A recent biotech industry training-needs survey revealed a strong need for cGMP training in Massachusetts biotechnoogy companies.  GMP Training is a regulatory requirement by the FDA, and thus companies are required to provide this training to their employees.

There are several FDA rule changes that went into effect in December 2008. Stay up-to-date and learn about these changes in this next program!

The goal of this course is to provide an introduction into the current Good Manufacturing Practices (cGMP) and to help companies and their employees remain in compliance with FDA requirements. The session will benefit individuals new to this highly regulated industry and will also serve as a refresher course for the experienced biotech employees. 

Learning Objectives

• Understand the importance of cGMPs and how history shaped cGMPs and FDA’s role in regulating food and drugs.
• Review key terms common to the biopharmaceutical industry (ex. IND, ANDA, PAI, 483, Warning Letter, BLA, NDA, Aseptic Processing, Verification, Review, etc)
• Understand the key concepts of each subpart of 21 CFR Part 211, as well as EUGMPs, and 21 CFR Part 600, and how they apply to participants' specific jobs.
• Understand current thinking in cGMPs, including process control and continuous improvement, in the context of Quality Systems and recent guidances ICH Q8, Q9, and Q10, and FDA’s Quality Systems Approach to Pharmaceutical cGMPs (2006)
• Understand consequences of not following cGMPs
• Create good GMP work habits, and apply Good Manufacturing and Good Documentation Practices on the job every day.

Click here to register!

About the Course Instructor

Matthew Peplowski has over 15 years of experience in Biotechnology industry, including 10 years in Manufacturing, 4 years in Quality Management, and over 10 years in training.  In recent years, Matt has also provided related consulting services for several companies, developing and delivering cGMP and related quality training programs for a diverse range of companies and participants.

Matt is currently the Associate Director of Training for Genzyme in Framingham, MA.  His GMP and other training programs have been audited extensively, and have received highly positive feedback from international, domestic, and internal regulators and auditors.  He is a member of the Parenteral Drug Association and Biopharmaceutical Education and Training Association.

A former instructor in graduate Genetics, Anatomy, and Physiology at Northeastern University, Matt Peplowski has an MS in Biology, and a BA in Secondary Education.

For more information about this course, please contact courses@massbio.org

PLEASE NOTE: To receive the MassBio Member discount, you must select "Yes" in response to the "MassBio Member?" question on the registration form.  To  see whether your company is an MassBio member, click here.

Location:
Massachusetts Biotechnology Council, 300 Technology Square in Cambridge, Massachusetts.

https://secure.massbioed.org/courses/index.php?page_function=detail&course_id=66

Drug Development Primer is a one-day class delivering an overview of the development and regulatory process for bringing a new drug, either a small or large molecule, to market. Participants learn about drug discovery/product development as well as preclinical research, regulated clinical trials and post-approval commercial considerations.

Topics Covered Include:

• Drug Development Overview
• Origin of New Drugs
• Selecting Drug Candidates
• Target Product Profile
• The Regulatory Process
• Drug Development Pre-IND
• Clinical Development

Instructor: Simon J. Tulloch, MD

Dr. Tulloch has more than 20 years of pharmaceutical and biotech experience in clinical development, R&D management, and business roles, both in Europe and the USA. For the last three years he has been the Chief Medical Officer at InfaCare Inc, a privately funded biotech company in the Philadelphia area. Prior to InfaCare, Dr. Tulloch spent ten years at Shire Pharmaceuticals Inc. He moved to the USA to establish a U.S. research and development organization- Shire Pharmaceutical Development Inc. Dr. Tulloch built the organization to 70 people, from all areas of drug development, and successfully conducted the development and NDA approval of Adderall XR, now a billion dollar drug, for Shire. During that time his organization also developed and got NDA approvals for Fosrenol (Shire’s first global NCE) and Equetro, as well as providing CMC, preclinical, and marketing medical support to all of Shire’s U.S. products. Latterly, he assumed the role of head of the global CNS Business Unit as Shire underwent significant management change in its transition to a big pharmaceutical company.

Prior to his time at Shire, Dr. Tulloch spent eight years with Johnson and Johnson companies, including five years as clinical research director for R.W. Johnson PRI’s European R&D facility in Zurich, Switzerland, working on multiple projects in various therapeutic areas and stages of development.

Fees: $795 for MassBio Members; $845 for non-members.

Click here to register: https://secure.massbioed.org/courses/index.php?page_function=detail&course_id=70

Two full days: Wednesday October 3rd and Thursday November 1st, 2012 9:00 AM -5:00 PM

Why this Seminar is Essential

Effective scientific work requires high levels of leadership competence in communications and collaboration. Successful science requires both excellent technical skills and high performance in leadership, communications, and collaboration throughout the organization.

Click here to register!

Purpose/ Outcomes

Seminar participants improve performance in the most important communications and leadership strategies and skills for scientific organizations:

• Increased understanding and data on how they impact others, how others perceive them
• Improved effectiveness giving and receiving criticism and feedback
• Improved performance in managing, informal influencing, collaborating and coaching
• More effective balance and integration of technical, communications and management tasks
• Building high performance teams within and across disciplines, projects and departments
• Strategic thinking and planning for projects, departments and disciplines

Participants’ sponsoring organizations also benefit from the program. Outcomes for participants’ sponsoring organizations include:

• Increased performance, productivity, and efficiency in science tasks
• Stronger, more positive culture for scientific achievement, more positive organization culture
• Opportunity to import, adopt current best practices for performance management and organization
• Strengthened partnering and communications with customers, users and staff they work with
• Reduced costly employee turnover, increased ability to promote from within

The program features:

• Two full-day sessions separated by one month to allow for practice and collection of 360 survey results
• 360 surveys for each participant to provide objective information about how key others perceive their communications effectiveness. Participants use our on-line survey tool, collecting 8 – 12 responses. Results are anonymous and confidential. Doing the survey is not required, but is highly recommended.
• Strong focus on participants applying seminar skills and tools between sessions
• Science/ R&D applications of current best practice leadership strategies and tools

About the Course Instructor

Dr. William Ronco consults on strategic planning, partnering and leadership training for some of the world’s best-run organizations: Fortune 500 corporations, pharmaceutical companies, research and development organizations, laboratories and think tanks, colleges and universities, professional firms, technology companies, hospitals, government and community organizations.

Dr. Ronco has extensive experience working with:

• Leadership training for experienced managers and professionals. His customized programs for specific groups in organizations and Leaders Circle programs have consistently enables participants to develop key competencies, take on new challenges and improve their leadership effectiveness.
• Strategic planning for mid-sized organizations and large departments. Dr. Ronco’s strategic planning work has enables numerous organizations to resolve current performance problems and develop new paths for success. His work includes both empirical business and survey analysis and strategic planning workshops that fully implement plans throughout the organization.
• Partnering and teambuilding. An international expert in this area, Dr. Ronco has led over 200 successful partnering projects resulting in improved communications and performance among organizations and groups working together on projects, in outsourcing, in mergers and alliances of all kinds. Dr. Ronco’s book The Partnering Solution (Career Press, 2005) has earned strong, positive reviews and widespread use among professionals and managers who must partner effectively in order to succeed.

A former professor in the MBA program at Northeastern University, Dr. Ronco earned his BA at Rutgers University, his Ed.M. at Harvard University and his Ph.D. in Urban Planning at the Massachusetts Institute of Technology.

For more information about this course, please contact Julie Deschenes julie.deschenes@massbio.org

NOTE: BOTH FULL-DAY SESSIONS SHOULD BE ATTENDED. The tuition covers both days, and if your company is an MassBio Member, you must select "Yes" in response to the MassBio Member question on the registration form to be eligible for the discounted rate.

Fees:
$1350 for MassBio Members; $1500 for non-members.

https://secure.massbioed.org/courses/index.php?page_function=detail&course_id=68

For the first time ever, AdvaMed 2012:The MedTech Conference, will take place in Boston, one of the largest MedTech clusters in the world. Building on the success of our first five years in Washington, DC, international MedTech executives with regulatory, reimbursement, business development, legal, IP, marketing, quality, compliance, and other key responsibilities will meet in Boston to attend AdvaMed 2012.  Along with industry leaders, business development professionals, investors, policy-makers, members of the media, legal experts, consultants, distributors, and other important stakeholders will attend this international conference.

Whether you want to network, share insights, do business with, gain access to capital or learn, no other industry gathering hosted in North America brings together more of the people you want to see.

For more information, visit AdvaMed 2012's website.

To register, click here.

Cutting edge advancements in in vitro models to mitigate toxicity, streamline drug development and direct clinical strategy

With low efficacy and high toxicity accounting for 70% of Phase II and 87% of Phase III clinical attrition, improving predictive in vitro models has never been such a high priority.

The 3rd Annual Developing More Predictive In Vitro Models Summit will showcase a range of new platforms and technologies that address this issue directly. High potential compounds will be prioritized, toxicity mitigated and clinical strategy directed by development and validation of this new breed of in vitro models.

During research for this meeting, your peers asked for an agenda packed full with thelatest improvements in established in vitro models and exciting developments in 3D culture, stem cell and lab-on-a-chip technologies. With candid discussion on these issues guaranteed from senior level figures at the FDA,Novartis, Roche, Abbott, Pfizer and many more, this meeting will provide the most valuable strategic learning experience of the year.

Don’t miss out on this chance to go back to the lab with the tools to direct your preclinical and clinical strategy towards improved clinical performance.

**MassBio members get a 10% discount. Quote ‘MASSBIO’ when registering!**

www.invitro-models.com

High-throughput screening (HTS) of chemical libraries is a powerful and well-established method for identifying bioactive molecules for probe and therapeutic development.  However, primary screening hits rarely possess the necessary attributes for pharmacological agents, such as appropriate specificity, potency, and bioavailability.  The process of hit-to-lead maturation aims to optimize such properties and typically requires an extensive medicinal chemistry effort in conjunction with various in vitro and in vivo studies.

As academic investigators increasingly engage in HTS projects, it has become vital to promote their understanding of how primary screening positives are developed into viable pharmacological molecules.  This one-day workshop will provide a basic introduction to medicinal chemistry and preclinical development of small molecule therapeutics, as well as case studies from academic labs that have matured molecules to various stages.  The program will emphasize topics of particular relevance for academic biologists who are engaged in high-throughput chemical screens against infectious disease targets.

Confirmed speakers:

Rosemarie Aurigemma (Chief, Biodefense Drug Development Section, NIH)
Marceline Côté (Brigham and Women's Hospital)
Greg Cuny (University of Houston)
R. Kip Guy (St. Jude Children's Research Hospital)
Lizbeth Hedstrom (Brandeis University)
Edward Kerns (National Center for Advancing Translational Sciences, NIH)
Yueh-Ming Loo (University of Washington)

Registration is free but required. Space for this event may be limited, and registration does not guarantee participation in the workshop. NERCE will contact registrants by August 31, 2012 to confirm participation.

Online registration can be completed at: http://medchemworkshop.eventbrite.com.

The Stem Cells USA & Regenerative Medicine Congress is where science and business come together to advance the commercialization of stem cells and regenerative medicine. Speakers include senior director-level executives from pharmaceutical companies, biotechnology companies, government agencies, and venture capital firms.

The Stem Cells USA & Regenerative Medicine Congress is part of Terrapinn’s successful portfolio of globally renowned life science events. Terrapinn’s Stem Cells & Regenerative Medicine brand has an established track record in the USA, Europe and Asia.

Click here to register!

http://www.terrapinn.com/2012/stem-cells-usa-regenerative-medicine/index.stm

Are you a non-scientist working in or with the biotech industry?
Do you need to better understand the science & technology driving the industry?

Become more instrumental in your company's success by understanding the science and technology driving the biotech and pharmaceutical industries.  Be more strategic in your relationship-building by knowing who the industry players are and how they interact. Learn from credentialed instructors that have the skill and expertise to teach individuals with a wide variety of non-science backgrounds in an engaging environment.

Class Topics Include:

• Industry Overview
• Biology Basics
• DNA
• Gene Expression
• Genomics         
• Genetic Engineering   
• Proteomics
• Stem Cells
• Immunology
• Drug Discovery & Development

Who Will Benefit:

•     Professional from all sectors of the biotech, pharma, and life sciences industries, including: sales, marketing, HR, legal, manufacturing, business development, finance, management, government relations, IT, safety, tech transfer
•     Policy makers, lobbyists, attorneys
•     Venture capitalists, angel investors, banks, analysts, financial managers
•     Insurance brokers, real estate professionals
•     Consultants, public relations specialists, journalists
•     University administrators, research institute support staff

Fees: $1160 for MassBio Members; $1310 for non-members.

Click here to learn more & register: https://secure.massbioed.org/courses/index.php?page_function=detail&course_id=64

It is our goal to make BioPharm America 2012, the major deal making event on the East Coast and the primary event (other than the medical meetings) to showcase therapeutic and research innovation, including major clinical advancements. No host community is better positioned to do this than the Boston/Cambridge life sciences community.

BioPharm America™ is where biotech industry partnerships get started. Meet face-to-face with biotech and pharma executives from around the world to identify and enter strategic relationships. Equipped with partneringONE®, the world’s leading web-based partnering system for the life science industry, BioPharm America is the only event in North America based on the same reputable formula as EBD Group’s acclaimed European events BIO-Europe® and BIO-Europe Spring®.

Join us September 19-21 at the Westin Boston Waterfront.

 BioPharm America 2011 Highlights

• 2,550 one-to-one meetings
• 950+ delegates
• 760 licensing opportunities
• 588 companies
• 82 company presentations
• 34 countries represented
• 22 exhibitors
• 21 workshops and panels

Check out scenes from BioPharm America 2011.

Check out video highlights from BioPharm America 2011.

Profile of Participants at BioPharm America

 Learn more and register today!

Sponsorship opportunities are available. Contact lauren.laidlaw@massbio.org for more details.

Hosted by Germany Trade & Invest and MassBio

Open to MassBio members & non-members. Click here to register.

The program is organized in collaboration with BioTOP Berlin, BioM Munich – Germany’s two top clusters -- and approx. 10 companies representing these two robust clusters.

This session will offer an overview of BioTOP and BioM’s therapeutic companies, extensive research funding programs currently available and best-in-class bio manufacturing programs.

This event is complimentary and open to MassBio members and other interested individuals representing life science organizations.

Agenda:

8:00-8:30am:      Registration

8:30 -8:40am:     Welcome & Introductions by Peter Abair, Director of Economic Development & Global Affairs, MassBio and Omar Oweiss, Senior Manager, Life Sciences, Germany Trade and Invest

8:40 – 8:50am:   Overview and moderation by representative of Consulate General of Germany

8:50 – 9:20am:   BioTOP Berlin and BioM Munich

The leader of each cluster will provide an overview of the companies, capabilities and opportunities available:

• Dr. Kai Bindseil, Managing Director, BioTOP Berlin-Brandenburg and Cluster Manager for Health Capital, Germany

• Prof. Dr. Horst Domdey, Managing Director, BioM Biotech Cluster Development GmbH

9:20 – 9:35am    Success Story/Testimonial - Bio manufacturing in Germany

This session will feature several companies who are using German organizations for bio manufacturing.

Speakers to be announced shortly.

9:35 -10:15am:   Panel discussion, “German and U.S. markets – where is the industry going?”

This panel will feature both US and German biotech executives in a discussion about the current EU issues, how they relate to Germany specifically,  followed by a discussion about common issues faced by both markets, and how the German and U.S. companies can best work together.

Speakers to be announced shortly.

Biographies:

Dr. Kai Bindseil

Managing Director at BioTOP Berlin-Brandenburg and Cluster Manager for Health Capital, Germany

Dr. Kai Bindseil studied chemistry and pharmacology at Georg-August-University in Göttingen. In 1993, he wrote his doctoral thesis in bioorganic chemistry under the guidance of Prof. A. Zeeck. After a post-doctoral fellowship at Ciba-Geigy AG in Switzerland, in 1994 Dr. Bindseil moved to AnalytiCon AG in Berlin and became head of the drug discovery and development department in 1997. In 2000, he founded AnalytiCon Discovery GmbH and served as COO, overseeing drug discovery and development, as well as international business development. In 2001, Dr. Bindseil moved towards research management and became managing director of BioTOP Berlin-Brandenburg, the one-stop agency for biotechnology in the capital region of Germany. He has been responsible for the life science and health activities within the Technologiestiftung Berlin since 2007, and was appointed Cluster Manager HealthCapital Berlin Brandenburg in 2010.

Dr. Bindseil has authored more than 30 scientific papers, reviews and patents. He is the spokesman for the working council of German BioRegions and a member of the Steering Committee of the Scanbalt network, as well as the Council of European Bioregions (CEBR).

Prof. Dr. Horst Domdey

Managing Director of the BioM Biotech Cluster Development GmbH, Martinsried and Speaker of the Bavarian Biotechnology Cluster, Germany

Horst Domdey, a trained biochemist, held research positions in Germany, Switzerland and the United States before he became Professor for Biochemi-stry at the University of Munich in 1994. In the same year he co-founded MediGene, one of the first biotech companies in Germany. In 1996 he successfully led the Munich Biotech Initiative in the German Bio-Regio Competition. Since 1997 he has been the Managing Director of BioM, the cluster manage-ment organization of the Munich Biotech Cluster. From 1998 to 2008 he was also in charge of the Martinsried-based Innovation Center for Biotechnology, a thriving biotech incubator. Since 2003, he is the Scientific Manager of the Bavarian Genome Network BayGene.

He is the cofounder of BIO Deutschland, the Association of the German BioRegions as well as the Council of the European BioRegions (CEBR). Since 2006 he also manages the Bavarian Biotechnology Cluster. Under his leadership, the Munich Biotech Cluster became one of the winners of the German Leading-Edge Cluster Competition in 2010.

Event Organizing Partners

Learn about the 2012 Life Sciences Tax Incentive Program (now open). Applications can be submitted online via the Massachusetts Life Sciences Center's website. (Deadline: October 25, 2012 at noon EDT.)

The Program invests in job creation by offering tax incentives to growing companies engaged in life sciences research and development, commercialization and manufacturing in Massachusetts. The Life Sciences Initiative authorizes the Center to award up to $25 million in tax incentives each year.  Through three prior rounds, the Center has fifty-seven (57) active awards totaling $56.7 million involving companies that have created or are promising to create more than 2,000 jobs. 

Applicants are generally companies that have transitioned or are transitioning from pure life sciences research and development ("R&D") to commercialization and manufacturing. The Center recognizes that many companies struggle to address the significant capital investment associated with the long life sciences R&D cycle and the high cost of translating research into a commercially viable product. This solicitation is designed to help sustain these companies through a critical stage of development and to leverage additional sources of capital to bring cutting-edge innovation to the marketplace.

You can learn more about the Life Sciences Tax Incentive Program by visiting the Center's website.  The Center will also be offering information sessions for interested applicants throughout the state. The dates and locations of these information sessions are listed below.

• Waltham, July 31, 8:30-10:00 am, 1100 Winter Street, Center entrance, 1st floor
• Worcester, September 11, 8:30-10:00 am, Worcester Polytechnic Institute, 60 Prescott Street
• Waltham, September 13, 8:30-10:00 am,1100 Winter Street, Center entrance, 1st floor 
• Cambridge, September 14, 8:30-10:00 am, MassBio, 300 Technology Square, 8th floor 
• Waltham, October 10, 8:30-10:00 am, 1100 Winter St., Center entrance, 1st floor.

Questions about the program can be emailed to TaxProgram@masslifesciences.com.

Unprecedented growth in the BRIC markets (Brazil, Russia, India and China) has pharmaceutical companies rapidly aligning their strategies to understand what it takes to do business in these markets.             

This course will provide an overview of the regulatory history, climate, and cultural drivers in the BRIC countries and other locations such as Turkey, Mexico and key Middle Eastern states. For instance, China (SFDA) and Brazil (Anvisa) regulatory bodies were only established in 1999; however agencies are changing rapidly and collaborating with other well established regulatory bodies. The pace of change and the regulatory trends driven by actions in the BRIC states must be appreciated. These countries are issuing GMP guidances with clear national compliance expectations and are increasingly demanding pre-approval inspections of export markets to gain access.   

What You Will Learn             

You will review and appreciate the regulatory history of key emerging markets including Brazil, Russia, India, China and Turkey and Russia. The course will cover the regulatory structure in these key emerging markets and highlight approval processes for clinical and commercial product.             

You will gain insight to common issues encountered relating to regulatory and product quality. In- country testing requirements and technology transfer issues will be reviewed for each country. Inspection trends and expectations will be covered along with the role of PIC/S and ICH in guiding these agencies towards current quality management expectations.             

In addition, cultural drivers within the key emerging markets will be reviewed, including advice on business conduct based on our experience with both industry and agency leaders in these markets.

Please join us as we discuss approaches to foreign patent filings, including maximizing benefit for your legal budget, patentable subject matter, the size of biotech and pharma markets, and data exclusivity throughout the world.

Propel Careers, MassBio, and the MassBioEd have joined together to organize a series of networking and panel events focused on raising awareness of career paths that exist in life sciences for individuals with advanced degrees. This Futures in Life Science program will bring together experts across a wide range of disciplines and functional areas within the life science industry, who will detail their roles and will provide a rich context for the audience to gain a clear understanding of the skills, aptitudes, competencies, and personalities that thrive in their particular functions. 

Attendance for this program is open to current graduate students, post doctoral fellows, and medical residents who are interested in careers in the life sciences industry.  Space is limited to 100 individuals. Food and refreshments will be provided.

The event will focus on the various career options within the Bioinformatics, Systems Biology, and Modeling areas of the life sciences sector where individuals with advanced degrees can thrive.

Click here to register 

Meeting Agenda:

 5:30pm-6:00pm– Registration and Open Networking              

6:00pm-6:10pm – Introductions, Overview, and Recognition of Sponsors

6:10pm-7:30pm – Panel Discussion

7:30pm-8:00pm – Open Networking

Speakers:  TBA

To register: http://fils62012.eventbrite.com/

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *

MassBio is moving! As of April 2^nd our offices will be located at 300 Technology Square, 8^th Floor, just a few blocks across Kendall Square. Find directions online. Parking is available in the Technology Square Garage, off of Portland Street or Tech Square Drive.

Regis College

Regulatory & Clinical Research Management
Professional Advancement Courses
Fall 2012

(RA 633) Chinese Medical Device Regulation

This course introduces the student to the basics of Chinese regulations for medical devices and in-vitro diagnostic (IVD) reagents. Subjects will include product registration, quality systems, manufacturing and distribution licenses and post market surveillance regulations. The course will discuss the strategy issues in planning a China submission and the process and requirements of product approvals by the China State Food & Drug Administration (SFDA). At end of the course, students should have full understanding of the SFDA regulations for medical devices, be able to effectively plan and manage a China submission, and actively manage potential issues. The instructor, Chang-Hong Whitney, has been in the medical device industry for more than 30 years and manages a China RA firm. She will share her personal experience in managing various product registrations and clinical trials, and interactions with the SFDA, and other officials, with a unique perspective.

Who should take this course?

• Industry professionals working in the medical device and IVD fields
• Professionals whose business has been or will be expanding into emerging markets
• Graduate Students in Regulatory and Clinical Research Management

Fall 2012 Meeting Dates
Four Monday Evenings, 6pm – 9pm: September 10, 17, 24, October 1

Classes will be held in Marlborough, MA and virtual classroom access will be available

Tuition for 1 credit professional advancement courses:
$1000/course

To register for courses, or for more information, please contact:
The Office of Graduate Admission- 781.768.7330, or graduatedepartment@regiscollege.edu

Please join us for MassBio’s 18th Annual Golf Classic – to be held at the prestigious Pinehills Golf Club in Plymouth, MA! The proceeds of the tournament help support the MassBioEd Foundation—the thought leader, advocate, and invaluable resource for preparing Massachusetts’ biotechnology workforce.

In these difficult economic times, Massachusetts schools are especially challenged to find the resources to prepare teachers and adequately supply their science labs. The MassBioEd Foundation strives to close this resource gap by providing Massachusetts high school teachers the skills and equipment necessary to teach biotechnology. To date the foundation has worked with 177 high schools and trained over 500 teachers.

To continue this work MassBioEd needs your support, now, more than ever before. Please support science education by sponsoring and attending this event.

 REGISTER TODAY!

Sponsorship opportunities are available.

Contact lauren.perna@massbio.org for more information.

MassBio members, you are cordially invited to:

The Second Annual MassBio Purchasing Consortium Member Appreciation & Networking Event!

The quality of a medicine depends in no small part on the quality of its ingredients, and in particular the drug substance. Thus, the Quality Leader and other key professionals in drug product manufacture must have a thorough understanding of how the manufacture and control of drug substances and their supply chain may influence the fitness for use of the drug product. This is applicable for drug substances derived from both chemical synthesis and biological or biotechnology origins, but there are significant differences between the two.             

The need for product and process understanding is recognized by the regulators, and places the responsibility for assuring the quality of the drug substance firmly on the shoulders of the drug product manufacturers and their quality systems, with certain expectations specifically for the quality professional. This course is designed to provide you with the knowledge and understanding to fulfil your responsibilities with competence and confidence.             

Continuing discoveries in molecular biology, genetics, and process science provide the foundation for new and improved processes and products in today's biochemical process industry. The production of therapeutic proteins, which is made possible by discoveries in biotechnology, will generate sales exceeding $100 billion in 2010. In addition, biotechnology has led to marked improvement and expansion in the traditional biochemical process industry for production of enzymes, diagnostics, chemicals, pharmaceuticals, and foods. Continued introduction of new technology necessitates innovation in process development scale-up and design. As a consequence, there is the need to design new, as well as to improve existing, processes. An integral and cost intensive part of these processes is associated with downstream processing for product isolation and purification.

WHO SHOULD ATTEND

The course covers fundamental principles of downstream processing with practical examples and case studies to illustrate the problems and solutions faced by the practitioner. It is intended to provide both insight into and an overview of downstream processing for individuals actively engaged in process research and development, as well as those who manage and innovate in the biochemical process industry. Increasingly, scientists and engineers engaged in fermentation and cell culture development attend the course to better understand the context of the whole process. Attendees include:

• Engineers and scientists interested in design, economics, validation optimization and scale-up of biochemical product recovery;
• Protein biochemists and chemists involved in design of recovery processes;
• Managers responsible for biochemical process development;
• Entrepreneurs, attorneys, and business leaders wanting an overview and insight into biochemical manufacturing.

STAFF

The program is under the direction of Professor Charles L. Cooney. Lectures will be presented by:

Dr. Stuart E. Builder, Strategic Biodevelopment, Belmont, CA

Dr. Charles L. Cooney, Professor of Chemical and Biochemical Engineering at MIT

Dr. Brian D. Kelley, Vice President - BioProcess Development, Genentech, South San Francisco, CA

Dr. Daniel I.C. Wang, Institute Professor of Chemical Engineering, Department of Chemical Engineering at MIT

Dr. Inger Mollerup, Vice President, Novo Nordisk, Denmark

Mr. Jean-Francois Hamel, MIT, runs the teams projects

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Learn more about all MIT Professional Education Short Programs

http://web.mit.edu/professional/short-programs/courses_topic.html

Midsummer Nights' Science: 

Harnessing genomics to decipher fundamental differences

Stacey Gabriel, Ph.D.

Since the days of the Human Genome Project, the Broad’s Genomics Platform has harnessed DNA sequencing and genotyping technologies to illuminate similarities and differences in the strings of As, Ts, Gs & Cs found in different cells, organisms, and species. Stacey Gabriel will discuss the implications of using these techniques to compare DNA from cancerous cells to normal cells, from one person to another, and from humans to other animals.

To register, click here.

Midsummer Nights' Science  

Midsummer Nights' Science is an annual lecture series that explores key advances in genomic research. This lecture series is held each summer, and is free and open to the general public. Midsummer Nights' Science at the Broad Institute takes place at 7 Cambridge Center, in Kendall Square in Cambridge. Come experience science!

The 2012 series will run on Wednesday evenings on July 11th, 18th, 25th and August 1st from 6pm to 7pm. Space will be limited, so we ask attendees to register ahead of time. Registration instructions for the 2012 series can be found here.

For full series information click here.