Online

ONLINE:

Chemistry Manufacturing Control and Regulatory Affairs

Thank you to those that joined us for the first Online CMC & Regulatory Affairs Strategy Meeting on the 2nd & 3rd June. The post-event report coming soon available for download. We’ll be hosting more upcoming Strategy Meetings later on in the year, keep an eye out for the latest announcements.

Dates

02 Jun, 2020

ONLINE STRATEGY MEETINGS

CMC and Regulatory Affairs insight without ever leaving your home

Need a unique online conference experience? Looking for a chance for real discussions and genuine networking? Proventa International’s online manufacturing strategy meetings can help you make those important connections through interactive roundtable discussions, exclusive networking apps and keynote panel debates – all in a totally online format.

Join chemistry manufacturing controls and regulatory affairs professionals from all over the world. Engage with your senior peers, discover new insights and help take your company to the next level.

Download The Full Event Brochure

Online Strategy Meetings

What makes our online strategy meetings unique?

No other event creates such a unique and personalised online experience. From the tailored agenda, to the senior delegation to our networking apps, our online strategy meetings provide the perfect learning and networking environment.

Roundtable Discussions

Intimate discussions led by renowned industry experts. Have your voice heard and debate alongside like-minded life science executives.

Unrivalled Networking

With senior delegation from big pharma and innovative biotech. Join in roundtables, set-up private 1-to-1 meetings via our networking app.

Personalised Agenda

Choose the topics that matter to you. Reserve your place at roundtable discussions and ensure your whole day delivers the insights you need to hear.

Totally Online Format

It’s more important than ever to encourage collaboration while promoting safety and accessibility. That’s exactly what you can expect from our online meeting format.

Meet the Facilitators

Our panel of facilitators play a key role in shaping the agenda

Sheng Cui

Executive Director CMC Boston Pharmaceuticals

Session – Selecting the right route to ensure fast development and scale-up across all the project phases and supporting the API projects requirements
Cui Sheng is a CMC pharmaceutical development leader with extensive experience in advancing synthetic drug candidates from discovery to commercialization with major contribution/leadership roles on numerous IND, INDa, NDA and major post-approval variations for Boston Pharmaceuticals. Cui Sheng has a proven track record of driving innovation while balancing strategic development considerations to align innovation with business objectives and maximize the value of innovation. With demonstrated success in partnering with CROs and CMOs for process development, innovation, supply and continuous improvement.
Cui Sheng received his Bachelor’s degree in Chemistry from Nankai University and his PhD in Chemistry from Case Western Reserve University. Notably, Cui Sheng has 19 publications in the CMC sector as well as 5 patents.

Stan Russell

Former Vice President, Quality TCR2 Therapeutics Inc.

Gregg Keaney

Vice President of Product Development Atlas Venture NewCo

Qinghai Zhao

VP Technical Development and Manufacturing (Chemistry Manufacturing Controls) Forty Seven Inc.

Session – Early stage CMC development strategy to speed IND
Qinghai Zhao, PhD VP Technical Development & Manufacturing Qinghai has over 25 years of experience in biological CMC development and manufacturing and is the company’s Vice President of Technical Development and Manufacturing. Prior to <a href="https://www.fortyseveninc.com/">Forty Seven</a>, he was Vice President of CMC/Manufacturing at AnaptysBio. Prior to that, he held various CMC leader positions including Head of CMC at NGM Biopharmaceuticals, Director of CMC Management at Teva Biologicals USA and Associate Director of Process Development at Cogenesys. Qinghai has extensive knowledge of all biological CMC functions with executive experience of developing CMC strategy from early stage to late-stage for commercialization. Prior to Cogenesys, he was a Sr. Scientist of Lead Development at Human Genome Sciences and a Research Fellow at National Institute of Health and Georgetown University Lombardi Cancer Center.
Qinghai received his PhD for Biomedical Research at Uppsala University, Sweden.

Nick Dunwoody

Vice President, CMC Tetraphase Pharmaceuticals, Inc.

Session – How to ensure clarity and communication of goals and expectations for successful technology transfer during drug development with your CDMO
Nicholas Dunwoody has served as Vice President, CMC at Tetraphase Pharmaceuticals since April 2015, responsible for all CMC functional areas including clinical supply chain. Dr. Dunwoody joined Tetraphase in June 2008, and in his tenure has held various positions in Analytical Chemistry and Formulation Sciences. Prior to joining Tetraphase, Dr. Dunwoody served as Director of Analytical Chemistry and Pharmaceutical Services at Nucryst Pharmaceuticals, Inc. from 2004-2008. Dr. Dunwoody began his professional career as an investigator at Vertex Pharmaceuticals, from 2000-2004. Notable achievements in his career include the development of 14 small molecule products, one biologic pharmaceutical product and a series of nano-materials in pharmaceutical and medical device applications. Dr. Dunwoody has been pivotal in the development of Tetraphase’s first commercial product, XERAVATM (eravacycline for injection), launched in September 2018 for the treatment of complicated intra-abdominal infections (cIAI).

James Stahl

Senior Director (Chemistry Manufacturing Controls) Promedior

Art Faulkner

Vice President, Regulatory CMC TG Therapeutics, Inc.

Fernando Aleman

Chief Scientific Officer Navega Therapeutics

Daniela Drago

Senior Director Regulatory Sciences Biogen

Session – Regulatory Challenges and Opportunities for the Global Development of Gene Therapies 
Daniela Drago, Ph.D., RAC is Senior Director Regulatory Sciences at Biogen. Prior to joining Biogen, she has held senior positions in global regulatory and medical affairs at F. Hoffman-La Roche, Vifor Pharma, Reckitt Benckiser, and Bausch & Lomb. During her career, she was an Associate Professor at George Washington University’s School of Medicine and served as a Premier Consultant at NDA Partners. Daniela has significant global experience in the development of small molecules, biologics, and gene therapies in rare and common disease areas, including oncology, ophthalmology, and neuroscience. She received the TOPRA Award for Regulatory Excellence and the RAPS Community Leadership Award. She serves on the Regulatory Affairs Certification Board, is the former Chair of the RAPS DC/Baltimore Chapter, and is a member of the Advisory Council to the TOPRA Board of Directors.

Daniel Hogan

Associate Director Tech Transfer and Manufacturing Portola Pharmaceuticals

Alex Goraltchouk

Vice President, Operations Anika Therapeutics

Session – Using “one-stop-shop” CDMOs compared to using providers best suited for each step of the process – advantages and disadvantages
Alex Goraltchouk joined Anika Therapeutics, Inc. as Vice President of Operations on June 11, 2018. Most recently, Mr. Goraltchouk served as Vice President of Operations at Avedro, Inc. where he was responsible for managing all aspects of Clinical and Commercial Production, Technical Operations, Procurement, and Supply Chain Management for the organization. Prior to his work at Avedro, Alex held senior leadership roles in Operations, Supply Chain Management, and R&D for several firms including Allergan, Inc., Regeneron, Inc., and Biogen, Inc.
Mr. Goraltchouk holds a B.S. in Materials Engineering and an M.S. in Chemical Engineering from the University of Toronto, as well as an M.B.A. and M.S. in Finance from Indiana University. He is a Cornell Certified Six Sigma Black Belt and holds professional certifications from Stanford University (Genetics and Genomics), Massachusetts Institute of Technology (Supply Chain Management), and the Project Management Institute (Project Management Professional).

Cecile Riboud

Senior Director Europe IQVIA Integrated Global Compliance (Regulatory, Safety and Quality)

Session – Ensuring Business Continuity during Mergers & Acquisitions, Divestments and Portfolio Swaps
Cecile is currently responsible for IQVIA’s Global Integrated Technology and Compliance Solutions in 
Europe, including regulatory, safety/pharmacovigilance and quality compliance. She has over 17 years of 
life sciences experience across Scientific Information Management, Global Regulatory Affairs, Mergers 
and Acquisitions and Product Development. Having worked for large pharmaceutical groups and 
companies of all sizes in Europe, Cecile has an excellent understanding of the pharmaceutical and MD- 
IVD industry. She has held global management leadership positions leading large international 
programs, projects and teams of experts. Prior to joining IQVIA, Cecile worked at a well-known 
regulatory consulting firm in Germany, where she served as acting deputy head of an office totaling 60 
international consultants and led global project regulatory activities involving 70 consultants worldwide. 
She was responsible for client delivery and was actively involved in Business Development. Cecile holds a 
M.Sc. in Analytical Sciences from the University of Strasbourg, France and an Executive MBA from 
EMLyon Business School, France – Shanghai, China.

Lisa Kelsey

Head of Commercial Labelling Genentech

Session – Regulatory Partnerships on Human Factor/BLA/NDA Labeling
Lisa M. Kelsey, M.A, LMFT is the Head, Commercial Labeling, Associate Group Director at Genentech.  She received her Bachelor of Arts in Psychology, May 1997 at San Francisco State University, and her Master of Arts in Psychology, May 2001 from College of Notre Dame in Belmont.  She became licensed as a Marital Family Therapist, May 2011 and has a thriving private practice in Burlingame, California.
She has 20 years regulatory experience and became Head of Commercial Labeling group in 2015.  Her group consists of 9 hard working, dedicated members that she manages directly.  In her role she enjoys collaboration, coaching, and partnering with her team to grow, learn, lead and broaden their visibility throughout the organization. The team focuses on the commercial printed labeling for product launches, human factor studies and maintenance of labeling changes for the full US portfolio.  She prides herself in both careers and helping patients and clients on a daily basis.

Karin McIntosh

Executive Director Stemline Therapeutics

Marcel J. Velterop

President – Drug Discovery Services & CDMO Jubilant Biosys Limited

Session – Difficulties in Development
Marcel J. Velterop, as President Drug Discovery Services & CDMO will lead Jubilant Drug Discovery Services and Contract Development & Manufacturing Organisation (CDMO) to provide an integrated solution to our life science customers from drug development to scale-up and then commercial manufacturing designed for maximum speed and compliance.
Marcel brings over 25 years of business, pharmaceutical & CDMO experience and leadership to JDDS. He is a chemical engineering graduate from Delft University of Technology and has an in-house DSM course in business management from Rotterdam School of Management. He started his career with DSM in 1989 where he held various roles in Marketing, Logistics, Sales, Product Management & Strategy Development. He has also been associated with Dr Reddy’s where he held Senior Leadership roles for Europe, Japan & North America. In a career spanning almost three decades, Marcel has had rich experience across diverse businesses and global markets.

Roger McDonald

Business Development – CMC services MercachemSyncom

Jim Stout

VP CMC Shattuck Labs

Session – Mitigating risks associated with API suppliers
Jim Stout has over 25 years of experience in biopharmaceutical process development, manufacturing sciences, and technology with large biopharmaceutical and smaller biotechnology companies and is currently working for <a href="https://www.shattucklabs.com/">Shattuck Labs.</a> He has utilized all the tools gained from the advanced training to enter into biopharmaceutical process development and manufacturing, where he started at Alexion Pharmaceuticals and continued advancing bioprocess and people leadership at Medarex, Inc.; Abbott Bioresearch Center; Amgen; Shire HGT; Immunogen; Natrix Separations, Inc./EMD Millipore_Sigma; HOST Therabiomics, Inc.; and BioVectra, Inc./Mallinckrodt Pharmaceuticals. Jim managed many different recombinant protein programs at various stages from Research, all Clinical Phases, and Commercial and was privileged to contribute to the advancement of commercial Humira® and Enbrel®.
He received his B.S. in Chemistry from Denison University and a PhD in Biochemistry (with a minor in Analytical Chemistry) from the University of Cincinnati. Jim extended his education in protein chemistry and separation science with an NIH post-doctoral Fellowship at the University of Cincinnati College of Medicine in the Department of Pharmacology & Cell Biophysics (mostly working with animal-derived membrane proteins from tissues) and further expanded his knowledge/ experience at the Blood Research Institute, The Blood Center of Southeastern Wisconsin, in the Department of Immunochemistry (working on human systems, Red Blood Cells and membrane proteins).

Dean Edney

Head of Process Research & Development (API) Sai Life Sciences Ltd

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<div>Session – CMC Complexities & Challenges in Drug Development</div>
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<div>Dean Edney is an accomplished scientific leader with over 25 years of experience in small molecule pharmaceutical process and product development. He joined Sai Life Sciences as the Global Head of Process R&D in January 2020 with a mandate to enhance the organization’s process research & development capability, across the UK and India, allowing its customers to accelerate their research and development programs through the rapid application of high quality science to all areas of API process research, development and manufacturing. Throughout his previous career at GlaxoSmithKline Dean demonstrated a strong track record of cross-functional leadership to deliver projects and develop capability across all phases of API process research & development, from early non-clinical supply and route scouting through to validation of commercial control strategies. He also has experience of developing both inhaled and oral solid dose 
pharmaceutical products including physicochemical developability criteria; the importance and control of physical properties and the regulatory requirements at each phase of development.</div>
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<div>Dean received his BSc in Chemistry and Ph.D. in Synthetic Organic Chemistry from the University of Nottingham, UK.</div>
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Praveen Prasanna

Senior Director Technical Operations AVEO Oncology

Session – Preparation and Process Validation Practices for Drug Product Development & Manufacturing and Concerns Surrounding Outsourcing Partners
Praveen Prasanna is currently Senior Director and Head of Biologics Development and Manufacturing at <a href="https://www.aveooncology.com/">AVEO Oncology</a>.  He is responsible for the development of AVEO’s biologics pipeline including Ficlatuzumab and AV-380. Praveen previously worked at ImmunoGen as Director, External Manufacturing and Supply Chain and Shire as Associate Director and Principal Engineer.  Praveen facilitated the process transfer, validation, routine manufacturing initiation for four commercial products including liquid vials, lyophilized vials, and pre-filled syringes. Praveen is active in the Parenteral Drug Association and was a co-author of Technical Report 60.  His interests are phase appropriate QbD implementation and external manufacturing best practices.
Praveen Prasanna received his Bachelors and Masters of Engineering from McGill University and his PhD in Chemical Engineering from Tufts University.

Branden Lee

Director Business Development Birdotech

Theodore Martinot

Head of Chemical Development Infinity Pharmaceuticals

Session – Maximising the value and impact of a technology transfer package by facilitating the interplay between data, its integration into the knowledge base, decision making based on said knowledge based and ensuring data integrity
Theodore Martinot is a scientific innovator, skilled problem-solver, synthetic organic chemist, and CMC professional from <a href="http://www.infi.com/">Infinity Pharmaceutical</a>. Demonstrated success in methodology development, total synthesis of natural products and complex pharmaceutical targets. Theodore Martinot has fostered direct interaction with regulatory agencies and authored multiple regulatory filings, from IND to NDA | Leader in Quality by Design (QbD) by implementing a Design of Experiments (DoE) approach to projects in all stages of development. He is an innovator for the Laboratory of the Future (LotF) through the deliberate application of automation and data capture, driving efficiency improvements and progress via knowledge infrastructure (Lab Equipment Integration, Data-Rich Experimentation, etc.).
Theodore Martinot received his Bachelor’s of Science in Chemistry and PhD in Organic Chemistry from the University of Florida.

Yuyi Shen

Vice President, Technical Operations Abcuro,Inc.

Yuyi Shen is an inspirational CMC thought leader with management experience in biopharmaceutical development, manufacturing, and clinical supply chain. She is an accomplished program leader in the early to late phase development and commercialization of a wide range of recombinant proteins for immuno-oncology, infectious and rare disease drug platforms. She brings extensive expertise in CDMO selection and oversight, facility/team build- out, technology transfer, budget planning, partner collaboration, and CMC strategic direction of global regulatory filings. She is also an industry-recognized innovation-driven CMC expert on disruptive technology implementation, including process modeling, to deliver with high efficiency and better quality under an accelerated timeline.
She served various leadership roles in CMC at large pharma to emerging biotech companies, including Bolt, XOMA, Bayer, BioMarin, and Grifols. She holds a Ph.D. degree in Chemical Engineering from the University of California, Davis.

Angela Johnson

Senior Director Regulatory Affairs Sigilon Therapeutics, Inc.

Ramzan Tabasum

Head of manufacturing quality CSL Behring

Subhadip Jana

Emerging Market Regulatory Lead, Global Regulatory Affairs Takeda Pharmaceutical Company

Weijun Li

Director, Analytical Development and Quality Control Allakos Inc.

Trey Putnam

Vice President, Regulatory Affairs and CMC FAST BioMedical, Inc.

Van Leang

Sr. Director Global CMC Operations HJB Bio

Arul Joseph

Senior Director, Pharmaceutical Development and Clinical Supply Chain Avanir Pharmaceuticals

CMC and Regulatory Affairs

Online Strategy Meeting Agenda

Comparative analysis of available CDMOs – does more expensive always mean better?

Advances and Challenges in Nanomedicine and Nanotechnology

How to ensure clarity and communication of goals and expectations for successful technology transfer during drug development with your CDMO

Clinically Relevant Specifications

How to generate value for clinical stage companies with CMC strategy for commercial readiness

Addressing a wide range of API crystallization and early formulation challenges for drug development programs

Shifting to a unified RIM model with one unifying global process and system

Regulatory Challenges and Opportunities for the Global Development of Gene Therapies

Green/Brown fields – managing quality, regulatory and supply chain aspects for chemical raw materials and consumables during tech transfer

How to effectively manage shorter product life cycles, when taking into account increased legal and regulatory scrutiny across the global supply chain.

Multinational Trials – effectively translating, formatting and inspecting different languages and fonts for open and blinded labels

Strategies to manage differing country-specific requirements for submissions

Allocating an adequate yet conservative CMC budget from investment fund, investor recommendations.

We encourage all participants to login to our networking app. Details will be sent via email prior to the event starting and the networking features will be held open for a week following the online event.

Emerging Biopharma: Difficulties in Development – From MedChem to first GMP supplies

Integrated Drug Development: CMC Complexities & Challenges in Drug Development

Process Research & Scale-Up: It is not enough to have the best chemistry – working well with upstream and downstream partners makes for seamless collaboration

Intermediates & API: Appropriate Development: why, what and when…

RIM and Data Management: IDMP and the impact in regulatory affairs

Regulatory Operations/Regulatory Strategy: Ensuring Business Continuity during Mergers & Acquisitions, Divestments and Portfolio Swaps

Medical Devices: When regulatory strategy planning becomes a benefit in global submissions

Kick the afternoon off with a keynote presentation given by a renowned industry leader.

Strategies to Ensure Strong and Efficient CMC Function at Startup Biotechs

Key considerations for sterile drug product development for the marketplace

Development and Transfer of Analytical Assays for Polysorbate Excipients in your Drug Product

Early stage CMC development strategy to speed IND

Selecting the right route to ensure fast development and scale-up across all the project phases and supporting the API projects requirements

Rationale, Strategies and Execution for Developing API & Intermediate Supply

Impact of E2E solutions on the drug development workflows and roles

Early communication with regulatory agencies for gene therapy products: INTERACT and ITF meetings

Implementing change control in a newly commercialised company

How to comply with industry standards such as 21 CFR Part 11, 21 CFR Part 820, cGMP, ICH, ISO 13485, ISO 14971, and ISO 9000

Strategies to mitigate the risk of noncompliance

Strategies to reduce resource requirements and increase efficiency through the Parent-Child framework

How a shared-risk partnership model can reduce the cost of outsourcing manufacturing – advantages and disadvantages

Using “one-stop-shop” CDMOs compared to using providers best suited for each step of the process – advantages and disadvantages

Preparation and Process Validation Practices for Drug Product Development & Manufacturing and Concerns Surrounding Outsourcing Partners

Maximising the value and impact of a technology transfer package by facilitating the interplay between data, its integration into the knowledge base, decision making based on said knowledge based and ensuring data integrity

Methods to drive new regulatory and drug pricing policies.

Scale-Out Biomanufacturing – A Paradigm Change to Scale-Up

Mitigating risks associated with API suppliers

How gaining intelligence from RIM via utilizing medicinal product analytics can accelerate business

Effectively preparing for late phase development and mitigation of risk associated

How to ensure proper quality oversight of change management at CROs/CMOs

Drug-Device Combination Treatments & Diagnostics

Switching to electronic labelling to improve patient engagement and experience

Strategies to successfully transmit information in the required format while maintaining an audit trail throughout the process

Key considerations when approaching investors – investor insights

Quick Links

Want to find out more?

Check out the full agenda for 2020 or read the reports from the 2019 strategy meetings.

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