Outsourcing in Clinical Trials & Clinical Trial Supply Israel 2023

The Clinical Outsourcing & Supply Israel conference is returning to Tel Aviv, Israel in February 2023. The conference focuses on providing delegates with practical takeaways and solutions to their most current operational, outsourcing and supply challenges in clinical trials, this event is not to be missed.

6 - 7

February

2023
  • Intercontinental David Tel-Aviv, Israel
  • Complimentary

Why attend?

WHAT TO EXPECT IN 2023?

Outsourcing Clinical Trial Israel is the meeting place for the local pharmaceutical, biotechnology and medical device community. Discover how to excel in outsourcing operations and clinical supply strategy as well as form key connections for long-term success for your clinical trial.

150+

Attendees

15+

Exhibitors

30+

Speakers

85%

Attendees at Director+ level

150+

Attendees

15+

Exhibitors

30+

Speakers

85%

Attendees at Director+ level

See What It's All About

Agenda

  • 6 Feb 2023
  • 7 Feb 2023
Expand All

Streams

Stream one

Outsourcing & Clinical Operations

Stream two

Clinical Trial Supply

8 AM

REGISTRATION AND REFRESHMENTS

8:50 AM

Chair’s Opening Remarks

Speakers

9 AM

“Your Avatar Doctor Will Be with You Shortly”

  • Considering whether the health care sector and pharmaceutical companies should think about the Metaverse as an Ecosystem?
  • Exploring how the Metaverse is expected to imminently impact patient relationships within health care
  • Investigating what plans for Physicians and touch bases will look like in a decade from now?
  • Focusing on how the Metaverse and Web 3.0 will affect the future of Decentralized Clinical Trials

Speakers

9:30 AM

Transformational Relationships: How a consultative approach from a CRO could add value to your development program

  • How to unlock the full power of your CRO partner
  • How a CRO partner helps you navigate the interface between science and operations – and why that improves your study
  • Why early engagement can be a key to your study’s success

Speakers

10 AM

PANEL Key Components of Successful Clinical Trials to Ensure Study Success

  • Efficient utilisation of resources
  • Risk prevention vs issue management
  • Effective communication and transparency to minimise unforeseen issues
  • Learning from failure and celebrating successes

Speakers

10:45 AM

COFFEE BREAK

Outsourcing in Clinical Trials

Speakers

11:15 AM

Using Real World Data in your clinical development program

  • How real-world data can inform clinical trial planning
  • Highlights of regulatory guidelines for the use of real-world data in clinical development
  • How can real-world data add value in the clinical development process

Speakers

11:45 AM

Data Management in Emerging Medical Device and Biotech

  • Corneat: Introduction, products, studies, company status. Medidata Introduction 
  • Site Coordinator perspective: Rave EDC as an end user Sponsor perspective: 
  • Data capture for emerging companies
  • How emerging companies can “own” their DM processes
  • Adoption of new technology - Interpreting a protocol into an eCRF
  • Interactive build process - for sponsor and DB builder

Speakers

12:15 PM

Decentralised Clinical Trials Decentralised solutions throughout the lifecycle of a clinical trial – do they add quality?

  • Looking into the stakeholders roles 
  • Outlining the challenges to operators and discuss alternatives and mitigations
  • Connecting the dots between Decentralized Clinical Trials and quality

Speakers

12:45 PM

LUNCH BREAK

The exhibition will feature a varied line-up of innovative technologies to support the Israeli life sciences sector.

No matter your job function you’ll find providers to meet your needs; we’ll be showcasing new solutions for trial operations, supply and beyond to give you a comprehensive suite of solutions to maximise trial success.

2 PM

Regulation requirements for applying cannabis-based clinical trials in Israel

  • Development of the medical cannabis field in Israel – from the ground-breaking research of Prof. Mechoulam to the present day
  • Review of cannabis innovation, research and development in Israel
  • Identifying the unique requirements need to be implemented to receive a license to conduct a cannabis-based clinical trial

Speakers

2:30 PM

FIRESIDE CHAT: Focusing on the importance of Diversity & Inclusion in clinical trials & supply

Diversity matters because inclusion, trust and equity matter for pharma. When developing therapies and medications, pharmaceutical and life sciences companies are tasked with designing products for a diverse range of patients and care providers. We will be discussing how to ensure diversity in clinical trials for the future of global health.

Speakers

3 PM

COFFEE BREAK

3:30 PM

Fundraising and venture Capitals – how to best promote and raise funding for your study

  • Understanding what VCs are looking for to give your study the best possibility of success
  • Pinpointing key components when compiling your proposal
  • Promoting the niche selling points to best showcase your study

Speakers

4 PM

Patient engagement in R&D Clinical Trials

  • Discussing the personal experiences of the patient
  • Understanding the patient’s perspective
  • Defining ‘patient centricity’

Speakers

4:30 PM

Chair’s closing remarks

Clinical Trial Supply

Speakers

11:15 AM

KEYNOTE Q&A Discussion: Explore importing and exporting requirements for biological materials and how preparation is everything in the modern world

  • Important steps to take to help expedite the clearance of biological materials.
  • Case studies of inspections: when it really goes wrong and how to tackle it
  • Discover resources and contacts available to help facilitate your imports, especially time-sensitive/temperature dependent shipments, at U.S. ports of entry
  • Highlighting the key takeaways for ensuring a smooth inspection as we look to the future

Speakers

11:45 AM

Clinical Trials 2023 and beyond – What do we need to consider preparing a robust and flexible supply chain?

  • Expected and unexpected challenges when planning your clinical trial/clinical supply chain.
  • Innovations leading to an increased patient adherence and engagement.
  • Examples that can help you building a flexible and robust supply chain

Speakers

12:15 PM

Temperature Controlled Airfreight Global Logistics for Clinical Trials

  • Can standards and certifications improve the quality of temperature-controlled air cargo shipments?
  • How is risk management performed for ramp/tarmac operations?
  • How does the audit process work in the air cargo supply chain?

Speakers

12:45 PM

LUNCH BREAK

The exhibition will feature a varied line-up of innovative technologies to support the Israeli life sciences sector.

No matter your job function you’ll find providers to meet your needs; we’ll be showcasing new solutions for trial operations, supply and beyond to give you a comprehensive suite of solutions to maximise trial success.

2 PM

Blinding in Clinical studies – Why, How, and related challenges

  • Protecting against bias; a deeper understanding
  • To Blind or not to Blind?
  • Addressing challenges associated with blinding

Speakers

2:30 PM

PANEL DISCUSSION: Safeguarding the Supply Chain Landscape Post Covid and Through the Challenging Political Environment

  • Managing supply timelines to not delay your study
  • Recognising the limited financial environment post covid; shipment and the release of products
  • Investigating Sea vs Air transit to decrease timelines and outgoings
  • Addressing the political challenges with both China and Russia to which are affecting your supply chain
  • Discussing the lack of personnel in supply chain post pandemic

Speakers

3 PM

COFFEE BREAK

3:30 PM

Managing clinical vendors during a global crisis period

  • Identifying gaps and risks in the vendors performance impacting the clinical study
  • Developing organizational awareness to global trends which influence the vendors performance (e.g., The Great Resignation)
  • Establishing internal and external mitigation plans to minimize the impact on ongoing studies

Speakers

4 PM

Running your clinical trial internationally: overcoming logistical challenges to maximize supply chain efficiency

  • Managing the supply chain to improve the effectiveness of the process
  • Risk based assessment on supply chain optimization, outsourcing strategy and logistics

Speakers

4:30 PM

Chair’s closing remarks

Streams

Stream one

Outsourcing & Clinical Operations

Stream two

Medical Devices

8 AM

REGISTRATION AND REFRESHMENTS

9 AM

ROUNDTABLE DISCUSSIONS

Roundtables offer delegates the opportunity to delve into a topic or issue and unpack this in a thoughtful and constructive manner. Each host is a subject matter expert in their field and comes prepared with questions which will allow attendees the chance to debate and discuss in detail.

Each session lasts 45 minutes and delegates will be able to attend 2 sessions

 

Roundtable 1: Complexity of Randomised Controlled Trial’s in Geriatric Population

Amir Zaher, Head of pharmacy geriatric department, Ministry of Health Israel

 

Roundtable 2: Clinical Trial Educators, how to make the impossible, possible!

Nina Hershkowitz, Global Training & Patient Education Sr. Manager, Neuroderm

 

Roundtable 3: How to find your perfect CRO

Edith Dekel, Senior Director Clinical Operations, Karyopharm Therapeutics

 

Roundtable 4: Q&A Session with U.S. Customs and Border Protection – Here to help with any questions you may have about how to import or export biological materials to or from the U.S. 

Sean Smith, Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection

Adam Pitt, Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection

Speakers

10:30 AM

COFFEE BREAK

Outsourcing in Clinical Trials

Speakers

11 AM

Strategies for Country and Site Selection; enhancing one’s knowledgebase for the best move forward

  • Robust feasibility for clinical trials; from protocol design to country & site selection
  • Access to sites and site selection within Israel to refrain from going elsewhere
  • Analysing various countries to indicate the best options for site selection
  • Understanding new landscapes from a legislative perspective

Speakers

11:30 AM

Drug-drug combinations – study design and conduct: the P2B001 experience

  • Study design, multiple arms vs study complexity
  • Compliance with written/unwritten US and EU regulatory requirements
  • Running a Parkinson’s study during the COVID pandemic, our experience
  • Study results

Speakers

12 PM

LUNCH BREAK

The exhibition will feature a varied line-up of innovative technologies to support the Israeli life sciences sector.

No matter your job function you’ll find providers to meet your needs; we’ll be showcasing new solutions for trial operations, supply and beyond to give you a comprehensive suite of solutions to maximise trial success.

1 PM

From bench to bedside: taking a drug from the lab to a clinic to treat Williams Syndrome

  • Natural history studies and preparing for a rare disease trial
  • Assessing unmet needs and long-term outcomes for orphan drugs in situations with no alternative treatments
  • Identifying endpoints when there is no precedence or pre-existing treatment for a rare or ultra-rare disease

Speakers

1:30 PM

Development of therapeutics to neurodevelopmental/neurodegenerative disorders: Davunetide as a case study focusing on the most recent advances and scientific discoveries

  • Developing therapeutics for rare diseases: the case of the ADNP syndrome and Davunetide
  • Exploring the tools, technologies and data management techniques used to streamline the process
  • Pitfalls encountered and how they were overcome 
  • Advice on vendor negotiation and management – how to ensure you are working with a partner who can cater to your specific trial needs 

Speakers

2 PM

Building clinical trials with the perspective of the patients in mind; exploring patient collaboration and the benefits it can bring to the sponsor and the patient

  • Discussing the collaboration that has to exist between all parties (patients, coordinators, doctors) in order to have a successful trial
  • Importance of good communication to the patients and how this can streamline trial timelines
  • Exploring how patients could, and should, be influencing decisions and the R&D process
  • Highlighting the importance of patient collaboration during COVID

Speakers

2:30 PM

Chair’s summary and close of conference

Medical Devices

Speakers

11 AM

Preparing the foundation of your regulatory plan in order to build a successful study

  • Focusing on FDA Regulations
  • Delving into the new EU MDR Regulations
  • Conflicting advisory opinions and how to manage this

Speakers

11:30 AM

Creating Value once your product goes to market: Gathering, analysing, and creating relevant products of real-world use of medical device

  • Data gathering: Sources, challenges, and tips
  • Creating relevant knowledge: data analysis in light of various internal and external costumers
  • How knowledge gained through your real-world clinical experience can provide benefits to your company: IFU, SOPs, Training, Marketing and Sales

Speakers

12 PM

LUNCH BREAK

The exhibition will feature a varied line-up of innovative technologies to support the Israeli life sciences sector.

No matter your job function you’ll find providers to meet your needs; we’ll be showcasing new solutions for trial operations, supply and beyond to give you a comprehensive suite of solutions to maximise trial success.

1 PM

Investigator initiated studies

  • Definition and what makes a successful IIS trial?
  • What role does the company play
  • Providing examples of both the advantages and challenges
  • key points to remember

Speakers

1:30 PM

IVDR; how our diagnostic companies are addressing the increased regulatory requirements in the EU?

  • Requirements for IVD clinical performance studies: what has changed?
  • Legacy products: how can we continue to market legacy products on the market?
  • Introducing new products to the market: how are we going to adapt and address the new requirements?

Speakers

2:30 PM

Chair’s summary and close of conference

Speakers

Select a speaker to learn more

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Jessica Marer
Sr. Manager, Smart Planning – Innovative Medicine, Teva Pharmaceuticals

Session Details:

FIRESIDE CHAT

2023-02-06, 5:00 PM

Session Details:

FIRESIDE CHAT: Focusing on the importance of Diversity & Inclusion in clinical trials & supply

2023-02-06, 2:30 PM

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Tami Rachmilewitz
Chief Medical Officer, BioLineRX

Dr. Rachmilewitz serves as the Chief Medical Officer at BioLineRx, formerly the Senior Vice President of Clinical Development at VBL Therapeutics. She is a clinical research physician executive with over 15 years of experience in Clinical Development and Medical Affairs roles in the Healthcare Industry previously working at, Teva, Novartis and Neuroderm. Dr. Rachmilewitz holds an M.D. from the Hadassah Medical School at the Hebrew University in Jerusalem.

Session Details:

Blinding in Clinical studies – Why, How, and related challenges

2023-02-06, 2:00 PM

Session Details:

Blinding in Clinical studies – Why, How, and related challenges

2023-02-06, 2:00 PM

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Sonia Ben Hamida
Ph.D Head Of Special Cargo, International Air Transport Association (IATA)

As Head of Special Cargo at the International Air Transport Association (IATA), Dr Sonia Ben Hamida leads the development of the special cargo agenda, delivering standards, business processes, and solutions for the air cargo supply chain related to the transport of live animals, perishables, and temperature-sensitive cargo, and all other special cargo. Prior to joining IATA, Sonia held several roles in France where she spent 8 years driving innovation in the aerospace industry. Then she joined academia in 2019 as a lecturer and researcher at EPFL, the Swiss Federal Institute of Technology in Lausanne, and UNIGE, the University of Geneva. Over the past 12 years, I have built a strong expertise in project management, innovation, design, and business and systems modeling. Sonia holds an engineering degree in Aviation and Computer Science from the French Civil Aviation University - ENAC (France) and a PhD in Innovation from CentraleSupélec (France).

Session Details:

PANEL DISCUSSION: Safeguarding the Supply Chain Landscape Post Covid and Through the Challenging Political Environment

2023-02-06, 2:30 PM

Session Details:

Temperature Controlled Airfreight Global Logistics for Clinical Trials

2023-02-06, 12:15 PM

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Nina Hershkowitz
Global Training & Patient Education Sr. Manager, Neuroderm

After 3 years in a clinical field as a registered nurse and almost 15 years of various positions in the pharmaceutical and medical device industries, in 2019 Nina joined Neuroderm as a Global Training and Patient Education Manager, mainly responsible for managing global company clinical trials training program and managing global CTEs (Clinical Trial Educators) activities and training.

Session Details:

ROUNDTABLE DISCUSSIONS

2023-02-07, 9:00 AM

Session Details:

ROUNDTABLE DISCUSSIONS

2023-02-07, 9:00 AM

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Edith Dekel
Senior Director Clinical Operations, Karyopharm Therapeutics

Experienced Clinical Operations Manager with a demonstrated history of working in the pharmaceuticals industry. Broad experience in pharma products development, drug-device combinations, Oncology, Cardiology and Neurology, Good Clinical Practice (GCP), and Biotechnology. Strong operations professional with a MBA focused in Bio medical from College of Management.

Session Details:

ROUNDTABLE DISCUSSIONS

2023-02-07, 9:00 AM

Session Details:

ROUNDTABLE DISCUSSIONS

2023-02-07, 9:00 AM

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Maayan Tsur
Director Of Operations, Neuroderm, Mitsubishi Tanabe Pharma

Maayan Tsur, Director of Operations in Neuroderm, manages the company’s strategic vendors. During covid-19 pandemic Neuroderm had to adjust the management model of the clinical vendors in order to accommodate new constraints arising from the crisis period. Maayan led a risk management processes in Neuroderm and in external CRO which allowed identifying risks and mitigation plans, and worked with the team on its implementation. Maayan holds MSc in Bio medical studies and MBA from Tel Aviv university Neuroderm develops next-generation drug-device combination solutions for central nervous system disorders. NeuroDerm is an Israel-based, wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation

Session Details:

Managing clinical vendors during a global crisis period

2023-02-06, 3:30 PM

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Anat Naschitz
Creator, 9xc; Venture Partner, OrbiMed

Session Details:

Fundraising and venture Capitals – how to best promote and raise funding for your study

2023-02-06, 4:01 PM

Session Details:

Fundraising and venture Capitals – how to best promote and raise funding for your study

2023-02-06, 3:30 PM

Session Details:

COFFEE BREAK

2023-02-06, 3:00 PM

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Nitsan Halevy
Chief Medical Officer, Pluri-Biotech

Dr. Nitsan Halevy is the Chief Medical Officer at Pluristem Therapeutics, where she leads clinical and regulatory activities. Nitsan has over 15 years of experience leading global clinical research and drug development projects. From an academic setting at Brigham and Women’s Hospital (Boston), Nitsan transitioned to industry, where she has held roles of increasing responsibility and scope at Novartis, Teva and Quark Pharmaceuticals. She holds an MD from Ben-Gurion University.

Session Details:

Using Real World Data in your clinical development program

2023-02-06, 11:30 AM

Session Details:

Using Real World Data in your clinical development program

2023-02-06, 11:15 AM

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Hilla Debby
Clinical Director, IceCure Medical

Hilla Debby Clinical Director at Icecure-Medical with over twenty years of experience in medical device industry. Her experience covers leading global clinical and regulatory activities. Holds a BsC in medical science.

Session Details:

Investigator initiated studies

2023-02-07, 1:31 PM

Session Details:

Investigator initiated studies

2023-02-07, 1:00 PM

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Liat Ben David
Director of Clinical Trials Operations & Ethics Committee (regulatory), Tel Aviv Medical Center

Liat Ben David, Ph.D, Ms.C., Bs.C is a well experience Quality and Clinical Trials expert (Operational, Regulations, Quality; global & local); 20 years of experience in different organization types, in various therapeutic areas and various drug development phases. In her Ph.D., Liat focused on the development of a Quality Management model for clinical trials. A proactive, dynamic and innovative person; a strong believer in collaboration and teams' empowerment. A proven track record in developing effective processes and leading complex projects from idea to success. An experienced tutor / lecturer in professional related fields.

Session Details:

Solutions to fully adapt to the future of Decentralised Clinical Trials to transform clinical trial development

2023-02-06, 12:31 PM

Session Details:

Decentralised Clinical Trials Decentralised solutions throughout the lifecycle of a clinical trial – do they add quality?

2023-02-06, 12:15 PM

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Boaz Albo
Director, Medical Cannabis Treatment & Clinical Research Center, Sheba Medical Center

Boaz Albo is Head of the Medical Cannabis Treatment and Clinical Research Institute that was established in 2020 at the Sheba Medical Center, and also serves as the academic coordinator in leading academies for training programs of physicians, pharmacists and medical professions in the subject of "Treatment with Medical Cannabis" delivered by Sapir College, the Israeli Medical Association, the Hebrew University and Tel Aviv University. From 2014 till 2020 Boaz served as deputy to the director and as department head of R&D, Quality and Vocational Training in the Medical Cannabis Agency (IMCA of the Israeli Ministry of Health's. There, he took a major part in designing the policy and regulation for the emerging medical cannabis industry, including writing the clinical methodology and quality procedures for medical cannabis products. In his Academic training Boaz holds an M.Sc. graduate in life sciences and Biotechnology from the Hebrew University of Jerusalem and gained a vast experience in the biomed industry and research and development of innovative botanical products.

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Illana Gozes
PhD, Professor Emerita of Clinical Biochemistry/Chief Scientific Officer, Tel Aviv University/ ATED Therapeutics Ltd.

Professor Emerita Tel Aviv University (TAU), formerly Lily and Avraham Gildor Chair and Director of the Adams Super Center for Brain Studies. Currently, Director, Elton Laboratory for Molecular Neuroendocrinology. B.Sc. TAU, Ph.D., Weizmann Institute of Science, postdoc. MIT and Salk Institute. Associate Professor, Weizmann Institute, Fogarty-Scholar-in-Residence, NIH, Humboldt Awardee, Germany. Mentored >65 students. Published ~350 papers (h-index 79). Inventor of multiple patents including (NAP, Davuentide), a clinical drug candidate targeted at the rare disease indication, the ADNP syndrome. Discovered ADNP, essential for brain formation implicated in autism, schizophrenia, Alzheimer’s disease and cancer. NAP is the active site of ADNP. Multiple prizes including Teva Founders Prize, Landau Prizes and best applied scientist, TAU. Ex-President, Israel Society for Neuroscience (Honorary Member), Ex-Member, Council of Higher Education. Secretary, European Society for Neurochemistry. Editor-in-Chief, Journal of Molecular Neuroscience. Chief Scientific Officer, ATED Therapeutics.

Session Details:

PANEL DISCUSSION: Safeguarding the Supply Chain Landscape Post Covid and Through the Challenging Political Environment

2023-02-06, 2:30 PM

Session Details:

Development of therapeutics to neurodevelopmental/neurodegenerative disorders: Davunetide as a case study focusing on the most recent advances and scientific discoveries

2023-02-07, 1:30 PM

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Giora Sharf
Patient advocate, Founder: Israeli CML Patients Organization, Halil Haor- home of blood cancer patients, global CML advocates network

Leukemia Patients Advocates Foundation host of: CML Advocates Network and MPN Advocates Network Israeli CML Patient’s Organisation Israeli Flute of Light- Home of blood cancers in Netanya, Israel Giora Sharf was diagnosed with chronic myeloid leukemia (CML) in March 2000 at the age of 47. After the initial shock of the diagnosis and some research on treatment options, he elected to wait for a clinical trial with a new agent, STI571. He joined the IRIS trial in June 2000 and after 7 months on interferon, he began taking Imatinib. After being PCR negative for 14 years he has stooped treatment more than 8 years ago and is on a Treatment Free Remission (TFR). Mr Sharf decided to use his experience to help other CML patients by founding the Israeli CML Patient's Organization in April 2001. What began with 7 local patients at a small hospital in the city of Netanya, Israel, has since grown to support more than 550 patients from all around the country. The main goal of the patient organization is to empower patients to be active and involved partners in their own disease management. In 2014, Mr Sharf founded a new Israeli blood cancer patient organization called "Flute of Light." The organization is a resource for patients in Israel with leukemia, lymphoma, and other blood disorders also helping patients deal with psychological challenges of diagnosis and treatments. In addition to his work with the Israeli Patient’s Organizations, Mr Sharf is a co-founder of the Leukemia Patients Advocates Foundation (LePAF) which is the host for 4 global blood cancer patients advocates networks including CML Advocates Network, which connects 128 leukemia patient groups from 95 countries and also MPN Patients Advocates. They are also involved in research, and Mr Sharf has led 2 global studies on Adherence and TFR for CML patients, which were presented at the ASH, EHA, ESH and other meetings and also published in scientific magazines like Leukemia. Mr Sharf serves on several advisory boards representing the patient’s perspective on CML and other blood cancers, and attends medical conventions, such as ASH and EHA, to report on updates for patients. He is also an alumni of EUPATI and has been a driver in opening a patient advocacy academy in Israel in 2021.

Session Details:

Patient engagement in R&D Clinical Trials

2023-02-06, 5:01 PM

Session Details:

Patient engagement in R&D Clinical Trials

2023-02-06, 4:00 PM

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Mor Buchshtav
Director Of Clinical & Regulatory Affairs, Medasense Biometrics

Mor Buchshtav, B.Sc., is the Director of Clinical & Regulatory Affairs at Medasense Biometrics Ltd. with over 12 years of experience in the medical device industry both from the clinical and the regulatory aspects. Mor is experienced with planning, executing, monitoring and analyzing bench tests, clinical studies and human factor studies, and has a record of successful regulatory submission of medical devices to Europe, United States, Canada, Brazil and various other jurisdictions. Her work is characterized by meticulous attention to details, dedication, drive to success and a love of the profession.

Session Details:

Preparing the foundation of your regulatory plan in order to build a successful study

2023-02-07, 11:00 AM

Session Details:

Preparing the foundation of your regulatory plan in order to build a successful study

2023-02-07, 11:00 AM

Session Details:

Preparing the foundation of your regulatory plan in order to build a successful study

2023-02-07, 11:00 AM

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Julio Burman
Patient Advocate and Vice-president of ELPA, European Liver Patient association

Julio discovered he had Hepatitis C by chance in 1994. He went through three year-long
courses on interferon treatment. These years were not easy and Julio struggled with
many challenges and questions and he looked for support.

When he realized there are no support groups or patient associations for liver patients in
Israel, Julio decided in 1998 to establish Hetz- the Israeli Organization for Liver Health.

Today Julio is cured from HCV. Nevertheless, he dedicates his life to supporting liver
patients and their families, strengthening Hetz's capacity to advocate for the PATIENTS'
RIGHT TO KNOW they have a liver disease, and the government's obligation to screen
and to treat them.

Actually Julio is directing HETZ and is representative of the patients in the National
Council of Liver of the Ministry of Health in Israel.

Session Details:

Building clinical trials with the perspective of the patients in mind; exploring patient collaboration and the benefits it can bring to the sponsor and the patient

2023-02-07, 2:00 PM

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Efrat Hartog-David
Ph.D, VP Of Regulatory Affairs And Quality Assurance, MeMed Diagnostics

Efrat Hartog-David, VP of Regulatory Affairs and Quality Assurance at MeMed has over a decade of experience in Quality Assurance, Clinical and Regulatory Affairs. She has managed product lifecycle quality and regulatory submissions for clearances of numerous medical devices in the US, EU, China, and rest of the world. Before joining MeMed, Efrat was Regulatory Affairs Manager at GE Healthcare, responsible for leading and executing the global regulatory strategy for the Nuclear Medicine business. As part of her role at GE Healthcare she led a team responsible for providing leadership and guidance on global compliance, developing global regulatory strategies and plans, and preparing regulatory submissions and worldwide registrations. Efrat has also served as Regulatory Affairs specialist at Philips Healthcare, where she was the regulatory lead for programs aimed at introduction of new product, and played a key role in internal and external audits. Prior to that, Efrat served as a consultant for a wide range of medical device companies, focusing on clinical study design, quality system management, and regulatory strategy development and execution. Efrat holds a B.Sc. and Ph.D. in Biotechnology and Food Engineering from the Technion, Haifa, Israel.

Session Details:

IVDR; how our diagnostic companies are addressing the increased regulatory requirements in the EU?

2023-02-07, 2:30 PM

Session Details:

IVDR; how our diagnostic companies are addressing the increased regulatory requirements in the EU?

2023-02-07, 1:30 PM

Session Details:

Clinical Trial Supply

2023-02-06, 11:00 AM

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Boaz Barak
Assistant Professor, Tel Aviv University

Session Details:

From bench to bedside: taking a drug from the lab to a clinic to treat Williams Syndrome

2023-02-07, 2:31 PM

Session Details:

From bench to bedside: taking a drug from the lab to a clinic to treat Williams Syndrome

2023-02-07, 1:00 PM

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Uri Heiman
Clinical Development Director, Laminate Medical Technologies

Dr. Uri Heiman, Married with two teenage kids and a cat. Currently works for Laminate medical, Medical device startup as Clinical development Director responsible for training and establishing proper use of the devices the company provides, to support creation of innovative data and knowledge and to support further development of new devices. Previously have worked as a clinical specialist for local distributer in the field of cardiac surgery and ultrasound systems for cardiac use BSc. Biology, DVM Veterinary, Hebrew university MBA Tel Aviv university

Session Details:

Creating Value once your product goes to market: Gathering, analysing, and creating relevant products of real-world use of medical device

2023-02-07, 12:01 PM

Session Details:

Creating Value once your product goes to market: Gathering, analysing, and creating relevant products of real-world use of medical device

2023-02-07, 11:30 AM

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Hadas Friedman
VP QA/RA And Clinical Affairs, Pharma Two B

Hadas Friedman serves as Pharma Two B’s VP QA, RA and Clinical Affairs since 2013. Prior to this served as the VP QA, RA and Clinical Affairs at Intec Pharma from 2004. Previous companies include Procognia and Rafa Laboratories. Completed a Bachelors of Science and a Masters of Science at the Bar-Ilan University.

Session Details:

Drug-drug combinations – study design and conduct: the P2B001 experience

2023-02-07, 12:00 PM

Session Details:

Drug-drug combinations – study design and conduct: the P2B001 experience

2023-02-07, 11:30 AM

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Tali Schaffer
Executive Director Of Clinical Affairs, ELGAN Pharma

Session Details:

Chair’s Opening Remarks

2023-02-06, 8:50 AM

Session Details:

PANEL Key Components of Successful Clinical Trials to Ensure Study Success

2023-02-06, 10:00 AM

Session Details:

Chair’s closing remark

2023-02-07, 4:30 PM

Session Details:

Strategies for Country and Site Selection; enhancing one’s knowledgebase for the best move forward

2023-02-07, 11:00 AM

Session Details:

FIRESIDE CHAT: Focusing on the importance of Diversity & Inclusion in clinical trials & supply

2023-02-06, 2:30 PM

Session Details:

Outsourcing in Clinical Trials

2023-02-07, 10:45 AM

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Outsourcing in Clinical Trials

2023-02-06, 11:00 AM

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Amir Zaher
Head Of Department, Ministry Of Health Israel

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ROUNDTABLE DISCUSSIONS

2023-02-07, 9:00 AM

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ROUNDTABLE DISCUSSIONS

2023-02-07, 9:00 AM

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Yigal Aviv
Patient And Healthcare Experience Lead, Pfizer

Patient & Healthcare professional experience Lead at Pfizer | Advancing innovative & Data driven communication in healthcare | Lecturing on: Data driven & Omni-Channel marketing, Metaverse as an ecosystem in healthcare

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“Your Avatar Doctor Will Be with You Shortly”

2023-02-06, 9:00 AM

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“Your Avatar Doctor Will Be with You Shortly”

2023-02-06, 9:00 AM

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Luba Vitkin Katz
Clinical Trials Manager, Corneat

Luba Vitkin Katz has over 10 years of experience in the clinical trials field, including a specialization in monitoring and documentation. Mrs. Vitkin Katz holds a B.Sc. in Life Science from the Hebrew University of Jerusalem, an MA in Science Education (cum laude) from Bar-Ilan University and is also a certified Clinical Research Associate (CRA) and completed a course of Auditing of Clinical Trials.

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PANEL: Key Components of Successful Clinical Trials to Ensure Study Success

2023-02-06, 10:00 AM

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PANEL Key Components of Successful Clinical Trials to Ensure Study Success

2023-02-06, 10:00 AM

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Data Management in Emerging Medical Device and Biotech

2023-02-06, 11:45 AM

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Adam Pitt
Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection

Adam Pitt is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Biological Threat Exclusion. As a BTEC, Mr. Pitt is charged with supporting and developing U.S. Customs and Border Protection (CBP) operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S. Mr. Pitt has more than 18 years of public service with CBP and the National Institutes of Health (NIH), and has worked in a variety of environments, including air passenger, cargo, and express consignment carrier locations.

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KEYNOTE Q&A Discussion: Explore importing and exporting requirements for biological materials and how preparation is everything in the modern world

2023-02-06, 11:15 AM

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ROUNDTABLE DISCUSSIONS

2023-02-07, 9:00 AM

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Sean Smith
Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection

Sean Smith is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Biological Threat Exclusion. As a BTEC, Mr. Smith is charged with supporting and developing U.S. Customs and Border Protection (CBP) operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S. Mr. Smith has more than 17 years of public service with CBP, and has worked in a variety of environments, including on the southern land border, maritime, air passenger, and cargo locations. He has also been able to assist in several past domestic and international CBP disaster recovery operations.

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KEYNOTE Q&A Discussion: Explore importing and exporting requirements for biological materials and how preparation is everything in the modern world

2023-02-06, 11:15 AM

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ROUNDTABLE DISCUSSIONS

2023-02-07, 9:00 AM

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Rochelle Pakier
Associate Manager, CTA, TEVA

Rochelle has held various positions within Innovative R&D, Global Clinical Operations at Teva Pharmaceuticals, for the last 11 years. She has over 30 years of experience in the healthcare industry, and holds a BBA in International Marketing, and an MBA in Entrepreneurship.

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PANEL: Key Components of Successful Clinical Trials to Ensure Study Success

2023-02-06, 10:00 AM

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PANEL Key Components of Successful Clinical Trials to Ensure Study Success

2023-02-06, 10:00 AM

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Elvira Suniega-Tolentino
Clinical Project Manager Team Lead (Asia), Nestlé

Elvira Suniega-Tolentino is the Clinical Project Manager Team Leader for Singapore at the Nestlé Clinical Research Unit, responsible for end-to-end clinical project management and operational activities of Nestlé corporate clinical trials serving all Business Units. At the Clinical Research Unit, she is also leading the Vendor/Out-sourcing activities where she drives strategic partnerships with CROs, Universities, Laboratories, etc. Prior to joining Nestlé, Elvira was the Area Clinical Operations Manager for Abbott Nutrition R&D, Asia Pacific Center in Singapore for 11 years. Over the years, she has sharpened her expertise in the industry, bringing in thoughtful and strong competency into Nestlé’s clinical projects.  The combination of her expertise, leadership and passion for innovation strongly supports the continuous improvement and excellence of Nestlé’s clinical research activities to further unlock the power of food to enhance the quality of life for every consumers, today and for generations to come.

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Medical Devices

2023-02-07, 10:45 AM

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Yael Genosar
Associate Director of Clinical Supply Chain, OPKO Biologics

Yael Genosar, Associate Director of Clinical Supply Chain at OPKO Biologics Israel. Experienced Clinical Supply Chain manager with a four years' experience of managing supply chain in a global clinical trial. Previously Project Manager at Hot Mobile a wireless telecommunications company, leading technologies projects.

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PANEL DISCUSSION: Safeguarding the Supply Chain Landscape Post Covid and Through the Challenging Political Environment

2023-02-06, 2:30 PM

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Lionel Philippe
PhD, Clinical Supply Manager, Nestlé

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Running your clinical trial internationally: overcoming logistical challenges to maximise supply chain efficiency

2023-02-06, 4:00 PM

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PANEL DISCUSSION: Safeguarding the Supply Chain Landscape Post Covid and Through the Challenging Political Environment

2023-02-06, 2:30 PM

Session Details:

Running your clinical trial internationally: overcoming logistical challenges to maximise supply chain efficiency

2023-02-07, 4:00 PM

Session Details:

Running your clinical trial internationally: overcoming logistical challenges to maximize supply chain efficiency

2023-02-06, 4:00 PM

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Rich Bennett
Senior Director, Therapeutic Strategy Lead, Neuroscience, Worldwide Clinical Trials

Mr. Bennett has worked in clinical development for approximately 20 years and has worked for WCT since September 2021. He began his career in clinical research in a phase 1 clinic and soon after held roles as a Clinical Research Associate on both early and late phase clinical trials with responsibilities for data validation and site management. This solid base experience in ICH-GCP was further supplemented with broad operational knowledge regarding the conduct of clinical trials when he was appointed as a Clinical Trial Manager of Phase I, II and II trials within global programs. Building on this operational grounding, he has latterly (seven years) held positions where he has led cross-functional project teams within clinical research and has been responsible for project strategies, clinical development plans, clinical trial methodologies (concept/design), protocol authorship and the transformation of the scientific endeavor into an operationalized activity. Through being part of R&D leadership teams, he has contributed to business management and the development of operating models and outsourcing strategies. He has been responsible for representing pipeline projects in R&D governance boards and holds experiences throughout the drug development life cycle.

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PANEL Key Components of Successful Clinical Trials to Ensure Study Success

2023-02-06, 10:00 AM

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Transformational Relationships: How a consultative approach from a CRO could add value to your development program

2023-02-06, 9:30 AM

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Transformational Relationships: How a consultative approach from a CRO could add value to your development program

2023-02-06, 9:30 AM

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Paul Finney
Senior Strategic Services Account Manager, Medidata

Paul has 28 years’ experience working in Life Sciences; 7 researching Respiratory indications (asthma, COPD, PPH) and 9 years in Clinical Research for emerging Biotechs managing programs in across Respiratory, Oncology, Gastro-Enterology, Endocrinology therapeutic areas. Over the last 12 years Paul has specialised in eClinical, working for CROs and technology providers with a focus on clinical trial processes, ICH GCP, the use of technology to solve industry problems, and is also an SME in RBQM.

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Data Management in Emerging Medical Device and Biotech

2023-02-06, 11:45 AM

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Sascha Sonnenberg
Vice President Global Business Development & Country Head Germany, SanaClis

Sascha held numerous positions in business development and operations, most notably in global Commercial Operations AMERICAS & EMEA at Marken and VP Business Development at Sharp Clinical Services, where he formed a new business development team and implemented novel services. Sascha is a subject matter expert of a broad range of services along the clinical supply chain such as Direct-to-Patient, labelling & packaging, cell & gene therapies , and global distribution strategies. Sascha studied economics and holds a MBA in International Management and Leadership. He has been a long-term member of the ISPE Investigational Product community, contributed to the development of several Good Practice Guides and was a member of the European IP Steering Committee. At SanaClis Sascha is leading global business development and acts as Country Head Germany.

Session Details:

Clinical Trials 2023 and beyond – What do we need to consider preparing a robust and flexible supply chain?

2023-02-06, 11:45 AM

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PANEL DISCUSSION: Safeguarding the Supply Chain Landscape Post Covid and Through the Challenging Political Environment

2023-02-06, 2:30 PM

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Eti Lavi
Director, Head of Clinical Operations, Neuroderm

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PANEL Key Components of Successful Clinical Trials to Ensure Study Success

2023-02-06, 10:00 AM

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Dr Tamir Gedo
former CEO, BOL Pharma

Dr. Gedo draws upon 25 years of experience as a marketing and business strategy expert serving in academic, government, and industry functions. Dr. Gedo’s extensive expertise in international marketing, branding, entrepreneurship, and business strategy has served him in his various leadership roles. He has contributed to a wide range of branding, strategic planning, and market penetration activities as a senior manager or executive director of major companies in a variety of industries, including the pharmaceutical industry. Dr. Gedo founded BOL Pharma and served as CEO and founding Board member, during his period he grew the company from four employees to become the largest cannabis company in Israel which owned around 50% market share. He served as executive director at Lundbeck Israel and Maccabi Healthcare which is the second largest health medical organization in Israel. As a consultant, Dr. Gedo provided services to companies in the medical, nutrition, and pharmaceutical industries. In addition to his business and consulting practice, Dr. Gedo has served as the head of the marketing department and other faculty positions of several colleges in Israel such as the Max Stern Yizrael Valley College and IDC Herzelia College and has guest lecturer in the Department of Business Administration of Shanghai University. He has taught undergraduate and graduate-level courses in global marketing, business strategy, innovation, and entrepreneurship. Dr. Gedo received his Ph.D. in Economics from Manchester Business School (UK) and an MBA from Ben Gurion University (Israel). He completed a B.Sc. in Molecular Biology at Bar Ilan University (Israel).

Session Details:

Regulation requirements for applying cannabis-based clinical trials in Israel

2023-02-06, 2:00 PM

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Ben Lloyd-Davies

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+44 (0)20 7936 6948

SPEAKER ENQUIRES

To enquire about speaking opportunities for the conference, please contact:

Maya Hudson

Senior Conference Producer


+44 (0) 204 540 7766