Andrew J. RANKIN, PhD, Cert.Pharm.Med

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1 Andrew J. RANKIN, PhD, Cert.Pharm.Med A proven drug development leader and consultant experienced from research to market driven by a passion to get new medicines to the patients that need them Expertise and Experience: Ph1-4 Drug Development in Pain, CNS, Auto-Immune, Oncology, Biosimilars, Metabolic, Rare-Diseases Flexible, energetic, enthusiastic self-starter, demonstrating hands-on and functional line/matrix leadership skills to drive delivery of key inflection points in large and small business environments from virtual biotech to global pharmaceutical Hands-on and leadership expertise across the drug development paradigm from First in Human to Phase 3, global Market Authorizations (including US, EMA, Japan) and successful market launches Multiple FDA and European regulatory agency interactions, end of Phase 2, pre-nda and successful label negotiation In-depth experience designing and managing clinical trials and matrix leadership of global drug development programs across multiple therapeutic areas with in-depth knowledge of auto-immune, CNS, oncology, pain, biosimilars, metabolic and rare diseases Additional Consultancy Experience: strategic, clinical operational and due diligence for small biotech, venture capital and major pharma in CNS, Pain and Biosimilars PROFESSIONAL EXPERIENCE, ACHIEVMENTS AND IMPACT Vice President, Global Development, Alexion Pharmaceuticals, New Haven, CT USA 06/15-current Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare diseases. Alexion s goal is to deliver medical breakthroughs where none currently exist to patients with these life-threatening rare diseases. - Strategic direction and operational leadership of global development programs achieving targeted registrations, label enhancements, post-marketing commitments and registry activities - Supporting global commercialization and Pricing and Reimbursement strategies and negotiations - Global Development Team Leader for an enzyme replacement therapy (ERT) of a lysosomal storage disease;; matrix leadership and overall responsibility and accountability for successful development, regulatory approval and lifecycle management. - Member of R&D leadership team and strategic development teams (competitive intelligence, biosimilars, company integration) - Led transition and continuity of late stage drug development program in face of major personnel departure and change following Biotech acquisition and integration;; successful maintenance and completion of pivotal trials and commitments - FDA, EMA, Japan and multiple country market authorization of ERT (sebelipase alfa) for ultra-rare disease - Successful launch of ERT in EU and US with conversion of patients from clinical trials to commercially funded therapy - In depth analysis of Life Cycle Management opportunities with proposed strategies - Development of novel diagnostic assay for configuration into Mass Spectrometry platform;; development of pathway to incorporate into New Born Screening assay - Successful integration of legacy business and drug development program into Alexion Chief Operating Officer, Qforma (acquired by Veeva Inc. 02/15), Morris Plains, NJ, USA 04/14-02/15 Qforma provides enterprise technology and services to understand, monitor and activate influence in the healthcare market, applied throughout a product s lifecycle from late stage, market authorization, launch to maturity - Leadership and management of 40 operations personnel across USA, Germany, Austria and Ukraine - Evaluating and enhancing structural organization and processes to improve efficiency and cost-effectiveness;; aligning objectives, structure and processes from 3 legacy organizations - Supporting business development and sales process;; developing new products and business opportunities Pharma Client including, - Identified opportunities and led workshop to develop strategy and tactics for expanding label of major CNS medicine in China and Japan markets for major global pharma - Identification of patient advocacy groups and connections to influential clinical leaders for major pharma 1

2 Vice President Biopharmaceuticals, Prescient Life Sciences, Summit, NJ, USA 06/12-04/14 Strategic consultancy supporting the life sciences industry, providing insight and solutions to key questions and decisions - Project Directing: overall ownership and effective execution of assigned programs, leading internal teams and managing client expectations to ensure quality, timely and cost-contained deliverables with high levels of client satisfaction. - Business Development: New business won with major pharma and biotechs in Oncology/Hematology, Pain, Endocrinology, Generics and Biosimilars, plus account management of existing clients. - Employee Management: Direct line-management of executives in New Jersey and San Francisco, responsible for hiring, career development, resource management, performance review and disciplinary action. - Business Improvement: evaluating business processes being used and advising and driving necessary changes Pharma Client including, - Provided focussed client support and strategic consultation in Oncology (particularly Hematology), Autoimmune Disease (Lupus, RA), Neurology (MS, Pain, Alzheimers), Biosimilar drug development, LoE defense strategies - Successful projects delivered include biosimilar competitor landscape;; drug development, regulatory and launch strategies;; oncology competitors and strategy;; biotech business strategy;; generic threat analysis in EU/LatinAmerica;; SLE / Lupus Nephritis landscape and strategic simulation workshop with client project team - Analysis of competitor biosimilar Ph3 hematology and autoimmune programs for global biotech and pharma companies with high value biologicals under threat from potential Biosimlar incursion. - Analysis of small and mid-sized pharma internal and competitor Ph2/Ph3 hematology drug development programs allowing strategic selection of patient populations and pivotal trial design Global Head of Clinical Development, Global Branded Products / Biosimilars, Teva Pharma Ltd, 06/09-05/12 Drug Development Achievements: Responsibility for more than 20 clinical programs from Ph1-4 for innovative small molecule/biological development across Oncology/Hematology, Neurology/Substance-Abuse, Autoimmune diseases and for Biosimilar development. Sample of studies under responsibility: - Ph2 Multiple System Atrophy (MSA) clinical study from design to completion - 2xPh3 clinical studies for oral and 1xPh3 clinical studies for subcutaneous treatment of Multiple Sclerosis - 2x Ph3 clinical studies for solid tumour (prostate / lung) treatment by antisense oligonucleotide - Ph1 and 3 clinical studies of neugranin biosimilar in Breast Cancer Patients Receiving Doxorubicin/Docetaxel - Ph1b PK/PD study of rituximab biosimilar in combination with CHOP in previously untreated patients with diffuse large B cell lymphoma - Ph2 safety and pharmacology clinical study of rituximab biosimilar in patients with severe rheumatoid arthritis - 3x Ph2 clinical studies for treatment of autoimmune diseases Lupus Nephritis, Lupus Arthritis and Crohn s disease - 2 x Ph1 clinical studies for solid tumour treatment by small molecule - Ph3b Disease Modifying clinical study in Parkinsons s Disease - Ph 4 Retrospective epidemiological study to estimate the incidence rate of malignant melanoma in patients with Parkinson s disease and to examine the association with the use of anti-parkinson s drugs. - Ph1/2 clinical studies for treatment of drug addiction Drove the creation of clinical development strategies, including medical and scientific assessments of product concepts and clinical data to allow clear and timely decision-making while assuring patient safety. Developed and led relationships with key external consultants, partners (including FDA / EMA biosimilar and biological regulatory interactions). Led overall clinical due diligence of in-licensing opportunities that fuel Teva development pipeline Led overall R&D due diligence and key recommendations for company acquisitions, including Cephalon with specific responsibility for pain and neurology recommendations Providing clinical leadership and expertise to in-licensing/business acquisition activities: - Smooth integration of Ratiopharm clinical research/development team into Teva with seamless continuity and completion of critical Biosimilar clinical trials and programs - Leading due diligence and making key recommendations for potential acquisition of a Specialty Pharma company with pain management portfolio - Leading overall R&D due diligence and key recommendations for acquisition of Cephalon with specific responsibility for pain and neurology recommendations - Leading overall clinical due diligence of in-licensing opportunities that fuel Teva development pipeline, including specific responsibility for assessment of products for treatment of neurology, pain, autoimmune and cardiovascular diseases. 2

3 Global Head of Clinical Development, Global Branded Products / Biosimilars, Teva Pharma Ltd, 06/09-05/12 (continued) Key R&D leader / member of Senior Management Team: - Senior Management Team led strategic direction of 500-strong R&D Division and specifically responsible for leadership of Department of Clinical Development during period of rapid growth and business acquisition / integration. - Leading process improvements to improve efficiency, including clinical trial completion and reporting, SoP harmonisation and data safety management to meet ever more challenging milestone timelines while maintaining quality and integrity. - Leading and managing functional department of Global Clinical Leaders in Israel, Germany, US and Safety Medical Monitors in Israel;; managing resources across programs and priorities in partnership with other professional functions while ensuring compliance with FDA, ICH guidelines and internal SOPs Chief Scientific Officer, Pharmaceutical Profiles (acquired by Quotient Clinical, 01/09), UK 11/07 01/09 Drug Development Achievements: Supported client drug development objectives: Worked with around 100 companies, mainly speciality pharma/biotech, to design strategies and studies utilising innovative technologies and expertise to optimise drug delivery and rationalise drug development to answer specific questions and reach definitive decision-points. Leadership of scientific strategy: - Developed novel business opportunity for offering rapid make/test of formulations, led discussion with MHRA and gained regulatory agency agreement on principles of design. - Led new opportunity for utilising company expertise and experience in exploring internal development of reformulated and repurposed medicines Led new business objectives: Led initiatives to increase income stream from new service offerings. - Identified company strength and opportunity in supporting specific therapeutic areas - Supported marketing and business development in targeting specialty companies and presenting company offerings and track record at scientific meetings and regular international client visits with business colleagues. Executive Board Director: Responsible for scientific and medical innovation and leadership of 100 strong company specialising in early clinical development through GMP facilities and 30-bed clinic. - Leader in analysis of strategic direction resulting in restructuring company 2Q08 to improve efficiency and reduce costs and ultimate trade-sale in Unified fractured elements of medical and science teams and re-organised into a single department with single vision, fostering collaboration and partnership in delivering company strategic objectives PFIZER PHARMACEUTICALS LTD, SANDWICH UK: JULY 1993 OCTOBER 2007 Executive Director / Development Team Leader, Pain, Pfizer UK, Drug Development Achievements: Matrix leadership and overall responsibility for global development program in Neuropathic Pain and Fibromyalgia Transitioned and led development program from Ph2a through to Phase 3: Initiated 6 x Ph2a/b clinical trial starts in 9 months which led to key development decisions. Cut original timelines to filing and launch by 14 months: Negotiated efficient, registerable and cost-effective Ph3 development plan with internal stakeholders and EU / US regulatory agencies. Conceived a second indication to add commercial value: Convinced senior management to invest in new Fibromyalgia program. Moved project from inception to Ph3 in under 2 years. Strategic Development Transformation Leader : Identified CRO to outsource UK study management department - Selected vendor that met business needs, cost constraints and future development opportunities for study manager team;; identified Pfizer leaders to manage the operation Built high-performing multi-functional matrix team: identified key leaders from legacy exploratory and experienced late stage development personnel;; introduced Mission Leadership philosophy to define a single, common mission and deliver challenging milestones in reduced time allowing early and clear strategic decisions Line-managed clinical and project management team: Motivated team during two periods of major organisational restructuring and individual transition to ensure continued key deliverables. Senior Director / Development Team Leader, CNS, Pfizer UK, Drug Development Achievements: Matrix leadership and overall responsibility for global Ph3 development program in Parkinson s Disease/Restless Leg Syndrome - Built and integrated global team from legacy Pharmacia and internal Pfizer colleagues, ensuring continuity of clinical trials - Completed large, global Ph2b and Ph3 program on time and within budget. - Redefined Ph3 development program milestones and objectives and developed objective criteria to drive clear decisions. 3

4 Senior Director / Global Candidate Team / Clinical Leader, CNS, Pfizer UK, (continued) Drove methodology and delivery of decision-making process at end of Phase 3. - Partnered with commercial team in analysis of data package to assess potential commercial value - Convinced senior management to terminate program rather than filing NDA based upon clinical and commercial rationale, including lack of differentiability;; allowing diversion of resource to programs with higher probability of success and value - Managed regulatory, investigator, patient group and media issues to close remaining studies to minimise business impact. Drug Development Achievements: Matrix leadership and overall responsibility for Phase 3 migraine program through FDA approval and launch. - Transformed poorly functioning multi-discipline matrix team to lead completion of high risk final study and filed NDA of Relpax TM within 14 months, building strong partnership with New York commercial team. - Led development of novel formulation for product enhancement to End of Phase 2, including discussion with FDA/EU - Negotiated commercially viable label with FDA and led regulatory submissions to Japan and Canada. - Championed product with internal / external stakeholders and motivated 3000 strong sales team Exploratory Development Director, Cardiovascular/Tissue Repair, Pfizer UK, Drug Development Achievements: Matrix leadership and overall responsibility for early clinical stage NCE s Transitioned Cardiovascular and Tissue Repair NCEs through Ph1, Ph2a studies onto late-stage development or terminated non-viable programs through clear, decision-making milestones. Managed European CV/TR exploratory development portfolios, prioritising programs to maximise productivity and value Associate/Senior Associate Director / Clinical Project Manager, Urology / Cardiovascular, Experimental Medicine, Pfizer UK, Drug Development Achievements: Designed and managed early-stage clinical program and trials - Designed and executed First in Human and Ph2 Proof of Concept clinical trials in Urology, CV and Renal TA. - Set up collaborative research programs with university medical departments (Dundee, Liverpool, Edinburgh, St.Mary s London) to develop novel translational medicine biomarkers/methodologies, including imaging & physiological surrogates - Assessed In-Licencing opportunities as clinical representative on business development teams - Line managed clinical team and supervised external MD/PhD students, adding value to teams and milestone delivery Drug Discovery Team Leader, Discovery Biology, Pfizer UK, Led drug discovery programs and teams Independent drug development consultant, 06/ /2015 (intermittent activity) Drug Development Achievements: Clinical Advisory Board member, Solace Pharmaceuticals: advised and worked with CEO and Drug Development Director of virtual pharma company on development strategy, clinical trial design and operational issues for delivery of pain drug clinical program. Resulting Proof of Concept gave clear, unequivocal result within 1 yr, driving decision to terminate. Drug Development Consultant, AdnovateClinical (1Q2015): Assessing asset and designing clinical drug development plan for clinical stage asset being spun out into start-up company by major pharma divesting urology portfolio Due Diligence assessment for Venture Capital investors: advised on value of major investment in a speciality CNS pharma through critical assessment and report on regulatory submission package for transdermal Parkinson s Disease treatment, allowing clear (negative) investment decision Consultant to Virtual/Speciality Pharma: assessed early development data packages of novel mechanism migraine and pain drugs;; advised strategic next steps / clinical design for achieving value inflection points within limited budget. Consultant to Large Pharma/Biotech: strategic and competitive intelligence advice to major companies with high value oncology and autoimmune biologicals under threat from potential Biosimlar incursion. 4

5 ACADEMIC CAREER: JANUARY 1984 JULY 1993 MRC Visiting Scientist to Baker Medical Research Unit, Victoria, Australia, September 1992 July Collaborated on cardiovascular/renal research during sabbatical research year Assistant/Associate Professor of Physiology, Memorial University, Canada, April July Set up and ran an active and well-funded research team - Set up and managed systems based teaching courses for medical and post-graduate residency training Research Fellow / Lecturer in Physiology, University of BC, Vancouver, Canada, January1984-April1987. EDUCATION AND QUALIFICATIONS Certificate in Pharmaceutical Medicine PhD, Cardiovascular Studies BSc (Tech), Applied Biology (Hons) European Centre for Pharmaceutical Medicine, University of Basel, Switzerland University of Leeds, UK University of Wales Institute of Science and Technology, Cardiff, UK PERSONAL DETAILS Telephone Cell: (personal) Address DrAndyRankin@gmail.com 66 Quarry Dock Rd., Branford, CT 06405, USA RECENT INVITED KEY SPEAKER ENGAGEMENTS World Drug Safety Congress, April 2016, Chicago DIA th Annual Meeting,June 2014, San Diego DIA India 8 th Annual Conference, Bangalore, 2013 North America CI Pharma Annual Meeting, September, 2013, East Hanover DIA th Annual Meeting. Advancing Therapeutic Innovation and Regulatory Science June 2013, Boston Biosimilars and Biobetters London UK, September 2012 Effective Biosimilar Development: Ensuring Safety for Ultra-Rare Medicines Challenges for Attaining Biosimilar Success in the Regulated Markets Biosimilar Development for Regulated Markets Managing Loss of Exclusivity: an integrated insight approach to help manage LoE Challenges and Strategic Approaches to Biosimilar Development Clinical approach to biosimilar development REFERENCES Liam Ratcliffe MD PhD MBA Managing Director, New Leaf Ventures (Former SVP, Pfizer Global R&D) Martin MacKay PhD Exec.VP R&D Head, Alexion Pharmaceuticals 5

Global Allied Pharmaceuticals, LLC. Innovation, Research, and Technology. Breaking the bounders, first in its class, thinking outside the box.

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