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Proprietary and Confidential
Utilizing and Managing
Smart Technologies
Peniel Ortega, PMP
Managing Director
How can you utilize your PMP
skills in the midst of a rapidly
evolving Biotech climate?
Question of the Night
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
Agenda
• AI and ML
• 3D Printing
• Smart Packaging
• CAR-T Cell
Agenda
AI and
Machine
Learning
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?
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?
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
• 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?
Agenda
3D Printing
• 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?
• 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?
• 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?
• Orphan Drugs
• Rare diseases
• Lack of Money
• Automated Process
• Integration with AI
3-D Printing
How will 3-D printing affect manufacturing?
• 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?
• 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
• 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
Agenda
Smart
Packaging
• 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?
• 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?
• 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?
• 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?
What does Smart
Packaging look like?
Smart Packaging
Blister Pak
Smart Packaging
Smart Pill Bottles
Smart Packaging
Smart Bottle Necks – Customizable
Agenda
CAR-T Cell
• CAR T- cell therapy
• Form of immunotherapy
• Uses specially altered T cells
to fight cancer
CAR-T cell therapy
What is CAR-T?
• 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?
• 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?
• 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
Close to 150 CAR-T cell therapies are being investigated
in nearly 200 clinical trials within the G7 countries.
CAR-T cell therapy
Innovators
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
• Evaluation
• Collection
• Engineering
• Multiplication
• Conditioning Therapy
• Infusion
• CAR-T Attacks Cancer
CAR-T cell therapy
CAR-T process?
How can you utilize your PMP
skills in the midst of a rapidly evolving Biotech climate?
Thank You!
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
References
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References
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<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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