Biotechnology Focus Podcast

In the previous episode of the Biotechnology Focus podcast, we heard from Dean Fulford, vice-president of Stratford Managers Corp. talked about the impact that a younger cohort of workers on the biotech industry.

We're still on the topic of the 2017 Bio Employee Survey. Janet Le Clair, senior HR consultant for Stratford Managers, will talk about further takeaways from the survey and how Canadian biotech companies can use the survey results to enhance their relationships with employees and further grow their businesses.

Listen to what Janet had to say …

In this episode of the Biotechnology Podcast, Dean Fulford, vice-president of HR consulting for Stratford Managers Corp. discusses some key points from the recently concluded 2017 Bio Employee Survey conducted by Biotechnology Focus, Stratford Managers and BioTalent Canada.

A younger cohort of employees are making their voices heard, and it will serve biotech companies to listen to their demands, according to Dean.

The results of this year's Bio Employee Survey are in. And for this week's episode of the Biotechnology Focus podcast, we're providing you with an exclusive sneak peek of what the pollsters found.

The follow-on poll to Canada's first-ever biotech and life science HR-focused survey shows encouraging signs regarding the industry's workplace, according to Dean Fulford, vice president of human resources consulting at Stratford Managers Corp.

A few weeks ago, Biotechnology Focus, Stratford Managers, and BioTalent Canada launched the poll in order to take the pulse of the Canadian biotech and life science workplace. This is only the second time such a survey was conducted by the group. The first one in 2015, helped established key benchmarks for the industry.

How did the Canadian biotech and life science sector workplace fare this time? Listen to what Dean Fulford has to say……

China's 3SBio gains a North American through its $290 million purchase of Canada's Therapure Biopharma

Marck's cladribine tablet Mavenclad achieves sustained control of relapsing multiple sclerosis.

A patient enrolled in a CAR-T trial dies.

I'm Nestor Arellano. And these are the stories we'll discuss today on the Biotechnology Focus Podcast.

But first, let's talk about the future of Canada's life science workplace and workforce

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What are the things that employees in Canada's life science industry value about their workplace?

What is it about their organization that keep life science professionals and workers engage and productive each day?

How can you, as an employer attract and retain great talent?

These are just some of the crucial questions many operators and owners of Canadian life science companies face as they work to grow their business.

The key to finding the answers to these questions is data. And the best way to get that data is through the ongoing

Biotechnology Focus, Stratford Managers Corporation, and BioTalent Canada nationwide 2017 Life Science Workplace Survey.

The poll is one of the most comprehensive attempts to take the pulse Canada's life science workplace environment.

The findings of the survey will provide life science organizations across the country a critical guide on what areas to focus on in order to enhance their operations and relationships with their workers.

Don't miss this chance. There's still time to take part in the poll. All you have to do is head over to

Surveymonkey.com/r/biotechEOS and spend a few minutes taking the poll.

Remember that's surveymonkey.com/r/biotechEOS.

Do the survey now and have your say counted.

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Early this month, Chinese biotech firm 3SBio Inc., shelled out $290 million

For Mississauga, ont's biologics manufacturer Therapure Biophrama.

3SBio is focused on oncology, nephrology and auto-immune diseases. It has been slowly extending its reach out of its Shenyang headquarters in north China.

By purchasing Therapure, 3SBio has effectively put its North American expansion plans into high gear.

"3SBio's global expansion strategy is now on fast track," according to Dr. Jing Lou, chairman of 3SBio

He called the purchase "a key milestone of the global expansion strategy" of his business.

The acquisition integrates 3SBio's mammalian cell culture capabilities and Therapure's downstream purification and plasma source technologies.

This also combines the production capacity of the Chinese company's recently acquired stakes in Sunshine Guojian Pharmaceutical and Sirton Pharmaceuticals SpA with Therapure's operations.

More than 340 biologics professionals in North America focusing on operations and management, market development, R&D, and manufacturing are expected to join 3SBio.

3SBio will also get certain rights to Therapure's plasma production and technology, according to the Canadian company.

Therapure's CDMO business will continue to operate under the Therapure brand and be led by Therapure's CEO Nick Green and the current senior management team at its manufacturing facilities located in Mississauga.

+++++ Merck's Mavenclad branded cladribine tablets for the treatment of

highly active relapsing multiple sclerosis has

demonstrated the medication a achieve sustained control of the disease over four years with a maximum of only 20 days of oral treatment.

The trial, included 806 patients out of 1,184 patients who completed an earlier study.

The latest study assessed several clinical efficacy endpoints including annualized relapse rate (ARR) and confirmed three-month Expanded Disability Status Scale (EDSS) progression.

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CAR-T therapy has been getting a lot of attention recently.

Earlier this month, the FDA gave the green light to Novartis' CAR-T therapy which uses a patient's own immune cells to destroy aggressive blood cancer cells.

With this method, the patient's T-cells are collected and sent to a manufacturing centre

where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells

to target and kill leukemia cells that have a specific antigen (CD19) on the surface.

French biopharmaceutical firm Cellectis was not a fortunate with its own research.

The company's work on an off-the-shelf CAR-T therapy

was placed on hold by the United States Food and Drug Administration

following the death of one of the patients enrolled in the company's clinical trial for the therapy.

The hold was placed on both UCART123 ongoing Phase 1 studies, respectively in acute myeloid leukemia (AML)

and in blastic plas macy toid dend ritic cell neoplasm (BPDCN).

A 78-year-old BPDCN male patient received a dose of CD123-targeting CAR-T UCART 123 on August 16. Nine days later, the patient died.

Another patient treated in the study experienced a similar but less severe reaction.

The 58-year-old woman with AML was given the same dose of UCART 123 as the BPDCN patient.

Now Cellectis has to determine what precautions to take

before moving forward with enrolling more BPDCN and AML patients for the two phase 1 trials it plans.

The (Data Safety Monitoring Board) has recommended lowering the dose of UCART123 in both studies to 4g over 3 days.

The French biopharmaceutical firm is now working closely with the investigators and the FDA

in order to resume the trials with an amended protocol including a lowered dosing of UCART123.

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That's all the time we have for today.

Thank you very much for listening in and I hope you enjoyed our podcast.

This is your host Nestor Arellano

Inviting you to join us again next week for more biotech news and views on the Biotechnology Focus Podcast.

In this episode of the Biotechnology Focus podcast, Rob Henderson, the president and CEO of BioTalent Canada, discusses what can be done to avert a life science industry talent shortage and why it is important to take the pulse of the sector's workforce landscape. 

Recently, BioTalent Canada has partnered with Biotechnology Focus and Stratford Managers Corporation on a life science HR-focused online survey which is open to Canada's life science professionals and organizations from August 28 to September 15. 

Henderson discusses how data from the survey can be used by companies to attract new talent, and enhance workplace conditions and work-life balance to retain existing life science professionals. 

What are the things that employees in Canada's life sciences sector value about their workplace? What attributes of their organization keep them engage and productive each day? How can you, as an employer attract and retain great talent? How can you, as an employee, let your employee recognize what you need to grow your career, become more productive, and engage in your work?

In this episode of the Biotechnology Focus podcast, Deal Fulford, vice-president of human resources consulting for Startford Managers Corporation, talks about the nationwide life sciences HR-focus survey his company is conducting with Biotechnology Focus and BioTalent Canada.

The poll is one of the most comprehensive attempts to take the pulse Canada's life science workplace environment. The findings of survey will provide organizations a critical guide on what areas to focus on in order to enhance their operations and relationships with their workers.

Dean explains why is important for Canada's life science professionals, businesses and organization to take part in the survey and have their voices heard.

Mario Lebrun, former BIO Quebec managing director passes away, Mylan introduces three generic drugs for HIV, and Shire Pharma's Onivide has been approved for metastatic adeno carcinoma of the pancreas.

In this week's Biotechnology Focus Podcast, we observe the passing of Mario Lebrun. The former managing director of BIO Quebec succumbed to cancer earlier this month. In other news, Mylan of the Netherlands announced it is rolling out in Canada, three generic drugs for the treating HIV. Shire Pharma Canada ULC said its injectable drug Onivyde has been approved for the treatment of metastatic adeno carcinoma of the pancreas.

The read the whole stories, please click on the links below:

• MARIO LEBRUN FORMER BIO QUEBEC MANAGING DIRECTOR PASSES AWAY
• MYLAN INTRODUCES THREE HIV DRUGS IN CANADA
• ONIVYDE APPROVED FOR TREATMENT OF PANCREATIC CANCER: SHIRE PHARMA

The ups and down of an Ontario-based pharma company seeking to develop a solution for the world's deadly opioid epidemic.

A custom DNA nucleotide maker locks in on the problem of CRISP Cas9 off-targets

I'm Nestor Arellano. And these are the biotech news we'll talk about today on the Biotechnology Focus podcast

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Intellipharmaceutics International of Etobicoke, Ont. was decidedly upbeat when it announced a couple of weeks ago the upcoming review by the FDA of its tamper resistant opioid medication called Rexista.

Rexista was product squarely aimed at an unmet need.

In recent years, Opioid addiction has become a major problem and growing cause of drug overdose deaths in Canada and the United States.

At least 2,458 people were reported to have died in Canada last year due to opioid-related overdose.

INtellipharma's product appeared to promise to turn the tide.

Rexista was being positioned as an abuse and alcohol-deterrent .

It was a controlled-release oral formulation of oxycodone hydrochloride. A Bioequivalet of Purdue Pharma's OxyContin.

Among other things, Rexista contains a blue dye which would mark those who tamper with or crush the tablet.

It also contains a nasal irritant designed to keep the drug from being easily inhaled with the application of heat or an open flame.

Wow, the FDA review must have looked like a slam dunk.

But a few days later, reports came out that a Los Angeles law firm to investigate Intellipharmaceutics and its company's officers for possible violation of federal security laws.

The complaint, filed by a certain Shawn Shanawaz against Intellipharmaceuticas and two of its executives,

alleges that the company and its officers violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5

by making allegedly false and misleading statements or failed to disclose certain information regarding Rexista. Then another law firm law firm Glancy Prongay & Murray LLP (GPM) of L.A.

issued a press release saying that it was looking into reports of alleged misconduct by Intellipharmaceutical executives.

The press release indicates that the investigation may have something to do with share prices of Intellipharmaceutical.

According to GPM the FDA committees voted that Rexista

"had not demonstrated properties that can be expected to deter abuse" by the intravenous means and that there was not enough data to support the company's claims of the product's abilities to deter abuse by this means.

"On this news, the Company's share price fell $1.13 per share, or 45.3% on July 27, 2017, thereby injuring investors," GPM said.

The law firm was inviting eople who have purchased Intellipharmaceutics or anyone that may have information or questions about the claims to contact GPM.

The company's CEO had earlier said "We are very pleased with the progress made towards our goal of securing FDA approval of our RexistaTM NDA candidate."

A few days later, Intellipharmaceutics issued a statement saying "its management intends to vigorously defend against the allegations set forth in the complaint."

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The ability to modify the gene of an organism through CRISPR genome editing

holds the promise of curing diseases such as cancer and leukemia.

However, there are also growing concerns that the innovative gene editing technology could alter regions of the genome which researchers are not targeting.

A California-based custom manufacturer of DNA and RNA oligo nucleo tides believes it can lick this problem.

The company launched a Cas9 enzyme variant which it said can drastically reduce off-target effects in CRISPR genome editing.

Integrated DNA Technologies (IDT) said the Alt-R S.p. HiFi Cas9 Nuclease 3NLS enzyme

Ok that's a mouthful. Let's just call it variant enzyme.

The variant enzyme is a recombinant S Pyogenes Cas9 mutant

The company said that when used in gene editing it improves specificity

while maintaining a high editing efficiency similar to wild-type Cas9.

IN short the variant enzyme is able to cut down off target effects.

Why is this important?

CRISPR Cas9 editing is not as accurate as we would want it to be.

There have been warning from experts that it is possible to cause the editing an unintended gene.

For example, genome editing could inadvertently disable a tumour-suppressor gene or activate a cancer-causing gene.

Or, consider the possibility of an off-target effect where two different chromosomes are joined in a phenomenon called translocation.

Translocation is the cause of chronic myeloid leukemia and other conditions.

Yeah. That's bad news.

But IDT's variant enzyme seems to be right on target.

"We performed an unbiased evaluation of several versions of high fidelity Cas9 enzyme in primary human stem cells," said Dr. Matt Porteus from the Stanford University's

Division of Stem Cell Transplantation and Regenerative Medicine.

"We have been very impressed with the characteristics of this new IDT enzyme," he said.

He said that unlike other versions, the variant enzyme consistently achieved high on-target editing activity while having low off-target activity.

Porteus was so happy with the results he even said his team intends to use the variant enzyme in future experiments on developing genome editing therapies.

If you're interested to learn more about this story Head over to our site Biotechnologyfocus.ca and click on the story: IDT launches Cas9 enzyme which cuts down CRISPR off-targets

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Ok folks, that all the time we have for today.

I hope you enjoyed the stories we just discussed.

This is your host Nestor Arellano

Inviting you to joins us again next week for more biotech news and views

Creative Destruction Lab probably conjures up images of exploding beakers and test tubes, or worse a company that demolishes buildings.

If you're a researcher or scientist working on potential new treatment or therapy.

If you're a founder or a fledgling company with IP rights to the next killer technology.

And your problem is how to get that product to market. You'll be interested with what the CDL has to offer.

The Creative Destruction Lab is actually an exciting new program that pair startup founders experienced entrepreneurs. The aim is to help innovators transition from science projects to high-growth companies.

I had a chance to speak with Ajay Agawal, founder of CDL and he'll be discussing how the Creative Destruction Lab is helping build successful Canadian biotechnology companies.