4th Annual HPAPI Summit - DSN210

Sponsors:

“Nice job with the networking. This was extremely valuable for future business and info sharing opportunities Ricerca Biosciences

Tel: +1 212 537 5898 | Email: [email protected]

www.hpapi-summit.com RESEARCHED & DEVELOPED BY:

Enable Safe, Robust & Cost Effective Production Of Highly Potent APIs

July 13-15 2015 Boston, MA

19 Expert Speakers

Tel: +1 212 537 5898 Email: [email protected] www.hpapi-summit.com

4th Annual HPAPI Summit Boston, USA July 13-15 2015

WELCOME TO HPAPI SUMMIT: BENEFITS OF ATTENDING

EXPERT INDIVIDUALS - Attracting the value chain across pharma, biotech, CMOs and containment providers the HPAPI Summit pulls together different perspectives for a unified approach to HPAPI development.

INTERACTIVE – Bringing together decision making units, this highly interactive meeting will challenge opinions and engage cross-functional conversations. Critically evaluate your approaches and gather alternatives for your team to effectively develop highly potent APIs.

IMPORTANT TOPICS – From research with Johnson & Johnson, Merck & AbbVie the HPAPI Summit reflects the most pressing challenges of today and tomorrow. This scientifically driven, technically detailed meeting will leave you with valuable new tools and approaches. Integrate occupational toxicology assessment into the early drug development process, effectively scale up production within internal timeframes and implement the latest flexible containment technologies.

WHAT MAKES THE HPAPI SUMMIT SPECIAL?

CONTENTS

Meet the Speakers: 3

Review The Agenda Day 1: 4

Review The Agenda Day 2: 6

Review The Workshops: 8

See Who Attends & How Networking Works: 10

The Venue & Pricing Options: 11

The 4th Annual HPAPI Summit will help you to safely, robustly and cost effectively produce highly potent APIs. Different to any other meeting, it focuses on bench to point of outsource for drug developers. This summit will cover improving process development, reducing occupational toxicology risk, strengthening primary containment and effectively setting CMO outsourcing strategies.

Join key thought leaders from SafeBridge Consultants, Genentech, Bristol Myers Squibb, Pfizer and others to:

• Transform safety in the work environment to guarantee maximum protection of laboratory scientists with Seattle Genetics

• Minimize cost and save time with effective tech transfer by setting comprehensive outsourcing strategies with experiences from Genentech, Takeda, Pfizer & Sanofi

• Efficiently produce HPAPIs by learning of Boehringer Ingelheim’s practical approaches to developing robust and scalable processes to important deadlines

• Reduce cross-contamination in multi-product facilities by evaluating new technologies for increased safety with Biogen Idec

• Develop robust process chemistry to efficiently transition antibody drug conjugate linker-payloads from discovery to FIH studies with lessons learned from Pfizer

• Navigate the new European Medicines Agency (EMA) guidelines with Genentech and decipher the impact of ADEs on your containment and product quality

• Improve potent handling capabilities by identifying cutting edge containment solutions with insight from AbbVie and Genentech

Leave the HPAPI Summit with solutions and tools to power efficiency, guarantee safety and streamline budget for the development and manufacture of potent compounds.



SPEAKERS

Bob Sussman Managing Principal, Eastern Operations SafeBridge Consultants

Gregory Erexson Principal Toxicologist AbbVie

Marc Abromovitz Global Director Industrial Hygiene & EHS Project Engineering Novartis

Wendel Doubleday Director, Process Development Seattle Genetics

Jack Brown Senior Principal Site Manager Boehringer Ingelheim

Patricia Weideman Director, Product Quality & Occupational Toxicology, Genentech

Jeffrey SperryPrincipal Scientist, Process ChemistryPfizer

Polina RapoportSenior Site Manager, CMOGenentech

Barry BallingerSenior Manager, EHSBiogen Idec

Lisa ThomascoSenior Manager, ProcurementPfizer

Brian WardIndependent Consultant

Neil FaiberManager, OutsourcingTakeda

Alan BensonDirector, Custom Synthesis & API Contract ManufacturingSanofi

Jason HammDirector, Chemical Development OperationsBristol Myers Squibb

Christine VannaisSenior Manager, HSEFujifilm Diosynth

Whoever designed the structure of this summit deserves credit. Lots of thought has been put into organization and selection of topics. Kudos to the organizing team. Great for people involved in high potent API/drug product manufacturing.

Coldstream Laboratories

Excellent conference with good presentations and wonderful networking opportunities.

ImmunoGen

Hairong Zhou Senior Sourcing Manager, Project Management Genentech

Dean CalhounPresident & CEOAffygility Solutions

Joel BercuAssociate Director, Safety Drug FormulationGilead Sciences

Jennifer JanowitzPrincipal Environmental Health & Safety EngineerMallinckrodt Pharmaceuticals



CONFERENCE DAY ONE

8.00 Registration, Coffee & Networking

8.50 Chair’s Opening Remarks Bob Sussman, Managing Principal, Eastern Operations, SafeBridge Consultants

9.00 KEYNOTE: Evaluation Of New European Medicines Agency (EMA) Regulatory Guidance• Navigate the new EMA guidelines

• Decipher impact of ADEs on containment & product quality

Patricia Weideman, Director, Product Quality & Occupational Toxicology, Genentech

Developing Robust & Scalable Processes

9.30 Lessons Learned From The Early Development Of Linker-Payloads For Antibody Drug Conjugates • Discussion of how Pfizer classifies HPAPIs

• Communication of several lessons learned from transitioning a linker-payload from discovery to FIH studies

Jeffrey Sperry, Principal Scientist, Process Chemistry, Pfizer

10.00 Speed Networking A revolutionary & highly valued way to meet fellow attendees in a 60 minute session. Bring lots of business cards!

11.00 Morning Refreshments & Networking

11.30 Challenges With Design & Scale Up Of New Chemical Entity (NCE) Processes• Evaluate creative, practical approaches to developing robust & scalable processes

in desired timeframes

• Overcome unique challenges of highly potent compounds

• Meet regulatory & business requirements

Jack Brown, Senior Principal Site Manager, Boehringer Ingelheim

12.00 Quick Fire Innovation Talk Christine Vannais, Senior Manager, HSE, Fujifilm Diosynth

12.15 Quick Fire Innovation Talk To Be Confirmed

12.30 Developing Highly Potent Cytotoxic Agents In A Biotech Environment – Technical & Operational Challenges• How to develop safe laboratory work practices & to ensure minimal exposure of

laboratory scientists

• Challenges of developing & transferring chemical processes which require high containment for full scale implementation

Wendel Doubleday, Director, Process Development, Seattle Genetics

TUESDAY, JULY 14 2015 Keynote Session Interactive Session Networking Session



CONFERENCE DAY ONE

1.00 Networking Lunch

2.00 From Bench to Outsource: HPAPI Process, Scalability & Robustness • Effectively scaling up potent APIs from clinical to manufacturing scale

• Implement successful tech-transfer approaches up to & for commercial manufacture

• Optimization of processes in pilot plant to manufacture compounds for the drug development

Jason Hamm, Director, Chemical Development Operations, Bristol Myers Squibb

Successfully Navigate The Occupational Toxicology Landscape

2.30 Proactive Integration Of Occupational Toxicology Assessments Into The Drug Development Process• Urgent implementation of occupational exposure limits (OELs & cleaning limits)

for any manufactured API, potent or not

• HPAPI containment measures – dedicated facility versus dedicated equipment versus biological safety cabinet versus glove box versus cleaning, etc

Gregory Erexson, Principal Toxicologist, AbbVie

3.00 How OELs & ADEs Develop Over The Life Cycle Of A Drug• Developing occupational health categorization over the course of development for

a molecule

• Evaluate the latest advancements in technologies

Joel Bercu, Associate Director, Safety Drug Formulation, Gilead Sciences

3.30 Afternoon Networking & Refreshments

4.00 Think Tank Roundtable SessionsMore practical and highly interactive breakout roundtables where attendees can crowd-source solutions and share opinions around pre-assigned topic areas. A valuable chance for attendees to unite around hot topics and debate best practice. No more sitting quietly, this is a dedicated opportunity for you to voice your experiences and identify unique solutions

4.30 Moderator Feedback & Audience DebateModerators will be assigned to each roundtable to facilitate discussion and collate the findings. Following the roundtables, they will present back to the entire delegation as part of a panel discussion for information dissemination.

All roundtable feedback to be typed up and released to delegates immediately following the conference so you won’t miss anything

Wendel Doubleday, Director, Process Development, Seattle Genetics Jason Hamm, Director, Chemical Development Operations, Bristol Myers Squibb Lisa Thomasco, Senior Manager, Procurement, Pfizer

5.00 Chair’s Closing Remarks Bob Sussman, Managing Principal, Eastern Operations, SafeBridge Consultants

TUESDAY, JULY 14 2015 Keynote Session Interactive Session Networking Session

Very good mix of speakers from various origins. Very valuable. UCB Pharma



CONFERENCE DAY TWO

8.50 Chair’s Opening Remarks Bob Sussman, Managing Principal, Eastern Operations, SafeBridge Consultants

9.00 Validating Engineering Controls • The value proposition for validating exposure controls

• Explore Novartis approach to overcoming challenges of validating engineering controls

Marc Abromovitz, Global Director Industrial Hygiene & EHS Project Engineering, Novartis

9.30 Panel: Global Overview & Analysis of HPAPI Market Trends • Lessons learned from progress in the field so far

• Perspectives on the future of highly potent API development & manufacture

• Evaluate how, as an industry, to overcome the field’s great challenges

Alan Benson, Director, Custom Synthesis & API Contract Manufacturing, Sanofi

Jennifer Janowitz, Principal Environmental Health & Safety Engineer, Mallinckrodt Pharmaceuticals

Neil Faiber, Manager, Outsourcing, Takeda

10.00 Morning Refreshments & Networking

Improve Cross-Functional Collaboration

11.00 Implement A Holistic Approach To Justification – “Building The Business Case”• Effectively breakdown organizational silos

• Implement a cross-functional approach to potent API development

Hairong Zhou, Senior Sourcing Manager, Project Management, Genentech

Creative & Innovative Containment Solutions

11.30 Evaluate New Technologies That Can Provide Increased Protection Of The API From Cross-Contamination In Multiproduct Facilities • Overcome containment challenges; case study of Tecfidera drug product

• Biogen’s experiences of overcoming cross contamination issues in multiproduct sites

Barry Ballinger, Senior Manager, EHS, Biogen Idec

12.00 Lunch & Networking

1.00 Case Study: Containment Solutions For Current HPAPI Development Challenges• Identify current HPAPI challenges

• Evaluate the latest containment solutions

Jennifer Janowitz, Principal Environmental Health & Safety Engineer, Mallinckrodt Pharmaceuticals

WEDNESDAY, JULY 15 2015 Keynote Session Interactive Session Networking Session



CONFERENCE DAY TWO



2.00 Afternoon Refreshments & Networking

Setting Excellent Outsourcing Strategies for HPAPIs

2.30 Best Practices For Selection & Oversight Of CMOs For Manufacturing • Critical elements to consider in the evaluation & selection of CMOs

• Keys to successful, productive CMO-Sponsor partnerships

Polina Rapoport, Senior Site Manager, CMO, Genentech

3.00 Case Study: Handling HPAPIs Throughout The Pipeline• Managing highly potent compound development safely & robustly

• Overcome outsourcing challenges with insight on Takeda’s approach

Neil Faiber, Manager, Outsourcing, Takeda

3.30 Chair’s Closing Remarks Bob Sussman, Managing Principal, Eastern Operations, SafeBridge Consultants

WEDNESDAY, JULY 15 2015 Keynote Session Interactive Session Networking Session

Don’t forget to book your place on our interactive pre-conference workshops!

Bring your own experiences and challenges into the workshops and discuss your work.

8:30am-11:30am

Workshop A: Effective Occupational Health Categorization & Banding Bob Sussman, Managing Principal, Eastern Operations, SafeBridge Consultants

12:00pm-3:00pm

Workshop B: A Case Study Of Integrating Containment Into The Design & Construction Of A Multi-Zone Full Scale Bulk Pharmaceutical Manufacturing Facility Brian Ward, Independent Consultant

3:30pm-6:30pm

Workshop C: Risk Management & Industrial Hygiene: Preventing Cross Contamination & Employee Exposures In The Context Of HPAPIsDean Calhoun, CEO & President, Affygility Solutions

WORKSHOP A

WORKSHOP B

This workshop will seek to improve industry consistency with defining and maintaining categorization. Furthermore, this session will provide a general overview of handling recommendations and basic descriptors of safe work environments based on categorization.

Qualitative health-based approaches have been developed to assess and communicate the potential health hazards of these novel compounds to workers. This approach, called “categorization” or “banding,” typically places compounds into one of several bands or categories depending on the anticipated potency and toxicity of the compound. A corresponding set of handling guidelines is “linked” to the category or band.

Discussion will take real life case studies and address:• Cytotoxic: What’s your definition?• Aligning hazard assessment classifications • Understanding the toxicological criteria of a potent compound • Assigning banding classifications and creating an industry standard • Ensuring equipment meets requirements and development demands

This workshop is an interactive and hands-on session which allows you to really get to grips with containment challenges.

Based on real life case studies, the workshop will detail the time and efforts leading to a fully operational 4-storey 4-rig containment facility.

Discussion will focus on a real life case study:• Detail the talents involved and why• Timeline and budget• Adjacent project inputs• Data collection and outcomes• Parallel operations with critical findings• Company engineering grapevine impact• Expertise lost during design and the impact• Exporting the experiences gained • Lessons learned

Currently Managing Principal of SafeBridge Consultants’ Eastern Operations, Bob is a board certified toxicologist with 25 years experience in the pharmaceutical industry. He has a degree in Engineering from Brown University and a Ph.D. in Environmental Health Science from NYU.

Workshop leaderBob Sussman Managing Principal, Eastern Operations SafeBridge Consultants

Effective Occupational Health Categorization & BandingMonday, July 13, 8:30am-11:30am

A Case Study Of Integrating Containment Into The Design & Construction Of A Multi- Zone Full Scale Bulk Pharmaceutical Manufacturing FacilityMonday, July 13, 12:00pm-3:00pm

Workshop leaderBrian Ward Independent Consultant



WORKSHOP C

This workshop will cover how the right hazard control strategy can maximize regulatory and manufacturing effectiveness and minimize risk levels in potent facilities. Manufacturing high hazard products can be challenging and when manufacturing several in the same facility the risk of cross contamination and employee exposures is a real concern. Discussion will take real life case studies and focus on:• How would you answer the question, “Do I need a dedicated facility or equipment?”• Is your facility controlling this risk to acceptable levels?• Do you know what an acceptable level is?• Do you know which product is your highest risk?• Common misconceptions regarding ADEs and OELs

Dean Calhoun, CIH is the President and CEO of Affygility Solutions, a consulting company serving the life sciences industry. He is a Certified Industrial Hygienist with over 29 years of experience. He is also an internationally known speaker on the topic of potent compound safety.

Workshop leaderDean Calhoun CEO & President Affygility Solutions

Risk Management & Industrial Hygiene: Preventing Cross Contamination & Employee Exposures In The Context Of HPAPIsMonday, July 13, 3:30pm-6:30pm

Fujifilm Diosynth Biotechnologies is a dedicated biopharmaceutical CDMO business with development and manufacturing sites in Billingham, UK and Research Triangle Park, North Carolina, USA, and College Station, TX, USA employing over 1000 staff. Globally we have over 30 years of clinical and commercial experience in biopharmaceutical development and cGMP manufacturing.

Our goal is to work as your partner at every stage in the development of your therapeutic candidates.

HPAPI SUMMIT PARTNERS

MEDIA PARTNERS



75%

35%

15%30%

10%

10%

5%

3%5%

5%7%

NETWORKING

COMPANIES WHO HAVE ATTENDED

YOU’LL MEET PEOPLE FROM...

3 interactive workshops attendees

*Predicted figures based on attendance from previous year’s events.

65+ 12+hours networking

AT 4TH ANNUAL HPAPI SUMMIT

SPEED NETWORKING

A structured networking session - run like speed dating - especially designed to facilitate quick introductions to the majority of attendees. Use the time wisely to meet new contacts, reconnect with old friends and identify those you want to spend more time with....

ROUND TABLE DISCUSSIONS

Take part in facilitated discussion sessions focused around specific, high priority issues. Discuss your experiences and observations within focus groups then share your and the other groups’ finding with the main conference.

STRUCTURED NETWORKING BREAKS

In between the formal presentations the networking carries on. Use the multiple refreshment and lunch breaks to continue your discussions in an informal relaxed atmosphere.

A well organized opportunity to meet all the leading market players and influencers.

Lonza

USA

UK

France

Germany

Canada

Remainder Europe

Large Pharma

Small/Medium Biotech

CMO

Disposable Technologies

Containment Solutions

ATTENDING COUNTRIES

ATTENDING COMPANIES

The conference was fantastic. The group in general and presenters in particular were very open to new technologies and ideas- at least to listen.

Alvos Therapeutics

QUICK FIRE FIGURES



Code: 5524

PRICES AND DISCOUNTS

REGISTRATION CHECKLIST1. Have you checked if anyone else from your business is attending? If 3 or more of you register together, you will all benefit from reduced rates.

2. Could you register your place early to take advantage of early booking rates?

3. Have you carefully evaluated which package will best help you achieve your goals?

✔

✔

✔

TEAM DISCOUNTS*

Full payment is due on registration. Cancellation and Substitution Policy: Cancellations must be received in writing. If the cancellation is received more than 14 days before the conference attendees will receive a full credit to a future conference. Cancellations received 14 days or less (including the four-teenth day) prior to the conference will be liable for the full fee. A substitution from the same organization can be made at any time.

Changes to Conference & Agenda: Hanson Wade reserves the right to postpone or cancel an event, to change the location or alter the advertised speakers. Hanson Wade is not responsible for any loss or damage or costs incurred as a result of substitution, alteration, postponement or cancellation of an event for any reason and including causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade or industrial disputes, terrorism or hostilities.

Data Protection: The personal information shown and/or provided by you will be held in a database. It may be used to keep you up to date with developments in your industry. Sometimes your details may be obtained or made available to third parties for marketing purposes. If you do not wish your details to be used for this purpose, please write to: Database Manager, Hanson Wade, Suite A, 6 Honduras Street, London EC1Y 0TH

TERMS & CONDITIONS

SECURE YOUR PLACE*When you’ve made your selections

VENUE

3+ Delegates: 10% Discount4+ Delegates: 15% Discount5+ Delegates: 20% Discount

*Please note: Team discounts are only valid when three or more delegates from one company book and pay at the same time. ‘Early Bird’ discounts require payment at the time of registration (or prior to the cut-off date) to secure the applicable discount. All advertised discounts cannot be combined with any other offer.

PACKAGE PRICES Register & Pay before Friday May 29th Standard Pricing

PLATINUMConferece & 3 workshops $4196 (save $500) $4396 (save $300)

GOLD PACKAGE Conference & 2 workshops $3597 (save $400) $3797 (save $200)

SILVER PACKAGEConference & 1 workshop $2998 (save $300) $3198 (save $100)

BRONZE PACKAGEConference only $2399 (save $200) $2599

WORKSHOPS - INDIVIDUAL $699 $699

You can register your place quickly and easily online. Visit:www.hpapi-summit.com/take-part/registerContact us: If you require any further information on the event, or would like us to assist you in making your booking, please contact Hanson Wade via the contact details below.

All talks were divergent and complimented each other well. Venue great, organizers brilliant and friendly.

GSK

Courtyard Marriott Boston, 275 Tremont Street, Boston, MA, 02116-5615. http://www.marriott.com/hotels/travel/bosdm-courtyard-boston-downtown/Overnight accommodation is not included in the registration fee, however accommodation options will be sent out with your confirmation email upon registering.



4th Annual HPAPI Summit - DSN210

Documents

Transcript of 4th Annual HPAPI Summit - DSN210