World-Class Speaker Line-Up Includes:

Speakers

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Nancy McClellan
Co-Chair, Occupational Hygiene Training Association, President, Occupational Health Management

Prior to returning to independent consulting practice, Nancy McClellan practiced industrial hygiene management on a global scale for both AbbVie, a major producer of highly potent biopharmaceuticals and LafargeHolcim, the world’s largest building materials corporation.  She has invested over 25 years in practicing occupational hygiene in a wide variety of high hazard industries.  As a self-employed consultant for over 15 years she provides management, training, and field services to sectors such as the pharmaceutical, automotive, military, hospital, electronic, food, chemical, and housing industries.  She has also provided legal expert witnessing services for nationally-profiled, catastrophic incidents.   In her volunteer professional life, Ms. McClellan recently served on the Board of Directors for both the American Industrial Hygiene Association and American Board of Industrial Hygiene and continues as the co-chair for the globally recognized Occupational Hygiene Training Association (OHTA).  As part of her service to OHTA and the pharmaceutical industry, she led the effort to produce an occupational hygiene training module specifically for the pharmaceutical industry to improve global occupational hygiene competency in the industry.  She has also served as the Chair of the Joint Occupational Hygiene Ethics Education Committee.  She has been active member of the British and Irish Occupational Hygiene Societies and a number of AIHA Chapters as a highly rated AIHA Distinguished Lecturer and organizational liaison to AIHA and OHTA.

Graeme McKilligan
Lead Senior GMP Inspector, MHRA (2005- May 2020); Independent GMP Consultant

Graeme will start as an independent GMP consultant in May 2020 having previously been with the MHRA GMP inspection group since 2005. Graeme was a Lead Senior GMDP Inspector within the Inspection Enforcement and Standards Division at MHRA performing inspections across a wide range of pharmaceutical manufacturing and import activities in the UK and overseas. Graeme led the EU Implementation team for Health Based Exposure Limits (HBEL) and chapters 3 & 5 updates, resulting in issue of a Q&A document issued via the European Medicines Agency (EMA) as well as training of EU GMP inspectors in 2018. Graeme also led the PIC/S Working Group and Expert Circle Co-ordinating Committee on Control of Cross Contamination in Shared facilities (CCCISF). The group issued Aide-Memoires for Inspectors on inspection of cross contamination and Health Based Exposure Limits in 2019 and 2020. Graeme specified technical content, chaired and presented at the inaugural PIC/S Expert Circle on CCCISF in Taiwan in June 2019. Graeme led the MHRA Cross Contamination Technical Sub-Group and was the GMP Inspectorate lead on the MHRA Inspection Action Group (IAG), a multidisciplinary group administering the regulatory action process on behalf of the UK Licensing Authority. Graeme also led for the inspectorate Compliance Management Team (CMT) an Inspectorate based senior inspection group managing sites with poor inspection performance with a goal to prevent the need for regulatory action. Graeme is a Chemist and before joining MHRA he worked in the Active Pharmaceutical Ingredient industry for 13 years with GSK in a variety of Quality Assurance management roles and the Medical Device industry with Ethicon Ltd (a J&J company) for 12 years in Quality Control and management roles.

Day One

Tuesday, June 2 2020

8:45 am | In an Increasingly Toxic Landscape, How is Regulation adapting to address this?

9:15 am | Panel Discussion: How Can We Be More Proactive in Ensuring Safe HPAPI Handling?

Cornelia Rudolph
Clean water DG Environment
European Commission

Born in Essen, Germany, in 1986 I grew up in the Ruhr area. For my study program I focused on water with a Bachelor Degree in ‘Water Science – Chemistry and Microbiology in Water’ and a Double-Master Degree in ‘Transnational ecosystem-based Water Management’, an international study program in cooperation between Germany and the Netherlands. I am a civil servant for Baden-Württemberg, Germany, seconded to the European Commission since mid of 2019 working on Pharmaceuticals in the Environment . Before I worked for the regional administration in Freiburg on governmental aid for water-related ecological measures and for the county administration of Konstanz supervising local wastewater treatment plants and their upgrade to a fourth treatment stage and the implementation of the EU Water Framework Directive.  

Andrew Hopkins
Director, Operation Quality, QA Audit and Compliance
Abbvie

Andrew was has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His career history covers a number of areas over approximately 35 years. Currently Andrew is a Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies. Prior to this Andrew was an Inspector with the MHRA for nearly 14 years. This role included:

  • Routine (and less routine!) inspections across the world, including joint inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in a number of technical areas including, sterile products, biological products, blood components and plasma.
  • Chairperson of the Inspectorates Compliance Management Team (working with marginally compliant companies to support them back to full compliance)
  • Part of the MHRAs inspection Action Group (taking actions regarding non-compliant sites)
  • Inspector training and mentoring
  • Taking part in the writing of regulatory guidance documents including:
    • MHRAs Data Integrity guidance
    • EMA guidance on water systems
    • Chair for the working group for the revision of Annex 1
    • MHRA blog regarding the fragility of VHP
  • Supporting external industry bodies with technical monographs such as PDA TR1 and PHSS TM20.
Prior to joining the MHRA Andrew worked for more than 20 years in a number of different areas and technologies in the Pharmaceutical industry. These included QA, Validation and Production Management in both sterile and non-sterile manufacturing facilities.      

Day One

Tuesday, June 2 2020

9:15 am | Panel Discussion: How Can We Be More Proactive in Ensuring Safe HPAPI Handling?

Todd Davidson
Lead - Environmental Product Stewardship/Environmental Fate and Effects
Bristol-Myers Squibb

Todd, a board-certified toxicologist, currently leads the Environmental Product Stewardship Program at Bristol-Myers Squibb (BMS).  He has been with BMS for ~8 years and has spent ~15 years in the pharmaceutical industry doing occupational/environmental toxicology and environmental stewardship work.  Todd sits on numerous Pharmaceuticals in the Environment (PIE)-related technical groups with organizations such as the Pharmaceutical Supply Chain Initiative and the European Federation of Pharmaceutical Industries and Associations.  In addition to his current position at BMS, Todd lectures at New York University on PIE.  In his free time, Todd’s interests include sports (Yankees, Giants, Knicks, Rangers and Miami Hurricanes), SCUBA diving, underwater photography, golf and mixed martial arts.

Philip Glover
Research & Development Engineer
Pacira Pharmaceuticals

Philip is a Chemical Engineer by education and a lab rat spliced with a bookworm in practice. With his lifelong passion for research, if there's a problem needing a novel solution, he's interested in finding one that works. He is now 9 years into a career in R&D in industry, primarily in the development of materials for drug delivery. Currently in his fifth year with Pacira Pharmaceuticals, he endeavors to apply fundamentals of emulsion science gleaned from scholarly literature to guide the development of Pacira's newest DepoFoam products - suspensions of multivesicular liposomes providing extended, multiday release of drug with a single injection. Over the past year, Philip has been tasked with designing and implementing new equipment to enable operations with HPAPIs in a lab space with minimal environmental controls. By applying principles learned from the 2019 HPAPI Summit, he is actively developing a flexible containment approach suitable for the purpose. He will be discussing his team's philosophy and strategy to accomplish this task, addressing the complexities, difficulties, and constraints involved in meeting the specific needs for their application.

Day One

Tuesday, June 2 2020

4:30 pm | Implementing Flexible Containment for Process Development with Potent Compounds in a General Lab Space

Christopher Sears
Sr. Director CMC
Tarveda Therapeutics

Chris Sears has a background in chemical engineering and 18 years experience in the pharmaceutical industry working in both small startups and established pharmaceutical manufacturers. He has broad experience managing drug substance and drug product supply chains, process R&D, scale-up, equipment design & qualification, GMP manufacturing, aseptic processing, validation, CIP/SIP, and contamination control including both investigatory and commercial drugs. Currently, Chris is the Senior Director of CMC at Tarveda Therapeutics, Inc.

Day Two

Wednesday, June 3 2020

11:30 am | Panel Discussion: What Do Pharma Need from Outsourcing & How Can Both Sides Communicate Better to Expedite Speed to Market

Yossi Shapira
Associate Director, MS&T S.M.E
Teva

My education is BSc in biology. Working for Teva Pharmaceutical Industries in the last 39 years. During the first 18 years I experienced parenteral anticancer drugs production. Lyophilized and solution cytotoxic drugs were manufactured. following visually inspection and packing took place. Protective working SOPs for preventing over exposure were developed. Further  I designed and constructed contained equipment, isolated activity and HVAC applications which allowed safe manufacturing, I wrote safety operating procedures and guide lines for the manufacturing staff and environment protection. I introduced  relevant related knowledge and experience which was used for potent laboratories, and customized protective isolators design. As HPAPI manufacturing increased, I moved to API industry in which I was nominated to review containment projects for HPAPI band 4-6. I thoroughly studied the manufacturing processes, and adapted containment approach all types of HPAPI manufacturing processes: weighing, loading, unloading, milling, blending, micronization etc. In the last 5 years I am responsible for the design of all containment applications for potent drugs handling.  

Dr. Jack Brown
Former Senior Research Fellow
Boehringer Ingelheim

Dr. Jack Brown is a Senior Principle Scientist at Boehringer Ingelheim Pharmaceuticals with over 25 years of experience in the pharmaceutical industry. Prior to the current position, he held positions with Boehringer Ingelheim Chemicals (as Associate Director of Process Chemistry and prior to that was the Director of Technical Operations), Roche Colorado Corporation (Distinguished Scientist), and Syntex Chemicals, Inc (Senior Research Chemist). Through his career he has worked in the API manufacturing area, process development, and in process research. Published 20 peer- reviewed articles and six patents. Was awarded a Six Sigma Black Belt in 2009; the South East Regional ACS Innovator of the Year (2011); awarded the Boehringer Ingelheim Chemicals, Inc. Team Award (2006); Syntex Chemicals Inc. R & D Award (1990).

Youngmi Girard
Associate Director
AstraZeneca

Michael Rasmussen
Tech Ops Senior Scientist Process R&D
Abbvie

Michael graduated from the University of Wisconsin Parkside in 1992 with a B.S. in Chemistry and began work in the process development group of Abbott Labs in 1993.  Within Abbott and Abbvie he has held roles in process development, solid state engineering, scale up laboratory supervision, pilot plant supervision, and currently the Technical Operations group. (55)  Potent compound processing in a kilo-lab environment was the focus of Michael’s role in the Abbvie pilot plant where synthesis of extremely potent compounds was executed including potent drug linkers and antibody drug conjugates.  Currently, he works closely with development teams and operations teams to ensure the success of clinical development programs in the Abbvie pharmaceutical pipeline.

Day One

Tuesday, June 2 2020

5:10 pm | Panel Discussion: Single Use Technology vs Rigid Systems

Day Two

Wednesday, June 3 2020

3:45 pm | Assessing the Suitability of Two Flexible Containment Systems Backed by Industrial Hygiene Data

Mariann Neverovitch
Research Scientist
Bristol-Myers Squibb

Cleaning Validation Subject Matter Expert with over 15 years of experience in cleaning verification method development and support. Leading cleaning verification program in Support of Clinical Supply Operations for the last nine years. Presented a number of papers on Cleaning Validation Lifecycle management and co-authored number of papers along with the international team of industry experts on Cleaning validation in the 21st Century. Co-Author of ASTM Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation. Member of the task force team for PDA TR 29. Member of Eastern Analytical Symposium Governing Board Member of USP Expert Committee

Winston Nilumol
Scale-up Operations Manager
Genentech

As one of the leaders in the manufacturing group, Winston oversees the development and manufacture of APIs at Genentech in South San Francisco.  He recently led the efforts to commission the new HP API Facility in a multi-drug product facility.  Winston also sits on the Technical Working Group team to focus on green and sustainable manufacturing and is a member of the Global Roche Cleaning Technical Community.  He is passionate about sustainable manufacturing and innovation, and plans to leverage his experiences to create a more safe, robust, and sustainable environment within small molecule development.  

Day Two

Wednesday, June 3 2020

9:00 am | Strategic Considerations in the Development of a HPAPI Facility

Peter Marshall
Associate Director – Engineering
AstraZeneca

Associate Engineering Director, AstraZeneca Global Engineering and Real Estate, Macclesfield, Cheshire, UK. Originally trained as a Biochemical Engineer at University College London, Peter has worked for ICI/Zeneca/AstraZeneca for 34 years, with more than 25 years working with high hazard chemicals and APIs. Responsibilities include Company Global Subject Matter Expert for containment systems and Project Technical Manager/Engineering Lead for multiple international OSD developments, responsible for ensuring appropriate technology is procured and installed to meet client requirements. Support to multiple emerging market CMOs in areas of technical transfer and worker safety. Developed qualitative risk assessment tools for cross contamination and worker exposure risks in development and operational scale activities. 2005 Astrazeneca Global R&D prize for development of flexible containment technology in API/Chemical development areas. External Activities Member of ISPE, IChemE, BOHS, UK Nuclear Isolator User Forum Co-chair ISPE Containment CoP Committee 2006-9, current member of committee. Member of Author teams for ‘SMEPAC’ containment system testing good practise guide (1st and 2nd Edns), Cross Contamination Baseline guide (RiskMAPP) (1st/2nd Edns) OSD Baseline Guide 3rd Edition author team. Personal Peter is married with three children and a dog. He is interested in all periods of military history and still plays cricket (badly).

Day One

Tuesday, June 2 2020

5:10 pm | Panel Discussion: Single Use Technology vs Rigid Systems

Day Two

Wednesday, June 3 2020

10:00 am | Remote Presentation: The Application of Single Use Containment Approach to an ADC Development Facility

Richard Arnett
Manager, Industrial Hygiene
Pharmascience

Martin Kohan
Senior Occupational Toxicologist
AstraZeneca UK

BSc/MSc in Biochemistry from La Plata National University, Argentina; MSc in Pharmacology and PhD in Medical Sciences both from the Hebrew University of Jerusalem, Israel. Over 9 years of industry experience in the field of Toxicology conducting and managing over 900 hazard assessments, including calculation of exposure limits and/or determination of exposure control bands of drug substances and of their intermediates for Teva (2010 to 2018) and AstraZeneca (2018 to present). Diplomate of the American Board of Toxicology (DABT), European Registered Toxicologist (ERT), and Member of the UK Register of Toxicologists and of the British Toxicology Society.  

David Conlon
Senior Director, CMC Management and Operations
Daiichi Sankyo, Inc.

  • Key member of the technical teams that transferred the asthma drug Singulair® and the antifungal Cancidas® from the Merck Research Laboratories to the manufacturing division.
  • Established the strategy and directed the activities of a team of over 20 scientists who took a holistic approach to design a completely de novo synthesis of the antiretroviral clinical candidate BMS-663068-03 that resulted in a significant improvement in the efficiency of the synthesis with an increase in the overall yield from 2.3% to 12.3%.
  • Directed the activities of multiple teams that were responsible for global, cross-functional projects that delivered drug substance and the required documentation for a dual NK-1/serotonin receptor antagonist, 2 nonsteroidal glucocorticoid receptor modulators and a selective ErbB VEGF receptor inhibitor. Conducted the external and internal technology transfer and contributed to the preparation of regulatory documents and responses to health authorities.
  • Author or co-author on 60 manuscripts, 4 book chapters and 10 US patents. Presented nearly 20 lectures at universities and national/international conferences.

Day Two

Wednesday, June 3 2020

11:30 am | Panel Discussion: What Do Pharma Need from Outsourcing & How Can Both Sides Communicate Better to Expedite Speed to Market

Omid Soltani
Principal Scientist
Seattle Genetics

Omid Soltani joined Seattle Genetics in September 2013 as a Senior Scientist in Process Chemistry. He has led several teams tasked with developing efficient, safe, and scalable processes for highly potent and structurally complex cytotoxic drug-linker components of anticancer antibody drug conjugates. Prior to joining Seattle Genetics Omid was a Senior Scientist in the Chemical Development group at Bristol-Myers Squibb where he developed processes for several small molecule API’s utilized in a variety of disease areas including oncology and inflammation. Dr. Soltani received a B.S. in Chemistry from St. Mary’s University in San Antonio, TX. He then carried out his Ph.D. studies on complex molecule total synthesis and photochemical based reaction development at U.T. Southwestern Medical Center at Dallas. Following his doctoral studies, he carried out post-doctoral research with Erick M. Carreira at the ETH in Zurich. While at the ETH Omid’s research focused on developing water-soluble transition metal catalysts for transfer hydrogenation of functionalized ketones and olefins.

John Roosa
Associate Director, New Technology Development & Industrial Hygiene Lead
Merck

John Roosa is a Senior Engineer and Six Sigma Black Belt with over twenty years’ industry experience. He has extensive responsibility for leading multi-discipline teams, most recently to install new technologies and improve industrial hygiene in an API Pilot Plant.  

Day Two

Wednesday, June 3 2020

3:45 pm | Containment Technology From a Perspective of Operator Safety & Product Quality

David Eherts
Vice President of Global EHS
Allergan

Dr. Eherts joined Allergan (then Actavis) Pharmaceuticals in March of 2014 as Vice President of Global EHS.  Allergan employs a centralized organization model around this function so all EHS and medical professionals worldwide at Allergan report in through David’s organization.  The company (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical company and a leader in a new industry model – Growth Pharma.  AbbVie announced their planned acquisition of Allergan in 2019 and the deal is generally expected to close in March 2020. Prior to Allergan, David has worked over 35 years in the fields of Safety and EHS starting as a toxicologist in Pre-Clinical Drug Safety Assessment at Merck.  He moved to EHS and has held positions of increasing responsibility at Merck, sanofi-aventis, Purdue Pharmaceuticals and most recently, Aviation and Product Safety at Sikorsky Aircraft as their Vice President and Chief Safety Officer.  His experience and expertise span aviation, environmental toxicology, occupational health, potent compound control and management systems in the aerospace, healthcare and pharmaceutical industries.  Dave holds Bachelor’s degrees in Chemistry and Biology and a Masters and PhD in Environmental Toxicology from Drexel University.   In his spare time, he's an adjunct professor at New York Medical College and at Tulane University where he teaches courses in EHS Management, Environmental Toxicology, Finance, Industrial Hygiene and Occupational Health.

Day One

Tuesday, June 2 2020

9:15 am | Panel Discussion: How Can We Be More Proactive in Ensuring Safe HPAPI Handling?

Mirjam Sax
Principal Site Manager
Genentech

With over 14 years of experience in the pharmaceutical industry, Mirjam has held various positions within the industry.  Currently working as Principal Site Manager at Genentech since 2017, she is responsible in managing the relationships and projects with partners in the DP/DS space for clinical trial materials. She is also the Single Point of Contact for ES&H questions and assessments (IH and general requirements by the Roche group) of partners the team at Genentech works with. Mirjam started her career at a CMO based in Switzerland, where she moved to for her PhD at the Federal Institute of Technology in Zuerich. After working at Roche, Basel for just over a year, she relocated to San Francisco to Genentech.

Day Two

Wednesday, June 3 2020

11:30 am | Panel Discussion: What Do Pharma Need from Outsourcing & How Can Both Sides Communicate Better to Expedite Speed to Market

Bob Sussman
Managing Director
SafeBridge Consultants, Inc

Dr Robert Sussman is currently the Managing Director of SafeBridge Consultants, Inc.  He has over 30 years of experience in the pharmaceutical industry where he has worked in various capacities in corporate occupational toxicology groups for Warner-Lambert and Pfizer.  Bob has an undergraduate degree in Bioenvironmental Engineering from Brown University and a Ph.D. in Environmental Health Science from New York University.  He is a Diplomate of the American Board of Toxicology, a past chair of the AIHA’s WEEL Committee, and a founding member of the Occupational Toxicology Roundtable.  He also has an adjunct appointment at the New York University Medical Center.

Day One

Tuesday, June 2 2020

5:55 pm | Chair’s Closing Remarks & End of Day 1

9:15 am | Panel Discussion: How Can We Be More Proactive in Ensuring Safe HPAPI Handling?

8:30 am | Chair’s Opening Address

Day Two

Wednesday, June 3 2020

4:45 pm | Chairs Closing Remarks

8:45 am | Chair’s Opening Address

Scott Patterson
VP, Technical Support
ILC Dover

Day One

Tuesday, June 2 2020

5:10 pm | Panel Discussion: Single Use Technology vs Rigid Systems

9:45 am | Safe Handling of HPAPI in Development & Scale-Up Manufacturing

Sean Diver
Director, Commercial Development
Lonza

Sean Diver is currently Director, Commercial Development for the Active Pharmaceutical Ingredient (API) Business Unit at Lonza. Throughout his career, Mr. Diver has worked across a broad portfolio of technologies in cGMP Chemical & Biological custom manufacturing from early stage to late phase/commercial and gained significant experience and has presented on Highly Potent Active Pharmaceutical Ingredients (HPAPI, incl. ADC). Mr. Diver is responsible for a number of on-going HPAPI programs at Lonza at present. Mr. Diver will present how a fully integrated service offering can be beneficial to drug developers in achieving their goals for delivering a cost-efficient final product.

Day Two

Wednesday, June 3 2020

9:30 am | APIs & Toxins/Linkers for ADCs: A Vision on Highly Potent Development, Scale-up & Manufacturing

Robert Herrmann
Managing Director
EHS Solutions LLC

Robert has over 17 years of industry experience in custom engineering controls and has travelled to many pharmaceutical manufacturing sites throughout the world. Robert holds a bachelor's degree in Mechanical Engineering.

Day One

Tuesday, June 2 2020

4:00 pm | Introducing A Fully Automated, High Containment Dispensing System for APIs

Mark Maier
Managing Partner
BioRisk Sciences

In a career spanning more than 30-years, Dr. Mark Maier is currently the managing partner of BioRisk Sciences, LLC, a professional scientific toxicological risk assessment, regulatory acceptance and medicolegal practice that provides pharmacology, bioscience, toxicology, chemistry, biocompatibility & health risk assessment services. BioRisk Sciences specializes in toxicological and exposure assessment of materials and molecules that lack biological effects data for applications in pharmaceutical manufacturing, medical devices, pharmaceutical packaging, and food contact materials. Dr. Maier earned his BSc in Chemistry, MSc in Environmental Health, and his PhD in Toxicology from Colorado State University, and is certified in general toxicology by the American Board of Toxicology.  

Denis Angioletti
CCO
Cerbios

Day Two

Wednesday, June 3 2020

12:15 pm | Gain More Value From An Effective CDMO Partnership; From A CDMO Perspective

Jason Korbel
Technical Services Manager
Cambrex Charles City

Technical Services Manager at Cambrex Charles City. Jason has worked at Cambrex for 15 years in the areas of Operations, Project Management and most recently Engineering/Maintenance as Technical Services Manager. Jason has been involved with the design and construction of Pharma 2 and Pharma 3 expansion projects at Cambrex Charles City since 2012. The most recent expansion of the site is a mid-scale HPAPI workcenter expected to startup 2nd quarter 2019. Jason has a Bachelor of Science degree in Chemical Engineering from Iowa State University.

Claudio Salvagnini
Director - Sales & Business Development
Minakem

Since 2015 responsible of the High Potent business of Minakem from the High containment dedicated facility of Louvain-la-Neuve, Belgium. Previously covered other international sales and business development roles in global CDMO and fine chemicals company. Holding a PhD in Organic Synthesis from university of Louvain-la-Neuve, Belgium and degree in Chemistry from University of Padova, Italy.

Senior Representative

Ajinomoto Bio-Pharma Services

Day One

Tuesday, June 2 2020

5:00 pm | Lessons Learned from Commissioning an Aseptic (ISO5) High Containment Fill Line (OEB 5 <5ng/m3

Martyn Ryder
Founder
Solo Containment

Martyn Ryder founded the containment organisation Extract Technology in 1981 and went on to develop high performance surrogate API containment testing methodology to give an insight into the effect of operator SOP’s on typical containment devices. This work lead to the running major containment performance studies in 1989,1991 and 1998. This work was the forerunner to the development of SMEPAC guide by the ISPE. Ryder was a co author to the 2001 IchemE containment design guide and developed the Extract Technology “Containment Strategy Pyramid”. Ryder founded Solo Containment in 2011 with the intent to bring the containment performance of hard shell isolation systems into the single use flexible film isolator arena. Solo is now recognised as leading vendor in the field of Bio-Pharma and HP API containment “single use” containment systems.

Marco Jonas
Associate Research Fellow, Process Development
AMRI