utilizing and managing smart technologies · smart packaging what is smart packaging? • the...
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Proprietary and Confidential
Utilizing and Managing
Smart Technologies
Peniel Ortega, PMP
Managing Director
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How can you utilize your PMP
skills in the midst of a rapidly
evolving Biotech climate?
Question of the Night
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Our Goals For This Webinar
• Insight into the Life Science Tech Revolution
• Birds-Eye View on Impact to Entire Industry and End User
• Remind You to Use the Basics:
• Leadership
• Project Management
• Relationship
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Agenda
• AI and ML
• 3D Printing
• Smart Packaging
• CAR-T Cell
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Agenda
AI and
Machine
Learning
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AI and Machine Learning
• AI is the theory and development of computer systems able to perform tasks that normally require human intelligence, such as:
• visual perception
• speech recognition
• decision-making
• translation between languages
What is AI and Machine Learning?
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AI and Machine Learning
• Machine learning is an application of artificial intelligence (AI) that provides systems the ability to automatically learn and improve from experience without being explicitly programmed.
• Machine learning focuses on the development of computer programs that can access data and use it to learn for themselves.
What is AI and Machine Learning?
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AI and Machine Learning
How are we currently using AI and ML in the Life Sciences?
• Precision Medicine
• Interpretation of X-Rays/MRIs
• Recognition of potentially cancerous lesions
• ChatBots Providing Telehealth
• Preventative Healthcare (Patterns)
• Robot-assisted Surgery
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• Recognition of Transmission Trends
• Delivery of Medical Supplies to Quarantined
• Non-Compliant Individuals
• Drug Development
• Google DeepMind
• AI Search for Vaccine Formula
• Eventual EHR Integration
AI and Machine Learning
What role is AI/ML playing in the COVID–19 Pandemic?
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Agenda
3D Printing
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• The action or process of making a physical object from a three-dimensional digital model, typically by laying down many thin layers of a material in succession.
• Concept Introduced in the 1970s
• Multiple Materials
• Many Layers of Building
• Also called Additive Manufacturing
• Smallest Building Layer ~50 Microns
• Applications Everywhere
3-D Printing
What is 3D Printing?
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• Drug Release Kinetics
• Bio-Tech • Largely limited to tissue cultures
• Custom Prostheses
• Implants & Surgical Guides • Scans of a patient’s anatomy
• Creation of incredibly precise implants
• “N of 1” Innovation
3-D Printing
What are the life science applications of 3D printing? of 3D printing?
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• Major Pharmaceutical Products
• Infrastructure has been built
• Money is being made
• Efficiency is at a premium
• No need to change
3-D Printing
What are the life science applications of 3D printing?
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• Orphan Drugs
• Rare diseases
• Lack of Money
• Automated Process
• Integration with AI
3-D Printing
How will 3-D printing affect manufacturing?
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• 3-D printed drugs offer the ability to
• Individualize dosing
• Tailor drug release profiles
• Drug combinations
• Supply Chain Optimization
3-D Printing
How will 3-D printing affect manufacturing?
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• In 2015, Aprecia Pharmaceuticals developed Zipdose
• Patented technology for 3D printing drugs
• Enable high-dose medications in a rapidly disintegrating form
3-D Printing
1St 3-D printed FDA Approve Drug
• Using this technology, they then produced Spritam, which treats Epilepsy
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• Currently, it might be too early to consider 3-D printing as an
alternative technology for manufacturing drugs
• While the prospect of personalized medicines using 3D printing
seems exciting, there are also several risks associated with it
• That is where regulations play an important role
• We need to license these 3D printed drugs only after exhaustive trials
• Nevertheless, 3D printing drugs is a promising area, which
should prove to be beneficial once it properly takes hold of the
industry
3-D Printing
A Glimpse of the Future
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Agenda
Smart
Packaging
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• Embedding advanced
features into packaging
such as sensing or
wireless communication
makes packaging “smart”
which can provide
significant functionality.
Smart Packaging
What is Smart Packaging?
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• The packaging then
becomes not only a way to
protect and provide
information on medicines,
but can add a whole host
of extra functionality
which can even be part of
a IoT enabled connected
system.
Smart Packaging
What is Smart Packaging?
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• Pharmaceutical Industry
• Reduce supply chain losses through enhanced
environmental monitoring.
• Support improved patient adherence through smart
adherence packaging.
• Increase security through adding anti-tamper or
unclonable serialization technologies.
Smart Packaging
How would these Smart applications change the Life Sciences?
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• Opioid Crisis
• Experts say that 18,000,000
people have abused prescription
medication in the last year alone.
• Dementia
• Approx. 5,000,000 in 2020
• Predicted 14,000,000 by 2050
Smart Packaging
How do these directly affect the end user?
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What does Smart
Packaging look like?
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Smart Packaging
Blister Pak
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Smart Packaging
Smart Pill Bottles
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Smart Packaging
Smart Bottle Necks – Customizable
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Agenda
CAR-T Cell
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• CAR T- cell therapy
• Form of immunotherapy
• Uses specially altered T cells
to fight cancer
CAR-T cell therapy
What is CAR-T?
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• A sample of a patient’s T cells • Collected from the blood
• Modified to produce special structures called
• Chimeric Antigen Receptors (CARs) on their surface
• When these CAR T cells are re-infused into the patient, the new receptors enable them to latch onto a specific antigen on the patient's tumor cells and kill them.
CAR-T cell therapy
What is CAR-T?
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• The FDA has approved CAR-T cell therapy for
• Adult patients with certain types of lymphoma
• Children and young adults with acute lymphoblastic leukemia
• Clinical trials of CAR-T cell therapy
• Other types of blood cancer
• Research in Solid Tumor CAR-T
CAR-T cell therapy
Who does CAR-T treat?
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• Novartis • Kymriah a CAR-T Cell therapy, the first ever such therapy to receive
regulatory approval for the treatment of B-cell acute lymphoblastic leukemia, a hematological malignancy
- Approved August 2017
• Gilead/Kite Pharma’s
• Yescarta — also a CAR-T cell therapy — targeting diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), subtypes of non-Hodgkin’s lymphoma (NHL).
– Approved October 2017
CAR-T cell therapy
Innovators
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Close to 150 CAR-T cell therapies are being investigated
in nearly 200 clinical trials within the G7 countries.
CAR-T cell therapy
Innovators
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0 2 4 6 8 10 12
Celgene
Kite Pharma (a Gilead company)
Autolus
Novartis
Miltenyi Biotech
Juno Therapeutics
Sorrento
Celyad
Amgen
Cartesian Therapeutics
CAR-T cell Clinical top 10 Innovator
# of ongoing clinical trials # of CAR T-cell therapies in development
CAR-T cell therapy
Innovators
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• Evaluation
• Collection
• Engineering
• Multiplication
• Conditioning Therapy
• Infusion
• CAR-T Attacks Cancer
CAR-T cell therapy
CAR-T process?
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How can you utilize your PMP
skills in the midst of a rapidly evolving Biotech climate?
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Thank You!
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Justin Bechtel – Lead of Business Development
908-671-1784 x701
908-967-1870 (m)
Peniel Ortega - Managing Director
908-671-1784 x700
201-921-0258 (m)
Thank you for the opportunity to partner!
We Would Love to Connect
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References
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References
1. Pharma Mirror Magazine. 2020. The New Booster Of The Pharma Industry: Smart Packaging - Pharma Mirror Magazine. [online] Available at:
<https://www.pharmamirror.com/pharmaceutical-articles/new-booster-pharma-industry-smart-packaging/> [Accessed 14 May 2020].
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<https://blog.drupa.com/de/pharmaceutical-industry-benefit-intelligent-packaging/> [Accessed 14 May 2020].
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May 2020].
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cancer/treatment/research/car-t-cells> [Accessed 14 May 2020].
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