justice Department’s history and more than a third of total recoveries since the act was amended 26 years ago in 1986.  Housing and mortgage fraud accounted for an unprecedented $1.4 billion. 

Most false claims actions are filed under the act’s whistleblower, or qui tam, provisions, which allow private citizens to file suits alleging false claims on behalf of the government.  If the United States prevails in the action, the whistleblower, known as a relator, receives up to 30 percent of the recovery.  The department saw a record 647 qui tam suits filed last fiscal year and recovered a record $3.3 billion in suits filed by whistleblowers during the same period. 

OIG reported FY 2012 exclusions of 3,131 individuals and entities from participation in Federal health care programs; 778 criminal actions against individuals or entities that engaged in crimes against HHS programs; and 367 civil actions, which include false claims and unjust-enrichment lawsuits filed in Federal district court, civil monetary penalties (CMP) settlements, and administrative recoveries related to provider self-disclosure matters. 

On April 4, 2012, HHS and DOJ hosted the seventh regional Health Care Fraud Prevention Summit, held in Chicago. The Summits bring together a wide array of Federal, state, and local partners, beneficiaries, providers, and other interested parties to discuss innovative ways to eliminate fraud within the U.S. health care system.  The Chicago Summit focused on the latest technological advancements, including data analytics, now being used to identify, prevent, and prosecute fraud. 

During FY 2012, Medicare/Medicaid Strike Force efforts resulted in the filing of charges against 305 individuals or entities, 181 convictions, and $151 million in investigative receivables.  For example, on May 2, 2012, over 200 OIG Special Agents, Forensic Examiners and Analysts participated in Medicare Fraud Strike Force operations in 7 cities that resulted in charges against 107 individuals, including doctors, nurses, and other licensed medical professionals, for their alleged participation in Medicare fraud schemes involving approximately $452 million in false billing. The coordinated takedown involved the highest amount of Medicare false billings in a single takedown by the HEAT strike force.   

Of interest to our readers, OIG noted several FDA regulatory issues.  For example, OIG noted that Medicare Pays Too Much for the Drug Avastin When Used in Treating Wet Age-Related Macular Degeneration.  OIG found that for the first quarter of 2010, physicians could purchase Avastin at 53 percent below the average Medicare payment for providing the drug in treating wet age-related macular degeneration (wet AMD) in physician office settings.  Wet AMD is a leading cause of vision loss in older people. Wasteful spending has occurred because Medicare does not have a national payment amount for such use of Avastin.  Medicare’s payment contractors independently set the payment amounts, which differed as much as 28 percent.  CMS set a national payment amount for Avastin but rescinded it in 2009  

OIG also identified a need for Resolving Scientific Disagreements on Regulatory Decisions.  OIG reviewed 36 medical device submissions for which FDA’s Center for Devices and Radiological Health (CDRH) had scientific disagreements on regulatory decisions between 2008 and 2010 and found a number of challenges associated with the resolution process.  CDRH annually processes about 6,000 submissions for approval of medical devices that require regulatory decisions.  Scientific disagreements are defined as being consequential to a regulatory decision where taking one position on an issue would lead to a different decision than taking another position.  

CDRH did not start formally tracking such disagreements until 2010.  OIG found that CDRH faces broad challenges in identifying and resolving scientific disagreements because of uncertainty about regulatory definitions and processes and staff perceptions about expressing differences of opinion.  The nature and resolutions of the 36 disagreements reviewed varied widely.  The disagreements often involved multiple issues, and most of their resolutions did not lead directly to the approval or clearance of devices.  Most administrative files related to the disagreements contained required documentation, but accountability for file completeness was unclear.  Also, not all of CDRH’s managers and reviewers had received training on the new procedures implemented in 2009. OIG recommended that  

  • FDA define more clearly its requirements for documenting and resolving scientific disagreements,
  • train all reviewers and managers on the new policies and procedures for resolving scientific disagreements, and
  • more clearly assign accountability for the contents of the administrative files of all submissions 

HHS-OIG Compendium 

At the beginning of each fiscal year (FY) OIG follows up with HHS and its operating and staff divisions to determine their progress in implementing significant recommendations that were included in the preceding edition of the Compendium and in reports that were issued during the closed fiscal year.  This edition of the Compendium updates the status of recommendations made through FY 2011 that were not fully implemented as of December 2012 and represent significant opportunities for action in FY 2013.

Each narrative in the Compendium contains for pertinent reports the open recommendations, background, progress of implementation, report titles, numbers, and issue dates.  

Medicare Part A and Part B—Traditional Medicare  

  • Hospitals—Eliminate or Reduce Medicare Payments for Hospital Bad Debts
  • Physicians—Adjust Global Surgery Fees To Reflect the Number of Evaluation and Management Services Actually Being Provided by Physicians
  • Medical Equipment—Reduce the Rental Period for Medicare Home Oxygen Equipment
  • Hospices—Ensure That Hospice Claims for Beneficiaries in Nursing Homes Comply With Medicare Coverage Requirements
  • Independent Diagnostic Testing Facilities—Implement Unannounced Site Visits and Other Actions To Prevent Improper Payments (New).
  • Medical Equipment—Ensure That Claims for Lower Limb Prostheses Meet Requirements (New). 

Medicare Part C —Medicare Advantage  

  • Medicare Advantage Payment Amounts—Modify Payments to Medicare Advantage Organizations.
  • Medicare Advantage Aggressive Marketing—Ensure That New Enrollees Understand Plan Rules.  

Medicare Part D—Prescription Drug Benefit  

  • CMS—Develop a Comprehensive Safeguard Strategy for Overseeing Part D Prescription Drug Plans.
  • Sponsor Data—Ensure the Accuracy of Sponsors’ Cost Estimates in Part D Bids.
  • Claims Processing—Ensure the Validity of Prescriber Identifiers on Claims.
  • Atypical Antipsychotic Drugs—Ensure That Part D Sponsors Have Information Needed To Make Accurate Coverage and Reimbursement Determinations (New).  

Medicaid Reviews  

  • Prescription Drugs—Develop National Pharmacy Acquisition Cost Data as a Benchmark for Reimbursing Prescription Drugs (New).
  • Prescriptions Drugs—Establish a Connection Between the Calculations of Medicaid Drug Reimbursements and Rebates.
  • Prescriptions Drug Rebates—Extend the Additional Rebate Payment Provisions for Brand-Name Drugs to Generic Drugs.
  • Payments to Public Providers—Limit Medicaid Payments to Costs and Require That Payments Returned by Public Providers Be Used To Offset the Federal Share.
  • Improve Medicaid Children’s Utilization of Preventive Screening Services.  

Public Health Reviews  

  • Centers for Disease Control and Prevention—Improve States’ and Localities’ Medical Surge Preparedness for Pandemics.
  • Food and Drug Administration—Ethics Oversight—Ensure That Clinical Investigators Disclose All Financial Interests.
  • National Institutes of Health—Ethics Oversight—Require NIH Grantee Institutions To Identify, Report, and Address Institutional Financial Conflicts of Interest (New
  • Food and Drug Administration Ethics Oversight—Ensure That Clinical Investigators Disclose All Financial Interests
  • Safety of Medical Devices—Use Adverse Event Reports To Detect and Address Safety Concerns


Preview | Powered by FeedBlitz


February 2018
Sun Mon Tue Wed Thu Fri Sat
1 2 3
4 5 6 7 8 9 10
11 12 13 14 15 16 17
18 19 20 21 22 23 24
25 26 27 28