Workshop program (English)

ADVANCED THERAPY MEDICINAL PRODUCTS (ATMP)

2nd PHARMACEUTICAL BIOTECHNOLOGY WORKSHOP PROGRAM

NOVEMBER 28-29, 2019

ANKARA – TURKEY

         We are very pleased to inform and invite you to the “2nd Pharmaceutical Biotechnology Workshop on Advanced Therapy Medicinal Products (ATMP)” to be held in November 28 and 29, 2019 in Ankara at Atlı Otel.  The workshop will cover invited presentations on the regulatory, scientific and therapeutic aspects of the ATMP and a panel discussion will take place on the national requirements.  All of the presentations and panel discussions will be in Turkish, apart from the invited presentations from the EMA-Committee for Advanced Therapies that will be given in English. Our Pharmaceutical Biotechnology Workshop will be the first event about the ATMP  in our country, and will provide a discussion platform for the current developments and information on the ATMP which are known as complex and high-risk biotechnological-biological drugs and manufactured using cell and gene technologies.

Dr. Türkan Eldem

2nd Pharmaceutical Biotechnology Workshop – ATMP,  Chair

DAY-1 (November 28, 2019)   

REGISTRATION: 08.00-09.00

OPENING CEREMONY: 9.00 -09.45

Dr. TÜRKAN ELDEM – Advanced Therapy Medicinal Products-2nd Pharmaceutical Biotechnology Workshop, Chair

Dr. GÜLTEN KANTARCI – Pharmaceutical Biotechnology Association, Chair

Dr. HARUN KIZILAY – Turkish Medicines and Medical Devices Agency (TMMDA) Vice-President

Dr. HALUK ÖZEN – Hacettepe University President  

SESSION-1

Legislation on Advanced Therapy Medicinal Products-1
Session Chair: Dr. TÜRKAN ELDEM
09.45-10.30 Advanced Therapy Medicinal Products: International (European)  Legislation 
Dr. SOL RUIZ (European Medicines Agency-Committee for Advanced Therapies, Spain)
10.30-11:00 The Status of Advanced Threapy Medicinal Products in  Turkey
ÜMİT ÜREK  (Turkish Medicines and Medical Devices Agency (TMMDA)
11.00-11.15 Q&A and Discussion

COFFEE BREAK :11.15-11.30

SESSION2

Legislation on Advanced Therapy Medicinal Products-2
Session Chair: Dr. A. GÜLTEN  KANTARCI
11.30-12:15 Fundemental Requirements for Somatic Cell Therapy Medicinal Products, Gene Therapy Medicinal Products, Tissue Engineered Products  and Combined ATMP
Dr. SOL RUIZ (European Medicines Agency-Committee for Advanced Therapies, Spain)
12:15-12.45 Registration of Medicinal Products for Human Use and Advanced Therapy Medicinal Products
ÜMİT ÜREK  (Turkish Medicines and Medical Devices Agency (TMMDA)
12.45-13.15 An comparative overview for legislation on advanced therapies, cell and tissue  products, stem cell-based ATMP, orphan and regenerative medicines
Dr. TÜRKAN ELDEM (Hacettepe University, Faculty of Pharmacy, Pharmaceutical Biotechnology Department;
Hacettepe University, Health Sciences Institute, Stem Cell Sciences Department)                
13.15-13.30 Q&A and Discussion

WORKSHOP GROUP PHOTO

LUNCH:  13.30-14.45

SESSION3

Advanced Therapy Medicinal Products and Cell and Gene Technologies-1
Session Chairs: Dr. ZEKİ TOPÇU – Dr. FİLİZ ÖNER
14.45.-15.15 Recombinant Cell and Gene Technologies: Introduction and Definitions
Dr. ZEKİ TOPÇU  (Ege University, Faculty of Pharmacy, Pharmaceutical Biotechnology Department )
15.15-15.45 Recombinant Cell and Gene Technologies: Viral Vectors
Dr. AYŞEN GÜNEL ÖZCAN  (Hacettepe University., Health Sciences Institute, Stem Cell Sciences Department)         
15.45-16.15 Recombinant Cell and Gene Technologies: Gene-Genome Editing Technologies and R&D
Dr. EMİNE ŞALVA (İnönü University, Faculty of Pharmcy, Pharmaceutical Biotechnology Department )
16.15-16.30 Q&A and Discussion

COFFEE BREAK: 16.30-17.00

SESSION4

Advanced Therapy Medicinal Products and Cell and Gene Technologies-2
Session Chair: Dr. GÜLAY BÜYÜKKÖROĞLU
17.00-17.30 Gene Therapy Medicinal Products: Non-Viral Vectors
Dr. A. GÜLTEN KANTARCI  (Ege University, Faculty of Pharmacy, Pharmaceutical Biotechnology Department )
 17.30-18.00 Characterization for Gene Therapy Medicinal Products, 
Dr. DEVRİM D. DORA (Akdeniz University, Faculty of Medicine, Medical Pharmacology Department )
18.00-18.15 Q&A and Discussion

SECOND DAY: 29 KASIM 2019

SESSION5

Advanced Therapy Medicinal Products and Cell and Gene Technologies-3
Session Chair: Dr. JÜLİDE AKBUĞA– Dr. SUNA ÖZBAŞ
09.00- 09.30 Cell-Stem Cell Manufacturing Technologies and Tissue Engineered Products
Dr. BETÜL ÇELEBİ SALTIK   ( Hacettepe University., Health Sciences Institute, Stem Cell Sciences Department)         
09.30-10.00 Cell-Gene Technologies and transgenic animal models
Dr. AYTEKİN AKYOL (Hacettepe University, Faculty of Medicine, Medical Pathology  Department, Hacettepe University., Health Sciences Institute, Stem Cell Sciences Department)
10.00-10.15 Q&A and Discussion

COFFEE BREAK: 10.15-10.45

SESSION6

Manufacturing and Quality Assurance in Advanced Therapy Medicinal Products
Session Chairs: Dr. ALİ DEMİR SEZER
10.45-11.15 Quality Assurance in Somatic Cell Therapy Medicinal Products
Dr. PELİN KILIÇ, (Ankara Üniversity, Stem Cell Institute)
11.15-11.45 Manufacturing Site and Inspection for Advanced Therapy Medicinal Products
Dr. PELİN KILIÇ, (Ankara Üniversity, Stem Cell Institute)
11.45-12.00 Q&A and Discussion

LUNCH:  12.30-13.30

SESSION7

Advanced Therapy Medicinal Products: Therapeutic Aspects and Clinical Trials
Session Chair: Dr. HALUK TOPALOĞLU
13.30-14.00 Rare Diseases and Gene Therapy
Dr. HALUK TOPALOĞLU,  (Hacettepe University, Faculty of Medicine, Medical  Department of Pediatrics, Division of Pediatric Neurology )
14.00-14.30 Gene Therapy with Genetically Modified T Cells in Hematologic-Oncological Diseases
Dr. ERDEN.ATİLLA (Baylor College of Medicine (USA),  and Ankara Üniversity, Stem Cell Institute)
14:30-15.00 Gene Therapy in Hereditary Retinal Diseases and Retinal Dystrophies
Dr. BORA ELDEM  (Hacettepe University, Faculty of Medicine, Medical  Department of Ophthalmology)
15.00-15.30 Advanced Therapy Medicinal Products and Clinical Trials Dr. TÜRKAN ELDEM (Hacettepe University, Faculty of Pharmacy, Pharmaceutical Biotechnology Department;
Hacettepe University, Health Sciences Institute, Stem Cell Sciences Department)
15.30-15.45 Q&A and Discussion

COFFEE BREAK : 15.45-16.15

SESSION8

PANEL DISCUSSION
Advanced Therapy Medicinal Products and National Requirements Moderator: Dr. TÜRKAN ELDEM
16.15-18.15: Representatives from:
University (Dr. HALUK TOPALOĞLU),
Institute (Dr. PELİN KILIÇ),
Clinical Trials Ethics Committee (Dr. MUTLU HAYRAN),
Industry – İEİS (Dr. SERDAR ALPAN)
Industry – AİFD (Ms. BAŞAK YILMAZ)
The Pharmaceutical Biotechnology Association (Dr. ZEKİ TOPÇU)

CLOSING: 18.15-18.30