Healthcare Businesswomen’s Association (HBA) Boston Chapter Presents the Healthcare Forum: Impact of Healthcare Reform on Innovation
Dynamic, multi-sector panel of Boston healthcare leaders will discuss the impact of reform on their company strategies

The Healthcare Businesswomen’s Association (HBA) Boston chapter is pleased to announce a provocative panel discussion on the impact of healthcare reform on innovation. The Forum will be held on Thursday, September 13, 2012 from 5:30 – 9:00 pm at the Langham Hotel, 250 Franklin Street, Boston. Local healthcare business leaders will discuss how reform and regulation are driving and inhibiting innovation across the spectrum of healthcare businesses in Boston. In this time of transition, these thought leaders will speak about how their organizations are using new business models, novel partnerships, and out-of-the-box thinking to change how healthcare is delivered.

Martha Bebinger, WBUR Healthcare Reporter, will moderate the panel of distinguished speakers including:

• Naomi Fried, Chief Innovation Officer, Children’s Hospital Boston
• Justine M. Carr, M.D., CMO, Steward Health Care System
• Nancy J. Gagliano, M.D., CMO, CVS MinuteClinic
• Tamima Itani, Vice President of Global Regulatory Affairs and Regulatory Compliance, Boston Scientific Corporation
• Christina Severin, President, Network Health
• Samantha Singer, Vice President of Corporate Strategy, Biogen Idec.

“This forum is designed to allow attendees to obtain new awareness of changes being driven right here in Boston in all healthcare sectors, understanding of the impact of reform on their roles and their companies,” said Keri Collette, President of the HBA Boston chapter. “The event will offer network-building opportunities as well, because we believe that this will spark stimulating dialogue both at the event and going forward.”

Register and see details of event information at www.hbanet.org/Boston.

About Healthcare Businesswomen’s Association (HBA) and the Boston chapter

Healthcare Businesswomen’s Association (HBA) is in its fourth decade as a global not-for-profit organization dedicated to furthering the advancement of women in healthcare worldwide. With 15 chapters throughout the United States and Europe, HBA provides educational opportunities for women and men to develop cutting-edge healthcare industry knowledge and leadership skills, recognizes outstanding women and men in the industry, provides opportunities for networking, creates greater visibility for women in the industry, fosters mentoring relationships and serves as a conduit and sponsor for research on career advancement issues. HBA has nearly 6,000 individual members and over 130 corporate partners, and is widely recognized as a catalyst for leadership development of women in healthcare worldwide. The Boston chapter has over 700 members and a network of over 2,000 followers. The Healthcare Forum initiates the theme of “Equipping Members for Change” that will be carried through its Boston programs for 2013.

Packaging Anti-Counterfeiting Measures (08:30 – 12:00)

This course will provide an overview of the current situation regarding counterfeit pharmaceutical products and a discussion of the use of packaging in detecting counterfeit products. It will then consider reasonable expectations for an anti-counterfeiting program, types of technologies available, where they are most appropriately used, and what types of protection the features will provide.

Packaging Component Supplier Assurance (13:00 – 16:30)

This course will first discuss key points for a packaging vendor qualification program. Secondly, it will review specific issues on printed packaging materials, including fundamental information on printing technology, leading to a discussion of the cost of errors, where errors occur, and how they may be prevented or detected. This section will include hands-on exercises to provide attendees with the knowledge to work with printed packaging vendors and respond appropriately to issues with printed materials that can potentially lead to costly recalls.

IBC’s BioProcess International Conference & Exhibition
Conference: October 8-12, 2012
Exhibition: October 9-11, 2012
Rhode Island Convention Center, Providence, RI
Event Website: http://bit.ly/MvdTx0

**Special MassBio Member Discount & Complimentary Exhibit Hall & Keynote Pass**
Mention priority code, BPI12MBC and you can save 20% off the standard conference rates or get your complimentary Exhibit Hal/Keynote Pass (Savings $150).
This discount is only available for new registrations.

Register online at: http://www.IBCLifeSciences.com/BPI or call 800.390.4078.

Experience more perspectives and strategies than any other event of its kind where every presentation has been carefully selected to offer new ideas and real-world solutions to improve your processes and overcome your most pressing challenges.

BPI is your industry resource to expand your knowledge with unparalleled access to new, unpublished data and exclusive case studies from companies of all sizes and perspectives at the most comprehensive event for those directly involved with improving the speed, cost and quality of developing and manufacturing biotherapeutics.

Join Over 1,500 of your colleagues at BioProcess International 2012 to:

• Improve Manufacturing & Development Efficiency
• Enhance Process Understanding & Quality
• Advance Cell Culture & Upstream Processing
• Streamline Recovery & Purification
• Optimize the Quality and Novelty of Your Next Generation of Biologic Drug Products
• Interact with the Largest Gathering of Industry Suppliers & Collaborators

The complete agenda can be downloaded at: http://bit.ly/OOe1vU

The Pharmaceutical Industry and the Regulatory Authorities are becoming increasingly aware of the benefits that statistical techniques can provide and the vital information that can be obtained by trend analysis. This is true in the context of ICH Q8, 9 and 10 and the 2011 FDA Guidance of Process Validation. This module is designed for delegates who have little or no experience in the application of statistical data analysis techniques.

How This Training will Benefit You             

Mathematics and Statistics represents a key element for the Quality Leader and the Technical Professional. This course provides the tools and techniques required to make informed, science and risk based decisions to benefit both the business and the patient.             

 It will provide the background and knowledge needed by every Quality Professional and Technical Leader whether in Production, Quality, R&D, Validation, Engineering, or any other technical discipline. As with all of NSF-DBA’s courses, it is led by industry and academic experts; frequently incorporating case studies and small group sessions to facilitate learning.             

NSF-DBA’s format of extended days and pre-work ensures that both you and your company benefit from the learning experience in an efficient way and with minimal time away from the workplace.             

This course on Mathematics and Statistics is based upon a key component of the Qualified Persons instruction which NSF-DBA offers in Europe. It sets a new standard for practical, results oriented instruction.             

MassBio members—say goodbye to summer and hello to fall at our Oktoberfest Open House! Join us to celebrate Oktoberfest with all the traditions of this fun event-- beer, food and music—while learning a little bit more about MassBio and meeting your fellow members.

So, besides the free beer and pretzels, why should you come?

• Find out how you can get more involved with MassBio
• Learn what MassBio can do for you
• Meet your industry peers
• Expand your network
• Meet the MassBio Purchasing Consortium vendors, and find out if you can save money on everyday supplies
• Learn what MassBio has on the horizon for 2013

Whether you are a seasoned member or new to the membership, this is a great way to be part of the MassBio community! MassBio Staff will discuss the exciting initiatives we are working on, and the many ways that YOU can take advantage our benefits. Here is your chance to find out what MassBio is all about, and get connected to the industry.

Agenda:

• 4:00pm-4:15pm—Registration
• 4:15pm-4:20pm—Introduction from Robert Coughlin, President & CEO
• 4:20pm—4:40pm—MassBio Overview from Jon Allard, Manager of Business Development
• 4:40pm—4:45pm—Wrap up
• 4:45pm—6:00pm—Reception

Already familiar with MassBio? Bring a coworker who should get involved!  

(Lederhosen not required.)

MCPHS Volunteer and Internship Fair— please join us to recruit qualified health professions students seeking internship opportunities as well as students, faculty and staff who want to volunteer with your agency or organization!

Where: Massachusetts College of Pharmacy and Health Sciences - Griffin Building, 6th Floor 

670 Huntington Avenue   Boston, MA 02115

 When:  Friday, September 21, 2012    11:00am-2:00pm

 Network with motivated students in academic programs including:

• Pharmaceutical and Healthcare Business
• Pharmaceutical Sciences
• Health Psychology
• Public Health
• Nursing
• Physician Assistant Studies
• Pre-Medical and Health Studies
• Radiologic Sciences and Nuclear Medicine
• Pharmacy & Toxicology
• Medical & Molecular Biology
• Pharmaceutical Chemistry

and more....

Light Lunch will be served

Please share this announcement with any organization you think may benefit!

This event is free to you and we encourage information exchange. 

 *MCPHS is located on the D branch of the MBTA Green Line*

 For more information, or to sign up for this event, please contact Jill Harkin at: 617.735.1526 or jill.harkin@mcphs.edu

Pepper Hamilton Life Sciences Speaker Series - Boston

The Life Sciences Speaker Series focuses on legal issues for life sciences, health care, medical device and pharmaceutical companies. Please join us for the next session of our Boston series:

Recent State and Federal Enforcement Activities - Lessons for Life Sciences Companies and Individuals Developing or Marketing Medicines or Medical Devices

Pepper partner Thomas M. Gallagher, will review recent Federal and state enforcement activity in the Life Sciences industry, focusing on a renewed effort to hold individuals liable. The enforcement authorities continue to focus on off-label promotion, but there is increased investigation related to cGMP violations and allegedly false or misleading communications to regulators, investors, or health care professionals. Companies and individuals are increasingly facing enforcement risk, this session will explore best practices companies can put in place to minimize risk and reduce potential personal exposure in this enforcement environment.

To register visit  http://www.regonline.com/Boston92512

There is no fee to attend this seminar.

For more information please contact Kim MacAlister at macalisterk@pepperlaw.com or 215.981.4249

The Consumer Genetics Conference (CGC) covers the key issues facing clinical genetics, personalized medicine, molecular diagnostics, and consumer-targeted DNA applications. It provides a unique outlet where all voices can be heard: pro & con, physician & consumer, research & clinical, academic & corporate, financial & regulatory. CGC is more than just another personalized medicine conference. 

The objectives of the symposium are:

• to discuss and share experiences of SBV IMPROVER and the Diagnostic Signature Challenge
• to engage with experts in the fields of system biology, crowd-sourcing and related topics
• to present awards to each of the best performing teams

In addition, the award winners will share their approaches with the scientific community.

Key Note Speakers include:

• Dr. Donna L. Mendrick, Director, Division of Systems Biology, NCTR/FDA
• Prof. John Quackenbush, Prof. of Computational Biology & Bioinformatics, Dana-Farber Cancer Institute
• Dr. Birgit Schoeberl, Vice President of Discovery, Merrimack Pharmaceuticals.

Please Note: There is no registration fee. Click here to register.

http://www.sbvimprover.com
http://www.sbvimprover.com/symposia/list
http://sbvimprover.com/upload/symposium_registration/symposium_registration.php

 
The SBV Improver Project, the sbvimprover website, and the Symposium are part of a collaborative project designed to enable scientists to learn about and contribute to the development of a new crowd sourcing method for verification of scientific data and results. The project team includes scientists from Philip Morris International's Research and Development department and IBM's Thomas J. Watson Research Center. The project is funded by PMI.

The GHS is OSHA’s newly mandated system for standardizing and harmonizing the classification and labeling of chemicals. Ms. Jean Manoli, a Training Specialist with the OSHA Consultation Program - MA Department of Labor Standards, will discuss the new requirements and how they could impact SEF members.  Ms. Manoli was also a former U.S. OSHA Assistant Area Director for 10 years and has presented at a previous SEF meeting.  Following the presentation, as time allows, we will have an open discussion on impacts, challenges, and best management practices for complying with the new GHS requirements. 

On Monday, August 6, 2012, the U.S. Small Business Administration (SBA) published in the Federal Register amendments to the Small Business Innovation Research (SBIR) and Small Business Technology Transfer Program (STTR) Policy Directives.  On behalf of Dr. Winslow Sargeant, Chief Counsel for the Office of Advocacy, Small Business Administration, it is my pleasure to extend an invitation to you to join us for an Office of Advocacy roundtable to discuss this new SBA SBIR Directive.  The roundtable will be held in the SBA Eisenhower Conference Room, second floor of the SBA Headquarters, 409 3rd Street SW, Washington DC 20416, on September 12th from 2 until 4 pm. 

This roundtable is open to all interested parties and it is free.  Because the SBA headquarters is in a federal building we ask that you RSVP if you plan to attend. This will help us help you get through security in a timely manner.  Please send your response to angela.hamilton@sba.gov.

The entire directive may be viewed at: Federal Register Volume 77, Number 151 (Monday, August 6, 2012), pages 46805-46855. These amendments implement provisions of the National Defense Authorization Act for Fiscal Year 2012. The Defense Authorization Act contained the SBIR/STTR Reauthorization Act of 2011 (Reauthorization Act), which made several key changes to the programs relating to eligibility, the SBIR award process, program administration, fraud, waste and abuse.

Model-Based Drug Development in Multiple Sclerosis:
Integrating Disease, Drug and Market Data for Improved Decision Making

Date & Time:
Wednesday, September 12, 2012 - 11 am EDT

Presenter:
Francois Mercier, Ph.D., Senior Scientist, Pharsight Consulting Services

Webinar Description:
The benefits of model-based drug development have been well demonstrated by FDA and industry sponsors. This webinar will cover the strategic use and value of modeling and simulation as a tool to integrate and rationalize data, knowledge, and expertise in Multiple Sclerosis (MS), taking sphingosine 1-phosphate receptor (S1Pr) modulators as a case study.

Please take 5 minutes to complete the IP committee's very short membership survey. We are seeking your suggestions and feedback on proposed program topics for year.

https://www.surveymonkey.com/s/IPFallsurvey

Finding Business Value in Global Patent Portfolios

MassBio will host a panel discussion with area intellectual property counsel to discuss strategies for foreign patent filing strategies on September 12, 2012.  Where to file, tips for reducing cost and administration in patent filings, and strategies for obtaining and maintaining patent protection outside the US will be among the topics discussed at this event.  

Business strategies often include obtaining patent coverage in multiple countries. However, the costs of obtaining and maintaining patent protection in multiple jurisdictions can be significant. In addition, patent applicants face deadlines for deciding when to pursue patent coverage in individual countries. The result can be a need for patent applicants to weigh the cost of pursuing patent protection in one or more countries against an uncertain future benefit of pursuing such patent protection.

Panelists:

• Deborah Miller (Director, Intellectual Property, Infinity Pharmaceuticals)
• Jennifer Sieczkiewicz (Associate General Counsel, Intellectual Property, Biogen Idec)
• David Resnick (Co-Leader of the Patents Practice Group, Nixon Peabody)

Discussion Topics:

Our panel will address topics with opportunities for audience discussion and questions, including:  

• Understanding when patent filing decision points occur (e.g., 1 year and 30 months after initial filing in many cases)
• The timing, cause and estimated scope of costs for foreign filing (e.g., filing fees, attorney fees, foreign agent fees, excess claim fees, examination fees, translation costs, validation and maintenance fees and the like)
• Types of business considerations that can influence foreign filing decisions (e.g., How are filing decisions made and re-evaluated within an organization? What types of questions should clients be asking their business partners and outside counsel to inform their foreign filing strategy?).

Speaker Bios

Jen Zarutskie Sieczkiewicz has been Associate General Counsel, IP at BiogenIdec since 2010, where she is responsible for intellectual property management of several key neurology and immunology programs.  Prior to joining BIIB, she was Director of IP at Dyax Corp. from 2007 to 2010.  She received her J.D. from Boston University Law School, her Ph.D., in Biological Chemistry from the Massachusetts Institute of Technology, and her A.B. in Chemistry from Bryn Mawr College.  Before moving in-house, she was an associate at Foley Hoag LLP, and Goodwin Procter LLP, both in Boston, MA.

Deborah Miller leads the intellectual property group at Infinity Pharmaceuticals Inc., an innovative drug discovery and development company in Cambridge, Massachusetts.  Prior to joining Infinity in 2010, Deborah worked as corporate patent counsel at Sunovion Pharmaceuticals Inc. (formerly Sepracor Inc.), where she helped manage various patent litigations including a multiparty ANDA litigation.  Deborah began her legal career as a technical specialist/patent agent at the Boston law firm, Nutter McClennen & Fish LLP, where she spent nearly seven years in the intellectual property and life sciences groups.   Deborah has received recognition as a leading IP practitioner and was named as one of the “2012 In-House Leaders in the Law “ by Massachusetts Lawyers Weekly.  Deborah earned her J.D. from Suffolk University, a Ph.D. in biochemistry and molecular pharmacology from Harvard University, an M.M.Sc. from Harvard Medical School, and a B.A. in chemistry from Swarthmore College. 

David Resnick is the co-leader of the Patents practice group at Nixon Peabody. His practice is focused on patent prosecution and overall portfolio management, transactional matters, and associated client counseling. David represents, and manages the portfolios of, some of the leading academic research institutions in the U.S., as well as some of the world’s most recognized life science companies. He has extensive experience in the life sciences and is widely regarded as a thought leader in the area of personalized medicine, particularly with respect to pharmacogenomics, proteomics, and disease biomarkers, and their application in the field of personalized medicine.

Emerging Business Trends in Biomedicine

Co-Sponsored by HBS Healthcare Alumni & Pfizer

Event Co-Chairs

• Jose-Carlos Gutierrez-Ramos, PhD, SVP R&D, Biotherapeutics, Pfizer
• Wolfgang Klietmann, MD, Lecturer on Pathology, Harvard Medical School

REGISTER NOW

AGENDA

Overview:

In the recent past pharmaceutical companies have been forging new relationships with academic institutions with the goals of spurring innovation in drug development and reversing pipeline attrition. Academic research labs posssess a repository of experience not existing in the pharmaceutical industry laboratories. However, bringing a new compound to market (which can take over a decade and cost + $1 billion) needs the collaboration of both academia and industry: specifically the R&D resources, manufacturing experience, and financing power of big pharma.

The symposium will explore the complexities of this process from scientific discovery through commercialization as well as provide a forum for a dialogue regarding the challenges of the entire industry. In specific we will explore how Pfizer's unique CTI (Centers of Therapeutic Innovation) model creates an amalgamated new collaboration between scientists from academia and industry that will assist all collaborators to better understand the disruptive changes in the drug-developing industry, and how to work together productively for the future.

Logistics:

    Date:  Monday, September 10, 2012
    Time:  8:00am - 6:00pm
    Venue:  Joseph P. Martin Conference Center, Harvard Medical School
    Cost:  $295

http://www.hbshealthalumni.org/article.html?aid=615

North Shore Technology Council First Friday Bioscience Seminar Series:

TripleMap: Next Generation Semantic Search & Analytics for Big Data

Join scientists and executives from local biomedical companies for the North Shore Technology Council’s First Friday Bioscience seminar series, sponsored by the Biosciences Group. In this informal venue you will meet industry peers, learn about  the science behind area biomedical companies, and hear how they tackle business challenges. You’ll also connect with other scientists and executives and become part of a community of business neighbors who are committed to accelerating the growth of their companies and the region biomedical business sector.

Speaker:

• Christopher Bouton, Ph.D., CEO of Entagen, LLC

Dr. Bouton will describe semantic technology approaches to address search, visualization, analytics and collaboration can create dynamic knowledge maps. Knowledge maps provide users, such as biologists, chemists, patent attorneys, market analysts, and clinical trial specialists, a “bird’s eye view” of patterns of interconnection between entities of interest. Dr. Bouton holds the position of CEO at Entagen, LLC (http://www.entagen.com), a biotechnology company that provides computational research in data analytics and bioinformatics, analysis and custom software development services for biomedicalorganizations.
 
Cost for members and nonmembers: Thanks to our host, Laureate Biopharma, this event is FREE for NSTC members and affiliates; $10 for all others. Light refreshments served.

Please register in advance at www.NSTC.org. For more information, email FirstFridayBiosci@nstc.org

Host: Laureate Biopharma, http://www.lbios.com/, is a leader in biopharmaceutical contract development and manufacturing. Their scientists are expert in process development and cGMP production of therapeutic proteins, including monoclonal antibodies and Fc-fusion proteins. In addition, the portfolio of services includes aseptic filling, cell line development, analytical and stability testing, and regulatory support. Laureate has served a global client base since 1981. Laureate is a portfolio company of Saints Capital, LLC.
 

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

Packaging Anti-Counterfeiting Measures (08:30 – 12:00)

This course will provide an overview of the current situation regarding counterfeit pharmaceutical products and a discussion of the use of packaging in detecting counterfeit products. It will then consider reasonable expectations for an anti-counterfeiting program, types of technologies available, where they are most appropriately used, and what types of protection the features will provide.

Packaging Component Supplier Assurance (13:00 – 16:30)

This course will first discuss key points for a packaging vendor qualification program. Secondly, it will review specific issues on printed packaging materials, including fundamental information on printing technology, leading to a discussion of the cost of errors, where errors occur, and how they may be prevented or detected. This section will include hands-on exercises to provide attendees with the knowledge to work with printed packaging vendors and respond appropriately to issues with printed materials that can potentially lead to costly recalls.

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