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)

Justin.Bechtel@PharmAllies.com

Peniel Ortega - Managing Director

908-671-1784 x700

201-921-0258 (m)

Peniel.Ortega@PharmAllies.com

Thank you for the opportunity to partner!

We Would Love to Connect

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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