ISCR AUTUMN CONFERENCE “CLINICAL RESEARCH LANDSCAPE … · Hemato-Oncology Clinic, Vedanta Ahmedabad Representing Regulatory Affairs (Corporate) Ms. Smriti Bhat Manager Regulatory

Day One - Friday, 9 Oct 2020 (IST 1400 to 1800 hours)Track 1 - Clinical Trial ManagementTrack 2 - Academia & Quality

Day Two - Saturday, 10 Oct 2020 (IST 1600 to 2030 hours)Track 3 - Medical Writing. Pharmacovigilance & Real-World Evidence (RWE)Track 4 - Data Management & Biostatistics

“CLINICAL RESEARCH

LANDSCAPE-POST 2020”

Highlights: This conference is intended to look at

the changing landscape in clinical research in the

current scenario. Our experienced speakers will

discuss various aspects of vaccine trials, use of

technology, ar�ficial intelligence, and scien�fic

repor�ng with focus on what/how things have

changed. In this two-day conference, each

par�cipant will be able to understand and discuss

these aspects and have a be�er picture of the

clinical research arena post 2020.

Who Should A�end: Professionals in Clinical

Research, Medicine, Research Scholars, Scien�sts,

Ethics Commi�ee Members, Healthcare

Professionals from the Pharmaceu�cal Industry,

Contract Research Organiza�ons, Government

Agencies, Non-profit Organiza�ons/Associa�ons

and Academia. Students from Medical, Nursing,

Pharmacy or Life Sciences, aspiring for a career in

Clinical Research

ISCR AUTUMN CONFERENCEon

Also includes talks and knowledge-sharing sessions by clinical research experts on the Applica�on of Data Analy�cs, Ar�ficial Intelligence and Machine Learning in Pharmacovigilance, Data Management and Quality Assurance

For the first �me, as a Fully Virtual Conference, ISCR South Chapter has been able to bring together top global leaders who will share insights on per�nent topics relevant to clinical research amidst the current pandemic situa�on with one of the most important talks being on "Vaccine Clinical Trials"

Technology is a huge enabler in contribu�ng to more efficient conduct of clinical development from quality, cost, and �melines perspec�ve especially in these challenging �mes. You will hear experts talk on Leveraging Technology in the Changing Clinical Research Landscape

organized by

South Chapter

Data Quality and Integrity is key to clinical research you will hear from industry leaders on Effec�veness of Remote Audits

...and many more!!

Thank You Partners

KEY SPEAKERS & DISTINGUISHED PANELISTS

Dr. Jerome H. KimDirector General

International Vaccine Institute, Korea

Ms. Susan Trainor CEO,

Trainor & Partners EU

Mr. Jivan AchrejaChief Technology Officer Advarra,

USA

Mr. Ajit SimhPresident,

Shiba Biotechnology Inc USA

Dr. Vijay VenkatramanMD & CEO,

Oviya Medsafe

Dr Ramesh JagannathanVP, Medical Affairs, BharatSerums and Vaccines Ltd.

Ms Lakshmi Achuta Strategic Advisor-Biotech, Pharma & Medical Devices

Dr. Anvita PandiyaGlobal Head CQA DU

Global Health, Novartis

Dr. Ananya ChakrabortyHead of Department Pharmacology VIMS

Dr. Chirag DesaiConsultant & Director

Hemato-Oncology Clinic, Vedanta

Organizing CommitteeDr. Gaurav Mathur (IQVIA)Ms. Mala Srivastava (Nextvel)Dr. Ramesh Jagannathan (ISCR EC) Mr. Rakesh Dadhania (Quinary)Dr. Radhika Bobba (PSl-CRO)Ms. Thanuja Naidu (Pharm-Olam) Mr. Sachin Tonapi (Covance)Ms. Swetha Khokale (Advarra)Dr. Rajani Menon (Syneos Health)

Online Registration: http://www.iscr.org/events-registration/ ;

Online Payment: http://www.iscr.org/payment-events-workshops/ ;

Offline Payment: Cheque/DD payable at Mumbai should be made in favour of

“Indian Society for Clinical Research” & mailed to us at ISCR Secretariat, c/o Pfizer Limited,

The Capital 1802, 18th Floor, Plot No. C-70, 'G' Block, Bandra Kurla Complex, Bandra (E), Mumbai – 400051

For any query, please contact ISCR on Email: ; Telephone: [email protected]

Dr. Vijay Venkatraman (Oviya MedSafe) Mr. Gaurab Chakraborty (Covance)Dr. S. Poongothai (MDRF)Ms. Anushila Vaishali (Eli Lilly) Ms. Chandrika Arora (QMatra)Ms. Lakshmi AchutaMr. Sanjay Kabra (Novotech) Ms. Ami Shah (Speramed)Mr. Abby Abraham (George Clinical)

Registration & SponsorshipRegistration Fee Rs. 500/- Students: FREE (Limited Seats!)

Sponsorship: Rs 25,000/- (Limited Sponsorship for the Virtual Conference)

Dr. Sunil Modali, Medical Director, Novartis

Ms. Lehar Zaidi Assoc. Director, Biostatistics,

IQVIA

Ms. Nivedita Sahoo,Senior Scientific Writer, Redaction

for Disclosure SME, GSK

Dr. Arkhendu ChatterjeeAssoc. Director,

Biostatistics, BMS, USA

Ms. Teresa Armstrong, Advisor Submissions and

Transparency, Global Scientific Communications Eli Lilly, USA

Thank You Partners

INDIAN SOCIETY FOR CLINICAL RESEARCH

Organized by

South Chapter

ISCR AUTUMN CONFERENCE

on

“CLINICAL RESEARCH LANDSCAPE-POST 2020”

Day One Friday, 9 Oct 2020 (IST 2:00 to 6:00 PM)

Day Two Saturday, 10 Oct 2020 (IST 4:00 to 8:30PM)

Track 1 Clinical Trial Management Track 3 Medical Writing, Pharmacovigilance &

Real-World Evidence (RWE) Track 2 Academia & Quality Track 4 Data Management & Biostatistics

Organizing Team

Dr. Gaurav Mathur (IQVIA) Ms. Mala Srivastava (Nextvel) Dr. Ramesh Jagannathan (ISCR-EC) Mr. Rakesh Dadhania (Quinary) Dr. Radhika Bobba (PSI-CRO) Ms. Thanuja Naidu (Pharm-Olam) Mr. Sachin Tonapi (Covance) Ms. Swetha Khokale (Advarra) Dr. Rajani Menon (Syneos Health) Dr. Vijay Venkatraman (Oviya MedSafe) Mr. Gaurab Chakraborty (Covance) Dr. Poongothai (MDRF) Ms. Anushila Vaishali (Eli Lilly) Ms. Chandrika Arora (QMatra) Ms. Lakshmi Achuta Mr. Sanjay Kabra (Novotech) Ms. Ami Shah (Speramed) Mr. Abby Abraham (George Clinical)

Registration

Registration Fee: Rs 500/-

Students: Free

(Hurry Limited Seats!!!)

Sponsorship:

Rs 25,000/- per Sponsor

Track 1: Clinical Trial Management Track

Date October 9th, 2020, Friday

Time: 2:00 to 6:00 PM (IST)

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2:00 to 2:15PM Welcome and Introduction Ms. Swetha Khokale (On behalf of ISCR South Chapter) Sr. Director – Business Operations Services Forte Research Systems, now part of Advarra.

Introduction to ISCR and South Chapter Activities

Ms. Mala Srivastava Co-founder and Managing Partner Nextvel Consulting LLP

2:15 to 3:15 PM Vaccine Clinical Trials Dr. Jerome Kim Director General International Institute of Vaccine Moderator: Dr. Radhika Bobba Regional Director, PSI CRO AG

3:15 to 3:20 PM Break

3:20 to 4:00 PM Introducing the next talk and speaker

Mr. Sanjay Kabra Director, Global Services Center (India), Novotech

ISO 14155 (GCP for Medical Devices) Versus ICH GCP E6

Mr. Sudhakar Mairpadi Head QA and Regulatory Philips India Limited

Conclusive Remarks on the talk and introducing the next speaker

Mr. Sanjay Kabra Director, Global Services Center (India), Novotech

4:00 to 4:40 PM Leveraging Technology in the New Clinical Research Landscape

Mr. Jivan Achreja Chief Technology Officer, Advarra

Concluding the talk and announce the break

Ms. Ami Shah Director and Co-founder SperaMed Consulting


4:45 to 5:45 PM Introducing Panel Discussion and Moderator

Ms. Ami Shah Director and Co-founder SperaMed Consulting

Panel Discussion Stakeholder Perspectives: Clinical Trial Practices Rebooting -The Global Pandemic Impact (5 stakeholders to speak for 10 mins each (50 mins) followed by 10 mins of panel discussion and 10 mins of Q&A.

Moderator Mr. Abby Abraham Global Head, Data Sciences & Country Head- India, George Clinical Representing Ethics Committee: Dr. Ananya Chakraborty HOD, Pharmacology VIMS, Bangalore Representing Sponsor Mr. Sivakumar Vaidyanathan General Manager/ Therapeutic Area Lead Biocon Biologics Representing Site Principal Investigator Dr. Chirag Desai Consultant & Director Hemato-Oncology Clinic, Vedanta Ahmedabad Representing Regulatory Affairs (Corporate) Ms. Smriti Bhat Manager Regulatory Affairs and Patient Safety

5:45 to 6:00PM Wrap-up and Vote of Thanks Mr. Sanjay Kabra Director, Global Services Center (India), Novotech Ms. Swetha Khokale Sr. Director – Business Operations Services Forte Research Systems, now part of Advarra

Track 2: Academia and Quality Assurance

Date October 9th, 2020, Friday


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Time in IST Topic Speakers /Panel Members

2:00 to 2:15PM Inauguration Welcome About ISCR

Introduction of Speaker

Ms. Chandrika Arora Founder & CEO, Qmatra Mr. Rakesh Dadhania Executive Director Quinary Clinical Research

2:15 to 3:00 PM Academic Topic: Challenges of Managing Multiple Stakeholders at Research Site in the Current Pandemic

Ms. Priyadarshini Arambam General Manager, Academics & Research Department, Batra Hospital & Medical Research Centre, New Delhi

Wrap Up Mr. Rakesh Dadhania Executive Director Quinary Clinical Research

3:00 to 3:50 PM Introducing the Speaker

Ms. Lakshmi Achuta Strategic Advisor-Biotech, Pharmaceuticals & Medical Devices

Application of AI and Data Analytics in Clinical Quality

Mr. Raghunandan Mishra Senior Product Manager, AI Innovation, Data Foundry

Wrap up Ms. Lakshmi Achuta Strategic Advisor-Biotech, Pharmaceuticals & Medical Devices

3:50 to 3:55PM Break

3:55 to 4:40 PM Introducing the speaker

Ms. Chandrika Arora Founder & CEO, Qmatra

GDPR and its impact on the Conduct of Clinical Trials

Ms. Susan Trainor CEO, Trainor & Partners

Wrap up and Introducing the next Speaker

Ms. Chandrika Arora Founder & CEO, Qmatra

4:40 to 5:15 PM Data Integrity in Clinical Trials

Ms. Lakshmi Achuta Strategic Advisor-Biotech, Pharmaceuticals & Medical Devices

Wrap up Ms. Chandrika Arora Founder & CEO, Qmatra


5:20 to 6:00 PM Introduction of Panelists /Moderator

Ms Lakshmi Achuta

Strategic Advisor-Biotech, Pharmaceuticals & Medical Devices

Panel Discussion Stakeholders perspective: Remote Audits: Conduct and Management

Moderator Ms. Chandrika Arora, Founder & CEO, Qmatra Panellists: Mr. Ajit Simh President, Shiba Biotechnology Inc Ms. Susan Trainor CEO, Trainor & Partners Dr. Thuppil Venkatesh CEO & Director, Foundation for Quality India Dr. Moorthy Head, GCP QA, Syngene International Ltd Dr. Anvita Pandiya Site Quality Head, Hyderabad; Global head CQA DU Global Health, Novartis

Vote of Thanks Ms. Chandrika Arora Founder & CEO, Qmatra

Track 3: Medical Writing and Pharmacovigilance & Real-

World Evidence (RWE)

Date October 10th, 2020, Saturday


MEDICAL WRITING 4:00 to 6:00 PM (IST)

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Time in IST Topic Speaker (s) / Panel members

4:00 to 4:05 PM Introduction Anushila Vaishali

4:05 to 4:45 PM Writing Clinical Trial Documents

in The Post-Pandemic Time:

Perspective from Protocol and

Clinical Study Report (CSR)

What changed in protocol

writing: impact,

changes/updates, how to

manage (15 min)

Managing a study report

post pandemic: impact on

trial, changes to the study

Protocol: Sunil Modali Clinical Development Medical Director, Novartis CSR: Teresa Armstrong

Advisor-Submissions and

Transparency, Global Scientific

Communications (Eli Lilly, US)

report, how to handle the

changes (15 min)

Q&A (15 min)

4:45 to 5:30 PM Writing a Vaccine Dossier:

Especially in a Fast Track Mode

Planning for a vaccine

dossier preparation

COVID19, its impact on

vaccine trials and

submission Q&A (10 min)

Albertina Fannelli Head, Scientific Communications, GSK, Italy Nivedita Sahoo

Scientific Communications, GSK

Vaccines, India


5:35 to 6:00 PM Panel discussion

Medical Writers Embracing the

Virtual Mode of Working:

Managing the Changes While

Maintaining Quality and

Consistency in Documents

Chair: Dr. Rajesh Kher, Ms. Anushila

Vaishali

Panel: All the Speakers

BREAK – 15 minutes

PHARMACOVIGILANCE & REAL-WORLD EVIDENCE 6:15 to 8:30 PM (IST)

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Time in IST Topic Speaker (s) / Panel members

6:15 to 6:25 PM Introduction and Context Setting

Dr. Ramesh Jagannathan

VP, Medical Affairs, Bharat

Serums and Vaccines Ltd., Navi

Mumbai

Dr J Vijay Venkatraman

Managing Director & CEO,

Oviya MedSafe

6:25 to 6:50 PM

Impact of RWE on Physician's

choice of treatment options for

optimal patients' outcomes: Focus

on Safety and Quality of Life

Dr. L. Sreenivasa Murthy

Senior Consultant Physician

& Diabetologist

Lifecare Hospital & Research

Centre Bengaluru

6:50 to 7:15 PM Value of Real-World Evidence

(RWE) Studies for Demonstrating

Product Effectiveness and Safety

Dr. Deepa Chodankar

Sr. Medical Advisor Sanofi,

Mumbai

7:15 to 7:45 PM Role of Artificial Intelligence in

improving efficiency of Life Cycle

PV

Dr. Mahesh Kumar

Senior Director & Client Partner

– Strategic Accounts, Aris Global

Darmstadt, Germany

7:45 to 8:30 PM

Panel Discussion: Challenges in SAE

Management in the Current

Scenario

Moderator:

Dr. P S Karthik Babu

[Multi Country Safety Head

(South Asia), Sanofi & Chair –

ISCR PV Council]

Panelists:

Dr. Pingali Usharani

(Ethics Committee) – Prof. &

HOD, Clinical Pharmacology &

Therapeutics, NIMS, Hyderabad

Dr. Srikanth Krishnamurthy

(Investigator) – Consultant

Pulmonologist, Hindusthan

Hospital, Coimbatore

Dr. Jamal Baig

(Industry) – Associate Director-

Drug Safety, MSD & Co-Chair of

ISCR PV Council

Track 4: Data Management & Biostatistics

Date October 10th, 2020, Saturday


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Time in IST Topics Speaker (s) / Panel members

4:00 to 4:45 PM Intelligent Machines Take on

Clinical Data Management

Prasanna Rao

Head, Artificial Intelligence and Data

Science, Pfizer

Mahesh Narasimhan

Saama Technologies

4:45 to 5:30 PM Decentralized Clinical Trials in

The Post COVID-19 World

Michelle Longmire

Physician and CEO at Medable Inc, USA

5:30 to 6:15 PM Improving Prediction of

Overall Survival Using Joint

Modelling Approach

Arkendu Chatterjee

Associate Director, Biostatistics, BMS,

USA

6:15 to 7:00 PM Role of Public-Private

partnerships in COVID Vaccine

Development

Lehar Zaidi

Associate Director, Biostatistics, IQVIA

7:00 to 8:00 PM A Check on the CDISC Interim

User Guide on COVID-19

Sumeet Subhedar

Principal Statistical Programmer,

Covance