Chief Executive Officer

South African Health Products Regulatory Authority

Boitumelois the CEO of the South African Health Products Regulator. She has a Ph.D. (Biochemistry) and holds MSc in Management Finance and Investment. She is also a fellow of the African Leadership Initiative. Within the technology innovation space, she was the Executive Director at CSIR Biosciences and prior to that she managed a biotechnology incubator at The Innovation Hub Management Company. She was with McKinsey & Company for 2 years as a McKinsey Leadership Fellow. Prior to that, she was at the CSIR as a Senior Researcher. She completed her postdoctoral research at the University of Nottingham and EPFL, Switzerland.She has published as a first author and co-author in scientific publications, review articles and book chapters. She sits on a number of scientific advisory committees and Board of Directors. She is also involved a number of thought leadership projects such as the African Union Strategy for Health Research, the East Africa Community Bioeconomy strategy development team and WHO Expert Panel on scaling health Innovations in Africa.

Roche

LATAM Regulatory Policy Lead

Specialist in Global Health and Health Regulation, with a Master’s Degree in Development and International Cooperation. Broad experience in regulatory policy, both as regulator and industry, leading or contributing to bilateral and multilateral negotiations, harmonization and convergence initiatives. Specialized and policy activities include: working within WHO, PAHO, Mercosur, ICH, IPRP, IMDRF, ICMRA, UNODC, and industry associations; liaising with government agencies, industry and other stakeholders in the area of health regulation; organization of and institutional representation in information sharing events. Currently working in Roche as a Regulatory Policy Lead for Latin America.

Partner and Deputy Chair, FDA & Life Sciences Practice

King & Spalding LLP

Chris Markus focuses on federal and state regulation of drugs, biologics, biotechnology and related products. As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.

Chris represents drug, biologic and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA) and related state agencies such as boards of pharmacy. She also represents clients in business transactions, including strategic planning, due diligence and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing and supply chain.

Based on her experience, Chris was chosen to serve as the legal member of the Institute of Medicine's Committee on Pediatric Studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. IOM evaluated studies of drugs and biologics performed under two statutory regimes that provide incentives and, in some instances, mandate pediatric research through the drug approval process. The Committee assessed the findings and offered recommendations and briefings to FDA and the U.S. Congress. Committee findings and recommendations were considered during the reauthorization of BPCA and PREA in July of 2012.

Chris has been recognized by the BTI Consulting Group as a 2017 "Client Service All-Star" and was also named a 2016 "Life Sciences Star" by LMG Life Sciences. Chris has also been identified as one of The Best Lawyers in America for FDA Law, and ranked as a life sciences practitioner by The Legal 500.

EVP-Regulatory Compliance

Greenleaf Health and Former FDA

Cynthia Schnedar, Executive VP of Regulatory compliance at Greenleaf Health, provides strategic advice to clients in the life sciences industry. She was formerly Director of the Office of Compliance for FDA CDER, where she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety.

Cynthia previously served at the Department of Justice (DOJ) as Acting Inspector General and in other leadership positions focused on compliance and enforcement issues. Cynthia also served as a prosecutor and a civil trial attorney for DOJ. Cynthia clerked for a judge on the U.S. Court of Appeals for the Ninth Circuit and worked as a television reporter for local stations in New Mexico and Texas. Cynthia earned a B.A. with Distinction from the University of New Mexico and a J.D. with Honors from the University of Texas School of Law.

Executive Director - Global Head External Development Collaborations

Genentech/Roche

Emma Ramnarine is Global Head of External Development Collaborations at Genentech/Roche, managing the external network for development, manufacturing, and clinical collaborations of Roche’s Biologics and Small Molecules development portfolio. Prior to this, she was the Global Head of Analytical Science and Technology at Genentech/Roche, providing strategic direction and leadership for product control systems lifecycle management, analytical technology innovation and tech transfers. She is also a worldwide-recognized expert on Quality Risk Management (QRM), and continues to provide QRM training to regulatory authorities and at industry forums.

Emma is currently Co-lead for the Industry One-Voice-of-Quality (1VQ) Initiative on Post Approval Changes. This initiative is sponsored by Chief Quality Officers of 20+ global pharma companies who have decided to speak with a unified voice, and develop standard solutions to reduce global PAC complexity.

Emma has 20+ years of global experience in the pharmaceutical, biotechnology and medical device industries in Analytical Science & Technology, Risk Management, Quality Control and Quality Management Systems. She is an Officer on the PDA Board Executive Committee and has led several PDA Task Forces and Technical Reports (TR).

She holds an M.S. in Pharmaceutical Sciences from the University of Connecticut, an M.S. in Medicinal & Pharmaceutical Chemistry, and a B.S. in Pharmacy, both from University of Indore, India.

Associate Director for Science and Communication, Office of Lifecycle Drug Products, OPQ, CDER

US Food and Drug Administration

Commander Geoffrey Wu, Ph.D., PMP, CPH, acting Deputy Director, OLDP, OPQ, joined FDA’s OTR in 2010, has served as research scientist, science staff, chemistry reviewer, special assistant to the Office Director, staff supervisor (Division Director equivalent), Associate Director of Sciences and Communication (ADSC), acting Division Director, and acting Deputy Office Director. He is a scientist officer in the United States Public Health Service. Throughout his FDA tenure, he has been deeply involved, leading or co-leading regulatory review and research for Controlled Correspondence, ANDAs, and supplemental ANDAs and NDAs. Between 2013 and 2017, he served as a founding member on the OPQ Emerging Technology Team (ETT). He was a core member in multiple policy development efforts, such as emerging technology, continuous manufacturing, and comparability protocols. Dr. Wu has training and education in pharmacy, pharmaceutical science, protein chemistry, polymer chemistry, and process analytical technology. He has more than 20 peer-reviewed publications, and been invited to multiple national and international conferences to present or discuss the above related topics. His Ph.D. thesis from the University of Utah focused on self-assembly of hybrid hydrogels containing coiled-coils and drug-free macromolecular therapeutics to induce apoptosis by coiled-coiled mediated crosslinking of antigens.

GMDP Operations Manager and Senior Inspector

Medicines and Healthcare Products Regulatory Agency

Graham co-ordinates the MHRA’s GMP risk-based inspection programme, which has been adapted significantly in response to the challenges of the coronavirus pandemic. Graham specialises in the inspection of sterile product manufacturing as well as the collection, processing and supply of blood and blood components. He also represents the MHRA on the PIC/S Quality Risk Management Expert Circle.

Graham is a Mechanical Engineer (MEng) by training. Prior to joining the MHRA he spent eight years working in the pharmaceutical industry in the areas of human plasma fractionation and sterile product manufacturing, including operational and managerial roles in Validation and Quality Assurance.

General Manager - Medicines and Biological Products

ANVISA

Gustavo Mendes Lima Santos, Specialist in Regulation and Health Surveillance. Safety and Effectiveness Assessment Manager. Therapeutic Equivalence Coordinator at Anvisa. Graduated in Industrial Pharmacy from the University of São Paulo (2001), Specialization in Sanitary Surveillance from FIOCRUZ (2007) and Master in Toxicology applied to Sanitary Surveillance from the State University of Londrina (2013).

Health Science - Director, Analytical Operations

SGS Lifesciences

Dr. Houri Simonian has over 20 years’ experience in the pharmaceutical industry, working primarily in product development and is currently the Director for Analytical operations with SGS Health – Drug Development. She is responsible for the operations in Chemistry in a GMP lab, supporting pre-clinical to Phase I to III, CMC activities, to commercial products, in collaboration with clients, with a focus on analytical method development, validation, stability and micro. In her previous roles, Houri has led the CMC activities for the development and submission of multiple products, including solid dose, semi-solid, nasal/inhalation products to various regulatory agencies including, FDA, Health Canada, EMEA, TGA. Houri holds a PhD in Organic Chemistry from the University of Nottingham.

Former Director

ANVISA

Ivo is an Economist with post graduate in Public Administration. He is currently Executive Director and Senior Consultant of Orplavi Consultoria Ltda. A Consulting in the areas of Regulatory Intelligence in the sanitary area, Economy and Market intelligence in the area of health.

Earlier Ivo was Director at the ANVISA from 2013 to 2016. Executive Secretary of the Inter-ministerial Chamber of Economic Regulation of the Medicine Market (CMED) – ANVISA.-2011-2013 and Head of Cabinet of the Ministry of Environment. of Brazil- 2008-2010

Head of GMP Compliance & Aseptic Process Integration

F Ziel GbmH

PHSS: Pharmaceutical & Healthcare Science Society Head of Aseptic processing and ATMP Special interest group plus co-lead of Annex 1 & Contamination Control Strategy (CCS) Focus group.

James is based in the UK with a global support role at F Ziel (Germany) who manufacture technologies for environmental control in sterile pharmaceuticals & ATMP manufacturing. Together with the role at F Ziel James is the former Chairman (10 years) and current elected Head of the Not-for-Profit PHSS: Pharmaceutical & Healthcare Sciences Society Aseptic processing and ATMP special interest group and Co-lead of the EU GMP Annex 1 and Contamination Control Strategy (CCS) Focus group. Working experience includes 10 years in radio pharmaceutical manufacturing (Amersham-GE Healthcare) and over 30 years working in sterile medicinal product manufacturing support where increasingly aseptic processing applies to ATMPs, particularly Gene and Cell therapies. James is a qualified pharmaceutical process engineer with addition education in pharmaceutical microbiology and a subject matter expert in Barrier Technology (Isolators and RABS) and Bio-decontamination with Hydrogen peroxide vapour (H202-VHP). James is also a Member of ISPE and Pharmaceutical Quality Group UK (PQG).

President

Mexican Pharmaceutical Institute

Co-founder and President of the Pharmaceutical Institute (INEFAM: LATAM®), since 2006.

He graduated Master in Business Administration (MBA) from Tulane University in 2006. His experience in the pharmaceutical industry began at Eli Lilly México, when he was in charge of various strategic marketing and project management positions from 1999 to 2005. Previously, he had been an alternate deputy of the Local Congress of Nuevo León at the age of 23, which led him to know in depth the law and procurement processes and the entire legal framework related to the right to health.

To date, he continues to be an advisor to the Health, Anti-Corruption and Transparency Commissions, both for Deputies and Senators, in pro-bono activity, as he aspires for the health system to resume the path that has been abandoned during the current federal administration in México.

José Carlos is a keynote speaker at various international congresses, and has given more than 100 conferences, highlighting his extensive command of several languages. Of the main conferences he has given, his participation in the Open Parliament of the Chamber of Deputies stands out, on July 27, 2020, with the presentation "Comparative Active Transparency 2018 versus 2019 - Results of Submitting 10,000 Transparency requests per year", as well as a plenary session on the biosimilars market in Mexico and LATAM at Harvard Medical School in October 2018, for over 500 attendees and delegates from different countries.

He is a member of the board of directors of SOHIN, one of the most promising companies in the healthcare provider sector.

His differentiating expertise lies in the understanding of field procedures and strategies, in medical units, developing complex strategies to increase average consumption and authorized consumption at the hospital, delegation, and national levels.

In his academic activity, he is the creator of the philosophy of "Inventory Based Medicine", where he justifies that the Physician in Mexican government institutions can only prescribe what he can (national formularies, included and authorized), and what there is on inventory (must be available at the pharmacy at the time of prescription), as well as "The 6 Jobs of the Government Sales Forces", as a way to differentiate and land the work of KAM's and KAE's. He has also innovated with his very peculiar technique of therapeutic substitution analysis by NFC.

His international experience extends to being a nomad who has lived in the CDMX, MTY, Puerto Rico, Bucharest and Sao Paulo, which has led him to have an extensive domain of 4 languages, although he assures that he can read in 6. He loves wines, he considers himself a wine connoisseur.

Executive Director

The Caribbean Public Health Agency

Dr St John rose in the ranks of Public Health in Barbados from 1994 to become the first Barbadian Chief Medical Officer of Barbados in 2005. Dr St John held the position of International Health Regulations Focal Point, Liaison Officer for IAEA for Barbados and sat on the QEH Board, the NCD Commission and the Board of the Barbados Water Authority, among many.

Dr St John also represented Barbados on the Executive Board of WHO and then became the first Caribbean person to Chair the Executive Board from 2012 to 2013.

Dr St John had two stints with other organizations during the twelve years she was the CMO. She was a Senior Advisor with WHO, supporting the co-facilitators of the UNGA Review of the High-Level Summit on NCDs in 2014, then she was the Director of Surveillance, Disease Prevention and Control at CARPHA from October 2015 to August 2016 until she left finally left the post of CMO in 2017 when she became the Assistant Director General at the WHO HQ in Switzerland. There she held the Portfolio of Climate and Other Determinants of Healthand successfully completed the first phase of the Climate Change and Health SIDS Initiative.

In July 2019 Dr St John became the Executive Director of the Caribbean Public Health Agency. There she hassteered CARPHA through a CARICOM Evaluation, selected new Directors, improved the governance and accountability frameworks of CARPHA, as well as focused on strengthening CARPHA’s resource mobilization and partnership portfolios.

CARPHA has led the public health response to the COVID-19 pandemic and Dr St John’s leadership has seen her have over 100 speaking engagements as she engages with multiple sectors, andthe Health leaders and Heads of Government in CARICOM.

Director Biosimilar Policy & Science

Medicines for Europe

Julie has been leading the Biosimilar Medicines Group, a sector group of Medicines for Europe since 2015. Her work consists in creating and nurturing partnerships with experts in (bio)pharmaceuticals and across healthcare systems, balancing interests for a resilient and sustainable healthcare framework. The main objectives of the biosimilar medicines group are to support and facilitate the design, evolution and implementation of policies aimed at creating efficiency gains thanks to biosimilar medicines use and greater access to health services and products for all patients. Since January 2019 on, she has been the co-chair of the Biosimilars committee of the International Generic and Biosimilar medicines Association (IGBA) focusing on convergence of global policies and standards. Her knowledge and understanding of the scientific, regulatory and health policy environment at EU and international levels, as well as of the functioning of the EU ecosystem, greatly supports her effective engagement with all the players involved.

Part of the Medicines for Europe Management Team, she is responsible for the People & Organisation matters, focused on employees professional growth.

With a MSc in Pharmacology, she previously worked in the pharmaceutical industry.

President

ALó ProScience and former Federal Commissioner COFEPRIS - Mexico

Mr. Julio Sánchez y Tépoz is a Mexican Lawyer with more than 20 years experiencein regulatory agencies in the Mexican Government. He is an expert in sanitary andhealth affairs; for 8 years he worked at the Mexican Sanitary Agency, the FederalCommission for the Protection against Sanitary Risk, COFEPRIS.

Mr. Sánchez y Tépoz holds a law degree from Escuela Libre de Derecho in Pueblaand studied a master’s degree in Economic Development from UniversidadComplutense in Madrid, Spain. He has several specialized studies in sanitary affairs,foreign trade, health regulation, economics, competition policy, research onmonopolistic practices, growth and competitiveness, foreign investment, legalargumentation, applied intelligence, advertising, among others.

He was appointed Head of COFEPRIS by the Mexican President in 2016 and actedas such until December 2018. Mr. Sánchez y Tépoz initially joined COFEPRIS in 2011as Chief of Staff of the Federal Commissioner and on July 2012 he becameCommissioner of Health Promotion.

During his time in COFEPRIS, he coordinated and directed several strategies focusedon the improvement of access to quality medicines in the public and private market. During his work in COFEPRIS he was appointed as Vice President of the InternationalCoalition of Medicines Regulatory Authorities (ICMRA) for the Period 2017-2018,where he participated on facilitating greater co-operation and to enable Heads ofMedicines Regulatory Authorities to exercise collective and concerted strategicleadership over existing and new international initiatives and enablers, as well as overshared regulatory issues and challenges.

Mr. Julio Sánchez y Tépoz currently presides over the international nonprofit academicorganization AlóProScience, a Latin American Association of Regulatory AffairsProfessionals focused on promoting Good Regulatory Practices and Regulatory Policyin the region while training and educating regulatory professionals. He also teachesHealth Protection Law class at the Mexican National Autonomous University (UNAM)and gives regulatory assistance to the private and public sector on Mexican sanitaryand health topics.

He has also worked in various institutions of the Mexican Federal Governmentincluding the Federal Competition Commission, the Federal Consumer ProtectionAgency (PROFECO), the Attorney General´s Office of the Mexican Government,where he performed legal analysis and was involved in international cooperation withEurope, Latin America, the UN, and other specialized organizations.

In 2020 Julio Sánchez was elected as member of the Board of Trustees of the UnitedStates Pharmacopeia, for the period 202-2025. In the same year Mr. Julio Sánchez yTépoz became Partner of Health Sanitary Consulting, a specialized firm on legal andregulatory services across North and Latin America.

Vice President-Regulatory & Access

Parexel and Former FDA

EXPERIENCE
Acts as a trusted advisor for business solutions addressing specific client needs using expertise in CMC regulatory, bioprocess technology, biotech risk assessment and mitigation and compliance.

Senior CMC coach and subject matter expert for project teams for multiple clients and projects.

Over 30 years of experience in biotech and biomedical science in NIH, FDA and Parexel, including industry standards ideation and creation and technical report building

EXPERTISE
Supported FDA Office of Biotechnology Products as part of the product quality (CMC) review team

Novel Biologics, Biosimilars, Transition Products, and Drug-Device Combination Products

Extensive FDA review experience with 351(a) and 351(k) BLA pathways, CMC and Inspections

Widely considered to be a world-class expert in viral safety risk assessment and mitigation for biopharmaceuticals; organizing international conferences and technical task forces

Currently helping multiple clients mapping out regulatory strategies for biotech drug and drug-device combination candidates ranging from pre-IND to NDA/BLA stages in multiple therapeutic areas.

EDUCATION
Postdoctoral Fellow, National Institute or Allergy and Infectious Disease, NIH, Bethesda MD

Ph.D., California Institute of Technology, Pasadena CA

B.A. Biology, University of Chicago, Chicago IL

Vice President - Quality and Regulatory

EISAI India

Madan Mohan Reddy is a Pharmaceutical professional with about 24+ years of experience insterile and non-sterile formulations and APIs in the disciplines of Quality management, audit and compliance, validations and Regulatory affairs. He has been associated with Eisai for the past 13 years and is currently head of India regional Quality and Regulatory operations of Eisai. Prior to joining Eisai, Madan worked for Indian generic companies such as Dr. Reddy’s, Orchid healthcare and Gland Pharma. He holds a PhD degree in Pharmaceutical sciences and master’s degree in Quality management from Birla Institute of technology Pilani, India. Madanworked in highly regulated and complex market environment with demonstrated knowledge of global regulations, product approval and lifecycle processes for major markets.

Senior Director-Regulatory Affairs CMC

Celldex and Former FDA

Mamta Gautam-Basak spent 20+ years with the Food and Drug Administration (FDA) working in various scientific, CMC, and regulatory roles primarily within the Center for Drug Evaluation and Research (CDER). She is excited to help the next generation of biotech and pharmaceutical entrepreneurs understand the complexities of drug development regulation so that they can build proactive strategies into their growth plans as early and efficiently as possible.

She is fluent in all aspects of the regulatory process in drug development and has seen what happens when companies miss critical requirements and details. She is excited to share her thoughts with biotech and pharma entrepreneurs on their plans to bring critically-needed therapeutics to market in a safe and compliant way.

Mamta currently serves as a senior technical advisor for US Pharmacopeia’s Promoting the Quality of Medicines (PQM+) program, a USAID-funded initiative that helps low- and middle- income countries improve the systems that ensure the quality of and increase the supply of priority medicines. She provides technical oversight and direction to all global implementation activities related to regional and country regulatory systems. She earned her PhD in analytical chemistry from the Indian Institute of Technology-Delhi.

Partner and Head of UK Life Sciences

Sidley Austin LLP

Maria Isabel Manley leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law. She advises on a broad spectrum of matters, both contentious and non-contentious, including IP regulatory rights, market access, advertising, product liability and competition; as well as on issues relating to Brexit. She has represented a number of the world’s leading pharmaceutical companies in landmark cases before the EU and English Courts, as well as before the regulatory authorities, including the European Commission, the European and UK medicines authorities (EMA and MHRA), the National Institute for Health and Clinical Excellence and the Department of Health.

Marie is the co-author of “Navigating European Pharmaceutical Law,” Oxford University Press, 2015. Most recently, she has been listed in Best Lawyers 2020 for Life Sciences Law and has been awarded Best in Life Sciences at the LMG Europe Women in Business Law Award 2019. Sidley were also awarded Law Firm of the Year for FDA Law by the U.S News – Best Lawyers 2020.

Founder

Barragan BioConsulting and Former FDA

Dr. María José (Pepa) López-Barragán is a former U.S. FDA (CDER) regulator and founder of BarragánBioConsulting, a company that offers consulting services to pharmaceutical companies globally. Pepa has 16 years of combined experience in regulatory affairs (CMC), facility compliance, and multiple aspects of drug development and research. While serving at the FDA, she participated in the approval of 15 original and biosimilar biologic license applications and was responsible for the product quality assessment of over 200 regulatory submissions and nearly 20 facility inspections in 8 countries. Pepa was recipient of two FDA special recognition awards for her contributions to BLA assessments and the facility inspectorate team. Prior to serving at the FDA, Pepa was Principal Scientist at GlaxoSmithKline and GeneDx and co-authored 20 peer-reviewed scientific publications and one biotechnology patent. Pepa holds a PhD in Biochemistry and Molecular Biology by Complutense University (Madrid, Spain) and completed a 5-year postdoctoral research program at the U.S. National Institute of Allergy and Infectious Diseases, Bethesda, MD.

Principal Auditor

MFM GMP Consulting and Former FDA

Experienced former US FDA Drug Specialist with a demonstrated history of working extensively in the pharmaceuticals industry in the US and multiple other countries including: China, India, Germany, Italy, Austria, Ireland, France, the UK and the Netherlands to name a few.

Now putting those skills to work as the owner of her own consulting firm providing insight into the workings of the US FDA through: training, conducting Mock FDA audits, advising on facility set up and layouts and advising on the preparation of responses to FDA-483's and Warning Letters.

Skilled at auditing a wide variety of manufacturers of: Sterile and non-sterile API's, Sterile and Non-Sterile Finished products, Immediate release, Extended release and Timed release Capsules and Tablets, Good Laboratory Practice (GMP) Labs, Good Laboratory Practice (GLP) Lab facilities, Biologically produced APIs and Finished Products and Medical Device manufacturers. With wide experience evaluating and improving documentation in relation to: Change Control, Deviations, Complaints, Investigations and CAPA as well as laboratory documents, raw data and OOS investigations. Well versed in Pharmaceutical, Biotechnology, and Regulatory Requirements.

Deputy Director General

European Healthcare Distribution Association

Martin is the Deputy Director General for the European Healthcare Distribution Association (GIRP). Martin duties include day to day management, supporting the implementation of the strategic and policy decisions of the associations governing bodies, dealing with the association relations with its member organizations, authorities and other stakeholders. With a legal background he also deals with the broad range of legislative and regulatory issues affecting the pharmaceutical full-line wholesalers as healthcare distributors in Europe.

GIRP is the umbrella organization of pharmaceutical full-line wholesalers in Europe. It represents the national associations of over 750 healthcare distributors and pharmaceutical full-line wholesalers serving 33 European countries, including major pan-European pharmaceutical full-line wholesaling companies

Scientific Director

GSK Pharmaceuticals, UK

Mike Urquhart (Ph.D.) has over 20 years’ experience within the Pharmaceutical industry, working mainly in process development as a synthetic organic chemist. Since starting at GlaxoSmithKline (GSK), Mike has had positions of increasing responsibility ranging from lab chemist and team manager through to Chemistry Manufacturing and Control (CMC) project manager. During his GSK career, Mike has led the primary development / delivery of 10 products, spanning early through to late phase development. Mike’s current rolesare co-chair of the Impurities Oversight Panel, where he is a GSKmutagenic impurity risk assessment subject matter expert and Scientific Director as well as the GSK Drug Substance nitrosamine risk assessment lead for small molecules. Mike also represents GSK on the Lhasa Mirabilis Pharmaceutical Consortium and presents externally on best practice for mutagenic impurity control strategies for pharmaceutical products.

Sr. Vice President – Global Regulatory Affairs

Aurobindo Pharma

Former VP-Regulatory Affairs, Latin America and Canada

Allergan

Paula carries 30 years of experience in the pharmaceutical industry working in US and EU multinational companies such as Allergan (Abbvie), Hoechst (Sanofi) and Syntex (Roche).Career developed in Research and Development, Regulatory Affairs, Safety, Quality and Technology at Latin America and Canada with close interface with Europe, USA and Asia markets. She has deep knowledge in biologics, drug products, medical devices, combinations, implants, and electromedical equipment. Her experience is in product development from strategy, development, clinical operations, registration, pricing, market access and launch. With solid relationships with Regulatory Agencies, Key Opinion Leaders, External Trade Associations she has been worked to shape the regulatory environment at emerging markets for existing and new technologies including support for the creation of new standards. Strong experience in regulatory inspections, conductingtraining and qualification programs for internal teams and suppliers.

Paula is a Pharmacist, Master in Pharmaceutical Sciences, and MBA in Project Management.

Former Regulatory Counsel

US FDA

Mr. Crooker is a valuable, scientifically trained drug development attorney with a highly desirable combination of U.S. Food and Drug Administration (FDA) and private sector experience in global large-cap, mid-size specialty and closely held pharmaceutical and biotechnology companies. Mr. Crooker has accumulated extensive global professional and practice experience for 21 years in applying laws, regulations, and policy to successfully solve complex problems confronting pharmaceutical and biotechnology firms engaged in all stages of product development; chemistry, manufacturing and controls (CMC) and product quality strategy; the regulatory approval process and health authority engagement; product commercialization and lifecycle management; and drug manufacturing compliance and enforcement for both conventional commercial manufacturers and compounding pharmacies.

Mr. Crooker readily identifies, analyzes and capably resolves complex legal, regulatory, and technical issues in a high risk and heavily regulated environment. Mr. Crooker has a proven record of effectively counseling and communicating with organizations on the analysis of issues at the interface of product development and commercialization, regulation, and business; creating successful technical, regulatory and compliance strategies for all stages of pharmaceutical product lifecycle management; assessing and integrating new product acquisitions; and leading and growing business functions

He has presented at numerous meetings for the American Association for Pharmaceutical Scientists (AAPS) and participates in the International Society of Pharmaceutical Engineering (ISPE), the Food and Drug Law Institute (FDLI) and the American Society for Testing and Materials (ASTM).

Mr. Crooker holds an undergraduate degree in chemistry and a law degree. He remains an active member of the California Bar and has also been admitted to the U.S. District Court for the Central District of California.

Director – Regulatory Affair

Cipla

Dr. Praveen Kumar is currently working as Directory of Regulatory Affairs at Cipla, heading Medical Devices, India Regulatory, Regulatory Assurance and Data Systems functions. He has around 20+ years of Healthcare Regulatory and Quality experience in Combination Products, Medical Devices, Pharma, BioPharma including research experience.

Deputy Chief Executive

Health Products Regulatory Authority

Rita Purcell is the Deputy Chief Executive at the Health Products Regulatory Authority where she has responsibility for international affairs, finance, legal, regulatory affairs, corporate governance and infrastructure. She has lead on a number of international initiatives and is an active participant in the International Coalition of Medicines Regulatory Authorities (ICMRA). Rita is the alternate member of the Board of the European Medicines Agency andis on the Council of the Pharmaceutical Society of Ireland, the regulator of pharmacies and pharmacists. Since 2016 Rita has lead the internal HPRA Brexit Task Force and represents the management team for Brexit coordination and planning at national government leveland leads HPRA’s engagement with the European network and stakeholders in Brexit preparations. She read law at University College Dublin and is qualified as a Chartered accountant. She previously worked for Price Waterhouse in Dublin and San Francisco and also has worked in the construction and food industries in the areas of finance, acquisitions and internal audit.

Executive Director-Pharma Regulatory Affairs & Strategic Alliances

Corning Incorporated and Former FDA

Robert (Bob) Guidos, J.D. serves as executive director of pharmaceutical regulatory affairs and strategic alliances for Corning Incorporated. Guidos joined Corning in 2017 after serving as senior advisor to the director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and as CDER’s associate director for legislative affairs. Based in Washington, DC, he directs Corning’s government affairs’ global policy and strategy in support of its life sciences technologies divisions. In 2020, Guidos helped launch Corning’s strategic response to the SARS-CoV-2 pandemic by assisting in securing a $204M award from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to accelerate manufacture of Corning’s innovative pharmaceutical glass vials for use with COVID-19 vaccines. As a health policy executive with 27+ years experience with the FDA, U.S. Congress and the Infectious Diseases Society of America (IDSA), he has successfully led strategic initiatives by mobilizing multidisciplinary teams of experts in medicine, science, public health, law, regulation, and government and public relations. Guidos received his juris doctor degree from the University of Pittsburgh School of Law and bachelors in chemistry and business from Gannon University in Erie, Pennsylvania.

Managing Director

Misom Labs and Chairman of RA Committee, IDMA

S.M.Mudda is a Pharmacy graduate with a Postgraduate Diploma in Management Studies. He has more than 42 years of wide experience in pharmaceutical industry covering all aspects of pharmaceutical manufacturing. He was associated with Micro Labs Limited for more than 30 years and served them as Executive Director Technical and operations and later as Director Global Strategies. He is the Managing Director of Misom Labs Limited, Malta, an EU GMP Licensed Pharmaceutical Testing Laboratory. President – NSF Health Sciences (India) representing NSF International UK, a Global GMP Consulting and Education company in Asia Pacific Region. Program Director, NSF UK, Advanced Program in Pharmaceutical Quality Management offered in collaboration with Indian Drug Manufacturers’ Association (IDMA) for the senior executives of the industry. He is actively associated with IDMA and is Chairman of Regulatory Affairs Committee. He is serving as Technical Advisor and Leadership Mentor to leading companies.

Director-Drug Regulatory Affairs

Boehringer Ingelheim, Canada

Samar began her career in basic research in private and hospital settings, before transitioning to Regulatory Affairs. Currently, Samar is the Director of Regulatory Affairs at Boehringer-Ingelheim (Canada) Ltd., a global family owned Pharmaceutical Company. Samar’s proficiency includes over 26 years of experience in progressive roles in the Pharmaceutical Industry, with more than 18 years of proven strategic leadership and people management skills, motivating various teams in different functions to deliver high quality results in line with business priorities.

She graduated from the University of Western Ontario with a Master of Science degree in Molecular Biology, and most recently completed her Executive Master of Business Administration degree from the Ivey Business School in London, Ontario, Canada.

Senior Director-Regulatory CMC/CMO

AstraZeneca

Sarah Pope Miksinski has been with AstraZeneca since February 2018 and is currently a Senior Director in Regulatory CMC, AstraZeneca. Her duties include leadership of a global team covering CMC regulatory strategy for development and pre-approval health authority submissions, as well as serving as a key contributor to several ongoing initiatives including continuous manufacturing and Q12 implementation. She represents AstraZeneca in various external capacities – including serving with Tony Mires-Sluis on PhRMA’s Global Quality and Manufacturing Committee, serving as chair of ISPE’s Regulatory Steering Council, and supporting multiple other advocacy efforts.

At the time of her departure from FDA, she was the head of two offices in FDA’s Office of Pharmaceutical Quality – serving permanently as the director of the Office of New Drug Products (2014-2018) and simultaneously serving as the interim director of the Office of Surveillance (2016-2017). Collectively, both roles placed her in OPQ’s senior leadership team for several years, where she contributed heavily to OPQ’s strategic direction including numerous recent quality review, communications, and GMP/inspectional efforts. On behalf of FDA, she also played a key role in FDA/nonprofit interface discussions (e.g. PhRMA, ISPE, AAM) and in development of international strategy and related ICH proposals.

Sarah began her FDA career in 2002 and served as a primary, secondary and tertiary reviewer before being selected as a senior management official. Prior to joining FDA, she completed a postdoctoral fellowship at the National Institute of Health. She is trained as an organic chemist and possesses a PhD in organic chemistry (Oklahoma State University, 1999). She also has a B.A. in chemistry (Earlham College, 1994).

In her free time, Sarah greatly enjoys spending time with her husband (Ted) and their son (Adam). She is an avid musician and enjoys skiing and oil painting.

Board Member

Alliance for Safe Biologic Medicines

Stephen lives in Scotland and is a member of the International Advisory Board of the Alliance for Safe Biologic Medicines (USA) and speaks on patient, prescriber and pharmacist perspectives of biosimilars. Since 2006 his career has been in public health. Initially as CEO of Cystic Fibrosis Victoria, with several national and international committee & board roles. In recognition of his work, he was made an Honorary Life Member of the Australian peak patient body (2014) and later elected to Fellowship of the Royal Society for Public Health (2021).

Prior to 2006, Stephen was Vice President of Swinburne University of Technology. Before Swinburne, he was Foundation Head of Continuing and Community Education at the, now, Open University of Hong Kong (1992-95). His career in education started in 1979 and was varied, diverse and fast moving. In 2001 I became a Life Fellow of the Royal Society for Arts and a Life Member of the Graduate Union of the University of Melbourne.

Secretary General

Indian Pharmaceutical Alliance

Sudarshan has a strong passion for healthcare and the education sector. Currently, he is the Secretary-General of the Indian Pharmaceutical Alliance (www.ipa-india.org), Senior Advisor - Apax Partners and Board member of multiple organizations. He is also the Chair of International Generic and Biosimilar Medicines Association (IGBA) for 2021. He has served in several leadership positions for over 40 years in Healthcare industry (Lupin, Johnson & Johnson, Piramal, Abbott) and was formerly the Managing Director at Abbott Healthcare Solutions.

His current Board engagements include Abbott India, Healthium Limited (Apax portfolio company), Indian Education Society (IES), Advisory Board of Narsee Monjee University, Mumbai (NMIMS). He is the Visiting Faculty at Indian Institute of Management (IIM), Ahmedabad. He has contributed in shaping the healthcare policy and improving access to healthcare in India.

Sudarshan is an Alumnus of St. Stephens College, Delhi University and Indian Institute of Management (IIM), Ahmedabad.

Executive Vice President - Regulatory Affairs

GSK Pharmaceuticals, India

Sukanya Choudhury is currently heading the Regulatory Affairs function for GlaxoSmithKline Pharmaceuticals Limited, India as Executive Vice President, Regulatory Affairs and is a member of the India Leadership Team as well as the Regulatory Affairs Leadership team for Emerging market at GSK

Ms. Choudhury holdsa Master’s degree in Pharmaceutical Sciences and has more than 22 years of experience in both pharmaceutical and medical device industry in the Regulatory and Quality Assurance functions.

Her areas of expertise include in depth knowledge of the regulatory environment in India and insights in Emerging Markets pertaining to clinical trials and registration of new drugs, biologicals, and vaccines.

Senior Application Manager

EXTEDO Inc

I have been working in the Pharmaceutical industry for software companies for 15 years. This includes covering document publishing, submission publishing, software support and regulatory assistance. My current focus is the regulatory support and monitoring for changes. My regional focus is the US FDA, Canada, Australia, Japan, and monitoring the emerging markets in Latin America but is not exclusive to these regions.

Chief Executive Officer

Drug Development and Regulation

Independent consultant, he founded DDR (Drug Development and Regulation, www.ddrmedic.com), located in Barcelona, Amsterdam and London, where he is the CEO and Senior Consultant. DDR provides highquality regulatory assistance to companies and institutions developing drugs and medical devices.

He was Head of Safety and Efficacy of Medicines at the European Medicines Agency (EMA) during 2005-2012, and previously held leadership positions in the biopharmaceutical industry for more than eighteen years, covering international clinical development, drug safety, pharmacovigilance, biostatistics and medical affairs.

In addition to Dr. Luria’s specialty in internal medicine, and pharmaceutical medicine and biostatistics (University Autonomous Barcelona), he has developed expertise in several specific therapeutic areas, carried out postgraduate qualification in clinical pharmacology, drug development and regulation (Tufts University School of Medicine, Boston), and he is a recognized expert on regulatory systems and benefit-risk assessment (modelling, development and methodologies).

Furthermore, he is member of the Board of Directors of the IFAPP-King’s College Postgraduate Course, Senior Visiting Lecturer at the King’s College in London and lecturer at several other academic institutions in Europe and USA.

He is currently member of the advisory board of several biopharmaceutical and medical devices companies and serves as consultant and regulatory service provider to many others in Europe, Japan, US, Australia, Israel and Latin America.

Former Director Regulatory Affairs

Emcure Pharmaceuticals

Santosh Savarkar is Regulatory affairs and Quality compliance professional with rich 27+ years of experience in the pharmaceutical industry. Certified lead auditor of ISO13485 systems for Med. Devices. Santosh has In-depth exposure and experience working as Associate Vice President - Regulatory affairs at Umedica Laboratories. In his vast carrier Santosh handled the regulatory strategies and filings for US, Europe, Canada, Australia and emerging Markets and India. Actively involved in GMP inspection compliance for EU/MHRA/BfArM/EDQM, COFEPRIS/ANVISA/ KFDA/MCC for Formulation, API facilities.