The Enterprisers

This column offers a deeper look into especially innovative or entrepreneurial biopharma companies, individuals, or institutions through our special lens — lessons learned, actionable info, benchmarking, best practices, etc.

  • The Enterprisers: CohBar - Producing Mitochondria Medicine
    The Enterprisers: CohBar - Producing Mitochondria Medicine

    Why shouldn’t our mitochondria want us to live long, prospering in good health? Why shouldn’t they — as symbiotic microbes turned cellular organelles with their own mini-genomes — carry genes that help ensure our healthful survival?

  • NOVAVAX: Scouting Past The Long Trail To Market
    NOVAVAX: Scouting Past The Long Trail To Market

    Clinical challenges lurk all along the pathway for any company developing new vaccine candidates and technology — and that goes at least twice for Novavax. As we go to press with this, the company is dealing with an anxious investment community about the “failed” Phase 3 trial of its RSV F vaccine in older adults, for protection against respiratory syncytial virus (RSV). (See “Press-Time Thunder.”)

  • How Rebiotix Avoids The Typical Biopharma Startup Missteps
    How Rebiotix Avoids The Typical Biopharma Startup Missteps

    A straightforward purpose and premise were the words that came to mind in my first impression of this company. Lee Jones, the CEO and cofounder of Rebiotix, describes building the company in an “of course, this is how you do it” manner. The larger issue — whether the company’s Microbiota Restoration Therapy (MRT) platform will succeed in a somewhat besieged field — can only be resolved over time. But it will most likely be biology that decides the matter, not the typical lack of clear direction or organization that plagues so many biopharma startups.

  • Life Science Leadership In Action: RespireRx
    Life Science Leadership In Action: RespireRx

    Suffocation seldom gets the credit it deserves for causing death in so many conditions — from sleep apnea to heart failure to drug overdose. But if you view the large variety of those cases at a higher resolution, you will see “respiratory failure” as the common final, fatal effect.

  • InVivo Therapeutics: Taking On Spinal-Cord Injury
    InVivo Therapeutics: Taking On Spinal-Cord Injury

    Not everyone knows someone with a spinal-cord injury. I did. We met as teenagers, shared a few years as friends but lost touch when I drifted to the opposite end of the country

  • Amarantus: Risen From The Ashes
    Amarantus: Risen From The Ashes

    One startup’s bad luck in the clinic leads to the creation of  a new company — Amarantus

  • Codagenix, A Tiny Start-Up Ready To Take On The Goliaths Of The Vaccine Industry
    Codagenix, A Tiny Start-Up Ready To Take On The Goliaths Of The Vaccine Industry

    One egg per person. That is what it takes to produce a flu vaccine. The standard, predominant method has not changed in more than 70 years.

  • The Enterprisers -- ContraVir: Mapping A Circuitous Route To Value
    The Enterprisers -- ContraVir: Mapping A Circuitous Route To Value

    If a person can be a legend, a company should be a saga. ContraVir contains both dramatic elements — a personal path through Big Pharma to small biopharma and an extended quest through a thick forest of data to find undiscovered treasure among some overlooked compounds. When I speak with CEO James Sapirstein, he takes me on a long journey full of the intertwining twists and turns of his own career and of the company he now heads. The story gives new meaning to “follow the data.”

  • The Enterprisers -- Velocity Pharmaceutical Development: A Novel Start-Up Model
    The Enterprisers -- Velocity Pharmaceutical Development: A Novel Start-Up Model

    In the typical start-up company, which parts are absolutely essential, and which parts are replaceable? The question really stems from a subaxiom of the virtual company concept, which normally places a small corporate-style management team at the center of operations and services supplied by outsourcing.

     

  • The Enterprisers -- Agile Therapeutics: Reengineering Innovation
    The Enterprisers -- Agile Therapeutics: Reengineering Innovation

    The top management team at Agile Therapeutics reflects an atypical bounty of experience and expertise for a small life sciences company. That was no accident, though it came of necessity following a near calamity. The attributes of the relatively new team proved essential in helping the company survive a key clinical trial setback that might have otherwise derailed it.

More From The Enterprisers

LIFE SCIENCE EVENTS

Root Cause Analysis Post ICH GCP E6 (R2): Beyond Fishbones and 5 Whys! March 27, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Document Management Systems (EDMS) And Electronic Common Technical Documents (eCTD) – An Overview March 28, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
5th Euro-Global Summit on Aquaculture & Fisheries March 30 - 31, 2017
Madrid, NV
Clinical Trial Collaborations April 3 - 4, 2017
Renaissance Boston Waterfront Hotel, Boston, MA
Electronic Informed Consent (eIC): How The New FDA/OHRP Final Guidance Affects You April 4, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Drug Development 101 – How A Drug Is Made April 5, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding The New NIH/HHS Final Rule On Clinical Trial Reporting – Tips For Compliance Success April 6, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
4th Middle East Pharma Cold Chain Congress April 10 - 12, 2017
Dubai
Qualifying Your Trainers – What Do They Need For Your Training To Be Effective? April 11, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Designing GxP Onboarding Programs for the Life Sciences: Ensuring Employee Success April 12, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Change Management Plan Development for Risk-Based Clinical Studies: From Site Monitoring to Vendor Management and Beyond April 13, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Best Practices in CMC Dossier Preparation – Facing Tough Challenges April 24, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Document Authoring, Archive, and Inspection – Challenges And Tips For Establishing Audit-Proof Processes April 25, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Cleaning Validation – Health Based Limits and Beyond: Answers to Current Industry Gaps April 26, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Cleanroom Microbiology – A Foundational Introduction April 27, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Computer Systems Validation (CSV) – Avoiding The Top Five Regulatory Pitfalls May 2, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response May 9, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!