2nd annual medical affairs leaders forum asia- august 5th - 6th, 2014

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MEDICAL AFFAIRS LEADERS FORUM ASIA Le Meridien Cyberport, Hong Kong August 5th-6th, 2014 2 EVENTS IN ONE: Hear keynote presentations from the experts: with more than 16 presentations from expert medical affairs leaders • Best Practices in Medical affairs ManageMent in asia • late Phase & real-World evidence generation for Medical affairs richard nieman Senior Vice President, Head of Global Medical Affairs teva, Usa Kurt rimkus, M.d., Ph.d. Senior Director, Head Medical Affairs shire, Japan Yoko fujimoto, M.d., Ph.d. Sr. Director, Head of Medical Affairs, Global Established Products Pfizer Japan lynne Kelley, Md, facs Worldwide Vice President Medical Affairs Medical Surgical Systems Bd, Usa dr.timothy low VP Medical Affairs, Asia Pacific covidien, singapore dr. samuel dyer Chairman of the Board, Medical science liaison society, Usa dr sadhna Joglekar Vice President and Area Medical Director Asia Pacific, North Asia and South Asia, gsK 2ND ANNUAL

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Dr. Samuel Dyer will be moderating the 2nd Annual Medical Affairs Leaders Forum Asia in Hong Kong on August 5th-6th, 2014. Dr. Samuel Dyer will also be speaking at the event and will represent the Medical Science Liaison Society.

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Page 1: 2nd Annual Medical Affairs Leaders Forum Asia- August 5th - 6th, 2014

MEDICAL AFFAIRSLEADERS FORUM ASIALe Mer id ien Cyberpor t , Hong Kong

August 5th-6th, 2014

2 EVENTS IN ONE:

Hear keynote presentations from the experts:

with more than 16 presentations from expert medical affairs leaders

• BestPracticesinMedicalaffairsManageMentinasia

• latePhase&real-WorldevidencegenerationforMedicalaffairs

richardniemanSenior Vice President, Head of Global Medical Affairsteva,Usa

Kurtrimkus,M.d.,Ph.d.Senior Director, Head Medical Affairsshire,Japan

Yokofujimoto,M.d.,Ph.d.Sr. Director, Head of Medical Affairs,Global Established ProductsPfizerJapan

lynneKelley,Md,facsWorldwide Vice President Medical Affairs Medical Surgical SystemsBd,Usa

dr.timothylowVP Medical Affairs, Asia Pacificcovidien,singapore

dr.samueldyerChairman of the Board, Medicalscienceliaisonsociety,Usa

drsadhnaJoglekarVice President and Area Medical Director Asia Pacific, North Asia and South Asia,gsK

2ND ANNUAL

Page 2: 2nd Annual Medical Affairs Leaders Forum Asia- August 5th - 6th, 2014

Speaker Over v iew

eventstructure:

day1(august5th) BestPracticesinMedicalaffairsManagementinasia

day2(august6th) latePhase&real-WorldevidencegenerationforMedicalaffairs

PHARMA & MEDICAL DEVICE INDUSTRY EXPERTS

richardniemanSenior Vice President, Head of Global Medical Affairsteva,Usa

drsadhnaJoglekarVice President and Area Medical Director Asia Pacific, North Asia and South AsiagsK

elizabethKupferer,Phd,WhnP-BcMedical Affairs Consultant, USA(formerly,sr.directorMedicalaffairs,sequenom,inc.)

Kurtrimkus,M.d.,Ph.d.Senior Director, Head Medical Affairsshire,Japan

danWangMedical Director for Greater ChinaBd,china

chernsearnlimCountry Head of Medical Affairs, Pacific Rimshire,singapore

dr.timothylowVP Medical Affairs, Asia Pacificcovidien,singapore

amitgargMedical Head - Emerging Marketsdrreddys,india

BeataniechodaExecutive Committee of the australianPharmaceuticalPhysiciansassociation(aPPa)

dr.Kyoungsooha,Md,PhdMedical Advisor / Regional Project Lead (Diabetes)sanofi,Korea

helenlinMedical Affairs Director,astrazeneca,china

dr.cristinachangindependentexpertMedicalaffairs,taiwan

lynneKelley,Md,facsWorldwide Vice President Medical Affairs Medical Surgical SystemsBd,Usa

Yokofujimoto,M.d.,Ph.d.Senior. Director, Head of Medical Affairs Global Established ProductsPfizer,Japan

dr.samueldyerChairman of the BoardMedicalscienceliaisonsociety,Usa

YolaMoridePresidentYolarxconsultants,canada

eventPartners:

Page 3: 2nd Annual Medical Affairs Leaders Forum Asia- August 5th - 6th, 2014

Event & StreamsOver v iew

eventoverviewAsia’s pharma market is already worth more than $200 billion and is expected to grow strongly in the coming years. The market is incredibly diverse, from advanced economies such as Japan, South Korea, Taiwan, Singapore, Australia and New Zealand, to large and rapidly developing markets such as China, India, Indonesia, Thailand or The Philippines. The population in Asia is over 4 billion and the Asian middle class is growing very quickly. Factors such as rising incomes, increased government expenditure on healthcare and the growing incidence of chronic developed-world diseases associated with changing lifestyles, have all significantly contributed to increased healthcare demand in Asia. Therefore, many global pharmaceutical companies are looking at Asia to counter stalling or falling revenue streams in more developed markets. In order to maximize their performance in these emerging markets, pharmaceutical companies increasingly rely on medical affairs to facilitate the achievement of their goals.

day1-BestPracticesinMedicalaffairsManagementinasiaThe roles of medical affairs and liaison have never before been so crucial to the success of pharmaceutical strategic and operational commercial objectives. Medical departments play a vital role in generating quality clinical and real-world data that payers and prescribersneed to improve decision making when uncertainty is high. In Asia, medical affairs and (increasingly liaisons) also play an increasingly important role in communicating the value message to physicians in an objective and ethical manner, providing education on product benefits and risks. This is even more essential as busy doctors in the region have little time for sales pitches from commercial executives, but do often appreciate the “neutral” education of benefits vs risks that medical professionals are in a position to discuss. The medical affairs department is increasingly becoming central to the coordination of internal stakeholders (commercial, market access, regulatory, clinical development, drug safety) with the needs of external stakeholders and achieving more client-centric business models. Medical teams not only need to develop strong data, but also need to help educate KOLs and payers on the value of that data, especially for complex diseases.

day2-latePhase&real-WorldevidencegenerationforMedicalaffairsGenerating real-world evidence via observational studies and the use of patient registries is one of the fastest growing areas of pharmaceutical R&D internationally, as well as in Asian countries. Such post-marketing studies are becoming increasingly important as regulatory agencies and key-stakeholders demand more real-life, long-term data which demonstrates efficacy, safety and quality. Furthermore, a key driver for these types of studies are the growing demands of both global and increasingly, Asian health technology assessors (HTAs) and payers and their need for evidence-based health economic data, based on unique local conditions. As more patients than ever before in the region have access to advanced medicines, Asia is also an increasingly popular place to conduct late phase studies, to study large real-world patients subsets and to satisfy the data requirements of regulators and HTAs in more developed markets. Planning and implementing late phase studies are a major challenge, especially in a region with little experience in this area. Getting the trial design right is essential, as designs from Europe or The USA may not be suitable for Asian populations. Patient populations in Asia are as spread out and diverse as much as the huge market itself. Implementing real-world studies are also a major difficulty, especially in terms of patient selection and investigator recruitment. Less-experienced KOLs and physicians need detailed education on trial protocols as well as best practices in this area where experience is often limited at best. Close monitoring and effective data management is extremely crucial in ensuring the success of late phase studies in Asia.

Whyattend?This event will offer a unique chance to benchmark and network with Asia’s medical affairs experts to discuss best practices in medical affairs management, KOL education, communication, engagement and data generation, specifically in an Asian context. Attendees will appreciate how to maximise the performance of medical teams, which can facilitate the enhanced productivity of other key departments, and as a result, enhance a product’s profile in the eyes of key stakeholders and customers.

WhoWillBenefit:

PHARMA & MEDICAL DEVICE:

vPs,regional&globaldirectors,managersofMedicalaffairs,Medicalscienceliaisons,Medicaleducation,healthoutcome&liaison,MedicalMarketing&communications.

Kol&stakeholderengagement,latePhase,clinicaldevelopment,scientificaffairs,Medicaladvisors,customerrelations.

Page 4: 2nd Annual Medical Affairs Leaders Forum Asia- August 5th - 6th, 2014

08.00 Registration & Coffee 08.30 Chairperson’s Opening Remarks: dr.samueldyer,Chairman of the Board Medicalscienceliaisonsociety,Usa

ASIAN MEDICAL AFFAIRS WITHIN THE GLOBAL CONTEXT

08.40 Bestpracticeinglobalmedicalaffairs:impactonasia

❖ Overview of best practice in US/Europe and how that can benefit medical affairs in Asia-Pacific.

richardnieman Senior Vice President, Head of Global Medical Affairs, teva,Usa

SETTING UP SUCCESSFUL MEDICAL AFFAIRS TEAMS FOR MAXIMUM PRODUCT SUCCESS

09.20 WhatshouldagreatMsllooklikeintheevolving healthcarelandscapeinasia?

❖ Evolution of MSL role. ❖ External customer perspective. ❖ Internal customer perspective. ❖ Best practices while designing and determining the role of an

MSL in Asia.

drsadhnaJoglekar,Vice President and Area Medical Director Asia Pacific, North Asia and South AsiagsK

10.00 thegrowingimportanceoftheMslroleglobally

❖ Activities and how MSLs are being utilized in Asia. ❖ Growth rates. ❖ KOL perspectives on the MSL role versus sales reps.

dr.samueldyer,Chairman of the BoardMedicalscienceliaisonsociety,Usa

10.40 Networking & Coffee Session

11.00 casestudy:establishmentofanewmedicalaffairs department

❖ Assessment of practical considerations for the establishment of a new medical affairs department.

❖ Discuss the development of clear goals and objectives for internal medical affairs functions and alignment with preexisting clinical teams overlap.

❖ Discuss the considerations for medical affairs external expansion of a field based MSL team.

❖ Communicate the importance of cross-functional team buy in and continued support.

elizabethKupferer,Phd,WhnP-Bc,Medical Affairs Consultant, USA; (formerly,sr.directorMedicalaffairs,sequenom,inc.)

11.40 MedicalaffairsandMslmanagementinJapanin comparisontoothercountries

❖ MSL backgrounds and job profile. ❖ Training necessities. ❖ The Scientific Strategic Platform (SSP) communication. ❖ MSL involvement into data generation. ❖ KPIs for MSLs (frequency and reach, agreement levels to SSP,

advocacy evaluations etc.).

Kurtrimkus,M.d.,Ph.d.,Senior Director, Head Medical Affairsshire,Japan

12.20 Luncheon Break

STRATEGIC MEDICAL AFFAIRS MANAGEMENT

13.30 comparingmedicalfunctionsandmedicalstrategies: Pharmavs.Medicaldevice

❖ Highlight the current status of the development of the device industry.

❖ Illustrate the top needs for medical affairs within the device company; (in comparison with Pharma).

❖ Describe how medical affairs establish the sub-function and organization to meet the needs from the company and industry.

❖ Brief the difference of clinical trials between device and pharma from protocol design, trial execution, to data analysis.

danWangMedical Director for Greater ChinaBd,china14.10 Whatistheidealroleofthemedicalaffairsdepartment todayinadynamiccross-functionalteam

❖ The right competencies that supports cross functional teams of therapeutic expertise, commercial, regulatory, R&D, legal, compliance etc.

❖ Collaborations and setting expectations with different team members.

❖ Cultural differences across borders.

chernsearnlimCountry Head of Medical Affairs, Pacific Rimshire,singapore

KOL & STAKEHOLDER MANAGEMENT IN ASIA

14.50 anapproachtoKolcustomisation,engagementand management

❖ Understanding KOL and stakeholder needs. ❖ KOL matrix: A common language across multiple markets. ❖ KOL database: Managing KOL engagement and communication. ❖ KOL action planning and harnessing for business improvement.

dr.timothylowVP Medical Affairs, Asia Pacificcovidien,singapore15.30 Networking & Coffee Session

MEDICAL COMMUNICATION TO ENHANCE THE EFFECTIVENESS OF BRAND COMMUNICATIONS

15.50 developingandpracticingthe“artofMedical communication”

❖ Basics of medical communication, some concepts about layout, referencing, regarding communication.

❖ Highlighting how medical heads can lead the brand communications because they are the people who understand medical issues, doctors and patients.

amitgargMedical Head - Emerging Marketsdrreddys,india

16.30 Paneldiscussion:Bestpracticesinmedicalaffairs management

❖ Medical affairs in Asia: Roles and challenges. ❖ Enhancing the medical department’s role in managing the

product’s lifecycle. ❖ Enhancing effectiveness of the MSL role specifically in the

APAC region. ❖ Measuring and maximizing performance of medical teams.

richardnieman,teva,Usa danWang, Bd,chinaKurtrimkus,M.d.,Ph.d, shire,Japan

17.10 Chairperson’s Closing Remarks

17.20 End of Day One

5th August, 2014DAY 1

19:30-exclusivenetworkingdinnerforallparticipants

BEST PRACTICES IN MEDICAL AFFAIRS MANAGEMENT IN ASIA

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Page 5: 2nd Annual Medical Affairs Leaders Forum Asia- August 5th - 6th, 2014

08.30 Registration & Coffee09.00 Chairperson’s Opening Remarks: Beataniechoda, australianPharmaceuticalPhysiciansassociation(aPPa)

LATE-PHASE CLINICAL PERSPECTIVE

09.10 clinicaltrialsandtheroleofMedicalteamsandclinical teams:What’sthedifference?

Beataniechoda,Executive Committee of the australianPharmaceuticalPhysiciansassociation(aPPa)

LATE PHASE AND REAL-WORLD STUDIES IN ASIA

09.50 real-worldevidencegenerationinaPacregion

❖ Unmet needs of real-world evidence: Value demonstration to stakeholders in the region.

❖ Solutions with consideration: Advantages and limitations from real-world examples.

dr.Kyoungsooha,Md,Phd, Medical Advisor / Regional Project Lead (Diabetes)sanofi,Korea

10.30 Networking & Coffee Session

11.00 latephaseresearch:Makingthebestuseofevidence generationtools

❖ Operational challenges. ❖ Managing CROs, selecting sites, motivating investigators.

helenlin,Medical Affairs Director,astrazeneca,china

11.40 Practicalimplicationsoflatephaseresearchand pharmacovigilanceprograms

❖ Increasing demand for more valuable and pragmatic data that are needed to achieve or maximize business growth.

❖ Late phase research as critical tool that provide relevant insights to understand the effectiveness and safety of a product after launch.

❖ The pharmaco-economic approach of a drug presented to the main stakeholders with post-marketing and specific market data do help the stakeholders in their decision making to approve a drug or continue to support it versus others of the same or other class.

dr.cristinachangindependentexpertMedicalaffairs,taiwan

12.20 Luncheon Break

13.30 latephaseresearchinchina

❖ What do you want the research to achieve? ❖ What are the options, roles and responsibilities?

❖ Investigator-initiated. ❖ Sponsor-initiated. ❖ Hybrid models.

❖ Who owns the data? ❖ How do you manage poor results from a poorly designed

study? ❖ Compliance and ethics in post-marketing trials.

lynneKelley,Md,facsWorldwide Vice President Medical Affairs Medical Surgical SystemsBd,Usa

14.10 latephaseresearch&real-worldevidencegenerationin Japan

❖ What type of studies produce the best quality data in the eyes of stakeholders in Japan.

❖ New approach of using real-world data to produce the reliable evidence in eyes of stakeholders in Japan.

Yokofujimoto,M.d.,Ph.d.Senior. Director, Head of Medical Affairs Global Established ProductsPfizer,Japan

14.50 Networking & Coffee Session

15.20 findingfit-for-purposedatabasesforreal-world investigations:evidence-basedmappingsolutions

Databases are increasingly recognized by regulators and payers as a valuable tool for real-world investigations since they provide data on drug usage and endpoints in a clinical practice setting.

❖ Present an evidence-based solution for the identification of less traditional databases and patient populations.

❖ Review the criteria of selection of databases (e.g. availability of endpoints, population covered, accessibility…).

❖ Present a framework to assess the utility of databases for the conduct of studies on disease progression, patient journey, unmet needs, etc…

❖ Showcase examples of database mapping.

YolaMoridePresidentYolarxconsultants,canada

16.00 Paneldiscussion:latephaseresearchinasia:challenges ofdesignandimplementationspecificallyforasia.

❖ Study design to generate quality evidence. ❖ Stakeholder needs and their impact on RWE requirements in

Asia. ❖ Motivating investigators to participate in late phase studies. ❖ Challenges of outsourcing late phase research in Asia.

dr.Kyoungsooha,Md,Phd, Medical Advisor / Regional Project Lead (Diabetes)sanofi,Korea

helenlin,Medical Affairs Director,astrazeneca,china

lynneKelley,Md,facsWorldwide Vice President Medical Affairs Medical Surgical SystemsBd,Usa

Yokofujimoto,M.d.,Ph.d.Senior. Director, Head of Medical Affairs Global Established ProductsPfizer,Japan

16.40 Chairperson’s closing remarks

16.50 End of day two

DAY 2 6th August 2014

LATE PHASE & REAL-WORLD EVIDENCE GENERATION FOR MEDICAL AFFAIRS

Page 6: 2nd Annual Medical Affairs Leaders Forum Asia- August 5th - 6th, 2014

Speaker Biogr aph iesdr.timothylow,VP Medical Affairs, Asia Pacificcovidien,singapore

Dr. Timothy Low is a medical doctor and is currently the Vice President for Medical Affairs for Asia Pacific at Covidien. He manages the medical affairs and clinical development of new

and current devices for the unmet needs of doctors and patients in this region. He was the immediate-past Regional Medical Director for a top-ten pharmaceutical company and was awarded the ‘Best Outstanding New Talent’ for Asia Pacific in 2007. He has also been bestowed the Clinical Trials Honor Roll for 2011 and 2012. Dr Low was also the CEO of Gleneagles Hospital where he successfully led Gleneagles to establish itself as a 6-star private healthcare provider by clinching 14 local and regional awards including the highly prestigious Asian Hospital Management Award. With his expertise, he has not only contributed significantly in Clinical Research, but also to the pharmaceutical industry, medical device industry, as well as the medical community.

Kurtrimkus,M.d.,Ph.dSenior Director, Head Medical Affairsshire,Japan

My career in Pharmaceutical Industry spans 24 years, 23 years of which I have worked in Japan. Early on I have been involved

on the commercial side in sales force management and marketing and later in the R&D area, in clinical project management. Since 2003 I am leading Medical Affairs functions. This helped me to gain deep and brought insights into the Japanese pharmaceutical market environment and its regulations. In 2005, I became Medical Director of the Medical Affairs Division at Nippon Organon. This developed into the Medical Director position at MSD through 2 consecutive mergers: In 2008 Schering Plough acquired Organon and I was appointed Medical Director for the newly merged company under the name of Schering Plough K.K. in Japan. At the end of 2009, Merck Inc. acquired Schering Plough and again I became Executive Director and Medical Director for the newly created entity MSD K.K. in Japan. In October 2012, after 7 consecutive years, I decided to leave MSD Japan and join Shire Pharmaceuticals Japan as Senior Regional Medical Director

dr.Kyoungsooha,Md,PhdMedical Advisor / Regional Project Lead (Diabetes)sanofi,Korea

Dr. Kyoungsoo Ha is a Medical Advisor in Sanofi Korea and leading JPAC regional project to build medical affairs strategies

for diabetes pipeline. He is currently leading real-world data mining project for diabetes portfolio. During his career, he led Medical Affairs and MSL team in multiple TA’s in Sanofi and Novartis Korea and worked as Regional Medical Expert in Diabetes. He has designed late phase clinical trials in cardiovascular area and real world studies with risk sharing model for Oncology portfolio. He is a board certified Preventive Medicine and PhD of Public Health with the research in cardiovascular epidemiology.

lynneKelley,Md,facsWorldwide Vice President Medical Affairs Medical Surgical Systems,Bd,Usa

Lynne Kelley, MD, FACS, is the World Wide Vice President, Medical Affairs for Medical Surgical Systems at Becton

Dickinson. Dr. Kelley is a board certified general and vascular surgeon having received her medical degree from Dartmouth Medical School and completed her Residency in General Surgery at Dartmouth Hitchcock Medical Center. During her training she was awarded an NIH sponsored basic science research grant at Harvard Medical School. She completed a Fellowship in Vascular Surgery at Harvard Medical School, Massachusetts General Hospital and was awarded the Marco Polo Fellowship providing advance training in Endovascular Surgery at the University Paris Hospital, Henri Mondor. Dr. Kelley was an assistant professor of vascular surgery and radiology at Yale University. In 2005 she joined Boston Scientific where she was the medical director for the peripheral interventions and vascular surgery business as well as neuro-interventions. Dr. Kelley joined Kimberly Clark 2008 as Vice President Medical Director for the healthcare business and later assumed responsibility for the medical, professional and consumer divisions of the entire company for clinical strategy and monitoring, trial design and execution, clinical education, global coordination of professional and government relationships, reimbursement and due diligence as well as being part of the leadership for the company. In January 2011 Dr. Kelley joined Becton Dickinson as the World Wide Vice President of Medical Affairs Medical Surgical Systems. She leads a global team of medical professionals in a wide variety of activities including innovation, due diligence, clinical trials, safety evaluations, product development and key opinion leader management. Lynne is also an integral member of the business team determining strategy and execution for both organic and inorganic growth opportunities. Lynne also serves on the board of directors for BDRx a generic pharmaceutical company.

elizabethKupferer,Phd,WhnP-Bc,Medical Affairs Consultant, USA; (formerly,sr.directorMedicalaffairs,sequenom,inc.)

Dr. Elizabeth Kupferer is a senior level Medical Affairs professional with over 12 years of experience within

Pharmaceutical Industry as a Medical Science Liaison (MSL) and MSL Director. In her most recent role, she was employed as the Senior Director of Medical Affairs at a Molecular Diagnostics Company. Here, she quickly built out a full function Medical Affairs Department from the ground level, which ultimately set the Industry standard for this market. Elizabeth gained her Industry expertise as an MSL at Organon (now Merck) and Duramed (now TEVA). She began her passage into MSL leadership at Bayer as a Deputy Director in Medical and Scientific Affairs in Women’s Health Care (WHC). Prior to her Industry experience, Elizabeth spent over 25 years as a health care provider and educator. In the healthcare field, Elizabeth held many roles from an entry level RN with progressive management roles up to the hospital director level, private practice, Nurse Practitioner, as well as teaching at the University graduate level. She currently serves as an Adjunct Clinical Faculty at the University of Texas at Austin, School of Nursing. Elizabeth has been an author and coauthor of peer reviewed journal publications in Women’s Health. She has been a frequently invited speaker for Medical Affair Forums and has presented clinical, medical and scientific information to small and large groups, locally, nationally and internationally.

dr.cristinachangindependentexpertMedicalaffairs,taiwanDr. Chang is the current Medical Director for Sanofi Taiwan, Hong Kong and Macau, based in Taiwan, overseeing the medical and clinical activities that support the life cycle of approved products and cross-functional Life Cycle Management. She is

board certified in Gastroenterology and General Surgery. She has extensive experience in medical affairs and pharmaco-vigilance and authored the design and undertaking of company sponsored phase I-III and post-marketing clinical trials. Dr. Chang is a medical professional with 10 years of experience in biopharmaceuticals strategic planning and medical operations with expertise on a wide range of therapeutic area including oncology, cardiovascular and endocrinology, medical and pediatric nutrition, gastroenterology and respiratory. She has led different top pharmaceutical organizations including Novartis, Astrazeneca, Abbott and Sanofi with impactful results and visionary leadership. She had played pivotal role in the development of successful launch plan and many medical affairs talents. She is also committed to develop educational programs and scientific initiatives with patient centered mindset.

amitgarg,Medical Head - Emerging Marketsdrreddys,indiaDr. Amit Garg is MD Physician and MBA in Pharmaceutical Marketing. He has worked in Indian as well as multinational companies in India. Currently he heads Medical Affairs in Dr. Reddy’s Labs for Emerging Markets and his area of expertise

spans across branded & branded generics portfolio. Apart from his efforts of seamlessly merging the science of drug development to art of brand communication and marketing, he gets excited by technology, especially online platforms and mobile Apps. Apart from having various publications in indexed journals, Dr. Garg is also a reviewer of mobile apps for Medical-App-Journal.

danWang,Medical Director for Greater China, Bd,china

Dan Wang, Medical Director for Greater China (Mainland China, Hong Kong, Taiwan), and Chair of China Innovation Council. She is leading the medical team and responsible for clinical trials and clinical activities for both new products and marketed products. She holds MD from Peking University, MBA and MPH from Emory University in the U.S.A. She was a dermatologist in the first hospital of Peking University. She was over 10 years of experience in healthcare industry, particularly in drug development, product life cycle management, clinical trial design, and safety monitoring. She has served as Medical Director for Janssen China, a Johnson & Johnson company; Chief Medical Director for Express Scripts, a US pharmacy benefit management company; and Executive Director for Healthcare in China prior to working in the healthcare industry.

chernsearnlim,Country Head of Medical Affairs, Pacific Rim, shire,singaporeDr Chern Searn (CS) Lim was appointed Medical Director (Pacific Rim) for Shire Singapore Pte Ltd since Jan 2012. He has 7 years of pharmaceutical industry experience ranging from Analgesic, Antisepsis, Women Healthcare, Gastrointestinal,

Hematology, ADHD to Nephrology. CS spent 5 years developing his clinical expertise in Obstetric & Gynaecology specialty. Prior to Shire, CS was the Regional Medical Affairs Manager with Mundipharma (Singapore) and before that in Novartis, Bayer Schering Pharma, and Schering Plough. CS graduated with B. Med Sc (Hons) and subsequently earned a Doctor of Medicine. In 2011, CS received his MBA.

Page 7: 2nd Annual Medical Affairs Leaders Forum Asia- August 5th - 6th, 2014

Speaker Biogr aph iesYokofujimoto,M.d.,Ph.d.Sr. Director, Head of Medical Affairs, Global Established ProductsPfizerJapan

Yoko Fujimoto is currently head of Medical Affairs, Global Established Products, Pfizer Japan. Dr. Fujimoto graduated from Tokyo Medical and Dental University. She received her M.D. degree and Ph.D. degree from the university. She made her clinical fellowship in Neurology and received her certificate as a Neurologist from the Japanese Society of Neurology. She started her basic research career at the Department of Immunology, Duke University in the US and her research discoveries were published by major journals, including Cell and Nature Immunology. She joined Pfizer in 2002 and led Japan development program of a smoking cessation drug, Champx as a Japan team leader, until the Japan approval in 2008. Then she served as a Japan Disease Area Leader for Neurology, Cardiovascular and Metabolic and led a long list of development programs, including Bapineuzmab (ant-A-antibody) for Alzheimer’s disease and Eliquis (Apixaban, factor Xa inhibitor) for the patients with atrial fibrillation. In 2013, she was appointed as Sr. Medical Director, Established Products and took responsibility as a Japan Medical Affairs Lead. She also had taken a responsibility of APAC medical Lead concurrently by December 2013. She is engaged in developing new value in the pharmaceutical industry by establishing new model of medical affairs with innovative approach and contributing to the total healthcare of patients and society in Japan and Asia.

dr.samueldyer,Chairman of the Board, Medicalscienceliaisonsociety,Usa

Dr. Samuel Dyer has over 12 years experience within International Medical Affairs for a number of companies. During his career, he has led MSL / Medical Teams in multiple

TA’s in over 60 countries throughout the U.S., Canada, Europe, Africa, Middle East, New Zealand and Australia. His management experience includes small (2+) to large (240+) medical teams across multiple TA’s. Throughout his career, Dr. Dyer has worked on MSL and Medical Affairs strategy and has extensive experience in creating strategic MSL utilization and medical communication plans. He has designed, and created global Medical Affairs and MSL programs that have included: KOL Medical communication plans, strategic assessments, planning, and execution in geographical locations with diverse cultures/languages. Dr. Dyer has been involved in the successful launch of both pharmaceutical and medical device products both in the U.S. and internationally. Over the years Dr. Dyer has developed an extensive international network within the Pharmaceutical, CRO, Medical Device, and Medical Communication industries. He has been an invited speaker at several conferences on various topics including KOL management, creating MSL teams, international MSL teams, and the value of the MSL role and Medical Affairs. He has also worked as a consultant with a number of companies for Medical Affairs projects including recently with McKinsey Consulting, Bain and Co., and Philips Healthcare. Dr. Dyer has a B.S. in Biology and did his Medical training in Chicago. He has a Master’s Degree in Tropical Biology (where he studied in the Amazon) and a Ph.D. in Medical Science. Dr. Dyer also completed a certificate program at Harvard Business School, for Executive Leadership and Strategy in Pharmaceuticals and Biotechnology. Dr. Dyer is the author of a first of its kind book on the MSL role that is expected to be published in the Summer of 2013. Dr. Dyer is a founder and the Chairman of the Board of the Medical Science Liaison Society (www.themsls.org), which is the first ever global Non-Profit organization, dedicated to advancing the global MSL profession.

drsadhnaJoglekarVice President and Area Medical Director Asia Pacific, North Asia and South Asia,gsK

Dr Sadhna Joglekar is a MD (Pharmacology) from KEM Hospital Mumbai (India). She is a gold medalist in pharmacology

from Mumbai University. Dr Sadhna Joglekar is currently Area Medical Director for Asia Pacific, North Asia and South Asia at GlaxoSmithKline. She is responsible for more than 12 markets within Asia. Prior to this role, she was Executive Vice President and Medical Director for India and Sri Lanka. She worked for Pfizer prior to joining GSK, initially in Medical Affairs and later in Strategy and Business Development, followed by Regulatory Affairs departments. During her career in the pharmaceutical industry, she has had extensive experience in clinical research, medical affairs, regulatory affairs and pharmacovigilance. She has been the Vice Chair of the Medical Committee of OPPI (industry association in India) from 2008 till 2012 and has been a member of several ad hoc task forces convened by Indian regulatory authorities to look at India Clinical Trial Regulations, India GCP Guidelines, etc. She has over 30 publications to her credit and is an invited speaker at several congresses and workshops. She has a chapter to her credit in the API textbook of Medicine (2010) and in Innovative India, a Medialand London Publication. She has been a visiting faculty at Narsee Monjee Institute of Management Studies for the Post-graduate Diploma in Pharmaceutical Medicine. She is often invited by the Indian regulators to train the drug inspectors on GCP inspections as well as some aspects of clinical research.

BeataniechodaExecutive Committee of the australianPharmaceuticalPhysiciansassociation(aPPa)

I’m an ex-clinician with professional background is in general and plastic surgery which I practised in Poland before practising

in Australia until 2007. Following my PhD in bone regeneration and an MBA at UNSW, I joined sanofi-aventis Australia in 2006, where I worked as a Clinical Safety Officer for the Clinical Research Unit later transitioning to the Medical Manager’s role at sanofi-aventis. In that time, I learned a lot about the design and management of clinical trials in Australia and New Zealand and how they relate to a globalised clinical trial market. Later, in the Medical Manager’s role at sanofi-aventis Australia I learned about the role of Medical Affairs and other scientific disciplines (such as Regulatory Affairs and Pharmacovigilance) within the Pharmaceutical organisation. This was where I also learned how important the evidence based knowledge is within the Pharmaceutical industry. I recognised that the organisations that excel in this industry are experts in using this knowledge. I was subsequently promoted to a regional Medical Manager for an osteoporosis product which enabled me to understand the challenges in managing business beyond the local, Australian organisation. In my current role as a Medical Director I use my well rounded knowledge of all aspects of pharmaceutical industry on a daily basis to increase the value my company creates and provides to support patients, healthcare community, regulator and payors.

Page 8: 2nd Annual Medical Affairs Leaders Forum Asia- August 5th - 6th, 2014

EventPar tner s & Networ k ing

Thank you to our Event Partners.

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Austria Trend Hotel, Bratislava, Slovakia

(Just 45mins from ViennaInternational Airport,

Austria

Austria Trend Hotel, Bratislava, Slovakia October 21-22nd, 2014Day 1 - Medical Affairs for Enhanced Stakeholder Communications & EngagementDay 2 - Stream 1 - Best Practices in Late-Phase ResearchDay 2 - Stream 2 - Investigator Initiated TrialsDay 2 - Stream 3 - Medical Affairs Management for Devices & DiagnosticsDay 3 - Interactive Workshop: Medical Writing & Communication for Medical Affairs

- AUTUMN EDITION -

Day 1 - Medical Affairs for Enhanced Stakeholder Communications & EngagementDay 2 - Stream 1 - Best Practices in Late-Phase ResearchDay 2 - Stream 2 - Investigator Initiated TrialsDay 2 - Stream 3 - Medical Affairs Management for Devices & DiagnosticsDay 3 - Interactive Workshop: Medical Writing & Communication for Medical Affairs

- AUTUMN EDITION -

Vienna, Austria October 21st-22nd, 2014

MEDICAL AFFAIRS MANAGEMENT FOR DEVICES & DIAGNOSTICS

- AUTUMN EDITION -

- AUTUMN EDITION -

Vienna, Austria October 21st-22nd, 2014

BEST PRACTICES IN LATE-PHASE RESEARCH

DAY 2: STREAM 1

DAY 2: STREAM 3

Vienna, Austria October 21st-22nd, 2014

INTERACTIVE WORKSHOP: MEDICAL WRITING & COMMUNICATION FOR MEDICAL AFFAIRS

- AUTUMN EDITION -

DAY 3:

Vienna, Austria October 21st-22nd, 2014

INVESTIGATOR INITIATED TRIALS

- AUTUMN EDITION -

DAY 2: STREAM 2

Vienna, Austria October 21st-22nd, 2014

INVESTIGATOR INITIATED TRIALS

- AUTUMN EDITION -

DAY 2: STREAM 2

Austria Trend Hotel, Bratislava, Slovakia October 21-22nd, 2014Austria Trend Hotel, Bratislava, Slovakia

(Just 45mins from ViennaInternational Airport,

Austria

Austria Trend Hotel, Bratislava, Slovakia

(Just 45mins from ViennaInternational Airport,

Austria

Strategic Views and Practical Experiences to Demonstrate Best Practice Management of The Changing Role of Medical Affairs in Latin America

Location: Rio de Janeiro, Brazil Conference Dates: 28th-30th October (2.5 days), 2014

Strategic Views and Practical Experiences to Demonstrate Best Practice Management of The Changing Role of Medical Affairs in Latin AmericaLocation: Rio de Janeiro, Brazil Conference Dates: 28th-30th October (2.5 days), 2014

Best Practices inMedical Affairs Management in

Latin America

Best Practices in

Medical Affairs Management inLatin America

Best Practices in

Medical Affairs Management inLatin America

Strategic Views and Practical Experiences to Demonstrate Best Practice Management of The Changing Role of Medical Affairs in Latin America

Location: Rio de Janeiro, Brazil Conference Dates: 28th-30th October (2.5 days), 2014

Best Practices inMedical Affairs Management in

Latin America

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