2017 bridge program - qut · 2017-12-12 · residential training 21st, 22nd, 23rd october 2017...

RESIDENTIAL TRAINING21st, 22nd, 23rd October 2017

National Wine Centre, Adelaide, South Australia

T R A N S F E R R I N G S K I L L S O N T H E C O M M E R C I A L I S A T I O N O F P H A R M A C E U T I C A L R E S E A R C H

The Bridge Program has received industry-matched funding through the MTPConnect Project Fund Program – investing in ideas to improve the productivity, competitiveness and innovative capacity of Australia’s medtech, biotech and pharmaceutical sector.

LinkedIn: @The-Bridge-Program

Twitter: @program_bridge

#BridgeProgram2017

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Dear Bridge Program participants,

Congratulations on being part of the first cohort to take part in this fantastic program!

The strengthening of collaboration and ongoing development of commercialisation and business-management

skills is vital to support Australia’s impressive life sciences ecosystem, and The Bridge Program provides a unique

opportunity to learn practical skills directly from practitioners with proven success in the pharmaceutical sector.

The MTPConnect Project Fund Program was developed to bring together industry, research organisations, and

universities to drive collaboration and commercialisation; overcoming identified constraints and barriers in the

sector, such as the skills-gap, to contribute to realising its full potential and projected growth of an additional

28,000 jobs by 2025.

The Bridge Program has delivered outstanding training to its first 101 participants since its launch in June, and

these last few days of face-to-face training offer the perfect opportunity to network with your fellow participants,

the 15 consortia members without whom The Bridge Program wouldn’t be possible, and a range of key national

and international guests.

It has been fantastic to see such a broad range of participants so enthusiactically take part in the program, and we

have no doubts that the program and you, the graduating participants, will have immense positive impact on the

future of the Australian sector. We look forward to celebrating your future successes!

Yours sincerely,

Sue MacLeman

CEO and Managing Director

W E LCO M E

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PROGRAM

How the Global Pharmaceutical Industry Discovers and Develops Drugs

DAY 1

TIME SESSION PRESENTER CHAIR

08:00 – 08:50 Registration

08:50 – 09:00 Presentation: Welcome to The Bridge Program Riad El-Dada, MSD Christian Sellars, MSD

09:00 - 09:10 Official Opening Senator the HON Anne Ruston Professor Lyn Griffiths, QUT

09:10 – 09:20 Presentation: Outline of the Residential Program Professor Lyn Griffiths, QUT Christian Sellars, MSD

09:20 – 09:50 Presentation: The Evolution of Pharmaceutical Dr Anna Lavelle, Medicines Australia Sean Lybrand, Amgen Discovery, Development and Commercialisation in Australia

09:50 – 10:40 Presentation: Understanding the Pharmaceutical Dr Garnet Howells, Amgen Sean Lybrand, Amgen Development Pathway - What Drives Discovery and Investment Decisions?

10:40 – 11:00 Morning tea

11:00 – 11:20 Biotech Commercialisation and Collaboration Dr Cynthia Cliff, QUT Professor Lyn Griffiths, QUT Experience: Orientation

11:20 – 12:00 Presentation: The Path to an Investigational Dr Ed Lobenhofer, Amgen Professor Lyn Griffiths, QUT New Drug (IND)

12:00 – 12:30 Lunch

12:30 – 14:00 Presentation: Due Diligence and IP Rob McInnes, DibbsBarker Kathy Connell, Johnson & Johnson Innovation

14:00 – 15:30 Biotech Commercialisation and Collaboration Rob McInnes, DibbsBarker Kathy Connell, Johnson & Experience: Framing a Potential Deal and Dr Cynthia Cliff, QUT Johnson Innovation Establishing your ‘Ask’

15:30 – 16:00 Afternoon tea

16:00 – 16:30 Case Study: Pharmaxis – Facing Early Challenges and Gary Phillips, Pharmaxis Anne-Maree Englund, MSD Implementing a Successful Turnaround Strategy

16:30 – 17:00 Case Study: Positioning Successfully Dr Deborah Rathjen, Bionomics Anne-Maree Englund, MSD

17:00 – 18:30 Speed Networking , Drinks and Canapes Anna Grocholsky, Macquarie University


PROGRAM

Bench to Biotech

DAY 2


09:00 – 09:10 Presentation: Recap of Day 1, Overview of Day 2 Professor Lyn Griffiths, QUT Dr Phil Kearney, MSD Agenda and Biotech Commercialisation and Collaboration Experience Activities

09:10 – 09:50 Presentation: Designing Clinical Trials for Regulatory Dr Roy Baynes, MSD Dr Phil Kearney, MSD Approval and Reimbursement

09:50 – 10:20 Case Study: An Early Trial Dr Garnet Howells, Amgen Sean Lybrand, Amgen

10:20 – 10:50 Case Study: Mid Stage, Global Trial Andy Lee, MSD Sean Lybrand, Amgen


11:20 – 11:40 Presentation: Navigating National and International Neama Baho, CSL Peter Germanos, Boehringer Regulatory and Reimbursement Approval Ingelheim

11:40 – 12:30 Panel Discussion: How Clinical Development Realises Peter Germanos, Boehringer Peter Germanos, Boehringer the Value of Pharmaceutical Research Ingelheim (Chair) Ingelheim • Neama Baho, CSL • Andy Lee, Merck • Dr Roy Baynes, Merck • Dr Raymond Bain, Merck • Dr Garnet Howells, Amgen

12:30 – 13:00 Lunch

13:00 – 13:40 Presentation: Raising Capital – Australian Perspective Dr Stephen Thompson, Brandon Peter Murphy, Novartis Capital Partners

13:40 – 14:10 Panel Discussion: Raising Capital Dr Stephen Thompson, Brandon Peter Murphy, Novartis Capital Partners (Chairs) • Professor Darren Kelly, Occurx • Kathy Connell, Johnson & Johnson Innovation

14:10 – 14:40 Case Study: Fibrotech Professor Darren Kelly, Occurx Peter Murphy, Novartis

14:40 – 15:00 Afternoon tea

15:00 – 16:30 Biotech Commercialisation and Collaboration Dr Stephen Thompson, Brandon Kathy Connell, Johnson & Experience: Refining a Pitch and Crafting a Deal Capital Partners Johnson Innovation Rob McInnes, DibbsBarker Dr Cynthia Cliff, QUT

16:30 – 18:00 Break and Travel to Dinner Venue

18:00 – 18:45 Pre-Dinner Drinks South Australian Museum Professor Lyn Griffiths, QUT

18:45 – 21:00 Networking Dinner and Announcement of Professor Lyn Griffiths, QUT Pitch Winners - South Australian Museum


PROGRAM

Biotech to Patient

DAY 3


09:00 – 09:10 Presentation: Recap of Day 2, Overview of on Professor Lyn Griffiths, QUT Elizabeth de Somer, Day 3 Agenda and Simulation Activities Medicines Australia

09:10 – 09:50 Presentation: How the Australian Government Dr Ashley Bates, AusIndustry Dr David Thomson, AbbVie Supports Innovation Sue MacLeman, MTPConnect

09:50 – 10:30 Presentation: The Value of Pharmaceutical Science to Wes Cook, Medicines Australia Elizabeth de Somer, the Economy and Health System Medicines Australia


10:50 – 11:20 Case Study: The CRC for Cancer therapeutics Dr Warwick Tong, Cancer Therapeutics CRC Dr Brian Muller, Mundipharma

11:20 – 12:00 Panel Discussion: Using Public and Other Programs Dr David Thomson, AbbVie (Chair) Dr Brian Muller, Mundipharma to Build Capacity and Support Collaboration • Dr Jessica Droge, Amgen • Dr Ashley Bates, AusIndustry • Sue MacLeman, MTPConnect • Dr Warwick Tong, Cancer Therapeutics CRC

12:00 – 12:30 Presentation: A Career in the Australian Life Dr Stewart Washer, Zelda Therapeutics LTD Dr Brian Muller, Mundipharma Science Industry

12:30 – 13:00 Lunch

13:00 – 13:30 Presentation: How to Optimise your Interactions Dr Mary Chamberlain, AbbVie Dr David Thomson, AbbVie with Global Pharma

13:30 – 14:00 Panel Discussion: What Does Success Feel Like? Dr David Thomson, AbbVie (Chair) Dr David Thomson, AbbVie Managing a Successful Partnership or Deal with a • Dr Jessica Droge, Amgen Pharmaceutical Company • Dr Mary Chamberlain, AbbVie • Wes Cook, Medicines Australia • Kathy Connell, Johnson & Johnson Innovation

14:00 – 15:50 Biotech Commercialisation and Collaboration Rob McInnes, DibbsBarker Simon Higgins, Bristol-Myers Experience: Culmination, Learnings and Evaluation Dr Cynthia Cliff, QUT Squibb

15:50 – 16:00 Presentation: Program Wrap Up Christian Sellars, MSD Professor Lyn Griffiths, QUT

16:00 – 17:00 Official Close and Networking Drinks Sue Macleman, MTPConnect Professor Lyn Griffiths, QUT

B I O G R A P H I E S


Dr Ashley Bates Director Medical Technologies and Pharmaceuticals, AusIndustry

Dr Bates has been worked in the Pharmaceutical Industry for around 25 years. Starting as a research scientist in product development at The Upjohn Company, now Pfizer, he worked in the UK and USA before moving to Australia.

Dr Bates has a deep understanding of the commercialisation of biomedical innovation gained form having held senior roles in new product development, business development and, for over 10 years, responsible for GSK’s research collaboration and licencing activities in Australia. Dr Bates also has worked with a variety of SMEs, government funded bodies and has served on the boards of not-for-profits, Cooperative Research Centres and industry associations in the health industry sector. Dr Bates took up his current role in the Entrepreneurs’ Programme in January 2016.

Neamo Baho Head of Regulatory Affairs, Asian Pacific, CSL

Ms Baho is the Regional Head of Regulatory Affairs, responsible for Australian, New Zealand and international markets within CSL Behring. She is also the Site Head for the Global Regulatory Affairs team based in Australia.

Ms Baho has over 25 years’ experience in the pharmaceutical industry, 16 of which have been dedicated to regulatory affairs, built on an extensive base of expertise in quality with sterile & injectable biological products (blood products and recombinant products).

Over the years, Ms Baho has worked on many successful registrations and development projects of strategic importance that required innovative regulatory strategies. The complexity of manufacturing and licencing biological product has required her to build professional relationships founded on trust and respect with different customers, including Health Authorities. The product types, their indications, and the variability of patient needs have required Ms Baho to build an understanding of rare diseases and the different medical approaches to their treatment.

Ms Baho enjoys diversity in her work and professional relationships. The satisfaction in helping to bring new lifesaving medicines to patients keeps Ms Baho engaged and motivated in the ever-changing world of regulatory affairs.

Dr Raymond P. Bain Senior Vice President and Head of Biostatistics and Research Decision Sciences, Merck Research Laboratories

Dr Bain is responsible for MRL Biostatistics supporting Discovery and Pre-Clinical Sciences and Early & Late Clinical Development. The Global MRL-BARDS organisation (located in the US, Europe and Asia Pacific regions) develops and applies statistical science methodology in the targeting, discovery, development, manufacturing and marketing of pharmaceutical products through the design, conduct, analysis, interpretation and communication of pre-clinical and clinical investigations.

Prior to Merck, Dr Bain was a member of The Biostatistics Center at George Washington University (GWU) where he was Co-Director of the Center and Research Professor of Statistics. While at GWU he was a Coordinating Center Principal Investigator for the National Institutes of Health.

Professionally, Dr Bain is a Fellow of the American Statistical Association and a Fellow of the Society for Clinical Trials. He is a member of the Board of Trustees for the National Institute of Statistical Sciences and participates in the Clinical Trials Transformation Initiative (a public-private partnership) as a Team Leader on the Data Monitoring Committees project.



Dr Cynthia Cliff Director (Knowledge Transfer and Partnership Development), QUT

Dr Cliff is the Director (Knowledge Transfer & Partnership Development) in the Faculty of Health at Queensland University of Technology (QUT) in Brisbane Australia. This pioneering role, in academic terms, reflects a career-long fascination with innovation at the industry-academic interface.

Prior to joining QUT’s Faculty of Health, Dr Cliff assisted government, the private sector and NGOs with business innovation across a diversity of industries ranging from mining to the arts and space technology. She has also worked with the government examining future directions in tertiary education, and with the consumer movement on the impact of manufacturing and marketing practice on consumer health and the environment.

At QUT her enterprise, international and engagement skills have contributed to the university’s ability to solve real world problems by actively fostering multidisciplinary and inter-professional teaching and research in the Faculty of Health. Her passion for innovation and active promotion of deep, enduring and mutually beneficial international and industry collaboration has contributed significantly to QUT’s long-term relationships in Australia, PR China, Vietnam, Indonesia, Finland and the UK.

Dr Roy Baynes

Senior Vice President and Head Global Clinical Development and Chief Medical Officer, Merck Research Laboratories

Dr Baynes is Senior Vice President Global Clinical Development and Chief Medical Officer at Merck Research Laboratories in Rahway, New Jersey. He was previously Senior Vice President of Oncology, Inflammation and Respiratory Therapeutics at Gilead Sciences and, prior to that, was Vice President Global Clinical Development and Therapeutic Area (TA) Head for Hematology / Oncology, at Amgen Inc.

Dr Baynes graduated as a Medical Doctor and obtained a Master of Medicine and Doctor of Philosophy from the University of the Witwatersrand, Johannesburg, South Africa. He has had a long and distinguished career in the haematology-oncology and stem cell transplantation fields, including drug development, basic research, clinical practice, clinical research, teaching and administration.

Dr Baynes is a member of many international societies, including the American Society of Hematology (ASH) and the American Society of Clinical Oncology (ASCO), and has authored some 150 publications. He has been recurrently named among America’s top physicians. Before joining Amgen in 2002, Dr Baynes was the Charles Martin Professor of Cancer Research at the Barbara Ann Karmanos Cancer Institute, an NCI designated Comprehensive Cancer Center, at Wayne State University, Detroit, Michigan, USA.

Dr Mary Chamberlain Head of Academics - Search and Evaluation, AbbVie

Dr Chamberlain is responsible for all relevant therapeutic and functional areas of interest across all phases of development as they pertain to relationships with academic and research institutions around the globe. She joined AbbVie approximately 3 years ago in this newly created role which speaks to AbbVie’s dedication to leveraging and nurturing relationships in this space. During her time at AbbVie, she has led the execution of multiple collaborations.

Prior to AbbVie, Dr Chamberlain was at Eli Lilly for 17 years where she headed up Neuroscience Global External Research and Development. Dr Chamberlain was also head of all East Coast Operations in Global External Research and Development across all the relevant therapeutic areas. She has a Bachelor of Science in Genetics, a PhD in Psychiatric Epidemiology and an MBA in Finance and Marketing.



Wesley Cook Chairman Medicines Australia; Managing Director, Boehringer Ingelheim Australia and New Zealand

Since January 2012, Mr Cook has held the position of Managing Director of Boehringer Ingelheim Australia and New Zealand. He also currently holds the position of Chairman of Medicines Australia, the industry organisation representing the innovative pharmaceutical industry. With over 25 years’ experience in the pharmaceutical industry both in Australia and overseas, Mr Cook has gained an in-depth understanding of the impact of government health policies in the developed world, including Germany, the United Kingdom, the United States and Japan, where increasingly innovative medicines face mounting challenges to reach patients in need of new therapies.

Mr Cook is passionate about the Australian Medicines Industry and is proud of the role Boehringer Ingelheim has played in making innovative medicines available to Australian doctors and patients to help achieve real and meaningful health outcomes.

Kathy Connell Senior Director, New Ventures, ANZ, Johnson and Johnson Innovation

Ms Connell has a clinical, academic, commercial and legal background with more than 25 years cross-sector experience including in the pharmaceutical, biotechnology, academia and hospital industries. Today she is responsible for implementing Johnson and Johnson Innovation’s external partnerships and growth strategy across Australia and NZ for pharmaceuticals, medical device and consumer health.

Ms Connell’s remit is to identify, assess and establish early stage collaborative research, licensing and investment opportunities to support Johnson & Johnson’s global R&D pipelines. Passionate about encouraging and building global collaborations to deliver new and disruptive healthcare solutions, Ms Connell works closely with university, government, venture capital and industry stakeholders to identify novels ways of engaging with the innovation communities to help drive and build bio-economies across Australia and NZ. These activities are undertaken with the joint objectives to develop sustainable and long term sources of healthcare innovations and deliver healthcare solutions to patients.

Prior to joining Johnson & Johnson Innovation, Ms Connell held various roles in the healthcare, biotech, academic and pharmaceutical sectors. A proactive supporter of women in STEM, Ms Connell is also a founding member of the Medicines Australia PAGE (Pharmaceuticals Australia Gender Equity) working group and has driven various diversity & inclusion STEM initiatives across Australia and NZ.

Elizabeth de Somer Director, Policy and Research, Medicines Australia

Ms de Somer has over 20 years’ experience in health care and pharmaceutical health policy including drug development, clinical research, manufacturing, drug safety, regulatory affairs, and medicines and vaccines health policy.

Ms de Somer also contributes her clinical and industry expertise to a number of expert committees providing advice to government, including representing the industry on the sub-committees to the Pharmaceutical Benefits Advisory Committee (PBAC) the Economic Sub-Committee ESC and Drug Utilisation Sub-Committees DUSC.

Ms de Somer’s academic qualifications lie in medical sciences and drug development, which lead her to provide occasional lectures on drug development, regulation of medicines, quality use of medicines and the policy environment affecting access to medicines in Australia.

Ms de Somer is the Director of Policy and Research at Medicines Australia, the peak body representing research-based pharmaceutical companies in Australia, where she leads collaboration with government and the development of sound policies to support access to prescription medicines for Australian patients.


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Riad El-Dada Vice President & Managing Director, MSD

Mr El-Dada began his marketing career at Merck on the atherosclerosis team in 1996, when he worked on both MEVACOR and ZOCOR. Over the years, he had responsibility for marketing a wide variety of Merck products in urology (PROSCAR), dermatology (PROPECIA), arthritis & analgesia (ARCOXIA and VIOXX) and hypertension (COZAAR/HYZAAR). Most recently Mr El-Dada was Senior Vice President of the Primary Care/Women’s Health Business Unit in the US. Prior to this role, he ran US Commercial Operations, comprising sales teams across primary care, hospital and specialty as well as sales operation functions.

Before joining Merck, Riad was a consultant at McKinsey & Co., Inc. for six years. He worked for a variety of Fortune 500 clients in several industries, including healthcare, consumer products, telecommunications, industrial manufacturing, and financial services.

Dr Jessica Droge Executive Director of Business Development, Amgen

Dr Droge is an Executive Director of Business Development at Amgen, where she leads the search and evaluation efforts for drug therapeutics. Her group identifies and reviews approximately 1500 preclinical through marketed stage external opportunities per year in support of all licensing, collaboration, and acquisition deals.

Dr Droge brings over 20 years of drug development experience to her role, with expertise in both small and large molecules as well as medical devices. She has led clinical development activities to support global scientific, regulatory, and commercial strategies across multiple therapeutic areas in the settings of academic, start-up, and large companies.

Dr Droge began her career in drug development by leading large clinical trials in experimental vaccines for the Centers for Disease Control and UCLA’s Center for Vaccine Research. This was followed by her work heading the Clinical Affairs departments at a series of private companies. Dr Droge joined Amgen in 2005 as part of the Clinical Development group, and transitioned to Business Development in 2011.

Dr Droge received her undergraduate degree from University of California San Diego (UCSD) and her PhD from UCLA.

Anne-Maree Englund Policy Manager, MSD

Anne-Maree is passionate about using innovative technologies to improve health outcomes. An engineer by trade, she also has a master’s in public policy, and combines a thorough knowledge of product development with a strong understanding of the broader health and innovation policy landscape. She started her career at the medical device innovator Cochlear, has been the Operations Manager at health IT start up SmartWard, and is currently the Policy Manager at MSD.


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Peter Germanos

Head of Market Access, Pricing and Outcomes Research, Boehringer Ingelheim Australia and New Zealand

Working within the market access and policy areas, Mr Germanos has over 20 years of experience with Boehringer Ingelheim. He is also currently a member of the Health Economics Working Group of Medicines Australia and has served on various Medicines Australia committees for over 15 years. Mr Germanos has also worked for Wellcome within its medical function for over three years before it was incorporated within Glaxo. Prior to working in the pharmaceutical industry, Mr Germanos managed a community pharmacy for almost 10 years

Professor Lyn Griffiths Executive Director, Institute of Health and Biomedical Innovation, QUT

Professor Griffiths is a molecular geneticist who has been studying the genes involved in common human disorders for nearly two decades. Her expertise is in the field of human gene mapping and focuses on identifying the genes involved in common complex disorders, including migraine, cardiovascular disease and several types of cancer.

Professor Griffiths graduated from the University of NSW Biochemistry Department in 1980, and gained a PhD from the Faculty of Medicine, University of Sydney in 1990. Following her PhD she moved to Queensland where she established the Genomics Research Centre at Griffith University on the Gold Coast. Professor Griffiths was also Head of the School of Medical Science for many years, and held the role of Dean Research 2007-2012 and Director of the Griffith Health Institute, before recently taking on the role of Executive Director of the Institute of Health and Biomedical Innovation at QUT.

Professor Griffiths was a Queensland Finalist for Australian of the Year in 2005, a nominee for the Queenslander of the Year award in 2006 and has been awarded an Australian Centenary Medal for Distinguished Service to Education and Medical Research.

Anna Grocholsky

Director, Commercialisation and Innovation, Macquarie University

Ms Grocholsky is a successful strategist, negotiator and intellectual property (IP) specialist. With a materials science background, Ms Grocholsky broadened her skills and qualifications through management and creative problem solving and by studying law. Ms Grocholsky is a registered trademarks attorney and is one of a handful of Australians who has achieved Registered Technology Transfer Professional (RTTP) status through the Alliance of Technology Transfer Professionals.

After successfully specialising in product development at A Goninan & Co., Email Limited and James Hardie Industries Ltd. Ms Grocholsky embraced the challenges of IP and commercialisation moving into roles at the University of Sydney in business development and IP management. In 2011 Ms Grocholsky established her own thriving business in IP and commercialisation. Clients included individuals, small and medium enterprises and larger companies and institutes. In the two years Ms Grocholsky has been at Macquarie University there has been an increase in innovation disclosures and commercial deals have doubled.

Ms Grocholsky welcomes the opportunity to promote innovations generated within the Macquarie University research community and to foster commercialisation partnerships by engaging with an entrepreneurial spirit.



Dr Phil Kearney Director External Licensing, MSD

Dr Kearney joined MSD Australia in 2007 as the key scout for innovative research and development in the Asia Pacific region for India, South East Asia, Australia, & New Zealand. The Sydney-born scientist has the challenge of uncovering and commercialising discoveries by local researchers that have strong potential to benefit the health of people around the globe.

Dr Kearney is responsible for identifying partnership opportunities with research institutes and biotechnology companies to secure high-value intellectual property for the Merck & Co pipeline. Dr Kearney regularly liaises with Australian and New Zealand biotechnology companies and research institutes to look for new chemical and biological entities with therapeutic potential, validated drug targets and new platform technologies.

Dr Kearney’s extensive background in oncology and haematology is in keeping with one of MSD key focuses as the company looks to secure novel drug targets for cancer treatment and a range of other diseases. As an ambassador for regional science, he places a strong emphasis on his role in convincing international decision-makers within Merck of the worth of investing in Asia-Pacific health and medical research, especially Australian and New Zealand discoveries.

Simon Higgins

Director of Access, Policy and Advocacy, Bristol-Myers Squibb

Mr Higgins has a broad base of experience in the ANZ and APAC pharmaceutical industry over the past 15 years. Commencing in healthcare as a physiotherapist, he has acquired a Master of Public Health and MBA through the University of Melbourne.

Mr Higgins occupied Health Economics and Market Access roles at Boehringer Ingelheim and Hospira before transitioning into commercial roles of increasing seniority. These have included managing Hospira’s New Zealand operations prior to their acquisition by Pfizer, and the management of Pfizer’s Hospital Injectables business post acquisition.

Dr Garnet Howells

Global Product General Manager Cardiovascular, Amgen

Dr Howells has worked for 20 years in the pharmaceutical industry. He has led cross-functional teams for global development of multi-modality (mAb, siRNA and small molecule) medicines across multiple therapy areas and throughout all stages of development (preclinical, Phase I, II, III and LCM development) in large and niche indications.

Dr Howells is focused on delivering and being part of the next wave of new therapies in disease areas where there are significant unmet needs.



Andy Lee Senior Vice President and Head Global Clinical Trial Operations (GCTO), Merck Research Laboratories

Mr Lee leads and manages GCTO, with particular focus on global, in-patient clinical trials, designed and executed to meet cost, speed and quality standards. He is also responsible for the design and study/data management of clinical protocols in all regions and countries, as well as the tools, systems and processes to conduct Merck clinical trials.

Mr Lee joined Merck in September 2014 from Sanofi, where he served as Senior Vice President and Deputy Head of Clinical Sciences and Operations (CSO) and Head of the CSO Clinical Operations Cluster. In addition to directing the CSO, Mr Lee led the integration of Sanofi with Genzyme, where he was Senior Vice President, Global Clinical Operations. Earlier in his career, he spent more than 16 years in a range of positions of increasing responsibility at Pfizer.

Mr Lee holds leadership positions in a number of professional societies, including the role of Treasurer of TransCelerate Biopharma, Inc., a non-profit organization that comprises the world’s leading pharmaceutical and biotech companies. He also serves as a member of the TransCelerate Operating Committee. Mr Lee received his Master’s in Bioenergetics and Physiology from Ball State University in Indiana and two undergraduate degrees from Rhodes University in South Africa.

Professor Darren Kelly CEO and Managing Director, Occurx; Associate Dean (Innovation and Enterprise), University of Melbourne; Director Biomedical Research in the Department of Medicine, St Vincent’s Hospital Melbourne

Professor Kelly brings over 25 years of management and research expertise in the life sciences and biotech sector. In Professors Kelly’s role at St Vincent’s Hospital, his research expertise lies in progressing pre-clinical novel interventions and developing experimental models of cardiovascular disease. Professor Kelly has published over 200 manuscripts in the field of translational research and novel interventions, many of which have had a direct impact on human disease. In 2009, Professor Kelly was a recipient of the prestigious TJ Neale award for outstanding contribution to nephrology. In 2015 he joined the Medical Research Commercialisation Fund as Venture Partner.

Professor Kelly has proven history in translational research. He was previously Founder, CEO and Director of Fibrotech Therapeutics, a company that developed orally active anti-fibrotic inhibitors to treat underlying pathological fibrosis in kidney and heart failure, which was ultimately acquired by Shire Plc for a record 75 million USD upfront including milestone payments up to 600 million USD.

Professor Kelly is a current member of the Australian Institute of Company Directors, AusBiotech, BioMelbourne Network and a Fellow of the American Society of Nephrology.

Dr Anna Lavelle Owner Armytage Advisory; Deputy Chair Board of Directors and Chair Advisory Council, Medicines Australia

Dr Lavelle is an experienced non–executive director serving for over 25 years on the boards of not for profit, government and for profit entities. As executive director or non-executive director she has a lengthy track record in healthcare delivery, technology development and negotiating government policy.

Dr Lavelle has a PhD in Genetics from the University of Melbourne and is a Graduate of the Australian Institute of Company Directors (AICD). Dr Lavelle is a Fellow of the Academy of Technology Science and Engineering (FTSE) and is also a Fellow of the Leadership Victoria Program. In 2015 Scientific America, World View ranked Dr Lavelle in the global top 100 “World Visionaries” in biotechnology. She was the only Australian to be named.

From 2005 to 2016, Dr Lavelle was the CEO of AusBiotech; the national industry association for the biotechnology, pharmaceutical and medical devices sectors. Dr Lavelle is now serving on several boards including - Deputy Chair and Independent Director of Medicines Australia, Non-executive Director Haemokinesis, Chair Australia National Digital Health initiative (ANDHealth), Independent Director CRCHPS, ATSE Audit and Risk Committee and Advisor MTPConnect.



Sue MacLeman Chief Executive Officer, MTPConnect

Ms MacLeman has more than 25 years’ experience as a pharmaceutical, biotechnology and medical technology executive with roles in corporate, medical, commercial and business development at Schering-Plough Corporation (now Merck), Amgen, Bristol-Myers Squibb and Mesoblast Ltd.

Ms MacLeman graduated with a Bachelor of Pharmacy from the University of Queensland. In addition to pharmacy qualifications, Ms MacLeman has completed a Masters of Marketing degree at Melbourne University (Melbourne Business School) , a Masters of Law degree (Deakin University) and a Fellowship with the ACPP and is a Fellow of AICD. She was previously a member of the Pharmaceutical Industry Council (PIC) , the Federal Government Pharmaceutical Industry Working Group (PIWG) and the Victorian Government Biotechnology Advisory Council.

Ms MacLeman has served as CEO and Board member of several ASX and NASDAQ listed companies in the sector and is currently a non-executive director at RHS Ltd, veski and Oventus Medical Ltd.

Ms MacLeman was recognised for her leadership with a BioMelbourne Network’s 2017 Women in Leadership award.

Dr Ed Lobenhofer Principal Scientist, Amgen

Dr Lobenhofer’s passion for positively affecting patients’ lives began in high school while volunteering at a local hospital in suburban Chicago. After obtaining an undergraduate degree in Biology Education, he earned a doctorate of philosophy in Cell and Molecular Biology from the Pathology Department at Duke University, conducting research on elucidating the molecular mechanisms underlying breast cancer.

The early part of Dr Lobenhofer’s scientific career concentrated on the then-burgeoning field of genomics and its application in identifying biomarkers of disease, as well as the field of toxicology. For the past 9 years, Dr Lobenhofer’s has worked at Amgen as a nonclinical safety scientist, developing preclinical safety packages for both small and large molecules in order to advance meaningful therapeutics in to the clinic.

Sean Lybrand Director, Value, Access and Policy, Amgen

Mr Lybrand is leading a team of health economics experts, government affairs staff and hospital account managers in engagements on reimbursement and policy matters for Amgen in Australia and New Zealand.

Mr Lybrand has had a considerable breadth of career in academia and the pharmaceutical industry. Following on from his studies, Mr Lybrand moved to Sydney where he began working for Merck, Sharp & Dohme, and onto Merck & Co Inc (parent company of MSD). He subsequently became Regional Director of Vaccine Policy for Merck in the Asia Pacific region. His career highlight at Merck, was establishing a country-wide vaccination program for human papillomavirus in the Kingdom of Bhutan, as a partnership with the Australian Cervical Cancer Foundation, Merck & Co Inc, and The Royal Government of Bhutan. Returning to Australia, Mr Lybrand established the market access and government affairs function at Biogen Australia Pty Ltd.

His passion in health remains in seeking to improve health outcomes, and is committed to ensuring that he finds ways for governments, pharmaceutical companies, prescribers and health consumer organisations to work together to seek the best interests for the population.



Peter Murphy Director of Public Affairs and Communications, Novartis Australia & New Zealand

Mr Murphy has nearly twenty years in the pharmaceutical industry in various communications, digital, policy and stakeholder engagement roles. Mr Murphy first role was GlaxoWellcome’s head office in London, prior to the merger with SmithKline Beecham. Following the merger, he moved to a digital communications role and a medical education agency in London before moving to Sydney in 2003.

Mr Murphy was then appointed to a role within the healthcare practice of Edelman Public Relations, working on a number of high profile policy challenges, including the Roche breast cancer medicine, Herceptin. He then joined Novartis in 2007, spending most of his time in the Oncology division, driving policy reform to accommodate the new era of personalized medicines. Earlier this year Mr Murphy took on a cross divisional Public Affairs and Communications role with responsibilities for Sandoz, Alcon and Innovative Medicines divisions.

Rob McInnes Partner and IP Licencing and Technology Commercialisation Lawyer, DibbsBarker

Mr McInnes is a Partner of DibbsBarker, specialising in intellectual property transactions. He has over 25 years’ experience in the management, commercialisation and enforcement of IP rights. Mr McInnes assists clients with planning, negotiating and drafting licensing and other IP agreements, and the setting up and financing of new technology ventures.

In addition to his career as a lawyer in private practice, Mr McInnes has a degree in chemistry and has been an in-house Manager of IP and Technology Transfer with a large company.

Mr McInnes is listed by Intellectual Asset Management Magazine as Australia’s only ‘highly recommended’ patent and technology licensing lawyer. He is one of the few Australian lawyers to have met the requirements for the US-based Certified Licensing Professional qualification.

Dr Brian Muller Medical Affairs Director, Mundipharma

Dr Muller has been the Medical Affairs Director at Mundipharma for almost two years. He was a full time clinician for 13 years prior to entering the pharmaceutical industry where he has worked for the last 17 years. Dr Muller has an Australian clinical Fellowship and is on the General Medical Council specialist register in the UK. Managing the Regulatory, Medical, and Quality teams, he is also very involved in Business Development. Dr Muller also maintains a clinical commitment at a private hospital in Sydney.



Dr Stephen Thompson Co-Founder and Managing Director, Brandon Capital Partners

Dr Thompson is a founding partner of Brandon Capital Partners, manager of the Medical Research Commercialisation Funds (MRCF). Before moving to Australia in 2004 Dr Thomson was a director with Apax Partners (London) focused on venture investing. Previously he worked with Cantab Pharmaceuticals (UK), following 10 years of medical research in London and California.

Dr Thompson has a Bachelor of Science degree, PhD in immunology and an MBA. He is a director of portfolios companies; Auspherix Ltd, Elastagen Pty Ltd, Vaxxas Pty Ltd and a director of AVCAL.

Dr Deborah Rathjen CEO and Managing Director, Bionomics

Dr Rathjen joined Bionomics in 2000 from Peptech Limited, where she was general manager of business development and licensing. Dr Rathjen was a co-inventor of Peptech’s TNF technology and leader of the company’s successful defence of its key TNF patents against a legal challenge by BASF.

Dr Rathjen has significant experience in company building and financing, mergers and acquisitions, therapeutic product research and development, business development, licensing and commercialisation. Dr Rathjen has been recognised both in Australia and internationally through awards and honours including the 2004 AusBiotech President’s Medal, 2006 Flinders University Distinguished Alumni Award, 2009 BioSingapore Asia Pacific Biotechnology Woman Entrepreneur of the Year, 2009 Regional Finalist Ernst & Young, Young Entrepreneur of the Year, and 2014 Woman Executive of the Year BioPharm Industry Awards. In 2015 Dr Rathjen was included in the Top 50 most influential Australia business women by The Australian newspaper.

Gary Phillips Chief Executive Officer, Pharmaxis

Mr Phillips has more than 30 years of operational management experience in the pharmaceutical and healthcare industry in Europe, Asia and Australia. After managing country operations for Swiss multinational pharmaceutical company Ciba Geigy and then Novartis in Eastern Europe and Asia, Mr Phillips came to Australia as CEO of Novartis in 2001. He joined Sydney based biotech company Pharmaxis in December 2003 when the company listed on the Australian Securities Exchange.

In the role of Chief Operating Officer he expanded Pharmaxis’ Commercial infrastructure in Europe and the USA, and supported the clinical development, regulatory approval and reimbursement of Pharmaxis products Aridol and Bronchitol. Aridol, an innovative lung function test, was the first Australian drug discovery to be approved by the US Food and Drug Administration. Bronchitol was the subject of two large scale clinical trials and is approved for the treatment of cystic fibrosis in Australia and Europe. Both products are produced at Pharmaxis’ approved high-tech manufacturing facility which now exports finished product to world markets.

Christian Sellars Director, Market Access and Public Affairs, MSD

Christian has led MSD Australia’s Market Access and Public Affairs team since 2010. He has worked at MSD for 18 years, and has held positions in marketing, sales and public affairs in Australia & Asia. He has worked previously in government and the trade union sector and holds graduate degrees in economics and business administration.



Dr David Thomson External Affairs Manager, AbbVie

Dr Thomson has been employed at Abbvie since April 2016 and has responsibilities across a number of areas including government affairs, biological medicines policy and advocacy and innovation policy. He is an active member of the gastroenterology brand team.

Dr Thomson is a member of the AmCham Innovation Committee and Medicines Australia’s Biologics and Biosimilars Issues Group. Prior to joining AbbVie Dr Thomson worked for the Australian Government for three years in the Department of Industry, Innovation and Science and at the Department of Prime Minister and Cabinet, concentrating on innovation, venture capital and industry policy. He worked on both the National Industry Innovation and Competitiveness Agenda and the National Innovation and Science Agenda. Dr Thomson has a PhD from the University of Queensland with a project based on using bionanotechnology approaches to develop amplification-free viral load assays for resource limited environments.

Dr Stewart Washer Executive Director, Zelda Therapeutics LTD

Dr Washer has 25 years of CEO and Board experience in medical and agrifood biotech companies. He is currently the Executive Director of Zelda Therapeutics Ltd (ASX:ZLD) in the medicinal cannabis space, Chairman of Orthocell Ltd (ASX:OCC), a regenerative medicine company, Founding Chairman and current Director of Cynata Therapeutics Ltd (ASX:CYP) who are developing global stem cell therapies and Chairman of Minomic International Ltd with a novel approach to cancer diagnosis and treatment. Dr Washer is also a founder and consultant to AusCann Ltd (ASX:AC8), the largest medicinal cannabis company in Australia.

Dr Washer has held a number of Board positions in the past, including Chairman of Hatchtech Pty Ltd that was sold in 2015 for A$279m and was a Director of iCeutica that was sold to a US Pharma. He was also a Senator with Murdoch University and was a Director of AusBiotech Ltd.

Dr Warwick TongCEO Cancer Therapeutics CRC

Dr Tong has 20 years’ experience in the pharmaceutical and biotechnology industry. Dr Tong is currently CEO of a public-private partnership oncology drug development company, Cancer Therapeutics CRC (CTx). CTx was successful in a 2013 rebid for further funding from the Australian Government Cooperative Research Centre (CRC) Programme. In January 2016 CTx licensed its PRMT5 Inhibitor project to MSD (Merck).

Dr Tong’s career has spanned General Practice, Addiction Services, and a wide variety of roles in the pharmaceutical and biotech industry in NZ, Singapore, London, Boston and Melbourne. In addition to his role as CEO of CTx he is a member of the Governance Board of the Australian Research Council (ARC) Centres of Excellence in Convergent Bio Nano Science, a member of the SAB of the Maurice Wilkins Centre in Auckland NZ, a member of the University of Melbourne School of Biomedical Sciences Industry Advisory Board and the Advisory Board of Cortex Health, Melbourne.


Nicky Agahari In-Confidence

Seckin Akgul QIMR Berghofer Medical Research Institute

Katerina Aleksoska Department of Economic Development, Jobs, Transport and Resources

Ash Amirshahi QUT

Kathy Andrews Griffith University

Ben Atcliffe UniSA Ventures

Andy Bean CSIRO

Kirsten Bernhardt University of Adelaide

Nilesh Bokil University of Technology Sydney

Anthony Bosco Telethon Kids Institute

Emile Brys UK Department for International Trade

Christopher Burns Metabloq Pharmaceuticals

Peter Chandler Monash University

Colin Cheng StickyCell Pty Ltd

Sue Choong Cochlear Ltd.

Mark Condina The University of Adelaide

Deirdre Coombe Curtin University

Tamara Cooper University South Australia

Philip Crealy Petri Exchange

Wayne Crismani St Vincent’s Institute of Medical Research

Claretta D Souza MTPConnect

Macabe Daley QUT

Chiragkumar Desai Oak Laboratories

Kamal Dua University of Technology Sydney

Stephen Earl UniQuest Pty Ltd

Mark Edwards In-Confidence

Ebony Fietz AdAlta Limited

Darren Gibson Edith Cowan University

Marianne Gillard Australian Institute for Bioengineering and Nanotechnology

Lauren Giorgio The Walter and Eliza Hall Institute

Alison Greenway RMIT University

Nuri Gueven University of Tasmania

Mehra Haghi University of Technology Sydney

Johanna Hann Pharma To Market Pty Ltd

Joy Hewitt Regarwen Pty Ltd

James Hill The University of Queensland

Kerrie-Anne Ho CaPPRe

Kerstin Holata UniSA Ventures

Jessica Holien St Vincent’s Institute of Medical Research

Priscilla Hong The University of Queensland

Jamie Hughes Grunbiotics

Flavia Huygens QUT

Reuben Jacob TechInSA

Bevyn Jarrott BJ Consultancy

Elizabeth Johnstone Harry Perkins Institute of Medical Research

Sandip Kamath James Cook University

Naveed Khan Griffith University

Rene Koopman The University of Melbourne

Smriti Krishna James Cook University

Caitlin Larsen Certara USA, Inc.

Katharine Leviton Phillips Ormonde Fitzpatrick

PARTIC IPANTS


Charles Lindall CSIRO

Daniela Loessner QUT

Duncan Macinnis Vectus Biosystems Ltd

Lorraine Mackenzie University of South Australia

Marie Magnusson James Cook University

Eliana Marino Monash University

Cameron McDonald QIMR Berghofer - SEEDbox®

Nyree McKenzie In-Confidence

Declan McKeveney Fisher Adams Kelly Callinans

Tamara Mills De Motu Cordis

Gorjana Mitic Bio-Link Australia Pty Ltd

Marcela Montes de Oca QIMR Berghofer Medical Research Institute

Peter Mulvey James Cook University

Jonathan Nambiar Magellan Asset Management

Pavlina Naydenova University of Technology Sydney

Delia Nelson Curtin University

Ruth Park-Jones University of Melbourne

Adam Pirie AusIndustry

Sally-Ann Poulsen Griffith Universitty

Daniel Priebbenow Deakin University

Louis Pymar The University of Western Australia

Qiao Qiao UNSW innovations

Chengxue Qin Baker Heart and Diabetes Institute

Reyna Michelle Quezada The University of Newcastle

Prashanth Rajan The University of Queensland

Jai Rautela The Walter and Eliza Hall Institute of Medical Research

Ashley Schoof Telethon Kids Institute

David Segal The Walter and Eliza Hall Institute of Medical Research

Ken Seidenman FB Rice

Mihir Shanker In-Confidence

Stephanie Simonds Monash University

Tina Skinner-Adams Griffith University

Seun Sogbesan Therapeutic Goods Administration

Garrick Spencer The University of Queensland

Mohan Sridhar James Cook University

Con Stough Swinburne University of Technology

Kathryn Sunn University of Sydney

Nicky Thomas University of South Australia

Edward Tyndall Novogen Laboratories

Peter van Wijngaarden Centre for Eye Research Australia

Stephane Verhaeghe Novartis

Michaela Waibel St Vincent’s Institute of Medical Research

Nicholas Ward Pharma to Market Pty Ltd

Jerome Wielens Wielens Consulting

Claire Williams Griffith University

Shakeel Yusuf SSD Consulting

Xin-Fu Zhou University of South Australia

PARTIC IPANTS

The Bridge Program has received industry-matched funding through the MTPConnect Project Fund Program – investing in ideas to improve the productivity, competitiveness and innovative capacity of Australia’s medtech,

biotech and pharmaceutical sector.

S U P P O R T E D B Y

2017 bridge program - qut · 2017-12-12 · residential training 21st, 22nd, 23rd october 2017...

Documents