1. SAFE-BioPharma Association Blocking the Big Breach SCOPE Summit 2016 Mollie Shields Uehling SAFE-BioPharma Association

2. Life Science and Healthcare: Rich Targets for Cyber-Criminals and Cyber-Spies Current: 2015: Year of the Healthcare Breach –Healthcare #1 target –Over 100 million health records compromised; 34% of all records –Credit card info brings $2-4 on the dark net; health record ~$50 Certain nation states targeting commercial innovation – pharma a leading target Coming Attractions: IOT (Internet of Things) –4.5b connected things on the internet in 2015; 30% increase over 2014. –Expected to reach 25b by 2020. Sharing Mobile Cloud 2 SAFE-BioPharma Association

3. Why the Need for Standardized Identity Trust On-Line? Leading reasons for breaches: –physical loss of devices –internal threats –weak security controls –operating system and application vulnerabilities –malicious attacks 2 out of every 3 breaches from hijacked user/names and passwords OPM (21m records), Anthem (80m), IRS (104K) breaches caused by hijacked administrator user name/passwords. Addressing attacks: Encryption, segregate data, privilege, multiple security layers Strong Authentication: Over one-half of all breaches could have been prevented by strong authentication 3 SAFE-BioPharma Association

4. The SAFE-BioPharma Digital Identity and Signature Standard 2005, leading pharma firms created the SAFE-BioPharma standard to provide community with standardized identity trust and, where required, digital signatures –Authentication credentials – trust in who is accessing portals, applications, sensitive information –Digital signing credentials – uniquely links on-line identity to digital signature (EMA, DEA, FDA) SAFE-BioPharma –maintains and evolves the global standard –certifies commercial providers, products and applications –works with policy and regulatory authorities –serves as a collaborative community for shared use cases and best practices 4 SAFE-BioPharma Association

5. Standardized, Trusted Identities and Signatures Protecting IP, PHI, and Securing Free Flow of Information Pfizer’s global discovery collaboration – digital signatures Merck’s Engage Zone – collaborative site for all external partnerships –TransCelerate single sign on via a SAFE-BioPharma compliant digital identity ACRES (Alliance for Clinical Research Excellence and Safety) Apollo Platform 5 SAFE-BioPharma Association

6. 6 Please visit the SAFE-BioPharma website: http://safe-biopharma.org/ http://safe-biopharma.org/ Please visit the 4BF website: http://www.the4bf.com/ Watch the SAFE-BioPharma introductory video: http://www.safe-biopharma.org/video.htm Contact us for more information: Mollie Shields Uehling CEO mollie@safe-biopharma.org (703) 821-7927 (201) 925-2173 (cell) Gary Wilson Prog. Mgr (781) 962-3172 Gwilson@safe- biopharma.org Jon Weisberg Communications 801-359-9977 o 801-860-9977 m jweisberg@safe-biopharma.org Gary Secrest, CTO Gsecrest@safe- biopharma.org (609) 306-5560 Peter Alterman, COO Palterman@safe- biopharma.org (301) 943-7452 Betsy Fallen Global Programs and Marketing (610) 716-3271 Bfallen@SAFE-BioPharma.org