One of the most important links in any supply chain - is the link between drug developers and the pharma/biotech CMOs they partner with. Choosing the right vendor and/or partner for outsourcing manufacturing and/or development activities and performing successful Technology Transfer is one of the critical stages on the path from clinical trials to the market. Also, the use of a CMO is one of the most practical ways to advance manufacturing, for example when your company may be lacking technology and/or capacity.

This seminar will provide information on everything from the most important factors to consider when choosing your CMO partner, to learning how to navigate the technology transfer, to building partnership with your contract manufacturer, whether for biologics or for small molecules. Experts from the pharma/biotech industry, as well as from the leading Contract Development and Manufacturing Organizations will share their knowledge and experience. The seminar will be concluded with an open discussion with participation of the Israeli Ministry of Health.

CMO exhibition will be accompanying the seminar: Merck, ThermoFisher Scientific (Patheon), Recipharm, Harro Hoefliger (Experic), Carbogen Amcis, Siegfried, Isotopia, Sharp Services.

Agenda:

Duration

Topic Speaker
08:30-09:00 Registration and Exhibition
09:00-09:20

Introduction

Sasha Nezlin
Intec Pharma
09:20-10:00 To outsource or not to outsource
Outsourcing in a small / medium company: why to outsource, what to outsource
Sylvia Kachalsky
Recipharm
10:00-10:45 Technology Transfer: case studies from the real world
Key steps in technology transfer of biotech products.
Case Study - Technology transfer of API manufacturing.
Case Study - Technology transfer of finished product preparation
Ofer Dubinsky
BTG Israel (Ferring Pharmaceuticals)
10:45-11:15 Coffee Break and Exhibition
11:15-11:45 Building effective Quality Agreements with a CMO
Overview of the requirements and practical approach for setting up an effective quality agreement as the basis for a successful project
Drorit Lew
Phibro Animal Health Corporation
11:45-12:15 Creating partnership through improved communication: Technology Transfer of an innovative oral drug delivery system –
The “Accordion Pill”

Startup - establishing commercialization capabilities. Building communication. Project management approaches – two different ways to get things done. Customer vs. Partner relationship.
Ronny Reinberg
Intec Pharma
12:15-12:45 Vendor management - make it simple
Managing a supplier in the life science industry is complicated, managing CMO's is doubly so. SMS is a system that was developed at Omrix to solve this complicated equation
Ran Wiesel
J&J (Omrix Biopharmaceuticals Ltd.)
13:00-14:00 Lunch and Exhibition
14:00-14:40 Tech transfer: the good, the bad and the ugly!
From conception to production - a pragmatic approach
Guido Kremer-van der Kamp
Merck
14:40-15:10 Technology transfer and working with a CDMO: challenges and important aspects to consider for an efficient partnership
Prerequisites for a successful tech transfer, typical example of tech transfer – tips, common mistakes, lessons learned
Riccardo Bernasconi
Carbogen Amcis
15:15-15:45 Coffee Break and Exhibition
15:45-16:10 CMO - from Theory to the Real World
What are the key factors and risks to a successful CMO project starting from lab scale to commercial batches. Decisions and milestones along the way (quality, regulations, operations and marketing)
Mor Berlinski
Isotopia Molecular Imaging
16:10-16:30 Intellectual Property challenges in CMO-Sponsor Relationship
Alex Weisman
Calathea Pharma
16:30-17:00 Round table IMOH and presenters

Note: the program and speakers are tentative and subject to change without prior notice.
Please note that some of the lectures will be in English.


Target Audience:

Executives, Managers, Scientists, Specialists of pharmaceutical / biotechnology companies and Startups in the fields of: Operations, Manufacturing, Process Engineering and Validation, Quality Assurance, Qualified Persons/Pharmacists, Supply Chain, Regulation, Analytical Sciences.


Participation Fees:
PDA members - 850 NIS
Non members - 1100 NIS 

 

Sylvia Kachalsky, Ph.D. Sylvia Kachalsky is the co-founder and CEO of Recipharm Israel, a CDMO offering one shop chemistry services from the first synthesis of a molecule to commercial production. Sylvia has 22 years of experience in Biotech development, including industrial enzymes, diagnostics and pharmaceutical companies. She managed R&D groups in Pharmos, QBI and Synteza Molecular Detection, managed several biotech start-ups and consulted to Eurostars and others before starting OnTarget Chemistry Israel which was acquired by Recipharm (Sweden). Today, Sylvia is committed, in addition to her role as Recipharm Israel CEO, to the development of a sustainable and growing biotech ecosystem enabling companies to work and grow in Israel.


Ofer Dubinsky, Ph.D. is Senior Director Scientific Affairs at Bio-Technology General (Israel) Ltd. (part of Ferring Pharmaceuticals). Ofer has 27 years of experience in the pharmaceutical world, focused on biotech processes and analytical sciences. Ofer worked for several years in pharmaceutical and analytical development, and was involved in tech transfer from BTG to third companies world-wide, he headed the QC at BTG for 10 years, was Medical Director in Ferring Pharmaceuticals Ltd. in Israel for several years, and in the last 5 years he is part of the Innovation group in BTG. As an expert in CMC and analytical sciences, mainly in the Biotech field, Ofer is a member in several Ferring’s due diligence teams who are looking for new products from third companies.


Drorit Lew has over 25 years of experience in the pharma industry; 9 years in CTS Industries (Generic company), 13 years in Kamada (Biopharmaceutical company) and is now working in Phibro vaccines (veterinary industry). Most of her career Drorit was a manager of QC labs, and for the last 8 years Drorit had moved to Quality: 4 years as Kamada's VP Quality, and currently she is the GMP Compliance Manager of Phibro vaccines. Drorit holds M.Sc. in Chemistry from Ben Gurion University, Israel.


Ronny Reinberg is the VP Technology Affairs at Intec Pharma, responsible for the R&D unit and the Tech Transfer activities. Ronny joined Intec Pharma in 2009 and since then has been involved in the evolution of the technology from lab scale to commercial capabilities. Prior to Intec Pharma, Ronny was a part of TEVA’s generic R&D division and developed several complex projects, utilizing various pharmaceutical manufacturing technologies.


Guido Kremer-van der Kamp has more than 20 years of experience in the BioPharmaceutical industry with single-use, multi-use, facility, and process design. He has held various positions with global responsibilities in process development, operations, consulting and technology management. He is currently Associate Director of Technology Management at Merck developing and implementing Global Programs. Guido graduated in Biotechnology at the University of Applied Science in Mannheim with tenures at the National University of Singapore and a student fellowship at the Institute of Molecular and Cell Biology (IMCB) in Singapore.


Ran Wiesel is the Supply chain and Planning Manager responsible for Omrix (J&J) Production planning, Procurement and Logistics. Ran is an operations professional with over than 22 years’ experience in the Pharma, semiconductor & high-tech industries. In the past 10 years Ran led many improvements in the supply chain with the focus on Supplier management, adopting innovative approaches and efficient up to date processes. Prior to joining Johnson&Johnson Ran worked for 15 years for Intel in various engineering and management positions. Ran holds a B.Sc. degree in Materials Engineering from Ben-Gurion University, Israel.


Riccardo Bernasconi, Ph.D. is a Sales Manager at Carbogen Amcis AG (a Swiss-based CDMO with worldwide footprint), responsible for the Israeli and Southern European clients. With 8 years of academic experience matured at Swiss Federal Institute of Technology (ETH Zurich), Riccardo has moved into the CDMO world, working in different Sales positions within Swiss CDMOs.


Mor Berlinski is the New Product development and Contract Manufacturing Manager, Isotopia Molecular Imaging Ltd. Responsible for Technology Transfer of new products from R&D to commercial manufacturing, site leader of the Contract Manufacturing activities. In the past 10 years Mor worked in the pharma industry in various Quality positions, managing challenging sub-contracting project. Mor has extensive experience in GMP manufacturing processes of Sterile and Aseptic products, standards and procedures. She holds B.Sc. degree in Chemistry and Biotechnology Engineering from Ariel University, Israel.


Alex Weisman, Ph.D. is co-founder of Calathea Pharma Ltd. after 25 years of in executive positions in pharmaceutical industry (Active Pharmaceutical Ingredients + Drug products), including as VP and CSO of Agis/Perrigo corporation; Member of portfolio committee and business development teams. Alex is an expert in development of small molecules and transfer to production, and is highly experienced in managing complex multidisciplinary and multinational projects and teams.


Sasha Nezlin is VP Quality of Intec Pharma Ltd., clinical-stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion PillTM platform technology. With nearly 20 years of industry experience, Sasha had worked for companies big and small, including startups, service providers and multinationals, in various positions of increasing responsibility in R&D, QC and QA. Prior to joining Intec Pharma Sasha was Director of Quality at J&J (Omrix), leading Quality & Compliance business activities across three cGMP biotechnological plants.

Exhibitors:

recipharm
   



 

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