Microsoft PowerPoint - One Week Program(ENG, KOR V2).pptx

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1 Drug Development Processes & Regulatory Approaches 신약개발과정및규제적접근을위한 1 주일집중교육과정 Time: June th, 2012 기간 : 2012년 6월 11일 ( 월 )-15일( 금 ) Venue: University of Maryland Schools of Pharmacy 장소 : 메릴랜드약학대학 20 N. Pine Street, Baltimore, MD Organizer/ 주최 State of Maryland Business Office-Korea(SOMBOK) University of Maryland School of Pharmacy Support / 후원 JG Business Link International Food and Drug Administration(FDA)

2 Program Introduction/ 프로그램소개 One-week training program for Korea s discovery/drug development, regulatory scientists, and industrial pharmaceutical scientists interested in understanding the drug development process, regulatory aspects of this process in the U.S., and biosimilarguidance from the U.S. Food and Drug Administration for further regulatory harmonization from the KORUS Free Trade Agreement 본과정은한국내의신약개발, 규제관련과학자, 제약회사소속과학자들을대상으로미국에서의신약개발과정및규제에관련된절차와미연방식품의약안정청 (FDA) 의바이오시밀러에관한지침에대한이해를높이기위해마련되었으며, 한 - 미 FTA 타결로인한앞으로의변화에대응하기위해마련하였습니다. Target Audience / 교육대상 Korea s leading pharmaceutical company executives, academic researchers, and governmental regulatory and economic development officials 국내주요제약회사임원, 연구원, 규제관련정부부서담당자및경제관료 Leaning Objectives / 교육목적 To understand the scientific, clinical and regulatory process used in the development of drugs for the treatment of various diseases (e.g., HIV, hypertension, cardiovascular disease, lipid lowering agents). 에이즈, 고혈압, 심혈관질환, 고지혈증과같은다양한질병의치료를위한신약개발과정에있어서의과학적, 임상적, 규제과정에관한명확한이해도모 To review the content required for a Clinical protocol (Phase I-III) from the perspective of IRB policies, regulator policies and the pharmaceutical industry. 임상시험심사위원회 (IRB) 의정책, 규제정책및제약업계관점에서임상 1 상에서 3 상까지필요한임상프로토콜을위해필요한내용리뷰 To review the content preclinical, toxicological and clinical protocol that comprise and IND and NDA 전임상, 독성학, 그리고임상시험계획승인 (IND) 과신약승인신청 (NDA) 의임상프로토콜의내용리뷰 To review various pertinent FDA guidancesthat are critical to the drug design process and streamlining of this process. 신약개발과정및이의간소화를위해매우중요한미연방식품의약안전청 (FDA) 지침의올바른리뷰 To review the current FDA draft guidanceson biosimilarsreleased on February 9 th, 년 2 월 9 일에미연방식품의약안정청 (FDA) 가발표한바이오시밀러지침에대한리뷰 In addition, the program participants will have the opportunity to meet individually with leading faculty from UMB s Schools of Pharmacy, Medicine, Nursing, and Dentistry to discuss specific clinical trials and research collaborations. 또한, 본과정의참석자들에게특정임상시험및연구협의방안을논의하기위한메릴랜드약학대학, 의과대학, 간호대학, 치과대학의유명교수진들과개인적으로면담을할수있는기회가주어집니다.

3 Course Overview This course provides the clinical, scientific and regulatory perspective on design, development and evaluation of new chemical entities. The target audience for this course is clinical and regulatory officers and Korean pharmaceutical companies, drug reviewers, and biotechnology scientists. The course will focus on the drug development process from Investigational New Drug Application (IND) to a New Drug Application (NDA) for various diseases (e.g., HIV/AIDS, depression, hypertension, cardiovascular agents). This will be accomplished by real world examples for an industrial and regulatory perspective that focus on Phase I-IV protocol development and study implementation. Protocol review will also be presented from an institutional Review Board perspective by the use of a mock IRB session. The course will also provide a regulatory review of Preclinical studies including pharmacology and toxicology, Phase I studies (e.g., single dose ADME, dose proportionality, and drug interactions), Phase II studies (clinical trials in small number of patients) and pivotal Phase III studies (clinical trials in large number of patients). Critical regulatory guidanceswill be presented Food Effect studies, Biomarkers in Clinical Drug Development, Exposure-Response, Scale-Up and Post Approval Changes. The impact of Pharmacoeconomics on drug development will be presented. The course introduces FDA guidances of biomarker development and validation of case studies, bioequivalenceswitchability, and biosimilars. On February 9 th 2012, draft guidance regarding regulations of biosimilarsat the US FDA was completed. With the Korea-USA Free Trade Agreement taking effect, the Korean pharmaceutical industry will be adversely affected by US pharmaceutical regulations if harmonization is not completed. Through this course paths to understanding the U.S regulations and policies of pharmaceuticals and biosimilarsin IRB and U.S FDA will promote further Korean pharmaceutical development. This course will be led by faculty from the University of Maryland Schools of Pharmacy and Medicine, as well as officials from the U.S. Food and Drug Administration. The course is arranged by JG Business Link International. 본교육과정에서는신약개발후보물질의설계, 개발, 안전성평가를하는데있어서의임상적, 과학적, 규제적관점을다루게됩니다. 에이즈, 우울증, 고혈압, 심혈관질환과같은다양한질병치료를위한신약개발의임상시험계획승인 (IND) 부터신약승인신청 (NDA) 까지를모두다루며, 한국제약회사및규제관련기관종사자와생명공학과학자를주교육대상으로준비된프로그램입니다. 본과정은제약업계와규제기관의실제사례를통하여임상시험 1 상부터 4 상까지의프로토콜개발과연구구현에초점을맞추어진행됩니다. 또한프로토콜의리뷰는임상시험심사위원회 (IRB) 의평가모형에맞추어진행됩니다. 본과정은약리학, 독성학, 임상 1 상연구 ( 일회분약의흡수, 분포, 대사및배출에관한영양분의효과, 용량비, 약물상호작용 ), 임상 2 상연구 ( 소수환자에대한임상시험 ), 그리고매우중요한임상 3 상연구 ( 다수환자에대한임상시험 ) 를포함한전임상단계에서의규제관련관점을제시합니다. 또한식효연구, 임상신약개발에있어서의바이오마커, 노출평가, 규모확대및승인후변경에관한임상규제지침을제공하고신약개발에있어서의약물경제성평가의영향에관해서도제시해드립니다. 본과정을통해바이오마커개발과검증의임상사례연구와생물학적동등성및변경가능성그리고바이오시밀러에대한미연방식품의약안정청 (FDA) 의지침을소개해드립니다. 지난 2012 년 2 월 9 일자로미국내바이오시밀러승인에관한미연방식품의약안전청 (FDA) 에서지침서가완성되었습니다. 또한, 한미양국간의자유무역협정서 (FTA) 가발효됨에따라한국의제약분야산업이미국의약품관리규정에의하여불리한위치에놓이게되었으나미국임상시험심사위원회 (IRB) 와미연방식품의약안전청 (FDA) 의바이오시밀러정책을완전히이해할수있다면한국의제약산업의새로운출구가만들어질것이며, 또한미국시장으로진출할수있는기회를본과정을통해가지게될것입니다. 본과정은메릴랜드약학대학과의과대학, 미연방식품의약안전청 (FDA) 소속의유명강사진들에의하여진행되며, 교육과정관련모든업무는 JG BLI 사가주관합니다.

4 PROGRAM (June 11-15, 2012) / 5일간의교육일정표 Date / 날짜 Time/ 시간 Program / 프로그램 9:00-9:30 am Opening/Welcome (Organizers)/ 환영인사 ( 주최측 ) 9:30-12:00 pm Drug Development Process/ 신약개발절차 Natalie D. Eddington,PhD, Dean and Professor of Pharmaceutical Sciences; Director of Pharmacokinetics Laboratory, University of Maryland School of Pharmacy 메릴랜드약학대학의약과학부교수및학장, 약물동태학실험실디렉터 June 11, 2012 (Mon/ 월 ) 12:30-1:00 pm Lunch/ 점심 IND Process Nonclinical / 임상시험계획승인절차 DME and transporter studies guidance 당뇨병성황반부종및운반체에관한연구지침 Pharmacology and Toxicity study design and guidance 약리학및독성학연구기획과지침 Rodent study design 설치류연구기획 Determination of LD50 LD50( 약물독성치사량단위 ) 의결정 Case Studies in Pharmacology and Toxicology 약리학및독성학에서의사례연구 승인절차 비임상 Ken Bauer, PharmD, PhD; Associate Professor of Pharmacy Practice and Science, Director of Clinical Pharmacology Unit, University of Maryland School of Pharmacy 메릴랜드약학대학제약실무와과학부부교수및임상약학부디렉터 Peter Swaan, PhD; Professor of Pharmaceutical Sciences; Director of Center of Nanomedicineand Cellular Delivery, Associate Dean of Research and GradauteEducation; University of Maryland School of Pharmacy 메릴랜드약학대학의약과학부교수및나노의약과세포전달연구부서디렉터, 대학원부학장 HongbingWang, PhD.; Associate Professor of Pharmaceutical Sciences, University of Maryland School of Pharmacy 메릴랜드약학대학의약과학부부교수 1:00-5:00 pm CMC Process/ CMC 절차 USP Identification Standards / 미약전협의회검사기준 Chemistry Section/ 화학분야 Specifications for CMC/ CMC 명세서 FDA Pertinent Guidances/ 미연방식품의약안정청 (FDA) 의적용지침

5 VibhakarJ. Shah, Office of New Drug Quality, Center for Drug Evaluation Research, Food and Drug Administration FDA 의의약품질검사센터 / 신약품질검사 Stephen Hoag, PhD; Professor of Pharmaceutical Sciences; Director of cgmplaboratory, National Institute of Pharmaceutical Technology and Education, University of Maryland School of Pharmacy 메릴랜드약학대학의약과학부교수, cgmp 실험실디렉터 IND Process Clinical Studies / 임상시험계획승인절차 - 임상연구 PBPK extrapolation studies to Man 인간에게 PBPK( 위해평가위한 PBPK 모델 : 약물속도론 ) 외삽법 First Time in Man studies (protocol design) / 인간연구에의첫시도 ( 프로토콜기획 ) IRB Processes and requirements case studies IRB( 임상시험심사위원회 ) 절차와요구사항들- 사례연구 Case Studies and FDA pertinent guidance review/ 사례연구와 FDA 지침 Deanna L. Kelly, Pharm.D., BCPP; Associate Professor of Psychiatry; Director and Chief, Treatment Research Program (TRP); Maryland Psychiatric Research Center; University of Maryland School of Medicine 메릴랜드의과대학정신의학부부교수및메릴랜드정신의학리서치센터치료연구프로그램 (TRP) 디렉터 JiaBeiWang, PhD; Professor of Pharmaceutical Sciences, University of Maryland, School of Pharmacy/ 메릴랜드약학대학의약과학부교수 Mohamed S. Al-Ibrahim, MD; Chief Medical Officer and President, SNBL Clinical Pharmacology Center /SNBL Clinical Pharmacology Center 사장 9:00-12:00 pm Clinical Study Design Phase I, Phase II, Phase IIA, Phase III Drugs 임상연구기획단계 I, 단계 II, 단계 IIA, 단계 III- 의약품들 June 12, 2012 (Tue/ 화 ) Protocol Design, power analysis, / 프로토콜기획및분석 Drug Classes --Antimicrobials, Antihypertensives, Cardiovascular, Antipsychotics/ 약효군-항균제, 항고혈압제, 심혈관제, 항정신병치료제 Historical controls, placebo controls, standard therapy controls study 위약, 표준치료통제- 연구 IRB Processes and requirements case studies IRB( 임상시험심사위원회 ) 절차및요구사항- 사례연구 Biomarker Development and Validation / 바이오마커개발및검증 Clinical Case Studies and Pertinent FDA Guidance review 임상사례연구와적절한 FDA 지침리뷰 Islam Younis, PhD; Senior Reviewer, Office of Clinical Pharmacology, Center of Drug Evaluation Research, Food and Drug Administration FDA 약품평가리서치센터, 임상약리학사무국상임검토위원 Deanna L. Kelly, Pharm.D., BCPP; Associate Professor of Psychiatry; Director and Chief, Treatment Research Program (TRP); Maryland Psychiatric Research Center; University of Maryland School of Medicine 메릴랜드의과대학정신의학부부교수및메릴랜드정신의학리서치센터치료연구프로그램 (TRP) 디렉터 Michael L TerrinM.D.,C.M., M.P.H, Professor of Epidemiology and Public Health, University of Maryland School of Medicine 메릴랜드대학의대역학과공중보건학부교수

6 12:00 1:00pm Lunch / 점심 1:00-5:00pm Clinical Study Design Phase I, Phase II, Phase IIA, Phase III Drugs (Cont d) 임상연구기획 I, 단계 II, 단계 IIA, 단계 III- 의약품들 ( 계속 ) June 13, 2012 (Wed/ 수 ) June 14, 2012 (Thur/ 목 ) 9:00-12:00 pm Pharmacometrics and Clinical Trials Design/ 계량약리학과임상시험 Data Analysis, Pharmacometrics and Clinical Trial Design 데이터분석, 계량약리학과임상시험기획 Statistical methodology for design, and evaluation of Clinical Trials 기획을위한통계방법론그리고임상시험평가 Use of SAS, population modeling, PK/PD modeling SAS( 통계분석용프로그램 ) 의사용, 인구모델,PK/PD모델 Case Studies and pertinent FDA Guidances 사례연구와적절한 FDA 지침 12:00-1:00 pm Lunch / 점심 임상시험기획 JogaGobburu, PhD, Professor of Pharmacy Practice and Science, Director Center of Translational Sciences, University of Maryland School of Pharmacy (Note: formerly Director of Pharmacometrics, Center of Drug Evaluation Research, Food and Drug Administration) 메릴랜드약학대학제약실무와과학부교수및중계연구센터디렉터 (FDA의약품평가연구센터의계량약리학부전디렉터 ) 1:00-5:00 pm Pharmacometrics and Clinical Trials Design (Cont d) 계량약리학과임상시험기획 ( 계속 ) 9:00-12:00 pm Bioequivalence / 생물학적동등성 ANDA Process and Hatch-Waxman Law ANDA Process( 약식신약신청서절차 ) 와헤치-왁스만법 ( 의약품의허가및특허연계조항 ) Orange Book designations / 오렌지북 ( 특허목록 ) 지정 Narrow Therapeutic Index Drugs 약물농도측정 (ED 50: 50% 효과용량과 LD50: 약물독성치사량단위사이의두부분의차이가적을때 ) Old drug exceptions / 오래된약품예외 Bioavailability study design / 생물학적가용능연구기획 Bioequivalency study design / 생물학적동등성연구기획 Dissolution, SUPAC and IVIVC 용해,SUPAC( 살리실산유도체 : 아스피린 ) 과IVIC( 상관성 : 생체내와생체외상관관계 ) Bioequiavalence switchability(narrow therapeutic indices) 생물학적동등성-변경가능성 ( 약물농도측정 ) Review of pertinent FDA guidances SUPAC and IVIVC 적절한 FDA 지침의리뷰- SUPAC와 IVIC MehulMehta, PhD; Director of Clinical Pharmacology, Center of Drug Evaluation Research, Food and Drug Administration FDA 약품평가리서치센터의임상약리학부디렉터

7 Francis B. Palumbo, PhD, JD; Professor of Pharmaceutical Health Services Research; Executive Director; Center of Drugs and Public Policy, University of Maryland School of Pharmacy 메릴랜드약학대학약품과공공정책센터상임감독, 제약건강서비스리서치교수 James E. Polli, PhD. Ralph ShangrawProfessor of Pharmaceutical Sciences; Director of the Food and Drug Administration Center of Excellence in Regulatory Science and Innovation, University of Maryland, School of Pharmacy 메릴랜드약학대, 의약과학교수, FDA 규제과학및혁신센터의디렉터 12:00-1:00 pm Lunch / 점심 1:00-5:00 pm Bioequivalence (Cont d)/ 바이오동등성 ( 계속 ) 9:00am- 12:00pm Biologicals and Biosimilars/ 생물학및바이오시밀러 Clinical Study Design Phase 1-3- Biologicals 1상에서 3상까지의임상연구기획 생물학 Protocol Design, Drug Classes TNF inhibitors, anticancer agents, antiarthritis agents 프로토콜기획, 약효군-TNF inhibitors( 종양괴사인자길항제 ), 항암제, 항관절염제 Biomarker Development and Validation 바이오마커개발및검증 Biosimilars/follow on biologics; pertinent FDA guidances 바이오시밀러 / 이에관한 FDA의적합한지침 June 15, 2012 (Fri/ 금 ) JogaGobburu, PhD, Professor of Pharmacy Practice and Science, Director Center of Translational Sciences, University of Maryland School of Pharmacy (Note: formerly Director of Pharmacometrics, Center of Drug Evaluation Research, Food and Drug Administration) 메릴랜드약학대학제약실무와과학부교수및중계연구센터디렉터 (FDA의약품평가연구센터의계량약리학부전디렉터 ) Francis B. Palumbo, PhD, JD; Professor of Pharmaceutical Health Services Research; Executive Director; Center of Drugs and Public Policy, University of Maryland School of Pharmacy 메릴랜드약학대학제약건강서비스연구교수및약품및공공정책센터의상임디렉터 12:00-1:00 pm Lunch / 점심 1:00-5:00 pm Group Discussions and Q & A Session/ 그룹토론및질의 Closing Ceremony/ 폐회식 Certification / 수료식

8 Seminar Services & Admission Fee / 제공되는 제공되는서비스및등록비용 During this seminar, speakers from the University of Maryland School Of Pharmacy, University of Maryland School of Medicine, and the U.S. Food & Drug Administration will be provided. 본교육은메릴랜드약학대학, 메릴랜드의학대학, 미연방식품의약안전청 (FDA) 로부터선별된최고의교수및강사진들로진행됩니다. Attendees will also be provided for all five program days from June 11-15: 교육에참가하는모든분들께 6 월 11 일부터 15 일까지 5 일동안아래의서비스가제공됩니다. Handouts / 교육자료 Programs / 프로그램북 Breakfast / 아침식사 Lunch / 점심식사 2 Coffee Breaks / 다과 Space at the University of Maryland School of Pharmacy will also be provided along with the audio-visual presentations. 메릴랜드약학대학의강의실제공은물론시청각프리젠테이션을통한교육이진행됩니다. The total cost for this program is: $5,000 USD per Attendee 본교육프로그램총비용은한사람당미화 5,000 달러입니다. Additional Services / 추가 추가서비스 Additional services for transport (to and from the hotel and airport), hotel accommodations, evening meals and breakfast prior to departure, and an additional guide can be provided for and additional: $1,000 USD per Attendee 공항, 호텔, 교육장소로의차량이동서비스, 6박7일간의호텔숙박비용, 7일간의저녁식사비용, 통역안내서비스가제공되며, 이에관한추가서비스비용은한사람당미화 1,000 달러입니다. If there are any questions, please contact State of Maryland Office-Korea at or at contact@sombok.org website : 궁금한사항이있으시면메릴랜드주한국무역통상부로연락을주시기바랍니다. 미국 : 본부장 이봉환 blee@jgbli.com 주무관 김영은 youkim@jgbli.com 자문위원 최현경 maconchoi@yahoo.com 한국 : 자문대사 박흥민 hmsspark@yahoo.co.kr 자문위원 이선상 ceo@sundisplay.co.kr 자문위원 황유성 hwangys@neodin.com We look forward to your participation and success from this seminar. 귀하의본교육과정에의참여와앞날의성공을빌겠습니다.

시안

ULSAN NATIONAL INSTITUTE OF SCIENCE AND TECHNOLOGY GRADUATE SCHOOL OF TECHNOLOGY & INNOVATION MANAGEMENT 울산과학기술원 기술경영전문대학원 http://mot.unist.ac.kr 02 03 Global Study Mission CURRICULUM 2 Practicality Global