Can Indonesia be a Biopharmaceutical Manufacturing Powerhouse?

5 – 7 November 2019

i3L Campus

Jl. Pulomas Barat Kavling 88, East Jakarta

Indonesia

ABOUT

Accelerating the Growth of the Biopharmaceutical Industry in Indonesia

AICON Life Sciences is an annual triple-helix conference that brings together academia, industry, and government stakeholders to explore emerging developments in the life science sectors in Asia. This year, we are highlighting the growth of the biopharmaceutical industry in South East Asia with a special focus on Indonesia as the largest economy in the region.

According to Global Data, Indonesia’s pharmaceutical market, the largest in South East Asia, is expected to grow at a CAGR of 10.0% to reach beyond US$10 billion in revenue by 2021 with major growth occurring in the generic and biopharmaceutical sectors. To realize this tremendous opportunity, the biopharmaceutical industry in Indonesia needs to overcome many challenges, including regulatory hurdles and a lack of skilled human resources. This conference aims to facilitate networking and knowledge sharing among key stakeholders to accelerate and solidify the growth of the biopharmaceutical in Indonesia. A key question that we seek to explore during the conference is this: Can Indonesia be a biopharmaceutical manufacturing powerhouse?

Keynote Speakers

Professor Helen McCarthy

School of Pharmacy, Queen’s University Belfast

DR. JEREMY LIM

Partner Health & Life Sciences Asia Pacific

Oliver Wyman

RACHEL ARMSTRONG

Senior Manager Strategy

Price Waterhouse Coopers

DINESH KHOKAL, Ph.D.

Director of External Affairs
JAPAC and Intercontinental – LatAm

Amgen Biotechnology Singapore

President, Singapore Chapter PDA

Conference Tracks

1. Regulation

“Regulatory Convergence of Biopharmaceutical Products: Current State and Challenges”

The rise of biopharmaceutical products used for therapy in Indonesia has resulted in recent increase of biopharmaceutical products’ demand. This increased demand leads to the increasing amount of biopharmaceutical products registered and are about to be registered through the National Agency of Drug and Food Control of Indonesia (Badan Pengawas Obat dan Makanan or BPOM). This track will further discuss the current regulatory affairs of biopharmaceutical products in Indonesia, its challenges and its comparison to global regulatory requirements.

Speaker:

  • Dra. Lucky S. Slamet, M.Sc., Apt.
  • GP Farmasi*
  • Dr. Dinesh Khokal
  • BPOM*

*to be confirmed

2. Upstream

“Cell Culture and Upstream Technologies”

The ever evolving increase of biopharmaceuticals raise the need of continuous innovation in biopharmaceuticals manufacturing technology. New technology innovations related to the upstream manufacturing of biopharmaceuticals involving single-use system, cell culture and cell development are constantly being developed to ensure integrated solution of large-scale biopharma production. Due to these reasons, this track will discuss the current situation, challenges, limitation, future prospect, and development of biopharmaceutical manufacturing technology worldwide as well as its feasibility for application in Indonesia.

Speaker:

  • Florentin Devina Tanasal, R & D Manager Kalbio
  • Krishna Karnati, Senior Product Leader, GE Healthcare
  • Ravin Mehta, Business Development Manager-Asia, Sartorius Stedim Biotech
3. Quality Control of Biologics

“Bioanalytical and Bioassay for Biopharmaceutical Products”

Production of biopharmaceutical products faces many challenges compared to the conventional drugs. Due to their complexity, the deep understanding of quality control assessment for biopharmaceutical products is required. This track helps the attendee to gain the knowledge of bioanalytical and bioassay for biopharmaceutical products, develop quality culture, while in the meantime, updating the global standardization of biopharmaceuticals.

Speaker:

  • Dr. Ranjan Chakrabarti, Vice President – Scientific Outreach, Biologics at United States Pharmacopeia.
  • Dr. Jonathan How, Application Specialist, ASEAN
4. Downstream

“Process Development in Downstream Processing”

Downstream is a crucial part of biopharmaceutical manufacturing as this step purifies the products from contaminants to meet quality requirements. Unfortunately, this step is regarded as the bottleneck in the manufacturing process. Common challenges in downstream processing and various approaches to overcome these challenges are discussed in details within this track.

Speaker:

  • Azaz Rulyaqien, Senior Technology Manager Merck Life Science – Global Pharma Processing
  • Johan Naslund, Technical & Applications Manager, ASEAN
  • Yusdy Pan, Ph.D., Principal Scientist, Process Development, Amgen Singapore Manufacturing
5. Good Distribution Practices

“Implementation of Good Distribution Practice of Biologics as a Part of Quality Assurance”

The high demand for biopharmaceutical products globally has to be accompanied by the implementation of good distribution practice. To ensure the quality of biopharmaceuticals until the consumer’s hands, it is important to design a supply chain that is robust and meet international standards. This track will explore the recent breakthrough in global supply chain security, as well as provide the insight into global regulatory trends in biopharmaceutical supply chain.

Speaker:

  • Brett Marshall, Corporate Head of Quality Assurance, Zuellig Pharma
  • Alan Kennedy, Director, TEAM POSEIDON & exec director, PHARMA TEAM-UP – pharma ocean freight mode
  • Sateesh Yelisetti, Quality Assurance Director, Baxter International, Singapore
6. Operations

“GMP compliance for Biopharmaceutical Products”

The overall operation in biopharmaceutical industries requires to comply regulation as stated in current Good Manufacturing Practice (cGMP). This track covers cGMP aspects for biologics and challenges that biopharmaceutical industries face in complying cGMP. Specific aspects that support cGMP compliance will also be discussed in details.

Speaker:

  • Chris Sweeney, Associate Director Kalbio Global Medika
  • Norhisham Iskandar bin Rahmad, Operations Director of PT. HGP
  • Richard Chai, Technical Service Manager, STERIS Corporation
7. Emerging Therapeutic Biologics

“Clinical Study, Therapeutic Success, and Cost-analysis of Emerging Biologics”

Biologics and biosimilars can be used to treat a broad spectrum of diseases such as cancer, autoimmune disorders, and chronic kidney disease. These products are required to go through clinical trial to ensure the safety and efficacy. This track will allow the attendees to gain knowledge in clinical trials for biosimilar, the success rate of therapy involving biopharmaceuticals and how these products are used in community in regards to their affordability and accessibility.

Speaker:

  • Liza Munira, Health Economist, Faculty of Economics and Business, Universitas Indonesia

Invited Speakers

Dra. Lucky S. Slamet, M.Sc., Apt.

Advisory Member on Biological Standardization

WHO
Brett Marshall

Corporate Head of Quality Assurance

Zuellig Pharma
Dr. Liza Munira

Health Economist

University of Indonesia
Christ Sweeney

Associate Director

Kalbio Global Medika
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Call for Abstracts

Asia Integrated Conference on Life Sciences 2019 is inviting students, researchers, and lecturers to submit abstracts (max 250 words) for oral (Track 8) and poster presentations. Upon abstract acceptance, presenters are invited to publish their papers in Asia Integrated Proceeding of Life Sciences.

Key dates

5 September

Submit your abstract before 5 September 2019. Please indicate whether your abstract is for oral or poster presentation.

19 September

Authors with accepted abstract will be notified on 19 September 2019.

31 October

Authors need to confirm their attendance by registering on the registration page and proceed to payment by 31 October 2019

Topics that will be accepted for academic oral and poster presentations include the following :

 

  • Biopharmaceutical drug design and development
  • Clinical trials on biopharmaceutical products
  • Analytical characterization of biopharmaceutical products
  • Formulation of biopharmaceutical products
  • Bioavailability/bioequivalence of biopharmaceutical products
  • Pharmacokinetics/Pharmacodynamics for biopharmaceutical products
  • Biosimilar Liquid chromatography/mass spectroscopy for discovery, preclinical and clinical trials
  • Optimization process of biopharmaceutical production
  • Drug delivery system for biologics product

Conference Fees

 Registration Fees
Student – Indonesian Passport/KITAS HolderIDR 1,250,000
Academics and Regulators – Indonesian Passport/KITAS HolderIDR 1,500,000
Public – Indonesian Passport HolderIDR 3,000,000
Student – Foreign Passport HolderUSD 100
Academics and Regulators – Foreign Passport HolderUSD 150
Public – Foreign Passport HolderUSD 250
  • Registration fees apply to both academic presenters and conference attendees. Invited speakers are exempt from registration fees.
  • On-site payment is limited only for conference attendees (non-presenter)

Sponsors

Contact Us: organizer@aicon.id

Platinum Sponsor
Gold Sponsor
Silver Sponsor
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Pre-Conference Agenda

Tuesday, 5 November 2019 – Day 0 (Free of Charge)

Smart Supply Chains for the Biopharmaceutical Industry

TimeActivity
08.30 - 09.00Registration/ Breakfast
09.00 - 09.15  Welcome (Hisfarin)
09.15 - 09.30
Welcome (i3L)
09.30 - 10.00Update on Indonesia Requirements for Serialization (BPOM)
10.00 - 10.20Q & A with BPOM
10.20 - 11.00Coffee Break
11.00 - 11.30Pharmaceutical 4.0: Digitalization of the Supply Chain for the Biopharmaceutical/Pharmaceutical Manufacturing Industry (Bokun Cho, Consultant, HGP Asia Pte Ltd)
11.30 - 12.15Serialization and Digital Supply Chain: Importance of Digital Network for Drug Distribution in Indonesia (Graham Clarke, Vice President, Strategic Alliance, TraceLink)
12.15 - 13.00Implementing Serialization in Pharmaceutical Manufacturing (Ir. Novian Zein, M.M., S.E., Plant Director, PT. Merck Sharp Dohme Pharma, Tbk.)
13.00 - 13.30
Q&A (Moderator – i3L; Panelists: Tracelink, HGP, Merck Sharp Dohme Pharma)
13.30 -14.30
Lunch

Conference Agenda

Tuesday, 5 November 2019 – Day 0
TimeActivityLocation
15.00 - 17.30Speaker RegistrationLobby - 1st Floor
18.00 - 20.00Speaker Welcome DinnerTBC
Wednesday, 6 November 2019 – Day 1
TimeActivitySpeakerTopicLocation
07.00 Registration & BreakfastLobby – 1st Floor / Wing A – 7th Floor
08.00 - 08.30Breakfast TalkWing A – 7th Floor
08.30 - 08.45Opening CeremonyAuditorium – 7th Floor
08.45 - 09.30Plenary Talk 1
DR. JEREMY LIM
Partner, Health & Life Sciences Asia Pacific,
Oliver Wyman
Market Trends for Biopharmaceutical productsAuditorium – 7th Floor
09.30 - 10.00Coffee Break/ExpoWing A – 7th Floor / Lobby – 1st Floor
10.00 - 10.45Plenary Talk 2DR. DINESH KHOKAL - Director, External Affairs, Corporate Quality, Japan-Asia Pacific & Intercontinental Amgen President, Singapore Chapter PDACertificate of Suitability to the European Pharmacopeia MonographsAuditorium – 7th Floor
10.45 - 12.00
TRACK 1 - PANEL DISCUSSION – REGULATORY

“Regulatory Convergence of Biopharmaceutical Products: Current State and Challenges”
1. Dra. Lucky S. Slamet, M.Sc., Apt.
2. Sie Djohan
3. Dinesh Khokal, Ph.D
4. BPOM *to be confirmed
Auditorium – 7th Floor
12.00 - 12.15Gold Sponsor 1 TalkAuditorium – 7th Floor
12.15 - 13.15LunchAuditorium – 7th Floor
13.15 - 15.30TRACK 2 - UPSTREAM
“Cell Culture and Upstream Technologies”














TRACK 3 - QUALITY CONTROL OF BIOLOGICS
“Bioanalytical and Bioassay for Biopharmaceutical Products”
1. Florentin Devina Tanasal, R & D Manager Kalbio (13.15-13.55)
2. Krishna Karnati, Senior Product Leader, GE Healthcare (13.55-14.35)
3. Ravin Mehta, Business Development Manager-Asia, Sartorius Stedim Biotech (14.35-15.15)


1. Dr. Jonathan How, Application Specialist, ASEAN, GE Healthcare (13.15-13.55)
2. Dr. Ranjan Chakrabarti, Vice President - Scientific Outreach,Biologics at United States Pharmacopeia (13.55-14.35;14.35-15.15)
* To be confirmed



Achieving high titers through advanced technologies and process optimization
Driving Rapid Biologics
Development – From
Cell line to Clinic





Innovative Biacore Assays for Characterization and QC of Biologics



Standards for the Analysis of Biotherapeutics

Analytical method
Development and Validation for Biologics
Room 208 & 209
15.30 - 16.00Coffee Break/Expo
Lobby – 1st Floor
16.00 - 17.15Poster Session/Expo
Lobby – 1st Floor
17.15 - 18.00
Platinum Sponsor TalkAuditorium – 7th Floor
18.00 - 20.00Conference DinnerWing B – 7th Floor
Thursday, 7 November 2019 – Day 2
TimeActivitySpeakerTopicLocation
07.00Registration & BreakfastLobby – 1st Floor / Wing A – 7th Floor
08.00 - 08.30
Breakfast TalkWing A – 7th Floor
08.30 - 10.45TRACK 4 - DOWNSTREAM
“Process Development and Downstream Processing”

















TRACK 5
“Implementation of Good Distribution Practice of Biologics
as a Part of Quality Assurance”
1. Johan Naslund, Technical & Applications Manager, ASEAN (08.30-09.10)
2. Kenny Tay, Business Manager – Biomonitoring, Regional Marketing, Business development, Application, Validation and Technical support and BioM RegionalAsian Trainer (09.10-09.50)
3. Yusdy Pan, Ph.D., Principal Scientist, Process Development, Amgen Singapore Manufacturing (09.50-10.30)


1. Brett Marshall, Corporate Head of Quality Assurance, Zuellig Pharma (08.30-09.10)
2. Alan Kennedy, Director, TEAM POSEIDON & exec director, PHARMA TEAM-UP pharma ocean freight mode (09.10-09.50)
3. Sateesh Yelisetti, Quality Assurance Director, Baxter International, Singapore (09.50-10.30)
Intensified chromatography operations through connected and continuous processing

Environmental Monitoring best practice in Bioprocess








Viral Risk Mitigation In Biologics Manufacturing






Evolving GDP and the Challenges of Managing the Pharma Supply Chain for Cold Chain

* To be confirmed






* To be confirmed
Room 208 & 209
10.45 - 11.15
Coffee Break/ExpoLobby – 1st Floor
11.15 - 12.00
Plenary Talk 3
Rachel Armstrong
Senior Manager Strategy, Price Waterhouse Coopers
Business Strategy to Excel at Biopharmaceutical MarketAuditorium – 7th Floor
12.00 - 12.15
Gold Sponsor 2 Talk
Auditorium – 7th Floor
12.15 - 13.15 LunchWing A – 7th Floor
13.15 - 15.30TRACK 6 - OPERATIONS
“GMP compliance for Biopharmaceutical Products”









TRACK 7 - EMERGING THERAPEUTIC BIOLOGICS
“Clinical Study, Therapeutic Success, and Cost-analysisof Emerging Biologics”
1. Chris Sweeney, Associate Director Kalbio Global Medika (13.15-13.55)
2. Norhisham Iskandar bin Rahmad, Operations Director of PT. HGP (13.55-14.35)
3. Richard Chai, Technical Service Manager, STERIS Corporation (14.35-15.15)

1. Dr. Syarifah Liza Munira, Director, Graduate Program in Population and Labour Economics, Faculty of Economics and Business Universitas Indonesia (13.15-13.55)
2. Martin Lim, MBA, Founder and CEO, Onward Health Research *To be Confirm (13.15-13.55)
3. Dr. Tanya Lewanowitsch, Senior Business Development Manager, Asia, GE Health Care (14.35-15.15)
Starting up a Biotechnology Manufacturing Facility in South East Asia


Data Integrity in QC Laboratory


Best Practices in Cleanroom Contamination Control




Indonesia’s Biopharmaceutical Market: its affordability & accessibility under JKN





Clinical Study for Biologics




Future trends and insights & Accelerating your bioprocess journey
Room 208 & 209
15.30 - 16.00
Coffee Break/ExpoLobby – 1st Floor
16.00 - 17.00Plenary Talk 4Prof. Helen McCarthy
School of Pharmacy, Queen’s University Belfast
Biopharmaceutical Product Development: from Bench to BedsideAuditorium – 7th Floor
17.00 - 18.00
Closing Session
Auditorium – 7th Floor

Gallery

Theatre Class
Auditorium
7th Floor Hall
Theatre Class
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