May 27, 2020

Why Canada Needs a National Vaccine Strategy

Ali Ardakani

COVID-19, coronavirus, vaccine, strategy, vaccine manufacturing, drug development, Canada, Health Canada

CDC coronavirus illustration

May 04, 2020

Serological Diagnostics Regulatory Pathway - May 4th Update

Ian McGill

Regulatory, FDA, Emergency Use Authorization, EUA, COVID-19, SARS-CoV-2, Diagnostics, Serological Diagnostics Regulatory Pathway, antibody tests

‘20

Apr 28, 2020

FDA’s Emergency Use Authorization: A Rapid & Effective Path to Market for COVID-19 Diagnostic Tests

Ian McGill

Regulatory, FDA, Emergency Use Authorization, EUA, COVID-19, SARS-CoV-2, Diagnostics, Devices

Nov 19, 2019

Novateur Knows the Cannabinoid Biosynthesis Landscape

Dr. Colin Funk

Cannabinoid Biosynthesis Landscape, Cannabis

Mar 25, 2019

Importance of Women's Leadership in Life Sciences

Ali Ardakani

Health Science, Leadership, Science, Technology, Women in Science

‘19

Mar 22, 2019

Tips for Raising Venture Capital

Eric Zimmerman

Entrepreneurship, Financing, Investing, Venture Capital

Oct 23, 2018

With BioEurope Around the Corner: Are Your Meeting Requests Getting Rejected or Never Answered?

Dr. Anne Assmus

Biotechnology, Drug Development, Events, Life Sciences, Novateur, Pharmaceutical

Oct 03, 2018

Key Takeaways from Global Perspectives on Early-Stage Investment and Partnering 2018

Simran Kohli

Biotechnology, Canada, Events, Financing, Life Sciences, Novateur, Pharmaceutical

Sep 07, 2018

Rewarding Summer for Novateur and Its Clients and Portfolio Investment Companies

Ali Ardakani

Biotechnology, Life Sciences, Novateur, Pharmaceutical

Sep 04, 2018

Clinical Evaluation Reports for EU-Marketed Medical Devices – A Summary of the Regulatory Guidance

Mayme Wong

Clinical Development, EMA, Regulatory

‘18

Feb 26, 2018

Go Luke! Luke Timmerman Is Hiking to the Top of Mt. Everest for Cancer Research

Ali Ardakani

Biotechnology, Cancer Research, Fundraising, Novateur

Nov 28, 2017

Quality Assurance: An Important Contributor to Value Creation

Dr. Gina Stetsko

Novateur, Regulatory

Nov 23, 2017

Cannabis In Canada – Sweeping Changes

Brian Wagner

Cannabis, Health Canada

Nov 07, 2017

Diagnostics: The Good, the Bad & the Ugly

Ali Ardakani

Biotechnology, Companion Diagnostics, Events

Nov 07, 2017

More Than Engaging with Government – Let’s Work Together

Ali Ardakani

Biotechnology, British Columbia, Government, Life Sciences

Oct 10, 2017

Why Did We Go Fishing with Roche Venture Fund?

Ali Ardakani

Events, Financing, Novateur

Oct 10, 2017

Companion Diagnostics: A Guide to Cure?

Ali Ardakani

Biotechnology, Companion Diagnostics, Drug Development, Pharmaceutical

Sep 26, 2017

Forgoing Retirement: Why I Became an Advisor at Novateur Ventures

Dr. Gina Stetsko

Career, CMC, Drug Development, Novateur

May 11, 2017

Entrepreneurial Pharma: Confronting the Adage, “Experience Is Something You Get Just After You Need It.”

Dr. Gina Stetsko

505(b)(2), Drug Development, Label, NDA, Pharmaceutical, Regulatory

May 11, 2017

How Trump Presidency and BREXIT Are Creating the Perfect Storm for Reversing Canada’s Brain Drain

Ali Ardakani

BREXIT, Biotechnology, Government, Trump, Pharmaceutical

‘17

Apr 10, 2017

Conquering the South Pole and Lessons for Biotechs

Ali Ardakani

Biotechnology, Drug Development, Pharmaceutical

Nov 21, 2016

Trends at the FDA in Medical Device Approvals

Dr. Carol Stephens

FDA, Government, Medical Devices, Pharmaceutical, Regulatory

Nov 21, 2016

Trends at the FDA in Drug Approvals

Dr. Thomas Stephens

Drug Development, FDA, Government, Pharmaceutical, Regulatory

Nov 03, 2016

How Would the Biotech Landscape Change After the Election?

Ali Ardakani

Biotechnology, Drug Development, FDA, Pharmaceutical

Sep 07, 2016

505(b)(2) Regulatory Submissions Require Flexibility, Creativity and Resilience

Dr. Gina Stetsko

505(b)(2), FDA, NDA

May 26, 2016

How to Decipher Large Pharma’s Dating Game?

Dr. Hooshmand Sheshbaradaran

Biotechnology, Drug Development, Pharmaceutical

Apr 14, 2016

The Serendipity of Drug Development

Ali Ardakani

Biotechnology, Drug Development, Financing, Pharmaceutical

Feb 18, 2016

Two Must Know Themes in Biotech for 2016

Ali Ardakani

Biotechnology, Public Markets

‘16

Feb 11, 2016

Expanding in a Restricting World: Value Added Medicine

Brent Korte

Government, Market Access, Pharmaceutical, Research

Dec 10, 2015

How Do We Create the Most Value With Limited Resources?

Dr. Thomas Stephens

Drug Development, EMA, FDA, Regulatory

Dec 03, 2015

What One Tool Is the Most Useful in Guiding Clinical Drug Development?

Dr. Carol Stephens

approval, drug development, drug label, efficacy, FDA, IND, label, pre-IND, regulatory, safety, submission

Nov 13, 2015

Applying the Supreme Court’s New Standard of Definiteness

Dianna G. El Hioum

claims, intellectual property, legal, Nautilus, patents

Nov 03, 2015

The Evolving Biotechnology Regulatory Landscape

Dr. Thomas Stephens

biotechnology, diagnostics, drug development, EMA, European Medicines Agency, FDA, global environment, Health Canada, medical devices, MHLW, pharmaceutical, regulatory

Oct 21, 2015

5 Things You Need to Know About Expedited Drug Development

Dr. Carol Stephens

Accelerated Approval Pathway, Breakthrough Therapy Designation, drug development, expedited development, expedited programs, Fast Track Designation, FDA, Priority Review Designation, regulatory, regulatory authorities, review programs

Oct 09, 2015

How to Navigate a Period of Market Instability in Biotech Financing?

Ali Ardakani

biotech, financing, biotechnology, drug pricing, financing, pharma, pharmaceutical, public markets, stock exchange

Jul 09, 2015

Reference Standard – An Essential Investment to Expedite Development Milestones

Dr. Rick Rhinebarger

certified reference standard, CMC, development, R&D, reference standard, research

Jun 25, 2015

5 Key Facts About EMA

Beate Schmidt

biotechnology, development, EMA, EU, European Medicines Agency, European Union, pharma, regulatory

Jun 17, 2015

Virtually Seamless: Best Practices for Working in a Global Environment

Janice Williams

biotechnology, global environment, pharma, virtual operations, virtual team

Jun 11, 2015

Quality: Your “Q” to Increase R&D Productivity

Victoria Levesque

biotechnology, clinical development, clinical trial, pharma, quality, regulatory development

Jun 04, 2015

Building Blocks of Biotech Success

Ali Ardakani

biotechnology, clinical development, regulatory development, virtual operations, virtual team

‘15

May 27, 2015

Think Globally, Work Virtually: The Future of Biotech Success

Ali Ardakani

biotechnology, clinical development, regulatory development, virtual operations, virtual team

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