i Clinical Trial Tips: Practical and Actionable By polarisconsultants.blogspot.com Published On :: Mon, 19 Aug 2019 16:19:00 +0000 Over the years, attendees of MAGI Clinical Research Conferences have collected a set of practical, actionable suggestions for improving clinical trials. More than eighty such tips appear in the July 2019 edition of Journal of Clinical Research Best Practices*. In this post, Polaris auditors weigh in on some of their favorite MAGI suggestions. Surprising no one, they also were eager to share some of their own. Our Favorites Tips from MAGISo how does a clinical trial tip earn a spot on our exalted Faves List? First, it must be something we don’t see too often, or not as much as we’d like.(If most organizations already do a useful thing, it doesn’t really qualify as a helpful tip; it’s really just a common practice.) Second, the effort to implement the tip can’t be too onerous. If a practice requires too much interdepartmental coordination, change management, training, money, or resources, it’s not a tip. It’s a full-blown initiative.So here they are. Each tip from MAGI attendees is in bold font. Our accompanying commentary is in plain text:To help ensure quality study conduct, clinical sites should prepare protocol-specific quality checklists for each study. We’ve written about quality checklists from the auditing perspective before. They’re not a panacea, certainly, but that doesn’t mean they can’t be very useful. After study close-out, sponsors and CROs should consider holding conference calls with groups of sites to capture lessons learned. This in turn could be used to improve training, SOPs, SIVs, etc.As a recruitment aid, clinical sites should create pocket-sized, laminated study cards that list the inclusion/exclusion criteria for a study. Site staff members can keep these cards in their lab coat pockets and quickly refer to them when treating a patient who could be a potential subject.CROs should share risk assessments and mitigation plans with Sponsors. We agree, but would also encourage CROs to keep the sites involved and aware of risks so they can anticipate them and proceed accordingly. Sponsors/CROs should ensure proper qualifications of vendors prior to executing contracts. It’s hard to argue with this logic, but we don’t see it as much as we should. Too often qualification audits come after the paperwork has been signed. Should the audit uncover noncompliance or quality risks at the vendor site, it’s much harder to get the vendor to make necessary changes after the contract is in place.CROs should align 3rd party contracts with the Sponsor/CRO contract and the Clinical Trial Agreement. Yep.Additional Tips from Polaris QA/Compliance AuditorsThe MAGI list of clinical trial tips brought others to mind that we wanted to share. We applied the same criteria to these suggestions as we did to the MAGI contributions: (1) not necessarily rare, but not as common as it could be, and (2) not overly complex or expensive to implement.When evaluating outsourcing partners and clinical sites, Sponsors and CROs should make sure to look at personnel turnover rates. Frequent turnovers may suggest underlying problems that could jeopardize study conduct and quality.Sponsors and CROs should make sure their Monitoring Report templates are consistent with the Clinical Monitoring Plan (CMP). For example:The CMP calls for a focus on a particular set of critical variables, but the report template only has a place for recording that 100% SDV was completed. This means that there’s no way to document that the monitor put special emphasis on anything.The CMP requires bi-direction review of study data – a confirmation that what is in the CRF can be verified in the source, and all pertinent data in the source can be found in the CRF – but the report template only allows for the former to be documented.Every member of the site team has valuable input. It’s important to include the study PI, CRC, pharmacist, and other key personnel in the discussions. In 2017, we wrote an article about the important, yet often overlooked, input that the pharmacist on site can provide.There are many reasons that trial participants leave a study, many of which can’t be remedied with improved site practices. But sites that demonstrate they value the participation of their study volunteers, and honor the time they’re spending and contribution they’re making, tend to have better retention results. To that end:To help participants schedule their time, sites can prepare calendars that include all study visit dates and indicate the activities and procedures they entail. (This, of course, needs to be approved by the IRB).When participants arrive, they shouldn’t have to sit in a waiting room or empty exam room; they should be seen immediately so they don’t feel their time is being wasted.Sites can provide beverages and light snacks to their study participants who especially appreciate them immediately after a fasting blood draw (protocol permitting, naturally). It’s a small courtesy, and not difficult to do. Whose day isn’t brightened by a proffered nosh?**Uh oh. Now we got you all thinking about mini muffins and cheddar popcorn. Go ahead. Grab a treat. We'll talk later.________________________________________________________________ * Journal of Clinical Research Best Practices, July 2019** Proffered Nosh™ would be a really great name for a restaurant. Or a fictional Scotland Yard Inspector -- legendary for his wit, brilliance, wine pairings, and fashion sense. Full Article clinical research clinical sites clinical trials close-out CRO GCP monitoring plan retention risk assessment suggestions tips
i Philly-based gene therapy firm teams up with UMass Medical researcher By www.bizjournals.com Published On :: Thu, 20 Oct 2016 09:13:26 +0000 Guangping Gao, the head of the Horae Gene Therapy Center at the University of Massachusetts Medical School, will partner with Philadelphia-based Spark Therapeutics to figure out better ways to get disease-curing genes into cells. The collaboration, announced this morning, gives Spark (Nasdaq: ONCE) the option for an exclusive, world-wide license for any intellectual property to come out of it. No financial terms were disclosed. Earlier this year, Gao was featured in Newsweek magazine for seemingly… Full Article
i Nursing home pharmacy to pay $476K settlement to Mass. after kickback charges By www.bizjournals.com Published On :: Thu, 20 Oct 2016 10:27:51 +0000 The nation’s largest pharmacy serving elder care facilities will pay Massachusetts nearly half a million dollars to settle allegations that it got kickbacks more than eight years ago from Abbott Laboratories to promote the anti-seizure drug, Depakote. The settlement was signed by Omnicare, a pharmacy services company that was acquired by CVS Health Corporation (NYSE: CVS) in August 2015. The $476,216 payment to Massachusetts is part of a $28 million multi-state settlement that included 47 states… Full Article
i Vertex boosts market cap on plan for cystic fibrosis 'triple combo' By www.bizjournals.com Published On :: Wed, 26 Oct 2016 11:18:33 +0000 Vertex Pharmaceuticals announced a plan late Tuesday to begin trials before the end of the year of the third in its so-called “triple combo” of pills designed to treat as much as 90 percent of the 75,000 patients worldwide who suffer from cystic fibrosis. That news, announced in conjunction with the Boston-based drugmaker’s third-quarter financial results last night, spurred a 6 percent stock increase after hours, implying the company’s market cap could increase by about half a billion dollars… Full Article
i Ra makes nine Mass. biotech IPOs, over $640M raised, this year By www.bizjournals.com Published On :: Thu, 27 Oct 2016 09:50:20 +0000 Wednesday’s initial public offering for Cambridge-based Ra Pharmaceuticals marked the ninth biotech startup to go public this year, tying the number in 2013 but still less than either of the two years since. Ra (Nasdaq: RARX), which has 40 employees in one of the former Pfizer buildings in Alewife, ended up with the third-largest IPO size for any Massachusetts-based biotech in 2016, with a total of $92 million raised from the sale of 7 million shares for $13 each. That’s more than the $86 million… Full Article
i Medtech startups to pitch investors at annual MassMEDIC Showcase By www.bizjournals.com Published On :: Thu, 27 Oct 2016 15:24:39 +0000 On Friday, 21 emerging medical device companies will present their technologies and business plans to a group of local investors at the annual MedTech Showcase, hosted by the Massachusetts Medical Device Industry Council. More than 300 venture leaders and business leaders are expected to attend the event tomorrow, Oct. 28 from 8 a.m. to 2 p.m. at the Westin Waltham, 70 Third Ave. As a main event, John McDonough, president and CEO of Lexington-based T2 Biosystems (Nasdaq: TTOO), will be interviewed… Full Article
i FDA approval delayed for Sanofi Genzyme’s next blockbuster By www.bizjournals.com Published On :: Fri, 28 Oct 2016 11:11:53 +0000 Editor's note: This story was originally published Friday morning, and has been updated to reflect the FDA's decision regarding the drug later that day. A U.S. approval decision for a major drug planned to be marketed by Cambridge-based Sanofi Genzyme that had been expected last Friday has been delayed due to “deficiencies” found during a manufacturing site inspection in France. In its third quarter report, released Friday morning, French drugmaker Sanofi (NYSE: SNY) disclosed that “manufacturing… Full Article
i Venture firm Third Rock raises $616M fund, names female partner By www.bizjournals.com Published On :: Mon, 31 Oct 2016 10:00:10 +0000 Third Rock Ventures, the Boston-based venture capital firm behind some of the Bay State’s most prominent biotechs, has reclaimed its title as the biggest life science-focused VC firm in the state with a new $616 million round, and has also named its first female partner in eight years. With the announcement of its Fund IV today — its largest ever — the firm now has raised $1.9 billion in the nine years since it was formed. That eclipses its rival across the Charles River, Flagship Ventures,… Full Article
i Shire quietly halts new investments coming out of Baxalta Ventures By www.bizjournals.com Published On :: Mon, 31 Oct 2016 18:41:20 +0000 Today, Shire plc confirmed it won’t make any new investments from Baxalta Ventures, the short-lived venture capital arm of the drug company Shire acquired in June. Full Article
i Trial suggests Flexion’s knee injection may be safer for diabetes patients By www.bizjournals.com Published On :: Tue, 01 Nov 2016 11:00:12 +0000 The results of a 33-patient study conducted by a Burlington biotech suggest its long-acting steroid injection for osteoarthritis of the knee may be safer for the large percentage of those patients who also have type 2 diabetes. Flexion Therapeutics (Nasdaq: FLXN) has for years been developing its lead drug candidate, Zilretta (formerly called FX006), a reformulation of a common corticosteroid that’s used with osteoarthritis patients. Flexion’s version combines the drug with a employs proprietary… Full Article
i Harvard to open new lab space named after Celtics co-owner By www.bizjournals.com Published On :: Tue, 01 Nov 2016 11:06:22 +0000 On Thursday, Harvard University will open a 15,000-square-foot life science lab in Allston named after Steve Pagliuca, and executive at Bain Capital and co-owner of the Boston Celtics. The Pagliuca Harvard Life Lab will be the home to 20 startup ventures founded and run by Harvard faculty, alumni, students, and postdocs. The first 17 of those were revealed by the university a couple weeks ago, and they include drug and vaccine developers as well as DNA sequencing companies. Mayor Marty Walsh will… Full Article
i Sanofi at forefront of fight against COVID-19 in Q1 2020 By www.news.sanofi.us Published On :: Fri, 24 Apr 2020 07:00:00 -0400 Full Article
i FDA approves MenQuadfiTM, the latest innovation in meningococcal (MenACWY) vaccination By www.news.sanofi.us Published On :: Fri, 24 Apr 2020 08:00:00 -0400 Latest innovation in quadrivalent meningococcal vaccination designed for use in persons 2 years of age and older in the U.S. Full Article
i Sanofi and Regeneron provide update on U.S. Phase 2/3 adaptive-designed trial in hospitalized COVID-19 patients By www.news.sanofi.us Published On :: Mon, 27 Apr 2020 06:58:00 -0400 • Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced “critical” group with Kevzara higher-dose versus placebo and discontinuing less advanced “severe” group Full Article
i Phase 3 trial of Libtayo® (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival By www.news.sanofi.us Published On :: Mon, 27 Apr 2020 08:40:00 -0400 - Libtayo decreased the risk of death by 32.4% compared to chemotherapy Full Article
i Libtayo® (cemiplimab) shows clinically meaningful and durable responses in second-line advanced basal cell carcinoma By www.news.sanofi.us Published On :: Tue, 05 May 2020 08:25:00 -0400 Objective responses seen in 29% of patients with locally advanced basal cell carcinoma (BCC) Full Article
i Biocon/Mylan launch pegfilgrastim biosimilar Fulphila in Australia By www.gabionline.net Published On :: Mon, 04 May 2020 08:08:24 +0000 US-based drugmaker Mylan and partner India-based biologicals specialist Biocon have announced the launch of their pegfilgrastim biosimilar, Fulphila, in Australia. The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients. Full Article
i Non-innovator biologicals in India: regulatory context and areas for improvement By www.gabionline.net Published On :: Mon, 04 May 2020 08:14:37 +0000 There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal. Full Article
i FDA approves Proventil and Daraprim generics By www.gabionline.net Published On :: Fri, 08 May 2020 08:26:22 +0000 The US Food and Drug Administration (FDA) has approved the first generic version of a commonly used inhaler, marketed as Proventil, and the anti-parasitic Daraprim, which has previously been the subject of a price gouging scandal. Full Article
i Celltrion files application with EMA for adalimumab biosimilar By www.gabionline.net Published On :: Fri, 08 May 2020 08:28:50 +0000 Celltrion has submitted an application to the European Medicines Agency (EMA) for its adalimumab biosimilar, currently known as CT-P17. Full Article
i Online education for diabetes specialists on biosimilar insulins By www.gabionline.net Published On :: Fri, 08 May 2020 08:30:39 +0000 An online educational course has been published by Medscape in collaboration with the Association of Diabetes Care & Education Specialist. Full Article
i COVID-19 brings new collaborations to Australia and the EU By www.gabionline.net Published On :: Fri, 08 May 2020 08:33:05 +0000 In response to the COVID-19 pandemic, authorities in Australia and the European Union have allowed drug producers to collaborate to ensure medicine production and supply. Full Article
i Mycenax sells tocilizumab biosimilar to Richter By www.gabionline.net Published On :: Fri, 08 May 2020 08:35:44 +0000 Taiwanese biosimilars developer Mycenax announced on 28 April 2020 that it had made a deal with Hungary-based Gedeon Richter (Richter) regarding its tocilizumab biosimilar. Full Article
i How to make biological drugs more affordable By www.gabionline.net Published On :: Fri, 08 May 2020 08:37:35 +0000 Biological drugs remain unaffordable for many in the US due to strategies used by pharmaceutical companies and negative messaging about biosimilars, explains a recent commentary by Dr Joel Lexchin, School of Health Policy and Management at York University, Canada [1]. Full Article
i China publishes draft guideline for bevacizumab copy biologicals By www.gabionline.net Published On :: Fri, 08 May 2020 08:41:25 +0000 On 7 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of bevacizumab copy biologicals. This guidance is the second specific guideline released by the CDE in April. The agency also released guidance on adalimumab on 1 April 2020 [1]. Full Article
i Pegfilgrastim biosimilar Fulphila launched in Canada By www.gabionline.net Published On :: Fri, 08 May 2020 08:42:40 +0000 US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 28 April 2020 the launch of their pegfilgrastim biosimilar, Fulphila, in Canada. This is the second biosimilar from the pair to be launched in the country. Full Article
i The COVID-19 Pandemic and Maintenance of a Continued Safe Food Supply By strengthenfda.org Published On :: Fri, 17 Apr 2020 18:38:51 +0000 The Alliance met (virtually) on April 15 with Dr. Caitlin Boon, FDA Associate Commissioner for Food Policy and Response and several of her colleagues. She described CFSAN’s and CVM’s role in responding to the current pandemic, as well as how the agency is assuring a continued safe food supply. About 50% of food spending in the […] Full Article Analysis and Commentary Boon chain coronavirus Food safety supply
i How Can Congress Agree to Appropriations for FY 21? By strengthenfda.org Published On :: Fri, 24 Apr 2020 17:35:23 +0000 Q: Congress must act on FY 21 appropriations. What are the possible ways for Congress to address this? A: Congress must decide if they will do substantive work on the 12 appropriations bills with the goal of passing full-year funding bills before October 1. One alternative would be to fund the beginning of the fiscal year […] Full Article Analysis and Commentary appropriation cap Congress continuing resolution
i No Need for a Crystal Ball in Some Scenarios By strengthenfda.org Published On :: Fri, 01 May 2020 17:05:32 +0000 FDA — along with NIH, CDC, and other front-line public health agencies — is caught up in the urgent COVID-19 efforts. Appropriately, enormous resources are being devoted to fighting the pandemic and more funding will come, if needed. At the same time, we are getting positive reports on the FDA’s efforts to carry out the […] Full Article Analysis and Commentary appropriations complex planning Resources science vaccine workload
i The Frieden Health Defense Funding Proposition By strengthenfda.org Published On :: Fri, 08 May 2020 19:30:32 +0000 Congress is starting to consider ways to address the budget cap problem that hangs over the entire FY 21 appropriations process for non-defense discretionary (NDD) programs. Last year, Congress broke a long-running stalemate by agreeing to budget caps for FY 20 and FY 21. They decided to front-load the increases, making spending decisions (relatively) easier […] Full Article Analysis and Commentary appropriation budget cap defense Frieden FY 21 HDO health operations
i McCaul Speaks in Support of the Childhood Cancer STAR Act By childhoodcancer-mccaul.house.gov Published On :: Tue, 22 May 2018 04:00:00 +0000 Full Article
i McCaul Speaks with The Atlantic about Combating Childhood Cancer By childhoodcancer-mccaul.house.gov Published On :: Wed, 23 May 2018 04:00:00 +0000 Full Article
i STAR Act Heads to President’s Desk By childhoodcancer-mccaul.house.gov Published On :: Wed, 23 May 2018 04:00:00 +0000 WASHINGTON, D.C. – Co-Chairs of the Childhood Cancer Caucus, Reps. Michael McCaul (R-TX), Jackie Speier (D-CA), Mike Kelly (R-PA), and G. K. Butterfield (D-NC), applaud the passage of the Senate companion to their bill – S. 292, the Childhood Cancer STAR Act. The STAR Act passed the House today by a unanimous vote. It addresses the four major concerns facing the pediatric cancer community: Survivorship, Treatment, Access, and Research, and will elevate and prioritize the fight against childhood cancer at the National Institute of Health (NIH). The members released the following joint statement: "Today was a long anticipated day for the pediatric cancer community, and one to be celebrated. This bill is the most comprehensive childhood cancer bill to ever pass Congress and will finally head to the president’s desk to be signed into law. Childhood cancer remains one of the deadliest killers of our kids and we as a Congress, and a nation, must say, ‘Enough is enough.’ As co-chairs of the Childhood Cancer Caucus, we would like to thank all those who made this possible, including the Alliance for Childhood Cancer and the entire childhood cancer advocacy community.” Click here to watch McCaul’s floor remarks ahead of the House passage of the STAR Act. Full Article
i McCaul on KRIV Discuss the Childhood Cancer STAR Act By childhoodcancer-mccaul.house.gov Published On :: Fri, 25 May 2018 04:00:00 +0000 Full Article
i McCaul Talks Childhood Cancer STAR Act with Sadie Keller on Lone Star Politics By childhoodcancer-mccaul.house.gov Published On :: Mon, 04 Jun 2018 04:00:00 +0000 Full Article
i McCaul Talks Childhood Cancer STAR Act with Sadie Keller on Inside Texas Politics By childhoodcancer-mccaul.house.gov Published On :: Mon, 04 Jun 2018 04:00:00 +0000 Full Article
i McCaul Speaks About Childhood Cancer STAR Act with Sadie Keller on FOX's Good Day By childhoodcancer-mccaul.house.gov Published On :: Mon, 04 Jun 2018 04:00:00 +0000 Full Article
i New Bipartisan ChiPACC Act Provides Better Medicaid Coverage to Children in Need By childhoodcancer-mccaul.house.gov Published On :: Fri, 27 Jul 2018 04:00:00 +0000 WASHINGTON, D.C. – Five lawmakers introduced a bipartisan bill giving a full range of medical services to families with children who have life-limiting illnesses and who qualify for Medicaid, which currently has gaps in such coverage. The Children’s Program of All-Inclusive Coordinated Care (ChiPACC) Act (H.R. 6560) would let states create comprehensive care programs for these children. Its authors are the Co-Chairs of the Congressional Childhood Cancer Caucus: Representatives Michael McCaul (R-TX), Jackie Speier (D-CA), G.K. Butterfield (D-NC), and Mike Kelly (R-PA), together with Representative Diana DeGette (D-CO), a senior member of the House Energy and Commerce Committee. “Families with children facing life-limiting illnesses need all the support they can get, and they should be empowered to seek out that support,” the bill’s sponsors said in a joint statement. “We owe it to these kids and their loved ones to help ensure more compassionate care in their most trying times.” Gaps in Medicaid coverage of hospice and palliative services have deprived many beneficiaries of the care they need because the program does not cover some of children’s unique medical needs. Under this bill, the family of every child who qualifies for Medicaid will receive a specialized care plan covering a range of services – palliative, counseling, respite, expressive therapy and bereavement – providing them and their families greater comfort and peace of mind. ### Full Article
i 9th Annual Childhood Cancer Summit By childhoodcancer-mccaul.house.gov Published On :: Tue, 14 Aug 2018 17:28:21 +0000 Full Article
i 9th Annual Childhood Cancer Summit By childhoodcancer-mccaul.house.gov Published On :: Fri, 14 Sep 2018 20:52:23 +0000 Full Article
i Director of BARDA leaves position amid pandemic By www.biopharma-reporter.com Published On :: Wed, 22 Apr 2020 11:33:00 +0100 Rick Bright confirmed as having left his position as director of BARDA as the agency provides aid to develop solutions for COVID-19. Full Article Bio Developments
i MilliporeSigma set to build $100m facility for viral and gene therapies By www.biopharma-reporter.com Published On :: Thu, 23 Apr 2020 09:26:00 +0100 The facility will be the companyâs second facility in Carlsbad specifically for its BioReliance viral and gene therapy service. Full Article Upstream Processing
i Mogrify and Sangamo in license agreement for ‘off-the-shelf’ CAR-Treg By www.biopharma-reporter.com Published On :: Thu, 23 Apr 2020 12:16:00 +0100 Sangamo plans to utilize Mogrifyâs cell conversion technology to develop CAR-Treg cell therapies. Full Article Bio Developments
i J&J strikes CDMO deal to add capacity for COVID-19 vaccine By www.biopharma-reporter.com Published On :: Mon, 27 Apr 2020 14:47:00 +0100 J&J agrees a manufacturing partnership with Emergent, as it looks to hit its target of one billion doses. Full Article Bio Developments
i Takeda agrees license to strengthen plasma pipeline By www.biopharma-reporter.com Published On :: Mon, 27 Apr 2020 14:53:00 +0100 Takeda in global licensing agreement with ProThera to develop plasma-based therapies for inflammatory conditions. Full Article Markets & Regulations
i AskBio buys BrainVectis for early-stage gene therapies By www.biopharma-reporter.com Published On :: Mon, 27 Apr 2020 15:00:00 +0100 AskBio acquires gene therapy biotech working on treatments for neurodegenerative disorders. Full Article Markets & Regulations
i Sanofi receives FDA approval for quadrivalent meningococcal vaccine By www.biopharma-reporter.com Published On :: Tue, 28 Apr 2020 16:00:00 +0100 The company receives approval for MenQuadfi to prevent meningococcal disease. Full Article Markets & Regulations
i World leaders work on $8bn vaccine fund effort By www.biopharma-reporter.com Published On :: Tue, 28 Apr 2020 16:05:00 +0100 The WHO and world leaders commit to a fund to accelerate development of vaccines, tests and treatments for COVID-19. Full Article Bio Developments
i Hired & Retired: Changes amid COVID-19 By www.biopharma-reporter.com Published On :: Wed, 29 Apr 2020 15:55:00 +0100 As the industry shifts gears to combat the novel coronavirus, a number of leadership changes have taken place. Full Article Bio Developments
i AZ and Oxford University partner to develop coronavirus vaccine By www.biopharma-reporter.com Published On :: Thu, 30 Apr 2020 13:02:00 +0100 Under the agreement, AZ will develop, manufacture and distribute the vaccine that has already begun Phase I trials. Full Article Bio Developments