risk and reward of being an entreprenur in china · pdf filerisk and reward of being an...

Risk and Reward of Being an Entrepreneur in China

Dan ZhangExecutive Chairman

Feb. 19, 2017

Fountain Medical Development

FMD

WWW.FOUNTAIN-MED.COM 2

1. Risk & Reward of Being An Entrepreneur in China

2. Brief Introduction of FMD: A Cast Study

CO

NTEN

TS

u Natural bonding with folks in USA/Europe: Huge information Advantageu More up-to-date information and technologies for the biotech

u More Innovative ideas

u More solid basic researches

u More comprehensive R&D system

u More talents

u More predictable regulatory framework

u Easy to learn non-technical knowledgeu Company sponsored training/studying u EMBA or MBA

u More amicable environment for being an entrepreneuru Easy to find qualified partners to start the businessu Easy to find angel investor with amicable business termu Failure is acceptable and no repercussion for your future activity u Government support: small business loan/support; Minority advantage


Strength of Being an Returnee

u Overestimate the value of his/her technical/Culture strengthenu Technical advantage does not guarantee commercial success

u Must follow “Market Demand”: a case of solar power

u Must fit-in the regulatory environment: a case of radiation-therapy

u Good at sciences does not imply good at business: u A loner vs team work

u Deal with internal and external people: flexibility is needed

u A wondering soul vs a decisive leader

u Never-ending research to satisfy curiosity vs target at the regulatory required piece

u Understanding Chinese does not imply the understanding of concurrent change of government policies in China

u State council announcement No. 13 and No. 44

u More than 100 new guidelines issued by CFDA

u Anti-Corruption Act and its impact on the behavior of government officials


Weakness of Being an Returnee

u Underestimate the competitiveness from localsu Truly understand the market demand and government demandu Have an established network built on shared value/benefitu Cutting-throat competitive skills

u Low, lower and lowest cost

u Adapting standard Chinese tactics: spreading rumors online and in community

u Steal your key employees and trade-secret

u Hiring talents from global companies to become a truly competitive

u Get help from all sources (government officials, suppliers, etc.) to solicit customers

u Willing to do anything to win the business

u Not fully prepared when starting the new venture in Chinau Do you understand your strength and weakness? Can you convince your

family to go with your plan?u Where is your targeted market? Why China? u Where is your team? Can you convince your best friends to join you?u What do you see you and your team in next 3-5 years?u Can you support your family for 3-5 years without salary from new venture?


Weakness of Being an Returnee

u 天时(demand)，地利(Policy)，人和(Talent)u Demand for better medicine is inelastic

u Richer and live longer: healthcare is a luxury good

u Pollution in China would predict a steady increase on morbidity and mortality

u Policies become more favorable u National Funding program for new drug development

u More and more private investment on

u CFDA’s new policies are pro-new drug development

u More in-line with ICH approach (AE/SAE, acceptance of global data, timeline)

u Entrepreneurship is greatly appreciated by central and local government

u Talents Attraction Program are abundantu National and provincial/city level talent recruitment programs

u Green Card program for global talents is actively implemented across the whole country

u More successful cases for returnees u Investment for returnees become more


Opportunities for the Returnees

u Too late for certain type of products/servicesu Generics?

u Certain type of CRO services

u Too late for certain supports due to age limitationu National Talent Program

u National Funding for New Drug Development

u New technologies being developed in China firstu Such as WeChat

u New Policies in China would make it much more competitiveu Vast treatment-naïve cancer patient + fast IND/CTA approvals

u One pivotal trial is needed for NDA + conditional approval at the Phase II

u New drug definition: global newu NDA must be filed before NDA being approved outside of China


Threats for Returnees

u Risks can be managedu Calculated risk

u Identify idiosyncratic risk to your own project

u Diversify this kind of risk by managing a portfolio with a team effort

u Identify systematic risks

u Can you identify the positive trending to deal with this type of risk

u If government can help?

u Can your team manage this type of risk

u Can you afford to lose due to this type of risk?

u Any hedging possibility?

u Spreading risks with your team and your investors

u Ready to accept the failure and then start again


Risk/Reward Analysis

u Reward is abundantu Social reward:

u Linkage between No.1 and No. 2 largest economies

u Benefit global community, particularly US and China

u Building up a team of operation for local, regional and global reach

u Personal reward:u Testing your boundary of capabilities

u Financial rewardu Lower your expectation

u Risk/Reward:u We are lucky by living in this world

u Learn/work in USA, current world leader in many aspects

u Have the opportunity to make an impact in China, potential world leader

u We would waste this millennium opportunity if we do not give ourselves a chance to try


Risk/Reward Analysis

General Introduction

FMD COMPANY GROWTH HISTORY

2015/01Armenia

2015Q4Japan

K&L

FMD

2007/11Tianjin

2007/12HK

2008/05Beijing

2009/10Taiwan

2010/07Shanghai

2011/05SouthKorea

2012/08Nanjing

2013/06Guangzhou

2014/05Chengdu

FMD K&L

1995/11USA

2009CDISC Certified

Solution Provider

2011Accredited Partner with Medidata

2013Accredited partner with

Oracle


2016Q1Shenyang

2011/05FMD K&L

2016/Q3iMEDGlobal

BRANCHES AND OFFICES


u Offices DistributionDomestic： Beijing、Shenyang、Shanghai、Tianjin、Nanjing、Guangzhou、

Chengdu、Wuhan、Hong Kong、TaipeiOverseas： USA、South Korea、Armenia、Japan、India、Philippines、UK

19 Offices40 Cities1200 Employees


The President ofFMDGreater China

Yi Feng

Associate Director,PM

Chunjing NiAlice WuYing

Guo

Director, ClinicalResearchShen Niu

VP, SMOSam Xia

Associate Director,QA, ChinaBrenda Zhou

Associate Director,MT

Yingxian Shi

Senior Director, MAYinkun Lv

CFOJerry Zhang

Associate Director,Finance, China

Ying Shi

Senior Director, RALijun Xiao

Executive ChairmanDan Zhang

Director, HR, ChinaJingxuan Deng

VP, InternationalIntegrationEmil Fu

Strategy Committee

Audit Committee

CompensationCommittee

Nomination Committee

Secretary oftheBoard

CEO, FMD K&L(Non-China BUs)

Dr. Xin KeAdvisor

Global BiometricsPresident

Dr. Tiepu LiuAmericas President

Tim Seitter

Asia RegionPresident

Mahesh Mudnur

Global StatProgramming

Sr. Vice PresidentYuguang Zhao

Global DataManag.Sr. DirectorsLily Zhu, Qi Xie

Project Manag.Sr. Director

Lin Ye

Biometrics China GMSophie Su

Japan OperationsDirector

Sanae Fujita

Bus DevSr. Vice President

Ken Smith

HR/OperationsDirectorLei Lu

Global ITVicePresident Dr.Adam Chen

Global QASr .DirectorJames Liu

EuropeHead(Acting)

Somodipto Basu

Client EngagementAssoc. DirectorJimish Shah

Bus Dev WestCoast Sr. Director

Marco Nonni

MarketingSr.Manager

Catherine Ditzler

HRDirectorBiju John

MarketingManagerGargi

Kumari,

MarketingManager

Ashwini Wasalwar

Armenia Site HeadKirit Velani

Finance (Non-ChinaBUs) VPJenny Lin

Asia RegionCOODr. Ganesh Ks

Asia Region HR,Vice PresidentRadhakrishna P

Asia RegionCFOJayaraj R

Headof BD, ChinaDaorong Zhang

AssociateDirector,Clinical

Coordination&Research

Shengrong Xie

ORGANIZATION CHART

MANAGEMENT TEAM

Dan Zhang (MD, MPH, MA) Executive Chairman of FMDu MPH in Health Policy and Management from Harvard University

u MA Health Care Administration from The Wharton School, University of Pennsylvania

u MD from Peking Union Medical College

u 20 years of experience in the Pharma industry

u Head of Global Safety Assessment and Clinical Drug Development at Sigma-Tau USA (largest pharmaceutical company in Italy)

u Vice President of Quintiles Transnational Corporation.

u Long time advisor for the CFDA

u New Drug Review Committee

u Member of grant review committee for the National Key Drug Development

Xin Ke (PhD) CEO of FMD K&Lu Ph.D. in Mathematics from Rutgers University, New

Jersey, U.S.A

u BSc in Applied Mathematics from Tsinghua University, Beijing, China

u 23 years of pharmaceutical industry experience in management and statistical programming.

u Has served Novartis, J&J and Merck & Co (MSD)

u Led K&L team to help clients successfully complete a number of New Drug Applications in USA


MANAGEMENT TEAM


Yi Feng, MD, President of FMD Greater Chinau MD from the Fourth Military Medical University and

Master of Medicine from the Academy of Military Medical Sciences

u Over 25 years of drug discovery & development experience

u 5 years of clinician experience

u Senior consultant for Drug Regulatory Affairs, Covington & Burling LLP (a global consultancy)

u Associate Director, Center of Drug Evaluation, CFDA

u Deputy Director of the Office of National Key New Drug Discovery Projects

u 17 years of experience at CFDA and CDE

Emil Fu PhD, VP of International Integrationu PhD in Physical Chemistry from Case Western Reserve

University, Cleveland, Ohio, USA.

u Over 30 years of drug discovery & development experience

u 25+ years at Novartis

u Vice President and Head of Discovery Technologies, US (Analytical Sciences, Protein Structure, Imaging)

u Two years as Vice President, BioProcesses at A-Bio, Singapore.

u Two years as Vice President of Research, AscletisPharma, Hangzhou, China.

16www.fountain-med.com

TiepuLiuPhD,GlobalBiometricsPresident

p Ph.D.inBiostatistics/EpidemiologyfromUAB

p M.D.andM.S.fromTongjiMedicalUniversity

p 18yearsofindustryexperience

p PreviouslyworkedforPPD,UBC,Graceway,TheMedicinesCompany

p Servedasleadstatisticianformanysubmissionprojectsindifferentphasesofclinicaltrialsinvarioustherapeuticareas,includingmultipleNDAsandFDAAdvisoryCommitteeMeetings.

TaoWangMD,VicePresidentofClinicalAffairs

p AberdeenUniversity,UK,MSc

p ShanxiMedicalUniversity,China,MDbytraining

p 20yearsexperienceinClinicalDevelopment

p PreviouslyworkedforAlcon/Novartis,Ipsen,Genzyme,NovoNordisk,J&JandOtsuka

p ServedasCRA,Local/GlobalCPM,ChinaandPanAsiaClinicalOperationsHead

p Managedmanylocal/globalclinicaltrialsfordrug/devicefromPhaseItoPhaseIVinvarioustherapeuticareasunderCFDA,FDAandEMEAregulations

THEEXECUTIVES

WWW.FOUNTAIN-MED.COM 17www.fountain-med.com 17

YingkunLv,SeniorDirectorofMedicalAffairs

p ClinicalMedicineDegreeofTianjinMedical University

p 6yearsofphysicianexperienceinneurology

p 16yearsexperienceinmultinationalpharmaceutical/biotechnology /medicaldevicesindustry

p PreviouslyworkedforGSK;Becton,Dickinson; IPSEN;SOTIO

p Roleshaveincluded:MedicalAffairsManager,MedicalMKTManager,HeadofMedicalAffairs,MedicalDirectorofGreaterChina,SeniorMedicalDirector

p Hasledteam tosuccessfullycompletemanyclinicaldevelopmentcasesfromprotocoldesignofregistryclinical trialstomarketingpromotion inmultipletherapeuticareas

LijunXiaoMD,SeniorDirectorofRegulatoryAffairsp Pharmacy,JiamusiMedicalCollege

p 9yearsofdrugdevelopmentexperience

p Over14yearsofRAexperience

p Successfullyregisteredanumberoflocaldrugs,drugsforglobalstudiesandimporteddrugs.

p MostrecentsuccessincludesfilingandobtainingINDapprovalatCFDAforseveralimporteddrugs,includingsmallchemicaldrugsandlargemoleculedrugs.

THE EXECUTIVES

SCOPE OF SERVICES

IND PhaseI PhaseII PhaseIII NDA PhaseIV

Pharmacoeconomics Safety Evaluation

Medical Translation

3rd Party Audit Central Lab

RegulatoryAffairs


One-stopservicesandintegratedsolutions

Medical Affairs

Clinical Trial DM &STAT SMO

OUR COMPETITIVE STRENGTHS


u Rigorous adherence to international quality standards, as reflected in company motto: “Global Quality, Local Price”

u Strongest regulatory affairs team in China – devising and executing the best regulatory strategy for your product from IND to NDA

u The largest and most experienced Data Management & Biostatistics team among national CROs with state-of-art standards and most extensive global experiences

u Submitted 17 New Drug Applications to FDA and EMA within the last 3 years; 11 of these applications were successful. Submitted 55 IND/CTA/NDA’s to CFDA, 54 of which were approved.

u Completed the IND filing and development of 71 innovative drugs in China.

FMD QUALITY- Successfully Passed All Clients’ Audit

Clients’ CRO System Audit


u FMD has completed and successfully passed the CRO system audit by about 40 pharmaceutical and medical device companies

uAmong the 40 companies: Roche, Novartis, Abbott, Bayer, BMS, Pfizer, J&J, Merck, Schering-Plough, Servier, GSK, GE, Boston Scientific, Sanofi, AstraZeneca, Medtronic, etc

FMD EXPERIENCE – BY THERAPEUTIC AREAS


8680 79

69

46

30

2023 22

1912 11 10 10 9 8 8 7 5

0

10

20

30

40

50

60

70

80

90

100Project geography

Global Studies

54%Local

Studies46%

22

OUR MAIN CLIENTS

FMD EXPERIENCE – ON INNOVATIVE DRUGS

u Participated in clinical development and application

for 71 innovative drugs

u Therapeutic areas covered: Oncology, Hepatitis,

AIDS, Asthma, Diabetes, etc

u Engaging in multinational innovative drug

applications and clinical development projects such

as China-US, China-Australia, China-Europe, etc

83%

15%

2%

Chemical

MedicineBiologicals

Others

36%

6%11%4%

43%

I

I/II

II

II/III

III


REGULATORY AFFAIRS – FMD ADVANTAGES

u Peerless expertise in China’s regulatory policies and environment.

u In-depth knowledge of regulatory environments of mature markets such as US FDA and EMA.

u Insights and up-to-date knowledge of regulation reforms currently changing China’s pharma landscape.

u Experts in developing individualized regulatory strategy that maximize speed, cost efficiency and chances of success while minimizing risks and costly delays.

u A 20-member Regulatory Affair team and more than 20 regulatory consultants

u Participated in Regulatory Affairs projects for 55 drugs and 45 medical devices, 99 of them were successfully approved.

u Ability to effectively interact with the CFDA


CLINICAL TRIALS MANAGEMENT – FMD ADVANTAGES

200+CRA

40PM

6Directors

Oncology, Cardiovascularology, CNS, Respiratory, Endocrinology, Gastroenterology, Dermpatology, Pediatrics, Hematology, Gynaecology , Ophthalmology, Orthopedics, Pain, Anesthesiology, etc

Experience with broad range of therapeutical

areas, plus medical device, vaccine,

medical technology, etc

Systematic in-house training program Well-run management system

Professional monitoring and QC team

Stable management team with rich experiences Beneficial for long-term projects

Extensive databaseFast trial initiationCost-control discipline

36 domestic cities 3 continents - Asia, North

America and Europe

Execution of global multicenter projects with speed and quality.


• Over 20 years of experience in DM & STATExtensive

Experience

• 200+ team at US, China and Armenia, the biggest DM & STAT team among local CROsTeam Strength

• Accredited CRO partner of Medidata & OracleEDC

• Gold Member & Certified Solution provider• The only local CRO to have successfully

submitted with CDISCCDSIC

• Submitted 17 NDA/BLA to FDA within 3 years,

11 of which received approvalNDA


DM & STAT – FMD ADVANTAGES

MEDICAL WRITING – FMD ADVANTAGES

8 medical writers with extensive experiences60 protocols, 100 CSRs, 10 meta-analysis, etc

2 medical writers

PhD：15+ years of writing experiences, familiar with 80+ drugs

and medical devices

MPH：20+ years of writing experiences, 30+ Phase I~IV protocol

writing

8+ years experience of medical background staffs : 4

8- years experience of medical background staffs : 5


RA Introduction- AdPharma USA

- FMD RA Alliance

u All core team members are former FDA review staffs who worked at FDA for extensive period of time, and have strong regulatory background for US FDA submissions.

u We provide “hands-on” expertise in all aspects of regulatory sciences, including CMC, nonclinical, clinical pharmacology, clinical, for small molecule drugs, biologicals and medical devices.

u We provide strategic and tactical assistance to biotech and pharmaceutical companies for their drug and biological product development.

u Our philosophy is to become a strategic partner with our clients, accelerate our clients’ development programs through our expertise, trustworthiness, integrity and impeccable work ethic.


US RA TEAM – OVERVIEW

Regulatory Strategiesu Regulatory development pathways for new drugs (505 (b)(1)) and

biologics (351 a), biosimilar products (351k), 505(b)(2) drug products and generic drug products (ANDA),and FDA expedited review applications (fast track designation, breakthrough designation, accelerated approval, and priority review)

Clinical Development Strategiesu Study design, protocol development, data interpretation, CSR discussion

Biological Product Developmentu CMC regulatory consulting for biologic products development, including

monoclonal antibodies, antibody fragments, fusion proteins, antibody drug conjugate, combination products, cytokines, enzymes, vaccines, gene and cell products and radiolabeled antibodies

u EMA IMPD preparationu GMP manufacturing facility inspection and pre-approval inspection


SCOPE OF SERVICES (1)

CMC for Small Moleculesu Strategic consulting through development phases including quality

target product profiling, R&D planning, developing control strategy, establishing quality system, compliance enhancement

u Regulatory filling of API Drug Master Files, CMC sections of ANDAs, INDs and NDAs, and their corresponding amendments, post-approval supplements, written and face-to-face communication with regulatory bodies

Non-clincial Servicesu Nonclinical package preparation and study design to support PIND,

IND, and NDA/BLA

Pharmacokinetics/Pharmacodynamicsu Exposure-response correlation, population PK, analyses of

bioavailability and bioequivalence



Pre-IND Servicesu Pre-IND Meeting Request Letter and Pre-IND Meeting Information Packageu Pre-IND meeting attendance training for the Sponsoru Pre-IND FDA Meeting attendance, and meeting minutes draft

IND Preparation and Submissionu Module 1u Module 2u Module 3u Module 4u Module 5u eCTD preparation/submission

IND Maintenance and Regulatory Supportu Amendment preparation/submission including the 7-day, 15-day SAE

submissions, and significant manufacturing change submissionsu Annual Report



CRO Selection and Assistance in bidding process in US

Medical Devices and In Vitro Diagnostic Kit Support in US and Chinau Pre-Market Notification (510(k)) preparation and submission

u Pre-Investigational Device Exemption (IDE) preparation and submission

u IDE preparation and submission

u Pre-Market Approval (PMA) preparation and submission

u De novo petition



Audrey Jia, PhD (biologic CMC expert)n Dr. Jia specializes in both novel proteins/antibodies and biosimilar

products

n 10 years in the biopharmaceutical companies working on monoclonal antibody engineering, humanization, affinity maturation, expression, and purification from 1999 to 2009

n 6 years working as Senior CMC Reviewer at FDA from 2009 to 2015

- for IND/BLA of biological products especially monoclonal antibodies including antibody fragments, fusion proteins, antibody drug conjugate, combination products, and radiolabeled antibodies.

- performed US and international cGMP pre-approval inspections (PAIs).

n Dr. Jia holds a Master degree in Bioscience Regulatory Affairs from Johns Hopkins University, and a PhD degree in microbiology and molecular genetics from Emory University. Prior to that, Dr. Jia obtained her bachelor’s degree of medicine from Peking University


CORE MEMBER OF THE US TEAM (1)

Joe Chang, PhD (small molecule CMC expert)n A former senior reviewer at Center for Drug Evaluation and Research

(CDER), FDA.

- Led a chemistry review team in quality assessment of drug applications including INDs, NDAs, ANDAs and DMFs, and also participated in pre-approval inspections.

- Actively involved in several working groups within the agency to draft the guidances for industry.

n Before joining FDA, he worked in the pharmaceutical industry for many years with increasing responsibilities. He has wide exposure and hands-on experience in drug discovery, lead optimization, candidate selection, process development, tech transfer, clinical trial material and commercial production.

n Dr. Chang holds Bachelor and Ph.D. in Pharmaceutical Sciences and had two-year postdoctoral training in Chemistry.



Jim Wei, MD, PhD (early phase clinical development expert)n Dr. Wei is a seasoned clinical pharmacologist and expert in early phase drug

development and US regulatory affairs.

n A senior reviewer in the Office of Clinical Pharmacology at CDER/FDA for nearly 10 years and received a FDA Outstanding Service Award in 2005.

n Served as Medical Director at a global clinical CRO

- His expertise is study design for first-in-human (FIH), proof-of-concept (POC), dose-ranging/dose finding, drug interactions, bioavailability/bioequivalence, special populations and thorough QTc studies. He has been actively involved in many early phase studies in oncology and metabolic drug development programs.

n He has been involved in many 505(b)(2) drug product development programs.

n Dr. Wei received his Ph.D. in Pharmaceutical Sciences at the Idaho State University in 1995 and his medical degree from Zhejiang University School of Medicine in 1983 and finished his internal medicine and cardiology fellowship in China and clinical pharmacology fellowship in US. He is board certified in Clinical Pharmacology in US.



Randy Yang, MD (late phase clinical development expert)n Dr. Randy Yang worked at FDA more than 10 years as medical

reviewer and supervisory medical officer in multiple therapeutic areas. He was responsible for the clinical examination and approval of drug products in relevant therapeutic areas served as a senior clinical examination and approval officer.

n Dr. Yang was also involved in FDA guidance development in related therapeutic areas. He was responsible for approving numerous applications for new drug trials and new drug applications (INDs / NDAs), which also included applications for Chinese herbal medicines. He received numerous awards, including the FDA's Center for Excellence in Leadership, etc. Dr. Yang graduated from the Medical School in China and received residence training in US.



Leon Sun, PhD (statistical, medical device, and eCTD expert)n Dr. Sun was a former lead epidemiologist and a review team leader at the FDA's

Center for Devices and Radiological Health (CDRH).

- clinical trial designs and protocols for medical devices and in vitro diagnostic kits

- verification of medical devices and in vitro diagnostic kits in the approval of post-approval studies and reporting.

- monitoring the serious quality problems and side effects of all cardiovascular medical devices after approval for listing.

n His technical expertise is biological experiment and clinical trial design, database, data statistics and analyses, QC quality control and FDA submission materials for devices.

n Dr. Sun holds Bachelor of Medicine from Bethune Medical University, Master degree in Pathophysiology from the Third Military Medical University and Doctor Degree in clinical surgery.



RA Introduction- The China Team

FMDRegulatoryAffairsServices- RAwithintelligence

• PeerlessexpertiseonChina’sregulatorypoliciesandenvironment.• Thoroughknowledgeofregulatoryenvironmentsofmature

marketssuchasUSFDAandEMEA.• Insightsandup-to-dateknowledgeofregulationreformscurrently

changingChina’spharmalandscape.• Expertsindevelopingindividualizedregulatorystrategythat

maximizespeed,costefficiencyandchancesofsuccesswhileminimizingrisksandcostlydelays.

COMPREHENSIVE CAPABILITIES

Innovative drug registration

• Crafting of global drug development strategies• Preparation of CMC dossier• Preparation of non-clinical and clinical dossier• Clinical study protocol design• Communication and consultation with regulatory authorities• Coordination of expert panel meetings

Sound judgement + risk mitigation + key process control + interaction with authority

41


Imported drug registration

• Document translation and quality control• Revision of CMC contents to meet CFDA requirements (Regulatory

authority’s CMC requirements can be different) • Drafting of key points, summary, case justifications etc for dossier.• Organization and integration of pivotal study data• Facilitate communication between sponsor and authority

Sound judgement + risk mitigation + key process control + interaction with authority

42


Generic drug registration

Interpretation of new CFDA requirements on “Quality and Efficacy Consistency”Generic Drug Re-evaluation consultationConduct BE study fillingDevelop registration strategies for complex (non-oral) drug formulationsClinical data self-inspection expertiseQuality control of NDA documentation

Customer focus + sound judgement + risk mitigation + quality control + strong oversight

43

44

Dan Zhang (MD, MPH, MA)

Executive Chairman of FMD

As a long term advisor for CFDA, Dr. Zhang is on the New Drug Review Committee of CFDA, and a CFDA invited trainer/speaker.

Award of Special Services

In 2009, Dr. Dan Zhang, accepted the “Award of Special Services” awarded by the Center for Drug Evaluation, CFDA on behalf of FMD.

CORE MEMBER OF THE CHINA TEAM (1)

45

Yi Feng MD, President of FMD Greater ChinaDr. Feng graduated from the Fourth Military Medical University, had worked in China Food and Drug Administration-Drug Evaluation (CFDA CDE) for 17 years. He has expert knowledge and extensive experience in drug evaluation and regulatory policies. As a regulator, Dr. Feng was heavily involved in the development of many of China's newly approved drugs in a variety of therapeutic areas. Dr. Feng was personally involved in many risk / benefit analysis and high level decision-making at CDE. He coordinated the development of regulatory policies and procedures, and he led and participated in the drafting of many CFDA laws, regulations and guidelines. He has in-depth knowledge of the regulatory systems in Europe, US and other countries and regions, and spearheaded the introduction of the international consensus on the concept of the regulatory body, Good Review Practices (GRPs).


46

Lijun Xiao, Senior Director of Regulatory Affairs

Ms. Xiao has over 14 years of RA experience and she has successfully registered a number of local drugs, drugs for global studies and imported drugs. Her most recent success includes filing and obtaining IND approval at CFDA for several imported drugs, including small chemical drugs and large molecule drugs. She has been in FMD for 5 years, lead and coach RA team go strong.

Tel: +8601084406940 ext.6089Email:[email protected]


47

Lei Liu, Director of Regulatory Affairs.

Ms. Liu has over 6 years experience in biotechnical research and over 8 years experience in regulatory affairs. Ms. Liu’s successful registration cases involve pharmaceutical drugs as well as some health foods. She is several projects’ leader for implementing and managing the applications and responsible for communication with the competent authority and the sponsor.

Tel: +8601084406940ext.6090Email:[email protected]


u Under the direction of CFDA, FMD drafted:– Technical Guide of Phase I Clinical Trials (First edition)

– Technical Guide of Pharmacokinetics (First edition)

– Technical Guide of Data Management (Third edition)

– Provided translation for FDA and EMA Technical Guides (more

than 200) and edited the Chinese editions.

48

COLLABORATIONS WITH THE CFDA

Through CFDA’s public consultation sessionsu Technical consultations with CDE reviewers every work day

afternoonu Face-to-face communication with reviewers in CDE open daysu Organize formal communication meeting with CDE reviewersu Involved in committee meeting with CDE reviewers

Other fruitful collaborationsu Conducted CFDA-sponsored trainings/workshops

Ø For CFDA staff

Ø For clinical trial professionals from industry

u Served as expert for CDE technical reviewu Chaired CFDA working committee

49

INTERACTIONS WITH THE CFDA

FMD RA team currently collaborates with 53 different companies:

– 25 domestic clients

– 28 international clients

CFDApolicyinterpretation&strategicplanning

RAoperations

Interfacewithclinicaloperation

InteractionwithCFDAandclinical

investigators

Clinicaldevelopmentplan&marketaccess

analysis

CUSTOMERS OF FMD’s REGULATORY AFFAIRS Dept.

50

Global Biotech GlobalPharma

Local Biotech LocalPharma

UNMATCHED EXPERISE IN CFDA REGULATORY AFFAIRS

n Executed more than 50 IND/CTA/NDA and regulatory consulting projects.

n In-depth knowledge of CFDA policies and regulations. FMD has filed more “green channel” applications than any other CROs in China.

n Knowledge of reviewer mindset and proactive dossier preparation mitigates costly delay associated with “reviewer request for more information”

n Successfully guided many clients on the design and execution of winning regulatory strategies

51

EXAMPLES OF SUCCESSFUL CASESFMD helped obtained the approval for a client’s phase I/II trial application in China while the client had just started a phase I trial in the US. This was a breakthrough in China then because, for the first time, the CFDA approved an early phase clinical trial almost simultaneously as those going on outside of China.

A German global pharma company enlisted FMD’s service to file 4 INDs after its own applications were rejected. FMD successfully filed all 4 applications.

After several rounds of consultations with the CFDA, FMD, together with the sponsor, successfully convinced the CDE (Center for Drug Evaluation) to reverse the decision to reject the MRCT application for the product. This enabled the first-ever clinical trial of a new class of drug products in China.

A local company received a rejection notification from the CFDA. FMD reassessed the available technical evidences and explored an appeal process. The CDE agreed to reevaluate the application as a result of our effort.

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SponsorType Phase DrugClass CTAorNDA TherapeuticArea

LocalCompany I 1.1 CTA Infectiousdiseases

LocalCompany BEstudy 6 CTA Infectiousdiseases

MNC Ib/IIa 1.1 CTA Oncology

MNC Ib/IIa 1.1 CTA Oncology

LocalCompany I 1 CTA(Biologic) Diabetes

LocalCompany I 1.1 CTA Oncology

ResearchInstitute I 15 CTA Vaccine

MNC III 3.1 CTA(pediatric) Dermatology

MNC II/III 1.1 CTA(orphan) Ophthalmology

RA EXPERIENCE OF THE CHINA TEAM

54


MNC II 1.1 CTA(HK+SG) Oncology

MNC II 1.1 CTA Infectiousdiseases

LocalCompany II 1.1 CTA HepatitisB

LocalCompany PK+II+III 1.1 CTA+NDA Hepatitis C

LocalCompany II 1.1 CTA Oncology

MNC III+PK 1.1 CTA Cardiovascular

MNC III 1 CTA(Biologic) Oncology

MNC III+PK 1.1 CTA Diet

MNC IV 6 NDA(pediatric) Antipyretic


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MNC III 3.1 NDA GIdisease

MNC III 3.1 NDA Oncology

LocalCompany GenericDrug NDA(OTC) Respiratory

LocalCompany GenericDrug NDA(OTC) Respiratory

MNC III+PK 3.1 NDA(OTC) Respiratory

MNC III+PK 3.1 NDA(OTC) Respiratory

LocalCompany I/II/III 1.1 NDA Oncology

MNC III 3.1 NDA Infectiousdiseases


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MNC III 3.1 NDA CNS

MNC III 3.1 NDA CNS

MNC III 3.1 NDA CNS

MNC III 3.1 NDA Ophthalmology

MNC III 3.1 NDA Ophthalmology


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MNC I 3.1 NDA Ati-infective

MNC III 3.1 NDA Cardiovascular

MNC III 3.1 NDA Diabetes

MNC III 3.1 NDA GI

MNC III 3.1 NDA Metabolic

MNC IV 6 NDA(OTC) WomenHealth

MNC III 3.1 NDA Osteoporosis

MNC III 3.1 NDA Diabetes


58


MNC III 3.1 NDA PeripheralVascularDisease

MNC III 3.1 NDA PeripheralNeuropathy

LocalCompany III+Ext 1.1 NDA Dermatology


Oncology Experience of FMD

ONCOLOGY PROJECTS BY PHASE


PhaseI22%

PhaseII12%

PhaseIII10%

PhaseIV7%

RegulatoryAffairs12%

DM/BS16%

StatisticalProgramming7%

MedicalWriting14%

Oncology Trials by Phase

ONCOLOGY PROJECTS BY THERAPEUTIC AREA


SolidTumor16%

Heme12%

Lung14%

Breast14%

GI30%

CNS4%

Ovarian4%

GU6%

Oncology Trials by Therapeutic Area

TherapeuticArea Indication Phase No.ofSites

No.ofPatients Country ServicesProvided

Oncology Solidtumor I 1 20 China PKTrial



Oncology LowWBCcausedbychemo I 1 30 China

CentralLab,DM/BS,MedicalWriting,ClinicalMonitoring

OncologyAdvancedsolidtumorandlymphoma

I 2 30 ChinaPK,Clinical

Monitoring,MedicalWriting

Oncology LowWBCcausedbychemo I 1 46 China PK,DM/BS,Medical

Writing

Oncology/Hematology MyelodysplasticSyndrome I 1 30 China PKTrial

Oncology Trial Experience

WWW.FOUNTAIN-MED.COM62

TherapeuticArea Indication Phase No.ofSites

No.ofPatients Country ServicesProvided

Oncology Solidtumor I 1 36 China ClinicalSiteMonitoring

Oncology Solidtumor I 1 36 China ClinicalSiteMonitoring

Oncology Solidtumor I 1 TBD China ClinicalSiteMonitoring

Oncology SolidTumor I 1 36 China Antibody PKTrial

Oncology

Recurrentmetastaticheadandnecksquamous cellcarcinomasor

metastaticcolorectalcancer

I 1 36 China ClinicalSiteMonitoring

Oncology Leukemia I 3 30 China

RegulatoryConsulting,Monitoring, ProjectManagement,DM/Biostat,Medical

Writing,CentralLab,Safetyand

Pharmacoeconomics


63

Oncology Trial ExperienceTherapeuticArea

Indication Phase No.ofSites

No.ofPatients

Country ServicesProvided

Oncology Esophagealcancer I 1 36 ChinaMedicalwriting

DM/SA,ClinicalSiteMonitoring

Oncology Tumorauxiliarymedicine Ia 1 46 China PKTrial

Oncology Lungcancer Ib 1 24 ChinaCentralLab,DM/BS,

MedicalWriting,ClinicalMonitoring

Oncology Solidtumor Ib 2 48 China PKTrial

Oncology Solidtumor Ib 1 24 China PKTrial

OncologyUnresectablelocalizedor

metastaticNSCLCI/IIa 20 90 Taiwan

RegulatorySubmission,InvestigatorMeeting,DM,ClinicalSiteMonitoring,

ArchivingWWW.FOUNTAIN-MED.COM 64


TherapeuticArea


No.ofPatients


Oncology Glioblastoma I/II 1 60 China

Protocoldesign,ProjectManagement,Monitoring,EDC,DM/Biostat,Medical

Writing,andSafetyHandling

Oncology Pancreaticcancer I&II 15 100 China/Taiwan

Regulatory,ProjectManagement,Monitoring,EDC,DM/Biostat,MedicalWriting,SafetyHandling

andDMCservice

Oncology Pancreaticcancer II 5 90 China RegulatorySubmission,PV

OncologyHER2positivestageII-IIIEarlyBreastCancer

II 13 100 China

Investigatormeeting,DM/SA,ClinicalSiteMonitoring,Medical

Writing,PV,QA,ArchivingWWW.FOUNTAIN-MED.COM 65



No.ofPatients


Oncology Ovariancancer II 10 200 China PV

OncologyRadiationinducedfatigue

II 10 200 China PV

Oncology Melanoma II 15 100 China PV

Oncology NSCLC II 10 100 China DM/SA,ClinicalSiteMonitoring

Oncology Breastcancer II 2 400 China ClinicalSiteMonitoring,MedicalWriting

Oncology NSCLC II 10 100 China

RegulatorySubmission,InvestigatorMeeting,DM/SA,ClinicalSiteMonitoring,MedicalWriting,IVRS,QA

Oncology NSCLC II 1 60 China ClinicalSiteMonitoringWWW.FOUNTAIN-MED.COM 66



No.ofPatients


Oncology LungCancer III 12 80 China

DM/SA,ClinicalSiteMonitoring,Medical

Writing

Oncology BreastCancer III 25 387 China

RegulatorySubmission,DM/SA,ClinicalSiteMonitoring,Medical

Writing,QA

Oncology Sarcoma III 50 300 China RegulatorySubmission,ClinicalSiteMonitoring

Oncology Breastcancer III 6 750 China Clinical SiteMonitoring, BS

Oncology NSCLC III 16 140 China Clinical SiteMonitoringWWW.FOUNTAIN-MED.COM 67


Indication Phase No.ofSites No.ofPatients


Oncology Livercancer III 5 100 China ClinicalSiteMonitoring,CentralLab

Oncology Gastriccancer III 20 200 S.Korea

InvestigatorMeeting,IPManagement,Clinical

SiteMonitoring

Oncology NSCLC III 10 120 China ClinicalSiteMonitoring

Oncology Pancreaticcancer III 20 273 China SMO:ClinicalResearch

Associates

Oncology mRCC IV 15 155 China

Invest.Meeting,DM/BS,ClinicalSiteMonitoring,MedicalWriting,QA,Pt.

Recruitment,PVWWW.FOUNTAIN-MED.COM 68




Oncology/Hematology

Acutelymphoblasticleukemia

IV 8 50 China ClinicalSiteMonitoring

Oncology NSCLC IV 20 200 S.Korea InvestigatorMeeting,ClinicalSiteMonitoring

Oncology

HER2positivestageII-IIIearlybreast

cancer

IV 13 100 China

CentralLab,Invest.Meeting,DM/BS,ClinicalSiteMonitoring,Medical

Writing,QA,Pt.Recruitment,PV

Oncology NSCLC IV 25 1000 China ClinicalSiteMonitoring

Oncology NSCLC IV 40 636 ChinaProjectManagement,EDC,DM/Biostat,SafetyandMedicalWriting69




Oncology NSCLC SurveyProject 25 N/A China ClinicalSiteMonitoring

Oncology Breastcancer Devicetrial 2 400 China ClinicalSiteMonitoring

70

Oncology Experience: Regulatory Affairs

TherapeuticArea Indication Country ServicesProvided

Oncology Hepaticcancer HongKongandSingapore RegulatoryDocumentPreparation&Submission

Oncology Pancreaticcancer China RegulatoryDocumentPreparation&Submission

Oncology Glioblastoma(Orphandrug) China RegulatoryDocument

Preparation&Submission

Oncology Cancer(Antibody) China RegulatoryDocumentPreparation&Submission

Oncology Pancreaticcancer China RegulatoryDocumentPreparation&Submission

Oncology Livercancer China RegulatoryDocumentPreparation&Submission

Oncology BRCA1&2 ChinaRegulatoryDocument


Oncology OvarianCancer ChinaRegulatoryDocument

Preparation&SubmissionWWW.FOUNTAIN-MED.COM 71

Oncology Experience: Regulatory Affairs


Oncology Hepaticcancer China RegulatoryDocumentPreparation&Submission

Oncology Gastroenteropancreaticneuroendocrinetumors China RegulatoryDocument


Oncology Pancreaticcancer China/USA Consulting,RegulatoryDocumentPreparation&Submission


Oncology Experience: DM/BSTherapeuticArea Indication Country ServicesProvided

Oncology Prostatecancer China DM/SA

Oncology Prostatecancer China DM/SA

Oncology Ovariancancerperitonealeffusion China DM/SA

Oncology T/NKcelllymphoma China DM/SA

Oncology/Hematology Leukemia China DM/SA

Oncology GastricCancer China DM/SA

Oncology Hepatocellularcarcinoma(HCC) China DM/SA

73

Oncology Experience: DM/BS


Oncology DLBCL China DM/SA

Oncology HepatitisCirrhosis(LiverCancer) China DM/SA

Oncology Colorectalcarcinoma China DM/SA

Oncology Advancedmalignantneoplasm China DM/SA

Oncology/Hematology ChemoInducedNeutropenia China DM/SA

Oncology Malignantneoplasmofretroperitoneum China DM/SA

Oncology Hepatocellularcarcinoma(HCC) China DM/SA

74

Oncology Experience: Biostatistics & CDISC


Oncology/Hematology

AcuteMyeloidLeukemia(AML) USA:FDAadvisorymeeting

Fullstatisticsandprogrammingsupport forCSR

Preparedfull e-Submission packageincluding CDISCcompliantdata

packageandTLFforCSR

Oncology BreastCancer

USA&

Support forEMA,Japan,Canada,Singaporeagency

submission

Fullstatisticalandprogrammingsupport forpivotalprotocolSAP,shells, methodology, generationof

TLFforCSR.Fullstatisticalandprogrammingsupport forISS/ISEincluding11

studiesPreparedfull CDISCcompliancee-submission datapackagetoFDA

Oncology Non-Hodgkin’sLymphoma USA

CreatedCDISCcompliancee-submission datapackagefor7

studiesProvided statisticalconsultationsupport toreviewandcomments

forcurrentstudiesProvided adhocprogramming

support75

Oncology Experience: Biostatistics & CDISC


Oncology/Hematology

Myelodysplasticsyndrome(MDS)

USA,EMA,Canada,Japan,South Korea,Singaporesubmissionsapproved!

Statisticsandprogrammingsupport forpivotalstudy;Preparedfulle-Submission packageincludingCDISCcompliantdatapackageand

TLFforCSR

Oncology BreastCancer Global

PerformedTraceabilitychecksforSDTMandanalysis datasetstoFDA

submissions. Thedrugissubsequently approvedbythe

FDA.

Oncology/Hematolgy Myelofibrosis Global

Support ISSforaNDAsubmissionincluding 16studies.Scopeofworkincludes legacydataSDTMconversions, SDTM,ADaM andTLFsupport forpivotalstudyaswellasADaM andTLFsupportforISS.

eSubmission datapackagesincludeSDTM,ADaM,corresponding

define.xmlandReviewer'sGuide

Support ISSforaNDA76

Other Oncology ExperienceTherapeuticArea Indication Country ServicesProvided

Oncology Prostatecancer China CentralLab

Oncology Hepatocellularcancer China CentralLab

Oncology Gastriccancer China MedicalWriting

Oncology Metastaticcolorectalcancer China MedicalWriting

Oncology Recurrentmetastaticheadandneckcancer China MedicalWriting

Oncology HCC China MedicalWriting

Oncology SolidTumor China MedicalWritingWWW.FOUNTAIN-MED.COM 77

Other Oncology ExperienceTherapeuticArea Indication Country ServicesProvided

Oncology Solidtumor China MedicalWriting

Oncology Braintumor China MedicalWriting

Oncology Lymphoma China MedicalWriting

Oncology Prostatecancer China MedicalWriting

Oncology Lungcancer China MedicalWriting

OncologySquamouscell

carcinoma(SCC)oftheoralcavity

China StudyFeasibility

Oncology BraincancerandNSCLC China Consulting,KOLWWW.FOUNTAIN-MED.COM 78

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