biotech pharma summit55 case study | unmesh lal - program manager, life sciences at frost &...

Featured Speakers

PHARMA 30-31 MARCH 2017 | PORTO, PORTUGAL 30-31 MARCH 2017 | PORTO, PORTUGAL

SUMMIT’17

BIOTECH

Biosimilars & Biologics: The future of Biotech Medicines

KEY PRACTICAL LEARNING POINTS OF THE SUMMIT

Biosimilars Interchangeability

Biosimilar Orphan Drugs: The Next Regulatory Challenge

The latest trends of the Biosimilars & Biologics

Prognosis for the Global Biologics market in an era of transformative new technologies

Innovative products and technologies in the global biologics market

Sustainable biotech innovation and the emergence of biosimilars

Obtaining patent protection while operating in an "anti-patent" climate

From biosimilar approval to biogenerics in clinical practice

Biosimilars in emerging markets – regulatory and commercial considerations

Establishing “Finger-print Like” Biosimilarity – Critical Characterization Strategies for Biosimilar Assessment

Javier Camposano, KRManaging Director DrugProduct Division at Celltrion Inc.

Cecil Nick, UKVP (Technical)at PAREXEL Consulting

Edward Abrahams, USAPresidentat Personalized Medicine Coalition

Joanna Brougher, USAOwner & Principal, BioPhama Law Group, PLLC, Adjunct Lecturer,at Harvard School of Public Health

Paul H. Song, KRVP Business Development Teamat Samsung Bioepis

Sarah Rickwood, UKVP, Thought Leadershipat QuintilesIMS

Hotel Infante Sagres

Group

Program Commitee

Program Chair

David Brindley, UKChief Scientific Officer, Aegate; Managing Partner, IP Asset Ventures; Senior Research Fellow, at University of Oxford

James Smith, UKProgramme Coordinatorand Research Associateat CASMI Translational StemCell Consortium

Arnout Ploos van Amstel, CHHead of Global Business Franchise Immunology & Dermatology (I&D)at Novartis Pharmaceuticals

Steinar Madsen, NOMedical directorat Norwegian Medicines Agency

Rodeina Challand, UKDirectorChalland Biosimilar Consulting Ltd.




Uwe Gudat, CHHead of Safety Biosimilarsat Merck


Abhishek Kulshrestha, INPrincipal scientific Managerat Biocon

António Pregueiro, CHVP Life Sciences Europe at HighPoint Solutions

Shane Maloney, SETransaction Directorat AstraZeneca

Dairine Dempsey, UKVP, Strategic Regulatory Affairs at ICON plc

Fiona M. Greer, UKGlobal Director - Life Sciences, at SGS


Samir Kulkarni, INAssociate Vice President, R&Dat Intas Biopharmaceuticals


Unmesh Lal, INProgram Manager, Life Sciencesat Frost & Sullivan

Group

Biologics/Biotechnology/ Biogenerics

Biopharmaceuticals

Business Development

Chief Scientific Officer

Clinical Immunology

Commercial Affairs

Drug and Safety Assessment

Drug Safety & Risk Management

Health Economics

Intellectual property

Legal Affairs

Legislation and Policy Advice

Manufacturing

Market Strategy

Marketing & sales

New Product Development

Pharmacovigilance

Preclinical and Clinical Development

Pricing and Reimbursement

Principal Scientist

Process Control and Analytical

Technologies

Quality Affairs/ Quality Control

Regulatory Affairs

Regulatory Compliance

R & D

The BioTech Pharma Summit 2017 is an exclusive event designed for senior level attendees from leading pharmaceutical, biopharmaceutical, biotechnology, diagnostics, CRO and solution provider companies, along with highly esteemed members of academic and government institutions.Chief Executives, Executive Directors, Vice Presidents, Heads and Team Leaders and Managers including:

JOIN US FOR A SERIES OF KEYNOTES, PRESENTATIONS AND ROUNDTABLES

Learn best practices on the global R&D and regulatory landscape, designing biosimilar development programmes and bioan-alytics of biosimilars.

“ The qual ity of attendees – as well as speakers – was the key differentiator for me.“ David Brindley, DPhil MEng FRSA | Senior Research Fellow Healthcare Translation

EXPERTS FROM AROUND THE WORLD IN ONE PLACE

EPM Group is proud to present The BioTech Pharma Summit 2017, taking place in 30-31 of March 2017 in Porto, Portugal.

Over 100 delegates working in biosimilars and biologics, proteins, antibodies and peptides, representing global pharmaceuti-cal organisations, leading biotech companies and internationally renowned academic institutions will be joining the Global summit in Porto, reserve your seat now!The BioTech Pharma Summit 2017 will address issues around biosimilars science, global regulatory pathways, evidence for clinical applications, and education for prescribers and patients that are key to successful uptake of these products.

About us

EPM Group is a unique company that promotes global summits, conferences, B2B (business-to-business) meetings, seminars, workshops and develops collaborations between all enterprises in order to promote business development in all areas.

New trends, Innovations, Modern technologies, New products, Emerging topics are generated for senior level executives to provide a cutting edge of business information and maximum return of investment for our clients from different areas, such as Pharmaceutical, Renewable Energy, Oil & Gas, Logistics and Supply Chain and Infrastructure.

Our goal is to become a top event company of designing, producing and delivering highly conceptual and fully integrated events.

Hear latest regulatory updates for smooth and speedy approval

Learn successful biosimilar case studies to reshape your business model

Dissect regional market growth opportunities – where should you go next ?

Network with like-minded senior experts and engage in interactive debates

Pharmaceutical and biotechnology

From Industries including

Who should attend

Benefits of attending

Group

Day 1 - Conference

08:20 Registration and Welcome Coffee

09:00 Opening of the BioTech Pharma Summit with Prof. Dr. Hélder Mota Filipe, member of the board directors of INFARMED

Evolution, latest Trends and future of Biosimilars & Biologics

Regulatory Landscape & Patent Protection

09:10 Case Study | Uwe Gudat - Head of Safety Biosimilars at Merck

What’s in it for me: accounting for and reconciling multiple stakeholder perspectives in the adoption of biosimilars

10:15 Case Study | António Pregueiro - Vice President Life Sciences Europe at HighPoint SolutionsBiosimilars: A market to grow

11:20 Case Study | David Brindley - Chief Scientific Officer, Aegate; Managing Partner, IP Asset Ventures; Senior Research Fellow,

at University of OxfordChallenges and opportunities in development of Biosimilars: Global Perspective

Exhaustive information about new products, untapped geographies, recent developments, and investments in the

biosimilars market

New guidance from FDA to help manufacturers develop more treatment options

Biosimilars: current state and future challenges

Leading companies and key drivers

Market Opportunities and Forecast

10:50 Morning Coffee and Networking Break

11:55 Case Study | Joanna Brougher - Owner & Principal, BioPhama Law Group, PLLC, Adjunct Lecturer

at Harvard School of Public HealthObtaining patent protection while operating in an "anti-patent" climate

Overview of recent cases affecting the biotechnology industry

Impact on biosimilar development

Strategies for obtaining adequate patent protection

12:30 Case Study | Dairine Dempsey - VP, Strategic Regulatory Affairs at ICON plcOverview of the regulatory Landscape for Biologics and Biosimilars

A summary of the global regulations for biologics and biosimilars

Similarities and differences between the key geographies

Challenges and opportunities in biologics and biosimilar licencing

09:45 Speed Networking | Innovative approach to maximize networking capabilities through two minute periods, where

delegates can meet their peers and exchange business cards before rotating to the next company representative

13:00 Business Lunch

14:00 Case Study | Rodeina Challand - Director at Challand Biosimilar Consulting LtdBiosimilar Orphan Drugs: The Next Regulatory Challenge

Regulatory Pathway

Historical data

Effect size

Sample size

Recruitment

Comparator sourcing and cost

Investments, Business Models and Developing Partnerships

14:35 Case Study | Javier Camposano - Managing Director Drug Product Division at Celltrion Inc.Biosimilars Interchangeability and Extrapolation

Current Biosimilar interchangeability and extrapolation issues

Key factors in Biosimilar interchangeability and extrapolation

Group

16:15 Case Study | Arnout Ploos van Amstel - Head of Global Business Franchise Immunology & Dermatology (I&D) at Novartis

Sustainable biotech innovation and the emergence of biosimilars: opportunities to create enterprise synergies and enhance

patient outcomes

Biotech produced transformational breakthroughs for patients

Need to balance reward for innovation with increasing budget impact

Emergence of biosimilars creates opportunities to address this challenge

Biotech innovation and biosimilars under one roof: enterprise strategies

17:20 Chairman’s Closing Remarks

19:30 Gala Dinner

We have programmed a dinner in one of the finest restaurants of the city of Porto

09:00 Registration & Coffee

09:30 Opening Address from the Chairman

Methods & Analytical Strategies for Biologics and Biosimilars

09:40 Case Study | Sarah Rickwood - VP, Thought Leadership at QuintilesIMSFrom disruption to maturity: the prognosis for the Global Biologics market in an era of transformative new technologies, payer pushback and biosimilars

The rise of the global biologics market from niche to the mainstream

The next steps for the global biologics market as it transitions to maturity

The impact of biosimilars and the promise of cost transformation

Biologics entering new therapeutic areas

Lifecycle management of biologics

10:15 Case Study | Fiona M Greer - Global Director, BioPharma Services Development – Life Sciences at SGSEstablishing “Finger-print Like” Biosimilarity – Critical Characterization Strategies for Biosimilar Assessment

Comprehensive physicochemical structural characterization of the (glyco)protein to demonstrate “Biosimilarity”

with the originator

Glycosylation and variability of quality attributes to establish the QTTP

Comparative data for the Biosimilar side by side with the originator. Structural and functional activities

Strategies for primary and higher-order structure determination. LC/MS/MS approaches. Orthogonal analytical techniques

for “finger-print like” assessment

11:20 Case Study | Cecil Nick - VP (Technical) at PAREXEL ConsultingAnalytical Comparability of Biologics and Biosimilars

Applying state of the art techniques

Value and limitations of analytical and biological testing

Assigning criticality to quality attributes

Statistical approaches

Justifying differences in critical quality attributes

10:50 Coffee & Networking Break

16:50 Panel discussion | Interchangeability

Panelists:

Rodeina Challand | Director at Challand Biosimilar Consulting Ltd

Dairine Dempsey | VP, Strategic Regulatory Affairs at ICON plc

Joanna Brougher | Owner & Principal, BioPhama Law Group, PLLC, Adjunct Lecturer, at Harvard School of Public Health

Cecil Nick | Vice President (Technical) at PAREXEL Consulting

Javier Camposano | Managing Director Drug Product Division at Celltrion

The long-awaited guidance documents regarding biosimilars

15:45 Coffee Break

Day 2 - Conference

15:10 Case Study | Shane Maloney - Transaction Director at AstraZenecaDeveloping partnerships and making deals

Environment for deal making

Getting to a deal

Leveraging partnerships for success

Group

12:30 Case Study | Steinar Madsen - Medical director at Norwegian Medicines AgencyFrom biosimilar approval to biogenerics in clinical practice

Attitudes and acceptance in clinical practice

Uptake in clinical practice

Nor-Switch study and other clinical trials

Switching and interchangeability

The development of biosimilars

15:45 Coffee Break

13:00 Business Lunch

R&D Manufacturing of Biosimilars

16:15 Case Study | Samir Kulkarni - Associate VP, Product Development and Strategic Program Management

at Intas Biopharmaceuticals

Process development in R&D for event free manufacturing

Investigating the role of R&D before transfer of process ownership

Establishing critical aspects which requires evaluation to ensure event free manufacturing operations

Communication and training to prepare for successful technology transfer and manufacturing processes (Associated

Real-Life Examples)

17:20 Chairman’s Closing Remarks and End of Summit

16:50 Panel discussion | The implementation of biosimilars in the market

Global debate on naming of biosimilars

What can we expect as we moving closer to 2020?

Partnerships play in the development of biosimilars

Panelists:

Edward Abrahams | President at Personalized Medicine Coalition

Paul H. Song | VP at Samsung Bioepis

Unmesh Lal | Program Manager, Life Sciences at Frost & Sullivan

Abhishek Kulshrestha | Principal scientific Manager at Biocon

14:35 Case Study | Paul H. Song - Vice President at Samsung BioepisBiosimilar Development at Samsung Bioepis

Introduction of Samsung Bioepis and its vision

Our competitive advantage during biosimilar development : process innovation

SB4 (Enbrel biosimilar) development story

14:00 Case Study | Abhishek Kulshrestha- Principal scientific Manager at BioconBiosimilarity assessment- The process of designing biosimilars

Quality by design

Quality target product profile

Analytical similarity

Process control

Totality of evidence

15:10 Case Study | Edward Abrahams - President at Personalized Medicine CoalitionWhy Personalized Medicine Matters?

The promise of PM

The current status of the field

The challenges to the field

11:5511:55 Case Study | Unmesh Lal - Program Manager, Life Sciences at Frost & SullivanData-driven Solutions Transforming the Global Biopharmaceuticals Manufacturing Industry

Big Themes for Biologics Manufacturing

How are Biopharma & CDMOs Responding to the Challenges and Opportunities?

Data Driven Transformation of the Industry Ecosystem

Group

António Pregueiro , PhD has over 12 years of experience in the pharmaceutical and biotechnology industries combined with a strong research background prior to his business career . He s p e n t 5 ye a r s wo r k i n g i n co n s u l t i n g fi r m s fo c u s e d i n t h e l i fe-sciences developing expert ise in strategy, management and technology across several therapeutic areas . He gained exper ience in the US, Europe, South America , Russia and the Midd le Eas t . He the n s pe nt 8 ye a r s wor k ing in b io tech and pharmaceutical at companies l ike Amgen, Bausch & Lomb and Takeda. In his most recent industr y posit ion at Takeda he was t h e h e a d o f a b u s i n e s s u n i t fo r a E U 5 co u n t r y w i t h f u l l P & L responsibi l i ty and leading a sales and marketing organization respons ib le for launching the company´s flagship b i o l o g i c product .

António Pregueiro, CHVP Life Sciences Europe at HighPoint Solutions

Speakers Biographies

His industry expertise l ies among l i fe sciences engagements across var ious therapeutic areas , leveraging relat ionships w i t h k e y o p i n i o n l e a d e r s i n s e c t o r s s u c h a s G l o b a l P h a r m a ce u t i ca l & B i o l o g i c s Co n t ra c t O u t s o u r c i n g , A P I manufacturing in India & China, European Oncology & Diabetes market prognosis & Pharma sales force ef fect iveness .He has authored thought leadership on Biologics & Biologics Contract Manufactur ing , Growth Opportunit ies in the EU B i o s i m i l a r M a r k e t , C R O & B i o - a n a l y t i c a l M a r k e t , Pharmaceutical Extractables and Leachables, Cell Banking, Pharmaceutical Stabi l i ty Test ing and Analys is of the Global Contract Manufactur ing Organizat ion Market . In addit ion, he has hosted briefings with leading market part icipants on 'B io log ics Manufactur ing – I s Your Company Ready? ' and ' G r ow t h O p p o r t u n i t i e s a n d D i s r u p t i ve B u s i n e s s M o d e l s Emerge in the Contract Manufacturing Organisation Market'.

Unmesh Lal, INProgram Manager, Life Sciencesat Frost & Sullivan

Cecil Nick, Vice President (Technical) , at PAREXEL Consulting has been working in regulatory affairs and clinical development for over 30 years; for over 25 years he has focused on biological medicines. Cecil Nick has particular expertise in monoclonals and biosimilars , having worked on over 20 such programs, engaged in over 50 interactions and meetings with regulatory agenc ies and supported 6 submiss ions in the EU and US including the first monoclonal biosimilar to be approved there. Cecil has extensive experience in orphan drugs and in numerous therapeutic areas including, but not l imited to , oncology , inflammatory disease, diabetes , growth and hematology.


Dr. Dempsey is VP, Strategic Regulatory Affairs at ICON plc . She is a PhD pharmacist with over 15 years ’ experience as a pharmaceutical regulator. She has previously held a number of senior posit ions in the Ir ish competent authority (HPRA) where she represented Ireland at the EU Medicines Agency, the EU Commission and internationally. She later worked as a pharmaceutical consultant to pharmaceutical companies & governments in the EU, US & globally during which t ime she led the establishment of Bahrain’s national regulatory agency for pharmaceut ical products regulat ion . She i s cur rent ly responsible for g lobal regulator y strategy at ICON plc .

Dairine Dempsey, UKVP, Strategic Regulatory Affairs at ICON plc

1

Arnout Ploos van Amstel has over 25 years of business and operations experience in the bio-pharmaceutical business in a wide variety of leadership posit ions. Currently , Mr Ploos van Amstel leads the Global Business Franchise Immunology & Dermatology ( I&D) at Novart is Pharmaceuticals . The I&D Business of $3 ,2bn includes the recently launched, game changing biologic Cosentyx, the first IL17A inhibitor. Cosentyx addresses significant unmet needs for patients with the skin disease Psoriasis and the rheumatology disorders Psoriatric Arthrit is (PsA) and Ankylosing Spondyl it is (AS) . I t is one of the most promising assets of Novart is .

Arnout Ploos van Amstel, CHHead of Global Business Franchise Immunology & Dermatology (I&D)at Novartis

Dr David Brindley is an international research and industrial l e a d e r i n h e a l t h ca r e t ra n s l a t i o n . H e h o l d s a ca d e m i c appointments a t the Univers i t y o f Ox ford , Har vard , UCL , S tanford-UCSF-FDA Cent re fo r Regulator y Sc iences and CASMI, and is an enthusiastic and diligent advisor to a portfolio o f hea l thcare sector companies , rang ing f rom too l s and technologies providers to l i fe science focussed investors .David is a Managing Partner at IP Asset Ventures Ltd. He is also Chief Scientific Officer of Aegate Ltd.

David Brindley, UKChief Scientific Officer, Aegate; Managing Partner, IP Asset Ventures; Senior Research Fellow, at University of Oxford

Group

2

Edward Abrahams, Ph.D. , is the president of the Personalized Medicine Coalition (PMC). Representing innovators, scientists, patients, providers and payers, PMC promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. It has grown from its or iginal 18 founding members in 2004 to more than 225 today.Prev ious ly , Dr . Abrahams was the execut ive d i rector o f the Pennsylvania Biotechnology Association, where he spearheaded the successful effort that led to the Commonwealth of Pennsylvania’s investment of $200 mill ion to commercialize biotechnology in the state. Earlier, he had been assistant vice president for federal relat ions at the Univers ity of Pennsylvania and held a senior administrative position at Brown University.


Dr Fiona Greer was a founding Director of M-Scan, contract ana lys ts spec ia l iz ing in b iopharmaceut ica ls . Fo l lowing acquis it ion (2010) , she is now Global Director , Biopharma Services Development, SGS Life Sciences. Following a Ph.D. in Protein Biochemistry from Aberdeen University (1984) she joined M-Scan to establish and direct biologics characterization services. Here, she pioneered new developments for structural ana lys i s and sequencing of prote ins and carbohydrates resulting in numerous publications and patents. With over 36 years exper ience in g lycoprote in analys i s us ing mass spectrometr y and other inst rumenta l techniques , she i s involved with a diverse range of biotech products, both novel and biosimilar . She consults to companies throughout the world and is regularly invited to give presentations. In 2016 she was named in the Medicine Makers “Power List – Top 100 influencers” .

Fiona M. Greer, UKGlobal Director - Life Sciences, at SGS

Javier Camposano is the Managing Director and Head of the Drug Product Division at Celltr ion’s Inc. South Korea. Prior to Ce l l t r ion he worked for Baxter fo r 17 years in a var iety o f technical and Management positions, including Facil ity and Equipment Project managing, Leading Aseptic Filling Capital Projects, participating in commercial development projects and Supervising cross functional projects between facilities. In 2011 Javier moved to Celltr ion to co-lead a newly formed Drug Product Division. In 2015 Javier became the head of the DP division assuming responsibil it ies for the DP commercial manufacturing of Celltr ion biosimilars .


Joanna is a patent attorney who focuses her practice on al l aspects of ser v ices re lated to patents in the l i fe sc iences . J o a n n a h a s ex p e r i e n ce co u n s e l i n g c l i e n t s o n t h e Hatch-Waxman Act and is monitoring developments involving b ios imi la r s under the B io log ics P r ice Com pe t i t ion and Innovat ion Act . Joanna i s a l so an Adjunct Lecturer at the H a r v a r d T. H . C h a n S c h o o l o f P u b l i c H e a l t h a n d t h e Editor-in-Chief of the Journal of Commercial Biotechnology. She regular ly speaks or lectures on inte l lectual property related topics and is a frequent author of articles related to patent law and healthcare. In 2013, Joanna published a book called Intellectual Property and Health Technologies: Balancing Innovat ion and the Publ ic ' s Heal th which examines the relationship between patents and public health in the context of medical technologies. Joanna received her J.D. degree from B o s t o n Co l l e g e L aw S c h o o l , a n d i s a d m i t t e d t o t h e Massachusetts and New York State Bars as well as the USPTO.

D r . P a u l H . S o n g h a s 2 3 y r s o f i n - d e p t h b i o l o g i c s d r u g d i scover y /deve lopment exper iences in both innovat i ve biologics and biosimilar drugs targeting immunology and oncology indications. In his current role as Vice President at Samsung Bioepis, Paul is leading the Cel l Engineering team with responsibi l i t ies for generating commercial production cel l l ines for the 2nd wave biosimilars targeting both oncology and immunology ind icat ions , and technology deve lopment fo r advanced production cel l l ine and vector system. Between 2010~2014, Paul led the Biotherapeut ics Lab at S a m s u n g Ad va n ce d I n s t i t u te o f Te c h n o l o g y ( SA I T ) , t h e Samsung Group’s central research center .



Uwe Gudat received his medical degree from the University of Marburg, Germany. He is l icensed in internal medicine and diabetology as a sub- speciality, training under Michael Berger in Düsseldorf Germany. In this time he has led global clinical development teams, served as global medical brand director, led clinical teams for in-licensing due- diligence and managed clinical-trial review, first in man transitions and product safety assessments. Currently he is Head of Safety of the Merck Serono Biosimilars Unit. He has published a number of scientific papers in the field of diabetes and is currently on the editorial advisory board of Applied Clinical Trials.

Uwe Gudat, CHHead of Safety Biosimilarsat Merck

Group

3

Rodeina Challand B.Sc., Director, Challand Biosimilar Consulting Ltd . , Graduate f rom London Univers i ty with over 25 years of experience in healthcare, cancer research and pharmaceutical industry across a wide range of roles including developing and implementing clinical development strategies for biosimilars at Hospira Inc. as Director of Clinical Projects and Head of Clinical Operations in the EU. Was the lead in the development of Hospira’s first b ios imi lar , Hospira GCSF, f rom lab to c l in ic and Hospira Epoetin biosimilar Retacrit, for both the EU and the US programs. Experience in all aspects of biosimilar development including study design and regulatory agency discussions and worked on over 12 bios imi lar molecules across a range of products and indications. In my most recent role as Executive Director Biosimilar Development PRA Health Sciences, worked on several Biosimilar programs with several companies ranging from start up to large Biotech Pharma.

Dr. Samir Kulkarni is leading the Process Development efforts at Intas Biopharmaceuticals as an Associate VP. He holds a PhD in Chemica l Engineer ing in addi t ion to which , h i s educational background includes a combination of faculties such as Pharmaceutical Sciences, BioProcessing and Business Administration from Reputed institutes such as ICT (Mumbai) and I IM (Bangalore) .Samir has more than 16 years of exper ience in the area of biological sciences with strong technical depth in Protein Chemistry and Process development having worked in the Biopharma Development Groups at Dr. Reddy’s Laboratories and USV in his earl ier tenures . His experience extends into overa l l unders tanding o f B io log ics and Pharma Product D eve l o p m e n t b u s i n e s s t h r o u g h m a n a g i n g B i o s i m i l a r s Programs at Dr Reddy’s Biologics and as the global Business Development lead for Accutest Biologics .

Samir Kulkarni, INAssociate Vice President, R&Dat Intas Biopharmaceuticals

Rodeina Challand, UKDirectorChalland Biosimilar Consulting Ltd.

Abhishek is working as Principal scientific Manager at Biocon. In Biocon, he leads the Biosimilar recombinant human Insulin program for regulated markets. He also leads the bioanalytical functions related to Pharmacokinetics, Immunogenicity and HCP assessment. With close to 10 years of industry experience in biosimilar and biologics development, he has successfully led research teams working on phage display based antibody libraries, mammalian and bacterial cell line development, bioassays and bioanalytical development.

Dr . S te inar Madsen i s medica l d i rector a t the Nor wegian M e d i c i n e s Ag e n c y . H e h a s b e e n wo r k i n g w i t h g e n e r i c substitution since it was introduced in Norway in 2001 and with biosimilars s ince 2006. He is member and previously chairman of the committee for generic substitution at the Agency. Dr . Madsen is also engaged in the drug information service, with a special interest in the safe and cost-ef fective use o f d rugs . He i s a spec ia l i s t in in te rna l medic ine and cardiology and works part time as a consultant in cardiology.

Steinar Madsen, NOMedical directorat Norwegian Medicines Agency

Shane Maloney is a Transact ion Director in AstraZeneca ’s business development group, based in Gothenburg, Sweden. He has worked in bus iness development for Ast raZeneca s ince 2001 , o r ig ina l l y in the UK and now in Sweden ; and starting with technology platforms and early-discovery deals, before gradual ly moving to c l in ical -stage and on-market deals. Prior to joining AstraZeneca, Shane worked in university technology transfer, out-licensing inventions as well as managing spin-out companies. By training, he is a PhD microbiologist with an MBA.

Shane Maloney, SETransaction Director at AstraZeneca

Sarah Rickwood has 20 years ’ experience as a consultant to the pharmaceutical industry. She has worked with most of the world ’s leading pharmaceutical companies in the US, Europe, Japan, and leading emerging markets . During her time at QuintilesIMS, Sarah has played a key role in developing the Launch Excellence thought leadership studies and Launch Readiness offerings which provide QuintilesIMS’ pharmaceutical clients with comprehensive and critical guidance during the crucial pre-launch and launch periods for their key brands. In particular, she has advised companies on the launch of current a n d p o te n t i a l b l o c k b u s te r s i n m a ny t h e ra py a r e a s a n d countries. Sarah leads a team which puts together more than 180 client presentations a year , and develops new Thought Leadership on launch excel lence, biosimilars , commercial analytics , healthcare system changes, blockbusters ; the top 10 companies of the future and uptake and access of innovative medicines , social media and pharmaceutical companies , and mobile apps in patient healthcare.


Abhishek Kulshrestha, INPrincipal scientific Managerat Biocon

Group

Exhibitor

Partners

Hotel Venue

The venue of the BioTech Pharma Summit 2017 will be at the Hotel Infante Sagres*****

Address

Hotel Infante SagresPraça D. Filipa de Lencastre, 62 4050-259 Porto – Portugal

Group

biotech pharma summit55 case study | unmesh lal - program manager, life sciences at frost &...

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