Agenda

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Drug Development & Delivery

Keynote: The Patient Experience
10:00 AM - 10:30 AM Drug Development & Delivery Theater
Drug Development & Delivery

The Patient is at the core of drug product development, delivery and design. In this presentation, hear from an oncology patient, advocate, author and international speaker on her own experience related to drug delivery and patient centricity. Learn how to increase alignment between patients and life science companies. Hear challenges and successes of collaboration and more.

Speaker: Heidi Floyd, Author, International Speaker, Patient, Advocate, Activist

Panel Discussion: Patient Centricity – Beyond the Buzzword
10:30 AM - 11:30 AM Drug Development & Delivery Theater
Drug Development & Delivery

• What are the trends transforming the drug delivery landscape?
• Putting patient experience at the heart of drug delivery – what are the latest approaches for paediatrics, geriatrics, palatability and taste?
• Delivering value with digital – connected devices, smart solutions and wearables

Powered by Drug Delivery Partnerships

Moderator: Cornell Stamoran, VP of Corporate Strategy and Government Affairs, Catalent Pharma Solutions

Panellists:
• Aurelio Arias, Senior Consultant, Thought Leadership, IQVIA
• Heidi Floyd, Author, International Speaker, Patient, Advocate, Activist

Innovation in Alternative Delivery Mechanisms
11:30 AM - 12:30 PM Drug Development & Delivery Theater
Drug Development & Delivery

11:30-11:45: Chairperson Introduction: New Approaches to Drug Delivery

11:45-12:00: Not Just a Star-Trek Dream: Improving the Patient Experience with Needle-Free Drug Delivery
While it is easy to disdain in the name of ‘the science and having the best drug option’, patients do not like taking injections. High viscosity, high concentration biologics can be slow and painful, and patients feel a stigma and anxiety with using needles. Meanwhile, drug adherence is a well-known problem costing billions of dollars per year. The Portal Needle-Free Injector offers a transformed patient experience that is needle-free, fast, and easy to use. Connectivity tools augment the delivery and provide patient support, motivation and education while giving unprecedented insights on patient behavior. We will present our recent progress including patient preference and tolerability.
Speaker: Andjela Stojkovic, Clinical Test Engineer, Portal Instruments

12:00-12:15: Novel Oral Long-Acting Drugs Utilizing Advanced Delivery Technologies to Improve Patient Care and Quality of Life
Speaker: Pavan Handa, Senior Vice President, Business Development & Strategy, Kashiv BioSciences LLC

12:15-12:30: Inhalation

12:30-12:45: Transdermal delivery
Transdermal delivery – Sensile Medical.

12:45-13:00: Q&A

Powered by Drug Delivery Partnerships

Drug Manufacturing

Securing the Supply Chain via Innovations in Active Pharmaceutical Ingredient Manufacturing: Medicines for All Institute Approach
10:00 AM - 10:30 AM Drug Manufacturing Theater
Drug Manufacturing

For many drugs, synthesis of the active pharmaceutical ingredient (API) represents the most economically important and technically demanding element of pharmaceutical manufacturing. Therefore, improving manufacturing efficiency represents an important step towards cost-effective access to healthcare and enhanced security of sources of supply globally. The Medicines for All Institute has developed a series of core principles that yield dramatic improvements in chemical efficiency and lowering the cost of API manufacturing processes. The Institute’s new chemical process technologies address cost savings across three major areas: high cost of starting materials, high solvent consumption, and inflexible manufacturing processes.

What stakeholders will learn from the talk:

• The Medicines for All Institute’s core competency in chemical process development for APIs demonstrate that cost savings can be made to reduce the price of treatments.
• The chemical processes developed by the Medicines for All Institute also contribute to the sustainability of the manufacturing process by introducing greener processes which is rapidly becoming an important factor for raw material suppliers.
• By offering alternative routes and strategies for producing starting materials, key intermediates, and APIs, these multiple options enable more suppliers to enter into these markets, strengthening the supply chain.
• The Medicines for All Institute also offers alternative strategies that leverage innovative technology platforms, including continuous processing, that can expand the number of suppliers for a particular market.

Speaker: Eugene Choi, Ph.D, Executive Director, Medicines for All Institute, Virginia Commonwealth University

Advances in API Synthesis and Manufacturing
10:30 AM - 11:00 AM Drug Manufacturing Theater
Drug Manufacturing
Break
11:00 AM - 11:30 AM Drug Manufacturing Theater
Drug Manufacturing
Enzymatic Wound Debridement: What’s changed since the FDA’s approval in 1965
11:30 AM - 12:00 PM Drug Manufacturing Theater
Drug Manufacturing

What will you learn:
• Collagenase is the primary active pharmaceutical ingredient (API) approved for topical enzymatic wound debridement, no change in this API since 1965
• Recent research indicates how collagenase may accelerate wound healing
• New manufacturing methods to prepare the collagenase API improves product purity and consistency at a reduced cost when compared to the collagenase APIs used in today’s products
The collagenase APIs contained in today’s wound debridement products were manufactured using 1960s knowledge and technology: salt precipitation of a bacterial culture supernatant followed by dialysis, then lyophilization. No changes have been made to these products because any material change to the manufacture of the collagenase API will require the performance of new clinical trials to demonstrate efficacy. Collagenase containing debridement ointments are manufactured by mixing lyophilized granules of Clostridium histolyticum collagenase into petrolatum jelly. This ointment is smeared on problematic wounds to accelerate wound healing. Recent reports indicate that collagenase generates collagen peptides that activate cells that are responsible for accelerating wound healing.
VitaCyte has developed a highly enriched preparation of C. histolyticum collagenase using current protein purification technologies. The purity of this enriched enzyme is comparable to that found in highly purified collagenase used for mammalian cell isolation. Minimal proteolytic degradation of VitaCyte’s collagenase API results in a product with higher potency and greater effectiveness, reducing the amount of product used for treatment. The collagenase manufacturing process is robust with 12 fermentations having nearly identical biochemical characteristics. The manufacture of this material is easily scaled to meet customer needs.
VitaCyte’s collagenase API is lyophilized in a USP excipient to protect enzyme activity during storage and to enable efficient compounding into any delivery vehicle or wound dressing. VitaCyte is one of several manufacturers that have the capability to manufacture a consistent collagenase API with high functional activity. Product consistency reflects the rigorous enzymatic and physico-chemical characterization performed on each lot of collagenase enzyme

Speaker: Robert C. McCarthy Ph.D, President, VitaCyte LLC

Data Integrity and Patient Safety
12:00 PM - 12:30 PM Drug Manufacturing Theater
Drug Manufacturing

Attendees will learn more about the following topics:
• Importance and principles of data integrity with respect to patient safety
• What are expectations of regulators with respect to data integrity?
• What are the challenges that the pharmaceutical industry is facing during implementation of guidances set by regulators?
• How to practically integrate the principles of data integrity and quality risk management throughout product life cycle to assure compliance and patient safety?

Speaker: Muhammad Naeem, Chief Operating Officer, Indus Pharma (Pvt.) Limited

Bioprocessing & Manufacturing

Continuous Bioprocessing
10:00 AM - 11:30 AM Bioprocessing & Manufacturing Theater
Bioprocessing & Manufacturing

10:00-10:30: Economics of Continuous & Intensified Bioprocessing
10:30-11:30: Panel Discussion | Strategies to Implement Intensified and Continuous Processing - Overcoming Current and Planning for Future Challenges

Digitalisation in Bioprocessing
11:30 AM - 12:30 PM Bioprocessing & Manufacturing Theater
Bioprocessing & Manufacturing

Digital Transformation in Bioprocessing: Opportunities and Implementation Challenges