Agenda

All times displayed for Europe/Berlin timezone.

Pharma Insight Briefings

The Future of Medicine: What are the therapies of tomorrow?
10:30 - 11:40 61D61
CPhI Theatre
Senior Consultant
IQVIA
Global Head Product Development
Sandoz
President & Co-Founder
Camargo Pharmaceutical Services
Partner | Vice President
Strategy&
CEO
Crystec Pharma
Head of Oncology and Hematology
KSBL

Oncology, auto-immune, cardiovascular, pulmonary and mental health are all key therapy areas for Pharma companies to crack. This panel will examine emerging therapies for the future pharma toolkit – both developing the new and repurposing the old.
• Value added medicines - Innovation through repurposing, and reformulating.
• New-gen APIs
• Personalised therapies
• The shift from mass market to niche therapies
• Balancing the needs of patients and payers
• What does the future hold for generics?

The vast opportunities in the Emerging Markets for OTC, Pharma and Medical Device companies. Effective market entry, how to avoid typical pitfalls in regulatory and commercial processes. Practical case studies on Market Entry!
11:50 - 12:20 61D61
CPhI Theatre

Sponsored by:

Participants of this session will get first class insights into the most recent developments of the best growing international OTC & Pharma markets. After attending this session you will know more about the most promising Emerging Markets and on how to plan your successful Market Entry. If you are interested in expanding your international business to Europe, Latin America, Asia or CIS/CEE and generating Extra Sales in those regions you are exactly right here.
We would like to invite you to an exciting 25 minute journey around the globe.

Reiner Christensen has 20+ years of experience in the international pharma markets and is happy to discuss with you and to answer your questions after the presentation.

Continuous manufacturing: Current and Future Role of Excipient Suppliers
12:30 - 13:00 61D61
CPhI Theatre
Principal Scientist, Pharma Solutions
DuPont Nutrition & Biosciences

Sponsored by:

Continuous manufacturing of oral solid dosage forms is a trend whose early adopters are larger innovator pharma companies. It seems that, now a second wave of implementation at Contract Development and Manufacturing Organization (CDMO) is enabling medium and smaller sized companies to leverage capacity and knowledge. In this way the burden of high investment costs and time consumed in know-how development are mitigated. Excipients typically build the major part of a tablet formulation and as the technology of continuous manufacturing is advancing the key role of excipients to address quality and productivity challenges is becoming more and more important. DuPont Nutrition & Biosciences has a broad portfolio of excipients that are engineered to facilitate tableting processes in an integrated manner. There is a range of particle-engineered and co-processed ingredients developed to facilitate this new process setup. It is true that commonly used excipients like the industry standard AVICEL® PH102 and even some ‘less commonly used’ excipients are suited for a continuous manufacturing platform as well. The next stage of realizing the projected benefits of continuous manufacturing will be however based on intensified cooperation of pharmaceutical companies, equipment vendors and excipient suppliers.     

Leading the way in capsule-based DPIs through customization with the Capsugel Zephyr Portfolio
13:10 - 13:40 61D61
CPhI Theatre
Business Development, Manager Innovative Products
Capsugel - Lonza

Sponsored by:

Birds of a Different Feather: Natural, Semi-synthetic and transgenic cannabinoids do not flock together
13:50 - 14:20 61D61
CPhI Theatre
Professor
Università del Piemonte Orientale, Faculty of Pharmacy

Sponsored by:

Progress in organic synthesis and in techniques of cloning and heterologous expression have the potential to replace isolation as a source of bioactive natural products. On the other hand, natural-, synthetic-and biotechnological versions of an active principle can be significantly different not only in their14C contents and the overall isotopic profile, but also in terms of impurity profile. Therefore, their biological profile might not be completely overlapping, at leastwhen the therapeutic dosages arehigh and high-potency compounds are present as impurities. Cannabidiol (CBD) exemplifies this issue. The API version of the compound (Epidolex, an anti-epileptic drug) contains Delta-9-THC (Dronabinol) as an impurity. Given the high therapeutic dosages ofEpidiolex and thepotency of Delta-9-THC , treatment with Epidiolex is associated to the co-administration of clinical dosages of Dronabinol. This could have played a role in the clinical failure as anti-epileptic drug of a transdermal delivery system of CBD based on synthetic CBD(ZYN002), in contrast to the clinical efficacy of a syrup containing the natural product (Epidiolex).

Tailored Catalyst Processing
14:30 - 15:00 61D61
CPhI Theatre
General Manager
ECO-Mastermelt Pte Ltd

Sponsored by:

Precious metal catalysts are increasingly used in the pharmaceutical and chemical industries. In the Mastermelt showcase, we will share our tips for optimising returns from your on-site manufacturing route, as well as how our tailored recovery process can maximise your precious metal returns.

Data governance driving data integrity in computerized system validation
15:10 - 15:40 61D61
CPhI Theatre
Practice Manager, Compliance and Validation Services
PerkinElmer

Sponsored by:

Having a data governance program in place is key to establish the foundation for ensuring data integrity in computerized system validation. In addition, understanding the regulations and how they are applied to particular environments (GMP, GLP, GCP) help drive compliance in Pharmaceutical laboratories.The FDA defines data integrity as all data being complete, consistent and accurate throughout the data life cycle regardless of data being paper or electronic. As technologies advance and companies partner to grow, there is an increase in the number of data integrity violations seen by the FDA and many of the violations stem from 21 CFR Part 11 which was put into the federal registry in 1997 and contains the regulations pertaining to electronic records and signatures. While the regulations on electronic signatures is well understood, regulations surrounding electronic records still leads to confusion when it comes to computerized systems since is not a one-time event for laboratories and validation must be complete to satisfy the regulators. By linking data integrity with computerized system validation (CSV) in the data governance program, the pharmaceutical laboratories can feel confidence on their path to compliance

Revolution Beyond Innovation: Topical Application of Botulinum Toxin Type C Peptide in Pharmaceutical and Aesthetic Applications
15:50 - 16:00 61D61
CPhI Theatre

Sponsored by:

There are eight types of Botulinum toxins(BTX) known(A-H) and A and B are used in commercially and medically. Type C-G are less common in human and cause disease in animals. Peptide toxin(PTx) is a small peptide that has shown enzymatic cleavage activity in Syntaxin and SNAP-25 which decreases acetylcholine release in nerve cell, in result. Clinical test of topical PTx has shown strong wrinkle improvement, down regulation of sebum and pore size, and soothing effect in skin redness. Into the bargain, all other evidences imply that PTx can be used in topical in pharmaceutical applications, like hyperhidrosis, acne, atopic dermatitis, chronic pain relief, etc

From HPLC to industrial-scaleseparations: a complete rangeof ion exchange, adsorbentand affinity resins for smallto medium biomoleculepurification
16:30 - 17:00 61D61
CPhI Theatre
Business Development Manager
Purolite Life Sciences

Sponsored by:

We present an overview of industrial applications in downstream processing of small/medium biomolecules using adsorbents, preparative RP resins and IEX resins. Purolite Life Sciences has expanded its product portfolio to include highly hydrophobic and hydrophilic resins, particle sizes from 5 to 1200 micron and many functionalities to support a wide range of applications. Here, we focus on new Chromalite methacrylic range of products.