Industry Regulatory Issues to be Highlighted at 2012 BIO International Convention

Posted under 2012 BIO International Convention, biosimilars, biotech regulation, Blog, Companies, Diagnostics, Events, FDA, Food and Drug Administration, Funding, Medical Devices, Medical Supply, PDUFA, Pharmaceuticals, regulation, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

In the words of BIO’s Andrew Emmett, Managing Director, Science & Regulatory Affairs, ‘2012 is shaping up to be a momentous year for FDA reform.’ From the reauthorization of the Prescription Drug User Fee Act (PDUFA V) to modernizing and expediting the approval of new drugs and biologics, implementing the new biosimilars pathways and addressing the growing global drug shortage crisis, all eyes are on the current regulatory environment and its role in supporting innovation.

The 2012 BIO International Convention will return to Boston, MA and the Boston Convention and Exhibition Center, June 18-21, 2012 and will feature a breakout session track on regulatory issues.

Attendees can expect the Achieving Regulatory Approval and Compliance educational track to feature leading Food & Drug Administration (FDA) leaders who will share their prospective priorities, senior European medical agency executives discussing international and harmonization issues as well as major biotechnology and pharmaceutical companies exploring best practices and addressing questions.

With drug development a long and costly process, speakers will also address how companies can continue to innovate and attract investor capital.

Highlights include:

FDA Town Hall

Tuesday, June 19, 2:00 p.m. – 3:30 p.m.

Speakers: Karen Midthun, MD, Director, Center for Biologics Evaluation and Research, Food and Drug Administration (FDA) and Janet Woodcock, Center for Drug Evaluation and Research, Food and Drug Administration (FDA)

PDUFA V: Impact on Innovation, Patients, and Modern Medicines – Super Session

Wednesday, June 20, 3:30 p.m. – 5:15 p.m.

Moderator: Steve Usdin, Washington Editor, BioCentury, Co-host, BioCentury This Week

Speakers: Marc Boutin, JD, Executive Vice President and Chief Operating Officer, National Health Council, Peter Greenleaf, President, MedImmune, and Margaret Hamburg, M.D., Commissioner of Food and Drug Administration (FDA)

Analysis and Impact of PDUFA V: What Regulatory Affairs Professionals Need to Know

Tuesday, June 19, 8:30 a.m. – 9:45 a.m.

Moderator:  Janet Jenkins-Showalter, Senior Regulatory Group Director, Genzyme, A Member of the Roche Group

Speakers:  Andrew Emmett, Managing Director, Science and Regulatory Affairs, Biotechnology Industry Organization, Kay Holcombe, Senior Policy Advisor, Genzyme, a Sanofi Company, and Patrick Frey, Director, Office of Planning and Analysis, Center for Drug Evaluation and Research (CDER), Food and Drug Administration

Interchangeable Biosimilars: Distinguishing between Aspiration and Achievement

Thursday, June 21, 8:30 a.m. – 9:45 a.m.

Moderator:  Ramsey Baghdadi, Senior Editor, The RPM Report

Speakers: Erika Lietzan, Special Counsel, Covington & Burling LLP, Joseph Miletich, Senior Vice President, Research and Development, Amgen, Gregory Schimizzi, Co-Founder, Carolina Arthritis, Coalition of State Rheumatology Organizations and Jan Wyatt, Patient Advocate, Arthritis Foundation

Biological Product Pediatric Development in the US: Implementation of PREA and BPCIA

Monday, June 18, 3:45 p.m. – 5:00 p.m.

Moderator: Chin Koerner, Executive Director, Novartis Pharmaceuticals

Speakers: Barbara Buch, MD, Supervisory Medical Officer, Center for Biologics and Evaluation Research, Food and Drug Administration (FDA), Sharon Olmstead, Vice President, Novartis Pharmaceuticals and Karen Weiss, Vice President, Janssen Research and Development

To learn more about the Achieving Regulatory Approval and Compliance educational track and get the most up-to-date program and speaker information, visit http://convention.bio.org/program/.

2012: A Critical Year for Biotechnology

Posted under biotech regulation, Blog, Companies, Diagnostics, economy, FDA, Food and Drug Administration, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Public Policy, regulation, Startups, therapeutics, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

In 2012, we must continue to look for ways to reduce risk; enhance reward; reduce uncertainty; and reinforce the position of the industry as a major contributor resolving society’s most pressing needs. Policies to encourage investment in innovation and to speed discovery to scientific breakthroughs simply must be the priority in 2012.

The industry relies on a policy and regulatory environment that encourages innovation for much needed treatments and cures for some of the most devastating and life threatening diseases. BIO will continue to engage with leaders in Washington to ensure that policies support an economic environment that encourages innovation and enables our members to saves lives and transform our world.

BIO has developed a comprehensive national policy strategy – Unleashing the Promise of Biotechnology – designed to incentivize investors, strengthen small business, and promote innovation in the U.S.

The creation of a 21^st century Food and Drug Administration (FDA) is critical right now. Congress must provide the FDA with the resources it needs to keep pace with rapidly evolving biomedical science and fulfill its vital health and safety mission. The FDA must recognizes its national role in advancing innovation by reviewing innovative products in a timely manner and promoting a consistent and science-based decision making process that is reflective of patient needs.

Strengthening the FDA’s review process is also a focus of our ongoing discussions with policymakers about the next renewal of the Prescription Drug User Fee Act (PDUFA V) to get back-to-basics for patients based on principles that are science-based and transparent. The review process should be well-managed to appropriately balance benefits and risks, enhance public trust, and increase patient access to new medicines.

The Therapeutic Discovery Project (TDP) program, enacted in 2010, is an example of the type of policies necessary to spur continued medical innovation, while at the same time protecting and growing high-paying U.S. jobs. The TDP program provided $1 billion in research grants and credits for small biotech companies pursuing new therapies for diseases such as Alzheimer’s, HIV/AIDs, Parkinson’s and MS. BIO is now calling on Congress and the Administration to work together to extend and expand the Therapeutic Discovery Project in early 2012 to support continued American innovation and further accelerate the development of life-saving cures.

Furthermore, current tax law does not do enough to foster investment in health care, green technology, or energy-focused biotechnology companies. Given the economic and societal benefits of ensuring a robust biotech industry, it is imperative that Congress and the Administration adopt policies that recognize the unique financial structure and capital needs of biotech companies.

Other BIO policy priorities include ensuring the National Institutes of Health has sufficient funding to sustain the public-private collaboration that is transforming biomedical discoveries into innovative treatments for patients.

In addition, along with our state affiliates, we will continue to work with states governments seeking to grow their biotech sectors as part of their economic development and job creation strategies.

The Ethics of Global Clinical Trials

Posted under bioethics, Blog, clinical trial, Companies, Diagnostics, FDA, FDA approval, Food and Drug Administration, Funding, Health, Medical Devices, Medical Supply, Pharmaceuticals, regulation, Research and Development, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

By Dr. Russell Medford, Salutria Pharmaceuticals

Recent reports have raised concerns about how clinical trials are being performed in other countries, particularly in the developing world. Even prior to these reports, some have asserted that sponsors conduct clinical trials abroad to avoid red tape and avoid overly stringent and time consuming regulatory processes. However, research done by companies with the intent of seeking FDA approval and access to the U.S. market must still meet FDA standards regardless of where the research is conducted. FDA regulations require trial sponsors to undertake several quality assurance and audit activities, and failure to abide by these rules could delay or disqualify a product’s chances of getting marketing approval.  Companies develop numerous processes to ensure compliance and protect patient safety, including:

• Pharmacovigilance conducted by experts (oftentimes hundreds of individuals in one company) who collect, analyze, follow-up, and distribute safety-related information from new drug trials.
• Establishment of data and safety monitoring boards to impartially evaluate safety as studies progress.
• Regular sponsor monitoring of clinical trial sites to ensure quality, compliance, and safety of research participants.
• Quality assurance units that audit operations associated with clinical research to ensure adherence of company personnel to regulations, guidelines, and internal and external procedures, policies, and programs.

Unethical clinical trials, however rare, tarnish the reputation of all researchers and their work. BIO members are deeply concerned about any instance of unethical clinical research, and take seriously the ethical issues involved in conducting overseas clinical trials. BIO has long supported responsible and ethical testing, protection of individual privacy and genetic information, and regulatory systems that best serve humanity and advance research into new treatments for patients, regardless of where research is conducted. Toward that end, BIO supports appropriate oversight of clinical trials and medical research, whether conducted in the U.S. or elsewhere in the world. Performing important research and protecting research subjects are mutually attainable goals, and decisions regarding whether and how to use medical products and technologies must always be made with profound respect for the rights of patients. Appropriate regulation of biotech should be solidly rooted in values such as autonomy, privacy, beneficence, social justice, and intellectual freedom. Encouraging and enabling innovation through a timely and consistent regulatory process will ultimately result in medical treatments and cures for some of the most devastating and life-threatening diseases.