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SMi is delighted to announce its Highly Potent Active Pharmaceutical Ingredients conference coming to Boston on the 21st - 22nd October 2019.

The HPAPI global market is growing at an ever-increasing rate of CAGR at 8.6% that is projected to reach USD $31.56 Billion by 2025, with a significant segment market of HPAPI being oncology ADC which is at a CARG of a staggering 20%. The continual elevation of HPAPI potencies along with toxicity will further drive the needs for more cutting-edge containment solutions and best practices guidelines to ensure worker safety. 

The event will explore how the latest technologies can benefit HPAPI with artificial intelligence and machine learning to hasten risk assessment and validation. We will also be dedicating much deserved attention on emerging HPAPI therapies including bispecific antibodies, oncolytic viral complexes and hormones. Will the super-high level 5 banding for these biologics prove effective or inept? Are current containment planning and solutions truly ensuing the health of workers? Come and find the answers to these hot topics of HPAPI along with the other unique insights such as continuous HPAPI manufacturing technologies.

Attend this conference and join our networking platform for industry professionals to provide you with the expertise to overcome the challenges of the HPAPI industry.

LEARN how to rationally categorise your HPAPI project into a containment banding and implement containment solutions to mitigate the occupational health risks

GRASP the current landscape of HPAPI ADCs and other emerging biologics-based therapies including hormones, oncolytic viral complexes, bispecific antibodies and oligonucleotide

DISCOVER the emerging HPAPI manufacturing technologies to reduce powder exposure with the possibility of continuous manufacturing for HPAPI

UNDERSTAND the steps involved to evolve a containment environment to match that of the its scale of production and value of this practice

 

We Are One of A Kind...

Networking: We keep networking at the forefront when it comes to our attendees. Expand your community with every part of the industry and with the right people to benefit your company and develop your career.

The Agenda: Be sure to have your pen and pad ready at all times! A valuable time is spent to discover the latest trends and hottest topics in the industry to provide the best possible agenda for our attendees.

Location/Venue: Being held in Boston, a centre for scientific innovations, you will be surrounded by like-minded thinkers who are always aiming to go further than the frontier of science.

Onsite: Our knowledgeable events team will provide you with an exceptional service onsite. They will answer any questions you may have and inform you about any changes to the agenda.<br /> &nbsp;</p>

API specialists, Containment Engineers, Senior Scientists, Head of Scale-up Processings, Occupational Health Officers, Industrial Hygiene Leads, Head of Bioconjugations, Pharmaceutical Company Directors,Preclinical Safety Experts, Biopharmaceutical Developers, Industrial Hygienist, Industrial Hygienist Consultants, Occupational Toxicologists, Occupational Health Experts, Pharamaceutical Company Presidents and Vice Presidents, Head of Toxicology, Process Chemists, Process Research &amp; Develpoment, Head of Technology Transfer

AbbVie; Accord Healthcare; ACRAF S.P.A; ADC Biotechnology; ADC Biotechnology Ltd; Affygility Solutions; Antikor Biopharma; ARCINOVA; Astrazeneca&aacute;; Bayer Pharma; BSP Pharmaceuticals S.p.A.; CARBOGEN AMCIS AG; Cortex Consultancy; Cristalia Produtos Quimicos Farmaceuticos; Dec Group; Dishman Europe Limited; DSTL; Egis Pharmaceuticals PLC; Ferring Pharmaceuticals; Ferring Pharmaceuticals A/S; Gedeon Richter Plc.; Genentech; GlaxoSmithKline; Glythera; HPAPI Project Services Limited; Ipsen; Merck; Merck Group; Merck Serono GmbH; MINAKEM SAS; Nicomac Europe; Oncogen Pharma; Oril Industrie; Roche Pharma Research &amp; Early Development; SafeBridge Consultants, Inc; SafeBridge Europe Ltd; SK Biotek; Skyepharma S A; Swish Tech Limited; The University of Edinburgh

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

9:10 Demonstrating that exposure controls are effective

Dr. Charlyn Reihman

Dr. Charlyn Reihman, Principal Occupational Health Consultant, SafeBridge Consultants Ltd
View Bio

• Examples of control devices and their performance.
• Where does the data come from?
• ADCs – can we really measure nanogramme concentrations?
 

9:50 Preforming quantitative cost-benefit analysis of containment technologies

Dr. David Eherts

Dr. David Eherts, Vice President Global EHS, Allergan Inc
View Bio

· What is the most appropriate method of acquiring data to assist in the assessment of the risk posed in a workplace and correctly categorising the OEL and band
· Which containment banding or OEL are most relevant to you and who’s risk standards and guidelines to follow
· Understand how the large initial investment into HPAPI containment will return value on the long term
 

10:30 Morning Coffee

11:00 Manufacturing of oncological products by a CDMO

Fabio  Zenobi

Fabio Zenobi, EHS & Toxicology Director, BSP Pharmaceuticals S.p.A.
View Bio

• New Product Introduction: Change Control - Risk Assessment
• Case Study: ADC Manufacturing
• Waste & Wastewater treatment
• Project phase out
 

11:40 Control banding – the power of hypnosis

Marc Abromovitz

Marc Abromovitz, Director, Occupational Health and Hygiene, Novartis

• The value of applying risk-based data driven making process to your API risk management program
• Using data to identify appropriate technical solutions based on risk vs hazard
• Eliminate waste associated with over and under engineering and Personal Protective Equipment
 

12:20 Networking lunch

13:20 Requirements for fully-integrated service offerings in a HPAPI and cytotoxic environment

Maurits Janssen

Maurits Janssen, Senior Director, Head Of Commercial Development, Lonza Pharma & Biotech
View Bio

The development of drug products based on potent compounds can be quite challenging. Complications with the interface between operations in drug substance and drug product handling can also result in increased program complexity and cost. This presentation will elaborate on best practices and infrastructure requirements that facilitate accelerated timelines to clinic and market.

· A case study describing the development, rapid scaling, and commercial production of HPAPI drug substance
· Integrated containment requirements for particle engineering and drug products
· Impact of supporting integrated service offerings on expansion strategies
 

14:00 Emergency procedures for HPAPI Disasters and how to manage an HPAPI accident

Aysha Ovais

Aysha Ovais, EHS Professional, Taro Pharmaceuticals
View Bio

· Gain-awareness of dangers of unforeseen circumstances and accidents for HPAPIs and learn of the fail-safes and back-up procedures that can be implemented to mitigate risk
· Understand the long term cost savings from planning and implementing emergency procedures
· How to manage risks in an HPAPI workplace environment to minimise the chance of disasters
· Learn of the best practices of disposing HPAPI waste
 

14:40 Industrial hygiene and potent compound containment

Joseph Grills

Joseph Grills, Former Associate Director EHS, Former Purdue Pharma, LP

· Learn of the common pitfalls in industrial hygiene with highly potent APIs and the means to avoid them
· Understand when flexible containment are more suited than rigid containment
· Discover the advantages of externalisation, and the potential of hastening R&D
 

15:30 Chair’s closing remarks followed by Afternoon Tea and Networking

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Dr. Janet Gould

Dr. Janet Gould, Senior Managing Toxicologist, SafeBridge Consultants Inc
View Bio

9:10 How to effectively plan out your plant, what are the goals you should aim to achieve and thoroughly understand the scale-up process

Rich Arnett

Rich Arnett, Manager, Industrial Hygiene, Pharmascience Inc
View Bio

· Discover the guidelines and practices for the most cost-effective large-scale production of HPAPI products
· How to most plan a pilot plant, what are the goals that you should strive and achieve and the purpose of these goals
· Understand what equipment, training and containment are needed, along with the value of their implementation as production size increases
· Recognize the tech transfers involved for scale up and their importance
 

9:50 ADC manufacturing in a multipurpose environment

Dr. Anthony Haight

Dr. Anthony Haight, Senior Director, AbbVie
View Bio

· Understand the entire ADC manufacturing process and the containment involved
· Learn of the safety requirements for cleaning standards and how to apply them to ensure worker safety
· Discover how to use analytical techniques to validate and establish cleaning protocols
· What scenarios are best suited for disposable containment or fixed containment with cleaning
 

10:30 Morning Coffee

11:00 OH/Containment strategy and NPI at AbbVie

Sara Martens

Sara Martens, Associate Director, Occupational Hygiene and Containment , AbbVie
View Bio

· OH/containment improvement targets and LRP
· Risk assessment, containment improvements and OH metrics
· Team approach – community of practice and collaboration
· Strategies, standards and technical guidance
· NPI and technology transfer
 

11:40 Assessing and deriving the associated HPAPI related risks with emerging technologies and therapies

Dr. Janet Gould

Dr. Janet Gould, Senior Managing Toxicologist, SafeBridge Consultants Inc
View Bio

• Understand the intensity of hazard imposed by emerging biologics-based therapies that requires super-high-level band 5 containment
• Understand how to apply a level 5 banding with rational and cost-effective containment planning that is sufficiently backed by data
• Learn of the best procedure for mitigating biologics-based HPAPI projects
 

12:20 Networking Lunch

13:20 Effective and safe containment solutions for biologics based HPAPIs along with cleaning and cross contamination requirements

Richard Denk

Richard Denk, Head Containment, SKAN AG
View Bio

· Regulatory requirements for highly potent biologics-based Pharmaceuticals
· Requirements for aseptic manufacturing and Containment
· Cleaning and Cross Contamination Requirements
 

14:00 Alternative HPAPI manufacturing technologies to reduce powder exposure and improving safety along with enabling continuous manufacturing

Dr. Keith Jensen

Dr. Keith Jensen, Owner and Consultant, Keith Jensen Consulting
View Bio

· Discover alternative drug manufacture through nanocrystal formulations, thin films and hot-melt extrusion/injection molding that reduces HPAPI powder exposure and improve safety
· Detailing step-by-step process along with the equipment needed to achieve these alternative HPAPI manufacturing techniques
· Learn of the advantages of continuous manufacturing and how to achieve this via alternative manufacturing technologies
 

14:40 HPAPI Panel Discussion

Manufacturing: The Environment of the Analysis and Development of highly potent compounds
• Reviewing the practical hurdles faced when cleaning in a GMP environment
• Assessing the equipment level of performance after one- or two-years lifecycle and the important considerations to note?
• Maintaining high performance, how can you ensure the robustness, efficiency of the containment system?
• Assessing the challenges from development to manufacture process 

 

Marc Abromovitz

Marc Abromovitz, Head of Industrial Hygiene, Novartis Pharmaceuticals Corp

Richard Denk

Richard Denk, Head Containment, SKAN AG
View Bio

Maurits Janssen

Maurits Janssen, Senior Director, Head Of Commercial Development, Lonza Pharma & Biotech
View Bio

15:30 Chair’s closing remarks followed by Afternoon Tea and Networking

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FEATURED SPEAKERS

Dr. Janet Gould

Dr. Janet Gould

Senior Managing Toxicologist, SafeBridge Consultants Inc
Maurits Janssen

Maurits Janssen

Senior Director, Head Of Commercial Development, Lonza Pharma & Biotech
Richard Denk

Richard Denk

Head Containment, SKAN AG

Aysha Ovais

EHS Professional, Taro Pharmaceuticals
Aysha Ovais

Aysha Ovais completed Bachelor of Civil Engineering and Masters Degree in Environmental Engineering from NED University of Engineering and Technology and has further advanced education at University of Toronto.

Over the course of many years, she has cultivated a nuanced understanding of the drivers behind a safe environment and healthy workplace. She has over 10 years of knowledgeable experience in the management of Environmental Health and Safety. Working at the leading pharmaceutical & medical device companies, she developed and implemented a series or initiatives, under corporate targets to achieve environmental health safety and quality goals. Honed skills and understanding of Environment Health & Safety principles, taking an active role in execution strategies, complemented by ISO certification in EHS Management and Lean Sigma Green Belt.
 

Dr. Anthony Haight

Senior Director, AbbVie
Dr. Anthony Haight

Anthony Haight is Senior Research Fellow & Senior Director in Development Sciences at Abbvie. A chemist, Anthony has experience in small molecule development, radiochemistry, and antibody drug conjugates. Currently, Anthony leads a cross-functional effort for integrating ADC learnings into discovery programs. Anthony received his BS from The Ohio State University and his PhD from the University of Wisconsin-Madison. He has presented research, authored or coauthored more than 25 articles, and is inventor or co-inventor on more than 50 patents or patent applications.
 

Dr. Charlyn Reihman

Principal Occupational Health Consultant, SafeBridge Consultants Ltd
Dr. Charlyn Reihman

Charlyn Reihman, MPH, CIH is a Principal Occupational Health Consultant for SafeBridge Consultants, Inc. based in Exton, Pennsylvania. She has over 30 years of safety and health experience in pharmaceutical/vaccine manufacturing and research & development, including 28 years at Merck. Her experience includes pharmaceutical industrial hygiene and exposure control, biosafety, ADC handling and controls, program development, training, management system implementation, remediation, and conducting EHS compliance and pharmaceutical supply chain audits. She also has experience providing safety and industrial hygiene support to other industries include the lead industry, medical device manufacturing, construction, chemical manufacturing, and academic research and development. Charlyn has a wealth of experience providing regulatory and best practice recommendations for improving performance and minimizing risk.
 

Dr. David Eherts

Vice President Global EHS, Allergan Inc
Dr. David Eherts

Dr. Eherts joined Allergan (then Actavis) Pharmaceuticals in March of 2014 as Vice President of Global EHS. Allergan is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. They market products and have R&D and manufacturing operations in more than 60 countries worldwide. Allergan is a leader in a new segment called “Growth Pharma” and Forbes has ranked Allergan #1 in its list of the top 17 global large cap ($50+ billion market capitalization) pharmaceutical companies.


Dave holds Bachelor’s degrees in Chemistry and Biology and a Masters and PhD in Environmental Toxicology from Drexel University. He’s served on various boards and committees including an appointment by the US Secretary of Labor under the Obama administration to serve on the Federal Whistleblower Protection Advisory Committee. More conventionally, he’s served on advisory boards for ORCHSE's Executive Business Issues Forum, CAE Flight Training and the Board of Directors for Occupational Knowledge International (an NGO dedicated to preventing overexposures to toxic chemicals in developing countries) and SoundWaters (protecting the environment of Long Island Sound). In his spare time, he's an adjunct professor at New York Medical College and Tulane University where he teaches courses in Finance, EHS Management, Environmental Toxicology, Industrial Hygiene and Occupational Health.
 

Dr. Janet Gould

Senior Managing Toxicologist, SafeBridge Consultants Inc
Dr. Janet Gould

Dr. Janet Gould, PhD, DABT, CIH is a Principal Toxicologist at SafeBridge Consultants based in New York, NY. She has over 20 years of experience in occupational toxicology including 14 years at Bristol-Myers Squibb, which also included general EHS support for R&D. In addition, she has experience with chemical industry product safety and regulatory toxicology support. She has numerous presentations, training and publications including topics of occupational exposure limits, banding, sensitization, biologics, ADCs, and structure activity relationship. She is a member of the Workplace Environmental Exposure Level (WEEL) Committee, Occupational Toxicology Roundtable, Society of Toxicology, AIHA and the NIOSH Hazardous Drug Alert Committee.
 

Dr. Keith Jensen

Owner and Consultant, Keith Jensen Consulting
Dr. Keith Jensen

Dr. Keith Jensen has been consulting for companies in the US and China on continuous manufacturing and pharmaceutical formulation and process development. Before consulting, Keith was the Associate Director and Principle Investigator of the Novartis-MIT Center of Continuous Manufacturing at MIT from 2014 to 2017. He led a translation team of research scientists, engineers, and post-docs working on several continuous crystallization projects as well as new processes to continuously manufacture pharmaceutical products including hot-melt extrusion, thin-films, and electrospinning. Keith is also on the USP Expert Panel for Continuous Manufacturing and a Scientific Advisor for Veramorph Materials.

Keith’s background includes a Bachelor of Science in Chemistry, Ph.D. in Pharmaceutics and Pharmaceutical Chemistry and a postdoctoral fellowship at the University of Utah before entering the pharmaceutical industry. He joined LTS Lohmann where he led a formulation group developing oral thin film dosage forms.

 

Dr. Patricia Weideman

President & Principal, Sakari Consultants
Dr. Patricia Weideman

Fabio Zenobi

EHS & Toxicology Director, BSP Pharmaceuticals S.p.A.
Fabio  Zenobi

EHS Director, BSP Pharmaceuticals S.p.A.
Fabio is responsible of Environment, Health and Safety at BSP Pharmaceuticals S.p.A., Latina Italy, a Contract Development and Manufacturing Organization focused on anticancer product, small molecules and ADC compounds. He is a Pharmaceutical Chemist and has over 20 years of experience in pharmaceutical industries as Serono, Bristol-Myers Squibb and Intervet, in Manufacturing, Quality Assurance, Technical Operations and EHS.
 

Joseph Grills

Former Associate Director EHS, Former Purdue Pharma, LP
Joseph Grills

Marc Abromovitz

Director, Occupational Health and Hygiene, Novartis
Marc Abromovitz

Marc Abromovitz

Head of Industrial Hygiene, Novartis Pharmaceuticals Corp
Marc Abromovitz

Maurits Janssen

Senior Director, Head Of Commercial Development, Lonza Pharma & Biotech
Maurits Janssen

Maurits Janssen is Senior Director, Head of Commercial Development for the Active Pharmaceutical Ingredient (API) Business Unit at Lonza.
Mr. Janssen earned his doctorate in organic chemistry from Utrecht University in The Netherlands (1996) and subsequently fulfilled several functions with increasing responsibility in consulting, marketing and sales, and research and development.
Mr. Janssen has over 20 years of experience in the chemical and pharmaceutical industry and over 15 years in the custom manufacturing of active pharmaceutical ingredients.
Throughout his career, Mr. Janssen worked across a broad portfolio of technologies in cGMP chemical and biological custom manufacturing from early stage to late phase/commercial and gained significant experience with highly potent active pharmaceutical ingredients (HPAPI).
Mr. Janssen 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.
 

Rich Arnett

Manager, Industrial Hygiene, Pharmascience Inc
Rich Arnett

Currently IH Manager at Pharmascience Inc., Rich leads a team tasked with determining HBEL’s and collaborating with the various functional areas to ensure safe product manipulation. Prior to joining Pharmascience, Rich held different roles in IH and Production management for solid dose & injectable products at Uman Pharma.

Rich began his career at Merck Frosst Canada in 1998 supporting the formulation/process development, scale-up and tech-transfer of numerous dosage forms while executing the manufacture of worldwide clinical supplies for various Merck programs. While at Merck, Rich held several positions of increasing responsibility, including leading the Canadian GMP Pilot Plant Operations.
 

Richard Denk

Head Containment, SKAN AG
Richard Denk

Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Head Containment. Mr. Denk founded 10 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the ISPE Containment Manual Mr. Denk was responsible for in September 2015. He is Member of the ISPE SIG BioTech Group in Europe and Steering Committee Member of the ISPE SPP (Sterile Product Processing) CoP. Furthermore Mr. Denk founded the PDA Expert Group about Cleaning and Cross Contamination Requirements for Biopharmaceutical Products and published this topic as PDA Paper. Mr. Denk is co Autor of the ISPE OSD Baseline Guide Volume 2 and Volume 3. Mr. Denk has spent 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.
 

Sara Martens

Associate Director, Occupational Hygiene and Containment , AbbVie
Sara Martens

Sara Martens is Occupational Hygiene and Containment Associate Director for AbbVie. She has responsibility for managing the development, implementation and global oversight of AbbVie OH and containment programs, and for ensuring that OH aspects and activities are properly integrated during new product introduction and product transfer. Sara has 25 years of experience with AbbVie, the majority of which was spent managing the company’s internal EHS Laboratory. Sara holds a Master's Degree in Industrial Hygiene from the University of Michigan, Ann Arbor, USA.
 

Sponsors

Exhibitors

Supporting Media Partners

Supporters

VENUE

Sheraton Boston Hotel

39 Dalton Street, Boston, MA, USA

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
 

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
HOTEL BOOKING FORM

HPAPI USA Conference Brochure

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HPAPI USA October 2 Press Release

Download

2019 HPAPI USA ATTENDEE LIST

Download

Interview with Richard Arnett

Download

Presentation: Adaptations of Containment Designs

Download

Presentation: Manufacturing of Oncological Products by a CDMO

Download

Presentation: Occupational Exposure Limits

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Presentation by Andrew Kyle on SK biotech

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HPAPI UK 2019 Attendees

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HPAPI USA Speaker Line-Up

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HPAPI USA Full Program

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HPAPI USA Workshops

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Sponsors


BSP Pharmaceuticals

Sponsors
http://www.bsppharmaceuticals.com

BSP Pharmaceuticals S.p.A. is a CDMO (Contract Development and Manufacturing Organization), focused on the development and manufacturing of anticancer drugs with High Potency and Cytotoxic characteristic and It is specialized on formulation and manufacturing of Small Molecules and ADC products (Antibody Drug Conjugate). BSP has been at the forefront in the fight against cancer since 2006. Innovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant. With its state-of-the-art technology and highly skilled personnel, BSP sets out to be a valuable point of reference to serve the principal actors of the pharmaceutical field involved in research on new generation anticancer therapies. BSP clients can avoil of this integrated services: • DEVELOPMENT SERVICES • CLINICAL SUPPLY • COMMERCIAL SUPPLY BSP has been conceived starting from a basic but essential operating requirement: segregate the high potent components from the surrounding and create a system suitable to manage pharmaceutical processes. With this primary idea in mind, layouts, flows of materials and personnel, air flows have been designed to minimize the risk of contamination for the environment, for the employees and for the product that is intended for patients with low level of immune defenses. The Manufacturing plant is located in Italy, 60 kilometers southbound of Rome. A single campus extended to more than 40 acres hosts all the main buildings supporting the capacities to manage a wide range of batch sizes: 2| DEVELOPMENT LABORATORIES 3| CONJUGATION SUITES 6| STERILE SUITES with more than 170 m2 fully dedicated to production anticancer and cytotoxic drugs 1| ORAL DEPARTMENT with multiple lines suitable to manufacture Clinical and Commercial products


Lonza

Sponsors
http://pharma.lonza.com/small-molecules

At Lonza Pharma & Biotech we provide contract development and manufacturing services that enable pharma and biotech companies to bring medicines to patients in need.

From the building blocks of life to the final drug product, our solutions are created to simplify your outsourcing experience and provide a reliable outcome, at the time when you expect it.

Our extensive track record includes commercialization of pioneering therapies and manufacturing of a wide variety of biological and chemical drugs. We continuously invest to solve not just the current, but also the future challenges. Together, we can bring your next medicine to life.



SafeBridge Consultants, Inc.

Sponsors
http://www.safebridge.com

SafeBridge Consultants, Inc. is the premier resource for high level safety, health and environmental support to the pharmaceutical and biotechnology industries. We provide services in occupational and environmental toxicology, risk assessment, product safety, industrial hygiene and analytical chemistry to clients worldwide from offices in California, New York and Liverpool, UK.

Exhibitors


MINAKEM

Exhibitors
http://www.minakem.com

Minakem is a fully integrated CDMO for HPAPIs and ADC drug-linkers thanks to a dedicated site (FDA approved) having more than 40 years’ experience in HPAPIs, state-of-the-art containment systems, capability to handle broad range of chemistry and technologies including preparative-HPLC from grams to hundreds of kg per batch (GMP).

Media Partners


Pharmavision

Supporting Media Partners
http://www.pharmavision.co.uk

PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


Pharmaceutical Manufacturing and Packing Sourcer (PMPS)

Supporting Media Partners
http://www.samedanltd.com/magazine/15

Pharmaceutical Manufacturing and Packing Sourcer (PMPS) is a specialist magazine for the pharmaceutical manufacturing, packaging and supply chain sectors. Every quarterly edition features articles written by key opinion leaders, ranging from pharmaceutical sponsors and key services providers, to industry associations and regulatory authorities. PMPS combines technological, operational and corporate perspectives on this growing sector, along with industry interviews, event previews and book reviews. Now you can also read PMPS on the go with the new Samedan app. Click here to download it now for your iPhone or iPad: http://bit.ly/IJECug


Gate2Biotech

Supporting Media Partners
http://www.gate2biotech.com

Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


International Pharmaceutical Industry (IPI)

Supporting Media Partners
http://ipimediaworld.com/

IPI – International Pharmaceutical Industry IPI – was established to fill in the void for effective marketing and communication between all stakeholders in the Life sciences sector globally. Edited by our carefully selected editorial advisory panel, and extensive research network, IPI provides a proven supportive means of communication to the pharmaceutical, bio pharmaceutical, nutraceutical and medical devices industry the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies which will enable them to be more efficient, bring products to market faster, reduce cost and make healthcare accessible to all.

Media Partners


Drug Discovery Today

Supporters
http://www.drugdiscoverytoday.com/

Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


World Pharma News

Supporters
http://www.worldpharmanews.com/



pharmanews hq

Supporters
http://http://pharmanewshq.com

MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


CanBiotech

Supporters
http://www.canbiotech.com

CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venture capital directories and databases. Publications include the BioMedical Outsourcing Report and the Bio Outsourcing Asia© Publication.


Mednous

Supporters
http://www.MedNous.com

MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


pharmaphorum

Supporters
http://www.pharmaphorum.com

pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


Pharma Manufacturing

Supporters
https://www.pharmamanufacturing.com/

Pharmaceutical Manufacturing, is the only publication devoted to serving the informational needs of pharma and biopharma professionals in manufacturing and operations, QA and QC, regulatory affairs, engineering and project management, packaging and corporate management. Pharma Manufacturing magazine and PharmaManufacturing.com are dedicated to being key catalysts for improving the pharmaceutical industry’s: • Manufacturing risk scenarios • Manufacturing and operational efficiencies • Quality control/quality assurance programs • Drug development • Speed to market initiatives • Process development • Compliance/validation programs. www.pharmamanufacturing.com


ASD MEDIA

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http://www.asd-network.com

Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
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The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

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Pharma Journalist

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http://www.pharmajournalist.com

Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


Biocompare

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http://www.biocompare.com

Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


Technology Networks

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Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com

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Sheraton Boston Hotel

39 Dalton Street
Boston 02199
USA

Sheraton Boston Hotel

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
 

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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Contact SMi GROUP LTD

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