innovate. collaborate. commercialise. - indian pharma… india 2016 brochure.pdf · innovate....
TRANSCRIPT
Innovate. Collaborate.
Commercialise.
www.terrapinn.com/biopharmaindia
15-16 November 2016 Hyatt RegencyMumbai, India
100+ local pharma & biotech
companies
50+ Speakers
350 Attendees
1 event2
Conference streams
till 1st July. Book your
tickets today!
Managing Director, Indian Immunologicals
GREAT EXPOSURE TO THE DEVELOPMENTS IN BIOPHARMA INDUSTRY - BOTH TECHNICAL AND COMMERCIAL ASPECTS.”
“
Join us as we navigate India’s biopharma future
India’s biopharma market has huge potential, there’s no doubt. But let’s take a moment to consider the generics market. Branded generics make up around 80% of India’s domestic pharmaceutical market, and India is a major generics supplier to the global pharma market. So how can we replicate that success and growth in India’s biopharma industry?
Welcome to BioPharma India 2016.
With a move towards a more transparent regulatory regime, strong efforts to encourage entrepreneurship and innovation, a widely available patient population and low manufacturing cost base, India is an attractive biopharma market, whether you’re a local company or an international pharma player. But we need to do more. If India is to become the number one pharma industry in the world, and wants to supply into the world’s most lucrative international markets, we need to continue to encourage new biotech start-ups to develop cutting-edge solutions and products, address quality assurance and control concerns, and create a coherent pricing and reimbursement strategy.
This November, together with leading biotech entrepreneurs, innovative start-ups and major pharma players from both within and outside India, BioPharma India will offer practical insights into how you can operate effectively in India’s biopharma market, whether from a manufacturing, branding or innovation perspective. We will also explore how you can leverage India’s strength to boost your presence in the global biopharma market.
BioPharma India isn’t a trade show. We bring senior executives together to explore the most exciting opportunities India’s biopharma industry has to offer. With case studies, innovation showcases and interactive panel discussions, you can hear from the movers and shakers and then meet them.
If you are part of India’s biopharma ecosystem, or want to be, you should join us.
100+ local pharma & biotech
companies
50+ Speakers
350 Attendees
1 event
2 Conference
streams
Contact Pinky Fadullon at (65) 6322 23738 or email [email protected] to get involved
Our story
WHO ATTENDS?
WHERE FROM?
COMPANIES WHICH ATTEND:
JOB TITLES
Who attends?
Research & Development
Medical AffairsProcess Development & Optimization
Drug or Vaccine Delivery
Government Affairs & Market Access
Chromatography
82%
India
9% Rest of Asia
Vice Presidents & Directors
22%
Others 16%
Managers & Heads 41%
Researchers, Engineers, Scientists
8% CXOs, Managing Directors, Presidents
10%
Local biotechstart-ups
Regulatory Compliance
Upstream / Cell culture
Drug Discovery
Business Units (Biosimilar, Vaccine, Oncology, Cardiology, etc)
Manufacturing Science and Technology (MSAT)
BioprocessPricing & Reimbursement
Facility Design
Research institutesQuality Assurance and Control
Manufacturing Technology
1% ROW
8% US & UK
The conferenceWe’ve restructured the event for 2016, to focus on the key challenges facing India’s biopharma industry.
Our brand new Therapeutic Innovation track (Day 1) will cover the latest breakthrough discoveries in the sector, including our Biotech Innovation Showcase, where groundbreaking Indian biotechs will offer 10-minute insights into their products, pipelines & pathway to commercialization.
Our Market Access track (Day 2) will offer practical insights into the realities of operating in India’s biopharma market, including pricing & reimbursement strategies, branding & communications, and also address the challenges of Indian biopharma businesses supplying the global market.
Our two-day Manufacturing track (Day 1 & 2) will focus on the key challenges facing India’s biopharma manufacturers and showcase the latest technologies shaking up the sector.
CONFERENCE DAY 1 – 15th November 2016
Therapeutic Innovation
Infectious Diseases & Cancer Vaccines
Biotech Innovation Showcase
Roundtable Discussion SessionChoose from our 8 roundtable discussions. Simply pick a table and join the debate.
Networking Lunch
Networking Refreshment Break
Opening Keynote Plenary: Encouraging innovation & entrepreneurship
Networking Refreshment Break
Networking Refreshment Break
Plenary: Innovative Partnering Models in India
Beers & Biotechs Networking Reception
Manufacturing
Process Development
Upstream
CONFERENCE DAY 2 – 16th November 2016
Market Access
Access & Reimbursement
Branding & Communications
Going Global
Networking Lunch
Networking Refreshment Break
Close of BioPharma India 2016
Keynote Plenary: Industry outlook
Manufacturing
Upscaling
Quality Assurance
Quality Control
Speak at the conference. Contact Pinky Fadullon at (65) 6322 23738 or email [email protected] to get involved
Abbott Healthcare Pvt. Ltd. Astrazeneca Pharma India Ltd Aura Biotechnologies Pvt Ltd Bayer Healthcare Bharat Serums And
Vaccines Ltd Biocon Research Limited Biological E Ltd Biotech Research Society India Boehringer Ingelheim Pharma G.M.B.H.
and Company K.G. Bristol-Myers Squibb Cadila Pharmaceuticals Ltd Central Drugs Standard Control Organization (West Zone)
Centre for Cellular and Molecular Platforms Cipla Ltd Clonz Biotech Pvt Ltd CPL Biologicals CSIR NIIST Trivandrum DGHS,
Dhaka, Bangladesh Dr. Reddys Laboratories Limited Eisai Pharmaceuticals India Pte Ltd Eli Lilly And Company India Ltd Enzene
Biosciences Ltd. Epirus Biopharmaceuticals, Inc. Finesse Solutions Glenmark Pharmaceuticals Ltd GSK India Haffkine Bio-Pharma
Corp Ltd Hetero Drugs Ltd Hospira Indian Immunologicals Limited Intas Pharmaceuticals Ltd J&J Innovation Centre Lupin Ltd Msd
Wellcome Trust Hilleman Labs Novalead Pharma Panacea Biotec Pfizer India Regrow Reliance Life Sciences Seagull BioSolutions
Pvt. Ltd. Shantha Biotechnics Stelis Biopharma Stempeutics Research Strand Life Sciences Ltd Tran-Scell Biologics Pvt. Ltd
Vatera Holdings Llc Vyome Biosciences
Director, Advent Worldwide
EXCELLENT OPPORTUNITY TO MEET TOP DECISION MAKERS, WHO ARE NORMALLY IN-ACCESSIBLE.”
“ Advisory Board
Dr Ajith V. Kamath
Senior Director and Head, External R&D Innovation, IndiaWorldwide Research & DevelopmentPfizer Inc.
Prof Ashok Pandey
Founder President, Biotech Research Society India, Former Chief Scientist and Head of Biotechnology Division, CSIR National Institute for Interdisciplinary Science and Technology
Dr G S Reddy
Chief General Manager, ManufacturingIndian ImmunologicalsLimited
Dr Kaushik Desai
Honorary General SecretaryIndian Pharmaceutical Association
Dr Sandhya Kumaraswamy
Associate Director, Quality AssuranceDr Reddy’s Laboratories
Dr Manjunath Ramarao
Group Director and Head, Disease Sciences and TechnologyBristol-Myers Squibb
Mr Swapnil BallalSenior DirectorDr Reddy’s Laboratories
Subhra Ranjan Chaktrabarti Associate Vice President Shantha Biotechnics (a Sanofi Company)
If you have an interesting case study to share, please contactEmily Chong at (65) 6322 2339 or email [email protected]
Speakers
Pazhanimuthu Annamalai Managing Director, AuraBiotech
Sudeep Singh GadokSenior Vice President, Enterprise Development, MSD Wellcome Trust Hilleman Labs
Atin Tomar President, CPL Biologicals
Ravishankar KasturiAsst. Vice President and Head of Manufacturing & Process Development, Reliance Life Sciences
Harish ShandilyaHead Global Product Development and Regulatory Affairs, Enzene Biosciences, part of Alkem Laboratories
Subhadra DravidaCo-Founder and CEO, Transcell
Stefan HartDirector, New Ventures, Johnson & Johnson
Rajinder Kumar SuriSenior Advisor and Former Chief Executive Biologicals, Panacea Biotech
Vikram Paradkar, Senior Vice President, Technical Operations, Biological E
Satyen SanghaviChief Scientific Officer, Regrow
Madhavan NampoothiriPrincipal Scientist and Head, Biotechnology Division, CSIR-NIIST
B N ManoharCEO & MD, Stempeutics
Neelam MukherjeeRegional Manager, Clinical Development Quality Assurance, APAC, Japan and EM, R&D, GSK
Venkateswarlu NelabhotlaCo-Founder & CEO, Vyome Biosciences
Davinder GillCEO, MSD Wellcome Trust Hilleman Labs
Ankur Bhatnagar, Associate Director, Biocon
Supreet DeshpandeCEO, NovaLead Pharma
Nirav DesaiVice President, CPL Biologicals
Dhaval TrivediAssistance Vice President, Regulatory Affairs, Stelis Biopharma (Strides Shasun Entreprise)
Barbara Paldus CEO, Finesse
Sundar KodiyalamManaging Director and Co-Founder, Vatera Healthcare Partners
Alok SharmaPrincipal Scientist and Head, Analytical Development Lab, Biotech Division, Lupin Limited
Chandru Chawla, Head of Corporate Strategy and New Ventures, Cipla
Arnab KapatDirector, Reliance Institute of Life Sciences and Vice President, Reliance Life Sciences
Natasha ShankerAssociate Director, Quality Control, Dr Reddy’s Laboratories
Vijay ChandruExecutive Chairman, Strand Life Sciences
SD SinhaVice President, Global Pharmacovigilance Clinical Development and Medical Affairs, Hetero Drugs Ltd
Rajendra JaniSenior Vice President, Clinical R&D, Zydus Cadila
Randy HiceManager, Global Strategy Abbott Information
Manoj KumarDirector, R&D, MSD Wellcome Trust Hilleman Labs
If you have an interesting case study to share, please contact
Emily Chong at (65) 6322 2339 or email [email protected]
AGENDA DAY ONE AGENDA DAY ONETUESDAY, 15 NOVEMBER 2016 TUESDAY, 15 NOVEMBER 20161/2 2/2OPENING KEYNOTE PLENARY: ENCOURAGING INNOVATION AND ENTREPRENEURSHIP
09:30
GUEST OF HONOUR KEYNOTE OPENING ADDRESS
Fostering biotechnology innovation and entrepreneurship in India - Where we are now & what’s next?India is the third largest biotechnology economy in the APAC region and the number 1 producer of Hepatitis B vaccines recombinant. As biotechnology brings solutions to the needs and problems of human society in the coming years, government support is paramount to the success of this industry. Join this session to find out how India’s government is working to encourage biotechnology and entrepreneurship in India.
Addressing pricing, reimbursement and compulsory licensing issues in IndiaPricing remains a contentious issues in India. While it is understandable that various government agencies try to reduce drug prices to ensure affordability in India, the lack of reimbursement and potential compulsory licensing of products pose serious operational challenges to pharmaceutical companies. The big question here, is how can we find the middle point between pharma and government, to ensure success for all concerned?
Organiser’s opening remarks
Chair’s opening remarks
10:00
15:20
16:00
Bridging the gap between research and commercialisation in the development of novel bacterial vaccines• Understanding the major hurdles to bringing novel vaccines
to commercialisation phase• Strategies for encouraging production of more
‘commercialisable’ and patentable innovations• Training and developing younger talents to instil use-inspired
researchManoj Kumar, Director, R&D, MSD Wellcome Trust Hilleman Labs
This exciting new addition to BioPharma India 2016 will see 8 of India’s most exciting and innovative biotechs offering 10-minute insights into their products, pipelines and their pathway to commercialization. Join us and hear from the innovators at the forefront of India’s biotech sector.
Chairman:Sundar Kodiyalam, Managing Director and Co-Founder, Vatera Healthcare Partners
Biotech companies:• Satyen Sanghavi, Chief Scientific Officer,
Regrow• B N Manohar, CEO & MD, Stempeutics• Subhadra Dravida, Co-Founder and CEO,
Transcell• Supreet Deshpande, CEO, NovaLead
Pharma• Pazhanimuthu Annamalai, Managing
Director, AuraBiotech• Vijay Chandru, Executive Chairman,
Strand Life Sciences• Vishwas D Joshi, Director, Seagull
Biosolutions• Venkateswarlu Nelabhotla, Co-Founder
& CEO, Vyome Biosciences
The role of bio-manufacturing plant automation in productivity enhancement, quality improvement and regulatory compliance • Understanding automation in the bio-manufacturing context• Exploring productivity enhancement through the seamless
automation of unit operations• Meeting international regulatory standards through
automated solutions Arnab Kapat, Director, Reliance Institute of Life Sciences and Vice President, Reliance Life Sciences
Managing multi-batch manufacturing: An upstream perspective• Understanding the requirements for managing multi-batch upstream processes• Building scalable, flexible control platform with multi-batch production tools • Using centralised plant management to avoid cross contaminationRavishankar Kasturi, Assistant Vice President and Head of Manufacturing & Process Development, Reliance Life Sciences
Overcoming quality issues in clinical development and research in India• Meeting the challenges of fulfilling Indian clinical trial
requirements• Exploring solutions to improve India’s clinical trials results
and quality• Improving clinical data with risk-based monitoring: A
case studyNeelam Mukherjee, Regional Manager, Clinical Development Quality Assurance, APAC, Japan and EM, R&D, GSK
Innovating vaccine manufacturing in India: Where are we now?• Addressing the challenges imposed by regulatory restrictions
on vaccine manufacturers• Overcoming the complexity of improving vaccine manufacturing
processes to increase efficiency and reduce cost• Understanding the role of vaccine manufacturers in
innovating processes to remain competitive in quality and product pricing
Subhra Ranjan Chaktrabarti, Associate Vice President, Shantha Biotechnics (a Sanofi Company)
Understanding the role of venture capital in duplicating India’s generics success to NCE and biologics development• Exposing Indian scientists and entrepreneurs to alternative
funding and sources of capital for building a biotech in India• Building a successful biotech/specialty pharma company: A
case study• What does it take to secure venture capital funding: Elements
of a successful business planSundar Kodiyalam, Managing Director and Co-Founder, Vatera Healthcare Partners
Understanding India’s latest biosimilar guidelines: How to make sure you’re compliant CDSCO share what you need to take note of when:• Documenting your upstream process • Producing upstream kinetics data • Reproducing fermentation data before upscaling from pilot scale
Bringing drugs targeting in tuberculosis fromthe laboratory to the commercial phase • Discovering the latest tuberculosis research in India • Working with industry partners to make the next scientific breakthrough• Understanding the best partnership and discovery model for scientific communities in IndiaMadhavan Nampoothiri, Principal Scientist and Head, Biotechnology Division, CSIR-NIIST
Building a seamless, smart production facility in India• Discovering strategies to overcome challenges in scaling up
production values from lab to manufacturing• Exploring smart technologies available for effective
manufacturing process design • Balancing the costs and benefits in implementing a smart
factory in India Barbara Paldus, CEO, Finesse
Chair’s opening remarks Chair’s opening remarksBarbara Paldus, CEO, Finesse
Networking Refreshment Break
Networking Refreshment Break
MANUFACTURING
UPSTREAM
PROCESS DEVELOPMENTTHERAPEUTIC INNOVATION
BIOTECH INNOVATION SHOWCASE11
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Improving cell density, productivity and scalability in antibody production • Investigating the limitations of current antibody production methods• Discovering how upstream perfusion helps to improve cell
density and productivity• Understanding how perfusion systems help to build flexibility
in scaling production sizesAnkur Bhatnagar, Associate Director, Biocon
Developing a cell-based vaccine manufacturing process• Exploring the potential for mass production of cell-based
influenza vaccines• Strategies to generate mammalian cell lines for vaccine production• Balancing the cost and efficiency of cell vs egg based productionSenior representative, Merck
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ROUNDTABLE DISCUSSION SESSIONChoose from our 8 roundtable discussions. Simply pick a table and join the debate.
Table 3: Integrating continuous
processing with existing biophamanufacturing facilities
Table 5: Low cost, high quality
biomanufacturing
Table 7: Improving novel cell lines to
improve expression and quality
PLENARY: INNOVATIVE PARTNERING MODELS IN INDIA
Making affordable, accessible, and thermo-stable vaccines in India Due to insufficient cold chain infrastructure, providing essential vaccines to less accessible regions is a great challenge in India. To overcome this difficulty, researchers worked to create thermo-stable biological products to minimize the need of cold chain services in storage and transportation stages. Leading Hilleman Labs, a joint venture between MSD and WEllcome Trust, Dr Davinder Gill, its CEO Of Hilleman Labs shares their journey from development of thermo-stable, to finding the right manufacturing partner, and improving access to essential vaccines to prevention of diseases in India. Davinder Gill, CEO, MSD Wellcome Trust Hilleman Labs
Managing partnerships in joint-venture settings Joint venture is among the popular choices in for-profit company to improve visibility and reach in global pharmaceutical industry. Representing CPL Biologicals as its newly appointed president, Atin joins us in this conference to share his view on the key strategies for him and his team in managing the different aspects of this India-USA joint venture in India. Key discussions include managing stakeholder relationship, creating melting pot in the organisation, recruiting and retaining talents and moving forward from status quo.Atin Tomar, President, CPL Biologicals
16:50
17:10
BEERS & BIOTECHS NETWORKING SESSIONGrab a beer and join us for this exciting session where 8 exciting new biotechs will have the opportunity to showcase their elevator pitch.
Hear from some of India’s hottest new biotech prospects whilst enjoying a drink – don’t forget to bring your business cards!
17:30With so much great content, book you tickets now. Or bring your team! There are special group packages available. Call Pinky Fadullon at (65) 6322 23738 or email [email protected]
12:25 Networking Lunch
Supporting continuous upstream processing with advanced single use technology• Discovering how single use technology can help build next
generation continuous bioprocessing systems• Overcoming implementation challenges of single use
technology in the existing manufacturing facilities• Exploring the potential for building fully single use bio
manufacturing in IndiaSenior representative, Wipro-GE Healthcare
Table 1:Building local and international
partnershipsStefan Hart, Director, New Ventures,
Johnson & Johnson
Table 4: Improving healthcare access
in IndiaSudeep Singh Gadok, Senior Vice President, Enterprise Development, MSD Wellcome Trust Hilleman Labs
Table 2: Building an innovation
ecosystem in India - where we are now and what’s next?
Table 6: GMP in biomanufacturing
Table 8: Upscaling novel therapeutic
productsSenior representative, Merck
AGENDA DAY TWO AGENDA DAY TWOWEDNESDAY, 16 NOVEMBER 2016 WEDNESDAY, 16 NOVEMBER 20161/2 2/2KEYNOTE PLENARY: INDUSTRY OUTLOOK
09:30
FROM IMITATOR TO INNOVATOR: HOW INDIA CAN BECOME THE NEXT INTERNATIONAL R&D DESTINATION FROM AN API & GENERICS MANUFACTURING HUB With increasingly skilled and affordable labour, and a growing commitment to strengthening IPR and infrastructure within the country, India is now transforming itself from an API and generics manufacturer to an innovation-driven manufacturing hub. Find out how India can improve its infrastructure and create more transparent policies to encourage its growth into future pharmaceutical and medical devices hub. Rajinder Kumar Suri, Senior Advisor and Former Chief Executive Biologicals, Panacea Biotech
KEYNOTE PANEL DISCUSSION: BIOPHARMA INDIA INDUSTRY OUTLOOK 2020 Whilst India is set on the path to growth, we undoubtedly still face some challenges. To attract more foreign direct investment, we need to overcome fragmented policy and funding shortages, and further improve infrastructure and IPR protection. In this session, a panel of analysts and pharma leaders will address the following topics:• Where are we now in encouraging innovation in India?• Repositioning India as a new innovation hub by building a sustainable ecosystem• Advice to local biotechs: Strategies to build up a strong base in India without losing out to competition• Shooting for success: Strategies for replicating India’s success in generics to become the global leader in biologics production and research
Chair’s opening remarks
10:10
Balancing access, quality and cost: What are the best pricing strategies for antibodies and biosimilars in India?• Improving accessibility and affordability of prescription drugs by setting a price ceiling• Understanding how biosimilars pricing policies affect opportunities for domestic and international pharma players• Investigating methods to reduce operational costs to remain profitable while reducing product prices
PANEL DISCUSSION: Moving beyond traditional reimbursement pathway to make drugs more affordable in IndiaLess than 1% of India government’s GDP is invested yearly in healthcare research and reimbursement. In this panel discussion, regulators and pharma leaders investigate the topics below in an attempt to build a more sustainable healthcare ecosystem in India:
• How can the government better support local companies to build a stronger domestic pharmaceutical market?• What is the role of pharma in making drugs more affordable while remaining profitable?• Alternative models to provide affordable drugs without depending on traditional reimbursement models
Navigating India’s regulatory landscape to get your new drugs and biosimilars approved • Understanding the current challenges in getting new drugs
and clinical trials approved in India• Crafting corrective measurements to improve drugs and trials
approved in India• Getting your biosimilars approved in India- A case study
Building a hybrid system to create a scalable manufacturing facility• Balancing costs and benefits by creating a hybrid manufacturing facility in India• Achieving production scale flexibility by integrating traditional manufacturing techniques with semi-perfusion systems• Exploring how single use technology can help in scaling manufacturing production
Chair’s opening remarks Chair’s opening remarks
Networking Refreshment Break
MANUFACTURINGUPSCALING
MARKET ACCESSACCESS AND REIMBURSEMENT
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Bringing Indian biologics products to global markets – A case study of CPL Biologicals• From early stage development to the manufacturing phase-
how Indian biologics manufacturers can comply with regulatory guidelines and ensure high quality development and production
• Overcoming regulatory challenges in exporting Indian products to the global market
• Bridging the gap between India and international health product rules and requirements
Nirav Desai, Vice President, CPL Biologicals
Building a “patient-first” brand in India• Understanding what it means to be a truly “patient-first”
business• How can you demonstrate “patient-first” as a key element of
your brand, whether you are a local or international player?• How can different functions within your business work
together to consolidate this approach?
Developing an effective medical communications strategy for India’s biopharma market• What restrictions are there on marketing strategies for
biopharmaceuticals in India?• How can you reach your market? • The bridge between development and commercialisation: What
role does medical affairs play in your communications strategy? • Balancing commercial value whilst delivering credible
medical information
Establishing health economics and outcome research (HEOR) data to your expand international market share • Strategies for presenting clinical and economic evidence to makers, payers and providers in the international arena• Gaining market access and reimbursement with convincing HEOR data• Delivering essential courses to provide trained workforce to conduct HEOR studiesRajendra Jani, Senior Vice President, Clinical R&D, Zydus Cadila
Biosimilars comparability studies and method development in early phase production• Building target-specific, robust testing kits• Ensuring reproducibility of biologics kits• Optimising assays to ensure successful regulatory
submissionAlok Sharma, Principal Scientist and Head, Analytical Development Lab, Biotech Division, Lupin Limited
Selecting the right CMO to produce high quality biologics products• Analysing the most important factors to consider when
deciding on a CMO to serve your manufacturing objectives • Differentiating industry reputation and brand recognition from
marketing promotional strategies• Cost versus usage rate- are you making the right choice
when selecting your CMO?
Laboratory Information Management Systems (LIMS) as compliance management tool• How can modern LIMS keep a company compliant?• Increasing productivity & confidence by reducing transciption
and calculation errors• Tools to assure quick response to regulatory audits Randy Hice, Manager, Global Strategy, Abbott Informations
Establishing proper control strategies for a risk free commercial manufacturing• Identification of critical quality attributes • Drafting effective control strategies to ensure quality
biosimilars production• Working closely with regulators to minimise risk• Continuous process verificationHarish Shandilya, Head Global Product Development and Regulatory Affairs, Enzene Biosciences, part of Alkem Laboratories
Networking refreshment break
15:35 Closing Networking Refreshments
QUALITY CONTROLGOING GLOBAL
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Overcoming downstream bottlenecks in the upscaling process• Investigating how efficient downstream process help to establish flexible manufacturing systems • Strategies for reducing your downstream footprint whilst speeding up the purification process • Selecting the best innovative tools to overcome downstream bioproduction bottlenecks
12:15 Networking Lunch
From Bedside to Market- Strategies for transitioning from an investigator to a prescriber • How is the role of medical affairs personnel evolving, and how
can you use it as a tool for building recognition in the market?• Identifying the key stakeholders you need to be interacting
with to build credibility
Quality risk management (QRM) in implementing new bioprocesses• Developing the best tools to implement QRM in bioprocessing• From batch to continuous processing, how can pharma
manufacturers manage the inherent risks?
QUALITY ASSURANCE BRANDING & COMMUNICATIONS
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Showcase your technologies to the BioPharma India audience. Contact Pinky Fadullon at(65) 6322 2738 or email [email protected] for a discussion on how you can be involved.
PANEL DISCUSSION: Scalable, single use, and continuous systems for improving biomanufacturing productivity in India: What’s possible?• Understanding the current regulatory challenges in
implementing new biomanufacturing processes in Indian manufacturing plants
• Exploring strategies to improve productivity with robust and scalable technology transfer systems
• Investigating cost effective methods to implement single use manufacturing systems in India
• Understanding how continuous systems help to improve productivity and scalability of biologics production
• Developing critical attributes to effectively monitor scalable, single use and continuous manufacturing process
• Performing the right comparability assessments to ensure system robustness
Moderator: G S Reddy, Chief General Manager, Manufacturing, Indian Immunologicals LimitedPanellists: Vikram Paradkar, Senior Vice President, Technical Operations, Biological E
Successfully launching biosimilars in international markets• Providing essential efficacy data to speed up biosimilars
launch in international markets• Justifying pre- and post- launch marketing investment to
improve brand awareness• Building international confidence in Indian biosimilar products• How can we replicate India’s success as the number one
generics supplier to achieve the same status in the global biologics industry?
Chandru Chawla, Head of Corporate Strategy and New Ventures, Cipla
From development to validation: Analytical method LCM and its associated challenges• Overview of various method development approaches and
highlighting stability indicating assays • Method validation & performance tracking to cope with latest
configurations, reagents and alternatives• Exploring automation as a method for streamlining QC
processes and maintaining uniformity of analytical processes• Balancing benefits and limitations of automation in data analysis.Natasha Shanker, Associate Director, Quality Control, Dr Reddy’s Laboratories
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Branding strategies for supplying drugs to international market• Overcoming international concerns around the quality of
Indian products• Building relationships with the right people to ensure
branding success• Overcoming the challenge of a lack of brand recognition in
foreign markets
Design principles for conducting GMP stability storage and biological stability testing• Crafting critical quality attributes and stability testing
strategies • Deriving control strategies to ensure identity, drug quality,
purity and potency • Developing stability protocols for GMP stability testing
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• Providing value-added services to patients and other personnel to establish a market leadership positionpersonnel to establish a market leadership position
SD Sinha, Vice President, Global Pharmacovigilance Clinical Development and Medical Affairs, Hetero Drugs Ltd
• Batch vs Semi-batch vs continuous processing: Comparing risk management perspectivesDhaval Trivedi, Assistance Vice President, Regulatory Affairs, Stelis Biopharma (Strides Shasun Entreprise)
BioPharma India will serve as a marketplace bringing all elements of the eco system together. Regulators, local biotechs, global pharmas, IP consultants, manufacturing equipmentproviders, API and cell line providers and regulatory consultants will come together, allowing India’s biotechs to assess topics such as: drug development, manufacturing and quality.
This event is your prime opportunity to meet with regulators, local pharma representatives and biotech start-ups with local expertise as they look to adopt new technologies to accelerate their drug development.
Why sponsor?ways to engage clients8
If your area of expertise falls under these categories, then you should be exhibiting at BioPharma India 2016:
Manufacturing solutions
• Scale-up• BioreactorsPlatform technology• Purification/ Decontamination• Process Design/ Optimization• Contract Design & Manufacturing
Market Access• Pricing & reimbursement• Health economics• Health communications• Pharma marketing
Research & development solutions
• Vaccine delivery technology• Protein characterization• Biosimilar comparability
Quality Assurance/Control solutions
• GMP Audit• Temperature & humidity control• Cold chain supply• Track & trace
EXHIBITShowcase yourself to over 300 of India’s leading biopharma players by taking a stand on the exhibition floor.
THOUGHT LEADERSHIP PRESENTATIONSDeliver your message as a thought leader on a chosen topic to a room of senior decision makers from India’s local pharma.
PANEL DISCUSSIONSSit alongside the leaders in India’s biopharma industry to discuss key challenges of the market on one of our expert panel discussions.
CASE STUDY PRESENTATIONSShowcase your best customer case study to establish awareness and viability to a room full of prospects.
ROUNDTABLESHost a roundtable of up to 20 industry professionals around a key topic. The format is a really powerful forum to meet qualified, self-selected attendees to debate a problem they have, that you can solve.
WORKSHOPSHost an exclusive workshop on a topic chosen by you for up to 20 prequalified biopharma leaders.
BRANDINGThis event is already being marketed by us. The sooner you join the more exposure you will get, via our website and other digital channels, print media and online community.
LEAD GENERATIONThis is a digital inbound marketing program that uses social marketing and CRM to create awareness for your product or services. It allows you to generate leads that you can add to your sales pipeline.
Contact Pinky Fadullon at (65) 6322 23738 or email [email protected] to get involved
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Kaneka
BioPharmaSpec
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Abbott Informatics
ACRO Biosystems
Prometic
Malvern Aimil
GE Healthcare
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Partner with us: The BioPharma India opportunity
Benefits Platinum Gold Silver Exhibitor
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Conference Track Chair 1
Conference Track Presentation 1 1
Hosted Roundtable Discussions 1 1 1
Staff Conference Passes 3 2 1 0
Client Conference Passes 5 4 3 0
Table-top Booth Yes Yes Yes Pod-stand
You’ve got goals? We can help you achieve them. We can work with you to achieve your targets in 2016 by positioning your brand in front of India’s biopharmaceutical industry. Join us as a sponsor to:
Meet, interact and network with senior level decision makers from India’s biopharma industry
Generate qualified and targeted leads for your sales team
Showcase your solutions to an audience keen to explore new technology
Extend your marketing footprint within India’s biopharma space
Sponsors & exhibitors
Gold Sponsors
Silver Sponsors
Contact Pinky Fadullon at (65) 6322 23738 or email [email protected] to get involved
For sponsorship or exhibition opportunities, contact Pinky Fadullon at (65) 6322 23738 or email [email protected] to get involved
Exhibitors