Novotech and CNS Deal Expands CRO Services for Biopharma Clients Across Asia-Pacific

Novotech the largest Asia-Pacific-based CRO has acquired Australasian specialist CRO Clinical Network Services (CNS) as part of a mutual mission to expand services to biopharma for early phase product development and clinical research through to later phase regional and global trials.

Both companies will continue to retain their separate brands and identities.

 

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Early phase CNS clients wishing to advance development into later phase regional trials can tap into Novotech’s Asia-Pacific expertise backed by 10 partnership agreements with leading hospitals and medical institutions that offer access to more than 1.4 billion people living in urban areas in the region.

 

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Novotech has more than 400 staff across Asia-Pacific and business development offices in the USA, and CNS has more than 140 staff in Australia, New Zealand and the USA.

As part of the deal, clients can access leading services from both groups including the CNS BioDesk, that provides early stage product development advice including toxicology, CMC and FDA/EMA regulatory consulting and interactions; and Novotech’s advanced regional IT infrastructure, to support their clinical research programs.

Novotech CEO John Moller said:

“Biopharma clients should know this is a bringing together of the highest quality CROs in the region.   Very importantly, we have developed remarkably similar company cultures, and I know the teams are excited about the opportunity to work together.

Novotech and CNS will continue to operate under separate brands with CNS specialising in early phase non-oncology clinical trials across Australia and New Zealand, and Novotech specialising in regional Asia-Pacific and global project delivery across all phases.

Our Asia-Pacific in-country relationships enable a comprehensive understanding of local regulatory requirements and changes, access to leading investigators, strong site connections, and accessible patient populations to deliver success for our clients within timelines and budgets.”

CNS Managing Director, Russ Neal commented:

“Early phase research in Australasia has seen incredible growth over the last 6-7 years and CNS is proud to be a significant part of this proven capability. As our clients have experienced success with us, we have often wished we had the international reach to continue supporting them. This truly complimentary association with Novotech now means that we are able to offer our clients access to Novotech’s Asia-Pacific experience and expertise in later phase regional or global trials. On the other hand, Novotech clients can access our highly regarded global product development and regulatory affairs consultancy team, BioDesk, based out of Washington DC, London and Australia”

CNS COO and Executive Director Gabrielle McKee further added:

“CNS clients will also benefit from many of Novotech’s strengths, including IT infrastructure and specialist functions such as legal, learning and development and marketing and analytics and particularly exciting is that together CNS and Novotech offer our clients one of the most experienced and knowledgeable biometrics teams in the region with about 70 staff in the combined unit.”

 

About Novotech – https://novotech-cro.com/welcome
Headquartered in Sydney, Novotech is internationally recognized as the leading regional full-service contract research organization (CRO). With a focus on clinical monitoring, Novotech has been instrumental in the success of hundreds of Phase I – IV clinical trials in the Asia-Pacific region.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech’s strong Asia-Pacific presence includes running clinical trials in all key regional markets. Novotech also has worldwide reach through the company’s network of strategic partners.

About Clinical Network Services https://clinical.net.au/

Clinical Network Services (CNS) is an integrated service group focused on product development headquartered in Australia with offices in New Zealand, the UK and the USA, who create value for small to medium sized biotechnology companies by progressing early stage products through phase 1 & 2 clinical trials or the marketplace sooner. CNS offers a unique service where it integrates BioDesk, an intelligent global product development and regulatory affairs consultancy, with our committed, highly experienced Australian/New Zealand clinical services and biometrics team. CNS’ regional clinical advantage is driven by the extremely pragmatic regulatory environment in Australia and New Zealand that makes it possible for clients to enter the clinic quickly, without prior regulatory approval. CNS offers a uniquely differentiated, customer-orientated, suite of services to clients which enables CNS to guide products efficiently through critical post-discovery development and into initial human trials. Throughout, CNS takes a global development/ regulatory strategic approach to ensure that value is added at every stage of the product development life cycle.

Number of UK clinical trials in decline since Brexit vote

Ongoing uncertainty and concern about Brexit has already cut the number of clinical trials carried out in the UK.

The number of drug trials started in Britain in 2017 was a staggering 25% lower than the average for 2009-2016.

A Fitch analysis showed that 597 trials were initiated in Britain in 2017, against an average of 806 over the previous eight years.

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The referendum on whether Britain should stay in the EU was held in 2016 and despite two years of wrangling between and within political parties, no clarity over what Brexit means in real terms has emerged.

Britain is currently due to leave the EU on March 29 next year – less than six months from now.

According to a report by Reuters, the Association of the British Pharmaceutical Industry (ABPI), said the NHS, which has been used for research into groundbreaking and life changing drugs, could suffer through the lack of investment.

Patients could also be deprived of the benefits of new medicines, according to the report.

Speaking to Reuters, Sheuli Porkess, deputy chief scientific officer at the ABPI, said: “We know from our members that Brexit-related uncertainty is a major concern when it comes to decisions about whether to set up trials in the NHS.

“This is why it’s vital that we get a Brexit deal to keep the investment and skills in clinical trials here in the UK.”

If no deal is struck, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) would have to operate as a stand-alone regulator, a possibility that is currently out for industry and public consultation.

And, there is still no transparency over how UK data would be treated by the European Medicines Agency (EMA), although the government says it wants the MHRA to align itself with decisions made by the agency as far as the latest novel drugs are concerned.

Recardio stopped its UK-based drug trials earlier this month, citing uncertainty over Brexit as the reason.

It pulled out of trials for dutogliptin, which is designed to help heal heart tissue post-heart attack, saying the instability caused by Brexit was “very difficult” and was a “significant risk” to the business.

 

Drug firms retaining old brand names for new medicines

Pharma firms prefer to go with the existing brand names for new fixed dose combinations (FDCs) as it is easier to market them

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What’s in a name? A lot, according to pharmaceutical companies, many of whom have already launched or are gearing up to introduce new fixed dose combinations (FDCs) by tweaking the compositions but retaining the same brand name as the original product.

For example, in 2016, when popular cough syrup Corex was banned, Pfizer Ltd, the Indian subsidiary of US-based drug maker Pfizer Inc., was quick to discontinue the cough syrup Corex in its then form, changed the composition but decided to retain the brand name for its future respiratory products. The company decided to stop making the Corex cough syrup formulation, a combination of codeine phosphate 10 mg and chlorpheniramine maleate 4mg, changed the formulation and extended the same brand name. The new formulation is now called Corex T (Codeine + Triprolidine) .

According to Pfizer spokesperson “Pfizer discontinued the manufacture of ‘Corex Cough Syrup’ in 2016 as an outcome of a regular review of the product portfolio. However Corex remains an important umbrella brand for Pfizer that has long been associated with a broad range of safe and effective products and continues to be an essential part of our portfolio.”

Likewise, Glenmark Pharmaceuticals Ltd’s pain relief formulation called Vorth TP earlier contained tapentadol and paracetamol. It has now been tweaked to include tramadol and paracetamol. The brand name, however, remains unchanged.

Experts said companies prefer to continue popular brand names for new products containing different ingredients as it becomes easier to market them. “The companies want to retain the brand name as they spend a lot of money in building a name. As long as it is for the same indication by virtue of reformulation to make it a rational combination, the companies prefer to use the same name,” said D.G. Shah, secretary general of Indian Pharmaceutical Alliance, which represents large number of domestic drug makers. Shah said extending the brand names to new products also make it easier for doctors and chemists to remember while dispensing or prescribing the medicines.

“The brands have been in the market for decades and companies invest a lot on these brands. Hence, they would like to save them by moving to combinations that have been approved by the Drug Controller General of India for the same indication with the addition or change of a suffix or prefix to the original name,” said Sunil Attavar, president, Karnataka Drugs and Pharmaceuticals Manufacturers’ Association.

The Union health ministry on 12 September, banned about 328 FDCs after an expert panel formed under the chairmanship of Nilima Kshirsagar, professor of head clinical pharmacology at G.S. Medical College KEM Hospital, Mumbai, to review the safety, efficacy and therapeutic justification of these drugs, found these FDCs “irrational”, citing safety issues and lack of therapeutic justification, recommended the ban. The ban on FDCs included painkillers, anti-diabetic, respiratory and gastro-intestinal medicines.

While Glenmark, Wockhardt Ltd, Alkem Laboratories Ltd, Obsurge Biotech, Coral Laboratories, Lupin, Mankind Pharma, Koye Pharmaceuticals, Macleods and Laborate moved the high court against the ministry’s decision, some companies are busy tweaking compositions and launching their new formulations in the market.

Macleods Pharmaceuticals, which makes anti-fungal Panderm Plus is gearing up to launch its new combination called Panderm NM and is awaiting approval from India’s drug regulator.

“Panderm Plus steroid has been fixed with an antibiotic which is never allowed in any country of the world and that is the reason that it has been banned,” Chandra M. Gulhati, editor, Monthly Index of Medical Specialities (MIMS).

An FDC drug contains two or more active ingredients in a fixed dosage ratio. The ban covered about 6,000 brands from top pharma companies, including Pfizer, Wockhardt, Alkem Laboratories, Cipla, Sanofi India and Sun Pharmaceutical Industries Ltd.

Half of EU Clinical Trial Results Not Reported

Despite EU requirements for clinical trials to report results to the EU Clinical Trials Register within a year of a trial’s completion, sponsors have only reported about half of them so far.

The analysis, led by University of Oxford researcher Ben Goldacre, found trial sponsors only reported about 51 percent of 7,274 clinical trial results since publication of the European Commission’s guidelines in 2014. Of these, 68 percent of trials with a commercial sponsor posted the results, while only 11 percent of non-sponsored trials shared theirs.

The study found that 32 major universities did not report results for any trials they sponsored. Eleven drugmakers whose trial data the researchers analyzed reported all the trials they sponsored, including Genentech, Gilead and Boehringer Ingelheim. On the other end of the spectrum, Eli Lilly reported only 52 percent of its trials.

“The biggest offenders of not publicly releasing clinical trial data are academic institutions,” says Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, a nonprofit medical issues research group. “Part of the problem is academic institutions don’t feel the need to abide by the same standards pharmaceutical companies do” when it comes to reporting clinical trials data.

Another problem in reporting trial data is methodological, according to Pitts, because sponsors don’t feel obligated to release early stage data.

“Clearly what’s most important are human trials,” he says, “but oftentimes early studies aren’t released because sponsors don’t think they have any relevance.”

Independent researchers are often unable to verify and build on clinical trial findings without access to this data, but no entity has ever been penalized for failing to fulfill the reporting requirements, according to the study published in BMJ. The EU regulation calls on all trial sponsors to report results one year after a trial concludes, or within six months in the case of research involving children. Trials that miss reporting deadlines by three months or more are to be flagged by the EU, but there is no system in place to flag overdue trials.

“We need to reflect on how we can improve our communication with academic sponsors and smaller sponsor organizations. This study helps to spread the word on how important it is to post trial results once a clinical trial is over,”  Fergus Sweeney, head of inspections for the EMA Human Medicines Pharmacovigilance and Committees, said. “We … are firm believers that transparency and public availability and scrutiny of clinical trial information and results are fundamental for the protection and promotion of public health.”

Clinical Trials: There’s an App for That

When Apple introduced the latest iteration of its Apple Watch earlier this month, it was hailed by an unlikely source: FDA Commissioner Scott Gottlieb.

“The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly,” Gottlieb said about the tech company’s freshest entry into the world of wearables.

In what may be the first of its kind, the newest Apple Watch offers two FDA-approved apps: one an EKG and the other a pulse monitor, both designed to detect atrial fibrillation and heart arrhythmia.

 

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For some, the FDA’s embrace of these apps is further proof that the revolution in consumer electronics may finally be coming to clinical trials.

“The obvious benefit is that people are already using it. That’s a big plus. Compliance is going to be built in,” says Sofija Jovic, an advisor at MedAvante-ProPhase.

In the seven years since the first smart phone hit the U.S. market, the percentage of people who own one has more than doubled, according to a recent survey by the Pew Research Center. More than three-quarters of Americans now own a smart phone of some kind, Pew reports.

Wearable devices such as the Apple Watch seem like they may be the answer to long-vexing recruitment problems: the average clinical trial requires 11 site visits and soaks up hours of participants’ free time.

Wearables offer a chance to harvest massive amounts of data without the time-suck — and, in some cases, the gadget itself can be a recruiting tool.

For example, AOBiome recently gave patients in a skin treatment trial cell phones – and had them take photos of their acne and send them to researchers digitally.

The trial was coordinated by the telemedicine company Science 37.

“We’ve built a technology platform to support doing clinical research so that trials can be centered around patients in their homes,” says Belinda Tan, Science 37’s founder.

“Participants don’t need to drive four hours to a university to go to a trial every other week,” she adds, noting that she believes wearables may also help boost diversity in clinical trials.

The revolution is already well underway.

In March, Swiss pharma giant Novartis announced a deal with Science 37 to conduct at least 10 wearable-assisted trials over the next three years.

That doesn’t mean that sponsors and sites can shed their brick-and-mortar clinics, though.

Jovic says that writing a wearable, mobile device into a protocol presupposes enrolling people already comfortable wearing gadgets — which may limit recruiting to people who already have or are familiar with such devices or can afford to buy them if not provided as part of a trial.

Jovic notes there are also some concerns about privacy and informed consent. “Is there such as a thing as too seamless data collection?” she wonders.

Mobile devices are so good at tracking data subtly that most consumers forget that it’s happening. Whatever problems that raises for the larger society, it’s a lot more troubling in a clinical trial context.

“You want some visible way,” Jovic says, “in which people continue to give consent.”

In an effort to keep pace with the Digital Age, the FDA has asked Congress to set aside money in the fiscal year 2019 budget for what it’s calling a Center of Excellence for Digital Health.

Gottlieb says the center will be designed to help the agency deal with lingering questions and craft regulations to adapt to wearables in clinical trials and public health.

Global Regulatory & Consumer Insights company, Announces Strategic Collaboration Agreement with Indian Institute of Technology – Bombay

Cancer therapeutics currently have the lowest clinical trial success rate of all major diseases. Partly as a result of the paucity of successful anti-cancer Medical Devices, cancer will soon be the leading cause of mortality in developed countries.

Global Regulatory and Consumer Insights, a leading provider of drug development consulting and regulatory services, is pleased to announce a strategic partnership with Indian Institute of Management (IIT) Bombay – The Department of Biosciences and Bioengineering (BSBE) in IIT Bombay is a nodal center for applying science and engineering principles to further fundamental knowledge and applications in biology and biomedical engineering. The BSBE department aims to create an ambience for the smooth pursuit of scholarly activities in research and education, to make an international impact, and to produce future leaders in the field of Biosciences and Bioengineering.

 

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“The collaboration offers our early stage clients a streamlined service to move efficiently through preclinical development to creation of high quality IND submissions”, said Tarun Pandotra, Global Regulatory & Consumer Insights’ Founder & Director. “This approach, coupled with our expertise will provide our clients, with the ability to accelerate the development of their products and stay ahead of the competition.”

Prohibition and restriction of manufacture, sale and distribution of Fixed Dose Combinations (FDCs)

 

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The Ministry of Health and Family Welfare has prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) with immediate effect. It has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.

Earlier, the Central Government had, through its notifications published on the 10th March, 2016 in the Gazette of India, prohibited the manufacture for sale, sale and distribution for human use of 344 FDCs under section 26 A of the Drugs and Cosmetics Act, 1940. Subsequently, the Government had prohibited five more FDCs in addition to the 344 under the same provisions.

However, the matter was contested by the affected manufacturers in various High Courts and the Supreme Court of India. In compliance with the directions given by the Supreme Court of India in its judgment dated the 15th December, 2017, the matter was examined by the Drugs Technical Advisory Board constituted under section 5 of the Drugs and Cosmetics Act, 1940 which furnished its report on these drugs to the Central Government.The Drugs Technical Advisory Board recommended, amongst other things, that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings. The Board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under section 26 A of the Drugs and Cosmetics Act, 1940 in the larger public interest. With regard to six FDCs, the Board recommended that their manufacture, sale and distribution be restricted subject to certain conditions based on their therapeutic justification. Fifteen FDCs out of the 344 prohibited on the 10th March, 2016, which were claimed to be manufactured prior to 21stSeptember, 1988, have been kept out of the purview of current notifications.

Earlier, an Expert Committee appointed by the Central Government had also examined these FDCs and made recommendations in line with those of the Board as indicated above.

The Central Government considered the recommendations of the Expert Committee and Drugs Technical Advisory Board, and based on such consideration, it was concluded that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of these 328 FDCs in the country.

Accordingly, the Ministry of Health and Family Welfare has, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940,prohibited the manufacture for sale, sale or distribution for human use of 328 FDCs through its gazette notifications dated 7th September 2018; it has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions. These notifications will take immediate effect.

RE-NAMING OF INDIAN REGULATORY AGENCY (CDSCO)

Central Drugs Standard Control Organization (CDSCO) is the national drug regulatory agency under the Ministry of  Health and Family Welfare, Government of India.

Over the years, the role of CDSCO has expanded to several areas, for the same the Drugs Technical Advisory Board (DTAB) in its 75th meeting recommended renaming of CDSCO.

In view of this, CDSCO has asked for suggestion for re-naming and logo for CDSCO.

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Experts highlight Ebola vaccine progress and suggest next steps

Despite promising advances, important scientific questions remain unanswered in the effort to develop a safe and effective Ebola vaccine, according to members of an international Ebola research consortium. In a Viewpoint published in The Lancet, the experts review the current field of Ebola vaccine candidates and clinical trials and highlight key gaps in knowledge that need to be addressed by future research.

Researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, are among the Viewpoint’s authors. All authors are with the Partnership for Research on Ebola VACcination (PREVAC). In addition to NIAID, the partnership, established in 2017, comprises experts from the French National Institute of Health and Medical Research (Inserm), the London School of Hygiene & Tropical Medicine (LSHTM), the West African Clinical Research Consortium and their collaborators. PREVAC is currently conducting a Phase 2 clinical trial in Guinea, Liberia, Sierra Leone and Mali to evaluate three Ebola vaccination strategies in people one year and older.

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Ebola virus disease remains a public health threat — the Democratic Republic of the Congo (DRC) already has experienced two Ebola outbreaks in 2018 —  underscoring the need for continued efforts to develop an effective vaccine. The authors note that 36 trials of Ebola vaccine candidates have been completed and another 14 are active, according to clinicaltrials.gov. The rVSV-ZEBOV experimental vaccine, which has been deployed in the DRC, is the only candidate with some clinical efficacy data, which were obtained in a clinical trial in Guinea conducted during the 2014-2016 Ebola outbreak in Guinea.

After reviewing the status of four additional vaccine candidates under study (Ad26.ZEBOV, MVA-BN-Filo, chAd3-EBO-Z, and the GamEvac-Combi vaccine), the authors highlight areas where more research is required. Specifically, they note the need for more data in pregnant women, children and immunocompromised populations, including people infected with HIV and the elderly. Additionally, they say more research is needed on the durability and rapidity of immune responses generated by various vaccine approaches. The experts also call for studies to identify reliable correlates of protection (the specific and measurable part of an immune response that would indicate a person is protected from Ebola) as well as large-scale trials to fully evaluate the safety and efficacy of experimental vaccines.

The authors conclude by underscoring the value of embedding social science research in clinical trial design to help build trust and engagement with the affected communities. They note that in addition to the need to investigate various vaccines and vaccination strategies to respond more effectively to future outbreaks, improving the global capacity to conduct clinical research and forming collaborative partnerships, such as PREVAC, are crucial for success.

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